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Sample records for prospective single blinded

  1. Single-Blind, Prospective, Randomized Study of Cefmetazole and Cefoxitin in the Treatment of Postcesarean Endometritis

    PubMed Central

    Martens, Mark; Grimes, David A.; Chatterjee, Molly; Noah, Melvin; Stamp-Cole, Marion M.; Perry, Kimberly T.; the Cefmetazole Study Group

    1995-01-01

    Objective: The purpose of this study was to compare the clinical efficacy and safety of cefmetazole given by IV push with that of parenterally administered cefoxitin for the treatment of endometritis following cesarean delivery. Methods: In a single-blind, multicenter, prospective, randomized study, 355 patients with endometritis after cesarean delivery were enrolled and received medication. Administered was either cefmetazole sodium, 2 g by IV push over 1 min q 8 h, or cefoxitin sodium, 2 g IV q 6 h in a 2:1 ratio. The patients were followed for clinical responses and side effects. Results: The cure rate for cefmetazole was 89% and for cefoxitin it was 79% (P = 0.006). The adverse events were similar in both groups. Conclusions: Cefmetazole was significantly more effective than cefoxitin in the treatment of endometritis following cesarean delivery. PMID:18475417

  2. Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

    PubMed Central

    2014-01-01

    Background Unstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple, intuitive, and inexpensive alternative for primary sternal repair following open heart surgery. Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire. We present our initial experience in a prospective, randomized, single blinded pilot study utilizing this FDA approved system. Methods Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage. All surgeries were performed by a single board certified cardiothoracic surgeon. Data collected included: Age, BMI, pump time, off pump to surgical stop time, length of hospital stay after surgery, cost from time of surgery to discharge, and pain on a visual analog pain scale on the day of discharge, day 30, and day 60. Results The groups were well matched. Patients receiving the Figure 8 FlatWire (33) had a reduction in length of stay compared to patients receiving steel wire circlage (30), but it was not statistically significant (6.8 vs. 7.8 days respectively, p < 0.093). Additionally those with the FlatWire reported significantly decreased pain at day of discharge (3.07 vs. 4.92 points on pain scale, p < 0.0066), with similar pain scores at 30 and 60 days. Off pump to surgery stop time was increased by 15.9 minutes in patients receiving the FlatWire vs. steel wires (55.7 vs. 71.6 minutes, p = 0.00025). Mean cost from surgery until discharge was $87,820.98 in the FlatWire group vs. $91,930.29 in the steel wire group (p < 0.3082). Conclusion Early clinical results suggest that

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

    PubMed

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

    2009-03-01

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

  4. 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

  5. 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

  6. Effects of isoflurane, sevoflurane, and desflurane on platelet function: A prospective, randomized, single-blind, in vivo study

    PubMed Central

    Bozdogan, Nesrin; Madenoglu, Halit; Dogru, Kudret; Yildiz, Karamehmet; Kotanoglu, Mustafa S.; Cetin, Mustafa; Boyaci, Adem

    2005-01-01

    Background: The primary physiologic function of platelets is to facilitate hemostasisby aggregation. Volatile anesthetics have been reported to decrease platelet aggregation in vivo and in vitro. Objective: The aim of this study was to investigate the hematologic effectsof the anesthetics isoflurane, sevoflurane, and desflurane on hemoglobin (Hb), hematocrit (Hct), platelet count, activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), and platelet aggregation after minor surgery. Methods: Patients aged 20 to 60 years who were scheduled to undergominor surgery and American Society of Anesthesiologists physical status P1 or P2 (healthy or mild systemic disease) were randomized to 1 of 3 groups: 1 minimum alveolar concentration (MAC) of isoflurane, sevoflurane, or desflurane. None of the patients received premedication. Anesthesia was induced using IV thiopental 5 to 6 mg/kg, fentanyl 1 to 2 μg/kg, and vecuronium 0.1 mg/kg, and maintained with 1 MAC of isoflurane, sevoflurane, or desflurane in 66% nitrous oxide and 33% oxygen. Vecuronium 0.03 mg/kg was given when necessary for muscle relaxation. All patients were monitored throughout surgery; isotonic saline was given at a rate of 5 mL/kg · h. Hematologic studies were performed preoperatively, 15 minutes after intubation, and 1 hour after the end of surgery. Platelet aggregation tests were performed in a laboratory using a platelet function analyzer (PFA), collagen/epinephrine PFA test cartridges, collagen/adenosine diphosphate PFA test cartridges, and PFA trigger solution. Results: This prospective, randomized, single-blind, in vivo study was conducted at Gevher Nesibe Teaching Hospital, Erciyes University, Kayseri, Turkey. Thirty patients (15 men, 15 women) were randomized to the 3 treatment groups (each, n = 10). Hb, Hct, platelet count, aPTT, PT, and INR were statistically similar between all 3 groups. The measured parameters were not significantly different

  7. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    PubMed Central

    Kong, Moonkyoo; Shin, Sung Hee; Lee, Eunmi; Yun, Eun Kyoung

    2014-01-01

    Background There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT). We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients’ evaluation of pain within the RT field was also assessed. Results In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%), five (33.3%), and five patients (33.3%), respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%), nine (47.4%), two (10.5%), and one patient (5.3%), respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%). The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not statistically significant. Conclusion The results of this study show that laughter therapy can have a beneficial role in preventing radiation dermatitis in patients with breast cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes are required. PMID:25395864

  8. Prevention of surgical site infection in lower limb skin lesion excisions with single dose oral antibiotic prophylaxis: a prospective randomised placebo-controlled double-blind trial

    PubMed Central

    Smith, Samuel C; Heal, Clare F; Buttner, Petra G

    2014-01-01

    Objectives To determine the effectiveness of a single perioperative prophylactic 2 g dose of cephalexin in preventing surgical site infection (SSI) following excision of skin lesions from the lower limb. Design Prospective double-blinded placebo-controlled trial testing for difference in infection rates. Setting Primary care in regional North Queensland, Australia. Participants 52 patients undergoing lower limb skin lesion excision. Interventions 2 g dose of cephalexin 30–60 min before excision. Main outcome measures Incidence of SSI. Results Incidence of SSI was 12.5% (95% CI 2.7% to 32.4%) in the cephalexin group compared with 35.7% (95% CI 18.6% to 55.9%) in the placebo group (p=0.064). This represented an absolute reduction of 23.21% (95% CI −0.39% to 46.82%), relative reduction of 65.00% (95% CI −12.70% to 89.13%) and number-needed-to-treat of 4.3. Conclusions Administration of a single 2 g dose of cephalexin 30–60 min before skin lesion excision from the lower limb may produce a reduction in the incidence of infection; however, this study was underpowered to statistically determine this. Trial registration number ACTRN12611000595910. PMID:25079934

  9. 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.

  10. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

    PubMed Central

    2010-01-01

    Background It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion

  11. 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

  12. 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

  13. [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.

  14. [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. PMID:12611200

  15. 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.

  16. An Education- and Telephone-Based Intervention to Improve Follow-up to Vision Care in Patients With Diabetes: A Prospective, Single-Blinded, Randomized Trial.

    PubMed

    Zangalli, Camila S; Murchison, Ann P; Hale, Nicole; Hark, Lisa A; Pizzi, Laura T; Dai, Yang; Leiby, Benjamin E; Haller, Julia A

    2016-01-01

    The aim was to evaluate the effectiveness of a multipronged intervention on diabetic dilated fundus examination (DFE) adherence. In a prospective trial, 521 patients with diabetes who were due for follow-up DFEs were randomized to usual care or the intervention group. Usual care received a form letter reminder to schedule and an automated reminder phone call prior to their appointment. Intervention participants received an educational brochure about diabetic eye disease and a personalized letter reminder to schedule. A research assistant called intervention participants to help schedule the appointment, and they received a reminder letter and an automated phone call prior to the scheduled visit. Patients in the intervention group were significantly more likely to schedule (63% vs 40%; P < .0001) and complete their appointment (48% vs 30%; P < .0001) compared with usual care. A multipronged intervention, including an educational mailing and telephone assistance with scheduling an appointment, significantly improved diabetic DFE adherence. PMID:25270737

  17. 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.

  18. 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. PMID:24522897

  19. 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.

  20. The Efficacy and Safety of Jaungo, a Traditional Medicinal Ointment, in Preventing Radiation Dermatitis in Patients with Breast Cancer: A Prospective, Single-Blinded, Randomized Pilot Study

    PubMed Central

    Kong, Moonkyoo; Hwang, Deok-Sang; Lee, Jee Young; Yoon, Seong Woo

    2016-01-01

    Purpose. This study was performed to evaluate the efficacy and safety of Jaungo in preventing radiation dermatitis in patients with breast cancer. Methods. Thirty patients were prospectively enrolled and randomly assigned to receive Jaungo or general supportive skin care. Radiation dermatitis and pain were examined at daily intervals from the start of radiotherapy until 4 weeks after its completion. The primary endpoint of this study was the incidence of radiation dermatitis. The secondary endpoints were time to onset of radiation dermatitis, duration of radiation dermatitis, and maximum pain score. Results. Jaungo reduced the incidence of grade ≥2 (46.7% versus 78.6%) and grade 3 radiation dermatitis (20.0% versus 50.0%) in comparison with general supportive skin care. Jaungo also delayed the onset of grade 2 dermatitis (35 days versus 30 days). In terms of time to onset of grade 3 dermatitis, duration of dermatitis, and maximum pain score, Jaungo showed results comparable to those achieved with general supportive skin care. No patients experienced adverse effects caused by Jaungo administration. Conclusions. Jaungo minimized radiation dermatitis in patients with breast cancer without causing adverse effects. Further randomized studies with a larger sample size are required to assess clinical use of Jaungo. PMID:27066103

  1. Prospects and blind spots for neutralino dark matter

    NASA Astrophysics Data System (ADS)

    Cheung, Clifford; Hall, Lawrence J.; Pinner, David; Ruderman, Joshua T.

    2013-05-01

    Using a simplified model framework, we assess observational limits and discovery prospects for neutralino dark matter, taken here to be a general admixture of bino, wino, and Higgsino. Experimental constraints can be weakened or even nullified in regions of parameter space near 1) purity limits, where the dark matter is mostly bino, wino, or Higgsino, or 2) blind spots, where the relevant couplings of dark matter to the Z or Higgs bosons vanish identically. We analytically identify all blind spots relevant to spin-independent and spin-dependent scattering and show that they arise for diverse choices of relative signs among M 1, M 2, and μ. At present, XENON100 and IceCube still permit large swaths of viable parameter space, including the well-tempered neutralino. On the other hand, upcoming experiments should have sufficient reach to discover dark matter in much of the remaining parameter space. Our results are broadly applicable, and account for a variety of thermal and non-thermal cosmological histories, including scenarios in which neutralinos are just a component of the observed dark matter today. Because this analysis is indifferent to the fine-tuning of electroweak symmetry breaking, our findings also hold for many models of neutralino dark matter in the MSSM, NMSSM, and Split Supersymmetry. We have identified parameter regions at low tan β which sit in a double blind spot for both spin-independent and spin-dependent scattering. Interestingly, these low tan β regions are independently favored in the NMSSM and models of Split Supersymmetry which accommodate a Higgs mass near 125 GeV.

  2. 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

    Sansalone, Salvatore; Leonardi, Rosario; Antonini, Gabriele; Vitarelli, Antonio; Vespasiani, Giuseppe; Basic, Dragoslav; Morgia, Giuseppe; Cimino, Sebastiano; Russo, Giorgio Ivan

    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.

  3. 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

  4. Blindness

    MedlinePlus

    ... The problem may affect one eye or both eyes. When you think of being blind, you might imagine total darkness. But most people who are blind can still see a little light or shadows. They just can't see things clearly. People who have some sight, but still need a lot of help, are ...

  5. 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

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

    PubMed

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

    2016-09-01

    Patients with transient monocular blindness (TMB) can present with many different symptoms, and diagnosis is usually based on the history alone. In this study, we assessed the risk of vascular complications according to different characteristics of TMB. We prospectively studied 341 consecutive patients with TMB. All patients were interviewed by a single investigator with a standardized questionnaire; reported symptoms were classified into predefined categories. We performed Cox regression analyses with adjustment for baseline vascular risk factors. During a mean follow-up of 4.0 years, the primary outcome event of vascular death, stroke, myocardial infarction, or retinal infarction occurred in 60 patients (annual incidence 4.4 %, 95 % confidence interval (CI) 3.4-5.7). An ipsilateral ischemic stroke occurred in 14 patients; an ipsilateral retinal infarct in six. Characteristics of TMB independently associated with subsequent vascular events were: involvement of only the peripheral part of the visual field (hazard ratio (HR) 6.5, 95 % CI 3.0-14.1), constricting onset of loss of vision (HR 3.5, 95 % CI 1.0-12.1), downward onset of loss of vision (HR 1.9, 95 % CI 1.0-3.5), upward resolution of loss of vision (HR 2.0, 95 % CI 1.0-4.0), and the occurrence of more than three attacks (HR 1.7, 95 % CI 1.0-2.9). We could not identify characteristics of TMB that predicted a low risk of vascular complications. In conclusion, careful recording the features of the attack in patients with TMB can provide important information about the risk of future vascular events. PMID:27314958

  7. 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. PMID:14579160

  8. Ondasetron versus haloperidol for the treatment of postcardiotomy delirium: a prospective, randomized, double-blinded study

    PubMed Central

    2012-01-01

    Background To investigate the controlling efficacy of ondasetron and haloperidol in regard to the postcardiotomy delirium. Methods We included in this prospective, randomized, double-blinded study 80 patients who developed delirium after heart surgery with the application of heart lung-machine. The patients were divided into two, equally-sized groups, which on detection of delirium received ondasetron 8 mg iv or haloperidol 5 mg iv respectively. The statistical analysis compared the baseline and demographic characteristics of the two groups (age, gender, comorbidities, years of education, type of surgery etc.). Results Both ondasetron and haloperidol had very good delirium controlling effects, without statistically significant differences. Discussion-Conclusions Ondasetron and haloperidol are efficient agents as far as the treatment of postcardiotomy delirium is concerned. As, in addition, ondasetron bares milder side-effects, we believe this could be the agent of choice in patients developing postcardiotomy delirium in the future. PMID:22436170

  9. Emerging Evidence from Single-Subject Research in the Field of Deaf-Blindness

    ERIC Educational Resources Information Center

    Parker, Amy T.; Davidson, Roseanna; Banda, Devender R.

    2007-01-01

    Professionals in the field of deaf-blindness are challenged to use instructional practices that have been tested using experimental methodology. Single-subject design has been examined as a form of research that assists in substantiating practice. In a review of the literature, the authors identified 54 single-subject studies from 1969 to 2006…

  10. DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY COMPARING POLYETHYLENE GLYCOL TO LACTULOSE FOR BOWEL PREPARATION IN COLONOSCOPY

    PubMed Central

    MENACHO, Aline Moraes; REIMANN, Adriano; HIRATA, Lie Mara; GANZERELLA, Caroline; IVANO, Flavio Heuta; SUGISAWA, Ricardo

    2014-01-01

    Background Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. PMID:24676290

  11. [Enteral nutrition and changes in taste in diabetic patients: a double-blind prospective study].

    PubMed

    Sánchez Nebra, J; Aníbarro García, L; Vázquez Vizoso, F; Carabelos Acuña, P; Cristóbal García, F; García Vázquez, M; Martínez-Almeida, R; Gutiérrez-Solana, V; Fernández García, L; Luna Ortiz de Zárate, B

    1993-12-01

    The authors present a prospective double blind test aimed at objectively determining the acceptance of flavoured orally administered enteric diets specific to patients with glucose metabolism alterations (Glucerna and Precitene Diabet), in the light of the taste disorders described in such patients. Sixty-two patients were studied, 32 diabetics and 32 control patients, who were given a sample of each product; the level of acceptance was quantified on a modified wine-tasting scale. The average taste of the diabetics was 12.1 points (SD = 4.34) for Glucerna, and 10.1 (SD = 3.91) for the Precitene Diabet. In the control patients, the scores were 12.7 (SD = 3.78) and 13.2 (SD = 3.23) respectively. Multiple regression analysis did not reveal significant differences in taste according to age, sex or place of origin. Average taste among the diabetic patients as a whole with both products was 11.2 points and, for the nondiabetics, 12.92. The model detected significant differences (p = 0.01) between the two groups. The average taste of the diabetics was less than that of the non-diabetics, irrespective of all the remaining variables examined, including the type of preparation. These results confirm the lower oral acceptance in diabetic patients, possibly associated with disorders in the sense of taste, showing the utility of the modified wine-tasting scale as a test in evaluating the acceptance of enteric diets which must be administered orally.

  12. 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.

  13. Oral clonidine and gabapentin suppress pressor response: A prospective, randomized, double blind study

    PubMed Central

    Kapse, Upendra Kumar S.; Bhalerao, Pradnya Milind

    2016-01-01

    Background: Pressor response is a part of stress response caused by reflex sympathetic discharge due to direct laryngoscopy and tracheal intubation resulting in tachycardia, hypertension and arrhythmias. Both clonidine, and gabapentin administered orally can effectively blunt this detrimental hemodynamic response. Aim: To study the effect of oral clonidine to blunt the pressor response to direct laryngoscopy and to compare it with oral gabapentin. To observe for postoperative sedation and side effects if any. Settings and Design: Sixty patients of American Society of Anaesthesiologist Grade I and II scheduled for surgery under general anesthesia were considered in this prospective randomized double-blind study. They were randomly allocated into two groups of 30 each using computerized randomization. Materials and Methods: Group A was given oral clonidine 5 μg/kg and Group B was given oral gabapentin 800 mg. Both the drugs were given 90 min prior to surgery. Heart rate (HR) and blood pressure were monitored at baseline, 0, 1, 3, 5, 10, 15, and 30th min of laryngoscopy. Sedation was monitored by Ramsay Sedation Scale score and side effects were noted. Results: HR decreased in both groups at 0 and 1 min, increased at 3rd min and gradually decreased by 30th min. Statistically, significant difference was found between two groups at 1, 3, 5, 10, and 15th min (P < 0.05). Though there was no significant difference in systolic blood pressure, diastolic blood pressure and mean arterial pressure between the two groups, there was no rise in these parameters. Gabapentin produced more sedation than clonidine postoperatively, and few side effects were noted. Conclusion: Both oral clonidine and gabapentin are effective in obtunding pressor response to direct laryngoscopy, clonidine being better in terms of controlling HR. Gabapentin produces more postoperative sedation than clonidine. PMID:26957684

  14. Palonosetron and granisetron in postoperative nausea vomiting: A randomized double-blind prospective study

    PubMed Central

    Gugale, Amrita A.; Bhalerao, Pradnya Milind

    2016-01-01

    Background: Postoperative nausea and vomiting (PONV) is a common occurrence after laparoscopic surgeries. A number of pharmacological agents (antihistamines, butyrophenones, dopamine receptor antagonists) have been tried of which the 5-hydroxytryptamine type 3 receptor antagonists are devoid of most side effects and highly effective in prevention and treatment of PONV. Thus, we evaluated the effectiveness of granisetron and palonosetron in prevention of PONV after laparoscopic surgeries under general anesthesia. Aims: We conducted a study to evaluate the effectiveness of granisetron and palonosetron, to compare the duration of action and side effects if any, in patients undergoing elective laparoscopic surgery under general anesthesia. Settings and Design: This was a prospective, randomized, double-blinded, comparative study. Sixty patients (18–65 years of age) of the American Society of Anesthesiologists Grade I and II undergoing elective laparoscopic surgeries were considered. Materials and Methods: They were randomly allocated into one of the two groups (Group G and Group P) of thirty patients each. Group G received injection granisetron 0.05 mg/kg; Group P received injection palonosetron 1.5 mcg/kg intravenous bolus 30 min before the induction of anesthesia. Statistical Tests: All statistical analyses were performed using the SPSS® statistical package version 18.0 (Chicago: SPSS Inc). Two independent sample t-test was used for quantitative data, and the χ2 or Fisher's exact test was used for qualitative data. A difference was regarded as statistically significant at a P < 0.05. Results: The need for rescue antiemetic was significantly lower in Group P in the 24–72 h postoperative period (ρ - 0.007). The PONV score was significantly less in Group P in the same period (ρ - 0.008). The incidence of side effects was statistically insignificant in both the groups (ρ - 0.999). Conclusion: Prophylactic therapy with palonosetron is more effective than

  15. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions

    SciTech Connect

    Mooney, V. )

    1990-07-01

    A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.

  16. 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

  17. 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

  18. 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.

  19. 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. PMID:27047362

  20. 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

  1. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today. PMID:24451886

  2. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today.

  3. Randomised single blind trial to compare the toxicity of subconjunctival gentamicin and cefuroxime in cataract surgery.

    PubMed

    Jenkins, C D; McDonnell, P J; Spalton, D J

    1990-12-01

    Comparatively little attention has been paid to the conjunctival toxicity of antibiotics administered at the time of cataract surgery. We have observed the effect of subconjunctival gentamicin and cefuroxime injection, using colour photography in a randomised single blind trial of 121 patients undergoing routine cataract surgery. Our results suggest that a hyperaemic eye is likely to occur about twice as often in patients injected with gentamicin (p less than 0.001). Gentamicin is associated with more pain postoperatively (p less than 0.05). Significant manifestations of gentamicin toxicity are conjunctival oedema and capillary closure. Cefuroxime has some theoretical advantages over gentamicin in its antibacterial spectrum.

  4. 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

  5. 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.

  6. A blind signal separation method for single-channel electromagnetic surveillance system

    NASA Astrophysics Data System (ADS)

    Pang, Lihui; Qi, Zhilong; Li, Shuai; Tang, Bin

    2015-10-01

    In this paper, a blind signal separation (BSS) methodology for simultaneously received multisystem frequency-overlapped signals in a single-channel (SC) electromagnetic surveillance system is proposed using fast independent component analysis (FastICA) in a dynamical embedding (DE) framework. Firstly, an appropriate DE matrix is constructed out of a series of delay vectors from the SC recording. The lag-time and the dimensional of embedding matrix setting principal are introduced in details. Next, multiple independent components (ICs) are calculated by decomposing the embedding matrix through FastICA algorithm, and ICs can be regarded as a convenient expansion basis of the original signals. Then, these ICs are projected back into the measurement space. After that, these projected ICs are classified and used for recovering the sources of interest based on their independent nature and their power density spectrum. Numerical simulation results obtained in evaluating the proposed methodology's performance confirmed the effectiveness of the proposed algorithm.

  7. Single-blind clinical trial comparing use of fentiazac and paracetamol in postendodontic periodontitis.

    PubMed

    Leguen, M A

    1985-01-01

    The efficacy of oral fentiazac (100 mg QID) was compared with that of paracetamol (500 mg QID) in a single-blind trial in 30 patients suffering from post-endodontic periodontitis secondary to infiltrative or abscessed pulpitis. Patients were allocated at random to two treatment groups and treated for four days. Over each of the four days, patients scored the severity of spontaneous pain and induced pain. The same symptoms were assessed by the investigator at 0, 48, and 96 hours. Special attention was paid to the occurrence of adverse reactions. A statistically significant difference favoring fentiazac was seen in the patients' assessments of induced pain (while eating) but not in the investigator's assessment of induced pain (percussion). There was no significant difference in the analgesic effects of fentiazac and paracetamol with respect to spontaneous pain scored by patients or the investigator. No side effects were seen. Fentiazac was shown to be an effective analgesic for use in this painful inflammatory condition.

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

    PubMed Central

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

    2015-01-01

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

  9. Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective double blind study.

    PubMed Central

    Bhagwanjee, S.; Muckart, D. J.; Jeena, P. M.; Moodley, P.

    1997-01-01

    OBJECTIVES: (a) To assess the impact of HIV status (HIV negative, HIV positive, AIDS) on the outcome of patients admitted to intensive care units for diseases unrelated to HIV; (b) to decide whether a positive test result for HIV should be a criterion for excluding patients from intensive care for diseases unrelated to HIV. DESIGN: A prospective double blind study of all admissions over six months. HIV status was determined in all patients by enzyme linked immunosorbent assay (ELISA), immunofluorescence assay, western blotting, and flow cytometry. The ethics committee considered the clinical implications of the study important enough to waive patients' right to informed consent. Staff and patients were blinded to HIV results. On discharge patients could be advised of their HIV status if they wished. SETTING: A 16 bed surgical intensive care unit. SUBJECTS: All 267 men and 135 women admitted to the unit during the study period. INTERVENTIONS: None. MAIN OUTCOME MEASURES: APACHE II score (acute physiological, age, and chronic health evaluation), organ failure, septic shock, durations of intensive care unit and hospital stay, and intensive care unit and hospital mortality. RESULTS: No patient had AIDS. 52 patients were tested positive for HIV and 350 patients were tested negative. The two groups were similar in sex distribution but differed significantly in age, incidence of organ failure (37 (71%) v 171 (49%) patients), and incidence of septic shock (20 (38%) v 54 (15%)). After adjustment for age there were no differences in intensive care unit or hospital mortality or in the durations of stay in the intensive care unit or hospital. CONCLUSIONS: Morbidity was higher in HIV positive patients but there was no difference in mortality. In this patient population a positive HIV test result should not be a criterion for excluding a patient from intensive care. PMID:9133887

  10. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    PubMed Central

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739

  11. Blinded prospective evaluation of computer-based mechanistic schizophrenia disease model for predicting drug response.

    PubMed

    Geerts, Hugo; Spiros, Athan; Roberts, Patrick; Twyman, Roy; Alphs, Larry; Grace, Anthony A

    2012-01-01

    The tremendous advances in understanding the neurobiological circuits involved in schizophrenia have not translated into more effective treatments. An alternative strategy is to use a recently published 'Quantitative Systems Pharmacology' computer-based mechanistic disease model of cortical/subcortical and striatal circuits based upon preclinical physiology, human pathology and pharmacology. The physiology of 27 relevant dopamine, serotonin, acetylcholine, norepinephrine, gamma-aminobutyric acid (GABA) and glutamate-mediated targets is calibrated using retrospective clinical data on 24 different antipsychotics. The model was challenged to predict quantitatively the clinical outcome in a blinded fashion of two experimental antipsychotic drugs; JNJ37822681, a highly selective low-affinity dopamine D(2) antagonist and ocaperidone, a very high affinity dopamine D(2) antagonist, using only pharmacology and human positron emission tomography (PET) imaging data. The model correctly predicted the lower performance of JNJ37822681 on the positive and negative syndrome scale (PANSS) total score and the higher extra-pyramidal symptom (EPS) liability compared to olanzapine and the relative performance of ocaperidone against olanzapine, but did not predict the absolute PANSS total score outcome and EPS liability for ocaperidone, possibly due to placebo responses and EPS assessment methods. Because of its virtual nature, this modeling approach can support central nervous system research and development by accounting for unique human drug properties, such as human metabolites, exposure, genotypes and off-target effects and can be a helpful tool for drug discovery and development. PMID:23251349

  12. 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

  13. 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.

  14. 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…

  15. 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

  16. Comparison between dexmedetomidine and fentanyl on intubation conditions during awake fiberoptic bronchoscopy: A randomized double-blind prospective study

    PubMed Central

    Mondal, Sudeshna; Ghosh, Sarmila; Bhattacharya, Susmita; Choudhury, Brojen; Mallick, Suchismita; Prasad, Anu

    2015-01-01

    Background and Aims: Various drugs are used for providing favorable intubation conditions during awake fiberoptic intubation (AFOI). However, most of them cause respiratory depression and airway obstruction leading to hypoxemia. The aim of this study was to compare intubation conditions, and incidence of desaturation between dexmedetomidine and fentanyl group during AFOI. Material and Methods: This randomized double-blind prospective study was conducted on a total of 60 patients scheduled for elective laparotomies who were randomly allocated into two groups: Group A received dexmedetomidine 1 mcg/kg and Group B received fentanyl 2 mcg/kg over 10 min. Patients in both groups received glycopyrrolate 0.2 mg intravenous, nebulization with 2% lidocaine 4 ml over 20 min and 10% lidocaine spray before undergoing AFOI. Adequacy of intubation condition was evaluated by cough score and post-intubation score. Incidence of desaturation, hemodynamic changes and sedation using Ramsay sedation scale (RSS) were noted and compared between two groups. Results: Cough Score (1-4), post-intubation Score (1-3) and RSS (1-6) were significantly favorable (P < 0.0001) along with minimum hemodynamic responses to intubation (P < 0.05) and less oxygen desaturation (P < 0.0001) in Group A than Group B. Conclusion: Dexmedetomidine is more effective than fentanyl in producing better intubation conditions, sedation along with hemodynamic stability and less desaturation during AFOI. PMID:25948903

  17. Preparation of nose for nasal endoscopy: cotton pledget packing versus topical spray. A prospective randomized blinded study.

    PubMed

    Mishra, Prasun; Kaushik, Maitri; Dehadaray, Arun; Qadri, Haris; Raichurkar, Annapurna; Seth, Tanvi

    2013-01-01

    During nasal endoscopy it is essential to have proper visualization of structures with minimal discomfort to patient and surgeon. For this it is essential that the nose is well prepared before the procedure. The main objective of the study is to compare and evaluate the efficacy of cotton pledget packing versus topical sprays in preparation of nose for nasal endoscopy. The method includes prospective randomized blinded study on 100 patients. Patients were randomly divided in two groups. In first group the nose was packed with 4% lignocaine with xylometazoline nasal drops and in the other group it was prepared with 10% lignocaine topical spray and xylometazoline nose drops. Following the procedure, patient and the surgeon were asked a pre-formed questionnaire to know their experience during endoscopy. It was observed the packing group required more preparatory time as compared to the spray group. The group which was packed had less discomfort, less pain while endoscopy. The visualization of structures was significantly better in the packed group. Eight patients in the packed group did have some mucosal bleed during the process of packing which was not seen in the spray group. Both methods of preparation have merits and demerits but in terms of discomfort, pain during procedure and visualization of structure, packing of nasal cavity with 4% lignocaine and xylometazoline drops is better than spraying of nose with 10% lignocaine and xylometazoline drops. PMID:22427029

  18. A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers.

    PubMed

    Bishop, J B; Phillips, L G; Mustoe, T A; VanderZee, A J; Wiersema, L; Roach, D E; Heggers, J P; Hill, D P; Taylor, E L; Robson, M C

    1992-08-01

    Chronic wounds such as venous stasis ulcers have become a socioeconomic problem. Even with successful initial management, the recurrence rate approaches 70%. With the advent of new wound healing agents, nonoperative attempts to heal these wounds appear indicated. This study reports a prospective randomized evaluator-blinded trial comparing two potential wound healing agents to an inert vehicle placebo. Eighty-six evaluable patients completed the trial. Silver sulfadiazine 1% in a cream proved to statistically reduce the ulcer size compared with a biologically active tripeptide copper complex 0.4% cream formulation or the placebo. There was no difference between the latter two treatments. Silver sulfadiazine has been shown to allow keratinocyte replication and to have antiinflammatory properties. In this trial its antibacterial action was not used since all ulcers had comparable bacterial levels (less than or equal to 10(5)/gm of tissue) before treatment. These results suggest that the silver sulfadiazine cream used in this study may facilitate healing in wounds healing largely by the process of epithelialization. PMID:1495150

  19. A prospective, randomized, blinded comparison of multiplane and biplane transesophageal echocardiographic techniques.

    PubMed

    Warner, J G; Nomeir, A M; Salim, M; Kitzman, D W

    1996-01-01

    Although multiplane transesophageal echocardiography has become an accepted diagnostic technique, there is a paucity of literature directly comparing the diagnostic yield of multiplane and biplane transesophageal examinations. This study was designed to compare the ability of multiplane and biplane transesophageal echocardiographic techniques to visualize intracardiac structures. Complete multiplane and biplane transesophageal studies were performed on each of 50 patients (100 total studies) referred to the echocardiography laboratory for elective transesophageal echocardiography. The biplane examinations were performed with a multiplane probe with angles only at 0 and 90 degrees. Images of 29 prospectively selected cardiac structures and valvular function parameters were scored as follows: 0 = not visualized, 1 = visualized well enough to identify structure, 2 = diagnostic quality, and 3 = exceptional quality. The scores for the individual structures were combined to identify total structure visualization quality scores for each of the imaging techniques. A separate subjective score was also determined to assess the overall adequacy of each study for addressing the clinical indication. The total structure visualization quality score was significantly higher for multiplane transesophageal echocardiography than for biplane transesophageal echocardiography (49 +/- 7 versus 45 +/- 7; p = 0.0001). Several individual structures were visualized significantly better (p < 0.05) by the multiplane technique, including the left upper pulmonary vein, fossa ovalis, left main coronary artery, and proximal ascending aorta. The subjective score of overall adequacy of the study for addressing the clinical indication showed a strong trend (p < 0.06) in favor of the multiplane technique, with higher scores in 11 of 50 multiplane studies versus three of 50 biplane studies when the two techniques were compared in individual patients. Therefore multiplane transesophageal

  20. 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.

  1. Effect of adding clonidine to intrathecal bupivacaine on the quality of subarachnoid block: A prospective randomized double-blind study

    PubMed Central

    Yallapragada, Srivishnu Vardhan; Vemuri, Nagendra Nath; Shaik, Mastan Saheb

    2016-01-01

    Context: The purpose of adding an adjuvant to local anesthetic in a central neuraxial blockade is to augment the desirable pharmacological actions of the agent and/or to minimize its undesirable pharmacological effects. Clonidine is an alfa-2 receptor agonist which has gained popularity in recent times as an adjuvant in spinal anesthesia. Aims: To evaluate the influence of clonidine on the hemodynamic stability and the duration of anesthesia when added to intrathecal hyperbaric bupivacaine. Settings and Design: Prospective randomized double blind study. Subjects and Methods: Fifty patients scheduled for spinal anesthesia were randomized into two Groups A and B with 25 in each. Group A patients received 3 ml 0.5% heavy bupivacaine + 30 μg (0.2 ml) clonidine and Group B patients received 3 ml 0.5% heavy bupivacaine + 0.2 ml normal saline in the subarachnoid space. The blood pressure and heart rate were closely monitored. The time for attaining peak sensory block, time for two segment regression, decrease in the heart rate, total requirement of mephentermine to counter the hypotension, and the number of patients requiring mephentermine in each group was tabulated and analyzed. Statistical Analysis Used: Descriptive and inferential statistical methods were used to analyse the data. The power of the study was calculated using online power calculator for two independent sample study. Results: The time for attaining peak sensory block was similar in both the groups. The time for two segment regression in Group A was 62.6 min and in Group B was 38.08 min. Twelve percent of patients in Group A and 52% of patients in Group B required mephentermine with the mean consumption being 0.72 mg in Group A and 5.65 mg in Group B. Conclusions: Addition of low-dose clonidine to intrathecal bupivacaine not only prolonged the duration of spinal anesthesia but also provided a stable intraoperative hemodynamic profile. PMID:27746531

  2. Assessing experimental visceral pain in dairy cattle: A pilot, prospective, blinded, randomized, and controlled study focusing on spinal pain proteomics.

    PubMed

    Rialland, P; Otis, C; de Courval, M-L; Mulon, P-Y; Harvey, D; Bichot, S; Gauvin, D; Livingston, A; Beaudry, F; Hélie, P; Frank, D; Del Castillo, J R E; Troncy, E

    2014-01-01

    Few studies have verified the validity of behavioral and physiological methods of pain assessment in cattle. This prospective, blinded, randomized controlled experimental study aimed to validate different methods of pain assessment during acute and chronic (up to 21 d postintervention) conditions in dairy cattle, in response to 3 analgesic treatments for traumatic reticuloperitonitis. Cerebrospinal fluid (CSF) biomarkers and mechanical sensitization were measured as indicators of centralized pain. Proteomics in the CSF were examined to detect specific (to pain intensity) and sensitive (responsive to analgesia) markers. Recordings of spontaneous behavior with video analysis, telemetered motor activity, pain scales, electrodermal activity, and plasma cortisol concentration were quantified at regular intervals. Cows were assigned to group 1 (n=4, standard control receiving aspirin), group 2 (n=5, test group receiving preemptive tolfenamic acid), or group 3 (n=3, positive control receiving preemptive multimodal analgesia composed of epidural morphine, plus tolfenamic acid and butorphanol). Rescue analgesia was administered as needed. Generalized estimating equations tested group differences and the influence of rescue analgesia on the measurements. All 3 groups demonstrated a long-term decrease in a CSF protein identified as transthyretin. The decrease in transthyretin expression inversely correlated with the expected level of analgesia (group 1<2<3). Moreover, in group 1, CSF noradrenaline decreased long term, cows were hypersensitive to mechanical stimulation, and they demonstrated signs of discomfort with higher motor activity and "agitation while lying" recorded from video analysis. Decreased "feeding behavior," observer-reported pain scales, electrodermal activity, and plasma cortisol concentration were inconsistent to differentiate pain intensity between groups. In summary, changes in CSF biomarkers and mechanical sensitization reflected modulation of central

  3. A combined single-blind, double-blind, placebo-controlled study to determine the reproducibility of hypersensitivity reactions to aspartame.

    PubMed

    Garriga, M M; Berkebile, C; Metcalfe, D D

    1991-04-01

    Aspartame is an O-methyl ester composed of phenylalanine and aspartic acid. After its final approval as a sweetener in 1981, a number of reports of adverse reactions to aspartame appeared in the literature. To explore the pathogenesis of such reactions, we initiated a study in July 1986 to identify subjects with hypersensitivity reactions to aspartame with blinded challenge procedures. The study was closed after 32 months. During that time, we advertised in local newspapers and worked closely with the local community of allergists and dermatologists in an attempt to recruit subjects with hypersensitivity reactions to aspartame. A total of 61 self-referrals and physician referrals were screened, with 20 referrals evaluated in clinic. After this evaluation, 12 patients underwent single- and double-blind challenge with up to 2000 mg of aspartame. No subject with a clearly reproducible adverse reaction to aspartame was identified. In summary, we found that it is difficult to recruit study subjects with a history of hypersensitivity reactions to aspartame and that subjects who believed themselves allergic to aspartame did not have reproducible reactions.

  4. Prospective Teachers' Understanding of Decimals with Single Repeating Digits

    ERIC Educational Resources Information Center

    Burroughs, Elizabeth A.; Yopp, David

    2010-01-01

    This article investigates prospective elementary teachers' conceptions of the repeating decimal 0.999... Five students from a first-semester undergraduate course "Mathematics for Elementary School Teachers" were interviewed to ascertain their conceptions about the mathematical statement 0.999... = 1. All of the students indicated they do not…

  5. Optical Sectioning and High Resolution in Single-Slice Structured Illumination Microscopy by Thick Slice Blind-SIM Reconstruction.

    PubMed

    Jost, Aurélie; Tolstik, Elen; Feldmann, Polina; Wicker, Kai; Sentenac, Anne; Heintzmann, Rainer

    2015-01-01

    The microscope image of a thick fluorescent sample taken at a given focal plane is plagued by out-of-focus fluorescence and diffraction limited resolution. In this work, we show that a single slice of Structured Illumination Microscopy (two or three beam SIM) data can be processed to provide an image exhibiting tight sectioning and high transverse resolution. Our reconstruction algorithm is adapted from the blind-SIM technique which requires very little knowledge of the illumination patterns. It is thus able to deal with illumination distortions induced by the sample or illumination optics. We named this new algorithm thick slice blind-SIM because it models a three-dimensional sample even though only a single two-dimensional plane of focus was measured.

  6. Optical Sectioning and High Resolution in Single-Slice Structured Illumination Microscopy by Thick Slice Blind-SIM Reconstruction.

    PubMed

    Jost, Aurélie; Tolstik, Elen; Feldmann, Polina; Wicker, Kai; Sentenac, Anne; Heintzmann, Rainer

    2015-01-01

    The microscope image of a thick fluorescent sample taken at a given focal plane is plagued by out-of-focus fluorescence and diffraction limited resolution. In this work, we show that a single slice of Structured Illumination Microscopy (two or three beam SIM) data can be processed to provide an image exhibiting tight sectioning and high transverse resolution. Our reconstruction algorithm is adapted from the blind-SIM technique which requires very little knowledge of the illumination patterns. It is thus able to deal with illumination distortions induced by the sample or illumination optics. We named this new algorithm thick slice blind-SIM because it models a three-dimensional sample even though only a single two-dimensional plane of focus was measured. PMID:26147644

  7. 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

  8. 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.

  9. Single-channel blind separation using L₁-sparse complex non-negative matrix factorization for acoustic signals.

    PubMed

    Parathai, P; Woo, W L; Dlay, S S; Gao, Bin

    2015-01-01

    An innovative method of single-channel blind source separation is proposed. The proposed method is a complex-valued non-negative matrix factorization with probabilistically optimal L1-norm sparsity. This preserves the phase information of the source signals and enforces the inherent structures of the temporal codes to be optimally sparse, thus resulting in more meaningful parts factorization. An efficient algorithm with closed-form expression to compute the parameters of the model including the sparsity has been developed. Real-time acoustic mixtures recorded from a single-channel are used to verify the effectiveness of the proposed method. PMID:25618092

  10. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  11. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  12. Metabolic parameters of postmenopausal women after quinoa or corn flakes intake--a prospective and double-blind study.

    PubMed

    De Carvalho, Flávia Giolo; Ovídio, Paula Payão; Padovan, Gilberto João; Jordão Junior, Alceu Afonso; Marchini, Julio Sérgio; Navarro, Anderson Marliere

    2014-05-01

    A prospective and double-blind study was conducted on 35 women with weight excess who consumed 25 grams of quinoa flakes (QF) or corn flakes (CF) daily during a period of four consecutive weeks. At the beginning (T1) and at the end (T2) of the intervention, total calorie intake was evaluated, anthropometric assessment was performed, blood was collected for the determination of glucose, total cholesterol and fractions, oxidative stress markers, vitamin E and enterolignans. Significant reductions were detected in serum triglyceride (CF group = 133.9 ± 89.4 to 113.7 ± 57 mg/dl and QF group = 112.3 ± 35 to 107.9 ± 33.1 mg/dl), TBARS (CF group = 3.2 ± 0.8 to 2.9 ± 0.5 µmol/l and QF group = 3.06 ± 0.6 to 2.89 ± 0.5 µmol/l) and vitamin E concentrations (CF group = 19.5 ± 5 to 17.9 ± 4 µM and QF group = 17.9 ± 4 to 16.9 ± 3 µM) and an increase in urinary excretion of enterolignans (CF group = 2.05 ± 1.3 to 2.24 ± 1.4 nm/ml and QF group = 2.9 ± 1.6 to 3.2 ± 2.7 nm/l), in both study groups. The reduction of total cholesterol (191 ± 35 to 181 ± 28 mg/dl) and LDL-cholesterol (LDL-c) (129 ± 35 to 121 ± 26 mg/dl), and the increase in GSH (1.78 ± 0.4 to 1.91 ± 0.4 µmol/l) occurred only in the QF group, showing a possible beneficial effect of QF intake.

  13. 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

  14. 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

  15. 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.

  16. 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

    2016-01-01

    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

  17. 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

  18. 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.

  19. 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.

  20. Transient improvement of poststroke apathy with zolpidem: a single-case, placebo-controlled double-blind study

    PubMed Central

    Autret, Katell; Arnould, Annabelle; Mathieu, Sarah; Azouvi, Philippe

    2013-01-01

    We report the case of a 44-year-old patient with severe and disabling apathy nearly 2 years after a right hemisphere haemorrhagic stroke. The effect of a single dose of zolpidem was tested over a 2-week period, in alternation with either no treatment or a placebo in a double-blind randomised trial. Zolpidem was associated with a dramatic improvement in apathy, as assessed with the Apathy Inventory and the Behavioral Dysexecutive Syndrome Inventory. No adverse effect occurred during the trial. PMID:23396925

  1. 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 -- ...

  2. Prospective blinded study of somatic mutation detection in cell-free DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients.

    PubMed

    Kim, Seung Tae; Lee, Won-Suk; Lanman, Richard B; Mortimer, Stefanie; Zill, Oliver A; Kim, Kyoung-Mee; Jang, Kee Taek; Kim, Seok-Hyung; Park, Se Hoon; Park, Joon Oh; Park, Young Suk; Lim, Ho Yeong; Eltoukhy, Helmy; Kang, Won Ki; Lee, Woo Yong; Kim, Hee-Cheol; Park, Keunchil; Lee, Jeeyun; Talasaz, AmirAli

    2015-11-24

    Sequencing of the mutant allele fraction of circulating cell-free DNA (cfDNA) derived from tumors is increasingly utilized to detect actionable genomic alterations in cancer. We conducted a prospective blinded study of a comprehensive cfDNA sequencing panel with 54 cancer genes. To evaluate the concordance between cfDNA and tumor DNA (tDNA), sequencing results were compared between cfDNA from plasma and genomic tumor DNA (tDNA). Utilizing next generation digital sequencing technology (DST), we profiled approximately 78,000 bases encoding 512 complete exons in the targeted genes in cfDNA from plasma. Seventy-five patients were prospectively enrolled between February 2013 and March 2014, including 61 metastatic cancer patients and 14 clinical stage II CRC patients with matched plasma and tissue samples. Using the 54-gene panel, we detected at least one somatic mutation in 44 of 61 tDNA (72.1%) and 29 of 44 (65.9%) cfDNA. The overall concordance rate of cfDNA to tDNA was 85.9%, when all detected mutations were considered. We collected serial cfDNAs during cetuximab-based treatment in 2 metastatic KRAS wild-type CRC patients, one with acquired resistance and one with primary resistance. We demonstrate newly emerged KRAS mutation in cfDNA 1.5 months before radiologic progression. Another patient had a newly emerged PIK3CA H1047R mutation on cfDNA analysis at progression during cetuximab/irinotecan chemotherapy with gradual increase in allele frequency from 0.8 to 2.1%. This blinded, prospective study of a cfDNA sequencing showed high concordance to tDNA suggesting that the DST approach may be used as a non-invasive biopsy-free alternative to conventional sequencing using tumor biopsy.

  3. A single blinded randomised controlled pilot trial of prism adaptation for improving self-care in stroke patients with neglect.

    PubMed

    Turton, Ailie J; O'Leary, Kelly; Gabb, Judith; Woodward, Rebecca; Gilchrist, Iain D

    2010-04-01

    Prism adaptation has been shown to alleviate the symptoms of unilateral spatial neglect following stroke in single case and small group studies. The purposes of this single blinded pilot randomised controlled trial were to determine the feasibility of delivering prism adaptation treatment in a clinically valid sample and to assess its impact on self-care. Thirty seven right hemisphere stroke patients with unilateral spatial neglect were randomised into either prism adaptation (using 10 dioptre, 6 degree prisms) or sham treatment (using plain glasses) groups. Treatment was delivered each weekday for two weeks. Pointing accuracy, without vision of the finger, was recorded each day before treatment. Outcome was measured, by blinded assessors, four days and eight weeks after the end of treatment using the Catherine Bergego Scale (CBS) and the conventional neuropsychological tests from the Behavioural Inattention Test (BIT). Thirty four patients received treatment: 16 with prisms, 18 sham. Mean compliance was 99% and 97%, respectively. Over the treatment days only the prism treated group showed increased leftward bias in open loop pointing to targets on a touch screen. However, despite the group level changes in pointing behaviour no overall effect of the treatment on self-care or BIT were found.

  4. 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.

  5. 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. PMID:26409531

  6. 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.

  7. 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.

  8. 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. PMID:27537209

  9. 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.

  10. 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

  11. Incidence and clinical significance of bone bruises after supination injury of the ankle. A double-blind, prospective study.

    PubMed

    Alanen, V; Taimela, S; Kinnunen, J; Koskinen, S K; Karaharju, E

    1998-05-01

    We used MRI to study a prospective series of 95 patients with inversion injuries of the ankle and no fracture on plain radiographs. We found an incidence of bone bruises of 27%, but these made no difference to the time of return to work, limitation of walking or physical activity, or the clinical outcome scores at three months. We conclude that bone bruises have very little clinical significance after inversion injuries of the ankle.

  12. Effectiveness of tranexamic acid on intraoperative blood loss in isolated Le Fort I osteotomies--a prospective, triple blinded randomized clinical trial.

    PubMed

    Christabel, Amelia; Muthusekhar, M R; Narayanan, Vinod; Ashok, Yashoda; Soh, Chen Loong; Ilangovan, Madivanan; Krishnan, Navaneetha

    2014-10-01

    The aim of this triple blinded randomized clinical trial was to evaluate the efficacy of tranexamic acid when used in conjunction with hypotensive anaesthesia exclusively for Le Fort I osteotomies. 49 patients undergoing Le Fort I osteotomy for correction of dentofacial deformity were divided into two groups; Group 1 received a placebo of saline 5 ml and Group 2 received 10 mg/kg body weight of tranexamic acid. The operating surgeon, anaesthetist and investigator were blinded. The variables of interest recorded in this study included the change in Hb%, PCV, total blood loss, total operating time and quality of the surgical field using Fromme's Ordinal Scale. Statistically significant differences between the two groups were found between the following variables: post-operative Hb%, drop in Hb%, post-operative PCV, drop in PCV, total surgical blood loss, total operating time and quality of surgical field (P < 0.05). Group 2 patients exhibited a smaller drop in Hb% and PCV, with a lower Fromme's Ordinal Scale value and decreased total blood loss and operating time. In conclusion single preoperative administration of tranexamic acid in the dose of 10 mg/kg, when combined with hypotensive anaesthesia is effective in controlling blood loss with regards to single piece Le Fort I surgery.

  13. The effect of a multispecies synbiotic mixture on the duration of diarrhea and length of hospital stay in children with acute diarrhea in Turkey: single blinded randomized study.

    PubMed

    Dinleyici, Ener Cagri; Dalgic, Nazan; Guven, Sirin; Ozen, Metehan; Kara, Ates; Arica, Vefik; Metin-Timur, Ozge; Sancar, Mesut; Kurugol, Zafer; Tanir, Gonul; Ozturk, Didem; Aydogdu, Selime; Tutanc, Murat; Eren, Makbule; Vandenplas, Yvan

    2013-04-01

    Probiotics have been successfully used for the treatment of acute diarrhea in children and this effect depends on the strains and dose. The aim of this study was to assess the effect of a synbiotic mixture on the duration of diarrhea and the length of hospital stay in children with acute watery diarrhea. This is a prospective randomized, multicenter single blinded clinical trial in hospitalized children with acute watery diarrhea. All children were treated with conventional hydration therapy with or without a daily dose of a synbiotic (2.5 × 10(9) CFU live bacteria including Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Enterococcus faecium, and 625 mg fructooligosaccharide) for 5 days. The primary endpoint was duration of diarrhea and duration of hospitalization was the secondary endpoint. Among 209 eligible children, 113 received the synbiotic mixture and 96 served as a control. The duration of diarrhea was significantly shorter (∼36 h) in children receiving the synbiotic group than the controls (77.9 ± 30.5 vs. 114.6 ± 37.4 h, p < 0.0001). The duration of hospitalization was shorter in children receiving the synbiotic group (4.94 ± 1.7 vs. 5.77 ± 1.97 days, p = 0.002). The effect of synbiotic mixture on diarrhea started after 24th hours and stool frequency significantly decreased after 24th and 48th hours. The percentage of diarrhea-free children is significantly higher in synbiotic group at 48th and 72nd hours of synbiotic group. In conclusion, this study showed a reduction in diarrhea duration by approximately 36 h and a reduction in the duration of hospitalization with approximately 1 day in children with acute diarrhea with this synbiotic mixture.

  14. Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

    PubMed Central

    Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi

    2014-01-01

    Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were established: one week, six months and twelve months after loading. Measurements were taken of peri-implant crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis. Implant success rates were evaluated for the two groups. The study sample included fifteen patients (nine women and six men) with a mean average age of 63.7 years. One hundred and forty-four implants were placed: 76 placed in healed sites and 68 placed immediately. Results: At the moment of prosthetic loading, keratinized mucosa width and probing depth were higher in immediate implants than delayed implants, with statistically significant differences. However, after six and twelve months, differences between groups had disappeared. Bone loss was 0.54 ± 0.39 mm for immediate implants and 0.66 ± 0.25 mm for delayed implants (p=0.201). No implants failed in either group. Conclusions: The present study with a short follow-up and a small sample yielded no statistically significant differences in implant success and peri-implant marginal bone loss between immediate and delayed implants with fixed full-arch prostheses. Peri-implant health showed no statistically significant differences for any of the studied parameters (crevicular fluid volume, plaque index, gingival retraction, keratinized mucosa, probing depth, modified gingival index and presence of mucositis) at the twelve-month follow-up. Key words:Immediate implants, delayed implants

  15. 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…

  16. 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

  17. 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

  18. Prevention of postoperative nausea and vomiting with a subhypnotic dose of Propofol in patients undergoing lower abdominal surgery: A prospective, randomized, double-blind study

    PubMed Central

    Naghibi, Khosrou; Kashefi, Parviz; Azarnoush, Hamed; Zabihi, Parisa

    2015-01-01

    Background: Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia in patients undergoing elective lower abdominal surgery. We aimed to compare the effect of a sub hypnotic dose of Propofol in the prevention of PONV after lower abdominal surgery with that of the conventional antiemetic drug Metoclopramide. Materials and Methods: In this prospective, randomized, double-blind, placebo-controlled study, 104 patients with American Society of Anesthesiologists (ASA) class I or II status, aged 18–65 years, and undergoing elective lower abdominal surgery were randomized to one of four groups (n = 26 each). The patients in the four groups were administered intravenously Propofol 20 mg (G1), Propofol 30 mg (G2), Metoclopramide 10 mg (G3), and placebo (G4), 15 min before skin closure. All episodes of PONV during the first 24 h after anesthesia were recorded by an investigator who was blinded to treatment assignment. Results: There were no significant differences between the treatment groups with regard to their gender, age, ASA class, duration of surgery, duration of recovery time and hospital stay, and also body mass index (BMI) (P > 0.05). The prevalence of PONV 0-6 h after anesthesia was 23.08% with Propofol 20 mg (P = 0.005), 15.38% with Propofol 30 mg (P = 0.016), 15.38% with Metoclopramide 10 mg (P = 0.016), compared to 30.77% with placebo (P = 0.005). Conclusions: Administration of a subhypnotic dose of Propofol (30 mg) was found to be as effective as 10 mg Metoclopramide in reducing the incidence and severity of PONV in adult patients undergoing elective lower abdominal surgeries under Isoflurane-based anesthesia in the early postoperative period. PMID:25789261

  19. 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

  20. High Zn Content Single-phase RS-MgZnO Suitable for Solar-blind Frequency Applications

    SciTech Connect

    Liang, H. L.; Mei, Z. X.; Liu, Z. L.; Guo, Y.; Du, X. L.; Azarov, A. Yu.; Kuznetsov, A. Yu.; Hallen, A.

    2010-11-01

    Single-phase rock-salt MgZnO films with high Zn content were successfully fabricated on the templates of MgO (111)/{alpha}-sapphire (0001) by radio-frequency plasma assisted molecular beam epitaxy. The influence of growth temperature on epitaxy of MgZnO alloy films was investigated by the combined studies of crystal structures, compositions, and optical properties. It is found that the incorporation of Zn atoms into the rock-salt MgZnO films is greatly enhanced at low temperature, confirmed by in-situ reflection high-energy electron diffraction observations and ex-situ X-ray diffraction characterization. Zn fraction in the single-phase rock-salt Mg{sub 0.53}Zn{sub 0.47}O film was determined by Rutherford backscattering spectrometry. Optical properties of the films were investigated by transmittance spectroscopy and reflectance spectroscopy, both of which demonstrate the solar-blind band gap and its dependence on Zn content.

  1. Role of silicone derivative plus onion extract gel in presternal hypertrophic scar protection: a prospective randomized, double blinded, controlled trial.

    PubMed

    Jenwitheesuk, Kamonwan; Surakunprapha, Palakorn; Jenwitheesuk, Kriangsak; Kuptarnond, Chusak; Prathanee, Sompop; Intanoo, Worawit

    2012-08-01

    Use of silicone derivative and onion extract had been reported in the prevention of hypertrophic scarring. Our experience showed the preventive use of silicone derivative plus onion extract gel on hypertrophic scars after median sternotomy. In a randomized, double blinded, placebo-controlled study, 60 patients after median sternotomy incisions were separated into two groups. All patients were treated either with silicone derivative plus onion extract gel (Cybele(®) scagel) or placebo gel twice daily for a total treatment period of 12 weeks. During each visit, pain and itching scores were graded by the patients and scar characteristics were observed by surgeons using the Vancouver scar scale. Pain and itch score values from patients' who applied silicone derivative plus onion extract gel was less than another group (P < 0·05). Pigmentation was significantly different between two groups (P < 0·05) and the reduction of scores on vascularity, pliability, height in treated group was not superior to the untreated group. No adverse events were reported by any of the patients. A silicone derivative plus onion extract gel is safe and effective for the preventing the hypertrophic scarring after median sternotomy. PMID:22168750

  2. A prospective, double-blind, randomized controlled trial of the angiotensin-converting enzyme inhibitor Ramipril In Aortic Stenosis (RIAS trial)

    PubMed Central

    Bull, Sacha; Loudon, Margaret; Francis, Jane M.; Joseph, Jubin; Gerry, Stephen; Karamitsos, Theodoros D.; Prendergast, Bernard D.; Banning, Adrian P.; Neubauer, Stefan; Myerson, Saul G.

    2015-01-01

    Aims Angiotensin-converting enzyme (ACE) inhibitors improve left ventricular (LV) remodelling and outcome in heart failure and hypertensive heart disease. They may be similarly beneficial in patients with aortic stenosis (AS), but historical safety concerns have limited their use, and no prospective clinical trials exist. Methods and results We conducted a prospective, randomized, double-blind, placebo-controlled trial in 100 patients with moderate or severe asymptomatic AS to examine the physiological effects of ramipril, particularly LV mass (LVM) regression. Subjects were randomized to ramipril 10 mg daily (n = 50) or placebo (n = 50) for 1 year, and underwent cardiac magnetic resonance, echocardiography, and exercise testing at 0, 6, and 12 months, with follow-up data available in 77 patients. There was a modest but progressive reduction in LVM (the primary end point) in the ramipril group vs. the placebo group (mean change −3.9 vs. +4.5 g, respectively, P = 0.0057). There were also trends towards improvements in myocardial physiology: the ramipril group showed preserved tissue Doppler systolic velocity compared with placebo (+0.0 vs. −0.5 cm/s, P = 0.04), and a slower rate of progression of the AS (valve area 0.0 cm2 in the ramipril group vs. −0.2 cm2 in the placebo arm, P = 0.067). There were no significant differences in major adverse cardiac events. Conclusion ACE inhibition leads to a modest, but progressive reduction in LVM in asymptomatic patients with moderate–severe AS compared with placebo, with trends towards improvements in myocardial physiology and slower progression of valvular stenosis. A larger clinical outcome trial to confirm these findings and explore their clinical relevance is required. PMID:25796267

  3. 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. PMID:27303937

  4. 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

  5. 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.

  6. Single-blind and Double-blind Randomized Controlled Trials of Palmtherapy(R), an Alternative Medical Approach, for Anxiety before Cardiac Catheterization.

    PubMed

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

    2008-03-01

    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(R), 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(R) from therapist-related variables. Whether alternative medicine deserves to be studied at all remains controversial. Palmtherapy(R) may offer anxiolytic benefit without the harm attributable to drugs.

  7. 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

  8. 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

  9. Preventive effects of ulinastatin on complications related to pancreaticoduodenectomy: A Consort-prospective, randomized, double-blind, placebo-controlled trial.

    PubMed

    Zhang, Hao; Tan, Chunlu; Wang, Xing; Kang, Deying; Chen, Yonghua; Xiong, Junjie; Tian, Bole; Li, Kezhou; Hu, Weiming; Chen, Xiaoli; Ke, Nengwen; Li, Ang; Liu, Xubao

    2016-06-01

    Postoperative pancreatic fistula (POPF) is one of the most common major complications after pancreaticoduodenectomy (PD). Ulinastatin is an intrinsic trypsin inhibitor and mainly used to treat acute pancreatitis, chronic recurrent pancreatitis, and acute circulatory failure. The study aims to investigate the efficacy of ulinastatin on pancreatic fistula and other complications after PD. This prospective, randomized, double-blind, placebo-controlled trial was conducted in West China Hospital of Sichuan University from December 2012 to December 2014. A total of 106 consecutive patients undergoing PD were randomly assigned to receive ulinastatin or placebo during and after the surgery for 5 days. Baseline clinical characteristics and outcomes of patients were recorded and analyzed. Ninety-two patients including 42 in the ulinastatin group and 50 in the placebo group were available for outcome assessment. The POPF rates were comparable between ulinastatin group (43%) and placebo group (26%), whereas the severe pancreatic fistula rate (grade B + C) was significantly less in ulinastatin group than that in placebo group (7% vs 24%, P = 0.045). For patients with small pancreatic duct diameter (≤3 mm), ulinastatin could significantly reduce the risk of POPF (P = 0.022). Ulinastatin had protective effects for patients undergoing PD on the prevention of severe postoperative pancreatic fistula.

  10. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

    PubMed

    Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

    2013-06-01

    Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

  11. Prospective, double-blinded, randomised controlled trial assessing the effect of an Octenidine-based hydrogel on bacterial colonisation and epithelialization of skin graft wounds in burn patients

    PubMed Central

    W, Eisenbeiß; F, Siemers; G, Amtsberg; P, Hinz; B, Hartmann; T, Kohlmann; A, Ekkernkamp; U, Albrecht; O, Assadian; A, Kramer

    2012-01-01

    Background: Moist wound treatment improves healing of skin graft donor site wounds. Microbial colonised wounds represent an increased risk of wound infection; while antimicrobially active, topical antiseptics may impair epithelialization. Objectives: The aim of this prospective randomised controlled clinical trial was to examine the influence of an Octenidine-dihydrochloride (OCT) hydrogel on bacterial colonisation and epithelialization of skin graft donor sites. Methods: The study was designed as a randomised, double-blinded, controlled clinical trial. Skin graft donor sites from a total of 61 patients were covered either with 0.05% OCT (n=31) or an OCT-free placebo wound hydrogel (n=30). Potential interaction with wound healing was assessed by measuring the time until 100% re-epithelialization. In addition, microbial wound colonisation was quantitatively determined in all skin graft donor sites. Results: There was no statistically significant difference in the time for complete epithelialization of skin graft donor sites in the OCT and the placebo group (7.3±0.2 vs. 6.9±0.2 days; p=0.236). Microbial wound colonisation was significantly lower in the OCT group than in the placebo group (p=0.014). Conclusions: The OCT-based hydrogel showed no delay in wound epithelialization and demonstrated a significantly lower bacterial colonisation of skin graft donor site wounds. PMID:23071904

  12. 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.

  13. Mini-midvastus vs standard medial parapatellar approach: a prospective, randomized, double-blinded study in patients undergoing bilateral total knee arthroplasty.

    PubMed

    Nestor, Bryan J; Toulson, Charles E; Backus, Sherry I; Lyman, Stephen L; Foote, Kristin L; Windsor, Russell E

    2010-09-01

    The purpose of this study was to determine whether the mini-midvastus approach to total knee arthroplasty (TKA) results in differences in quadriceps muscle strength as well as previously cited advantages in a double blind prospective randomized trial. Twenty-seven patients (54 TKAs) scheduled for bilateral TKA were randomized to undergo mini-midvastus approach on one knee and standard approach on the other. Incision lengths were the same. Postoperative strength was determined by isokinetic and isometric peak torque testing. Range of motion, pain Visual analog scale, side-preference, and gait analysis were assessed preoperatively and postoperatively. The only significant difference in strength testing was increased isokinetic and isometric extension torque at 3 weeks postoperatively for the mini-midvastus approach. No differences between the mini-midvastus and standard approach were observed for stride length, stance time, pain Visual analog scale, or knee range of motion. The mini-midvastus approach has limited benefit compared to the standard approach for TKA.

  14. 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

  15. 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.

  16. Randomized placebo-controlled, single blind trial of holy basil leaves in patients with noninsulin-dependent diabetes mellitus.

    PubMed

    Agrawal, P; Rai, V; Singh, R B

    1996-09-01

    Experimental studies on albino rats reported that leaf extract of Ocimum sanctum and Ocimum album (holy basil) had hypoglycemic effect. To explore further evidence we studied the effects of treatment with holy basil leaves on fasting and postprandial blood glucose and serum cholesterol levels in humans through randomized, placebo-controlled, crossover single blind trial. Results indicated a significant decrease in fasting and postprandial blood glucose levels during treatment with holy basil leaves compared to during treatment with placebo leaves. Fasting blood glucose fell by 21.0 mg/dl, confidence interval of difference -31.4 - (-)11.2 (p < 0.001), and postprandial blood glucose fell by 15.8 mg/dl, confidence interval -27.0 - (-)5.6 (p < 0.02). The lower values of glucose represented reductions of 17.6% and 7.3% in the levels of fasting and postprandial blood glucose, respectively. Urine glucose levels showed similar trend. Mean total cholesterol levels showed mild reduction during basil treatment period. The findings from this study suggest that basil leaves may be prescribed as adjunct to dietary therapy and drug treatment in mild to moderate NIDDM. PMID:8880292

  17. 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

  18. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    PubMed

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  19. Does platelet-rich plasma enhance healing in the idiopathic bone cavity? A single-blind randomized clinical trial.

    PubMed

    Tabrizi, R; Karagah, T; Shahidi, S; Zare, N

    2015-09-01

    The presence of an idiopathic bone cavity (IBC) is usually identified during routine dental radiographic examinations. The purpose of this study was to investigate the effect of platelet-rich plasma (PRP) on bone healing in the idiopathic bone cavity. This was a single-blind randomized clinical trial. Twenty-four subjects were assigned randomly to two groups. Subjects in group 1 received PRP through a buccal window approach, and those in group 2 underwent conventional management via the creation of a window on the buccal wall and curettage of the walls of the defect. Subjects were followed up at 3, 6, and 9 months after the intervention. The amount of bone formation as determined on panoramic radiographs was divided into four categories: stage 1: ≤25% of the defect showed opacity; stage 2: 25-50% of the defect showed opacity; stage 3: 50-75% of the defect showed opacity; and stage 4: >75% of the defect showed opacity. There was a significant difference between the two groups with regard to the various healing stages at the three time points (P<0.05). When compared with conventional management of the idiopathic bone cavity, the use of PRP may enhance bone formation. PMID:26074365

  20. Distant effects of locally injected botulinum toxin: a double-blind study of single fiber EMG changes.

    PubMed

    Lange, D J; Rubin, M; Greene, P E; Kang, U J; Moskowitz, C B; Brin, M F; Lovelace, R E; Fahn, S

    1991-07-01

    We used single fiber electromyography (SFEMG) to study 42 patients who had enrolled in a double-blind, placebo-controlled trial undertaken to assess the efficacy of botulinum toxin (BTX) injection of neck muscles to treat torticollis. SFEMG in a limb muscle was performed before treatment, 2, and 12 weeks after injection of placebo or BTX. Before treatment, the mean jitter was 26.8 microsec in patients who were to receive BTX, and 25.7 microsec in the placebo group. Two weeks after injection, mean jitter in the group receiving BTX was 43.6 microsec. In the placebo group, it was 26.5 microsec (P = less than .05). Twelve weeks after injection, mean jitter in the BTX group was 35.5; for the placebo group it was 24.5. Fiber density did not change in any patient during the study. There were no remote clinical effects of BTX. Injection of BTX into muscles affected with focal dystonia is a promising and safe treatment, but there are subclinical effects on uninjected muscles.

  1. 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.

  2. 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

  3. 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. PMID:24533747

  4. 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.

  5. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate

    SciTech Connect

    Kochhar, R.; Patel, F.; Dhar, A.; Sharma, S.C.; Ayyagari, S.; Aggarwal, R.; Goenka, M.K.; Gupta, B.D.; Mehta, S.K. )

    1991-01-01

    In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  11. 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

  12. 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

  13. 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.

  14. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    PubMed

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise.

  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. Adiposity, inflammation, genetic variants and risk of post-menopausal breast cancer findings from a prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) design approach.

    PubMed

    Yan, Xiaowei Sherry; Barnholtz-Sloan, Jill; Chu, Xin; Li, Ling; Colonie, Ryan; Webster, Jessica; Smelser, Diane; Patel, Nikitaban; Prichard, Jeffery; Stark, Azadeh

    2013-01-01

    Chronic internal inflammation secondary to adiposity is a risk factor for sporadic breast cancer and Post-Menopausal Breast Cancer (PMBC) is largely defined as such. Adiposity is one of the clinical criteria for the diagnosis of Metabolic Syndrome (MetS) and is a risk factor for PMBC. We examined SNPs of eight genes implicated in adiposity, inflammation and cell proliferation in a Prospective-specimen-collection, Retrospective-Blinded-Evaluation (PRoBE) design approach. A total of 180 cases and 732 age-matched controls were identified from the MyCode prospective biobank database and then linked to the Clinical Decision Information System, an enterprise-wide data warehouse, to retrieve clinico-demographic data. Samples were analyzed in a core laboratory where the personnel were masked to their status. Results from multivariate logistic regression yielded one SNP (rs2922126) in the GHSR as protective against PMBC among homozygotes for the minor allele (A/A) (OR = 0.4, 95% CI 0.18-.89, P-value = .02); homozygosity for the minor allele (C/C) of the SNP (rs889312) of the gene MAP3K1 was associated with the risk of PMBC (OR = 2.41, 95% CI 1.25-4.63 P-value = .008). Advanced age was protective against PMBC (OR = 0.98, 95% CI 0.95-0.99, P-value = .02). Family history of breast cancer (OR = 2.22, 95% CI 1.14-4.43. P = .02), HRT (OR = 3.35; 95% CI 2.15-5.21, P < .001), and MetS (OR = 14.83, 95% CI 5.63-39.08, P < .001) and interaction between HRT and MetS (OR = 39.38, 95% CI 15.71-98.70, P < .001) were associated with the risk of PMBC. We did not detected significant interactions between SNPs or between the SNPs and the clinico-demographic risk factors. Our study further confirms that MetS increases the risk of PMBC and argues in favor of reducing exposure to HRT. Our findings are another confirmation that low penetrance genes involved in the inflammatory pathway, i.e. MAP3KI gene, may have a plausible causative role in

  17. Adiposity, inflammation, genetic variants and risk of post-menopausal breast cancer findings from a prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) design approach.

    PubMed

    Yan, Xiaowei Sherry; Barnholtz-Sloan, Jill; Chu, Xin; Li, Ling; Colonie, Ryan; Webster, Jessica; Smelser, Diane; Patel, Nikitaban; Prichard, Jeffery; Stark, Azadeh

    2013-01-01

    Chronic internal inflammation secondary to adiposity is a risk factor for sporadic breast cancer and Post-Menopausal Breast Cancer (PMBC) is largely defined as such. Adiposity is one of the clinical criteria for the diagnosis of Metabolic Syndrome (MetS) and is a risk factor for PMBC. We examined SNPs of eight genes implicated in adiposity, inflammation and cell proliferation in a Prospective-specimen-collection, Retrospective-Blinded-Evaluation (PRoBE) design approach. A total of 180 cases and 732 age-matched controls were identified from the MyCode prospective biobank database and then linked to the Clinical Decision Information System, an enterprise-wide data warehouse, to retrieve clinico-demographic data. Samples were analyzed in a core laboratory where the personnel were masked to their status. Results from multivariate logistic regression yielded one SNP (rs2922126) in the GHSR as protective against PMBC among homozygotes for the minor allele (A/A) (OR = 0.4, 95% CI 0.18-.89, P-value = .02); homozygosity for the minor allele (C/C) of the SNP (rs889312) of the gene MAP3K1 was associated with the risk of PMBC (OR = 2.41, 95% CI 1.25-4.63 P-value = .008). Advanced age was protective against PMBC (OR = 0.98, 95% CI 0.95-0.99, P-value = .02). Family history of breast cancer (OR = 2.22, 95% CI 1.14-4.43. P = .02), HRT (OR = 3.35; 95% CI 2.15-5.21, P < .001), and MetS (OR = 14.83, 95% CI 5.63-39.08, P < .001) and interaction between HRT and MetS (OR = 39.38, 95% CI 15.71-98.70, P < .001) were associated with the risk of PMBC. We did not detected significant interactions between SNPs or between the SNPs and the clinico-demographic risk factors. Our study further confirms that MetS increases the risk of PMBC and argues in favor of reducing exposure to HRT. Our findings are another confirmation that low penetrance genes involved in the inflammatory pathway, i.e. MAP3KI gene, may have a plausible causative role in

  18. 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

  19. Laparoscopic bridging vs. anatomic open reconstruction for midline abdominal hernia mesh repair [LABOR]: single-blinded, multicenter, randomized, controlled trial on long-term functional results

    PubMed Central

    2013-01-01

    Background Re-approximation of the rectal muscles along the midline is recommended by some groups as a rule for incisional and ventral hernia repairs. The introduction of laparoscopic repair has generated a debate because it is not aimed at restoring abdominal wall integrity but instead aims just to bridge the defect. Whether restoration of the abdominal integrity has a real impact on patient mobility is questionable, and the available literature provides no definitive answer. The present study aims to compare the functional results of laparoscopic bridging with those of re-approximation of the rectal muscle in the midline as a mesh repair for ventral and incisional abdominal defect through an “open” access. We hypothesized that, for the type of defect suitable for a laparoscopic bridging, the effect of an anatomical reconstruction is near negligible, thus not a fixed rule. Methods and design The LABOR trial is a multicenter, prospective, two-arm, single-blinded, randomized trial. Patients of more than 60 years of age with a defect of less than 10 cm at its greatest diameter will be randomly submitted to open Rives or laparoscopic defect repair. All the participating patients will have a preoperative evaluation of their abdominal wall strength and mobility along with volumetry, respiratory function test, intraabdominal pressure and quality of life assessment. The primary outcome will be the difference in abdominal wall strength as measured by a double leg-lowering test performed at 12 months postoperatively. The secondary outcomes will be the rate of recurrence and changes in baseline abdominal mobility, respiratory function tests, intraabdominal pressure, CT volumetry and quality of life at 6 and 12 months postoperatively. Discussion The study will help to define the most suitable treatment for small-medium incisional and primary hernias in patients older than 60 years. Given a similar mid-term recurrence rate in both groups, if the trial shows no differences

  20. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial

    PubMed Central

    Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of

  1. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device.

    PubMed

    Gollwitzer, Hans; Diehl, Peter; von Korff, Alexej; Rahlfs, Volker W; Gerdesmeyer, Ludger

    2007-01-01

    Published data describing the efficacy of extracorporeal shock wave therapy for the treatment of plantar heel pain provide conflicting results, and optimal treatment guidelines are yet to be determined. To assess the efficacy and safety of extracorporeal shockwave therapy compared with placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device, we undertook a prospective, double-blind, randomized, placebo-controlled trial conducted among 40 participants who were randomly allocated to either active, focused extracorporeal shockwave therapy (0.25 mJ/mm(2)) or sham shockwave therapy. Both groups received 3 applications of 2000 shockwave impulses, each session 1 week apart. The primary outcome was the change in composite heel pain (morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter) as quantified using a visual analog pain scale at 12 weeks after completion of the interventions compared with baseline. Secondary endpoints included changes in morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter, as measured on a visual analog pain scale, as well as the change in the Roles and Maudsley score, at 12 weeks after the baseline measurement. Active extracorporeal shockwave therapy resulted in a 73.2% reduction in composite heel pain, and this was a 32.7% greater reduction than that achieved with placebo. The difference was not statistically significant (1-tailed Wilcoxon Mann-Whitney U test, P =.0302), but reached clinical relevance (Mann-Whitney effect size = 0.6737). In regard to the secondary outcomes, active extracorporeal shockwave therapy displayed relative superiority in comparison with the sham intervention. No relevant adverse events occurred in either intervention group. The results of the present study support the use of electromagnetically generated extracorporeal shockwave therapy for the treatment of

  2. A Prospective Randomized Double Blind Placebo Controlled Trial on the Efficacy of Ethanol Celiac Plexus Neurolysis in Patients with Operable Pancreatic and Periampullary Adenocarcinoma

    PubMed Central

    Lavu, Harish; Lengel, Harry B; Sell, Naomi M; Baiocco, Joseph A; Kennedy, Eugene P; Yeo, Theresa P; Burrell, Sherry A; Winter, Jordan M; Hegarty, Sarah; Leiby, Benjamin E.; Yeo, Charles J

    2015-01-01

    Background Ethanol celiac plexus neurolysis (ECPN) has been shown to be effective in reducing cancer-related pain in patients with locally advanced pancreatic and periampullary adenocarcinoma (PPA). This study examined its efficacy in patients undergoing PPA resection. Study Design 485 patients participated in this prospective, randomized, double blind placebo controlled trial. Patients were stratified by preoperative pain and disease resectability. They received either ECPN (50% ethanol) or 0.9% normal saline placebo control. The primary endpoint was short and long-term pain and secondary endpoints included postoperative morbidity, QOL and overall survival. Results Data from 467 patients were analyzed. The primary endpoint, the percentage of PPA patients experiencing a worsening of pain compared to preoperative baseline for resectable patients, was not different between the ethanol and saline groups in either the resectable/pain stratum (22% vs 18%, RR 1.23 (0.34, 4.46)), or the resectable/no pain stratum (37% vs 34%, RR 1.10 (0.67, 1.81)). On multivariable analysis of resected pancreatic ductal adenocarcinoma (PDA) patients, there was a significant reduction in pain in the resectable/pain group, suggesting that surgical resection of the malignancy alone (independent of ECPN) decrements pain to a significant degree. Conclusions In this study, we have demonstrated a significant reduction in pain following surgical resection of PPA. However the addition of ECPN did not synergize to result in a further reduction in pain, and in fact its effect may have been masked by surgical resection. Given this, we cannot recommend the use of ECPN to mitigate cancer related pain in resectable PPA patients. PMID:25667135

  3. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial.

    PubMed

    Al Balushi, Ruqaiya M; Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ

  4. 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

  5. Tissue injuries after single-port and multiport laparoscopic gynecologic surgeries: A prospective multicenter study

    PubMed Central

    So, Kyeong A; Lee, Jae Kwan; Song, Jae Yun; Kim, Jae Won; Lee, Nak Woo; Ki, Kyung-Do; Lee, Jong-Min; Song, Yong Jung; Na, Yong Jin; Ku, Chun Hoe; Shin, Jin Woo; Kim, Chul Jung; Jung, Un Suk

    2016-01-01

    The present study focused on the degree of tissue injury following single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for the treatment of various benign gynecologic diseases. A total of 228 patients were prospectively enrolled at seven academic centers in South Korea between April 2011 and September 2012. Of these, 122 patients underwent SPLS and 106 patients underwent MPLS. The serum levels of C-reactive protein, creatine phosphokinase, lactic dehydrogenase and cancer antigen 125 were measured preoperatively and on postoperative day 4 by immunonephelometry. Cosmetic satisfaction and postoperative pain scores (visual analogue scale) were analyzed. Postoperative changes in the levels of the serum markers were found to be similar between the SPLS and MPLS groups. However, the postoperative pain scores at 48 h were significantly lower in the SPLS group when compared with those in the MPLS (P=0.001). In addition, patient-controlled analgesia was used more frequently by patients in the MPLS group (P=0.003). The present study is the first prospective investigation of tissue injury resulting from SPLS and MPLS in gynecology. In conclusion, the current study demonstrated that serum marker levels during SPLS were similar to those during MPLS in the treatment of benign gynecologic diseases. However, SPLS is a reasonable alternative to MPLS and is associated with comparable tissue injury, improved cosmesis and reduced postoperative pain. PMID:27698717

  6. Tissue injuries after single-port and multiport laparoscopic gynecologic surgeries: A prospective multicenter study

    PubMed Central

    So, Kyeong A; Lee, Jae Kwan; Song, Jae Yun; Kim, Jae Won; Lee, Nak Woo; Ki, Kyung-Do; Lee, Jong-Min; Song, Yong Jung; Na, Yong Jin; Ku, Chun Hoe; Shin, Jin Woo; Kim, Chul Jung; Jung, Un Suk

    2016-01-01

    The present study focused on the degree of tissue injury following single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for the treatment of various benign gynecologic diseases. A total of 228 patients were prospectively enrolled at seven academic centers in South Korea between April 2011 and September 2012. Of these, 122 patients underwent SPLS and 106 patients underwent MPLS. The serum levels of C-reactive protein, creatine phosphokinase, lactic dehydrogenase and cancer antigen 125 were measured preoperatively and on postoperative day 4 by immunonephelometry. Cosmetic satisfaction and postoperative pain scores (visual analogue scale) were analyzed. Postoperative changes in the levels of the serum markers were found to be similar between the SPLS and MPLS groups. However, the postoperative pain scores at 48 h were significantly lower in the SPLS group when compared with those in the MPLS (P=0.001). In addition, patient-controlled analgesia was used more frequently by patients in the MPLS group (P=0.003). The present study is the first prospective investigation of tissue injury resulting from SPLS and MPLS in gynecology. In conclusion, the current study demonstrated that serum marker levels during SPLS were similar to those during MPLS in the treatment of benign gynecologic diseases. However, SPLS is a reasonable alternative to MPLS and is associated with comparable tissue injury, improved cosmesis and reduced postoperative pain.

  7. 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

  8. Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease

    PubMed Central

    2013-01-01

    Background Cereals of baking quality with absent or reduced toxicity are actively sought as alternative therapy to a gluten-free diet (GFD) for patients with coeliac disease (CD). Triticum monococcum, an ancient wheat, is a potential candidate having no toxicity in in-vitro and ex-vivo studies. The aim of our study was to investigate on the safety of administration of a single dose of gluten of Tm in patients with CD on GFD. Methods We performed a single blind, cross-over study involving 12 CD patients who had been on a GFD for at least 12 months, challenged on day 0, 14 and 28 with a single fixed dose of 2.5 grams of the following (random order): Tm, rice (as reference atoxic protein) and Amygluten (as reference toxic protein) dispersed in a gluten-free pudding. The primary end-point of the study was the change in intestinal permeability, as assessed by changes in the urinary lactulose/rhamnose ratio (L/R ratio) measured by High Pressure Liquid Chromatography. We also assessed the occurrence of adverse gastrointestinal events, graded for intensity and duration according to the WHO scale. Variables were expressed as mean ± SD; paired t-test and χ2 test were used as appropriate. Results The urinary L/R ratio did not change significantly upon challenge with the 3 cereals, and was 0.055 ± 0.026 for Tm Vs 0.058 ± 0.035 for rice (p = 0.6736) and Vs 0.063 ± 0.054 with Amygluten (p = 0.6071). Adverse gastrointestinal events were 8 for Tm, Vs 11 for rice (p = 0.6321) and Vs 31 for Amygluten p = 0.0016), and, in all cases events were graded as “mild” or “moderate” with TM and rice, and as “severe” or “disabling” in 4 cases during Amygluten. Conclusions No definite conclusion can be drawn on the safety of Tm, based on no change in urinary L/R because even Amygluten, a toxic wheat protein, did not cause a significant change in urinary L/R indicating low sensitivity of this methodology in studies on acute toxicity. Tm was

  9. 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.

  10. 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

  11. A Prospective, Comparative, Evaluator-blind Clinical Study Investigating Efficacy and Safety of Two Injection Techniques with Radiesse® for the Correction of Skin Changes in Aging Hands

    PubMed Central

    Gubanova, Elena I; Starovatova, Polina A

    2015-01-01

    Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse®. Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse® (0.8 mL/0.2 mL 2% lidocaine) was injected subdermally on Day (D)01, using a needle multipoint technique in one hand (N) and a fan-like cannula technique in the other (C). Assessments were made pre-injection, on D14, Month (M)02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS) and Global Aesthetic Improvement Scale (GAIS). Participants completed questionnaires on satisfaction, pain and adverse events (AEs). Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene's tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse®). Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction) and 3 (optimal cosmetic result) at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30). Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse®. PMID:26644738

  12. Metastable inhomogeneous vortex configuration with non-uniform filling fraction inside a blind hole array patterned in a BSCCO single crystal and concentrating magnetic flux inside it

    NASA Astrophysics Data System (ADS)

    Shaw, Gorky; Banerjee, S. S.; Tamegai, T.; Suderow, Hermann

    2016-06-01

    Using magneto-optical imaging, we map the local magnetic field distribution inside a hexagonally ordered array of blind holes patterned in BSCCO single crystals. The nature of the spatial distribution of local magnetic field and shielding currents across the array reveals the presence of a non-uniform vortex configuration partially matched with the blind holes at sub-matching fields. We observe that the filling fraction is different in two different regions of the array. The mean vortex configuration within the array is described as a patchy vortex configuration with the patches having different mean filling fraction. The patchy nature of the vortex configuration is more pronounced at partial filling of the array at low fields while the configuration becomes more uniform with a unique filling fraction at higher fields. The metastable nature of this patchy vortex configuration is revealed by the application of magnetic field pulses of fixed height or individual pulses of varying height to the array. The metastability of the vortex configuration allows a relatively easy way of producing flux reorganization and flux focusing effects within the blind hole array. The effect of the magnetic field pulses modifies the vortex configuration within the array and produces a uniform enhancement in the shielding current around the patterned array edges. The enhanced shielding current concentrates magnetic flux within the array by driving vortices away from the edges and towards the center of the array. The enhanced shielding current also prevents the uninhibited entry of vortices into the array. We propose that the metastable patchy vortex configuration within the blind hole array is due to a non-uniform pinning landscape leading to non-uniform filling of individual blind holes.

  13. Acute benefits of the microbial-derived isoflavone metabolite equol on arterial stiffness in men prospectively recruited according to equol producer phenotype: a double-blind randomized controlled trial12

    PubMed Central

    Hazim, Sara; Curtis, Peter J; Schär, Manuel Y; Ostertag, Luisa M; Kay, Colin D; Minihane, Anne-Marie; Cassidy, Aedín

    2016-01-01

    Background: There is much speculation with regard to the potential cardioprotective benefits of equol, a microbial-derived metabolite of the isoflavone daidzein, which is produced in the large intestine after soy intake in 30% of Western populations. Although cross-sectional and retrospective data support favorable associations between the equol producer (EP) phenotype and cardiometabolic health, few studies have prospectively recruited EPs to confirm this association. Objective: The aim was to determine whether the acute vascular benefits of isoflavones differ according to EP phenotype and subsequently investigate the effect of providing commercially produced S-(–)equol to non-EPs. Design: We prospectively recruited male EPs and non-EPs (n = 14/group) at moderate cardiovascular risk into a double-blind, placebo-controlled crossover study to examine the acute effects of soy isoflavones (80-mg aglycone equivalents) on arterial stiffness [carotid-femoral pulse-wave velocity (cfPWV)], blood pressure, endothelial function (measured by using the EndoPAT 2000; Itamar Medical), and nitric oxide at baseline (0 h) and 6 and 24 h after intake. In a separate assessment, non-EPs consumed 40 mg S-(–)equol with identical vascular measurements performed 2 h after intake. Results: After soy intake, cfPWV significantly improved in EPs at 24 h (cfPWV change from 0 h: isoflavone, −0.2 ± 0.2 m/s; placebo, 0.6 ± 0.2 m/s; P < 0.01), which was significantly associated with plasma equol concentrations (R = −0.36, P = 0.01). No vascular effects were observed in EPs at 6 h or in non-EPs at any time point. Similarly, no benefit of commercially produced S-(–)equol was observed in non-EPs despite mean plasma equol concentrations reaching 3.2 μmol/L. Conclusions: Acute soy intake improved cfPWV in EPs, equating to an 11–12% reduced risk of cardiovascular disease if sustained. However, a single dose of commercially produced equol had no cardiovascular benefits in non-EPs. These

  14. Color blindness

    MedlinePlus

    Color deficiency; Blindness - color ... Color blindness occurs when there is a problem with the pigments in certain nerve cells of the eye that sense color. These cells are called cones. They are found ...

  15. 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…

  16. 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.

  17. A prospective, randomized, double-blind, and multicenter trial of prophylactic effects of ramosetronon postoperative nausea and vomiting (PONV) after craniotomy: comparison with ondansetron

    PubMed Central

    2014-01-01

    Background Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients. Methods A total of 160 American Society of Anesthesiologists physical status I–II patients aged 19–65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n  =  55), ondansetron (8 mg; group B, n  =  54), or ramosetron (0.3 mg; group C, n  =  51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively. Results Among the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P  <  0.001; vomiting, P  =  0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P  <  0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0–2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2–48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events. Conclusion Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients

  18. 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

  19. 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

  20. 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.

  1. Addition of sub-anaesthetic dose of ketamine reduces gag reflex during propofol based sedation for upper gastrointestinal endoscopy: A prospective randomised double-blind study

    PubMed Central

    Tandon, Manish; Pandey, Vijay Kant; Dubey, Gaurav Kumar; Pandey, Chandra Kant; Wadhwa, Nitya

    2014-01-01

    Background and Aims: Gag reflex is unwanted during upper gastrointestinal endoscopy (UGIE). Experimental studies have demonstrated that N-methyl-D-aspartate receptor antagonism prevents gag reflex. We conducted a study to determine if sub-anaesthetic doses of ketamine, added to propofol, reduce the incidence of gag reflex. Methods: This prospective, randomised, double-blind and placebo-controlled study was done in a tertiary care hospital. A total of 270 patients undergoing UGIE, were randomised to propofol (P) group (n = 135) or propofol plus ketamine (PK) group (n = 135). All patients received propofol boluses titrated to Ramsay sedation score of not <4. Patients in PK group in addition received ketamine, 0.15 mg/kg immediately before the first-propofol dose. Top-up doses of propofol were given as required. Stata 11 software (StataCorp.) was used to calculate the proportion of patients with gag reflex and the corresponding relative risk. Propofol consumed and time to recovery in the two groups was compared using Student's t-test and Cox proportional hazards regression respectively. Results: Significantly, fewer patients in the PK group had gag reflex compared to the P group (3 vs. 23, risk ratio = 0.214, 95% confidence interval [CI], 0.07-0.62; P = 0.005). The incidence of hypotension (6 vs. 16, risk ratio = 0.519, 95% CI = 0.25-1.038; P = 0.06), number of required airway manoeuvres (4 vs. 19, risk ratio = 0.32, 95% CI = 0.13-0.74; P = 0.014), median time to recovery (4 min vs. 5 min, hazard ratio = 1.311, 95% CI = 1.029-1.671; P = 0.028) and propofol dose administered (152 mg vs. 167 mg, 95% CI = 4.74-24.55; P = 0.004) was also less in the PK group compared to the P group. Conclusion: Ketamine in sub-anaesthetic dose decreases gag reflex during UGIE. PMID:25197112

  2. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study.

    PubMed

    Al-Moraissi, E A; Mounair, R M; El-Sharkawy, T M; El-Ghareeb, T I

    2015-03-01

    The aim of this study was to compare the clinical and radiological outcomes of mandibular angle fractures (MAFs) managed with three-dimensional (3D) miniplates and standard miniplates (according to Champy's principles). A prospective, randomized, controlled clinical study was carried out on 20 patients with MAFs, divided into two groups. Group A patients were treated with a single 1-mm 3D titanium miniplate; group B patients were treated with a single 2.0-mm standard titanium miniplate. Patients were followed for 6 months for infection, wound dehiscence, segmental mobility, malocclusion, mouth opening, hardware failure, hardware palpability, paraesthesia, and malunion/non-union. A densitometry analysis was performed using DIGORA software on digital panoramic radiographs to evaluate bone healing. Six complications occurred, representing a total rate of 30%. Three complications occurred in group A and three in group B, with identical complication rates of 30%. No major difference in terms of the radiographic assessment was observed between the two systems. The 3D curved strut plate is an effective treatment modality for the management of MAFs, with a complication rate comparable to that found with the standard miniplate. This trial is registered at ClinicalTrials.gov, number NCT01939015.

  3. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial.

    PubMed

    Chinnapongse, Robert; Gullo, Kristen; Nemeth, Paul; Zhang, Yuxin; Griggs, Lynn

    2012-02-01

    Sialorrhea (drooling) is a common symptom of Parkinson's disease (PD) that can significantly impair a patient's health and quality of life. Fifty-four PD subjects with troublesome sialorrhea were enrolled using a multicenter, randomized, double-blind, sequential-dose escalation design in which subjects received a single intraglandular treatment with botulinum toxin type B (doses of 1,500 Units [0.3 mL]; 2,500 Units [0.5 ml]; or 3,500 Units [0.7 ml]) or placebo. Postinjection, subjects were followed acutely for 4 weeks and long-term for up to 20 weeks. Safety/tolerability, as assessed by adverse events, was the primary outcome measure. Efficacy, as assessed by the Drooling Frequency and Severity Scale and unstimulated salivary flow rate, was secondary. Gastrointestinal-related adverse events occurred more frequently in the active groups versus placebo group (31% vs 7%), with dry mouth being most common (15%). There were no serious adverse events attributed to botulinum toxin type B or discontinuations due to adverse events from treatment. At 4 weeks postinjection, Drooling Frequency and Severity Scale scores significantly improved versus placebo (-1.3 ± 1.3) in a dose-related manner (-2.1 ± 1.2, P = 0.0191; -3.3 ± 1.4, P < 0.0001; -3.5 ± 1.1, P < 0.0001, respectively) and unstimulated salivary flow rates significantly decreased in all active groups versus placebo (P ≤ 0.0009). Furthermore, treated subjects appeared to have more sustained improvement in sialorrhea than placebo subjects. We conclude that intraglandular injection of botulinum toxin type B was safe, tolerable, and efficacious in treating sialorrhea in PD patients. Additional studies are warranted to further confirm the drug's robust efficacy, as well as evaluate its effect with repeated dosing.

  4. Comparison of clinical validation of acceleromyography and electromyography in children who were administered rocuronium during general anesthesia: a prospective double-blinded randomized study

    PubMed Central

    Jung, Woojun; Hwang, Minho; Won, Young Ju; Lim, Byung Gun; Kong, Myoung-Hoon

    2016-01-01

    Background Electromyography and acceleromyography are common neuromuscular monitoring devices. However, questions still remain regarding the use of acceleromyography in children. This study compared the calibration success rates and intubation conditions in children after obtaining the maximal blockade depending on each of the devices Methods Children, 3 to 6 years old, were randomly allocated to the TOF-Watch SX acceleromyography group or the NMT electromyography group. The induction was performed with propofol, fentanyl, and rocuronium. The bispectral index and 1 Hz single twitch were monitored during observation. The calibration of the each device was begun when the BIS dropped to 60. After successful calibration, rocuronium 0.6 mg/kg was injected. A tracheal intubation was performed when the twitch height suppressed to 0. The rocuronium onset time (time from administration to the maximal depression of twitch height) and intubating conditions were rated in a blinded manner. Results There was no difference in the calibration success rates between the two groups; and the calibration time in the electromyography group (16.7 ± 11.0 seconds) was shorter than the acceleromyography group (28.1 ± 13.4 seconds, P = 0.012). The rocuronium onset time of the electromyography group (73.6 ± 18.9 seconds) was longer than the acceleromyography group (63.9 ± 18.8 seconds, P = 0.042) and the intubation condition of the electromyography group (2.27 ± 0.65) was better than the acceleromyography group (1.86 ± 0.50, P = 0.007). Conclusions Electromyography offers a better compromise than acceleromyography with respect to the duration of calibration process and surrogate for the optimal time of tracheal intubation in children. PMID:26885297

  5. 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

  6. Professional brushing study comparing the effectiveness of sonic brush heads with manual toothbrushes: a single blinded, randomized clinical trial.

    PubMed

    Pelka, Anna-Kristina; Nagler, Tonia; Hopp, Imke; Petschelt, Anselm; Pelka, Matthias Anton

    2011-08-01

    The aim of this study was to evaluate the plaque removal efficacy of four toothbrushes: the Philips Sonicare Elite with medium and mini brush heads, the Elmex Sensitive, and the American Dental Association (ADA) reference toothbrush. This study was a randomized, controlled, investigator-blinded, four-brush crossover design study, which examined plaque removal following a consecutive repeated use. All brushes were used on each participant in a randomly assigned quadrant of the mouth. A total of 90 subjects participated in the study. Prior to the experiment, they received a professional prophylaxis and were requested to refrain from toothbrushing for 48 h. Teeth were professionally brushed consecutively for 10 to 90 s per quadrant. A Turesky-modified Quigley Hein Index score was assessed at baseline and after each brushing interval by one blinded investigator. Results showed reduction of mean plaque scores for all brushes with time from 10 to 90 s. After 30 s (2-min whole mouth equivalent) of brushing, the Sonicare brushes cleaned 19, the ADA brush 16, and the Elmex Sensitive 10 of in average 28 tooth surfaces. With time, the number of additional cleaned surfaces decreased. Time is an important variable in the evaluation of plaque-removing efficacy since absolute efficacy increases with time and differs per toothbrush. No differences could be found between the two brush heads of the Sonicare.

  7. Sleep, diurnal preference, health, and psychological well-being: a prospective single-allelic-variation study.

    PubMed

    Lázár, Alpár S; Slak, Ana; Lo, June Chi-Yan; Santhi, Nayantara; von Schantz, Malcolm; Archer, Simon N; Groeger, John A; Dijk, Derk-Jan

    2012-03-01

    Individual differences in sleep and diurnal preference associate with physical and mental health characteristics, but few genetic determinants of these differences have been identified. A variable number tandem repeat (VNTR) polymorphism in the PERIOD3 (PER3) gene (rs57875989) has been reported to associate with diurnal preference, i.e., preferred timing of waking and sleep. Here, the authors investigate in a prospective single-candidate genetic variant study whether allelic variation for this polymorphism associates also with reported actual sleep timing and sleep duration, as well as psychological and health measures. Six hundred and seventy-five subjects, aged 20 to 35 yrs, completed questionnaires to assess sleep and psychological and health characteristics and were genotyped for the PER3 VNTR. Homozygosity for the longer allele (PER3(5/5)) of the VNTR was associated with increased morning preference, earlier wake time and bedtime, and reduced daytime sleepiness. Separate analyses of work and rest days demonstrated that the increase in time in bed during rest days was greatest in PER3(5/5) homozygotes. PER3 genotype modified the effects of sleep timing and duration on fluid intelligence and body mass index. Genotype was not associated with physical or psychological characteristics as assessed by the SF-36 Health Questionnaire, the General Health Questionnaire, the Big Five Inventory, the Behavioral Inhibition System-Behavioral Activation System scales, and the Positive and Negative Affect Scale, even though these measures varied significantly with diurnal preference as assessed by the Morningness-Eveningness Questionnaire. Whereas diurnal preference also predicts mental health and psychological characteristics, as well as sleep timing, the PER3 VNTR specifically affects measures of sleep timing and may also modify the effects of sleep on health outcome measures. PMID:22324552

  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. Effects on obese women of the sugar sucrose added to the diet over 28 d: a quasi-randomised, single-blind, controlled trial.

    PubMed

    Reid, Marie; Hammersley, Richard; Duffy, Maresa; Ballantyne, Carrie

    2014-02-01

    To investigate whether obese women can compensate for sucrose added to the diet when it is given blind, rather than gaining weight or exhibiting dysfunctional regulation of intake, in the present study, forty-one healthy obese (BMI 30-35 kg/m²) women (age 20-50 years), not currently dieting, were randomly assigned to consume sucrose (n 20) or aspartame (n 21) drinks over 4 weeks in a parallel single-blind design. Over the 4 weeks, one group consumed 4 × 250 ml sucrose drinks (total 1800 kJ/d) and the other group consumed 4 × 250 ml aspartame drinks. During the baseline week and experimental weeks, body weight and other biometric data were measured and steps per day, food intake using 7 d unweighed food diaries, and mood using ten- or seven-point Likert scales four times a day were recorded. At the end of the experiment, the participants weighed 1·72 (SE 0·47) kg less than the value predicted by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) model; the predicted body weight accounted for 94·3% of the variance in the observed body weight and experimental group accounted for a further 1·1% of the variance in the observed body weight, showing that women consuming sucrose drinks gained significantly less weight than predicted. The reported daily energy intake did not increase significantly, and sucrose supplements significantly reduced the reported voluntary sugar, starch and fat intake compared with aspartame. There were no effects on appetite or mood. Over 4 weeks, as part of everyday eating, sucrose given blind in soft drinks was partially compensated for by obese women, as in previous experiments with healthy and overweight participants.

  10. Randomized, evaluator-blind, split-face comparison study of single cross-linked versus double cross-linked hyaluronic acid in the treatment of glabellar lines.

    PubMed

    Kono, Taro; Kinney, Brian M; Groff, William Frederick; Chan, Henry H; Ercocen, Ali Riza; Nozaki, Motohiro

    2008-06-01

    BACKGROUND At present, various hyaluronic acids are being used to rejuvenate facial skin. There is no comparative study of single cross-linked hyaluronic acid (SCHA) versus double cross-linked hyaluronic acid (DCHA). The objective of our study is to compare the effectiveness and complications of SCHA versus DCHA in the treatment of glabellar lines. METHODS Ten female patients were enrolled in this randomized, evaluator-blind study. One side (left vs. right) of each patient's glabellar lines was treated with SCHA and the other side was treated with DCHA. Two independent blinded observers reviewed the clinical photographs at 3, 6, 9, and 12 months after the treatment and assessed for degree of improvement as well as complications. RESULTS The two products were equally effective in producing an optimal cosmetic result, although at 6, 9, and 12 months posttreatment, a higher proportion of patients showed over 50% improvement with DCHA than with SCHA. At 12 months posttreatment, DCHA was considered superior in 70% of patients, whereas SCHA was superior in 10% of patients. CONCLUSIONS Both SCHA and DCHA are equally effective in producing an optimal cosmetic result. DCHA provides a more durable esthetic improvement when compared to SCHA in the treatment of glabellar lines.

  11. [A double-blind placebo-controlled study of a 2 percent foaming lotion of ketoconazole in a single application in the treatment of pityriasis versicolor].

    PubMed

    Rekacewicz, I; Guillaume, J C; Benkhraba, F; Archimbaud, A; Baspeyras, M; Boitier, F; Bussière, M; Coin, A; Di Crezenzo, M C; Duval, J

    1990-01-01

    A double-blind, placebo-controlled therapeutic trial of ketoconazole presented as a foam and applied only once was carried out on 61 patients by a group of 15 private dermatologists practising in the Paris region. All patients had tinea versicolor clinically diagnosed, then confirmed by a positive patch test, as assessed by a single mycologist. The main criterion of therapeutic effectiveness was negativation of the patch test 30 days after a single topical application of the ketoconazole foam. On day 30, the test was negative in 22 of the 28 patients in the ketoconazole group and in 5 of the 29 patients in the placebo (i.e. excipient) group (p less than 10(-5). Clinical and mycological cure was observed in only 11 of the 28 patients treated with the active substance, but among the 11 patients who still showed skin lesions despite a negative mycological examination 10 had achromic lesions which could be regarded as residual. This clearly indicates that the only criterion that can be used in a therapeutic trial on tinea versicolor is the mycological result. The active substance and the excipient were well tolerated; two patients in the ketoconazole group reported tingling of the skin at the site of application. We conclude that a single application of ketoconazole foam in effective and well tolerated in tinea versicolor. The single application technique unquestionably has advantages over repeated applications and should result in better patient's compliance and greater effectiveness in the long term.

  12. 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. PMID:19468962

  13. 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

  14. TOPICAL 0.03% ATROPINE VS. 15% ALUMINUM CHLORIDE IN TREATING MULTIPLE ECCRINE HIDROCYSTOMAS: A RANDOMIZED SINGLE BLIND CONTROLLED STUDY

    PubMed Central

    Amirhoushang, Ehsani; Mostafa, Mirshams Shashahani; Maryam, Akhyani; Pardis, Noormohamadpour; Pedram, Noormohamadpour

    2010-01-01

    Background: Multiple eccrine hidrocystomas pose a significant treatment challenge due to their facial location and tendency to scar after traditional surgical and other destructive modalities. Aims: To compare two frequently used non-destructive therapeutic modalities. Materials and Methods: Thirty patients with multiple eccrine hidrocystomas were enrolled in the study. They used topical 0.03% Atropine cream and 15% AlCl3 solution on left and right sides of their face randomly for 4 weeks. All the patients were visited before commencing the therapy as well as two and four weeks later by a dermatologist, blinded to the drugs and the number of lesions. Results: Twenty nine patients (25 females, four males) completed the study. The mean reduction in the number of lesions was significantly higher with Atropine cream in comparison with AlCl3 solution, 10.2±7.4 vs. 6.2±5.3 (P < 0.05). There were no recurrences after three months follow-up in both groups. Conclusion: It seems that both Atropine and AlCl3 are useful therapies in eccrine hidrocytomas but the former might be more effective. We think that other randomized clinical trials with larger sample sizes are needed. PMID:20418978

  15. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    PubMed Central

    Bowden, Deborah; Goddard, Lorna; Gruzelier, John

    2011-01-01

    This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood. PMID:21584234

  16. Color Blindness

    MedlinePlus

    ... three color cone cells to determine our color perception. Color blindness can occur when one or more ... Anyone who experiences a significant change in color perception should see an ophthalmologist (Eye M.D.). Next ...

  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. Effects of a single rectal dose of Misoprostol prior to abdominal hysterectomy in women with symptomatic leiomyoma: a randomized double blind clinical trial

    PubMed Central

    Tabatabai, Afsarosadat; Karimi-Zarchi, Mojgan; Meibodi, Bahare; Vaghefi, Marzie; Yazdian, Pouria; Zeidabadi, Mahbube; Dehghani, Atefe; Teimoori, Soraya; Jamali, Azadeh; Akhondi, Mehdi

    2015-01-01

    Background Fibroma, the most common benign pelvic tumor in women, affects 25 to 30% of women of reproductive age. Primary treatment for patients with symptomatic or large fibroma is surgery. Objective The purpose of this study was to investigate the effect of a single rectal dose of Misoprostol on bleeding during abdominal hysterectomy. Methods This double blind randomized clinical trial was conducted with 80 candidates for abdominal hysterectomy, due to uterine myoma, in the Shahid Sadoughi hospital of Yazd in 2012. The aim of this study was to assess the effect of single rectal dose of Misoprostol on peri-operational abdominal hysterectomy bleeding. Following administration of 400 micrograms of Misoprostol in the case group (n=40), predetermined criteria were compared with control group (n=40). Results Volume of bleeding during the operation was significantly lower in cases where Misoprostol was used. (268.71 ± 156.85 vs. 350.38 ± 152.61 cc in the case and control groups, respectively). Our findings also showed that Hemoglobin (Hb) levels before, 8, and 30 hours following the operation differed significantly (p=0.001), but these changes were similar in both groups. Pre-operative Hb levels were 11.90 ± 1.7 and 11.90 ± 2.0 in the case and control groups, respectively. Conclusion A single rectal dose of Misoprostol has positive effect on reducing peri-operational bleeding in women undergoing abdominal hysterectomy due to symptomatic leiomyoma. PMID:26516444

  19. Prospective Teachers' Inclination to Single Representation and Their Development of the Function Concept

    ERIC Educational Resources Information Center

    Bayazit, Ibrahim

    2011-01-01

    This study investigates prospective teachers' understanding of the connections between algebraic and graphical representations of the functions and their development of the concept via process-object conceptions in each of these situations. The results indicated that most of the participants were dependent upon an algebraic expression to think…

  20. 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

    2016-06-01

    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.

  1. A randomised, single-blind technical study comparing the ultrasonic visibility of smooth-surfaced and textured needles in a soft embalmed cadaver model.

    PubMed

    Munirama, S; Joy, J; Columb, M; Habershaw, R; Eisma, R; Corner, G; Cochran, S; McLeod, G

    2015-05-01

    Visibility of the needle tip and shaft is important during ultrasound-guided regional anaesthesia in order to prevent nerve trauma. Tip and shaft visibility is reduced when needles are inserted in-plane at wide angles and out-of-plane at narrow angles to the ultrasound probe. Although textured needles are more reflective than smooth needles, we hypothesised that poor visibility of the tip and shaft still remained using the above angle-probe combinations. In a single-blind study, we compared the visibility of a textured Tuohy needle, a textured single-shot needle and a conventional smooth-surfaced Tuohy needle when inserted into the biceps and deltoid muscles of a soft embalmed cadaver. One hundred and forty-four needles were block-randomised to in-plane and out-of-plane insertions at 30°, 45°, 60° and 75° to the ultrasound beam. Two blinded raters assessed needle tip visibility on video recordings of the insertions using a binary scale (0 = not visible, 1 = visible) and shaft visibility using a 5-point Likert scale. The median (IQR [range]) proportions of visible needle tips were 83% (67-83 [50-100]%) for the textured Tuohy, 75% (67-83 [33-83]%) for the textured single-shot needle and 33% (33-46 [0-50]%) for the smooth-surfaced Tuohy (p = 0.0007). Median (IQR [range]) needle shaft visibility was rated as 4.0 (3.5-4.7 [3.0-4.9]) for the textured Tuohy, 4.0 (3.8-4.5 [2.7-4.9]) for the textured single-shot needle and 3.0 (2.4-3.3 [2.3-3.5]) for the smooth-surfaced Tuohy (p = 0.015). Nevertheless, visibility was reduced at wide angles in-plane and narrow angles out-of-plane both for needle tips (p = 0.004) and shafts (p = 0.005).

  2. Comparison of single and combination diuretics on glucose tolerance (PATHWAY-3): protocol for a randomised double-blind trial in patients with essential hypertension

    PubMed Central

    Brown, Morris J; Williams, Bryan; MacDonald, Thomas M; Caulfield, Mark; Cruickshank, J Kennedy; McInnes, Gordon; Sever, Peter; Webb, David J; Salsbury, Jackie; Morant, Steve; Ford, Ian

    2015-01-01

    Introduction Thiazide diuretics are associated with increased risk of diabetes mellitus. This risk may arise from K+-depletion. We hypothesised that a K+-sparing diuretic will improve glucose tolerance, and that combination of low-dose thiazide with K+-sparing diuretic will improve both blood pressure reduction and glucose tolerance, compared to a high-dose thiazide. Methods and analysis This is a parallel-group, randomised, double-blind, multicentre trial, comparing hydrochlorothiazide 25–50 mg, amiloride 10–20 mg and combination of both diuretics at half these doses. A single-blind placebo run-in of 1 month is followed by 24 weeks of blinded active treatment. There is forced dose-doubling after 3 months. The Primary end point is the blood glucose 2 h after oral ingestion of a 75 g glucose drink (OGTT), following overnight fasting. The primary outcome is the difference between 2 h glucose at weeks 0, 12 and 24. Secondary outcomes include the changes in home systolic blood pressure (BP) and glycated haemoglobin and prediction of response by baseline plasma renin. Eligibility criteria are: age 18–79, systolic BP on permitted background treatment ≥140 mm Hg and home BP ≥130 mm Hg and one component of the metabolic syndrome additional to hypertension. Principal exclusions are diabetes, estimated-glomerular filtration rate <45 mL/min, abnormal plasma K+, clinic SBP >200 mm Hg or DBP >120 mm Hg (box 2). The sample size calculation indicates that 486 patients will give 80% power at α=0.01 to detect a difference in means of 1 mmol/L (SD=2.2) between 2 h glucose on hydrochlorothiazide and comparators. Ethics and dissemination PATHWAY-3 was approved by Cambridge South Ethics Committee, number 09/H035/19. The trial results will be published in a peer-reviewed scientific journal. Trial registration numbers Eudract number 2009-010068-41 and clinical trials registration number: NCT02351973. PMID:26253567

  3. Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502).

    PubMed

    Iguchi, Toshihiro; Sakurai, Jun; Hiraki, Takao; Gobara, Hideo; Fujiwara, Hiroyasu; Matsui, Yusuke; Masaoka, Yoshihisa; Kanazawa, Susumu

    2016-08-01

    This single center prospective study is being conducted to evaluate the safety of the cryoablation for patients with pathologically diagnosed painful bone and soft tissue tumors. Enrollment of 10 patients is planned over the 3-year recruitment period. Patients have related local pain after receiving medications or external radiation therapies will be included in this study. Cryoablation will be percutaneously performed under imaging guidance, and a temperature sensor will be used during treatment as necessary. The primary endpoint is prevalence of severe adverse events within 4 weeks after therapy. The secondary endpoint is effectiveness 4 weeks after the procedure. PMID:27549678

  4. 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.

  5. A Naturalistic, Single-blind Comparison of Rapid Dose Administration of Divalproex ER Versus Quetiapine in Patients with Acute Bipolar Mania

    PubMed Central

    Galangue, Barbara; MacDonald, Kai; Cobb, Patrice; Dinca, Ana; Becker, Olga; Cooper, J.; Hadley, Allison

    2011-01-01

    Objective: When treating acute bipolar mania, the speed of onset of anti-manic effects is crucial. Quetiapine and divalproex ER are widely used agents to treat acute mania. Rapid dose administration regimens for divalproex ER and for quetiapine have been described. We conducted a naturalistic, head-to-head, pilot study comparing the efficacy and safety of rapidly titrated divalproex ER and quetiapine in acutely manic inpatients, with the primary outcome being improvement within the first seven days. Method: Thirty consenting bipolar patients with acute mania (Young Mania Rating Scale >17 ) needing hospitalization due to acute mania were randomized to receive rapidly loaded divalproex ER (30mg/kg/day) or rapidly titrated quetiapine (200mg Day 1, raised by 200mg/day up to 800mg as tolerated). Assessments were made on Day 1 (baseline), Day 3, Day 7, Day 14, and Day 21 and included Young Mania Rating Scale, Clinical Global Impressions-Severity, Clinical Global Impressions-Improvement, and Montgomery-Asberg Depression Rating Scale. Raters but not patients or treating physicians were blinded (single-blinded study). Results: Subjects in both treatment groups exhibited significant and rapid improvement in their mania starting at Day 3 with few significant adverse effects; however, there were no significant differences in the degree or rate of improvement between the two treatment groups in any of the efficacy or adverse effects scales. Conclusion: Results of this small study indicate that rapid-dose administration of both quetiapine and divalproex ER produce rapid improvement in acute mania within the first seven days and both seem to be well tolerated. PMID:21311705

  6. 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. PMID:25917265

  7. A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene® Mesh Elastic versus the partly absorbable Ultrapro® Mesh for incisional hernia repair

    PubMed Central

    2010-01-01

    Background Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene® Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro® Mesh). Methods/Design In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention. Discussion This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients. Trial registration NCT00646334 PMID:20624273

  8. No negative symptoms in healthy volunteers after single doses of amisulpride, aripiprazole, and haloperidol: a double-blind placebo-controlled trial.

    PubMed

    Park, Chul-Hyun; Park, Tae-Won; Yang, Jong-Chul; Lee, Keon-Hak; Huang, Guang-Biao; Tong, Zhao; Park, Myung-Sook; Chung, Young-Chul

    2012-03-01

    Noncompliance and poor outcome in patients with schizophrenia are closely related to the negative symptoms secondary to antipsychotics. No controlled study has evaluated whether amisulpride and aripiprazole induce negative symptoms. The aim of this study was to assess the effects of single doses of amisulpride, aripiprazole, haloperidol, and risperidone in healthy volunteers. Seventy-eight young volunteers took part in this double-blind, randomized, placebo-controlled, parallel study of four antipsychotics: 400 mg amisulpride, 10 mg aripiprazole, 3 mg haloperidol, and 2 mg risperidone. Assessments of negative symptoms were done 4 h after administration using both subjective rating scales (Neuroleptic Induced Deficit Syndrome Scale and Subjective Deficit Syndrome Scale) and an objective rating scale (Scale for the Assessment of Negative Symptoms). Risperidone only produced significant increases on the avolition score of the Neuroleptic Induced Deficit Syndrome Scale and blunted affect and alogia scores of the Scale for the Assessment of Negative Symptoms compared with placebo. The effect on blunted affect persisted after controlling for mental sedation. Amisulpride, aripiprazole, and haloperidol did not induce negative symptoms. Aripiprazole and risperidone induced mild extrapyramidal symptoms. The most common adverse events were somnolence and cognitive slowing. These data indicate that a single risperidone dose induces negative symptoms in normal volunteers, whereas amisulpride, aripiprazole, and haloperidol do not. These characteristics of antipsychotics should be considered when choosing optimal drugs for patients with psychosis.

  9. Detecting changes in respiratory patterns in high frequency chest compression therapy by single-channel blind source separation.

    PubMed

    Zhu, Xiaoming; Parhi, Keshab K; Warwick, Warren J

    2009-01-01

    High Frequency Chest Compression (HFCC) is used as a method to remove the mucus in the airway for Cystic Fibrosis (CF) patients. As the characteristics of the tracheal sound reflect the conditions of airways, in this paper, we propose a novel method to evaluate the respiratory patterns in HFCC therapy by using single channel tracheal sounds only. The difficulty of analyzing tracheal sounds lies in that it has a wider frequency band than the air flow at the mouth, and is always corrupted by other biomedical signals and noises. During HFCC therapy, the tracheal sound is also affected by the HFCC machine noise. For this reason, it is difficult to extract respiratory patterns and other related features by traditional filtering techniques. In this paper, we demonstrate use of single-channel independent component analysis to extract respiratory patterns from the tracheal sounds before, during and after HFCC therapy, and use basis features in the tracheal sound to detect the change in respiratory patterns.

  10. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction—A Phase III Double Blind, Randomized Clinical Trial

    PubMed Central

    Pereira, Valeria Fontenelle Angelim; Pietrobon, Ricardo S.; Schmidt, Andre P.; Oses, Jean P.; Portela, Luis V.; Souza, Diogo O.; Vissoci, João Ricardo Nickenig; da Luz, Vinicius Fernando; Trintoni, Leticia Maria de Araujo de Souza; Nielsen, Karen C.; Carmona, Maria José Carvalho

    2016-01-01

    Postoperative cognitive dysfunction (POCD) is a multifactorial adverse event most frequently in elderly patients. This study evaluated the effect of dexamethasone on POCD incidence after noncardiac and nonneurologic surgery. METHODS: One hundred and forty patients (ASA I-II; age 60–87 years) took part in a prospective phase III, double blind, randomized study involving the administration or not of 8 mg of IV dexamethasone before general anesthesia under bispectral index (BIS) between 35–45 or 46–55. Neuropsychological tests were applied preoperatively and on the 3rd, 7th, 21st, 90th and 180th days after surgery and compared with normative data. S100β was evaluated before and 12 hours after induction of anesthesia. The generalized estimating equations (GEE) method was applied, followed by the posthoc Bonferroni test considering P<0.05 as significant. RESULTS: On the 3rd postoperative day, POCD was diagnosed in 25.2% and 15.3% of patients receiving dexamethasone, BIS 35–45, and BIS 46–55 groups, respectively. Meanwhile, POCD was present in 68.2% and 27.2% of patients without dexamethasone, BIS 35–45 and BIS 46–55 groups (p<0.0001). Neuropsychological tests showed that dexamethasone associated to BIS 46–55 decreased the incidence of POCD, especially memory and executive function. The administration of dexamethasone might have prevented the postoperative increase in S100β serum levels. CONCLUSION: Dexamethasone can reduce the incidence of POCD in elderly patients undergoing surgery, especially when associated with BIS 46–55. The effect of dexamethasone on S100β might be related with some degree of neuroprotection. Trial Registration: www.clinicaltrials.gov NCT01332812 PMID:27152422

  11. Predictors of Impaired Postpartum Renal Function in Women after Preeclampsia: Results of a Prospective Single Center Study

    PubMed Central

    Stock, A.; Panayotopoulos, D.; Vonend, O.; Fehm, T.; Kaisers, W.

    2016-01-01

    Objective. The purpose of this prospective study was to investigate the predictive value of single prepartum findings combined with serum biomarkers sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor) indicating severity of preeclampsia (PE) for occurrence and extent of impaired postpartum kidney function. Study Design. In this prospective, single center study 44 PE patients were compared to 39 healthy controls (similar in age and gestational age with singleton pregnancy) evaluated at time of delivery and at 6 months and 12 months postpartum. p values below 0.05 are considered statistically significant. Results. The majority of the PE patients had persistence of proteinuria (>120 mg/L after delivery) 6 months (p = 0.02) and 12 months postpartum (p < 0.0001) compared to controls. Also reduced GFR (glomerular filtration rate) persisted up to 6 months postpartum in PE patients compared to controls (p < 0.001). Prepartum sFlt-1 levels indeed correlated with impaired renal function parameters. Conclusion. A significant proportion of our PE patients had lower GFR levels and persistent proteinuria up to 12 months postpartum. Prepartum sFlt-1 is a trend-setting marker for impaired renal function postpartum, but it is not sufficient enough to predict renal impairment after PE. An evaluation of 24-month follow-up data is scheduled. PMID:27563165

  12. The Impact of Oxytocin on Food Intake and Emotion Recognition in Patients with Eating Disorders: A Double Blind Single Dose Within-Subject Cross-Over Design

    PubMed Central

    Kim, Youl-Ri; Eom, Jin-Sup; Yang, Jae-Won; Kang, Jiwon; Treasure, Janet

    2015-01-01

    Background and Aim Social difficulties and problems related to eating behaviour are common features of both anorexia nervosa (AN) and bulimia nervosa (BN). The aim of this study was to examine the impact of intranasal oxytocin on consummatory behaviour and emotional recognition in patients with AN and BN in comparison to healthy controls. Materials A total of 102 women, including 35 patients with anorexia nervosa (AN), 34 patients with bulimia nervosa (BN), and 33 healthy university students of comparable age and intelligence, participated in a double-blind, single dose placebo-controlled cross-over study. A single dose of intranasal administration of oxytocin (40 IU) (or a placebo) was followed by an emotional recognition task and an apple juice drink. Food intake was then recorded for 24 hours post-test. Results Oxytocin produced no significant change in appetite in the acute or 24 hours free living settings in healthy controls, whereas there was a decrease in calorie consumption over 24 hours in patients with BN. Oxytocin produced a small increase in emotion recognition sensitivity in healthy controls and in patients with BN, In patients with AN, oxytocin had no effect on emotion recognition sensitivity or on consummatory behaviour. Conclusions The impact of oxytocin on appetite and social cognition varied between people with AN and BN. A single dose of intranasal oxytocin decreased caloric intake over 24 hours in people with BN. People with BN showed enhanced emotional sensitivity under oxytocin condition similar to healthy controls. Those effects of oxytocin were not found in patients with AN. Trial Registration ClinicalTrials.gov KCT0000716 PMID:26402337

  13. 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…

  14. 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…

  15. Blind separation of multiple physiological sources from a single-channel recording: a preprocessing approach for antenatal surveillance

    NASA Astrophysics Data System (ADS)

    Jiménez-Gonzalez, Aída; James, Christopher J.

    2013-11-01

    Today, it is generally accepted that current methods for biophysical antenatal surveillance do not facilitate a comprehensive and reliable assessment of foetal well-being and thus, that continuing research into alternative methods is necessary to improve antenatal monitoring procedures. Here, attention has been paid to the abdominal phonogram, a signal that is recorded by positioning an acoustic sensor on the maternal womb and contains valuable information about foetal status, but which is hidden by maternal and environmental sources. To recover such information, this work describes single-channel independent component analysis (SCICA) as an alternative signal processing approach for analyzing the abdominal phonogram. The approach, based on the method of delays, the Temporal Decorrelation Source SEParation implementation (TDSEP) of Independent Components Analysis (ICA), and an automatic grouping algorithm, has managed to successfully retrieve estimates of: (1) the foetal cardiac activity (in the form of the foetal phonocardiogram, FPCG), (2) the maternal cardiovascular activity (in the form of the maternal phonocardiogram, MPCG, and/or pulse wave), (3) the maternal respiratory activity (in the form of the maternal respirograma, MResp), and (4) noise (N). These results have been obtained from a dataset of 25 single-channel phonograms and point at the possibilities of using SCICA to address a fundamental problem faced in antenatal surveillance, i.e. the extraction of information from a non-invasive signal like the abdominal phonogram. Future work will test the possibility of using SCICA to recover information regarding the foetal breathing movements (FBM), another physiological parameter of interest in foetal surveillance.

  16. 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

  17. A single-blind, randomized study to compare the efficacy of two ear drop preparations ('Audax' and 'Cerumol') in the softening of ear wax.

    PubMed

    Dummer, D S; Sutherland, I A; Murray, J A

    1992-01-01

    A parallel group, single-blind, randomized study was carried out in a general practice to compare the effectiveness and tolerability of two ear drop preparations ('Audax' and 'Cerumol') in the softening of ear wax in 50 adult patients with impacted or hardened ear wax. Assessments were made on entry of the amount, colour and consistency of the ear wax, symptoms, and objective hearing. Patients were then allocated at random to receive one or other preparation and instructed to use the drops, morning and evening, for 4 days after which they were reassessed. Details were recorded of any side-effects or discomfort caused by the study medication and both physician and patients were asked to give their overall opinion of treatment efficacy. Both treatments were shown to be effective in the softening of ear wax and were well tolerated, there being no significant difference between the two groups in these parameters. However, patients who had abnormal hearing before treatment had a significantly greater improvement in objective hearing after treatment with 'Audax' ear drops compared to those patients treated with 'Cerumol' ear drops. There were no between-treatment differences in either either the physician's or patient's overall assessments of effectiveness.

  18. 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

  19. Long-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study.

    PubMed

    Rinaldi, Salvatore; Mura, Marco; Castagna, Alessandro; Fontani, Vania

    2014-01-01

    The aim of this randomized double-blind study was to evaluate in healthy adult subjects, with functional magnetic resonance imaging (fMRI), long lasting changes in brain activation patterns following administration of a single, 250 milliseconds pulse emitted with radio-electric asymmetric conveyer (REAC) technology in the Wi-Fi bands. The REAC impulse was not administered during the scan, but after this, according to a protocol that has previously been demonstrated to be effective in improving motor control and postural balance, in healthy subjects and patients. The study was conducted on 33 healthy volunteers, performed with a 1.5 T unit while operating a motor block task involving cyclical and alternating flexion and extension of one leg. Subsequently subjects were randomly divided into a treatment and a sham treatment control group. Repeated fMRI examinations were performed following the administration of the REAC pulse or sham treatment. The Treated group showed cerebellar and ponto-mesencephalic activation components that disappeared in the second scan, while these activation components persisted in the Sham group. This study shows that a very weak signal, such as 250 milliseconds Wi-Fi pulse, administered with REAC technology, could lead to lasting effects on brain activity modification. PMID:25011544

  20. Long-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study

    PubMed Central

    Rinaldi, Salvatore; Mura, Marco; Castagna, Alessandro; Fontani, Vania

    2014-01-01

    The aim of this randomized double-blind study was to evaluate in healthy adult subjects, with functional magnetic resonance imaging (fMRI), long lasting changes in brain activation patterns following administration of a single, 250 milliseconds pulse emitted with radio-electric asymmetric conveyer (REAC) technology in the Wi-Fi bands. The REAC impulse was not administered during the scan, but after this, according to a protocol that has previously been demonstrated to be effective in improving motor control and postural balance, in healthy subjects and patients. The study was conducted on 33 healthy volunteers, performed with a 1.5 T unit while operating a motor block task involving cyclical and alternating flexion and extension of one leg. Subsequently subjects were randomly divided into a treatment and a sham treatment control group. Repeated fMRI examinations were performed following the administration of the REAC pulse or sham treatment. The Treated group showed cerebellar and ponto-mesencephalic activation components that disappeared in the second scan, while these activation components persisted in the Sham group. This study shows that a very weak signal, such as 250 milliseconds Wi-Fi pulse, administered with REAC technology, could lead to lasting effects on brain activity modification. PMID:25011544

  1. A randomised, single blinded trial, assessing the effect of a two week preoperative very low calorie diet on laparoscopic cholecystectomy in obese patients

    PubMed Central

    Burnand, Katherine M.; Lahiri, Rajiv P.; Burr, Nicholas; Jansen van Rensburg, Lize; Lewis, Michael P.N.

    2016-01-01

    Background Laparoscopic cholecystectomy (LC) can be technically challenging in the obese. The primary aim of the trial was to establish whether following a Very Low Calorie Diet (VLCD) for two weeks pre-operatively reduces operation time. Secondary outcomes included perceived operative difficulty and length of hospital stay. Methods A single-blinded, randomized controlled trial of consecutive patients with symptomatic gallstones and BMI >30 kg/m2 46 patients were randomized to a VLCD or normal diet for two weeks prior to LC. Food diaries were used to document dietary intake. The primary outcome measure was operation time. Secondary outcomes were length of stay, weight change operative complications, day case rates and perceived difficulty of operation. Results The VLCD was well tolerated and had significantly greater preoperative weight loss (3.48 kg vs. 0.98 kg; p < 0.0001). Median operative time was significantly reduced by 6 min in the VLCD group (25 vs. 31 min; p = 0.0096). There were no differences in post-operative complications, length of stay, or day case rates between the groups. Dissection of Calot's triangle was deemed significantly easier in the VLCD group. Conclusion A two week VLCD prior to elective laparoscopic cholecystectomy in obese patients is safe, well tolerated and was shown to significantly reduce pre-operative weight and operative time. Trial registration ISRCTN: 61630192. http://www.isrctn.com/ISRCTN61630192 Trial registration. PMID:27154810

  2. A single-blind placebo-controlled investigation into the analgesic effects of interferential currents on experimentally induced ischaemic pain in healthy subjects.

    PubMed

    Johnson, Mark I; Tabasam, Ghazala

    2002-05-01

    The aim of this single-blind placebo-controlled study was to examine the analgesic effects of interferential currents (IFC) on experimentally induced ischaemic pain. Ischaemic pain was induced using the submaximal effort tourniquet technique (SETT) and pain intensity was recorded using a visual analogue scale at 1-min intervals was used as the primary outcome measure. Following baseline recordings 30 healthy volunteers received either active IFC, sham IFC, or no treatment (10 subjects per group). Data were analysed by calculating the mean change in pain intensity at each 1-min interval by subtracting data during treatment from the baseline data. IFC was administered throughout the duration of the ischaemic pain test via four electrodes (quadripolar application) on the forearm. Active IFC delivered electrical currents at a 'strong but comfortable' intensity. A 'dummy' stimulator that delivered no current was used as sham IFC. Subjects in the no treatment control group were informed that the IFC device was not switched on. There were significant effects for Groups (P=0.04) which were attributed to a significant reduction in pain intensity for the IFC group when compared with sham and no-treatment control (P< or =0.05). There were no significant effects for Time (P=0.69) or Group-Time interaction (P=0.45). In conclusion, IFC produced significantly greater analgesia than sham and no-treatment control groups under the present experimental conditions.

  3. Long-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study.

    PubMed

    Rinaldi, Salvatore; Mura, Marco; Castagna, Alessandro; Fontani, Vania

    2014-07-11

    The aim of this randomized double-blind study was to evaluate in healthy adult subjects, with functional magnetic resonance imaging (fMRI), long lasting changes in brain activation patterns following administration of a single, 250 milliseconds pulse emitted with radio-electric asymmetric conveyer (REAC) technology in the Wi-Fi bands. The REAC impulse was not administered during the scan, but after this, according to a protocol that has previously been demonstrated to be effective in improving motor control and postural balance, in healthy subjects and patients. The study was conducted on 33 healthy volunteers, performed with a 1.5 T unit while operating a motor block task involving cyclical and alternating flexion and extension of one leg. Subsequently subjects were randomly divided into a treatment and a sham treatment control group. Repeated fMRI examinations were performed following the administration of the REAC pulse or sham treatment. The Treated group showed cerebellar and ponto-mesencephalic activation components that disappeared in the second scan, while these activation components persisted in the Sham group. This study shows that a very weak signal, such as 250 milliseconds Wi-Fi pulse, administered with REAC technology, could lead to lasting effects on brain activity modification.

  4. 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.

  5. 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

  6. The effects of open and closed endotracheal suctioning on intracranial pressure and cerebral perfusion pressure: a crossover, single-blind clinical trial.

    PubMed

    Uğraş, Gülay Altun; Aksoy, Güler

    2012-12-01

    Although endotracheal suctioning is a routine nursing intervention, this procedure can lead to an increase in intracranial pressure (ICP). This study was planned to determine the appropriate suctioning technique (open system suctioning [OS] and closed system suctioning [CS]) to minimize variability of ICP and cerebral perfusion pressure (CPP) in neurologically impaired patients. The study, which was designed as a crossover, single-blind clinical trial, consisted of 32 neurosurgical patients who underwent ICP monitoring, intra-arterial blood pressure monitoring, and endotracheal intubation in the intensive care unit. According to the need for suctioning, each patient in the experimental and control groups underwent suctioning with both closed and open systems. Recordings were composed of the patients' ICP, mean arterial blood pressure, CPP, heart rate (HR), and arterial blood gases during suctioning. It was observed that both suctioning techniques significantly increased ICP, mean arterial blood pressure, CPP, and HR; ICP was found to be significantly higher in OS compared with CS, whereas there were no significant differences in CPP and HR between the two techniques. The patients suctioned using OS had significantly lower mean PaO(2) than those suctioned using CS; however, the comparison of the two techniques revealed no significant differences in PaCO(2). The data obtained indicate that CS, compared with OS, can be used safely on this patient group.

  7. Effect of pretreatment with acetaminophen on withdrawal movements associated with injection of rocuronium: a prospective, randomized, double-blind, placebo controlled study

    PubMed Central

    Jeon, Younghoon; Baek, Sung-Uk; Park, Sung Sik; Kim, Si Oh; Baek, Woon-Yi

    2010-01-01

    Background Withdrawal movement during rocuronium injection is a common, unresolved adverse effect. We aimed to investigate the effect of IV acetaminophen pretreatment on withdrawal movement during rocuronium injection. Methods This study enrolled 120 American Society of Anesthesiologists (ASA) I-II patients undergoing general anesthesia. They were randomly assigned to three treatment groups. After occluding venous drainage using a tourniquet on the upper arm, the saline group received 5 ml of 0.9% sodium chloride solution, the lidocaine group received 40 mg of lidocaine, and the acetaminophen group received 50 mg of acetaminophen. During injection of pretreatment drug, pain was assessed on a four-point scale. The tourniquet was released after 120 seconds and anesthesia was performed using thiopental sodium 5 mg/kg followed by rocuronium 0.6 mg/kg. The withdrawal movement was graded on a four-point scale in a double-blind manner. Results The incidence of pain on pretreatment injection in saline, lidocaine, and acetaminophen groups was 7.7%, 5.1%, and 2.5%, respectively. The incidence of withdrawal movements was 77.5% in saline group, 32.5% in lidocaine group, and 37.5% in acetaminophen group (P < 0.05). Conclusions Acetaminophen and lidocaine reduced the incidence of withdrawal movement after rocuronium injection compared with saline. PMID:20651992

  8. Effect of probiotic Lactobacillus (Lacidofil® cap) for the prevention of antibiotic-associated diarrhea: a prospective, randomized, double-blind, multicenter study.

    PubMed

    Song, Hyun Joo; Kim, Jin-Yong; Jung, Sung-Ae; Kim, Seong-Eun; Park, Hye-Sook; Jeong, Yoolwon; Hong, Sung Pil; Cheon, Jae Hee; Kim, Won Ho; Kim, Hyo-Jong; Ye, Byong Duk; Yang, Suk-Kyun; Kim, Sang-Woo; Shin, Sung-Jae; Kim, Hyun-Soo; Sung, Jae-Kyu; Kim, Eun Young

    2010-12-01

    Antibiotic-associated diarrhea (AAD) is a common complication of antibiotic use. There is growing interest in probiotics for the treatment of AAD and Clostridium difficile infection because of the wide availability of probiotics. The aim of this multicenter, randomized, placebo-controlled, double-blind trial was to assess the efficacy of probiotic Lactobacillus (Lacidofil® cap) for the prevention of AAD in adults. From September 2008 to November 2009, a total of 214 patients with respiratory tract infection who had begun receiving antibiotics were randomized to receive Lactobacillus (Lacidofil® cap) or placebo for 14 days. Patients recorded bowel frequency and stool consistency daily for 14 days. The primary outcome was the proportion of patients who developed AAD within 14 days of enrollment. AAD developed in 4 (3.9%) of 103 patients in the Lactobacillus group and in 8 (7.2%) of 111 patients in the placebo group (P=0.44). However, the Lactobacillus group showed lower change in bowel frequency and consistency (50/103, 48.5%) than the placebo group (35/111, 31.5%) (P=0.01). Although the Lacidofil® cap does not reduce the rate of occurrence of AAD in adult patients with respiratory tract infection who have taken antibiotics, the Lactobacillus group maintains their bowel habits to a greater extent than the placebo group.

  9. Effect of Probiotic Lactobacillus (Lacidofil® Cap) for the Prevention of Antibiotic-associated Diarrhea: A Prospective, Randomized, Double-blind, Multicenter Study

    PubMed Central

    Song, Hyun Joo; Kim, Jin-Yong; Kim, Seong-Eun; Park, Hye-Sook; Jeong, Yoolwon; Hong, Sung Pil; Cheon, Jae Hee; Kim, Won Ho; Kim, Hyo-Jong; Ye, Byong Duk; Yang, Suk-Kyun; Kim, Sang-Woo; Shin, Sung-Jae; Kim, Hyun-Soo; Sung, Jae-Kyu; Kim, Eun Young

    2010-01-01

    Antibiotic-associated diarrhea (AAD) is a common complication of antibiotic use. There is growing interest in probiotics for the treatment of AAD and Clostridium difficile infection because of the wide availability of probiotics. The aim of this multicenter, randomized, placebo-controlled, double-blind trial was to assess the efficacy of probiotic Lactobacillus (Lacidofil® cap) for the prevention of AAD in adults. From September 2008 to November 2009, a total of 214 patients with respiratory tract infection who had begun receiving antibiotics were randomized to receive Lactobacillus (Lacidofil® cap) or placebo for 14 days. Patients recorded bowel frequency and stool consistency daily for 14 days. The primary outcome was the proportion of patients who developed AAD within 14 days of enrollment. AAD developed in 4 (3.9%) of 103 patients in the Lactobacillus group and in 8 (7.2%) of 111 patients in the placebo group (P=0.44). However, the Lactobacillus group showed lower change in bowel frequency and consistency (50/103, 48.5%) than the placebo group (35/111, 31.5%) (P=0.01). Although the Lacidofil® cap does not reduce the rate of occurrence of AAD in adult patients with respiratory tract infection who have taken antibiotics, the Lactobacillus group maintains their bowel habits to a greater extent than the placebo group. PMID:21165295

  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. PMID:27324263

  11. XG-102 administered to healthy male volunteers as a single intravenous infusion: a randomized, double-blind, placebo-controlled, dose-escalating study

    PubMed Central

    Deloche, Catherine; Lopez-Lazaro, Luis; Mouz, Sébastien; Perino, Julien; Abadie, Claire; Combette, Jean-Marc

    2014-01-01

    The aim of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of the JNK inhibitor XG-102 in a randomized, double blind, placebo controlled, sequential ascending dose parallel group Phase 1 Study. Three groups of male subjects received as randomly assigned ascending single XG-102 doses (10, 40, and 80 μg/kg; 6 subjects per dose) or placebo (2 subjects per dose) as an intravenous (IV) infusion over 60 min. Safety and tolerability were assessed by physical examination, vital signs, electrocardiography, eye examination, clinical laboratory tests and adverse events (AEs). PK was analyzed using noncompartmental methods. All reported AEs were mild to moderate and neither their number nor their distribution by System Organ Class suggest a dose relationship. Only headache and fatigue were considered probably or possibly study drug related. Headache frequency was similar for active and placebo, consequently this was not considered to be drug related but probably to study conditions. The other examinations did not show clinically relevant deviations or trends suggesting a XG-102 relationship. Geometric mean half-life was similar among doses, ranging from 0.36 to 0.65 h. Geometric mean XG-102 AUC0–last increased more than linearly with dose, 90% confidence intervals (CIs) did not overlap for the two highest doses. Geometric mean dose normalized Cmax values suggest a more than linear increase with dose but 90% CIs overlap. It may be concluded that XG-102 single IV doses of 10–80 μg/kg administered over 1 h to healthy male subjects were safe and well tolerated. PMID:25505576

  12. 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

  13. 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

  14. A Randomized, Single-Ascending-Dose, Ivermectin-Controlled, Double-Blind Study of Moxidectin in Onchocerca volvulus Infection

    PubMed Central

    Opoku, Nicholas O.; Attah, Simon K.; Lazdins-Helds, Janis; Kuesel, Annette C.

    2014-01-01

    Background Control of onchocerciasis as a public health problem in Africa relies on annual mass ivermectin distribution. New tools are needed to achieve elimination of infection. This study determined in a small number of Onchocerca volvulus infected individuals whether moxidectin, a veterinary anthelminthic, is safe enough to administer it in a future large study to further characterize moxidectin's safety and efficacy. Effects on the parasite were also assessed. Methodology/Principal Findings Men and women from a forest area in South-eastern Ghana without ivermectin mass distribution received a single oral dose of 2 mg (N = 44), 4 mg (N = 45) or 8 mg (N = 38) moxidectin or 150 µg/kg ivermectin (N = 45) with 18 months follow up. All ivermectin and 97%–100% of moxidectin treated participants had Mazzotti reactions. Statistically significantly higher percentages of participants treated with 8 mg moxidectin than participants treated with ivermectin experienced pruritus (87% vs. 56%), rash (63% vs. 42%), increased pulse rate (61% vs. 36%) and decreased mean arterial pressure upon 2 minutes standing still after ≥5 minutes supine relative to pre-treatment (61% vs. 27%). These reactions resolved without treatment. In the 8 mg moxidectin and ivermectin arms, the mean±SD number of microfilariae/mg skin were 22.9±21.1 and 21.2±16.4 pre-treatment and 0.0±0.0 and 1.1±4.2 at nadir reached 1 and 3 months after treatment, respectively. At 6 months, values were 0.0±0.0 and 1.6±4.5, at 12 months 0.4±0.9 and 3.4±4.4 and at 18 months 1.8±3.3 and 4.0±4.8, respectively, in the 8 mg moxidectin and ivermectin arm. The reduction from pre-treatment values was significantly higher after 8 mg moxidectin than after ivermectin treatment throughout follow up (p<0.01). Conclusions/Significance The 8 mg dose of moxidectin was safe enough to initiate the large study. Provided its results confirm those from this study, availability of moxidectin to control

  15. Short-term effect of a new mouthrinse formulation on oral malodour after single use in vivo: a comparative, randomized, single-blind, parallel-group clinical study.

    PubMed

    Wilhelm, D; Gysen, K; Himmelmann, A; Krause, C; Wilhelm, K-P

    2010-09-01

    This study aimed to compare a new chlorhexidine (CHX)-free mouthrinse containing amine fluoride/stannous fluoride (ASF) against a benchmark containing CHX with respect to their effect on oral malodour after single use. A total of 42 male and female subjects with an intraoral cause of bad breath, each with an organoleptic rating (OR) of at least 2 and a total volatile sulfur compound (VSC) concentration higher than 130 ppb, participated in the study. Subjects were allocated to one of three treatment groups (i.e. CHX-free ASF mouthrinse, CHX benchmark mouthrinse or water) according to a randomization list. Participants received written instructions on precautions to be taken for optimal breath analysis. Eight trained and qualified odour judges assessed the subjects' malodour by OR at baseline and 30 min and 4 h after single use of the mouthrinses. Additionally, VSC levels were measured at baseline and 4 h after using the mouthrinse. Treatment with water alone led already to some reduction in OR with mean differences to baseline of -1.13 at 30 min and -0.64, 4 h after treatment. Both CHX-free ASF product (-1.51) and CHX (-1.48) provided a significantly stronger OR reduction than water at 30 min (p < 0.05). Only CHX-free ASF treatment showed a sustained benefit in terms of significantly better OR reduction after 4 h (-1.17, p < 0.05), whereas CHX (-0.81) was not significantly different from water (-0.64, p = 0.517). Both ASF (-90.9%) and CHX (-81.6%) reduced VSC levels significantly stronger than water (-53.5%; p < 0.001). OR and VSC readings in the group using the CHX mouthrinse did not differ significantly from those in the group using the CHX-free ASF formulation. The newly developed CHX-free ASF mouthrinse significantly reduced oral malodour after single use, both in terms of OR and VSC levels. Efficacy was comparable to that of the CHX benchmark product.

  16. 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.

  17. Silicon carbide light-emitting diode as a prospective room temperature source for single photons

    PubMed Central

    Fuchs, F.; Soltamov, V. A.; Väth, S.; Baranov, P. G.; Mokhov, E. N.; Astakhov, G. V.; Dyakonov, V.

    2013-01-01

    Generation of single photons has been demonstrated in several systems. However, none of them satisfies all the conditions, e.g. room temperature functionality, telecom wavelength operation, high efficiency, as required for practical applications. Here, we report the fabrication of light-emitting diodes (LEDs) based on intrinsic defects in silicon carbide (SiC). To fabricate our devices we used a standard semiconductor manufacturing technology in combination with high-energy electron irradiation. The room temperature electroluminescence (EL) of our LEDs reveals two strong emission bands in the visible and near infrared (NIR) spectral ranges, associated with two different intrinsic defects. As these defects can potentially be generated at a low or even single defect level, our approach can be used to realize electrically driven single photon source for quantum telecommunication and information processing. PMID:23572127

  18. 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.

  19. 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.

  20. Evaluation of the lower limb vasculature before free fibula flap transfer. A prospective blinded comparison between magnetic resonance angiography and digital subtraction angiography.

    PubMed

    Klein, Steven; Van Lienden, Krijn P; Van't Veer, Marcel; Smit, Jeroen M; Werker, Paul M N

    2013-10-01

    Introduction The aim of this study was to compare magnetic resonance angiography (MRA) with digital subtraction angiography (DSA) in the preoperative assessment of crural arteries and their skin perforators prior to free fibular transfer. Patients and methods Fifteen consecutive patients, scheduled for free vascularized fibular flap transfer, were subjected to DSA as well as MRA of the crural arteries of both legs (n = 30). All DSA and MRA images were assessed randomly, blindly, and independently by two radiologists. Each of the assessors scored the degree of stenosis of various segments on a 5 point scale from 0 (occlusive) to 4 (no stenosis). The Cohen's Kappa coefficient was used to assess the agreement between DSA and MRA scores. In addition, the number of cutaneous perforators were scored and the assessors were asked if they would advise against fibula harvest and transplantation based on the images. Results A Cohen's Kappa of 0.64, indicating "substantial agreement of stenosis severity scores" was found between the two imaging techniques. The sensitivity of MRA to detect a stenosis compared with DSA was 79% (CI 95%:60-91), and a specificity of 98% (CI 95%: 97-99). In 53 out of 60 assessments, advice on suitability for transfer were equal between DSA and MRA. The median number of cutaneous perforators that perfuse the skin overlying the fibula per leg was one for DSA as well as MRA (P = 0.142).Conclusions A substantial agreement in the assessment of stenosis severity was found between DSA and MRA. The results suggest that MRA is a good alternative to DSA in the preoperative planning of free fibula flap transplantation. PMID:24038374

  1. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study

    PubMed Central

    Perrotti, Pasquale; Dominici, Patrizia; Grossi, Enzo; Cerutti, Renata; Antropoli, Carmine

    2010-01-01

    Background Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy, a common and distressing experience. We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter. Methods We conducted a multicentre randomized, double-blind trial to compare the efficacy of 0.3% nifedipine and 1.5% lidocaine ointment versus 1.5% lidocaine ointment alone in reducing pain after hemorrhoidectomy. A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale (ACCS) at baseline; soon after surgery; at 2, 4, 6, 8 and 24 hours after surgery; on day 7 after surgery; and at a final visit 14 days after surgery. The physician also noted the time to first analgesic administration within 24 hours after surgery. Results In all, 135 patients per group participated (270 total). Evaluation of the delta ACCS score versus basal value, a covariate for rescue analgesic administration time, revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 (p < 0.011 and p < 0.054, respectively). We noticed no difference between groups for time of administration of rescue analgesic, blood pressure, heart rate or frequency of headache. Conclusion Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy, the patients’ assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery. Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended. Further research focusing on these outcomes is warranted. PMID:20100408

  2. Effect of locally applied GM-CSF on oral mucositis after stem cell transplantation: a prospective placebo-controlled double-blind study.

    PubMed

    van der Lelie, H; Thomas, B L; van Oers, R H; Ek-Post, M; Sjamsoedin, S A; van Dijk-Overtoom, M L; Timmer, J G; von dem Borne, A E

    2001-03-01

    Oral mucositis is a frequent side effect of myeloablative chemo- and radiotherapy preceding stem cell transplantation. It causes pain, poor food intake, and is a port of entry for infection. We studied whether GM-CSF applied topically in the oral cavity can prevent or ameliorate this mucositis. In 36 consecutive patients undergoing a stem cell transplantation, we performed a double-blind placebo-controlled study of 300 micrograms GM-CSF in a 2% methylcellulose gel daily versus a 2% methylcellulose gel alone. Both were locally applied in the oral cavity. The primary end-point was mucositis as measured by the WHO toxicity scale for mucositis, oral assessment scale, and a subjective pain scale, all scored daily. The secondary end-points were need to give parenteral nutrition and morphine, incidence of fever and infections, and duration of neutropenia and hospitalization. No differences were found in the median subjective pain scores, WHO scores, and oral assessment scores between the placebo and the GM-CSF groups. In both groups, nine patients required morphine for pain control. Ten patients in the placebo group and 11 in the GM-CSF group received parenteral nutrition. Documented infections, use of broad-spectrum antibiotics, and number of days with fever were similar in the placebo and the GM-CSF groups. The duration of neutropenia below 0.5 x 10(9)/l (median 14.5 days in the placebo group versus 17 days in the GM-CSF group) and the duration of hospitalization (28.5 versus 29 days) was also not significantly different. We found no beneficial effect of 300 micrograms GM-CSF dissolved in a 2% methylcellulose gel applied locally for chemo- and radiotherapy-induced mucositis in patients undergoing a stem cell transplantation.

  3. 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

  4. Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial

    PubMed Central

    2013-01-01

    Background Recently, a number of studies using intra-articular application of tranexamic acid (IA-TXA), with different dosage and techniques, successfully reduced postoperative blood loss in total knee replacement (TKR). However, best of our knowledge, the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied. This study aimed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss and blood transfusion reduction. Methods Between 2010 and 2011, a triple-blinded randomized controlled study was conducted in 135 patients undergoing conventional TKR. The patients were allocated into three groups according to intra-articular solution received: Control group (physiologic saline), TXA-250 group (TXA 250 mg), and TXA-500 group (TXA 500 mg). The solution was injected after wound closure followed by drain clamping for 2 hours. Blood loss and transfusion were recorded. Duplex ultrasound was performed. Functional outcome and complication were followed for one year. Results There were forty-five patients per groups. The mean total hemoglobin loss was 2.9 g/dL in control group compared with 2.2 g/dL in both TXA groups (p > 0.001). Ten patients (22%, control), six patients (13%, TXA-250) and none (TXA-500) required transfusion (p = 0.005). Thromboembolic events were detected in 7 patients (4 controls, 1 TXA-250, and 2 TXA-500). Functional outcome was non-significant difference between groups. Conclusions Combined low-dose IA-TXA, as 500 mg, with 2-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional TKR without significant difference in postoperative knee function or complication. Trial registration ClinicalTrials.gov NCT01850394. PMID:24308672

  5. Prospects for single-molecule detection in liquids by laser-induced fluorescence

    SciTech Connect

    Trkula, M.; Keller, R.A.; Martin, J.C.; Jett, J.H.; Dovichi, N.J.

    1983-01-01

    A laser-induced fluoresence determination of aqueous solutions of rhodamine 6G resulted in a detection limit of 18 attograms, or 22,000 molecules, of rhodamine 6G. These results allow the projection to single-molecule detection with reasonable improvements in the experimental apparatus.

  6. Prospective HLA-DR matching in cadaveric renal transplants: a single center study.

    PubMed

    Mendez, R; Iwaki, Y; Mendez, R; Bogaard, T; Self, B

    1983-03-01

    We reviewed 77 potential cadaveric allograft recipients who had undergone prospective HLA-A and B locus and HLA-DR antigen identification. Matching was accomplished, giving first priority to HLA-DR compatibility and relying on HLA-A and B antigen matching only in situations of total HLA-DR incompatibility. Complete HLA-DR identification occurred in 56 per cent of all patients. There were 15 patients (19.5 per cent) who received a 2/2 HLA-DR perfect match, with 86.7 plus or minus 8.8 per cent 1-year actuarial graft survival, and 41 (53 per cent) who received a 1/2 HLA-DR match, with 58.2 plus or minus 7.8 per cent 1-year actual allograft survival. Finally, 21 patients (27 per cent) received a 0/2 HLA-DR match, with 64.9 plus or minus 10.7 per cent actual survival. These results and their mirrored mismatching results showed statistically significant allograft success in only the HLA-DR 2/2 matches. Matching for HLA 2 DR donors proved a statistically significant success over the other HLA-DR allograft matches and the older controversial matching system based on HLA-A and B locus antigens. The restricted gene polymorphism of the HLA-DR systems allows for a relatively high percentage of perfect HLA-DR matches.

  7. 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.

  8. A longitudinal prospective study of bleeding diathesis in Egyptian pediatric patients: single-center experience.

    PubMed

    Mokhtar, Galila M; Tantawy, Azza A G; Adly, Amira A M; Telbany, Manal A S; El Arab, Sahar Ezz; Ismail, Mona

    2012-07-01

    Keeping an updated registry of bleeding disorders is crucial for planning care and documenting prevalence. We aimed to assess the prevalence of various bleeding disorders including rare inherited coagulation and platelet disorders concerning their clinico-epidemiological, diagnostic data and bleeding manifestations severity. Patients suffering from manifestations of bleeding or coagulation disorders presented to Hematology Clinic during 16 years were included and prospectively followed up. Demographics, clinical characteristics, complete blood count, bleeding, prothrombin and activated partial thromboplastin times, platelet aggregation tests and bone marrow aspiration were recorded. Overall 687 patients with bleeding disorders from total 2949 patients were identified. Inherited coagulation defects were found in 27.2%; hemophilia A (70.6%), hemophilia B (13.9%), factor I deficiency (2.3%), factor V deficiency (1.6%), factor X deficiency (4.2%), factor VII deficiency (2.6%), factor XIII deficiency (1.1%), combined factor deficiency (2.1%) and unclassified coagulation disorders in 1.6% of studied patients. Overall 72.7% had diagnosed with platelet disorders; immune thrombocytopenia was the commonest (74.8%), and inherited conditions represent (25.2%) in the following order: Glanzman's thrombasthenia (11.2%), von Willebrand disease (6.6%), Bernard-Soulier syndrome (1%) and Chediak Higashi in 0.4% and unclassified in 6%. Median age of diagnosis of coagulation and platelet disorders were 33 and 72 months. Presenting symptoms of coagulation disorders were: 25.1% post circumcision bleeding, 22.5% ecchymosis, 20.9% hemoarthrosis and 15% epistaxis. Symptoms of rare coagulation disorders were postcircumcision bleeding (20%), bleeding umbilical stump (20%), epistaxis (12%), hemoarthrosis (8%) and hematomas (4%). Presenting symptoms in rare inherited platelet disorders were purpura, ecchymosis, epistaxis and bleeding gums, respectively. Analysis of the clinico

  9. 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.

  10. [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

  11. [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

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

    PubMed

    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 37(0/7) (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.

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

    PubMed

    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 37(0/7) (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

  14. 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

  15. Effects of Aloe vera cream on chronic anal fissure pain, wound healing and hemorrhaging upon defection: a prospective double blind clinical trial.

    PubMed

    Rahmani, N; Khademloo, M; Vosoughi, K; Assadpour, S

    2014-01-01

    Aloe vera is a medicinal plant that promotes wound healing in burn injuries. A prospective clinical trial was conducted to evaluate the effects of a topical cream containing 0.5% Aloe vera juice powder in the treatment of chronic anal fissures. The aloe cream was applied by the patients to the wound site 3 times per day for 6 weeks following the instructions of a physician. Pain was assessed with a visual analog scale before treatment and at the end of each week of treatment. Wound healing and the amount and severity of bleeding were examined and evaluated before and at the end of each week of treatment. There were statistically significant differences in chronic anal fissure pain, hemorrhaging upon defection and wound healing before and at the end of the first week of treatment also in comparison with control group (p < 0.0001). In this study, a topical cream containing aloe vera juice was an effective treatment for chronic anal fissures. This is a promising result indicating that further comparative studies are justified.

  16. Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial

    PubMed Central

    Tapia, Milagritos D; Sow, Samba O; Lyke, Kirsten E; Haidara, Fadima Cheick; Diallo, Fatoumata; Doumbia, Moussa; Traore, Awa; Coulibaly, Flanon; Kodio, Mamoudou; Onwuchekwa, Uma; Sztein, Marcelo B; Wahid, Rezwanul; Campbell, James D; Kieny, Marie-Paule; Moorthy, Vasee; Imoukhuede, Egeruan B; Rampling, Tommy; Roman, Francois; De Ryck, Iris; Bellamy, Abbie R; Dally, Len; Mbaya, Olivier Tshiani; Ploquin, Aurélie; Zhou, Yan; Stanley, Daphne A; Bailer, Robert; Koup, Richard A; Roederer, Mario; Ledgerwood, Julie; Hill, Adrian V S; Ballou, W Ripley; Sullivan, Nancy; Graham, Barney; Levine, Myron M

    2016-01-01

    Summary Background The 2014 west African Zaire Ebola virus epidemic prompted worldwide partners to accelerate clinical development of replication-defective chimpanzee adenovirus 3 vector vaccine expressing Zaire Ebola virus glycoprotein (ChAd3-EBO-Z). We aimed to investigate the safety, tolerability, and immunogenicity of ChAd3-EBO-Z in Malian and US adults, and assess the effect of boosting of Malians with modified vaccinia Ankara expressing Zaire Ebola virus glycoprotein and other filovirus antigens (MVA-BN-Filo). Methods In the phase 1, single-blind, randomised trial of ChAd3-EBO-Z in the USA, we recruited adults aged 18–65 years from the University of Maryland medical community and the Baltimore community. In the phase 1b, open-label and double-blind, dose-escalation trial of ChAd3-EBO-Z in Mali, we recruited adults 18–50 years of age from six hospitals and health centres in Bamako (Mali), some of whom were also eligible for a nested, randomised, double-blind, placebo-controlled trial of MVA-BN-Filo. For randomised segments of the Malian trial and for the US trial, we randomly allocated participants (1:1; block size of six [Malian] or four [US]; ARB produced computer-generated randomisation lists; clinical staff did randomisation) to different single doses of intramuscular immunisation with ChAd3-EBO-Z: Malians received 1 × 1010 viral particle units (pu), 2·5 × 1010 pu, 5 × 1010 pu, or 1 × 1011 pu; US participants received 1 × 1010 pu or 1 × 1011 pu. We randomly allocated Malians in the nested trial (1:1) to receive a single dose of 2 × 108 plaque-forming units of MVA-BN-Filo or saline placebo. In the double-blind segments of the Malian trial, investigators, clinical staff, participants, and immunology laboratory staff were masked, but the study pharmacist (MK), vaccine administrator, and study statistician (ARB) were unmasked. In the US trial, investigators were not masked, but participants were. Analyses were per

  17. A single-blind randomised controlled trial of the effects of a web-based decision aid on self-testing for cholesterol and diabetes. study protocol

    PubMed Central

    2012-01-01

    Background Self-tests, tests on body materials to detect medical conditions, are widely available to the general public. Self-testing does have advantages as well as disadvantages, and the debate on whether self-testing should be encouraged or rather discouraged is still ongoing. One of the concerns is whether consumers have sufficient knowledge to perform the test and interpret the results. An online decision aid (DA) with information on self-testing in general, and test specific information on cholesterol and diabetes self-testing was developed. The DA aims to provide objective information on these self-tests as well as a decision support tool to weigh the pros and cons of self-testing. The aim of this study is to evaluate the effect of the online decision aid on knowledge on self-testing, informed choice, ambivalence and psychosocial determinants. Methods/Design A single blind randomised controlled trial in which the online decision aid 'zelftestwijzer' is compared to short, non-interactive information on self-testing in general. The entire trial will be conducted online. Participants will be selected from an existing Internet panel. Consumers who are considering doing a cholesterol or diabetes self-test in the future will be included. Outcome measures will be assessed directly after participants have viewed either the DA or the control condition. Weblog files will be used to record participants' use of the decision aid. Discussion Self-testing does have important pros and cons, and it is important that consumers base their decision whether they want to do a self-test or not on knowledge and personal values. This study is the first to evaluate the effect of an online decision aid for self-testing. Trial registration Dutch Trial Register: NTR3149 PMID:22216905

  18. Low-intensity case management increases contact with primary care in recently released prisoners: a single-blinded, multisite, randomised controlled trial

    PubMed Central

    Alati, Rosa; Longo, Marie; Spittal, Matthew J; Boyle, Frances M; Williams, Gail M; Lennox, Nicholas G

    2016-01-01

    Background The world prison population is large and growing. Poor health outcomes after release from prison are common, but few programmes to improve health outcomes for ex-prisoners have been rigorously evaluated. The aim of this study was to evaluate the impact of individualised case management on contact with health services during the first 6 months post-release. Methods Single-blinded, randomised, controlled trial. Baseline assessment with N=1325 adult prisoners in Queensland, Australia, within 6 weeks of expected release; follow-up interviews 1, 3 and 6 months post-release. The intervention consisted of provision of a personalised booklet (‘Passport’) at the time of release, plus up to four brief telephone contacts in the first 4 weeks post-release. Results Of 1179 eligible participants, 1003 (85%) completed ≥1 follow-up interview. In intention-to-treat analyses, 53% of the intervention group and 41% of the control group reported contacting a general practitioner (GP) at 1 month post-release (difference=12%, 95% CI 5% to 19%). Similar effects were observed for GP contact at 3 months (difference=9%, 95% CI 2% to 16%) and 6 months (difference=8%, 95% CI 1% to 15%), and for mental health (MH) service contact at 6 months post release (difference=8%, 95% CI 3% to 14%). Conclusions Individualised case management in the month after release from prison increases usage of primary care and MH services in adult ex-prisoners for at least 6 months post-release. Given the poor health profile of ex-prisoners, there remains an urgent need to develop and rigorously evaluate interventions to increase health service contact in this profoundly marginalised population. Trial registration number ACTRN12608000232336. PMID:26787201

  19. Comparison of Pap Smear Quality With Anatomical Spatula Method and the Common Method (Spatula-Cytobrush): A Single Blind Clinical Trial

    PubMed Central

    Soleimani, M; Abdali, Kh; Khajehei, M; Tabatabaee, HR; Komar, PV; Riaz Montazer, N

    2012-01-01

    Background Cervical cancer is the third most common cancer in women in the world. Papanicolaou smear is known as a standard test for cervical cancer screening; however, the most important challenge is high rates of false negative results. The aim of this study was to compare the quality of smears obtained by anatomical spatula and spatula-cytobrush. The most important factor in false negative result is inappropriate tool of sampling. Methods One hundred married women participated in this single blind clinical trial. All participants were interviewed; two samples were obtained from every participant: one with spatula-cytobrush and another one with anatomical spatula. All slides were encoded and were assessed by two pathologists. Then, data were analyzed by means of kappa coefficient. Results Cell adequacy was 96.1 % in anatomical spatula method and 91.2 % in spatula-cytobrush method (p= 0.016). The rates for endocervical cells and metaplasia cells in anatomical spatula method were 70.6% and 24.5% respectively and these amounts were 69.6% and 24.5% respectively in the spatula-cytobrush method (p <0.001). No one reported any pain and the amount of bleeding was 38.2% in both methods (P>0.05). Regarding infection and inflammatory reactions there was no statistically significant difference between two methods (p>0.05). Conclusion Based on our findings in this study, results of sampling with anatomical spatula method were more acceptable and better than those with spatula-cytobrush sampling. PMID:25780537

  20. 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

  1. 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. PMID:25805886

  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. Oral L-Arginine Administration Improves Anthropometric and Biochemical Indices Associated With Cardiovascular Diseases in Obese Patients: A Randomized, Single Blind Placebo Controlled Clinical Trial

    PubMed Central

    Dashtabi, Arash; Mazloom, Zohreh; Fararouei, Mohammad; Hejazi, Najmeh

    2015-01-01

    Background: Recently, the potential of L-arginine supplementation as a novel and effective strategy for weight loss and improving biochemical parameters in obese patients has been under consideration. Objectives: To evaluate the influence of 8-week oral L-arginine supplementation on body mass index (BMI), waist circumference (WC), triceps skinfold (TS), subscapular skinfold (SS), systolic blood pressure (SBP), diastolic blood pressure (DBP), plasma fasting blood sugar (FBS), glycated hemoglobin (HbA1c), triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and malondialdehyde (MDA) in patients with BMI values > 29.9 or visceral obesity (WC > 102 cm in men or > 88 cm in women). Patients and Methods: Ninety obese patients were included in a single-blind randomized controlled trial. Patients were randomized to receive either L-arginine (3 or 6 g thrice daily) or placebo for 8 weeks. Anthropometric and biochemical indices, dietary intake, and blood pressure values were measured at the baseline and after the 8-week intervention. Results: Significant decreases in anthropometric parameters, blood pressure (SBP, DBP), FBS, HbA1c, LDL, MDA (P < 0.001), TG (P = 0.02), and TC (P = 0.002) and a significant increase in HDL (P < 0.001) were observed in the intervention group, compared to the control group. In the control group, no significant differences were found between the baseline and end-of-intervention measurements. Conclusions: In conclusion, oral L-Arginine supplementation appears to improve anthropometric parameters, blood pressure values, and some blood biochemical indices associated with cardiovascular disease prevention. PMID:26889456

  4. Traditional Chinese medicine versus western medicine as used in China in the management of rheumatoid arthritis: a randomized, single-blind, 24-week study.

    PubMed

    He, Yi-Ting; Ou, Ai-Hua; Yang, Xiao-Bo; Chen, Wei; Fu, Li-Yuan; Lu, Ai-Ping; Yan, Xiao-Ping; Feng, Xing-Hua; Su, Li; Song, Yue-Jin; Zeng, Sheng-Ping; Liu, Wei; Qian, Xian; Zhu, Wan-Hua; Lao, Ying-Rong; Xu, Wei-Hua; Wen, Ze-Huai; He, Xiao-Hong; Wang, Bao-Juan; Chen, Geng-Xin; Xue, Su-Qin

    2014-12-01

    This study is designed to compare the efficacy and safety of traditional Chinese medicine (TCM) with western medicine (WM) in the management of rheumatoid arthritis (RA). This is a 24-week, randomized, multicenter, single-blind study comparing TCM with WM (as used in China) carried out between June 2002 and December 2004 in nine research centers in China, involving 489 patients. Patients were randomized to receive TCM (n = 247), MTX and SSZ (n = 242). MTX was started at a dose of 5 mg to a final dose of 7.5-15 mg weekly. The maintenance dose was 2.5-7.5 mg weekly. The starting dose of SSZ was 0.25 g bid, increasing by 0.25 g a day once a week to a final dose of 0.5-1 g qid. The maintenance dose was 0.5 g tid to qid. Primary end point was the proportion of patients with response according to the American College of Rheumatology 20 % improvement criteria (ACR20) at weeks 24. At 24 weeks, ACR20 responses were 53.0 % in TCM group and 66.5 % in WM group, (P < 0.001) at 24 weeks. ACR 50 responses were 31.6 % of TCM group and 42.6 % in WM group, (P = 0.01). ACR70 responses were 12.6 % in TCM group and 17.4 % in WM group, (P = 0.14). Side effects were observed more frequently in WM group. In this study, ACR20, ACR50 responses at 24 weeks were significantly better in the WM treated group, by intention to treat (ITT) and per protocol analysis. The ACR 70 response showed no significant difference between the two groups. TCM, while effective in treating RA, appears to be less effective than WM in controlling symptoms, but TCM is associated with fewer side effects.

  5. The effect of intranasal oxytocin versus placebo treatment on the autonomic responses to human sounds in autism: a single-blind, randomized, placebo-controlled, crossover design study

    PubMed Central

    2014-01-01

    Background Many individuals with autism spectrum disorders (ASD) have difficulty with verbal communication, which might be due to a lack of spontaneous orientation toward social auditory stimuli. Previous studies have shown that a single dose of oxytocin improves speech comprehension in autism. The primary aim of this study was to investigate whether the orientation behaviors toward human sounds are different for neurotypical (NT) adults and adults with ASD and whether oxytocin has an effect on their orientation behaviors toward human sounds. Methods This was a randomized, placebo-controlled, within-subject, crossover design study of intranasal oxytocin versus placebo in 13 NT adults and 16 adults with ASD. Subjects were randomized to 24 IU intranasal oxytocin or placebo on different days, and they were blind to the treatment. The participants then listened passively to human and non-human affective sounds while their skin conductance responses (SCRs) and the changes in peripheral blood vessel constriction were monitored as an indicator of spontaneous orientation. The monitored data were analyzed by a mixed-design ANOVA. Results Oxytocin enhanced the difference between the SCRs to human and non-human sounds in both the NT and ASD groups (F(1,56) = 6.046, p = 0.017). Further correlation coefficient analysis showed significant correlations between this SCR difference and the scores in the autism spectrum quotient ‘attention to detail’ and ‘social skill’ subscales and interpersonal reactivity index and social functioning scale in the ASD group. Oxytocin was well tolerated, and no serious adverse effects were reported. Conclusions The difference in SCRs implies that oxytocin nasal spray may enhance orientation behaviors toward human sounds in the presence of other environmental sounds in both ASD and NT adults. Trial registration UMIN-CTR Clinical Trial, Unique trial number: UMIN000005809 PMID:24576333

  6. The effect of a single, large bolus of vitamin D in healthy adults over the winter and following year: a randomized, double-blind, placebo-controlled trial

    PubMed Central

    Kearns, MD; Binongo, JNG; Watson, D; Alvarez, JA; Lodin, D; Ziegler, TR; Tangpricha, V

    2014-01-01

    BACKGROUND/OBJECTIVES Although single, high doses of vitamin D effectively maintain vitamin D sufficiency in several populations, no studies have evaluated healthy adults over winter, during which vitamin D status declines. This study investigated whether high-dose vitamin D3 given once to healthy adults before winter will (1) prevent the wintertime decline in vitamin D status, (2) promote vitamin D sufficiency 1 year following the dose and (3) prevent the rise of parathyroid hormone (PTH) concentrations. SUBJECTS/METHODS In this double-blind, placebo-controlled trial, we assessed plasma 25(OH)D and PTH concentrations at baseline, 5, 90 and 365 days after drug administration in 28 healthy adults. In all, >80% of subjects returned at each time point. RESULTS At baseline, the young, healthy participants had a mean plasma 25(OH)D concentration of 17.5 ± 6.1 ng/ml. Only two subjects exhibited plasma 25(OH)D concentrations >30 ng/ml. At 5 days, subjects randomized to vitamin D3 had a higher mean plasma 25(OH)D concentration compared with the placebo group (39.1 vs 19.1 ng/ml, P<0.001). Plasma 25(OH)D concentrations returned to baseline at 90 and 365 days in the vitamin D3 group and remained unchanged in the placebo group. PTH and calcium concentrations were unrelated to changes in 25(OH)D levels and similar between groups over time. CONCLUSIONS A dose of 250 000 IU of vitamin D3 given once in November resulted in a robust increase in plasma 25(OH)D after 5 days, but it was unable to sustain this increase after 90 days. A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency. PMID:25271011

  7. 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.

  8. Video-assisted thoracic surgery reduces early postoperative stress. A single-institutional prospective randomized study

    PubMed Central

    Asteriou, Christos; Lazopoulos, Achilleas; Rallis, Thomas; Gogakos, Apostolos S; Paliouras, Dimitrios; Tsakiridis, Kosmas; Zissimopoulos, Athanasios; Tsavlis, Drosos; Porpodis, Konstantinos; Hohenforst-Schmidt, Wolfgang; Kioumis, Ioannis; Organtzis, John; Zarogoulidis, Konstantinos; Zarogoulidis, Paul; Barbetakis, Nikolaos

    2016-01-01

    Background Video-assisted thoracic surgery (VATS) has been shown to effectively reduce postoperative pain, enhance mobilization of the patients, shorten in-hospital length of stay, and minimize postoperative morbidity rates. The aim of this prospective study is to evaluate neuroendocrine and respiratory parameters as stress markers in cancer patients who underwent lung wedge resections, using both mini muscle-sparing thoracotomy and VATS approach. Methods The patients were randomly allocated into two groups: Group A (n=30) involved patients who were operated on using the VATS approach, while in group B (n=30), the mini muscle-sparing thoracotomy approach was used. Neuroendocrine and biological variables assessed included blood glucose levels, C-reactive protein (CRP) levels, cortisol, epinephrine, and adrenocorticotropic hormone (ACTH) levels. Arterial oxygen (PaO2) and carbon dioxide (PaCO2) partial pressure were also evaluated. All parameters were measured at the following time points: 24 hours preoperatively (T1), 4 hours (T2), 24 hours (T3), 48 hours (T4), and 72 hours (T5), after the procedure. Results PaO2 levels were significantly higher 4 and 24 hours postoperatively in group A vs group B, respectively (T2: 94.3 vs 77.9 mmHg, P=0.015, T3: 96.4 vs 88.7 mmHg, P=0.034). Blood glucose (T2: 148 vs 163 mg/dL, P=0.045, T3: 133 vs 159 mg/dL, P=0.009) and CRP values (T2: 1.6 vs 2.5 mg/dL, P=0.024, T3: 1.5 vs 2.1 mg/dL, P=0.044) were found increased in both groups 4 and 24 hours after the procedure. However, their levels were significantly lower in the VATS group of patients. ACTH and cortisol values were elevated immediately after the operation and became normal after 48 hours in both groups, without significant difference. Postoperative epinephrine levels measured in group A vs group B, respectively, (T2: 78.9 vs 115.6 ng/L, P=0.007, T3: 83.4 vs 122.5 ng/L, P=0.012, T4: 67.4 vs 102.6 ng/L, P=0.021). The levels were significantly higher in group B. Conclusion This

  9. Carbamazepine as a single drug in the treatment of epilepsy. A prospective study of serum levels and seizure control.

    PubMed Central

    Callaghan, N; O'Callaghan, M; Duggan, B; Feely, M

    1978-01-01

    Serum levels and seizure control were investigated in a prospective study when carbamazepine was given as a single drug to 32 patients with a variety of seizures. The patients included 13 previously untreated patients (group 1), and 19 who were unresponsive to other anticonvulsant drugs used in different combinations or as a single treatment (group 2). Thirteen patients (10 from group 1, and three from group 2) became seizure-free, and a greater than 50% reduction in seizure frequency occurred in 10 patients (nine from group 2, and one from group 1). Less than 50% reduction in seizure frequency occurred in five patients from group 2. As a wide range of serum levels was associated with complete freedom from seizures, or a greater than 50% reduction in seizure frequency, it was not possible to define a therapeutic range for carbamazepine. Side effects occurred at the start of treatment or after a dose increase. A wide range of serum levels was associated with side effects, and some patients could not tolerate levels greater than 42 mumol/l. PMID:731240

  10. Colour blindness.

    PubMed

    Gordon, N

    1998-03-01

    The physiology of colour vision is discussed; as is the way in which the human eye can detect various combinations of red, green and blue. Red-green colour blindness, with X-linked inheritance, is the most common, but other types are also considered. Methods of testing relating to the age of the child are reviewed. The use of colours in teaching is widespread, but there is controversy over the difficulties this may cause a colour blind child. A review of the literature does not reveal much information on this, and any problems that do arise are likely to be individual to the child, and to depend on such factors as overall intelligence, the attitude of the teacher, and the personality of the child. There is not doubt that it is essential to recognise colour vision defects when it comes to choosing a career, and that tests must be done during secondary schooling, but in order to avoid some affected children being disadvantaged there is enough evidence to support testing at school entry.

  11. 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

  12. 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

  13. The Cherenkov Telescope Array single-mirror small size telescope project: status and prospects

    NASA Astrophysics Data System (ADS)

    Aguilar, J. A.; Bilnik, W.; Bogacz, L.; Bulik, T.; Christov, A.; della Volpe, D.; Dyrda, M.; Frankowski, A.; Grudzińska, M.; Grygorczuk, J.; Heller, M.; Idźkowski, B.; Janiak, M.; Jamrozy, M.; Karczewski, M.; Kasperek, J.; Lyard, E.; Marszalek, A.; Michalowski, J.; Rameez, M.; Moderski, R.; Montaruli, T.; Neronov, A.; Nicolau-Kukliński, J.; Niemiec, J.; Ostrowski, M.; Paśko, P.; Płatos, Ł.; Prandini, E.; Rafalski, J.; Rajda, P. J.; Rataj, M.; Rupiński, M.; Rutkowskai, K.; Seweryn, K.; Sidz, M.; Stawarz, Ł.; Stodulska, M.; Stodulski, M.; Tokarz, M.; Toscano, S.; Troyano Pujadas, I.; Walter, R.; Wawer, P.; Wawrzaszek, R.; Wiśniewski, L.; Winiarski, K.; Zietara, K.; Ziółkowski, P.; Źychowski, P.

    2014-07-01

    The Cherenkov Telescope Array (CTA), the next generation very high energy gamma-ray observatory, will consist of three types of telescopes: large (LST), medium (MST) and small (SST) size telescopes. The small size telescopes are dedicated to the observation of gamma-rays with energy between a few TeV and few hundreds of TeV. The single-mirror small size telescope (SST-1M) is one of several SST designs. It will be equipped with a 4 m-diameter segmented mirror dish and a fully digital camera based on Geiger-mode avalanche photodiodes. Currently, the first prototype of the mechanical structure is under assembly in Poland. In 2014 it will be equipped with 18 mirror facets and a prototype of the camera.

  14. 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

  15. 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. PMID:16706918

  16. Lack of efficacy of an intradural somatic-to-autonomic nerve anastomosis (Xiao procedure) for bladder control in children with myelomeningocele and lipomyelomeningocele: results of a prospective, randomized, double-blind study.

    PubMed

    Tuite, Gerald F; Polsky, Ethan G; Homsy, Yves; Reilly, Margaret A; Carey, Carolyn M; Parrish Winesett, S; Rodriguez, Luis F; Storrs, Bruce B; Gaskill, Sarah J; Tetreault, Lisa L; Martinez, Denise G; Amankwah, Ernest K

    2016-08-01

    OBJECTIVE Xiao et al. and other investigators have studied an intradural somatic-to-autonomic (e.g., L-5 to S3-4) nerve transfer as a method to create a reflex arc to allow bladder emptying in response to cutaneous stimulation (the Xiao procedure). In previous clinical studies of patients with spinal dysraphism who underwent the Xiao procedure, high success rates (70%-85%) were reported for the establishment of a "skin-CNS-bladder" reflex arc that allows spontaneous, controlled voiding in children with neurogenic bladder dysfunction. However, many of these studies did not use blinded observers, did not have control groups, and/or featured only limited follow-up durations. METHODS A randomized, prospective, double-blind trial was initiated in March 2009, enrolling children with myelomeningocele (MM), lipomyelomeningocele (LMM), and neurogenic bladder dysfunction who were scheduled for spinal cord detethering (DT) for the usual indications. At the time of DT, patients were randomized between 2 arms of the study: half of the patients underwent a standard spinal cord DT procedure alone (DT group) and half underwent DT as well as the Xiao procedure (DT+X group). Patients, families, and study investigators, all of whom were blinded to the surgical details, analyzed the patients' strength, sensory function, mobility, voiding, and urodynamic bladder function before surgery and at regular intervals during the 3-year follow-up. RESULTS Twenty patients were enrolled in the study: 10 underwent only DT and the other 10 underwent DT+X. The addition of the Xiao procedure to spinal cord DT resulted in longer operative times (p = 0.024) and a greater chance of wound infection (p = 0.03). Patients in both treatment arms could intermittently void or dribble small amounts of urine (< 20% total bladder capacity) in response to scratching in dermatomes T-9 through S-2 using a standardized protocol, but the voiding was not reproducible and the volume voided was not clinically useful in

  17. Lack of efficacy of an intradural somatic-to-autonomic nerve anastomosis (Xiao procedure) for bladder control in children with myelomeningocele and lipomyelomeningocele: results of a prospective, randomized, double-blind study.

    PubMed

    Tuite, Gerald F; Polsky, Ethan G; Homsy, Yves; Reilly, Margaret A; Carey, Carolyn M; Parrish Winesett, S; Rodriguez, Luis F; Storrs, Bruce B; Gaskill, Sarah J; Tetreault, Lisa L; Martinez, Denise G; Amankwah, Ernest K

    2016-08-01

    OBJECTIVE Xiao et al. and other investigators have studied an intradural somatic-to-autonomic (e.g., L-5 to S3-4) nerve transfer as a method to create a reflex arc to allow bladder emptying in response to cutaneous stimulation (the Xiao procedure). In previous clinical studies of patients with spinal dysraphism who underwent the Xiao procedure, high success rates (70%-85%) were reported for the establishment of a "skin-CNS-bladder" reflex arc that allows spontaneous, controlled voiding in children with neurogenic bladder dysfunction. However, many of these studies did not use blinded observers, did not have control groups, and/or featured only limited follow-up durations. METHODS A randomized, prospective, double-blind trial was initiated in March 2009, enrolling children with myelomeningocele (MM), lipomyelomeningocele (LMM), and neurogenic bladder dysfunction who were scheduled for spinal cord detethering (DT) for the usual indications. At the time of DT, patients were randomized between 2 arms of the study: half of the patients underwent a standard spinal cord DT procedure alone (DT group) and half underwent DT as well as the Xiao procedure (DT+X group). Patients, families, and study investigators, all of whom were blinded to the surgical details, analyzed the patients' strength, sensory function, mobility, voiding, and urodynamic bladder function before surgery and at regular intervals during the 3-year follow-up. RESULTS Twenty patients were enrolled in the study: 10 underwent only DT and the other 10 underwent DT+X. The addition of the Xiao procedure to spinal cord DT resulted in longer operative times (p = 0.024) and a greater chance of wound infection (p = 0.03). Patients in both treatment arms could intermittently void or dribble small amounts of urine (< 20% total bladder capacity) in response to scratching in dermatomes T-9 through S-2 using a standardized protocol, but the voiding was not reproducible and the volume voided was not clinically useful in

  18. Bioequivalence of acenocoumarol in chilean volunteers: an open, randomized, double-blind, single-dose, 2-period, and 2-sequence crossover study for 2 oral formulations.

    PubMed

    Sasso, J; Carmona, P; Quiñones, L; Ortiz, M; Tamayo, E; Varela, N; Cáceres, D; Saavedra, I

    2012-08-01

    The aim of this study was to compare the bioavailability of an oral formulation of the coumarin derivative-vitamine K antagonist acenocoumarol (Acebron™ 4 mg, Test) with the reference formulation (Neo-Sintrom™ 4 mg). We performed a single-dose, double-blind, fasting, 2-period, 2-sequence, crossover study design. Plasma concentrations of acenocoumarol were determined using a validated UPLC-MS/MS method. 24 healthy Chilean volunteers (11 male, 13 female) were enrolled and all of them completed the study. Adverse events were monitored throughout the study. The values of the pharmacokinetic parameters were (mean ± SD): AUC0-24 =1 364.38±499.26 ngxh/mL for the test and 1 328.39±429.20 ngxh/mL for the reference; AUC0-∞ =1 786.00±732.85 ngxh/mL for the test and 1 706.71±599.66 ngxh/mL for the reference; Cmax =180.69±35.11 ng/mL with a Tmax of 1.83±0.95 h for the test and 186.97±38.21 ng/mL with a Tmax of 2.19±0.83 h for the reference. Regarding half life measurements, the mean ± SD of t1/2 were 11.84±4.54 h for the test and 11.08±3.28 h for the reference. The 90% confidence intervals for the test/reference ratio using logarithmic transformed data were 97.89-100.87%, 98.62-101.99% and 98.64-102.38% for Cmax, AUC0-t(24) and AUC0-∞. There were no significant differences in pharmacokinetic parameters between groups.The results obtained in this study lead us to conclude, based on FDA criteria, that the test acenocoumarol formulation (Acebron™, 4 mg tablets) is bioequivalent to the reference product (Neo-Sintrom™, 4 mg tablets). PMID:22773430

  19. 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

  20. The Effect of G-ORS Along With Rice Soup in the Treatment of Acute Diarrhea in Children: A Single-Blind Randomized Controlled Trial

    PubMed Central

    Kianmehr, Mojtaba; Saber, Ashraf; Moshari, Jalil; Ahmadi, Reza; Basiri-moghadam, Mahdi

    2016-01-01

    Background The world health organization guidelines for treatment of diarrhea in children emphasize on continued feeding together with prescription of oral rehydration solution (ORS) and supplementary zinc therapy. However, conflicting viewpoints exist regarding the optimal diet and dietary ingredients for children with diarrhea. Moreover, few studies have investigated the effect of rice soup along with ORS in the treatment of this disease. Objectives This study aimed to explore effects of simultaneous taking of glucose oral rehydration solution (G-ORS) and rice soup in the treatment of acute diarrhea in 8 to 24-month-old children. Patients and Methods This single-blind controlled clinical trial was conducted in the pediatric ward of 22nd of Bahman hospital, Gonabad, Iran between June 2013 and February 2014. Forty children aged 8-24 months with acute diarrhea were randomly assigned into an intervention group (G-ORS plus rice soup group) comprising 20 babies and a control group (G-ORS) of 20 children based on balanced blocking randomization. The variables under investigation were diarrhea duration, patient hospitalization, need for intravenous (IV) fluids and stool output frequency. Data was analyzed using independent samples t and chi-square test. Results At the end of study, the time for treating acute watery diarrhea in the intervention and control groups were 21.10 ± 8.81 and 34.55 ± 5.82 hours (P < 0.001) and hospital stay were 34.05 ± 6.62 and 40.20 ± 6.32 hours (P = 0.005). Moreover, stool output frequency were 4.20 ± 0.95 and 8.00 ± 1.37 (P < 0.001) in the first 24 hours, and 2.18 ± 0.60 and 2.80 ± 0.76 (P = 0.03) in the second 24 hours of treatment in intervention and control groups, respectively. Conclusions Rice soup regimen was highly effective and inexpensive in the treatment of acute diarrhea in children. Thus, in addition to the common treatment by G-ORS, rice soup can be consumed simultaneously with G-ORS. PMID:27556051

  1. Single-blinded, randomised preliminary study evaluating the effects of 2 Hz electroacupuncture for postoperative pain in patients with total knee arthroplasty

    PubMed Central

    Tzeng, Chung-Yuh; Chang, Shih-Liang; Wu, Chih-Cheng; Chang, Chu-Ling; Chen, Wen-Gii; Tong, Kwok-Man; Huang, Kui-Chou; Hsieh, Ching-Liang

    2015-01-01

    Objective To explore the point-specific clinical effect of 2 Hz electroacupuncture (EA) in treating postoperative pain in patients undergoing total knee arthroplasty (TKA), Methods In a randomised, partially single-blinded preliminary study, 47patients with TKA were randomly divided into three groups: control group (CG, n=17) using only patient-controlled analgesia (PCA); EA group (EAG, n=16) with 2 Hz EA applied at ST36 (Zusanli) and GB34 (Yanglingquan) contralateral to the operated leg for 30 min on the first two postoperative days, also receiving PCA; and non-point group (NPG, n=14), with EA identical to the EAG except given 1 cm lateral to both ST36 and GB34. The Mann–Whitney test was used to show the difference between two groups and the Kruskal–Wallis test to show the difference between the three groups. Results The time until patients first required PCA in the CG was 34.1±22.0 min, which was significantly shorter than the 92.0±82.7 min in the EAG (p<0.001) and 90.7±94.8 min in the NPG (p<0.001); there was no difference between the EAG and NPG groups (p>0.05). The total dosage of PCA solution given was 4.6±0.9 mL/kg body weight in the CG, 4.2±1.0 mL/kg in the EAG and 4.5±1.0 mL/kg in the NPG; there were no significant differences (p>0.05) among the three groups. Conclusions In this small preliminary study, EA retarded the first demand for PCA in comparison with no EA. No effect was seen on the total dosage of PCA required and no point-specific effect was seen. PMID:25910930

  2. Antidepressant Efficacy of Adjunctive Aerobic Activity and Associated Biomarkers in Major Depression: A 4-Week, Randomized, Single-Blind, Controlled Clinical Trial

    PubMed Central

    Siqueira, Cristiana Carvalho; Valiengo, Leandro L.; Carvalho, André F.; Santos-Silva, Paulo Roberto; Missio, Giovani; de Sousa, Rafael T.; Di Natale, Georgia; Gattaz, Wagner F.; Moreno, Ricardo Alberto; Machado-Vieira, Rodrigo

    2016-01-01

    Background Major depressive disorder (MDD) is a highly prevalent, heterogeneous and systemic medical condition. Treatment options are limited, and recent studies have suggested that physical exercise can play an important role in the therapeutics of MDD. The aim of this study was to evaluate the antidepressant efficacy of adjunctive aerobic activity in association with pharmacotherapy (selective serotonin reuptake inhibitor) in symptomatic MDD as well as its association with physiological biomarkers. Methods In this randomized, single-blind, add-on, controlled clinical trial, 57 patients (18–55 years of age) were followed-up for 28 days. All patients were drug-free, had been diagnosed with symptomatic MDD and received flexible dose of sertraline during the trial. Patients were randomized to either a 4-week program (4x/week) of add-on aerobic exercise (exercise group, N = 29) or no activity (control group, N = 28). Depression severity was assessed using the Hamilton Rating Scale for Depression (HAM-D) as the primary outcome. At baseline and endpoint, all patients underwent a comprehensive metabolic/cardiopulmonary exercise testing—including determination of maximal oxygen uptake (VO2max), VO2 at the second ventilatory threshold (VO2-VT2), and oxygen pulse (O2 pulse). Results Depression scores significantly decreased in both groups after intervention. Importantly, patients in the aerobic exercise group required lower sertraline dose compared to the control group (sertraline monotherapy). The VO2max and O2 pulse parameters increased over time only in the exercise group and remained unchanged in the control group. Conclusions The present findings suggest that a 4-week training of aerobic exercise significantly improves functional capacity in patients with MDD and may be associated with antidepressant efficacy. This approach may also decrease the need for higher doses of antidepressants to achieve response. Further studies in unmedicated and treatment-resistant MDD

  3. 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

  4. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial.

    PubMed

    Kim, Myoung Hwa; Lee, Ki Young; Lee, Kang-Young; Min, Byung-Soh; Yoo, Young Chul

    2016-03-01

    Carbon dioxide (CO2) absorption and increased intra-abdominal pressure can adversely affect perioperative physiology and postoperative recovery. Deep muscle relaxation is known to improve the surgical conditions during laparoscopic surgery. We aimed to compare the effects of deep and moderate neuromuscular block in laparoscopic colorectal surgery, including intra-abdominal pressure. In this prospective, double-blind, parallel-group trial, 72 adult patients undergoing laparoscopic colorectal surgery were randomized using an online randomization generator to achieve either moderate (1-2 train-of-four response, n = 36) or deep (1-2 post-tetanic count, n = 36) neuromuscular block by receiving a continuous infusion of rocuronium. Adjusted intra-abdominal pressure, which was titrated by a surgeon with maintaining the operative field during pneumoperitoneum, was recorded at 5-minute intervals. Perioperative hemodynamic parameters and postoperative outcomes were assessed. Six patients from the deep and 5 from the moderate neuromuscular block group were excluded, leaving 61 for analysis. The average adjusted IAP was lower in the deep compared to the moderate neuromuscular block group (9.3 vs 12 mm Hg, P < 0.001). The postoperative pain scores (P < 0.001) and incidence of postoperative shoulder tip pain were lower, whereas gas passing time (P = 0.002) and sips of water time (P = 0.005) were shorter in the deep neuromuscular block than in the moderate neuromuscular block group. Deep neuromuscular blocking showed several benefits compared to conventional moderate neuromuscular block, including a greater intra-abdominal pressure lowering effect, whereas surgical conditions are maintained, less severe postoperative pain and faster bowel function recovery. PMID:26945393

  5. Safety and Efficacy of Botulinum Toxin to Preserve Gland Function after Radiotherapy in Patients with Head and Neck Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Phase I Clinical Trial.

    PubMed

    Teymoortash, Afshin; Pfestroff, Andreas; Wittig, Andrea; Franke, Nora; Hoch, Stephan; Harnisch, Susanne; Schade-Brittinger, Carmen; Hoeffken, Helmut; Engenhart-Cabillic, Rita; Brugger, Markus; Strauch, Konstantin

    2016-01-01

    This prospective, randomized, placebo-controlled, double-blinded phase I clinical trial investigates safety and efficacy of botulinum toxin (BoNT) to preserve gland function after radiotherapy in patients with head and neck cancer. Twelve patients with advanced head and neck cancer were injected with BoNT into the submandibular glands prior to primary radiochemotherapy. Six patients received BoNT/A and 6 patients BoNT/A and B, half of each subgroup into their left and the other half into their right gland. As an internal control, sodium chloride was injected into the respective contralateral gland (placebo). For the evaluation of the salivary gland function, technetium pertechnetate salivary gland scintigraphy was performed before and after the end of radiotherapy. BoNT/A and B were well tolerated. Analysis of the scintigraphic data revealed no statistically significant difference between BoNT and placebo regarding the scintigraphic uptake difference (pBoNT/A = 0.84 and pBoNT/A-B = 0.56 for BoNT/A vs. placebo and BoNT/A-B vs. placebo, respectively). We also found no significant difference in treatment between BoNT and placebo in terms of salivary excretion fraction (pBoNT/A = 0.44; pBoNT/A-B = 0.44). This study demonstrates that BoNT can be safely combined with radiochemotherapy. Dosing and timing of BoNT injection should be further investigated for efficacy analysis. Trial Registration German Registry for Clinical Trails DRKS00004595.

  6. 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

  7. Safety and Efficacy of Botulinum Toxin to Preserve Gland Function after Radiotherapy in Patients with Head and Neck Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Phase I Clinical Trial

    PubMed Central

    Teymoortash, Afshin; Pfestroff, Andreas; Wittig, Andrea; Franke, Nora; Hoch, Stephan; Harnisch, Susanne; Schade-Brittinger, Carmen; Hoeffken, Helmut; Engenhart-Cabillic, Rita; Brugger, Markus; Strauch, Konstantin

    2016-01-01

    This prospective, randomized, placebo-controlled, double-blinded phase I clinical trial investigates safety and efficacy of botulinum toxin (BoNT) to preserve gland function after radiotherapy in patients with head and neck cancer. Twelve patients with advanced head and neck cancer were injected with BoNT into the submandibular glands prior to primary radiochemotherapy. Six patients received BoNT/A and 6 patients BoNT/A and B, half of each subgroup into their left and the other half into their right gland. As an internal control, sodium chloride was injected into the respective contralateral gland (placebo). For the evaluation of the salivary gland function, technetium pertechnetate salivary gland scintigraphy was performed before and after the end of radiotherapy. BoNT/A and B were well tolerated. Analysis of the scintigraphic data revealed no statistically significant difference between BoNT and placebo regarding the scintigraphic uptake difference (pBoNT/A = 0.84 and pBoNT/A-B = 0.56 for BoNT/A vs. placebo and BoNT/A-B vs. placebo, respectively). We also found no significant difference in treatment between BoNT and placebo in terms of salivary excretion fraction (pBoNT/A = 0.44; pBoNT/A-B = 0.44). This study demonstrates that BoNT can be safely combined with radiochemotherapy. Dosing and timing of BoNT injection should be further investigated for efficacy analysis. Trial Registration German Registry for Clinical Trails DRKS00004595 PMID:26991494

  8. 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

  9. The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749)

    PubMed Central

    2013-01-01

    Background Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. Methods/Design A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubine ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. Discussion A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. Trial Registration German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749. PMID:23356494

  10. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial.

    PubMed

    Kim, Myoung Hwa; Lee, Ki Young; Lee, Kang-Young; Min, Byung-Soh; Yoo, Young Chul

    2016-03-01

    Carbon dioxide (CO2) absorption and increased intra-abdominal pressure can adversely affect perioperative physiology and postoperative recovery. Deep muscle relaxation is known to improve the surgical conditions during laparoscopic surgery. We aimed to compare the effects of deep and moderate neuromuscular block in laparoscopic colorectal surgery, including intra-abdominal pressure. In this prospective, double-blind, parallel-group trial, 72 adult patients undergoing laparoscopic colorectal surgery were randomized using an online randomization generator to achieve either moderate (1-2 train-of-four response, n = 36) or deep (1-2 post-tetanic count, n = 36) neuromuscular block by receiving a continuous infusion of rocuronium. Adjusted intra-abdominal pressure, which was titrated by a surgeon with maintaining the operative field during pneumoperitoneum, was recorded at 5-minute intervals. Perioperative hemodynamic parameters and postoperative outcomes were assessed. Six patients from the deep and 5 from the moderate neuromuscular block group were excluded, leaving 61 for analysis. The average adjusted IAP was lower in the deep compared to the moderate neuromuscular block group (9.3 vs 12 mm Hg, P < 0.001). The postoperative pain scores (P < 0.001) and incidence of postoperative shoulder tip pain were lower, whereas gas passing time (P = 0.002) and sips of water time (P = 0.005) were shorter in the deep neuromuscular block than in the moderate neuromuscular block group. Deep neuromuscular blocking showed several benefits compared to conventional moderate neuromuscular block, including a greater intra-abdominal pressure lowering effect, whereas surgical conditions are maintained, less severe postoperative pain and faster bowel function recovery.

  11. Effects of dabigatran on the cellular and protein phase of coagulation in patients with coronary artery disease on dual antiplatelet therapy with aspirin and clopidogrel. Results from a prospective, randomised, double-blind, placebo-controlled study.

    PubMed

    Franchi, Francesco; Rollini, Fabiana; Cho, Jung Rae; King, Rhodri; Phoenix, Fladia; Bhatti, Mona; DeGroat, Christopher; Tello-Montoliu, Antonio; Zenni, Martin M; Guzman, Luis A; Bass, Theodore A; Ajjan, Ramzi A; Angiolillo, Dominick J

    2016-03-01

    There is growing interest in understanding the effects of adding an oral anticoagulant in patients on dual antiplatelet therapy (DAPT). Vitamin K antagonists (VKAs) and clopidogrel represent the most broadly utilised oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, VKAs can interfere with clopidogrel metabolism via the cytochrome P450 (CYP) system which in turn may result in an increase in platelet reactivity. Dabigatran is a direct acting (anti-II) oral anticoagulant which does not interfere with CYP and has favourable safety and efficacy profiles compared with VKAs. The pharmacodynamic (PD) effects on platelet reactivity and clot kinetic of adjunctive dabigatran therapy in patients on DAPT are poorly explored. In this prospective, randomised, double-blind, placebo-controlled PD study, patients (n=30) on maintenance DAPT with aspirin and clopidogrel were randomised to either dabigatran 150 mg bid or placebo for seven days. PD testing was performed before and after treatment using four different assays exploring multiple pathways of platelet aggregation and fibrin clot kinetics: light transmittance aggregometry (LTA), multiple electrode aggregometry (MEA), kaolin-activated thromboelastography (TEG) and turbidimetric assays. There were no differences in multiple measures of platelet reactivity investigating purinergic and non-purinergic signaling pathways assessed by LTA, MEA and TEG platelet mapping. Dabigatran significantly increased parameters related to thrombin activity and thrombus generation, and delayed fibrin clot formation, without affecting clot structure or fibrinolysis. In conclusion, in patients on DAPT with aspirin and clopidogrel, adjunctive dabigatran therapy is not associated with modulation of profiles of platelet reactivity as determined by several assays assessing multiple platelet signalling pathways. However, dabigatran significantly interferes with parameters related to thrombin activity and delays fibrin clot formation

  12. Stochastic blind motion deblurring.

    PubMed

    Xiao, Lei; Gregson, James; Heide, Felix; Heidrich, Wolfgang

    2015-10-01

    Blind motion deblurring from a single image is a highly under-constrained problem with many degenerate solutions. A good approximation of the intrinsic image can, therefore, only be obtained with the help of prior information in the form of (often nonconvex) regularization terms for both the intrinsic image and the kernel. While the best choice of image priors is still a topic of ongoing investigation, this research is made more complicated by the fact that historically each new prior requires the development of a custom optimization method. In this paper, we develop a stochastic optimization method for blind deconvolution. Since this stochastic solver does not require the explicit computation of the gradient of the objective function and uses only efficient local evaluation of the objective, new priors can be implemented and tested very quickly. We demonstrate that this framework, in combination with different image priors produces results with Peak Signal-to-Noise Ratio (PSNR) values that match or exceed the results obtained by much more complex state-of-the-art blind motion deblurring algorithms. PMID:25974941

  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. Is there any Exciton (bottleneck) in an Excitonic Solar Cell: Revisiting the Prospects of Single-Semiconductor OPV

    NASA Astrophysics Data System (ADS)

    Alam, Muhammad

    2014-03-01

    The discovery dye sensitized and bulk heterojunction (BHJ) solar cells in early 1990s introduced a new class of PV technology that rely on (i) distributed photogeneration of excitons, (ii) dissociation of excitons into free carriers by the heterojunction between two organic semiconductors (OSC), and (iii) collection of free carriers through electron and hole transport layers. The success of the approach is undisputed: the highest efficiency OPV cells have all relied on variants of BHJ approach. Yet, three concerns related to the use of a pair of OSCs, namely, low Voc, process sensitivity, and reliability, suggest that the technology may never achieve efficiency-variability-reliability metrics comparable to inorganic solar cells. This encourages a reconsideration of the prospects of Single semiconductor OPV (SS-OPV), a system presumably doomed by the exciton bottleneck. In this talk, we use an inverted SS-OPV to demonstrate how the historical SS-OPV experiments may have been misinterpreted. No one disputes the signature of excitons in polymer under narrowband excitation, but our experiments show that exciton dissociation need not be a bottleneck for OPV under broadband solar illumination. We demonstrate that an alternate collection-limited theory consistently interprets the classical and new experiments, resolves puzzles such as efficiency loss with increasing light intensity, and voltage-dependent reverse photo-current, etc. The theory and experiments suggest a new ``perovskite-like'' strategy to efficiency-variability-reliability of organic solar cells. The work was supported by the Columbia DOE-EFRC (DE-SC0001085) and NSF-NCN (EEC-0228390).

  15. A single-blinded, single-centre, controlled study in healthy adult smokers to identify the effects of a reduced toxicant prototype cigarette on biomarkers of exposure and of biological effect versus commercial cigarettes

    PubMed Central

    2013-01-01

    Background Despite universal acceptance that smoking is harmful, a substantial number of adults continue to smoke. The development of potential reduced exposure products (more recently termed modified risk tobacco products) has been suggested as a way to reduce the risks of tobacco smoking. This trial is designed to investigate whether changes in toxicant exposure after switching from a commercial to reduced toxicant prototype (RTP) cigarette (7 mg International Organisation for Standardisation (ISO) tar yield) can be assessed by measurement of biomarkers and other factors. The primary objective is to descriptively assess changes in selected biomarkers of exposure (BoE) and biomarkers of biological effect (BoBE) within participants and within and between groups after switching. Secondary objectives are to assess similarly changes in other biomarkers, quality of life, smoking behaviours, physiological measures, mouth-level exposure to toxicants and sensory perception. Methods/design This trial will assess current smokers, ex-smokers and never-smokers in a single-centre single-blind, controlled clinical trial with a forced-switching design and in-clinic (residential) and ambulatory (non-residential) periods. Smokers will be aged 23–55 years (minimum legal smoking age plus 5 years) and non-smokers 28–55 years (minimum legal smoking age plus 5 years, plus minimum 5 years since last smoked). Smokers will be allowed to smoke freely at all times. We will assess changes in selected BoE and BoBE and effective dose in urine and blood after switching. Creatinine concentrations in serum, creatinine clearance in urine, cotinine concentration in saliva, diaries and collection of spent cigarette filters will be used to assess compliance with the study protocol. Mouth-level exposure to toxins will be assessed by filter analysis. Discussion Data from this study are expected to improve scientific understanding of the effects of RTP cigarettes on BoE and BoBE, and

  16. 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 Central

    Pai, Vikas; Paneerselvam, A; Mukhopadhyay, Satinath; Bhansali, Anil; Kamath, Dinesh; Shankar, V; Gambhire, Dhiraj; 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/m2; 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

  17. A Multicenter, Prospective, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared with Placebo in Type 2 Diabetes Mellitus Patients Having Hypertriglyceridemia Not Controlled with Atorvastatin Therapy (PRESS VI)

    PubMed Central

    Pai, Vikas; Jha, Pramod; Jariwala, Gunjan; Mukhopadhyay, Satinath; Bhansali, Anil; Joshi, Shashank

    2014-01-01

    Abstract Background: Dyslipidemia due to diabetes is characterized by hypertriglyceridemia and reduced levels of high-density lipoprotein cholesterol (HDL-C) and elevated or normal levels of low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM). The objectives of this Phase III study were to evaluate the safety, tolerability, and efficacy of saroglitazar (ZYH1) 2-mg and 4-mg tablets (Lipaglyn™; Zydus Cadila, Ahmedabad, India) compared with placebo in patients with diabetic dyslipidemia who are not controlled with atorvastatin 10 mg therapy. Subjects and Methods: This was a 16-week prospective, multicenter, randomized, double-blind, placebo controlled, three-arm Phase III study in subjects with hypertriglyceridemia (>200 and <500 mg/dL) with T2DM not controlled with atorvastatin 10 mg. The study consisted of a run-in period of 4 weeks of life-style modification followed by 12 weeks of treatment with saroglitazar (2-mg or 4-mg) or placebo tablets. The primary end point was the change in plasma triglyceride level compared with baseline and the placebo arm at the end of Week 12. The secondary exploratory end points were change in lipid profile and fasting plasma glucose at Week 12. In total, 302 subjects were randomized to receive one of the treatments, saroglitazar 2 mg (n=101) or saroglitazar 4 mg (n=99), or matching placebo (n=102). Patients who received study medication and had undergone at least one post baseline efficacy evaluation were included in the efficacy analysis. Results: At Week 12, saroglitazar 2-mg and 4-mg tablets significantly reduced mean plasma triglyceride levels by −45.5±3.03% and −46.7±3.02% (mean±SE), respectively, and the difference was significant (P<0.001) compared with placebo. Saroglitazar 2 mg demonstrated significant decrease in levels of non-HDL-C, very LDL-C, total cholesterol, and fasting plasma glucose. Additionally, saroglitazar 4 mg also significantly reduced LDL-C and apolipoprotein

  18. 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

  19. Nutritional status of elderly patients during recovery from chest infection and the role of nutritional supplementation assessed by a prospective randomized single-blind trial.

    PubMed

    Woo, J; Ho, S C; Mak, Y T; Law, L K; Cheung, A

    1994-01-01

    We examined changes in the nutritional status of elderly patients with chest infection for a period of 3 months after discharge from hospital, including the effects of nutritional supplementation on well-being and functional status as well as on nutritional indices. Eighty-one subjects admitted to an acute medical ward aged 65 years and over with chest infection were recruited consecutively, and randomized to receive supplement (500 ml of Ensure liquid daily) for 1 month, or no supplement, on discharge. Assessment at baseline, 1, 2 and 3 months included a questionnaire to determine health, mental and functional status, and anthropometric measurements. Biochemical nutritional status was assessed at baseline, 1 and 3 months, and dietary intake (24 h recall method) at 1 and 3 months. During recovery, both supplement and non-supplement groups showed improvement in various measures of well-being and biochemical status. In addition, the former group showed improvement in more anthropometric measurements, in thiamine and pyridoxine status, while the non-supplement group showed a lower level of functional ability after 3 months. Various measures of well-being and biochemical status of the water-soluble vitamins were better in the supplement groups. We conclude that nutritional supplementation may have a role in helping elderly patients to recover from chest infections.

  20. 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…

  1. Evaluating the effects of ice application on the pain felt during botulinum toxin type-a injections: a prospective, randomized, single-blind controlled trial.

    PubMed

    Sarifakioglu, Nedim; Sarifakioglu, Evren

    2004-12-01

    The pain felt during botulinum toxin type-A injections and the troubled and distressed treatment it induces is common and well known for the patient and the doctor applying the treatment. This problem is further intensified on the patients who have needle phobia. The effect of ice application on the treatment zone before botulinum toxin type-A treatment on the pain felt during injections is investigated. Totally, 24 patients who underwent botulinum toxin type-A treatment in upper face region for esthetic purposes are included in the study. Ice was applied 5 minutes before the injections on the right lateral orbital zones (crow's feet area) of the patients, whereas on their left sides, toxin was injected without applying any ice. All the drugs were diluted by normal saline; 5 U of active botulinum toxin type-A was used in each diziem (0.1 mL). Total injection number was determined both in right and left areas as 8. Visual analog scale (VAS) was used for pain intensity and evaluation. On the side where ice was applied, the treatment was completed in 1 session and lasted shorter when compared with that of the control side. However, the average VAS values defining the pain that the patients felt in their right and left sides were found as 1.1 and 5.9, respectively. The clinical findings obtained indicated that pain is significantly reduced on the side where ice is applied. The statistical significance of the test results were evaluated by Student's t test, and the difference between VAS values was found statistically significant (P = 0.000).

  2. 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.

  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. 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

  5. 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…

  6. 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

  7. Single-use instruments, cutting blocks, and trials increase efficiency in the operating room during total knee arthroplasty: a prospective comparison of navigated and non-navigated cases.

    PubMed

    Mont, Michael A; McElroy, Mark J; Johnson, Aaron J; Pivec, Robert

    2013-08-01

    The purpose of this prospective controlled trial was to determine if efficiency increases could be achieved in non-navigated and navigated total knee arthroplasties by replacing traditional saws, cutting blocks, and trials with specialized saws and single-use cutting blocks and trials. Various timing metrics during total knee arthroplasty, including operating room preparation times and specific intra-operative times, were measured in 400 procedures performed by eight different surgeons at 6 institutions. Efficiency increases were the result of statistically significant reductions in combined instrument setup and cleanup times as well as in adjusted surgical episode times in navigated total knee arthroplasties. Single-use instruments show promising benefits, but adequate patient follow-up is needed to confirm safety and efficacy before they can be widely adopted. Nevertheless, the authors believe that the use of single-use instruments, cutting guides, and trial implants for total knee arthroplasty will play an increasing role in improving operating room efficiency.

  8. How we do it: coblation tonsillectomy complication rates from a single ENT department compared with the National Prospective Tonsillectomy Audit.

    PubMed

    Clark, M P A; Smithard, A; Jervis, P

    2006-04-01

    Coblation tonsillectomy is a relatively new technique, the results of which need auditing within practising units, to justify its continued usage. * The National Prospective Tonsillectomy Audit provides an excellent source of data for individual units to compare their results to. * This retrospective audit of 391 coblation tonsillectomies shows that our units haemorrhage and return to theatre rates are similar to the National rates for cold steel & ties data. * Resolution of training issues and patient selection may lead to increased use of this technique.

  9. 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

  10. 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

  11. 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

  12. Duration of cortisol suppression following a single dose of dexamethasone in healthy volunteers: a randomised double-blind placebo-controlled trial.

    PubMed

    Elston, M S; Conaglen, H M; Hughes, C; Tamatea, J A U; Meyer-Rochow, G Y; Conaglen, J V

    2013-09-01

    The synthetic glucocorticoid dexamethasone is administered to many patients receiving a general anaesthetic to reduce the risk of postoperative nausea and vomiting. Dexamethasone is known to suppress the hypothalamic-pituitary-adrenal axis; however, the duration of this suppression following the standard anti-emetic intravenous dose of 4 to 8 mg used with anaesthesia is unknown. A randomised controlled double-blind crossover trial assessing the effects of 8 mg intravenous dexamethasone versus saline control was performed in ten healthy male volunteers. The adrenal, thyroid and gonadal axes and glucose levels were assessed over a four-day period after dexamethasone administration. All participants had normal baseline hypothalamic-pituitary-adrenal axis function. No difference in cortisol levels was demonstrated at four or eight hours after dexamethasone administration compared with placebo. At 24 hours post dexamethasone, the cortisol had dropped to less than 5% of baseline and returned to normal during the subsequent day. Increased plasma glucose levels were also observed in the dexamethasone group as compared with placebo. A dose of 8 mg of dexamethasone results in significant suppression of the hypothalamic-pituitary-adrenal axis and elevated plasma glucose levels. The cortisol suppression is maximal at approximately 24 hours post dose.

  13. 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

  14. A prospective comparison of rubidium-82 PET and thallium-201 SPECT myocardial perfusion imaging utilizing a single dipyridamole stress in the diagnosis of coronary artery disease

    SciTech Connect

    Go, R.T.; Marwick, T.H.; MacIntyre, W.J.; Saha, G.B.; Neumann, D.R.; Underwood, D.A.; Simpfendorfer, C.C. )

    1990-12-01

    The purpose of the present study is to prospectively compare myocardial perfusion imaging with rubidium-82 ({sup 82}Rb) by positron emission tomography (PET) with thallium-201 ({sup 201}Tl) imaging by single-photon emission tomography (SPECT) by recording both studies with a single dipyridamole handgrip stress, and reading both sets of images with the same display technique. In a series of 202 patients with previous coronary arteriography, the sensitivity, specificity, and accuracy of {sup 82}Rb PET were 93%, 78%, and 90% and for {sup 201}Tl SPECT 76%, 80%, and 77%, respectively. When 70 patients with previous therapeutic interventions were excluded, the remaining 132 patients showed a sensitivity, specificity, and accuracy of 95%, 82% and 92% for {sup 82}Rb PET and 79%, 76%, and 78% for {sup 201}Tl SPECT. The improved contrast resolution of PET resulted in markedly superior images and a more confident identification of defects.

  15. 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.

  16. 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. PMID:27210845

  17. Demographics of Lower Limb Amputations in the Pakistan Military: A Single Center, Three-Year Prospective Survey.

    PubMed

    Rathore, Farooq A; 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. 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

  19. 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.

  20. Supervised walking in comparison with fitness training for chronic back pain in physiotherapy: results of the SWIFT single-blinded randomized controlled trial (ISRCTN17592092).

    PubMed

    Hurley, Deirdre A; Tully, Mark A; Lonsdale, Chris; Boreham, Colin A G; van Mechelen, Willem; Daly, Leslie; Tynan, Aódan; McDonough, Suzanne M

    2015-01-01

    Effectiveness of brief/minimal contact self-activation interventions that encourage participation in physical activity (PA) for chronic low back pain (CLBP >12 weeks) is unproven. The primary objective of this assessor-blinded randomized controlled trial was to investigate the difference between an individualized walking programme (WP), group exercise class (EC), and usual physiotherapy (UP, control) in mean change in functional disability at 6 months. A sample of 246 participants with CLBP aged 18 to 65 years (79 men and 167 women; mean age ± SD: 45.4 ± 11.4 years) were recruited from 5 outpatient physiotherapy departments in Dublin, Ireland. Consenting participants completed self-report measures of functional disability, pain, quality of life, psychosocial beliefs, and PA were randomly allocated to the WP (n = 82), EC (n = 83), or UP (n = 81) and followed up at 3 (81%; n = 200), 6 (80.1%; n = 197), and 12 months (76.4%; n = 188). Cost diaries were completed at all follow-ups. An intention-to-treat analysis using a mixed between-within repeated-measures analysis of covariance found significant improvements over time on the Oswestry Disability Index (Primary Outcome), the Numerical Rating Scale, Fear Avoidance-PA scale, and the EuroQol EQ-5D-3L Weighted Health Index (P < 0.05), but no significant between-group differences and small between-group effect sizes (WP: mean difference at 6 months, 6.89 Oswestry Disability Index points, 95% confidence interval [CI] -3.64 to -10.15; EC: -5.91, CI: -2.68 to -9.15; UP: -5.09, CI: -1.93 to -8.24). The WP had the lowest mean costs and the highest level of adherence. Supervised walking provides an effective alternative to current forms of CLBP management.

  1. 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

  2. A double-blind controlled trial of a single dose naproxen and an amino acid medical food theramine for the treatment of low back pain.

    PubMed

    Shell, William E; Charuvastra, Elizabeth H; DeWood, Marcus A; May, Lawrence A; Bullias, Debora H; Silver, David S

    2012-03-01

    To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was present for at least 6 weeks and was not mild. Patients were randomly assigned to receive medical food alone (n = 43), naproxen alone (250 mg/d, n = 42), or both medical food and naproxen (n = 44). All patients were assessed by using Roland-Morris Disability Questionnaire, Oswestry Low Back Pain Scale, Visual Analog Scale Evaluation and laboratory analysis performed at baseline and at 28 days for assessing the safety and impact on inflammatory markers, which included complete blood counts, C-Reactive protein (CRP), and liver function (alkaline phosphatase, aspartate transaminase, and alanine transaminase). At baseline, there were no statistically significant differences in low back pain when assessed by Roland-Morris function or Oswestry assessments nor were there differences in the blood indices of inflammation. At day 28, both the medical food group and combined therapy group (medical food with naproxen) were statistically significantly superior to the naproxen-alone group (P < 0.05). The medical food and naproxen group showed functional improvement when compared to the naproxen-alone group. The naproxen-alone group showed significant elevations in CRP, alanine transaminase, and aspartate transaminase when compared with the other groups. Medical food alone or with naproxen showed no significant change in liver function tests or CRP, with medical food potentially mitigating the effects seen with naproxen alone. The medical food (Theramine) appeared to be effective in relieving back pain without causing any significant side effects and may provide a safe alternative to presently available therapies.

  3. 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

  4. Prospective comparative study of single-layer versus double-layer closure of leg wounds after long saphenous vein harvest in coronary artery bypass graft operations

    PubMed Central

    Siddiqi, Mohammad Salman; Al Sabti, Hilal; Mukaddirov, Mirdavron; Sharma, Ashok Kumar

    2011-01-01

    Introduction Wound infection is one of the major complication post CABG that leads to prolonged length of stay and cost post surgery. Coronary artery bypass grafting is one of the most commonly performed operations in the world. The long saphenous vein harvested by traditional techniques is still widely used and caries a risk of wound infection. Objective The purpose of this study is to ascertain if a single-layer closure result in better wound healing and functional outcome as compared with the traditional two-layer closure after harvest of saphenous vein. Methods Sixty-seven consecutive patients undergoing CABG were prospectively randomized to have their leg wound closed by either a single-layer technique with a suction drain or double layers without suction drain. All wounds were assessed for the presence of serous discharge, inflammation, edema, purulent exudates, infection of the deep tissues, and pain postoperatively and two weeks after discharge. Results There were trends towards increased rates of wound related outcomes in patients in double layer group when compared with single layer group. Out of 77 patients in our study, 52 patients underwent single layer closure (males, n = 37; females, n= 15) and 25 patients underwent double layer closure (males, n = 21; females, n = 04). There was significant statistical difference between the treatment groups with single layer group having lower average scores (4.038) compared to double layer group (9.467), P- value 0.001. Patients whose legs were closed with the single layer technique had less post operative edema (23.07% vs 53.30) and pain (44.2 vs 73.33) compared with the double layer group. Conclusions Single-layer leg wound closure over a suction drain has shown a better wound outcome compared to traditional double-layer closure. A possible mechanism of better wound healing in the former technique might be through decreased tissue handling and a reduction in leg edema. PMID:22263084

  5. Effectiveness of hydrochlorothiazide in combination with telmisartan and olmesartan in adults with moderate hypertension not controlled with monotherapy: a prospective, randomized, open-label, blinded end point (PROBE), parallel-arm study

    PubMed Central

    Fogari, Roberto; Zoppi, Annalisa; Mugellini, Amedeo; Preti, Paola; Destro, Maurizio; Rinaldi, Andrea; Derosa, Giuseppe

    2008-01-01

    Background:The potential combinations of antihypertensive agents are many, and making rational choices depends on the characteristics of each drug and on their complementary mechanisms of action. Objective: The aim of this study was to evaluate the effectiveness of adding hydrochlorothiazide (HCTZ) 12.5 mg to olmesartan 20 mg or telmisartan 80 mg on blood pressure (BP) in patients with moderate hypertension. Methods: Consecutive outpatients at the Centro per l'Ipertensione e la Fisiopatologia Cardiovascolare, University of Pavia, Pavia, Italy, of both sexes aged 39 to 75 years were considered eligible for enrollment if they had a sitting diastolic BP (DBP) ->99 mm Hg and <110 mm Hg at the end of an initial 2-week washout period. Patients were random- ized to olmesartan 20 mg QD or telmisartan 80 mg QD according to a prospective, open-label, blinded end point, parallel-arm design. After 8 weeks of monotherapy, patients whose BP was not controlled (DBP ->90 mm Hg) received HCTZ 12.5 mg QD for 8 additional weeks. Clinical and ambulatory BPs were measured at the end of the washout period and at the end of both treatment periods. Adverse events (AEs) were recorded from spontaneous reports and direct inquiry from investigators. Results: One hundred forty-five patients, all of whom were white, were recruited for the study. After the initial washout period, 13 patients did not meet the inclusion criteria and 6 refused to continue. A total of 126 white patients (69 men, 57 women; mean [SD] age, 60.2 [11.6] years) were randomized to receive monotherapy. Of these, 35 patients (56%) in the olmesartan group and 33 (52%) in the telmisartan group had previously received antihypertensive therapy. At the end of monotherapy, the 52 patients in the olmesartan group and the 49 patients in the telmisartan treatment group who were still in the study and had their BP inadequately controlled by treatment had HCTZ 12.5 mg QD added to their treatment regimen. Both combinations induced a

  6. 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

    2016-06-01

    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

  7. Parent-mediated intervention versus no intervention for infants at high risk of autism: a parallel, single-blind, randomised trial

    PubMed Central

    Green, Jonathan; Charman, Tony; Pickles, Andrew; Wan, Ming W; Elsabbagh, Mayada; Slonims, Vicky; Taylor, Carol; McNally, Janet; Booth, Rhonda; Gliga, Teodora; Jones, Emily J H; Harrop, Clare; Bedford, Rachael; Johnson, Mark H

    2015-01-01

    Summary Background Risk markers for later autism identified in the first year of life present plausible intervention targets during early development. We aimed to assess the effect of a parent-mediated intervention for infants at high risk of autism on these markers. Methods We did a two-site, two-arm assessor-blinded randomised controlled trial of families with an infant at familial high risk of autism aged 7–10 months, testing the adapted Video Interaction to Promote Positive Parenting (iBASIS-VIPP) versus no intervention. Families were randomly assigned to intervention or no intervention groups using a permuted block approach stratified by centre. Assessors, but not families or therapists, were masked to group assignment. The primary outcome was infant attentiveness to parent. Regression analysis was done on an intention-to-treat basis. This trial is registered with ISCRTN Registry, number ISRCTN87373263. Findings We randomly assigned 54 families between April 11, 2011, and Dec 4, 2012 (28 to intervention, 26 to no intervention). Although CIs sometimes include the null, point estimates suggest that the intervention increased the primary outcome of infant attentiveness to parent (effect size 0·29, 95% CI −0·26 to 0·86, thus including possibilities ranging from a small negative treatment effect to a strongly positive treatment effect). For secondary outcomes, the intervention reduced autism-risk behaviours (0·50, CI −0·15 to 1·08), increased parental non-directiveness (0·81, 0·28 to 1·52), improved attention disengagement (0·48, −0·01 to 1·02), and improved parent-rated infant adaptive function (χ2[2] 15·39, p=0·0005). There was a possibility of nil or negative effect in language and responsivity to vowel change (P1: ES–0·62, CI −2·42 to 0·31; P2: −0·29, −1·55 to 0·71). Interpretation With the exception of the response to vowel change, our study showed positive estimates across a wide range of behavioural and brain function

  8. Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial

    PubMed Central

    2010-01-01

    Background This randomised, single-blind controlled pilot trial aimed to determine the effectiveness of a physiotherapy program, including exercise and manual therapy, in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture. Methods 20 participants were randomly allocated to an intervention (n = 11) or control (n = 9) group. The intervention group attended individual sessions with an experienced clinician once a week for 10 weeks and performed daily home exercises with adherence monitored by a self-report diary. The control group received no treatment. Blinded assessment was conducted at baseline and 11 weeks. Questionnaires assessed self-reported changes in back pain, physical function, and health-related quality of life. Objective measures of thoracic kyphosis, back and shoulder muscle endurance (Timed Loaded Standing Test), and function (Timed Up and Go test) were also taken. Results Compared with the control group, the intervention group showed significant reductions in pain during movement (mean difference (95% CI) -1.8 (-3.5 to -0.1)) and at rest (-2.0 (-3.8 to -0.2)) and significantly greater improvements in Qualeffo physical function (-4.8 (-9.2 to -0.5)) and the Timed Loaded Standing test (46.7 (16.1 to 77.3) secs). For the perceived change in back pain over the 10 weeks, 9/11 (82%) participants in the intervention group rated their pain as 'much better' compared with only 1/9 (11%) participants in the control group. Conclusion Despite the modest sample size, these results support the benefits of exercise and manual therapy in the clinical management of patients with osteoporotic vertebral fractures, but need to be confirmed in a larger sample. Trail registration NCT00638768 PMID:20163739

  9. 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

  10. 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

    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.

  11. 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)

  12. Foundation Fighting Blindness

    MedlinePlus

    ... Vision Seminar Series Find an Event Near You Pictures from FFB Events Fundraise for Research VisionWalk My Campaign to End Blindness Other Ways to Fight Blindness Corporate Support Volunteer Take Action Honor a Loved One + + Honor a Loved One ...

  13. "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…

  14. 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

  15. Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport) for the relief of upper back myofascial pain syndrome: results from a randomized double-blind placebo-controlled multicentre study.

    PubMed

    Göbel, Hartmut; Heinze, Axel; Reichel, Gerhard; Hefter, Harald; Benecke, Reiner

    2006-11-01

    Botulinum type A toxin (BoNT-A) has antinociceptive and muscle-relaxant properties and may help relieve the symptoms of myofascial pain syndrome. In this study we evaluated the efficacy and tolerability of BoNT-A (Dysport) in patients with myofascial pain syndrome of the upper back. We conducted a prospective, randomized, double-blind, placebo-controlled, 12-week, multicentre study. Patients with moderate-to-severe myofascial pain syndrome affecting cervical and/or shoulder muscles (10 trigger points, disease duration 6-24 months) were randomized to Dysport or saline. Injections were made into the 10 most tender trigger points (40 units per site). The primary outcome was the proportion of patients with mild or no pain at week 5. Secondary outcomes included changes in pain intensity and the number of pain-free days per week. Tolerability and safety were also assessed. At week 5, significantly more patients in the Dysport group reported mild or no pain (51%), compared with the patients in the placebo group (26%; p=0.002). Compared with placebo, Dysport resulted in a significantly greater change from baseline in pain intensity during weeks 5-8 (p<0.05), and significantly fewer days per week without pain between weeks 5 and 12 (p=0.036). Treatment was well tolerated, with most side effects resolving within 8 weeks. In conclusion, in patients with upper back myofascial pain syndrome, injections of 400 Ipsen units of Dysport at 10 individualised trigger points significantly improved pain levels 4-6 weeks after treatment. Injections were well tolerated.

  16. 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

  17. 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.

  18. 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…

  19. 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.

  20. 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

  1. 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. PMID:27313616

  2. Quantum-dot single-photon sources: Prospects for applications in linear optics quantum-information processing

    NASA Astrophysics Data System (ADS)

    Kiraz, A.; Atatüre, M.; Imamoǧlu, A.

    2004-03-01

    An optical source that produces single-photon pulses on demand has potential applications in linear optics quantum computation, provided that stringent requirements on indistinguishability and collection efficiency of the generated photons are met. We show that these are conflicting requirements for anharmonic emitters that are incoherently pumped via reservoirs. As a model for a coherently pumped single photon source, we propose cavity-assisted spin-flip Raman transitions in a single electron charged quantum dot embedded in a microcavity. We demonstrate that using such a source, arbitrarily high collection efficiency and indistinguishability of the generated photons can be obtained simultaneously with increased cavity coupling. We analyze the role of errors that arise from distinguishability of the single-photon pulses in linear optics quantum gates by relating the gate fidelity to the strength of the two-photon interference dip in photon cross-correlation measurements. We find that performing controlled phase operations with error <1 % requires nanocavities with Purcell factors FP ⩾40 in the absence of dephasing, without necessitating the strong coupling limit.

  3. Pharmacokinetics and safety of single doses of drisapersen in non-ambulant subjects with Duchenne muscular dystrophy: Results of a double-blind randomized clinical trial

    PubMed Central

    Flanigan, Kevin M.; Voit, Thomas; Rosales, Xiomara Q.; Servais, Laurent; Kraus, John E.; Wardell, Claire; Morgan, Allison; Dorricott, Susie; Nakielny, Joanna; Quarcoo, Naashika; Liefaard, Lia; Drury, Tom; Campion, Giles; Wright, Padraig

    2014-01-01

    Duchenne muscular dystrophy (DMD) is a progressive, lethal neuromuscular disorder caused by the absence of dystrophin protein due to mutations of the dystrophin gene. Drisapersen is a 2′-O-methyl-phosphorothioate oligonucleotide designed to skip exon 51 in dystrophin pre-mRNA to restore the reading frame of the mRNA. This study assessed safety, tolerability, and pharmacokinetics of drisapersen after a single subcutaneous administration in non-ambulatory subjects. Eligible subjects were non-ambulant boys aged ≥9 years, in wheelchairs for ≥1 to ≤4 years, with a diagnosis of DMD resulting from a mutation correctable by drisapersen treatment. Four dose cohorts were planned (3, 6, 9 and 12 mg/kg), but study objectives were met with the 9 mg/kg dose. Less than proportional increase in exposure was demonstrated over the 3–9 mg/kg dose range, though post hoc analysis showed dose proportionality was more feasible over the 3–6 mg/kg range. Single doses of drisapersen at 3 and 6 mg/kg did not result in significant safety or tolerability concerns; however, at the 9 mg/kg dose, pyrexia and transient elevations in inflammatory parameters were seen. The maximum tolerated dose of 6 mg/kg drisapersen was identified for further characterization in multiple dose studies in the non-ambulant DMD population. PMID:24321374

  4. Correlating perceived arrhythmia symptoms and QoL in the elderly with Heart Failure in an urban clinic: A prospective, single center study

    PubMed Central

    Hickey, Kathleen T.; Reiffel, James; Sciacca, Robert R.; Whang, William; Biviano, Angelo; Baumeister, Maurita; Castillo, Carmen; Talathothi, Jyothi; Garan, Hasan

    2013-01-01

    Aim To determine the relationship between quality of life (QoL) and perceived self reported symptoms in an elderly, ambulatory, urban population living with heart failure (HF). Background While arrhythmias in the elderly with HF are well documented, the association between perceived arrhythmia symptoms and QoL is not well defined. Design Prospective, cross sectional single center study. Methods A single-center, prospective study was conducted with HF patients recruited from an urban outpatient cardiology clinic in the United States. Fifty-seven patients completed a baseline QoL survey with 42 of these completing the 6-month follow-up survey. QoL was evaluated with the SF-36v2™ and frequency of symptoms with the Atrial Fibrillation Severity Scale. Subjects wore an auto triggered cardiac loop monitor (LifeStar AF Express®) for 2-weeks to document arrhythmias. Data analysis utilized Spearman’s rank correlation and logistic regression. Results Baseline and 6-month QoL measures did not correlate with recorded arrhythmias. However, perceptions of diminished general health correlated significantly with symptoms of exercise intolerance, lightheadedness/dizziness, palpitations, and chest pain/pressure. By multivariable logistic regression, more severe perceived arrhythmic, symptoms of exercise intolerance, and lightheadedness/dizziness were independently associated with diminished QoL. Conclusion QoL was significantly worse in patients with perceptions of severe arrhythmic episodes and in those whose symptoms of dizziness and exercise intolerance. Relevance to clinical practice The findings of this study indicate that symptomatic HF patients suffer from poor QoL and that interventions are needed to improve QoL and decrease symptom severity. Nurses who care for HF patients play an essential role in symptom evaluation and management and could significantly improve overall QoL in these patients by carefully evaluating symptomatology and testing interventions and

  5. 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

  6. Does Percutaneous Kyphoplasty Have Better Functional Outcome Than Vertebroplasty in Single Level Osteoporotic Compression Fractures? A Comparative Prospective Study

    PubMed Central

    Omidi-Kashani, F.; Samini, F.; Hasankhani, E. G.; Kachooei, A. R.; Toosi, K. Z.; Golhasani-Keshtan, F.

    2013-01-01

    Purpose. To evaluate the relative differences in surgical outcome of kyphoplasty (KP) versus vertebroplasty (VP) in the patients with single level refractory osteoporotic compression fractures (OCFs). Method. From August 2008 to May 2012, we intermittently treated 57 patients with single level OCF by PV and KP (Groups A and B, resp.). We used visual analogue scale (VAS) and short form 36 (SF36) questionnaire to measure functional recovery and followed them for six months. Independent samples t- and Kendall's tau-b tests were for statistics. Results. In terms of age, number, and bone mineral density of the patients, there were no significant differences between the two groups. In both groups, VAS and SF-36 scores improved significantly and remained relatively stable throughout the follow-up period. We had 9 and 6 asymptomatic cement extravasations and 5 and 8 new vertebral fractures in Group A and B, respectively. In comparing the two groups, the results indicated that KP almost failed to show any significant higher effect relative to VP during this period. Conclusions. In considering the high cost of KP relative to VP in the developing countries like Iran, there is no logical reason to use KP in a single level refractory OCF in these regions. PMID:23970997

  7. 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

  8. 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

  9. Intra-gastric pH following single oral administrations of rabeprazole and esomeprazole: double-blind cross-over comparison

    PubMed Central

    Furuta, Kenji; Kohata, Yukie; Fujiwara, Yasuhiro; Sugimoto, Mitsushige; Uotani, Takahiro; Yamade, Mihoko; Sahara, Shu; Ichikawa, Hitomi; Furuta, Takahisa; Nio, Kenta; Iwakiri, Ryuichi; Inamori, Masahiko; Kawamura, Osamu; Kusano, Motoyasu; Kato, Mototsugu; Kawami, Noriyuki; Iwakiri, Katsuhiko; Takeuchi, Toshihisa; Higuchi, Kazuhide; Aimi, Masahito; Naora, Kohji; Fujimoto, Kazuma; Arakawa, Tetsuo; Kinoshita, Yoshikazu

    2014-01-01

    Comparisons between the acid inhibitory effects of rabeprazole and esomeprazole after single oral administration with standard doses have not been previously presented. We examined intra-gastric pH after oral administrations of these two proton pump inhibitors using 24-h pH monitoring. Fifty-four normal volunteers not infected by Helicobacter pylori were investigated. Using a cross-over design, we administered 10 mg of rabeprazole or 20 mg of esomeprazole in 27 at 30 min after supper and in the remaining 27 subjects at 15 min before supper, and performed 24-h pH monitoring. Intra-gastric pH data were nearly identical when the proton pump inhibitors were taken after meals. Even if the data were compared in different CYP2C19 genotypes, rabeprazole and esomeprazole did not show the difference. In poor metabolizer, both of the drugs showed stronger acid inhibition. When taken before meals, intra-gastric pH after esomeprazole administration was slightly but not significantly higher than that observed after rabeprazole administration not only in daytime but also in nighttime period. In conclusion, rabeprazole and esomeprazole were similarly effective when administered after a meal. PMID:25411523

  10. Intra-gastric pH following single oral administrations of rabeprazole and esomeprazole: double-blind cross-over comparison.

    PubMed

    Furuta, Kenji; Kohata, Yukie; Fujiwara, Yasuhiro; Sugimoto, Mitsushige; Uotani, Takahiro; Yamade, Mihoko; Sahara, Shu; Ichikawa, Hitomi; Furuta, Takahisa; Nio, Kenta; Iwakiri, Ryuichi; Inamori, Masahiko; Kawamura, Osamu; Kusano, Motoyasu; Kato, Mototsugu; Kawami, Noriyuki; Iwakiri, Katsuhiko; Takeuchi, Toshihisa; Higuchi, Kazuhide; Aimi, Masahito; Naora, Kohji; Fujimoto, Kazuma; Arakawa, Tetsuo; Kinoshita, Yoshikazu

    2014-11-01

    Comparisons between the acid inhibitory effects of rabeprazole and esomeprazole after single oral administration with standard doses have not been previously presented. We examined intra-gastric pH after oral administrations of these two proton pump inhibitors using 24-h pH monitoring. Fifty-four normal volunteers not infected by Helicobacter pylori were investigated. Using a cross-over design, we administered 10 mg of rabeprazole or 20 mg of esomeprazole in 27 at 30 min after supper and in the remaining 27 subjects at 15 min before supper, and performed 24-h pH monitoring. Intra-gastric pH data were nearly identical when the proton pump inhibitors were taken after meals. Even if the data were compared in different CYP2C19 genotypes, rabeprazole and esomeprazole did not show the difference. In poor metabolizer, both of the drugs showed stronger acid inhibition. When taken before meals, intra-gastric pH after esomeprazole administration was slightly but not significantly higher than that observed after rabeprazole administration not only in daytime but also in nighttime period. In conclusion, rabeprazole and esomeprazole were similarly effective when administered after a meal. PMID:25411523

  11. 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 Central

    Ferraresi, Cleber; Beltrame, Thomas; Fabrizzi, Fernando; do Nascimento, Eduardo Sanches Pereira; Karsten, Marlus; de Oliveira Francisco, Cristina; Borghi-Silva, Audrey; Catai, Aparecida Maria; Cardoso, Daniel Rodrigues; Ferreira, Antonio Gilberto; Hamblin, Michael R.; Bagnato, Vanderlei Salvador; Parizotto, Nivaldo Antonio

    2015-01-01

    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 (1H NMR). A LED cluster with 50 LEDs (λ = 850 nm; 50mW 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. PMID:25585514

  12. Clinical experience and results of treatment with suprofen in pediatrics. 3rd communication: Antipyretic effect and tolerability of repeat doses of suprofen and paracetamol syrup in hospitalized children/A single-blind study.

    PubMed

    Weippl, G; Michos, N; Sundal, E J; Stocker, H

    1985-01-01

    Antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol), syrup and paracetamol (acetaminophen) were compared within the scope of the present randomized single-blind study; the test population included a total of 115 children ranging in age from 6 months to 12 years. All patients were admitted to the hospital with an average temperature of 39.3 degrees C, their disease being caused by bacterial or viral infections. The dose levels for treatment with syrup depended upon the children's age and body weight. Treatment was in most cases given for two days; a three-times-a-day schedule was used. The (rectal) temperature as well as pulse and respiratory rates were measured prior to treatment and 0.5, 1, 1.5, 2, 3, 4, 5, 6 h after first administration of the test preparations. The results showed that the antipyretic effect of suprofen was in both age groups at all rating times statistically significantly superior to that of paracetamol. Pulse and respiratory rates dropped in both age groups after treatment; the means were within the normal range at all rating times. Adverse drug reactions were seen in 5 patients on suprofen and in 3 cases on paracetamol. It is, however, questionable whether such reactions are drug-dependent. PMID:3911963

  13. Clinical experience and results of treatment with suprofen in pediatrics. 5th communication: a single-blind study on antipyretic effect and tolerability of suprofen syrup versus metamizole drops in pediatric patients.

    PubMed

    Giovannini, M; Longhi, R; Besana, R; Michos, N; Sarchi, C

    1986-06-01

    In a single-blind study, 60 children in two age groups (30 patients: 6 months to 3 years; 30 patients: 3 years to 12 years), were orally treated with either alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol), syrup 10 mg/ml or metamizole drops 50% for a maximum period of 4 days, up to 4 times a day. The children presented with high fever due to bacterial or virus infections. Body temperature, pulse rate, and respiratory rate were evaluated at the beginning and then 30 min, 1, 1 1/2, 2, 3, 4, 5, and 6 h after the first administration of the respective drug. Significant differences between the drugs were found for all variables; this demonstrated that with suprofen the antipyretic effect set in more rapidly than with the reference drug. No side-effects were observed in children treated with suprofen syrup. Two patients showed adverse effects, i.e. sweating and hypotension, during the treatment with metamizole. Due to its good antipyretic effect and good tolerability, suprofen appears to be particularly useful for symptomatic treatment of pediatric patients with fever caused by bacterial or virus infections. PMID:3527181

  14. 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

  15. Blinded by irrelevance: pure irrelevance induced "blindness".

    PubMed

    Eitam, Baruch; Yeshurun, Yaffa; Hassan, Kinneret

    2013-06-01

    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 which was previously manipulated-and were subsequently asked to identify these colors. Whereas knowledge of the task-relevant color was near perfect, up to a quarter of the participants could not name the color of the irrelevant stimulus, even though a control experiment indicated there were sufficient resources to process both stimuli. The results are a first demonstration of blindness when mental resources are clearly available and challenge attentional theories predicting strong selection only when resources are taxed.

  16. 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.

  17. Patient experiences with self-monitoring renal function after renal transplantation: results from a single-center prospective pilot study

    PubMed Central

    van Lint, Céline L; van der Boog, Paul JM; Wang, Wenxin; Brinkman, Willem-Paul; Rövekamp, Ton JM; Neerincx, Mark A; Rabelink, Ton J; van Dijk, Sandra

    2015-01-01

    Background After a kidney transplantation, patients have to visit the hospital often to monitor for early signs of graft rejection. Self-monitoring of creatinine in addition to blood pressure at home could alleviate the burden of frequent outpatient visits, but only if patients are willing to self-monitor and if they adhere to the self-monitoring measurement regimen. A prospective pilot study was conducted to assess patients’ experiences and satisfaction. Materials and methods For 3 months after transplantation, 30 patients registered self-measured creatinine and blood pressure values in an online record to which their physician had access to. Patients completed a questionnaire at baseline and follow-up to assess satisfaction, attitude, self-efficacy regarding self-monitoring, worries, and physician support. Adherence was studied by comparing the number of registered with the number of requested measurements. Results Patients were highly motivated to self-monitor kidney function, and reported high levels of general satisfaction. Level of satisfaction was positively related to perceived support from physicians (P<0.01), level of self-efficacy (P<0.01), and amount of trust in the accuracy of the creatinine meter (P<0.01). The use of both the creatinine and blood pressure meter was considered pleasant and useful, despite the level of trust in the accuracy of the creatinine device being relatively low. Trust in the accuracy of the creatinine device appeared to be related to level of variation in subsequent measurement results, with more variation being related to lower levels of trust. Protocol adherence was generally very high, although the range of adherence levels was large and increased over time. Conclusion Patients’ high levels of satisfaction suggest that at-home monitoring of creatinine and blood pressure after transplantation offers a promising strategy. Important prerequisites for safe implementation in transplant care seem to be support from physicians

  18. Vision Impairment and Blindness

    MedlinePlus

    ... TV may be hard to do. The leading causes of low vision and blindness in the United ... disorders, eye injuries and birth defects can also cause vision loss. Whatever the cause, lost vision cannot ...

  19. Prevent Blindness America

    MedlinePlus

    ... to eNews Close Donate A Lifetime of Healthy Vision See well to learn, work, play, and live ... the sight-saving work of
 Prevent Blindness. Donate Vision Problems in the U.S. Prevalence of Adult Vision ...

  20. Leading Causes of Blindness

    MedlinePlus

    ... Navigation Bar Home Current Issue Past Issues Feature: Vision Leading Causes of Blindness Past Issues / Summer 2008 ... of the lenses in your eyes. They affect vision and are very common in older people. More ...

  1. Blinding laser weapons.

    PubMed

    Peters, A

    1996-01-01

    At its October 1995 Review Conference, the Convention on Conventional Weapons added a protocol banning the use and transfer of blinding laser weapons. The background to, and significance and limitations of this ban are discussed.

  2. Blind loop syndrome

    MedlinePlus

    ... operations for extreme obesity As a complication of inflammatory bowel disease Diseases such as diabetes or scleroderma may slow down movement in a segment of the intestine, leading to blind loop syndrome.

  3. Haptic choice blindness

    PubMed Central

    Steenfeldt-Kristensen, Catherine; Thornton, Ian M.

    2013-01-01

    Choice blindness is the failure to notice a mismatch between intention and outcome when making decisions. It is unknown whether choice blindness occurs when participants have extended interaction with real objects. Here, we examined the case when objects could be touched but not seen. Participants examined pairs of common, everyday objects inside a specially constructed box where a silent turntable was used to switch objects between initial choice and later justification. For similar pairs of objects, we found detection rates of around 22%, consistent with previous studies of choice blindness. For pairs consisting of more distinctive exemplars, the detection rate rose to 70%. Our results indicate that choice blindness does occur after haptic interaction with real objects, but is strongly modulated by similarity. PMID:23799197

  4. 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.

  5. New Prospective for the Management of Low-Risk Pulmonary Embolism: Prognostic Assessment, Early Discharge, and Single-Drug Therapy with New Oral Anticoagulants

    PubMed Central

    2012-01-01

    Patients with pulmonary embolism (PE) can be stratified into two different prognostic categories, based on the presence or absence of shock or sustained arterial hypotension. Some patients with normotensive PE have a low risk of early mortality, defined as <1% at 30 days or during hospital stay. In this paper, we will discuss the new prospective for the optimal management of low-risk PE: prognostic assessment, early discharge, and single-drug therapy with new oral anticoagulants. Several parameters have been proposed and investigated to identify low-risk PE: clinical prediction rules, imaging tests, and laboratory markers of right ventricular dysfunction or injury. Moreover, outpatient management has been suggested for low-risk PE: it may lead to a decrease in unnecessary hospitalizations, acquired infections, death, and costs and to an improvement in health-related quality of life. Finally, the main characteristics of new oral anticoagulant drugs and the most recent published data on phase III trials on PE suggest that the single-drug therapy is a possible suitable option. Oral administration, predictable anticoagulant responses, and few drug-drug interactions of direct thrombin and factor Xa inhibitors may further simplify PE home therapy avoiding administration of low-molecular-weight heparin. PMID:24278706

  6. 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

  7. 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

  8. Polyphenol- and fibre-rich dried fruits with green tea attenuate starch-derived postprandial blood glucose and insulin: a randomised, controlled, single-blind, cross-over intervention.

    PubMed

    Nyambe-Silavwe, H; Williamson, G

    2016-08-01

    Polyphenol- and fibre-rich foods (PFRF) have the potential to affect postprandial glycaemic responses by reducing glucose absorption, and thus decreasing the glycaemic response of foods when consumed together. A randomised, single-blind, cross-over study was conducted on sixteen healthy volunteers to test whether PFRF could attenuate postprandial blood glucose in healthy volunteers when added to a source of carbohydrate (starch in bread). This is the first study to examine the effects of a meal comprised of components to inhibit each stage of the biochemical pathway, leading up to the appearance of glucose in the blood. The volunteers were fasted and attended four visits: two control visits (bread, water, balancing sugars) and two test visits (single and double dose of PFRF) where they consumed bread, water and PFRF. Blood samples were collected at 0 (fasted), 15, 30, 45, 60, 90, 120, 150 and 180 min after consumption. The PFRF components were tested for α-amylase and α-glucosidase inhibitory potential in vitro. Plasma glucose was lower after consumption of both doses compared with controls: lower dose, change in mean incremental areas under the glucose curves (IAUC)=-27·4 (sd 7·5) %, P<0·001; higher dose, IAUC=-49·0 (sd 15·3) %, P<0·001; insulin IAUC was also attenuated by-46·9 (sd 13·4) %, P<0·01. Consistent with this, the polyphenol components of the PFRF inhibited α-amylase (green tea, strawberry, blackberry and blackcurrant) and α-glucosidase (green tea) activities in vitro. The PFRF have a pronounced and significant lowering effect on postprandial blood glucose and insulin response in humans, due in part to inhibition of α-amylase and α-glucosidase, as well as glucose transport. PMID:27278405

  9. 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

  10. A prospective quality evaluation of single donor platelets (SDP) - an experience of a tertiary healthcare center in India.

    PubMed

    Pandey, Prashant; Tiwari, Aseem Kumar; Sharma, Jyoti; Singh, Mukesh Bikram; Dixit, Surbhi; Raina, Vimarsh

    2012-04-01

    Quality assurance of single donor platelets (SDP) is incomplete unless clinical response to platelet transfusion is measured. The primary objective of the study was to evaluate the quality of SDP derived from plateletpheresis procedures and to evaluate the response to platelet transfusion. Procedures were performed on 2287 accepted donors while 271 donors were deferred. Platelet count <1.5 lac/μl and hemoglobin <12.5 g/dl were the leading cause of deferral. The median platelet yield in a SDP bag was found to be 3.1×10(11). The median corrected count increment (CCI) and post-transfusion platelet recovery (PPR) were found to be 10110×m(2)/μl and 24.5%, respectively. In India, the criteria for the selection of plateletpheresis donors should be revisited. Based on quality parameters, the Fresenius COM.TEC cell separator is comparable to other cell separators.

  11. 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.

  12. Single-Nucleotide Variations in Cardiac Arrhythmias: Prospects for Genomics and Proteomics Based Biomarker Discovery and Diagnostics

    PubMed Central

    Abunimer, Ayman; Smith, Krista; Wu, Tsung-Jung; Lam, Phuc; Simonyan, Vahan; Mazumder, Raja

    2014-01-01

    Cardiovascular diseases are a large contributor to causes of early death in developed countries. Some of these conditions, such as sudden cardiac death and atrial fibrillation, stem from arrhythmias—a spectrum of conditions with abnormal electrical activity in the heart. Genome-wide association studies can identify single nucleotide variations (SNVs) that may predispose individuals to developing acquired forms of arrhythmias. Through manual curation of published genome-wide association studies, we have collected a comprehensive list of 75 SNVs associated with cardiac arrhythmias. Ten of the SNVs result in amino acid changes and can be used in proteomic-based detection methods. In an effort to identify additional non-synonymous mutations that affect the proteome, we analyzed the post-translational modification S-nitrosylation, which is known to affect cardiac arrhythmias. We identified loss of seven known S-nitrosylation sites due to non-synonymous single nucleotide variations (nsSNVs). For predicted nitrosylation sites we found 1429 proteins where the sites are modified due to nsSNV. Analysis of the predicted S-nitrosylation dataset for over- or under-representation (compared to the complete human proteome) of pathways and functional elements shows significant statistical over-representation of the blood coagulation pathway. Gene Ontology (GO) analysis displays statistically over-represented terms related to muscle contraction, receptor activity, motor activity, cystoskeleton components, and microtubule activity. Through the genomic and proteomic context of SNVs and S-nitrosylation sites presented in this study, researchers can look for variation that can predispose individuals to cardiac arrhythmias. Such attempts to elucidate mechanisms of arrhythmia thereby add yet another useful parameter in predicting susceptibility for cardiac diseases. PMID:24705329

  13. 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

  14. Randomized, open-label, blinded-endpoint, crossover, single-dose study to compare the pharmacodynamics of torasemide-PR 10 mg, torasemide-IR 10 mg, and furosemide-IR 40 mg, in patients with chronic heart failure

    PubMed Central

    Ballester, Maria Rosa; Roig, Eulàlia; Gich, Ignasi; Puntes, Montse; Delgadillo, Joaquín; Santos, Benjamín; Antonijoan, Rosa Maria

    2015-01-01

    Purpose Diuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics. Methods Randomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours. Results Ten patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096±0.03 mmol/μg vs 0.015±0.0007 mmol/μg; P<0.0001). Mictional urgency was lower and more delayed with torasemide-PR than with furosemide-IR. Conclusion In a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial†

    PubMed Central

    Weinstein, C.; Jordan, K.; Green, S. A.; Camacho, E.; Khanani, S.; Beckford-Brathwaite, E.; Vallejos, W.; Liang, L. W.; Noga, S. J.; Rapoport, B. L.

    2016-01-01

    Background To establish the role of antiemetic therapy with neurokinin-1 (NK1) receptor antagonists (RAs) in nonanthracycline and cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) regimens, this study evaluated single-dose intravenous (i.v.) fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with non-AC MEC. Patients and methods In this international, phase III, double-blind trial, adult cancer subjects scheduled to receive ≥1 non-AC MEC on day 1 were randomized to a regimen comprising single-dose i.v. fosaprepitant 150 mg or placebo along with ondansetron and dexamethasone on day 1; control regimen recipients received ondansetron on days 2 and 3. Primary end points were the proportion of subjects achieving a complete response (CR; no vomiting and no use of rescue medication) in the delayed phase (25–120 h after MEC initiation) and safety. Secondary end points included CR in the overall and acute phases (0–120 and 0–24 h after MEC initiation, respectively) and no vomiting in the overall phase. Nausea and the Functional Living Index-Emesis were assessed as exploratory end points. Results The fosaprepitant regimen improved CR significantly in the delayed (78.9% versus 68.5%; P < 0.001) and overall (77.1% versus 66.9%; P < 0.001) phases, but not in the acute phase (93.2% versus 91.0%; P = 0.184), versus control. In the overall phase, the proportion of subjects with no vomiting (82.7% versus 72.9%; P < 0.001) and no significant nausea (83.2% versus 77.9%; P = 0.030) was also significantly improved with the fosaprepitant regimen. The fosaprepitant regimen was generally well tolerated. Conclusion Single-dose fosaprepitant added to a 5-HT3 RA and dexamethasone was well tolerated and demonstrated superior control of CINV (primary end point achieved) associated with non-AC MEC. This is the first study to evaluate NK1 RA therapy as an i.v. formulation in a well-defined non-AC MEC population. Clinical

  1. A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin–noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine†

    PubMed Central

    Montgomery, Stuart A; Nielsen, Rebecca Z; Poulsen, Lis H; Häggström, Lars

    2014-01-01

    Objective This randomised, double-blind, 12-week study compared efficacy and tolerability of flexible-dose treatment with vortioxetine (10–20 mg/day) versus agomelatine (25–50 mg/day) in major depressive disorder patients with inadequate response to selective serotonin reuptake inhibitor (SSRI)/serotonin–noradrenaline reuptake inhibitor (SNRI) monotherapy. Methods Patients were switched directly from SSRI/SNRI to vortioxetine or agomelatine. Primary endpoint was change from baseline to week 8 in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score analysed by mixed model for repeated measurements, using a noninferiority test followed by a superiority test. Secondary endpoints included response and remission rates, anxiety symptoms (Hamilton Anxiety Rating Scale), Clinical Global Impression, overall functioning (Sheehan Disability Scale), health-related quality of life (EuroQol 5 Dimensions), productivity (work limitation questionnaire) and family functioning (Depression and Family Functioning Scale). Results Primary endpoint noninferiority was established and vortioxetine (n = 252) was superior to agomelatine (n = 241) by 2.2 MADRS points (p < 0.01). Vortioxetine was also significantly superior in response and remission rates at weeks 8 and 12; MADRS, Hamilton Anxiety Rating Scale, Clinical Global Impression, Sheehan Disability Scale and EuroQol 5 Dimensions scores at week 4 onwards; work limitation questionnaire at week 8 and Depression and Family Functioning Scale at weeks 8 and 12. Fewer patients withdrew because of adverse events with vortioxetine (5.9% vs 9.5%). Adverse events (incidence ≥5%) were nausea, headache, dizziness and somnolence. Conclusions Vortioxetine was noninferior and significantly superior to agomelatine in major depressive disorder patients with previous inadequate response to a single course of SSRI/SNRI monotherapy. Vortioxetine was safe and well tolerated. PMID:25087600

  2. 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

  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. 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.

  5. Effect of stretch frequency and sex on the rate of gain and rate of loss in muscle flexibility during a hamstring-stretching program: a randomized single-blind longitudinal study.

    PubMed

    Cipriani, Daniel J; Terry, Megan E; Haines, Michelle A; Tabibnia, Amir P; Lyssanova, Olga

    2012-08-01

    This study evaluated the effects of 4 different weekly stretching protocols on the rate of gain and decline in hamstring flexibility over an 8-week period, across sex. Using a randomized single-blind design, 53 healthy subjects aged 18-46 years were assigned to 1 of 4 stretching protocols or a control group. The stretching protocols consisted of either daily or 3 times per week stretching and performed once or twice each day. These protocols differed in terms of frequency and total weekly stretching time. All the subjects stretched their hamstring muscles for 4 weeks and were measured weekly for their hip range of motion (ROM). Stretching ceased the final 4 weeks as the weekly measurements continued. The results revealed no significant differences in the rate of gain or the rate of loss between the different stretching protocols (2-way analysis of variance, F = 2.60, p > 0.05). All the stretching groups gained in hip ROM from pre to week 4 (F = 269.24, p < 0.001). After cessation, the rate of loss was similar for all the 4 stretching groups (F = 102.86, p < 0.001); all the groups retained significant gains at the end of the study (p < 0.001). The control group did not change over time. Those who stretched at least 6 times per week gained more than those who stretched 3 times per week (24 and 16.8%, respectively, F = 5.20, p < 0.05). Subject sex did not influence ROM changes (p > 0.05). Stretching appears to be equally effective, whether performed daily or 3 times per week, provided individuals stretch at least 2 times each day. Moreover, although women are more flexible than men are, there was no sex difference in terms of stretching response.

  6. 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

  7. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study.

    PubMed

    Si, Tianmei; Zhang, Kerang; Tang, Jisheng; Fang, Maosheng; Li, Keqing; Zhuo, Jianmin; Feng, Yu

    2015-01-01

    This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75-150 mg eq, deltoid/gluteal injection) in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score ≥70), who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period). Primary efficacy endpoint was percentage of patients with ≥30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions-Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2%) completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years). Total, 443/610 (72.6%, full analysis set) patients achieved primary endpoint (mean [standard deviation] change from baseline: -30.9 [19.51]). All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5%) treatment-emergent adverse events were extrapyramidal disorders (8.4%). The efficacy and safety data are consistent with other short-term, placebo-controlled studies of paliperidone palmitate conducted in similar populations.

  8. A prospective randomised study of anatomical single-bundle versus double-bundle anterior cruciate ligament reconstruction: quantitative evaluation using an electromagnetic measurement system.

    PubMed

    Araki, Daisuke; Kuroda, Ryosuke; Kubo, Seiji; Fujita, Norifumi; Tei, Katsumasa; Nishimoto, Koji; Hoshino, Yuichi; Matsushita, Takehiko; Matsumoto, Tomoyuki; Nagamune, Koki; Kurosaka, Masahiro

    2011-03-01

    We conducted a prospective randomised study of anatomical single-bundle (A-SB group) versus double-bundle (A-DB group) anterior cruciate ligament (ACL) reconstruction using the hamstrings tendons. Twenty patients with unilateral ACL deficiency were randomised into two groups. We created the bone tunnels at the position of the original insertion of the anteromedial bundle footprint and posterolateral bundle footprint in the A-DB group and at the central position between these two bundles in the A-SB group. All of the patients were tested before ACL reconstruction and one year after surgery. The KT-1000 measurements, isokinetic muscle peak torque and heel-height difference were evaluated and the general knee condition was assessed by Lysholm score. For pre- and postoperative stability assessment, we used the six-degrees-of-freedom of knee kinematic measurement system using an electromagnetic device (the EMS) for quantitative assessment during the Lachman test and the pivot shift test. There were no significant differences in the KT-1000 measurements, isokinetic muscle peak torque, heel-height difference, and Lysholm score at one-year follow-up between these two groups. The EMS data showed there were significant differences in the acceleration of the pivot shift test between the operated knee and the contralateral normal knees in the A-SB group. In conclusion, clinical outcomes were equally good in both groups. However, the EMS data showed the anatomical double-bundle ACL reconstruction tended to be biomechanically superior to the single-bundle reconstruction.

  9. Prospective Phase II Single-Center Study of the Safety of a Single Very High Dose of Liposomal Amphotericin B for Antifungal Prophylaxis in Patients with Acute Myeloid Leukemia

    PubMed Central

    Annino, Luciana; Chierichini, Anna; Anaclerico, Barbara; Finolezzi, Erica; Norata, Marianna; Cortese, Stefania; Cassetta, Maria Iris; Fallani, Stefania; Novelli, Andrea

    2013-01-01

    Some preclinical and pharmacokinetic studies suggested the variable safety and the potential efficacy of an antifungal prophylaxis with a single high dose of liposomal amphotericin B (L-AmB) in high-risk patients. An open-label, prospective study was conducted with 48 adults receiving induction chemotherapy for acute myeloid leukemia (AML). Patients received a single infusion of 15 mg/kg of body weight L-AmB and, eventually, a second dose after 15 days of persistent neutropenia. The primary objective was tolerability and safety. Efficacy was also evaluated as a secondary endpoint. A pharmacokinetic study was performed with 34 patients in order to evaluate any association of plasma L-AmB levels with toxicity and efficacy. Overall, only 6 patients (12.5%) reported Common Toxicity Criteria (CTC) grade 3 hypokalemia, which was corrected with potassium supplementation in all cases, and no patient developed clinically relevant nephrotoxicity. Mild infusion-related adverse events occurred after 6 of 53 (11.3%) total infusions, with permanent drug discontinuation in only one case. Proven invasive fungal disease (IFD) was diagnosed in 4 (8.3%) patients. The mean AmB plasma levels at 6 h, 24 h, and 7 days after L-AmB administration were 160, 49.5, and 1 mg/liter, respectively. The plasma AmB levels were higher than the mean values of the overall population in 3 patients who developed CTC grade 3 hypokalemia and did not significantly differ from the mean values of the overall population in 3 patients who developed IFD. Our experience demonstrates the feasibility and safety of a single 15-mg/kg L-AmB dose as antifungal prophylaxis in AML patients undergoing induction chemotherapy. PMID:23529741

  10. A Prospective Randomized Double-blinded Pilot Study to Examine the Effect of Botulinum Toxin Type A Injection Versus Lidocaine/Depomedrol Injection on Residual and Phantom Limb Pain

    PubMed Central

    Wu, Hong; Sultana, Rizwana; Taylor, Kerrey Barton; Szabo, Aniko

    2013-01-01

    Objective Botulinum toxin type A (Botox) injection has been used to manage pain. However, it remains to be proved whether Botox injection is effective to relieve residual limb pain (RLP) and phantom limb pain (PLP). Design Randomized, double-blinded pilot study. Setting Medical College and an outpatient clinic in Department of Physical Medicine and Rehabilitation. Participants Amputees (n=14) with intractable RLP and/or PLP who failed in the conventional treatments. Interventions Study amputees were randomized to receive 1 Botox injection versus the combination of Lidocaine and Depomedrol injection. Each patient was evaluated at baseline and every month after the injection for 6 months. Main Outcome Measure The changes of RLP and PLP as recorded by VAS, and the changes of the pressure pain tolerance as determined by a pressure algometer. Results All patients completed the protocol treatment without acute side effects, and monthly assessments of RLP, PLP, and pain tolerance after the treatment. The time trend in the outcomes was modeled as an immediate change owing to the treatment followed by a linear tread afterward. Repeated measures were incorporated using mixed effects modeling. We found that both Botox and Lidocaine/Depomedrol injections resulted in immediate improvements of RLP (Botox: P=0.002; Lidocaine/Depomedrol: P=0.06) and pain tolerance (Botox: P=0.01; Lidocaine/Depomedrol: P=0.07). The treatment effect lasted for 6 months in both groups. The patients who received Botox injection had higher starting pain than those who received Lidocaine/Depomedrol injection (P=0.07). However, there were no statistical differences in RLP and pain tolerance between these 2 groups. In addition, no improvement of PLP was observed after Botox or Lidocaine/Depomedrol injection. Conclusions Both Botox and Lidocaine/Depomedrol injections resulted in immediate improvement of RLP (not PLP) and pain tolerance, which lasted for 6 months in amputees who failed in conventional

  11. 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

  12. 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.

  13. A prospective, randomized, double-blind study of vaginal microflora and epithelium in women using a tampon with an apertured film cover compared with those in women using a commercial tampon with a cover of nonwoven fleece.

    PubMed

    Chase, David J; Schenkel, Berenike P; Fahr, Anne-Marie; Eigner, Ulrich

    2007-04-01

    Healthy women with normal menstrual cycles were randomly assigned to use either a test tampon during cycle 1 and a reference tampon during cycle 2 or a reference tampon during cycle 1 and a test tampon during cycle 2. Tampons were identical except for their cover materials: apertured film for the test tampon and nonwoven fleece for the reference tampon. Product use was doubly blinded. Qualitative and quantitative analyses of vaginal cultures were done pre-, mid-, and postmenstrually for a broad panel of microorganisms, colposcopy was performed, and diary reports were collected; 101 of 105 enrolled subjects completed the study. Midmenstrual findings for a variety of organisms differed from pre- and postmenstrual observations whether subjects were using test or reference tampons. No statistically significant differences were noted in prevalence or colony counts at premenstrual versus mid- and postmenstrual visits for most microorganisms. Prevalences of Gardnerella and anaerobic gram-negative rods were significantly different between tampons at the premenstrual visit, when unusually low values were observed for the test and reference tampons, respectively. None of the changes or differences in microflora were considered to be clinically significant. It is noteworthy, however, that declines in the prevalence and abundance of Lactobacillus during the menstrual periods were less pronounced during the use of both test and reference tampons than those reported from previous studies. Colposcopy showed no abnormal findings with either tampon and no changes in vaginal or cervical epithelial integrity. Thus, all evidence from both microbiological and colposcopic evaluations indicates that the apertured film cover of the test tampon is as safe as the nonwoven cover of the reference tampon.

  14. 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

  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. 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.

  17. Testing Children for Color Blindness

    MedlinePlus

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

  18. Who's Leading the Blind?

    ERIC Educational Resources Information Center

    Dobbs, Kevin

    1999-01-01

    States that, although the nation's jobless rate hovers around 4-5%, 70% of the working-age blind who want jobs cannot find one, and 30% of those who are working are underemployed. Suggests that training, rehabilitation, and technology can help to solve the problem. (JOW)

  19. Autism and Congenital Blindness.

    ERIC Educational Resources Information Center

    Hobson, R. Peter; Lee, Anthony; Brown, Rachel

    1999-01-01

    This study compared a group of nine children (ages 3 to 8) with congenital blindness and an autism-like syndrome with nine sighted children. Children with autism had more severe abnormalities in terms of their relationships with people and emotional expressions, and were more impaired in the area of pretend play. (CR)

  20. On Simulating Blindness.

    ERIC Educational Resources Information Center

    Kappan, David

    Many educators in facilitative roles have approached the subject of visual disabilities by constructing activities designed to simulate blindness, using a blindfold or similar device. Participants are subsequently encouraged to perform rudimentary tasks such as eating a meal or moving about with a sighted companion as a guide. Frequently,…

  1. Corneal blindness and xenotransplantation.

    PubMed

    Lamm, Vladimir; Hara, Hidetaka; Mammen, Alex; Dhaliwal, Deepinder; Cooper, David K C

    2014-01-01

    Approximately 39 million people are blind worldwide, with an estimated 285 million visually impaired. The developing world shoulders 90% of the world's blindness, with 80% of causative diseases being preventable or treatable. Blindness has a major detrimental impact on the patient, community, and healthcare spending. Corneal diseases are significant causes of blindness, affecting at least 4 million people worldwide. The prevalence of corneal disease varies between parts of the world. Trachoma, for instance, is the second leading cause of blindness in Africa, after cataracts, but is rarely found today in developed nations. When preventive strategies have failed, corneal transplantation is the most effective treatment for advanced corneal disease. The major surgical techniques for corneal transplantation include penetrating keratoplasty (PK), anterior lamellar keratoplasty, and endothelial keratoplasty (EK). Indications for corneal transplantation vary between countries, with Fuchs' dystrophy being the leading indication in the USA and keratoconus in Australia. With the exception of the USA, where EK will soon overtake PK as the most common surgical procedure, PK is the overwhelming procedure of choice. Success using corneal grafts in developing nations, such as Nepal, demonstrates the feasibility of corneal transplantation on a global scale. The number of suitable corneas from deceased human donors that becomes available will never be sufficient, and so research into various alternatives, for example stem cells, amniotic membrane transplantation, synthetic and biosynthetic corneas, and xenotransplantation, is progressing. While each of these has potential, we suggest that xenotransplantation holds the greatest potential for a corneal replacement. With the increasing availability of genetically engineered pigs, pig corneas may alleviate the global shortage of corneas in the near future.

  2. Corneal blindness and xenotransplantation.

    PubMed

    Lamm, Vladimir; Hara, Hidetaka; Mammen, Alex; Dhaliwal, Deepinder; Cooper, David K C

    2014-01-01

    Approximately 39 million people are blind worldwide, with an estimated 285 million visually impaired. The developing world shoulders 90% of the world's blindness, with 80% of causative diseases being preventable or treatable. Blindness has a major detrimental impact on the patient, community, and healthcare spending. Corneal diseases are significant causes of blindness, affecting at least 4 million people worldwide. The prevalence of corneal disease varies between parts of the world. Trachoma, for instance, is the second leading cause of blindness in Africa, after cataracts, but is rarely found today in developed nations. When preventive strategies have failed, corneal transplantation is the most effective treatment for advanced corneal disease. The major surgical techniques for corneal transplantation include penetrating keratoplasty (PK), anterior lamellar keratoplasty, and endothelial keratoplasty (EK). Indications for corneal transplantation vary between countries, with Fuchs' dystrophy being the leading indication in the USA and keratoconus in Australia. With the exception of the USA, where EK will soon overtake PK as the most common surgical procedure, PK is the overwhelming procedure of choice. Success using corneal grafts in developing nations, such as Nepal, demonstrates the feasibility of corneal transplantation on a global scale. The number of suitable corneas from deceased human donors that becomes available will never be sufficient, and so research into various alternatives, for example stem cells, amniotic membrane transplantation, synthetic and biosynthetic corneas, and xenotransplantation, is progressing. While each of these has potential, we suggest that xenotransplantation holds the greatest potential for a corneal replacement. With the increasing availability of genetically engineered pigs, pig corneas may alleviate the global shortage of corneas in the near future. PMID:25268248

  3. Programs for the Deaf Blind.

    ERIC Educational Resources Information Center

    American Annals of the Deaf, 1987

    1987-01-01

    The directory lists 30 programs for deaf-blind children and youth, the 10 regional offices of the Helen Keller National Center for Deaf-Blind Youths and Adults, and five programs for training teachers of the deaf-blind. Provided for each program is address, director's name, and phone number. (DB)

  4. Postoperative pharyngolaryngeal adverse events with laryngeal mask airway (LMA Supreme) in laparoscopic surgical procedures with cuff pressure limiting 25 cmH₂O: prospective, blind, and randomised study.

    PubMed

    Kang, Joo-Eun; Oh, Chung-Sik; Choi, Jae Won; Son, Il Soon; Kim, Seong-Hyop

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH₂O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH₂O, L group) and high (at 60 cmH₂O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH₂O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334.

  5. 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. PMID:24850201

  6. Myelin Water Fraction Is Transiently Reduced after a Single Mild Traumatic Brain Injury--A Prospective Cohort Study in Collegiate Hockey Players.

    PubMed

    Wright, Alexander D; Jarrett, Michael; 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

  7. Circumcision with “no-flip Shang Ring” and “Dorsal Slit” methods for adult males: a single-centered, prospective, clinical study

    PubMed Central

    Lei, Jun-Hao; Liu, Liang-Ren; Wei, Qiang; Xue, Wen-Ben; Song, Tu-Run; Yan, Shi-Bing; Yang, Lu; Han, Ping; Zhu, Yu-Chun

    2016-01-01

    This paper was aimed to compare the clinical effectiveness and safety of adult male circumcision using the Shang Ring™ (SR) with the no-flip technique compared with Dorsal Slit (DS) surgical method. A single-centered, prospective study was conducted at the West China Hospital, where patients were circumcised using the no-flip SR (n = 408) or the DS (n = 94) procedure. The adverse events (AEs) and satisfaction were recorded for both groups, and ring-removal time and percentage of delayed removals were recorded for the SR group. Finally, complete follow-up data were collected for 76.1% of patients (SR: n = 306; DS: n = 76). The average ring-removal time for the SR group was 17.62 ± 6.30 days. The operation time (P < 0.001), pain scores during the procedure (P < 0.001) and at 24 h postoperatively (P < 0.001), bleeding (P = 0.001), infection (P = 0.034), and satisfaction with penile appearance (P < 0.001) in the SR group were superior to those in the DS group. After two postoperative weeks, the percentage of patients with edema in the SR group (P = 0.029) was higher but no differences were found at 4 weeks (P = 0.185) between the two groups. In conclusions, the no-flip SR method was found to be superior to the DS method for its short operation time (<5 min), involving less pain, bleeding, infection, and resulting in a satisfactory appearance. However, the time for recovery from edema took longer, and patients may wear device for 2–3 weeks after the procedure. PMID:26585694

  8. 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

  9. Myelin Water Fraction Is Transiently Reduced after a Single Mild Traumatic Brain Injury--A Prospective Cohort Study in Collegiate Hockey Players.

    PubMed

    Wright, Alexander D; Jarrett, Michael; 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.

  10. [The blindness in the literature-Jose Saramago: blindness and Albert Bang: the blind witness].

    PubMed

    Permin, H; Norn, M

    2001-01-01

    Two novels with different aspects of blindness seen through the doctors eyes. The Portuguese Nobel-prize winner José Saramago's story of a city struck by an epidemic of "white blindness", where the truth is what we cannot bear to see. The Danish author and unskilled labourer Albert Bang's (synonym with Karl E. Rasmussen) crime novel describes a blind or pretend to be blind butcher, who is a witness to a murder. Both novels are lyric, thought-provoking and insightful.

  11. A single blind randomized controlled trial of cognitive behavioural therapy in a help-seeking population with an At Risk Mental State for psychosis: the Dutch Early Detection and Intervention Evaluation (EDIE-NL) trial

    PubMed Central

    2010-01-01

    Background Psychotic disorders are a serious mental health problem. Intervention before the onset of psychosis might result in delaying the onset, reducing the impact or even preventing the first episode of psychosis. This study explores the effectiveness of cognitive behavioural therapy (CBT) in targeting cognitive biases that are involved in the formation of delusions in persons with an ultra-high risk for developing psychosis. A single blind randomised controlled trial compares CBT with treatment as usual in preventing or delaying the onset of psychosis. Method/design All help seeking patients aged 14 to 35 years referred to the mental health services in three regions in the Netherlands are pre-screened with the Prodromal Questionnaire during a period of two years. Patients with a score of 18 or more on the sub-clinical positive symptoms items (45 items in total) will be assessed with the Comprehensive Assessment of At Risk Mental State (CAARMS). In a different pathway to care model all referrals from the mental health services in Amsterdam to the specialized psychosis clinic of the Academic Medical Centre in Amsterdam are also assessed with the CAARMS. The primary outcome is the transition rate to psychosis according to the CAARMS-criteria. Group differences will be analysed with chi-square tests and survival analyses. Discussion CBT is a highly tolerated treatment. The psycho-educational CBT approach may prove to be a successful strategy since most people with an At Risk Mental State (ARMS) are distressed by odd disturbing experiences. Giving explanations for and normalising these experiences may reduce the arousal (distress) and therefore may prevent people from developing a catastrophic delusional explanation for their odd experiences and thus prevent them from developing psychosis. Screening the entire help-seeking population referred to community mental health services with a two-stage strategy, as compared with traditional referral to a specialist

  12. A multicentre, randomised, double-blind, single-dose study assessing the efficacy of AMC/DCBA Warm lozenge or AMC/DCBA Cool lozenge in the relief of acute sore throat

    PubMed Central

    2011-01-01

    Background Clinically proven over-the-counter (OTC) treatment options are becoming increasingly important in the self-management of acute sore throat. The aim of this study was to determine the analgesic and sensorial benefits of two different amylmetacresol/2,4-dichlorobenzyl alcohol (AMC/DCBA) throat lozenge formulation variants, AMC/DCBA Warm lozenge and AMC/DCBA Cool lozenge, compared with an unflavoured, non-medicated placebo lozenge in the relief of acute sore throat due to upper respiratory tract infections. Methods In this multicentre, randomised, double-blind, single-dose study, 225 adult patients with acute sore throat were randomly assigned to receive either one AMC/DCBA Warm lozenge (n = 77), one AMC/DCBA Cool lozenge (n = 74) or one unflavoured, non-medicated lozenge (matched for size, shape and demulcency; n = 74). After baseline assessments, patients received their assigned lozenge and completed four rating assessments at 11 timepoints from 1 to 120 minutes post dose. Analgesic properties were assessed by comparing severity of throat soreness and sore throat relief ratings. Difficulty in swallowing, throat numbness, functional, sensorial and emotional benefits were also assessed. Results Both the AMC/DCBA Warm and AMC/DCBA Cool lozenge induced significant analgesic, functional, sensorial and emotional effects compared with the unflavoured, non-medicated lozenge. Sore throat relief, improvements in throat soreness and difficulty in swallowing, and throat numbness were observed as early as 1-5 minutes, and lasted up to 2 hours post dose. Sensorial benefits of warming and cooling associated with the AMC/DCBA Warm and AMC/DCBA Cool lozenge, respectively, were experienced soon after first dose, and in the case of the latter, it lasted long after the lozenge had dissolved. Emotional benefits of feeling better, happier, less distracted and less frustrated were reported in those taking either of the AMC/DCBA throat lozenge variants, with no differences in

  13. Safety and Tolerability of Conserved Region Vaccines Vectored by Plasmid DNA, Simian Adenovirus and Modified Vaccinia Virus Ankara Administered to Human Immunodeficiency Virus Type 1-Uninfected Adults in a Randomized, Single-Blind Phase I Trial

    PubMed Central

    Hayton, Emma-Jo; Rose, Annie; Ibrahimsa, Umar; Del Sorbo, Mariarosaria; Capone, Stefania; Crook, Alison; Black, Antony P.; Dorrell, Lucy; Hanke, Tomáš

    2014-01-01

    Trial Design HIV-1 vaccine development has advanced slowly due to viral antigenic diversity, poor immunogenicity and recently, safety concerns associated with human adenovirus serotype-5 vectors. To tackle HIV-1 variation, we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome, which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA, a non-replicating simian (chimpanzee) adenovirus ChAdV-63 and a non-replicating poxvirus, modified vaccinia virus Ankara. A block-randomized, single-blind, placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1- vaccines or placebo to 32 healthy HIV-1/2-uninfected adults in Oxford, UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro. Here, detail safety and tolerability of these vaccines are reported. Methods Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards. Data on all other adverse events were collected using open questions. Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination. Results Two volunteers withdrew for vaccine-unrelated reasons. No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up. Local and systemic events after vaccination occurred in 27/32 individuals and most were mild (severity grade 1) and predominantly transient (<48 hours). Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo. There were no intercurrent HIV-1 infections during follow-up. 2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median (range) of 633 (231-1533) post-vaccination, which is of no safety concern. Conclusions These data demonstrate safety and good

  14. RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies

    PubMed Central

    Dahlberg, K; Odencrants, S; Hagberg, L

    2016-01-01

    Introduction Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient-related outcomes such as mobile applications. This article describes the Recovery Assessment by Phone Points (RAPP) study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost-effective and improves postoperative recovery, health and quality of life. Methods and analysis This study has a mixed-methods study design that includes a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. 1000 patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (ie, no follow-up). The primary aim is cost-effectiveness. Secondary aims are (A) to explore whether a systematic e-assessment follow-up after day surgery has a positive effect on postoperative recovery, health-related quality of life (QoL) and overall health; (B) to determine whether differences in postoperative recovery have an association with patient characteristic, type of surgery and anaesthesia; (C) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health and QoL; and (D) to describe day surgery patient and staff experiences with a systematic e-assessment follow-up after day surgery. The primary aim will be measured at 2 weeks postoperatively and secondary outcomes (A–C) at 1 and 2 weeks and (D) at 1 and 4 months. Trial registration number NCT02492191; Pre

  15. Nutrient-rich dairy proteins improve appendicular skeletal muscle mass and physical performance, and attenuate the loss of muscle strength in older men and women subjects: a single-blind randomized clinical trial

    PubMed Central

    Alemán-Mateo, Heliodoro; Carreón, Virginia Ramírez; Macías, Liliana; Astiazaran-García, Humberto; Gallegos-Aguilar, Ana Cristina; Ramos Enríquez, José Rogelio

    2014-01-01

    Background At present, it is unknown whether the use of nutrient-rich dairy proteins improves the markers of sarcopenia syndrome. Therefore, our proposal was to investigate whether adding 210 g of ricotta cheese daily would improve skeletal muscle mass, handgrip strength, and physical performance in non-sarcopenic older subjects. Subjects and methods This was a single-blind randomized clinical trial that included two homogeneous, randomized groups of men and women over 60 years of age. Participants in the intervention group were asked to consume their habitual diet but add 210 g of ricotta cheese (IG/HD + RCH), while the control group was instructed to consume only their habitual diet (CG/HD). Basal and 12-week follow-up measurements included appendicular skeletal muscle mass (ASMM) by dual-energy X-ray absorptiometry, handgrip strength by a handheld dynamometer, and physical performance using the short physical performance battery (SPPB) and the stair-climb power test (SCPT). The main outcomes were relative changes in ASMM, strength, SPPB, and SCPT. Results ASMM increased in the IG/HD + RCH (0.6±3.5 kg), but decreased in the CG/HD (−1.0±2.6). The relative change between groups was statistically significant (P=0.009). The relative change in strength in both groups was negative, but the loss of muscle strength was more pronounced in CG/HD, though in this regard statistical analysis found only a tendency (P=0.07). The relative change in the balance-test scores was positive for the IG/HD + RCH, while in the CG/HD it was negative, as those individuals had poorer balance. In this case, the relative change between groups did reach statistical significance. Conclusion The addition of 210 g of ricotta cheese improves ASMM and balance-test scores, while attenuating the loss of muscle strength. These results suggest that adding ricotta cheese to the habitual diet is a promising dietetic strategy that may improve the markers of sarcopenia in subjects without a pronounced

  16. Influence of habitual dietary fibre intake on the responsiveness of the gut microbiota to a prebiotic: protocol for a randomised, double-blind, placebo-controlled, cross-over, single-centre study

    PubMed Central

    Healey, Genelle; Brough, Louise; Butts, Chrissie; Murphy, Rinki; Whelan, Kevin; Coad, Jane

    2016-01-01

    Introduction The commensal gut microbiota have been shown to have an impact on human health as aberrant gut microbiota have been linked to disease. Dietary constituents are influential in shaping the gut microbiota. Diet-specific therapeutic strategies may therefore play a role in optimising human health via beneficial manipulation of the gut microbiota. Research has suggested that an individual's baseline gut microbiota composition may influence how the gut microbiota respond to a dietary intervention and individuals with differing habitual dietary intakes appear to have distinct baseline gut microbiota compositions. The responsiveness of the gut microbiota may therefore be influenced by habitual dietary intakes. This study aims to investigate what influence differing habitual dietary fibre intakes have on the responsiveness of the gut microbiota to a prebiotic intervention. Methods and analysis In this randomised, double-blind, placebo-controlled, cross-over, single-centre study, 20 low dietary fibre (dietary fibre intake <18 g/day for females and <22 g/day for males) and 20 high dietary fibre (dietary fibre intake ≥25 g/day for females and ≥30 g/day for males) consumers will be recruited. Participants will be randomised to a placebo (Glucidex 29 Premium) or a prebiotic (Synergy 1) intervention for 3 weeks with a 3-week washout followed by 3 weeks of the alternative intervention. Outcome measures of gut microbiota composition (using 16S rRNA gene sequencing) and functional capacity (faecal short chain fatty acid concentrations and Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt)) as well as appetite (visual analogue scale appetite questionnaire) will be assessed at the beginning and end of each intervention phase. Ethics and dissemination The Massey University Human Ethics Committee approved this study (Massey University HEC: Southern A application—15/34). Results will be disseminated through peer

  17. Quantum blind signature with an offline repository

    NASA Astrophysics Data System (ADS)

    Ribeiro, J.; Souto, A.; Mateus, P.

    2015-04-01

    We propose a quantum blind signature scheme that achieves perfect security under the assumption of an honest offline repository. The security of the protocol also relies on perfect private quantum channels, which are achievable using quantum one-time pads with keys shared via a quantum key distribution (QKD) protocol. The proposed approach ensures that signatures cannot be copied and that the sender must compromise to a single message, which are important advantages over classical protocols for certain applications.

  18. An evaluation of the effect of gonadotropin-releasing hormone analogs and medroxyprogesterone acetate on uterine leiomyomata volume by magnetic resonance imaging: a prospective, randomized, double blind, placebo-controlled, crossover trial.

    PubMed

    Carr, B R; Marshburn, P B; Weatherall, P T; Bradshaw, K D; Breslau, N A; Byrd, W; Roark, M; Steinkampf, M P

    1993-05-01

    The purpose of this study was to prospectively compare the effectiveness of administering medroxyprogesterone acetate (MPA; 20 mg/day) in either the first (protocol A) or last (protocol B) 12-week period along with a 6-month course of the GnRH analog (GnRH-a; leuprolide acetate; 1 mg/day, sc) on uterine and leiomyomata volumes and hormone (estradiol, LH, and FSH) and serum lipid (total cholesterol, triglycerides, and high and low density lipoprotein) levels. Sixteen women were randomized into protocol A or B, received either MPA or placebo along with GnRH-a, respectively, and were then crossed over at 12 weeks to placebo or MPA, respectively, for the final 12-week interval of GnRH-a therapy. Total, myoma, and nonmyoma uterine volumes were determined by magnetic resonance imaging, and serum studies were performed at the beginning of the study and at 12 and 24 weeks. In both protocols, LH and estradiol levels declined by 80-90% (P < 0.03) and 55-72% (P < 0.02) of the baseline, respectively, at 12 weeks and remained at this level at 24 weeks. There were no significant changes in the other laboratory tests between protocols or longitudinally over time. Total uterine volume decreased to 73% of the baseline at 12 weeks in protocol B (P < 0.04), but did not change in protocol A. After crossover at 12 weeks, the total uterine volume of women in protocol A decreased to 74% of the baseline (P < 0.02) at 24 weeks. Between-protocol comparisons demonstrated a greater decline in total uterine volume in protocol B than A at 12 weeks, but after cross-over, MPA addition was associated with a significant increase in total uterine volume (protocol B) compared to a decrease in protocol A at 24 weeks (P < 0.005). In contrast, although myoma volume declined in both protocols, no significant changes in myoma volume were detected within or between groups over the treatment period. Nonmyoma volume changes in protocols A and B roughly paralleled total uterine volume changes, with MPA

  19. Effect of an RNA interference drug on the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) and the concentration of serum LDL cholesterol in healthy volunteers: a randomised, single-blind, placebo-controlled, phase 1 trial

    PubMed Central

    Fitzgerald, Kevin; Frank-Kamenetsky, Maria; Shulga-Morskaya, Svetlana; Liebow, Abigail; Bettencourt, Brian R; Sutherland, Jessica E; Hutabarat, Renta M; Clausen, Valerie A; Karsten, Verena; Cehelsky, Jeffrey; Nochur, Saraswathy V; Kotelianski, Victor; Horton, Jay; Mant, Timothy; Chiesa, Joseph; Ritter, James; Munisamy, Malathy; Vaishnaw, Akshay K; Gollob, Jared A; Simon, Amy

    2015-01-01

    Summary Background Proprotein convertase subtilisin/kexin type 9 (PCSK9) binds to LDL receptors, leading to their degradation. Genetics studies have shown that loss-of-function mutations in PCSK9 result in reduced plasma LDL cholesterol and decreased risk of coronary heart disease. We aimed to investigate the safety and efficacy of ALN-PCS, a small interfering RNA that inhibits PCSK9 synthesis, in healthy volunteers with raised cholesterol who were not on lipid-lowering treatment. Methods We did a randomised, single-blind, placebo-controlled, phase 1 dose-escalation study in healthy adult volunteers with serum LDL cholesterol of 3·00 mmol/L or higher. Participants were randomly assigned in a 3:1 ratio by computer algorithm to receive one dose of intravenous ALN-PCS (with doses ranging from 0·015 to 0·400 mg/kg) or placebo. The primary endpoint was safety and tolerability of ALN-PCS. Secondary endpoints were the pharmacokinetic characteristics of ALN-PCS and its pharmacodynamic effects on PCSK9 and LDL cholesterol. Study participants were masked to treatment assignment. Analysis was per protocol and we used ANCOVA to analyse pharmacodynamic endpoint data. This trial is registered with ClinicalTrials.gov, number NCT01437059. Findings Of 32 participants, 24 were randomly allocated to receive a single dose of ALN-PCS (0·015 mg/kg [n=3], 0·045 mg/kg [n=3], 0·090 mg/kg [n=3], 0·150 mg/kg [n=3], 0·250 mg/kg [n=6], or 0·400 mg/kg [n=6]) and eight to placebo. The proportions of patients affected by treatment-emergent adverse events were similar in the ALN-PCS and placebo groups (19 [79%] vs seven [88%]). ALN-PCS was rapidly distributed, with peak concentration and area under the curve (0 to last measurement) increasing in a roughly dose-proportional way across the dose range tested. In the group given 0·400 mg/kg of ALN-PCS, treatment resulted in a mean 70% reduction in circulating PCSK9 plasma protein (p<0·0001) and a mean 40% reduction in LDL cholesterol from

  20. Single-Incision Slings (SIS) – a New Option for the Surgical Treatment of Female Stress Urinary Incontinence

    PubMed Central

    Naumann, G.; Albrich, S.; Skala, C.; Laterza, R.; Kölbl, H.

    2012-01-01

    The new development of single-incision slings (SIS) for the treatment of female stress urinary incontinence offers comparable results with only minimal side effects and will find wide acceptance in modern incontinence surgery. This mini-sling is inserted over a single vaginal incision and fixed on both sides to the pelvic wall tissue with special anchors, without passing through the groin and avoiding a blind tape passage. Compared with the established sub-urethral tapes, there are comparable success rates with fewer complications. Randomised prospective studies are needed to evaluate whether, in the long run, the benefits of the single incision technique can be correlated with satisfying continence results. PMID:25284829

  1. Iodinated Contrast Opacification Gradients in Normal Coronary Arteries Imaged with Prospectively ECG-Gated Single Heart Beat 320-Detector Row Computed Tomography

    PubMed Central

    Steigner, Michael L.; Mitsouras, Dimitrios; Whitmore, Amanda G.; Otero, Hansel J.; Wang, Chunliang; Buckley, Orla; Levit, Noah A.; Hussain, Alia Z.; Cai, Tianxi; Mather, Richard T.; Smedby, Örjan; DiCarli, Marcelo F.; Rybicki, Frank J.

    2011-01-01

    Background To define and evaluate coronary contrast opacification gradients using prospectively ECG-gated single heart beat 320-detector row coronary angiography (CTA). Methods and Results Thirty-six patients with normal coronary arteries determined by 320 × 0.5 mm detector row coronary CTA were retrospectively evaluated with customized image post-processing software to measure Hounsfield Units (HU) at 1 mm intervals orthogonal to the artery center line. Linear regression determined correlation between mean HU and distance from the coronary ostium (regression slope defined as the distance gradient Gd), lumen cross-sectional area (Ga), and lumen short axis diameter (Gs). For each gradient, differences between the three coronary arteries were analyzed with ANOVA. Linear regression determined correlations between measured gradients, heart rate, body-mass index (BMI), and cardiac phase. To determine feasibility in lesions, all three gradients were evaluated in 22 consecutive patients with left anterior descending artery lesions greater than or equal to 50% stenosis. For all 3 coronary arteries in all patients, the gradients Ga and Gs were significantly different from zero (p<0.0001), highly linear (Pearson r values 0.77-0.84), and had no significant difference between the LAD, LCx, and RCA (p>0.503). The distance gradient Gd demonstrated nonlinearities in a small number of vessels and was significantly smaller in the RCA when compared to the left coronary system (p<0.001). Gradient variations between cardiac phases, heart rates, BMI, and readers were low. Gradients in patients with lesions were significantly different (p<0.021) than in patients considered normal by CTA. Conclusions Measurement of contrast opacification gradients from temporally uniform coronary CTA demonstrates feasibility and reproducibility in patients with normal coronary arteries. For all patients the gradients defined with respect to the coronary lumen cross-sectional area and short axis

  2. Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

    PubMed Central

    Shin, Jae-Young; Lee, Jun-Hwan; Ku, Boncho; Bae, Jang Han; un, Min-Ho; Kim, Jaeuk U.; Kim, Tae-Hun

    2016-01-01

    Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer

  3. A Single-Center Pilot Prospective Study of Topical Application of Platelet-Derived Eye Drops for Patients with Ocular Chronic Graft-versus-Host Disease.

    PubMed

    Zallio, Francesco; Mazzucco, Laura; Monaco, Federico; Astori, Maria Rosa; Passera, Roberto; Drago, Giovanna; Tamiazzo, Stefania; Rapetti, Manuela; Dolcino, Daniela; Guaschino, Roberto; Pini, Massimo; Ladetto, Marco

    2016-09-01

    Ocular involvement of chronic graft-versus-host disease (cGVHD) is a complication that occurs in up to 60% of patients after allogeneic hematopoietic stem cell transplantation. Conventional therapeutic options include medical and surgical procedures that are administered depending on the severity of the condition, but most of them have provided unsatisfactory results and, to date, there is no consensus about treatment. We considered that topical application of a platelet lysate, administered as eye drops, might be considered an alternative worthwhile of investigation to treat ocular surface disorders in patients suffering from cGVHD. Therefore, we conducted a single-center prospective pilot study to assess the efficacy and safety of using eye drops made from reconstituted lysed platelet concentrate. Twenty-six patients with ocular cGVHD were eligible for the study; all but 2 completed their scheduled 1-year treatment and complied with the hematologic and ophthalmic regimen. At their first assessment interviews, after 30 days of treatment, 91% of patients reported an improvement in their symptoms and for 32%, substantive objective differences were measured. Remission of corneal damage was seen for 86% of our cohort, and improved National Institutes of Health scores for 73%, of whom 8% achieved the best score of 0 (ie, non-dry eye). Similar results were seen at later time points. Comparing outcomes for our patient cohort to those determined retrospectively for patients in our institutional database revealed a 5-year overall survival (OS) of 65%. This OS is comparable to patients with limited cGVHD (75%) and is superior to that of patients with nonocular extensive cGVHD or without cGVHD (30% and 59%, respectively) (P = .013). Our results suggest that platelet-derived eye drops are a safe, practical, and well-tolerated therapeutic option that offers substantial benefits for most patients affected by ocular cGVHD at onset. The favorable OS of our patient cohort

  4. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study

    PubMed Central

    Hibi, Toshifumi; Hirohata, Shunsei; Kikuchi, Hirotoshi; Tateishi, Ukihide; Sato, Noriko; Ozaki, Kunihiko; Kondo, Kazuoki; Ishigatsubo, Yoshiaki

    2016-01-01

    Abstract Behçet disease (BD) is a multisystem disease associated with a poor prognosis in cases of gastrointestinal, neurological, or vascular involvement. We conducted a multicenter, prospective, open-label, single-arm phase 3 study to determine the efficacy, safety, and pharmacokinetics of infliximab (IFX) in BD patients with these serious complications who had displayed poor response or intolerance to conventional therapy. IFX at 5 mg/kg was administered to 18 patients (11 intestinal BD, 3 neurological BD [NBD], and 4 vascular BD [VBD]) at weeks 0, 2, and 6 and every 8 weeks thereafter until week 46. In patients who showed inadequate responses to IFX after week 30, the dose was increased to 10 mg/kg. We then calculated the percentage of complete responders according to the predefined criteria depending on the symptoms and results of examinations (ileocolonoscopy, brain magnetic resonance imaging, computed tomography angiography, positron emission tomography, cerebrospinal fluid, or serum inflammatory markers), exploring the percentage of complete responders at week 30 (primary endpoint). The percentage of complete responders was 61% (11/18) at both weeks 14 and 30 and remained the same until week 54. Intestinal BD patients showed improvement in clinical symptoms along with decrease in C-reactive protein (CRP) levels after week 2. Consistently, scarring or healing of the principal ulcers was found in more than 80% of these patients after week 14. NBD patients showed improvement in clinical symptoms, imaging findings, and cerebrospinal fluid examinations. VBD patients showed improvement in clinical symptoms after week 2 with reductions in CRP levels and erythrocyte sedimentation rate. Imaging findings showed reversal of inflammatory changes in 3 of the 4 VBD patients. Irrespective of the type of BD, all patients achieved improvement in quality of life, leading to the dose reduction or withdrawal of steroids. IFX dose was increased to 10 mg/kg in 3

  5. Effects of Acupuncture Stimulation on the Radial artery’s Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

    PubMed Central

    Shin, Jae-Young; Lee, Jun-Hwan; Ku, Boncho; Bae, Jang Han; un, Min-Ho; Kim, Jaeuk U.; Kim, Tae-Hun

    2016-01-01

    Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery’s pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz (SE10-30Hz) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University’s Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer

  6. A Prospective, Multicentre, Open-Label Single-Arm Exploratory Study to Evaluate Efficacy and Safety of Saroglitazar on Hypertriglyceridemia in HIV Associated Lipodystrophy

    PubMed Central

    Joshi, Shashank

    2016-01-01

    Objective This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy. Methods During this 12-week prospective, multi-centric, open-label, single arm exploratory study, 50 patients were enrolled to receive saroglitazar 4 mg orally once daily in the morning before breakfast. The primary efficacy endpoint was the percent change in triglyceride (TG) levels from baseline to Week 6 and Week 12. The secondary efficacy endpoints were assessment of low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL), high-density-lipoprotein (HDL), non-HDL cholesterol, total cholesterol, apo-lipoprotein (Apo) A1, Apo B, and C-peptide and fasting insulin for HOMA beta and HOMA IR. Safety assessment was performed during the study. Results Saroglitazar 4 mg significantly decreased the serum TG levels from baseline at Week 6 (percent change: -40.98; 95% CI: -50.82, -31.15) and Week 12 (percent change -45.11; 95% CI: -52.37, -37.86). Reduction in VLDL cholesterol (percent change: -46.33; 95% CI: -52.89, -39.76) and total cholesterol (percent change: 7.37; 95% CI: 1.96, 12.78) was observed at week 12 from baseline. Saroglitazar increased HDL cholesterol (percent change: 34.56, 95% CI: 22.22, 46.90), Apo A1 (percent change: 33.16; 95% CI: 18.69, 47.63) and Apo B (percent change: 10.55, 95% CI: 2.86, 18.25) levels at week 12 from baseline. Saroglitazar treatment led to increase in the C-peptide (percent change: 59.42, 95% CI: 48.78, 70.06), fasting insulin levels (percent change: 47.10; 95% CI: 38.63, 55.57), HOMA of beta cell function for C-peptide (percent change: 71.67; 95% CI: 39.09, 104.26) and HOMA of insulin resistance for C-peptide (percent change: 58.29, 95% CI: 46.74, 69.83) at week 12 from baseline. Saroglitazar treatment was safe and well tolerated in this study. Conclusion Overall, the observed changes in lipid profile after 12 weeks of saroglitazar treatment were in the direction

  7. Malthus redux, and still blind in the same eye.

    PubMed

    Ross, Don

    2016-01-01

    Gowdy & Krall (G&K) essentially recapitulate Malthus's classic argument for ecological pessimism in modern biological dress. Their reasoning also reproduces Malthus's blindness to the implications of technological innovation. Agriculture might have suppressed human individualism as G&K insist, but technology has tended to foster it. This complicates human ecological prospects in a non-Malthusian way, and it might additionally provide the resources for deliverance from disaster.

  8. Malthus redux, and still blind in the same eye.

    PubMed

    Ross, Don

    2016-01-01

    Gowdy & Krall (G&K) essentially recapitulate Malthus's classic argument for ecological pessimism in modern biological dress. Their reasoning also reproduces Malthus's blindness to the implications of technological innovation. Agriculture might have suppressed human individualism as G&K insist, but technology has tended to foster it. This complicates human ecological prospects in a non-Malthusian way, and it might additionally provide the resources for deliverance from disaster. PMID:27562123

  9. Fighting blindness with microelectronics.

    PubMed

    Zrenner, Eberhart

    2013-11-01

    There is no approved cure for blindness caused by degeneration of the photoreceptor cells of the retina. However, there has been encouraging progress with attempts to restore vision using microelectronic retinal implant devices. Yet many questions remain to be addressed. Where is the best location to implant multielectrode arrays? How can spatial and temporal resolution be improved? What are the best ways to ensure the safety and longevity of these devices? Will color vision be possible? This Perspective discusses the current state of the art of retinal implants and attempts to address some of the outstanding questions.

  10. Effects of trans-4-(aminomethyl) cyclohexanecarboxylic acid/potassium azeloyl diglycinate/niacinamide topical emulsion in Thai adults with melasma: a single-center, randomized, double-blind, controlled study

    PubMed Central

    Viyoch, Jarupa; Tengamnuay, Isaree; Phetdee, Khemjira; Tuntijarukorn, Punpimol; Waranuch, Neti

    2010-01-01

    Background: Melasma is an acquired hyperpigmentary disorder characterized by dark patches or macules located on the cheeks, forehead, upper lip, chin, and neck. Treatment of melasma involves the use of topical hypopigmenting agents such as hydroquinone, tretinoin, and azelaic acid and its derivatives. Objective: The purpose of this study was to assess the efficacy of a formulation containing a combination of trans-4-(aminomethyl) cyclohexanecarboxylic acid/potassium azeloyl diglycinate/niacinamide compared with an emulsion-based control in the treatment of melasma in Thai adults. Methods: In this single-center, randomized, double-blind, controlled study, Thai patients with mild to moderate facial melasma (relative melanin value [RMV] in range of 20–120) were randomized for the application of either the test or the emulsion-based (control) product in the morning and before bedtime for 8 weeks. The supplemental sunscreen product with sun protection factor 30 was distributed to all patients. Subjects were assessed for the intensity of their hyperpigmented skin area by measuring the difference in the absolute melanin value between hyperpigmented skin and normal skin (RMV). This parameter was used as a primary outcome of this study. Additionally, the severity of melasma was determined visually using the Melasma Area and Severity Index (MASI) scored independently by 3 investigators. The assessments of melasma intensity and other skin properties were performed before administration (week 0) and every 2 weeks thereafter for up to 8 weeks. Other skin properties, including moisture content, pH, and redness (erythema value), were measured. Adverse events (AEs), including erythema, scaling, and edema, were also assessed by a dermatologist using the visual grading scale of Frosch and Kligman and COLIPA. Results: The resulting primary intent-to-treat (ITT) population included 33 patients in the test group and 34 patients in the control group. Sixty patients completed all 8

  11. Local restoration of dystrophin expression with the morpholino oligomer AVI-4658 in Duchenne muscular dystrophy: a single-blind, placebo-controlled, dose-escalation, proof-of-concept study

    PubMed Central

    Kinali, Maria; Arechavala-Gomeza, Virginia; Feng, Lucy; Cirak, Sebahattin; Hunt, David; Adkin, Carl; Guglieri, Michela; Ashton, Emma; Abbs, Stephen; Nihoyannopoulos, Petros; Garralda, Maria Elena; Rutherford, Mary; Mcculley, Caroline; Popplewell, Linda; Graham, Ian R; Dickson, George; Wood, Matthew JA; Wells, Dominic J; Wilton, Steve D; Kole, Ryszard; Straub, Volker; Bushby, Kate; Sewry, Caroline; Morgan, Jennifer E; Muntoni, Francesco

    2009-01-01

    Summary Background Mutations that disrupt the open reading frame and prevent full translation of DMD, the gene that encodes dystrophin, underlie the fatal X-linked disease Duchenne muscular dystrophy. Oligonucleotides targeted to splicing elements (splice switching oligonucleotides) in DMD pre-mRNA can lead to exon skipping, restoration of the open reading frame, and the production of functional dystrophin in vitro and in vivo, which could benefit patients with this disorder. Methods We did a single-blind, placebo-controlled, dose-escalation study in patients with DMD recruited nationally, to assess the safety and biochemical efficacy of an intramuscular morpholino splice-switching oligonucleotide (AVI-4658) that skips exon 51 in dystrophin mRNA. Seven patients with Duchenne muscular dystrophy with deletions in the open reading frame of DMD that are responsive to exon 51 skipping were selected on the basis of the preservation of their extensor digitorum brevis (EDB) muscle seen on MRI and the response of cultured fibroblasts from a skin biopsy to AVI-4658. AVI-4658 was injected into the EDB muscle; the contralateral muscle received saline. Muscles were biopsied between 3 and 4 weeks after injection. The primary endpoint was the safety of AVI-4658 and the secondary endpoint was its biochemical efficacy. This trial is registered, number NCT00159250. Findings Two patients received 0·09 mg AVI-4658 in 900 μL (0·9%) saline and five patients received 0·9 mg AVI-4658 in 900 μL saline. No adverse events related to AVI-4658 administration were reported. Intramuscular injection of the higher-dose of AVI-4658 resulted in increased dystrophin expression in all treated EDB muscles, although the results of the immunostaining of EDB-treated muscle for dystrophin were not uniform. In the areas of the immunostained sections that were adjacent to the needle track through which AVI-4658 was given, 44–79% of myofibres had increased expression of dystrophin. In randomly chosen

  12. A Single-blinded, Randomized Clinical Trial of How to Implement an Evidence-based Treatment for Generalized Anxiety Disorder [IMPLEMENT] — Effects of Three Different Strategies of Implementation

    PubMed Central

    Flückiger, Christoph; Forrer, Lena; Schnider, Barbara; Bättig, Isabelle; Bodenmann, Guy; Zinbarg, Richard E.

    2015-01-01

    Background Despite long-standing calls to disseminate evidence-based treatments for generalized anxiety (GAD), modest progress has been made in the study of how such treatments should be implemented. The primary objective of this study was to test three competing strategies on how to implement a cognitive behavioral treatment (CBT) for out-patients with GAD (i.e., comparison of one compensation vs. two capitalization models). Methods For our three-arm, single-blinded, randomized controlled trial (implementation of CBT for GAD [IMPLEMENT]), we recruited adults with GAD using advertisements in high-circulation newspapers to participate in a 14-session cognitive behavioral treatment (Mastery of your Anxiety and Worry, MAW-packet). We randomly assigned eligible patients using a full randomization procedure (1:1:1) to three different conditions of implementation: adherence priming (compensation model), which had a systematized focus on patients' individual GAD symptoms and how to compensate for these symptoms within the MAW-packet, and resource priming and supportive resource priming (capitalization model), which had systematized focuses on patients' strengths and abilities and how these strengths can be capitalized within the same packet. In the intention-to-treat population an outcome composite of primary and secondary symptoms-related self-report questionnaires was analyzed based on a hierarchical linear growth model from intake to 6-month follow-up assessment. This trial is registered at ClinicalTrials.gov (identifier: NCT02039193) and is closed to new participants. Findings From June 2012 to Nov. 2014, from 411 participants that were screened, 57 eligible participants were recruited and randomly assigned to three conditions. Forty-nine patients (86%) provided outcome data at post-assessment (14% dropout rate). All three conditions showed a highly significant reduction of symptoms over time. However, compared with the adherence priming condition, both resource

  13. Blind fastening apparatus

    NASA Astrophysics Data System (ADS)

    Willey, Norman F.; Linker, James F.

    1993-03-01

    An anchor nut insert is provided having external threads for engaging an internally threaded receptacle of a fixture to be installed. The fixture also has two side wings flanking the receptacle and having fastener holes. An insert driver is provided having a projecting blade which engages a slot in the anchor nut insert for driving the insert. A guide member, such as a wire, passes through symmetry axes of the anchor nut insert and insert driver such that the anchor nut insert is located between the insert driver and a first terminal end of the guide wire. A swag is provided on this terminal end to prevent the anchor nut insert and insert driver from sliding off the end. The fixture with the installed anchor nut insert is fed through the central hole in a structure wall having a blind side. The fixture is rotated until the wing holes are aligned with side holes in the wall and then the fixture is pulled flush against the blind side via the guide wire. Fasteners are then inserted through the hole and the anchor nut insert removed via the driver, exposing the fixed threaded receptacle for engagement as desired.

  14. Corneal blindness: a global perspective.

    PubMed Central

    Whitcher, J. P.; Srinivasan, M.; Upadhyay, M. P.

    2001-01-01

    Diseases affecting the cornea are a major cause of blindness worldwide, second only to cataract in overall importance. The epidemiology of corneal blindness is complicated and encompasses a wide variety of infectious and inflammatory eye diseses that cause corneal scarring, which ultimately leads to functional blindness. In addition, the prevalence of corneal disease varies from country to country and even from one population to another. While cataract is responsible for nearly 20 million of the 45 million blind people in the world, the next major cause is trachoma which blinds 4.9 million individuals, mainly as a result of corneal scarring and vascularization. Ocular trauma and corneal ulceration are significant causes of corneal blindness that are often underreported but may be responsible for 1.5-2.0 million new cases of monocular blindness every year. Causes of childhood blindness (about 1.5 million worldwide with 5 million visually disabled) include xerophthalmia (350,000 cases annually), ophthalmia neonatorum, and less frequently seen ocular diseases such as herpes simplex virus infections and vernal keratoconjunctivitis. Even though the control of onchocerciasis and leprosy are public health success stories, these diseases are still significant causes of blindness--affecting a quarter of a million individuals each. Traditional eye medicines have also been implicated as a major risk factor in the current epidemic of corneal ulceration in developing countries. Because of the difficulty of treating corneal blindness once it has occurred, public health prevention programmes are the most cost-effective means of decreasing the global burden of corneal blindness. PMID:11285665

  15. Long-Term Single and Joint Effects of Excessive Daytime Napping on the HOMA-IR Index and Glycosylated Hemoglobin: A Prospective Cohort Study.

    PubMed

    Li, Xue; Pang, Xiuyu; Zhang, Qiao; Qu, Qiannuo; Hou, Zhigang; Liu, Zhipeng; Lv, Lin; Na, Guanqiong; Zhang, Wei; Sun, Changhao; Li, Ying

    2016-02-01

    This prospective cohort study was conducted to assess the duration of daytime napping and its effect combined with night sleep deprivation on the risk of developing high HOMA-IR (homeostasis model assessment of insulin resistance) index and disadvantageous changes in glycosylated hemoglobin (HbA1c) levels.A total of 5845 diabetes-free subjects (2736 women and 3109 men), 30 to 65 years of age, were targeted for this cohort study since 2008. Multiple adjusted Cox regression models were performed to evaluate the single and joint effects of daytime napping on the risk of an elevated HbA1c level and high HOMA-IR index.After an average of 4.5 years of follow-up, >30 minutes of daytime napping was significantly associated with an increased risk of an elevated HbA1c level (>6.5%) in men and women (all P trend < 0.05). Hazard ratios (HRs) for an HbA1c level between 5.7% and 6.4% were also significant in the entire cohort and women, but nonsignificant in men. HRs (95% confidence interval, CIs) for the high HOMA-IR index in the entire cohort, men, and women were 1.33 (1.10-1.62), 1.46 (1.08-1.98), and 1.47 (1.12-1.91), respectively. The combination of sleep deprivation with no naps or >30 minutes napping and the combination of no sleep deprivation with >30 minutes daytime napping were all associated with an HbA1c level >6.5% (HR = 2.08, 95% CI = 1.24-3.51; HR = 4.00, 95% CI = 2.03-7.90; and HR = 2.05, 95% CI = 1.29-3.27, respectively). No sleep deprivation combined with >30 minutes daytime napping correlated with a high risk of an HbA1c level between 5.7% and 6.4% and high HOMA-IR index (HR = 2.12, 95% CI = 1.48-3.02; and HR = 1.35, 95% CI = 1.10-1.65, respectively).Daytime napping >30 minutes was associated with a high risk of an elevated HbA1c level and high HOMA-IR index. No sleep deprivation combined with napping >30 minutes carries a risk of abnormal glucose metabolism. Sleep deprivation combined with brief daytime napping <30

  16. Long-Term Single and Joint Effects of Excessive Daytime Napping on the HOMA-IR Index and Glycosylated Hemoglobin: A Prospective Cohort Study.

    PubMed

    Li, Xue; Pang, Xiuyu; Zhang, Qiao; Qu, Qiannuo; Hou, Zhigang; Liu, Zhipeng; Lv, Lin; Na, Guanqiong; Zhang, Wei; Sun, Changhao; Li, Ying

    2016-02-01

    This prospective cohort study was conducted to assess the duration of daytime napping and its effect combined with night sleep deprivation on the risk of developing high HOMA-IR (homeostasis model assessment of insulin resistance) index and disadvantageous changes in glycosylated hemoglobin (HbA1c) levels.A total of 5845 diabetes-free subjects (2736 women and 3109 men), 30 to 65 years of age, were targeted for this cohort study since 2008. Multiple adjusted Cox regression models were performed to evaluate the single and joint effects of daytime napping on the risk of an elevated HbA1c level and high HOMA-IR index.After an average of 4.5 years of follow-up, >30 minutes of daytime napping was significantly associated with an increased risk of an elevated HbA1c level (>6.5%) in men and women (all P trend < 0.05). Hazard ratios (HRs) for an HbA1c level between 5.7% and 6.4% were also significant in the entire cohort and women, but nonsignificant in men. HRs (95% confidence interval, CIs) for the high HOMA-IR index in the entire cohort, men, and women were 1.33 (1.10-1.62), 1.46 (1.08-1.98), and 1.47 (1.12-1.91), respectively. The combination of sleep deprivation with no naps or >30 minutes napping and the combination of no sleep deprivation with >30 minutes daytime napping were all associated with an HbA1c level >6.5% (HR = 2.08, 95% CI = 1.24-3.51; HR = 4.00, 95% CI = 2.03-7.90; and HR = 2.05, 95% CI = 1.29-3.27, respectively). No sleep deprivation combined with >30 minutes daytime napping correlated with a high risk of an HbA1c level between 5.7% and 6.4% and high HOMA-IR index (HR = 2.12, 95% CI = 1.48-3.02; and HR = 1.35, 95% CI = 1.10-1.65, respectively).Daytime napping >30 minutes was associated with a high risk of an elevated HbA1c level and high HOMA-IR index. No sleep deprivation combined with napping >30 minutes carries a risk of abnormal glucose metabolism. Sleep deprivation combined with brief daytime napping <30

  17. Overview on Deaf-Blindness

    ERIC Educational Resources Information Center

    Miles, Barbara

    2008-01-01

    It may seem that deaf-blindness refers to a total inability to see or hear. However, in reality deaf-blindness is a condition in which the combination of hearing and visual losses in children cause "such severe communication and other develop mental and educational needs that they cannot be accommodated in special education programs solely for…

  18. How to Succeed at Being Blind

    ERIC Educational Resources Information Center

    Selvin, Hanan C.

    1976-01-01

    The author, a professional sociologist who lost his sight, provides practical advice and information to people who are becoming blind or who have recently become blind, and others who know or work with blind persons. (Author/IM)

  19. Looking at a blinking quantum emitter through time slots: The effect of blind times

    NASA Astrophysics Data System (ADS)

    Shchukina, A. L.; Eremchev, I. Yu.; Naumov, A. V.

    2015-09-01

    Most experimental observations of physical processes are naturally accompanied by "blind" ("dead") times, which in principle can distort the result of measurements. Here we analyze how the presence of blind times in measurements changes the measured statistics of blinking fluorescence of single quantum dots. We show that information can be extracted even for blinking processes with characteristic times longer than both blind times and time slots between them.

  20. Long-term results from an epiretinal prosthesis to restore sight to the blind

    PubMed Central

    Ho, Allen C.; Humayun, Mark S.; Dorn, Jessy D.; da Cruz, Lyndon; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; de Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C.; Brown, Gary C.; Haller, Julia A.; Regillo, Carl D.; Del Priore, Lucian V.; Arditi, Aries; Geruschat, Duane R.; Greenberg, Robert J.

    2015-01-01

    Purpose Retinitis Pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. A rare disease, it affects about 100,000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in restoring some visual function to subjects completely blind from RP. Herein, we report clinical trial results at 1 and 3 years post-implant. Design The study is a multicenter, single-arm, prospective clinical trial. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Subjects served as their own controls – i.e., implanted eye vs. fellow eye, and System ON vs. System OFF (native residual vision). Methods The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Results Twenty-nine out of 30 subjects remained implanted with functioning Argus II Systems at 3 years post-implant. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the System ON than OFF on all visual function tests and functional vision assessments. Conclusions The three-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the FDA

  1. Blindness from quinine toxicity.

    PubMed Central

    Bacon, P; Spalton, D J; Smith, S E

    1988-01-01

    We report a case of quinine overdose in a 47-year-old man who presented with blindness. Fundus photography demonstrates the acute and subsequent retinal changes, and his visual recovery to normal acuity with visual field constriction is documented. Pupillary and electrodiagnostic findings are recorded. Stellate ganglion block has been widely advocated as a helpful therapeutic measure, but out patient was treated with a unilateral stellate ganglion block without apparent benefit to that eye. From a review of the literature we believe that quinine produces its effects by toxicity on the retina rather than by vasoconstriction and that stellate ganglion block probably does not alter the natural history of the retinal toxicity. Images PMID:3281709

  2. Blind Pilot Decontamination

    NASA Astrophysics Data System (ADS)

    Muller, Ralf R.; Cottatellucci, Laura; Vehkapera, Mikko

    2014-10-01

    A subspace projection to improve channel estimation in massive multi-antenna systems is proposed and analyzed. Together with power-controlled hand-off, it can mitigate the pilot contamination problem without the need for coordination among cells. The proposed method is blind in the sense that it does not require pilot data to find the appropriate subspace. It is based on the theory of large random matrices that predicts that the eigenvalue spectra of large sample covariance matrices can asymptotically decompose into disjoint bulks as the matrix size grows large. Random matrix and free probability theory are utilized to predict under which system parameters such a bulk decomposition takes place. Simulation results are provided to confirm that the proposed method outperforms conventional linear channel estimation if bulk separation occurs.

  3. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

    PubMed Central

    Festin, Mario P.R.; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M. Valeria; Kapp, Nathalie

    2016-01-01

    STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability

  4. Short-Term Effects of Kinesio Taping and Cross Taping Application in the Treatment of Latent Upper Trapezius Trigger Points: A Prospective, Single-Blind, Randomized, Sham-Controlled Trial.

    PubMed

    Halski, Tomasz; Ptaszkowski, Kuba; Słupska, Lucyna; Paprocka-Borowicz, Małgorzata; Dymarek, Robert; Taradaj, Jakub; Bidzińska, Gabriela; Marczyński, Daniel; Cynarska, Aleksandra; Rosińczuk, Joanna

    2015-01-01

    Kinesio taping (KT) may be a new treatment in patients with myofascial trigger points (MTrPs). A new method available for taping practitioners is cross taping (CT). The main objective was to determine how CT, KT, and medical adhesive tape (sham group) affect the subjective assessment of resting bioelectrical activity and pain of the upper trapezius muscle (UT) in patients with MTrPs. 105 volunteers were recruited to participate. The primary outcome was resting bioelectrical activity of UT muscle as assessed by surface electromyography (sEMG) in each group and pain intensity on a visual analog scale (VAS). Assessments were collected before and after intervention and after the 24-hours follow-up. No significant differences were observed in bioelectrical activity of UT between pre-, post-, and follow-up results. In three groups patients had significantly lower pain VAS score after the intervention (CT-p < 0.001, KT-p < 0.001, and sham-p < 0.01). The Kruskal-Wallis ANOVA showed no significant differences in almost all measurements between groups. The application of all three types of tapes does not influence the resting bioelectrical activity of UT muscle and may not lead to a reduction in muscle tone in the case of MTrPs. PMID:26491458

  5. Prospective, randomized, single-blind comparison of effects of 6 months' treatment with atorvastatin versus pravastatin on leptin and angiogenic factors in patients with coronary artery disease.

    PubMed

    Takahashi, Yuji; Satoh, Mamoru; Tabuchi, Tsuyoshi; Nakamura, Motoyuki

    2012-07-01

    Leptin has been reported to exert an atherosclerotic effect by regulating expression of angiogenic factors that have been implicated in the pathogenesis of coronary artery disease (CAD). The purpose of this study was to investigate whether lipid-lowering therapy (LLT) with statins could affect leptin levels and angiogenic factors in patients with CAD. This study included 76 patients with CAD and 15 subjects without CAD (non-CAD). CAD patients were randomized to 6 months of intensive LLT with atorvastatin or moderate LLT with pravastatin. Plasma leptin, angiopoetin-2 (Ang-2), hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF) levels were measured prior to statin therapy (baseline) and after 6 months. Baseline levels of leptin, Ang-2, HGF and VEGF were higher in the CAD group than in the non-CAD group (all P < 0.05). Treatment with intensive LLT decreased leptin, Ang-2, HGF and VEGF levels, whereas moderate LLT did not change these levels. This study suggests that LLT with atorvastatin decreases leptin levels and angiogenic factors in patients with CAD, possibly contributing to the beneficial effects of LLT with atorvastatin in CAD. PMID:21643812

  6. Comparison of the effectiveness and tolerability of intravenous or oral glucocorticoids associated with orbital radiotherapy in the management of severe Graves' ophthalmopathy: results of a prospective, single-blind, randomized study.

    PubMed

    Marcocci, C; Bartalena, L; Tanda, M L; Manetti, L; Dell'Unto, E; Rocchi, R; Barbesino, G; Mazzi, B; Bartolomei, M P; Lepri, P; Cartei, F; Nardi, M; Pinchera, A

    2001-08-01

    Eighty-two consecutive patients with moderate-to-severe and active Graves' ophthalmopathy were randomly treated with orbital radiotherapy combined with either oral (prednisone; starting dose, 100 mg/d; withdrawal after 5 months) or iv (methylprednisolone; 15 mg/kg for four cycles and then 7.5 mg/kg for four cycles; each cycle consisted of two infusions on alternate days at 2-wk intervals) glucocorticoids. The two groups did not differ for age, gender, duration of hyperthyroidism and ophthalmopathy, prevalence of smokers, thyroid volume, and pretreatment ocular conditions. Both groups of patients received radioiodine therapy shortly before treatment for Graves' ophthalmopathy. Follow-up lasted for 12 months. A significant reduction in proptosis (from 23.2 +/- 3.0 to 21.6 +/- 1.2 mm in the iv glucocorticoid group, P < 0.0001; and from 23 +/- 1.8 to 21.7 +/- 1.8 mm in oral glucocorticoid group, P < 0.0001) and in lid width (from 13.3 +/- 2.5 to 11.8 +/- 2.2 mm, and from 13.6 +/- 2.0 to 11.5 +/- 1.9 mm, respectively; P < 0.001 in both cases) occurred, with no difference between the two groups. Diplopia significantly improved in both groups: it disappeared in 13 of 27 (48.1%) iv glucocorticoid patients (P < 0.005) and in 12 of 33 (36.4%) oral glucocorticoid patients (P < 0.03). The degree of amelioration of diplopia did not significantly differ between the two groups (P = 0.82). Optic neuropathy improved in 11 of 14 iv glucocorticoid (P < 0.01) and only in 3 of 9 oral glucocorticoid (P = 0.57) patients, with no significant difference in these outcomes. The Clinical Activity Score decreased from 4.5 +/- 1.2 to 1.7 +/- 1.0 (P < 0.0001) in the iv glucocorticoid group and from 4.2 +/- 1.1 to 2.2 +/- 1.2 (P < 0.0001) in the oral glucocorticoid group; final Clinical Activity Score was significantly lower in iv glucocorticoid than in oral glucocorticoid patients (P < 0.01). By self-assessment evaluation, 35 (85.3%) iv glucocorticoid and 30 (73.2%) oral glucocorticoid patients reported an improvement of ocular conditions (P = 0.27). Overall, both treatments produced favorable effects in most patients, but responders in the iv glucocorticoid group (36 of 41, 87.8%) were more than in the oral glucocorticoid group (26 of 41, 63.4%) (P < 0.02). Moreover, iv glucocorticoid treatment was better tolerated than oral glucocorticoid treatment. Side effects occurred in 23 (56.1%) iv glucocorticoid and 35 (85.4%) oral glucocorticoid patients (P < 0.01); in particular, cushingoid features developed in 5 of the former and 35 of the latter patients. One iv glucocorticoid patient had severe hepatitis of undetermined origin at the end of glucocorticoid treatment, followed by spontaneous recovery. In conclusion, high-dose iv glucocorticoid and oral glucocorticoid (associated with orbital radiotherapy) are effective in the management of severe Graves' ophthalmopathy, but the iv route seems to be more effective and better tolerated than the oral route and associated with a lower rate of side effects.

  7. Short-Term Effects of Kinesio Taping and Cross Taping Application in the Treatment of Latent Upper Trapezius Trigger Points: A Prospective, Single-Blind, Randomized, Sham-Controlled Trial

    PubMed Central

    Halski, Tomasz; Ptaszkowski, Kuba; Słupska, Lucyna; Paprocka-Borowicz, Małgorzata; Dymarek, Robert; Taradaj, Jakub; Bidzińska, Gabriela; Marczyński, Daniel; Cynarska, Aleksandra; Rosińczuk, Joanna

    2015-01-01

    Kinesio taping (KT) may be a new treatment in patients with myofascial trigger points (MTrPs). A new method available for taping practitioners is cross taping (CT). The main objective was to determine how CT, KT, and medical adhesive tape (sham group) affect the subjective assessment of resting bioelectrical activity and pain of the upper trapezius muscle (UT) in patients with MTrPs. 105 volunteers were recruited to participate. The primary outcome was resting bioelectrical activity of UT muscle as assessed by surface electromyography (sEMG) in each group and pain intensity on a visual analog scale (VAS). Assessments were collected before and after intervention and after the 24-hours follow-up. No significant differences were observed in bioelectrical activity of UT between pre-, post-, and follow-up results. In three groups patients had significantly lower pain VAS score after the intervention (CT—p < 0.001, KT—p < 0.001, and sham—p < 0.01). The Kruskal-Wallis ANOVA showed no significant differences in almost all measurements between groups. The application of all three types of tapes does not influence the resting bioelectrical activity of UT muscle and may not lead to a reduction in muscle tone in the case of MTrPs. PMID:26491458

  8. Repetition blindness and homophone blindness in young and older adults.

    PubMed

    Tyrrell, Caitlin J; James, Lori E; Noble, Paula M

    2016-11-01

    We tested age effects on repetition blindness (RB), defined as the reduced probability of reporting a target word following presentation of the same word in a rapidly presented list. We also tested age effects on homophone blindness (HB), in which the first word is a homophone of the target word rather than a repeated word. Thirty young and 28 older adults viewed rapidly presented lists of words containing repeated, homophone, or unrepeated word pairs and reported all of the words immediately after each list. Older adults exhibited a greater degree of RB and HB than young adults using a conditional scoring method that provides certainty that blindness has occurred. The existence of RB and HB for both age groups, and increased blindness for older compared to young adults, supports predictions of a binding theory that has successfully accounted for a wide range of phenomena in cognitive aging.

  9. Implicit binding of facial features during change blindness.

    PubMed

    Lyyra, Pessi; Mäkelä, Hanna; Hietanen, Jari K; Astikainen, Piia

    2014-01-01

    Change blindness refers to the inability to detect visual changes if introduced together with an eye-movement, blink, flash of light, or with distracting stimuli. Evidence of implicit detection of changed visual features during change blindness has been reported in a number of studies using both behavioral and neurophysiological measurements. However, it is not known whether implicit detection occurs only at the level of single features or whether complex organizations of features can be implicitly detected as well. We tested this in adult humans using intact and scrambled versions of schematic faces as stimuli in a change blindness paradigm while recording event-related potentials (ERPs). An enlargement of the face-sensitive N170 ERP component was observed at the right temporal electrode site to changes from scrambled to intact faces, even if the participants were not consciously able to report such changes (change blindness). Similarly, the disintegration of an intact face to scrambled features resulted in attenuated N170 responses during change blindness. Other ERP deflections were modulated by changes, but unlike the N170 component, they were indifferent to the direction of the change. The bidirectional modulation of the N170 component during change blindness suggests that implicit change detection can also occur at the level of complex features in the case of facial stimuli.

  10. Facilitation of Communication Responses through Naturalized Sensory Reinforcement in Blind Mute/Profoundly Retarded Adults.

    ERIC Educational Resources Information Center

    Crawford, Michael E.

    The literature on symbolic forms of communication was reviewed, and an experimental program was designed to teach a single set of vocabulary to a group of four institutionalized profoundly retarded blind/mute adults through the use of gestures. Literature about deaf/blind persons suggested the use of coactive movement techniques and facilitation…

  11. Empathy's blind spot.

    PubMed

    Slaby, Jan

    2014-05-01

    The aim of this paper is to mount a philosophical challenge to the currently highly visible research and discourse on empathy. The notion of empathetic perspective-shifting-a conceptually demanding, high-level construal of empathy in humans that arguably captures the core meaning of the term-is criticized from the standpoint of a philosophy of normatively accountable agency. Empathy in this demanding sense fails to achieve a true understanding of the other and instead risks to impose the empathizer's self-constitutive agency upon the person empathized with. Attempts to 'simulate' human agency, or attempts to emulate its cognitive or emotional basis, will likely distort their target phenomena in profound ways. Thus, agency turns out to be empathy's blind spot. Elements of an alternative understanding of interpersonal relatedness are also discussed, focusing on aspects of 'interaction theory'. These might do some of the work that high-level constructs of empathy had been supposed to do without running into similar conceptual difficulties. PMID:24420745

  12. Evaluation of safety and immunogenicity of HNVAC, an MDCK-based H1N1 pandemic influenza vaccine, in Phase I single centre and Phase II/III multi-centre, double-blind, randomized, placebo-controlled, parallel assignment studies.

    PubMed

    Basavaraj, V H; Sampath, G; Hegde, Nagendra R; Mohan, V Krishna; Ella, Krishna M

    2014-07-31

    The clinical evaluation of the MDCK-based H1N1 pandemic influenza vaccine HNVAC in adults aged 18-65 years is reported. In the Phase I randomized, double-blind, placebo-controlled, single-centre study, 160 subjects were parallelly assigned 3:1 to vaccine:placebo groups (n=60:20) with both the aluminium hydroxide adjuvanted and non-adjuvanted vaccine formulations. A single dose of both the formulations containing 15 μg of haemagglutinin protein showed minimal adverse reactions, the most common of which were pain at injection site (11.67%) and fever (10.00%). Both formulations produced 74-81% seroprotection (SRP: titre of ≥40), 67-70% seroconversion (SRC: four-fold increase in titres between days 0 and 21), and a four-fold increase in geometric mean titres (GMT). Aluminium hydroxide did not have a significant effect either on immunogenicity or on reactogenicity. Nevertheless, based on its recognized positive effects on the stability and immunogenicity of many vaccines, and its marginal benefit in both pre-clinical and Phase I studies of HNVAC, alum adjuvanted HNVAC was further tested in a staggered Phase II/III randomized, double-blind, placebo-controlled, multi-centre study of 200 and 195 subjects, respectively, parallelly assigned 4:1 to adjuvanted vaccine and placebo groups. In these studies, the most common adverse reactions were pain at injection site (6.88% and 5.77% in Stage 1 and Stage 2, respectively) and fever (7.50% and 7.05%, respectively), and a single dose resulted in 87-90% SRP, 85-86% SRC, and a nearly six-fold increase in GMT, meeting or exceeding licensing criteria. It is concluded that HNVAC is safe and immunogenic to adults of 18-65 years.

  13. Laboratory Techniques for the Blind

    ERIC Educational Resources Information Center

    Tombaugh, Dorothy

    1972-01-01

    Describes modifications of laboratory procedures for the BSCS Green Version biology, including dissection, microbiology, animal behavior, physiology, biochemistry, and genetics that make the methods suitable for direct experimentation by blind students. Discusses models as substitutes for microscopy. (AL)

  14. Student Art for Blind Children.

    ERIC Educational Resources Information Center

    Vanda, Kay

    1982-01-01

    Describes a project in which high school student volunteers designed art activities for blind children. Students incorporated the sensation of motion and texture into their designs for toys, puzzles, games, and story illustrations. (AM)

  15. Image Quality and Radiation Dose for Prospectively Triggered Coronary CT Angiography: 128-Slice Single-Source CT versus First-Generation 64-Slice Dual-Source CT

    PubMed Central

    Gu, Jin; Shi, He-shui; Han, Ping; Yu, Jie; Ma, Gui-na; Wu, Sheng

    2016-01-01

    This study sought to compare the image quality and radiation dose of coronary computed tomography angiography (CCTA) from prospectively triggered 128-slice CT (128-MSCT) versus dual-source 64-slice CT (DSCT). The study was approved by the Medical Ethics Committee at Tongji Medical College of Huazhong University of Science and Technology. Eighty consecutive patients with stable heart rates lower than 70 bpm were enrolled. Forty patients were scanned with 128-MSCT, and the other 40 patients were scanned with DSCT. Two radiologists independently assessed the image quality in segments (diameter >1 mm) according to a three-point scale (1: excellent; 2: moderate; 3: insufficient). The CCTA radiation dose was calculated. Eighty patients with 526 segments in the 128-MSCT group and 544 segments in the DSCT group were evaluated. The image quality 1, 2 and 3 scores were 91.6%, 6.9% and 1.5%, respectively, for the 128-MSCT group and 97.6%, 1.7% and 0.7%, respectively, for the DSCT group, and there was a statistically significant inter-group difference (P ≤ 0.001). The effective doses were 3.0 mSv in the 128-MSCT group and 4.5 mSv in the DSCT group (P ≤ 0.001). Compared with DSCT, CCTA with prospectively triggered 128-MSCT had adequate image quality and a 33.3% lower radiation dose. PMID:27752040

  16. Programs for the Deaf-Blind.

    ERIC Educational Resources Information Center

    American Annals of the Deaf, 1991

    1991-01-01

    This directory lists contact information for programs for the deaf-blind in the United States in 3 categories: (1) programs for deaf-blind children and youth (29 programs listed); (2) Helen Keller National Center for Deaf-Blind Youth and Adults (1 national and 10 regional offices); and (3) programs for training teachers of the deaf-blind (4…

  17. What It's Like to Be Color Blind

    MedlinePlus

    ... Homework? Here's Help White House Lunch Recipes What It's Like to Be Color Blind KidsHealth > For Kids > What It's Like to Be Color Blind Print A A ... blind. But some people really are color blind. It doesn't mean they can't see any ...

  18. ESTIMATED STATISTICS ON BLINDNESS AND VISION PROBLEMS. NATIONAL SOCIETY FOR THE PREVENTION OF BLINDNESS FACT BOOK.

    ERIC Educational Resources Information Center

    HATFIELD, ELIZABETH M.

    CURRENT ESTIMATES AND SOME TREND DATA ARE PRESENTED ON THE FOLLOWING SUBJECTS -- POPULATION GROWTH (1940-1960), PREVALENCE OF LEGAL BLINDNESS, NEW CASES OF LEGAL BLINDNESS, AGE DISTRIBUTION OF LEGALLY BLIND PERSONS, CAUSES OF LEGAL BLINDNESS, CHANGING PATTERNS IN CAUSES OF LEGAL BLINDNESS, CASES OF GLAUCOMA, SCHOOL CHILDREN NEEDING EYE CARE,…

  19. SMA CARNI-VAL TRIAL PART II: A Prospective, Single-Armed Trial of L-Carnitine and Valproic Acid in Ambulatory Children with Spinal Muscular Atrophy

    PubMed Central

    Kissel, John T.; Scott, Charles B.; Reyna, Sandra P.; Crawford, Thomas O.; Simard, Louise R.; Krosschell, Kristin J.; Acsadi, Gyula; Elsheik, Bakri; Schroth, Mary K.; D'Anjou, Guy; LaSalle, Bernard; Prior, Thomas W.; Sorenson, Susan; Maczulski, Jo Anne; Bromberg, Mark B.; Chan, Gary M.; Swoboda, Kathryn J.

    2011-01-01

    Background Multiple lines of evidence have suggested that valproic acid (VPA) might benefit patients with spinal muscular atrophy (SMA). The SMA CARNIVAL TRIAL was a two part prospective trial to evaluate oral VPA and l-carnitine in SMA children. Part 1 targeted non-ambulatory children ages 2–8 in a 12 month cross over design. We report here Part 2, a twelve month prospective, open-label trial of VPA and L-carnitine in ambulatory SMA children. Methods This study involved 33 genetically proven type 3 SMA subjects ages 3–17 years. Subjects underwent two baseline assessments over 4–6 weeks and then were placed on VPA and L-carnitine for 12 months. Assessments were performed at baseline, 3, 6 and 12 months. Primary outcomes included safety, adverse events and the change at 6 and 12 months in motor function assessed using the Modified Hammersmith Functional Motor Scale Extend (MHFMS-Extend), timed motor tests and fine motor modules. Secondary outcomes included changes in ulnar compound muscle action potential amplitudes (CMAP), handheld dynamometry, pulmonary function, and Pediatric Quality of Life Inventory scores. Results Twenty-eight subjects completed the study. VPA and carnitine were generally well tolerated. Although adverse events occurred in 85% of subjects, they were usually mild and transient. Weight gain of 20% above body weight occurred in 17% of subjects. There was no significant change in any primary outcome at six or 12 months. Some pulmonary function measures showed improvement at one year as expected with normal growth. CMAP significantly improved suggesting a modest biologic effect not clinically meaningful. Conclusions This study, coupled with the CARNIVAL Part 1 study, indicate that VPA is not effective in improving strength or function in SMA children. The outcomes used in this study are feasible and reliable, and can be employed in future trials in SMA. Trial Regsitration Clinicaltrials.gov NCT00227266 PMID:21754985

  20. Biodiversity Prospecting.

    ERIC Educational Resources Information Center

    Sittenfeld, Ana; Lovejoy, Annie

    1994-01-01

    Examines the use of biodiversity prospecting as a method for tropical countries to value biodiversity and contribute to conservation upkeep costs. Discusses the first agreement between a public interest organization and pharmaceutical company for the extraction of plant and animal materials in Costa Rica. (LZ)

  1. Famciclovir suppression of asymptomatic and symptomatic recurrent anogenital herpes simplex virus shedding in women: a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single-center trial.

    PubMed

    Sacks, Stephen L

    2004-04-15

    Genital herpes is most often transmitted while the patient is asymptomatic, presumably during episodes of viral shedding. To determine whether famciclovir is effective in reducing asymptomatic shedding, women with frequent, recurrent genital outbreaks were enrolled in a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 112-day trial of suppressive treatment with famciclovir for anogenital viral shedding. Sixty women received 125 mg of famciclovir 3 times daily, 59 received 250 mg of famciclovir 3 times daily, and 58 received placebo. Patients recorded symptoms and self-obtained cultures daily. Famciclovir reduced asymptomatic shedding, compared with placebo (P < .0001). The onset of asymptomatic shedding was also delayed (P < .0001). Famciclovir reduced symptomatic shedding in a dose-dependent manner (0.72% for 125 mg 3 times daily vs. 0.19% for 250 mg 3 times daily [P < .0001] vs. 5.53% for placebo [P < .0001]). In conclusion, suppressive treatment with famciclovir reduced both asymptomatic and symptomatic viral shedding and delayed the onset of asymptomatic shedding in women with frequently recurring genital herpes. Studies to examine the effects of suppression by famciclovir on the transmission of genital herpes are warranted.

  2. IRR: A Blind Guide

    ERIC Educational Resources Information Center

    Kierulff, Herbert

    2012-01-01

    Over the past 60 years the internal rate of return (IRR) has become a major tool in investment evaluation. Many executives prefer it to net present value (NPV), presumably because they can more easily comprehend a percentage measure. This article demonstrates that, except in the rare case of an investment that is followed by a single cash return,…

  3. 20 CFR 416.982 - Blindness under a State plan.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Blindness under a State plan. 416.982 Section..., BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.982 Blindness under a State... plan because of your blindness for the month of December 1973; and (c) You continue to be blind...

  4. 20 CFR 416.982 - Blindness under a State plan.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false Blindness under a State plan. 416.982 Section..., BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.982 Blindness under a State... plan because of your blindness for the month of December 1973; and (c) You continue to be blind...

  5. 20 CFR 416.983 - How we evaluate statutory blindness.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false How we evaluate statutory blindness. 416.983... AGED, BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.983 How we evaluate statutory blindness. We will find that you are blind if you are statutorily blind within the meaning...

  6. 20 CFR 416.982 - Blindness under a State plan.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false Blindness under a State plan. 416.982 Section..., BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.982 Blindness under a State... plan because of your blindness for the month of December 1973; and (c) You continue to be blind...

  7. 20 CFR 416.982 - Blindness under a State plan.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Blindness under a State plan. 416.982 Section..., BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.982 Blindness under a State... plan because of your blindness for the month of December 1973; and (c) You continue to be blind...

  8. 20 CFR 416.983 - How we evaluate statutory blindness.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false How we evaluate statutory blindness. 416.983... AGED, BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.983 How we evaluate statutory blindness. We will find that you are blind if you are statutorily blind within the meaning...

  9. 20 CFR 416.983 - How we evaluate statutory blindness.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 2 2013-04-01 2013-04-01 false How we evaluate statutory blindness. 416.983... AGED, BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.983 How we evaluate statutory blindness. We will find that you are blind if you are statutorily blind within the meaning...

  10. 20 CFR 416.983 - How we evaluate statutory blindness.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 2 2014-04-01 2014-04-01 false How we evaluate statutory blindness. 416.983... AGED, BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.983 How we evaluate statutory blindness. We will find that you are blind if you are statutorily blind within the meaning...

  11. 20 CFR 416.982 - Blindness under a State plan.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 2 2011-04-01 2011-04-01 false Blindness under a State plan. 416.982 Section..., BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.982 Blindness under a State... plan because of your blindness for the month of December 1973; and (c) You continue to be blind...

  12. 20 CFR 416.983 - How we evaluate statutory blindness.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false How we evaluate statutory blindness. 416.983... AGED, BLIND, AND DISABLED Determining Disability and Blindness Blindness § 416.983 How we evaluate statutory blindness. We will find that you are blind if you are statutorily blind within the meaning...

  13. Outcome of probe-based confocal laser endomicroscopy (pCLE) during endoscopic retrograde cholangiopancreatography: A single-center prospective study in 45 patients

    PubMed Central

    Lönnebro, Ragnar; Stigliano, Serena; Haas, Stephan L; Swahn, Fredrik; Enochsson, Lars; Noel, Rozh; Segersvärd, Ralf; Chiaro, Marco Del; Verbeke, Caroline S; Arnelo, Urban

    2015-01-01

    Background Diagnosis of pre-malignant and malignant lesions in the bile duct and the pancreas is sometimes cumbersome. This applies in particular to intraductal papillary mucinous neoplasia (IPMN) and bile duct strictures in primary sclerosing cholangitis (PSC). Aims To evaluate in a prospective cohort study the sensitivity and specificity of probe-based confocal laser microscopy (pCLE) during endoscopic retrograde cholangiopancreatography (ERCP). Methods We performed pCLE together with mother-baby endoscopy (SpyGlass) during 50 ERCP sessions in 45 patients. The Miami and Paris criteria were applied. Clinical diagnosis via imaging was compared to pCLE and the final pathological diagnosis from surgically-resected, biopsy, or cytology specimens. Patients were followed up for at least 1 year. Results We were able to perform pCLE in all patients. Prior to endoscopy, the diagnosis was benign in 23 patients and undetermined (suspicious) in 16 patients, while six patients had an unequivocal diagnosis of malignancy. Sensitivity was 91% and specificity 52%. The positive (PPV) and negative predictive value (NPV) was 82% and 100%, respectively. Apart from mild post-ERCP pancreatitis in two patients, no complications occurred. Conclusions Our study showed that pCLE is a safe, expert endoscopic method with high technical feasibility, high sensitivity and high NPV. It provided diagnostic information that can be helpful for decisions on patient management, especially in the case of IPMN and unclear pancreatic lesions, in individuals whom are at increased risk for pancreatic cancer. PMID:26668748

  14. Independent Prognostic Value of Single and Multiple Non-Specific 12-Lead Electrocardiographic Findings for Long-Term Cardiovascular Outcomes: A Prospective Cohort Study

    PubMed Central

    Sawano, Mitsuaki; Kohsaka, Shun; Okamura, Tomonori; Inohara, Taku; Sugiyama, Daisuke; Shiraishi, Yasuyuki; Watanabe, Makoto; Nakamura, Yasuyuki; Higashiyama, Aya; Kadota, Aya; Okuda, Nagako; Murakami, Yoshitaka; Ohkubo, Takayoshi; Fujiyoshi, Akira; Miura, Katsuyuki; Okayama, Akira; Ueshima, Hirotsugu

    2016-01-01

    Aims The long-term prognostic effect of non-specific 12-lead electrocardiogram findings is unknown. We aimed to evaluate the cumulative prognostic impact of axial, structural, and repolarization categorical abnormalities on cardiovascular death, independent from traditional risk scoring systems such as the Framingham risk score and the NIPPON DATA80 risk chart. Methods and Results A total of 16,816 healthy men and women from two prospective, longitudinal cohort studies were evaluated. 3,794 (22.6%) individuals died during a median follow-up of 15 years (range, 2.0–24 years). Hazard ratios for cardiovascular death, all-cause death, coronary death and stroke death were calculated for the cumulative and independent axial, structural, and repolarization categorical abnormalities adjusted for the Framingham risk score and the NIPPON DATA80 risk chart. Individuals with two or more abnormal categories had a higher risk of cardiovascular death after adjustment for Framingham risk score (men: HR 4.27, 95%CI 3.35–5.45; women: HR 4.83, 95%CI 3.76–6.22) and NIPPON DATA80 risk chart (men: HR 2.39, 95%CI 1.87–3.07; women: HR 2.04, 95%CI 1.58–2.64). Conclusion Cumulative findings of axial, structural, and repolarization abnormalities are significant predictors of long-term cardiovascular death in asymptomatic, healthy individuals independent of traditional risk stratification systems. PMID:27362562

  15. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    PubMed Central

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3°; p < 0.001), remained at 12 months (−4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery. PMID:26844224

  16. [Aiming for zero blindness].

    PubMed

    Nakazawa, Toru

    2015-03-01

    Glaucoma is the leading cause of acquired blindness in Japan. One reason that it often leads to