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

    PubMed Central

    Abdalla, W; Elgendy, M; Abdelaziz, AA; Ammar, MA

    2016-01-01

    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. PMID:27375379

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

    PubMed Central

    Toscano, I. L.; Rezende, M.V.; Mello, L. F.; Pires, L.; Paulillo, D.; Glina, S.

    2016-01-01

    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. PMID:24893912

  3. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial.

    PubMed

    Li, Tsung-Ying; Chang, Chih-Ya; Chou, Yu-Ching; Chen, Liang-Cheng; Chu, Heng-Yi; Chiang, Shang-Lin; Chang, Shin-Tsu; Wu, Yung-Tsan

    2016-05-01

    Recently, studies have reported that extracorporeal shock wave therapy (ESWT) is a safe, noninvasive, alternative treatment for spasticity. However, the effect of ESWT on spasticity cannot be determined, because most studies to date have enrolled small patient numbers and have lacked placebo-controlled groups and/or long-term follow-up. In addition, whether varying the number of ESWT sessions would affect the duration of the therapeutic effect has not been investigated in a single study. Hence, we performed a prospective, randomized, single blind, placebo-controlled study to investigate the long-term effect of radial ESWT (rESWT) in patients with poststroke spasticity and surveyed the outcome of functional activity.Sixty patients were randomized into 3 groups. Group A patients received 1 session of rESWT per week for 3 consecutive weeks; group B patients received a single session of rESWT; group C patients received one session of sham rESWT per week for 3 consecutive weeks. The primary outcome was Modified Ashworth Scale of hand and wrist, whereas the secondary outcomes were Fugl-Meyer Assessment of hand function and wrist control. Evaluations were performed before the first rESWT treatment and immediately 1, 4, 8, 12, and 16 weeks after the last session of rESWT.Compared to the control group, the significant reduction in spasticity of hand and wrist lasted at least 16 and 8 weeks in group A and B, respectively. Three sessions of rESWT had a longer-lasting effect than one session. Furthermore, the reduction in spasticity after 3 sessions of rESWT may be beneficial for hand function and wrist control and the effect was maintained for 16 and 12 weeks, respectively.rESWT may be valuable in decreasing spasticity of the hand and wrist with accompanying enhancement of wrist control and hand function in chronic stroke patients.

  4. Comparison of Nerve Stimulation-guided Axillary Brachial Plexus Block, Single Injection versus Four Injections: A Prospective Randomized Double-blind Study

    PubMed Central

    Badiger, Santoshi V.; Desai, Sameer N.

    2017-01-01

    Background: A variety of techniques have been described for the axillary block using nerve stimulator, either with single injection, two, three, or four separate injections. Identification of all the four nerves is more difficult and time-consuming than other methods. Aims: Aim of the present study is to compare success rate, onset, and duration of sensory and motor anesthesia of axillary block using nerve stimulator, either with single injection after identification of any one of the four nerves or four separate injections following identification of each of nerve. Setting and Design: Prospective, randomized, double-blind study. Patients undergoing forearm and hand surgeries under axillary block. Methodology: One hundred patients, aged 18–75 years, were randomly allocated into two groups of 50 each. Axillary block was performed under the guidance of nerve stimulator with a mixture of 18 ml of 1.5% lignocaine and 18 ml of 0.5% bupivacaine. In the first group (n = 50), all 36 ml of local anesthetic was injected after the identification of motor response to any one of the nerves and in Group 2, all the four nerves were identified by the motor response, and 9 ml of local anesthetic was injected at each of the nerves. The success rate of the block, onset, and duration of sensory and motor block was assessed. Statistical Analysis: Categorical variables were compared using the Chi-square test, and continuous variables were compared using independent t-test. Results: The success rate of the block with four injection technique was higher compared to single-injection technique (84% vs. 56%, P = 0.02). Four injection groups had a faster onset of sensory and motor block and prolonged duration of analgesia compared to single-injection group (P < 0.001). There were no significant differences in the incidence of accidental arterial puncture and hemodynamic parameter between the groups. Conclusion: Identification of all the four nerves produced higher success rate and better

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

    PubMed Central

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

    2017-01-01

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

  6. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet—NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial

    PubMed Central

    Balayssac, David; Ferrier, Jérémy; Pereira, Bruno; Gillet, Brigitte; Pétorin, Caroline; Vein, Julie; Libert, Frédéric; Eschalier, Alain; Pezet, Denis

    2015-01-01

    Introduction Oxaliplatin remains the most widely used chemotherapeutic agent for treating advanced colorectal cancer but its efficacy is hampered by dose-limiting neurotoxicity manifested by a painful polyneuropathy. Oxaliplatin-induced peripheral neuropathy (OIPN) is characterised by acute and transient cold hyperaesthesia in the hours and days following oxaliplatin infusion (>90% of patients), but also by retarded chronic neuropathy due to the repetition of chemotherapy cycles (30–50% of patients). OIPN impairs the health-related quality of life (HRQOL) of patients and no preventive or curative strategies have as yet proven effective. A polyamine-reduced diet (PRD) has recently demonstrated its efficacy to prevent OIPN in animals without adverse effects. Methods and analysis The NEUROXAPOL trial is a prospective, randomised, controlled, single-blind, monocentric and interventional study. This trial is aimed at evaluating the efficacy and feasibility of a PRD compared to a normal polyamine containing diet to prevent OIPN in patients treated by oxaliplatin-based chemotherapy. Patients (n=40 per group) will be randomly assigned to receive either a PRD or a normal diet before and during the chemotherapy regimen. The main objectives are to improve the cold pain thresholds, neuropathic pain symptoms, comorbidities (anxiety and depression) and HRQOL of patients. The primary end point is the assessment of cold pain thresholds 2 weeks after the third cycle of chemotherapy. The secondary end points are the evaluation of thermal pain thresholds, the grade of neuropathy, neuropathic pain, symptoms of anxiety and depression and HRQOL, until the 12th cycle of chemotherapy. Ethics and dissemination The study was approved by an independent medical ethics committee 1 (CPP Sud Est 1, Saint Etienne, France) and registered by the competent French authority (ANSM, Saint Denis, France). The results will be disseminated in a peer-reviewed journal and presented at international

  7. A Prospective, Multicenter, Single-Blind Study Assessing Indices of SNAP II Versus BIS VISTA on Surgical Patients Undergoing General Anesthesia

    PubMed Central

    Bergese, Sergio D; Puente, Erika G; Marcus, R-Jay L; Krohn, Randall J; Docsa, Steven; Soto, Roy G; Candiotti, Keith A

    2017-01-01

    Background Traditionally, anesthesiologists have relied on nonspecific subjective and objective physical signs to assess patients’ comfort level and depth of anesthesia. Commercial development of electrical monitors, which use low- and high-frequency electroencephalogram (EEG) signals, have been developed to enhance the assessment of patients’ level of consciousness. Multiple studies have shown that monitoring patients’ consciousness levels can help in reducing drug consumption, anesthesia-related adverse events, and recovery time. This clinical study will provide information by simultaneously comparing the performance of the SNAP II (a single-channel EEG device) and the bispectral index (BIS) VISTA (a dual-channel EEG device) by assessing their efficacy in monitoring different anesthetic states in patients undergoing general anesthesia. Objective The primary objective of this study is to establish the range of index values for the SNAP II corresponding to each anesthetic state (preinduction, loss of response, maintenance, first purposeful response, and extubation). The secondary objectives will assess the range of index values for BIS VISTA corresponding to each anesthetic state compared to published BIS VISTA range information, and estimate the area under the curve, sensitivity, and specificity for both devices. Methods This is a multicenter, prospective, double-arm, parallel assignment, single-blind study involving patients undergoing elective surgery that requires general anesthesia. The study will include 40 patients and will be conducted at the following sites: The Ohio State University Medical Center (Columbus, OH); Northwestern University Prentice Women's Hospital (Chicago, IL); and University of Miami Jackson Memorial Hospital (Miami, FL). The study will assess the predictive value of SNAP II versus BIS VISTA indices at various anesthetic states in patients undergoing general anesthesia (preinduction, loss of response, maintenance, first purposeful

  8. The dose-dependent efficiency of radial shock wave therapy for patients with carpal tunnel syndrome: a prospective, randomized, single-blind, placebo-controlled trial.

    PubMed

    Ke, Ming-Jen; Chen, Liang-Cheng; Chou, Yu-Ching; Li, Tsung-Ying; Chu, Heng-Yi; Tsai, Chia-Kuang; Wu, Yung-Tsan

    2016-12-02

    Recently, extracorporeal shock wave therapy (ESWT) has been shown to be a novel therapy for carpal tunnel syndrome (CTS). However, previous studies did not examine the diverse effects of different-session ESWT for different-grades CTS. Thus, we conducted a randomized, single-blind, placebo-controlled study. Sixty-nine patients (90 wrists) with mild to moderate CTS were randomized into 3 groups. Group A and C patients received one session of radial ESWT (rESWT) and sham eESWT per week for 3 consecutive weeks, respectively; Group B patients received a single session of rESWT. The night splint was also used in all patients. The primary outcome was Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) points, whereas secondary outcomes included the sensory nerve conduction velocity and cross-sectional area of the median nerve. Evaluations were performed at 4, 10, and 14 weeks after the first session of rESWT. Compared to the control group, the three-session rESWT group demonstrated significant BCTQ point reductions at least 14 weeks, and the effect was much longer lasting in patients with moderate CTS than mild CTS. In contrast, the effect of single-session rESWT showed insignificant comparison. rESWT is a valuable strategy for treating CTS and multiple-session rESWT has a clinically cumulative effect.

  9. The dose-dependent efficiency of radial shock wave therapy for patients with carpal tunnel syndrome: a prospective, randomized, single-blind, placebo-controlled trial

    PubMed Central

    Ke, Ming-Jen; Chen, Liang-Cheng; Chou, Yu-Ching; Li, Tsung-Ying; Chu, Heng-Yi; Tsai, Chia-Kuang; Wu, Yung-Tsan

    2016-01-01

    Recently, extracorporeal shock wave therapy (ESWT) has been shown to be a novel therapy for carpal tunnel syndrome (CTS). However, previous studies did not examine the diverse effects of different-session ESWT for different-grades CTS. Thus, we conducted a randomized, single-blind, placebo-controlled study. Sixty-nine patients (90 wrists) with mild to moderate CTS were randomized into 3 groups. Group A and C patients received one session of radial ESWT (rESWT) and sham eESWT per week for 3 consecutive weeks, respectively; Group B patients received a single session of rESWT. The night splint was also used in all patients. The primary outcome was Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) points, whereas secondary outcomes included the sensory nerve conduction velocity and cross-sectional area of the median nerve. Evaluations were performed at 4, 10, and 14 weeks after the first session of rESWT. Compared to the control group, the three-session rESWT group demonstrated significant BCTQ point reductions at least 14 weeks, and the effect was much longer lasting in patients with moderate CTS than mild CTS. In contrast, the effect of single-session rESWT showed insignificant comparison. rESWT is a valuable strategy for treating CTS and multiple-session rESWT has a clinically cumulative effect. PMID:27910920

  10. Comparisons of single-injection thoracic paravertebral block with ropivacaine and bupivacaine in breast cancer surgery: A prospective, randomized, double-blinded study

    PubMed Central

    Sahu, Ashutosh; Kumar, Rajnish; Hussain, Mumtaz; Gupta, Ajit; Raghwendra, K. H.

    2016-01-01

    Background: Regional anesthesia using paravertebral block has been suggested as an ideal adjunct to general anesthesia for modified radical mastectomy. Paravertebral block is an effective management of peri-operative pain for Modified radical mastectomy, however, there are no established guidelines regarding what is the most suitable strategy when varying drugs and dosages between different groups. Aim: To evaluate the effectiveness of paravertebral block comparing the most frequently employed drugs in this procedure (bupivacaine vs ropivacaine). Study Design: Prospective randomized double blind study. Methods: A total 70 ASA I and II adult female patients undergoing Modified radical mastectomy under paravertebral block followed by general anesthesia were randomly divided into two groups. The first group was administered 0.375% Ropivacaine in a dose 0.25 ml /kg in paravertebral block. The second group was administered bupivacaine 0.375% in dose 0.25 ml /kg in paravertebral block. Standard induction technique followed. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), were recorded pre block, post block 5 min, post block 10 min, at skin incision, post skin incision initially at 5 interval for first 15 min till one hour, and every 30 min till end of surgery. Post-operative visual analogue score for pain was recorded at 1 hr, 6 hr and 24 hr. Statistical Analysis: Chi-square test (Fisher's exact test) for qualitative variables. Independent sample t-test for quantitative data. Results: Ropivacaine and Bupivacaine had no difference in intraoperative analgesia as shown by intraoperative hemodynamic parameters. Bupivacaine got better post-operative VAS scores (P < 0.05) in mean and after first, 6 h and 24 h. PMID:27746568

  11. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial.

    PubMed

    Wu, Yung-Tsan; Ho, Tsung-Yen; Chou, Yu-Ching; Ke, Ming-Jen; Li, Tsung-Ying; Huang, Guo-Shu; Chen, Liang-Cheng

    2017-12-01

    Recently, a few small reports with short follow-up period have shown clinical benefits of platelet-rich plasma (PRP) for peripheral neuropathy including one pilot study and one small, non-randomized trial in patients with carpal tunnel syndrome (CTS). Therefore, we conducted a randomized, single-blind, controlled trial to assess the 6-month effect of PRP in patients with CTS. Sixty patients with unilateral mild-to-moderate CTS were randomized into two groups of 30, namely the PRP and control groups. In the PRP group, patients were injected with one dose of 3 mL of PRP using ultrasound guidance and the control group received a night splint through the study period. The primary outcome measure was the visual analog scale (VAS) and secondary outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score, the cross-sectional area (CSA) of the median nerve (MN), electrophysiological findings of the MN, and finger pinch strength. The evaluation was performed before treatment and at 1, 3, and 6 months post-injection. The PRP group exhibited a significant reduction in the VAS score, BCTQ score, and CSA of MN compared to the those of control group 6 months post-treatment (p < 0.05). Our study demonstrates that PRP is a safe modality that effectively relieves pain and improves disability in the patients with CTS.

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

    PubMed

    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.

  13. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study.

    PubMed

    Lee, Jin Young; Park, Yongbum; Park, Ki Deok; Lee, Ju Kang; Lim, Oh Kyung

    2014-12-01

    The objective of this study is to evaluate the degree of symptom improvement and the change of electrophysiological and ultrasonographic findings after sonographically guided local steroid injection using an in-plane ulnar approach in carpal tunnel syndrome (CTS). Seventy-five cases of 44 patients diagnosed with CTS were included and evaluated at baseline and at 4 and 12 weeks after injection. All patients received injection with 40 mg of triamcinolone mixed with 1 mL of 1% lidocaine into the carpal tunnel using an in-plane Ultrasound (US)-guided ulnar approach, out-plane US-guided approach, and blind injection. For clinical evaluation, we used the Boston Carpal Tunnel Questionnaire (BCTQ) and electrophysiological tests. The ultrasonographic findings were also evaluated with regard to cross-sectional area and the flattening ratio of the median nerve. Subjective symptoms measured by BCTQ and median nerve conduction parameters showed significant improvement at 4 weeks in the in-plane ulnar approach group compared with the out-plane ulnar approach and blind injection. This improvement was still observed at 12 weeks. The flattening ratio and cross-sectional area of the median nerve showed a more significant decrease with the in-plane ulnar approach than with the out-plane ulnar approach and blind injection (P < 0.05). US-guided local steroid injection using an in-plane ulnar approach in the CTS may be more effective than out-plane or blind injection.

  14. A prospective, single-blind, multicenter, dose escalation study of intracoronary iNOS lipoplex (CAR-MP583) gene therapy for the prevention of restenosis in patients with de novo or restenotic coronary artery lesion (REGENT I extension).

    PubMed

    von der Leyen, Heiko E; Mügge, Andreas; Hanefeld, Christoph; Hamm, Christian W; Rau, Mathias; Rupprecht, Hans J; Zeiher, Andreas M; Fichtlscherer, Stephan

    2011-08-01

    Neointimal hyperplasia causing recurrent stenosis is a limitation of the clinical utility of percutaneous transluminal coronary interventions (PCI). Nitric oxide (NO) inhibits smooth muscle cell proliferation, platelet activation, and inflammatory responses, all of which have been implicated in the pathogenesis of restenosis. In animals, neointimal proliferation after balloon injury has been shown to be effectively reduced by gene transfer of the inducible NO synthase (iNOS). The primary objective of this first multicenter, prospective, single-blind, dose escalation study was to obtain safety and tolerability information of the iNOS lipoplex (CAR-MP583) gene therapy for reducing restenosis following PCI. Local coronary intramural CAR-MP583 delivery was achieved using the Infiltrator balloon catheter. A total of 30 patients were treated in the study (six patients, 0.5 μg; six patients, 2.0 μg; six patients, 5.0 μg; and 12 patients, 10 μg). There were no complications related to local application of CAR-MP583. In one patient, PCI procedure-related transient vessel occlusion occurred with consecutive troponin elevation. There were no signs of inflammatory responses or hepatic or renal toxicity. No dose relationship was seen with regard to adverse events across the dose groups. Thus, coronary intramural lipoplex-enhanced iNOS gene therapy during PCI is feasible and appears to be safe. These initial clinical results are encouraging to support further clinical research, in particular in conjunction with new local drug delivery technologies.

  15. The comparison of the effects of three physiotherapy techniques on hamstring flexibility in children: a prospective, randomized, single-blind study.

    PubMed

    Czaprowski, Dariusz; Leszczewska, Justyna; Kolwicz, Aleksandra; Pawłowska, Paulina; Kędra, Agnieszka; Janusz, Piotr; Kotwicki, Tomasz

    2013-01-01

    The aim of the study was to evaluate changes in hamstring flexibility in 120 asymptomatic children who participated in a 6-week program consisting of one physiotherapy session per week and daily home exercises. The recruitment criteria included age (10-13 years), no pain, injury or musculoskeletal disorder throughout the previous year, physical activity limited to school sport. Subjects were randomly assigned to one of the three groups: (1) post-isometric relaxation - PIR (n = 40), (2) static stretch combined with stabilizing exercises - SS (n = 40) and (3) stabilizing exercises - SE (n = 40). Hamstring flexibility was assessed with straight leg raise (SLR), popliteal angle (PA) and finger-to-floor (FTF) tests. The examinations were conducted by blinded observers twice, prior to the program and a week after the last session with the physiotherapist. Twenty-six children who did not participate in all six exercise sessions with physiotherapists were excluded from the analysis. The results obtained by 94 children were analyzed (PIR, n = 32; SS, n = 31; SE, n = 31). In the PIR and SS groups, a significant (P<0.01) increase in SLR, PA, FTF results was observed. In the SE group, a significant (P<0.001) increase was observed in the SLR but not in the PA and FTF (P>0.05). SLR result in the PIR and SS groups was significantly (P<0.001) higher than in the SE group. As far as PA results are concerned, a significant difference was observed only between the SS and SE groups (P = 0.014). There were no significant (P = 0.15) differences regarding FTF results between the three groups. Post-isometric muscle relaxation and static stretch with stabilizing exercises led to a similar increase in hamstring flexibility and trunk forward bend in healthy 10-13-year-old children. The exercises limited to straightening gluteus maximus improved the SLR result, but did not change the PA and FTF results.

  16. Efficacy of botulinum toxin type B for the treatment of primary palmar hyperhidrosis: a prospective, open, single-blind, multi-centre study.

    PubMed

    Basciani, Mario; Di Rienzo, Filomena; Bizzarrini, Massimo; Zanchi, Malvina; Copetti, Massimiliano; Intiso, Domenico

    2014-07-01

    Primary palmar hyperhidrosis is a distressing and disabling condition that can produce social, psychological and occupational problems. Although the use of botulinum toxin type A (BoNT-A) has been reported as an efficacious and safe intervention to improve palmar hyperhidrosis, only one study concerned botulinum toxin type B (BoNT-B) in this disorder. The aim of study was to evaluate the efficacy and safety of BoNT-B in treating primary palmar hyperhidrosis. Participants were injected with 5,000 IU of BoNT-B in each palm. Visual analogue test (VAS) to evaluate the intensity of decrease in sweat production, Minor's iodine starch test and measurement of paper towels' weight were used to ascertain palmar sweating at baseline, 4, 12 and 24 weeks after BoNT-B injections by a blind examiner. Thirty-two subjects (12 males, 20 females, mean age 31 ± 11) were enrolled. Significant reduction of palmar sweating was detected after BoNT-B injection: 2.9 ± 1.4, 0.3 ± 0.4, 0.9 ± 0.8, and 2.1 ± 1.5 g (p < 0.001) of paper towels' weight for the right palm at baseline, 4, 12 and 24 weeks; and 2.8 ± 1.7, 0.5 ± 0.6, 0.8 ± 0.7, and 1.8 ± 1.25 g (p < 0.001) at same time, respectively for the left palm. Significant reduction of mean VAS values were also detected after BoNT-B injections: 8.6 ± 1.1, 0.6 ± 0.8, 3.5 ± 2.5, and 7.1 ± 2.4 (p < 0.0001) at baseline, 4, 12 and 24 weeks, respectively. Mild side effects consisting in local pain and hand weakness were observed in 4 (12.5%) subjects. The findings indicated that the use of 5,000 IU BoNT-B injection in each palm was safe and significantly improved the severity of palmar hyperhidrosis.

  17. Primary analysis of a prospective, randomized, single-blinded phase II trial evaluating the HER2 peptide GP2 vaccine in breast cancer patients to prevent recurrence

    PubMed Central

    Ardavanis, Alexandros; Litton, Jennifer K.; Shumway, Nathan M.; Hale, Diane F.; Murray, James L.; Perez, Sonia A.; Ponniah, Sathibalan; Baxevanis, Constantin N.; Papamichail, Michael

    2016-01-01

    GP2 is a HER2-derived, HLA-A2+ restricted peptide. Phase I studies showed GP2 administered with GM-CSF to be safe and immunogenic. Here we report the primary analysis of a prospective, randomized, multicenter phase II adjuvant trial conducted to determine the vaccine's efficacy. The trial enrolled HLA-A2+, clinically disease-free, node-positive and high-risk node-negative breast cancer patients with tumors expressing HER2 (immunohistochemistry[IHC] 1+-3+). Patients were randomized to GP2+GM-CSF versus GM-CSF alone. Disease-free survival (DFS) was analyzed in intention-to-treat (ITT) and per-treatment cohorts; pre-specified subgroup analyses were performed for patients with IHC 3+ or FISH+ disease. The trial enrolled 180 patients; 89 received GP2+GM-CSF and 91 received GM-CSF alone. The groups were well-matched for clinicopathologic characteristics. Toxicities have been minimal. The Kaplan-Meier estimated 5-year DFS rate in the ITT analyses was 88% (95% CI:78-94%) in vaccinated vs. 81% (95% CI:69-89%) (P = 0.43) in control patients after a 34 month median follow-up. In the per-treatment analysis, the estimated 5-year DFS rates were 94% (95% CI:83-98%) and 85% (73-92%) (P = 0.17). In IHC 3+/FISH+ patients, the estimated 5-year DFS rate was 94% (82-98%) in vaccinated patients (n = 51) vs. 89% (71-96%) in control patients (n = 50), (P = 0.86) in the ITT analyses and 100% vs. 89% (71-96%) in vaccinated vs. control patients in the per-treatment analyses (P = 0.08). While the overall ITT analysis did not demonstrate benefit to vaccination, this trial confirmed that the GP2 vaccine is safe and suggests that vaccination may have clinical activity, particularly in patients with HER2 overexpression who received the full vaccine series (ie per-treatment group). PMID:27589688

  18. Anesthetic efficacy of a combination of 0.5 M mannitol plus 36.8 mg of lidocaine with 18.4 μg epinephrine in maxillary infiltration: a prospective, randomized, single-blind study.

    PubMed

    Younkin, Kevin; Reader, Al; Drum, Melissa; Nusstein, John; Beck, Mike

    2014-01-01

    The purpose of this prospective, randomized, single-blind study was to determine the anesthetic efficacy of lidocaine with epinephrine compared to lidocaine with epinephrine plus 0.5 M mannitol in maxillary lateral incisor infiltrations. Forty-one subjects randomly received 2 maxillary lateral infiltrations consisting of a 1.84-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (control solution) and a 2.90-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (1.84 mL) plus 0.5 M mannitol (1.06 mL) in 2 separate appointments spaced at least 1 week apart. The maxillary lateral incisor was blindly electric pulp-tested in 2-minute cycles for 60 minutes postinjection. No response from the subject to the maximum output (a reading of 80) of the pulp tester was used as the criterion for pulpal anesthesia. Total percent pulpal anesthesia was defined as the total of all pulpal anesthesia readings (at output of 80) over the 60-minute test period. Pain during solution deposition and postoperative pain were also measured. The results demonstrated that a 2.90-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine (1.84 mL) plus 0.5 M mannitol (1.06 mL) was not statistically significantly superior to a 1.84-mL solution of 36.8 mg lidocaine with 18.4 μg epinephrine. The pain of solution deposition was lower with the lidocaine/mannitol formulation. Postoperative pain was not statistically significantly different between the lidocaine/mannitol formulation and the lidocaine formulation without mannitol. We concluded that adding 0.5 M mannitol to a lidocaine with epinephrine formulation was not significantly more effective in achieving a greater percentage of total pulpal anesthesia (as defined in this study) than a lidocaine formulation without mannitol in the maxillary lateral incisor.

  19. Prospective Double-Blind Study of Zidovudine (AZT) in Early Stage HIV infection

    DTIC Science & Technology

    1988-05-01

    FRONT COVER FUNDING NO. 87PP7875 S L. TITLE: Prospective Double-Blind Study of Zidovudine (AZT) in Early Stage HIV Infection PRINCIPAL INVESTIGATOR...Prospective Double-Blind Study of Zidovudine (AZT) in Early State HIV Infection 12. PERSONAL AUTHOR(S) Shannon M. Harrison 13a. TYPE OF REPORT 113b...COSATI CODES 18. SUBJECT TERMS (Continue on reverse if necessary and identify by block number) FIELD GROUP SUBGROUP HIV , Zidovudine, Early, Infection 06

  20. Evaluation of sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride. Results of a prospective, randomized, double-blind, placebo-controlled trial.

    PubMed

    Dulin, J; Kovács, L; Ramm, S; Horvath, F; Ebeling, L; Kohnen, R

    1998-07-01

    Sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride (Mydocalm), a centrally active muscle-relaxing agent, were evaluated in a placebo-controlled double-blind clinical trial. A total of 72 healthy young adults balanced by sex were randomized to receive 50 mg or 150 mg tolperisone hydrochloride or placebo t.i.d. for a period of 8 days. Control examinations were performed in the mornings of days 1 and 8 before intake of the morning dose and at 1.5, 4 and 6 hours postdose. The psychomotoric test battery used in this trial revealed no sedative effects of tolperisone hydrochloride in the given doses at any control examination. Subjective mood ratings quantified by the Welzel Colored Scales were not impaired either. The lack of differences in sedative potentials of tolperisone hydrochloride and placebo was confirmed by tests on differences and by tests on equivalence using 95% CI. The present study substantiates clinical experience and previous clinical trials demonstrating that tolperisone hydrochloride, though being a centrally active muscle relaxant, does not cause any sedation and does not impair reaction times.

  1. Central venous catheterization: a prospective, randomized, double-blind study.

    PubMed

    Mer, Mervyn; Duse, Adriano Gianmaria; Galpin, Jacqueline Suzanne; Richards, Guy Antony

    2009-02-01

    Central venous catheters (CVCs) are extensively used worldwide. Mechanical, infectious and thrombotic complications are well described with their use and may be associated with prolonged hospitalization, increased medical costs and mortality. CVCs account for an estimated 90% of all catheter-related bloodstream infections (CRBSI) and a host of risk factors for CVC-related infections have been documented. The duration of use of CVCs remains controversial and the length of time such devices can safely be left in place has not been fully and objectively addressed in the critically ill patient. Antimicrobial-impregnated catheters have been introduced in an attempt to limit catheter-related infection (CRI) and increase the time that CVCs can safely be left in situ. Recent meta-analyses concluded that antimicrobial-impregnated CVCs appear to be effective in reducing CRI. The authors conducted a prospective, randomized, double-blind study at Johannesburg Hospital over a 4-year period. The study entailed a comparison of standard triple-lumen versus antimicrobial impregnated CVCs on the rate of CRI. Our aim was to determine whether we could safely increase the duration of catheter insertion time from our standard practice of seven days to 14 days, to assess the influence of the antimicrobial impregnated catheter on the incidence of CRI, and to elucidate the epidemiology and risks of CRI. One hundred and eighteen critically ill patients were included in the study which spanned 34 951.5 catheter hours (3.99 catheter years). It was found that antimicrobial catheters did not provide any significant benefit over standard catheters, which the authors feel can safely be left in place for up to 14 days with appropriate infection control measures. The most common source of CRI was the skin. The administration of parenteral nutrition and the site of catheter insertion (internal jugular vein vs subclavian vein) were not noted to be risk factors for CRI. There was no clinical evidence

  2. Blindness

    MedlinePlus

    ... de los dientes Video: Getting an X-ray Blindness KidsHealth > For Kids > Blindness Print A A A ... help, are sometimes called "legally blind." What Causes Blindness? Vision problems can develop before a baby is ...

  3. Blindness

    MedlinePlus

    ... Emergency Room? What Happens in the Operating Room? Blindness KidsHealth > For Kids > Blindness A A A What's ... help, are sometimes called "legally blind." What Causes Blindness? Vision problems can develop before a baby is ...

  4. Alga Ecklonia bicyclis, Tribulus terrestris, and Glucosamine Oligosaccharide Improve Erectile Function, Sexual Quality of Life, and Ejaculation Function in Patients with Moderate Mild-Moderate Erectile Dysfunction: A Prospective, Randomized, Placebo-Controlled, Single-Blinded Study

    PubMed Central

    Sansalone, Salvatore; Leonardi, Rosario; Antonini, Gabriele; Vitarelli, Antonio; Vespasiani, Giuseppe

    2014-01-01

    We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction. PMID:25136552

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

    PubMed

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    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.

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

    PubMed Central

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    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. PMID:27247936

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

    PubMed Central

    Banerjee, Debasis; Das, Anjan; Majumdar, Saikat; Mandal, Rahul Deb; Dutta, Soumyadip; Mukherjee, Anindya; Chakraborty, Aparna; Chattopadhyay, Sandip

    2014-01-01

    Background: postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6, 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg) has better efficacy than single dose IV Ondansetron (4 mg) in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia. PMID:24665236

  8. Efficacy of transforaminal versus interspinous corticosteroid injectionin discal radiculalgia - a prospective, randomised, double-blind study.

    PubMed

    Thomas, E; Cyteval, C; Abiad, L; Picot, M C; Taourel, P; Blotman, F

    2003-10-01

    A prospective, randomised, double-blind study was carried out to compare the respective efficacies of transforaminal and interspinous epidural corticosteroid injections in discal radiculalgia. Thirty-one patients (18 females, 13 males) with discal radicular pain of less than 3 months' duration were consecutively randomised to receive either radio-guided transforaminal or blindly performed interspinous epidural corticosteroid injections. Post-treatment outcome was evaluated clinically at 6 and 30 days, and then at 6 months, but only by mailed questionnaire. At day 6, the between-group difference was significantly in favour of the transforaminal group with respect to Schober's index, finger-to-floor distance, daily activities, and work and leisure activities on the Dallas pain scale. At day 30, pain relief was significantly better in the transforaminal group. At month 6, answers to the mailed questionnaire still showed significantly better results for transforaminal injection concerning pain, daily activities, work and leisure activities and anxiety and depression, with a decline in the Roland-Morris score. In recent discal radiculalgia, the efficacy of radio-guided transforaminal epidural corticosteroid injections was higher than that obtained with blindly-performed interspinous injections.

  9. Dissolution of gall stones with an ursodeoxycholic acid menthol preparation: a controlled prospective double blind trial.

    PubMed Central

    Leuschner, M; Leuschner, U; Lazarovici, D; Kurtz, W; Hellstern, A

    1988-01-01

    In a controlled prospective double blind trial patients with cholesterol gall bladder stones are treated with ursodeoxy-cholic acid (group A: UDCA 11.1 mg/kg per day; n = 16) and Ursomenth respectively (group B: a mixture of UDCA/menthol: 4.75 mg/kg per day each; n = 17). With same stone number and size (10-12 mm) there is a complete dissolution rate in group A of 38%, and of 53% in group B within 15-16.9 months. The response rate (complete + partial dissolution) amounted to 75% and 76% respectively. In group A there is one case of stone calcification, in group B none. Both preparations are free of unwanted effects. This suggests that the cyclic monoterpene menthol enhances the effect of UDCA and is of comparable effect to a mixture of six different terpenes used in former times. PMID:3286383

  10. Cantharidin for the Treatment of Molluscum Contagiosum: A Prospective, Double-Blinded, Placebo-Controlled Trial

    PubMed Central

    Dosal, Jacquelyn Coloe; Stewart, Paul W.; Lin, Ja-An; Williams, Christianna S.; Morrell, Dean S

    2012-01-01

    Background/Objective To study the effects and safety of cantharidin in the treatment of molluscum contagiosum. Methods We conducted a prospective, double-blinded, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of topical cantharidin for treatment of pediatric molluscum contagiosum in an academic ambulatory care center. Twenty-nine children aged 5–10 with the diagnosis of molluscum contagiosum were enrolled to receive treatment with cantharidin or placebo. The main outcome measure was complete clearance of molluscum lesions. Results In contrast to previous retrospective observational studies, the performance of cantharidin treatment over 2 months was not substantially better than the performance of placebo. Limitations The scope of follow-up was limited to 5 visits over 2 months of treatment. In hindsight, we can hypothesize that a longer follow up period may have captured a greater effect of cantharidin. Conclusion We conclude that during a 2 month period, the magnitude of the cantharidin treatment effects in the target population are, at best, not large. This study provided objective unbiased estimates of the magnitude of cantharidin treatment effects and provided important prospective safety data. Our subjects experienced minimal side effects when treated with cantharidin. PMID:22897595

  11. Ultrasound-Guided Pulsed Radiofrequency for Carpal Tunnel Syndrome: A Single-Blinded Randomized Controlled Study

    PubMed Central

    2015-01-01

    Objective We assessed the therapeutic efficiency of ultrasound-guided pulsed radiofrequency (PRF) treatment of the median nerve in patients with carpal tunnel syndrome (CTS). Methods We conducted a prospective, randomized, controlled, single-blinded study. Forty-four patients with CTS were randomized into intervention or control groups. Patients in the intervention group were treated with PRF and night splint, and the control group was prescribed night splint alone. Primary outcome was the onset time of significant pain relief assessed using the visual analog scale (VAS), and secondary outcomes included evaluation of the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) results, cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity (SNCV) of the median nerve, and finger pinch strength. All outcome measurements were performed at 1, 4, 8, and 12 weeks after treatment. Results Thirty-six patients completed the study. The onset time of pain relief in the intervention group was significantly shorter (median onset time of 2 days vs. 14 days; hazard ratio = 7.37; 95% CI, 3.04–17.87) compared to the control group (p < 0.001). Significant improvement in VAS and BCTQ scores (p < 0.05) was detected in the intervention group at all follow-up periods compared to the controls (except for the severity subscale of BCTQ at week 1). Ultrasound-guided PRF treatment resulted in a lower VAS score and stronger finger pinch compared to the control group over the entire study. Conclusions Our study shows that ultrasound-guided PRF serves as a better approach for pain relief in patients with CTS. Trial Registration ClinicalTrials.gov NCT02217293 PMID:26067628

  12. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial.

    PubMed

    Goudakos, John K; Markou, Konstantinos D; Psillas, George; Vital, Victor; Tsaligopoulos, Miltiadis

    2014-05-01

    IMPORTANCE The management of patients with unilateral acute vestibular neuritis (VN) has not been established to date. OBJECTIVE To compare the use of vestibular exercises vs corticosteroid therapy in the recovery of patients with acute VN. DESIGN, SETTING, AND PARTICIPANTS Prospective, single-blind, randomized clinical trial at a primary referral center. Among all patients with acute vertigo, those having VN were eligible for inclusion in the study. INTERVENTIONS Forty patients with acute VN were randomly assigned to perform vestibular exercises or to receive corticosteroid therapy. After a baseline examination, follow-up evaluations were performed at 1, 6, and 12 months. MAIN OUTCOMES AND MEASURES Efficacy outcomes included clinical, canal, and otolith recovery. Scores on the European Evaluation of Vertigo Scale and the Dizziness Handicap Inventory were used for the evaluation of clinical recovery. Findings of caloric irrigation and vestibular evoked myogenic potentials indicated canal and otolith improvement, respectively. RESULTS Comparing the 2 treatment groups, no statistically significant differences were found in clinical, canal, or otolith recovery. At the 6-month examination, the number of patients with complete disease resolution in the corticosteroids group was significantly higher than that in the vestibular exercises group. However, at the end of the follow-up period, 45%(9 of 20) of patients in the vestibular exercises group and 50% (10 of 20) of patients in the corticosteroids group had complete disease resolution (P > .05). CONCLUSIONS AND RELEVANCE Treating patients who have acute VN with vestibular exercises seems equivalently effective as treating them with corticosteroid therapy in clinical, caloric, and otolith recovery. Corticosteroid therapy seems to enhance earlier complete acute VN resolution, with no added benefit in the long-term prognosis.

  13. Construction of Skin Graft Seams in Burn Patients: A Prospective Randomized Double-Blinded Study.

    PubMed

    Isaac, Kathryn; Umraw, Nisha; Cartotto, Robert

    Prominent scars and contractures may form along the seams between adjacent skin grafts. Seams may be constructed either by approximating the graft edges (AP), or by slightly overlapping the graft edges (OV), but it is not known if one technique creates a less conspicuous seam scar. The purpose of this study was to compare seam scars between seams constructed using the AP and OV techniques. This was a prospective within-patient and within-seam controlled study in adult burn patients treated at an American Burn Association-verified burn center. At skin graft application and seam construction, study seams were divided in half. One half of the seam was made by approximating the graft edges (AP group), while the other half was made by overlapping graft edges (OV group), before identical staple or suture fixation of each half. The AP or OV technique was randomly assigned to the medial or lateral ends of transversely oriented seams or to the proximal and distal ends of longitudinally oriented seams. At 3, 6, and 12 months post surgery, a blinded rater compared the two halves of each study seam scar using the Vancouver Scar Score (VSS). Subjects were also blinded and rated each half of their study seam using a 0 (poor) to 10 (excellent) visual analogue scale. Values are shown as the median (Q1-Q3). There were 44 study seams among 19 subjects (age 51 [36-70] years, with % TBSA burn 10 [7-18], % BSA full-thickness burn 8 [6-15]). Study seams were constructed at 10 (4-15) days post burn. Study seam length was 14.5 (10.3-18.0) cm, with 25% transversely oriented and 75% longitudinally oriented, and with 35/44 seams (80%) between meshed grafts and 9/44 (20%) between sheet grafts. There were no significant differences in any of the individual domain VSS scores (height, pliability, vascularity, and pigmentation) or total VSS score between AP and OV seams at 3, 6, and 12 months. At 12 months, among the 30 study seams that were visible to the subjects, the visual analogue scale

  14. Single-channel mixed signal blind source separation algorithm based on multiple ICA processing

    NASA Astrophysics Data System (ADS)

    Cheng, Xiefeng; Li, Ji

    2017-01-01

    Take separating the fetal heart sound signal from the mixed signal that get from the electronic stethoscope as the research background, the paper puts forward a single-channel mixed signal blind source separation algorithm based on multiple ICA processing. Firstly, according to the empirical mode decomposition (EMD), the single-channel mixed signal get multiple orthogonal signal components which are processed by ICA. The multiple independent signal components are called independent sub component of the mixed signal. Then by combining with the multiple independent sub component into single-channel mixed signal, the single-channel signal is expanded to multipath signals, which turns the under-determined blind source separation problem into a well-posed blind source separation problem. Further, the estimate signal of source signal is get by doing the ICA processing. Finally, if the separation effect is not very ideal, combined with the last time's separation effect to the single-channel mixed signal, and keep doing the ICA processing for more times until the desired estimated signal of source signal is get. The simulation results show that the algorithm has good separation effect for the single-channel mixed physiological signals.

  15. A Prospective, Randomized, Double-Blind Study of Coblation versus Dissection Tonsillectomy in Adult Patients.

    PubMed

    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.

  16. Single-image noise level estimation for blind denoising.

    PubMed

    Liu, Xinhao; Tanaka, Masayuki; Okutomi, Masatoshi

    2013-12-01

    Noise level is an important parameter to many image processing applications. For example, the performance of an image denoising algorithm can be much degraded due to the poor noise level estimation. Most existing denoising algorithms simply assume the noise level is known that largely prevents them from practical use. Moreover, even with the given true noise level, these denoising algorithms still cannot achieve the best performance, especially for scenes with rich texture. In this paper, we propose a patch-based noise level estimation algorithm and suggest that the noise level parameter should be tuned according to the scene complexity. Our approach includes the process of selecting low-rank patches without high frequency components from a single noisy image. The selection is based on the gradients of the patches and their statistics. Then, the noise level is estimated from the selected patches using principal component analysis. Because the true noise level does not always provide the best performance for nonblind denoising algorithms, we further tune the noise level parameter for nonblind denoising. Experiments demonstrate that both the accuracy and stability are superior to the state of the art noise level estimation algorithm for various scenes and noise levels.

  17. Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial

    PubMed Central

    2014-01-01

    Background Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. Methods/Design We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Discussion Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-13003708. PMID:24693945

  18. Label-Free, Single Molecule Resonant Cavity Detection: A Double-Blind Experimental Study

    PubMed Central

    Chistiakova, Maria V.; Shi, Ce; Armani, Andrea M.

    2015-01-01

    Optical resonant cavity sensors are gaining increasing interest as a potential diagnostic method for a range of applications, including medical prognostics and environmental monitoring. However, the majority of detection demonstrations to date have involved identifying a “known” analyte, and the more rigorous double-blind experiment, in which the experimenter must identify unknown solutions, has yet to be performed. This scenario is more representative of a real-world situation. Therefore, before these devices can truly transition, it is necessary to demonstrate this level of robustness. By combining a recently developed surface chemistry with integrated silica optical sensors, we have performed a double-blind experiment to identify four unknown solutions. The four unknown solutions represented a subset or complete set of four known solutions; as such, there were 256 possible combinations. Based on the single molecule detection signal, we correctly identified all solutions. In addition, as part of this work, we developed noise reduction algorithms. PMID:25785307

  19. Barack Obama Blindness (BOB): Absence of Visual Awareness to a Single Object

    PubMed Central

    Persuh, Marjan; Melara, Robert D.

    2016-01-01

    In two experiments, we evaluated whether a perceiver’s prior expectations could alone obliterate his or her awareness of a salient visual stimulus. To establish expectancy, observers first made a demanding visual discrimination on each of three baseline trials. Then, on a fourth, critical trial, a single, salient and highly visible object appeared in full view at the center of the visual field and in the absence of any competing visual input. Surprisingly, fully half of the participants were unaware of the solitary object in front of their eyes. Dramatically, observers were blind even when the only stimulus on display was the face of U.S. President Barack Obama. We term this novel, counterintuitive phenomenon, Barack Obama Blindness (BOB). Employing a method that rules out putative memory effects by probing awareness immediately after presentation of the critical stimulus, we demonstrate that the BOB effect is a true failure of conscious vision. PMID:27047362

  20. Barack Obama Blindness (BOB): Absence of Visual Awareness to a Single Object.

    PubMed

    Persuh, Marjan; Melara, Robert D

    2016-01-01

    In two experiments, we evaluated whether a perceiver's prior expectations could alone obliterate his or her awareness of a salient visual stimulus. To establish expectancy, observers first made a demanding visual discrimination on each of three baseline trials. Then, on a fourth, critical trial, a single, salient and highly visible object appeared in full view at the center of the visual field and in the absence of any competing visual input. Surprisingly, fully half of the participants were unaware of the solitary object in front of their eyes. Dramatically, observers were blind even when the only stimulus on display was the face of U.S. President Barack Obama. We term this novel, counterintuitive phenomenon, Barack Obama Blindness (BOB). Employing a method that rules out putative memory effects by probing awareness immediately after presentation of the critical stimulus, we demonstrate that the BOB effect is a true failure of conscious vision.

  1. The Gabbs Valley, Nevada, geothermal prospect: Exploring for a potential blind geothermal resource

    NASA Astrophysics Data System (ADS)

    Payne, J.; Bell, J. W.; Calvin, W. M.

    2012-12-01

    The Gabbs Valley prospect in west-central Nevada is a potential blind geothermal resource system. Possible structural controls on this system were investigated using high-resolution LiDAR, low sun-angle aerial (LSA) photography, exploratory fault trenching and a shallow temperature survey. Active Holocene faults have previously been identified at 37 geothermal systems with indication of temperatures greater than 100° C in the western Nevada region. Active fault controls in Gabbs Valley include both Holocene and historical structures. Two historical earthquakes occurring in 1932 and 1954 have overlapping surface rupture patterns in Gabbs Valley. Three active fault systems identified through LSA and LiDAR mapping have characteristics of Basin and Range normal faulting and Walker Lane oblique dextral faulting. The East Monte Cristo Mountains fault zone is an 8.5 km long continuous NNE striking, discrete fault with roughly 0.5 m right-normal historic motion and 3 m vertical Quaternary separation. The Phillips Wash fault zone is an 8.2 km long distributed fault system striking NE to N, with Quaternary fault scarps of 1-3 m vertical separation and a 500 m wide graben adjacent to the Cobble Cuesta anticline. This fault displays ponded drainages, an offset terrace riser and right stepping en echelon fault patterns suggestive of left lateral offset, and fault trenching exposed non-matching stratigraphy typical of a significant component of lateral offset. The unnamed faults of Gabbs Valley are a 10.6 km long system of normal faults striking NNE and Quaternary scarps are up to 4 m high. These normal faults largely do not have historic surface rupture, but a small segment of 1932 rupture has been identified. A shallow (2 m deep) temperature survey of 80 points covering roughly 65 square kilometers was completed. Data were collected over approximately 2 months, and continual base station temperature measurements were used to seasonally correct temperature measurements. A 2

  2. Non-blind acoustic invisibility by dual layers of homogeneous single-negative media.

    PubMed

    Gao, He; Zhu, Yi-Fan; Fan, Xu-Dong; Liang, Bin; Yang, Jing; Cheng, Jian-Chun

    2017-02-14

    Non-blind invisibility cloaks allowing the concealed object to sense the outside world have great application potentials such as in high-precision sensing or underwater camouflage. However the existing designs based on coordinate transformation techniques need complicated spatially-varying negative index or intricate multi-layered configurations, substantially increasing the difficulty in practical realization. Here we report on the non-blind acoustic invisibility for a circular object in free space with simple distribution of cloak parameters. The mechanism is that, instead of utilizing the transformation acoustics technique, we develop the analytical formulae for fast prediction of the scattering from the object and then use an evolutionary optimization to retrieve the desired cloak parameters for minimizing the scattered field. In this way, it is proven possible to break through the fundamental limit of complementary condition that must be satisfied by the effective parameters of the components in transformation acoustics-based cloaks. Numerical results show that the resulting cloak produces a non-bflind invisibility as perfect as in previous designs, but only needs two layers with homogenous single-negative parameters. With full simplification in parameter distribution and broken symmetry in complementary relationship, our scheme opens new route to free-space non-blind invisibility, taking a significant step towards real-world application of cloaking devices.

  3. Non-blind acoustic invisibility by dual layers of homogeneous single-negative media

    NASA Astrophysics Data System (ADS)

    Gao, He; Zhu, Yi-Fan; Fan, Xu-Dong; Liang, Bin; Yang, Jing; Cheng, Jian-Chun

    2017-02-01

    Non-blind invisibility cloaks allowing the concealed object to sense the outside world have great application potentials such as in high-precision sensing or underwater camouflage. However the existing designs based on coordinate transformation techniques need complicated spatially-varying negative index or intricate multi-layered configurations, substantially increasing the difficulty in practical realization. Here we report on the non-blind acoustic invisibility for a circular object in free space with simple distribution of cloak parameters. The mechanism is that, instead of utilizing the transformation acoustics technique, we develop the analytical formulae for fast prediction of the scattering from the object and then use an evolutionary optimization to retrieve the desired cloak parameters for minimizing the scattered field. In this way, it is proven possible to break through the fundamental limit of complementary condition that must be satisfied by the effective parameters of the components in transformation acoustics-based cloaks. Numerical results show that the resulting cloak produces a non-bflind invisibility as perfect as in previous designs, but only needs two layers with homogenous single-negative parameters. With full simplification in parameter distribution and broken symmetry in complementary relationship, our scheme opens new route to free-space non-blind invisibility, taking a significant step towards real-world application of cloaking devices.

  4. Non-blind acoustic invisibility by dual layers of homogeneous single-negative media

    PubMed Central

    Gao, He; Zhu, Yi-fan; Fan, Xu-dong; Liang, Bin; Yang, Jing; Cheng, Jian-Chun

    2017-01-01

    Non-blind invisibility cloaks allowing the concealed object to sense the outside world have great application potentials such as in high-precision sensing or underwater camouflage. However the existing designs based on coordinate transformation techniques need complicated spatially-varying negative index or intricate multi-layered configurations, substantially increasing the difficulty in practical realization. Here we report on the non-blind acoustic invisibility for a circular object in free space with simple distribution of cloak parameters. The mechanism is that, instead of utilizing the transformation acoustics technique, we develop the analytical formulae for fast prediction of the scattering from the object and then use an evolutionary optimization to retrieve the desired cloak parameters for minimizing the scattered field. In this way, it is proven possible to break through the fundamental limit of complementary condition that must be satisfied by the effective parameters of the components in transformation acoustics-based cloaks. Numerical results show that the resulting cloak produces a non-bflind invisibility as perfect as in previous designs, but only needs two layers with homogenous single-negative parameters. With full simplification in parameter distribution and broken symmetry in complementary relationship, our scheme opens new route to free-space non-blind invisibility, taking a significant step towards real-world application of cloaking devices. PMID:28195227

  5. Prospective randomized clinical trial: single and weekly viscosupplementation

    PubMed Central

    Zóboli, Alejandro Agustin Carri; de Rezende, Márcia Uchôa; de Campos, Gustavo Constantino; Pasqualin, Thiago; Frucchi, Renato; de Camargo, Olavo Pires

    2013-01-01

    OBJECTIVE: To compare two different dosages of an intermediate molecular weight sodium hyaluronate (HA) (Osteonil®-TRB Pharma) assessing whether a single 6 ml application of this HA has the same effectiveness as the classical three-weekly 2 ml dose. METHODS: 108 patients with knee osteoarthritis were randomized into two groups of 54 patients each. The groups were designated "single" (S) and "weekly" (W). Patients in group S underwent a viscosupplementation procedure by application of only 6 ml of sodium hyaluronate and 1 ml triamcinolone hexacetonide. Patients in group W underwent the procedure of viscosupplementation through three applications with 2 ml sodium hyaluronate with a week interval between them, and the first application was also performed with the infiltration of 1 ml (20 mg) of Triamcinolone Hexacetonide. Both groups were assessed before, at one month and three months after application, by responding to the WOMAC, Lequesne, IKDC and VAS questionnaires. RESULTS: There was no statistical difference between the single application of 6 ml of sodium hyaluronate and classic application with three weekly injections. However, only the classical regime showed statistically significant improvement in baseline pain (WOMAC pain and VAS). CONCLUSION: Our results suggest that both application schemes improve application function, but the three-weekly regimen of 2 ml was more effective in reducing pain. Level of Evidence I, Prospective Randomized, Clinical Trial. PMID:24453681

  6. Cardiovascular clinical trials in Japan and controversies regarding prospective randomized open-label blinded end-point design.

    PubMed

    Kohro, Takahide; Yamazaki, Tsutomu

    2009-02-01

    Recently, results of several cardiovascular clinical trials conducted in Japan were published. Most of them were designed as prospective randomized open-label blinded end-point (PROBE)-type trials, in which patients were randomly allocated to different regimens and both the patients and doctors are aware of the regimen being administered. Although the PROBE design enables performing trials resembling real-world practices, entails low costs and renders patient recruitment easier, it presents several conditions that have to be satisfied to acquire accurate results, due to its open-label nature. Principally, the so-called hard end points, which are judged by objective criteria, should be used as primary end points in order to prevent biases. In this article, a general description of various designs of clinical studies is provided, followed by a description of the PROBE design, and the precautions to be taken while conducting PROBE-designed trials by comparing trials conducted in Japan and the West.

  7. Prospects of Optical Single Atom Detection for Nuclear Astrophysics

    NASA Astrophysics Data System (ADS)

    Singh, Jaideep

    2015-10-01

    We will discuss the prospects of optically detecting single atoms captured in a cryogenic thin film of a noble gas such as neon. This proposed detection scheme, when coupled with a recoil separator, could be used to measure rare nuclear reactions relevant for nuclear astrophysics. In particular, we will focus on the 22Ne(α, n)25Mg reaction, which is an important source of neutrons for the s-process. Noble gas solids are an attractive medium because they are optically transparent and provide efficient, pure, stable, & chemically inert confinement for a wide variety of atomic and molecular species. Atoms embedded inside of noble gas solids have a fluorescence spectrum that is often significantly shifted from its absorption spectrum. This makes possible the detection of individual fluorescence photons against a background of intense excitation light, which can be suppressed using the appropriate optical filters. We will report on our efforts to optically detect single Yb atoms in solid Ne. Yb is an ideal candidate for initial studies because it emits a strong green fluorescence when excited by blue light and it has an atomic structure that very closely resembles that of Mg. This work is supported by funds from Michigan State University.

  8. A new blind fault component separation algorithm for a single-channel mechanical signal mixture

    NASA Astrophysics Data System (ADS)

    Wang, Dong; Tse, Peter W.

    2012-10-01

    A vibration signal collected from a complex machine consists of multiple vibration components, which are system responses excited by several sources. This paper reports a new blind component separation (BCS) method for extracting different mechanical fault features. By applying the proposed method, a single-channel mixed signal can be decomposed into two parts: the periodic and transient subsets. The periodic subset is related to the imbalance, misalignment and eccentricity of a machine. The transient subset refers to abnormal impulsive phenomena, such as those caused by localized bearing faults. The proposed method includes two individual strategies to deal with these different characteristics. The first extracts the sub-Gaussian periodic signal by minimizing the kurtosis of the equalized signals. The second detects the super-Gaussian transient signal by minimizing the smoothness index of the equalized signals. Here, the equalized signals are derived by an eigenvector algorithm that is a successful solution to the blind equalization problem. To reduce the computing time needed to select the equalizer length, a simple optimization method is introduced to minimize the kurtosis and smoothness index, respectively. Finally, simulated multiple-fault signals and a real multiple-fault signal collected from an industrial machine are used to validate the proposed method. The results show that the proposed method is able to effectively decompose the multiple-fault vibration mixture into periodic components and random non-stationary transient components. In addition, the equalizer length can be intelligently determined using the proposed method.

  9. Forskolin versus sodium cromoglycate for prevention of asthma attacks: a single-blinded clinical trial.

    PubMed

    González-Sánchez, R; Trujillo, X; Trujillo-Hernández, B; Vásquez, C; Huerta, M; Elizalde, A

    2006-01-01

    To determine the efficacy of forskolin in preventing asthma attacks, we performed a single-blinded clinical study in children and adult out-patients at a public hospital in Mexico. Forty patients of either sex with mild persistent or moderate persistent asthma were assigned randomly to 6 months of treatment with forskolin at 10 mg/day orally (capsules) or with two inhalations of sodium cromoglycate every 8 h, i.e. three times a day. The number of patients who had asthma attacks during the treatment period was significantly lower among those receiving forskolin (8/20, 40%) than among those receiving sodium cromoglycate (17/20, 85%). Values of forced expiratory volume in 1 s and forced expiratory flow, mid-phase, A similar in the two groups during the treatment period. We conclude that forskolin is more effective than sod cromoglycate in preventing asthma attacks in patients with mild persistent or moderate persistent asthma.

  10. Extracorporeal shock wave therapy for chronic calcific tendinitis of the shoulder: single blind study

    PubMed Central

    Cosentino, R; De Stefano, R; Selvi, E; Frati, E; Manca, S; Frediani, B; Marcolongo, R

    2003-01-01

    Methods: 70 patients showing chronic, symptomatic, calcifying tendinitis of the shoulder were examined. A single blind randomised study was performed with 35 patients undergoing a regular treatment (group 1) and 35 a simulated one (group 2). Pain and functional assessment was carried out according to Constant and Murley. Variations in the dimension of the calcification were evaluated by anteroposterior x ray films. Results: A significant decrease of pain and a significant increase in shoulder function was seen in group 1. Examination by x ray showed partial resorption of the calcium deposits in 40% of cases and complete resorption in 31% of cases in group 1. In the control group no significant decrease of pain and no significant increase in shoulder function was seen. No modifications were observed by x ray examination. Conclusion: Because of its good tolerance, safety, and clinical radiological response, ESWT can be considered as an alternative treatment for chronic calcific tendinitis of the shoulder. PMID:12594112

  11. A prospective, randomized, triple-blind comparison of articaine and bupivacaine for maxillary infiltrations

    PubMed Central

    Vílchez-Pérez, Miguel A.; Sancho-Puchades, Manuel; Valmaseda-Castellón, Eduard; Paredes-García, Jordi; Berini-Aytés, Leonardo

    2012-01-01

    Objectives: To compare the clinical anesthetic efficacy of 0.5% bupivacaine and 4% articaine (both with 1:200.000 adrenaline) for anterior maxillary infiltration in healthy volunteers. Material and methods: A triple-blind split-mouth randomized clinical trial was carried out in 20 volunteers. A supraperiosteal buccal injection of 0.9 ml of either solution at the apex of the lateral incisor was done in 2 appointments separated 2 weeks apart. The following outcome variables were measured: latency time, anesthetic efficacy (dental pulp, keratinized gingiva, alveolar mucosa and upper lip mucosa and tissue) and the duration of anesthetic effect. Hemodynamic parameters were monitored during the procedure. Results: Latency time recorded was similar for both anesthetic solutions (p>0.05). No statistically significant differences were found in terms of anesthetic efficacy for dental pulp, keratinized gingiva or alveolar mucosa. Articaine had a significant higher proportion of successful anesthesia at 10 minutes after infiltration in lip mucosa and lip skin (p=0.039). The duration of anesthesia was 336 minutes for bupivacaine and 167 minutes for articaine. (p<0.001). No significant hemodynamic alterations were noted during the procedure. Conclusions: Articaine and bupivacaine exhibited similar anesthetic efficacy for maxillary infiltrations. The duration of anesthesia was longer with the bupivacaine solution, but lip anesthesia was better with articaine. Key words:Articaine, bupivacaine, maxillary, infiltrative anesthesia, long-acting anesthetics. PMID:22143708

  12. A single-blinded phenobarbital-controlled trial of levetiracetam as mono-therapy in dogs with newly diagnosed epilepsy.

    PubMed

    Fredsø, N; Sabers, A; Toft, N; Møller, A; Berendt, M

    2016-02-01

    Treatment of canine epilepsy is problematic. Few antiepileptic drugs have proven efficacy in dogs and undesirable adverse effects and pharmacoresistance are not uncommon. Consequently, the need for investigation of alternative treatment options is ongoing. The objective of this study was to investigate the efficacy and tolerability of levetiracetam as mono-therapy in dogs with idiopathic epilepsy. The study used a prospective single-blinded parallel group design. Twelve client-owned dogs were included and were randomised to treatment with levetiracetam (30 mg/kg/day or 60 mg/kg/day divided into three daily dosages) or phenobarbital (4 mg/kg/day divided twice daily). Control visits were at days 30, 60 and then every 3 months for up to 1 year. Two or more seizures within 3 months led to an increase in drug dosage (levetiracetam: 10 mg/kg/day, phenobarbital: 1 mg/kg/day). Five of six levetiracetam treated dogs and one of six phenobarbital treated dogs withdrew from the study within 2-5 months due to insufficient seizure control. In the levetiracetam treated dogs there was no significant difference in the monthly number of seizures before and after treatment, whereas in the phenobarbital treated dogs there were significantly (P = 0.013) fewer seizures after treatment. Five phenobarbital treated dogs were classified as true responders (≥50% reduction in seizures/month) whereas none of the levetiracetam treated dogs fulfilled this criterion. Adverse effects were reported in both groups but were more frequent in the phenobarbital group. In this study levetiracetam was well tolerated but was not effective at the given doses as mono-therapy in dogs with idiopathic epilepsy.

  13. Effects of one session radial extracorporeal shockwave therapy on post-stroke plantarflexor spasticity: a single-blind clinical trial.

    PubMed

    Radinmehr, Hojjat; Nakhostin Ansari, Noureddin; Naghdi, Soofia; Olyaei, Gholamreza; Tabatabaei, Azadeh

    2017-03-01

    Purpose To examine the effects of radial extracorporeal shockwave therapy (rESWT) on plantarflexor spasticity after stroke. Method Twelve patients with stroke were randomly included for this prospective, single-blind clinical trial. Patients received one rESWT session (0.340 mJ/mm(2), 2000 shots) on plantarflexor muscle. The Modified Modified Ashworth Scale (MMAS), H-reflex tests, ankle range of motion (ROM), passive plantarflexor torque (PPFT) and timed up and go test (TUG) were measured at baseline (T0), immediately after treatment (T1) and one hour after the end of the treatment (T2). Results Patients had improved the MMAS scores for both the gastrocnemius and the soleus muscles, active and passive ROM, PPFT and TUG over time after rESWT. For the PPFT, it was greater at high velocity than at low velocity, and there was a significant three-way interaction between time, knee position (extended/flexed) and velocity (low/high). The H-reflex latency had decreased at T1, but there was no significant effect on Hmax/Mmax ratio. Conclusions The rESWT improved plantarflexor spasticity, and the effects sustained for one hour, whereas it was not effective in improving spinal excitability. Implications for Rehabilitation One session radial extracorporeal shock wave therapy (rESWT) is safe and effective in improving post stroke plantarflexor spasticity, ankle active and passive range of motion, passive torque, and walking capability. The spasticity scores improved for both the gastrocnemius and the soleus muscles and persisted one hour after rESWT. The magnitude of resistive plantarflexor passive torque in the knee extended position and high velocity was larger over time suggesting greater gastrocnemius spasticity than soleus. The rESWT had no significant effects on alpha motorneuron excitability.

  14. Lidocaine-Prilocaine Cream as Analgesia for IUD Insertion: A Prospective, Randomized, Controlled, Triple Blinded Study

    PubMed Central

    Tavakolian, Samira; Doulabi, Mahbobeh Ahmadi; Baghban, Alireza Akbarzade; Mortazavi, Alireza; Ghorbani, Maryam

    2015-01-01

    Introduction: Copper IUD is a long term and reversible contraception which equals tubal ligation in terms of sterilization. One of the barriers to using this contraception method is the fear and the pain associated with its insertion. Eutectic mixture of local anesthetics (EMLA) 5% is a local anesthetic that contains 25 mg lidocaine and 25 mg of prilocaine per gram. Application of topical analgesic cream to the cervix for laser surgery, hysteroscopy and hysterosalpingography is known Aims: this study aimed to determine the effect of EMLA on IUD insertion pain. Methods: This triple blind clinical trial was conducted on 92 women in a clinic in Hamedan in 2012. After applying the cream on the cervix, pain in three steps, after using Tenaculum, after inserting hystrometr and after inserting IUD and removing IUD insertion tube were assessed with visual analog scale and were compared in EMLA group and placebo group Statistical analysis used to determine and compare the pain of independent t tests, Mann-Whitney U test and repeated measures analysis of variance and chi-square tests to determine the homogeneity of variables and Fisher’s exact test was used Results: Insertion hystrometr was determined as the most painful IUD insertion. The mean pain at step 2 (inserting hystrometr) was (3/11±2/53) in EMLA group, (5/23±2/31) in placebo group. EMLA cream significantly reduced the pain after using tenaculum (P<0/001), pain inserting Hystrometr (P< 0/001) and pain at IUD insertion and removing insertion tube (P< 0/001) Conclusions: Topical Application of EMLA 5% cream as a topical anesthetic on the cervix before insertion IUD reduced the pain during this procedure. PMID:25946948

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  16. Single dose vitamin A treatment in acute shigellosis in Bangladesh children: randomised double blind controlled trial.

    PubMed Central

    Hossain, S.; Biswas, R.; Kabir, I.; Sarker, S.; Dibley, M.; Fuchs, G.; Mahalanabis, D.

    1998-01-01

    OBJECTIVE: To evaluate the efficacy of a single large oral dose of vitamin A in treating acute shigellosis in children in Bangladesh. DESIGN: Randomised double blind controlled clinical trial. SETTING: Dhaka Hospital, International Centre for Diarrhoeal Disease Research, Bangladesh. SUBJECTS: 83 children aged 1-7 years with bacteriologically proved shigellosis but no clinical signs of vitamin A deficiency; 42 were randomised to treatment with vitamin A and 41 formed a control group. INTERVENTION: Children were given a single oral dose of 200,000 IU of vitamin A plus 25 IU vitamin E or a control preparation of 25 IU vitamin E. MAIN OUTCOME MEASURES: Clinical cure on study day 5 and bacteriological cure. RESULTS: Baseline characteristics of the subjects in the two treatment groups were similar. Significantly more children in the vitamin A group than in the control group achieved clinical cure (19/42 (45%) v 8/14 (20%); chi 2 = 5.14, 1 df, P = 0.02; risk ratio = 0.68 (95% confidence interval; 0.50 to 0.93)). When cure was determined bacteriologically, the groups had similar rates (16/42 (38%) v 16/41 (39%); chi 2 = 0.02, 1 df, P = 0.89; risk ratio = 0.98 (0.70 to 1.39)). CONCLUSIONS: Vitamin A reduces the severity of acute shigellosis in children living in areas where vitamin A deficiency is a major public health problem. PMID:9492664

  17. Effects of pulsed electromagnetic stimulation on patients undergoing hip revision prostheses: a randomized prospective double-blind study.

    PubMed

    Dallari, Dante; Fini, Milena; Giavaresi, Gianluca; Del Piccolo, Nicolandrea; Stagni, Cesare; Amendola, Luca; Rani, Nicola; Gnudi, Saverio; Giardino, Roberto

    2009-09-01

    In this prospective, randomized, double-blind study, the effect of Pulsed Electromagnetic Fields (PEMFs) was investigated in 30 subjects undergoing hip revision using the Wagner SL stem. The subjects were treated for 6 h/day up to 90 days after revision. Study end points were assessed clinically by the functional scale of Merle D'Aubigné and instrumentally by Dual-Energy X-ray Absorptiometry (DXA) at the Gruen zones. Subject improvement according to Merle D'Aubigné scale was higher (P < 0.05) in subjects undergoing active stimulation compared to placebo. In analyzing the DXA findings, we subtracted for each area the postoperative bone mineral density (BMD) values from those measured at 90 days and we considered all results above 3.5% as responders. There were no significant differences in the average BMD values at each Gruen zone between the two groups both postoperatively and at 90 days investigation. In Gruen zones 5 and 6, corresponding to the medial cortex, we observed six responders (40%) in both areas in the control group, while in the stimulated group we observed 14 (93%) and 10 (66%) responders, respectively (both P < 0.05). This study showed that PEMF treatment aids clinical recovery and bone stock restoration.

  18. Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period

    PubMed Central

    de la Barrera-Núñez, María C.; Yáñez-Vico, Rosa M.; Batista-Cruzado, Antonio; Heurtebise-Saavedra, Jean M.; Castillo-de Oyagüe, Raquel

    2014-01-01

    Objectives: To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. Study Design: This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples. Results: Although there were no statistically significant differences between the treatment groups, a trend towards less inflammation and improved oral aperture was observed in the group that received bromelain, compared to the group that received placebo. This trend can be attributed completely to random reasons, since there is no statistical difference in the results. Conclusions: Further studies are necessary to analyze different administration patterns and doses of bromelain for the use in the postoperative of impacted third molars. Key words:Tooth extraction, third molar, postoperative period, bromeline, clinical study. PMID:24316697

  19. Clinical tolerability of perioperative tenoxicam in 1001 patients--a prospective, controlled, double-blind, multi-centre study.

    PubMed

    Merry, Alan F; Webster, Craig S; Holland, Robin L; Middleton, Neil G; Schug, Stephan A; James, Margaret; McGrath, Ken A

    2004-10-01

    We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, prospective, randomised study. Patients undergoing surgery, screened for contraindications to non-steroidal anti-inflammatory drug, received tenoxicam (n=750) on 2843 days or placebo (n=251) on 988 days, in courses of 1-12 days. There was no increase in the overall incidence of side effects with tenoxicam (33 vs 38% with placebo: P=0.15), or in major side effects (3.9 vs 2.0% with placebo: P=0.11). Of major side effects possibly or probably related to tenoxicam (2.1 vs 1.2% with placebo: P=0.26), all but one involved post-operative surgical site bleeding. However, in the subgroup of patients undergoing otorhinolaryngology surgery, surgical site bleeding occurred in 18 of 171 (10.5%) patients on tenoxicam and one of 57 (1.8%) on placebo (P=0.026); of these, nine in the tenoxicam group and 0 in the placebo were classified as major (P=0.07). One patient on tenoxicam experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicam is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than 1 in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding.

  20. Cytological changes in the oral mucosa after use of a mouth rinse with alcohol: A prospective double blind control study

    PubMed Central

    Vera-Sempere, Francisco; Marzal, Cristina; Pellín-Carcelén, Ana; Martí-Bonmatí, Ezequiel; Bagan, Leticia

    2012-01-01

    Aim: The aim of this preliminary study was to detect cytological changes in the oral mucosa after using a mouth wash with alcohol. Material and Methods: A prospective double-blind, controlled study was performed, for 6 months. Group 1 consisted of 30 subjects who used a mouth rinse with 26.9% of alcohol [Listerine®] and Group 2 consisted of 30 subjects who used a mouth rinse with the same ingredients but with no alcohol. We obtained three cytological samples from the oral mucosa. The presence of cytological atypia, binucleation and karyorrhesis, and type of cells were studied. We also used a fluorescent in situ hybridization technique (FISH) in 15 samples in each group, for the micronucleus. Results: We found no clinical mucosal alteration after using the mouth wash at the end of the study in either group. We observed no cytological differences between the groups at the end of the study (p>0.05). Regarding the study of the micronucleus by FISH, we observed no significant difference between the groups (p>0.05). Conclusions: Our results showed no cytological alteration in patients using a mouth rinse with alcohol, but these findings should be considered preliminary results, to be confirmed in a greater sample of patients. Key words:Mouth wash, oral mucosa, cytological change, alcohol. PMID:23085712

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

    PubMed Central

    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 < 0.05 was considered statistically significant. Results: There was a significant decrease in pain score after CRF without any added side effect. Pain relief after 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

  2. Validation of Reference Genes for Oral Cancer Detection Panels in a Prospective Blinded Cohort

    PubMed Central

    Martin, Jack L.

    2016-01-01

    Background Reference genes are needed as internal controls to determine relative expression for clinical application of gene expression panels. Candidate constitutively expressed genes must be validated as suitable reference genes in each body fluid and disease entity. Prior studies have predominantly validated oral squamous cell carcinoma associated messenger RNAs (mRNAs) based on quantitative polymerase chain reaction (qPCR) quantification cycle (Cq) values without adjustment for housekeeping genes. Methods One hundred sixty eight patients had saliva collected before clinically driven biopsy of oral lesions suspicious for cancer. Seven potential housekeeping mRNAs and six pre-specified oral cancer associated mRNAs were measured with qPCR by personnel blinded to tissue diagnosis. Housekeeping gene stability was determined with the NormFinder program in a training set of 12 randomly selected cancer and 24 control patients. Genes with stability indices <0.02 were then tested in the validation set consisting of the remaining cancer and control patients and were further validated by the geNorm program. Cancer gene delta Cqs were compared in case and control patients after subtracting the geometric mean of the reference gene raw Cqs. Results B2M and UBC had stability indices >0.02 in the training set and were not further tested. MT-ATP6, RPL30, RPL37A, RPLP0 and RPS17 all had stability indices <0.02 in the training set and in the verification set. The geNorm M values were all ≤1.10. All six pre-specified cancer genes (IL8, IL1, SAT, OAZ1, DUSP1 and S100P) were up-regulated in cancer versus control patients with from nearly twofold to over threefold higher levels (p<0.01 for all based on delta Cq values). Conclusions Five reference genes are validated for use in oral cancer salivary gene expression panels. Six pre-specified oral carcinoma associated genes are demonstrated to be highly significantly up-regulated in cancer patients based on delta Cq values. These cancer

  3. Prospective double-blind preoperative pain clinic screening before microsurgical denervation of the spermatic cord in patients with testicular pain syndrome.

    PubMed

    Oomen, Robert J A; Witjens, Annemijke C; van Wijck, Albert J M; Grobbee, Diederik E; Lock, Tycho M T W

    2014-09-01

    Testicular pain syndrome (TPS), defined as an intermittent or constant pain in one or both testicles for at least 3 months, resulting in significant reduction of daily activities, is common. Microsurgical denervation of the spermatic cord (MDSC) has been suggested as an effective treatment option. The study population comprised 180 TPS patients admitted to our outpatient urology clinic between 1999 and 2011. On 3 different occasions, patients were offered a double-blind, placebo-controlled temporary blockade of the spermatic cord. A single blockade consisted of 10 mL 2% lidocaine, 10 mL 0.25% bupivacaine, or 10 mL 0.9% sodium chloride. If the results of these blockades were positive, MDSC was offered. All MDSCs were performed by a single urologist (M.T.W.T.L.) using an inguinal approach. Pain reduction was determined at prospective follow-up. This study evaluated 180 patients. Most patients (61.1%) had undergone a scrotal or inguinal procedure. Patients had complaints during sexual activities (51.7%), sitting (37.5%), and/or cycling (36.7%); 189 randomized blockades were offered to all patients. There was a positive response in 37% and a negative response in 51%. MDSC was performed on 58 testicular units, including 3 patients with a negative outcome of the blockades. At mean follow-up of 42.8 months, 86.2% had a ≥ 50% reduction of pain and 51.7% were completely pain free. MDSC is a valuable treatment option for TPS patients because in this study 86.2% experienced a ≥ 50% reduction of pain. To prevent superfluous diagnostics and treatment, it is mandatory to follow a systematic protocol in the treatment of TPS.

  4. Bacterial overgrowth during treatment with omeprazole compared with cimetidine: a prospective randomised double blind study.

    PubMed Central

    Thorens, J; Froehlich, F; Schwizer, W; Saraga, E; Bille, J; Gyr, K; Duroux, P; Nicolet, M; Pignatelli, B; Blum, A L; Gonvers, J J; Fried, M

    1996-01-01

    BACKGROUND: Gastric and duodenal bacterial overgrowth frequently occurs in conditions where diminished acid secretion is present. Omeprazole inhibits acid secretion more effectively than cimetidine and might therefore more frequently cause bacterial overgrowth. AIM: This controlled prospective study compared the incidence of gastric and duodenal bacterial overgrowth in patients treated with omeprazole or cimetidine. METHODS: 47 outpatients with peptic disease were randomly assigned to a four week treatment regimen with omeprazole 20 mg or cimetidine 800 mg daily. Gastric and duodenal juice were obtained during upper gastrointestinal endoscopy and plated for anaerobic and aerobic organisms. RESULTS: Bacterial overgrowth (> or = 10(5) cfu/ml) was present in 53% of the patients receiving omeprazole and in 17% receiving cimetidine (p < 0.05). The mean (SEM) number of gastric and duodenal bacterial counts was 6.0 (0.2) and 5.0 (0.2) respectively in the omeprazole group and 4.0 (0.2) and 4.0 (0.1) in the cimetidine group (p < 0.001 and < 0.01; respectively). Faecal type bacteria were found in 30% of the patients with bacterial overgrowth. Basal gastric pH was higher in patients treated with omeprazole compared with cimetidine (4.2 (0.5) versus 2.0 (0.2); p < 0.001) and in patients with bacterial overgrowth compared with those without bacterial overgrowth (5.1 (0.6) versus 2.0 (0.1); p < 0.0001). The nitrate, nitrite, and nitrosamine values in gastric juice did not increase after treatment with either cimetidine or omeprazole. Serum concentrations of vitamin B12, beta carotene, and albumin were similar before and after treatment with both drugs. CONCLUSIONS: These results show that the incidence of gastric and duodenal bacterial overgrowth is considerably higher in patients treated with omeprazole compared with cimetidine. This can be explained by more pronounced inhibition of gastric acid secretion. No patient developed signs of malabsorption or an increase of N

  5. A single-blind trial of reflexology for irritable bowel syndrome.

    PubMed Central

    Tovey, Philip

    2002-01-01

    BACKGROUND: Irritable bowel syndrome (IBS) is a significant problem for primary care, as treatment options are limited and it can frequently develop into a chronic condition. Complementary and alternative medicine, including reflexology, is being turned to increasingly in an attempt to manage symptoms. There are currently no studies which address the effectiveness of reflexology for IBS. Despite this, it continues to be advocated and used. AIM: To provide the first evidence on the effectiveness of reflexology in the management of the core defining symptoms of IBS. DESIGN OF STUDY: A single-blind trial carried out in primary care settings. SETTING: Thirty-four participants diagnosed with IBS on the basis of the Rome Criteria. METHOD: Participants were allocated to receive either a reflexology foot massage or a non-reflexology foot massage control group. RESULTS: On none of the three symptoms monitored--abdominal pain, constipation/diarrhoea, and abdominal distention--was there a statistically or clinically significant difference between reflexology and control groups. CONCLUSION: On the basis of these results there is nothing to suggest that reflexology produces any specific benefit for patients with IBS. There is currently no evidence to support its use. However this was one (relatively) small scale study; further research that, for example, assesses the impact of therapist (professional and lay) versus therapy, is still needed. PMID:11791811

  6. Forskolin compared with beclomethasone for prevention of asthma attacks: a single-blind clinical trial.

    PubMed

    Huerta, M; Urzúa, Z; Trujillo, X; González-Sánchez, R; Trujillo-Hernández, B

    2010-01-01

    This single-blind study compared the efficacy of oral forskolin versus inhaled beclomethasone for mild or moderately persistent adult asthma. Patients were randomly assigned to receive forskolin (one 10-mg capsule orally per day; n = 30) or beclomethasone (two 50 microg inhalations every 12 h; n = 30) for 2 months. No statistically significant improvement occurred in any lung function parameter in the forskolin-treated patients. Subjects in the beclomethasone-treated group presented a slight but statistically significant improvement in percentage forced expiratory volume in 1 s (FEV(1)), percentage forced expiratory flow in the middle (25 - 75%) expiratory phase (FEF(25 - 75%)) and percentage forced vital capacity (FVC) after 2 months of treatment, though the improvement in absolute values for FEV(1), FEF(25 - 75%), FVC and FEV(1):FVC did not reach statistical significance. There was no statistically significant difference between the forskolin and beclomethasone treatment groups for any lung function parameter at baseline or after treatment. None of the beclomethasone-treated patients had an asthma attack and one forskolin-treated patient had a mild asthma attack during the 2-month study period. More studies are needed in adult asthma patients to confirm whether forskolin may be a useful preventive treatment for mild or moderately persistent adult asthma.

  7. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial.

    PubMed

    Wu, Yung-Tsan; Ke, Ming-Jen; Chou, Yu-Ching; Chang, Chih-Ya; Lin, Ching-Yueh; Li, Tsung-Ying; Shih, Feng-Mei; Chen, Liang-Cheng

    2016-06-01

    Three recent studies demonstrated the positive effect of extracorporeal shock wave therapy (ESWT) for treating carpal tunnel syndrome (CTS). However, none have entirely proved the effects of ESWT on CTS because all studies had a small sample size and lacked a placebo-controlled design. Moreover, radial ESWT (rESWT) has not been used to treat CTS. We conducted a prospective randomized, controlled, double-blinded study to assess the effect of rESWT for treating CTS. Thirty-four enrolled patients (40 wrists) were randomized into intervention and control groups (20 wrists in each). Participants in the intervention group underwent three sessions of rESWT with nightly splinting, whereas those in the control group underwent sham rESWT with nightly splinting. The primary outcome was visual analog scale (VAS), whereas the secondary outcomes included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. Evaluations were performed before treatment and at 1, 4, 8, and 12 weeks after the third rESWT session. A significantly greater improvement in the VAS, BCTQ scores, and CSA of the median nerve was noted in the intervention group throughout the study as compared to the control group (except for BCTQ severity at week 12 and CSA at weeks 1 and 4) (p < 0.05). This is the first study to assess rESWT in a randomized placebo-controlled trial and demonstrate that rESWT is a safe and effective method for relieving pain and disability in patients with CTS. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:977-984, 2016.

  8. Cardiovascular effects of dietary salt intake in aged healthy cats: a 2-year prospective randomized, blinded, and controlled study.

    PubMed

    Chetboul, Valérie; Reynolds, Brice Stéphane; Trehiou-Sechi, Emilie; Nguyen, Patrick; Concordet, Didier; Sampedrano, Carolina Carlos; Testault, Isabelle; Elliott, Jonathan; Abadie, Jérôme; Biourge, Vincent; Lefebvre, Hervé Pierre

    2014-01-01

    High salt dry expanded diets are commercially available for cats to increase water intake and urine volume, as part of the prevention or treatment of naturally occurring urinary stone formation (calcium oxalates and struvites). However, chronic high salt intake may have potential cardiovascular adverse effects in both humans, especially in aging individuals, and several animal models. The objective of this prospective, randomized, blinded, and controlled study was to assess the long-term cardiovascular effects of high salt intake in healthy aged cats. Twenty healthy neutered cats (10.1 ± 2.4 years) were randomly allocated into 2 matched groups. One group was fed a high salt diet (3.1 g/Mcal sodium, 5.5 g/Mcal chloride) and the other group a control diet of same composition except for salt content (1.0 g/Mcal sodium, 2.2 g/Mcal chloride). Clinical examination, systolic and diastolic arterial blood pressure measurements, standard transthoracic echocardiography and conventional Doppler examinations were repeatedly performed on non-sedated cats by trained observers before and over 24 months after diet implementation. Radial and longitudinal velocities of the left ventricular free wall and the interventricular septum were also assessed in systole and diastole using 2-dimensional color tissue Doppler imaging. Statistics were performed using a general linear model. No significant effect of dietary salt intake was observed on systolic and diastolic arterial blood pressure values. Out of the 33 tested imaging variables, the only one affected by dietary salt intake was the radial early on late diastolic velocity ratio assessed in the endocardium of the left ventricular free wall, statistically lower in the high salt diet group at 12 months only (P = 0.044). In conclusion, in this study involving healthy aged cats, chronic high dietary salt intake was not associated with an increased risk of systemic arterial hypertension and myocardial dysfunction, as observed in some

  9. 1-year follow-up after radiofrequency tonsillotomy and laser tonsillotomy in children: a prospective, double-blind, clinical study.

    PubMed

    Stelter, Klaus; Ihrler, Stephan; Siedek, Vanessa; Patscheider, Martin; Braun, Thomas; Ledderose, Georg

    2012-02-01

    In the last decade, tonsillotomy has come into vogue again, whereas the number of tonsillectomies is decreasing rapidly. In a previous study, the tonsillotomy with laser or radiofrequency therapy proved as a safe and effective procedure with minimal pain and hemorrhage. This follow-up study determines which method is more effective with respect to long-term outcome, recurrence of tonsillar hyperplasia and recurrence of tonsillitis. A prospective, randomised, double-blinded controlled clinical study was conducted at the Department of Otorhinolaryngology of the Ludwig-Maximilians-University, Munich, Germany. Twenty-six children with tonsillar hypertrophy were included. Tonsillotomy was performed on one side with monopolar radiofrequency and on the other side with a carbon dioxide laser. Exactly 1 year after the procedure, all 26 patients were documented by digital photography to define a possible recurrence of tonsillar hyperplasia. All parents were asked for occurring tonsillitis and fulfilled the Glasgow Children's Benefit Inventory (GCBI) for health-related quality of life after surgical procedures. In seven children, a slightly visible recurrence of the tonsillar hyperplasia occurred, without any symptoms or correlation to the different methods and sides. One child with recurrent tonsillitis and hyperplasia had to be tonsillectomized 8 months after the initial tonsillotomy procedure. The specimen showed open crypts with bacterial infection in the deep. The GCBI resulted in highly significant benefits of the surgery in all categories and subcategories. In conclusion, both methods, the laser tonsillotomy and the radiofrequency method, were equal concerning the effectiveness and safety after 1 year. Further investigations have to aim at the long-term outcome after tonsillotomy in patients with recurrent infections.

  10. Dexamethasone as An Additive to Bupivacaine in Fascia Lliaca Compartment Block: A Prospective, Randomized and Double Blind Study

    PubMed Central

    Kumar N, Suresh; N, Kiran; Sebastian, Don; Gowda RM, Punith

    2014-01-01

    Background: Patients with fracture femur experience severe pain on movement during positioning for spinal anaesthesia. Fascia Iliaca Compartment Block (FICB) has been used effectively for providing analgesia during positioning of the patient for spinal anaesthesia. Aim: To test the hypothesis that, adding dexamethasone would significantly prolong the duration of Bupivacaine in FICB. Materials and Methods: Sixty patients aged 18 to 80 years posted for ORIF (Open Reduction and Internal Fixation) of fracture femur were included to receive FICB. This was a prospective, randomized, double blind study done at tertiary medical college hospital. Thirty patients received 38ml of 0.25 % bupivacaine with 2ml saline and another 30 patients received 38ml of 0.25 % bupivacaine with 2ml dexamethasone (8mg). Thirty minutes after FICB, patient satisfaction during positioning for spinal anesthesia was recorded. In the post-operative period, duration of analgesia and the total doses of rescue analgesics were recorded in both the groups. Results: Patients who received Bupivacaine with dexamethasone had significant prolongation of analgesia and required fewer doses of rescue analgesics as compared to patients who received Bupivacaine alone for FICB. However, the onset of analgesia, VAS scores and patient satisfaction during positioning for spinal anaesthesia were similar in both groups. Conclusion: Our study shows that adding Dexamethasone (8mg) to Bupivacaine for FICB significantly prolonged the duration of block and decreased the requirement of rescue analgesics as compared to patients who received Bupivacaine alone. FICB is relatively easy and safe to perform. In our study we did not encounter any complication while doing the procedures and also by adding dexamethasone. PMID:25302209

  11. Effect of discontinuing morning dose of antihypertensive for renal transplant surgery on haemodynamic and early graft functioning: A prospective, double-blind, randomised study

    PubMed Central

    Kumar, Vinod; Arya, Virendra Kumar; Sondekoppam, Rakesh V; Arora, Suman; Minz, Mukut; Garg, Rakesh; Gupta, Nishkarsh

    2017-01-01

    Background and Aims: Antihypertensive drugs are continued until the day of renal transplant surgery. These are associated with increased incidence of hypotension and bradycardia. Hence, this study was designed to evaluate perioperative haemodynamic and early graft functioning in renal recipients with discontinuation of antihypertensive drugs on the morning of surgery. Methods: This prospective, randomised, double-blind study recruited 120 patients. Group 1 patients received placebo tablet while Group 2 patients received usual antihypertensive drugs on the day of surgery. Perioperative haemodynamics and time for reinstitution of antihypertensives were the primary outcome measures. The secondary outcome measures were need for inotropic support and graft function. Perioperative haemodynamics were analysed using ANOVA and Student's t-tests with Bonferroni correction. Fischer's exact test was used for analysis. Results: Systolic blood pressure (SBP) declined, which was more in Group 2. Forty-one patients developed significant hypotension; a correlation was found between the maximum observed hypotension and number of antihypertensive medications (P = 0.003). Four cases had slow graft function (one in Group 1 and three in Group 2). Twenty-eight patients in Group 2 required mephentermine boluses to maintain their SBP compared to 13 patients in Group 1 (P < 0.001). Two patients in Group 2 required dopamine to maintain SBP above 90 mmHg after the establishment of reperfusion as compared to none in Group 1. Conclusion: Single dose of long-acting antihypertensive drugs can be omitted on the morning of surgery without any haemodynamic fluctuations and graft function in controlled hypertensive end-stage renal disease renal transplant patients receiving a combined epidural and general anaesthesia. PMID:28250484

  12. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study

    PubMed Central

    Kim, Sung-Hoon; Hong, Jeong-Yeon; Kim, Won Oak; Karm, Myong-Hwan; Hwang, Jai-Hyun

    2013-01-01

    Background Postoperative nausea and vomiting (PONV) continues to be a major problem, because PONV is associated with delayed recovery and prolonged hospital stay. Although the PONV guidelines recommended the use of 5-hydroxy-tryptamine (5-HT3) receptor antagonists as the first-line prophylactic agents in patients categorized as high-risk, there are few studies comparing the efficacies of ondansetron, ramosetron, and palonosetron. The aim of present study was to compare the prophylactic antiemetic efficacies of three 5HT3 receptor antagonists in high-risk patients after laparoscopic surgery. Methods In this prospective, randomized, double-blinded trial, 109 female nonsmokers scheduled for elective laparoscopic surgery were randomized to receive intravenous 4 mg ondansetron (n = 35), 0.3 mg ramosetron (n = 38), or 75 µg palonosetron (n = 36) before anesthesia. Fentanyl-based intravenous patient-controlled analgesia was administered for 48 h after surgery. Primary antiemetic efficacy variables were the incidence and severity of nausea, the frequency of emetic episodes during the first 48 h after surgery, and the need to use a rescue antiemetic medication. Results The overall incidence of nausea/retching/vomiting was lower in the palonosetron (22.2%/11.1%/5.6%) than in the ondansetron (77.1%/48.6%/28.6%) and ramosetron (60.5%/28.9%/18.4%) groups. The rescue antiemetic therapy was required less frequently in the palonosetron group than the other groups (P < 0.001). Kaplan-Meier analysis showed that the order of prophylactic efficacy in delaying the interval to use of a rescue emetic was palonosetron, ramosetron, and ondansetron. Conclusions Single-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery. PMID:23814652

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

    NASA Astrophysics Data System (ADS)

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

    2017-02-01

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

  14. Comparative effectiveness of quetiapine and haloperidol in delirium: A single blind randomized controlled study

    PubMed Central

    Grover, Sandeep; Mahajan, Sudhir; Chakrabarti, Subho; Avasthi, Ajit

    2016-01-01

    AIM To evaluate the effectiveness of quetiapine and haloperidol in patients of delirium referred to psychiatry consultation liaison services. METHODS The study followed a single blind randomised controlled trial design. Thirty-two patients in the haloperidol group and 31 patients in the quetiapine group were assessed at the baseline and 6 consecutive days. Flexible dosing regimen (haloperidol: 0.25-1.25 mg; quetiapine 12.5-75 mg/d) was used. Delirium Rating Scale-Revised-98 (DRS-R-98) and mini mental status examination (MMSE) were the primary and secondary efficacy measures respectively. RESULTS Baseline DRS-R-98 severity score and MMSE scores did not differ between the 2 study groups. From baseline to day 6, there was significant reduction in the total DRS-R-98 scores, DRS-R-98 cognitive domain scores, DRS-R-98 non-cognitive domain scores and significant increase in the MMSE scores in both the groups. Both the groups did not differ on any of the assessments in terms of DRS-R98 and MMSE scores. The effectiveness of both the medications was similar in adult and elderly (≥ 60 years) patients. At the end of the trial, 68.75% and 67.74% of subjects in the haloperidol and quetiapine group respectively had mean DRS-R-98 scores below 10. By 6th day, 12 (37.5%) patients in haloperidol group and 9 (29.03%) patients in the quetiapine group had DRS-R98 score of “0” with no significant difference between the two groups (P = 0.47). CONCLUSION Quetiapine is as effective as haloperidol in the management of delirium. PMID:27679777

  15. Effect of tomato consumption on high-density lipoprotein cholesterol level: a randomized, single-blinded, controlled clinical trial

    PubMed Central

    Cuevas-Ramos, Daniel; Almeda-Valdés, Paloma; Chávez-Manzanera, Emma; Meza-Arana, Clara Elena; Brito-Córdova, Griselda; Mehta, Roopa; Pérez-Méndez, Oscar; Gómez-Pérez, Francisco J

    2013-01-01

    Introduction Epidemiologic evidence suggests that tomato-based products could reduce the risk of cardiovascular diseases. One of the main cardiovascular risk factors is low levels of high-density lipoprotein cholesterol (HDL-C). This study aimed to prospectively evaluate the effect of tomato consumption on HDL-C levels. Subject and methods We conducted a randomized, single-blinded, controlled clinical trial. We screened 432 subjects with a complete lipid profile. Those individuals with low HDL-C (men <40 mg/dL and women <50 mg/dL) but normal triglyceride levels (<150 mg/dL) were included. Selected participants completed a 2-week run-in period on an isocaloric diet and then were randomized to receive 300 g of cucumber (control group) or two uncooked Roma tomatoes a day for 4 weeks. Results A total of 50 individuals (women = 41; 82%) with a mean age of 42 ± 15.5 years and a mean body mass index of 27.6 ± 5.0 kg/m2 completed the study. A significant increase in HDL-C levels was observed in the tomato group (from 36.5 ± 7.5 mg/dL to 41.6 ± 6.9 mg/dL, P < 0.0001 versus the control group). After stratification by gender, the difference in HDL-C levels was only significant in women. The mean HDL-C increase was 5.0 ± 2.8 mg/dL (range 1–12 mg/dL). Twenty patients (40%) finished the study with levels >40 mg/dL. A linear regression model that adjusted for those parameters that impact HDL-C levels (age, gender, waist-to-hip ratio, body mass index, fasting triglyceride concentration, simple sugars, alcohol, physical activity, and omega-3 consumption) showed an independent association between tomato consumption and the increase in HDL-C (r2 = 0.69; P < 0.0001). Conclusion Raw tomato consumption produced a favorable effect on HDL-C levels in overweight women. PMID:23935376

  16. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial.

    PubMed

    Dale, Gregory J; Phillips, Stephanie; Falk, Gregory L

    2016-01-01

    This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation) at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286) or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487). Three adverse events occurred in the lidocaine group (25% of patients). Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested.

  17. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial

    PubMed Central

    Dale, Gregory J; Phillips, Stephanie; Falk, Gregory L

    2016-01-01

    This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation) at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286) or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487). Three adverse events occurred in the lidocaine group (25% of patients). Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested. PMID:27980437

  18. Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study

    PubMed Central

    Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

    2016-01-01

    Background Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. Objective This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients’ perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. Methods The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Results Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). Conclusions This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. Trial Registration German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http

  19. Prospects for single-particle imaging at XFELs

    SciTech Connect

    Chapman, H N; Hau-Riege, S P; London, R A; Marchesini, S; Noy, A; Szoke, A; Szoke, H; Ingerman, E; Hajdu, J; Huldt, G; Howells, M R; He, H; Spence, J H; Weierstall, U

    2004-04-25

    X-ray free-electron lasers will produce pulses of x-rays that are 10 orders of magnitude brighter than today's undulator sources at synchrotrons. This may enable atomic resolution imaging of single macromolecules.

  20. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial

    PubMed Central

    Ruha, Anne-Michelle; Seifert, Steven A.; Morgan, David L.; Lewis, Brandon J.; Arnold, Thomas C.; Clark, Richard F.; Meggs, William J.; Toschlog, Eric A.; Borron, Stephen W.; Figge, Gary R.; Sollee, Dawn R.; Shirazi, Farshad M.; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D.; Boyer, Leslie V.

    2015-01-01

    Background. Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. Methods. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count < 150 K/mm3, fibrinogen level < 150 mg/dL) between end of maintenance dosing and day 8. Results. 121 patients were randomized at 18 clinical sites and received at least one dose of study drug. 114 completed the study. Of these, 11/37 (29.7%) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. Conclusions. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation

  1. Cardiovascular Effects of Dietary Salt Intake in Aged Healthy Cats: A 2-Year Prospective Randomized, Blinded, and Controlled Study

    PubMed Central

    Chetboul, Valérie; Reynolds, Brice Stéphane; Trehiou-Sechi, Emilie; Nguyen, Patrick; Concordet, Didier; Sampedrano, Carolina Carlos; Testault, Isabelle; Elliott, Jonathan; Abadie, Jérôme; Biourge, Vincent; Lefebvre, Hervé Pierre

    2014-01-01

    High salt dry expanded diets are commercially available for cats to increase water intake and urine volume, as part of the prevention or treatment of naturally occurring urinary stone formation (calcium oxalates and struvites). However, chronic high salt intake may have potential cardiovascular adverse effects in both humans, especially in aging individuals, and several animal models. The objective of this prospective, randomized, blinded, and controlled study was to assess the long-term cardiovascular effects of high salt intake in healthy aged cats. Twenty healthy neutered cats (10.1±2.4 years) were randomly allocated into 2 matched groups. One group was fed a high salt diet (3.1 g/Mcal sodium, 5.5 g/Mcal chloride) and the other group a control diet of same composition except for salt content (1.0 g/Mcal sodium, 2.2 g/Mcal chloride). Clinical examination, systolic and diastolic arterial blood pressure measurements, standard transthoracic echocardiography and conventional Doppler examinations were repeatedly performed on non-sedated cats by trained observers before and over 24 months after diet implementation. Radial and longitudinal velocities of the left ventricular free wall and the interventricular septum were also assessed in systole and diastole using 2-dimensional color tissue Doppler imaging. Statistics were performed using a general linear model. No significant effect of dietary salt intake was observed on systolic and diastolic arterial blood pressure values. Out of the 33 tested imaging variables, the only one affected by dietary salt intake was the radial early on late diastolic velocity ratio assessed in the endocardium of the left ventricular free wall, statistically lower in the high salt diet group at 12 months only (P = 0.044). In conclusion, in this study involving healthy aged cats, chronic high dietary salt intake was not associated with an increased risk of systemic arterial hypertension and myocardial dysfunction, as observed in some

  2. Intravenous ciprofloxacin and ceftazidime in serious infections. A prospective, controlled clinical trial with third-party blinding.

    PubMed

    Sifuentes-Osornio, J; Macías, A; Amieva, R I; Ramos, A; Ruiz-Palacios, G M

    1989-11-30

    Oral ciprofloxacin has been shown to be effective in the treatment of infections due to gram-positive cocci and gram-negative rods. The efficacy and safety of intravenous ciprofloxacin was compared with that of intravenous ceftazidime in the treatment of 59 patients with well-documented serious infections in a prospective, controlled, randomized study with a third-party blinding. Thirty-three patients were treated with intravenous ciprofloxacin (200 mg every 12 hours, plus a daily extra placebo dose); 26 patients were treated with ceftazidime (1 g every eight hours). The severity of the infections, underlying diseases, and demographic features were comparable in both groups, although there were more men in the ciprofloxacin group. For ciprofloxacin/ceftazidime treatments, respectively, the evaluated infections were: pyelonephritis (16 patients/nine patients), pneumonia (three/five), soft-tissue infections (four/zero), spontaneous peritonitis (five/two), primary bacteremia (three/eight), and other (two/two). Isolated pathogens included: Escherichia coli (22/12), Klebsiella sp. (five/four), Pseudomonas aeruginosa (two/three), Haemophilus influenzae (one/one), Proteus mirabilis (two/zero), Proteus vulgaris (one/zero), Salmonella sp. (zero/two), Plesiomonas shigelloides (one/zero), and others (one/four). The clinical responses were cure or improvement in 31 ciprofloxacin cases/21 ceftazidime cases; failure, zero/four; and indeterminate, two/one. The bacteriologic responses were eradication in 28 ciprofloxacin cases/22 ceftazidime cases; persistence, one/three; and indeterminate, four/one. Mild intolerance occurred in three ciprofloxacin cases and two ceftazidime cases. A mild increase in serum hepatic enzymes was observed in two patients in each group. Superinfections occurred in five patients: enterococcal septicemia (zero/two) and urinary tract infections (one/two). The results presented suggest that intravenous ciprofloxacin is an effective and safe antimicrobial

  3. Switching from clozapine to zotepine in patients with schizophrenia: a 12-week prospective, randomized, rater blind, and parallel study.

    PubMed

    Lin, Chao-Cheng; Chiu, Hsien-Jane; Chen, Jen-Yeu; Liou, Ying-Jay; Wang, Ying-Chieh; Chen, Tzu-Ting; Bai, Ya-Mei

    2013-04-01

    Clozapine is the most effective antipsychotic for patients with treatment-refractory schizophrenia, but many adverse effects are noted. Clinicians usually hesitate to switch from clozapine to other antipsychotics because of the risk of a re-emergence or worsening of the psychosis, although empirical studies are very limited. Zotepine, an atypical antipsychotic with a pharmacologic profile similar to clozapine, was found to be an effective treatment for patients with treatment-resistant schizophrenia in Japan. This 12-week study is the first prospective, randomized, and rater-blind study to investigate the efficacy and tolerability of switching from clozapine to zotepine. Fifty-nine patients with schizophrenia, who had taken clozapine for at least 6 months with a Clinical Global Impression-Severity score of at least 3, were randomly allocated to the zotepine and the clozapine groups. At the end of the study, 52 patients (88%) had completed the trial. The 7 withdrawal cases were all in the zotepine group. The final mean (SD) dose of zotepine and clozapine was 397.1 (75.7) versus 377.1 (62.5) mg/d, respectively. Patients in the zotepine group showed a significant increase in the Brief Psychiatric Rating Scale [mean (SD), 4.7 (8.7) vs -1.3 (6.3); P = 0.005], more general adverse effects as revealed by the Udvalg for Kliniske Undersogelser Rating Scale [mean (SD), 1.74 (3.9) vs -0.2 (2.8); P = 0.039], more extrapyramidal adverse effects as demonstrated by the Simpson and Angus Scale [mean (SD), 1.29 (3.5) vs 0.17 (2.1); P = 0.022], an increased use of propranolol (37.1% vs 0%, P < 0.0001) and anticholinergics (25.7% vs 0%, P = 0.008), and an increased level of prolactin (29.6 vs -3.8 ng/ mL, P < 0.0005), compared with the clozapine group. The results suggested that switching from clozapine to zotepine treatment should be done with caution.

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

    PubMed

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

    2017-02-16

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

  5. Single-cell protein: current status and future prospects.

    PubMed

    Tusé, D

    1984-01-01

    The consumption of microorganisms by man and animals is not a revolutionary new idea. For thousands of years man has consumed, either intentionally or unintentionally, such products as alcoholic beverages, cheeses, yogurt, and soya sauce and, along with these products, the microbial biomass responsible for their production. The rapid growth rate and high protein content of microbes and their ability to utilize inexpensive feedstocks as sources of carbon and energy for growth have made microorganisms prime candidates for use as human food and animal feed protein supplements. Yet, in spite of their promise, only a limited number of commercial-scale, single-cell protein (SCP) processes have been seen. Recently, with the advent of recombinant DNA technology a rebirth of interest in SCP has resulted. This review analyzes the answers to two questions: (1) how far have we come?; and (2) what impact, if any, will the new biotechnologies have in this field?

  6. A prospective study of Astra single tooth implants.

    PubMed

    Palmer, R M; Smith, B J; Palmer, P J; Floyd, P D

    1997-06-01

    A new design of single tooth implant (AstraTech, Molndal Sweden) featuring a microthreaded conical neck and TiO blast surface was evaluated clinically and radiographically after 2 years in function. Fifteen patients (age range 16 to 48) with missing maxillary anterior teeth (6 central incisors, 8 laterals, 1 bicuspid) had 4, 13 mm and 11, 15 mm implants placed under local anaesthesia and left for a period of 6 months before exposure and abutment connection/crown fabrication. All patients were seen at 4 to 6 monthly intervals for hygienist maintenance. Radiographs using Rinn holders and a long cone technique were taken at the crown insertion and after 1 year (14 subjects) and 2 years (12 subjects). All implants were successfully integrated at stage 2, and no implants have been lost. The internal conical seal design of the abutment/implant interface facilitated connection and there were no cases of abutment screw loosening. No soft tissue problems were observed, and the gingival morphology/health was well maintained. One crown was recemented after 18 months in function, and 1 crown was replaced because of a fracture to the porcelain incisal edge. At crown insertion, the mean bone level was 0.46 to 0.48 mm apical to the top of the implant and there were no statistically significant changes in the bone level over the 2 years of the study. In conclusion, the single tooth Astra implants were highly successful and bone changes within the first 2 years of function were comparable with other systems reporting high long-term success rates.

  7. Single Photon Counting UV Solar-Blind Detectors Using Silicon and III-Nitride Materials

    PubMed Central

    Nikzad, Shouleh; Hoenk, Michael; Jewell, April D.; Hennessy, John J.; Carver, Alexander G.; Jones, Todd J.; Goodsall, Timothy M.; Hamden, Erika T.; Suvarna, Puneet; Bulmer, J.; Shahedipour-Sandvik, F.; Charbon, Edoardo; Padmanabhan, Preethi; Hancock, Bruce; Bell, L. Douglas

    2016-01-01

    Ultraviolet (UV) studies in astronomy, cosmology, planetary studies, biological and medical applications often require precision detection of faint objects and in many cases require photon-counting detection. We present an overview of two approaches for achieving photon counting in the UV. The first approach involves UV enhancement of photon-counting silicon detectors, including electron multiplying charge-coupled devices and avalanche photodiodes. The approach used here employs molecular beam epitaxy for delta doping and superlattice doping for surface passivation and high UV quantum efficiency. Additional UV enhancements include antireflection (AR) and solar-blind UV bandpass coatings prepared by atomic layer deposition. Quantum efficiency (QE) measurements show QE > 50% in the 100–300 nm range for detectors with simple AR coatings, and QE ≅ 80% at ~206 nm has been shown when more complex AR coatings are used. The second approach is based on avalanche photodiodes in III-nitride materials with high QE and intrinsic solar blindness. PMID:27338399

  8. Single Photon Counting UV Solar-Blind Detectors Using Silicon and III-Nitride Materials.

    PubMed

    Nikzad, Shouleh; Hoenk, Michael; Jewell, April D; Hennessy, John J; Carver, Alexander G; Jones, Todd J; Goodsall, Timothy M; Hamden, Erika T; Suvarna, Puneet; Bulmer, J; Shahedipour-Sandvik, F; Charbon, Edoardo; Padmanabhan, Preethi; Hancock, Bruce; Bell, L Douglas

    2016-06-21

    Ultraviolet (UV) studies in astronomy, cosmology, planetary studies, biological and medical applications often require precision detection of faint objects and in many cases require photon-counting detection. We present an overview of two approaches for achieving photon counting in the UV. The first approach involves UV enhancement of photon-counting silicon detectors, including electron multiplying charge-coupled devices and avalanche photodiodes. The approach used here employs molecular beam epitaxy for delta doping and superlattice doping for surface passivation and high UV quantum efficiency. Additional UV enhancements include antireflection (AR) and solar-blind UV bandpass coatings prepared by atomic layer deposition. Quantum efficiency (QE) measurements show QE > 50% in the 100-300 nm range for detectors with simple AR coatings, and QE ≅ 80% at ~206 nm has been shown when more complex AR coatings are used. The second approach is based on avalanche photodiodes in III-nitride materials with high QE and intrinsic solar blindness.

  9. CH3NH3PbCl3 Single Crystals: Inverse Temperature Crystallization and Visible-Blind UV-Photodetector.

    PubMed

    Maculan, Giacomo; Sheikh, Arif D; Abdelhady, Ahmed L; Saidaminov, Makhsud I; Haque, Md Azimul; Murali, Banavoth; Alarousu, Erkki; Mohammed, Omar F; Wu, Tom; Bakr, Osman M

    2015-10-01

    Single crystals of hybrid perovskites have shown remarkably improved physical properties compared to their polycrystalline film counterparts, underscoring their importance in the further development of advanced semiconductor devices. Here we present a new method of growing sizable CH3NH3PbCl3 single crystals based on the retrograde solubility behavior of hybrid perovskites. We show, for the first time, the energy band structure, charge recombination, and transport properties of CH3NH3PbCl3 single crystals. These crystals exhibit trap-state density, charge carrier concentration, mobility, and diffusion length comparable with the best quality crystals of methylammonium lead iodide or bromide perovskites reported so far. The high quality of the crystal along with its suitable optical band gap enabled us to build an efficient visible-blind UV-photodetector, demonstrating its potential in optoelectronic applications.

  10. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial

    PubMed Central

    Andersson, Erik; Mataix-Cols, David; Lichtenstein, Linn; Alström, Katarina; Andersson, Gerhard; Ljótsson, Brjánn; Rück, Christian

    2016-01-01

    Objectives To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. Design A 12 week single blind parallel group randomised controlled trial. Setting Academic medical centre. Participants 94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. Interventions Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. Main outcome measures The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. Results BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference −7.1 points, 95% confidence interval −9.8 to −4.4), depression (MADRS-S group difference −4.5 points, −7.5 to −1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self

  11. Efficacy of Losartan in the management of Post-Dialysis Euvolemic Hypertension (HELD-Trial): A Single-Blind Randomized Control Trial.

    PubMed

    Aftab, Raja Ahsan; Khan, Amer Hayat; Adnan, Azreen Syazril; Sulaiman, Syed Azhar Syed; Khan, Tahir Mehmood

    2016-12-06

    To assess the effectiveness of losartan 50 mg on post dialysis euvolemic hypertensive patients against standard antihypertensive pharmacotherapy. A multicentre, prospective, randomized, single-blind trial was conducted to assess the effect of losartan 50 mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Covariate-adaptive randomization was used to allocate participants to a standard or treatment arm, and they were followed up for eight weeks. Pre-, intra- and post-dialysis session blood pressure (BP) measurements were recorded along with any adverse events. A total of 88 patients were randomized into standard (n = 44) and treatment arms (n = 44) and were followed for a period of 8 weeks. In the standard group, the mean post-dialysis blood pressure dropped by 0.3 mmHg by the end of the 8(th) week. However the treatment arm reported a drop of 2.4 mmHg of BP drop during the 8-week trial period. Analysis suggests that there was a significant difference in blood pressure readings at the end of 8 weeks among patients treated with losartan (P < 0.001). However, no such statistical association was observed in the standard arm (P 0.75). A slow, steady significant decline in post-dialysis BP was observed among euvolemic hypertensive patients that were treated with losartan 50 mg.

  12. Efficacy of Losartan in the management of Post-Dialysis Euvolemic Hypertension (HELD-Trial): A Single-Blind Randomized Control Trial

    PubMed Central

    Aftab, Raja Ahsan; Khan, Amer Hayat; Adnan, Azreen Syazril; Sulaiman, Syed Azhar Syed; Khan, Tahir Mehmood

    2016-01-01

    To assess the effectiveness of losartan 50 mg on post dialysis euvolemic hypertensive patients against standard antihypertensive pharmacotherapy. A multicentre, prospective, randomized, single-blind trial was conducted to assess the effect of losartan 50 mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Covariate-adaptive randomization was used to allocate participants to a standard or treatment arm, and they were followed up for eight weeks. Pre-, intra- and post-dialysis session blood pressure (BP) measurements were recorded along with any adverse events. A total of 88 patients were randomized into standard (n = 44) and treatment arms (n = 44) and were followed for a period of 8 weeks. In the standard group, the mean post-dialysis blood pressure dropped by 0.3 mmHg by the end of the 8th week. However the treatment arm reported a drop of 2.4 mmHg of BP drop during the 8-week trial period. Analysis suggests that there was a significant difference in blood pressure readings at the end of 8 weeks among patients treated with losartan (P < 0.001). However, no such statistical association was observed in the standard arm (P 0.75). A slow, steady significant decline in post-dialysis BP was observed among euvolemic hypertensive patients that were treated with losartan 50 mg. PMID:27922020

  13. Blindness - resources

    MedlinePlus

    Resources - blindness ... The following organizations are good resources for information on blindness : American Foundation for the Blind -- www.afb.org Foundation Fighting Blindness -- www.blindness.org National Eye Institute -- ...

  14. Lack of effect of ivermectin on prepatent guinea-worm: a single-blind, placebo-controlled trial.

    PubMed

    Issaka-Tinorgah, A; Magnussen, P; Bloch, P; Yakubu, A

    1994-01-01

    The effect of ivermectin on prepatent guinea-worm was tested in a single-blind placebo-controlled trial; 400 adults were randomly allocated to a single dose of ivermectin (150 micrograms/kg) or placebo. Fifty-four of the 385 participants who were followed for 15 months developed a total of 69 emergent guinea-worms. There was no significant difference in the proportion of persons with emergent guinea-worms between the 2 treatment groups; 58% appeared in males. 80% of emergent guinea-worms were located below the knee. Migration of guinea-worms in the tissues was not affected. It is concluded that ivermectin has no effect on prepatent guinea-worms nor does it disturb their migration pattern. No adverse reaction to treatment was seen. It appears that ivermectin can be used safely as mass chemotherapy against onchocerciasis and lymphatic filariasis in areas where guinea-worm is also endemic.

  15. A single cohort prospective trial of the immediate effects of spinal manipulation on visual acuity

    PubMed Central

    Athaide, Michelle; Rego, Carol; Budgell, Brian

    2016-01-01

    Introduction: There is no high quality evidence on which to judge the generalizability of isolated reports of improvement in vision following manipulation. The current paucity of research results also precludes the thoughtful design of a controlled, prospective clinical study. Hence, the purpose of the current study was to test the feasibility of conducting a clinical trial of the acute effects of spinal manipulation on visual acuity. Methods: New adult patients presenting to a community based chiropractic clinic were recruited into a single cohort prospective trial to determine the immediate effects of cervical spinal manipulation on visual acuity. Results: The experimental protocol was well accepted by patients and caused minimal or no disruption of the clinic routine. By some measures, chiropractic treatment was accompanied by statistically significant improvements in visual acuity. Discussion: The results of this study indicate that it is quite feasible to conduct a prospective, community based clinical study of the acute effects of spinal manipulation on visual acuity. PMID:27069271

  16. A method for extracting fetal ECG based on EMD-NMF single channel blind source separation algorithm.

    PubMed

    He, Pengju; Chen, Xiaomeng

    2015-01-01

    Nowadays, detecting fetal ECG using abdominal signal is a commonly used method, but fetal ECG signal will be affected by maternal ECG. Current FECG extraction algorithms are mainly aiming at multiple channels signal. They often assume there is only one fetus and did not consider multiple births. This paper proposed a single channel blind source separation algorithm to process single abdominal acquired signal. This algorithm decomposed single abdominal signal into multiple intrinsic mode function (IMF) utilizing empirical mode decomposition (EMD). Correlation matrix of IMF was calculated and independent ECG signal number was estimated using eigenvalue method. Nonnegative matrix was constructed according to determined number and decomposed IMF. Separation of MECG and FECG was achieved utilizing nonnegative matrix factorization (NMF). Experiments selected four channels man-made signal and two channels ECG to verify correctness and feasibility of proposed algorithm. Results showed that the proposed algorithm could determine number of independent signal in single acquired signal. FECG could be extracted from single channel observed signal and the algorithm can be used to solve separation of MECG and FECG.

  17. Efficacy and Safety of Two Different n-Butyl-2-Cyanoacrylates for the Embolization of Varicoceles: A Prospective, Randomized, Blinded Study

    SciTech Connect

    Vanlangenhove, Peter Keukeleire, Katrien De; Everaert, Karel; Maele, Georges Van; Defreyne, Luc

    2012-06-15

    Purpose: This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. Methods: A total of 112 insufficient spermatic veins (left-sided, n = 84; right-sided, n = 28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n = 54; Histoacryl, Braun, Germany) or NBCA-MS (n = 58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Results: Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n = 54/54, 100% vs. NBCA-MS, n = 54/57, 94.7%; P = 0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n = 45/54, 83.3% vs. NBCA-MS, n = 41/58, 70.7%; P = 0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n = 25/54, 46.3% vs. NBCA-MS, n = 29/58, 50%; P = 0.71). No glue-related complications were noted. Conclusions: NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

  18. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke

    PubMed Central

    Morel, Claire; Hauret, Isabelle; Andant, Nicolas; Bonnin, Armand; Pereira, Bruno; Coudeyre, Emmanuel

    2016-01-01

    Introduction Botulinum toxin injections are an effective treatment for limb spasticity following stroke. Different tracking techniques are used for this purpose: palpation, electrostimulation, electromyography and ultrasound. Yet very few studies have compared these different techniques, and none has successfully proved the superior efficacy of ultrasound-guided injections compared to another tracking method. The primary objective of our study was therefore to compare the efficacy of botulinum toxin injections depending on the tracking technique used: ultrasound versus electrostimulation. Methods and analysis This is a clinical, single-centre, prospective, interventional, single-blind, crossover, randomised trial. In total, 30 patients aged between 18 and 80 years presenting with triceps surae spasticity (evaluated >1 on the modified Ashworth scale) associated with hemiplegia sequelae due to stroke will be included. The patients will be selected among those who attend for consultation the Physical Medicine and Rehabilitation Department of the Clermont-Ferrand University Hospital. One group will receive the abobotulinumtoxinA (BoNT-A) injection guided by electrostimulation then ultrasound, and the second group's botulinum toxin injections will be guided by ultrasound then electrostimulation. For each patient, the duration of study participation is 5 months. The primary end point is variation in passive ankle dorsiflexion range of motion at slow and high speeds (Tardieu scale) with the knee straight. Ethics and dissemination This study received ethics approval form the CPP of Rhônes-Alpes region. Results will be published in a peer-reviewed journal. Trial registration number NCT01935544; pre-results. PMID:27852706

  19. Single dose cabergoline versus bromocriptine in inhibition of puerperal lactation: randomised, double blind, multicentre study. European Multicentre Study Group for Cabergoline in Lactation Inhibition.

    PubMed Central

    1991-01-01

    OBJECTIVE--To compare the efficacy and safety of a single dose of 1 mg of cabergoline with that of bromocriptine 2.5 mg twice daily for 14 days in the inhibition of puerperal lactation. DESIGN--Prospective, randomised, double blind, parallel group, multicentre study. SETTING--University of hospital departments of obstetrics and gynaecology in different European countries. SUBJECTS--272 puerperal women not wishing to lactate (136 randomised to each drug). INTERVENTIONS--Women randomised to cabergoline received two 0.5 mg tablets of cabergoline and one placebo tablet within 27 hours after delivery and then placebo twice daily for 14 days. Those randomised to bromocriptine received 2.5 mg of bromocriptine and two placebo tablets within 27 hours and then 2.5 mg of bromocriptine twice daily for 14 days. MAIN OUTCOME MEASURES--Success of treatment (complete or partial) according to milk secretion, breast engorgement, and breast pain; rebound symptomatology; serum prolactin concentrations; and number of adverse events. RESULTS--Complete success was achieved in 106 of 136 women randomised to cabergoline and in 94 of 136 randomised to bromocriptine and partial success in 21 and 33 women respectively. Rebound breast symptomatology occurred respectively in five and 23 women with complete success up to day 15 (p less than 0.0001). Serum prolactin concentrations dropped considerably with both drugs from day 2 to day 15; a prolactin secretion rebound effect was observed in women treated with bromocriptine. cabergoline and 36 receiving bromocriptine (p = 0.054), occurring most during the first treatment day. CONCLUSION--A single 1 mg dose of cabergoline is at least as effective as bromocriptine 2.5 mg twice daily for 14 days in preventing puerperal lactation. Because of the considerably lower rate of rebound breast activity and adverse events and the simpler administration schedule cabergoline should be the drug of choice for lactation inhibition. PMID:1676318

  20. Solar-blind deep-ultraviolet photodetectors based on an LaAlO(3) single crystal.

    PubMed

    Xing, Jie; Guo, Erjia; Jin, Kui-Juan; Lu, Huibin; Wen, Juan; Yang, Guozhen

    2009-06-01

    Solar-blind deep-ultraviolet (DUV) photoconductive detectors based on an LaAlO(3) (LAO) single crystal with interdigitated electrodes are reported. The LAO detectors show a high sensitivity to DUV light with wavelengths less than 210 nm, and the DUV/UV (200 versus 290 nm) contrast ratio is more than 2 orders of magnitude. The photocurrent responsivity of LAO detector reaches 71.8 mA/W at 200 nm at 10 V bias, and the corresponding quantum efficiency eta is 44.6%. The noise current under sunlight at midday outdoors is only 77 pA. The experimental results indicate that the LAO detectors have attractive potential applications in DUV detection.

  1. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    PubMed

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  2. Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials.

    PubMed

    Gould, A Lawrence

    2016-12-30

    Conventional practice monitors accumulating information about drug safety in terms of the numbers of adverse events reported from trials in a drug development program. Estimates of between-treatment adverse event risk differences can be obtained readily from unblinded trials with adjustment for differences among trials using conventional statistical methods. Recent regulatory guidelines require monitoring the cumulative frequency of adverse event reports to identify possible between-treatment adverse event risk differences without unblinding ongoing trials. Conventional statistical methods for assessing between-treatment adverse event risks cannot be applied when the trials are blinded. However, CUSUM charts can be used to monitor the accumulation of adverse event occurrences. CUSUM charts for monitoring adverse event occurrence in a Bayesian paradigm are based on assumptions about the process generating the adverse event counts in a trial as expressed by informative prior distributions. This article describes the construction of control charts for monitoring adverse event occurrence based on statistical models for the processes, characterizes their statistical properties, and describes how to construct useful prior distributions. Application of the approach to two adverse events of interest in a real trial gave nearly identical results for binomial and Poisson observed event count likelihoods. Copyright © 2016 John Wiley & Sons, Ltd.

  3. One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial

    NASA Astrophysics Data System (ADS)

    Fioravanti, A.; Bacaro, G.; Giannitti, C.; Tenti, S.; Cheleschi, S.; Guidelli, G. M.; Pascarelli, N. A.; Galeazzi, M.

    2015-09-01

    The objective of this prospective parallel randomized single-blind study was to assess that a cycle of mud-bath therapy (MBT) provides any benefits over usual treatment in patients with bilateral knee osteoarthritis (OA). Patients with symptomatic primary bilateral knee OA, according to ACR criteria, were included in the study and randomized to one of two groups: one group received a cycle of MBT at spa center of Chianciano Terme (Italy) in addition to the usual treatment, and one group continued their regular care routine alone. Clinical assessments were performed 7 days before enrollment (screening visit), at the time of enrollment (basal time), after 2 weeks, and after 3, 6, 9, and 12 months after the beginning of the study. All assessments were conducted by two researchers blinded to treatment allocation. The primary efficacy outcomes were the global pain score evaluated by Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore for physical function (W-TPFS). Of the 235 patients screened, 103 met the inclusion criteria: 53 patients were included in the MBT group and 50 in the control group. In the group of patients treated with MBT, we observed a statistically significant ( p < 0.001) reduction of VAS and W-TPFS score at the end of the treatment; this improvement was significant ( p < 0.05) also at 3 months of follow-up. The control group did not show significant differences between baseline time and all other times. The differences between one group were significant for both primary parameters already from the 15th day and persisted up to the 9th month. This beneficial effect was confirmed by the significant reduction of symptomatic drug consumption. Tolerability of MBT seemed to be good, with light and transitory side effects. Our results confirm that a cycle of MBT added to usual treatment provides a beneficial effect on the painful symptoms and functional capacities in patients with knee OA that

  4. Prophylactic doxycycline for travelers' diarrhea: results of a prospective double-blind study of Peace Corps volunteers in Morocco.

    PubMed

    Sack, R B; Froehlich, J L; Zulich, A W; Hidi, D S; Kapikian, A Z; Orskov, F; Orskov, I; Greenberg, H B

    1979-06-01

    A second randomized double-blind study to determine the efficacy of doxycycline, 100 mg daily, for the prevention of travelers' diarrhea was carried out among 50 Peace Corps Volunteers during their first 10 wk in Morocco. The volunteers took either doxycycline or placebo for 3 wk, and were observed for an additional 7 wk. Eleven of 24 taking the placebo and 2 of 26 taking doxycycline had travelers' diarrhea during the treatment period (P less than 0.01). One week after cessation of the doxycycline, however, persons in that group developed an increase in frequency of travelers' diarrhea (P less than 0.05) so that by 3 wk after the drug was stopped, there were no differences between groups. Enterotoxigenic E. coli, most of which were sensitive to doxycycline, were the most frequently isolated pathogens during the entire study. This study corroborates the effectiveness of doxycycline prophylaxis for travelers' diarrhea.

  5. Prophylactic doxycycline for travelers' diarrhea. Results of a prospective double-blind study of Peace Corps volunteers in Kenya.

    PubMed

    Sack, D A; Kaminsky, D C; Sack, R B; Itotia, J N; Arthur, R R; Kapikian, A Z; Orskov, F; Orskov, I

    1978-04-06

    We performed a randomized double-blind study to determine the efficacy of doxycycline (100 mg daily) in preventing travelers' diarrhea among 39 Peace Corps volunteers during their first five weeks in Kenya. The volunteers took either doxycycline or placebo for three weeks and were observed for an additional two weeks. Nine of 21 taking placebo and one of 18 taking doxycycline had travelers' diarrhea during the treatment period (P = 0.012). The protection seemed to persist for at least one week after the drug was stopped. Enterotoxigenic Escherichia coli was the only pathogen isolated from the placebo group, but was not detected in persons taking doxycycline. None of these organisms were resistant to doxycycline or tetracycline, whereas resistance to tetracyclines and other antibiotics was common among the nonenterotoxigenic Esch. coli. We conclude that doxycycline effectively prevented most episodes of travelers' dirrhea.

  6. Fostering Harmonious Interactions in a Boy with Congenital Deaf-Blindness: A Single-Case Study

    ERIC Educational Resources Information Center

    Janssen, Marleen J.; Riksen-Walraven, J. Marianne; van Dijk, Jan P. M.; Huisman, Mark; Ruijssenaars, Wied A. J. J. M.

    2011-01-01

    This article demonstrates the effectiveness of applying the Diagnostic Intervention Model for fostering harmonious interactions by describing a single-case study. Changes in the caregiver's turn-giving had substantial effects on the child's turn-taking, regulation of intensity, and approving and disapproving answers. The interaction effects were…

  7. Prospective diagnostic performance evaluation of single-voxel 1H MRS for typing and grading of brain tumours.

    PubMed

    Julià-Sapé, Margarida; Coronel, Indira; Majós, Carles; Candiota, Ana Paula; Serrallonga, Marta; Cos, Mònica; Aguilera, Carles; Acebes, Juan José; Griffiths, John R; Arús, Carles

    2012-04-01

    The purpose of this study was to evaluate whether single-voxel (1)H MRS could add useful information to conventional MRI in the preoperative characterisation of the type and grade of brain tumours. MRI and MRS examinations from a prospective cohort of 40 consecutive patients were analysed double blind by radiologists and spectroscopists before the histological diagnosis was known. The spectroscopists had only the MR spectra, whereas the radiologists had both the MR images and basic clinical details (age, sex and presenting symptoms). Then, the radiologists and spectroscopists exchanged their predictions and re-evaluated their initial opinions, taking into account the new evidence. Spectroscopists used four different systems of analysis for (1)H MRS data, and the efficacy of each of these methods was also evaluated. Information extracted from (1)H MRS significantly improved the radiologists' MRI-based characterisation of grade IV tumours (glioblastomas, metastases, medulloblastomas and lymphomas) in the cohort [area under the curve (AUC) in the MRI re-evaluation 0.93 versus AUC in the MRI evaluation 0.85], and also of the less malignant glial tumours (AUC in the MRI re-evaluation 0.93 versus AUC in the MRI evaluation 0.81). One of the MRS analysis systems used, the INTERPRET (International Network for Pattern Recognition of Tumours Using Magnetic Resonance) decision support system, outperformed the others, as well as being better than the MRI evaluation for the characterisation of grade III astrocytomas. Thus, preoperative MRS data improve the radiologists' performance in diagnosing grade IV tumours and, for those of grade II-III, MRS data help them to recognise the glial lineage. Even in cases in which their diagnoses were not improved, the provision of MRS data to the radiologists had no negative influence on their predictions.

  8. Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

    PubMed Central

    2013-01-01

    Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized

  9. Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial (CUSTOM): design of a prospective blinded randomised controlled multicentre trial

    PubMed Central

    van Beers, Loes W A H; van Oldenrijk, Jakob; Scholtes, Vanessa A B; Geerdink, Carel H; Niers, Bob B A M; Runne, Wouter; Bhandari, Mohit; Poolman, Rudolf W

    2016-01-01

    Introduction Answering the demands of an increasingly young and active patient population, recent developments in total hip arthroplasty (THA) have shifted towards minimising tissue damage. The Collum Femoris Preserving (CFP) stem was developed to preserve the trochanteric region of the femur, which potentially preserves the insertion of the gluteus musculature. This might accelerate early postoperative rehabilitation and improve functional outcome. Currently the functional results of the CFP stem have not been compared with conventional straight stems in a randomised controlled trial (RCT). The primary purpose of this trial is to compare the functional result of CFP stem THA with conventional uncemented straight stem THA, measured by the Dutch Hip disability and Osteoarthritis Outcome Score (HOOS) at 3-month follow-up. Methods A prospective blinded multicentre RCT will be performed. We aim to recruit 150 patients. The patients will be randomly allocated to a THA with a straight or a curved stem. All patients, research assistants, clinical assessors and investigators will be blinded for the type of prosthesis for 5 years. Clinical assessments and roentgenograms will be taken preoperative, at 6 weeks after surgery, at 1, 2, 3, 4 and 5 years after surgery. Patient reported outcome measures (PROMs) will be obtained at the same follow-up moments. In addition, the PROMs will also be sent to the patients at 3 and 6 months after surgery. The HOOS at 3-month follow-up will be our primary outcome. Ethics and dissemination This trial will be performed in accordance with the Declaration of Helsinki. A local ethics committee has approved this trial. Written informed consent will be obtained from all participating patients. All serious adverse events will be reported to the ethics committee. Results Results will be submitted for publication to an orthopaedics related journal. Trial registration number NTR1560. PMID:27009147

  10. Comparison of ondansetron and granisetron for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective, randomised, and double blind study

    PubMed Central

    2016-01-01

    Objectives To compare the efficacy of intravenous ondansetron (4 mg, 2 mL) and granisetron (2 mg, 2 mL) for preventing postoperative nausea and vomiting (PONV) in patients during oral and maxillofacial surgical procedures under general anesthesia. Materials and Methods A prospective, randomized, and double blind clinical study was carried out with 60 patients undergoing oral and maxillofacial surgical procedures under general anesthesia. Patients were divided into two groups of 30 individuals each. Approximately two minutes before induction of general anesthesia, each patient received either 4 mg (2 mL) ondansetron or 2 mg (2 mL) granisetron intravenously in a double blind manner. Balanced anesthetic technique was used for all patients. Patients were assessed for episodes of nausea, retching, vomiting, and the need for rescue antiemetic at intervals of 0-2, 3, 6, 12, and 24 hours after surgery. Incidence of complete response and adverse effects were assessed at 24 hours postoperatively. Data was tabulated and subjected to statistical analysis using the chi-square test, unpaired t-test, or the Mann-Whitney U-test as appropriate. A P-value less than 0.05 was considered statistically significant. Results There was no statistically significant difference between the two groups for incidence of PONV or the need for rescue antiemetic. Both study drugs were well tolerated with minimum adverse effects; the most common adverse effect was headache. The overall incidence of complete response in the granisetron group (86.7%) was significantly higher than the ondansetron group (60.0%). Conclusion Granisetron at an intravenous dose of 2 mg was found to be safe, well tolerated, and more effective by increasing the incidence of complete response compared to 4 mg intravenous ondansetron when used for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia. Benefits of granisetron include high receptor specificity and high potency, which make it a

  11. Effectiveness of probiotic, chlorhexidine and fluoride mouthwash against Streptococcus mutans – Randomized, single-blind, in vivo study

    PubMed Central

    Jothika, Mohan; Vanajassun, P. Pranav; Someshwar, Battu

    2015-01-01

    Aim: To determine the short-term efficiency of probiotic, chlorhexidine, and fluoride mouthwashes on plaque Streptococcus mutans level at four periodic intervals. Materials and Methods: This was a single-blind, randomized control study in which each subject was tested with only one mouthwash regimen. Fifty-two healthy qualified adult patients were selected randomly for the study and were divided into the following groups: group 1- 10 ml of distilled water, group 2- 10 ml of 0.2% chlorhexidine mouthwash, group 3- 10 ml of 500 ppm F/400 ml sodium fluoride mouthwash, and group 4- 10 ml of probiotic mouthwash. Plaque samples were collected from the buccal surface of premolars and molars in the maxillary quadrant. Sampling procedure was carried out by a single examiner after 7 days, 14 days, and 30 days, respectively, after the use of the mouthwash. All the samples were subjected to microbiological analysis and statistically analyzed with one-way analysis of variance (ANOVA) and post-hoc test. Results: One-way ANOVA comparison among groups 2, 3, and 4 showed no statistical significance, whereas group 1 showed statistically significant difference when compared with groups 2, 3, and 4 at 7th, 14th, and 30th day. Conclusion: Chlorhexidine, sodium fluoride, and probiotic mouthwashes reduce plaque S. mutans levels. Probiotic mouthwash is effective and equivalent to chlorhexidine and sodium fluoride mouthwashes. Thus, probiotic mouthwash can also be considered as an effective oral hygiene regimen. PMID:25984467

  12. Efficacy of chlorophyll c2 for seasonal allergic rhinitis: single-center double-blind randomized control trial.

    PubMed

    Fujiwara, Takashi; Nishida, Naoya; Nota, Jumpei; Kitani, Takashi; Aoishi, Kunihide; Takahashi, Hirotaka; Sugahara, Takuya; Hato, Naohito

    2016-12-01

    Chlorophyll c2 extracted from Sargassum horneri improved allergic symptoms in an animal model of allergic rhinitis. In the present study, we explored the efficacy of chlorophyll c2 in patients with seasonal allergic rhinitis. This was a single-center, randomized, double-blind placebo-controlled trial. Sixty-six patients aged 20-43 years, each with a 2-year history of seasonal allergic rhinitis, were randomly assigned to receive either a single daily dose (0.7 mg) of chlorophyll c2 or placebo for 12 weeks. The use of medications including H1-antihistamines and topical nasal steroids was recorded by rescue medication scores (RMSs) noted after 4, 8, and 12 weeks of treatment. Disease-specific quality of life was measured using the Japan Rhinitis Quality of Life Questionnaire (JRQLQ) both before and after 4, 8, and 12 weeks of treatment. The RMS at 8 weeks was significantly better in the chlorophyll c2 than the placebo group (mean RMS difference = -3.09; 95 % confidence interval = -5.96 to -0.22); the mean RMS at 4 weeks was only slightly better in the chlorophyll c2 group. The JRQLQ scores did not differ significantly between the two groups. Chlorophyll c2 would have a potential to be an alternative treatment for allergic rhinitis.

  13. Treatment of open hand injuries: does timing of surgery matter? A single-centre prospective analysis.

    PubMed

    Juon, Bettina H; Iseli, Michelle; Kreutziger, Janett; Constantinescu, Mihai A; Vögelin, Esther

    2014-10-01

    The 6-hour paradigm for surgical treatment of open injuries should be re-evaluated in the era of systematic use of antiseptic solutions and systemic antibiotics. The current study investigates prospectively the impact of timing of surgery on the outcome of open hand injuries. The prospective evaluation included adult patients presenting with open hand injuries between 1 September 2009 and 30 June 2010 to the emergency department of the University Hospital of Berne, Switzerland. Multiple trauma, bilateral hand injuries, bite injuries, and infections were excluded. All patients underwent a standardised treatment protocol with antiseptic solution, sterile dressing, antibiotic prophylaxis, and surgical treatment upon admission. Demographic data, injury details, and delay from trauma to therapy were recorded. Microbiology was gained at surgery. Outcome measurements included infections, complications, pain, and function (clinically, DASH, Mayo score). From 116 patients (mean age 43 years) six patients suffered an infection (5.2%). The observed infections were statistically not associated with delay to surgery, treatment protocol, or to injury complexity. Neither complications, pain, nor functional outcome were statistically associated with delay to surgery, wound disinfection, or administration of antibiotics. In conclusion, early or late timing of surgical treatment of open hand injuries did not show any impact on outcome (infections, complications, pain, function) in this prospective single-centre patient evaluation.

  14. A prospective double-blinded comparative analysis of framycetin and silver sulphadiazine as topical agents for burns: a pilot study.

    PubMed

    Ahuja, Rajeev B; Gupta, Amit; Gur, Renu

    2009-08-01

    Burn wound sepsis remains the leading cause of mortality if conservative methods of wound management are employed. Topical agents are still the mainstay of such wound management in the developing world. Non availability of agents like Mafenide or silver ion dressings in the developing world due to corporate strategies or cost concerns necessitates a search for alternatives to silver sulphadiazine, which is the gold standard. We report the use of framycetin 1% cream (Soframycin) in 20 patients of major burns (ranging from 15% to 40% TBSA), and in a double blinded study quantitatively comparing the bacterial load on day 4 and day 7 with a group of similar patients in whom silver sulphadiazine was used. The age group of the 40 patients was 10-50 years and they were without any co-morbid condition. All bacterial isolates from the 40 patients were also tested for framycetin sensitivity. Serial kidney function tests were done on all patients, and patients in the framycetin group underwent an audiometric testing at a mean time of 28 days. All results were statistically analyzed. It was noted that there was no statistically significant difference in the colony counts on days 4 and 7 between the two groups. As a corollary, it was also evident that there was no statistically significant difference in the rise in colony counts from day 4 to day 7 in the two groups. Sixty-four percent of all bacterial isolates were sensitive to framycetin, although, this could not be compared with sensitivity to silver sulphadiazine. It was not possible to do assays for framycetin levels in blood but no patient developed nephrotoxicity or ototoxicity with its use. According to our pilot study results framycetin appears to be an alternative to silver suphadiazine as a topical agent for major burns. Framycetin application is also painless and it leads to no discoloration of the wound.

  15. Effect of Microvascular Anastomosis Technique on End Product Outcome in Simulated Training: A Prospective Blinded Randomized Controlled Trial.

    PubMed

    Kim, Eunsol; Singh, Masha; Akelina, Yelena; Shurey, Sandra; Myers, Simon R; Ghanem, Ali M

    2016-09-01

    Background The aim of this article is to evaluate the difference in skills acquisition of two end-to-end microvascular anastomosis techniques-the triangulation and biangulation-in early microsurgery training. Method In this study, 32 candidates ranging from medical students to higher surgical trainees underwent a 5-day basic microsurgery course. On days 3 and 5 of the course, candidates performed two end-to-end anastomoses on cryopreserved rat aortas. One anastomosis was performed using the biangulation technique and the other using the triangulation technique. Candidates were randomized to the order of technique performed. Structural patency, errors performed, and suture distribution were evaluated randomly by a blinded reviewer using the anastomosis lapse index score and ImageJ (U.S. National Institutes of Health, Bethesda, MD) Software. Results A total of 128 anastomoses were evaluated during the study period. A total of six anastomoses performed with the biangulation technique, and four anastomoses with the triangulation technique, were physically occluded on day 3 of the course. On day 5, two biangulation technique anastomoses and one triangulation technique produced a nonpatent outcome. There was a statistically significant difference of patency rate between the 2 days of evaluation confirming evidence of skill acquisition but no statistically significant difference between the two techniques in relation to anastomotic patency, errors performed, or suture placement quality. Conclusion The biangulation and triangulation techniques of microvascular anastomosis produce similar outcomes in relation to vessel structural patency and quality of anastomosis when taught in early stages of microsurgery training. Our results suggest that both techniques are equally suitable in training novices, basic microsurgical skills.

  16. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

    PubMed Central

    Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M

    2016-01-01

    Background/Aims The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. Methods We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. Results In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (P<0.05). Moreover, the patients in the gluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (P<0.05), and their symptoms worsened within 1 week of the rechallenge. Conclusions A gluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions. PMID:27799885

  17. Ketamine versus magnesium sulfate with caudal bupivacaine block in pediatric inguinoscrotal surgery: A prospective randomized observer-blinded study

    PubMed Central

    Farrag, Waleed S. H.; Ibrahim, Abdelrady S.; Mostafa, Mostafa Galal; Kurkar, Adel; Elderwy, Ahmad A.

    2015-01-01

    Introduction: Possible approaches for postoperative analgesia after pediatric inguinoscrotal surgery are caudal block by bupivacaine/ketamine (BK) and bupivacaine/magnesium sulfate (BM). Aim: The purpose of the following study is to compare the analgesic efficacy and safety of ketamine and magnesium sulfate in combination with bupivacaine for caudal blockade in pediatric patients after inguinoscrotal operations. Materials and Methods: Patients randomly received one of the two solutions for caudal epidural injection after induction of general anesthesia. Group-BK: Were given a mixture of 0.25% bupivacaine and 0.5 mg/kg of ketamine. Group-BM: Were given a mixture of 0.25% bupivacaine and 50 mg magnesium sulfate. Postoperatively, a blinded post-anesthesia care unit nurse assessed the quality of analgesia with a visual pain analog scale (VPAS). Significant pain is defined as one that has a VAPS of ≥3. Results: Forty American Society of Anesthesiologists I-II children (20 in each group) completed the study. The two groups were comparable regards age, sex, body mass index, anesthesia and surgery durations, recovery time and sevoflurane concentration. The mean duration of caudal analgesia ± standard deviation was 462 ± 17.2 min versus 398.05 ± 12.9 min for BK and BM groups, receptively (P < 0.001). Supplemental rectal paracetamol within 12 h postoperatively were 15% for BK group versus 25% for BM (P = 0.05). Four patients in BK group only experienced postoperative nausea and vomiting (P = 0.053). Conclusion: Caudal administration of BK is efficient and safe for pediatric inguinoscrotal operations with longer postoperative analgesia than BM sulfate. PMID:26229319

  18. A double-blind, randomized, prospective trial to evaluate topical vitamin C solution for the prevention of radiation dermatitis

    SciTech Connect

    Halperin, E.C.; George, S.; Darr, D.; Pinnell, S. ); Gaspar, L. )

    1993-06-15

    The object of this study was to ascertain the value of topical ascorbic acid in the prevention of radiation dermatitis. Patients with primary or metastatic brain tumors were eligible. Patients applied a topical solution, twice per day prior to and throughout the course of radiotherapy, to the left and right sides of the head. The radiotherapist and the patient were blinded as to the contents of the solutions. The bottle for one side of the head contained topical ascorbic acid solution. THe bottle for the other side of the head contained only vehicle. During and after the course of treatment the radiotherapist scored the skin reaction on both the left and right sides of the irradiated head using a skin reaction scale. The data were analyzed with a matched pair analysis. Since each patient received both treatments (ascorbic acid and control solutions) the statistical analysis concentrated on the paired differences in scores based on the probability of a [open quotes]preference[close quotes] for the treatment or control. Eighty-four patients entered the study. Sixty-five were suitable for analysis. In 10 patients there was a preference for ascorbic acid solution (15%), in 20 patients there was a preference for placebo (31%), and there was a preference for neither in 35 patients (54%). Ascorbic acid solution could be considered to have an effect if the percentage of preferences favoring ascorbic acid over placebo, among those subjects with a preference, significantly exceeded the 50% expected by chance. The observed percentage of preferences for ascorbic acid was only 33% (10 of 30 with a preference; p = .10, two-sided sign test). Patient age, race, sex, and total dose of irradiation had no detectable influence on the comparative skin toxicity scores. There is no discernible benefit to ascorbic acid lotion, in the manner in which it was used it in this trial, for the prevention of radiation dermatitis. 19 refs., 1 tab.

  19. Surveillance of FAP: a prospective blinded comparison of capsule endoscopy and other GI imaging to detect small bowel polyps

    PubMed Central

    2010-01-01

    Background Familial adenomatous polyposis (FAP) is a hereditary disorder characterized by polyposis along the gastrointestinal tract. Information on adenoma status below the duodenum has previously been restricted due to its inaccessibility in vivo. Capsule Endoscopy (CE) may provide a useful adjunct in screening for polyposis in the small bowel in FAP patients. This study aims to evaluate the effectiveness of CE in the assessment of patients with FAP, compared to other imaging modalities for the detection of small bowel polyps. Method 20 consecutive patients with previously diagnosed FAP and duodenal polyps, presenting for routine surveillance of polyps at The Royal Melbourne Hospital were recruited. Each fasted patient initially underwent a magnetic resonance image (MRI) of the abdomen, and a barium small bowel follow-through study. Capsule Endoscopy was performed four weeks later on the fasted patient. An upper gastrointestinal side-viewing endoscopy was done one (1) to two (2) weeks after this. Endoscopists and investigators were blinded to results of other investigations and patient history. Results Within the stomach, upper gastrointestinal endoscopy found more polyps than other forms of imaging. SBFT and MRI generally performed poorly, identifying fewer polyps than both upper gastrointestinal and capsule endoscopy. CE was the only form of imaging that identified polyps in all segments of the small bowel as well as the only form of imaging able to provide multiple findings outside the stomach/duodenum. Conclusion CE provides important information on possible polyp development distal to the duodenum, which may lead to surgical intervention. The place of CE as an adjunct in surveillance of FAP for a specific subset needs consideration and confirmation in replication studies. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12608000616370 PMID:20361877

  20. Single-Cell Sequencing for Precise Cancer Research: Progress and Prospects.

    PubMed

    Zhang, Xiaoyan; Marjani, Sadie L; Hu, Zhaoyang; Weissman, Sherman M; Pan, Xinghua; Wu, Shixiu

    2016-03-15

    Advances in genomic technology have enabled the faithful detection and measurement of mutations and the gene expression profile of cancer cells at the single-cell level. Recently, several single-cell sequencing methods have been developed that permit the comprehensive and precise analysis of the cancer-cell genome, transcriptome, and epigenome. The use of these methods to analyze cancer cells has led to a series of unanticipated discoveries, such as the high heterogeneity and stochastic changes in cancer-cell populations, the new driver mutations and the complicated clonal evolution mechanisms, and the novel identification of biomarkers of variant tumors. These methods and the knowledge gained from their utilization could potentially improve the early detection and monitoring of rare cancer cells, such as circulating tumor cells and disseminated tumor cells, and promote the development of personalized and highly precise cancer therapy. Here, we discuss the current methods for single cancer-cell sequencing, with a strong focus on those practically used or potentially valuable in cancer research, including single-cell isolation, whole genome and transcriptome amplification, epigenome profiling, multi-dimensional sequencing, and next-generation sequencing and analysis. We also examine the current applications, challenges, and prospects of single cancer-cell sequencing.

  1. Prophylactic Treatment with Adlay Bran Extract Reduces the Risk of Severe Acute Radiation Dermatitis: A Prospective, Randomized, Double-Blind Study.

    PubMed

    Huang, Chih-Jen; Hou, Ming-Feng; Kan, Jung-Yu; Juan, Chiung-Hui; Yuan, Shyng-Shiou F; Luo, Kuei-Hau; Chuang, Hung-Yi; Hu, Stephen Chu-Sung

    2015-01-01

    Acute radiation dermatitis is a frequent adverse effect in patients with breast cancer undergoing radiotherapy, but there are only a small number of studies providing evidence-based interventions for this clinical condition. Adlay is a cereal crop that has been previously shown to have anti-inflammatory and antioxidant properties. In this study, we seek to evaluate the effectiveness of oral prophylactic treatment with adlay bran extract in reducing the risk of severe acute radiation dermatitis. A total of 110 patients with breast cancer undergoing radiotherapy were analyzed. Using a prospective, randomized, double-blind design, 73 patients received oral treatment with adlay bran extract and 37 patients received olive oil (placebo). Treatment was started at the beginning of radiation therapy and continued until the termination of radiation treatment. Our results showed that the occurrence of severe acute radiation dermatitis (RTOG grade 2 or higher) was significantly lower in patients treated with oral adlay bran extract compared to placebo (45.2% versus 75.7%, adjusted odds ratio 0.24). No serious adverse effects from adlay bran treatment were noted. In conclusion, prophylactic oral treatment with adlay bran extract reduces the risk of severe acute radiation dermatitis and may have potential use in patients with breast cancer undergoing radiotherapy.

  2. Prophylactic Treatment with Adlay Bran Extract Reduces the Risk of Severe Acute Radiation Dermatitis: A Prospective, Randomized, Double-Blind Study

    PubMed Central

    Huang, Chih-Jen; Hou, Ming-Feng; Kan, Jung-Yu; Juan, Chiung-Hui; Yuan, Shyng-Shiou F.; Luo, Kuei-Hau; Chuang, Hung-Yi; Hu, Stephen Chu-Sung

    2015-01-01

    Acute radiation dermatitis is a frequent adverse effect in patients with breast cancer undergoing radiotherapy, but there are only a small number of studies providing evidence-based interventions for this clinical condition. Adlay is a cereal crop that has been previously shown to have anti-inflammatory and antioxidant properties. In this study, we seek to evaluate the effectiveness of oral prophylactic treatment with adlay bran extract in reducing the risk of severe acute radiation dermatitis. A total of 110 patients with breast cancer undergoing radiotherapy were analyzed. Using a prospective, randomized, double-blind design, 73 patients received oral treatment with adlay bran extract and 37 patients received olive oil (placebo). Treatment was started at the beginning of radiation therapy and continued until the termination of radiation treatment. Our results showed that the occurrence of severe acute radiation dermatitis (RTOG grade 2 or higher) was significantly lower in patients treated with oral adlay bran extract compared to placebo (45.2% versus 75.7%, adjusted odds ratio 0.24). No serious adverse effects from adlay bran treatment were noted. In conclusion, prophylactic oral treatment with adlay bran extract reduces the risk of severe acute radiation dermatitis and may have potential use in patients with breast cancer undergoing radiotherapy. PMID:26495009

  3. Comparative evaluation of intrathecal morphine and intrathecal dexmedetomidine in patients undergoing gynaecological surgeries under spinal anaesthesia: A prospective randomised double blind study

    PubMed Central

    Kurhekar, Pranjali; Kumar, S Madan; Sampath, D

    2016-01-01

    Background and Aims: Inrathecal opioids like morphine added to local anaesthetic agents have been found to be effective in achieving prolonged post-operative analgesia. Intrathecal dexmedetomidine may be devoid of undesirable side effects related to morphine and hence, this study was designed to evaluate analgesic efficacy, haemodynamic stability and adverse effects of both these adjuvants in patients undergoing gynaecological surgeries. Methods: This was a prospective, randomised, double blind study involving 25 patients in each group. Group M received 15 mg of 0.5% hyperbaric bupivacaine with 250 μg of morphine while Group D received 15 mg of 0.5% hyperbaric bupivacaine with 2.5 μg of dexmedetomidine. Characteristics of spinal block, time for first rescue analgesic and total dose of rescue analgesics were noted. Vital parameters and adverse effects were noted perioperatively. Data analysis was done with independent two sample t-test and Mann–Whitney U test. Results: Time for first rescue analgesic (P = 0.056) and total analgesic demand were similar in both groups. Duration of sensory (P = 0.001) and motor (P = 000) block was significantly higher in dexmedetomidine group. Itching was noticed in 36% and nausea in 52% of patients in the morphine group, either of which was not seen in dexmedetomidine group. Conclusion: Intrathecal dexmedetomidine produces prolonged motor and sensory blockade without undesirable side effects but intraoperative hypotension was more frequent in dexmedetomidine group. PMID:27330198

  4. Effects of Korean red ginseng as an adjuvant to bile acids in medical dissolution therapy for gallstones: a prospective, randomized, controlled, double-blind pilot trial.

    PubMed

    Lee, Jun Kyu; Kang, Hyoun Woo; Kim, Jae Hak; Lim, Yun Jeong; Koh, Moon-Soo; Lee, Jin Ho

    2013-01-01

    Although ginseng, the root of Panax quinquefolium and P. ginseng, was reported to have anti-cholelithogenic effects in animal experiments, there have, to date, been no human studies. We conducted this prospective, controlled, double-blind pilot trial to evaluate the safety and efficiency of Korean red ginseng (KRG), the steamed root of P. ginseng C.A. Meyer. Twenty eight consecutive patients were randomized to receive either KRG (7.5 g divided into three daily doses) or a placebo as an adjuvant to the standard regimen of bile acids for gallstones (500 mg of chenodeoxycholic acid and 500 mg of ursodeoxycholic acid divided into three daily doses) for 24 weeks. No case of serious adverse reaction occurred in both groups. Although the decrease in stone burden was larger in the KRG group (3.4 ± 0.6 ml3) than in the placebo group (2.3 ± 1.1 ml(3)), it did not reach statistical significance (p = 0.09). Also there were no differences in the rate of complete dissolution, subjective improvement in symptoms, and the rate of cholecystectomy due to worsening pain or the development of complications and changes in laboratory tests before and after treatment. In conclusion, the addition of KRG as an adjuvant was safe for patients undergoing bile acid dissolution therapy for gallstones although it did not affect the results. Large-scaled trials to optimize regimens are expectantly needed.

  5. A prospective, randomized, double-blind study of the tolerability of rifapentine 600, 900, and 1,200 mg plus isoniazid in the continuation phase of tuberculosis treatment.

    PubMed

    Bock, Naomi N; Sterling, Timothy R; Hamilton, Carol D; Pachucki, Connie; Wang, Yong-Cheng; Conwell, Donna S; Mosher, Ann; Samuels, Mary; Vernon, Andrew

    2002-06-01

    Once-weekly rifapentine 600 mg plus isoniazid (INH) during the continuation phase treatment of tuberculosis is associated with a relapse rate higher than that of twice-weekly rifampin plus INH. The safety and tolerability of higher rifapentine doses need to be determined. We conducted a prospective, randomized, double-blind trial of rifapentine at three doses (600, 900, and 1,200 mg) plus INH 15 mg/kg once weekly in the continuation phase treatment of culture-positive tuberculosis in 150 human immunodeficiency virus-seronegative adults. Outcome measures were discontinuation of therapy for any reason and adverse events on therapy. Treatment was discontinued in 3 of 52 (6%), 2 of 51 (4%), and 3 of 47 (6%) in the rifapentine 600-, 900-, and 1,200-mg treatment arms, respectively. Only one discontinuation, in the rifapentine 1,200-mg arm, was due to an adverse event possibly associated with study therapy. There was a trend toward more adverse events, possibly associated with study therapy, in the highest-dose arms (p = 0.051). Rifapentine 900-mg, once-weekly dosing appears to be safe and well tolerated and is being evaluated in Phase III efficacy trials of treatment of latent tuberculosis. Further evaluation of the safety and tolerability of rifapentine 1,200 mg is warranted.

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

    PubMed

    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 (P<0.0001). None of the patients required rescue medication. There was a statistically significant difference in maximum mouth opening between the preoperative and postoperative periods (P<0.0001). Ketoprofen and nimesulide were effective at controlling pain, swelling, and trismus after the surgical removal of third molars.

  7. A prospective double-blind randomized controlled trial comparing the suitability of KTP laser tonsillectomy with conventional dissection tonsillectomy for day case surgery.

    PubMed

    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.

  8. Ketamine does not inhibit interleukin-6 synthesis in hepatic resections requiring a temporary porto-arterial occlusion (Pringle manoeuvre): a controlled, prospective, randomized, double-blinded study

    PubMed Central

    Bonofiglio, Francisco Carlos; Molmenti, Ernesto P; de Santibañes, Eduardo

    2011-01-01

    Introduction Previous studies have shown that interleukin-6 (IL-6) levels correlated with mortality in critically ill patients. Goal To determine the effect of ketamine on IL-6 levels in liver resections patients with a temporary porto-arterial occlusion (Pringle manoeuvre). Materials and methods Controlled, prospective, randomized, double-blinded study. One group (n = 21) received ketamine whereas the other group (n = 17) received placebo. IL-6 levels were obtained at baseline, 4, 12, 24 h, 3 and 5 days. Results There were no significant differences in IL-6 levels between the groups (basal P = 089, 4 h P = 0.83, 12 h P = 0.39, 24 h, P = 0.55, 3 days P = 0.80 and 5 days P = 0.45). Both groups had elevated IL-6 levels that became almost undetectable by day 5. There was no major morbidity and no mortality in either group. Conclusions Ketamine does not seem to have an effect on plasma levels of IL-6. This could be interpreted as a potential finding associated with outcome as we did not encounter any deaths or major complications. Further studies will likely be needed to determine the range of IL-6 levels associated with survival and mortality, and whether it could be a predictor of survival. PMID:21929671

  9. Tranexamic acid reduces blood loss and need of blood transfusion in total knee arthroplasty: A prospective, randomized, double-blind study in Indian population

    PubMed Central

    Shinde, Abhishek; Sobti, Anshul; Maniar, Shriji; Mishra, Amit; Gite, Raju; Shetty, Vivek

    2015-01-01

    Introduction: For quite a few years, tranexamic acid (TEA) has been used during total knee arthroplasty (TKA) to reduce blood loss. However, no consensus exits regarding its timing and doses. Materials and Methods: We conducted a prospective, randomized double-blinded study of 56 patients in the Indian population undergoing TKA from 2011 to 2012. A dose of 10 mg/kg body weight of TEA (three doses) was given in one group and normal saline was administered in the other. Results: The mean blood loss in the TEA unilateral group was 295 mL ± 218 mL and in the placebo group was 482 mL ± 186 mL (P < 0.005). In the bilateral TEA group, the mean blood loss was 596 mL ± 235 mL and in the placebo group was 1349 mL ± 41 mL (P < 0.005). Conclusion: The number of patients requiring blood transfusion reduced substantially. There was no increase in the risk of deep vein thrombosis (DVT) and pulmonary embolism. TEA reduces intraoperative and postoperative blood loss and thus reduces the need of allogenic blood transfusion. PMID:26420938

  10. A double-blind, randomized controlled, prospective trial assessing the effectiveness of oral corticoids in the treatment of symptomatic lumbar canal stenosis

    PubMed Central

    2014-01-01

    Background Corticoids have potent anti-inflammatory effects, which may help in relieving pain and dysfunction associated with lumbar canal stenosis. We assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospective, double-blind, randomized, placebo-controlled trial. Results Sixty-one patients with lumbar canal stenosis (50–75 years; canal area < 100 mm2 at L3/L4, L4/L5, and/or L5/S1on magnetic resonance imaging; and claudication within 100 m were electronically randomized to an oral corticoid group (n = 31) or a placebo group (n = 30). The treatment group received 1 mg/kg of oral corticoids daily, with a dose reduction of one-third per week for 3 weeks. Patients and controls were assessed by the Short Form 36 Health Survey, Roland–Morris Questionnaire, 6-min walk test, visual analog scale, and a Likert scale. All instruments showed similar outcomes for the corticoid and placebo groups (P > 0.05). Obese patients exhibited more severe symptoms compared with non-obese patients. L4/L5 stenosis was associated with more severe symptoms compared with stenosis at other levels. Conclusion The oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis. PMID:25099318

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

    PubMed Central

    Trybulski, R.; Kucharzewski, M.; Kucio, C.; Mikusek, W.; Klakla, K.

    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. PMID:24377096

  12. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial

    PubMed Central

    Eftekharsadat, Bina; Babaei-Ghazani, Arash; Zeinolabedinzadeh, Vahideh

    2016-01-01

    Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar extension[ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant changes after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean of MDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeks of intervention (p<0.001). Conclusion: Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improving the severity of heel pain, can be used as a good alternative option before proceeding to more invasive therapies of plantar fasciitis. PMID:27683642

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

    PubMed

    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.

  14. Double-blind single-session neurofeedback training in upper-alpha for cognitive enhancement of healthy subjects.

    PubMed

    Escolano, C; Olivan, B; Lopez-del-Hoyo, Y; Garcia-Campayo, J; Minguez, J

    2012-01-01

    This paper reports on a single-session neurofeedback (NF) training procedure on the user-specific upper alpha band for cognitive enhancement in healthy users. A double-blind study was designed using a NF group and an active control group. Control group performed as the NF group but received sham feedback, minimizing the non-specific factors of training. This design aimed to (i) investigate upper alpha as a NF parameter, (ii) evaluate the NF effects on upper alpha during the execution of a cognitive task, and (iii) evaluate the effects on cognitive performance by means of a cognitive task and a battery of psychological tests. Results of EEG analysis show the key role of the feedback: only the NF group enhanced upper alpha during the training, and it led to a desynchronization increase during the execution of the cognitive task. Regarding the behavioral results, a strong learning effect was observed, with the NF group performing better in almost all measurements but many of them without statistical significance.

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

    PubMed

    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.

  16. Enhancing kidney function with thrombolytic therapy following donation after cardiac death: a multicenter quasi-blinded prospective randomized trial.

    PubMed

    Woodside, Kenneth J; Goldfarb, David A; Rabets, John C; Sanchez, Edmund Q; Lebovitz, Daniel J; Schulak, James A; Fung, John J; Eghtesad, Bijan

    2015-12-01

    Kidneys from donors after cardiac death (DCD) are at risk for inferior outcomes, possibly due to microthrombi and additional warm ischemia. We describe an organ procurement organization-wide trial utilizing thrombolytic tissue plasminogen activator (tPA) during machine pulsatile perfusion (MPP). A kidney from each recovered kidney pair was prospectively randomized to receive tPA (50 mg Alteplase) or no tPA (control) in the MPP perfusate. From 2011 to 2013, 24 kidneys were placed with enrolled recipients from 19 DCD kidney donors. There were no significant differences for absolute values of flow or resistance while undergoing MPP between the groups, nor rates of achieving discrete flow and resistance targets. While there was a trend toward lower creatinine and higher glomerular filtration rates in the tPA group at 3, 6, 9, and 12 months, these differences were not significant. Delayed graft function (DGF) rates were 41.7% in the tPA group vs. 58.4% in the control group (OR 0.51, 95%CI 0.10-2.59, p = 0.68). Death-censored graft survival was similar between the groups. In this pilot study, encouraging trends are seen in kidney allograft function independent of MPP parameters following DCD kidney transplantation for those kidneys receiving thrombolytic tPA and MPP, compared with standard MPP.

  17. Effects of cisapride on gall bladder emptying, intestinal transit, and serum deoxycholate: a prospective, randomised, double blind, placebo controlled trial

    PubMed Central

    Veysey, M; Malcolm, P; Mallet, A; Jenkins, P; Besser, G; Murphy, G; Dowling, R

    2001-01-01

    BACKGROUND—Octreotide inhibits gall bladder emptying and prolongs intestinal transit. This leads to increases in the proportion of deoxycholic acid in, and cholesterol saturation of, gall bladder bile, factors that contribute to the pathogenesis of octreotide induced gall stones.
AIMS—To see if an intestinal prokinetic, cisapride, could overcome these adverse effects of octreotide and if so, be considered as a candidate prophylactic drug for preventing iatrogenic gall bladder stones.
METHODS—A randomised, double blind, placebo controlled, crossover design was used to examine the effects of cisapride (10 mg four times daily) on gall bladder emptying, mouth to caecum and large bowel transit times, and the proportions of deoxycholic acid and other bile acids, in fasting serum from: (i) control subjects (n=6), (ii) acromegalic patients not treated with octreotide (n=6), (iii) acromegalics on long term octreotide (n=8), and (iv) patients with constipation (n=8).
RESULTS—Cisapride had no prokinetic effect on the gall bladder. In fact, it significantly increased both fasting and postprandial gall bladder volumes. However, it shortened mouth to caecum (from 176 (13) to 113 (11) minutes; p<0.001) and large bowel (from 50 (3.0) to 31 (3.4) h; p<0.001) transit times. It also reduced the proportion of deoxycholic acid in serum from 26 (2.3) to 15 (1.8)% (p<0.001), with a reciprocal increase in the proportion of cholic acid from 40 (3.5) to 51 (3.8)% (p<0.01). There were significant linear relationships between large bowel transit time and the proportions of deoxycholic acid (r=0.81; p<0.001) and cholic acid (r=−0.53; p<0.001) in fasting serum.
INTERPRETATION/SUMMARY—Cisapride failed to overcome the adverse effects of octreotide on gall bladder emptying but it countered octreotide induced prolongation of small and large bowel transit. Therefore, if changes in intestinal transit contribute to the development of octreotide induced gall bladder stones

  18. Treatment of severe, nonfulminant acute hepatitis B with lamivudine vs placebo: a prospective randomized double-blinded multicentre trial.

    PubMed

    Wiegand, J; Wedemeyer, H; Franke, A; Rößler, S; Zeuzem, S; Teuber, G; Wächtler, M; Römmele, U; Ruf, B; Spengler, U; Trautwein, C; Bock, C T; Fiedler, G M; Thiery, J; Manns, M P; Brosteanu, O; Tillmann, H L

    2014-10-01

    Acute hepatitis B virus (aHBV) infection can lead to fulminant liver failure, which likely is prevented by early lamivudine therapy. Even nonfulminant but severe acute hepatitis B can lead to significant morbidity and impaired quality of life. Therefore, lamivudine was evaluated in patients with severe aHBV in a placebo-controlled trial. Patients with severe aHBV infection (ALT >10× ULN, bilirubin >85 μm, prothrombin time >50%) were prospectively treated with lamivudine 100 mg/day or with placebo within 8 days after the diagnosis. The primary end point was time to bilirubin <34.2 μm. Secondary end points were time to clear HBsAg and HBV-DNA, development of anti-HBs and normalization of ALT. Eighteen cases were randomized to lamivudine, 17 to placebo. 94% of patients were hospitalized. No individual progressed to hepatic failure; all but one patient achieved the primary end point. Due to smaller than expected patient numbers, all study end points did not become statistically significant between treatment arms. Median time end points [in days] were bilirubin <34.2 μm (26.5 vs 32), ALT normalization (35 vs 48) and HBsAg clearance (48 vs 67) referring to earlier recovery under lamivudine, in contrast to loss of HBV-DNA (62 vs 54) and development of anti-HBs (119 vs 109). In all but two patients (one in every group), HBsAg clearance was reached in the study. Adverse events occurred more frequently during lamivudine therapy, but did not reach statistical significance. Lamivudine may ameliorate severe aHBV infection, but limited patient numbers prevented definite conclusions.

  19. Increased Cardiovascular Events and Subclinical Atherosclerosis in Rheumatoid Arthritis Patients: 1 Year Prospective Single Centre Study

    PubMed Central

    Ruscitti, Piero; Cipriani, Paola; Masedu, Francesco; Romano, Silvio; Berardicurti, Onorina; Liakouli, Vasiliki; Carubbi, Francesco; Di Benedetto, Paola; Alvaro, Saverio; Penco, Maria; Valenti, Marco; Giacomelli, Roberto

    2017-01-01

    Objectives Several studies showed the close relationship between Rheumatoid Arthritis (RA) and cerebro-cardiovascular events (CVEs) and subclinical atherosclerosis. In this study, we investigated the occurrence of CVEs and subclinical atherosclerosis during the course of RA and we evaluated the possible role of both traditional cardiovascular (CV) and disease related risk factors to predict the occurrence of new CVEs and the onset of subclinical atherosclerosis. Methods We designed a single centre, bias-adjusted, prospective, observational study to investigate, in a homogeneous subset of RA patients, the occurrence of new onset of CVEs and subclinical atherosclerosis. Statistical analyses were performed to evaluate the role of traditional CV and disease-related risk factors to predict the occurrence of new CVEs and subclinical atherosclerosis. Results We enrolled 347 RA patients prospectively followed for 12 months. An increased percentage of patients experienced CVEs, developed subclinical atherosclerosis and was affected by systemic arterial hypertension (SAH), type 2 diabetes mellitus and metabolic syndrome (MS), at the end of follow up. Our analysis showed that the insurgence of both SAH and MS, during the follow up, the older age, the CVE familiarity and the lack of clinical response, were associated with a significantly increased risk to experience CVEs and to develop subclinical atherosclerosis. Conclusions Our study quantifies the increased expected risk for CVEs in a cohort of RA patients prospectively followed for 1 year. The occurrence of both new CVEs and subclinical atherosclerosis in RA patients may be explained by inflammatory burden as well as traditional CV risk factors. PMID:28103312

  20. PEDIATRIC DELIRIUM AND ASSOCIATED RISK FACTORS: A SINGLE-CENTER PROSPECTIVE OBSERVATIONAL STUDY

    PubMed Central

    Gerber, Linda M.; Sun, Xuming; Kearney, Julia; Patel, Anita; Greenwald, Bruce

    2016-01-01

    Objective To describe a single-institution pilot study regarding prevalence and risk factors for delirium in critically ill children. Design A prospective observational study, with secondary analysis of data collected during the validation of a pediatric delirium screening tool, the Cornell Assessment of Pediatric Delirium (CAPD). Setting This study took place in the pediatric intensive care unit (PICU) at an urban academic medical center. Patients 99 consecutive patients, ages newborn to 21 years. Intervention Subjects underwent a psychiatric evaluation for delirium based on the DSM-IV criteria. Measurements and Main Results Prevalence of delirium in this sample was 21%. In multivariate analysis, risk factors associated with the diagnosis of delirium were presence of developmental delay, need for mechanical ventilation, and age 2-5 years. Conclusions In our institution, pediatric delirium is a prevalent problem, with identifiable risk factors. Further large-scale prospective studies are required to explore multi-institutional prevalence, modifiable risk factors, therapeutic interventions, and effect on long-term outcomes. PMID:25647240

  1. Platelet-Rich Plasma Injections for Advanced Knee Osteoarthritis: A Prospective, Randomized, Double-Blinded Clinical Trial

    PubMed Central

    Joshi Jubert, Nayana; Rodríguez, Luciano; Reverté-Vinaixa, Maria Mercedes; Navarro, Aurora

    2017-01-01

    Background: Intra-articular injections of platelet-rich plasma (PRP) to treat symptoms of knee osteoarthritis (OA) have been successfully used in young patients and in the early stages of disease. No previous studies have analyzed outcomes of PRP injections during the late stages. Hypothesis: PRP reduces pain and leads to a more effective and lasting functional recovery than corticosteroid with local anesthetic. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 75 patients with symptomatic knee OA (Kellgren-Lawrence grade 3 to 4) were enrolled in this study between August 2013 and July 2014. Patients were randomized to treatment either with a single leukocyte-reduced PRP or corticosteroid intra-articular injection. The primary variable was visual analog scale assessment at 1 month. Secondary outcomes were the Knee injury and Osteoarthritis Outcome Score (KOOS) and Short Form–36 (SF-36) at 1, 3, and 6 months after treatment. Patient satisfaction at final follow-up was assessed. Both groups were homogeneous and comparable in baseline characteristics. Results: All variables improved in both groups. Statistical differences between groups were not found for the majority of the outcome variables, although the magnitude of improvements tended to be greater in the PRP group. Quality-of-life differences between values at 3 and 6 months versus baseline increased significantly more in the study group (P = .05 and .03, respectively), and so did general health perception differences at 6 months (P = .018). Conclusion: A single PRP intra-articular injection is effective for relieving pain and improving activities of daily living and quality of life in late-stage knee OA. For patients with late-stage knee OA who are 67 years or older, 1 intra-articular injection of PRP has similar results to 1 shot of corticosteroid. PMID:28255569

  2. Graphene-like single-layered covalent organic frameworks: synthesis strategies and application prospects.

    PubMed

    Liu, Xuan-He; Guan, Cui-Zhong; Wang, Dong; Wan, Li-Jun

    2014-10-29

    Two-dimensional (2D) nanomaterials, such as graphene and transition metal chalcogenides, show many interesting dimension-related materials properties. Inspired by the development of 2D inorganic nanomaterials, single-layered covalent organic frameworks (sCOFs), featuring atom-thick sheets and crystalline extended organic structures with covalently bonded building blocks, have attracted great attention in recent years. With their unique graphene-like topological structure and the merit of structural diversity, sCOFs promise to possess novel and designable properties. However, the synthesis of sCOFs with well-defined structures remains a great challenge. Herein, the recent development of the bottom-up synthesis methods of 2D sCOFs, such as thermodynamic equilibrium control methods, growth-kinetics control methods, and surface-assisted covalent polymerization methods, are reviewed. Finally, some of the critical properties and application prospects of these materials are outlined.

  3. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial

    PubMed Central

    Yuste Sánchez, María José; Zapico Goñi, Álvaro; Prieto Merino, David; Mayoral del Moral, Orlando; Cerezo Téllez, Ester; Minayo Mogollón, Elena

    2010-01-01

    Objective To determine the effectiveness of early physiotherapy in reducing the risk of secondary lymphoedema after surgery for breast cancer. Design Randomised, single blinded, clinical trial. Setting University hospital in Alcalá de Henares, Madrid, Spain. Participants 120 women who had breast surgery involving dissection of axillary lymph nodes between May 2005 and June 2007. Intervention The early physiotherapy group was treated by a physiotherapist with a physiotherapy programme including manual lymph drainage, massage of scar tissue, and progressive active and action assisted shoulder exercises. This group also received an educational strategy. The control group received the educational strategy only. Main outcome measure Incidence of clinically significant secondary lymphoedema (>2 cm increase in arm circumference measured at two adjacent points compared with the non-affected arm). Results 116 women completed the one year follow-up. Of these, 18 developed secondary lymphoedema (16%): 14 in the control group (25%) and four in the intervention group (7%). The difference was significant (P=0.01); risk ratio 0.28 (95% confidence interval 0.10 to 0.79). A survival analysis showed a significant difference, with secondary lymphoedema being diagnosed four times earlier in the control group than in the intervention group (intervention/control, hazard ratio 0.26, 95% confidence interval 0.09 to 0.79). Conclusion Early physiotherapy could be an effective intervention in the prevention of secondary lymphoedema in women for at least one year after surgery for breast cancer involving dissection of axillary lymph nodes. Trial registration Current controlled trials ISRCTN95870846. PMID:20068255

  4. High Power Laser for Treatment of Achilles Tendinosis – a Single Blind Randomized Placebo Controlled Clinical Study

    PubMed Central

    Mårdh, Anders; Lund, Iréne

    2016-01-01

    Introduction: Pain in the Achilles tendon during loading is a very common condition. Conservative treatments, such as low level laser therapy (LLLT) have been reported to give varying results. Recently, a new laser treatment technique, high power laser treatment (HPLT) (Swiss DynaLaser®), was introduced in Scandinavia, but has not, to our knowledge, been systematically tested before. The objective of this study was to evaluate the effects of HPLT compared to placebo HPLT in rated pain and assessed pain threshold in patients with chronic Achilles tendinosis. Methods: The study was a randomized, single blind, placebo controlled trial. Patients were randomized to receive 6 treatments of either HPLT or placebo HPLT during a period of 3-4 weeks with a follow up period of 8-12 weeks. Outcome measures were rated pain according to questions of the Foot and Ankle Outcome Score (FAOS, Swedish version LK1.0) and assessment of electro-cutaneous stimulated pain threshold and matched pain (PainMatcher). Results: The results of the study demonstrated significant changes of assessments within groups, that were more pronounced towards lower levels of rated pain in the HPLT group than in the placebo HPLT group. The between group difference were significant in four of nine questions regarding loading activities of the FAOS subscale. Assessed pain thresholds were found increased in the HPLT group, as compared to the placebo HPLT group. At individual level, the results varied. Conclusion: The results indicate that HPLT may provide a future option for treatment of Achilles tendinosis related pain, but further studies are warranted. PMID:27330704

  5. Myofascial Pain Syndrome in the Elderly and Self-Exercise: A Single-Blind, Randomized, Controlled Trial

    PubMed Central

    Kim, Minhee; Lee, Minyoung; Kim, Yushin; Oh, Sejun; Lee, Dongshin

    2016-01-01

    Abstract Objective: This study aimed to demonstrate the effect of self-exercise with a therapeutic inflatable ball (SEIB) in elderly patients with myofascial pain syndrome. Design: Single-blind, randomized, controlled noninferiority trial. Setting: University campus. Participants: Forty elderly patients with myofascial pain syndrome completed the study. They were randomly allocated to SEIB (n = 22; mean age, 70.23 ± 6.11 years) or ultrasound (US) therapy (n = 18; mean age, 67.99 ± 5.64 years). Intervention: SEIB and US therapy (twice weekly for 4 consecutive weeks). Outcome measures: Visual analog scale (VAS), pressure pain threshold (PPT), and cervical lateral flexion (CLF) were measured at baseline and at 1, 2, 3, and 4 weeks. Results: The noninferiority test indicated that SEIB was not inferior to US for VAS, PPT, and CLF. Between-group comparisons showed no significant differences in the VAS (F = 2.579; p = 0.117), the PPT (F = 0.245; p = 0.624), and the CLF (F = 2.072; p = 0.159). In within-group comparisons, both groups presented significant differences in VAS (SEIB after 1 week and US after 1 week), PPT (SEIB after 3 weeks and US after 4 weeks), and CLF (SEIB after 4 weeks and US after 4 weeks) compared with baseline values. Conclusions: SEIB for 4 weeks has an effect similar to that of US for desensitizing myofascial pain and increasing joint flexibility. High accessibility and low cost would make SEIB a practical self-treatment method in elderly patients with myofascial pain syndrome. PMID:26910293

  6. Self-Efficacy in Foot-Care and Effect of Training: A Single-Blinded Randomized Controlled Clinical Trial

    PubMed Central

    Seyyedrasooli, Alehe; Parvan, Kobra; Valizadeh, Leila; Rahmani, Azad; Zare, Maryam; Izadi, Tayyebeh

    2015-01-01

    Background Diabetes mellitus (DM) is one of the most common metabolic and non-communicable disorders worldwide and the mortality rates caused by the complications associated with the disease, such as diabetic foot ulcer, is increasing dramatically. Patient education is considered as an essential part of controlling DM. Therefore, we aimed to compare the effects of individual and group training methods on self-efficacy in foot care among the patients with DM. Methods In this single-blinded, randomized controlled clinical trial, we enrolled 150 patients with type 1 and 2 DM. The final participants were randomly assigned into two intervention groups (collective and individual training group) and a control group. Data were collected using foot-care self-efficacy questionnaire (Corrbet, 2003). A research assistant collected the data by interviewing the participants using the questionnaire once before and once one month after the intervention. The participants of the intervention groups attended a training program consisting of three sessions per week for one week. Statistical descriptive tests such as mean and standard deviation (SD) percentage were used to describe the features of the data inferential statistics test such as Chi-square, independent t-test and repeated measures analysis of variance and analysis co-variance (ANOVA, ANCOVA) tests were also used as appropriate. The significance level was set at <0.05. Results The results indicated that there was no significant difference between the three groups regarding the mean of self-efficacy scores before foot-care training intervention (P=0.39). But, comparison of the scores before and after the intervention showed that both group and individual training interventions increased the patients’ self-efficacy (P≤0/05). Conclusion It can be concluded that both group and individual training approaches could increase foot care self-efficacy in the patients with DM. Trial Registration Number: IRCT201203086918N6. PMID

  7. Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Tuchin, Peter J; Russell, Michael Bjørn

    2015-01-01

    Introduction Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT). Method and analysis According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12 months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs. Ethics and dissemination The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals. Trial registration number NCT01741714. PMID:26586317

  8. L-lysine as adjunctive treatment in patients with schizophrenia: a single-blinded, randomized, cross-over pilot study

    PubMed Central

    2011-01-01

    Background Accumulating evidence suggests that the brain's nitric oxide (NO) signalling system may be involved in the pathophysiology of schizophrenia and could thus constitute a novel treatment target. The study was designed to investigate the benefit of L-lysine, an amino acid that interferes with NO production, as an add-on treatment for schizophrenia. Methods L-lysine, 6 g/day, was administered to 10 patients with schizophrenia as an adjunctive to their conventional antipsychotic medication. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks. Results L-lysine treatment caused a significant increase in blood concentration of L-lysine and was well tolerated. A significant decrease in positive symptom severity, measured by the Positive And Negative Syndrome Scale (PANSS), was detected. A certain decrease in score was also observed during placebo treatment and the effects on PANSS could not unequivocally be assigned to the L-lysine treatment. Furthermore, performance on the Wisconsin Card Sorting Test was significantly improved compared to baseline, an effect probably biased by training. Subjective reports from three of the patients indicated decreased symptom severity and enhanced cognitive functioning. Conclusions Four-week L-lysine treatment of 6 g/day caused a significant increase in blood concentration of L-lysine that was well tolerated. Patients showed a significant decrease in positive symptoms as assessed by PANSS in addition to self-reported symptom improvement by three patients. The NO-signalling pathway is an interesting, potentially new treatment target for schizophrenia; however, the effects of L-lysine need further evaluation to decide the amino acid's potentially beneficial effects on symptom severity in schizophrenia. Trial registration NCT00996242 PMID

  9. Acute effects of beer on endothelial function and haemodynamics: a single-blind, cross-over study in healthy volunteers

    PubMed Central

    Karatzi, Kalliopi; Rontoyanni, Victoria G.; Protogerou, Athanase D.; Georgoulia, Aggeliki; Xenos, Konstantinos; Chrysou, John; Sfikakis, Petros P.; Sidossis, Labros S.

    2015-01-01

    Objective Moderate consumption of beer is associated with lower cardiovascular (CV) risk. To explore the underlying mechanisms we studied the acute effects of the constituents of beer (alcohol and antioxidants), on established predictors of CV risk: endothelial function, aortic stiffness, pressure wave reflections and aortic pressure. Research Methods & Proceedures In a randomized, singleblind, cross - over study 17 healthy, non-smoking, volunteers (28.5±5.2 years and 24.4±2.5 BMI) consumed in 3 separate days, at least one week apart: a) 400 ml of beer & 400 ml water, b) 800 ml of dealcoholized beer (same amount of polyphenols), and c) 67 ml of vodka & 733 ml water (same amount of alcohol). Each time aortic stiffness (pulse wave velocity, pressure wave reflections (Aix), aortic and brachial pressure (Sphygmocor device) and endothelial function (brachial flow mediated dilatation) were assessed at fast and 1 and 2 hours postprandial. Results Aortic stiffness was significantly and similarly reduced by all 3 interventions. However, endothelial function was significantly improved only after beer consumption (average of 1.33%, CI 0.15-2.53). Although wave reflections were significantly reduced by all 3 interventions (average of beer: 9.1%, dealcoholized beer: 2.8%, vodka 8.5%, all CI within limits of significance), the reduction was higher after beer consumption compared todealcoholized beer (p=0.018). Pulse pressure amplification (i.e. brachial/aortic) was increased by all 3 test drinks. Conclusions Beer improves acutely parameters of arterial function and structure, in healthy non-smokers. This benefit seems to be mediated by the additive or synergistic effects of alcohol and anti-oxidants and merits further investigation. PMID:23810643

  10. Aesthetic comparison between synthetic glue and subcuticular sutures in thyroid and parathyroid surgery: a single-blinded randomised clinical trial.

    PubMed

    Alicandri-Ciufelli, M; Piccinini, A; Grammatica, A; Molteni, G; Spaggiari, A; DI Matteo, S; Tassi, S; Ghidini, A; Izzo, L; Gioacchini, F M; Marchioni, D; DI Saverio, S; Presutti, L

    2014-12-01

    The aim of our study was to compare, in terms of aesthetic results, the use of synthetic glue to intradermal absorbable sutures in postthyroidectomy and parathyroidectomy wound closure in a single blinded, randomised, per protocol equivalence study. From September 2008 to May 2010, patients undergoing thyroid or parathyroid surgery (with an external approach) at the Otolaryngology Department of the University Hospital of Modena were assessed for eligibility. In total, 42 patients who had had synthetic glue application on surgical incisions (A) and 47 patients who had subcuticular sutures on their surgical incisions (B) were enrolled. The mean of the endpoint (based on the Wound Registry Scale) of group A at 10 days was 1.4, while that in group B (based on the Stony Brook Scar Evaluation Scale) was 2.9. Statistically significant (p = 0.002) and clinically significant (difference of the means = 1.5) differences in the aesthetic results were found between groups A and B at 10 days, with better results in group B. On the other hand, at 3 months, the mean of the endpoint in group A was 3.1 while that in group B was 2.8; no statistically significant (p = 0.62) or clinically significant (difference in means = 0.3) differences were found between groups A and B. In conclusion, synthetic glue differs from subcuticular suture in post-thyroidectomy or post-parathyroidectomy incision for early aesthetic results, with better outcomes for subcuticular sutures. At 3 months, there were no differences in aesthetic outcomes between groups. Moreover, sex, incision length, age, cold/hot blade and correspondence of the incision with a wrinkle in the skin did not seem to influence aesthetic outcomes with this type of incision.

  11. Effectiveness of different memory training programs on improving hyperphagic behaviors of residents with dementia: a longitudinal single-blind study

    PubMed Central

    Kao, Chieh-Chun; Lin, Li-Chan; Wu, Shiao-Chi; Lin, Ker-Neng; Liu, Ching-Kuan

    2016-01-01

    Background Hyperphagia increases eating-associated risks for people with dementia and distress for caregivers. The purpose of this study was to compare the long-term effectiveness of spaced retrieval (SR) training and SR training combined with Montessori activities (SR + M) for improving hyperphagic behaviors of special care unit residents with dementia. Methods The study enrolled patients with dementia suffering from hyperphagia resident in eight institutions and used a cluster-randomized single-blind design, with 46 participants in the SR group, 49 in the SR + M group, and 45 participants in the control group. For these three groups, trained research assistants collected baseline data on hyperphagic behavior, pica, changes in eating habits, short meal frequency, and distress to caregivers. The SR and SR + M groups underwent memory training over a 6-week training period (30 sessions), and a generalized estimating equation was used to compare data of all the three groups of subjects obtained immediately after the training period and at follow-ups 1 month, 3 months, and 6 months later. Results Results showed that the hyperphagic and pica behaviors of both the SR and SR + M groups were significantly improved (P<0.001) and that the effect lasted for 3 months after training. The improvement of fast eating was significantly superior in the SR + M group than in the SR group. The improvement in distress to caregivers in both intervention groups lasted only until the posttest. Improvement in changes in eating habits of the two groups was not significantly different from that of the control group. Conclusion SR and SR + M training programs can improve hyperphagic behavior of patients with dementia. The SR + M training program is particularly beneficial for the improvement of rapid eating. Caregivers can choose a suitable memory training program according to the eating problems of their residents. PMID:27307717

  12. Soothing and anti-itch effect of quercetin phytosome in human subjects: a single-blind study

    PubMed Central

    Maramaldi, Giada; Togni, Stefano; Pagin, Ivan; Giacomelli, Luca; Cattaneo, Roberta; Eggenhöffner, Roberto; Burastero, Samuele E

    2016-01-01

    Background We evaluated the ability of quercetin, a natural antioxidant formulated in a specific delivery system, to reduce skin inflammation induced by a variety of stimuli, including UV radiation, stimulation with a histamine solution, or contact with chemical irritants. In particular, we tested the soothing and anti-itch effect of Quercevita®, 1% cream for external use, a formulation characterized by a phospholipids-based delivery system. Patients and methods The study was a monocentric, single blind trial that enrolled a group of 30 healthy volunteers. The back of each subject was examined to identify four quadrants with no previous skin damage or naevi that were treated in order to induce a controlled and reversible form of skin stress. The areas were treated as follows: no product; Quercevita® 1% cream, 2 mg/cm2; placebo; positive control (a commercially available topical formulation containing 1% dexchlorpheniramine). Results Only quercetin phospholipids 1% and dexchlorpheniramine 1% achieved a significant reduction in erythema with comparable results: (–10.05% [P=0.00329] for quercetin phospholipids 1% vs –14.05% [P=0.00046] for the positive control). Moreover, quercetin phospholipids 1% and dexchlorpheniramine 1% were both associated with a significant decrease in mean wheal diameter: (–13.25% and –12.23% for dexchlorpheniramine 1%, respectively). Similar findings were reported for the other tested parameters. Conclusion Quercetin has a skin protective effect against damage caused by a variety of insults, including UV radiation, histamine, or contact with toxic chemical compounds. Indeed, quercetin is able to reduce redness, itching, and inflammation of damaged skin; it may also help restore skin barrier function, increasing hydration, and reducing water loss. PMID:27013898

  13. The effect of clove-based herbal mouthwash on radiation-induced oral mucositis in patients with head and neck cancer: a single-blind randomized preliminary study

    PubMed Central

    Kong, Moonkyoo; Hwang, Deok-Sang; Yoon, Seong Woo; Kim, Jinsung

    2016-01-01

    Purpose This study was performed to evaluate the efficacy and safety of clove-based herbal mouthwash in ameliorating radiation-induced oral mucositis in patients with head and neck cancer. Methods Fourteen patients were prospectively enrolled in this study and randomized to either an experimental group or a control group. The patients of the experimental group swished their mouths with a clove-based herbal mouthwash during radiotherapy (RT), while the patients of the control group swished with clear water. The primary end point of this study was incidence of radiation-induced oral mucositis. The secondary end points were time to onset of radiation-induced oral mucositis, duration of radiation-induced oral mucositis, incidence of supplemental nutrition through feeding tube, maximum pain score, body weight loss, incidence of RT interruption, and duration of RT interruption. Results The use of clove-based herbal mouthwash shortened the duration of grade ≥2 mucositis (24.3 days vs 37.1 days, P=0.044) and reduced body weight loss during RT (3.1% vs 7.4%, P=0.023) compared with clear water. The use of clove-based herbal mouthwash also reduced the incidence of grade 3 mucositis (28.6% vs 57.1%), supplemental nutrition (0% vs 28.6%), and RT interruption (14.3% vs 28.6%), and reduced the duration of grade 3 mucositis (5.1 days vs 17.7 days) and RT interruption (1 days vs 8.5 days). In addition, clove-based herbal mouthwash delayed the time to onset of mucositis (26.6 days vs 24.5 days) and reduced the maximum pain score (4.1 vs 4.9). However, these differences were not statistically significant. Conclusion Although we could not find significant differences in some end points, this single-blind randomized study showed that a clove-based herbal mouthwash can have a potentially beneficial effect on minimizing or preventing radiation-induced oral mucositis in patients with head and neck cancer. To confirm the results of our study, well-designed randomized studies with large

  14. Increased masticatory activity and quality of life in elderly persons with dementia-a longitudinal matched cluster randomized single-blind multicenter intervention study

    PubMed Central

    2013-01-01

    Background Worldwide, millions of people are suffering from dementia and this number is rising. An index of quality of life (QoL) can describe the impact a disease or treatment has on a person’s wellbeing. QoL comprises many variables, including physical health and function, and mental health and function. QoL is related to masticatory ability and physical activity. Animal studies show that disruption of mastication due to loss of teeth or a soft diet leads to memory loss and learning problems. Since these are common complaints in dementia, it is hypothesized that improvement of masticatory function and normalization of diet consistency can increase QoL in elderly persons suffering from dementia. Therefore, the goal of the present study is to examine whether an increase in masticatory activity, achieved by increased food consistency and enhancement of masticatory function through improved oral health care has a positive effect on QoL, including cognition, mood, activities of daily living (ADL), and circadian rhythm in elderly persons with dementia. Methods and design The described study is a prospective longitudinal matched cluster randomized single-blind multicenter study. Participants are elderly persons living in the Netherlands, suffering from dementia and receiving psychogeriatric care. An intervention group will receive improved oral health care and a diet of increased consistency. A control group receives care as usual. Participants will be assessed four times; outcome variables besides QoL are cognition, mood, independence, rest-activity rhythm, blood pressure, and masticatory function. Discussion This research protocol investigates the effect of an intervention executed by daily caregivers. The intervention will increase masticatory activity, which is achieved by three different actions, (providing oral health care, increasing food consistency, or a combination of both). There is a certain amount of variety in the nature of the interventions due to local

  15. Single-blind and Double-blind Randomized Controlled Trials of Palmtherapy®, an Alternative Medical Approach, for Anxiety before Cardiac Catheterization

    PubMed Central

    Jafari, Jamal; Podberezsky, Anna; David, Tamar; Reizin, Leonardo; Benjamin, Jonathan

    2008-01-01

    Alternative medicine is widely used, but lacks consensus regarding its amenability to scientific investigation. Anxiety increases morbidity and mortality in ischemic heart disease. We performed two studies of Palmtherapy®, an alternative treatment, for anxiety before cardiac catheterization. In the first study, patients were randomized to receive pressure at particular points on the palm, or at incorrect locations, for about 50 min, while the therapist conversed with them. In the second study, the conversation was conducted by a second, ‘blind’ investigator. In both studies, patients and nurses, all blind to treatment assignment, completed visual analog scale and National Institute of Mental Health measures of anxiety, respectively. Twenty-three subjects completed study 1, and 17 completed study 2. In study 1, palm therapy was superior to sham therapy for both outcome measures. In study 2, palm therapy was superior for self-reported anxiety, but not for nurses’ assessments of anxiety. Future studies should attempt to separate possible mechanistic effects of Palmtherapy® from therapist-related variables. Whether alternative medicine deserves to be studied at all remains controversial. Palmtherapy® may offer anxiolytic benefit without the harm attributable to drugs. PMID:18317556

  16. 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.

    PubMed

    Tomera, Kevin M; Burdmann, Emmanuel A; Reyna, Oscar G Pamo; Jiang, Qi; Wimmer, Wendy M; Woods, Gail L; Gesser, Richard M

    2002-09-01

    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 days, patients could be switched to an oral antimicrobial agent. A total of 159 patients in the ertapenem group and 171 patients in the ceftriaxone group were microbiologically evaluable. Approximately 95% of patients in each treatment group were switched to oral therapy. The most common pathogens were Escherichia coli and Klebsiella pneumoniae. At the primary efficacy endpoint 5 to 9 days after treatment, 91.8% of patients who received ertapenem and 93.0% of those who received ceftriaxone had a favorable microbiological response (95% confidence interval for the difference, adjusting for strata, -7.6 to 5.1%), indicating that outcomes in the two treatment groups were equivalent. Microbiological success rates for the two treatment groups were similar when compared by stratum and also by severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this study, ertapenem was as effective as ceftriaxone for the initial treatment of complicated UTIs in adults, was generally well tolerated, and had a similar overall safety profile.

  17. 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

    PubMed Central

    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 days, patients could be switched to an oral antimicrobial agent. A total of 159 patients in the ertapenem group and 171 patients in the ceftriaxone group were microbiologically evaluable. Approximately 95% of patients in each treatment group were switched to oral therapy. The most common pathogens were Escherichia coli and Klebsiella pneumoniae. At the primary efficacy endpoint 5 to 9 days after treatment, 91.8% of patients who received ertapenem and 93.0% of those who received ceftriaxone had a favorable microbiological response (95% confidence interval for the difference, adjusting for strata, −7.6 to 5.1%), indicating that outcomes in the two treatment groups were equivalent. Microbiological success rates for the two treatment groups were similar when compared by stratum and also by severity of infection. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this study, ertapenem was as effective as ceftriaxone for the initial treatment of complicated UTIs in adults, was generally well tolerated, and had a similar overall safety profile. PMID:12183244

  18. Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

    PubMed Central

    Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

    2017-01-01

    Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

  19. Effect of Dexmedetomidine as an Adjuvant to 0.75% Ropivacaine in Interscalene Brachial Plexus Block Using Nerve Stimulator: A Prospective, Randomized Double-blind Study

    PubMed Central

    Rashmi, H. D.; Komala, H. K.

    2017-01-01

    Background: Ropivacaine, a newer local anesthetic (LA), has been increasingly used nowadays in different concentrations for peripheral nerve blocks. It has lesser cardiac toxicity and higher safety margin when compared to bupivacaine. Dexmedetomidine, a novel α2 agonist, is widely used as adjuvant to LA in peripheral nerve blocks to decrease the time of onset and increase the duration of the block. In this study, we evaluated the effect of dexmedetomidine as an adjuvant with 0.75% ropivacaine for interscalene brachial plexus block using nerve stimulator. Aim: This study aims to know the effect of using dexmedetomidine as an adjuvant to 0.75% ropivacaine in interscalene brachial plexuses block using nerve stimulator. Settings and Designs: Sixty patients scheduled for elective orthopedic surgery of the upper limb under interscalene block were considered in this prospective randomized controlled double-blind study. The study population was randomly divided into two groups with thirty patients in each group by using computerized randomization. Materials and Methods: Group R received 30 ml of 0.75% ropivacaine with 0.5 ml normal saline and Group RD received 30 ml of 0.75% ropivacaine with 50 μg of dexmedetomidine. The onset of sensory and motor blocks, duration of sensory and motor block, and patient satisfaction score were observed. Results: Both the groups were comparable in demographic characteristics. The onset of the sensory and motor block is earlier and statistically significant in Group RD (P < 0.05) when compared to Group R. The duration of sensory and motor blockade were significantly prolonged in Group RD (P < 0.0001). Conclusion: Addition of dexmedetomidine to 0.75% ropivacaine in interscalene brachial plexus block significantly shortened the time of onset of the block and prolongs the duration sensory and motor blockade. PMID:28298772

  20. Postoperative Sore Throat Prevention in Ambulatory Surgery: A Comparison between Preoperative Aspirin and Magnesium Sulfate Gargle – A Prospective, Randomized, Double-blind Study

    PubMed Central

    Chattopadhyay, Surajit; Das, Anjan; Nandy, Sabyasachi; RoyBasunia, Sandip; Mitra, Tapobrata; Halder, Partha Sarathi; Chhaule, Subinay; Mandal, Subrata Kumar

    2017-01-01

    Background: Postoperative sore throat (POST) frequently hampers the positive feedback of ambulatory surgery in spite of so many measures. This study was carried out to compare the efficacy of preoperative magnesium sulfate and aspirin gargle in preventing POST after ambulatory surgery. Materials and Methods: It was a prospective, randomized, and double-blinded study. Fifty-six adult patients of either sex, aged 25–50, of American Society of Anesthesiologists physical status I–II, scheduled for day care surgery, were randomly allocated to Group A ([n = 28] receiving aspirin gargle [325 mg tablet]) and Group M ([n = 28] receiving magnesium sulfate [20 mg/kg] gargle). In both groups, the medications were made into 20 mL of (5% dextrose) solution. Patients were asked to gargle with this mixture for 30 s, 15 min before induction of anesthesia. Episodes of POST were measured at 0, 2, 4, 6, 9, 12, and 16 h postoperatively with a four-point scale. Results: Both groups had a similar demographic profile with comparable oxygen saturation, hemodynamics, and consciousness status at immediate postoperative period. Number of patients with sore throat was significantly lower in magnesium group compared to aspirin group at 0 h (P = 0.0376), 2 h (P = 0.0429), 4 h (P = 0.0394) after the operation. POST pain score (visual analog scale) was significantly (P < 0.05) lower in magnesium group compared to aspirin group after the operation at 0, 2, 4 h after operation. Conclusion: It is evident that preoperative magnesium sulfate gargle significantly attenuated the incidence and severity of POST, especially in the early postoperative period, with no adverse effects in patients undergoing day care surgery under general anesthesia. PMID:28298764

  1. Effect of Different Doses of Dexmedetomidine as Adjuvant in Bupivacaine -Induced Subarachnoid Block for Traumatized Lower Limb Orthopaedic Surgery: A Prospective, Double-Blinded and Randomized Controlled Study

    PubMed Central

    Halder, Susanta; Mandal, Debabrata; Chandra, Mainak; Ray, Souradeep; Biswas, Madhuri Ranjana; Mandal, Parthojit; Das, Tanuka

    2014-01-01

    Background and Aims: Improved pain management for blunt trauma to the lower extremity has shown to reduce morbidity, induce early ambulation and improve long-term outcomes. Dexmedetomidine; a selective α-2 agonist; has recently been used intrathecally in different doses to prolong spinal anaesthesia. We evaluated the effect of adding two different doses of dexmedetomidine to hyperbaric bupivacaine for spinal anaesthesia. The primary endpoints were the onset and duration of sensory, motor block and duration of analgesia. Materials and Methods: Eighty patients, (20-60yrs) posted for elective lower limb orthopedic surgery of traumatic origin under spinal anaesthesia were divided into 2 equal groups (Group D5&D10) in a randomized, double-blind fashion. In this prospective parallel group study, group D5(n=40) 3ml 0.5% hyperbaric bupivacaine+5μg dexmedetomidine in 0.5 ml of normal saline and group D10 (n=40) 3ml 0.5% bupivacaine+10μg dexmedetomidine in 0.5 ml of normal saline were administered intrathecally. Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative VAS, hemodynamics and side effects were recorded for each patient. Results: Though with similar demographic profile in both groups, sensory and motor block in group D10(p<0.05) was earlier than group D5. Sensory, motor block duration and time to first analgesic use were significantly longer and the need for rescue analgesics was lower in group D10(p<0.05) than D5. 24 h VAS score was significantly lower in group D10(p<0.05). Intergroup hemodynamics was comparable (p>0.05) without any appreciable side effects. Conclusion: Spinal dexmedetomidine increases the sensory, motor block duration and time to first analgesic use, and decreases analgesic consumption in a dose-dependent manner PMID:25584237

  2. Utility of an Abbreviated Dizziness Questionnaire to Differentiate between Causes of Vertigo and Guide Appropriate Referral: A Multicenter Prospective Blinded Study

    PubMed Central

    Roland, Lauren T.; Kallogjeri, Dorina; Sinks, Belinda C.; Rauch, Steven D.; Shepard, Neil T.; White, Judith A.; Goebel, Joel A.

    2015-01-01

    Objective Test performance of a focused dizziness questionnaire’s ability to discriminate between peripheral and non-peripheral causes of vertigo. Study Design Prospective multi-center Setting Four academic centers with experienced balance specialists Patients New dizzy patients Interventions A 32-question survey was given to participants. Balance specialists were blinded and a diagnosis was established for all participating patients within 6 months. Main outcomes Multinomial logistic regression was used to evaluate questionnaire performance in predicting final diagnosis and differentiating between peripheral and non-peripheral vertigo. Univariate and multivariable stepwise logistic regression were used to identify questions as significant predictors of the ultimate diagnosis. C-index was used to evaluate performance and discriminative power of the multivariable models. Results 437 patients participated in the study. Eight participants without confirmed diagnoses were excluded and 429 were included in the analysis. Multinomial regression revealed that the model had good overall predictive accuracy of 78.5% for the final diagnosis and 75.5% for differentiating between peripheral and non-peripheral vertigo. Univariate logistic regression identified significant predictors of three main categories of vertigo: peripheral, central and other. Predictors were entered into forward stepwise multivariable logistic regression. The discriminative power of the final models for peripheral, central and other causes were considered good as measured by c-indices of 0.75, 0.7 and 0.78, respectively. Conclusions This multicenter study demonstrates a focused dizziness questionnaire can accurately predict diagnosis for patients with chronic/relapsing dizziness referred to outpatient clinics. Additionally, this survey has significant capability to differentiate peripheral from non-peripheral causes of vertigo and may, in the future, serve as a screening tool for specialty referral

  3. A prospective, randomized, placebo-controlled, double-blind, multicenter study of the effects of irbesartan on aortic dilatation in Marfan syndrome (AIMS trial): study protocol

    PubMed Central

    2013-01-01

    Background Cardiovascular complications are the leading cause of mortality and morbidity in Marfan syndrome (MFS), a dominantly inherited disorder caused by mutations in the gene that encodes fibrillin-1. There are approximately 18,000 patients in the UK with MFS. Current treatment includes careful follow-up, beta blockers, and prophylactic surgical intervention; however, there is no known treatment which effectively prevents the rate of aortic dilatation in MFS. Preclinical, neonatal, and pediatric studies have indicated that angiotensin receptor blockers (ARBs) may reduce the rate of aortic dilatation. This trial will investigate the effects of irbesartan on aortic dilatation in Marfan syndrome. Methods/Design The Aortic Irbesartan Marfan Study (AIMS) is an investigator-led, prospective, randomized, placebo-controlled, double-blind, phase III, multicenter trial. Currently, 26 centers in the UK will recruit 490 clinically confirmed MFS patients (aged ≥6 to ≤40 years) using the revised Ghent diagnostic criteria. Patients will be randomized to irbesartan or placebo. Aortic root dilatation will be measured by transthoracic echocardiography at baseline and annually thereafter. The primary outcome is the absolute change in aortic root diameter per year measured by echocardiography. The follow-up period will be a minimum of 36 months with an expected mean follow-up period of 48 months. Discussion This is the first clinical trial to evaluate the ARB irbesartan versus placebo in reducing the rate of aortic root dilatation in MFS. Not only will this provide useful information on the safety and efficacy of ARBs in MFS, it will also provide a rationale basis for potentially lifesaving therapy for MFS patients. Trial registration ISRCTN, 90011794 PMID:24289736

  4. Safety and Effectiveness of Continuation Antidepressant Versus Mood Stabilizer Monotherapy for Relapse-prevention of Bipolar II Depression: A Randomized, Double-blind, Parallel-group, Prospective Study

    PubMed Central

    Amsterdam, Jay D.; Lorenzo-Luaces, Lorenzo; Soeller, Irene; Li, Susan Qing; Mao, Jun J.; DeRubeis, Robert J.

    2015-01-01

    Objective Compare the safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for preventing depressive relapse in bipolar II disorder. Methods Subjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium monotherapy for 12 weeks. Responders with a ≥50% reduction in depression score were continued for an additional 6 months of relapse-prevention monotherapy. Primary outcome was depressive relapse during continuation monotherapy. Secondary outcomes included sustained response rate from initiation of treatment to study end-point, relapse hazard, time to relapse, change in mania ratings, and frequency of treatment-emergent sub-syndromal hypomania and/or depressive episodes. Results Venlafaxine produced greater sustained response rate versus lithium (p<0.0001); however, there was no difference in relapse rate for venlafaxine (7.5%) versus lithium (26.7%) (p=0.079); relapse hazard (p=0.073), or time to relapse (p=0.090) between treatment conditions during continuation monotherapy. There were no group differences in mania rating scores over time and no difference in frequency or duration of syndromal or sub-syndromal hypomanic episodes. There were more sub-syndromal depressive episodes during lithium monotherapy (p=0.03). Limitations Sample size was limited by the lower sustained response rate for lithium versus venlafaxine; study was not specifically powered to detect differences in treatment-emergent hypomanic or depressive episodes between groups. Conclusion Results suggest that continuation venlafaxine monotherapy may provide similar prophylactic effectiveness relative to lithium, with no difference in treatment-emergent hypomanic episodes and without the need for frequent serum lithium level and metabolic monitoring. Larger, prospective trials are needed to confirm these observations. PMID:26143402

  5. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial

    PubMed Central

    Chevalier, X; Jerosch, J; Goupille, P; van Dijk, N; Luyten, F P; Scott, D L; Bailleul, F; Pavelka, K

    2010-01-01

    Objectives: The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection of hylan G-F 20 was also assessed. Methods: Patients with primary osteoarthritis knee pain were randomly assigned to arthrocentesis plus a 6 ml intra-articular injection of either hylan G-F 20 or placebo in a prospective, double-blind (one injector/one blinded observer) study. Results were evaluated at 4, 8, 12, 18 and 26 weeks post-injection. The primary outcome criterion was change from baseline over 26 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index A pain. Secondary outcome measures included WOMAC A1 and C, patient global assessment (PGA) and clinical observer global assessment (COGA) and Outcome Measures in Rheumatology, Osteoarthritis Research Society International responder rates. A 4-week, open, repeat treatment phase evaluated safety only. Results: A total of 253 patients (Kellgren–Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC A pain scores (−0.15, SE 0.076, p = 0.047), and several of the secondary outcome measures (WOMAC A1, PGA and COGA), than patients receiving placebo. There was no difference between the safety results of the two groups. No increased risk of local adverse events was observed in the open, repeat treatment phase. Conclusions: This placebo-controlled study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 26 weeks, with a modest difference versus placebo. Trial registration number: NCT00131352. PMID:19304567

  6. Comparable Efficacy of a 1-L PEG and Ascorbic Acid Solution Administered with Bisacodyl versus a 2-L PEG and Ascorbic Acid Solution for Colonoscopy Preparation: A Prospective, Randomized and Investigator-Blinded Trial

    PubMed Central

    Im, Jong Pil; Kim, Su Hwan; Koh, Seong-Joon; Kim, Byeong Gwan; Lee, Kook Lae; Kim, Sang Gyun; Kim, Joo Sung; Jung, Hyun Chae

    2016-01-01

    Background Two liters of polyethylene glycol (PEG) solution administered with ascorbic acid (Asc) can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis) has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution. Methods This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group) or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group). The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered. Results A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96) of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10). There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01). Conclusions Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution. Trial Registration ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS) KCT0000708 PMID:27588943

  7. No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy®

    PubMed Central

    de Kleuver, M.; Horsting, P. P.; Spruit, M.; Jacobs, W. C. H.; van Limbeek, J.

    2009-01-01

    Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy® (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person’s body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61

  8. Triple, double- and single-incision laparoscopic cholecystectomy: a prospective study

    PubMed Central

    Sabuncuoglu, Mehmet Zafer; Benzin, Mehmet Fatih; Cakir, Tugrul; Sozen, Isa; Sabuncuoglu, Aylin

    2014-01-01

    Purpose: Advances in laparoscopic techniques have enabled complicated intra-abdominal surgical procedures to be made with less trauma and a better cosmetic appearance. The techniques have been developed by decreasing the number of incisions in conventional laparoscopic procedures in order to increase patient satisfaction. The aim of this study was to compare the results of cholecystectomies made with 3, 2 or a single incision. Method: A total of 95 cholecystectomy patients from Elbistan State Hospital and Suleyman Demirel University Hospital between 2011 and 2013 were prospectively evaluated. The patients were separated into 3 groups as triple incision laparoscopic cholecystectomy (TILC), double incision laparoscopic cholecystectomy (DILC) and single incision laparoscopic cholecystectomy (SILC). Patients were evaluated in respect of demographic characteristics, operation time, success rate, analgesia requirement, length of hospital stay and patient satisfaction. Results: Successful procedures were completed in 40 TILC, 40 DILC and 15 SILC cases. Transfer to open cholecystectomy was not required in any case. The mean duration of operation was 71 mins (range, 55-120 mins) for SILC cases, 45 mins (range, 32-125 mins) for DILC cases and 42 mins (range, 29-96 mins) for TILC cases. The mean time for the SILC cases was statistically significantly longer than the other two groups (p < 0.000). Conclusions: At a comparable level with DILC and TILC, single incision laparosccopic cholecystectomy is a method which can be used without incurring any extra costs or requiring additional instrumentation or training and which has good cosmetic results and a low requirement for analgesia. PMID:25419372

  9. Comparison of efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis: A prospective, randomized, double-blind, parallel group study

    PubMed Central

    Dakhale, Ganesh; Tathod, Yogesh; Patel, Seema; Pimpalkhute, Sonali; Raghute, Latesh; Khamkar, Ajita

    2016-01-01

    Objective: To compare the efficacy, safety, and cost-effectiveness of rupatadine and olopatadine in patients of allergic rhinitis (AR). Materials and Methods: A 2-week, single-centered, randomized, double-blind, parallel group comparative clinical study was conducted on patients with AR. Following inclusion and exclusion criteria, 67 patients were recruited and randomized to two treatment groups and received the respective drugs for 2 weeks. At follow-up, parameters assessed were total nasal symptom score (TNSS), change in total and differential count of eosinophil. Results: In olopatadine group, there was a significantly higher reduction in TNSS (P < 0.05) than that of rupatadine. Both the drugs significantly reduced the absolute eosinophil count, but olopatadine (P < 0.001) was found to be superior. The incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Conclusion: Olopatadine is a better choice in AR in comparison to rupatadine due to its better efficacy and safety profile. PMID:28163538

  10. Ertapenem Once a Day Versus Piperacillin–Tazobactam Every 6 Hours for Treatment of Acute Pelvic Infections: A Prospective, Multicenter, Randomized, Double-Blind Study

    PubMed Central

    Roy, Subir; Higareda, Iliana; Angel-Muller, Edith; Ismail, Mahmoud; Hague, Caren; Adeyi, Ben; Teppler, Hedy

    2003-01-01

    Objective: To compare ertapenem therapy with piperacillin–tazobactam therapy for the management of acute pelvic infections. Methods: In a multicenter, double-blind study, 412 women with acute pelvic infection were assigned to one of two strata, namely obstetric/postpartum infection or gynecologic/postoperative infection, and were then randomized to ertapenem, 1 g once a day, or piperacillin–tazobactam, 3.375 g every 6 hours, both administered intravenously. Results: In total, 163 patients in the ertapenem group and 153 patients in the piperacillin–tazobactam group were clinically evaluable. The median duration of therapy was 4.0 days in both treatment groups. The most common single pathogen was Escherichia coli . At the primary efficacy endpoint 2–4 weeks post therapy, 93.9% of patients who received ertapenem and 91.5% of those who received piperacillin–tazobactam were cured (95% confidence interval for the difference, adjusting for strata, –4% to 8.8%), indicating that cure rates for both treatment groups were equivalent. Cure rates for both treatment groups were also similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both groups. Conclusions: In this study, ertapenem was as effective as piperacillin–tazobactam for the treatment of acute pelvic infection, was generally well tolerated, and had an overall safety profile similar to that of piperacillin–tazobactam. PMID:12839630

  11. Orientation and Mobility with Persons Who Are Deaf-Blind: An Initial Examination of Single-Subject Design Research

    ERIC Educational Resources Information Center

    Parker, Amy T.

    2009-01-01

    Persons who are deaf-blind represent a heterogeneous, low-incidence population of children and adults who, at some point in life, regardless of the presence of additional disabilities, may benefit from formal orientation and mobility (O&M) instruction. Current national policies, such as the No Child Left Behind Act, which emphasize that…

  12. Mid-regional pro-adrenomedullin and copeptin to predict short-term prognosis of COPD exacerbations: a multicenter prospective blinded study

    PubMed Central

    Dres, Martin; Hausfater, Pierre; Foissac, Frantz; Bernard, Maguy; Joly, Luc-Marie; Sebbane, Mustapha; Philippon, Anne-Laure; Gil-Jardiné, Cédric; Schmidt, Jeannot; Maignan, Maxime; Treluyer, Jean-Marc; Roche, Nicolas

    2017-01-01

    Background Exacerbations of COPD (ECOPD) are a frequent cause of emergency room (ER) visits. Predictors of early outcome could help clinicians in orientation decisions. In the current study, we investigated whether mid-regional pro-adrenomedullin (MR-proADM) and copeptin, in addition to clinical evaluation, could predict short-term outcomes. Patients and methods This prospective blinded observational study was conducted in 20 French centers. Patients admitted to the ER for an ECOPD were considered for inclusion. A clinical risk score was calculated, and MR-proADM and copeptin levels were determined from a venous blood sample. The composite primary end point comprised 30-day death or transfer to the intensive care unit or a new ER visit. Results A total of 379 patients were enrolled in the study, of whom 277 were eventually investigated for the primary end point that occurred in 66 (24%) patients. In those patients, the median (interquartile range [IQR]) MR-proADM level was 1.02 nmol/L (0.77–1.48) versus 0.83 nmol/L (0.63–1.07) in patients who did not meet the primary end point (P=0.0009). In contrast, copeptin levels were similar in patients who met or did not meet the primary end point (P=0.23). MR-proADM levels increased with increasing clinical risk score category: 0.74 nmol/L (0.57–0.89), 0.83 nmol/L (0.62–1.12) and 0.95 nmol/L (0.75–1.29) for the low-, intermediate- and high-risk categories, respectively (P<0.001). MR-proADM was independently associated with the primary end point (odds ratio, 1.65; 95% confidence interval [CI], 1.10–2.48; P=0.015). MR-proADM predicted the occurrence of primary end point with a sensitivity of 46% (95% CI, 33%–58%) and a specificity of 79% (95% CI, 74–84). Conclusion MR-proADM but not copeptin was significantly associated with outcomes at 30 days, even after adjustment for clinical risk category. Overall, MR-proADM, alone or combined with the clinical risk score, was a moderate strong predictor of short

  13. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-01-01

    Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group

  14. An Extract of Pomegranate Fruit and Galangal Rhizome Increases the Numbers of Motile Sperm: A Prospective, Randomised, Controlled, Double-Blinded Trial

    PubMed Central

    Fedder, Maja D. K.; Jakobsen, Henrik B.; Giversen, Ina; Christensen, Lars P.; Parner, Erik T.; Fedder, Jens

    2014-01-01

    Pomegranate fruit (Punica granatum) and galangal (Alpinia galanga) have separately been shown to stimulate spermatogenesis and to increase sperm counts and motility in rodents. Within traditional medicine, pomegranate fruit has long been used to increase fertility, however studies on the effect on spermatogenesis in humans have never been published. With this study we investigated whether oral intake of tablets containing standardised amounts of extract of pomegranate fruit and powder of greater galangal rhizome (Punalpin) would increase the total number of motile spermatozoa. The study was designed as a prospective, randomized, controlled, double-blinded trial. Enrolment was based on the mean total number of motile spermatozoa of two ejaculates. The participants delivered an ejaculate after 4–8 days of tablet intake and two ejaculates just before they stopped taking the tablets. Seventy adult men with a semen quality not meeting the standards for commercial application at Nordic Cryobank, but without azoospermia, were included in the study. Participants were randomized to take tablets containing extract of pomegranate fruit (standardised with respect to punicalagin A+B, punicalin and ellagic acid) and freeze-dried rhizome of greater galangal (standardised with respect to 1′S-1′-acetoxychavicol acetate) or placebo on a daily basis for three months. Sixty-six participants completed the intervention (active treatment: n = 34; placebo: n = 32). After the intervention the total number of motile spermatozoa was increased in participants treated with plant extracts compared with the placebo group (p = 0.026). After three months of active treatment, the average total number of motile sperm increased by 62% (from 23.4 to 37.8 millions), while for the placebo group, the number of motile sperm increased by 20%. Sperm morphology was not affected by the treatment. Our findings may help subfertile men to gain an improved amount of motile ejaculated sperm by

  15. Antiemetic effects of midazolam added to fentanyl-ropivacaine patient-controlled epidural analgesia after subtotal gastrectomy: A prospective, randomized, double-blind, controlled trial

    PubMed Central

    Kim, Sioh; Seo, Jeongwon; Jeon, Younghoon

    2010-01-01

    Background: Nausea and vomiting are frequent adverse effects of patient-controlled epidural analgesia (PCEA) with opioids. Objective: This study was designed to assess the antiemetic effect of midazolam added to fentanyl—ropivacaine PCEA. Methods: In a prospective, randomized, double-blind, controlled trial, smoking patients with gastric cancer undergoing elective subtotal gastrectomy were evenly allocated to 1 of 2 treatment groups to manage postoperative pain: 0.2% ropivacaine mixed with fentanyl 4 μg/mL and midazolam 0.2 mg/mL (test group) or 0.2% ropivacaine mixed with fentanyl 4 μg/mL (control group). The PCEA infusion was set to deliver 4 μL/h of the study solution, with a bolus of 2 mL per demand and a 15-minute lockout time. The incidence of postoperative nausea and vomiting (PONV), pain intensity, sedation score, usage of rescue analgesia and rescue antiemetic, respiratory depression, urinary retention, and pruritus were recorded at 2, 6, 12, 24, 48, and 72 hours after surgery. Total infused volume of PCEA at 72 hours after surgery was measured. Results: A total of 60 patients were approached and randomized to treatment. No patients were excluded by exclusion criteria and all enrolled patients completed this study. Incidence of nausea (7% vs 33%; P = 0.02) in the test group was significantly lower than in the control group. The overall frequency of PONV in the test group was significantly less than that of the control group (7% vs 40%; P = 0.006). In addition, the mean (SD) infused volume of PCEA in the test group was significantly lower than that in the control group (392.3 [68.9] vs 351.2 [49.8] mL; P = 0.01). However, there were no significant differences in pain intensity, usage of rescue antiemetics and rescue analgesics, and mild pruritus between groups. No patient reported moderate or severe sedation, respiratory depression, or hypoxemia. In addition, there were no severe adverse events. Conclusions: Midazolam added to fentanyl-ropivacaine PCEA

  16. Effects of Inhaled Nitrous Oxide on the Induction Dose and Time Requirements of Propofol: A Prospective, Randomized, Double-blind Study

    PubMed Central

    Jain, Kavita; Sethi, Surendra Kumar; Damor, Mamta; Jain, Neena

    2017-01-01

    Context: Propofol is a commonly used induction agent during general anesthesia. As a sole agent, it does not provide any strong analgesic effect. The nitrous oxide (N2O) used along with propofol for induction of anesthesia augments the induction characteristics and reduces the dose of propofol. Aims: To study the effects of inhaled N2O on the induction dose and time of propofol during general anesthesia and also its hemodynamic response and adverse effects. Settings and Design: The present research is a prospective, randomized, double-blind comparative study. Subjects and Methods: The study population consisted of eighty patients aged 18–60 years from either sex, American Society of Anesthesiologists physical status 1 and 2 which were scheduled for various elective surgical procedures under general anesthesia. The patients were randomly allocated into two groups comprising forty patients in each group. All patients were premedicated with glycopyrrolate 0.2 mg, ondansetron 4 mg, and fentanyl 1 μg/kg intravenously. Group FN received breathing mixture of gases (67% N2O @ 4 L/min and 33% O2 @ 2 L/min), and propofol and Group FO received 100% O2 @ 6 L/min and propofol. The different hemodynamic parameters (heart rate, mean arterial pressure, systolic blood pressure, diastolic blood pressure, and SpO2) were measured. Statistical Analysis: All observations were analyzed using Chi-square test, Student's t-test, and analysis of variance. Results: The mean induction time and dose were significantly less in Group FN as compared to Group FO (P < 0.05). The mean induction time was 172 ± 32 s in Group FN as compared to 242 ± 43 s in Group FO (P < 001), whereas the mean induction dose was 56.10 ± 13.92 mg in Group FN as compared to 81.67 ± 17.64 mg in Group FO (P < 0.05). The hemodynamic parameters remained stable with no complications. Conclusion: The coadministration of N2O during induction of anesthesia with propofol not only reduced the induction dose of propofol but

  17. Validation of the Spanish Version of the Eating Assessment Tool-10 (EAT-10spa) in Colombia. A Blinded Prospective Cohort Study.

    PubMed

    Giraldo-Cadavid, Luis Fernando; Gutiérrez-Achury, Alejandra María; Ruales-Suárez, Karem; Rengifo-Varona, Maria Leonor; Barros, Camilo; Posada, Andrés; Romero, Carlos; Galvis, Ana María

    2016-06-01

    Dysphagia might affect 12 % of the general population, and its complications include pneumonia, malnutrition, social isolation, and death. No validated Spanish symptom survey exists to quantify dysphagia symptoms among Latin Americans. Therefore, we performed a prospective cohort study in a tertiary care university hospital to validate the Spanish version of the 10-Item Eating-Assessment-Tool (EAT-10spa) for use in Colombia. After an interdisciplinary committee of five bilingual specialists evaluated the EAT-10spa (translated and validated in Spain) and deemed it appropriate for the Colombian culture, its feasibility, reliability, validity, sensitivity to change, and diagnostic capacity were evaluated. As a reference standard, we used the flexible endoscopic evaluation of swallowing with sensory testing and a standardized clinical evaluation. All assessments were blinded. In total, 133 subjects were included (52 % women, mean age 55 years) and completed the EAT-10spa (median completion time: 2 min [IQR 1-3 min]), 39 % of whom had an elementary-level education. Cronbach's α coefficient: 0.91; test-retest intra-class correlation coefficient: 0.94. The Spearman's correlation coefficient of the EAT-10spa with the 8-point penetration-aspiration scale was 0.54 (P < 0.001). The area under the receiver-operating-characteristic-curve (AUC-ROC) for dysphagia and aspiration were 0.79 (P < 0.001) and 0.81 (P < 0.001), respectively. The best cut-off points for dysphagia and aspiration were EAT-10spa ≥2 (sensitivity 93.6 %, specificity 36.4 %) and EAT-10spa ≥4 (sensitivity 94.3 %, specificity 49.5 %), respectively. A reduction in the EAT-10 ≥3 was the best cut-off point for a clinically significant improvement (AUC-ROC 0.83; P < 0.0001). The EAT-10spa showed excellent psychometric properties and discriminatory capacity for use in Colombia.

  18. Color blindness

    MedlinePlus

    ... have trouble telling the difference between red and green. This is the most common type of color ... color blindness often have problems seeing reds and greens, too. The most severe form of color blindness ...

  19. Single-Level Degenerative Cervical Disc Disease and Driving Disability: Results from a Prospective, Randomized Trial

    PubMed Central

    Kelly, Michael P.; Mitchell, M. David; Hacker, Robert J.; Riew, K. Daniel; Sasso, Rick C.

    2013-01-01

    Study Design Post hoc analysis of prospective, randomized trial. Objective To investigate the disability associated with driving and single-level degenerative, cervical disc disease and to investigate the effect of surgery on driving disability. Methods Post hoc analysis of data obtained from three sites participating in a multicenter, randomized, controlled trial comparing cervical disc arthroplasty (TDA) with anterior cervical discectomy and fusion (ACDF). The driving subscale of the Neck Disability Index (NDI) was analyzed for all patients. A dichotomous severity score was created from the NDI. Statistical comparisons were made within and between groups. Results Two-year follow-up was available for 118/135 (87%) patients. One half of the study population (49.6%) reported moderate or severe preoperative driving difficulty. This disability associated with driving was similar among the two groups (ACDF: 2.5 ± 1.1, TDA: 2.6 ± 1.0, p = 0.646). The majority of patients showed improvement, with no or little driving disability, at the sixth postoperative week (ACDF: 75%, TDA: 90%, p = 0.073). At no follow-up point did a difference exist between groups according to the severity index. Conclusions Many patients suffering from radiculopathy or myelopathy from cervical disc disease are limited in their ability to operate an automobile. Following anterior cervical spine surgery, most patients are able to return to comfortable driving at 6 weeks. PMID:24436875

  20. The effect of single incision laparoscopic cholecystectomy on systemic oxidative stress: a prospective clinical trial

    PubMed Central

    Ozturk, Bahadir; Yilmaz, Huseyin; Yormaz, Serdar; Şahin, Mustafa

    2017-01-01

    Purpose Single incision laparoscopic cholecystectomy (SILC) has become a more frequently performed method for benign gallbladder diseases all over the world. The effects of SILC technique on oxidative stress have not been well documented. The aim of this study was to evaluate the effect of laparoscopic cholecystectomy techniques on systemic oxidative stress by using ischemia modified albumin (IMA). Methods In total, 70 patients who had been diagnosed with benign gallbladder pathology were enrolled for this prospective study. Twenty-one patients underwent SILC and 49 patients underwent laparoscopic cholecystectomy (LC). All operations were performed under a standard anesthesia protocol. Serum IMA levels were analysed before operation, 45 minutes and 24 hours after operation. Results Demographics and preoperative characteristics of the patients were similiar in each group. The mean duration of operation was 37.5 ± 12.5 and 44.6 ± 14.3 minutes in LC and SILC group, respectively. In both groups, there was no statistically significant difference in hospital stay, operative time, or conversion to open surgery. Operative technique did not effect the 45th minute and 24th hour IMA levels. However, prolonged operative time (>30 minutes) caused an early increase in the level of IMA. Twenty-fourth hour IMA levels were not different. Conclusion SILC is an effective and safe surgical prosedure for benign gallbladder diseases. Independent of the surgical technique for cholecystectomy, the prolonged operative time could increase the tissue ischemia. PMID:28382289

  1. Blind Astronomers

    NASA Astrophysics Data System (ADS)

    Hockey, Thomas A.

    2011-01-01

    The phrase "blind astronomer” is used as an allegorical oxymoron. However, there were and are blind astronomers. What of famous blind astronomers? First, it must be stated that these astronomers were not martyrs to their craft. It is a myth that astronomers blind themselves by observing the Sun. As early as France's William of Saint-Cloud (circa 1290) astronomers knew that staring at the Sun was ill-advised and avoided it. Galileo Galilei did not invent the astronomical telescope and then proceed to blind himself with one. Galileo observed the Sun near sunrise and sunset or through projection. More than two decades later he became blind, as many septuagenarians do, unrelated to their profession. Even Isaac Newton temporarily blinded himself, staring at the reflection of the Sun when he was a twentysomething. But permanent Sun-induced blindness? No, it did not happen. For instance, it was a stroke that left Scotland's James Gregory (1638-1675) blind. (You will remember the Gregorian telescope.) However, he died days later. Thus, blindness little interfered with his occupation. English Abbot Richard of Wallingford (circa 1291 - circa 1335) wrote astronomical works and designed astronomical instruments. He was also blind in one eye. Yet as he further suffered from leprosy, his blindness seems the lesser of Richard's maladies. Perhaps the most famous professionally active, blind astronomer (or almost blind astronomer) is Dominique-Francois Arago (1786-1853), director until his death of the powerful nineteenth-century Paris Observatory. I will share other _ some poignant _ examples such as: William Campbell, whose blindness drove him to suicide; Leonhard Euler, astronomy's Beethoven, who did nearly half of his life's work while almost totally blind; and Edwin Frost, who "observed” a total solar eclipse while completely sightless.

  2. Development of the experimental setup for investigation of latching of superconducting single-photon detector caused by blinding attack on the quantum key distribution system

    NASA Astrophysics Data System (ADS)

    Elezov, M. S.; Ozhegov, R. V.; Goltsman, G. N.; Makarov, V.

    2016-12-01

    Recently bright-light control of the SSPD has been demonstrated. This attack employed a "backdoor" in the detector biasing scheme. Under bright-light illumination, SSPD becomes resistive and remains "latched" in the resistive state even when the light is switched off. While the SSPD is latched, Eve can simulate SSPD single-photon response by sending strong light pulses, thus deceiving Bob. We developed the experimental setup for investigation of a dependence on latching threshold of SSPD on optical pulse length and peak power. By knowing latching threshold it is possible to understand essential requirements for development countermeasures against blinding attack on quantum key distribution system with SSPDs.

  3. Solar-Blind Avalanche Photodetector Based On Single ZnO-Ga₂O₃ Core-Shell Microwire.

    PubMed

    Zhao, Bin; Wang, Fei; Chen, Hongyu; Wang, Yunpeng; Jiang, Mingming; Fang, Xiaosheng; Zhao, Dongxu

    2015-06-10

    High-performance solar-blind (200-280 nm) avalanche photodetectors (APDs) were fabricated based on highly crystallized ZnO-Ga2O3 core-shell microwires. The responsivity can reach up to 1.3 × 10(3) A/W under -6 V bias. Moreover, the corresponding detectivity was as high as 9.91 × 10(14) cm·Hz(1/2)/W. The device also showed a fast response, with a rise time shorter than 20 μs and a decay time of 42 μs. The quality of the detectors in solar-blind waveband is comparable to or even higher than that of commercial Si APD (APD120A2 from Thorlabs Inc.), with a responsivity ∼8 A/W, detectivity ∼10(12) cm·Hz(1/2)/W, and response time ∼20 ns. The high performance of this APD make it highly suitable for practical applications as solar-blind photodetectors, and this core-shell microstructure heterojunction design method would provide a new approach for realizing an APD device.

  4. Effects of cognitive stimulation therapy Japanese version (CST-J) for people with dementia: a single-blind, controlled clinical trial

    PubMed Central

    Yamanaka, Katsuo; Kawano, Yoshiyuki; Noguchi, Dai; Nakaaki, Shutaro; Watanabe, Norio; Amano, Takashi; Spector, Aimee

    2013-01-01

    Objectives Cognitive stimulation therapy (CST) has shown to have significant benefits in improving the cognitive function and quality of life (QOL) in people with mild-to-moderate dementia in a UK randomized controlled trial (RCT). We developed and examined the Japanese version of group CST (CST-J) in a single-blind, controlled clinical trial. Method CST-J consisting of 14 sessions was administered to a treatment group (n = 26) twice a week for 7 weeks. The treatment group was compared with a control group (n = 30). Based on single-blindness, cognition was evaluated by a researcher, and QOL and mood were rated by the participants themselves. Additionally, QOL and mood of participants were rated by care workers who were not blind but who observed them most directly in their daily life (important for social validity). Results A linear mixed model was used for analyses of cognition and QOL. There were significant improvements in cognition [COGNISTAT (Neurobehavioral Cognitive Status Examination) and MMSE (Mini-Mental State Examination)] for the treatment group compared with the control group (p < 0.01). Regarding QOL, the EQ-5D was significant (p = 0.019) and the QoL-AD (Quality of Life – Alzheimer's Disease) showed a positive trend (p = 0.06) when rated by care workers, although not when rated by the participants themselves. Using a nonparametrical analysis, there were significant improvements in the face scale for mood when rated by both the participants (p < 0.01) and the care workers (p = 0.017). Conclusion The CST-J shows promising improvements in cognition, mood, and aspects of QOL for people with dementia in Japanese care settings. A large RCT is now needed. PMID:23550665

  5. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

    PubMed Central

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large

  6. [Cortical blindness].

    PubMed

    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.

  7. [Global blindness].

    PubMed

    Schulze Schwering, M

    2007-10-01

    Worldwide there are 37 million people who are completely blind and another 112 million whose sight is severely restricted. Of all blind people throughout the world, 85% live in developing countries. In three quarters of cases, blindness could be prevented or treated. The VISION 2020 campaign is dedicated to halving the number of people suffering from the diseases leading to blindness by means of disease control, training of specialist ophthalmic staff and development of appropriate infrastructures. More effort is needed if these goals are to be met. German ophthalmologists engaged in conservative and surgical treatments who join in and support VISION 2020 will be welcomed.

  8. Efficacy and Tolerability of Conventional Nimesulide Versus Beta-Cyclodextrin Nimesulide in Patients with Pain After Surgical Dental Extraction: A Multicenter, Prospective, Randomized, Double-Blind, Double-Dummy Study☆

    PubMed Central

    Bocanegra, Mildred; Seijas, Alberto; Yibirín, Maria González

    2003-01-01

    Background: Pain following extraction of an impacted third molar is widely used to assess analgesic efficacy, especially that of a single dose of a drug. The analgesic activity of conventional nimesulide (CN) has been documented in a variety of types of acute and chronic pain. Beta-cyclodextrin nimesulide (BN) is a new formulation in which nimesulide is included in a cyclodextrin molecule, which increases its solubility in water and its dilution rate, allowing extended, rapid absorption of the drug. Objective: The aim of this study was to assess the efficacy and tolerability of a single dose of BN compared with CN in patients with pain following extraction of an impacted third molar. Methods: This was a prospective, randomized, double-blind, double-dummy study conducted at 3 dentistry centers in Venezuela. The patients were randomized to 1 of 2 groups. One group received a single dose of BN (400-mg tablet, equivalent to 100 mg of nimesulide); the other group received a single dose of CN (100-mg tablet). Both groups also received a placebo. The efficacy variables were (1) pain intensity (PI), assessed on a visual analog scale (VAS) at the following times: 0, 5, 10, 15, 30, and 45 minutes and 1, 2, 4, 6, 8, 10, and 12 hours after drug administration; (2) time to first measurable difference in PI from baseline (PID) (PID ≥1 cm on the VAS; ie, the beginning of analgesic action); (3) maximum PID (max PID); (4) sum of PIDs in the 12-hour observation period; (5) pain relief (PR), as rated on a 5-point scale; (6) maximum PR; and (7) sum of the PR scores in the 12-hour observation period (ie, total PR). For the tolerability analysis, all adverse events (AEs) were to be recorded, and the investigators were to assess whether each AE was drug related. Results: Seventy-two patients were enrolled in the study. Of these, 62 patients (40 women, 22 men; mean [SD] age, 20.1 [5.9] years) were assessed; 35 were treated with BN and 27 with CN. PI reduction was more rapid and greater

  9. Clinical and hemodynamic profiles of elderly patients with pulmonary arterial hypertension: a single center, prospective study

    PubMed Central

    Ozpelit, Ebru; Akdeniz, Bahri; Sezgin, Dilek; Sevinc, Can; Tertemiz, Kemal Can; Ozpelit, Mehmet Emre; Baris, Mustafa; Baris, Nezihi

    2017-01-01

    Backgrounds Pulmonary arterial hypertension (PAH) was previously considered an illness that affects mostly the young, but now it is also increasingly recognized in the elderly. The aim of this study was to compare the features of elderly versus younger patients diagnosed with PAH, and to define the prognostic factors which affect their long-term survival. Methods In this prospective, single center study, the clinical, echocardiographic, hemodynamic characteristics, and the outcomes of younger (18–65 years) and elderly (≥ 65 years) patients with definitive diagnosis of precapillary PAH were compared. Results A total of 119 patients were analyzed in this study; 43 were elderly (mean age: 71.5 ± 5.5 years), while 76 were non-elderly (mean age 44.5 ± 15.2 years). During the mean follow-up duration of 26.8 ± 25.0 months, 43 deaths occurred, 17 of which were among the elderly group, with 28 among non-elderly group. Comparison of baseline parameters showed that 6 min walking distance, hemoglobin levels, pulmonary artery pressures and pulmonary vascular resistance were significantly lower; and estimated glomerular filtration rate, body mass index, E/e' and pulmonary capillary wedge pressure were significantly higher in the elderly group than in the younger group. Survival analysis demonstrated that the independent predictors of death were tricuspid plane annular systolic excursion (TAPSE; HR: 1.272, 95% CI: 1.079–1.499, P = 0.004) and uric acid (HR: 1.291, 95% CI: 1.042–1.600, P = 0.019) in the elderly group. In contrast, in the non-elderly group, higher brain natriuretic peptide (HR: 1.002, 95% CI: 1.001–1.004, P < 0.001) and higher right atrial pressure (HR: 1.128, 95% CI: 1.026–1.241, P = 0.013) values were the only parameters associated with mortality. Conclusions Our data suggest that elderly PAH patients have a unique clinical and hemodynamic profile, with totally different prognostic markers compared to younger PAH patients. PMID:28270838

  10. Spectral tissue sensing to identify intra- and extravascular needle placement — A randomized single-blind controlled trial

    PubMed Central

    Balthasar, Andrea J. R.; van Geffen, Geert-Jan; van der Voort, Marjolein; Lucassen, Gerald W.; Roggeveen, Stefan; Bruaset, Ivar J.; Bruhn, Joergen

    2017-01-01

    Safe vascular access is a prerequisite for intravenous drug admission. Discrimination between intra- and extravascular needle position is essential for procedure safety. Spectral tissue sensing (STS), based on optical spectroscopy, can provide tissue information directly from the needle tip. The primary objective of the trial was to investigate if STS can reliably discriminate intra-vascular (venous) from non-vascular punctures. In 20 healthy volunteers, a needle with an STS stylet was inserted, and measurements were performed for two intended locations: the first was subcutaneous, while the second location was randomly selected as either subcutaneous or intravenous. The needle position was assessed using ultrasound (US) and aspiration. The operators who collected the data from the spectral device were blinded to the insertion and ultrasonographic visualization procedure and the physician was blinded to the spectral data. Following offline spectral analysis, a prediction of intravascular or subcutaneous needle placement was made and compared with the “true” needle tip position as indicated by US and aspiration. Data for 19 volunteers were included in the analysis. Six out of 8 intended vascular needle placements were defined as intravascular according to US and aspiration. The remaining two intended vascular needle placements were negative for aspiration. For the other 11 final needle locations, the needle was clearly subcutaneous according to US examination and no blood was aspirated. The Mann-Whitney U test yielded a p-value of 0.012 for the between-group comparison. The differences between extra- and intravascular were in the within-group comparison computed with the Wilcoxon signed-rank test was a p-value of 0.022. In conclusion, STS is a promising method for discriminating between intravascular and extravascular needle placement. The information provided by this method may complement current methods for detecting an intravascular needle position. PMID

  11. SMS text messaging as a means of increasing recall of therapy goals in brain injury rehabilitation: a single-blind within-subjects trial.

    PubMed

    Culley, Campbell; Evans, Jonathan J

    2010-01-01

    A single-blind within-subjects trial was used to test the efficacy of sending SMS text messages to patients with a traumatic brain injury as a means of improving their recall of rehabilitation goals. Eleven participants were recruited from two community-based rehabilitation centres and were sent text messages relating to three randomly selected goals from a selection of six current goals three times per day for 14 days. Participants' recall of their rehabilitation goals was assessed at baseline, seven days, and 14 days via free recall and cued recall procedures. Results showed that goals in the "text" condition were recalled better than goals in the "no text" condition. Practical applications and extensions are discussed.

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

    PubMed Central

    2012-01-01

    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 shown to be

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

    PubMed Central

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

    2009-01-01

    Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p < 0.05) with no increase in wrist stiffness. There was a consistent trend for the LS to be superior to the FS but this was statistically significant only for patient perceived occupational performance (p = 0.008) and satisfaction (p = 0.015). Lastly, 72% of patients preferred the custom-made leather splint compared to the commercially available splint. Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction. PMID:19843345

  14. Immediate effect of passive and active stretching on hamstrings flexibility: a single-blinded randomized control trial.

    PubMed

    Nishikawa, Yuichi; Aizawa, Junya; Kanemura, Naohiko; Takahashi, Tetsuya; Hosomi, Naohisa; Maruyama, Hirofumi; Kimura, Hiroaki; Matsumoto, Masayasu; Takayanagi, Kiyomi

    2015-10-01

    [Purpose] This study compared the efficacy of passive and active stretching techniques on hamstring flexibility. [Subjects] Fifty-four healthy young subjects were randomly assigned to one of three groups (2 treatment groups and 1 control group). [Methods] Subjects in the passive stretching group had their knees extended by an examiner while lying supine 90° of hip flexion. In the same position, subjects in the active stretching group extended their knees. The groups performed 3 sets of the assigned stretch, with each stretch held for 10 seconds at the point where tightness in the hamstring muscles was felt. Subjects in the control group did not perform stretching. Before and immediately after stretching, hamstring flexibility was assessed by a blinded assessor, using the active knee-extension test. [Results] After stretching, there was a significant improvement in the hamstring flexibilities of the active and passive stretching groups compared with the control group. Furthermore, the passive stretching group showed significantly greater improvement in hamstring flexibility than the active stretching group. [Conclusion] Improvement in hamstring flexibility measured by the active knee-extension test was achieved by both stretching techniques; however, passive stretching was more effective than active stretching at achieving an immediate increase in hamstring flexibility.

  15. Immediate effect of passive and active stretching on hamstrings flexibility: a single-blinded randomized control trial

    PubMed Central

    Nishikawa, Yuichi; Aizawa, Junya; Kanemura, Naohiko; Takahashi, Tetsuya; Hosomi, Naohisa; Maruyama, Hirofumi; Kimura, Hiroaki; Matsumoto, Masayasu; Takayanagi, Kiyomi

    2015-01-01

    [Purpose] This study compared the efficacy of passive and active stretching techniques on hamstring flexibility. [Subjects] Fifty-four healthy young subjects were randomly assigned to one of three groups (2 treatment groups and 1 control group). [Methods] Subjects in the passive stretching group had their knees extended by an examiner while lying supine 90° of hip flexion. In the same position, subjects in the active stretching group extended their knees. The groups performed 3 sets of the assigned stretch, with each stretch held for 10 seconds at the point where tightness in the hamstring muscles was felt. Subjects in the control group did not perform stretching. Before and immediately after stretching, hamstring flexibility was assessed by a blinded assessor, using the active knee-extension test. [Results] After stretching, there was a significant improvement in the hamstring flexibilities of the active and passive stretching groups compared with the control group. Furthermore, the passive stretching group showed significantly greater improvement in hamstring flexibility than the active stretching group. [Conclusion] Improvement in hamstring flexibility measured by the active knee-extension test was achieved by both stretching techniques; however, passive stretching was more effective than active stretching at achieving an immediate increase in hamstring flexibility. PMID:26644667

  16. The effect of sukha pranayama on anxiety in patients undergoing coronary angiography: a single -blind randomized controlled trial

    PubMed Central

    Mobini Bidgoli, Maryam; Taghadosi, Mohsen; Gilasi, Hamidreza; Farokhian, Alireza

    2016-01-01

    Introduction: Anxiety is among the most common problems experienced by coronary angiography (CA) candidates. Different modalities are used to manage anxiety. This study sought to examine the effects of a pranayama exercise on CA candidates’ anxiety. Methods: This double-blind randomized controlled trial was undertaken in 2015 on 80 eligible patients. The patients were randomly allocated to a control and an experimental group. Before undergoing angiography, patients in the experimental group performed sukha pranayama exercises. They were trained to breathe slowly and rhythmically at a rate of ten breathing per minute for five consecutive minutes. Patients in the control group only received routine preangiography care. Data collection tools were a demographic questionnaire and the Spielberger State Anxiety Inventory. The level of patients’ anxiety in both groups was measured before, half an hour after, and one hour after the intervention. The data were analyzed through doing the independent-sample t and the chi-square tests. Results: Before the intervention, the mean of anxiety score in the experimental group was 53.37, which significantly decreased to 40.75 after the intervention (P = 0.0001). In the control group, the mean of anxiety score decreased from 54.27 to 51.4. This decrease was not statistically significant. Moreover, between-group comparisons revealed significant differences between the groups regarding between-measurement mean differences of anxiety score (P < 0.01). Conclusion: Sukha pranayama is effective in alleviating CA candidates’ anxiety. PMID:28210473

  17. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection.

    PubMed

    Adegnika, Ayola A; Zinsou, Jeannot F; Issifou, Saadou; Ateba-Ngoa, Ulysse; Kassa, Roland F; Feugap, Eliane N; Honkpehedji, Yabo J; Dejon Agobe, Jean-Claude; Kenguele, Hilaire M; Massinga-Loembe, Marguerite; Agnandji, Selidji T; Mordmüller, Benjamin; Ramharter, Michael; Yazdanbakhsh, Maria; Kremsner, Peter G; Lell, Bertrand

    2014-05-01

    In many regions where soil-transmitted helminth infections are endemic, single-dose albendazole is used in mass drug administration programs to control infections. There are little data on the efficacy of the standard single-dose administration compared to that of alternative regimens. We conducted a randomized, controlled, assessor-blinded clinical trial to determine the efficacies of standard and extended albendazole treatment against soil-transmitted helminth infection in Gabon. A total of 175 children were included. Adequate cure rates and egg reduction rates above 85% were found with a single dose of albendazole for Ascaris infection, 85% (95% confidence interval [CI], 73, 96) and 93.8% (CI, 87.6, 100), respectively, while two doses were necessary for hookworm infestation (92% [CI, 78, 100] and 92% [CI, 78, 100], respectively). However, while a 3-day regimen was not sufficient to cure Trichuris (cure rate, 83% [CI, 73, 93]), this regimen reduced the number of eggs up to 90.6% (CI, 83.1, 100). The rate ratios of two- and three-dose regimens compared to a single-dose treatment were 1.7 (CI, 1.1, 2.5) and 2.1 (CI, 1.5, 2.9) for Trichuris and 1.7 (CI, 1.0, 2.9) and 1.7 (CI, 1.0, 2.9) for hookworm. Albendazole was safe and well tolerated in all regimens. A single-dose albendazole treatment considerably reduces Ascaris infection but has only a moderate effect on hookworm and Trichuris infections. The single-dose option may still be the preferred regimen because it balances efficacy, safety, and compliance during mass drug administration, keeping in mind that asymptomatic low-level helminth carriage may also have beneficial effects. (This study has been registered at ClinicalTrials.gov under registration number NCT01192802.).

  18. A Prospective, Randomized, Double-Blind Comparison of 2% Mepivacaine With 1 : 20,000 Levonordefrin Versus 2% Lidocaine With 1 : 100,000 Epinephrine for Maxillary Infiltrations

    PubMed Central

    Lawaty, Ingrid; Drum, Melissa; Reader, Al; Nusstein, John

    2010-01-01

    The purpose of this prospective, randomized, double-blind crossover study was to compare the anesthetic efficacy of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine in maxillary central incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary central incisor and first molar infiltrations of 1.8 mL of 2% mepivacaine with 1 : 20,000 levonordefrin and 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine at 2 separate appointments spaced at least 1 week apart. The teeth were electric pulp tested in 2-minute cycles for a total of 60 minutes. Anesthetic success (obtaining 2 consecutive 80 readings with the electric pulp tester within 10 minutes) was not significantly different between 2% mepivacaine with 1 : 20,000 levonordefrin and 2% lidocaine with 1 : 100,000 epinephrine for the central incisor and first molar. However, neither anesthetic agent provided an hour of pulpal anesthesia. PMID:21174567

  19. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    NASA Astrophysics Data System (ADS)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  20. The role of antibiotic prophylaxis in mesh repair of primary inguinal hernias using prolene hernia system: a randomized prospective double-blind control trial.

    PubMed

    Jain, S K; Jayant, M; Norbu, C

    2008-04-01

    Antibiotic prophylaxis is being commonly used in mesh repair of inguinal hernia but its role has been questioned in a recent Cochrane analysis performed in 2003. Routine use of antibiotic prophylaxis in mesh repair of inguinal hernia can lead to bacterial resistance and increase in cost. In a present double-blind placebo controlled trial involving 120 patients undergoing inguinal hernia repair using prolene hernia system, we did not find any benefit of the routine use of antibiotic prophylaxis in terms of wound infection rate.

  1. Does addition of `mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study

    NASA Astrophysics Data System (ADS)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

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

    PubMed Central

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

    2013-01-01

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

  3. Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study.

    PubMed

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  4. Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.

    PubMed

    Moore, Nicholas; Verdoux, Hélène; Fantino, Bruno

    2005-05-01

    Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.

  5. Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    Kusunoki, Hiroaki; Kamiya, Takeshi; Futagami, Seiji; Yamaguchi, Yasuharu; Nishizawa, Toshihiro; Iwasaki, Eisuke; Matsuzaki, Juntaro; Takahashi, Shinichi; Sakamoto, Choitsu; Haruma, Ken; Joh, Takashi; Asakura, Keiko; Hibi, Toshifumi

    2013-01-01

    Background: Since the publication of the Rome III criteria for functional dyspepsia (FD), the evidence about the efficacy of half-dose of proton pump inhibitors for dyspepsia symptoms have been limited. Objective: To examine the efficacy of lansoprazole for functional dyspepsia (FD) diagnosed with the Rome III criteria by the multicentre, double-blind, randomized, placebo-controlled study in Japan. Methods: A total of 54 FD participants were randomized to lansoprazole 15 mg once daily or placebo for a 4-week double-blind treatment period. The primary efficacy endpoint was an overall dyspeptic symptom relief rate evaluated by 5-point Likert scale scores. The alteration of dyspeptic symptom scores during the study period was also assessed. Results: At week 4, the overall dyspeptic symptom relief rates were higher in the lansoprazole group (30.4%) than in the placebo group (6.7%) (p = 0.045). The scores for epigastric pain (p = 0.045) and epigastric burning (p = 0.03) were significantly improved in the lansoprazole group compared to the placebo group, whereas the improvement of the scores for postprandial fullness (p = 0.81) and early satiation (p = 0.33) was not different between lansoprazole and placebo groups. Conclusions: Lansoprazole 15 mg ameliorates dyspeptic symptoms, particularly the epigastric pain syndrome-related symptoms of FD. PMID:24917996

  6. Drug user treatment failure blindness?

    PubMed

    Einstein, Stan

    2012-01-01

    An ethnographic case study of a "failed" single goal (abstinence) based individual and group therapy treatment of a New York City, Harlem-based, single, young-adult of color, IDU, mother, which ended in "death by overdose," after a period of abstinence, is presented almost 50 years later, in which complex, multidimensional structural barriers, "normed," consensualized, ideologically-driven preconceptions and an array of contextual, situational and relevant stakeholder factors, which may have resulted in intervention "failure blindness," are reviewed. The need to introduce failure analysis, blindness and management, as well as success analysis, blindness and management, as integral parts of treatment planning, implementation and assessment is raised.

  7. Optimal Blind Quantum Computation

    NASA Astrophysics Data System (ADS)

    Mantri, Atul; Pérez-Delgado, Carlos A.; Fitzsimons, Joseph F.

    2013-12-01

    Blind quantum computation allows a client with limited quantum capabilities to interact with a remote quantum computer to perform an arbitrary quantum computation, while keeping the description of that computation hidden from the remote quantum computer. While a number of protocols have been proposed in recent years, little is currently understood about the resources necessary to accomplish the task. Here, we present general techniques for upper and lower bounding the quantum communication necessary to perform blind quantum computation, and use these techniques to establish concrete bounds for common choices of the client’s quantum capabilities. Our results show that the universal blind quantum computation protocol of Broadbent, Fitzsimons, and Kashefi, comes within a factor of (8)/(3) of optimal when the client is restricted to preparing single qubits. However, we describe a generalization of this protocol which requires exponentially less quantum communication when the client has a more sophisticated device.

  8. Taking the 'ouch' out - effect of buffering commercial xylocaine on infiltration and procedure pain - a prospective, randomised, double-blind, controlled trial.

    PubMed Central

    Younis, I.; Bhutiani, R. P.

    2004-01-01

    AIMS: To compare the effect of buffered commercial 1% xylocaine (with 1:200,000 adrenaline) and the unbuffered commercial 1% xylocaine (with 1:200,000 adrenaline) preparation on pain during infiltration and procedure. PATIENTS AND METHODS: A randomised, double blind controlled trial involving 85 patients who underwent bilateral vasectomy under local infiltration anaesthesia. RESULTS: Each patient served as his own control by receiving the buffered commercial preparation on one side and unbuffered commercial preparation on the other. Linear analogue pain scores during infiltration and procedure were recorded and analysed. The study demonstrated that pain perceived by the patient both during infiltration and the procedure was significantly lower when buffered commercial xylocaine was used as compared to the pain perceived with the use of unbuffered commercial xylocaine. CONCLUSIONS: Use of buffered xylocaine is a simple, inexpensive and significantly effective way of reducing pain during infiltration and in surgical procedures performed under local anaesthesia. PMID:15140310

  9. Evaluation of the Etoricoxib-Mediated Pain-Relieving Effect in Patients Undergoing Lumbar Fusion Procedures for Degenerative Lumbar Scoliosis: A Prospective Randomized, Double-Blind Controlled Study.

    PubMed

    Shi, Yongxiang; Wang, Ping; Hu, Xinlei; Ye, Zhaoming

    2015-04-01

    This randomized, double-blind study was carried out to evaluate the effectiveness of etoricoxib in controlling the pain during lumbar fusion surgery of the degenerative lumbar scoliosis patients. We found that perioperative use of etoricoxib produced a significant reduction in the degree of pain compared to the patients treated with placebo. Etoricoxib eased the pain and helped to manage the discomfort of lumbar fusion surgery. In addition, etoricoxib was well tolerated as it caused no serious adverse reaction, suggesting a safe profile. Etoricoxib also appeared to ensure and promote the positive effect of surgery, however, insignificantly. Thus, the results suggest that etoricoxib was effective in safely managing the pain during the lumbar fusion surgery and recovery thereafter.

  10. Plasma and intraprostatic concentrations of ertapenem following preoperative single dose administration: a single-centre prospective experience and clinical implications-the ERTAPRO study.

    PubMed

    Dariane, Charles; Amin, Alexandre; Lortholary, Olivier; Lalli, Alexandre; Michel, Constance; Le Guilchet, Thomas; Treluyer, Jean-Marc; Nguyen-Khoa, Thao; De Toma, Claudia; Urien, Saïk; Méjean, Arnaud; Bourget, Philippe; Timsit, Marc-Olivier

    2016-08-01

    The incidence of urinary tract infections caused by extended-spectrum β-lactamase (ESBL)-producing pathogens is increasing. These infections are associated with a long hospital stay in patients undergoing urological procedures. We aimed to demonstrate that significant intraprostatic diffusion of ertapenem is achieved after a single preoperative administration. A referred sample of 19 patients requiring surgery for benign prostatic hyperplasia was prospectively included. Patients received a 1 g intravenous (i.v.) dose of ertapenem 1 h (n = 10, group A) or 12 h (n = 9, group B) before blood and prostatic samples were collected. Plasma and intraprostatic concentrations of ertapenem were measured using LC-MS/MS. Intraprostatic concentrations were considered satisfactory when higher than the MIC90 value of urinary-targeted pathogens perioperatively and for 40% of the dosing interval. The Wilcoxon test and a pharmacokinetic predictive model were used. Median plasma concentrations of ertapenem were 144.3 mg/L (95% CI 126.5-157.9) in group A and 30.7 mg/L (95% CI 22.9-36.4) in group B (P < 0.001); median intraprostatic concentrations were 16.6 mg/L (95% CI 13.3-31.4 mg/L) and 4.2 mg/L (95% CI 3.1-4.9 mg/L), respectively (P < 0.001), which were above the MIC90 values of bacteria, including ESBL-producers, during surgery and for 40% of the dosing interval. The plasma-to-prostate concentration ratio was not significantly different between groups (P = 0.97). Single-dose i.v. ertapenem reached satisfactory intraprostatic concentrations, suggesting that it could be a relevant prophylactic strategy for carriers of ESBL-producing bacteria undergoing prostatic procedures, which needs to be confirmed by further prospective trials.

  11. Double blind study on efficacy and safety of single doses of ivermectin and diethylcarbamazine for treatment of Polynesian Wuchereria bancrofti carriers. Results at six months.

    PubMed

    Cartel, J L; Spiegel, A; Nguyen, L; Genelle, B; Roux, J F

    1991-03-01

    In 1989, a double-blind trial was implemented in Tahiti to compare both efficacy and tolerability of single doses of ivermectin and diethylcarbamazine (DEC) for treatment of Wuchereria bancrofti carriers. Of 58 carriers, in whom microfilarial (mf) density was greater than or equal to 100 mf/ml, 23, 24 and 11 were randomly allocated to treatment with respectively ivermectin 100 mcg/kg, DEC 3 and DEC 6 mg/kg. One week after treatment, clearance of microfilaremia was complete in 22 of the 23 carriers treated with ivermectin and in one only of the 35 treated with DEC. Adjusted geometric mean for mf densities was significantly lower (p less than 0.001) in carriers treated with ivermectin than in those treated with DEC at one, but neither at 3 (p = 0.26) nor at 6 months (p = 0.63). At 3 and 6 months, mf levels were 14 and 28%, 21.6 and 19.4%, and 10.2 and 8.4% of pretreatment mf levels in carriers treated respectively with ivermectin 100 mcg/kg, DEC 3 and DEC 6 mg/kg. Side effects were experienced by 51 carriers (88%) of whom only 8 (14%) suffered a grade 3 reaction. Onset and intensity of side effects were significantly associated (p less than 0.01) with both pretreatment mf densities and peripheral blood parasite clearance. Efficacy of ivermectin single dose was superior to that of DEC single dose in terms of immediate mf clearance but not in terms of sustained mf decrease at 6 months.

  12. Effect of severe renal impairment on umeclidinium and umeclidinium/vilanterol pharmacokinetics and safety: a single-blind, nonrandomized study

    PubMed Central

    Mehta, Rashmi; Hardes, Kelly; Brealey, Noushin; Tombs, Lee; Preece, Andrew; Kelleher, Dennis

    2015-01-01

    Background Umeclidinium and vilanterol, long-acting bronchodilators for the treatment of chronic obstructive pulmonary disease, are primarily eliminated via the hepatic route; however, severe renal impairment may adversely affect some elimination pathways other than the kidney. Objectives To evaluate the effect of severe renal impairment on the pharmacokinetics of umeclidinium and umeclidinium/vilanterol. Methods Nine patients with severe renal impairment (creatinine clearance <30 mL/min) and nine matched healthy volunteers received a single dose of umeclidinium 125 μg; and after a 7- to 14-day washout, a single dose of umeclidinium/vilanterol 125/25 μg. Results No clinically relevant increases in plasma umeclidinium or vilanterol systemic exposure (area under the curve or maximum observed plasma concentration) were observed following umeclidinium 125 μg or umeclidinium/vilanterol 125/25 μg administration. On average, the amount of umeclidinium excreted in 24 hours in urine (90% confidence interval) was 88% (81%–93%) and 89% (81%–93%) lower in patients with severe renal impairment compared with healthy volunteers following umeclidinium 125 μg and umeclidinium/vilanterol 125/25 μg administration, respectively. Treatments were well tolerated in both populations. Conclusion Umeclidinium 125 μg or umeclidinium/vilanterol 125/25 μg administration to patients with severe renal impairment did not demonstrate clinically relevant increases in systemic exposure compared with healthy volunteers. No dose adjustment for umeclidinium and umeclidinium/vilanterol is warranted in patients with severe renal impairment. PMID:25565796

  13. Single photon avalanche detectors: prospects of new quenching and gain mechanisms

    NASA Astrophysics Data System (ADS)

    Hall, David; Liu, Yu-Hsin; Lo, Yu-Hwa

    2015-11-01

    While silicon single-photon avalanche diodes (SPAD) have reached very high detection efficiency and timing resolution, their use in fibre-optic communications, optical free space communications, and infrared sensing and imaging remains limited. III-V compounds including InGaAs and InP are the prevalent materials for 1550 nm light detection. However, even the most sensitive 1550 nm photoreceivers in optical communication have a sensitivity limit of a few hundred photons. Today, the only viable approach to achieve single-photon sensitivity at 1550 nm wavelength from semiconductor devices is to operate the avalanche detectors in Geiger mode, essentially trading dynamic range and speed for sensitivity. As material properties limit the performance of Ge and III-V detectors, new conceptual insight with regard to novel quenching and gain mechanisms could potentially address the performance limitations of III-V SPADs. Novel designs that utilise internal self-quenching and negative feedback can be used to harness the sensitivity of single-photon detectors,while drastically reducing the device complexity and increasing the level of integration. Incorporation of multiple gain mechanisms, together with self-quenching and built-in negative feedback, into a single device also hold promise for a new type of detector with single-photon sensitivity and large dynamic range.

  14. The administration of intermittent parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: a protocol for a prospective mixed method pilot study with randomisation of treatment allocation and blinded assessment (FRACTT)

    PubMed Central

    Chesser, Tim; Fox, Rebecca; Harding, Karen; Greenwood, Rosemary; Javaid, Kassim; Barnfield, Steven; Halliday, Ruth; Willett, Keith; Lamb, Sallie

    2014-01-01

    Introduction Pertrochanteric hip fractures occur in an elderly population and cause considerable morbidity and loss of functional ability as the fracture heals. Recently, parathyroid hormone (PTH), which is licensed for the treatment of osteoporosis, has been shown to potentially accelerate bone healing in animal and human studies. If its administration could allow a faster functional recovery after pertrochanteric hip fracture, then a patient's hospital stay may be reduced and rehabilitation could be potentially accelerated. PTH can currently only be administered by subcutaneous injection. The acceptability of this intervention is unknown in this elderly population. The aim of this pilot study is to inform the design of a future powered study comparing the functional recovery after pertrochanteric hip fracture in patients undergoing standard care versus those who undergo administration of subcutaneous injection of PTH. Methods and analysis The study is an open label, prospective, randomised, comparative pilot study with blinded outcomes assessment to establish feasibility of the trial design. Patients will be randomised to receive a 6-week course of PTH or usual treatment. Functional outcomes will be assessed at 6 weeks and 12 weeks. Blinded assessment will be used to minimise the effect of bias of an open label study design. A nested qualitative study will investigate the patient experience of, and expectations following, hip fracture and the patient important aspects of recovery compared with the outcome measures proposed. Results Results will be analysed to establish the potential recruitment, compliance and retention rates using 95% CIs, and trial outcomes quoted with SDs and 95% CIs for the effect size. Ethics and dissemination The study has been approved by the South West 2 Research Ethics committee (reference 10/H0206/34). The findings of this study will be disseminated to the medical community via presentations to orthopaedic, orthogeriatric and

  15. Idiopathic facial paralysis: a randomized, prospective, and controlled study using single-dose prednisone versus acyclovir three times daily.

    PubMed

    De Diego, J I; Prim, M P; De Sarriá, M J; Madero, R; Gavilán, J

    1998-04-01

    In a prospective, controlled, and randomized study, we compared the outcome of 101 Bell's palsy patients treated with acyclovir (54 patients) or prednisone (47 patients). The acyclovir dosage was 2400 mg (800 mg three times a day) for 10 days, and prednisone was given as a single daily dose of 1 mg/kg of body weight for 10 days and tapered to 0 over the next 6 days. Minimum follow-up was 3 months in all patients. Patients in the prednisone group had better clinical recovery than those treated with acyclovir. Less degree of neural degeneration was observed in the prednisone group compared with acyclovir patients. The incidence of sequelae was the same in both groups. According to these results, in a 10-day treatment cycle acyclovir given 800 mg three times is not as useful as prednisone given 1 mg/kg of body weight once a day in patients with idiopathic facial nerve paralysis.

  16. Prospective, Multi-Centre, Single-Arm Study of Mechanical Thrombectomy using Solitaire FR in Acute Ischemic Stroke-STAR

    PubMed Central

    Pereira, Vitor M; Gralla, Jan; Davalos, Antoni; Bonafé, Alain; Castaño, Carlos; Chapot, Rene; Liebeskind, David S; Nogueira, Raul G; Arnold, Marcel; Sztajzel, Roman; Liebig, Thomas; Goyal, Mayank; Besselmann, Michael; Moreno, Alfredo; Schroth, Gerhard

    2013-01-01

    Background and Purpose Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire FR in patients with acute ischemic stroke. Methods STAR was an international, multicenter, prospective, single-arm study of Solitaire FR thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary endpoint was the revascularization rate (3TICI 2b) of the occluded vessel as determined by an independent core lab. The secondary endpoint was the rate of good functional outcome (defined as 90-day modified Rankin scale (mRS) 0–2). Results A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale (NIHSS) was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and/or procedure related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions In this single arm study, treatment with the Solitaire™ FR device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration This study is registered with ClinicalTrials.gov, number NCT01327989. PMID:23908066

  17. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study.

    PubMed

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

  18. Comparison of chocolate to cacao-free white chocolate in Parkinson's disease: a single-dose, investigator-blinded, placebo-controlled, crossover trial.

    PubMed

    Wolz, Martin; Schleiffer, Christine; Klingelhöfer, Lisa; Schneider, Christine; Proft, Florian; Schwanebeck, Uta; Reichmann, Heinz; Riederer, Peter; Storch, Alexander

    2012-11-01

    A previous questionnaire study suggests an increased chocolate consumption in Parkinson's disease (PD). The cacao ingredient contains caffeine analogues and biogenic amines, such as β-phenylethylamine, with assumed antiparkinsonian effects. We thus tested the effects of 200 g of chocolate containing 80 % of cacao on UPDRS motor score after 1 and 3 h in 26 subjects with moderate non-fluctuating PD in a mono-center, single-dose, investigator-blinded crossover study using cacao-free white chocolate as placebo comparator. At 1 h after chocolate intake, mean UPDRS motor scores were mildly decreased compared to baseline in both treatments with significant results only for dark chocolate [-1.3 (95 % CI 0.18-2.52, RMANOVA F = 4.783, p = 0.013¸ Bonferroni p = 0.021 for 1 h values)]. A 2 × 2-cross-over analysis revealed no significant differences between both treatments [-0.54 ± 0.47 (95 % CI -1.50 to 0.42), p = 0.258]. Similar results were obtained at 3 h after intake. β-phenylethylamine blood levels were unaltered. Together, chocolate did not show significant improvement over white cacao-free chocolate in PD motor function.

  19. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  20. Efficacy and safety of Tinospora cordifolia lotion in Sarcoptes scabiei var hominis-infected pediatric patients: A single blind, randomized controlled trial

    PubMed Central

    Castillo, Agnes L.; Osi, Marina O.; Ramos, John Donnie A.; De Francia, Jean L.; Dujunco, Marylaine U.; Quilala, Peter F.

    2013-01-01

    Objective: To evaluate the clinical efficacy and safety of Tinospora cordifolia lotion including its cure rate and clearance time compared with permethrin lotion. Materials and Methods: A single blind, randomized, controlled, pilot clinical study was performed in three government institutions to investigate clinical efficacy of T. cordifolia lotion in sixty-six clinically-diagnosed scabies-infected patients. The patients were treated with T. cordifolia or permethrin lotions for three consecutive days for two weeks and clinical assessment of each patient was performed for five weeks. Results: T. cordifolia lotion and permethrin significantly reduced the mean global evaluation score after four weeks of treatment. The two lotions showed comparable effects as anti-scabies agent. Moreover, the clearance time (days) and cure rate using the two lotions did not differ. Clinical improvement, mean clearance time and cure rate of T. cordifolia lotion are comparable with permethrin. Conclusions: Tinospora cordifolia lotion exhibits anti-scabies activity comparable with permethrin. Its incorporation as therapeutic reagent in Sarcoptes scabiei infections is highly recommended. PMID:23662023

  1. The effect of Camellia Sinensis (green tea) mouthwash on plaque-induced gingivitis: a single-blinded randomized controlled clinical trial

    PubMed Central

    2012-01-01

    Abstract Background and the purpose of the Study Complementary medicine received high attention during last decades. We aimed to assess the efficacy of Green tea mouthwash on plaque-induced gingivitis as the most common form of periodontal disease. Methods and materials We designed a single blinded placebo controlled clinical trial. High school female students with chronic generalized plaque-induced gingivitis were distributed to receive either 5 ml of Green tea 5% two times/day or normal saline with the same dosage. Gingival index (Sillness & Loe), plaque index (Sillness & Loe) and bleeding index (Barnett) were recorded at baseline and five consecutive weeks. Comparisons were made by a general linear model, repeated measure ANOVA and a Bonferroni test applied for multiple comparisons. Results Twenty five students were recruited in each arm of the study. A significant improvement was observed in all periodontal indices during the study (P < 0.001). Two groups were contrasted by changing patterns of alteration of indices (P < 0.05). Although total amount of improvement was higher in mouthwash group, the differences did not reach a statistically significant level (P > 0.05, observed power for GI: 0.09, PI: 0.11 and BI: 0.07). Conclusion Green tea mouthwash may be a safe and feasible adjunct treatment for inflammatory periodontal diseases. A future larger scale study is warranted for better evaluating the effect of green tea. PMID:23351842

  2. Clinical effectiveness and safety of low cost versus innovator brand amlodipine in hypertension: A single-blinded, randomized, crossover, noninferiority trial

    PubMed Central

    Das, Alak Kumar; Chatterjee, Suparna; Pal, Jyotirmoy

    2016-01-01

    Objectives: A single-blinded, randomized, crossover, noninferiority trial was conducted to evaluate clinical effectiveness and safety of low-cost brand (LCB) versus innovator brand (IB) amlodipine in essential hypertension. Materials and Methods: The primary end-point was change of systolic blood pressure (BP) from baseline to study end. Adult patients with Stage 1 hypertension or isolated systolic hypertension were randomized to receive 5 mg amlodipine LCB or IB once daily for 6 weeks in each period in a 2 × 2 crossover manner with three follow-up visits in each sequence. In 28 evaluable patients, the reduction of systolic BP (SBP), diastolic BP, and safety profile between two brands was comparable. Results: The lower bound of the 95% confidence interval of the difference in reduction of SBP (−5.04 mmHg) was within the noninferiority margin of 10 mmHg. Conclusion: LCB amlodipine is noninferior to IB in terms of BP reduction and is a cost-effective alternative as it is less expensive than IB. PMID:28066111

  3. A single-blind, placebo-controlled study of glycosaminoglycan-peptide complex ('Rumalon') in patients with osteoarthritis of the hip or knee.

    PubMed

    Gramajo, R J; Cutroneo, E J; Fernandez, D E; Gibson, J L; Cáceres Maldonado, J C; Romero, F L; Houssay, R H

    1989-01-01

    A randomized, single-blind, placebo-controlled trial was carried out in 62 patients (30 with osteoarthritis of the hip, 32 with osteoarthritis of the knee) to examine the efficacy of glycosaminoglycan-peptide complex in the treatment of osteoarthritis. Patients received 8-week courses of trial medication, each consisting of intramuscular injections of 3 x 2 ml ampoules per week, alternating with 8-week periods free of trial medication, in addition to conventional drug therapy and physiotherapy, as required. After 2-years' treatment, glycosaminoglycan-peptide-treated patients showed significant improvements, as compared with placebo, in relation to night pain, pain during the day, joint mobility and walking ability. Similar results were seen with both osteoarthritis of the hip and knee. In osteoarthritis of the knee it was also possible to assess joint swelling and this also showed a significant improvement. There were no significant changes in range of joint movement except for a significant decrease in active flexion in the patients with osteoarthritis of the knee treated with placebo. In contrast with many anti-osteoarthritic drugs, glycosaminoglycan-peptide complex was very well tolerated. These results suggest that glycosaminoglycan-peptide complex may be a valuable alternative form of long-term therapy for patients with osteoarthritis.

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

    PubMed

    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.

  5. Effects of L-carnitine supplementation on respiratory distress syndrome development and prognosis in premature infants: A single blind randomized controlled trial.

    PubMed

    Ozturk, Mehmet Adnan; Kardas, Zehra; Kardas, Fatih; Gunes, Tamer; Kurtoglu, Selim

    2016-03-01

    The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome (RDS). A single blind, randomized controlled trial study was conducted on 130 infants with gestational ages of 28-36 weeks. Infants were assigned to experimental groups (groups 1 and 2) and control groups (groups 3 and 4). Groups 1 and 3 consisted of infants with RDS, and groups 2 and 4 groups were composed of infants without RDS. The experimental groups were treated with carnitine. No statistically significant differences in serum carnitine levels were detected between the study and the control groups on day 1 of treatment (P=0.06). However, on day 7 of treatment, serum carnitine levels in the experimental groups were significantly increased (P=0.02), as compared with the control groups. The surfactant requirement value, which is how many rounds of surfactant therapy were required, was 1.56±0.97 in group 1, and 2.12±0.99 in group 3 (P<0.001). The mean duration of mechanical ventilation required was 3.04±3.60 days in group 1, and 4.73±5.63 days in group 3 (P<0.001). The present results indicate that carnitine supplementation in premature infants with RDS may help to increase carnitine levels, thus decreasing the duration of mechanical ventilation and surfactant requirement.

  6. Management of post-ethmoidectomy crust formation: randomized single-blind clinical trial comparing pressurized seawater versus antiseptic/mucolytic saline.

    PubMed

    Pigret, D; Jankowski, R

    1996-03-01

    This study compared the efficacy of mechanical nasal lavages with pressurized seawater versus nasal irrigations with saline plus benzododecinium (antiseptic) plus oleosorbate (mucolytic). Twenty patients agreed to participate in a randomized, single-blind clinical trial. All patients underwent endoscopic endonasal ethmoidectomy for nasal polyps. The packing was removed after 48 h and patients were asked to start the same day nasal lavages three times a day. Clinical evaluations were performed: (1) by weighing residual nasal crusts and secretions after 21 +/- 2 days; and (2) by using visual analogue scales to daily record symptom scores. Data are presented as mean +/- SEM. T-test statistics for two independent groups were applied. The mean residual crust and secretion weights were 1,756 +/- 688 mg and 1,033 +/- 422 mg in the pressurized seawater group, 932 +/- 414 mg and 1,222 +/- 435 mg in the antiseptic-mucolytic saline group. No statistical differences were found. Sample size calculations showed that 100 subjects in each group would be necessary to confirm a 700-mg reduction in residual crusts in the antiseptic/mucolytic saline group (power = 0.80; two-sided type-I error = 0.05). Daily symptom score curves were similar in both groups and allowed us to give a description of post-operative complaints. The role of antiseptic, mucolytic and mechanical lavages in preventing post-ethmoidectomy crust formation is discussed.

  7. A single dose of the serotonin neurotransmission agonist paroxetine enhances motor output: double-blind, placebo-controlled, fMRI study in healthy subjects.

    PubMed

    Loubinoux, Isabelle; Pariente, Jérémie; Boulanouar, Kader; Carel, Christophe; Manelfe, Claude; Rascol, Olivier; Celsis, Pierre; Chollet, François

    2002-01-01

    Since serotonin (5-HT) stimulates motor function, pharmacological potentiation of 5-HT neurotransmission may improve motor function in healthy subjects and, possibly, recovery in post-stroke patients. Indeed, fluoxetine, a selective serotonin reuptake inhibitor (SSRI), increased activation in executive motor areas of healthy subjects as fenozolone, a releaser of monoamines (including noradrenaline, dopamine, and serotonin) from intracellular stores. This study is intended to test the hypothesis that paroxetine can likewise modulate brain motor activity in a dose-dependent manner in healthy subjects. In a double-blind counterbalanced study, six subjects underwent functional MRI examinations on three sessions 1 week apart (E1, E2, and E3) at the time of peak plasma concentrations (5 h after drug intake, i.e., either 20 or 60 mg of paroxetine or placebo) with a complex sequential opposition task. Rest and activation alternated in a block design. During activation, subjects performed, with the right hand, a 1-Hz-paced task that alternated two fist closings with a sequential opposition task. Paroxetine elicited effects similar to those reported for fluoxetine; notable changes were hyperactivation in the contralateral S1/M1, and posterior SMA and widespread hypoactivation of basal ganglia and cerebellum. There was an inverse correlation between dose and effect: significantly greater effects were observed with the 20-mg dose compared with 60 mg. Paroxetine dose-dependently modulates activation of the entire motor pathway in a way that favors motor output. Thus, a single dose of the SSRI paroxetine reorganized motor processing.

  8. Blind Ambition

    ERIC Educational Resources Information Center

    Olson, Catherine Applefeld

    2009-01-01

    No matter how dedicated they may be, some teachers are daunted by extreme challenges. Carol Agler, music director at the Ohio State School for the Blind (OSSB), is not one of those teachers. Since joining the OSSB staff 11 years ago, Agler has revived the school's long-dormant band program and created its first marching band. Next January, she…

  9. Blindness Clues

    ERIC Educational Resources Information Center

    Science Teacher, 2005

    2005-01-01

    Age-related macular degeneration is the leading cause of blindness in older adults, yet researchers are still in the dark about many of the factors that cause this incurable disease. But new insight from University of Florida (UF) and German researchers about a genetic link between rhesus monkeys with macular degeneration and humans could unlock…

  10. Blind whitening of correlated speckle to enforce despeckling of single-look high-resolution SAR images

    NASA Astrophysics Data System (ADS)

    Lapini, Alessandro; Bianchi, Tiziano; Argenti, Fabrizio; Alparone, Luciano

    2012-11-01

    During the last three decades, several methods have been developed for the despeckling of synthetic aperture radar (SAR) imagery. While some of them are totally empirical, the majority of those relying on signal and noise models has been derived under the assumption of a fully-developed speckle model, in which the multiplicative fading term is supposed to be a white process. Unfortunately, the frequency response of the SAR system may introduce a statistical correlation, which decreases the capability of reducing speckle for filters that assume a white speckle model. In this work, an unsupervised method for whitening single-look complex (SLC) images produced by very-high resolution (VHR) SAR systems is proposed. By using the statistical properties of the SLC image and some likely assumptions, estimation of the frequency response of the SAR system is performed. After that, a decorrelation stage is applied to the complex image in order to yield uncorrelated speckle in the intensity/amplitude component. Strong scatterers are automatically detected and left unprocessed. After the whitening step, the complex image is detected and the resulting intensity/amplitude may be despeckled. Experimental results have been carried out both on optical images corrupted by synthetic correlated complex speckle and on true SLC images acquired by the COSMO-SkyMed SAR satellite constellation. Both advanced and classical despeckling filters achieve significantly better performance when they are preceded by the proposed whitening step. On homogeneous areas the equivalent number of looks (ENL) increases by four-five times. The sharpness of edges and strong textures is negligibly diminished by the whitening step; this effect is even less noticeable after the despeckling step has been performed. The radiometric characteristics of images are preserved by the whitening process to a large extent.

  11. A prospective, randomized, double-blind study of the anesthetic efficacy of sodium bicarbonate buffered 2% lidocaine with 1:100,000 epinephrine in inferior alveolar nerve blocks.

    PubMed

    Whitcomb, Michael; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

    2010-01-01

    The authors, using a crossover design, randomly administered, in a double-blind manner, inferior alveolar nerve (IAN) blocks using a buffered 2% lidocaine with 1:100,000 epinephrine/sodium bicarbonate formulation and an unbuffered 2% lidocaine with 1:100,000 epinephrine formulation at 2 separate appointments spaced at least 1 week apart. An electric pulp tester was used in 4-minute cycles for 60 minutes to test for anesthesia of the first and second molars, premolars, and lateral and central incisors. Anesthesia was considered successful when 2 consecutive 80 readings were obtained within 15 minutes, and the 80 reading was continuously sustained for 60 minutes. For the buffered 2% lidocaine with 1:100,000 epinephrine/sodium bicarbonate formulation, successful pulpal anesthesia ranged from 10-71%. For the unbuffered 2% lidocaine with 1:100,000 epinephrine formulation, successful pulpal anesthesia ranged from 10-72%. No significant differences between the 2 anesthetic formulations were noted. The buffered lidocaine formulation did not statistically result in faster onset of pulpal anesthesia or less pain during injection than did the unbuffered lidocaine formulation. We concluded that buffering a 2% lidocaine with 1:100,000 epinephrine with sodium bicarbonate, as was formulated in the current study, did not statistically increase anesthetic success, provide faster onset, or result in less pain of injection when compared with unbuffered 2% lidocaine with 1:100,000 epinephrine for an IAN block.

  12. Metformin administration versus laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: a prospective parallel randomized double-blind placebo-controlled trial.

    PubMed

    Palomba, Stefano; Orio, Francesco; Nardo, Luciano Giovanni; Falbo, Angela; Russo, Tiziana; Corea, Domenico; Doldo, Patrizia; Lombardi, Gaetano; Tolino, Achille; Colao, Annamaria; Zullo, Fulvio

    2004-10-01

    At present, it is unclear what the role is of laparoscopic ovarian diathermy (LOD) and of metformin administration as second-line treatments for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of clomiphene citrate (CC) treatment. The aim of the present study was to compare in a randomized double-blind placebo-controlled fashion the effectiveness of LOD with metformin administration in the treatment of CC-resistant women with PCOS. A total of 120 overweight primary infertile anovulatory CC-resistant women with PCOS were enrolled and randomized into two groups of treatment. Group A underwent diagnostic laparoscopy, whereas group B underwent LOD. At hospital discharge, the patients were treated for 6 months with metformin cloridrate (group A; 850 mg twice daily) or with multivitamins (group B). The ovulation, pregnancy, abortion, and live-birth rates were evaluated. At the end of the study, the total ovulation rate was not statistically different between both treatment groups (54.8 vs. 53.2% [correction] in groups A and B, respectively), whereas the pregnancy (21.8 [correction] vs. 13.4%), the abortion (9.3 [correction] vs. 29.0%), and the live-birth (86.0 [correction] vs. 64.5%) rates were significantly (P < 0.05) different between the two groups. Our data show that metformin administration is more effective than LOD in overall reproductive outcomes in overweight infertile CC-resistant women with PCOS.

  13. Efficacy of methylprednisolone and lignocaine on propofol injection pain: A randomised, double-blind, prospective study in adult cardiac surgical patients

    PubMed Central

    Shivanna, Shivaprakash; Priye, Shio; Singh, Dipali; Jagannath, Sathyanarayan; Mudassar, Syed; Reddy, Durga Prasad

    2016-01-01

    Background and Aims: Propofol (2, 6-di-isopropylphenol) used for the induction of anaesthesia often causes mild to severe pain or discomfort on injection. We designed this double-blind study to compare the efficacy of methylprednisolone and lignocaine in reducing the pain of propofol injection in patients scheduled for cardiac surgery. Methods: A total of 165 adult patients, scheduled for elective cardiac surgery, were divided into three groups: saline (group S, n = 55), lignocaine 20 mg (Group L, n = 55) and methylprednisolone 125 mg diluted into 2 ml of distilled water (Group MP, n = 55). Drugs were administered after tourniquet application and occlusion was released after 1 min and 1/4th of the total dose of propofol (2 mg/kg) was administered at the rate of 0.5 ml/s. Pain on propofol injection was evaluated by four-point verbal rating scale. Statistical methods used included Student's t-test and Chi-square test/Fisher's exact test. Results: The overall incidence of pain was 70.9% in the saline group, 30.9% in the lignocaine group and 36.4% in the methylprednisolone group. The intensity of pain was significantly less in patients receiving methylprednisolone and lignocaine than those receiving saline (P < 0.012). Conclusion: Pre-treatment with intravenous methylprednisolone was found to be as effective as lignocaine in reducing propofol injection-induced pain. PMID:27942060

  14. Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults.

    PubMed

    Kalman, Douglas; Harvey, Philip D; Perez Ojalvo, Sara; Komorowski, James

    2016-11-18

    Inositol-stabilized arginine silicate (ASI; Nitrosigine(®)) has been validated to increase levels of arginine, silicon and nitric oxide production. To evaluate potential enhancement of mental focus and clarity, ASI (1500 mg/day) was tested in two double-blind placebo-controlled crossover (DBPC-X) studies using the Trail Making Test (TMT, Parts A and B). In the two studies, healthy males took ASI for 14 and 3 days, respectively. In the first study, after 14 days of dosing, TMT B time decreased significantly from baseline (28% improvement, p = 0.045). In the second study evaluating shorter-term effects, TMT B time decreased significantly compared to placebo (33% improvement, p = 0.024) in a 10-min period. After 3 days of dosing, TMT B time significantly decreased from baseline scores (35% improvement, p < 0.001). These findings show that ASI significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning.

  15. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial.

    PubMed

    Kolk, A; Yang, K G Auw; Tamminga, R; van der Hoeven, H

    2013-11-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were randomly allocated to a treatment group who received low-dose rESWT (three sessions at an interval 10 to 14 days, 2000 pulses, 0.11 mJ/mm(2), 8 Hz) or to a placebo group, with a follow-up of six months. The patients and the treating orthopaedic surgeon, who were both blinded to the treatment, evaluated the results. A total of 44 patients were allocated to the rESWT group and 38 patients to the placebo group. A visual analogue scale (VAS) score for pain, a Constant-Murley (CMS) score and a simple shoulder test (SST) score significantly improved in both groups at three and six months compared with baseline (all p ≤ 0.012). The mean VAS was similar in both groups at three (p = 0.43) and six months (p = 0.262). Also, the mean CMS and SST scores were similar in both groups at six months (p = 0.815 and p = 0.834, respectively). It would thus seem that low-dose rESWT does not reduce pain or improve function in patients chronic rotator cuff tendinitis compared with placebo treatment.

  16. How long does it take phentolamine to reverse adrenaline-induced vasoconstriction in the finger and hand? A prospective, randomized, blinded study: The Dalhousie project experimental phase.

    PubMed

    Nodwell, Trefor; Lalonde, Don

    2003-01-01

    At the Dalhousie Plastic Surgery Alumni Reunion at the Atlantic Plastic Surgery meeting in Halifax, Nova Scotia, in September 2001, 22 subjects, including 18 certified hand surgeons, were injected with 1.8 mL of 2% lidocaine with 1:100,000 adrenaline in three places in one finger of each hand. One hour later, the same sites of one hand were injected with phentolamine (1 mg in 1 mL), and the other hand was injected with saline. Subjects were blinded as to which hand received the phentolamine. It took an average of 85 min for the adrenaline-injected fingers to return to normal colour after phentolamine injection. It took an average of 320 min for the adrenaline-injected fingers to return to normal colour after saline injection (no phentolamine). We also observed that lidocaine with adrenaline provided an average of 549 min of anesthesia in nonphentolamine-injected fingers. Phentolamine consistently and reliably reversed adrenaline-induced vasoconstriction in the finger.

  17. Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults

    PubMed Central

    Kalman, Douglas; Harvey, Philip D.; Perez Ojalvo, Sara; Komorowski, James

    2016-01-01

    Inositol-stabilized arginine silicate (ASI; Nitrosigine®) has been validated to increase levels of arginine, silicon and nitric oxide production. To evaluate potential enhancement of mental focus and clarity, ASI (1500 mg/day) was tested in two double-blind placebo-controlled crossover (DBPC-X) studies using the Trail Making Test (TMT, Parts A and B). In the two studies, healthy males took ASI for 14 and 3 days, respectively. In the first study, after 14 days of dosing, TMT B time decreased significantly from baseline (28% improvement, p = 0.045). In the second study evaluating shorter-term effects, TMT B time decreased significantly compared to placebo (33% improvement, p = 0.024) in a 10-min period. After 3 days of dosing, TMT B time significantly decreased from baseline scores (35% improvement, p < 0.001). These findings show that ASI significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning. PMID:27869715

  18. A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of JDTic

    PubMed Central

    Buda, Jeffrey J; Carroll, F I; Kosten, Thomas R; Swearingen, Dennis; Walters, Bradford B

    2015-01-01

    Animal studies suggest that kappa opioid receptor antagonists (KORAn) potentially could treat a wide variety of addictive and depressive disorders. We assessed the KORAn JDTic for safety, tolerability, and pharmacokinetics in a double-blind, placebo-controlled, randomized trial evaluating single oral doses in healthy adult males. Predose and postdose safety assessments included orthostatic vital signs; 6-lead continuous telemetry monitoring (approximately 16 h predose to 24 h postdose); 12-lead electrocardiograms (ECGs); clinical chemistry, hematology, coagulation, and urinalysis; psychomotor functioning (using the Wayne Saccadic Fixator (WSF)); and adverse events. As a potential indicator of JDTic effects on affect, the POMS Standard instrument was administered predose and daily postdose Days 1–6. At 1 mg, 2 of the 6 JDTic (and 0/6 placebo) subjects experienced a single, asymptomatic event of multiple beats of nonsustained ventricular tachycardia (NSVT). Their events were temporally similar with respect to time postdose (and the postdose timing of an NSVT event in a monkey). These events triggered a study stopping rule. No differences were observed between the placebo and JDTic subjects with respect to clinical chemistry, hematology, coagulation, urinalysis, orthostatic vital signs, WSF, or 12-lead ECG parameters. Plasma JDTic levels were below the lower limit of quantitation (0.1 nM) in all subjects. There were no significant differences in POMS scores between the placebo and JDTic groups. Although the evidence is circumstantial, it suggests that NSVT is a potential JDTic toxicity in humans. Given the therapeutic potential of KORAn, further investigation is needed to determine whether a significant JDTic human cardiac effect indeed exists, and if so, whether it is specific to JDTic or represents a KORAn class effect. PMID:25628006

  19. Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection.

    PubMed

    Kohno, Shigeru; Yen, Muh-Yong; Cheong, Hee-Jin; Hirotsu, Nobuo; Ishida, Tadashi; Kadota, Jun-ichi; Mizuguchi, Masashi; Kida, Hiroshi; Shimada, Jingoro

    2011-11-01

    Antiviral medications with activity against influenza viruses are important in controlling influenza. We compared intravenous peramivir, a potent neuraminidase inhibitor, with oseltamivir in patients with seasonal influenza virus infection. In a multinational, multicenter, double-blind, double-dummy randomized controlled study, patients aged ≥ 20 years with influenza A or B virus infection were randomly assigned to receive either a single intravenous infusion of peramivir (300 or 600 mg) or oral administration of oseltamivir (75 mg twice a day [b.i.d.] for 5 days). To demonstrate the noninferiority of peramivir in reducing the time to alleviation of influenza symptoms with hazard model analysis and a noninferiority margin of 0.170, we planned to recruit 1,050 patients in South Korea, Japan, and Taiwan. A total of 1,091 patients (364 receiving 300 mg and 362 receiving 600 mg of peramivir; 365 receiving oseltamivir) were included in the intent-to-treat infected population. The median durations of influenza symptoms were 78.0, 81.0, and 81.8 h in the groups treated with 300 mg of peramivir, 600 mg of peramivir, and oseltamivir, respectively. The hazard ratios of the 300- and 600-mg-peramivir groups compared to the oseltamivir group were 0.946 (97.5% confidence interval [CI], 0.793, 1.129) and 0.970 (97.5% CI, 0.814, 1.157), respectively. Both peramivir groups were noninferior to the oseltamivir group (97.5% CI, <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg-peramivir group, but the incidence of severe reactions in either peramivir group was not different from that in the oseltamivir group. Thus, a single intravenous dose of peramivir may be an alternative to a 5-day oral dose of oseltamivir for patients with seasonal influenza virus infection.

  20. Pharmacokinetics and Bioavailability of Plant Lignan 7-Hydroxymatairesinol and Effects on Serum Enterolactone and Clinical Symptoms in Postmenopausal Women: A Single-Blinded, Parallel, Dose-Comparison Study

    PubMed Central

    Udani, Jay K.; Brown, Donald J.; Tan, Maria Olivia C.; Hardy, Mary

    2013-01-01

    Objective 7-Hydroxymaitairesinol (7-HMR) is a naturally occurring plant lignan found in whole grains and the Norway spruce (Piciea abies). The purpose of this study was to evaluate the bioavailability of a proprietary 7-HMR product (HMRlignan, Linnea SA, Locarno, Switzerland) through measurement of lignan metabolites and metabolic precursors. Methods A single-blind, parallel, pharmacokinetic and dose-comparison study was conducted on 22 post-menopausal females not receiving hormone replacement therapy. Subjects were enrolled in either a 36 mg/d (low-dose) or 72 mg/d dose (high-dose) regimen for 8 weeks. Primary measured outcomes included plasma levels of 7-HMR and enterolactone (ENL), and single-dose pharmacokinetic analysis was performed on a subset of subjects in the low-dose group. Safety data and adverse event reports were collected as well as data on hot flash frequency and severity. Results Pharmacokinetic studies demonstrated 7-HMR Cmax = 757.08 ng/ml at 1 hour and ENL Cmax = 4.8 ng/ml at 24 hours. From baseline to week 8, plasma 7-HMR levels increased by 191% in the low-dose group (p < 0.01) and by 1238% in the high-dose group (p < 0.05). Plasma ENL levels consistently increased as much as 157% from baseline in the low-dose group and 137% in the high-dose group. Additionally, the mean number of weekly hot flashes decreased by 50%, from 28.0/week to 14.3/week (p < 0.05) in the high-dose group. No significant safety issues were identified in this study. Conclusion The results demonstrate that HMRlignan is quickly absorbed into the plasma and is metabolized to ENL in healthy postmenopausal women. Clinically, the data demonstrate a statistically significant improvement in hot flash frequency. Doses up to 72 mg/d HMRlignan for 8 weeks were safe and well tolerated in this population. PMID:24606716

  1. Comparing the Healing Effects of Arnebia euchroma Ointment With Petrolatum on the Ulcers Caused by Fractional CO2 Laser: A Single-Blinded Clinical Trial

    PubMed Central

    Aliasl, Jale; Khoshzaban, Fariba; Barikbin, Behrooz; Naseri, Mohsen; Kamalinejad, Mohammad; Emadi, Fatemeh; Razzaghi, Zahra; Talei, Daryush; Yousefi, Maryam; Aliasl, Fatemeh; Barati, Maryam; Mohseni-Moghaddam, Parvaneh; Hasheminejad, Seyed Abbas; Esmailzad Nami, Hossein

    2014-01-01

    Background: Arnebia euchroma ointment (AEO) has been used in Iranian traditional medicine for burn wound healing. Objectives: The aim of this study is to evaluate wound healing efficacy of AEO in burn wounds after fractional Co2 laser. Patients and Methods: This split-face, single-blinded, single-center clinical study was performed in Shohada-e-Tajrish Hospital, Tehran, Iran. A total of 26 subjects with facial acne scar, who were to receive fractional CO2 laser resurfacing were recruited. After laser procedure, AEO was applied to one side of the face and petrolatum on the other side for wound healing. Digital photographs were taken from acne scar area before resurfacing and on each of the assessment sessions. Three researchers, who were unaware of the applied medications, assessed these digital photographs for erythema, edema, epithelial confluence, crusting/scabbing, and general wound appearance. Subject’s irritations such as dryness and itching were evaluated on the second, fifth, and seventh days. Results: Our study indicated higher epithelial confluence and general wound appearance scores (P = 0.045 for both) and less erythema and edema on fifth day in petrolatum (P = 0.009 and P = 0.034, respectively). The results showed less crusting and erythema (P = 0.016 and P = 0.035, respectively) and higher general wound appearance scores in petrolatum on the second day (P = 0.035 and P = 0.001, respectively). Dryness was the most common subjective complaint in both groups; however, it was more severe in AEO, especially on the second day (P = 0.023). Conclusions: Despite the healing effects of AEO in burn wounds, petrolatum was more effective than AEO in post-laser wound. PMID:25558382

  2. Double-blind, single-dose, cross-over study of the effects of pramipexole, pergolide, and placebo on rest tremor and UPDRS part III in Parkinson's disease.

    PubMed

    Navan, Prithiva; Findley, Leslie J; Jeffs, Jim A R; Pearce, Ronald K B; Bain, Peter G

    2003-02-01

    Tremor is one of the cardinal signs of Parkinson's disease (PD) but its response to antiparkinsonian medication is variable. It has been postulated that pramipexole may have a stronger antiparkinsonian tremor effect than pergolide, another direct acting dopamine agonist medication, possibly because the former has preferential affinity for the dopamine D3 receptor. The purpose of this pilot study was to compare the effects of a single oral dose of either pramipexole (Pr) or pergolide (Pe) or placebo (Pl) on parkinsonian tremor and the motor (part III) subsection of the UPDRS. Ten patients (6 men, 4 women), mean age 65.3 years, mean duration from diagnosis of 2.6 years, with tremor dominant PD were recruited. On three separate occasions a single dose of pramipexole (salt) 500 microg, pergolide 500 microg or placebo were administered in random order to each patient, who were pretreated with domperidone and had their antiparkinsonian medication withheld from midnight before study. After each medication patients were assessed at baseline and then every 30 min for 4 hr using a 0 to 10 tremor rating scale and the UPDRS (part III) in a double-blind protocol. Adverse effects were systematically recorded. The results demonstrate that 500 microg of either pramipexole or pergolide reduced PD rest tremor scores to a similar degree, which at peak effect was significantly greater than placebo (respectively Pe v Pl: P < 0.006, Pr v Pl: P < 0.033). The two active drugs also had weaker beneficial effects on the UPDRS part III. Pergolide, however, was significantly more likely than pramipexole to cause nausea (P = 0.005) or vomiting (P = 0.014).

  3. Ultrastructural changes in rat thyroid tissue after acute organophosphate poisoning and effects of antidotal therapy with atropine and pralidoxime: A single-blind, ex vivo study

    PubMed Central

    Satar, Deniz; Satar, Salim; Mete, Ufuk Ozgu; Suchard, Jeffrey R.; Topal, Metin; Karakoc, Emre; Kaya, Mehmet

    2008-01-01

    Background: Organophosphate (OP) insecticides are widely used in both agricultural and landscape pest control, and the potential for human exposure to these compounds is significant. Objectives: The aims of this study were to investigate the effects of acute poisoning with the OP methamidophos and the effects of antidotal therapy with atropine and pralidoxime on rat thyroid tissue ultrastructure. Methods: In this single-blind, ex vivo study, male Wistar albino rats weighing 220 to 230 g were divided into 4 treatment groups. Group 1 received a median lethal dose of methamidophos (30 mg/kg) via oral gavage. Group 2 received saline via oral gavage and served as the control group for group 1. Group 3 received methamidophos (30 mg/kg) via oral gavage, and after 8 minutes atropine 0.05 mg/kg and pralidoxime chloride (2-FAM) (40 mg/kg) were administered intraperitoneally (IP). Atropine was titrated to reverse signs of cholinergic excess. Group 4 received saline via oral gavage followed by IP injections and served as the control for group 3. Rat thyroid tissues were examined using electron microscopy, and the histologic changes were examined by a histopathologist who was blinded to treatment. All rats were euthanized by intracardiac blood collection. The rats in groups 1 and 2 were euthanized 8 minutes after treatment. The rats in groups 3 and 4 were euthanized 96 hours after treatment. Results: Thirty-four male rats (aged 16 weeks) were included in the study. The rats were grouped accordingly: group 1 (n = 10); group 2 (n = 7); group 3 (n = 10); and group 4 (n = 7). The mean (SD) pseudocholinesterase (FCE) activity was significantly lower in the methamidophos-treated rats (group 1) compared with the corresponding control group (group 2) (32.6 [17.0] vs 579.4 [59.0] U/L, respectively; P < 0.001). PCE activity was significantly higher in rats treated with atropine and 2-PAM (group 3) (392.5 [39.4] U/L; P < 0.001) compared with those not receiving antidotal therapy (group 1

  4. Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial

    PubMed Central

    2013-01-01

    Background Visual information comprises one of the most salient sources of information used to control walking and the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize, therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery and adaptability of gait following stroke. This feasibility trial aims to estimate probable recruitment rate, effect size, treatment adherence and response to gait training with visual cues in contrast to conventional overground walking practice following stroke. Methods/design A 3-arm, parallel group, multi-centre, single blind, randomised control feasibility trial will compare overground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants (n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment, delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the O-VCT or UC and in a University setting for T-VCT participants. Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included. The primary outcomes concerning participant enrolment, recruitment, retention, and health and social care resource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months (follow-up). Outcome measures will include gait speed and step length symmetry

  5. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  6. Stress and burnout among hemodialysis nurses: a single-center, prospective survey study.

    PubMed

    Karkar, Ayman; Dammang, Mienalyn Lim; Bouhaha, Betty Mandin

    2015-01-01

    Stress is a well known and identified problem within the nursing profession. Dialysis nurses are exposed to high level of stress. Increasing workload can aggravate stress and cause burnout and exhaustion. Stress and burnout are capable of having a detrimental impact on organizational productivity and pose serious health and safety hazards on the job. We aimed in this study to determine the type and level of stress and the amount of burnout among our dialysis nurses, and to evaluate the managing skills and the impact of stress on their work performance. There were 93 nurses (19 national and 74 expatriate nurses) who answered modified questionnaires to the aims of our prospective and descriptive correlational study. Our results show that most nurses involved in the study (national and expatriate) experienced a mild level of stress (79% and 68%, respectively) and moderate level of burnout (42% and 38%, respectively). The most common stressor among the national nurses was technical breakdowns of machines (15.9%) and that among expatriates was job insecurity (16.9%). The majority of the national nurses (21%) coped with this by increased sick leaves, whereas the majority (25%) of the expatriates responded by becoming easily frustrated. The most utilized coping skill among both groups was the relaxation methods (20.8% versus 24.9%) and the least utilized was denial (3.9% versus 0.5%). In conclusion, our results suggest the exposure of dialysis nurses to different types of stress and demonstrate the different experienced coping skills. These results may have implications for nursing management and hospital administration.

  7. Topical Hyaluronic Acid vs. Standard of Care for the Prevention of Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer: Single-Blind Randomized Phase III Clinical Trial

    SciTech Connect

    Pinnix, Chelsea; Perkins, George H.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy; Oh, Julia L.; Arriaga, Lisa; Munsell, Mark F.; Kelly, Patrick; Hoffman, Karen E.; Smith, Benjamin D.; Buchholz, Thomas A.; Yu, T. Kuan

    2012-07-15

    Purpose: To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of {>=}Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care. Methods and Materials: Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid-based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of {>=}Grade 2 dermatitis. Results: The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of {>=}Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only 1ne patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003). Conclusion: We found no benefit from the use of a topical hyaluronic acid-based gel for reducing the development of {>=}Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid-based gel in controlling radiation dermatitis symptoms after they develop.

  8. Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

    PubMed Central

    Davison, Beth A.; Filippatos, Gerasimos S.; Radovanovic, Slavica; Beleslin, Branko; Merkely, Bela; Musialek, Piotr; Wojakowski, Wojciech; Andreka, Peter; Horvath, Ivan G.; Katz, Amos; Dolatabadi, Dariouch; El Nakadi, Badih; Arandjelovic, Aleksandra; Edes, Istvan; Seferovic, Petar M.; Obradovic, Slobodan; Vanderheyden, Marc; Jagic, Nikola; Petrov, Ivo; Atar, Shaul; Halabi, Majdi; Gelev, Valeri L.; Shochat, Michael K.; Kasprzak, Jaroslaw D.; Sanz-Ruiz, Ricardo; Heyndrickx, Guy R.; Nyolczas, Noémi; Legrand, Victor; Guédès, Antoine; Heyse, Alex; Moccetti, Tiziano; Fernandez-Aviles, Francisco; Jimenez-Quevedo, Pilar; Bayes-Genis, Antoni; Hernandez-Garcia, Jose Maria; Ribichini, Flavio; Gruchala, Marcin; Waldman, Scott A.; Teerlink, John R.; Gersh, Bernard J.; Povsic, Thomas J.; Henry, Timothy D.; Metra, Marco; Hajjar, Roger J.; Tendera, Michal; Behfar, Atta; Alexandre, Bertrand; Seron, Aymeric; Stough, Wendy Gattis; Sherman, Warren; Cotter, Gad; Wijns, William

    2017-01-01

    Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients’ mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n = 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving > 24 million mesenchymal stem cells (n = 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n = 157) or sham procedure (n = 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n = 151 sham). The primary efficacy endpoint was a Finkelstein–Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann–Whitney estimator 0.54, 95% confidence interval [CI] 0.47–0.61 [value > 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200–370 mL (60% of patients) (Mann–Whitney estimator 0.61, 95% CI 0.52–0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. PMID:28025189

  9. Pre-emptive effect of dexamethasone injection and consumption on post-operative swelling, pain, and trismus after third molar surgery. A prospective, double blind and randomized study

    PubMed Central

    Chaudhary, Pradeep D.; Rastogi, Sanjay; Gupta, Prashant; Niranjanaprasad Indra, B.; Thomas, Roy; Choudhury, Rupshikha

    2015-01-01

    Aim To evaluate the preventative effect of intravenous 4 mg of dexamethasone and 8 mg oral dexamethasone on post-operative pain, swelling and trismus after the surgical extraction of mandibular third molars. Materials and methods A randomized clinical trial comprised of 200 patients (control group I intravenous and experimental group II orally) with impacted lower third molars, average age 20.8 years with no local or systemic problems, with bilateral impacted lower third molars, were operated under local anesthesia. Group I was given 4 mg IV and group II was given 8 mg orally of dexamethasone 1 h before procedure. The choice of which side to operate first and the amount of concentration of medication to use was made randomly and double-blindly. Post-operative pain was evaluated using a visual analog scale (VAS) and the degree of swelling was evaluated through facial reference points' variation. The presence of trismus was analyzed through measurement of the interincisal distance (IID). These assessments were obtained before the operation and 24 h, 48 h and 7th POD. Results No significant difference was found in facial swelling and trismus between IV 4 mg injection and oral 8 mg consumption after lower third molar surgery (student t test P > 0.05). The visual analogue scale scores for pain assessment showed no significant difference between IV injection and oral route of dexamethasone (student t test P > 0.05). Conclusion Patients can be administered 8 mg oral dexamethasone is as effective as 4 mg intra venous route without much difference in final outcome at any given point of time. PMID:25853044

  10. Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

    PubMed Central

    Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

    2017-01-01

    Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

  11. Evaluation of efficacy of amikacin for attenuation of catheter-related bladder discomfort in patients undergoing percutaneous nephrolithotomy: A prospective, randomized, placebo-controlled, double-blind study

    PubMed Central

    Verma, Ruchi; Agarwal, Anil; Singh, Prabhat Kumar; Gupta, Devendra; Shamim, Rafat

    2016-01-01

    Context: Catheter-related bladder discomfort (CRBD) is the most distressing symptom in patients due to intraoperative urinary catheterization. Amikacin significantly inhibits detrusor contraction evoked by prejunctional stimulation. Aims: The aim of this study is to evaluate the efficacy of amikacin in prevention of CRBD in patients undergoing percutaneous nephrolithotomy. Settings and Design: Study areas were operation theater and postanesthesia care unit of the Department of Anesthesiology, SGPGIMS, Lucknow. Subjects and Methods: One hundred adult patients of either sex were randomly assigned into two groups of fifty each. Patients in control group received normal saline whereas patients in amikacin group received amikacin 10 mg/kg just before induction. Grading of CRBD was done as none, mild, moderate, and severe by a blinded observer at 0, 1, 6, 12, and 24 h after surgery. Statistical Analysis Used: Data were analyzed using Student's t-test and Chi-square test among groups. Incidence of CRBD was compared with Chi-square test whereas severity was analyzed by the test of proportions (Z-test). Visual analog score was compared using Mann–Whitney U-test for surgical site pain. Results: Incidence of CRBD in control group was 66% as compared to 44% observed in amikacin group (P < 0.05). During intergroup comparison at different time points, incidence of CRBD was reduced at 1 and 6 h in the amikacin group (P < 0.05). Significant reduction in the severity of CRBD (moderate) was also observed at 1 h in the amikacin group (P < 0.05). At rest of the time points, there was no significant difference. Conclusions: Amikacin can significantly reduce the incidence and severity of CRBD in the first few hours after surgery. PMID:27746561

  12. Evaluation of the Analgesic Efficacy of Melatonin in Patients Undergoing Cesarean Section Under S pinal Anesthesia: A Prospective Randomized Double-blind Study

    PubMed Central

    Beigom Khezri, Marzieh; Delkhosh Reihany, Morteza; Oveisy, Sonia; Mohammadi, Navid

    2016-01-01

    Melatonin has been suggested as a new natural pain killer in inflammatory pain and during surgical procedures. We designed this randomized double-blind controlled study to evaluate the analgesic efficacy and also optimal preemptive dose of melatonin in patients undergoing cesarean section under spinal anesthesia . One hundred twenty patients scheduled for cesarean section under spinal anesthesia were randomly allocated to one of three groups of 40 each to receive melatonin 3 milligram (mg) (group M3), melatonin 6 mg (group M6) or placebo (group P) sublingually 20 min before the spinal anesthesia. The time to first analgesic request, analgesic requirement in the first 24 h after surgery, hemodynamic variables, anxiety scores nd the incidence of adverse events were recorded. The duration of anesthesia and analgesia didn’t show significant differences between three groups. Total analgesic request during 24 h after surgery was different among the three groups (P = 0.035). The incidence of headache in group M6 was significantly higher than others (P<0.001). However, after adjusting headache between groups of the study, we were unable to show the significant difference in the total analgesic request during 24 h after surgery among the three groups (p = 0.058). Although premedication of patients with 3 mg sublingual melatonin prolonged time to first analgesic request after cesarean delivery compared to placebo group, the difference was not statistically significant. Meanwhile increasing dose of melatonin to 6 mg failed to enhance analgesia and also increase the incidence of headache in patients undergoing cesarean section under spinal anesthesia. PMID:28243296

  13. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

    PubMed

    Ala, Shahram; Saeedi, Majid; Janbabai, Ghasem; Ganji, Reza; Azhdari, Elham; Shiva, Afshin

    2016-01-01

    Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

  14. Effect of Two Different Doses of Dexmedetomidine as Adjuvant in Bupivacaine Induced Subarachnoid Block for Elective Abdominal Hysterectomy Operations: A Prospective, Double-blind, Randomized Controlled Study

    PubMed Central

    Das, Anjan; Halder, Susanta; Chattopadhyay, Surajit; Mandal, Parthajit; Chhaule, Subinay; Banu, Rezina

    2015-01-01

    Objectives Improvements in perioperative pain management for lower abdominal operations has been shown to reduce morbidity, induce early ambulation, and improve patients’ long-term outcomes. Dexmedetomidine, a selective alpha-2 agonist, has recently been used intrathecally as adjuvant to spinal anesthesia to prolong its efficacy. We compared two different doses of dexmedetomidine added to hyperbaric bupivacaine for spinal anesthesia. The primary endpoints were the onset and duration of sensory and motor block, and duration of analgesia.   Methods A total of 100 patients, aged 35–60 years old, assigned to have elective abdominal hysterectomy under spinal anesthesia were divided into two equally sized groups (D5 and D10) in a randomized, double-blind fashion. The D5 group was intrathecally administered 3ml 0.5% hyperbaric bupivacaine with 5µg dexmedetomidine in 0.5ml of normal saline and the D10 group 3ml 0.5% bupivacaine with 10µg dexmedetomidine in 0.5ml of normal saline. For each patient, sensory and motor block onset times, block durations, time to first analgesic use, total analgesic need, postoperative visual analogue scale (VAS) scores, hemodynamics, and side effects were recorded.   Results Although both groups had a similar demographic profile, sensory and motor block in the D10 group (p<0.050) was earlier than the D5 group. Sensory and motor block duration and time to first analgesic use were significantly longer and the need for rescue analgesics was lower in the D10 group than the D5 group. The 24-hour VAS score was significantly lower in the D10 group (p<0.050). Intergroup hemodynamics were comparable (p>0.050) without any appreciable side effects.   Conclusion Spinal dexmedetomidine increases the sensory and motor block duration and time to first analgesic use, and decreases analgesic consumption in a dose-dependent manner. PMID:26366259

  15. Preventive effects of topical washing with miconazole nitrate-containing soap to diaper candidiasis in hospitalized elderly patients: A prospective, double-blind, placebo-controlled study.

    PubMed

    Takahashi, Hidenori; Oyama, Noritaka; Tanaka, Izumi; Hasegawa, Michiko; Hirano, Kaori; Shimada, Chieko; Hasegawa, Minoru

    2017-02-22

    The objective of the present randomized, double-blind trial was to evaluate the efficacy and safety of daily washing with miconazole nitrate-containing soap for candidiasis at diaper-covered sites in elderly subjects under long-term inpatient care. To confirm the onset and disappearance of candidiasis, we microscopically evaluated the existence of the pseudohyphae and/or blastoconidia of Candida spp. We enrolled 75 elderly patients who wore diapers all day in the hospital or nursing home. Patients were randomly assigned to receive treatment with either miconazole soap or miconazole-free placebo soap, and 28 patients in the miconazole group and 27 patients in the placebo group were followed for 4 weeks. Although washing with miconazole soap did not affect the frequency of pseudohyphae/blastoconidia-positive patients, it significantly inhibited the positive conversion of pseudohyphae/blastoconidia compared with the placebo group. As a result, the frequency of patients positive for pseudohyphae/blastoconidia was significantly lower in the miconazole group than in the control group at 4 weeks (17.9% vs 44.4%). Clinically apparent diaper candidiasis did not develop in either group. Washing with miconazole soap was a significant independent factor for reducing the cases positive for pseudohyphae/blastoconidia, while diarrhea and heart failure were significant factors associated with an increase in the positive rate at the end-point. Severe adverse effects were not found in any patients. Thus, washing with miconazole soap is well-tolerated and can inhibit the positive conversion of Candida in patients wearing diapers. Therefore, maintenance of genital hygiene using this soap may prophylactically decrease the overall prevalence of patients with diaper candidiasis.

  16. Microbiological Analysis of a Prospective, Randomized, Double-Blind Trial Comparing Moxifloxacin and Clindamycin in the Treatment of Odontogenic Infiltrates and Abscesses

    PubMed Central

    Sobottka, Ingo; Wegscheider, Karl; Balzer, Ludwig; Böger, Rainer H.; Hallier, Olaf; Giersdorf, Ina; Streichert, Thomas; Haddad, Munif; Platzer, Ursula

    2012-01-01

    The objective of this study was to identify the oral pathogens found in odontogenic infections, to determine their susceptibilities to amoxicillin-clavulanic acid (AMC), clindamycin (CLI), doxycycline (DOX), levofloxacin (LVX), moxifloxacin (MXF), and penicillin (PEN), and to search for associations between specific pathogens and types of infection. Swabs from patients enrolled in a randomized, double-blind phase II trial comparing MXF with CLI for the treatment of odontogenic abscesses or inflammatory infiltrates were cultured on media for aerobes and anaerobes. All bacterial isolates were identified at the species level. Overall, 205 isolates were cultured from 71 patients: 77 viridans group streptococci, 56 Prevotella spp., 19 Neisseria spp., 17 Streptococcus anginosus group isolates and hemolytic streptococci, 15 other anaerobes, and 21 other bacteria. Ninety-eight percent of pathogens were susceptible to MXF, 96% to AMC, 85% to LVX, 67% to PEN, 60% to CLI, and 50% to DOX. S. anginosus group and hemolytic streptococci were found significantly more frequently (P = 0.04) in patients with abscesses (12/95) than in patients with infiltrates (5/110). In four patients with infiltrates who failed to respond to CLI therapy, three isolates of the Streptococcus mitis group and four Neisseria spp. resistant to CLI were found. In this study, S. anginosus group and hemolytic streptococci were clearly associated with odontogenic abscesses. Our analysis suggests that viridans group streptococci and Neisseria spp. play a decisive role in the etiology of odontogenic infiltrates. The high in vitro activity of MXF against odontogenic bacteria corresponds well to its clinical results in the treatment of odontogenic abscesses and infiltrates. PMID:22354306

  17. Dynamic wetting: status and prospective of single particle based experiments and simulations.

    PubMed

    Cappelli, S; Xie, Q; Harting, J; de Jong, A M; Prins, M W J

    2015-09-25

    The fundamental molecular and microscopic properties of materials leading to dynamic wetting and relaxation effects have been subject to numerous studies in the past decades, but a thorough understanding is still missing. While most previous experiments utilize fluids deposited on planar substrates, this article focuses on an attractive alternative based on single colloidal particles: colloidal particles have the ability to strongly interact with fluid-fluid interfaces and the behavior strongly depends on the surface properties of the particles and the fluids used. Recent progress in the manipulation and synthesis of colloidal particles with well-defined surface properties and shapes makes them ideal candidates to probe the fundamental surface properties leading to dynamic wetting effects. In this paper we review and discuss the status of experimental and numerical techniques to characterize the dynamic wetting of single particles at fluid-fluid interfaces, with the aim to assist scientists and engineers in the design of new experimental techniques and particle-based (bio)analytical tools.

  18. In-stent Anchoring Facilitating Side-branch Balloon Delivery for Final Kissing: A Prospective, Single-center Registry Study

    PubMed Central

    Zhou, Yu; Xiao, Han; Wang, Yu-Qing; Liu, Huan-Yun; Bao, Pang; Song, Yao-Ming; Azzalini, Lorenzo; Huang, Lan; Zhao, Xiao-Hui

    2016-01-01

    Background: Recrossing the compromised side branch (SB) with a balloon is sometimes technically challenging. The aim of this study was to evaluate whether in-stent anchoring (ISA) is safe and effective to facilitate SB balloon delivery for final kissing. Methods: One hundred and fifty-nine consecutive patients were included (166 bifurcation lesions) in this prospective, single-center registry. ISA was used as a bailout method after unsuccessful SB crossing using conventional techniques, including low-profile balloons. Technique success was defined as SB balloon delivery and final kissing. Results: Kissing-balloon delivery was successfully performed with conventional strategies in 149 of 166 lesions (89.8%). In the remaining 17 lesions (10.2%), recrossing of the main vessel stent strut was not successful; therefore, ISA was attempted. The balloon successfully crossed the stent struts, and final kissing was achieved in 15 of 17 lesions (88.2%). Total final kissing was achieved in 164 of 166 lesions (98.8%), with success rates of 100% in the single-stent group and 97.6% in the two-stent group. Two cases without balloon delivery had complex bifurcation lesions with severe calcification. There was no vessel dissection in the anchoring zone. Conclusions: ISA is safe and effective for recrossing stent struts when conventional low-profile balloons have failed. However, large-scale trials are warranted for further evaluation. PMID:27823997

  19. Non-Publication Is Common among Phase 1, Single-Center, Not Prospectively Registered, or Early Terminated Clinical Drug Trials

    PubMed Central

    Souverein, Patrick C.; Brekelmans, Cecile T. M.; Janssen, Susan W. J.; Koëter, Gerard H.; Leufkens, Hubert G. M.; Bouter, Lex M.

    2016-01-01

    The objective of this study was to investigate the occurrence and determinants of non-publication of clinical drug trials in the Netherlands.All clinical drug trials reviewed by the 28 Institutional Review Boards (IRBs) in the Netherlands in 2007 were followed-up from approval to publication. Candidate determinants were the sponsor, phase, applicant, centers, therapeutic effect expected, type of trial, approval status of the drug(s), drug type, participant category, oncology or other disease area, prospective registration, and early termination. The main outcome was publication as peer reviewed article. The percentage of trials that were published, crude and adjusted odds ratio (OR), and 95% confidence interval (CI) were used to quantify the associations between determinants and publication. In 2007, 622 clinical drug trials were reviewed by IRBs in the Netherlands. By the end of follow-up, 19 of these were rejected by the IRB, another 19 never started inclusion, and 10 were still running. Of the 574 trials remaining in the analysis, 334 (58%) were published as peer-reviewed article. The multivariable logistic regression model identified the following determinants with a robust, statistically significant association with publication: phase 2 (60% published; adjusted OR 2.6, 95% CI 1.1–5.9), phase 3 (73% published; adjusted OR 4.1, 95% CI 1.7–10.0), and trials not belonging to phase 1–4 (60% published; adjusted OR 3.2, 95% CI 1.5 to 6.5) compared to phase 1 trials (35% published); trials with a company or investigator as applicant (63% published) compared to trials with a Contract Research Organization (CRO) as applicant (50% published; adjusted OR 1.7; 95% CI 1.1–2.8); and multicenter trials also conducted in other EU countries (68% published; adjusted OR 2.2, 95% CI 1.1–4.4) or also outside the European Union (72% published; adjusted OR 2.0, 95% CI 1.0–4.0) compared to single-center trials (45% published). Trials that were not prospectively registered

  20. A comparison of the effect of ramipril, felodipine and placebo on glomerular filtration rate, albuminuria, blood pressure and vasoactive hormones in chronic glomerulonephritis. A randomized, prospective, double-blind, placebo-controlled study over two years.

    PubMed

    Pedersen, E B; Bech, J N; Nielsen, C B; Kornerup, H J; Hansen, H E; Spencer, E S; Sølling, J; Jensen, K T

    1997-12-01

    The effects of an ACE-inhibitor (ramipril), a calcium antagonist (felodipine) and placebo on glomerular filtration rate (GFR), urinary albumin/creatinine ratio, blood pressure (BP) and vasoactive hormones were investigated in a randomized, prospective, double-blind, placebo-controlled study of patients with chronic glomerulonephritis and hypertension, with measurements at entrance and after 12 and 24 months. In total, 33 patients were included: 21 completed the study with 7 patients in each group. GFR was measured as 51Cr-EDTA clearance and the vasoactive hormones with radioimmunoassays. The reduction in GFR was significantly more pronounced in the felodipine group (-7 ml/min) than in the ramipril group (0 ml/min) but the same as in the placebo group (-6 ml/min). The urinary albumin/creatinine ratio was significantly more reduced in the ramipril group (-74 mg/mmol) than in the placebo group (-11 mg/mmol), which did not deviate from the felodipine group (-10 mg/mmol). BP was significantly reduced by ramipril and felodipine, but not by placebo. Angiotensin II and aldosterone in plasma increased or tended to increase in the felodipine and placebo groups, but were unchanged in the ramipril group. Endothelin increased only in the placebo group, and vasopressin, atrial natriuretic peptide, and brain natriuretic peptide were not significantly changed in any of the groups. It is concluded that ramipril seems to be superior to felodipine in chronic glomerulonephritis owing to better preservation of GFR.

  1. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial.

    PubMed

    Pratzel, H G; Alken, R G; Ramm, S

    1996-10-01

    The efficacy and safety of oral tolperisone hydrochloride (Mydocalm) in the treatment of painful reflex muscle spasm was assessed in a prospective, randomized, double-blind, placebo-controlled trial. A total of 138 patients, aged between 20 and 75 years, with painful reflex muscle spasm associated with diseases of the spinal column or proximal joints were enrolled in eight rehabilitation centers. Patients were randomized to receive either 300 mg tolperisone hydrochloride or placebo for a period of 21 days. Both treatment groups recovered during the 3 weeks rehabilitation program. However, tolperisone hydrochloride proved to be significantly superior to placebo: the change score of the pressure pain threshold as the primary target parameter significantly increased during therapy with tolperisone hydrochloride (P = 0.03, valid-case-analysis) compared to the results obtained on placebo treatment. The overall assessment of efficacy by the patient also demonstrated significant differences in favor of tolperisone hydrochloride. Best results were seen in patients aged between 40 and 60 years with a history of complaints shorter than 1 year and with concomitant physical therapy. The evaluation of safety data, i.e., adverse events, biochemical and hematological laboratory parameters, demonstrated no differences between tolperisone hydrochloride and placebo. As a conclusion tolperisone hydrochloride represents an effective and safe treatment of painful reflex muscle spasm without the typical side effects of centrally active muscle relaxants.

  2. Acute Blindness.

    PubMed

    Meekins, Jessica M

    2015-09-01

    Sudden loss of vision is an ophthalmic emergency with numerous possible causes. Abnormalities may occur at any point within the complex vision pathway, from retina to optic nerve to the visual center in the occipital lobe. This article reviews specific prechiasm (retina and optic nerve) and cerebral cortical diseases that lead to acute blindness. Information regarding specific etiologies, pathophysiology, diagnosis, treatment, and prognosis for vision is discussed.

  3. Effectiveness of a calcium sodium phosphosilicate containing prophylaxis paste in reducing dentine hypersensitivity immediately and 4 weeks after a single application: a double-blind randomized controlled trial

    PubMed Central

    Neuhaus, Klaus W; Milleman, Jeffery L; Milleman, Kimberly R; Mongiello, Kimberly A; Simonton, Thomas C; Clark, Courtney E; Proskin, Howard M; Seemann, Rainer

    2013-01-01

    Aims The aim of this single-site, randomized, controlled, double-blind, 3-arm parallel study was to determine the effectiveness of a prophylaxis paste containing 15% calcium sodium phosphosilicate (CSPS; NovaMin®) with and without fluoride in reducing dentine hypersensitivity immediately after a single application and 28 days following dental scaling and root planing. Materials & Methods Overall, 151 subjects were enrolled in this study. All subjects received a scaling and root planing procedure followed by a final prophylaxis step using one of three different prophylaxis pastes: Test-A (15% NovaMin® and NaF), Test-B (15% NovaMin®) and a control. Dentine hypersensitivity was assessed by tactile stimulus (Yeaple Probe®) and by air blast (Schiff scale) at baseline, immediately after and 28 days after a prophylaxis procedure. One hundred and forty-nine subjects completed the study. Results Subjects having received the test prophylaxis pastes showed statistically lower (anova, p < 0.05) dentine hypersensitivity compared with the control group immediately after the prophylaxis procedure (Yeaple Probe®: Test-A = 20.9 ± 12.6, Test-B = 22.7 ± 12.9, Control=11.2 ± 3.1; Schiff score: Test-A = 1.1 ± 0.6, Test-B = 1.1 ± 0.6, Control = 2.0 ± 0.7) and after 28 days (Yeaple probe: Test-A = 21.5 ± 11.9, Test-B = 20.6 ± 11.3, Control = 11.8 ± 6.0; Schiff score: Test-A = 1.0 ± 0.6, Test-B = 1.0 ± 0.6, Control = 2.0 ± 0.7). Conclusions In conclusion, the single application of both fluoridated and non-fluoridated prophylaxis pastes containing 15% CSPS (NovaMin®) provided a significant reduction of dentine hypersensitivity up to at least 28 days. PMID:23414245

  4. Pancreaticoduodenectomy for pancreatic adenocarcinoma: postoperative adjuvant chemoradiation improves survival. A prospective, single-institution experience.

    PubMed Central

    Yeo, C J; Abrams, R A; Grochow, L B; Sohn, T A; Ord, S E; Hruban, R H; Zahurak, M L; Dooley, W C; Coleman, J; Sauter, P K; Pitt, H A; Lillemoe, K D; Cameron, J L

    1997-01-01

    OBJECTIVE: This study was designed to evaluate prospectively survival after pancreaticoduodenectomy for pancreatic adenocarcinoma, comparing two different postoperative adjuvant chemoradiation protocol to those of no adjuvant therapy. SUMMARY BACKGROUND DATA: Based on limited data from the Gastrointestinal Tumor Study Group, adjuvant chemoradiation therapy has been recommended after pancreaticoduodenectomy for adenocarcinoma of the head, neck, or uncinate process of the pancrease. However, many patients continue to receive no such therapy. METHODS: From October 1991 through September 1995, all patients with resected, pathologically confirmed adenocarcinoma of the head, neck, or uncinate process of the pancreas were reviewed by a multidisciplinary group (surgery, radiation oncology, medical oncology, and pathology) and were offered three options for postoperative treatment after pancreaticoduodenectomy: 1) standard therapy: external beam radiation therapy to the pancreatic bed (4000-4500 cGy) given with two 3-day fluorouracil (5-FU) courses and followed by weekly bolus 5-FU (500 mg/m2 per day) for 4 months; 2) intensive therapy: external beam radiation therapy to the pancreatic bed (5040-5760 cGy) with prophylactic hepatic irradiation (2340-2700 cGy) given with and followed by infusional 5-FU (200 mg/m2 per day) plus leucovorin (5 mg/m2 per day) for 5 of 7 days for 4 months; or 3) no therapy: no postoperative radiation therapy or chemotherapy. RESULTS: Pancreaticoduodenectomy was performed in 174 patients, with 1 in-hospital death (0.6%). Ninety-nine patients elected standard therapy, 21 elected intensive therapy, and 53 patients declined therapy. The three groups were comparable with respect to race, gender, intraoperative blood loss, tumor differentiation, lymph node status, tumor diameter, and resection margin status. Univariate analyses indicated that tumor diameter < 3 cm, intraoperative blood loss < 700 mL, absence of intraoperative blood transfusions, and use

  5. A Perceptual Repetition Blindness Effect

    NASA Technical Reports Server (NTRS)

    Hochhaus, Larry; Johnston, James C.; Null, Cynthia H. (Technical Monitor)

    1994-01-01

    Before concluding Repetition Blindness is a perceptual phenomenon, alternative explanations based on memory retrieval problems and report bias must be rejected. Memory problems were minimized by requiring a judgment about only a single briefly displayed field. Bias and sensitivity effects were empirically measured with an ROC-curve analysis method based on confidence ratings. Results from five experiments support the hypothesis that Repetition Blindness can be a perceptual phenomenon.

  6. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

    PubMed Central

    Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

    2012-01-01

    Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7 (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone. PMID:22778774

  7. Upper Digestive Bleeding in Atrial Fibrillation: Evaluation of Gastroscopy Prior to Oral Anticoagulant Therapy (GOAT), Prospective, Randomized, Double Blind Study on a Community Population

    PubMed Central

    Lagi, Alfonso; Spini, Simona; Meucci, Elisa; Cartei, Alessandro; Cencetti, Simone

    2011-01-01

    Background The aim of this study was to investigate the incidence of digestive hemorrhages in patients with non-valvular atrial fibrillation (NVAF), scheduled for oral anticoagulant therapy. Methods We conducted, over 24 months, a prospective, randomized, population-based observational study on consecutive patients with recurrent paroxysmal, persistent, or permanent NVAF, scheduled for oral anticoagulant therapy. The study initially included 268 patients with NVAF (162 males and 106 females) with a mean age of 74 years (range 42-86 years). Patients were split into two groups: those undergoing preventive Esophago-Gastro-Duodenoscopy (EGD) (Group A) and those who did not (Group B). All patients positive by EGD underwent medical treatment and subsequent 30-day endoscopic controls showed complete healing. The primary outcome of the study was to determine if previous EGD in patients with NVAF resulted in a low risk of bleeding during oral anticoagulant therapy. The two groups were comparable for most variables. Results Significant differences were found between groups for the incidence of antiarrhythmic drugs and for early hemorrhage (P <0.001). The incidences of early hemorrhages were significantly different between the two groups with 12 in group B (12%) and 2 in group A (1.7%). Conclusions Preventive EGD can identify hidden digestive diseases, which may increase the incidence of early hemorrhages.

  8. [The application of n-acetylcysteine as an antioxidant and mucolytic in mechanical ventilation in intensive care patients. A prospective, randomized, placebo-controlled, double-blind study].

    PubMed

    Konrad, F; Schoenberg, M H; Wiedmann, H; Kilian, J; Georgieff, M

    1995-09-01

    Oxygen radicals and oxygen radial mediators are thought to be important components in the development of acute lung injury, sepsis, and multiple organ failure. Injured patients, patients with pulmonary diseases, and multiple trauma patients also showed an elevated lipid peroxidation, indicating increased oxidant stress. N-Acetylcysteine (NAC) has been used as an antioxidant in a wide variety of experiments. NAC has been suggested to act by raising concentrations of cysteine, and hence glutathione, and by scavenging of oxidant species [1, 11, 17, 29]. The present study was designed to investigate whether the application of NAC in intubated patients has an effect on concentrations of reduced glutathione in plasma and bronchoalveolar lavage fluid (BAL) and on the lipid peroxidation products malondialdehyde and conjugated dienes. Because NAC has been widely used as a mucolytic drug for the treatment of lung diseases, the influence on tracheobronchial mucus was studied, too. METHODS. In a randomized, double-blind, placebo-controlled study, a total of 38 long-term ventilated patients of a surgical intensive care unit were investigated. Patients were treated for 5 days with either 3 g NAC/day or placebo. The plasma concentration of reduced glutathione, malondialdehyde, and conjugated dienes were measured on admission and on the 3rd and 5th days of treatment [8, 34, 48]. Additionally, the numbers of tracheobronchial suctionings were registered and chest radiographs were evaluated. A fibre-bronchoscopy was performed on admission and on the 3rd day of treatment. The amount and viscidity of tracheobronchial secretions were examined semiquantitatively, and glutathione levels were measured in the unconcentrated BAL. The study was approved by the ethics committee of the University of Ulm. RESULTS. The two groups were comparable with respect to age, sex, APACHE II score and diagnosis (Table 1). We found no significant differences in reduced glutathione levels in the plasma or in

  9. Congenitally Blind Counselor, Adventitiously Blind Client.

    ERIC Educational Resources Information Center

    Roberts, A. H.

    1994-01-01

    A counselor blind from birth describes personal difficulties in fully understanding the experience of clients who are adventitiously blind. Congenitally blind counselors are urged to recognize that adaptive methods cannot compensate for the panoramic view of the environment provided by vision and that recently blinded individuals need to deal with…

  10. Prospective Study of Single vs. Two Unit Umbilical Cord Blood Transplantation Following Reduced Intensity Conditioning in Adults with Hematologic Malignancies

    PubMed Central

    Kindwall-Keller, Tamila L.; Hegerfeldt, Yael; Meyerson, Howard J.; Margevicius, Seunghee; Fu, Pingfu; van Heeckeren, Willem; Lazarus, Hillard M.; Cooper, Brenda W.; Gerson, Stanton L.; Barr, Paul; Tse, William W.; Curtis, Christine; Fanning, Laura R.; Creger, Richard J.; Carlson-Barko, Joanne M.; Laughlin, Mary J.

    2011-01-01

    As the threshold nucleated cell dose for single unit umbilical cord blood (UCB) in adults has not to date been firmly established, we prospectively compared single vs. 2-unit UCB transplantation after reduced intensity conditioning (RIC) in adult patients with hematologic malignancies. Study design specified one UCB unit if the cryopreserved total nucleated cell (TNC) dose was ≥2.5×107/kg recipient weight, otherwise 2-units matched at minimum 4/6 HLA loci to the patient and 3/6 to each other were infused. Twenty-seven patients received 1 unit; 23 patients received 2 units. Median time to absolute neutrophil count (ANC) >500/μL was 24 days (95% CI 22–28 days), 25 days for 1-unit and 23 days for 2-units (p=0.99). At day 100, ANC >500/μL was 88.4% and 91.3% in the 1 and 2-unit groups (p=0.99), respectively. Three-year event free survival (EFS) was 28.6% and 39.1% in the 1 and 2-unit groups (p=0.71), respectively. Infusion of 2 units was associated with significantly lower relapse risk, 30.4% vs. 59.3% (p=0.045). Infused cell doses (TNC, CD3+, CD34+, CD56+CD3neg) did not impact engraftment, overall survival (OS), or EFS. Taken together, single unit UCB transplantation with threshold cell dose ≥2.5×107/kg recipient weight after RIC is a viable option for adults, although infusion of 2 units confers a lower relapse incidence. PMID:22002488

  11. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    PubMed Central

    Casajuana, Josep; Iglesias, Begoña; Fàbregas, Mireia; Fina, Francesc; Vallès, Joan-Antoni; Aragonès, Rosa; Benítez, Mència; Zabaleta, Edurne

    2008-01-01

    Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients) compared to subcutaneous administration in the control group (100 patients). Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio) at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%). Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov PMID:18507871

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

    PubMed Central

    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

  13. Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)

    PubMed Central

    2013-01-01

    Background Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers. Methods/design In this multi-centre, single-blind randomised controlled trial, 480 people with early-stage dementia, each with a carer, will be randomised to receive either treatment as usual or cognitive rehabilitation (10 therapy sessions over 3 months, followed by 4 maintenance sessions over 6 months). We will compare the effectiveness of cognitive rehabilitation with that of treatment as usual with regard to improving self-reported and carer-rated goal performance in areas identified as causing concern by people with early-stage dementia; improving quality of life, self-efficacy, mood and cognition of people with early-stage dementia; and reducing stress levels and ameliorating quality of life for carers of participants with early-stage dementia. The incremental cost-effectiveness of goal-oriented cognitive rehabilitation compared to treatment as usual will also be examined. Discussion If the study confirms the benefits and cost-effectiveness of cognitive rehabilitation, it will be important to examine how the goal-oriented cognitive rehabilitation approach can most effectively be integrated into routine health-care provision. Our aim is to provide training and develop materials to support the implementation of this approach following trial completion. Trial registration Current Controlled Trials ISRCTN21027481 PMID:23710796

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

    PubMed Central

    Johari, Sarika; Gandhi, Tejal

    2016-01-01

    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 diarrhea and

  15. The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial.

    PubMed

    Kimhy, David; Vakhrusheva, Julia; Bartels, Matthew N; Armstrong, Hilary F; Ballon, Jacob S; Khan, Samira; Chang, Rachel W; Hansen, Marie C; Ayanruoh, Lindsey; Lister, Amanda; Castrén, Eero; Smith, Edward E; Sloan, Richard P

    2015-07-01

    Individuals with schizophrenia display substantial neurocognitive deficits for which available treatments offer only limited benefits. Yet, findings from studies of animals, clinical and nonclinical populations have linked neurocognitive improvements to increases in aerobic fitness (AF) via aerobic exercise training (AE). Such improvements have been attributed to up-regulation of brain-derived neurotrophic factor (BDNF). However, the impact of AE on neurocognition, and the putative role of BDNF, have not been investigated in schizophrenia. Employing a proof-of-concept, single-blind, randomized clinical trial design, 33 individuals with schizophrenia were randomized to receive standard psychiatric treatment (n = 17; "treatment as usual"; TAU) or attend a 12-week AE program (n = 16) utilizing active-play video games (Xbox 360 Kinect) and traditional AE equipment. Participants completed assessments of AF (indexed by VO2 peak ml/kg/min), neurocognition (MATRICS Consensus Cognitive Battery), and serum-BDNF before and after and 12-week period. Twenty-six participants (79%) completed the study. At follow-up, the AE participants improved their AF by 18.0% vs a -0.5% decline in the TAU group (P = .002) and improved their neurocognition by 15.1% vs -2.0% decline in the TAU group (P = .031). Hierarchical multiple regression analyses indicated that enhancement in AF and increases in BDNF predicted 25.4% and 14.6% of the neurocognitive improvement variance, respectively. The results indicate AE is effective in enhancing neurocognitive functioning in people with schizophrenia and provide preliminary support for the impact of AE-related BDNF up-regulation on neurocognition in this population. Poor AF represents a modifiable risk factor for neurocognitive dysfunction in schizophrenia for which AE training offer a safe, nonstigmatizing, and side-effect-free intervention.

  16. The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial

    PubMed Central

    Kimhy, David; Vakhrusheva, Julia; Bartels, Matthew N.; Armstrong, Hilary F.; Ballon, Jacob S.; Khan, Samira; Chang, Rachel W.; Hansen, Marie C.; Ayanruoh, Lindsey; Lister, Amanda; Castrén, Eero; Smith, Edward E.; Sloan, Richard P.

    2015-01-01

    Individuals with schizophrenia display substantial neurocognitive deficits for which available treatments offer only limited benefits. Yet, findings from studies of animals, clinical and nonclinical populations have linked neurocognitive improvements to increases in aerobic fitness (AF) via aerobic exercise training (AE). Such improvements have been attributed to up-regulation of brain-derived neurotrophic factor (BDNF). However, the impact of AE on neurocognition, and the putative role of BDNF, have not been investigated in schizophrenia. Employing a proof-of-concept, single-blind, randomized clinical trial design, 33 individuals with schizophrenia were randomized to receive standard psychiatric treatment (n = 17; “treatment as usual”; TAU) or attend a 12-week AE program (n = 16) utilizing active-play video games (Xbox 360 Kinect) and traditional AE equipment. Participants completed assessments of AF (indexed by VO2 peak ml/kg/min), neurocognition (MATRICS Consensus Cognitive Battery), and serum-BDNF before and after and 12-week period. Twenty-six participants (79%) completed the study. At follow-up, the AE participants improved their AF by 18.0% vs a −0.5% decline in the TAU group (P = .002) and improved their neurocognition by 15.1% vs −2.0% decline in the TAU group (P = .031). Hierarchical multiple regression analyses indicated that enhancement in AF and increases in BDNF predicted 25.4% and 14.6% of the neurocognitive improvement variance, respectively. The results indicate AE is effective in enhancing neurocognitive functioning in people with schizophrenia and provide preliminary support for the impact of AE-related BDNF up-regulation on neurocognition in this population. Poor AF represents a modifiable risk factor for neurocognitive dysfunction in schizophrenia for which AE training offer a safe, nonstigmatizing, and side-effect-free intervention. PMID:25805886

  17. A Randomized, Single-Blind, Placebo-Controlled Study on the Efficacy of the Arthrokinematic Approach-Hakata Method in Patients with Chronic Nonspecific Low Back Pain

    PubMed Central

    Kogure, Akira; Kotani, Kazuhiko; Katada, Shigehiko; Takagi, Hiroshi; Kamikozuru, Masahiro; Isaji, Takashi; Hakata, Setsuo

    2015-01-01

    Study design cized, single-blind, controlled trial. Objective To investigate the efficacy of the Arthrokinematic approach (AKA)-Hakata (H) method for chronic low back pain. Summary of Background Data The AKA-H method is used to manually treat abnormalities of intra-articular movement. Methods One hundred eighty-six patients with chronic nonspecific low back pain randomly received either the AKA-H method (AKA-H group) or the sham technique (S group) monthly for 6 months. Data were collected at baseline and once a month. Outcome measures were pain intensity (visual analogue scale [VAS]) and quality of life (the Roland-Morris Disability Questionnaire [RDQ] and Short Form SF-36 questionnaire [SF-36]). Results At baseline, the VAS, RDQ, and SF-36 scores showed similar levels between the groups. After 6 months, the AKA-H group had more improvement in the VAS (42.8% improvement) and RDQ score (31.1% improvement) than the sham group (VAS: 10.4% improvement; RDQ: 9.8% improvement; both, P < 0.001). The respective scores for the SF-36 subscales (physical functioning, role physical, bodily pain, social functioning, general health perception, role emotional, and mental health) were also significantly more improved in the AKA-H group than in the sham group (all, P < 0.001). The scores for the physical, psychological, and social aspects of the SF-36 subscales showed similar improvement in the AKA-H group. Conclusion The AKA-H method can be effective in managing chronic low back pain. Trial Registration UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006250. PMID:26646534

  18. Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water on Sleep: A Randomized Single-Blinded Crossover Pilot Study

    PubMed Central

    Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

    2016-01-01

    Abstract Objectives: Ayurvedic oil-dripping treatment (Shirodhara) is often used for treating sleep problems. However, few properly designed studies have been conducted, and the quantitative effect of Shirodhara is unclear. This study sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS) against warm water Shirodhara (WWS) on improving sleep quality and quality of life (QOL) among persons reporting sleep problems. Methods: This randomized, single-blinded, crossover study recruited 20 participants. Each participant received seven 30-minute sessions within 2 weeks with either liquid. The washout period was at least 2 months. The Shirodhara procedure was conducted by a robotic oil-drip system. The outcomes were assessed by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective sleep measures. Changes between baseline and follow-up periods were compared between the two types of Shirodhara. Analysis was performed with generalized estimating equations. Results: Of 20 participants, 15 completed the study. SOS improved sleep quality, as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval [CI], −3.37 to −0.30) at 2-week follow-up and 1.73 points lower (95% CI, −3.84 to 0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week follow-up compared with WWS. After SOS, no beneficial effects were observed on daytime sleepiness or objective sleep measures. Conclusions: This pilot study demonstrated that SOS may be a safe potential treatment to improve sleep quality and QOL in persons with sleep problems. PMID:26669255

  19. Safety and Immunogenicity of a Candidate Bioconjugate Vaccine against Shigella flexneri 2a Administered to Healthy Adults: a Single-Blind, Randomized Phase I Study

    PubMed Central

    Kaminski, Robert W.; Di Paolo, Claudio; Porter, Chad K.; Gutierrez, Ramiro L.; Clarkson, Kristen A.; Weerts, Hailey E.; Duplessis, Christopher; Castellano, Amy; Alaimo, Cristina; Paolino, Kristopher; Gormley, Robert

    2016-01-01

    Several candidate vaccines against Shigella spp. are in development, but the lack of a clear correlate of protection from challenge with the induction of adequate immune responses among the youngest age groups in the developing world has hampered Shigella vaccine development over the past several decades. Bioconjugation technology, exploited here for an Shigella flexneri 2a candidate vaccine, offers a novel and potentially cost-effective way to develop and produce vaccines against a major pathogen of global health importance. Flexyn2a, a novel S. flexneri 2a bioconjugate vaccine made of the polysaccharide component of the S. flexneri 2a O-antigen, conjugated to the exotoxin protein A of Pseudomonas aeruginosa (EPA), was evaluated for safety and immunogenicity among healthy adults in a single-blind, phase I study with a staggered randomization approach. Thirty subjects (12 receiving 10 μg Flexyn2a, 12 receiving Flexyn2a with aluminum adjuvant, and 6 receiving placebo) were administered two injections 4 weeks apart and were followed for 168 days. Flexyn2a was well-tolerated, independently of the adjuvant and number of injections. The Flexyn2a vaccine elicited statistically significant S. flexneri 2a lipopolysaccharide (LPS)-specific humoral responses at all time points postimmunization in all groups that received the vaccine. Elicited serum antibodies were functional, as evidenced by bactericidal activity against S. flexneri 2a. The bioconjugate candidate vaccine Flexyn2a has a satisfactory safety profile and elicited a robust humoral response to S. flexneri 2a LPS with or without inclusion of an adjuvant. Moreover, the bioconjugate also induced functional antibodies, showing the technology's features in producing a promising candidate vaccine. (This study has been registered at ClinicalTrials.gov under registration no. NCT02388009.) PMID:27581434

  20. The influence of established and new antiepileptic drugs on visual perception. 1. A placebo-controlled, double-blind, single-dose study in healthy volunteers.

    PubMed

    Steinhoff, B J; Freudenthaler, N; Paulus, W

    1997-12-01

    The influence of single oral dosages of carbamazepine (CBZ), valproic acid, vigabatrin (VGB), lamotrigine (LTG), gabapentin (GBP), and losigamone (LSG) on visual perception was investigated in ten healthy volunteers according to a double-blind, placebo-controlled, cross-over study design. The test battery comprised visual acuity, the Lanthony-D-15-désaturé colour perception test, increment, postadaptation and transient tritanopia threshold measurements, perception threshold assessment for monochromatic and chromatic gaussian dots, monochromatic gratings and gratings of differing spatial frequency, and critical flicker fusion tests with various stimuli. The only consistent and partly significant effects were seen after VGB and GBP. After VGB, increment, postadaptation and transient tritanopia thresholds and the critical flicker fusion increased, whereas GBP led to a somewhat converse profile. The other tests were not influenced consistently by any antiepileptic drug (AED). We conclude that: (i) gamma-amino-butyric acid-(GABA)-related properties as under the prototype drug VGB result in specific alterations of the transient tritanopia phenomenon which is consistent with the physiological hypothesis for this retinal paradigm based on extracellular recordings in primates. The possible mechanisms why VGB improved critical flicker fusion as the only AED in this trial are discussed. The profile of GBP indicates a unique mechanism of action. We have not observed specific influences on visual perception under AEDs which act mainly via alterations of ion membrane conductance. The transient tritanopia and flicker fusion paradigms we used appear to be promising to investigate antiepileptic drugs with hitherto unknown modes of actions in human noninvasively.

  1. Clinical evaluation of efficacy of Majoon Ushba and Roghane Hindi in the management of psoriasis: A randomized single-blind, placebo-controlled study.

    PubMed

    Lone, Azad Hussain; Ahmad, Tanzeel; Naiyar, A H

    2011-01-01

    Psoriasis is a common dermatological disease affecting up to 1-2% of the world's population. It is associated with both organic and psychosocial complications like psoriatic arthropathy, nephritis, infection, hyperuricemia, hypoproteinemia, depression, and stress, and is responsible for hindering patients' daily activities. The present study was conducted to assess the safety and efficacy of two pharmacopeial Unani formulations (Majoon Ushba and Roghane Hindi) in the management of psoriasis on scientific parameters. Thirty diagnosed psoriasis patients, satisfying the inclusion criteria, were selected for a randomized, single-blind, placebo-controlled study in the Department of Moalajat (Medicine), National Institute of Unani Medicine, Bangalore. The patients were divided by the method of Random Table Numbers into test and control groups after obtaining informed consent. The experimental group comprised 20 patients to whom Majoon Ushba 5 g was administered orally twice daily and Roghane Hindi was applied locally twice daily. The control group comprised 10 patients who were given placebo drugs orally and topically. The duration of the trial was 8 weeks and follow-up was done fortnightly. The severity of psoriasis and efficacy of the drug was assessed by the Psoriasis Area and Severity Index (PASI) Scale. The results of both groups were compared and analyzed statistically. The study showed significant reduction in the PASI score in the test group (P < 0.01) as compared to placebo. No obnoxious side effects were observed in the test group: toxicological parameters were within normal limits even after 2 months of treatment. It was therefore concluded that Majoon Ushba and Roghane Hindi are safe and effective in the management of psoriasis.

  2. Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors in Healthy Subjects: A Randomized, Controlled, Single-Blind Crossover Trial

    PubMed Central

    Sanders, Grant D.; Nitz, Arthur J.; Abel, Mark G.; Symons, T. Brock; Shapiro, Robert; Black, W. Scott; Yates, James W.

    2015-01-01

    Objective The purpose of this study was to investigate the effect of manual manipulations targeting the lumbar spine and/or sacroiliac joint on concentric knee extension and flexion forces. Torque production was measured during isometric and isokinetic contractions. Methods This was a randomized, controlled, single-blind crossover design with 21 asymptomatic, college-aged subjects who had never received spinal manipulation. During 2 separate sessions, subjects’ peak torques were recorded while performing maximal voluntary contractions on an isokinetic dynamometer. Isometric knee extension and flexion were recorded at 60° of knee flexion, in addition to isokinetic measurements obtained at 60°/s and 180°/s. Baseline measurements were acquired before either treatment form of lumbosacral manipulation or sham manipulation, followed by identical peak torque measurements within 5 and 20 minutes posttreatment. Data were analyzed with a repeated measures analysis of variance. Results A statistically significant difference did not occur between the effects of lumbosacral manipulation or the sham manipulation in the percentage changes of knee extension and flexion peak torques at 5 and 20 minutes posttreatment. Similar, nonsignificant results were observed in the overall percentage changes of isometric contractions (spinal manipulation 4.0 ± 9.5 vs sham 1.2 ± 6.3, P = .067), isokinetic contractions at 60°/s (spinal manipulation − 4.0 ± 14.2 vs sham − 0.3 ± 8.2, P = .34), and isokinetic contractions at 180°/s (spinal manipulation − 1.4 ± 13.9 vs sham − 5.5 ± 20.0, P = .18). Conclusion The results of the current study suggest that spinal manipulation does not yield an immediate strength-enhancing effect about the knee in healthy, college-aged subjects when measured with isokinetic dynamometry. PMID:26793035

  3. Effect of a single brushing with two Zn-containing toothpastes on VSC in morning breath: a 12 h, randomized, double-blind, cross-over clinical study.

    PubMed

    Young, A; Jonski, G

    2011-12-01

    This randomized, double-blind, 12 h clinical study tested the effect of a single brushing with two Zn-containing toothpastes on volatile sulfur compound (VSC) levels in morning breath. The following toothpastes were each tested by all 28 participants: A-Zn toothpaste, B--experimental toothpaste (Zn citrate + PVM/MA copolymer) and C--control toothpaste without Zn. The evening prior to test days participants brushed their teeth for 2 min with 1 g toothpaste. 12 h later and prior to eating or performing oral hygiene, morning breath levels of VSC (H(2)S, CH(3)SH) were analysed by gas chromatography. Subjects then rinsed for 30 s with 5 ml cysteine and breath samples were analysed for H(2)S (H(2)S(cys)). Median VSC (area under the curve) values were compared for A, B and C and the effects of A and B on VSC were compared with C. Toothpaste B was more effective than both toothpastes A and C in reducing H(2)S, CH(3)SH and H(2)S(cys) (p < 0.05). Compared with toothpaste C, toothpastes A and B reduced H(2)S by 35% and 68%, respectively (p = 0.003), and CH(3)SH by 12% and 47%, respectively (p = 0.002). Toothpaste B reduced H(2)S(cys) by 48% compared with toothpaste C (p = 0.001). It is suggested that the superior effect of the experimental toothpaste was most likely due to a higher Zn concentration combined with longer retention of Zn due to the PVM/MA copolymer.

  4. Effect of family members’ voice on level of consciousness of comatose patients admitted to the intensive care unit: A single-blind randomized controlled trial

    PubMed Central

    Tavangar, Hossein; Shahriary-Kalantary, Manijeh; Salimi, Tahereh; Jarahzadeh, Mohammadhossein; Sarebanhassanabadi, Mohammadtaghi

    2015-01-01

    Background: Coma is one of the most important complications of brain injury. Comatose patients in the intensive care units are exposed to sensory deprivation. This study aims to survey the effect of family members’ voice on level of consciousness of comatose patients hospitalized in the intensive care units. Materials and Methods: In this single-blind randomized controlled trial, 40 comatose patients with brain injury with acute subdural hematoma in intensive care units were randomly assigned into two groups. The intervention group was stimulated twice a day each time 5-15 min with a recorded MP3 from family members’ voice for 10 days. The patients’ level of consciousness was measured with Glasgow Coma Scale before and after auditory stimulations. In the control group, GCS was measured without auditory stimulation with the same time duration like intervention group. Data analysis in software SPSS version 15 and using Chi-square test, independent t-test, paired t- test and analysis of variance with repeated measures was done. Results: On the first day before the intervention, there was no a statistically significant difference between the mean of GCS in both groups (P = 0.89), but on the tenth day after the intervention, there was a significant difference (P = 0.0001) between the mean GCS in both control and intervention groups. Also, there was a significant difference between the mean daily GCS scores in two groups (P = 0.003). The findings during ten days showed the changes in the level of consciousness in the intervention group from the 4rd day of the study were more in the mean daily GCS scores than control group. Conclusion: This study indicated that family members’ voice can increase level of consciousness of comatose patients with acute subdural hematoma. PMID:26261808

  5. Do the blinds smell better?

    PubMed

    Luers, Jan Christoffer; Mikolajczak, Stefanie; Hahn, Moritz; Wittekindt, Claus; Beutner, Dirk; Hüttenbrink, Karl-Bernd; Damm, Michael

    2014-07-01

    If people lose a sense organ, there is thought to be an increase in the remaining sensory functions. Previous studies showed ambiguous results on this topic. In a prospective matched pair case-control study on 46 blind and 46 normal-sighted subjects, the olfactory performance was examined using the Sniffin' Sticks Test [threshold-discrimination-identification (TDI) test], determining the olfactory threshold, the identification and the discrimination performance. There was no significant difference between the groups. Neither the overall olfactory performance (TDI score) nor any of its subtests did correlate with the vision or with the duration of blindness. The study could not detect any superior smell abilities of blind subjects as compared to sighted subjects.

  6. The effect of ketorolac and dexamethasone on the incidence of sore throat in women after thyroidectomy: a prospective double-blinded randomized trial

    PubMed Central

    2017-01-01

    Background We evaluated the effect of two drugs with anti-inflammatory action, dexamethasone and ketorolac, on reduction of postoperative sore throat (POST) after general anesthesia with endotracheal intubation in patients undergoing thyroidectomy. Methods One hundred and ninety-two female patients scheduled to undergo general anesthesia with endotracheal intubation for thyroidectomy were enrolled in this prospective study. Participants were randomly allocated to receive intravenous medication; placebo (Group C, n = 45), ketorolac 30 mg immediately before intubation (Group Kpre, n = 47), ketorolac 30 mg at the end of surgery (Group Kpost, n = 45) and dexamethasone 10 mg (Group D, n = 43). The incidence and severity of POST and hoarseness were evaluated at 1, 6 and 24 hours after surgery. Results Incidences and severities of POST at rest and during swallowing in first 6 hours after extubation were comparable among 4 groups. At 24 hours postextubation, the incidence (P = 0.002, 95% CI of proportion differences; 0.05–0.39) and severity (P = 0.008) of POST during swallowing were significantly lower in group D than in group C. Kpre and Kpost groups did not show a greater reduction in POST than group C, despite lower rescue analgesic requirement at 1 hour after extubation in group Kpre (P = 0.006; 95% CI of proportion differences; 0.07–0.38). No intergroup differences were observed in incidences of hoarseness or adverse events. Conclusions Intravenous administration of dexamethasone 10 mg, but not ketorolac, before induction of anesthesia reduces the incidence and severity of POST during swallowing at 24 hours after thyroidectomy. PMID:28184269

  7. Awareness and apgar score in elective Cesarean section under general anesthesia with propofol or Isoflurane: A prospective, randomized, double-blinded clinical trial study

    PubMed Central

    Khanjani, Somayeh; Naghibi, Khosrou; Azarnoush, Hamed

    2014-01-01

    Background: Awareness is a postoperative recall of events experienced under general anesthesia. In this study, we compared the incidence of awareness between two routine methods used, inhalation (Isoflurane) and intravenous protocol (Propofol), in elective Cesarean section, and also evaluated the effect of these two different methods on the apgar score of newborns. Materials and Methods: In this prospective, clinical trial study, 90 pregnant women candidates for elective Cesarean section were randomly enrolled, after taking written consent. Induction of anesthesia in both groups was provided by propofol and succinylcholine in the same manner, and maintenance of anesthesia in Group 1 was provided by propofol 100 μg/kg/minute and in Group 2 with isoflurane 1 MAC, to maintain the bispectral index (BIS) between 45 and 60. Blood pressure, heart rate, electrocardiography (ECG), and also Etco2 and o2sat were recorded throughout the surgery and finally analyzed and compared. Results: From 90 patients, four cases of confirmed awareness were found in the propofol group and three cases in the Isoflurane group (8/9% vs. 6/7%), but the apgar scores were comparable between the two groups. Meanwhile there were no significant differences between the two groups in basic information, neonatal apgar scores, hemodynamic changes, and BIS, Electromyography (EMG), and signal quality index (SQI) values. Conclusion: According to the patient's state, diagnosis of the anesthesiologist, and other criteria like price and its availability, we could use these drugs in general anesthesia during Cesarean section, although it is recommended that more studies be done to compare the effect of these two drugs in larger groups. PMID:25538920

  8. Prospecting for pig single nucleotide polymorphisms in the human genome: have we struck gold?

    PubMed

    Grapes, L; Rudd, S; Fernando, R L; Megy, K; Rocha, D; Rothschild, M F

    2006-06-01

    Gene-to-gene variation in the frequency of single nucleotide polymorphisms (SNPs) has been observed in humans, mice, rats, primates and pigs, but a relationship across species in this variation has not been described. Here, the frequency of porcine coding SNPs (cSNPs) identified by in silico methods, and the frequency of murine cSNPs, were compared with the frequency of human cSNPs across homologous genes. From 150,000 porcine expressed sequence tag (EST) sequences, a total of 452 SNP-containing sequence clusters were found, totalling 1394 putative SNPs. All the clustered porcine EST annotations and SNP data have been made publicly available at http://sputnik.btk.fi/project?name=swine. Human and murine cSNPs were identified from dbSNP and were characterized as either validated or total number of cSNPs (validated plus non-validated) for comparison purposes. The correlation between in silico pig cSNP and validated human cSNP densities was found to be 0.77 (p < 0.00001) for a set of 25 homologous genes, while a correlation of 0.48 (p < 0.0005) was found for a primarily random sample of 50 homologous human and mouse genes. This is the first evidence of conserved gene-to-gene variability in cSNP frequency across species and indicates that site-directed screening of porcine genes that are homologous to cSNP-rich human genes may rapidly advance cSNP discovery in pigs.

  9. A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin in Transient Insomnia Induced by Sleep Phase Advance

    PubMed Central

    Rosenberg, Russell P.; Hull, Steven G.; Lankford, D. Alan; Mayleben, David W.; Seiden, David J.; Furey, Sandy A.; Jayawardena, Shyamalie; Roth, Thomas

    2014-01-01

    Study Objectives: To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic (PSG) and participant-reported sleep measures in a 5-h phase advance insomnia model. Methods: Adults reporting occasional disturbed sleep received gabapentin 500 mg (n = 125), 250 mg (n = 125), or placebo (n = 127) 30 min prior to bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, post-sleep questionnaire, and the Karolinska Sleep Diary (KSD). Next-day residual effects (Digit Symbol Substitution Test [DSST] and Stanford Sleepiness Scale [SSS]) and tolerability were assessed. Results: Demographics were comparable among groups. Among PSG endpoints, wake after sleep onset (primary endpoint) (135.7 [placebo], 100.7 [250 mg], and 73.2 [500 mg] min) was significantly lower and total sleep time (TST) (311.4, 356.5, and 378.7 min) significantly greater in both gabapentin groups versus placebo. Latency to persistent sleep was not significantly different among groups. Percent slow wave sleep (12.6%, 15.4%, and 17.0%, respectively) was significantly greater and percent stage 1 (15.1%, 11.8%, and 10.8%, respectively) significantly lower relative to placebo. Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant. Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS. Adverse events were infrequent (< 5%). Conclusion: Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth (versus placebo) in response to a phase advance manipulation known to disrupt sleep maintenance. Citation: Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient

  10. Early onset anxiolytic efficacy after a single dose of pregabalin: double-blind, placebo- and active-comparator controlled evaluation using a dental anxiety model.

    PubMed

    Nutt, D; Mandel, F; Baldinetti, F

    2009-11-01

    To evaluate acute onset of anxiolytic activity using a dental anxiety model, 89 patients were randomised to double-blind single dose pregabalin 150 mg, alprazolam 0.5 mg or placebo 4 h before a scheduled dental procedure. A Dental Anxiety Total score >12 (moderate-to-severe) without meeting Diagnostic and Statistical Manual of Mental Disorders (Fourth edition) (DSM-IV) anxiety disorder criteria was required. Efficacy and safety, assessed 2, 2.5, 3, 3.5 and 4 h postdose, included 100 mm Visual Analogue Scale for Anxiety (VAS-Anxiety; primary outcome), 100 mm VAS-Sedation and Time-to-Onset of Action Scale (TOAS), a patient-rated anti-anxiety drug-benefit scale (no [0] to full benefit [10]). Mixed model analysis found significantly greater VAS-A improvement slopes for pregabalin (t = -2.47; P = 0.014) and alprazolam (t = -2.39; P = 0.018). There was a significant improvement versus placebo in the TOAS from 2 h through endpoint in alprazolam patients and from 3 h onward in pregabalin patients. Pregabalin produced significantly greater increases in VAS-Sedation versus placebo from 2.5 h through 4 h (2 h onward for alprazolam). Notably, there was a higher correlation between TOAS and VAS-Sedation (r = +0.58) than VAS-Anxiety (r = -0.50) on Spearman's analysis. The majority of Adverse Effects (AEs) were mild, and the most frequent for pregabalin, alprazolam, and placebo, respectively, were fatigue (N = 7, 7, 3), dizziness (N = 6, 3, 3), attention disturbance (N = 3, 1, 0), somnolence (N = 3, 0, 0), feeling abnormal (N = 0, 2, 0) and balance disorder (N = 0, 2, 0). These results suggest that onset of clinically meaningful anxiolytic effect after single-dose pregabalin occurs within the first 3-4 h. Additional research is needed to determine whether anxiolytic effect occurs in generalized anxiety disorder populations by day 1 or within 3-4 h post-first dose.

  11. Monitoring Cortical Excitability during Repetitive Transcranial Magnetic Stimulation in Children with ADHD: A Single-Blind, Sham-Controlled TMS-EEG Study

    PubMed Central

    Helfrich, Christian; Pierau, Simone S.; Freitag, Christine M.; Roeper, Jochen; Ziemann, Ulf; Bender, Stephan

    2012-01-01

    Background Repetitive transcranial magnetic stimulation (rTMS) allows non-invasive stimulation of the human brain. However, no suitable marker has yet been established to monitor the immediate rTMS effects on cortical areas in children. Objective TMS-evoked EEG potentials (TEPs) could present a well-suited marker for real-time monitoring. Monitoring is particularly important in children where only few data about rTMS effects and safety are currently available. Methods In a single-blind sham-controlled study, twenty-five school-aged children with ADHD received subthreshold 1 Hz-rTMS to the primary motor cortex. The TMS-evoked N100 was measured by 64-channel-EEG pre, during and post rTMS, and compared to sham stimulation as an intraindividual control condition. Results TMS-evoked N100 amplitude decreased during 1 Hz-rTMS and, at the group level, reached a stable plateau after approximately 500 pulses. N100 amplitude to supra-threshold single pulses post rTMS confirmed the amplitude reduction in comparison to the pre-rTMS level while sham stimulation had no influence. EEG source analysis indicated that the TMS-evoked N100 change reflected rTMS effects in the stimulated motor cortex. Amplitude changes in TMS-evoked N100 and MEPs (pre versus post 1 Hz-rTMS) correlated significantly, but this correlation was also found for pre versus post sham stimulation. Conclusion The TMS-evoked N100 represents a promising candidate marker to monitor rTMS effects on cortical excitability in children with ADHD. TMS-evoked N100 can be employed to monitor real-time effects of TMS for subthreshold intensities. Though TMS-evoked N100 was a more sensitive parameter for rTMS-specific changes than MEPs in our sample, further studies are necessary to demonstrate whether clinical rTMS effects can be predicted from rTMS-induced changes in TMS-evoked N100 amplitude and to clarify the relationship between rTMS-induced changes in TMS-evoked N100 and MEP amplitudes. The TMS-evoked N100 amplitude

  12. Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix with co-trimoxazole in patients with acute and uncomplicated cystitis

    PubMed Central

    Stange, Rainer; Schneider, Berthold; Albrecht, Uwe; Mueller, Valentina; Schnitker, Joerg; Michalsen, Andreas

    2017-01-01

    Objectives To demonstrate non-inferiority of an herbal combination (horseradish root and nasturtium herb) to an antibiotic (co-trimoxazole) in acute uncomplicated cystitis. Design Randomized, prospective, double-blind, double-dummy, multicenter, phase III clinical study, using block randomization of 4 blocks (size 2). Setting Twenty-six centers in Germany, from May 2011 to June 2013. Participants Adult patients (median age, 38.5 years; 90% female) with acute uncomplicated cystitis confirmed via urinalysis and bacterial counts. Interventions Patients received the herbal combination (five tablets, four times per day) or the antibiotic (two tablets daily) for a period of 7 or 3 days, respectively, followed by a 21-days without drug treatment. Placebos ensured blinding. Primary and secondary outcome measures The primary endpoint was the percentage of responders, expressed as reduction of germ count from >105 to <103 CFU/mL of pathogens between visit 1 (day 0) and 3 (day 15). Secondary endpoints included change of symptom scores, duration of symptoms, efficacy assessments, relapse frequency, and safety. A sample size of 178 patients per group was estimated. Results Of the 96 randomized patients (intent-to-treat; 45 in the phytotherapy group, 51 in the antibiotic group), 51 were considered per-protocol patients (22 in the phytotherapy group, 29 in the antibiotic group). Responder rates were 10/22 (45.5%) for the phytotherapy group and 15/29 (51.1%) for the antibiotic group (group difference: −6.27% [95% CI: −33.90%–21.3%]). The study was terminated prematurely due to slow recruitment rates. Non-inferiority could not be assumed by predefined criteria. During the follow-up period, one relapse occurred in each group. Both treatments were well tolerated. Conclusion This clinical trial indicates comparable efficacy of the herbal combination and antibiotic, although non-inferiority was not proved. However, the results and lessons learned are important for the planning of

  13. A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

    PubMed Central

    Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

    2014-01-01

    Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

  14. Incoherently pumped high-power linearly-polarized single-mode random fiber laser: experimental investigations and theoretical prospects

    NASA Astrophysics Data System (ADS)

    Xu, Jiangming; Lou, Zhaokai; Ye, Jun; Wu, Jian; Leng, Jinyong; Xiao, Hu; Zhang, Hanwei; Zhou, Pu

    2017-03-01

    We present a hundred-watt-level linearly-polarized random fiber laser (RFL) pumped by incoherent broadband amplified spontaneous emission (ASE) source and prospect the power scaling potential theoretically. The RFL employs half-opened cavity structure which is composed by a section of 330 m polarization maintained (PM) passive fiber and two PM high reflectivity fiber Bragg gratings. The 2nd order Stokes light centered at 1178 nm reaches the pump limited maximal power of 100.7 W with a full width at half-maximum linewidth of 2.58 nm and polarization extinction ratio of 23.5 dB. The corresponding ultimate quantum efficiency of pump to 2nd order Stokes light is 89.01%. To the best of our knowledge, this is the first demonstration of linearly-polarized high-order RFL with hundred-watt output power. Furthermore, the theoretical investigation indicates that 300 W-level linearly-polarized single-mode 1st order Stokes light can be obtained from incoherently pumped RFL with 100 m PM passive fiber.

  15. Candida infections in paediatrics: Results from a prospective single-centre study in a tertiary care children's hospital.

    PubMed

    Mesini, Alessio; Bandettini, Roberto; Caviglia, Ilaria; Fioredda, Francesca; Amoroso, Loredana; Faraci, Maura; Mattioli, Girolamo; Piaggio, Giorgio; Risso, Francesco M; Moscatelli, Andrea; Loy, Anna; Castagnola, Elio

    2017-02-01

    To describe the epidemiology of invasive Candida infection in a tertiary care paediatric hospital. Prospective single-centre survey on all Candida strains isolated from normally sterile fluids and urines in the period 2005-2015 . A total of 299 ICI were documented in 262 patients. Urinary tract infection represented the most frequent diagnosis (62%), followed by fungaemia (34%) and peritonitis (4%). Fungaemia was most frequent in children with cancer (59%) or in low birth weight neonates (61%), while urinary tract infections were more frequent in patients with urinary tract malformation. C.albicans was the most frequently isolated species (60%) compared with C. non-albicans, but differences were present according to the site of isolation and underlying conditions. Overall 90-day mortality was 7%, 13% in fungaemias, 8% in peritonitis and 2% in urinary tract infections. The rates of invasive Candida infection increased during the study period. Invasive Candida infection is diagnosed with increasing frequency in children. Site of isolation and aetiology are frequently related with the presence of underlying, favouring conditions. Mortality was not negligible, especially in the presence of more invasive infections and specific underlying conditions.

  16. A randomized, prospective, parallel group study of laparoscopic versus laparoendoscopic single site donor nephrectomy for kidney donation.

    PubMed

    Aull, M J; Afaneh, C; Charlton, M; Serur, D; Douglas, M; Christos, P J; Kapur, S; Del Pizzo, J J

    2014-07-01

    Few prospective, randomized studies have assessed the benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN versus LDN from surgery through 5 years postdonation. Subjects complete recovery/satisfaction questionnaires at 2, 6 and 12 months postdonation; transplant recipient outcomes are also recorded. One hundred subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living-unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) versus 2 LDN (3.9%; p = 0.67). Questionnaires revealed that 97.2% of LESS-DN versus 79.5% of LDN (p = 0.03) were 100% recovered by 2 months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation.

  17. Estimating the weight of ethnically diverse children attending an Australian emergency department: a prospective, blinded, comparison of age-based and length-based tools including Mercy, PAWPER and Broselow

    PubMed Central

    John-Denny, Blessy; McGarvey, Kathryn; Hann, Alexandra; Pegiazoglou, Ioannis; Peat, Jennifer

    2017-01-01

    Objective To prospectively compare the actual weights of Australian children in an ethnically diverse metropolitan setting with the predicted weights using the Paediatric Advanced Weight Prediction in the Emergency Room (PAWPER) tape, Broselow tape, Mercy system and calculated weights using the updated Advanced Paediatric Life Support (APLS), Luscombe and Owens and Best Guess formulae. Methods A prospective, cross-sectional, observational, blinded, convenience study conducted at the Children's Hospital at Westmead Paediatric Emergency Department in Sydney, Australia. Comparisons were made using Bland-Altman plots, mean difference, limits of agreement and estimated weight within 10% and 20% of actual weight. Results 199 patients were enrolled in the study with a mean actual weight of 27.2 kg (SD 17.2). Length-based tools, with or without body habitus adjustment, performed better than age-based formulae. When measuring estimated weight within 10% of actual weight, PAWPER performed best with 73%, followed by Mercy (69%), PAWPER with no adjustment (62%), Broselow (60%), Best Guess (47%), Luscombe and Owens (41%) and revised APLS (40%). Mean difference was similar across all methods ranging from 0.4 kg (0.0, 0.9) for Mercy to −2.2 kg (−3.5, −0.9) for revised APLS. Limits of agreement were narrower for the length-based tools (−5.9, 6.8 Mercy; −8.3, 5.6 Broselow; −9.0, 7.1 PAWPER adjusted; −12.1, 9.2 PAWPER unadjusted) than the age-based formulae (−18.6, 17.4 Best Guess; −19.4, 15.1 revised APLS, −21.8, 17.7 Luscombe and Owens). Conclusion In an ethnically diverse population, length-based methods with or without body habitus modification are superior to age-based methods for predicting actual body weight. Body habitus modifications increase the accuracy and precision slightly. PMID:27799153

  18. Solar-blind ultraviolet photodetector based on (LaAlO3)0.3-(SrAl0.5Ta0.5O3)0.7 single crystal

    NASA Astrophysics Data System (ADS)

    Du, Jian-yu; Ge, Chen; Xing, Jie; Li, Jian-kun; Jin, Kui-juan; Yang, Jing-ting; Guo, Hai-zhong; He, Meng; Wang, Can; Lu, Hui-bin; Yang, Guo-zhen

    2017-03-01

    A solar-blind ultraviolet photodetector based on perovskite (LaAlO3)0.3-(SrAl0.5Ta0.5O3)0.7 (LSAT) single crystal has been fabricated. The Deep Ultra Violet (DUV)/Ultra Violet (UV) (200 versus 290 nm) ratio is more than three orders of magnitude under the applied bias voltage 200 V. Under illumination at 200 nm, the responsivity of this ultraviolet photodetector reaches 4 mA/W at 200 V bias. The corresponding quantum efficiency and detectivity are 2.76% and 1×1011 cmṡHz0.5/W, respectively. The ultrafast response with a rise time of 563 ps and full width half maximum (FWHM) of 1.085 ns is obtained. The high sensitivity, ultrafast response speed, and good signal-to-noise ratio demonstrate that the LSAT photodetector could be a promising candidate as the solar-blind ultraviolet photodetector.

  19. Effects on hemodynamics and gas exchange of omega-3 fatty acid-enriched lipid emulsion in acute respiratory distress syndrome (ARDS): a prospective, randomized, double-blind, parallel group study

    PubMed Central

    Sabater, Joan; Masclans, Joan Ramon; Sacanell, Judit; Chacon, Pilar; Sabin, Pilar; Planas, Merce

    2008-01-01

    Introduction We investigated the effects on hemodynamics and gas exchange of a lipid emulsion enriched with omega-3 fatty acids in patients with ARDS. Methods The design was a prospective, randomized, double-blind, parallel group study in our Intensive Medicine Department of Vall d'Hebron University Hospital (Barcelona-Spain). We studied 16 consecutive patients with ARDS and intolerance to enteral nutrition (14 men and 2 women; mean age: 58 ± 13 years; APACHE II score: 17.8 ± 2.3; Lung Injury Score: 3.1 ± 0.5; baseline PaO2/FiO2 ratio: 149 ± 40). Patients were randomized into 2 groups: Group A (n = 8) received the study emulsion Lipoplus® 20%, B.Braun Medical (50% MCT, 40% LCT, 10% ω-3); Group B (n = 8) received the control emulsion Intralipid® Fresenius Kabi (100% LCT). Lipid emulsions were administered during 12 h at a dose of 0.12 g/kg/h. Measurements of the main hemodynamic and gas exchange parameters were made at baseline (immediately before administration of the lipid emulsions), every hour during the lipid infusion, at the end of administration, and six hours after the end of administration lipid infusion. Results No statistically significant changes were observed in the different hemodynamic values analyzed. Likewise, the gas exchange parameters did not show statistically significant differences during the study. No adverse effect attributable to the lipid emulsions was seen in the patients analyzed. Conclusion The lipid emulsion enriched with omega-3 fatty acids was safe and well tolerated in short-term administration to patients with ARDS. It did not cause any significant changes in hemodynamic and gas exchange parameters. Trial registration ISRCTN63673813 PMID:18947396

  20. Effects of systemic lidocaine versus magnesium administration on postoperative functional recovery and chronic pain in patients undergoing breast cancer surgery: A prospective, randomized, double-blind, comparative clinical trial

    PubMed Central

    Kim, Myoung Hwa; Lee, Ki Young; Park, Seho; Kim, Seung Il; Park, Hyung Seok

    2017-01-01

    Introduction We aimed to compare the effects of intraoperative lidocaine and magnesium on postoperative functional recovery and chronic pain after mastectomy due to breast cancer. Systemic lidocaine and magnesium reduce pain hypersensitivity to surgical stimuli; however, their effects after mastectomy have not been evaluated clearly. Methods In this prospective, double-blind, clinical trial, 126 female patients undergoing mastectomy were randomly assigned to lidocaine (L), magnesium (M), and control (C) groups. Lidocaine and magnesium were administered at 2 mg/kg and 20 mg/kg for 15 minutes immediately after induction, followed by infusions of 2 mg/kg/h and 20 mg/kg/h, respectively. The control group received the same volume of saline. Patient characteristics, perioperative parameters, and postoperative recovery profiles, including the Quality of Recovery 40 (QoR-40) survey, pain scales, length of hospital stay, and the short-form McGill pain questionnaire (SF-MPQ) at postoperative 1 month and 3 months were evaluated. Results The global QoR-40 scores on postoperative day 1 were significantly higher in group L than in group C (P = 0.003). Moreover, in sub-scores of the QoR-40 dimensions, emotional state and pain scores were significantly higher in group L than those in groups M and C (P = 0.027 and 0.023, respectively). At postoperative 3 months, SF-MPQ and SF-MPQ-sensitive scores were significantly lower in group L than in group C (P = 0.046 and 0.036, respectively). Conclusions Intraoperative infusion of lidocaine improved the quality of recovery and attenuated the intensity of chronic pain in patients undergoing breast cancer surgery. PMID:28253307

  1. Comparison of 1470 nm Laser and Radial 2ring Fiber with 980 nm Laser and Bare-Tip Fiber in Endovenous Laser Ablation of Saphenous Varicose Veins: A Multicenter, Prospective, Randomized, Non-Blind Study

    PubMed Central

    Ogawa, Tomohiro; Sugawara, Hiromitsu; Shokoku, Shintaro; Sato, Shoji

    2015-01-01

    Objective: The aim of this study is to compare the clinical efficacy and safety of two laser wavelengths and fiber types in endovenous laser ablation (EVLA) of saphenous varicose veins of the lower limb. Design: Multi-center prospective randomized non-blind clinical trial. Patients and Methods: From January 2007 to December 2011, 113 patients (113 limbs) with primary varicose veins were randomized into two groups. They were treated with radial 2ring fiber and 1470 nm laser in Group I (57 limbs) and bare-tip fiber and 980 nm laser in Group E (56 limbs) in order to ablate the saphenous vein. Vein occlusion rates at 12 weeks and pain in treated region were recorded as primary endpoint. Visual analogue scale (VAS) for assessment of pain, rates of bruising, complications and equipment failure were recorded as secondary endpoint of safety. Results: Occlusion rates at 12 weeks were 100% in both groups. Rates of pain (0% vs. 25.0%) and bruising (7.0% vs. 57.1%) were significantly lower in Group I (p <0.0001). VAS of pain was significantly lower on postoperative day 1, day 5 and 2nd week in Group I. Conclusion: Treatment of saphenous varicose veins by EVLA using a 1470 nm laser and a radial 2ring fiber resulted in comparable occlusion rates at 12 weeks and less postoperative pain and bruising than EVLA with a 980 nm laser and a bare-tip fiber. (This article is a translation of Jpn J Vasc Surg 2014; 23: 964–971.) PMID:26730252

  2. Investigation of the clinical efficacy of 0.2% topical stannous fluoride for the treatment of canine superficial pyoderma: a prospective, randomized, double-blinded, placebo-controlled trial.

    PubMed

    Seltzer, Judith D; Flynn-Lurie, Alison K; Marsella, Rosanna; Brennan, Meghan M

    2010-06-01

    Stannous fluoride (SF) is an antibacterial compound that has been successfully used to treat gingivitis in people and dogs, and cutaneous bacterial infections in horses. The purpose of this prospective, double-blinded, placebo-controlled clinical trial was to investigate the efficacy of 0.2% SF spray (BacDerm; Emerald 3 Enterprises Inc., Camdenton, MO, USA) for the treatment of canine superficial pyoderma. Twenty-six privately owned dogs with bacterial skin infections diagnosed on clinical signs, cytology and aerobic culture were enrolled. Dogs were randomly assigned to vehicle only or active ingredient treatment groups. The product was applied topically to affected areas once daily for 28 days, with assessments at days 0, 14, 28 and 42. Clinical and cytological evaluations were performed by the same investigators at each visit. Owners scored the improvement of hair coat, odour, pruritus and overall improvement at each recheck. Linear mixed models showed significant effects of treatment (P < 0.0001) and time (P = 0.0037) for investigator's scores, and a significant time effect for owners' haircoat (P = 0.0077) and odour (P = 0.0170) improvement scores. Dogs in both placebo and SF groups showed some improvement over time, and the investigator's scores on days 0 and 28 were not significantly different between groups for both (t-test P > 0.05). Spearman's rho correlation coefficients revealed a significant negative correlation between investigator's scores and all categories of owners' assessment scores in dogs of both groups. Although some dogs improved on SF, this study does not support the use of 0.2% SF as sole therapy for canine superficial pyoderma.

  3. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study

    PubMed Central

    Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

    2016-01-01

    Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. Trial registration number 32017426, pre-results. PMID:27609859

  4. Cardiovascular risk and mortality in end-stage renal disease patients undergoing dialysis: sleep study, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life: a prospective, double blind, randomized controlled clinical trial

    PubMed Central

    2013-01-01

    Background Chronic kidney disease (CKD) is one of the most serious public health problems. The increasing prevalence of CKD in developed and developing countries has led to a global epidemic. The hypothesis proposed is that patients undergoing dialysis would experience a marked negative influence on physiological variables of sleep and autonomic nervous system activity, compromising quality of life. Methods/Design A prospective, consecutive, double blind, randomized controlled clinical trial is proposed to address the effect of dialysis on sleep, pulmonary function, respiratory mechanics, upper airway collapsibility, autonomic nervous activity, depression, anxiety, stress and quality of life in patients with CKD. The measurement protocol will include body weight (kg); height (cm); body mass index calculated as weight/height2; circumferences (cm) of the neck, waist, and hip; heart and respiratory rates; blood pressures; Mallampati index; tonsil index; heart rate variability; maximum ventilatory pressures; negative expiratory pressure test, and polysomnography (sleep study), as well as the administration of specific questionnaires addressing sleep apnea, excessive daytime sleepiness, depression, anxiety, stress, and quality of life. Discussion CKD is a major public health problem worldwide, and its incidence has increased in part by the increased life expectancy and increasing number of cases of diabetes mellitus and hypertension. Sleep disorders are common in patients with renal insufficiency. Our hypothesis is that the weather weight gain due to volume overload observed during interdialytic period will influence the degree of collapsibility of the upper airway due to narrowing and predispose to upper airway occlusion during sleep, and to investigate the negative influences of haemodialysis in the physiological variables of sleep, and autonomic nervous system, and respiratory mechanics and thereby compromise the quality of life of patients. Trial registration The

  5. Efficacy and tolerability of natural synergised pyrethrins in a new thermo labile foam formulation in topical treatment of scabies: a prospective, randomised, investigator-blinded, comparative trial vs. permethrin cream.

    PubMed

    Amerio, PierLuigi; Capizzi, Rodolfo; Milani, Massimo

    2003-01-01

    We compared in a prospective, randomised, investigator-blinded trial, the efficacy and tolerability of a new synergised-pyrethrins thermo-labile foam (F) formulation with permethrin 5 % cream (P) in 40 patients with scabies. Clinical evolution of scabetic lesions (Clinical grading = CG) and itching intensity (IS) were assessed, using a 5-point semi-quantitative score, at baseline, at week 2 and 4. F and P were equally effective in the clinical resolution of scabetic lesions. As compared to baseline, P reduced CG and IS from 3.4 0.7 and 3.1 0.4 to 0.2 0.6 and 1.4 1, at week 2, and to 0.0 0.0 and 0.1 0.3 at week 4, respectively (P < 0.001). F reduced CG and IS from 3.3 0.5 and 3.2 0.4 to 0.05 0.2 and 0.4 0.6 (week 2) and to 0.0 0.0 and 0.0 0.0 (week 4), respectively (P < 0.0001). As compared to P group, the IS in F group, at week 2, was significantly lower (0.4 0.6 vs. 1.4 1.1) (P < 0.0013). This foam formulation was at least as effective as permethrin 5 % cream in the treatment of scabies. In comparison with permethrin the foam induced a more rapid and complete resolution of itching.

  6. Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (StAR): A Single-Blind, Randomized Trial

    PubMed Central

    Bobrow, Kirsten; Farmer, Andrew J; Springer, David; Shanyinde, Milensu; Yu, Ly-Mee; Brennan, Thomas; Rayner, Brian; Namane, Mosedi; Steyn, Krisela; Tarassenko, Lionel; Levitt, Naomi

    2016-01-01

    Background We assessed the effect of automated treatment adherence support delivered via mobile-phone short message system (SMS) text-messages on blood pressure. Methods and Results In this pragmatic single-blind, three-arm randomized trial (StAR), undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information-only or interactive SMS text-messaging, or usual care. The primary outcome was change in systolic blood pressure at 12-months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012 and November 23, 2012, 1372 participants were randomized to receive information-only SMS text-messages (n=457), interactive SMS text-messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 (92%) participants. At 12-months, the mean adjusted change (95% CI) in systolic blood pressure compared to usual care was −2.2 mm Hg (−4.4 to −0.04) with information-only SMS and −1.6 mm Hg (−3.7 to 0.6) with interactive SMS. Odds ratios (95% CI) for the proportion of participants with a blood pressure <140/90mm Hg were for information-only messaging 1.42 (1.03 to 1.95) and for interactive messaging 1.41 (1.02 to 1.95) compared to usual care. Conclusions In this randomized trial of an automated adherence support program delivered by SMS text-message in a general outpatient population of adults with high blood pressure, we found a small, reduction in systolic blood pressure control compared to usual care at 12-months. There was no evidence that an interactive intervention increased this effect. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: South African National Clinical Trials Register number (SANCTR DOH-27-1212-386); Pan Africa Trial Register (PACTR201411000724141). PMID:26769742

  7. Effects of needs-based patient education on self-efficacy and health outcomes in people with rheumatoid arthritis: a multicentre, single blind, randomised controlled trial

    PubMed Central

    Ndosi, M; Johnson, D; Young, T; Hardware, B; Hill, J; Hale, C; Maxwell, J; Roussou, E; Adebajo, A

    2016-01-01

    Objectives The Educational Needs Assessment Tool (ENAT) is a self-completed questionnaire, which allows patients with arthritis to prioritise their educational needs. The aim of this study was to evaluate the effects of needs-based patient education on self-efficacy, health outcomes and patient knowledge in people with rheumatoid arthritis (RA). Methods Patients with RA were enrolled into this multicentre, single-blind, parallel-group, pragmatic randomised controlled trial. Patients were randomised to either the intervention group (IG) where patients completed ENAT, responses of which were used by the clinical nurse specialist to guide patient education; or control group (CG) in which they received patient education without the use of ENAT. Patients were seen at weeks 0, 16 and 32. The primary outcome was self-efficacy (Arthritis Self Efficacy Scale (ASES)-Pain and ASES-Other symptoms). Secondary outcomes were health status (short form of Arthritis Impact Measurement Scale 2, AIMS2-SF) and patient knowledge questionnaire-RA. We investigated between-group differences using analysis of covariance, adjusting for baseline variables. Results A total of 132 patients were recruited (IG=70 and CG=62). Their mean (SD) age was 54 (12.3) years, 56 (13.3)  years and disease duration 5.2 (4.9) years, 6.7 (8.9) years for IG and CG, respectively. There were significant between-group differences, in favour of IG at week 32 in the primary outcomes, ASES-Pain, mean difference (95% CI) −4.36 (1.17 to 7.55), t=−2.72, p=0.008 and ASES-Other symptoms, mean difference (95% CI) −5.84 (2.07 to 9.62), t=−3.07, p=0.003. In secondary outcomes, the between-group differences favoured IG in AIMS2-SF Symptoms and AIMS2-SF Affect. There were no between-group differences in other secondary outcomes. Conclusions The results suggest that needs-based education helps improve patients’ self-efficacy and some aspects of health status. Trial registration number ISRCTN51523281. PMID:26162769

  8. Laparo-endoscopic single site surgery in pediatrics: Feasibility and surgical outcomes from a preliminary prospective Canadian experience

    PubMed Central

    Khambati, Aziz; Wehbi, Elias; Farhat, Walid A.

    2015-01-01

    Introduction: Laparo-endoscopic single-site surgery (LESS) is becoming an alternative to standard laparoscopic surgery. Proposed advantages include enhanced cosmesis and faster recovery. We assessed the early post-operative surgical outcomes of LESS surgery utilizing different instruments in the pediatric urological population in Canada. Methods: We prospectively captured data on all patients undergoing LESS at our institution between February 2011 and August 2012. This included patient age, operative time, length of stay, complications and short-term surgical outcomes. Different instruments/devices were used to perform the procedures. Access was achieved through a transumbilical incision. Results: A total of 16 LESS procedures were performed, including seven pyeloplasties, four unilateral and one bilateral varicocelectomies, two simple nephrectomies, one renal cyst decortication and one pyelolithotomy. There was no statistical difference in the operative times, hospital length of stay and cost (pyeloplasty only) in patients undergoing pyeloplasty and varicocelectomy using the LESS technique when compared to an age matched cohort of patients managed with the traditional laparoscopic approach. One pyeloplasty in the LESS group required conversion to open due to a small intra-renal pelvis. There were no immediate or short term post-operative complications; however, one patient experienced a decrease in renal function status post LESS pyeloplasty. Since all procedures were performed by a vastly experienced surgeon at a tertiary center, the generalizability of the results cannot be assessed. Conclusions: There are only a few series that have assessed the role of LESS in pediatric urological surgery. Although our experience is limited by a heterogeneous group of patients with a short follow-up period, the present cohort demonstrates the safety and feasibility of LESS. Further evaluation with randomized studies is required to better assess the role of LESS in pediatric

  9. Geometry of blind thrusts

    SciTech Connect

    Kligfield, R.; Geiser, P.; Geiser, J.

    1985-01-01

    Blind thrusts are structures which at no time in their history broke the erosion surface and along which displacement progressively changes upwards. Faults of the stiff layer along which displacement progressively decreases to zero (tip) are one prominent type of blind thrust structure. Shortening above such tips is accommodated entirely by folding whereas shortening below the tip is partitioned between folding and faulting. For these types of faults it is possible to determine the original length of the stiff layer for balancing purposes. A systematic methodology for line length and area restoration is outlined for determining blind thrust geometry. Application of the methodology is particularly suitable for use with microcomputers. If the folded form of the cover is known along with the position of the fault and its tip, then it is possible to locate hanging and footwall cutoffs. If the fault trajectory, tip, and a single hanging wall footwall cutoff pair are known, then the folded form of the cover layer can be determined. In these constructions it is necessary to specify pin lines for balancing purposes. These pin lines may or may not have a zero displacement gradient, depending upon the amount of simple shear deformation. Examples are given from both Laramide structures of the western USA and the Appalachians.

  10. Repetition blindness is orientation blind.

    PubMed

    Corballis, Michael C; Armstrong, Cole

    2007-03-01

    In identifying rapid sequences of three letters, subjects were worse at identifying the first and third letters when they were the same than when they were different, indicating repetition blindness (RB). This effect occurred regardless of the angular orientations of the letters, but was more pronounced when the orientations of the repeated letters were different than when they were the same. In a second experiment, RB was also evident when the first and third letters were lowercase bs or ds, presented upright or inverted, even though they are differently named when inverted (q and p, respectively). Conversely, a third experiment showed that RB occurred when the letters had the same names but were repeated in different case. These results suggest that the early extraction of letter shape is independent of its orientation and left-right sense, and that RB can occur at the levels of both shape and name.

  11. Low-noise solar-blind photodetectors based on LaAlO3 single crystal with transparent indium-tin-oxide electrode as detection window.

    PubMed

    Guo, Er-Jia; Lu, Hui-Bin; He, Meng; Jin, Kui-Juan; Yang, Guo-Zhen

    2010-10-10

    The low-noise solar-blind photodetectors of indium-tin-oxide/LaAlO(3)/Ag (ITO/LAO/Ag) have been fabricated based on the properties of LAO bandgap excitation and the transparent conductance of ITO thin film. The ITO thin films are epitaxially grown on LAO wafers as the electrodes and detection windows of the photodetectors. The photodetectors have low noise and excellent electromagnetic shielding. The influence of the thickness of ITO thin films on the responsivity of the photodetectors has been studied. The photocurrent responsivity can reach 10.3 mA/W under the irradiation of 200-220 nm for a photodetector with 5 nm thick ITO film. The noise current is 1 pA order magnitude under the sunlight at midday. The experiment results suggest that ITO/LAO/Ag is one of the promising structures for the solar-blind deep-ultraviolet photodetectors.

  12. PA01.17. A clinical study to evaluate the effect of extract based herbal formulation on hypertension- a single blinded standard controlled randomized study

    PubMed Central

    Agrawal, Satish; Pol, Hemant

    2012-01-01

    Purpose: In Ayurveda although there is no such terminology like hypertension but still this work is an approach to establish relationship between Hypertension & vitiated functioning of three governing forces of our body i.e. Tridosha and to treat Hypertension on Ayurvedic principles. The logic behind such correlation is based on the fact that, like other physiological processes, B.P. too is normal phenomenon of our body which is governed by Tridosha. After going through modern pathogenesis of primary hypertension and its symptomology, in present study it has been correlated with Vata Kaphaja Vikara with Rasavaha, Raktavaha and Manovahi Srotas as the seat of disease. Looking at its pathogenesis, the term Uccha Vyan Bala (exaggerated physiological functioning of Vyan Vayu leading to increase contractility of heart & blood vessels) can be coined for hypertension. Method: Subjective criteria Headache, Palpitation, Vertigo, Dyspnoea on walks and Fatigue. Objective criteria BP value recorded by sphygmomanometer in supine position. Final assessment of results; Subjective assessment 75 to 100% disappearance of symptoms effectively cured. 50 to 74% disappearance of symptoms well cured. 25 to 49% disappearance of symptoms fairly cured. 0 to 24% disappearance of symptoms poorly cured. Objective assessment Patient showing reduction in BP by 10mmHg Poorly cured; Patient showing reduction in BP between 11 to 20mmHg Fairly cured; Patient showing reduction in BP between 21 to 30 mmHg Well cured; Patient showing reduction in BP by more than 30 mmHg Effectively cured. Research methodology Type of study-Single blinded comparative study. Study site IPD and OPD department of Shubhdeep ayurved medical college, Indore (MP). Sample size 50 patients divided randomly into two equal groups. Group A given trial drug whereas Group B given control drug. Drug dosage and vehicle 1 capsule twice daily with lukewarm water after meals. Duration of treatment one month (examined at weekly intervals

  13. 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).

    PubMed

    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 < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: -78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD -115.4 ± 68.11 mg/dL), respectively, as compared to 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

  14. Transcutaneous electrical acupoint stimulation in children with autism and its impact on plasma levels of arginine-vasopressin and oxytocin: a prospective single-blinded controlled study.

    PubMed

    Zhang, Rong; Jia, Mei-Xiang; Zhang, Ji-Sui; Xu, Xin-Jie; Shou, Xiao-Jing; Zhang, Xiu-Ting; Li, Li; Li, Ning; Han, Song-Ping; Han, Ji-Sheng

    2012-01-01

    Acupuncture increases brain levels of arginine-vasopressin (AVP) and oxytocin (OXT), which are known to be involved in the modulation of mammalian social behavior. Transcutaneous electrical acupoint stimulation (TEAS) is often used clinically to produce a similar stimulation to that of acupuncture on the acupoints. In the present study, TEAS was applied to children with autism to assess its therapeutic efficacy. Seventy-six autistic children receiving rehabilitation training were divided into 2 groups: a treatment group receiving TEAS 30min per day, 5 days per week for 12 weeks (n=37) and a control group without TEAS treatment (n=39). A series of rating scales was used in outcome assessment. Plasma levels of AVP and OXT were determined by enzyme immunoassay (EIA) before and after treatment. The TEAS group showed a significant improvement over the control in their emotional response, fear or anxiety, level/consistency of intellective relations and general impressions on the Childhood Autism Rating Scale (CARS) as well as improvements in the sensory and related factors in the Autism Behavior Checklist (ABC). In addition, the varieties of accepted food increased after TEAS treatment. It appears that TEAS was effective in autistic children who showed passive and aloof behavior, but not in those who were active but odd. The plasma level of AVP was significantly higher in the TEAS group than in the control group after the intervention. In addition, the change in the plasma AVP level paralleled the improvement of some of the behavior factors in CARS, including adaptation to environmental change, listening response, perceptive response and fear or anxiety. It is concluded that TEAS is effective for the treatment of autistic children with a passive and aloof social interaction style. Changes in plasma levels of AVP and possibly OXT may be involved in mediating the therapeutic effect of TEAS.

  15. Transcutaneous Electrical Acupoint Stimulation in Children with Autism and Its Impact on Plasma Levels of Arginine-Vasopressin and Oxytocin: A Prospective Single-Blinded Controlled Study

    ERIC Educational Resources Information Center

    Zhang, Rong; Jia, Mei-Xiang; Zhang, Ji-Sui; Xu, Xin-Jie; Shou, Xiao-Jing; Zhang, Xiu-Ting; Li, Li; Li, Ning; Han, Song-Ping; Han, Ji-Sheng

    2012-01-01

    Acupuncture increases brain levels of arginine-vasopressin (AVP) and oxytocin (OXT), which are known to be involved in the modulation of mammalian social behavior. Transcutaneous electrical acupoint stimulation (TEAS) is often used clinically to produce a similar stimulation to that of acupuncture on the acupoints. In the present study, TEAS was…

  16. Does Hamulotomy during Palatoplasty Have Any Effect on Hearing Ability in Nonsyndromic Cleft Palate Patients? A Prospective, Single Blind, Comparative Study

    PubMed Central

    Jain, Anuj; Nimonkar, Pranali; Bhola, Nitin; Borle, Rajiv; Sharma, Shishir; Oswal, Shrenik

    2016-01-01

    The primary goal of palatoplasty is to achieve a tension-free palatal closure ensuring no postoperative complications. Many surgeons fracture the pterygoid hamulus to minimize tension during palatoplasty. However, this maneuver gained criticism by some authors on the grounds that it may lead to Eustachian Tube dysfunction. Our study intended to figure out the relationship of hamulus fracture with the postoperative state of middle ear in cleft palate children. Fifty consecutive cleft palate patients with an age range of 10 months to 5 years were recruited. All the patients were assigned to either hamulotomy or nonhamulotomy group preoperatively. The patients were subjected to otoscopic examination and auditory function evaluation by brainstem evoked response audiometry (BERA) preoperatively and 1 month and 6 months postoperatively. Otoscopy revealed that the difference in the improvement of middle ear status in both groups was statistically insignificant. Moreover, there was no significant difference in the BERA outcomes of the fracture and nonfracture populations. Complication rate in both groups was also statistically not significant. It can be concluded that hamulotomy does not have any effect on the hearing ability in cleft palate population, so hamulotomy can be performed for tension-free closure during palatoplasty. PMID:27006862

  17. A prospective, randomized, single-blinded trial on the effect of early rehabilitation on daily activities and motor function of patients with hemorrhagic stroke.

    PubMed

    Bai, YuLong; Hu, YongShan; Wu, Yi; Zhu, Yulian; He, Qiang; Jiang, CongYu; Sun, LiMin; Fan, WenKe

    2012-10-01

    To investigate whether early rehabilitation has a positive impact on the recovery of the activities of daily living and motor function after intracerebral hemorrhagic stroke, 364 patients with hemorrhagic stroke were selected and randomly divided into a rehabilitation group and a control group. The rehabilitation group underwent a standardized, three-stage rehabilitation program. The control group was treated with standard hospital ward, internal medical intervention. The simplified Fugl-Myere assessment scale (FMA) and Modified Barthel Index (MBI) were administered at various time points. The magnitude of improvement was significantly higher in the rehabilitation group than in the control group for both the FMA (p<0.05) and MBI scores (p<0.05). The greatest improvement was observed in the first month post-stroke. Thus, our study shows that early rehabilitation can significantly improve the daily activities and motor functions of patients with stroke.

  18. Effect of Position During Spinal Anesthesia on Postdural Puncture Headache After Cesarean Section: A Prospective, Single-Blind Randomized Clinical Trial

    PubMed Central

    Davoudi, Maryam; Tarbiat, Masoud; Ebadian, Mohammad Reza; Hajian, Puran

    2016-01-01

    Background The most common method of anesthesia for cesarean section is spinal anesthesia, and postdural puncture headache (PDPH) remains a major complication of this procedure. Nowadays, PDPH is a major cause of morbidity in parturients after spinal anesthesia. This headache is the third most popular reason for claims against anesthesiologists in obstetrics. The position after spinal anesthesia has been evaluated as a contributory factor in the occurrence of PDPH, but the position before spinal anesthesia has not yet been evaluated. Objectives This study was designed to compare the incidence of PDPH following spinal anesthesia in the sitting position and in the left lateral decubitus position in parturients who underwent elective caesarian section. Patients and Methods After institutional approval, 100 parturients who had been scheduled for elective caesarian section with spinal anesthesia were enrolled in the study. Following patient preparation for the neuraxial blockade, spinal anesthesia was randomly performed in the sitting or in the left lateral decubitus position. Patients were interviewed for PDPH on either postoperative day one, two, or three. The incidence and intensity of PDPH were evaluated and compared using a numeric rating scale (NRS-11). Results A total of 94 patients were included in the data analysis. The overall incidence of PDPH was 12.7%. In the sitting group, ten patients (20.8%) had PDPH, compared with two patients (4.3%) in the lateral group (P = 0.017). Conclusions Spinal anesthesia in the sitting position is more associated with significant PHDH than that in the left lateral decubitus position for patients undergoing elective caesarian section. PMID:27843773

  19. Effects of an omega-3 fatty acid-enriched lipid emulsion on eicosanoid synthesis in acute respiratory distress syndrome (ARDS): A prospective, randomized, double-blind, parallel group study

    PubMed Central

    2011-01-01

    Background The use of lipid emulsions has been associated with changes in lung function and gas exchange which may be mediated by biologically active metabolites derived from arachidonic acid. The type and quantity of the lipid emulsions used could modulate this response, which is mediated by the eicosanoids. This study investigates the use of omega-3 fatty acid-enriched lipid emulsions in ARDS patients and their effects on eicosanoid values. Methods Prospective, randomized, double-blind, parallel group study carried out at the Intensive Medicine Department of Vall d'Hebron University Hospital (Barcelona-Spain). We studied 16 consecutive patients with ARDS and intolerance to enteral nutrition (14 men; age: 58 ± 13 years; APACHE II score 17.8 ± 2.3; Lung Injury Score: 3.1 ± 0.5; baseline PaO2/FiO2 ratio: 149 ± 40). Patients were randomized into two groups: Group A (n = 8) received the study emulsion Lipoplus® 20%, B. Braun Medical (50% MCT, 40% LCT, 10% fish oil (FO)); Group B (n = 8) received the control emulsion Intralipid® Fresenius Kabi (100% LCT). Lipid emulsions were administered for 12 h at a dose of 0.12 g/kg/h. We measured LTB4, TXB2, and 6-keto prostaglandin F1α values at baseline [immediately before the administration of the lipid emulsions (T-0)], at the end of the administration (T-12) and 24 hours after the beginning of the infusion (T 24) in arterial and mixed venous blood samples. Results In group A (FO) LTB4, TXB2, 6-keto prostaglandin F1α levels fell during omega-3 administration (T12). After discontinuation (T24), levels of inflammatory markers (both systemic and pulmonary) behaved erratically. In group B (LCT) all systemic and pulmonary mediators increased during lipid administration and returned to baseline levels after discontinuation, but the differences did not reach statistical significance. There was a clear interaction between the treatment in group A (fish oil) and changes in LTB4 over time. Conclusions Infusion of lipids enriched

  20. Decreased organ failure in patients with severe SIRS and septic shock treated with the platelet-activating factor antagonist TCV-309: a prospective, multicenter, double-blind, randomized phase II trial. TCV-309 Septic Shock Study Group.

    PubMed

    Poeze, M; Froon, A H; Ramsay, G; Buurman, W A; Greve, J W

    2000-10-01

    Sepsis and organ failure remain the main cause of death on the ICU. Sepsis is characterized by a severe inflammatory response, in which platelet-activating factor (PAF) is considered to play an important role. This study investigated whether treatment with the PAF-antagonist TCV-309 reduces morbidity and mortality in patients with septic shock. The study was conducted as a double-blind, randomized, placebo controlled multicenter study. The included patients had to fulfill the SIRS criteria with a clinical suspicion of infection, an admission APACHE II score greater than 15, and shock, defined as a mean arterial pressure <70 mmHg and/or a decrease > or =40 mmHg despite adequate fluid resuscitation. Patients received 1.0 mg/kg TCV-309 or placebo, twice daily, intravenously during 14 days. The prospectively set goals were MOF score, recovery from shock, mortality, and assessment of the safety of the medication. A total of 98 patients were included of which 97 were analyzed on an intention-to-treat basis. The overall survival at day 56 of TCV-309 treated patients was similar compared to placebo treated patients (51.0% vs. 41.7%, P = 0.47). In contrast, the mean percentage of failed organs per patient present after 14 days in the TCV-309 treated patients was significantly lower compared to the placebo treated patients (11.9% vs. 25.1%, P = 0.04), leading to a reduced need for vasopressors, dialysis, and ventilatory support. Furthermore, the mean APACHE-II score during treatment with TCV-309 was significantly lower and the number of patients recovered from shock after day 14 was significantly higher in the TCV-309 treated patient group (2/32 vs. 9/29, P = 0.01). The number of adverse events was not significantly different between the TCV-309 and placebo treated patients. TCV-309 did not change overall mortality of septic shock, however a substantial reduction in organ dysfunction and morbidity, frequently associated with septic shock was achieved, without significant

  1. Efficacy of High-Dose Supplementation With Oral Vitamin D3 on Depressive Symptoms in Dialysis Patients With Vitamin D3 Insufficiency: A Prospective, Randomized, Double-Blind Study.

    PubMed

    Wang, Ying; Liu, Ying; Lian, Yueying; Li, Ning; Liu, Hong; Li, Guanzeng

    2016-06-01

    Psychological problems are common among end-stage renal disease patients undergoing dialysis. We aim to evaluate whether high-dose vitamin D3 (VD3) supplementation has beneficial effects on depressive symptoms in dialysis patients. This prospective, randomized, and double-blind trial includes 746 dialysis patients with depression treated in 3 hospitals in Southeast China. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders criteria. Patients were randomly assigned to 52-week treatment of oral 50,000 IU/wk VD3 (cholecalciferol) (test group) or a placebo (control group). The presence of depressive symptoms was evaluated using the Chinese version of Beck Depression Inventory (BDI) II both before and after treatment. Sociodemographic data, clinical data, nutritional indexes, inflammatory biomarkers, and plasma VD3 concentrations were also determined. Finally, 726 patients completed the experiments, including 362 tested patients and 364 controls. After 52 weeks, the depressive symptoms were not significantly improved in the test group (mean BDI II scores changed from -1.1 ± 0.3 to -3.1 ± 0.6) versus the control group. Multivariable logistic regression showed BDI scores were not significantly improved in the test group versus the control group with adjustment for age, sex, comorbidity index, dialysis modality, or (OH)D levels (multivariable-adjusted mean change or MAMC [95% confidence interval (CI)], -2.3 [-2.48 to -1.83]) in the whole dialysis population. After stratification by depression types, the findings do support a significant relationship between the VD3 supplementation and the improvement in BDI II scores in dialysis patients with vascular depression (MAMC [95% CI], -4.4 [-5.08 to -2.76]), but the effect was not significant for major depressive disorders (MAMC [95% CI], -0.9 [-1.52 to -0.63]). The high-dose VD3 supplementation did not significantly reduce the depressive symptoms in our total dialysis population, but

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

    PubMed Central

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

    2016-01-01

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

  3. Lathosterol to cholesterol ratio in serum predicts cholesterol lowering response to plant sterol consumption in a dual center, randomized, single-blind placebo controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Benefits of plant sterols (PS) for cholesterol lowering are compromised by large variability in efficacy across individuals. High fractional cholesterol synthesis measured by deuterium incorporation has been associated with non-response to PS consumption; however, prospective studies showing this as...

  4. Using Synthetic Nanopores for Single-Molecule Analyses: Detecting SNPs, Trapping DNA Molecules, and the Prospects for Sequencing DNA

    ERIC Educational Resources Information Center

    Dimitrov, Valentin V.

    2009-01-01

    This work focuses on studying properties of DNA molecules and DNA-protein interactions using synthetic nanopores, and it examines the prospects of sequencing DNA using synthetic nanopores. We have developed a method for discriminating between alleles that uses a synthetic nanopore to measure the binding of a restriction enzyme to DNA. There exists…

  5. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study

    PubMed Central

    Juhász, Márk; Nagy, Viktor L.; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F.

    2014-01-01

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m−1 gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. PMID:25008086

  6. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

    PubMed

    Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

    2014-09-06

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated.

  7. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial

    PubMed Central

    Saposnik, Gustavo; Cohen, Leonardo G; Mamdani, Muhammad; Pooyania, Sepideth; Ploughman, Michelle; Cheung, Donna; Shaw, Jennifer; Hall, Judith; Nord, Peter; Dukelow, Sean; Nilanont, Yongchai; De los Rios, Felipe; Olmos, Lisandro; Levin, Mindy; Teasell, Robert; Cohen, Ashley; Thorpe, Kevin; Laupacis, Andreas; Bayley, Mark

    2016-01-01

    Summary Background Non-immersive virtual reality is an emerging strategy to enhance motor performance for stroke rehabilitation. There has been rapid adoption of non-immersive virtual reality as a rehabilitation strategy despite the limited evidence about its safety and effectiveness. Our aim was to compare the safety and efficacy of virtual reality with recreational therapy on motor recovery in patients after an acute ischaemic stroke. Methods In this randomised, controlled, single-blind, parallel-group trial we enrolled adults (aged 18–85 years) who had a first-ever ischaemic stroke and a motor deficit of the upper extremity score of 3 or more (measured with the Chedoke-McMaster scale) within 3 months of randomisation from 14 in-patient stroke rehabilitation units from four countries (Canada [11], Argentina [1], Peru [1], and Thailand [1]). Participants were randomly allocated (1:1) by a computer-generated assignment at enrolment to receive a programme of structured, task-oriented, upper extremity sessions (ten sessions, 60 min each) of either non-immersive virtual reality using the Nintendo Wii gaming system (VRWii) or simple recreational activities (playing cards, bingo, Jenga, or ball game) as add-on therapies to conventional rehabilitation over a 2 week period. All investigators assessing outcomes were masked to treatment assignment. The primary outcome was upper extremity motor performance measured by total time to complete the Wolf Motor Function Test (WMFT) at the end of the 2 week intervention period, analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NTC01406912. Findings The study was done between May 12, 2012, and Oct 1, 2015. We randomly assigned 141 patients: 71 received VRWii therapy and 70 received recreational activity. 121 (86%) patients (59 in the VRWii group and 62 in the recreational activity group) completed the final assessment and were included in the primary analysis. Each group

  8. Multiscale image blind denoising.

    PubMed

    Lebrun, Marc; Colom, Miguel; Morel, Jean-Michel

    2015-10-01

    Arguably several thousands papers are dedicated to image denoising. Most papers assume a fixed noise model, mainly white Gaussian or Poissonian. This assumption is only valid for raw images. Yet, in most images handled by the public and even by scientists, the noise model is imperfectly known or unknown. End users only dispose the result of a complex image processing chain effectuated by uncontrolled hardware and software (and sometimes by chemical means). For such images, recent progress in noise estimation permits to estimate from a single image a noise model, which is simultaneously signal and frequency dependent. We propose here a multiscale denoising algorithm adapted to this broad noise model. This leads to a blind denoising algorithm which we demonstrate on real JPEG images and on scans of old photographs for which the formation model is unknown. The consistency of this algorithm is also verified on simulated distorted images. This algorithm is finally compared with the unique state of the art previous blind denoising method.

  9. Single-Tooth Implant Restorations in Fresh Extraction Sockets of the Maxillary Esthetic Zone: Two-Year Results of a Prospective Cohort Study.

    PubMed

    Ganeles, Jeffrey; Norkin, Frederic J; Zfaz, Samuel

    In this prospective study, 15 patients received 15 variable-thread tapered implants placed in fresh extraction sites in the maxillary esthetic zone and immediately were provisionalized out of occlusion. Of the 15 patients, 11 completed their 2-year follow-up. At 2 years, the success and cumulative survival rates were both 100%, and the mean bone level gain was 0.83 mm. Soft tissue assessment showed no zero esthetic scores, improved papilla indices, and low bleeding on probing and plaque accumulation. Overall, the study implants showed excellent hard tissue, soft tissue, and esthetic outcomes, indicating a healthy tissue response in single-tooth extraction sites in the maxillary esthetic zone.

  10. Color Blindness Simulations

    MedlinePlus

    ... Coordinator Color blindness Simulations Normal Color Vision Deuteranopia Color blindness marked by confusion of purplish red and green Tritanopia A dichromatism in which the spectrum is seen in tones of red and green. ...

  11. A placebo controlled double-blind evaluation of the pharmacodynamics of fengabine vs amitriptyline following single and multiple doses in elderly volunteers.

    PubMed Central

    Fairweather, D B; Kerr, J S; Hilton, S; Hindmarch, I

    1993-01-01

    1. The effects of fengabine were compared with those of amitriptyline in healthy elderly volunteers. Doses were administered double-blind and assessments were made before and after ingestion. 2. Psychomotor performance and cognitive ability were measured using tests of choice reaction time, tracking, critical flicker fusion threshold, memory scanning and word recognition. Subjective feelings were assessed using the Leeds sleep evaluation questionnaire (LSEQ) and line analogue rating scales (LARS). 3. Pharmacokinetic data suggest that fengabine may induce its own metabolism following repeated dosing. 4. The findings of this study show that fengabine 200 mg and 400 mg does not produce any noticeable behavioural toxicity in elderly volunteers, in contrast to amitriptyline which had a disruptive effect throughout. PMID:8471403

  12. 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.

    PubMed

    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.

  13. Blind Quantum Signature with Blind Quantum Computation

    NASA Astrophysics Data System (ADS)

    Li, Wei; Shi, Ronghua; Guo, Ying

    2017-04-01

    Blind quantum computation allows a client without quantum abilities to interact with a quantum server to perform a unconditional secure computing protocol, while protecting client's privacy. Motivated by confidentiality of blind quantum computation, a blind quantum signature scheme is designed with laconic structure. Different from the traditional signature schemes, the signing and verifying operations are performed through measurement-based quantum computation. Inputs of blind quantum computation are securely controlled with multi-qubit entangled states. The unique signature of the transmitted message is generated by the signer without leaking information in imperfect channels. Whereas, the receiver can verify the validity of the signature using the quantum matching algorithm. The security is guaranteed by entanglement of quantum system for blind quantum computation. It provides a potential practical application for e-commerce in the cloud computing and first-generation quantum computation.

  14. Blind Quantum Signature with Blind Quantum Computation

    NASA Astrophysics Data System (ADS)

    Li, Wei; Shi, Ronghua; Guo, Ying

    2016-12-01

    Blind quantum computation allows a client without quantum abilities to interact with a quantum server to perform a unconditional secure computing protocol, while protecting client's privacy. Motivated by confidentiality of blind quantum computation, a blind quantum signature scheme is designed with laconic structure. Different from the traditional signature schemes, the signing and verifying operations are performed through measurement-based quantum computation. Inputs of blind quantum computation are securely controlled with multi-qubit entangled states. The unique signature of the transmitted message is generated by the signer without leaking information in imperfect channels. Whereas, the receiver can verify the validity of the signature using the quantum matching algorithm. The security is guaranteed by entanglement of quantum system for blind quantum computation. It provides a potential practical application for e-commerce in the cloud computing and first-generation quantum computation.

  15. A Double-Blind, Double-Dummy, Flexible-Design Randomized Multicenter Trial: Early Safety of Single- Versus Divided-Dose Rabbit Anti-Thymocyte Globulin Induction in Renal Transplantation.

    PubMed

    Stevens, R B; Wrenshall, L E; Miles, C D; Farney, A C; Jie, T; Sandoz, J P; Rigley, T H; Osama Gaber, A

    2016-06-01

    A previous nonblinded, randomized, single-center renal transplantation trial of single-dose rabbit anti-thymocyte globulin induction (SD-rATG) showed improved efficacy compared with conventional divided-dose (DD-rATG) administration. The present multicenter, double-blind/double-dummy STAT trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated SD-rATG versus DD-rATG induction for noninferiority in early (7-day) safety and tolerability. Ninety-five patients (randomized 1:1) received 6 mg/kg SD-rATG or 1.5 mg/kg/dose DD-rATG, with tacrolimus-mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12-month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of SD-rATG induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown SD-rATG induction to be noninferior to DD-rATG induction in early tolerability and equivalent in 12-month safety. (Clinical Trials.gov #NCT00906204.).

  16. Blindness and anorexia nervosa.

    PubMed

    McFarlane, A C

    1989-06-01

    Two cases of anorexia nervosa in blind patients are reported. They demonstrate that blind children experience many developmental problems which are thought to be important in the etiology of anorexia nervosa. Similarly, blind children are unusually susceptible to misperceive their body size and weight. The apparent absence of a strong association between congenital blindness and anorexia nervosa challenges the presumed aetiological link between disturbed body image and identity diffusion, and anorexia nervosa.

  17. Demographics of Lower Limb Amputations in the Pakistan Military: A Single Center, Three-Year Prospective Survey

    PubMed Central

    Ayaz, Saeed B; Mansoor, Sahibzada N; Qureshi, Ali R; Fahim, Muhammad

    2016-01-01

    Introduction  The Pakistan military has been actively engaged in the war against terror for more than a decade. Many officers and soldiers have lost their limbs in this war. But the data on traumatic lower limb amputations in Pakistan is sparse. The aim of this study is to prospectively document the epidemiological profile of lower limb military amputees presenting at the largest rehabilitation centre of Pakistan over a three-year period. Materials & methods  A prospective three-year survey was conducted at the Armed Forces Institute of Rehabilitation Medicine (AFIRM), Pakistan. One hundred twenty-three consecutive patients with lower limb amputations were enrolled in the survey. The demographic data, etiology, associated injuries, complications profile, and type of prosthesis provided were documented. The data analysis was done using the statistical analysis tool SPSS V 20 (IBM®,NY, USA).  Results  All patients were male. Most had traumatic amputation (119), were between 20–40 years (106), with unilateral amputation (115). Mine blast injury was the leading cause in 73 (59.3%) and most (58.5%) were fitted with modular prosthesis. Transtibial amputation was the commonest level (65), followed by transfemoral (30). The time of surgical amputation was not documented in 87% of the patients. Half of the patients (54%) had associated injuries. Seventy-nine patients had at least one complication with phantom pain being the commonest in 25% cases. Conclusions  This is the largest prospective demographic survey of lower limb amputees in Pakistan military to date. Scores of soldiers and civilians in Pakistan have suffered lower limb amputation. The availability of demographic data can improve the trauma and rehabilitation services for better understanding and management of such cases. There is a need to conduct large scale community-based epidemiological surveys to direct future policies and develop amputee rehabilitation services in the public sector. PMID:27186448

  18. Efficacy and safety of premedication with single dose of oral pregabalin in children with dental anxiety: A randomized double-blind placebo-controlled crossover clinical trial

    PubMed Central

    Eskandarian, Tahereh; Eftekharian, Hamidreza; Soleymanzade, Rojin

    2015-01-01

    Background: Dental anxiety is a relatively frequent problem that can lead to more serious problems such as a child entering a vicious cycle as he/she becomes reluctant to accept the required dental treatments. The aim of this randomized double-blind clinical trial study was to evaluate the anxiolytic and sedative effect of pregabalin in children. Materials and Methods: Twenty-five children were randomized to a double-blind placebo-controlled crossover clinical trial. Two visits were scheduled for each patient. At the first visit, 75 mg pregabalin or placebo was given randomly, and the alternative was administered at the next visit. Anxiolytic and sedative effects were measured using the visual analogue scale. The child's behavior was rated with the Frankl behavioral rating scale and the sedation level during the dental procedure was scored using the Ramsay sedation scale. The unpaired, two-tailed Student's t-test was used to compare the mean changes of visual analog scale (VAS) for anxiety in the pregabalin group with that of the placebo group. A repeated measures MANOVA model was used to detect differences in sedation level in the pregabalin and placebo groups regarding the interaction of 3-time measurements; sub-group analysis was performed using Student's t-test. The Mann–Whitney U-test was used to analyze the nonparametric data of the Frankl and Ramsay scales. A P < 0.05 was considered significant. Results: The reduction of the VAS-anxiety score from 2 h post-dose was statistically significant in the pregabalin group. From 2 h to 4 h post-dose, the VAS-sedation score increased significantly in the pregabalin group. The child's behavior rating was not significantly different between the groups. The number of “successful” treatment visits was higher in the pregabalin group compared to the placebo group. Conclusion: Significant anxiolytic and sedative effects can be anticipated 2 h after oral administration of pregabalin without serious side effects. PMID

  19. Cryotherapy for Primary Treatment of Prostate Cancer: Intermediate Term Results of a Prospective Study from a Single Institution

    PubMed Central

    Rodríguez, S. Alvarez; Arias Fúnez, F.; Bueno Bravo, C.; Rodríguez-Patrón Rodríguez, R.; Sanz Mayayo, E.; Palacios, V. Hevia; Burgos Revilla, F. J.

    2014-01-01

    Purpose. Published data about cryotherapy for prostate cancer (PC) treatment are based on case series with a lack of clinical trials and the inexistence of a validated definition of biochemical failure. A prospective study with standardized followup protocol was conducted in our institution. Material and Methods. Prospective study of a series of cases including 108 patients diagnosed with localized PC at clinical stage T1c-T2c treated by primary cryoablation and median followup of 61 months. Criteria of biochemical recurrence were unified according to the American Society for Therapeutic Radiology and Oncology (ASTRO). End points were biochemical progression-free survival (BPFS), cancer-specific survival, and overall survival. Rate of complications was reported. Results. The BPFS for low-, medium-, and high-risk patients was 96.4%, 91.2%, and 62.2%, respectively. Cancer-specific survival was 98.1%. Overall survival reached 94.4%. Complications included incontinence in 5.6%, urinary tract obstruction in 1.9%, urethral sloughing in 5.6%, haematuria in 1.9%, perineal pain in 11.1%, and prostatorectal fistula in 0.9%. Erectile disfunction was found in 98.1%. Conclusions. Cryotherapy is an effective and minimally invasive treatment for primary PC in well-selected cases, with low surgical risk and good results in terms of BPFS, cancer-specific survival, and overall survival. PMID:24693437

  20. Effects of esomeprazole on the healing process of post-endoscopic submucosal dissection gastric ulcers: a single arm, prospective trial

    PubMed Central

    Ichida, Takashi; Kusano, Fumihiko; Sakai, Yoshinori

    2016-01-01

    Objectives: Gastric endoscopic submucosal dissection (ESD) is currently a standard procedure. ESD enables en-bloc resection of large lesions, while inducing larger artificial ulcers to a greater extent than conventional procedures. Several studies have reported that proton pump inhibitors (PPIs) prevent delayed bleeding and expedite the artificial ulcer healing process. Esomeprazole, an S-isomer of omeprazole, is reportedly one of strongest inhibitors of gastric acid secretion. Previous studies have examined the effectiveness of esomeprazole. Our goal was to verify the effects of esomeprazole on artificial ulcers in a prospective study. Methods: A total of 185 patients underwent ESD for gastric neoplasms at our hospital between January 2013 and June 2015. Among these 185 patients, 49 post-ESD scar lesions were included in this prospective trial. First, 20 mg esomeprazole was orally administered to all subjects before and after the procedure. We then evaluated the delayed bleeding rate and ulcer scarring rates at 4 weeks and 8 weeks after the procedure by using a gastric ulcer stage system. Results: There was one case of delayed bleeding (2.0%). Regardless of Helicobacter pylori infection status, ulcer scarring rates at weeks 4 and 8 were respectively 28.6% (14/49) and 98% (48/49). Conclusions: Our results suggest that oral administration of esomeprazole alone may be sufficient for prompt healing of artificial gastric ulcers induced by ESD (UMIN000009367). PMID:27928455

  1. Global data on blindness.

    PubMed Central

    Thylefors, B.; Négrel, A. D.; Pararajasegaram, R.; Dadzie, K. Y.

    1995-01-01

    Globally, it is estimated that there are 38 million persons who are blind. Moreover, a further 110 million people have low vision and are at great risk of becoming blind. The main causes of blindness and low vision are cataract, trachoma, glaucoma, onchocerciasis, and xerophthalmia; however, insufficient data on blindness from causes such as diabetic retinopathy and age-related macular degeneration preclude specific estimations of their global prevalence. The age-specific prevalences of the major causes of blindness that are related to age indicate that the trend will be for an increase in such blindness over the decades to come, unless energetic efforts are made to tackle these problems. More data collected through standardized methodologies, using internationally accepted (ICD-10) definitions, are needed. Data on the incidence of blindness due to common causes would be useful for calculating future trends more precisely. PMID:7704921

  2. A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation

    PubMed Central

    Nikolis, Andreas; Bernstein, Steven; Kinney, Brian; Scuderi, Nicolo; Rastogi, Shipra; Sampalis, John S

    2016-01-01

    Purpose Many treatment modalities exist to counteract the effects of cutaneous aging. Ablative methods have been the mainstay for nonsurgical facial rejuvenation. In recent years, nonablative techniques have been developed with the aim of achieving facial rejuvenation without epidermal damage. Light-emitting diode (LED) photorejuvenation is a novel nonablative technique that induces collagen synthesis through biophotomodulatory pathways. Materials and methods A single-center, randomized, single-blinded, placebo-controlled, split-faced clinical trial was designed. Thirty-two patients were enrolled for a 12-week study. Patients were randomized into one of four groups: Group A, treatment with KLOX-001 gel formulation and white LED (placebo) light; Group B, treatment with a placebo/base gel (no active chromophore) formulation and KLOX LED light; Group C, treatment with KLOX-001 gel formulation and KLOX LED light; and Group D, treatment with the standard skin rejuvenating treatment (0.1% retinol-based cream). Patients received treatment at weeks 0, 1, 2, and 3, and returned to the clinic at weeks 4, 8, and 12 for clinical assessments performed by an independent, blinded committee of physicians using subjective clinician assessment scales. Tolerability, adverse outcomes, and patient satisfaction were also assessed. Results Analysis demonstrated that the KLOX LED light with KLOX placebo/base gel and the KLOX LED light + KLOX-001 gel formulation groups were superior to standard of care and KLOX-001 gel formulation with placebo light on subjective clinical assessment and multiple wrinkle scales, with statistically significant results obtained for brow positioning, perioral wrinkling, and total wrinkle score. Conclusion The study results show that KLOX LED light with KLOX-001 gel formulation and KLOX LED light with KLOX placebo/base gel are effective, safe, well-tolerated, and painless treatment modalities for skin rejuvenation. PMID:27257391

  3. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy

    PubMed Central

    Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-01-01

    Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772

  4. The efficacy of treatment of different intervention programs for patellofemoral pain syndrome--a single blinded randomized clinical trial. Pilot study.

    PubMed

    Avraham, Feazadeh; Aviv, Saposhnik; Ya'akobi, Pnina; Faran, Hava; Fisher, Zilla; Goldman, Yael; Neeman, Guy; Carmeli, Eli

    2007-08-24

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

  5. Acute effects of traditional Thai massage on cortisol levels, arterial blood pressure and stress perception in academic stress condition: A single blind randomised controlled trial.

    PubMed

    Bennett, Surussawadi; Bennett, Michael John; Chatchawan, Uraiwon; Jenjaiwit, Patcharaporn; Pantumethakul, Rungthip; Kunhasura, Soontorn; Eungpinichpong, Wichai

    2016-04-01

    Traditional Thai massage (TTM) has been applied widely to promote relaxation. However, there is little evidence to support its efficacy on academic stress. A randomised controlled trial was performed to examine the acute effects of TTM on cortisol level, blood pressure, heart rate and stress perception in academic stress. This prospective trial included 36 physiotherapy students with a self perceived stress score of between 3 and 5. They were randomly allocated into the TTM (18 people) group or the control group (18 people). Saliva cortisol level, blood pressure, heart rate and stress perception rating were measured before and after the intervention. Both groups showed a significant reduction in cortisol level and heart rate when compared with baseline (p < 0.001). There were no significant differences in cortisol level between the two groups. The results suggest the need for further study into other possible physiological effects on stress of TTM.

  6. Rapid effect of single-dose rosiglitazone treatment on endothelial function in healthy men with normal glucose tolerance: data from a randomised, placebo-controlled, double-blind study.

    PubMed

    Walcher, Thomas; Walcher, Daniel; Hetzel, Jürgen; Mielke, Catrin; Rau, Matthias; Rittig, Kilian; Balletshofer, Bernd; Schwedhelm, Edzard; Hombach, Vinzenz; Böger, Rainer H; Koenig, Wolfgang; Marx, Nikolaus

    2010-07-01

    Antidiabetic thiazolidinediones (TZDs) improve endothelial function in patients with or without type 2 diabetes. The present randomised, placebo-controlled, double-blind study examined the time course of a single dose of rosiglitazone on flow-mediated endothelium-dependent vasodilation (FMD), metabolic parameters, and its effect on inflammatory markers in non-diabetic men. Forty non-obese, healthy men with normal glucose tolerance were randomised to a single dose of rosiglitazone (8 mg) or placebo, and FMD was assessed at baseline as well as after 6 h and 24 h. Rosiglitazone did not significantly affect blood glucose and insulin levels or lipid parameters after 6 and 24 h compared with placebo. Treatment with rosiglitazone significantly increased FMD after 6 h from 4.3% (3.3; 4.9) to 7.6% (5.6; 9.2) (p<0.0001 vs. baseline) resulting in a highly significant effect compared with placebo (p<0.0001 for difference between groups). After 24 h FMD was still significantly higher in the rosiglitazone group compared with baseline (p=0.001), but the effect was no longer statistically significant versus placebo (p=0.171). Our study shows a very rapid effect of single dose rosiglitazone treatment on endothelial function in non-diabetic healthy men, underscoring the hypothesis that TZDs may exhibit direct effect in the vasculature independent of their metabolic action.

  7. A prospective randomized comparative trial between open subinguinal and loupe assisted subinguinal varicocelectome: A single center experience

    PubMed Central

    Vyas, Hari Gopal; Bhandari, Vimal; Kumar, Anup; Nanda, Biswajit; Singh, Harbinder; Bhowmick, Subroto

    2017-01-01

    Introduction: In our study, we reviewed efficacy and complication rates of open subinguinal varicocelectomy (OSV) and loupe assisted subinguinal varicocelectomy (LASV) using seminal and hormonal parameters in a prospective randomized study. Materials and Methods: We prospectively studied 60 males with Grade 2 and Grade 3 varicocele. Thirty patients underwent OSV and the other 30 patients underwent LASV. Intra-operative and post-operative complications along with pre-operative and post-operative seminal, hormonal parameters and testicular volume were compared between the groups. Results: Sperm count, motility and morphology increased significantly in both groups, but the improvement was significantly better in LASV group. (Group A – improvement in sperm count, motility and morphology by 25%, 8.5%, 10.3%, respectively and in Group B – improvement in sperm count, motility and morphology by 110%, 68.59%, 71.1%, respectively. Decrease in serum follicular stimulating hormone (FSH), luteinizing hormone (LH) and increase in serum testosterone were significant in both groups, but the improvement was significantly better in LASV group. (Group A – serum FSH and LH decreased by 17.2%, 23%, respectively and serum testosterone increased by 13.7% and in Group B – serum FSH and LH decreased by 56.9%, 56.65%, respectively and serum testosterone increased by 95.9%). The recurrence (OSV = 13.2% and LASV = 0, P = 0.01) and complication rates were significantly lower in LASV group. Conclusion: Our study shows that LASV is significantly better than OSV regarding efficacy and complication rates. PMID:28216922

  8. Refractive error blindness.

    PubMed Central

    Dandona, R.; Dandona, L.

    2001-01-01

    Recent data suggest that a large number of people are blind in different parts of the world due to high refractive error because they are not using appropriate refractive correction. Refractive error as a cause of blindness has been recognized only recently with the increasing use of presenting visual acuity for defining blindness. In addition to blindness due to naturally occurring high refractive error, inadequate refractive correction of aphakia after cataract surgery is also a significant cause of blindness in developing countries. Blindness due to refractive error in any population suggests that eye care services in general in that population are inadequate since treatment of refractive error is perhaps the simplest and most effective form of eye care. Strategies such as vision screening programmes need to be implemented on a large scale to detect individuals suffering from refractive error blindness. Sufficient numbers of personnel to perform reasonable quality refraction need to be trained in developing countries. Also adequate infrastructure has to be developed in underserved areas of the world to facilitate the logistics of providing affordable reasonable-quality spectacles to individuals suffering from refractive error blindness. Long-term success in reducing refractive error blindness worldwide will require attention to these issues within the context of comprehensive approaches to reduce all causes of avoidable blindness. PMID:11285669

  9. Effectiveness of low-level laser therapy for patients with carpal tunnel syndrome: design of a randomized single-blinded controlled trial

    PubMed Central

    2012-01-01

    Background Carpal tunnel syndrome is the most common neuropathy in the upper extremity, resulting from the compression of the median nerve at wrist level. Clinical studies are essentials to present evidence on therapeutic resources use at early restoration on peripheral nerve functionality. Low-level laser therapy has been widely investigated in researches related to nerve regeneration. Therefore, it is suggested that the effect of low-level laser therapy associated with other conservative rehabilitation techniques may positively affect symptoms and overall hand function in compressive neuropathies such as carpal tunnel syndrome. The aim of this study is to evaluate the effectiveness of low-level laser therapy in addition to orthoses therapy and home orientations in patients with carpal tunnel syndrome. Methods/Design Patients older than 18 years old will be included, with clinical diagnosis of carpal tunnel syndrome, excluding comorbidies. A physiotherapist will conduct intervention, with a blinding evaluator. Randomization will be applied to allocate the patients in each group: with association or not to low-level laser therapy. All of them will be submitted to orthoses therapy and home orientations. Outcome will be assessed through: pain visual analogic scale, Semmes Weinstein monofilaments™ threshold sensibility test, Pinch Gauge™, Boston Carpal Tunnel Questionnaire and two point discrimination test. Discussion This paper describes the design of a randomized controlled trial, which aim to assess the effectiveness of conservative treatment added to low-level laser therapy for patients with carpal tunnel syndrome. Trial registration Brazilian Clinical Trials Registry (ReBec) - 75ddtf / Universal Trial Number: U1111-1121-5184 PMID:23237204

  10. fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study

    PubMed Central

    Slaats-Willemse, Dorine; Kan, Cornelis C.; Goebel, Rainer; Buitelaar, Jan K.

    2017-01-01

    Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study’s small sample size, potential clinical benefits need to be further investigated in future studies. Trial Registration: ISRCTN12390961 PMID:28125735

  11. Mnemonic strategy training improves memory for object location associations in both healthy elderly and patients with amnestic mild cognitive impairment: a randomized, single-blind study

    PubMed Central

    Hampstead, Benjamin M.; Sathian, K.; Phillips, Pamela A.; Amaraneni, Akshay; Delaune, William R.; Stringer, Anthony Y.

    2012-01-01

    Objectives To evaluate the efficacy of mnemonic strategy training versus a matched-exposure control condition and also to examine the relationship between training-related gains, neuropsychological abilities, and medial temporal lobe volumetrics in patients with amnestic mild cognitive impairment (aMCI) and age-matched healthy controls. Methods Twenty-three of 45 screened healthy controls and 29 of 42 screened aMCI were randomized to mnemonic strategy or matched-exposure groups. Groups were run in parallel, with participants blind to the other intervention. All participants completed five sessions within two weeks. Memory testing for object-location associations was performed during sessions one and five and at a one-month follow-up. During sessions 2–4, participants received either mnemonic strategy training or a matched number of exposures with corrective feedback for a total of 45 object-location associations. Structural MRI was performed in most participants and medial temporal lobe volumetrics were acquired. Results Twenty-one healthy controls and 28 aMCI patients were included in data analysis. Mnemonic strategy training was significantly more beneficial than matched-exposure immediately after training, p =.006, pη2 = .16, and at one month, p<.001, pη2 = .35, regardless of diagnostic group (healthy controls or aMCI). Although aMCI patients demonstrated gains comparable to the healthy control groups, their overall performance generally remained reduced. Mnemonic strategy-related improvement was positively correlated with baseline memory and executive functioning and negatively with inferior lateral ventricle volume in aMCI patients; no significant relationships were evident in matched-exposure patients. Conclusions Mnemonic strategies effectively improve memory for specific content for at least one month in aMCI. PMID:22409311

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

    PubMed Central

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

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  13. Usefulness of a single-item measure of depression to predict mortality: the GAZEL prospective cohort study

    PubMed Central

    Lefèvre, Thomas; Singh-Manoux, Archana; Stringhini, Silvia; Dugravot, Aline; Lemogne, Cédric; Consoli, Silla M.; Goldberg, Marcel; Zins, Marie

    2012-01-01

    Background: It remains unknown whether short measures of depression perform as well as long measures in predicting adverse outcomes such as mortality. The present study aims to examine the predictive value of a single-item measure of depression for mortality. Methods: A total of 14 185 participants of the GAZEL cohort completed the 20-item Center-for-Epidemiologic-Studies-Depression (CES-D) scale in 1996. One of these items (I felt depressed) was used as a single-item measure of depression. All-cause mortality data were available until 30 September 2009, a mean follow-up period of 12.7 years with a total of 650 deaths. Results: In Cox regression model adjusted for baseline socio-demographic characteristics, a one-unit increase in the single-item score (range 0–3) was associated with a 25% higher risk of all-cause mortality (95% CI: 13–37%, P < 0.001). Further adjustment for health-related behaviours and physical chronic diseases reduced this risk by 36% and 8%, respectively. After adjustment for all these variables, every one-unit increase in the single-item score predicted a 15% increased risk of death (95% CI: 5–27%, P < 0.01). There is also an evidence of a dose–reponse relationship between reponse scores on the single-item measure of depression and mortality. Conclusion: This study shows that a single-item measure of depression is associated with an increased risk of death. Given its simplicity and ease of administration, a very simple single-item measure of depression might be useful for identifying middle-aged adults at risk for elevated depressive symptoms in large epidemiological studies and clinical settings. PMID:21840893

  14. Perceptual Repetition Blindness Effects

    NASA Technical Reports Server (NTRS)

    Hochhaus, Larry; Johnston, James C.; Null, Cynthia H. (Technical Monitor)

    1994-01-01

    The phenomenon of repetition blindness (RB) may reveal a new limitation on human perceptual processing. Recently, however, researchers have attributed RB to post-perceptual processes such as memory retrieval and/or reporting biases. The standard rapid serial visual presentation (RSVP) paradigm used in most RB studies is, indeed, open to such objections. Here we investigate RB using a "single-frame" paradigm introduced by Johnston and Hale (1984) in which memory demands are minimal. Subjects made only a single judgement about whether one masked target word was the same or different than a post-target probe. Confidence ratings permitted use of signal detection methods to assess sensitivity and bias effects. In the critical condition for RB a precue of the post-target word was provided prior to the target stimulus (identity precue), so that the required judgement amounted to whether the target did or did not repeat the precue word. In control treatments, the precue was either an unrelated word or a dummy.

  15. Enteral nutrition with eicosapentaenoic acid, γ-linolenic acid and antioxidants in the early treatment of sepsis: results from a multicenter, prospective, randomized, double-blinded, controlled study: the INTERSEPT Study

    PubMed Central

    2011-01-01

    Introduction Enteral nutrition (EN) with eicosapentaenoic acid (EPA)/γ-linolenic acid (GLA) is recommended for mechanically ventilated patients with severe lung injury. EPA/GLA has anti-inflammatory benefits, as evidenced by its association with reduction in pulmonary inflammation, improvement in oxygenation and improved clinical outcomes in patients with severe forms of acute lung injury. This study was a prospective, multicenter, randomized, double-blinded, controlled trial designed to investigate whether EPA/GLA could have an effective role in the treatment of patients with early sepsis (systemic inflammatory response syndrome with confirmed or presumed infection and without any organ dysfunction) by reducing the progression of the disease to severe sepsis (sepsis associated with at least one organ failure) or septic shock (sepsis associated with hypotension despite adequate fluid resuscitation). Secondary outcomes included the development of individual organ failure, increased ICU and hospital length of stay, need for mechanical ventilation and 28-day all-cause mortality. Methods Randomization was concealed, and patients were allocated to receive, for seven days, either an EPA/GLA diet or an isocaloric, isonitrogenous control diet not enhanced with lipids. Patients were continuously tube-fed at a minimum of 75% of basal energy expenditure × 1.3. To evaluate the progression to severe sepsis and/or septic shock, daily screening for individual organ failure was performed. All clinical outcomes were recorded during a 28-day follow-up period. Results A total of 115 patients in the early stages of sepsis requiring EN were included, among whom 106 were considered evaluable. Intention-to-treat (ITT) analysis demonstrated that patients fed the EPA/GLA diet developed less severe sepsis and/or septic shock than patients fed the control diet (26.3% versus 50%, respectively; P = 0.0259), with similar results observed for the evaluable patients (26.4% versus 50

  16. Psychophysiology of prospective memory.

    PubMed

    Rothen, Nicolas; Meier, Beat

    2014-01-01

    Prospective memory involves the self-initiated retrieval of an intention upon an appropriate retrieval cue. Cue identification can be considered as an orienting reaction and may thus trigger a psychophysiological response. Here we present two experiments in which skin conductance responses (SCRs) elicited by prospective memory cues were compared to SCRs elicited by aversive stimuli to test whether a single prospective memory cue triggers a similar SCR as an aversive stimulus. In Experiment 2 we also assessed whether cue specificity had a differential influence on prospective memory performance and on SCRs. We found that detecting a single prospective memory cue is as likely to elicit a SCR as an aversive stimulus. Missed prospective memory cues also elicited SCRs. On a behavioural level, specific intentions led to better prospective memory performance. However, on a psychophysiological level specificity had no influence. More generally, the results indicate reliable SCRs for prospective memory cues and point to psychophysiological measures as valuable approach, which offers a new way to study one-off prospective memory tasks. Moreover, the findings are consistent with a theory that posits multiple prospective memory retrieval stages.

  17. Effect of spa therapy with saline balneotherapy on oxidant/antioxidant status in patients with rheumatoid arthritis: a single-blind randomized controlled trial

    NASA Astrophysics Data System (ADS)

    Karagülle, Mine; Kardeş, Sinan; Karagülle, Oğuz; Dişçi, Rian; Avcı, Aslıhan; Durak, İlker; Karagülle, Müfit Zeki

    2017-01-01

    Oxidative stress has been shown to play a contributory role in the pathogenesis of rheumatoid arthritis (RA). Recent studies have provided evidence for antioxidant properties of spa therapy. The purpose of this study is to investigate whether spa therapy with saline balneotherapy has any influence on the oxidant/antioxidant status in patients with RA and to assess clinical effects of spa therapy. In this investigator-blind randomized controlled trial, we randomly assigned 50 patients in a 1:1 ratio to spa therapy plus standard drug treatment (spa group) or standard drug treatment alone (control group). Spa group followed a 2-week course of spa therapy regimen consisting of a total of 12 balneotherapy sessions in a thermal mineral water pool at 36-37 °C for 20 min every day except Sunday. All clinical and biochemical parameters were assessed at baseline and after spa therapy (2 weeks). The clinical parameters were pain intensity, patient global assessment, physician global assessment, Health Assessment Questionnaire disability index (HAQ-DI), Disease Activity Score for 28-joints based on erythrocyte sedimentation rate (DAS28-4[ESR]). Oxidative status parameters were malondialdehyde (MDA), nonenzymatic superoxide radical scavenger activity (NSSA), antioxidant potential (AOP), and superoxide dismutase (SOD). The NSSA levels were increased significantly in the spa group ( p = 0.003) but not in the control group ( p = 0.509); and there was a trend in favor of spa therapy for improvements in NSSA levels compared to control ( p = 0.091). Significant clinical improvement was found in the spa group compared to the control in terms of patient global assessment ( p = 0.011), physician global assessment ( p = 0.043), function (HAQ-DI) ( p = 0.037), disease activity (DAS28-4[ESR]) (0.044) and swollen joint count (0.009), and a trend toward improvement in pain scores (0.057). Spa therapy with saline balneotherapy exerts antioxidant effect in patients with RA as reflected by the

  18. Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine on psychomotor function and histamine-induced wheal- and flare-responses: a randomized double-blind, placebo-controlled study in healthy volunteers.

    PubMed

    Kamei, Hiroyuki; Isaji, Ami; Noda, Yukihiro; Ishikawa, Kazuhiro; Senzaki, Koji; Yamada, Kiyofumi; Sugiura, Kazumitsu; Tomita, Yasushi; Nabeshima, Toshitaka

    2012-05-01

    Since most first-generation antihistamines have undesirable sedative effects on the central nervous systems (CNS), newer (second-generation) antihistamines have been developed to improve patients' quality of life. However, there are few reports that directly compare the antihistaminic efficacy and impairment of psychomotor functions. We designed a double-blind, placebo controlled, crossover study to concurrently compare the clinical effectiveness of promethazine, a first-generation antihistamine, and fexofenadine and olopatadine, second-generation antihistamines, by measuring their potency as peripheral inhibitors of histamine-induced wheal and flare. Further, we investigated their sedative effects on the CNS using a battery of psychomotor tests. When single therapeutic doses of fexofenadine (60 mg), olopatadine (5 mg) and promethazine (25 mg) were given in a double-blind manner to 24 healthy volunteers, all antihistamines produced a significant reduction in the wheal and flare responses induced by histamine. In the comparison among antihistamines, olopatadine showed a rapid inhibitory effect compared with fexofenadine and promethazine, and had a potent effect compared with promethazine. In a battery of psychomotor assessments using critical flicker fusion, choice reaction time, compensatory tracking, rapid visual information processing and a line analogue rating scale as a subjective assessment of sedation, promethazine significantly impaired psychomotor function. Fexofenadine and olopatadine had no significant effect in any of the psychomotor tests. Promethazine, fexofenadine and olopatadine did not affect behavioral activity, as measured by wrist actigraphy. These results suggest that olopatadine at a therapeutic dose has greater antihistaminergic activity than promethazine, and olopatadine and fexofenadine did not cause cognitive or psychomotor impairment.

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

    PubMed Central

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

    2017-01-01

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

  20. 3D Printing/Additive Manufacturing Single Titanium Dental Implants: A Prospective Multicenter Study with 3 Years of Follow-Up.

    PubMed

    Tunchel, Samy; Blay, Alberto; Kolerman, Roni; Mijiritsky, Eitan; Shibli, Jamil Awad

    2016-01-01

    This prospective 3-year follow-up clinical study evaluated the survival and success rates of 3DP/AM titanium dental implants to support single implant-supported restorations. After 3 years of loading, clinical, radiographic, and prosthetic parameters were assessed; the implant survival and the implant-crown success were evaluated. Eighty-two patients (44 males, 38 females; age range 26-67 years) were enrolled in the present study. A total of 110 3DP/AM titanium dental implants (65 maxilla, 45 mandible) were installed: 75 in healed alveolar ridges and 35 in postextraction sockets. The prosthetic restorations included 110 single crowns (SCs). After 3 years of loading, six implants failed, for an overall implant survival rate of 94.5%; among the 104 surviving implant-supported restorations, 6 showed complications and were therefore considered unsuccessful, for an implant-crown success of 94.3%. The mean distance between the implant shoulder and the first visible bone-implant contact was 0.75 mm (±0.32) and 0.89 (±0.45) after 1 and 3 years of loading, respectively. 3DP/AM titanium dental implants seem to represent a successful clinical option for the rehabilitation of single-tooth gaps in both jaws, at least until 3-year period. Further, long-term clinical studies are needed to confirm the present results.

  1. 3D Printing/Additive Manufacturing Single Titanium Dental Implants: A Prospective Multicenter Study with 3 Years of Follow-Up

    PubMed Central

    2016-01-01

    This prospective 3-year follow-up clinical study evaluated the survival and success rates of 3DP/AM titanium dental implants to support single implant-supported restorations. After 3 years of loading, clinical, radiographic, and prosthetic parameters were assessed; the implant survival and the implant-crown success were evaluated. Eighty-two patients (44 males, 38 females; age range 26–67 years) were enrolled in the present study. A total of 110 3DP/AM titanium dental implants (65 maxilla, 45 mandible) were installed: 75 in healed alveolar ridges and 35 in postextraction sockets. The prosthetic restorations included 110 single crowns (SCs). After 3 years of loading, six implants failed, for an overall implant survival rate of 94.5%; among the 104 surviving implant-supported restorations, 6 showed complications and were therefore considered unsuccessful, for an implant-crown success of 94.3%. The mean distance between the implant shoulder and the first visible bone-implant contact was 0.75 mm (±0.32) and 0.89 (±0.45) after 1 and 3 years of loading, respectively. 3DP/AM titanium dental implants seem to represent a successful clinical option for the rehabilitation of single-tooth gaps in both jaws, at least until 3-year period. Further, long-term clinical studies are needed to confirm the present results. PMID:27313616

  2. Single versus Multiple Suicide Attempts: A Prospective Examination of Psychiatric Factors and Wish to Die/Wish to Live Index

    DTIC Science & Technology

    2013-04-18

    to another base, his post-traumatic stress and depressive symptoms worsened. Prior to his suicide , he made two unsuccessful attempts. His mother...one suicide attempt in women. Trauma history. Individuals with Posttraumatic Stress Disorder may display self-destructive and impulsive behaviors...Afghanistan war veterans reporting SINGLE VERSUS MULTIPLE SUICIDE ATTEMPTS 103       subthreshold and threshold Posttraumatic Stress

  3. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study

    PubMed Central

    Gonçalves, Anthony; Bertucci, François; Guille, Arnaud; Garnier, Severine; Adelaide, José; Carbuccia, Nadine; Cabaud, Oliver; Finetti, Pascal; Brunelle, Serge; Piana, Gilles; Tomassin-Piana, Jeanne; Paciencia, Maria; Lambaudie, Eric; Popovici, Cornel; Sabatier, Renaud; Tarpin, Carole; Provansal, Magali; Extra, Jean-Marc; Eisinger, François; Sobol, Hagay; Viens, Patrice; Lopez, Marc; Ginestier, Christophe; Charafe-Jauffret, Emmanuelle; Chaffanet, Max; Birnbaum, Daniel

    2016-01-01

    Background Routine feasibility and clinical impact of genomics-based tumor profiling in advanced breast cancer (aBC) remains to be determined. We conducted a pilot study to evaluate whether precision medicine could be prospectively implemented for aBC patients in a single center and to examine whether patient-derived tumor xenografts (PDX) could be obtained in this population. Results Thirty-four aBC patients were included. Actionable targets were found in 28 patients (82%). A targeted therapy could be proposed to 22 patients (64%), either through a clinical trial (n=15) and/or using already registered drugs (n=21). Ten patients (29%) eventually received targeted treatment, 2 of them deriving clinical benefit. Of 22 patients subjected to mouse implantation, 10 had successful xenografting (45%), mostly in triple-negative aBC. Methods aBC patients accessible to tumor biopsy were prospectively enrolled at the Institut Paoli-Calmettes in the BC-BIO study (ClinicalTrials.gov, NCT01521676). Genomic profiling was established by whole-genome array comparative genomic hybridization (aCGH) and targeted next-generation sequencing (NGS) of 365 candidate cancer genes. For a subset of patients, a sample of fresh tumor was orthotopically implanted in humanized cleared fat pads of NSG mice for establishing PDX. Conclusions Precision medicine can be implemented in a single center in the context of clinical practice and may allow genomic-driven treatment in approximately 30% of aBC patients. PDX may be obtained in a significant fraction of cases. PMID:27765906

  4. Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers

    PubMed Central

    Deng, Rong; Derby, Michael A.; Larouche, Richard; Horn, Priscilla; Anderson, Malia; Maia, Mauricio; Carrier, Stephanie; Pelletier, Isabelle; Burgess, Tracy; Kulkarni, Priya; Newton, Elizabeth; Tavel, Jorge A.

    2016-01-01

    Hospitalized patients with severe influenza are at significant risk for morbidity and mortality. MHAA4549A is a human monoclonal immunoglobulin (Ig) G1 antibody that binds to a highly conserved stalk region of the influenza A virus hemagglutinin protein and neutralizes all tested seasonal human influenza A virus strains. Two phase 1 trials examined the safety, tolerability, and pharmacokinetics of MHAA4549A in healthy volunteers. Both single ascending-dose trials were randomized, double blinded, and placebo controlled. Trial 1 randomized 21 healthy adults into four cohorts receiving a single intravenous dose of 1.5, 5, 15, or 45 mg/kg MHAA4549A or placebo. Trial 2 randomized 14 healthy adults into two cohorts receiving a single intravenous fixed dose of 8,400 mg or 10,800 mg of MHAA4549A or placebo. Subjects were followed for 120 days after dosing. No subject was discontinued in either trial, and no serious adverse events were reported. The most common adverse event in both studies was mild headache (trial 1, 4/16 subjects receiving MHAA4549A and 1/5 receiving placebo; trial 2, 4/8 subjects receiving MHAA4549A and 2/6 receiving placebo). MHAA4549A produced no relevant time- or dose-related changes in laboratory values or vital signs compared to those with placebo. No subjects developed an antitherapeutic antibody response following MHAA4549A administration. MHAA4549A showed linear serum pharmacokinetics, with a mean half-life of 22.5 to 23.7 days. MHAA4549A is safe and well tolerated in healthy volunteers up to a single intravenous dose of 10,800 mg and demonstrates linear serum pharmacokinetics consistent with those of a human IgG1 antibody lacking known endogenous targets in humans. (These trials have been registered at ClinicalTrials.gov under registration no. NCT01877785 and NCT02284607). PMID:27381392

  5. Evaluation of the Immediate Effect of Auricular Acupuncture on Pain and Electromyographic Activity of the Upper Trapezius Muscle in Patients with Nonspecific Neck Pain: A Randomized, Single-Blinded, Sham-Controlled, Crossover Study

    PubMed Central

    Silva, Andréia Cristina de Oliveira; Biasotto-Gonzalez, Daniela Aparecida; dos Santos, Douglas Meira; Melo, Nivea Cristina De; Gomes, Cid André Fidelis de Paula; Amorim, César Ferreira; Politti, Fabiano

    2015-01-01

    Background. The aim of the present study was to assess the immediate effects of auricular acupuncture (AA) on the electromyographic (EMG) activity of the upper trapezius muscle and pain in nonspecific neck pain (NS-NP) patients. Twelve patients with NS-NP (NS-NP group) and 12 healthy subjects (HS Group) were enrolled in a randomized, single-blinded, crossover study. Each subject received a single session of AA and sham AA (SAA). Surface EMG activity was measured in the upper trapezius muscle at different “step contractions” of isometric shoulder elevation (15%, 20%, 25%, and 30% MVC). The outcome measure in patients with NS-NP was based on the numerical pain rating scale (NRS). AA treatment led to a significant decrease in EMG activity in both groups (NS-NP group: p = 0.0001; HS group: p < 0.0001—ANOVA test). This was not the case for the SAA treatment (NS-NP group: p = 0.71; HS group: p < 0.54). Significant decreases (p < 0.001) in the NRS were found for both treatments (AA and SAA). This study demonstrated the immediate effect of auricular acupuncture on the electromyographic activity of the upper trapezius muscle but the effect of this intervention on pain symptoms in patients with nonspecific neck pain was inconclusive. PMID:26451155

  6. Photodynamic Therapy Followed by Mohs Micrographic Surgery Compared to Mohs Micrographic Surgery Alone for the Treatment of Basal Cell Carcinoma: Results of a Pilot Single-Blinded Randomised Controlled Trial

    PubMed Central

    Al-Niaimi, Firas; Sheth, Nisith; Kurwa, Habib A; Mallipeddi, Raj

    2015-01-01

    Introduction: Basal cell carcinoma is a common cutaneous malignant tumour. Surgical excision is the “gold standard” treatment for most subtypes, with Mohs micrographic surgery (MMS) offering the highest cure rate. Other treatment modalities used include photodynamic therapy (PDT). Background: We aimed to study the efficacy of combining MMS with PDT to see whether this would reduce the number of stages and final defect size when compared with MMS alone. Materials and Methods: Our study was a single-centre, single-blinded, randomised and controlled pilot study involving a total of 19 patients. Nine patients were randomised to pre-treatment with PDT followed by MMS of whom two withdrew; the remaining 10 patients were randomised to the MMS alone. Follow-up visits were arranged at 3 and 6 months post-surgery. Results: In the PDT arm, five out of the seven treated patients (71%) had their initial tumour size decreased following PDT treatment prior to MMS. The average number of stages in the PDT arm was 1.85, compared to 2.5 in the MMS arm. The average number of sections in the PDT arm was 4.2, in comparison to 5.2 in the MMS arm. Conclusion: Our pilot study showed a promising but limited role for PDT as an adjunct in MMS in the treatment of selected cases of basal cell carcinomas. Larger trials, preferably multi-centred are required to further examine the role of this combination therapy. PMID:26157307

  7. A Single Dose of Amoxicillin and Dexamethasone for Prevention of Postoperative Complications in Third Molar Surgery: A Randomized, Double-Blind, Placebo Controlled Clinical Trial

    PubMed Central

    Bortoluzzi, Marcelo Carlos; Capella, Diogo Lenzi; Barbieri, Tharzon; Pagliarini, Micheli; Cavalieri, Talita; Manfro, Rafael

    2013-01-01

    Background The aim of this study was to assess the efficacy of a single prophylactic dose of amoxicillin and/or dexamethasone in preventing postoperative complications (PC) after a surgical removal of a single mandibular third molar (M3). Methods This study is a randomized, placebo controlled clinical trial. Four groups were included: Group 1 (G1) included a prophylactic dose of 2 g of amoxicillin and 8 mg of dexamethasone; Group 2 (G2) included a prophylactic dose of 2 g of amoxicillin and 8 mg of placebo; Group 3 (G3) included a prophylactic dose of 8 mg of dexamethasone and 2 g of placebo and; Group 4 (G4) placebo. Results Fifty patients were included. It was observed one case of alveolar infection (2%) and two of alveolar osteitis (4%) resulting in three PC (6%). No statistical differences were observed between therapeutic groups for development of PC, trismus, pain and edema. The use of antibiotics showed an absolute risk reduction (ARR) for PC development of 3.52% and the number needed to treat (NNT) was 29. Conclusion Prophylactic antibiotics and corticoid in a single dose regimen did not bring any benefit on M3 surgeries. PMID:23390473

  8. Modulating arithmetic fact retrieval: a single-blind, sham-controlled tDCS study with repeated fMRI measurements.

    PubMed

    Clemens, Benjamin; Jung, Stefanie; Zvyagintsev, Mikhail; Domahs, Frank; Willmes, Klaus

    2013-06-01

    Transcranial direct current stimulation (tDCS) is a non-invasive technique which has been used to modulate various cognitive functions in healthy participants as well as stroke patients. Despite the increasing number of tDCS studies, it still remains questionable whether tDCS is suitable for modulating performance in arithmetic tasks and whether a single tDCS session may cause brain activity changes that can be detected with functional magnetic resonance imaging (fMRI). We asked healthy participants to repeatedly solve simple multiplication tasks in three conditions: STIMULATION (anodal tDCS over the right angular gyrus, AG), SHAM (identical electrode set-up without stimulation), and CONTROL (no electrodes attached). Before and after tDCS, we used fMRI to examine changes in brain activity. Behavioural results indicate that a single session of tDCS did not modulate task performance significantly. However, fMRI measurements revealed that the neural correlates of multiplication were modified following a single session of anodal tDCS. In the bilateral AG, activity was significantly higher for multiplication problems rehearsed during active tDCS, as compared to multiplication problems rehearsed without tDCS or during sham tDCS. In sum, we present first neuro-functional evidence that tDCS modulates arithmetic processing. Implications of these findings for future tDCS studies and for the rehabilitation of acalculic patients with deficits in arithmetic fact retrieval are discussed.

  9. Two-year survival analysis of twisted wire fixed retainer versus spiral wire and fiber-reinforced composite retainers: a preliminary explorative single-blind randomized clinical trial

    PubMed Central

    Sobouti, Farhad; Rakhshan, Vahid; Saravi, Mahdi Gholamrezaei; Zamanian, Ali

    2016-01-01

    Objective Traditional retainers (both metal and fiber-reinforced composite [FRC]) have limitations, and a retainer made from more flexible ligature wires might be advantageous. We aimed to compare an experimental design with two traditional retainers. Methods In this prospective preliminary clinical trial, 150 post-treatment patients were enrolled and randomly divided into three groups of 50 patients each to receive mandibular canine-to-canine retainers made of FRC, flexible spiral wire (FSW), and twisted wire (TW). The patients were monitored monthly. The time at which the first signs of breakage/debonding were detected was recorded. The success rates of the retainers were compared using chi-squared, Kaplan-Meier, and Cox proportional-hazard regression analyses (α = 0.05). Results In total, 42 patients in the FRC group, 41 in the FSW group, and 45 in the TW group completed the study. The 2-year failure rates were 35.7% in the FRC group, 26.8% in the FSW group, and 17.8% in the TW group. These rates differed insignificantly (chi-squared p = 0.167). According to the Kaplan-Meier analysis, failure occurred at 19.95 months in the FRC group, 21.37 months in the FSW group, and 22.36 months in the TW group. The differences between the survival rates in the three groups were not significant (Cox regression p = 0.146). Conclusions Although the failure rate of the experimental retainer was two times lower than that of the FRC retainer, the difference was not statistically significant. The experimental TW retainer was successful, and larger studies are warranted to verify these results. PMID:27019825

  10. Can we sense ART? The blinded examiner is not blind-a problem with follow-up studies on children born after assisted reproduction.

    PubMed

    Ludwig, Annika K; Katalinic, Alexander; Entenmann, Andreas; Thyen, Ute; Sutcliffe, Alastair G; Diedrich, Klaus; Ludwig, M

    2009-09-01

    In a prospective, controlled, blinded follow-up study of children born after intracytoplasmic sperm injection (ICSI), blinded examiners correctly intuited the mode of conception (ICSI versus spontaneous) in three out of four children, which must be considered when interpreting outcome data for children born after assisted reproduction.

  11. Imagery limitations in totally congenitally blind subjects.

    PubMed

    De Beni, R; Cornoldi, C

    1988-10-01

    Research on totally blind subjects performing tasks that involve visual imagery has often shown that they do not behave differently from matched sighted subjects, even when their blindness is congenital. If visual imagery is based on visual perception, such tasks may not required visual imagery. In the present article visual images are considered as representations maintaining some properties of visible objects and constructed on the basis of information from various sources. Owing to the absence of visual experience, the limitations of such representations are explored in a series of experiments requiring memorization of single nouns, pairs of nouns, or triplets of nouns associated with a cue noun. Recall by blind subjects was impaired when multiple interactive images (with noun pairs and triplets) are formed. The poorer recall of blind subjects reflected also loss of order information. Recall was better for both groups with locative noun cues and high-imagery targets.

  12. Infectious Mononucleosis at the United States Military Academy. A Prospective Study of a Single Class Over Four Years 1

    PubMed Central

    Hallee, T. James; Evans, Alfred S.; Niederman, James C.; Brooks, Charles M.; Voegtly, John H.

    1974-01-01

    A prospective study of EB virus infections was initiated in July, 1969 in the entering class of 1401 cadets, at the U.S. Military Academy at West Point, N.Y. and continued over 4 yr. On entry 63.5% possessed EBV antibody and 36.5 lacked EBV antibody. The rate of antibody prevalence varied with the geographic area from which the cadet originated. Except in two cadets already ill on first bleeding no evidence of clinical infectious mononucleosis (I.M.) occurred over the 4 yr period in the 890 cadets entering the Academy with EBV antibody. Among 437 cadets without antibody on entry, 54 or 12.4% were infected (seroconverted) in the freshman year; 15 of these had clinical I.M., 12 had suggestive I.M., and 39 had no known mono-like illness. The annual infection rates in susceptible cadets in the second, third, and fourth years were 24.4, 15.1, and 30.8 per 100, respectively. Of 201 cadets infected with EBV over 4 yr only 26.4% were manifested by heterophile positive clinical infectious mononucleosis. Overall, 46% of the 437 cadets entering without EBV antibody became infected over 40 mo of serologic observation; definite clinical infectious mononucleosis developed in 53 cadets, a clinical attack rate of 12.1 per 100 for 4 yr. The EBV infection rate among exposed and susceptible roommates of known cases was no higher than in roommates not so exposed. Elevations of EBV-specific and total IgM occurred during acute illness and disappeared in late convalescence. Total IgG and IgA levels were less commonly elevated. EBV-specific-IgM antibody was demonstrable during the acute illness but was absent 12 mo later. Analysis of EBV infection rates revealed no difference among persons of different ABO blood groups. PMID:4374836

  13. Symptoms and Clinical Course of EHEC O104 Infection in Hospitalized Patients: A Prospective Single Center Study

    PubMed Central

    Neumann-Grutzeck, Christine; Otto, Helge; Rüther, Christoph; von Seydewitz, Cay Uwe; Meyer, Gerd Peter; Ahmadi-Simab, Keihan; Röther, Joachim; Hogan, Barbara; Schwenk, Wolfgang; Fischbach, Roman; Caselitz, Jörg; Puttfarcken, Jochen; Huggett, Susanne; Tiedeken, Petra; Pober, Jordan; Kirkiles-Smith, Nancy C.; Hagenmüller, Friedrich

    2013-01-01

    Objectives Shiga-toxin producing O157:H7 Entero Haemorrhagic E. coli (STEC/EHEC) is one of the most common causes of Haemolytic Uraemic Syndrome (HUS) related to infectious haemorrhagic colitis. Nearly all recommendations on clinical management of EHEC infections refer to this strain. The 2011 outbreak in Northern Europe was the first to be caused by the serotype O104:H4. This EHEC strain was found to carry genetic features of Entero Aggregative E. coli (EAEC) and extended spectrum β lactamase (ESBL). We report symptoms and complications in patients at one of the most affected centres of the 2011 EHEC O104 outbreak in Northern Germany. Methods The courses of patients admitted to our hospital due to bloody diarrhoea with suspected EHEC O104 infection were recorded prospectively. These data include the patients’ histories, clinical findings, and complications. Results EHEC O104 infection was confirmed in 61 patients (female = 37; mean age: 44±2 years). The frequency of HUS was 59% (36/61) in our cohort. An enteric colonisation with co-pathogens was found in 57%. Thirty-one (51%) patients were treated with plasma-separation/plasmapheresis, 16 (26%) with haemodialysis, and 7 (11%) with Eculizumab. Patients receiving antibiotic treatment (n = 37; 61%) experienced no apparent change in their clinical course. Twenty-six (43%) patients suffered from neurological symptoms. One 83-year-old patient died due to comorbidities after HUS was successfully treated. Conclusions EHEC O104:H4 infections differ markedly from earlier reports on O157:H7 induced enterocolitis in regard to epidemiology, symptomatology, and frequency of complications. We recommend a standard of practice for clinical monitoring and support the renaming of EHEC O104:H4 syndrome as “EAHEC disease”. PMID:23460784

  14. Analysis of histopathological pattern of kidney biopsy specimens in Kuwait: A single-center, five-year prospective study.

    PubMed

    Abdallah, Emad; Al-Helal, Bassam; Asad, Reem; Kannan, Shreeram; Draz, Wael; Abdelgawad, Zeyad

    2015-11-01

    Glomerulonephritis (GN) varies in incidence in different geographical areas due to different socioeconomic conditions and ethnicity, genetic variability and environmental factors. Our study is aimed to determine the histopathological pattern of kidney biopsies in Kuwait over the preceding five years. In a prospective study, we analyzed the clinical and pathological data of 214 kidney biopsies that were performed during the period from November 2009 to November 2014 at the Al-Khezam Dialysis Center, Al-Adan Hospital, Kuwait. Kidney biopsies were performed percutaneously using an automated gun guided by ultrasound. The biopsy samples were processed for light microscopy and immunofluorescence. Electron microscopy was performed only in selected cases. Age, gender, serum creatinine, 24-h urinary protein, virology, immunology profiles, indication for renal biopsy and histopathological findings were recorded for analysis. Primary GN was reported in 46.7%, secondary GN was reported in 42.9% and tubulointerstitial disease was reported in 10.3% of the 214 kidney biopsies studied. Among primary GN, membranous GN (MGN) was the most common lesion (12.1%), followed by immunoglobulin A nephropathy (IgAN, 11.7%), minimal change disease (9.8%), focal and segmental glomerulosclerosis (9.3%), membranoproliferative GN (1.9%), Alport's syndrome (1.4%) and fibrillary GN (0.46%). Among biopsies that showed secondary GN, lupus nephritis was the most common (11.7%), followed by hypertensive glomerulosclerosis (10.3%), crescentic GN (7.1%), diabetic nephropathy (3.3%), thrombotic microangiopathy (2.3%), amyloidosis (2.3%), post-infectious GN (1.4%) and myeloma kidney (0.9%). Among biopsies that showed tubulointerstitial disease, acute interstitial nephritis was the most common lesion (6.1%), followed by chronic interstitial nephritis (2.8%) and acute tubular necrosis (1.4%). Our study indicates that MGN was the most common primary GN, followed by IgAN, while lupus nephritis was the most

  15. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison.

    PubMed

    Cury, Ricardo C; Kitt, Therese M; Feaheny, Kathleen; Akin, Jamie; George, Richard T

    2014-01-01

    Pharmacologic stress myocardial CT perfusion (CTP) has been reported to be a viable imaging modality for detection of myocardial ischemia compared with single-photon emission CT (SPECT) in several single-center studies. However, regadenoson-stress CTP has not previously been compared with SPECT in a multicenter, multivendor study. The rationale and design of a phase 2, randomized, cross-over study of regadenoson-stress myocardial perfusion imaging by CTP compared with SPECT are described herein. The study will be conducted at approximately 25 sites by using 6 different CT scanner models, including 64-, 128-, 256-, and 320-slice systems. Subjects with known/suspected coronary artery disease will be randomly assigned to 1 of 2 imaging procedure sequences; rest and regadenoson-stress SPECT on day 1, then regadenoson-stress CTP and rest CTP/coronary CT angiography (same acquisition) on day 2; or regadenoson-stress CTP and rest CTP/CT angiography on day 1, then rest and regadenoson-stress SPECT on day 2. The prespecified primary analysis examines the agreement rate between CTP and SPECT for detecting or excluding ischemia (≥2 or 0-1 reversible defects, respectively), as assessed by 3 independent blinded readers for each modality. Non-inferiority will be indicated if the lower boundary of the 95% CI for the agreement rate is within 0.15 of 0.78 (the observed agreement rate in the regadenoson pivotal trials). The protocol described herein will support the first evaluation of regadenoson-stress CTP by using multiple scanner types compared with SPECT.

  16. The ‘single big cryoballoon’ technique for acute pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a prospective observational single centre study

    PubMed Central

    Chun, Kyoung-Ryul Julian; Schmidt, Boris; Metzner, Andreas; Tilz, Roland; Zerm, Thomas; Köster, Ilka; Fürnkranz, Alexander; Koektuerk, Buelent; Konstantinidou, Melanie; Antz, Matthias; Ouyang, Feifan; Kuck, Karl Heinz

    2009-01-01

    Aims Cryothermal energy (CTE) ablation via a balloon catheter (Arctic Front, Cryocath™) represents a novel technology for pulmonary vein isolation (PVI). However, balloon-based PVI approaches are associated with phrenic nerve palsy (PNP). We investigated whether ‘single big cryoballoon’-deployed CTE lesions can (i) achieve acute electrical PVI without left atrium (LA) imaging and (ii) avoid PNP in patients with paroxysmal atrial fibrillation (PAF). Methods and results After double transseptal punctures, one Lasso catheter and a big 28 mm cryoballoon catheter using a steerable sheath were inserted into the LA. PV angiography and ostial Lasso recordings from all PVs were obtained. Selective PV angiography was used to evaluate balloon to LA–PV junction contact. CTE ablation lasted 300 s, and the PN was paced during freezing at right-sided PVs. Twenty-seven patients (19 males, mean age: 56 ± 9 years, LA size: 42 ± 5 mm) with PAF (mean duration: 6.6 ± 5.7 years) were included. PVI was achieved in 97/99 PVs (98%). Median (Q1; Q3) procedural, balloon, and fluoroscopy times were 220 min (190; 245), 130 min (90; 170), and 50 min (42; 69), respectively. Three transient PNP occurred after distal PV ablations. No PV stenosis occurred. Total median (Q1; Q3) follow-up time was 271 days (147; 356), and 19 of 27 patients (70%) remained in sinus rhythm (3-month blanking period). Conclusion Using the single big cryoballoon technique, almost all PVs (98%) could be electrically isolated without LA imaging and may reduce the incidence of PNP as long as distal ablation inside the septal PVs is avoided. PMID:19109353

  17. Blindness and Yoga

    ERIC Educational Resources Information Center

    Heyes, Anthony David

    1974-01-01

    Evidence is presented to support the claims that, among many blind persons, physical inactivity leads to poor physical fitness; that a state of anxiety is often a concomitant of unguided blind mobility; and that Yogic practices offer a solution to both difficulties. (GW)

  18. "Color-Blind" Racism.

    ERIC Educational Resources Information Center

    Carr, Leslie G.

    Examining race relations in the United States from a historical perspective, this book explains how the constitution is racist and how color blindness is actually a racist ideology. It is argued that Justice Harlan, in his dissenting opinion in Plessy v. Ferguson, meant that the constitution and the law must remain blind to the existence of race…

  19. Blindness after intranasal ethmoidectomy.

    PubMed

    Sözeri, B; Ataman, M; Gürsel, B

    1993-06-01

    Orbital haemorrhage is an unusual and frustrating complication of ethmoid surgery. A case of reversible blindness which was due to intra-operative orbital haemorrhage occurring after intranasal ethmoidectomy is presented. Prevention and management of this kind of blindness can be reversed, if treated aggressively.

  20. Stereotactic Body Radiotherapy for Medically Inoperable Lung Cancer: Prospective, Single-Center Study of 108 Consecutive Patients

    SciTech Connect

    Taremi, Mojgan; Hope, Andrew; Dahele, Max; Pearson, Shannon; Fung, Sharon; Purdie, Thomas; Brade, Anthony; Cho, John; Sun, Alexander; Bissonnette, Jean-Pierre; Bezjak, Andrea

    2012-02-01

    Purpose: To present the results of stereotactic body radiotherapy (SBRT) for medically inoperable patients with Stage I non-small-cell lung cancer (NSCLC) and contrast outcomes in patients with and without a pathologic diagnosis. Methods and Materials: Between December 2004 and October 2008, 108 patients (114 tumors) underwent treatment according to the prospective research ethics board-approved SBRT protocols at our cancer center. Of the 108 patients, 88 (81.5%) had undergone pretreatment whole-body [18F]-fluorodeoxyglucose positron emission tomography/computed tomography. A pathologic diagnosis was unavailable for 33 (28.9%) of the 114 lesions. The SBRT schedules included 48 Gy in 4 fractions or 54-60 Gy in 3 fractions for peripheral lesions and 50-60 Gy in 8-10 fractions for central lesions. Toxicity and radiologic response were assessed at the 3-6-month follow-up visits using conventional criteria. Results: The mean tumor diameter was 2.4-cm (range, 0.9-5.7). The median follow-up was 19.1 months (range, 1-55.7). The estimated local control rate at 1 and 4 years was 92% (95% confidence interval [CI], 86-97%) and 89% (95% CI, 81-96%). The cause-specific survival rate at 1 and 4 years was 92% (95% CI, 87-98%) and 77% (95% CI, 64-89%), respectively. No statistically significant difference was found in the local, regional, and distant control between patients with and without pathologically confirmed NSCLC. The most common acute toxicity was Grade 1 or 2 fatigue (53 of 108 patients). No toxicities of Grade 4 or greater were identified. Conclusions: Lung SBRT for early-stage NSCLC resulted in excellent local control and cause-specific survival with minimal toxicity. The disease-specific outcomes were comparable for patients with and without a pathologic diagnosis. SBRT can be considered an option for selected patients with proven or presumed early-stage NSCLC.

  1. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn’s Disease in a Randomized Single-Blinded Placebo Controlled Study

    PubMed Central

    Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

    2016-01-01

    Background Ingestion of AndoSanTM, based on the mushroom Agaricus blazei Murill, has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn’s disease (CD). In this randomized single-blinded placebo-controlled study we examined whether intake of AndoSanTM also resulted in clinical effects. Methods and Findings 50 patients with symptomatic CD were randomized for oral daily consumption of AndoSanTM or placebo for a 21-day experimental period, in this per-protocol study. Patients reported validated scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSanTM group (n = 25) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.52 (4.64–6.40), 4.48 (3.69–5.27) and 4.08 (3.22–4.94) (p<0,001). We found significant improvements in symptom score for both genders in the AndoSanTM group, and no significant changes in the placebo (n = 25) group. There were however no significant differences between the groups (p = 0.106), although a marginal effect in symptom score for men (p = 0.054). There were comparable improvements in physical, mental and total fatigue for both groups. HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the AndoSanTM group and for vitality and social functioning in the placebo group. No crucial changes in general blood samples and fecal calprotectin were detected. Conclusions The results from this single-blinded randomized clinical trial shows significant improvement on symptoms, for both genders, in the AndoSanTM group, but no significant differences between the study groups. The results on fatigue, HRQoL, fecal calprotectin and blood samples were quite similar compared with placebo. The patients did not report any harms or unintended effects of AndoSanTM. CD patients with

  2. Change blindness images.

    PubMed

    Ma, Li-Qian; Xu, Kun; Wong, Tien-Tsin; Jiang, Bi-Ye; Hu, Shi-Min

    2013-11-01

    Change blindness refers to human inability to recognize large visual changes between images. In this paper, we present the first computational model of change blindness to quantify the degree of blindness between an image pair. It comprises a novel context-dependent saliency model and a measure of change, the former dependent on the site of the change, and the latter describing the amount of change. This saliency model in particular addresses the influence of background complexity, which plays an important role in the phenomenon of change blindness. Using the proposed computational model, we are able to synthesize changed images with desired degrees of blindness. User studies and comparisons to state-of-the-art saliency models demonstrate the effectiveness of our model.

  3. A comparison of postoperative pain after conventional open thyroidectomy and single-incision, gasless, endoscopic transaxillary thyroidectomy: a single institute prospective study

    PubMed Central

    Kang, Jung Bong; Kim, Eun Young; Park, Yong Lai; Park, Chan Heun

    2017-01-01

    Purpose The aim of this study was to compare postoperative pain between single-incision, gasless, endoscopic transaxillary thyroidectomy (SET), and conventional open thyroidectomy. Methods From March to December 2015, patients with thyroid disease underwent total thyroidectomy or lobectomy. Patient's clinical and pathological characteristics, postoperative pain score using visual analog scale (VAS) were compared between the 2 groups. The primary endpoint was postoperative pain evaluated by VAS score and postoperative analgesic use. Operation time and length of postoperative hospital stay were secondary outcome measures. Results Conventional, open cervical surgery was performed on 30 patients (group O) and SET was performed on 27 patients (group E). Pain scores in shoulder area, which is the ipsilateral side of the tumor location at 1 hour and 24 hours after surgery, were higher in group E patients (P < 0.05). Pain scores 7 days after surgery did not differ between the 2 groups according to the locations (P < 0.05). Conclusion In conclusion, endocrine surgeons should be concerned about immediate higher postoperative pain scores in patients who undergo SET. PMID:28090500

  4. Prospective Observational Study of Single-Site Multiport Per-umbilical Laparoscopic Endosurgery versus Conventional Multiport Laparoscopic Cholecystectomy: Critical Appraisal of a Unique Umbilical Approach

    PubMed Central

    Jategaonkar, Priyadarshan Anand; Yadav, Sudeep Pradeep

    2014-01-01

    Purpose. This prospective observational study compares an innovative approach of Single-Site Multi-Port Per-umbilical Laparoscopic Endo-surgery (SSMPPLE) cholecystectomy with the gold standard—Conventional Multi-port Laparoscopic Cholecystectomy (CMLC)—to assess the feasibility and efficacy of the former. Methods. In all, 646 patients were studied. SSMPPLE cholecystectomy utilized three ports inserted through three independent mini-incisions at the umbilicus. Only the day-to-day rigid laparoscopic instruments were used in all cases. The SSMPPLE cholecystectomy group had 320 patients and the CMLC group had 326 patients. The outcomes were statistically compared. Results. SSMPPLE cholecystectomy had average operative time of 43.8 min and blood loss of 9.4 mL. Their duration of hospitalization was 1.3 days (range, 1–5). Six patients (1.9%) of this group were converted to CMLC. Eleven patients had controlled gallbladder perforations at dissection. The Visual Analogue Scores for pain on postoperative days 0 and 7, the operative time, and the scar grades were significantly better for SSMPPLE than CMLC. However, umbilical sepsis and seroma outcomes were similar. We had no bile-duct injuries or port-site hernias in this study. Conclusion. SSMPPLE cholecystectomy approach complies with the principles of laparoscopic triangulation; it seems feasible and safe method of minimally invasive cholecystectomy. Overall, it has a potential to emerge as an economically viable alternative to single-port surgery. PMID:24876955

  5. Perceptual repetition blindness effects.

    PubMed

    Hochhaus, L; Johnston, J C

    1996-04-01

    Repetition blindness (RB) may reveal a new limitation on human perceptual processing. Recently, however, researchers have attributed RB to postperceptual processes. The standard rapid serial visual presentation (RSVP) paradigm used in most RB studies is open to such objections. The "single-frame" paradigm introduced by J. C. Johnston and B. L. Hale (1984) allowed investigation of RB with minimal memory demands. Participants made a judgment about whether 1 masked target word was the same or different than a posttarget probe. Confidence ratings permitted use of signal detection methods. In the critical condition for RB, a precue of the posttarget word was provided prior to the target stimulus so that the required judgment amounted to whether the target did or did not repeat the precue word. In control treatments, the precue was an unrelated word or a dummy. Results showed that perceptual sensitivity was significantly reduced in the RB condition relative to baseline control conditions. The data showed that RB can be obtained under conditions in which memory problems are minimal and perceptual sensitivity is assessed independently of biases. RB therefore can be a perceptual phenomenon.

  6. Single versus repeated doses of ivermectin and diethylcarbamazine for the treatment of Wuchereria bancrofti var. pacifica microfilaremia. Results at 12 months of a double-blind study.

    PubMed

    Cartel, J L; Spiegel, A; Nguyen Ngnoc, L; Cardines, R; Plichart, R; Martin, P M; Roux, J F

    1991-12-01

    In October 1989, 58 apparently healthy Polynesian Wuchereria bancrofti carriers in whom microfilarial (mf) density was greater than or equal to 100 mf/ml were randomly allocated to treatment groups receiving single doses of either ivermectin at 100 mcg/kg or diethylcarbamazine (DEC) at 3 and 6 mg/kg. Six months later, half of the carriers initially treated with ivermectin 100 mcg/kg or DEC 3 mg/kg were given a second similar dose while the rest were given a placebo. By day 360 (6 months after retreatment), comparison of adjusted geometric mean mf counts per group indicated that (i) among the 3 treatments given once a year the DEC 6 mg/kg dose resulted in the highest efficacy, (ii) nevertheless, regarding either ivermectin 100 mcg/kg or DEC 3 mg/kg, 2 successive doses resulted in higher efficacy than one annual dose and (iii) though no significant difference could be evidenced between efficacy of ivermectin 100 mcg/kg and DEC 3 mg/kg given twice a year, DEC seemed to sustain the mf reduction for a longer period of time. During the 3 days following retreatment, adverse reactions (mild to moderate) were observed in 46% of carriers treated with microfilaricidal drugs and in 20% of those treated with placebo. These results suggest that single dose therapy with either DEC or ivermectin is safe and effective for prevention of lymphatic filariasis due to Wuchereria bancrofti in French Polynesia. The real impact on transmission by the vector, Aedes polynesiensis, of the complete negativation of microfilaremia observed during the previous part of the trial in carriers treated with ivermectin should be evaluated in a community-based trial including entomological study.(ABSTRACT TRUNCATED AT 250 WORDS)

  7. A Prospective Study of the Functional Outcome of Anterior Cervical Discectomy With Fusion in Single Level Degenerative Cervical Disc Prolapse

    PubMed Central

    Kamani, Mayur M; Shetty, Vikram; Rai, H. Ravindranath; Hegde, Deepak

    2016-01-01

    Introduction Cervical spondylotic myelo-radiculopathy is a form of spinal cord dysfunction syndrome and usually accompanies age related degeneration of the spine. Aim To determine the functional outcome of anterior cervical discectomy with fusion and plating in single level degenerative cervical disc prolapse. Materials and Methods A total of 20 patients diagnosed with degenerative single level cervical disc prolapse who presented to the Department of Orthopaedic Surgery, Justice KS Hegde Charitable Hospital, Mangalore from the period of November 2012 to May 2014 were enrolled in the study. Complete clinical and radiological evaluation of the patients was done. A trial of conservative management was tried in all these patients for a period of two months. They were taken up for surgery only when conservative management had failed. Scoring of neck function before the surgery was done as per the Modified Japanese Orthopaedic Association (MJOA) score. All patients underwent anterior cervical discectomy and fusion (ACDF) with tricortical iliac crest bone grafting. Fixation was performed with titanium locking cervical plates. All patients were reviewed at 6 weeks and 6 months postoperatively. Assessment of neck function was done as per the MJOA scoring during all the reviews. Radiographic assessment was also done during all the reviews. The complications noted were documented. The statistical analysis was done using percentages; the arithmetic mean was calculated using SPSS software (version 16.0). Results Amongst the 20 patients included in the study, 1 patient died postoperatively due to oesophageal rupture. of the remaining 19 patients reviewed and followed up, all of them had improvement of symptoms and were reported to be in the ‘mild category’ as per the MJOA score. One patient developed dysphonia, in the immediate postoperative period due to recurrent laryngeal nerve palsy which recovered in a period of three months postoperative. Conclusion Single level

  8. Blinded by Irrelevance: Pure Irrelevance Induced "Blindness"

    ERIC Educational Resources Information Center

    Eitam, Baruch; Yeshurun, Yaffa; Hassan, Kinneret

    2013-01-01

    To what degree does our representation of the immediate world depend solely on its relevance to what we are currently doing? We examined whether relevance per se can cause "blindness," even when there is no resource limitation. In a novel paradigm, people looked at a colored circle surrounded by a differently colored ring--the task relevance of…

  9. How "Blind" Are Double-Blind Studies?

    ERIC Educational Resources Information Center

    Margraf, Jurgen; And Others

    1991-01-01

    Compared alprazolam, imipramine, and placebo in the treatment of panic disorder patients (n=59) to investigate concerns about the internal validity of the double-blind design. Found that the great majority of patients and physicians were able to rate accurately whether active drug or placebo had been given and physicians could distinguish between…

  10. Methotrexate and Corticosteroids in the Treatment of Localized Scleroderma: A Standardized Prospective Longitudinal Single-center Study

    PubMed Central

    Torok, Kathryn S.; Arkachaisri, Thaschawee

    2013-01-01

    Objective To evaluate the effectiveness of a uniform single-center treatment protocol composed of high-dose methotrexate (MTX) and oral corticosteroids in a pediatric localized scleroderma (LS) cohort. Methods Thirty-six patients with LS were recruited. Patients with active disease, defined as erythematous lesions and/or new lesions, or expansion of existing lesions, were started on oral prednisone 2 mg/kg/day (maximum 60 mg/day) and subcutaneous (SC) MTX at 1 mg/kg/week (maximum 25 mg/week). Prednisone was tapered and kept at 0.25 mg/kg/day for 12 months. MTX SC was continued for 24 months, and then switched to oral administration to complete 36 months of therapy. Modified LS Skin Severity Index (mLoSSI) and the physician global assessment of disease activity (PGA-A) were used as outcome measures. Results Twenty-five patients with LS were female with a median age at onset of 7.86 years [interquartile range (IQR) 4.63–11.91]. Median disease duration from onset until start of this treatment regimen was 19.2 months (IQR 8.96–35.35). Median duration of followup was 36.40 months (IQR 29.39–45.36). All patients demonstrated significant improvement in mLoSSI at median 1.77 months (IQR 0.76–2.37, 95% CI 1.54, 2.01). PGA-A followed the same trend. No significant adverse reactions or flares were observed during therapy. Conclusion This single-center LS treatment protocol was effective and well tolerated. Clinical outcome in LS is affected by dose and route of administration of immunosuppressive regimens. Daily tapering dose of corticosteroids and parenteral MTX were effective in controlling LS activity without significant adverse reaction. This regimen should be considered as one of the therapies for LS clinical trials. PMID:22247357

  11. Incidence of Venous Thromboembolism in Patients Undergoing Major Hip Surgeries at a Single Institution: A Prospective Study

    PubMed Central

    Yamanaka, Yasuhiro; Ito, Hiroshi

    2016-01-01

    Background: Venous thoromboembolism (VTE) is one of the most significant complications after hip surgeries. Many studies have been reported about the incidence of VTE after THA, but a small number of reports were found concerning Periacetabular osteotomy, Revision THA and Surgery for hip fracture postoperatively. Furthermore, there exists no comparative study of the incidence of VTE among major hip surgeries at a single institution. We reported the incidence of VTE among hip surgeries performed at a single institution. Methods: A total of 820 Hip surgeries were performed at same institution. The procedures included 420 hips that underwent primary total hip arthroplasties (THA), 91 revision or removal of total hip arthroplasties (Revision THA), 144 periacetabular osteotomy (PAO) and 165 surgery for hip fracture (SHF) between 2006 and 2012. VTE was detected by Multidetector computed tomography (MDCT) that scanned 768 cases and by ultrasound that scanned 52cases postoperative 10-14 days. Results: The overall incidence of VTE was 12.2% (100 of 820). The incidence of VTE after THA was 13.1% (55 of 420), Revision THA was 13.2% (12 of 91), PAO was 2.1% (3 of 144) and SHF was 18.1% (30 of 165). The incidence of VTE was significantly higher in SHF than in PAO. Conclusion: This data indicates that the incidence of VTE after PAO is significantly lower than SHF and relatively lower than THA and Revision THA. A younger age and non-invasion of the bone marrow of the femur may have affected the result. Prophylaxis therapy was effective especially on SHF. PMID:27499823

  12. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    SciTech Connect

    Liss, Adam L.; Ben-David, Merav A.; Jagsi, Reshma; Hayman, James A.; Griffith, Kent A.; Moran, Jean M.; Marsh, Robin B.; Pierce, Lori J.

    2014-05-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.

  13. The Effects of High-Frequency Transcutaneous Electrical Nerve Stimulation for Dental Professionals with Work-Related Musculoskeletal Disorders: A Single-Blind Randomized Placebo-Controlled Trial.

    PubMed

    Suh, Hye Rim; Kim, Tae Hoon; Han, Gyeong-Soon

    2015-01-01

    Work-related musculoskeletal symptom disorders (WMSDs) have a significant issue for dental professionals. This study investigated the effects of high-frequency transcutaneous electrical nerve stimulation (TENS) on work-related pain, fatigue, and the active range of motion in dental professionals. Among recruited 47 dental professionals with WMSDs, 24 subjects received high-frequency TENS (the TENS group), while 23 subjects received placebo stimulation (the placebo group). TENS was applied to the muscle trigger points of the levator scapulae and upper trapezius, while placebo-TENS was administered without electrical stimulation during 60 min. Pain and fatigue at rest and during movement were assessed using the visual analog scale (VAS), pain pressure threshold (PPT), and active range of motion (AROM) of horizontal head rotation at six time points: prelabor, postlabor, post-TENS, and at 1 h, 3 h, and 1 day after TENS application. Both groups showed significantly increased pain and fatigue and decreased PPT and AROM after completing a work task. The TENS group showed significantly greater improvements in VAS score, fatigue, PPT, and AROM at post-TENS and at 1 h and 3 h after application (all P < 0.05) as compared to the placebo group. A single session high-frequency TENS may immediately reduce symptoms related to WMSDs in dental professionals.

  14. The Effects of High-Frequency Transcutaneous Electrical Nerve Stimulation for Dental Professionals with Work-Related Musculoskeletal Disorders: A Single-Blind Randomized Placebo-Controlled Trial

    PubMed Central

    2015-01-01

    Work-related musculoskeletal symptom disorders (WMSDs) have a significant issue for dental professionals. This study investigated the effects of high-frequency transcutaneous electrical nerve stimulation (TENS) on work-related pain, fatigue, and the active range of motion in dental professionals. Among recruited 47 dental professionals with WMSDs, 24 subjects received high-frequency TENS (the TENS group), while 23 subjects received placebo stimulation (the placebo group). TENS was applied to the muscle trigger points of the levator scapulae and upper trapezius, while placebo-TENS was administered without electrical stimulation during 60 min. Pain and fatigue at rest and during movement were assessed using the visual analog scale (VAS), pain pressure threshold (PPT), and active range of motion (AROM) of horizontal head rotation at six time points: prelabor, postlabor, post-TENS, and at 1 h, 3 h, and 1 day after TENS application. Both groups showed significantly increased pain and fatigue and decreased PPT and AROM after completing a work task. The TENS group showed significantly greater improvements in VAS score, fatigue, PPT, and AROM at post-TENS and at 1 h and 3 h after application (all P < 0.05) as compared to the placebo group. A single session high-frequency TENS may immediately reduce symptoms related to WMSDs in dental professionals. PMID:26664451

  15. Single-dose (30 mg/kg) azithromycin compared with 10-day amoxicillin/clavulanate for the treatment of uncomplicated acute otitis media: a double-blind, placebo-controlled, randomized clinical trial☆

    PubMed Central

    Block, Stan L; Arrieta, Antonio; Seibel, Matthew; McLinn, Samuel; Eppes, Stephen; Murphy, Mary J

    2003-01-01

    Background: The long half-life of azithromycin allows for single-dose oral therapy for acute otitis media (AOM). Objective: This study was designed to compare the efficacy and tolerability of single-dose azithromycin with 10-day, twice-daily amoxicillin/clavulanate for the treatment of new-onset, uncomplicated AOM in children. Methods: Children aged 6 months to 12 years with new-onset AOM were randomly assigned to receive either a single 30-mg/kg dose of azithromycin or standard-dose amoxicillin/clavulanate (45 mg/kg administered BID for 10 days) in a double-blind, double-placebo, multicenter clinical trial. The diagnosis of AOM was based on specific clinical signs and symptoms, and was confirmed by pneumatic otoscopy and acoustic reflectometry (level ≥3). Clinical response was assessed on days 12–16 and 28–32. Results: Mean (SD) age of children receiving azithromycin (n = 173) or amoxicillin/clavulanate (n = 173) was 2.7 (2.3) years and 3.4 (2.8) years, respectively, with 43% and 36% ≤2 years of age. Most (53.2%) of the children were boys, and most (51.2%) were white. Clinical success rates (intent-to-treat) for azithromycin and amoxicillin/clavulanate, respectively, were 87% and 88% (95% CI, −9.2 to 6.5) on day 12–16 and 75% and 75% (95% CI, −10.2 to 10.5) on day 28–32. The incidences of treatment-related adverse events for azithromycin and amoxicillin/clavulanate were 16.8% and 22.5%, respectively. Corresponding rates of diarrhea were 6.4% and 12.7%, respectively. Vomiting, which was generally mild, occurred in 7 children in each group. One azithromycin patient and 5 amoxicillin/clavulanate patients discontinued treatment because of adverse events. The compliance rate for azithromycin was significantly higher than that for amoxicillin/clavulanate (99% vs 83%; P<0.001). Conclusions: In this trial comparing the efficacy of single-dose azithromycin (30 mg/kg) with twice-daily amoxicillin/clavulanate (45 mg/kg) for the treatment of new

  16. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial

    PubMed Central

    Medrinal, Clément; Prieur, Guillaume; Debeaumont, David; Robledo Quesada, Aurora; Combret, Yann; Quieffin, Jean; Contal, Olivier; Lamia, Bouchra

    2016-01-01

    Introduction Chronic obstructive pulmonary disease (COPD) has systemic repercussions that can lead to peripheral muscle dysfunction. Muscle atrophy reduces aerobic capacity, greatly limiting activities of daily living and quality of life. Pulmonary rehabilitation is the gold standard treatment for these patients, however, patients may not be able to reach sufficient training intensities for benefits to occur. Technologies such as functional electrical stimulation (FES) are currently being adapted and tested to enhance exercise training. We hypothesise that FES coupled with cycling (FES-cycling) will improve maximal uptake of oxygen (VO2) and aerobic capacity more than endurance training with placebo stimulation. Methods A randomised, single-blind, placebo-controlled crossover trial will be carried out to evaluate the effects of FES-cycling on VO2 during endurance exercise on a cycle ergometer in patients with COPD. 25 patients with COPD will carry out two 30 min sessions at a constant load; one session with active and one with placebo FES. The primary outcome is oxygen uptake recorded with a metabolic measurement system. Secondary outcomes include ventilation equivalent for oxygen, ventilation equivalent for carbon dioxide, cardiac output, lactate values, perceived dyspnoea and perceived muscle fatigue. Results and conclusions Approval has been granted by our Institutional Review Board (Comité de Protection des Personnes Nord-Ouest 3). The results of the trial will be presented at national and international meetings and published in peer-reviewed journals. Trial registration number NCT02594722. PMID:27110364

  17. Double-blind controlled trial of a single dose of the combination ivermectin 400 micrograms/kg plus diethylcarbamazine 6 mg/kg for the treatment of bancroftian filariasis: results at six months.

    PubMed

    Glaziou, P; Moulia-Pelat, J P; Nguyen, L N; Chanteau, S; Martin, P M; Cartel, J L

    1994-01-01

    In 1993, a three-arm double-blind controlled trial was implemented in French Polynesia to compare the tolerance and efficacy of a single dose of the combination ivermectin (IVR) 400 micrograms/kg plus diethylcarbamazine (DEC) 6 mg/kg vs. IVR 400 micrograms/kg alone vs. DEC 6 mg/kg alone, for treatment of Wuchereria bancrofti carriers. Of the 57 treated male patients in whom microfilaria (mf) densities ranged from 22 to 4709 mg/mL, 3 groups of 19 were randomly selected and allocated to one of the 3 treatments. Side effects were experienced by 34 patients (60%), but none suffered a severe reaction. Grade of reaction did not differ between treatment group, but was significantly correlated with the pretreatment mf density. Six months after treatment, 26%, 32% and 53% of patients were amicrofilaraemic in the DEC, IVR and IVR+DEC groups, respectively. Mf levels were 6.3%, and 3.1% and 1.0% of the pretreatment level, respectively, significantly lower in the IVR+DEC group than in both the IVR and DEC comparison groups. The combination IVR+DEC showed promise in term of sustained mf decrease, and could be an effective alternative for lymphatic filariasis control programmes.

  18. Stereotactic Interstitial Radiosurgery With the Photon Radiosurgery System (PRS) for Metastatic Brain Tumors: A Prospective Single-Center Clinical Trial

    SciTech Connect

    Pantazis, Georgios; Trippel, Michael; Birg, Walter; Ostertag, Christoph B.; Nikkhah, Guido

    2009-12-01

    Purpose: To evaluate the efficacy and the treatment outcome of tumor patients being treated stereotactically with a miniature X-ray generator (Photon Radiosurgery System, PRS). Methods and Materials: Thirty-five patients with histologically diagnosed cerebral metastases were treated with a single fraction of stereotactic interstitial irradiation (median, 18 Gy). Clinical and neuroimaging evaluation were assessed at 2-, 6-, and 12-week intervals postoperatively and every 3 months thereafter. Survival, local control, and distant and overall brain freedom from progression were obtained using the Kaplan-Meier method. Results: Median survival was 7.37 months and the actuarial survival rates at 6 and 12 months were 60.0% and 34.3%, respectively. Acute complications on six patients were associated with shorter survival. Local tumor control at the initial stage and at the last follow-up were 82% and 50%. Eighteen patients (53%) developed distant brain metastases after treatment. At 1 year, the local control rate and distant and overall brain freedom from progression were 33.0%, 43.3%, and 14.7%, respectively. A shorter local tumor control was observed by PRS treatment of a recurrent tumor and by irregular tumor configuration. Conclusions: Interstitial radiosurgery with the PRS requires continued investigation. It allows for an immediate and potentially cost-efficient treatment for patients with singular, small (<= 6.36 cm{sup 3}; or <= 2.3 cm) spherical brain metastasis subsequent to a stereotactic biopsy.

  19. Biomass recovery during municipal wastewater treatment using photosynthetic bacteria and prospect of production of single cell protein for feedstuff.

    PubMed

    Saejung, Chewapat; Thammaratana, Thani

    2016-12-01

    Utilization of photosynthetic bacteria (PSB) for wastewater treatment and production of biomass for economical single cell protein production is a feasible option. In this study, Rhodopseudomonas sp. CSK01 was used for municipal wastewater treatment and the effect of initial pH, light intensity and additional carbon source was investigated. Optimum chemical oxygen demand (COD) removal and biomass production were achieved when the initial pH and light intensity were 7 and 4000 lux, respectively. The specific growth rate, biomass yield and biomass productivity were found to be 0.4/d, 3.2 g/g COD and 2.1 g/L/d, respectively, which were improved by 100%, 167% and 200% relative to the original condition. Under the optimal conditions, COD removal reached 85% and maximum biomass was 6.2 g/L accomplished within three days of cultivation. The biomass had a relatively high protein content (60.1%) consisting of all essential amino acids. The contents of histidine, lysine, phenylalanine and leucine were superior to those of the previously described PSB. Results showed that COD removal was not improved in the presence of additional carbon sources (glucose, sucrose and malic acid). The addition of malic acid significantly increased the biomass accumulation by 279% relative to the original condition, whereas COD removal was declined due to carbon catabolite repression. In this study, PSB biomass recovery and catabolite repression are proposed in municipal wastewater treatment by Rhodopseudomonas sp.

  20. Combination of Liechtenstein Repair with Herniorrhaphy in Open Inguinal Hernia Repair- A Prospective Observational Single Center Study

    PubMed Central

    Pukar, Mahesh

    2014-01-01

    Context: This study is about documentation of a technique which includes a combination of both hernioplasty and Herniorrhaphy, and its outcome in terms of recurrence rate and postoperative complications. It also compares the outcome of this method with routinely used techniques reported in the literature. Materials and Methods: LR with Herniorrhaphy was performed in the patients admitted with inguinal hernia under concerned surgeon. Their follow-up was assessed after 12 months. Incidences of recurrence rate and other postoperative complications like painful scar, atrophy of testis, urinary retention, hematoma, sinus and infection were noted and compared with other techniques of repair from published data. Statistical Analysis: was carried out by calculating the mean, standard deviation (SD), percentage and incidence rates. Results: LR with Herniorrhaphy performed in 475 patients showed recurrence rate of <<0.01% (n=1) and very low incidences of other postoperative complications like painful scar (0.01%, n=5), sinus (0%, n=0), atrophy of testis (0%, n=0), retention of urine (0.01%, n=6), hematoma (<<0.01%, n=1) and infection (0%, n=0); as compared to published data with different techniques. Conclusion: LR with Herniorrhaphy can be used for open inguinal hernia repair as the gold standard procedure as it has got low recurrence rate and other postoperative complications as compared to other techniques. However, the result of this study is based on the data from a single center, thus we recommend multicentric trials to test the efficacy of this technique. PMID:25478390

  1. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    PubMed

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  2. Tinnitus Suppression by Intracochlear Electrical Stimulation in Single Sided Deafness – A Prospective Clinical Trial: Follow-Up

    PubMed Central

    Arts, Remo A. G. J.; George, Erwin L. J.; Janssen, Miranda; Griessner, Andreas; Zierhofer, Clemens; Stokroos, Robert J.

    2016-01-01

    Introduction Earlier studies show that a Cochlear Implant (CI), capable of providing intracochlear electrical stimulation independent of environmental sounds, appears to suppress tinnitus at least for minutes. The current main objective is to compare the long-term suppressive effects of looped (i.e. repeated) electrical stimulation (without environmental sound perception) with the standard stimulation pattern of a CI (with environmental sound perception). This could open new possibilities for the development of a “Tinnitus Implant” (TI), an intracochlear pulse generator for the suppression of tinnitus. Materials and Methods Ten patients with single sided deafness suffering from unilateral tinnitus in the deaf ear are fitted with a CI (MED-EL Corporation, Innsbruck, Austria). Stimulation patterns are optimized for each individual patient, after which they are compared using a randomized crossover design, with a follow-up of six months, followed by a 3 month period using the modality of patient’s choice. Results Results show that tinnitus can be suppressed with intracochlear electrical stimulation independent of environmental sounds, even long term. No significant difference in tinnitus suppression was found between the standard clinical CI and the TI. Conclusion It can be concluded that coding of environmental sounds is no requirement for tinnitus suppression with intracochlear electrical stimulation. It is therefore plausible that tinnitus suppression by CI is not solely caused by an attention shift from the tinnitus to environmental sounds. Both the standard clinical CI and the experimental TI are potential treatment options for tinnitus. These findings offer perspectives for a successful clinical application of the TI, possibly even in patients with significant residual hearing. Trial Registration TrialRegister.nl NTR3374 PMID:27111333

  3. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan™, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study

    PubMed Central

    Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

    2016-01-01

    Background Ingestion of AndoSan™, based on the mushroom Agaricus blazei Murill, has previously been shown to exhibit anti-inflammatory effects because of reduction of pro-inflammatory cytokines in healthy individuals and patients with ulcerative colitis. In this randomized single-blinded placebo controlled study we examined whether intake of AndoSan™ also resulted in clinical effects. Methods and Findings 50 patients with symptomatic ulcerative colitis were block-randomized and blinded for oral daily intake of AndoSan™ or placebo for the 21 days’ experimental period. The patients reported scores for symptoms, fatigue and health related quality of life (HRQoL) at days 0, 14 and 21. Fecal calprotectin and general blood parameters were also analyzed. In the AndoSan™ group (n = 24) symptoms improved from baseline (day 0) to days 14 and 21, with respective mean scores (95% CI) of 5.88 (4.92–6.83), 4.71 (3.90–5.52) (p = 0.002) and 4.50 (3.70–5.30) (p = 0.001). Corresponding improved mean scores (±SD) for total fatigue were 16.6 (5.59), 14.1 (4.50) (p = 0.001) and 15.1 (4.09) (p = 0.023). These scores in the placebo group (n = 26) were not improved. When comparing the two study groups using mixed model statistics, we found significant better scores for the AndoSan™-patients. HRQoL for dimensions bodily pain, vitality, social functioning and mental health improved in the AndoSan™ group. There were no alterations in general blood samples and fecal calprotectin. Conclusions Beneficiary effects on symptoms, fatigue and HRQoL from AndoSan™ consumption were demonstrated in this per-protocol study, supporting its use as a supplement to conventional medication for patients with mild to moderate symptoms from ulcerative colitis. The patients did not report any harms or unintended effects of AndoSan™ in this study. Trial Registration ClinicalTrials.gov NCT01496053 PMID:26933886

  4. Leading Causes of Blindness

    MedlinePlus

    ... Cataract. Photo courtesy of National Eye Institute, NIH Cataracts Cataracts are a clouding of the lenses in your ... older people. More than 22 million Americans have cataracts. They are the leading cause of blindness in ...

  5. Vision - night blindness

    MedlinePlus

    ... People with night blindness often have trouble seeing stars on a clear night or walking through a ... certain drugs Vitamin A deficiency (rare) Nontreatable causes: Birth defects Retinitis pigmentosa

  6. Impact of Yoga and Meditation on Cellular Aging in Apparently Healthy Individuals: A Prospective, Open-Label Single-Arm Exploratory Study

    PubMed Central

    Tolahunase, Madhuri; Sagar, Rajesh

    2017-01-01

    This study was designed to explore the impact of Yoga and Meditation based lifestyle intervention (YMLI) on cellular aging in apparently healthy individuals. During this 12-week prospective, open-label, single arm exploratory study, 96 apparently healthy individuals were enrolled to receive YMLI. The primary endpoints were assessment of the change in levels of cardinal biomarkers of cellular aging in blood from baseline to week 12, which included DNA damage marker 8-hydroxy-2′-deoxyguanosine (8-OH2dG), oxidative stress markers reactive oxygen species (ROS), and total antioxidant capacity (TAC), and telomere attrition markers telomere length and telomerase activity. The secondary endpoints were assessment of metabotrophic blood biomarkers associated with cellular aging, which included cortisol, β-endorphin, IL-6, BDNF, and sirtuin-1. After 12 weeks of YMLI, there were significant improvements in both the cardinal biomarkers of cellular aging and the metabotrophic biomarkers influencing cellular aging compared to baseline values. The mean levels of 8-OH2dG, ROS, cortisol, and IL-6 were significantly lower and mean levels of TAC, telomerase activity, β-endorphin, BDNF, and sirtuin-1 were significantly increased (all values p < 0.05) post-YMLI. The mean level of telomere length was increased but the finding was not significant (p = 0.069). YMLI significantly reduced the rate of cellular aging in apparently healthy population. PMID:28191278

  7. A single-institution, 20-year prospective experience with an affordable Fc-receptor blockade method to treat patients with chronic, refractory autoimmune thrombocytopenic purpura.

    PubMed

    Estrada-Gómez, Roberto; Vargas-Castro, Olga; Oropeza-Borges, Mabel; González-Carrillo, Martha L; Pérez-Romano, Beatriz; Ruiz-Argüelles, Guillermo J

    2007-01-01

    In a 20-year period in a single institution, 34 patients with chronic, refractory autoimmune thrombocytopenic purpura were prospectively treated with ex vivo anti-D opsonized autologous red blood cells. All patients had received previous treatment with steroids and/or immunosuppressive agents, and 11 had been splenectomized. Twenty one patients had an increase in the platelet count; in five cases, the increase was more than 50 x 10(9)/L platelets and in 16 the increase was more than 100 x 10(9)/L platelets. Early responses were observed in 20 patients and late responses in seven, whereas seven patients (20%) did not respond at all. Nine of the 20 individuals who achieved an ER had a subsequent drop in the platelet count; however, only three had a drop below 50 x 10(9)/L. When last censored, of the 34 patients, 24 (70%) had a platelet count above 50 x 10(9)/L. The 84-month thrombocytopenia-free (over 50 x 10(9)/L platelets) status of the whole group is 70%, whereas the 84-month complete remission (over 100 x 10(9)/L platelets) status of the whole group is 50%. It is concluded that the use of ex vivo anti-D opsonized red blood cells may represent another, substantially cheaper treatment of patients with chronic, refractory, autoimmune thrombocytopenic purpura.

  8. Peyronie's disease and low intensity shock wave therapy: Clinical outcomes and patient satisfaction rate in an open-label single arm prospective study in Australian men

    PubMed Central

    2015-01-01

    Purpose To evaluate the efficacy, safety and patient satisfaction outcomes following low intensity extracorporeal shock wave therapy (LiESWT) in men with Peyronie's disease (PD) using a standardised protocol. Materials and Methods In this open-label single arm prospective study, patients with PD were enrolled following informed consent. Patient demographics, change in penile curvature and plaque hardness, International Index of Erectile Function (IIEF)-5 score, and overall satisfaction score (on a 5-point scale) were recorded. Treatment template consists of 3000 shock waves to the Peyronie's plaque over 20 minutes, twice weekly for 6 weeks. Results The majority of patients have PD history longer than 6 months (mean, 12.8 months; range, 6-28 months). Two thirds of patients have received and failed oral medical therapy. There were improvements in penile curvature (more than 15 degrees in 33% of men), plaque hardness (60% of men) and penile pain (4 out of 6 men) following LiESWT. There was a moderate improvement in IIEF-5 score (>5 points reported in 20% of men). No complication was reported and the majority of patients were satisfied (rated 4 out of 5; 70% of men) and would recommend this therapy to others. Conclusions In a carefully selected group of men with PD, LiESWT appears to be safe, has moderate efficacy and is associated with high patient satisfaction rate in the short term. PMID:26568796

  9. Impact of Yoga and Meditation on Cellular Aging in Apparently Healthy Individuals: A Prospective, Open-Label Single-Arm Exploratory Study.

    PubMed

    Tolahunase, Madhuri; Sagar, Rajesh; Dada, Rima

    2017-01-01

    This study was designed to explore the impact of Yoga and Meditation based lifestyle intervention (YMLI) on cellular aging in apparently healthy individuals. During this 12-week prospective, open-label, single arm exploratory study, 96 apparently healthy individuals were enrolled to receive YMLI. The primary endpoints were assessment of the change in levels of cardinal biomarkers of cellular aging in blood from baseline to week 12, which included DNA damage marker 8-hydroxy-2'-deoxyguanosine (8-OH2dG), oxidative stress markers reactive oxygen species (ROS), and total antioxidant capacity (TAC), and telomere attrition markers telomere length and telomerase activity. The secondary endpoints were assessment of metabotrophic blood biomarkers associated with cellular aging, which included cortisol, β-endorphin, IL-6, BDNF, and sirtuin-1. After 12 weeks of YMLI, there were significant improvements in both the cardinal biomarkers of cellular aging and the metabotrophic biomarkers influencing cellular aging compared to baseline values. The mean levels of 8-OH2dG, ROS, cortisol, and IL-6 were significantly lower and mean levels of TAC, telomerase activity, β-endorphin, BDNF, and sirtuin-1 were significantly increased (all values p < 0.05) post-YMLI. The mean level of telomere length was increased but the finding was not significant (p = 0.069). YMLI significantly reduced the rate of cellular aging in apparently healthy population.

  10. Single-stage osseointegrated reconstruction and rehabilitation of lower limb amputees: the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2) for a prospective cohort study

    PubMed Central

    Al Muderis, Munjed; Lu, William; Tetsworth, Kevin; Bosley, Belinda; Li, Jiao Jiao

    2017-01-01

    Introduction Lower limb amputations have detrimental influences on the quality of life, function and body image of the affected patients. Following amputation, prolonged rehabilitation is required for patients to be fitted with traditional socket prostheses, and many patients experience symptomatic socket–residuum interface problems which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel approach for the reconstruction of amputated limbs, which overcomes many of the socket-related problems by directly attaching the prosthesis to the skeletal residuum. To date, the vast majority of osseointegration procedures worldwide have been performed in 2 stages, which require at least 4 months and up to 18 months for the completion of reconstruction and rehabilitation from the time of the initial surgery. The current prospective cohort study evaluates the safety and efficacy of a single-stage osseointegration procedure performed under the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2), which dramatically reduces the time of recovery to ∼3–6 weeks. Methods and analysis The inclusion criteria for osseointegrated reconstruction under the OGAAP-2 procedure are age over 18 years, unilateral transfemoral amputation and experiencing problems or difficulties in using socket prostheses. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values are compared for each outcome measure, and the benefits and harms of the single-stage OGAAP-2 procedure will be compared with the results obtained using a previously employed 2-stage procedure. Ethics and dissemination This study has received ethics approval from the University of Notre Dame, Sydney

  11. Polyethylene glycol plus an oral sulfate solution as a bowel cleansing regimen for colon capsule endoscopy: a prospective, single-arm study in healthy volunteers

    PubMed Central

    Peled, Ravit

    2015-01-01

    Objectives: As with colonoscopy, adequate bowel cleansing is essential prior to colon capsule endoscopy (CCE). Because CCE requires that the capsule traverse the entire gastrointestinal tract during the examination, laxative ‘boosters’ are used. The objective of this prospective, single-center, single-arm study was to evaluate the safety of a bowel preparation consisting of polyethylene glycol (PEG) plus an oral sulfate solution. Methods: Subjects were healthy volunteers aged 50–75 years old with normal baseline serum chemistry. The bowel preparation consisted of 4 Senna tablets, 4 liters of PEG (split dose), 10 mg metoclopramide, 2 oral sulfate solution boosters (6 oz. and 3 oz.), and 10 mg bisacodyl. Serum chemistry was performed at baseline, following PEG intake, 24 hours after bisacodyl administration, and at 7 days post procedure (in subjects with abnormal 24 hour results). The primary endpoints were the percentage of subjects with a clinically significant change in serum chemistry at the last test and the adverse event (AE) rate. Results: A total of 25 subjects were enrolled. The serum chemistry was normal in all subjects at the final evaluation. One subject showed a slight elevation in creatinine (1.08 mg/dl 7 days post procedure from 0.84 mg/dl at baseline), deemed not clinically significant. Another subject had a transient elevation in serum creatinine (from 1.01 mg/dl at baseline to 1.45 mg/dl at 24 hours after the bowel preparation); values returned to near baseline at 7 days post procedure (1.06 mg/dl). There were no serious AEs, three moderate AEs related to the bowel preparation (nausea, headache, elevated creatinine) and two mild unrelated AEs (chills, abdominal cramping). Conclusions: A bowel cleansing regimen of PEG plus an oral sulfate solution can be used in healthy volunteers. These data provide support for the continued study of this regimen in future CCE clinical trials and in medical practice. PMID:26327914

  12. Efficient Universal Blind Quantum Computation

    NASA Astrophysics Data System (ADS)

    Giovannetti, Vittorio; Maccone, Lorenzo; Morimae, Tomoyuki; Rudolph, Terry G.

    2013-12-01

    We give a cheat sensitive protocol for blind universal quantum computation that is efficient in terms of computational and communication resources: it allows one party to perform an arbitrary computation on a second party’s quantum computer without revealing either which computation is performed, or its input and output. The first party’s computational capabilities can be extremely limited: she must only be able to create and measure single-qubit superposition states. The second party is not required to use measurement-based quantum computation. The protocol requires the (optimal) exchange of O(Jlog⁡2(N)) single-qubit states, where J is the computational depth and N is the number of qubits needed for the computation.

  13. Efficient universal blind quantum computation.

    PubMed

    Giovannetti, Vittorio; Maccone, Lorenzo; Morimae, Tomoyuki; Rudolph, Terry G

    2013-12-06

    We give a cheat sensitive protocol for blind universal quantum computation that is efficient in terms of computational and communication resources: it allows one party to perform an arbitrary computation on a second party's quantum computer without revealing either which computation is performed, or its input and output. The first party's computational capabilities can be extremely limited: she must only be able to create and measure single-qubit superposition states. The second party is not required to use measurement-based quantum computation. The protocol requires the (optimal) exchange of O(Jlog2(N)) single-qubit states, where J is the computational depth and N is the number of qubits needed for the computation.

  14. A higher response of plasma neuropeptide Y, growth hormone, leptin levels and extracellular glycerol levels in subcutaneous abdominal adipose tissue to Acipimox during exercise in patients with bulimia nervosa: single-blind, randomized, microdialysis study

    PubMed Central

    2011-01-01

    Background Neuropeptide Y (NPY) is an important central orexigenic hormone predominantly produced by the hypothalamus, and recently found to be secreted in adipose tissue (AT). Acipimox (Aci) inhibits lipolysis in AT and reduces plasma glycerol and free fatty acid (FFA) levels. Exercise and Aci are enhancers of growth hormone (GH) and NPY secretion and exercise may alter leptin levels. We expect to find abnormal neuropeptidergic response in plasma and AT in patients with bulimia nervosa (BN). We hypothesize that Aci influences these peptides via a FFA-independent mechanism and that Aci inhibits lipolysis through a cyclic adenosine monophosphate (cAMP)-dependent pathway. Dysregulations of the AT-brain axis peptides might be involved in binge eating as is the case in BN. Methods The objective of this study was to determine the responses of plasma NPY, GH, leptin, FFA and glycerol levels to exercise in BN patients and healthy women (C) given the anti-lipolytic drug Aci or placebo. The secondary objective of this study was to compare the responses of extracellular glycerol levels and plasma glycerol levels to exercise alone or together with Aci administration in BN patients and C women. Extracellular glycerol was measured in vivo in subcutaneous (sc) abdominal AT using microdialysis. Eight BN and eight C women were recruited for this single-blind, randomized study. Aci or placebo was given 1 hour before the exercise (45 min, 2 W/kg of lean body mass [LBM]). NPY, GH, leptin, FFA, glycerol plasma and AT glycerol levels were measured using commercial kits. Results The primary outcome of this study was that the exercise with Aci administration resulted in plasma NPY and GH increase (after a 45-minute exercise) and leptin (after a 90-minute post-exercise recovering phase) increased more in BN patients. The secondary outcomes of this study were that the exercise with Aci administration induced a higher decrease of extracellular glycerol in BN patients compared to the C group

  15. Effect of a Perioperative Nutritional Supplementation with Oral Impact® in Patients undergoing Hepatic Surgery for Liver Cancer: A Prospective, Placebo-Controlled, Randomized, Double-Blind Study.

    PubMed

    Seguin, Philippe; Locher, Clara; Boudjema, Karim; Hamon, Catherine; Mouchel, Catherine; Malledant, Yannick; Bellissant, Eric

    2016-01-01

    Perioperative nutrition with supplements containing L-arginine, ω3-polyunsaturated fatty acids, and nucleotides could boost liver function recovery, immune response, and resistance to infection after hepatic resection. We conducted a placebo-controlled, randomized, double-blind study to assess the effect of a perioperative nutritional supplementation with Oral Impact® in patients undergoing hepatic surgery for liver cancer. Treatment was given three times daily for 7 days before and 3 days after surgery. Primary outcome was factor V, 3 days after surgery. Thirty-five patients (placebo: 17; Oral Impact: 18) were included. Five patients (placebo: three; Oral Impact: two) were not operated and five (placebo: two; Oral Impact: three) did not undergo hepatic resection. Factor V (mean ± SD) was 70 ± 27% and 79 ± 25% (P = 0.409) 3 days after surgery and 90 ± 30% and 106 ± 16% (P = 0.066) 5 days after surgery, in placebo and Oral Impact groups, respectively. There were no significant differences between groups on other outcomes assessing liver function recovery (bile production, γ-glutamyl transferase, α-fetoprotein), immune response (CD3, CD4, CD8 cells, CD4/CD8 ratio, natural killer cells, B lymphocytes), number of infections, and tolerance. A 10-day perioperative nutritional supplementation with Oral Impact does not improve hepatic function, immune response, and resistance to infection in patients undergoing hepatic surgery for liver cancer.

  16. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner.

    PubMed

    Ferraresi, Cleber; Beltrame, Thomas; Fabrizzi, Fernando; do Nascimento, Eduardo Sanches Pereira; Karsten, Marlus; Francisco, Cristina de Oliveira; Borghi-Silva, Audrey; Catai, Aparecida Maria; Cardoso, Daniel Rodrigues; Ferreira, Antonio Gilberto; Hamblin, Michael R; Bagnato, Vanderlei Salvador; Parizotto, Nivaldo Antonio

    2015-07-01

    Recently, low-level laser (light) therapy (LLLT) has been used to improve muscle performance. This study aimed to evaluate the effectiveness of near-infrared light-emitting diode therapy (LEDT) and its mechanisms of action to improve muscle performance in an elite athlete. The kinetics of oxygen uptake (VO2), blood and urine markers of muscle damage (creatine kinase--CK and alanine), and fatigue (lactate) were analyzed. Additionally, some metabolic parameters were assessed in urine using proton nuclear magnetic resonance spectroscopy ((1)H NMR). A LED cluster with 50 LEDs (λ = 850 nm; 50 mW 15 s; 37.5 J) was applied on legs, arms and trunk muscles of a single runner athlete 5 min before a high-intense constant workload running exercise on treadmill. The athlete received either Placebo-1-LEDT; Placebo-2-LEDT; or Effective-LEDT in a randomized double-blind placebo-controlled trial with washout period of 7 d between each test. LEDT improved the speed of the muscular VO2 adaptation (∼-9 s), decreased O2 deficit (∼-10 L), increased the VO2 from the slow component phase (∼+348 ml min(-1)), and increased the time limit of exercise (∼+589 s). LEDT decreased blood and urine markers of muscle damage and fatigue (CK, alanine and lactate levels). The results suggest that a muscular pre-conditioning regimen using LEDT before intense exercises could modulate metabolic and renal function to achieve better performance.

  17. Effects of regularly consuming dietary fibre rich soluble cocoa products on bowel habits in healthy subjects: a free-living, two-stage, randomized, crossover, single-blind intervention

    PubMed Central

    2012-01-01

    Background Dietary fibre is both preventive and therapeutic for bowel functional diseases. Soluble cocoa products are good sources of dietary fibre that may be supplemented with this dietary component. This study assessed the effects of regularly consuming two soluble cocoa products (A and B) with different non-starch polysaccharides levels (NSP, 15.1 and 22.0% w/w, respectively) on bowel habits using subjective intestinal function and symptom questionnaires, a daily diary and a faecal marker in healthy individuals. Methods A free-living, two-stage, randomized, crossover, single-blind intervention was carried out in 44 healthy men and women, between 18-55 y old, who had not taken dietary supplements, laxatives, or antibiotics six months before the start of the study. In the four-week-long intervention stages, separated by a three-week-wash-out stage, two servings of A and B, that provided 2.26 vs. 6.60 g/day of NSP respectively, were taken. In each stage, volunteers' diet was recorded using a 72-h food intake report. Results Regularly consuming cocoa A and B increased fibre intake, although only cocoa B significantly increased fibre intake (p < 0.001) with respect to the non-cocoa stage. No changes in body weight were observed in either of the 4 week interventions. With cocoa product B, the number of daily bowel movements increased (p = 0.002), the frequency of having a bowel movement once a day increased (p = 0.009), the time to have a bowel movement was lower (p = 0.016) as well as the feeling of constipation (p = 0.046) without inducing adverse gastrointestinal symptoms, only flatulence increased (p = 0.019). Conclusions Regular consumption of the cocoa products increases dietary fibre intake to recommended levels and product B improves bowel habits. The use of both objective and subjective assessments to evaluate the effects of food on bowel habits is recommended. PMID:22512838

  18. Intake of a fermented soymilk beverage containing moderate levels of isoflavone aglycones enhances bioavailability of isoflavones in healthy premenopausal Japanese women: a double-blind, placebo-controlled, single-dose, crossover trial

    PubMed Central

    NAGINO, Takayuki; KANO, Mitsuyoshi; MASUOKA, Norie; KAGA, Chiaki; ANBE, Michitoshi; MIYAZAKI, Kouji; KAMACHI, Keiko; ISOZAKI, Mariko; SUZUKI, Chigusa; KASUGA, Chikako; TANAKA, Akira

    2015-01-01

    This study aimed to investigate the bioavailability of serum isoflavones after the intake of soymilk fermented by Lactobacillus casei strain Shirota containing 32.5% isoflavone aglycones (FSM) or placebo soymilk containing no isoflavone aglycones (SM). In a double-blind, placebo-controlled, single-dose, crossover trial, 7 healthy premenopausal Japanese women (mean age: 35.3 ± 11.0) consumed FSM or SM on day 1 and crossed over to the other soymilk after a 6-day washout period. Serum isoflavones in blood samples collected at 0, 1, 2, 3, 4, and 5 hr after intake were analyzed by liquid chromatography coupled with tandem mass spectrometry. The area under the curve (AUC) values for the serum concentrations of genistein and total isoflavones were significantly higher, by about 1.4-fold, up to 5 hr after FSM intake compared with SM intake (each p<0.05), and that of daidzein tended to be higher after FSM intake. In addition, AUC analysis of total isoflavones for individual subjects revealed that 5 out of 7 subjects had higher AUC values after FSM intake compared with SM intake and that the 2 remaining subjects had similar AUC values. These 2 subjects had higher AUC values after SM intake (mean, 2,502 ± 348) than those of the other subjects (mean, 1,158 ± 269). These results indicate that the bioavailability of isoflavones, especially genistein, is enhanced after the intake of FSM containing 32.5% isoflavone aglycones compared with intake of SM containing no isoflavone aglycones and that the enhancement is observed in healthy premenopausal Japanese women whose isoflavone absorption capacity is low after SM intake. PMID:26858926

  19. A single-blind, placebo-controlled, dose-ranging trial of oral hepatic-directed vesicle insulin add-on to oral antidiabetic treatment in patients with type 2 diabetes mellitus.

    PubMed

    Geho, W Blair; Rosenberg, Len N; Schwartz, Sherwyn L; Lau, John R; Gana, Theophilus J

    2014-05-01

    The dose response of postprandial plasma glucose (PPG) to add-on, premeal oral hepatic-directed vesicle-insulin (HDV-I), an investigational lipid bio-nanoparticle hepatocyte-targeted insulin delivery system, was evaluated in a 3-test-meal/day model in type 2 diabetes patients. The single-blind, placebo-controlled, dose-escalating trial enrolled 6 patients with HbA(1c) 8.6 ± 2.0% (70.0 ± 21.9 mmol/mol) and on stable metformin therapy. Patients received oral HDV-I capsules daily 30 minutes before breakfast, lunch, and dinner as follows: placebo capsules, 0.05, 0.1, 0.2, and 0.4 U/kg on days 1, 2, 3, 4, and 5, respectively. Outcome measures were PPG and incremental PPG area under the concentration-time curve (AUC). All 4 doses of oral HDV-I statistically significantly lowered mean PPG (P ≤ .0110 each) and incremental PPG (P ≤ .0352 each) AUC compared to placebo. A linear dose response was not observed. The 0.05 U/kg dose was the minimum effective dose in the dosage range studied. Three adverse events unrelated to treatment were observed. Add-on oral HDV-I 0.05-0.4 U/kg significantly lowered PPG excursions and the dose response curve was flat. These results are consistent with the lack of a linear dose response between portal and systemic plasma insulin concentrations in previous animal and human studies. Oral HDV-I was safe and well tolerated.

  20. Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder—the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial

    PubMed Central

    Faurholt-Jepsen, Maria; Vinberg, Maj; Christensen, Ellen Margrethe; Frost, Mads; Bardram, Jakob; Kessing, Lars Vedel

    2013-01-01

    Introduction Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms. It has never been tested in a randomised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder. We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder. Methods We developed the MONARCA application for Android-based Smartphones, allowing patients suffering from bipolar disorder to do daily self-monitoring—including an interactive feedback loop between patients and clinicians through a web-based interface. The effect of the application was tested in a parallel-group, single-blind randomised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18–60 years who were given the use of a Smartphone with the MONARCA application (intervention group) or to the use of a cell phone without the application (placebo group) during a 6-month study period. The study was carried out from September 2011. The outcomes were changes in affective symptoms (primary), social functioning, perceived stress, self-rated depressive and manic symptoms, quality of life, adherence to medication, stress and cognitive functioning (secondary and tertiary). Analysis Recruitment is ongoing. Ethics Ethical permission has been obtained. Dissemination Positive, neutral and negative findings of the study will be published. Registration details The trial is approved by the Regional Ethics Committee in The Capital Region of Denmark (H-2-2011-056) and The Danish Data Protection Agency (2013-41-1710). The trial is registered at ClinicalTrials.gov as NCT01446406. PMID:23883891

  1. Effects of exercise training on circulating levels of Dickkpof-1 and secreted frizzled-related protein-1 in breast cancer survivors: A pilot single-blind randomized controlled trial

    PubMed Central

    Park, Kyu-Sang; Park, Jeeyeon; Kim, Nahyun; Lee, Jong In; Kong, In Deok

    2017-01-01

    Background Wingless and integration site growth factor (Wnt) signaling is a tumorigenesis-related signaling pathway. Dickkpof-1 (DKK1) and secreted frizzled-related protein-1 (SFRP1) are endogenous negative regulators of Wnt/β-catenin signaling. Accumulating evidence indicates that higher serum levels of DKK1 are correlated with poor prognosis of various types of cancer. Here, we investigated whether exercise training causes changes in the serum levels of DKK1 and SFRP1 in patients with breast cancer. Methods Twenty-four breast cancer survivors, after chemo- or radiotherapy, participated in this single-blind randomized, controlled pilot study. Subjects were randomized to either an exercise program or a control group for 12 weeks and completed pre- and post-training tests for health-related fitness and body composition as well as blood biomarkers. The serum levels of DKK1 and SFRP1 were measured using enzyme-linked immunosorbent assay as the primary outcome. Results Exercise training for 12 weeks remarkably increased muscle strength, endurance, and flexibility and decreased body fat percentage, waist circumference, and visceral fat area (all p < 0.05). Exercise training lowered serum insulin levels and leptin/adiponectin ratios (all p < 0.05). The levels of DKK1 and SFRP1 were also significantly decreased by exercise training in breast cancer survivors (all p < 0.01). Conclusions Our results indicate that DKK1 and SFRP1 may be potentially useful biomarkers for evaluating the beneficial effects of long-term exercise on physical fitness and metabolism as well as the prognosis of patients with cancer. Trial registration ClinicalTrials.gov NCT02895178 PMID:28178355

  2. Differences in long-term fixation between mobile-bearing and fixed-bearing knee prostheses at ten to 12 years' follow-up: a single-blinded randomised controlled radiostereometric trial.

    PubMed

    Pijls, B G; Valstar, E R; Kaptein, B L; Nelissen, R G H H

    2012-10-01

    This single-blinded randomised controlled trial investigated whether one design of mobile-bearing (MB) total knee replacement (TKR) has any advantage over a fixed-bearing (FB) design on long-term fixation as measured by radiostereometry. The amount of wear underneath the mobile bearing was also evaluated. A series of 42 knees was randomised to MB or FB tibial components with appropriate polyethylene inserts and followed for between ten and 12 years, or until the death of the patient. The polyethylene in the MB group was superior in that it was gamma-irradiated in inert gas and was calcium-stearate free; the polyethylene in the FB group was gamma-irradiated in air and contained calcium stearate. In theory this should be advantageous to the wear rate of the MB group. At final follow-up the overall mean migration was 0.75 mm (SD 0.76) in the MB group and 0.66 mm (SD 0.4) in the FB group, with the FB group demonstrating more posterior tilt and the MB group more internal rotation. In the FB group there was one revision for aseptic loosening, but none in the MB group. There were no significant differences in clinical or radiological scores. For the MB group, the mean linear wear rate on the under-surface was 0.026 mm/year (SD 0.014). This was significantly smaller than the wear rate of 0.11 mm/year (SD 0.06) in the MB between femur and polyethylene (p < 0.001). Nevertheless, even in a best-case setting the mobile bearings of this TKR design had no apparent advantage in terms of fixation over the FB knee prosthesis at ten to 12 years. The wear underneath the mobile bearing was small and is unlikely to be clinically relevant.

  3. Probiotic strain Lactobacillus plantarum 299v increases iron absorption from an iron-supplemented fruit drink: a double-isotope cross-over single-blind study in women of reproductive age.

    PubMed

    Hoppe, Michael; Önning, Gunilla; Berggren, Anna; Hulthén, Lena

    2015-10-28

    Iron deficiency is common, especially among young women. Adding probiotics to foods could be one way to increase iron absorption. The aim of this study was to test the hypothesis that non-haem iron absorption from a fruit drink is improved by adding Lactobacillus plantarum 299v (Lp299v). Iron absorption was studied in healthy women of reproductive age using a single-blind cross-over design in two trials applying the double-isotope (55Fe and 59Fe) technique. In Trial 1, iron absorption from a fruit drink containing 109 colony-forming units (CFU) Lp299v was compared with that from a control drink without Lp299v. Trial 2 had the same design but 1010 CFU were used. The test and control drinks contained approximately 5 mg of iron as ferrous lactate and were labelled with 59Fe (B) and 55Fe (A), respectively, and consumed on 4 consecutive days in the order AABB. Retention of the isotopes was measured with whole-body counting and in blood. Mean iron absorption from the drink containing 109 CFU Lp299v (28·6(sd 12·5) %) was significantly higher than from the control drink (18·5(sd 5·8) %), n 10, P<0·028). The fruit drink with 1010 CFU Lp299v gave a mean iron absorption of 29·1(sd 17·0) %, whereas the control drink gave an absorption of (20·1(sd 6·4) %) (n 11, P<0·080). The difference in iron absorption between the 109 CFU Lp299v and the 1010 CFU Lp299v drinks was not significant (P=0·941). In conclusion, intake of probiotics can increase iron absorption by approximately 50 % from a fruit drink having an already relatively high iron bioavailability.

  4. Effect of Self Care Education with and without Telephone Follow-Up on the Level of Hope in Renal Dialysis Patients: A Single-Blind Randomized Controlled Clinical Trial

    PubMed Central

    Poorgholami, Farzad; Mansoori, Parisa; Montaseri, Zohreh; Najafi, Kazem

    2016-01-01

    Background: Various strategies such as teaching self care to hemodialysis patients have been employed to increase the level of their hope. This study aimed at examining the effects of a telephone follow-up program on the level of hope in a self care education program. Methods: In this single-blind randomized controlled clinical trial, 75 hemodialysis patients, selected by convenient sampling, were randomly assigned to 3 groups (n=25 each) including a control, a self care education, or a self care education with telephone follow-up. The control group received the routine care. The self care education group received 5 instruction sessions. The telephone follow-up group had similar instructional sessions followed by telephone calls during the subsequent 2 months. Data, collected using demographic information list and Miller’s hope questionnaire, were analyzed using Chi-Square, t-test, and one-way ANOVA followed by Scheffee test. Results: There was no significant difference among the scores of hope in the three groups before the intervention (P=0.40). However, after the intervention, the level of hope in the self care education group and self care education plus telephone follow-up groups were significantly higher than that of the control group (P=0.001). Moreover, the level of hope in the group with self care education plus telephone follow-up was significantly (P=0.001) more than that of the self care education group. Conclusion: Our findings indicated that teaching followed by telephone follow-up was associated with higher levels of hope. Therefore, such a strategy may be employed to improve the quality of life of patients with renal dialysis. Trial Registration Number: IRCT2014042617440N1 PMID:27382592

  5. Blind Quantum Computing with Weak Coherent Pulses

    NASA Astrophysics Data System (ADS)

    Dunjko, Vedran; Kashefi, Elham; Leverrier, Anthony

    2012-05-01

    The universal blind quantum computation (UBQC) protocol [A. Broadbent, J. Fitzsimons, and E. Kashefi, in Proceedings of the 50th Annual IEEE Symposiumon Foundations of Computer Science (IEEE Computer Society, Los Alamitos, CA, USA, 2009), pp. 517-526.] allows a client to perform quantum computation on a remote server. In an ideal setting, perfect privacy is guaranteed if the client is capable of producing specific, randomly chosen single qubit states. While from a theoretical point of view, this may constitute the lowest possible quantum requirement, from a pragmatic point of view, generation of such states to be sent along long distances can never be achieved perfectly. We introduce the concept of ɛ blindness for UBQC, in analogy to the concept of ɛ security developed for other cryptographic protocols, allowing us to characterize the robustness and security properties of the protocol under possible imperfections. We also present a remote blind single qubit preparation protocol with weak coherent pulses for the client to prepare, in a delegated fashion, quantum states arbitrarily close to perfect random single qubit states. This allows us to efficiently achieve ɛ-blind UBQC for any ɛ>0, even if the channel between the client and the server is arbitrarily lossy.

  6. Blind quantum computing with weak coherent pulses.

    PubMed

    Dunjko, Vedran; Kashefi, Elham; Leverrier, Anthony

    2012-05-18

    The universal blind quantum computation (UBQC) protocol [A. Broadbent, J. Fitzsimons, and E. Kashefi, in Proceedings of the 50th Annual IEEE Symposiumon Foundations of Computer Science (IEEE Computer Society, Los Alamitos, CA, USA, 2009), pp. 517-526.] allows a client to perform quantum computation on a remote server. In an ideal setting, perfect privacy is guaranteed if the client is capable of producing specific, randomly chosen single qubit states. While from a theoretical point of view, this may constitute the lowest possible quantum requirement, from a pragmatic point of view, generation of such states to be sent along long distances can never be achieved perfectly. We introduce the concept of ϵ blindness for UBQC, in analogy to the concept of ϵ security developed for other cryptographic protocols, allowing us to characterize the robustness and security properties of the protocol under possible imperfections. We also present a remote blind single qubit preparation protocol with weak coherent pulses for the client to prepare, in a delegated fashion, quantum states arbitrarily close to perfect random single qubit states. This allows us to efficiently achieve ϵ-blind UBQC for any ϵ>0, even if the channel between the client and the server is arbitrarily lossy.

  7. A Novel Quantum Proxy Blind Signature Scheme

    NASA Astrophysics Data System (ADS)

    Guo, Wei; Xie, Shu-Cui; Zhang, Jian-Zhong

    2017-02-01

    A novel quantum proxy blind signature scheme is proposed. In this scheme, a special type of non-maximally entangled three-qubit state is introduced as a quantum channel, which can realize perfect teleportation. The message sender U blinds his message by means of preparing two groups of non-orthogonal single-photon states. According to the original signer Charlie's delegation message, the proxy signer Alice generates a corresponding signature. The arbitrator Trent can help the receiver Bob verify the signature, and also prevent Bob from doing any damage. The above-mentioned advantages make this scheme different from some existing schemes. It is showed that our scheme has the properties of undeniability, unforgeability, blindness, untraceability. Moreover, it is free from intercept-resend attack.

  8. Epidemiology of blindness in Nepal*

    PubMed Central

    Brilliant, L. B.; Pokhrel, R. P.; Grasset, N. C.; Lepkowski, J. M.; Kolstad, A.; Hawks, W.; Pararajasegaram, R.; Brilliant, G. E.; Gilbert, S.; Shrestha, S. R.; Kuo, J.

    1985-01-01

    This report presents the major findings of the Nepal Blindness Survey, the first nationwide epidemiological survey of blindness, which was conducted in 1979-80. The survey was designed to gather data that could be used to estimate the prevalence and causes of blindness in the country. Ancillary studies were conducted to obtain information on socioeconomic correlates and other risk factors of blinding conditions and patterns of health care utilization. The nationwide blindness prevalence rate is 0.84%. Cataract is the leading cause of blindness, accounting for over 80% of all avoidable blindness. Trachoma is the most prevalent blinding condition, affecting 6.5% of the population. Very few cases of childhood blindness were detected. The implications of the survey findings for programme planning, health manpower development, and health education are discussed. PMID:3874717

  9. Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study

    PubMed Central

    2013-01-01

    Background Postoperative nausea and vomiting after general anesthesia is not only an unpleasant problem affecting 20-30% of surgical patients but may also lead to severe postoperative complications. There is a particularly high incidence of postoperative nausea and vomiting following thyroidectomy. Dexamethasone has been described as highly effective against chemotherapy-induced nausea and vomiting and has been proposed as a first-line method of postoperative nausea and vomiting prophylaxis. Despite this possible beneficial effect, the prophylactic administration of dexamethasone before surgery to prevent or ameliorate postoperative nausea and vomiting has not been established. A bilateral superficial cervical plexus block during thyroid surgery under general anesthesia significantly reduces pain. Of even greater clinical importance, this block prevents the need for postoperative opioids. Therefore, patients undergoing thyroidectomy and a bilateral superficial cervical plexus block are an ideal group to investigate the efficacy of dexamethasone for postoperative nausea and vomiting. These patients have a high incidence of postoperative nausea and vomiting and do not require opioids. They have no abdominal surgery, which can cause nausea and vomiting via a paralytic ileus. Combined with the highly standardized anesthesia protocol in use at our institution, this setting allows all known biases to be controlled. Methods/design We will perform a parallel two-arm, randomized (1:1), double-blind, placebo-controlled, single-center trial. Adults (≥18 years) scheduled for primary partial or total thyroidectomy because of a benign disease will be eligible for inclusion. The participants will be randomized to receive a single, intravenous preoperative dose of either 8 mg of dexamethasone in 2 ml saline (treatment group) or saline alone (placebo group). All the patients will receive a bilateral superficial cervical plexus block and standardized anesthesia. The primary

  10. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study.

    PubMed

    Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

    2015-03-01

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV.

  11. A Prospective, Randomized, Double-Blind Study of the Anesthetic Efficacy of Sodium Bicarbonate Buffered 2% Lidocaine With 1 : 100,000 Epinephrine in Inferior Alveolar Nerve Blocks

    PubMed Central

    Whitcomb, Michael; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

    2010-01-01

    Abstract The authors, using a crossover design, randomly administered, in a double-blind manner, inferior alveolar nerve (IAN) blocks using a buffered 2% lidocaine with 1 : 100,000 epinephrine/sodium bicarbonate formulation and an unbuffered 2% lidocaine with 1 : 100,000 epinephrine formulation at 2 separate appointments spaced at least 1 week apart. An electric pulp tester was used in 4-minute cycles for 60 minutes to test for anesthesia of the first and second molars, premolars, and lateral and central incisors. Anesthesia was considered successful when 2 consecutive 80 readings were obtained within 15 minutes, and the 80 reading was continuously sustained for 60 minutes. For the buffered 2% lidocaine with 1 : 100,000 epinephrine/sodium bicarbonate formulation, successful pulpal anesthesia ranged from 10–71%. For the unbuffered 2% lidocaine with 1 : 100,000 epinephrine formulation, successful pulpal anesthesia ranged from 10–72%. No significant differences between the 2 anesthetic formulations were noted. The buffered lidocaine formulation did not statistically result in faster onset of pulpal anesthesia or less pain during injection than did the unbuffered lidocaine formulation. We concluded that buffering a 2% lidocaine with 1 : 100,000 epinephrine with sodium bicarbonate, as was formulated in the current study, did not statistically increase anesthetic success, provide faster onset, or result in less pain of injection when compared with unbuffered 2% lidocaine with 1 : 100,000 epinephrine for an IAN block. PMID:20553136

  12. Perineural Nalbuphine in Ambulatory Upper Limb Surgery: A Comparison of Effects of Levobupivacaine with and without Nalbuphine as Adjuvant in Supraclavicular Brachial Plexus Block – A Prospective, Double-blinded, Randomized Controlled Study

    PubMed Central

    Das, Anjan; RoyBasunia, Sandip; Mukherjee, Anindya; Biswas, Hirak; Biswas, Rajasree; Mitra, Tapobrata; Chattopadhyay, Surajit; Mandal, Subrata Kumar

    2017-01-01

    Background and Aims: Various opioid additives have been trialed to prolong brachial plexus block. We evaluated the effect of adding nalbuphine hydrochloride to levobupivacaine for supraclavicular brachial plexus blockade. The primary end-points were the onset and duration of sensory and motor blocks and duration of analgesia. Materials and Methods: Seventy-eight patients (aged 25–45 years) posted for ambulatory forearm and hand surgery under supraclavicular brachial plexus block were divided into two equal groups (Groups LN and LC) in a randomized, double-blind fashion. In Group LN (n = 39), 30 ml 0.5% levobupivacaine + 10 mg (diluted in 2 ml 0.9% saline) nalbuphine hydrochloride, and in Group LC (n = 39), 30 ml 0.5% levobupivacaine + 2 ml normal saline (0.9%) were administered in supraclavicular block. Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics, and side effects were recorded for each patient. Results: Although with similar demographic profile and block (sensory and motor) onset time, sensory and motor block duration and time to first analgesic use were significantly longer and the total need for rescue analgesics was lower in Group LN (P < 0.05) than Group LC. Postoperative VAS value at 24 h was significantly lower in Group LN (P < 0.05). Intraoperative hemodynamics was comparable between two groups, and no any appreciable side effect was noted throughout the study period. Conclusion: It can be concluded that adding nalbuphine hydrochloride to supraclavicular brachial plexus block increases the sensory and motor block duration and time to first analgesic use, and decreases total analgesic use with no side effects. PMID:28298754

  13. Vitamin A supplementation effects on intestinal barrier function, growth, total parasitic and specific Giardia spp. infections in Brazilian children: a prospective randomized, double-blind, placebo-controlled trial

    PubMed Central

    Lima, Aldo A. M.; Soares, Alberto M.; Lima, Noélia L.; Mota, Rosa M. S.; Maciel, Bruna L. L.; Kvalsund, Michelle P.; Barrett, Leah J.; Fitzgerald, Relana P.; Blaner, William S.; Guerrant, Richard L.

    2009-01-01

    Background This study evaluates the effects of retinol on intestinal barrier function, growth, total parasites and Giardia spp. infections in children in the Northeast of Brazil. Methods The study was a double-blind, randomized placebo-controlled trial (http://clinicaltrials.gov;Register#NCT00133406) involving 79children reiceved vitamin A 100,000 - 200,000 IU (n = 39) or placebo (n = 40) at enrollment, 4 and 8 months, followed for 36 months. Intestinal barrier function was evaluated using the lactulose:mannitol test. Stool lactoferrin was used as a marker for intestinal inflammation. Results The groups were similar with regard to age, sex, nutritional parameters (z-scores), serum retinol concentrations, proportion of lactoferrin positive stool samples, and intestinal barrier function. The lactulose:mannitol ratio did not change during the same time of follow-up (p>0.05). The proportion of lactoferrin positive samples evaluated at one month did not change between groups (p>0.05). Total intestinal parasitic specifically new infections were significantly lower in the vitamin A treatment compared to control group; these were accounted for entirely by significantly fewer new Giardia infections in the vitamin A treatment group. The cumulative z-scores for weight-for-length or height (WHZ), length or height-for-age z-scores (HAZ), and weight-for-age (WAZ) did not change significantly with vitamin A intervention for 36 months of follow-up. Conclusions These data showed that total parasitic infection and Giardia spp. infections were significantly lower in the vitamin A treatment group when compared to the placebo group, suggesting that vitamin A improves host defenses against Giardia infections. PMID:20038852

  14. The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901

    SciTech Connect

    Ryu, Janice K. . E-mail: janice.ryu@ucdmc.ucdavis.edu; Swann, Suzanne; LeVeque, Francis; Johnson, Darlene J.; Chen, Allan; Fortin, Andre; Kim, Harold; Ang, Kian K.

    2007-03-01

    Purpose: Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients. Methods and Materials: Eligible patients included those with head-and-neck cancer with radiation ports encompassing >50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 {mu}g/m{sup 2} or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system. Results: Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was no statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006). Conclusion: This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer.

  15. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study

    PubMed Central

    Idorn, Thomas; Knop, Filip K; Jørgensen, Morten; Jensen, Tonny; Resuli, Marsela; Hansen, Pernille M; Christensen, Karl B; Holst, Jens J; Hornum, Mads; Feldt-Rasmussen, Bo

    2013-01-01

    Introduction Diabetes is the leading cause of end-stage renal disease (ESRD). Owing to renal clearance, several antidiabetic agents cannot be used in patients with ESRD. The present protocol describes an investigator-initiated trial aiming to test safety and efficacy of treatment with the glucagon-like peptide-1 receptor agonist liraglutide in patients with type 2 diabetes and dialysis-dependent ESRD. Methods and analysis Twenty patients with type 2 diabetes and ESRD will be compared with 20 matched patients with type 2 diabetes and normal kidney function in a randomised, parallel, placebo-controlled (1 : 1), double-blinded setting. All participants will receive 12 weeks of daily treatment with liraglutide/placebo in an individually titrated dose of 0.6, 1.2 or 1.8 mg. Over nine visits, plasma liraglutide, glycaemic control, β-cell response, cardiovascular parameters, various biomarkers and adverse events will be assessed. The primary endpoint will be evaluated from dose-corrected plasma trough liraglutide concentration at the final trial visit to determine potential accumulation in the ESRD group. Ethics and dissemination The study has been approved by the Danish Medicines Agency, the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the study. The results of the study will be presented at national and international scientific meetings, and publications will be submitted to peer-reviewed journals. Trial registration ClinicalTrials.gov Identifier: NCT01394341 PMID:23624993

  16. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

    PubMed Central

    2009-01-01

    Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Methods Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Results Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. Trial Registration ClinicalTrials.gov Identifier: NCT00881322 PMID:19922649

  17. Myelin Water Fraction Is Transiently Reduced after a Single Mild Traumatic Brain Injury – A Prospective Cohort Study in Collegiate Hockey Players

    PubMed Central

    Vavasour, Irene; Shahinfard, Elham; Kolind, Shannon; van Donkelaar, Paul; Taunton, Jack; Li, David; Rauscher, Alexander

    2016-01-01

    Impact-related mild traumatic brain injuries (mTBI) are a major public health concern, and remain as one of the most poorly understood injuries in the field of neuroscience. Currently, the diagnosis and management of such injuries are based largely on patient-reported symptoms. An improved understanding of the underlying pathophysiology of mTBI is urgently needed in order to develop better diagnostic and management protocols. Specifically, dynamic post-injury changes to the myelin sheath in the human brain have not been examined, despite ‘compromised white matter integrity’ often being described as a consequence of mTBI. In this preliminary cohort study, myelin water imaging was used to prospectively evaluate changes in myelin water fraction, derived from the T2 decay signal, in two varsity hockey teams (45 players) over one season of athletic competition. 11 players sustained a concussion during competition, and were scanned at 72 hours, 2 weeks, and 2 months post-injury. Results demonstrated a reduction in myelin water fraction at 2 weeks post-injury in several brain areas relative to preseason scans, including the splenium of the corpus callosum, right posterior thalamic radiation, left superior corona radiata, left superior longitudinal fasciculus, and left posterior limb of the internal capsule. Myelin water fraction recovered to pre-season values by 2 months post-injury. These results may indicate transient myelin disruption following a single mTBI, with subsequent remyelination of affected neurons. Myelin disruption was not apparent in the athletes who did not experience a concussion, despite exposure to repetitive subconcussive trauma over a season of collegiate hockey. These findings may help to explain many of the metabolic and neurological deficits observed clinically following mTBI. PMID:26913900

  18. CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase II trial

    PubMed Central

    Liu, Fangqi; Yang, Li; Wu, Yuchen; Li, Cong; Zhao, Jiang; Keranmu, Adili; Zheng, Hongtu; Huang, Dan; Wang, Lei; Tong, Tong; Xu, Junyan; Zhu, Ji; Cai, Sanjun; Xu, Ye

    2016-01-01

    Objective The aim of this prospective, single-arm phase II trial was to confirm the safety and efficacy of neoadjuvant chemotherapy (NAC) using oxaliplatin plus capecitabine (CapOX) for patients with operable locally advanced colon cancer (CC). Methods Patients with computed tomography-defined T4 or lymph node-positive CCs were enrolled. After radiological staging, patients were treated with at least 2 cycles of NAC consisting of 130 mg/m2 oxaliplatin on d 1, plus 1,000 mg/m2 capecitabine twice daily for 14 d every 3 weeks, followed by surgery, and then with the rest cycles of adjuvant chemotherapy. Radiological response was evaluated after 2 cycles of NAC. Tumor response, treatment toxicity, and surgical complications were recorded. The pathological response to therapy was evaluated according to the tumor regression grade (TRG) score. The primary endpoint was pathologic tumor response. This trial is registered in ClinicalTrials.gov (No: NCT02415829). Results Forty-seven patients were enrolled in the study. Forty-two patients completed the planned treatments. The total radiological response rate was 68% (32/47), including complete and partial response rates of 2% (1/47) and 66% (31/47), respectively. Stable disease was observed in 32% (15/47) and progressive disease was observed in none. Complete pathologic response, major regression, and at least moderate regression were achieved in 1 (2%), 2 (4%), and 29 (62%) patients, respectively. Four patients developed grade 3 treatment toxicities. One patient with wound infection occurred after operation (1/47, 2%). There was no treatment-related death. Conclusions Our results suggest that NAC with CapOX is an effective and safe treatment option for patients with locally advanced CCs. PMID:28174487

  19. Bleeding tendency in dual antiplatelet therapy with aspirin/clopidogrel: rescue of the template bleeding time in a single-center prospective study

    PubMed Central

    2012-01-01

    Background Patients with heightened platelet reactivity in response to antiplatelet agents are at an increased risk of recurrent ischemic events. However, there is a lack of diagnostic criteria for increased response to combined aspirin/clopidogrel therapy. The challenge is to identify patients at risk of bleeding. This study sought to characterize bleeding tendency in patients treated with aspirin and clopidogrel. Patients/methods In a single-center prospective study, 100 patients under long-term aspirin/clopidogrel treatment, the effect of therapy was assayed by template bleeding time (BT) and the inhibition of platelet aggregation (IPA) by light transmission aggregometry (LTA). Arachidonic acid (0.625 mmol/L) and adenosine diphosphate (ADP; 2, 4, and 8 μmol/L) were used as platelet agonists. Results Bleeding episodes (28 nuisance, 2 hematuria [1 severe], 1 severe proctorrhagia, 1 severe epistaxis) were significantly more frequent in patients with longer BT. Template BT ≥ 24 min was associated with bleeding episodes (28 of 32). Risk of bleeding increased 17.4% for each 1 min increase in BT. Correlation was found between BT and IPAmax in response to ADP 2 μmol/L but not to ADP 4 or 8 μmol/L. Conclusion In patients treated with dual aspirin/clopidogrel therapy, nuisance and internal bleeding were significantly associated with template BT and with IPAmax in response to ADP 2 μmol/L but not in response to ADP 4 μmol/L or 8 μmol/L. PMID:22236361

  20. Spiritual Care Therapy on Quality of Life in Cancer Patients and Their Caregivers: A Prospective Non-randomized Single-Cohort Study.

    PubMed

    Sankhe, A; Dalal, K; Agarwal, V; Sarve, P

    2017-04-01

    Spiritual care is still in infancy stage all over the globe including India. The present study was an original study evaluating the role of spiritual care in cancer patients and their primary caregivers regarding their spiritual and general well-being. The study was a prospective, non-randomized single-group study involving cancer patients undergoing surgery and their primary caregivers. Functional assessment of cancer therapy-general and functional assessment of chronic illness therapy-spiritual care was evaluated during the admission and at the time of discharge, two, four  and 6 months following discharge from the hospital. Descriptive statistics was used for demographic details and repeated measure ANOVA with Dunn's test was used for analysis of changes in the scores. A total of 107 (63 males and 44 females) patients with a mean (SD) of age 51 (13) years were recruited in the study. Similarly, for each patient one of their primary caregivers was recruited with their mean (SD) age of 39.4 (12.7) years. A total of 11/107 (10.3%) patients died and nine out of 107 (8.4%) were lost to follow-up eventually during the study period. There was a statistically significant (P < 0.0001) increase in the scores at all the follow-up periods in both the patient and their relative groups. To conclude, we found out that spiritual care on the basis of MATCH guideline improved the level of not only spiritual well-being but general well-being also in both the patients and their primary caregivers. Control group could have improved scientific validity of study in accessing effect of spiritual care. Authors believe that more robust comparative study on each principle against all five MATCH principles in future will add scientific validity and clear the various ambiguities in spiritual care.

  1. Setting up a Prospective Thyroid Biobank for Translational Research: Practical Approach of a Single Institution (2004-2009, Pasteur Hospital, Nice, France).

    PubMed

    Lassalle, Sandra; Hofman, Véronique; Ilie, Marius; Butori, Catherine; Bonnetaud, Christelle; Gaziello, Marie Clotilde; Selva, Eric; Gavric-Tanga, Virginie; Guevara, Nicolas; Castillo, Laurent; Santini, José; Chabannon, Christian; Hofman, Paul

    2011-03-01

    In the last few years, conditions for setting up a human biobank in France have been upgraded by taking into account (1) the new laws and regulations that integrate the ethical and societal dimension of biobanking and delineate the risks for patients associated with the procurement of human cells and tissues, (2) the increasing request by scientists for human samples with proven biological quality and sophisticated sets of annotations, including information produced through the evergrowing use of molecular biology in pathology, and (3) establishment of procedures concerning the safety of the personnel working with biological products. For this purpose, health authorities and national research institutes in France have provided significant support for the set up of biobanks. The present work was conducted to describe how we set up a biobank targeting diseases of a specific organ (thyroid gland), with the aim of rapidly developing translational research projects. The prospective experience of a single institution (Pasteur Hospital, Nice, France) over a 6-year period (2004-2009) is presented from the practical point of view of a surgical pathology laboratory. We describe different procedures required to obtain high-quality thyroid biological resources and clinical annotations. The procedures were established for the management of biological products obtained from 1454 patients who underwent thyroid surgery. The preanalytical steps leading to the storage of frozen specimens were carried out in parallel with diagnostic procedures. As the number of international networks for research programs using biological products is steadily increasing, it is crucial to harmonize the procedures used by biobanks. In this regard, the described thyroid biobank has been set up using criteria established by the French National Cancer Institute (Institut National du Cancer) to guarantee the quality of different collections stored in biobanks.

  2. Meningeal carcinomatosis and blindness

    PubMed Central

    Altrocchi, Paul H.; Eckman, Paul B.

    1973-01-01

    The clinical syndrome of meningeal carcinomatosis includes headache, dementia, radiculopathy, and cranial nerve palsies. Blindness may be the first, or most prominent, symptom. When blindness occurs in adult life, meningeal carcinomatosis should be included in the differential diagnosis, even in the absence of other symptoms and in the absence of known malignancy. Although all pathophysiological mechanisms of the blindness in meningeal carcinomatosis have not yet been elucidated, optic nerve involvement by meningeal tumour-cuffing, by chronic papilloedema, and by direct tumour infiltration represent the likeliest causes. In the neuropathological analysis of such cases, the importance of analysing the intra-orbital portion of the optic nerves, in addition to the portions of the optic nerve and chiasm usually examined at routine necropsy, is emphasized. A case is described to illustrate this point, with the only pathological abnormality in the optic nerves being found within 6 mm of the retina. Images PMID:4708455

  3. Blinded by headlights.

    PubMed

    Stevanovski, Biljana; Oriet, Chris; Jolicoeur, Pierre

    2002-06-01

    Target identification is impaired when targets are presented during the planning or execution of a compatible response (e.g., right-pointing arrow during a right keypress) relative to an incompatible response (Müsseler & Hommel, 1997 a, b). Examinations of this blindness to response-compatible stimuli have typically used arrowheads as targets ("<" and ">"). The importance of the target symbol was examined by manipulating subjects' interpretation of that symbol (i.e., ">" interpreted as a right-pointing arrow or as a headlight shining to the left). Targets were presented at varying times during the planning or execution of a response in order to examine the time-course of the effect. Results showed that the interpretation, and not the physical identity, of the target was important for the blindness effect. Although the blindness effect was largest during the planning and execution of a response, it was not always confined to that temporal interval.

  4. A PROSPECTIVE RANDOMIZED TRIAL OF TACROLIMUS AND PREDNISONE VERSUS TACROLIMUS, PREDNISONE AND MYCOPHENOLATE MOFETIL IN PRIMARY ADULT LIVER TRANSPLANTATION: A SINGLE CENTER REPORT1