A prospective single-blind randomized-controlled trial comparing two surgical techniques for the treatment of snoring: laser palatoplasty versus uvulectomy with punctate palatal diathermy.

PubMed

Uppal, S; Nadig, S; Jones, C; Nicolaides, A R; Coatesworth, A P

2004-06-01

The aim of this study was to compare laser palatoplasty with uvulectomy with punctate palatal diathermy as treatment modalities for snoring. The study design was a prospective, single-blind, randomized-controlled trial. Eighty-three patients entered the trial. After a mean follow-up period of more than 18 months there was no statistically significant difference between the two groups regarding the patient perception of benefit from surgery or the subjective improvement in snoring. However, there was a statistically significant difference in the degree of pain in the immediate postoperative period (mean difference = 22.14, 95% CI = 7.98-36.31, P = 0.003), with the pain being worse in the laser palatoplasty group. Relative risk of complications for laser palatoplasty was 1.42 (95% CI = 0.93-2.17). The snoring scores and Glasgow Benefit Inventory scores decreased with time in both the groups but there was no statistically significant difference between the two groups.

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

PubMed

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score <10 seconds on the One-Leg Stance Test (eyes open). All participants received 50-minutes individualised traditional physiotherapy sessions three times a week for seven weeks. In addition, the intervention group (N = 8) performed an individualised dual-task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial.

PubMed

Yu, Jianchun; Wu, Guohao; Tang, Yun; Ye, Yingjiang; Zhang, Zhongtao

2017-08-01

Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time. This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded. In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (Δ Prealb(StudyGroup) = 2.65 mg/dL, P < .001 vs Δ Prealb(ControlGroup) = 0.27 mg/dL, P = .606) and CRP values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t (StudyGroup) = 4.90 ± 4.41 minutes vs t (ControlGroup) = 12.13 ± 5.62 minutes, P < .001). No differences were detected for LOS, 30-day mortality, safety laboratory parameters, and postoperative AEs (37 vs 38 in study and control groups). The PN regimen provided by the 3-chamber bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

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

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

2015-01-01

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. 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. 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. 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. ClinicalTrials.gov KCT00000716.

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.

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.

Optimised quantum hacking of superconducting nanowire single-photon detectors

NASA Astrophysics Data System (ADS)

Tanner, Michael G.; Makarov, Vadim; Hadfield, Robert H.

2014-03-01

We explore bright-light control of superconducting nanowire single-photon detectors (SNSPDs) in the shunted configuration (a practical measure to avoid latching). In an experiment, we simulate an illumination pattern the SNSPD would receive in a typical quantum key distribution system under hacking attack. We show that it effectively blinds and controls the SNSPD. The transient blinding illumination lasts for a fraction of a microsecond and produces several deterministic fake clicks during this time. This attack does not lead to elevated timing jitter in the spoofed output pulse, and hence does not introduce significant errors. Five different SNSPD chip designs were tested. We consider possible countermeasures to this attack.

Optimised quantum hacking of superconducting nanowire single-photon detectors.

PubMed

Tanner, Michael G; Makarov, Vadim; Hadfield, Robert H

2014-03-24

We explore bright-light control of superconducting nanowire single-photon detectors (SNSPDs) in the shunted configuration (a practical measure to avoid latching). In an experiment, we simulate an illumination pattern the SNSPD would receive in a typical quantum key distribution system under hacking attack. We show that it effectively blinds and controls the SNSPD. The transient blinding illumination lasts for a fraction of a microsecond and produces several deterministic fake clicks during this time. This attack does not lead to elevated timing jitter in the spoofed output pulse, and hence does not introduce significant errors. Five different SNSPD chip designs were tested. We consider possible countermeasures to this attack.

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 Central

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

2015-01-01

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. PMID:25533447

A single dose of erythropoietin reduces perioperative transfusions in cardiac surgery: results of a prospective single-blind randomized controlled trial.

PubMed

Weltert, Luca; Rondinelli, Beatrice; Bello, Ricardo; Falco, Mauro; Bellisario, Alessandro; Maselli, Daniele; Turani, Franco; De Paulis, Ruggero; Pierelli, Luca

2015-07-01

We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; p<0.0005). After baseline Hb was controlled for, there was no difference in the incidence of aRBCt between HRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; p<0.0005). The distribution of number of units transfused was shifted toward fewer units in HRE (p<0.0005). The all-cause mortality at 45 days was 3.00% (HRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). In anemic patients (Hb<13 g/dL), a single high dose of HRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events. © 2015 AABB.

A randomized, double-blind, placebo-controlled trial of single-dose ciprofloxacin versus erythromycin for the treatment of chancroid in Nairobi, Kenya.

PubMed

Malonza, I M; Tyndall, M W; Ndinya-Achola, J O; Maclean, I; Omar, S; MacDonald, K S; Perriens, J; Orle, K; Plummer, F A; Ronald, A R; Moses, S

1999-12-01

A randomized, double-blind, placebo-controlled clinical trial was conducted in Nairobi, Kenya, to compare single-dose ciprofloxacin with a 7-day course of erythromycin for the treatment of chancroid. In all, 208 men and 37 women presenting with genital ulcers clinically compatible with chancroid were enrolled. Ulcer etiology was determined using culture techniques for chancroid, serology for syphilis, and a multiplex polymerase chain reaction for chancroid, syphilis, and herpes simplex virus (HSV). Ulcer etiology was 31% unmixed chancroid, 23% unmixed syphilis, 16% unmixed HSV, 15% mixed etiology, and 15% unknown. For 111 participants with chancroid, cure rates were 92% with ciprofloxacin and 91% with erythromycin. For all study participants, the treatment failure rate was 15%, mostly related to ulcer etiologies of HSV infection or syphilis, and treatment failure was 3 times more frequent in human immunodeficiency virus-infected subjects than in others, mostly owing to HSV infection. Ciprofloxacin is an effective single-dose treatment for chancroid, but current recommendations for empiric therapy of genital ulcers may result in high treatment failure due to HSV infection.

Effect of a single acupuncture treatment on surgical wound healing in dogs: a randomized, single blinded, controlled pilot study

PubMed Central

2010-01-01

Background The aim of the study was to investigate the effect of acupuncture on wound healing after soft tissue or orthopaedic surgery in dogs. Methods 29 dogs were submitted to soft tissue and/or orthopaedic surgeries. Five dogs had two surgical wounds each, so there were totally 34 wounds in the study. All owners received instructions for post operative care as well as antibiotic and pain treatment. The dogs were randomly assigned to treatment or control groups. Treated dogs received one dry needle acupuncture treatment right after surgery and the control group received no such treatment. A veterinary surgeon that was blinded to the treatment, evaluated the wounds at three and seven days after surgery in regard to oedema (scale 0-3), scabs (yes/no), exudate (yes/no), hematoma (yes/no), dermatitis (yes/no), and aspect of the wound (dry/humid). Results There was no significant difference between the treatment and control groups in the variables evaluated three and seven days after surgery. However, oedema reduced significantly in the group treated with acupuncture at seven days compared to three days after surgery, possibly due the fact that there was more oedema in the treatment group at day three (although this difference was nor significant between groups). Conclusions The use of a single acupuncture treatment right after surgery in dogs did not appear to have any beneficial effects in surgical wound healing. PMID:20950467

No influence of one right-sided prefrontal HF-rTMS session on alcohol craving in recently detoxified alcohol-dependent patients: results of a naturalistic study.

PubMed

Herremans, S C; Baeken, C; Vanderbruggen, N; Vanderhasselt, M A; Zeeuws, D; Santermans, L; De Raedt, R

2012-01-01

Prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral prefrontal cortex (DLPFC). However, no single sham-controlled session studies applied to the right DLPFC have been carried-out in recently detoxified alcohol-dependent patients. Furthermore, no studies examined the effect of a single HF-rTMS session on craving in these patients' natural habitat. To further investigate the effect of high-frequency (HF)-rTMS of the right DLPFC on alcohol craving, we performed a prospective, single-blind, sham-controlled study involving 36 hospitalized patients with alcohol dependence syndrome. After successful detoxification, patients were allocated receiving one active or one sham HF-rTMS session. The obsessive-compulsive drinking scale (OCDS) was administered to evaluate the extent of craving just before and after the HF-rTMS session (on Friday), on Saturday and Sunday during the weekend at home, and on Monday when the patient returned to the hospital. One single blind sham-controlled HF-rTMS session applied to the right DLPFC did not result in changes in craving (neither immediately after the stimulation session, nor in patients' natural environment during the weekend). One HF-rTMS stimulation session applied to the right DLPFC had no significant effects on alcohol craving in alcohol dependent patients. One such session could have been too short to alter alcohol craving in a sample of alcohol dependent patients. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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

The PEDALS Stationary Cycling Intervention and Health-Related Quality of Life in Children with Cerebral Palsy: A Randomized Controlled Trial

ERIC Educational Resources Information Center

DeMuth, Sharon K.; Knutson, Loretta M.; Fowler, Eileen G.

2012-01-01

Aim: The aim of this study was to assess health-related quality of life (HRQOL) following a stationary cycling intervention in children with cerebral palsy (CP). Method: This was a phase I multisite randomized controlled trial with single blinding. HRQOL was evaluated using the Pediatric Quality of Life Inventory SF15 (PedsQL; children) and…

Effects of a Web-Based Decision Aid Regarding Diagnostic Self-Testing. A Single-Blind Randomized Controlled Trial

ERIC Educational Resources Information Center

Ickenroth, Martine H. P.; Grispen, J. E. J.; de Vries, N. K.; Dinant, G. J.; Ronda, G.; van der Weijden, T.

2016-01-01

Currently, there are many diagnostic self-tests on body materials available to consumers. The aim of this study was to assess the effect of an online decision aid on diagnostic self-testing for cholesterol and diabetes on knowledge among consumers with an intention to take these tests. A randomized controlled trial was designed. A total of 1259…

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Blind and sighted pedestrians' road-crossing judgments at a single-lane roundabout.

PubMed

Guth, David A; Long, Richard G; Emerson, Robert S Wall; Ponchillia, Paul E; Ashmead, Daniel H

2013-06-01

The aim of this study was to evaluate the relative risk and efficiency of road crossing experienced by blind and sighted pedestrians at a single-lane roundabout with two levels of traffic volume and at two distances from the roundabout. With the rapid spread of modern roundabouts across the United States,their accessibility to blind pedestrians has become an important concern. To date, accessibility research relevant to blind pedestrians has focused on multilane roundabouts, and single-lane roundabouts have been virtually ignored. Blind and sighted participants made judgments about when they would cross a single-lane roundabout with high and low traffic volumes, at exit and entry lanes, and at the actual crosswalks and at locations farther from the roundabout. Relative to sighted participants, blind participants' judgments about when to cross were more frequently risky, especially when traffic volume was high. Blind participants also were slower to make crossing judgments and accepted fewer crossing opportunities. Both groups made somewhat safer and more efficient judgments at locations farther from the roundabout. Some single-lane roundabouts may pose greater risk to blind pedestrians than to sighted pedestrians, especially when traffic volume is high. Crosswalk location merits further investigation as a design issue. These findings are relevant to transportation planners and engineers who are responsible for the accessibility of public rights-of-way.

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

PubMed

Fell, P; Brostoff, J

1990-01-01

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

The superiority in voice processing of the blind arises from neural plasticity at sensory processing stages.

PubMed

Föcker, Julia; Best, Anna; Hölig, Cordula; Röder, Brigitte

2012-07-01

Blind people rely much more on voices compared to sighted individuals when identifying other people. Previous research has suggested a faster processing of auditory input in blind individuals than sighted controls and an enhanced activation of temporal cortical regions during voice processing. The present study used event-related potentials (ERPs) to single out the sub-processes of auditory person identification that change and allow for superior voice processing after congenital blindness. A priming paradigm was employed in which two successive voices (S1 and S2) of either the same (50% of the trials) or different actors were presented. Congenitally blind and matched sighted participants made an old-young decision on the S2. During the pre-experimental familiarization with the stimuli, congenitally blind individuals showed faster learning rates than sighted controls. Reaction times were shorter in person-congruent trials than in person-incongruent trials in both groups. ERPs to S2 stimuli in person-incongruent as compared to person-congruent trials were significantly enhanced at early processing stages (100-160 ms) in congenitally blind participants only. A later negative ERP effect (>200 ms) was found in both groups. The scalp topographies of the experimental effects were characterized by a central and parietal distribution in the sighted but a more posterior distribution in the congenitally blind. These results provide evidence for an improvement of early voice processing stages and a reorganization of the person identification system as a neural correlate of compensatory behavioral improvements following congenital blindness. Copyright © 2012 Elsevier Ltd. All rights reserved.

Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial.

PubMed

Grochola, Lukasz Filip; Soll, Christopher; Zehnder, Adrian; Wyss, Roland; Herzog, Pascal; Breitenstein, Stefan

2017-02-09

Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon's stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date. This study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon's stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon's physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1 st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon's comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10-15%) resulted in a number of 30 randomized patients per arm. The study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to conventional laparoscopic approaches in cholecystectomy, one of the most frequently performed operations in general surgery. This trial is registered at clinicaltrials.gov (trial number: NCT02485392 ). Registered February 19, 2015.

Auditory cues for orientation and postural control in sighted and congenitally blind people

NASA Technical Reports Server (NTRS)

Easton, R. D.; Greene, A. J.; DiZio, P.; Lackner, J. R.

1998-01-01

This study assessed whether stationary auditory information could affect body and head sway (as does visual and haptic information) in sighted and congenitally blind people. Two speakers, one placed adjacent to each ear, significantly stabilized center-of-foot-pressure sway in a tandem Romberg stance, while neither a single speaker in front of subjects nor a head-mounted sonar device reduced center-of-pressure sway. Center-of-pressure sway was reduced to the same level in the two-speaker condition for sighted and blind subjects. Both groups also evidenced reduced head sway in the two-speaker condition, although blind subjects' head sway was significantly larger than that of sighted subjects. The advantage of the two-speaker condition was probably attributable to the nature of distance compared with directional auditory information. The results rule out a deficit model of spatial hearing in blind people and are consistent with one version of a compensation model. Analysis of maximum cross-correlations between center-of-pressure and head sway, and associated time lags suggest that blind and sighted people may use different sensorimotor strategies to achieve stability.

Treatment of canine atopic dermatitis with cetirizine, a second generation antihistamine: A single-blinded, placebo-controlled study

PubMed Central

2004-01-01

Abstract Cetirizine and placebo were administered orally as individual agents to 23 dogs with atopic dermatitis. The pruritus was satisfactorily reduced in 4/22 (18%) dogs that completed the trial with cetirizine. Two dogs vomited after administration of the active drug. PMID:15206590

Gait analysis following treadmill training with body weight support versus conventional physical therapy: a prospective randomized controlled single blind study.

PubMed

Lucareli, P R; Lima, M O; Lima, F P S; de Almeida, J G; Brech, G C; D'Andréa Greve, J M

2011-09-01

Single-blind randomized, controlled clinical study. To evaluate, using kinematic gait analysis, the results obtained from gait training on a treadmill with body weight support versus those obtained with conventional gait training and physiotherapy. Thirty patients with sequelae from traumatic incomplete spinal cord injuries at least 12 months earlier; patients were able to walk and were classified according to motor function as ASIA (American Spinal Injury Association) impairment scale C or D. Patients were divided randomly into two groups of 15 patients by the drawing of opaque envelopes: group A (weight support) and group B (conventional). After an initial assessment, both groups underwent 30 sessions of gait training. Sessions occurred twice a week, lasted for 30 min each and continued for four months. All of the patients were evaluated by a single blinded examiner using movement analysis to measure angular and linear kinematic gait parameters. Six patients (three from group A and three from group B) were excluded because they attended fewer than 85% of the training sessions. There were no statistically significant differences in intra-group comparisons among the spatial-temporal variables in group B. In group A, the following significant differences in the studied spatial-temporal variables were observed: increases in velocity, distance, cadence, step length, swing phase and gait cycle duration, in addition to a reduction in stance phase. There were also no significant differences in intra-group comparisons among the angular variables in group B. However, group A achieved significant improvements in maximum hip extension and plantar flexion during stance. Gait training with body weight support was more effective than conventional physiotherapy for improving the spatial-temporal and kinematic gait parameters among patients with incomplete spinal cord injuries.

Plaque and gingivitis in the elderly: a randomized, single-blind clinical trial on the outcome of intensified mechanical or antibacterial oral hygiene measures.

PubMed

Schiffner, Ulrich; Bahr, Mathias; Effenberger, Susanne

2007-12-01

To study the outcome of intensified mechanical oral hygiene compared with the effect of an adjunctive antibacterial mouth rinse on plaque and gingivitis in elderly people. In a randomized, single-blind, 6-month controlled clinical study, 106 subjects, 55 years or older, were divided into four groups: (I) Participants were instructed on improved mechanical oral hygiene, including interdental hygiene; (II) subjects used an antibacterial mouth rinse containing amine and stannous fluoride in addition to their usual oral hygiene practices; (III) both intensive mechanical and antibacterial measures were combined; and (IV) a control group with no specific regimen. Gingivitis and plaque were examined. After 6 months, both plaque and gingivitis scores were significantly lower than at baseline in all groups. Reductions in gingivitis differed significantly between the control group and all other groups but not between the three intervention groups. Only groups with improved mechanical oral hygiene showed significant improvements in plaque scores compared with control. Intensive mechanical oral hygiene resulted in greater plaque reduction than the combination of an antibacterial rinse and usual oral hygiene procedures. Gingivitis was reduced by both intensive oral hygiene and use of the amine/stannous fluoride rinse. Combining intensive mechanical oral hygiene with the antibacterial rinse did not result in further gingivitis reduction.

Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study).

PubMed

Gaillard, Cathy; Allain, Laure; Legros, Hélène; Brucato, Sylvie; Desgue, Yohann; Rouillon, Christophe; Peyro-Saint-Paul, Laure; Dompmartin, Anne

2017-06-07

Despite the lack of scientific studies on biofield therapies, they are widely acclaimed by patients. The mechanisms of action are not explained by current allopathic medical approaches. Warts are common and contagious viral lesions that may be refractory to standard dermatologic treatments such as cryotherapy, laser therapy, and keratolytic ointments. Biofield therapies are efficient in various pathologies. Their ability to treat warts has never been demonstrated in a scientific study with a robust methodology. Patients with refractory warts often place their trust in these alternative therapies because of the poor results obtained from traditional medicine. We propose a prospective, randomized, single-blind, assessor-blind trial to evaluate the efficacy of treatment of warts by biofield therapy. Subjects with warts on their feet or hands will be randomized into two groups: real biofield therapy versus sham therapy. The diagnosis will be made at the time of inclusion, and follow-up will take place in week 3. Comparison of pictures of the warts at baseline and after 3 weeks will be used as the primary outcome measure. The hypothesis is that the extent of the disappearance of the original wart in the group treated by real biofield therapy will be 70% and that it will be 30% in the group treated by sham therapy. Using 90% power and an alpha risk of 5%, 31 subjects are required in each group for a two-tailed proportion comparison test. To our knowledge, this is the first study to evaluate the efficacy of biofield therapy on warts. Therefore, the aim of this study is to extend knowledge of biofield therapy to another area of medicine such as dermatology and to propose complementary or alternative practices to improve patient well-being. The main strength of the study is that it is a randomized, single-blind, assessor-blind, placebo-controlled study. ClinicalTrials.gov identifier: NCT02773719 . Registered on 22 April 2016.

Blood Pressure and Cognitive Performance After a Single Administration of a Camphor-Crataegus Combination in Adolescents with Low Blood Pressure.

PubMed

Schandry, Rainer; Lindauer, Daniela; Mauz, Matthias

2018-06-18

Low blood pressure is rather widespread among adolescents and frequently accompanied by complaints. Two single-center, double-blinded, randomized, and placebo-controlled trials were performed with adolescent participants in the age range of 14 - 17 y having a systolic blood pressure below 118 mmHg (boys) or 110 mmHg (girls). They received a single dose of 20 drops of a fixed combination of natural D-camphor and an ethanolic extract from fresh Crataegus berries (CCC) or of an ethanolic placebo. The efficacy of CCC (commercial name Korodin) has proven its efficacy in the treatment of low blood pressure in adults of all ages, although related placebo-controlled, double-blind studies for adolescents following European (EU) pediatric regulations are lacking. Blood pressure and heart rate were assessed during a rest period, prior to substance administration, 1 min thereafter, and after about 5 min. Additionally, performance was assessed by two cognitive tests. After administration of CCC, a significantly greater rise in blood pressure occurred compared to placebo. In the cognitive tasks, no significant differences were observed. No adverse events or subjective complaints were reported at the final examination; thus, the present study provides evidence for the safety and tolerability of CCC after a single administration. Georg Thieme Verlag KG Stuttgart · New York.

A single-blinded randomised controlled study to determine the efficacy of Omnilux Revive facial treatment in skin rejuvenation.

PubMed

Bhat, Jaideep; Birch, Jan; Whitehurst, Colin; Lanigan, Sean W

2005-01-01

To determine the efficacy of Omnilux Revive facial treatment in skin rejuvenation, twenty-three volunteers received randomised 20 min treatments three times a week for three weeks to one half of their face, with the untreated side acting as control. Regular assessments were carried out, focusing on parameters of subject satisfaction, photographic assessments, skin elasticity (Cutometer) and skin hydration (Corneometer CM825). Ninety-one percent of the volunteers reported visible changes to their skin. Blinded photographic evaluation reported a clinical response in 59% of the subjects. Objective analysis failed to show statistically significant changes in skin hydration or elasticity. The Omnilux Revive LED lamp is a safe alternative non-ablative skin rejuvenation treatment.

Brief review of published alprazolam clinical studies

PubMed Central

Straw, R. N.

1985-01-01

1 The clinical efficacy of alprazolam has been evaluated in both anxiety states and depressive disorders. In anxiety neurosis, studies have been conducted vs placebo and/or other benzodiazepine tranquilizers. Reports, to date, with regard to panic/phobia disorders have been limited to open-label studies and a single report from a placebo-controlled study. In depression, both open-label and double-blind studies (vs tricyclic antidepressants) have been published. PMID:2859879

Single and Multiple Ascending-dose Studies of Oral Delafloxacin: Effects of Food, Sex, and Age.

PubMed

Hoover, Randall; Hunt, Thomas; Benedict, Michael; Paulson, Susan K; Lawrence, Laura; Cammarata, Sue; Sun, Eugene

2016-01-01

The objective of this report is describe the results of 2 studies that examined the pharmacokinetic parameters, safety profile, and tolerability of single and multiple ascending doses of oral delafloxacin and the effects of food, sex, and age on oral delafloxacin pharmacokinetic parameters, safety profile, and tolerability. The first study contained 3 parts and used unformulated delafloxacin in a capsule. Part 1 was a randomized, double-blind, placebo-controlled, single (50, 100, 200, 400, 800, 1200, and 1600 mg) ascending-dose study of oral delafloxacin in healthy men. Part 2 was a single-dose crossover study in which 20 men received 250 mg delafloxacin with or without food. Part 2 also included a parallel group, double-blind, placebo-controlled study in 16 women and 16 elderly men and women who were randomized (3:1) to receive 250 mg delafloxacin or placebo. Part 3 was a randomized, double-blind, placebo-controlled, multiple (100, 200, 400, 800, 1200 mg once daily for 5 days) ascending-dose study of oral delafloxacin in healthy men. The second study was a single-dose, randomized, 3-period crossover study in which participants received 900 mg delafloxacin (2 × 450-mg tablets) under fasted conditions, with a high-fat meal, or fasted with a high-fat meal 2 hours after dosing. Serial blood samples were collected, and plasma pharmacokinetic parameters of delafloxacin were determined. Delafloxacin Cmax and AUC0-∞ increased with increasing oral dose over the dose range of 50 to 1600 mg. The increases in delafloxacin AUC0-∞ were dose proportional at doses of ≥200 mg. Steady state was reached by day 3 of dosing with minimal accumulation of delafloxacin. The Cmax of delafloxacin was decreased slightly in the presence of food. No sex difference in delafloxacin pharmacokinetic parameters was observed. In the elderly men and women, mean delafloxacin Cmax and AUC0-∞ were 35% higher than observed for young adults, which could be partially explained by a decrease in the creatinine clearance in the elderly men and women. Delafloxacin was well tolerated at the tested doses, with gastrointestinal adverse effects observed more commonly at doses ≥1200 mg. Delafloxacin exhibits linear pharmacokinetic parameters that reached steady state after 3 days of daily oral dosing with minimal accumulation. Delafloxacin was well tolerated throughout both studies, with gastrointestinal effects observed at the higher doses (≥1200 mg). Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Exenatide and the treatment of patients with Parkinson’s disease

PubMed Central

Aviles-Olmos, Iciar; Dickson, John; Kefalopoulou, Zinovia; Djamshidian, Atbin; Ell, Peter; Soderlund, Therese; Whitton, Peter; Wyse, Richard; Isaacs, Tom; Lees, Andrew; Limousin, Patricia; Foltynie, Thomas

2013-01-01

Background. There is increasing interest in methods to more rapidly and cost-efficiently investigate drugs that are approved for clinical use in the treatment of another condition. Exenatide is a type 2 diabetes treatment that has been shown to have neuroprotective/neurorestorative properties in preclinical models of neurodegeneration. Methods. As a proof of concept, using a single-blind trial design, we evaluated the progress of 45 patients with moderate Parkinson’s disease (PD), randomly assigned to receive subcutaneous exenatide injection for 12 months or to act as controls. Their PD was compared after overnight withdrawal of conventional PD medication using blinded video assessment of the Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), together with several nonmotor tests, at baseline, 6 months, and 12 months and after a further 2-month washout period (14 months). Results. Exenatide was well tolerated, although weight loss was common and l-dopa dose failures occurred in a single patient. Single-blinded rating of the exenatide group suggested clinically relevant improvements in PD across motor and cognitive measures compared with the control group. Exenatide-treated patients had a mean improvement at 12 months on the MDS-UPDRS of 2.7 points, compared with mean decline of 2.2 points in control patients (P = 0.037). Conclusion. These results demonstrate a potential cost-efficient approach through which preliminary clinical data of possible biological effects are obtainable, prior to undertaking the major investment required for double-blind trials of a potential disease-modifying drug in PD. Trial registration. Clinicaltrials.gov NCT01174810. Funding. Cure Parkinson’s Trust. PMID:23728174

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.

PubMed

Sundseth, Jarle; Fredriksli, Oddrun Anita; Kolstad, Frode; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Myrseth, Erling; Müller, Kay; Nygaard, Øystein P; Zwart, John-Anker

2017-04-01

Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. http://www.clinicaltrials.gov NCT 00735176.19.

Evaluation of the gastrointestinal tolerability of corn starch fiber, a novel dietary fiber, in two independent randomized, double-blind, crossover studies in healthy men and women.

PubMed

Crincoli, Christine M; Garcia-Campayo, Vicenta; Rihner, Marisa O; Nikiforov, Andrey I; Liska, DeAnn; van de Ligt, Jennifer L G

2016-11-01

Two independent clinical studies were conducted to compare the gastrointestinal (GI) tolerability of corn starch fiber, a novel dietary fiber, at up to 50 g/day (single-dose study) or 90 g/day (multiple-serving study) with a negative control (no fiber) and a positive control (50 or 90 g polydextrose, for single- and multiple-serving studies, respectively) in generally healthy study volunteers. Flatulence and borborygmus were the primary symptoms reported at the higher doses of corn starch fiber and for the positive control interventions. Bowel movements were increased over 48 h with corn starch fiber at 90 g. Thresholds for mild GI effects were established at 30 g as a single dose and 60 g as multiple servings spread over the day. Other than moderate abdominal pain and mild increased appetite in one subject at 90-g corn starch fiber, no test article-related adverse events were reported.

Pharmacokinetics and Safety of Intravenous Murepavadin Infusion in Healthy Adult Subjects Administered Single and Multiple Ascending Doses.

PubMed

Wach, Achim; Dembowsky, Klaus; Dale, Glenn E

2018-04-01

Murepavadin is the first in class of the outer membrane protein-targeting antibiotics (OMPTA) and a pathogen-specific peptidomimetic antibacterial with a novel, nonlytic mechanism of action targeting Pseudomonas aeruginosa Murepavadin is being developed for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The pharmacokinetics (PK) and safety of single and multiple doses of murepavadin were investigated in healthy male subjects. Part A of the study was a double-blind, randomized, placebo-controlled, single-ascending-dose investigation in 10 sequential cohorts where each cohort comprised 6 healthy male subjects; 4 subjects were randomized to murepavadin, and 2 subjects were randomized to placebo. Part B was a double-blind, randomized, placebo-controlled, multiple-ascending-dose investigation in 3 sequential cohorts. After a single dose of murepavadin, the geometric mean half-life (2.52 to 5.30 h), the total clearance (80.1 to 114 ml/h/kg), and the volume of distribution (415 to 724 ml/kg) were consistent across dose levels. The pharmacokinetics of the dosing regimens evaluated were dose proportional and linear. Murepavadin was well tolerated, adverse events were transient and generally mild, and no dose-limiting toxicity was identified. Copyright © 2018 American Society for Microbiology.

A randomized, controlled, single-blind, 6-month pilot study to evaluate the efficacy of MS-Line!: a cognitive rehabilitation programme for patients with multiple sclerosis.

PubMed

Gich, Jordi; Freixanet, Jordi; García, Rafael; Vilanova, Joan Carles; Genís, David; Silva, Yolanda; Montalban, Xavier; Ramió-Torrentà, Lluís

2015-09-01

MS-Line! was created to provide an effective treatment for cognitive impairment in multiple sclerosis (MS) patients. To assess the efficacy of MS-Line!. A randomized, controlled, single-blind, 6-month pilot study. Patients were randomly assigned to an experimental group (cognitive rehabilitation with the programme) or to a control group (no cognitive rehabilitation). Randomization was stratified by cognitive impairment level. Cognitive assessment included: selective reminding test, 10/36 spatial recall test (10/36 SPART), symbol digit modalities test, paced auditory serial addition test, word list generation (WLG), FAS test, subtests of WAIS-III, Boston naming test (BNT), and trail making test (TMT). Forty-three patients (22 in the experimental group, 21 in the control group) were analyzed. Covariance analysis showed significant differences in 10/36 SPART (P=0.0002), 10/36 SPART delayed recall (P=0.0021), WLG (P=0.0123), LNS (P=0.0413), BNT (P=0.0007) and TMT-A (P=0.010) scores between groups. The study showed a significant improvement related to learning and visual memory, executive functions, attention and information processing speed, and naming ability in those patients who received cognitive rehabilitation. The results suggest that MS-Line! is effective in improving cognitive impairment in MS patients. © The Author(s), 2015.

2-Methacryloyloxyethyl phosphorylcholine (MPC)-polymer suppresses an increase of oral bacteria: a single-blind, crossover clinical trial.

PubMed

Fujiwara, Natsumi; Yumoto, Hiromichi; Miyamoto, Koji; Hirota, Katsuhiko; Nakae, Hiromi; Tanaka, Saya; Murakami, Keiji; Kudo, Yasusei; Ozaki, Kazumi; Miyake, Yoichiro

2018-05-16

The biocompatible 2-methacryloyloxyethyl phosphorylcholine (MPC)-polymers, which mimic a biomembrane, reduce protein adsorption and bacterial adhesion and inhibit cell attachment. The aim of this study is to clarify whether MPC-polymer can suppress the bacterial adherence in oral cavity by a crossover design. We also investigated the number of Fusobacterium nucleatum, which is the key bacterium forming dental plaque, in clinical samples. This study was a randomized, placebo-controlled, single-blind, crossover study, with two treatment periods separated by a 2-week washout period. We conducted clinical trial with 20 healthy subjects to evaluate the effect of 5% MPC-polymer mouthwash after 5 h on oral microflora. PBS was used as a control. The bacterial number in the gargling sample before and after intervention was counted by an electronic bacterial counter and a culture method. DNA amounts of total bacteria and F. nucleatum were examined by q-PCR. The numbers of total bacteria and oral streptcocci after 5 h of 5% MPC-polymer treatment significantly decreased, compared to the control group. Moreover, the DNA amounts of total bacteria and F. nucleatum significantly decreased by 5% MPC-polymer mouthwash. We suggest that MPC-polymer coating in the oral cavity may suppress the oral bacterial adherence. MPC-polymer can be a potent compound for the control of oral microflora to prevent oral infection.

The Effects of Intrapartum Supportive Care on Fear of Delivery and Labor Outcomes: A Single-Blind Randomized Controlled Trial.

PubMed

İsbir, Gözde Gökçe; Serçekuş, Pinar

2017-04-01

Supportive care during labor, the primary role of intrapartum nurses and midwives, provides comfort to prepartum women and helps facilitate a positive labor experience. It has been argued that supportive care during labor reduces fear and anxiety as well as the resultant side effects. However, evidence supporting this argument is insufficient. The aim of this study was to assess the effects of intrapartum supportive care on fear of delivery and on the key parameters of the labor process. This study used a single-blind randomized controlled trial approach. Randomized block assignment was used to assign 72 participants to either the intervention group (n = 36) or the control group (n = 36). Three women in the intervention group and six in the control group were later excluded from the study because they received emergency cesarean delivery. The intervention group received continuous supportive care, and the control group received routine hospital care. No significant differences were identified between the two groups at baseline. The intervention group reported less fear of delivery during the active and transient phases of labor, higher perceived support and control during delivery, lower pain scores during the transient phase of labor, and a shorter delivery period than the control group (p < .05). However, no significant difference in the use of oxytocin during delivery between the two groups was reported. The results of this evidence-based study suggest that continuous support during labor has clinically meaningful benefits for women and that all women should receive this support throughout their labor and delivery process.

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single Enantiomer (+)-Mefloquine Compared with Racemic Mefloquine in Healthy Persons

PubMed Central

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

2010-01-01

Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (−) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (−)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted. PMID:21118921

Use of intralesional verapamil to dissolve Peyronie's disease plaque: a long-term single-blind study.

PubMed

Rehman, J; Benet, A; Melman, A

1998-04-01

Multiple conservative therapies for the treatment of Peyronie's disease have been offered with variable and poor response rates. Calcium channel blockers have been shown in vitro and in vivo to inhibit secretion and synthesis of extracellular matrix, including collagen, glycosaminoglycans, and fibronectin, as well as causing increased collagenase and anti transforming growth factor-beta activity. Calcium antagonists, including verapamil, are effective in stimulating the remodeling and degradation of extracellular matrix in tissue by altering the metabolic pathways of fibroblasts. Recently, a pilot study (1994) showed preliminary promising results in treating plaque caused by Peyronie's disease. This randomized single-blind placebo-based study (1994 to 1996) was undertaken to confirm the hypothesis. In this randomized single-blind study, 14 patients completed the study and were divided into two groups: the verapamil treatment group (n = 7) or the control saline group (n = 7). Verapamil or saline was injected directly into the Peyronie's plaque once a week for 6 months. Patients were evaluated before and after treatment with duplex ultrasound to confirm the extent of the lesion and to measure volume of the plaque, and by interview and mailed questionnaire 3 months after treatment. Patients being treated with oral calcium antagonists were excluded from the study. A decreased plaque volume was measured in 57% of the verapamil-treated men versus 28% in the control group (P <0.04). Penile curvature demonstrated an improvement trend of 37.71 +/- 9.3 degrees to 29.57 +/- 7.3 degrees in the verapamil-treated patients, but the difference was not significant (P <0.07). Plaque softening was noted in all patients treated with verapamil. There was significant objective improvement in plaque-associated penile narrowing in all patients in the verapamil group. Subjective plaque-associated erectile dysfunction (quality of erection) showed improvement in 42.87% of the verapamil group versus none in the control group (P <0.02). There was no local or systemic toxicity except for an occasional ecchymosis/bruise at the injection site. After a positive clinical response, plaque size, penile angulation, and symptoms continued to improve. Decrease in plaque size was noted in each of the responders in the first 3 months. This randomized single-blind study suggests that intralesional injection of calcium channel blocker may be a reasonable approach in some selected patients for the treatment of Peyronie's disease with noncalcified plaque and penile angulation of less than 30 degrees. Patients whose plaque failed to respond to intralesional verapamil therapy within 3 months or whose angulation was greater than 30 degrees at presentation were more likely to benefit from surgery.

The impact of eszopiclone on sleep and cognition in patients with schizophrenia and insomnia: a double-blind, randomized, placebo-controlled trial.

PubMed

Tek, Cenk; Palmese, Laura B; Krystal, Andrew D; Srihari, Vinod H; DeGeorge, Pamela C; Reutenauer, Erin L; Guloksuz, Sinan

2014-12-01

Insomnia is frequent in schizophrenia and may contribute to cognitive impairment as well as overuse of weight inducing sedative antipsychotics. We investigated the effects of eszopiclone on sleep and cognition for patients with schizophrenia-related insomnia in a double-blind placebo controlled study, followed by a two-week, single-blind placebo phase. Thirty-nine clinically stable outpatients with schizophrenia or schizoaffective disorder and insomnia were randomized to either 3mg eszopiclone (n=20) or placebo (n=19). Primary outcome measure was change in Insomnia Severity Index (ISI) over 8 weeks. Secondary outcome measure was change in MATRICS Consensus Cognitive Battery (MATRICS). Sleep diaries, psychiatric symptoms, and quality of life were also monitored. ISI significantly improved more in eszopiclone (mean=-10.7, 95% CI=-13.2; -8.2) than in placebo (mean=-6.9, 95% CI=-9.5; -4.3) with a between-group difference of -3.8 (95% CI=-7.5; -0.2). MATRICS score change did not differ between groups. On further analysis there was a significant improvement in the working memory test, letter-number span component of MATRICS (mean=9.8±9.2, z=-2.00, p=0.045) only for subjects with schizophrenia on eszopiclone. There were improvements in sleep diary items in both groups with no between-group differences. Psychiatric symptoms remained stable. Discontinuation rates were similar. Sleep remained improved during single-blind placebo phase after eszopiclone was stopped, but the working memory improvement in patients with schizophrenia was not durable. Eszopiclone stands as a safe and effective alternative for the treatment of insomnia in patients with schizophrenia. Its effects on cognition require further study. Copyright © 2014 Elsevier B.V. All rights reserved.

Lathosterol to cholesterol ratio in serum predicts cholesterol lowering response to plant sterol consumption in a dual center, randomized, single-blind placebo controlled trial

USDA-ARS?s Scientific Manuscript database

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...

Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study.

PubMed

Benussi, Alberto; Koch, Giacomo; Cotelli, Maria; Padovani, Alessandro; Borroni, Barbara

2015-10-01

Numerous studies have highlighted the possibility of modulating the excitability of cerebellar circuits using transcranial direct current stimulation. The present study investigated whether a single session of cerebellar anodal transcranial direct current stimulation could improve symptoms in patients with ataxia. Nineteen patients with ataxia underwent a clinical and functional evaluation pre- and post-double-blind, randomized, sham, or anodal transcranial direct current stimulation. There was a significant interaction between treatment and time on the Scale for the Assessment and Rating of Ataxia, on the International Cooperative Ataxia Rating Scale, on the 9-Hole Peg Test, and on the 8-Meter Walking Time (P < 0.001). At the end of the sessions, all performance scores were significantly different in the sham trial, compared to the intervention trial. A single session of anodal cerebellar transcranial direct current stimulation can transiently improve symptoms in patients with ataxia and might represent a promising tool for future rehabilitative approaches. © 2015 International Parkinson and Movement Disorder Society.

Drug user treatment failure blindness?

PubMed

Einstein, Stan

2012-01-01

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

The safety and effectiveness of a long-acting transdermal fentanyl solution compared with oxymorphone for the control of postoperative pain in dogs: a randomized, multicentered clinical study

PubMed Central

Martinez, S A; Wilson, M G; Linton, D D; Newbound, G C; Freise, K J; Lin, T-L; Clark, T P

2014-01-01

A prospective, double-blinded, positive-controlled, multicenter, noninferiority study was conducted to evaluate the safety and effectiveness of transdermal fentanyl solution (TFS) compared with oxymorphone for the control of postoperative pain in dogs. Five hundred and two (502) client-owned dogs were assigned to a single dose of TFS (2.7 mg/kg) applied 2–4 h prior to surgery or oxymorphone hydrochloride (0.22 mg/kg) administered subcutaneously 2–4 h prior to surgery and q6h through 90 h. Pain was evaluated over 4 days by blinded observers using a modified Glasgow composite pain scale, and the a priori criteria for treatment failure was a pain score ≥8 or adverse event necessitating withdrawal. Four TFS- and eight oxymorphone-treated dogs were withdrawn due to lack of pain control. Eighteen oxymorphone-treated, but no TFS-treated dogs were withdrawn due to severe adverse events. The one-sided upper 95% confidence interval of the difference between TFS and oxymorphone treatment failure rates was −5.3%. Adverse events associated with oxymorphone were greater in number and severity compared with TFS. It was concluded that a single administration of TFS was safe and noninferior to repeated injections of oxymorphone for the control of postoperative pain over 4 days at the dose rates of both formulations used in this study. PMID:24344787

TMS of the occipital cortex induces tactile sensations in the fingers of blind Braille readers.

PubMed

Ptito, M; Fumal, A; de Noordhout, A Martens; Schoenen, J; Gjedde, A; Kupers, R

2008-01-01

Various non-visual inputs produce cross-modal responses in the visual cortex of early blind subjects. In order to determine the qualitative experience associated with these occipital activations, we systematically stimulated the entire occipital cortex using single pulse transcranial magnetic stimulation (TMS) in early blind subjects and in blindfolded seeing controls. Whereas blindfolded seeing controls reported only phosphenes following occipital cortex stimulation, some of the blind subjects reported tactile sensations in the fingers that were somatotopically organized onto the visual cortex. The number of cortical sites inducing tactile sensations appeared to be related to the number of hours of Braille reading per day, Braille reading speed and dexterity. These data, taken in conjunction with previous anatomical, behavioural and functional imaging results, suggest the presence of a polysynaptic cortical pathway between the somatosensory cortex and the visual cortex in early blind subjects. These results also add new evidence that the activity of the occipital lobe in the blind takes its qualitative expression from the character of its new input source, therefore supporting the cortical deference hypothesis.

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. © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica.

PubMed

Rolan, Paul E; O'Neill, Gilmore; Versage, Eve; Rana, Jitesh; Tang, Yongqiang; Galluppi, Gerald; Aycardi, Ernesto

2015-01-01

To evaluate the safety, tolerability, and pharmacokinetics of single doses of BG00010 (neublastin, artemin, enovin) in subjects with unilateral sciatica. This was a single-center, blinded, placebo-controlled, randomized Phase 1 sequential-cohort, dose-escalation study (ClinicalTrials.gov identifier NCT00961766; funded by Biogen Idec). Adults with unilateral sciatica were enrolled at The Royal Adelaide Hospital, Australia. Four subjects were assigned to each of eleven cohorts (intravenous BG00010 0.3, 1, 3, 10, 25, 50, 100, 200, 400, or 800 μg/kg, or subcutaneous BG00010 50 μg/kg) and were randomized 3:1 to receive a single dose of BG00010 or placebo. The primary safety and tolerability assessments were: adverse events; clinical laboratory parameters and vital signs; pain as measured by a Likert rating scale; intra-epidermal nerve fiber density; and longitudinal assessment of quantitative sensory test parameters. Blood, serum, and plasma samples were collected for pharmacokinetic and pharmacodynamic assessments. Subjects were blinded to treatment assignment throughout the study. The investigator was blinded to treatment assignment until the Data Safety Review Committee review of unblinded data, which occurred after day 28. Beyond the planned enrollment of 44 subjects, four additional subjects were enrolled into to the intravenous BG00010 200 μg/kg cohort after one original subject experienced mild generalized pruritus. Therefore, a total of 48 subjects were enrolled between August 2009 and December 2011; all were included in the safety analyses. BG00010 was generally well tolerated: in primary analyses, the most common treatment-emergent adverse events were changes in temperature perception, pruritus, rash, or headache; no trends were observed in clinical laboratory parameters, vital signs, intra-epidermal nerve fiber density, or quantitative sensory testing. BG00010 was not associated with any clear, dose-dependent trends in Likert pain scores. BG00010 was rapidly distributed, with a prolonged terminal elimination phase. These data support the development of BG00010 for the treatment of neuropathic pain. ClinicalTrials.gov NCT00961766.

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

PubMed

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

2015-01-01

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

Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent Patients.

PubMed

Glue, Paul; Cape, Gavin; Tunnicliff, Donna; Lockhart, Michelle; Lam, Fred; Hung, Noelyn; Hung, C Tak; Harland, Sarah; Devane, Jane; Crockett, R S; Howes, John; Darpo, Borje; Zhou, Meijian; Weis, Holger; Friedhoff, Lawrence

2016-11-01

Ibogaine is a psychoactive substance that may reduce opioid withdrawal symptoms. This was the first clinical trial of noribogaine, ibogaine's active metabolite, in patients established on methadone opioid substitution therapy (OST). In this randomized, double-blind, placebo-controlled single ascending-dose study, we evaluated the safety, tolerability, and pharmacokinetics of noribogaine in 27 patients seeking to discontinue methadone OST who had been switched to morphine during the previous week. Noribogaine doses were 60, 120, or 180 mg (n = 6/dose level) or matching placebo (n = 3/dose level). Noribogaine was well tolerated. The most frequent treatment-emergent adverse events were noneuphoric changes in light perception ∼1 hour postdose, headache, and nausea. Noribogaine had dose-linear increases for AUC and C max and was slowly eliminated (mean t 1/2 range, 24-30 hours). There was a concentration-dependent increase in QTcI (0.17 ms/ng/mL), with the largest observed mean effect of ∼16, 28, and 42 milliseconds in the 60-, 120-, and 180-mg groups, respectively. Noribogaine showed a nonstatistically significant trend toward decreased total score in opioid withdrawal ratings, most notably at the 120-mg dose; however, the study design may have confounded evaluations of time to resumption of OST. Future exposure-controlled multiple-dose noribogaine studies are planned that will address these safety and design issues. © 2016, The American College of Clinical Pharmacology.

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

PubMed

Pavlović, M D; Adamič, M; Nenadić, D

2015-12-01

Diode lasers are the most commonly used treatment modalities for unwanted hair reduction. Only a few controlled clinical trials but not a single randomized controlled trial (RCT) compared the impact of various laser parameters, especially radiant exposure, onto efficacy, tolerability and safety of laser hair reduction. To compare the safety, tolerability and mid-term efficacy of fixed, low and incremental radiant exposures of diode lasers (800 nm) for axillary hair removal, we conducted an intrapatient, left-to-right, patient- and assessor-blinded and controlled trial. Diode laser (800 nm) treatments were evaluated in 39 study participants (skin type II-III) with unwanted axillary hairs. Randomization and allocation to split axilla treatments were carried out by a web-based randomization tool. Six treatments were performed at 4- to 6-week intervals with study subjects blinded to the type of treatment. Final assessment of hair reduction was conducted 6 months after the last treatment by means of blinded 4-point clinical scale using photographs. The primary endpoint was reduction in hair growth, and secondary endpoints were patient-rated tolerability and satisfaction with the treatment, treatment-related pain and adverse effects. Excellent reduction in axillary hairs (≥ 76%) at 6-month follow-up visit after receiving fixed, low and incremental radiant exposure diode laser treatments was obtained in 59% and 67% of study participants respectively (Z value: 1.342, P = 0.180). Patients reported lower visual analogue scale (VAS) pain score on the fixed (4.26) than on the incremental radiant exposure side (5.64) (P < 0.0003). The only side-effect was mild and transient erythema. Subjects better tolerated the fixed, low radiant exposure protocol (P = 0.03). The majority of the study participants were satisfied with both treatments. Both low and incremental radiant exposures produced similar hair reduction and high and comparable patient satisfaction. However, low radiant exposure diode laser treatments were less painful and better tolerated. © 2015 European Academy of Dermatology and Venereology.

Comparison of the Anti-Adhesion Activity of Three Different Cranberry Extracts on Uropathogenic P-fimbriated Escherichia coli: a Randomized, Double-blind, Placebo Controlled, Ex Vivo, Acute Study.

PubMed

Howell, Amy; Souza, Dan; Roller, Marc; Fromentin, Emilie

2015-07-01

Research suggests that cranberry (Vaccinium macrocarpon) helps maintain urinary tract health. Bacterial adhesion to the uroepithelium is the initial step in the progression to development of a urinary tract infection. The bacterial anti-adhesion activity of cranberry proanthocyanidins (PACs) has been demonstrated in vitro. Three different cranberry extracts were developed containing a standardized level of 36 mg of PACs. This randomized, double-blind, placebo controlled, ex vivo, acute study was designed to compare the anti-adhesion activity exhibited by human urine following consumption of three different cranberry extracts on uropathogenic P-fimbriated Escherichia coli in healthy men and women. All three cranberry extracts significantly increased anti-adhesion activity in urine. from 6 to 12 hours after intake of a single dose standardized to deliver 36 mg of PACs (as measured by the BL-DMAC method), versus placebo.

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.

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…

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.

Randomized, single blind, controlled trial of inhaled glutathione vs placebo in patients with cystic fibrosis.

PubMed

Calabrese, C; Tosco, A; Abete, P; Carnovale, V; Basile, C; Magliocca, A; Quattrucci, S; De Sanctis, S; Alatri, F; Mazzarella, G; De Pietro, L; Turino, C; Melillo, E; Buonpensiero, P; Di Pasqua, A; Raia, V

2015-03-01

In cystic fibrosis (CF) the defective CF transmembrane conductance regulator protein may be responsible for the impaired transport of glutathione (GSH), the first line defense of the lung against oxidative stress. The aim of this single-blind, randomized, placebo-controlled trial was to evaluate the effect of inhaled GSH in patients with CF. 54 adult and 51 pediatric patients were randomized to receive inhaled GSH or placebo twice daily for 12 months. Twelve month treatment with inhaled GSH did not achieve our predetermined primary outcome measure of 15% improvement in FEV1%. Only in patients with moderate lung disease, 3, 6 and 9 months therapy with GSH resulted in a statistically significant increase of FEV1 values from the baseline. Moreover GSH therapy improved 6-minute walking test in pediatric population. GSH was well tolerated by all patients. Inhaled GSH has slight positive effects in CF patients with moderate lung disease warranting further study. ClinicalTrials.gov; No.: NCT01450267; URL: www.clinicaltrialsgov. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

PubMed

Goldman, Mitchel P; Moradi, Amir; Gold, Michael H; Friedmann, Daniel P; Alizadeh, Kaveh; Adelglass, Jeffrey M; Katz, Bruce E

2018-01-01

Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.

Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

PubMed

Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

2017-02-01

To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( P<0.01). This pilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

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 physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Trial registration Number Dutch Trial registration (Nederlands Trial Register): NTR3437 PMID:23855591

Effects of fixed orthodontic treatment and two new mouth rinses on gingival health: A prospective cohort followed by a single-blind placebo-controlled randomized clinical trial.

PubMed

Sobouti, Farhad; Rakhshan, Vahid; Heydari, Mohaddeseh; Keikavusi, Shohreh; Dadgar, Sepideh; Shariati, Mahsa

2018-03-01

Routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. Antimicrobial mouth rinses are favorable in this regard. This two-phase study evaluated the effects of orthodontic treatment and the application of two mouthwashes not studied before on oral health indices. In this two-phase study (a prospective cohort followed by a parallel randomized controlled trial), plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and pocket probing depth (PPD) were measured in 54 orthodontic patients before orthodontic treatment and 4 months later. Then patients were randomized into three groups of mouthrinses: Persica (herbal), Ortho-Kin (containing diluted chlorhexidine), and Placebo (n=18×3). The effects of orthodontic treatment and mouthrinses were analyzed statistically (α=0.05). All the 4 indices increased between the baseline and 4th month of treatment (P values<0.01, paired t-test). They decreased back to baseline levels or below them, after one month of mouthwash application (P values<0.002). Both mouthwashes showed therapeutic effects compared to placebo in terms of PI and GBI. In the case of GI, only Persica showed significantly better results compared to placebo. Regarding PPD, only Ortho-Kin acted better than placebo (P values≤0.05, Tukey). Lack of positive control (regular chlorhexidine mouth rinse) and negative control (a group with no mouthwashes, even without the placebo). Lack of sample size predetermination based on a priori power calculations. The difference between the regime of Persica with that of Ortho-Kin and placebo (which had similar application protocols) disallowed perfectly effective blinding of the patients (hence, single-blind). Fixed orthodontic treatment might disrupt gingival health. Antimicrobial mouthwashes might reverse this. Both evaluated mouthwashes might have therapeutic effects. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

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

PubMed

van den Dool, Joost; Visser, Bart; Koelman, J Hans T M; Engelbert, Raoul H H; Tijssen, Marina A J

2013-07-15

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. 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. 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 physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Number Dutch Trial registration (Nederlands Trial Register): NTR3437.

Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

PubMed

Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

2015-03-08

Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol. The protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.

Distance education and diabetes empowerment: A single-blind randomized control trial.

PubMed

Zamanzadeh, Vahid; Zirak, Mohammad; Hemmati Maslakpak, Masomeh; Parizad, Naser

2017-11-01

Diabetes is one of the biggest problems in healthcare systems and kills many people every year. Diabetes management is impossible when only utilizing medication. So, patients must be educated to manage their diabetes. This study aims to assess the effect of education by telephone and short message service on empowering patients with type 2 diabetes (primary outcome). A single-blind randomized controlled trial was conducted in the Urmia diabetes association in Iran. Sixty six participants with definitive diagnosis of type 2 diabetes entered into the study. Patients with secondary health problems were excluded. Patients were selected by simple random sampling then allocated into intervention (n=33) and control (n=33) groups. The intervention group received an educational text message daily and instructive phone calls three days a week for three months along with usual care. The Diabetes Empowerment Scale (DES) with confirmed validity and reliability was used for collecting data. Data was analyzed using SPSS V6.1. Independent t-test, paired t-test and chi-square were used to analyze the data. The empowerment of the intervention group compared with the control group significantly improved after three months of distance education (p<0.00, EF=1. 16). The study findings show that the distance education has a significant effect on empowering patients with type 2 diabetes. Therefore, using distance education along with other diabetes management intervention is highly effective and should be part of the care in diabetes treatment. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial.

PubMed

Nyberg, Andrè; Saey, Didier; Martin, Mickaël; Maltais, François

2015-04-27

Low-load, high-repetitive single-limb resistance training may increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while minimizing the occurrence of limiting exertional symptoms. Whether high-repetitive single-limb resistance training would perform better than high-repetitive two-limb resistance training is unknown. In addition, the mechanisms underlying possible benefits of high-repetitive resistance training has not been investigated. The aims of this study are to compare single versus two-limb high-repetitive resistance training in patients with COPD and to investigate mechanisms of action of these training modalities. This trial is a prospective, assessor-blind, randomized controlled trial. The participants are patients with stable severe to very severe COPD who are older than 40 years of age and healthy controls. The intervention is single-limb, high-repetitive, resistance training with elastic bands, three times/week for 8 weeks. The control is two-limb high-repetitive resistance training with elastic bands, three times/week for 8 weeks. The primary outcomes is change in the 6-min walking distance after 8 weeks of single-limb or two-limb high-repetitive resistance training. The secondary outcomes are changes in limb muscle strength and endurance capacity, key protein involved in quadriceps anabolic/catabolic signalization, fiber-type distribution and capillarization, subjective dyspnea and muscle fatigue, muscle oxygenation, cardiorespiratory demand and health-related quality-of-life after 8 weeks of single-limb or two-limb high-repetitive resistance training. The acute effects of single-limb versus two-limb high-repetitive resistance training on contractile fatigue, exercise stimulus (the product of number of repetition and load), subjective dyspnea and muscle fatigue, muscle oxygenation, and cardiorespiratory demand during upper and lower limb exercises will also be investigated in patients with COPD and healthy controls. Randomization will be performed using a random number generator by a person independent of the recruitment process, using 1:1 allocation to the intervention and the control group using random block sizes. All outcome assessors will be blinded to group assignment. The results of this project will provide important information to help developing and implementing customized exercise training programs for patients with COPD. ClinicalTrials.gov Identifier NCT02283580 Registration date: 4 November 2014. First participant randomized: 10 November 2014.

Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial.

PubMed

Sheehy, L; Taillon-Hobson, A; Sveistrup, H; Bilodeau, M; Fergusson, D; Levac, D; Finestone, H

2016-03-31

Sitting ability and function are commonly impaired after stroke. Balance training has been shown to be helpful, but abundant repetitions are required for optimal recovery and patients must be motivated to perform rehabilitation exercises repeatedly to maximize treatment intensity. Virtual reality training (VRT), which allows patients to interact with a virtual environment using computer software and hardware, is enjoyable and may encourage greater repetition of therapeutic exercises. However, the potential for VRT to promote sitting balance has not yet been explored. The objective of this study is to determine if supplemental VRT-based sitting balance exercises improve sitting balance ability and function in stroke rehabilitation inpatients. This is a single-site, single-blind, parallel-group randomized control trial. Seventy six stroke rehabilitation inpatients who cannot stand independently for greater than one minute but can sit for at least 20 minutes (including at least one minute without support) are being recruited from a tertiary-care dedicated stroke rehabilitation unit. Participants are randomly allocated to experimental or control groups. Both participate in 10-12 sessions of 30-45 minutes of VRT performed in sitting administered by a single physiotherapist, in addition to their traditional therapy. The experimental group plays five games which challenge sitting balance while the control group plays five games which minimize trunk lean. Outcome measures of sitting balance ability (Function in Sitting Test, Ottawa Sitting Scale, quantitative measures of postural sway) and function (Reaching Performance Scale, Wolf Motor Function Test, quantitative measures of the limits of stability) are administered prior to, immediately following, and one month following the intervention by a second physiotherapist blind to the participant's group allocation. The treatment of sitting balance post-stroke with VRT has not yet been explored. Results from the current study will provide important evidence for the use of low-cost, accessible VRT as an adjunct intervention to increase sitting balance in lower-functioning patients receiving inpatient rehabilitation. The motivating and enjoyable attributes of VRT may increase exercise dosage, leading to improved function and optimal results from rehabilitation. https://clinicaltrials.gov/; Identifier: NCT02285933. Registered 06 November 2014. Funded by the Heart & Stroke Foundation of Canada and a generous donation from Tony & Elizabeth Graham.

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…

Early but not late-blindness leads to enhanced auditory perception.

PubMed

Wan, Catherine Y; Wood, Amanda G; Reutens, David C; Wilson, Sarah J

2010-01-01

The notion that blindness leads to superior non-visual abilities has been postulated for centuries. Compared to sighted individuals, blind individuals show different patterns of brain activation when performing auditory tasks. To date, no study has controlled for musical experience, which is known to influence auditory skills. The present study tested 33 blind (11 congenital, 11 early-blind, 11 late-blind) participants and 33 matched sighted controls. We showed that the performance of blind participants was better than that of sighted participants on a range of auditory perception tasks, even when musical experience was controlled for. This advantage was observed only for individuals who became blind early in life, and was even more pronounced for individuals who were blind from birth. Years of blindness did not predict task performance. Here, we provide compelling evidence that superior auditory abilities in blind individuals are not explained by musical experience alone. These results have implications for the development of sensory substitution devices, particularly for late-blind individuals.

Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study.

PubMed

Falls, Roman; Seman, Michael; Braat, Sabine; Sortino, Joshua; Allen, Jason D; Neil, Christopher J

2017-08-08

Acute heart failure (AHF) is a frequent reason for hospitalization worldwide and effective treatment options are limited. It is known that AHF is a condition characterized by impaired vasorelaxation, together with reduced nitric oxide (NO) bioavailability, an endogenous vasodilatory compound. Supplementation of inorganic sodium nitrate (NaNO 3 ) is an indirect dietary source of NO, through bioconversion. It is proposed that oral sodium nitrate will favorably affect levels of circulating NO precursors (nitrate and nitrite) in AHF patients, resulting in reduced systemic vascular resistance, without significant hypotension. We propose a single center, randomized, double-blind, placebo-controlled pilot trial, evaluating the feasibility of sodium nitrate as a treatment for AHF. The primary hypothesis that sodium nitrate treatment will result in increased systemic levels of nitric oxide pre-cursors (nitrate and nitrite) in plasma, in parallel with improved vasorelaxation, as assessed by non-invasively derived systemic vascular resistance index. Additional surrogate measures relevant to the known pathophysiology of AHF will be obtained in order to assess clinical effect on dyspnea and renal function. The results of this study will provide evidence of the feasibility of this novel approach and will be of interest to the heart failure community. This trial may inform a larger study.

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

PubMed Central

Tovey, Philip

2002-01-01

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

Treatment of canine atopic dermatitis with a commercial homeopathic remedy: A single-blinded, placebo-controlled study

PubMed Central

Scott, Danny W.; Miller, William H.; Senter, David A.; Cook, Christopher P.; Kirker, J. Edward; Cobb, Shaun M.

2002-01-01

A commercial homeopathic remedy and a placebo were administered orally as individual agents to 18 dogs with atopic dermatitis. The pruritus was reduced by less than 50% in only 2/18 dogs; 1 of these dogs was receiving the homeopathic remedy, the other was receiving the placebo. One dog vomited after administration of the homeopathic remedy. PMID:12170834

Two Double-Blind, Multicenter, Randomized, Placebo-Controlled, Single-Dose Studies of Sumatriptan/Naproxen Sodium in the Acute Treatment of Migraine: Function, Productivity, and Satisfaction Outcomes

PubMed Central

Landy, Stephen; DeRossett, Sarah E.; Rapoport, Alan; Rothrock, John; Ames, Michael H.; McDonald, Susan A.; Burch, Steven P.

2007-01-01

Objective To describe return to normal function, productivity, and satisfaction of patients with moderate or severe migraine attacks treated with combined sumatriptan/naproxen sodium, sumatriptan alone, naproxen sodium alone, or placebo. Patients, design, and setting Patients in 2 identical, US, phase 3, randomized, double-blind, parallel-group, placebo-controlled, single-dose, multicenter studies treated a single moderate or severe migraine attack with sumatriptan/naproxen sodium (85 mg sumatriptan formulated with RT Technology and 500 mg naproxen sodium in a single-tablet formulation), sumatriptan, naproxen sodium, or placebo. Main outcome measures Ability to function (not impaired, mildly impaired, severely impaired, or required bed rest) was collected in diary cards completed immediately prior to treatment, every 30 minutes for the first 2 hours, and hourly from 2 to 24 hours while awake. Patients completed the Productivity Assessment Questionnaire (PAQ) 24 hours after study drug administration. The Patient Perception of Migraine Questionnaire (PPMQ) was administered at screening and 24 hours post treatment to capture patient satisfaction. Results Compared with the other groups, the sumatriptan/naproxen sodium group reported significantly higher levels of normal or mildly impaired functioning as early as 2 and 4 hours after dosing. They also demonstrated greater reductions in workplace productivity loss compared with placebo in both studies, and were consistently more satisfied with their treatment compared with patients in other treatment groups and compared with their usual medications. Conclusions Treatment with sumatriptan/naproxen sodium allowed significantly more subjects to return to normal or mildly impaired functioning more quickly, and sumatriptan/naproxen sodium patients were significantly more satisfied with their treatment compared with other treatment groups. Overall productivity loss was significantly reduced following use of sumatriptan/naproxen sodium. PMID:17955107

Effects of Reiki on Pain and Vital Signs When Applied to the Incision Area of the Body After Cesarean Section Surgery: A Single-Blinded, Randomized, Double-Controlled Study.

PubMed

Sagkal Midilli, Tulay; Ciray Gunduzoglu, Nazmiye

This study was conducted to determine the effects of Reiki on pain and vital signs when applied for 15 minutes to the incision area of the body after cesarean section surgery. The study was single-blinded, randomized, and double-controlled (Reiki, sham Reiki, and control groups). Forty-five patients, equalized by age and number of births, were randomly assigned to the Reiki, sham Reiki, and control groups. The treatment, which was applied to the patients in these 3 groups, was applied for 15 minutes to the incision area of body in the first 24 and 48 hours after the operation within 4 to 8 hours of the application of standard analgesics. The study data were collected using a patient follow-up form and a visual analog scale. Mean visual analog scale measurement values were significantly different from each other according to groups and times (P < .05). A reduction in pain of 76.06% was determined in the Reiki group patients between day 1 pre-tx and after application on the second day (day 2 post-tx) measurements. Mean breathing rate and systolic blood pressure measurement values were significantly different from each other according to groups (P < .05). The Reiki group was observed to use fewer analgesics throughout the study and to need them after a longer time than the sham Reiki and control groups (P < .05). It was concluded that Reiki applied for 15 minutes to the incision area after a cesarean operation had the expected effects on pain and the need for the use of analgesics, but it had no effect on vital signs.

A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy.

PubMed

Preston, Nick; Weightman, Andrew; Gallagher, Justin; Levesley, Martin; Mon-Williams, Mark; Clarke, Mike; O'Connor, Rory J

2016-10-01

To evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on arm function of children with spastic cerebral palsy. A single-blind randomized controlled trial design. Power calculations indicated that 58 children would be required to demonstrate a clinically important difference. Intervention was home-based; recruitment took place in regional spasticity clinics. A total of 15 children with cerebral palsy aged five to 12 years were recruited; eight to the device group. Both study groups received 'usual follow-up treatment' following spasticity treatment with botulinum toxin; the intervention group also received a rehabilitation gaming device. ABILHAND-kids and Canadian Occupational Performance Measure were performed by blinded assessors at baseline, six and 12 weeks. An analysis of covariance showed no group differences in mean ABILHAND-kids scores between time points. A non-parametric analysis of variance on Canadian Occupational Performance Measure scores showed a statistically significant improvement across time points (χ 2 (2,15) = 6.778, p = 0.031), but this improvement did not reach minimal clinically important difference. Mean daily device use was seven minutes. Recruitment did not reach target owing to unanticipated staff shortages in clinical services. Feedback from children and their families indicated that the games were not sufficiently engaging to promote sufficient use that was likely to result in functional benefits. This study suggests that computer-assisted arm rehabilitation gaming does not benefit arm function, but a Type II error cannot be ruled out. © The Author(s) 2015.

Viewing videotaped identification procedure increases juror sensitivity to single-blind photo-array administration.

PubMed

Modjadidi, Karima; Kovera, Margaret Bull

2018-06-01

We investigated whether watching a videotaped photo array administration or expert testimony could sensitize jurors to the suggestiveness of single-blind eyewitness identification procedures. Mock jurors recruited from the community (N = 231) watched a videotaped simulation of a robbery trial in which the primary evidence against the defendant was an eyewitness identification. We varied whether the witness made an identification from a single- or double-blind photo array, the evidence included a videotape of the photo array procedure, and an expert testified about the effects of single-blind identification procedures on administrators' behaviors and witness accuracy. Watching the videotaped photo array administration sensitized mock jurors to the suggestiveness of the single-blind procedure, causing them to be less likely to convict a defendant identified through single-rather than double-blind procedures. Exposure to the videotaped procedure also decreased the favorability of mock jurors' ratings of the eyewitness, irrespective of whether the lineup was conducted by a single-blind administrator. Expert testimony did not sensitize jurors to administrator bias. Thus, videotaping identification procedures could serve as an important procedural reform that both preserves a record of whether the lineup administration was suggestive and might improve jurors' evaluations of eyewitness evidence. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Magnetic resonance therapy for knee osteoarthritis: a randomized, double blind placebo controlled trial.

PubMed

Gökşen, Nurgül; Çaliş, Mustafa; Doğan, Serap; Çaliş, Havva T; Özgöçmen, Salih

2016-08-01

Therapeutic nuclear magnetic resonance therapy (MRT) works based on the electromagnetic fields. To investigate efficacy of MRT in knee osteoarthritis (OA). Prospective, randomized, double-blind, placebo controlled trial. Outpatient clinic, university hospital. Patients who had mild to moderate knee OA at a single knee joint and between 30-75-years-old were randomized by blinded chip cards (1:1). The treatment group received ten sessions of one hour daily MRT, controls received placebo MRT. All patients underwent clinical examination at baseline, after 2 weeks, and 12 weeks. Imaging included blindly assessed ultrasonography and magnetic resonance (MR) of the knee. Ninety-seven patients completed the study. Both groups improved significantly but the average change from baseline in outcome parameters was similar in MRT group (on VAS-pain,-2.6; WOMAC-pain, -2.09; WOMAC-stiffness, -1.81; WOMAC-physical, -1.96) compared to placebo after two weeks (VAS-pain,-1.6; WOMAC-pain, -1.91; WOMAC-stiffness, -1.27; WOMAC-physical, -1.54). Also changes were quite similar at the 12th week after the treatment. SF-36 components at 12th week improved but changes were not significant. Imaging arm also failed to show significant differences between groups in terms of cartilage thickness on US and MR scores. No adverse events were recorded. MRT is safe, but not superior to placebo in terms of improvement in clinical or imaging parameters after a 10-day course of treatment in mild to moderate knee OA. The present study does not promote use of a 10-day course of MRT in mild to moderate knee OA.

Brief report: Pilot single-blind placebo lead-in study of acamprosate in youth with autistic disorder.

PubMed

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

2014-04-01

An excitatory/inhibitory (E:I) imbalance marked by enhanced glutamate and deficient gamma-aminobutyric acid (GABA) neurotransmission may contribute to the pathophysiology of autism spectrum disorders (ASD). We report on the first single-blind placebo lead-in trial of acamprosate, a drug with putative mechanisms restoring E:I imbalance, in twelve youth with ASD. We conducted a 12-week single-blind, placebo lead-in study of acamprosate in youth age 5-17 years with autistic disorder. Six of nine subjects who received active drug treatment were deemed treatment responders (defined by a score at final visit of "very much improved" or "much improved" on the Clinical Global Impressions Improvement scale) and ≥25% improvement on the Aberrant Behavior Checklist Social Withdrawal subscale. Future larger-scale dose finding studies of acamprosate in ASD may be warranted given this preliminary indication of benefit.

No difference in terms of radiostereometric analysis between fixed- and mobile-bearing total knee arthroplasty: a randomized, single-blind, controlled trial.

PubMed

Schotanus, M G M; Pilot, P; Kaptein, B L; Draijer, W F; Tilman, P B J; Vos, R; Kort, N P

2017-09-01

A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis. This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs). At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups. Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation. Randomized, single-blind, controlled trial, Level I.

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.).

Immediate effects of Tuina techniques on working-related musculoskeletal disorder of professional orchestra musicians.

PubMed

Sousa, Cláudia Maria; Moreira, Luis; Coimbra, Daniela; Machado, Jorge; Greten, Henry J

2015-07-01

Musicians are a prone group to suffer from working-related musculoskeletal disorder (WRMD). Conventional solutions to control musculoskeletal pain include pharmacological treatment and rehabilitation programs but their efficiency is sometimes disappointing. The aim of this research is to study the immediate effects of Tuina techniques on WRMD of professional orchestra musicians from the north of Portugal. We performed a prospective, controlled, single-blinded, randomized study. Professional orchestra musicians with a diagnosis of WRMD were randomly distributed into the experimental group (n=39) and the control group (n=30). During an individual interview, Chinese diagnosis took place and treatment points were chosen. Real acupoints were treated by Tuina techniques into the experimental group and non-specific skin points were treated into the control group. Pain was measured by verbal numerical scale before and immediately after intervention. After one treatment session, pain was reduced in 91.8% of the cases for the experimental group and 7.9% for the control group. Although results showed that Tuina techniques are effectively reducing WRMD in professional orchestra musicians of the north of Portugal, further investigations with stronger measurements, double-blinding designs and bigger simple sizes are needed.

Therapeutic touch and postoperative pain: a Rogerian research study.

PubMed

Meehan, T C

1993-01-01

This article details Meehan's research study concerning the conceptualization of therapeutic touch within Rogers' science of unitary human beings and an investigation of the effects of therapeutic touch on pain experience in postoperative patients. Using a single trial, single-blind, three-group design, 108 postoperative patients were randomly assigned to receive one of the following: therapeutic touch, a placebo control intervention which mimicked therapeutic touch, or the standard intervention of a narcotic analgesic. Using a visual analogue scale, pain was measured before and one hour following intervention. The hypothesis, that therapeutic touch would significantly decrease postoperative pain compared to the placebo control intervention, was not supported. Secondary analyses suggest that therapeutic touch may decrease patients' need for analgesic medication. Implications for further research and practice are suggested.

Effect of a single prophylactic preoperative oral antibiotic dose on surgical site infection following complex dermatological procedures on the nose and ear: a prospective, randomised, controlled, double-blinded trial.

PubMed

Rosengren, Helena; Heal, Clare F; Buttner, Petra G

2018-04-19

There is limited published research studying the effect of antibiotic prophylaxis on surgical site infection (SSI) in dermatological surgery, and there is no consensus for its use in higher-risk cases. The objective of this study was to determine the effectiveness of a single oral preoperative 2 g dose of cephalexin in preventing SSI following flap and graft dermatological closures on the nose and ear. Prospective double-blinded, randomised, placebo-controlled trial testing for difference in infection rates. Primary care skin cancer clinics in North Queensland, Australia, were randomised to 2 g oral cephalexin or placebo 40-60 min prior to skin incision. 154 consecutive eligible patients booked for flap or graft closure following skin cancer excision on the ear and nose. 2 g dose of cephalexin administered 40-60 min prior to surgery. Overall 8/69 (11.6%) controls and 1/73 (1.4%) in the intervention group developed SSI (p=0.015; absolute SSI reduction 10.2%; number needed to treat (NNT) for benefit 9.8, 95% CI 5.5 to 45.5). In males, 7/44 controls and 0/33 in the intervention group developed SSI (p=0.018; absolute SSI reduction 15.9%; NNT for benefit 6.3, 95% CI 3.8 to 19.2). SSI was much lower in female controls (1/25) and antibiotic prophylaxis did not further reduce this (p=1.0). There was no difference between the study groups in adverse symptoms attributable to high-dose antibiotic administration (p=0.871). A single oral 2 g dose of cephalexin given before complex skin closure on the nose and ear reduced SSI. ANZCTR 365115; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effect of acupuncture anesthesia on acne vulgaris of pricking-bloodletting cupping: a single-blind randomized clinical trail.

PubMed

Xu, Jianfeng; Lin, Ruizhu; Wang, Jing; Wu, Yongli; Wang, Yingxu; Zhang, Yuequan; Xi, Chaolei; Wu, Qiang

2013-12-01

To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui (GV 14) under acupuncture anesthesia, and establish whether providing anesthesia to the treatment area by manipulating Hegu (LI 4) and Quchi (LI 11) might have an additional therapeutic benefit. Thirty-eight patients were recruited and randomized into a control group and an intervention group with a single-blind (observer-blind) method. The control group was treated by pricking-bloodletting cupping at Dazhui (GV 14)-and the studied group by pricking-bloodletting cupping at Dazhui (GV 14) under acupuncture anesthesia at Hegu (LI 4) and Quchi (LI 11). Both groups were treated twice weekly for 6 weeks. The analgesic and therapeutic effects of acupuncture were evaluated on a visual analog scale (VAS) and global acne grading system (GAGS), respectively. There were differences in the VAS scores of pain on pricking and in the pricked area, and the duration of pain between the groups. After 12 treatments, there was a significant reduction in GAGS scores from baseline in both groups, but there was no significant difference between the groups. Acupuncture anesthesia at Hegu (LI 4) and Quchi (LI 11) is an effective means of alleviating the pain of pricking-bloodletting cupping and reducing the duration of pain in the treatment area. Pricking-bloodletting cupping at Dazhui (GV 14) improves the skin lesions of patients with moderate acne vulgaris, but acupuncture anesthesia does not appear to have an additional therapeutic effect.

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

PubMed

Zhou, Kaina; Wang, Duolao; He, Xiaole; Huo, Lanting; An, Jinghua; Li, Minjie; Wang, Wen; Li, Xiaomei

2016-08-31

Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer. This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer. Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

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

PubMed

Bremer, K

1992-01-01

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

Evaluation of the effect of balneotherapy in patients with osteoarthritis of the hands: a randomized controlled single-blind follow-up study.

PubMed

Horváth, Katalin; Kulisch, Ágota; Németh, András; Bender, Tamás

2012-05-01

To evaluate the effectiveness of thermal mineral water compared with magnetotherapy without balneotherapy as control, in the treatment of hand osteoarthritis. Randomized controlled single-blind follow-up study. Rheumatology specialist clinic of Gunaras Health Spa. Patients between 50 and 70 years of age with hand osteoarthritis, randomly assigned into three groups. The subjects in the first two groups bathed in thermal mineral water of two different temperatures (36°C and 38°C) for three weeks five times a week for 20 minutes a day and received magnetotherapy to their hands three times weekly. The third group received only magnetotherapy. Visual analogue scale scores, handgrip strength, pinchgrip strength, the number of swollen and tender joints of the hand, the duration of morning joint stiffness, Health Assessment Questionnaire, and Short Form-36 questionnaire. The study parameters were administered at baseline, immediately after treatment and after 13 weeks. The study included 63 patients. Statistically significant improvement was observed in several studied parameters after the treatment and during the follow-up study in the thermal water groups versus the control group. The 38°C thermal water treatment significantly improved the pinch strength of the right hand (0.6 (95% confidence interval (CI) 0.2 to 1.1) vs. 0.03 (95% CI -0.3 to 0.4), P < 0.05) and the Health Assessment Questionnaire parameters (-0.4 (95% CI -0.6 to -0.2) vs. -0.1 (95% CI -0.2 to 0.1), P < 0.01) even in the long term. Balneotherapy combined with magnetotherapy improved the pain and function as well as the quality of life in patients with hand osteoarthritis.

Efficacy and safety of adapalene gel 0.1% and 0.3% and tretinoin gel 0.05% for acne vulgaris: results of a single-center, randomized, double-blinded, placebo-controlled clinical trial on Mexican patients (skin type III-IV).

PubMed

Tirado-Sánchez, Andrés; Espíndola, Yareni Salas; Ponce-Olivera, Rosa María; Bonifaz, Alexandro

2013-06-01

The efficacy of topical retinoids is well known according to several clinical studies conducted predominantly among Caucasian patients. This study aimed to evaluate the efficacy and safety profile of adapalene and tretinoin among Mexican patients. To compare adapalene 0.1 and 0.3% and tretinoin 0.05% in Mexican subjects with acne vulgaris. We enrolled 171 patients in this single-center, randomized, double-blinded, placebo-controlled clinical trial. The patients applied on the face either adapalene 0.1%, adapalene 0.3%, tretinoin 0.05%, or placebo for 90 days and were evaluated for the reduction in total lesion counts and for the level of irritation. Tretinoin 0.05% and adapalene 0.3% were more effective than adapalene 0.1% and placebo in the reduction of both inflammatory and noninflammatory lesions. Most of adverse events to adapalene and many on tretinoin group were related to skin irritation, dry skin, scaling, pruritus, burning, and postinflammatory hyperpigmentation. Adapalene 0.3% and tretinoin 0.05% are comparable in efficacy, and adapalene 0.1% offers a better safety profile in Mexican patients. © 2013 Wiley Periodicals, Inc.

An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.

PubMed

Hunt, Sheena; Stebbings, Simon; McNamara, Debra

2016-10-28

This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.

Effect of fat on serum 25-hydroxyvitamin D levels after a single oral dose of vitamin D in young healthy adults: a double-blind randomized placebo-controlled study.

PubMed

Raimundo, Fabiana Viegas; Lang, Maria Augusta Britto; Scopel, Luciano; Marcondes, Natália Aydos; Araújo, Mirna Griselda Anocibar; Faulhaber, Gustavo Adolpho Moreira; Furlanetto, Tania Weber

2015-04-01

This double-blind placebo-controlled trial evaluated serum 25-hydroxyvitamin D [25(OH)D] levels after the oral intake of a single dose of cholecalciferol during one of the three meals, containing different amounts of fat or placebo. Sixty-four healthy medical residents or students of a university hospital in Porto Alegre, latitude 30° S, Brazil, were divided into four groups. Three groups received a single 50,000 IU oral dose of cholecalciferol during a meal containing 0 g (Group 1), 15 g (Group 2) or 30 g (Group 3) of fat, and one group received placebo (Group 4), according to randomization. Serum 25(OH)D, parathyroid hormone, total calcium, albumin, magnesium, and creatinine levels, and urinary calcium, magnesium, and creatinine levels were measured at baseline and after 14 days. Baseline mean serum 25(OH)D levels were low in all groups. Vitamin D given during breakfast increased the mean change of serum 25(OH)D levels, when compared to placebo. Furthermore, the intake of fat with vitamin D increased the mean change of serum 25(OH)D levels. A single oral dose of vitamin D given with food increased mean serum 25(OH)D levels, after 2 weeks, and the mean increase was larger, when the meal had at least 15 g of fat. These findings can have important implications to oral vitamin D supplementation.

Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial.

PubMed

Bikmoradi, Ali; Seifi, Zahra; Poorolajal, Jalal; Araghchian, Malihe; Safiaryan, Reza; Oshvandi, Khodayar

2015-06-01

At present, aromatherapy is used widely in medical research. This study aimed to investigate the effects of inhalation aromatherapy using lavender essential oil to reduce mental stress and improve the vital signs of patients after coronary artery bypass surgery (CABG). A single-blinded randomized controlled trial was conducted with 60 patients who had undergone CABG in a 2-day intervention that targeted stress reduction. Sixty subjects following coronary artery bypass surgery in two aromatherapy and control groups. The study was conducted in Ekbatan Therapeutic and Educational Center, Hamadan, Iran, in 2013. On the second and third days after surgery, the aromatherapy group patients received two drops of 2% lavender essential oil for 20min and the control group received two drops of distilled water as a placebo. The primary outcome was mental stress, which was measured before and after the intervention using the DASS-21 questionnaire. The secondary outcomes were vital signs, including the heart rate, respiratory rate, and systolic and diastolic blood pressure, which were measured before and after the intervention. The individual characteristics of the aromatherapy and control groups were the same. There were no significant difference in the mean mental stress scores and vital signs of the aromatherapy and control groups on the second or third days after surgery. Inhalation aromatherapy with lavender essential oil had no significant effects on mental stress and vital signs in patients following CABG, except the systolic blood pressure. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Randomized Controlled Trial of Brief and Ultrabrief Pulse Right Unilateral Electroconvulsive Therapy

PubMed Central

Katalinic, Natalie; Smith, Deirdre J.; Ingram, Anna; Dowling, Nathan; Martin, Donel; Addison, Kerryn; Hadzi-Pavlovic, Dusan; Simpson, Brett; Schweitzer,, Isaac

2015-01-01

Background: Some studies suggest better overall outcomes when right unilateral electroconvulsive therapy (RUL ECT) is given with an ultrabrief, rather than brief, pulse width. Methods: The aim of the study was to test if ultrabrief-pulse RUL ECT results in less cognitive side effects than brief- pulse RUL ECT, when given at doses which achieve comparable efficacy. One hundred and two participants were assigned to receive ultrabrief (at 8 times seizure threshold) or brief (at 5 times seizure threshold) pulse RUL ECT in a double-blind, randomized controlled trial. Blinded raters assessed mood and cognitive functioning over the ECT course. Results: Efficacy outcomes were not found to be significantly different. The ultrabrief group showed less cognitive impairment immediately after a single session of ECT, and over the treatment course (autobiographical memory, orientation). Conclusions: In summary, when ultrabrief RUL ECT was given at a higher dosage than brief RUL ECT (8 versus 5 times seizure threshold), efficacy was comparable while cognitive impairment was less. PMID:25522389

A randomized, controlled, single-blind trial of teaching provided by a computer-based multimedia package versus lecture.

PubMed

Williams, C; Aubin, S; Harkin, P; Cottrell, D

2001-09-01

Computer-based teaching may allow effective teaching of important psychiatric knowledge and skills. To investigate the effectiveness and acceptability of computer-based teaching. A single-blind, randomized, controlled study of 166 undergraduate medical students at the University of Leeds, involving an educational intervention of either a structured lecture or a computer-based teaching package (both of equal duration). There was no difference in knowledge between the groups at baseline or immediately after teaching. Both groups made significant gains in knowledge after teaching. Students who attended the lecture rated their subjective knowledge and skills at a statistically significantly higher level than students who had used the computers. Students who had used the computer package scored higher on an objective measure of assessment skills. Students did not perceive the computer package to be as useful as the traditional lecture format, despite finding it easy to use and recommending its use to other students. Medical students rate themselves subjectively as learning less from computer-based as compared with lecture-based teaching. Objective measures suggest equivalence in knowledge acquisition and significantly greater skills acquisition for computer-based teaching.

Is Pelvic Floor Muscle Training Effective for Men With Poststroke Lower Urinary Tract Symptoms? A Single-Blinded Randomized, Controlled Trial.

PubMed

Tibaek, Sigrid; Gard, Gunvor; Dehlendorff, Christian; Iversen, Helle K; Biering-Soerensen, Fin; Jensen, Rigmor

2017-09-01

The aim of the current study was to evaluate the effect of pelvic floor muscle training in men with poststroke lower urinary tract symptoms. Thirty-one poststroke men, median age 68 years, were included in this single-blinded randomized controlled trial. Thirty participants, 15 in each group, completed the study. The intervention consisted of 3 months (12 weekly sessions) of pelvic floor muscle training in groups and home exercises. The effect was evaluated by the DAN-PSS-1 (Danish Prostate Symptom Score) questionnaire, a voiding diary, and digital anal palpation of the pelvic floor muscle. The DAN-PSS-1, symptom score indicated a statistical significant improvement ( p < .01) in the treatment group from pretest to posttest, but not in the control group. The DAN-PSS-1, total score improved statistically significantly in both groups from pretest to posttest (treatment group: p < .01; control group: p = .03). The median voiding frequency per 24 hours decreased from 11 at pretest to 7 (36%; p = .04) at posttest and to 8 (27%; p = .02) at follow-up in treatment group, although not statistical significantly more than the control group. The treatment group but not the control group improved statistically significantly in pelvic floor muscle function ( p < .01) and strength ( p < .01) from pretest to posttest and from pretest to follow-up ( p = .03; p < .01). Compared with the control group the pretest to posttest was significantly better in the treatment group ( p = .03). The results indicate that pelvic floor muscle training has an effect for lower urinary tract symptoms, although statistical significance was only seen for pelvic floor muscle.

Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study.

PubMed

Albert, Jörg; Göbel, Christa-Maria; Lesske, Joachim; Lotterer, Erich; Nietsch, Hubert; Fleig, Wolfgang E

2004-04-01

Capsule endoscopy is a new imaging method for visualization of the entire small bowel. However, no standardized protocol for bowel preparation for capsule endoscopy has been evaluated. Capsule endoscopy was performed in 36 consecutive patients, all of whom fasted for 12 hours before ingestion of the capsule. Before capsule endoscopy, 18 patients received 80 mg simethicone and 18 had no supplemental medication for bowel preparation. Two observers, both experienced endoscopists, independently reviewed the examinations in a single-blinded and randomly assigned fashion. Mucosal visibility and intraluminal gas bubbles were assessed and graded by both observers. Bowel preparation with simethicone resulted in significantly better visibility because of fewer intraluminal bubbles (p<0.01). Interobserver agreement was excellent (r>/=0.8; k 0.78: 95% CI[0.57, 0.98] ). No adverse effect of simethicone was observed. Simethicone may be added to the routine preparation for capsule endoscopy to improve the visibility of small bowel mucosa.

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

PubMed

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

2013-03-01

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

Effectiveness of a low-cost virtual reality system for children with developmental delay: a preliminary randomised single-blind controlled trial.

PubMed

Salem, Yasser; Gropack, Stacy Jaffee; Coffin, Dale; Godwin, Ellen M

2012-09-01

Physical and occupational therapists have started to use the Nintendo Wii™ gaming system with adults and children as part of their regular treatment. Despite the growing use of the Wii and trend towards evidence-based practice, limited evidence is available on the effectiveness of virtual reality using the Wii for children with developmental delay. The purpose of this study was to determine the feasibility and preliminary effectiveness of a low-cost gaming system for young children with developmental delay. Single-blind, randomised controlled trial. Forty children with developmental delay (age 39 to 58 months) who attended a segregated or integrated preschool participated in this study. All children's parents read and signed an informed consent form approved by the institutional review board. Children were assigned at random to an experimental (Wii) group (n=20) or a control group (n=20). Two weekly sessions for 10 weeks using Nintendo Wii Sports™ and Nintendo Wii Fit™, including balance, strength training and aerobics games. Participants were evaluated 1 week before and 1 week after the programme by a blinded investigator. Primary outcomes were gait speed, timed up and go test, single leg stance test, five-times-sit-to-stand test, timed up and down stairs test, 2-minute walk test and grip strength. The Gross Motor Function Measure (GMFM) was used to assess gross motor skills. The two groups were homogenous regarding all parameters at baseline. The Wii training was feasible and enjoyable for those in the experimental group. There were no adverse effects or injuries reported over 267 training sessions. Comparison of groups following the intervention indicated that the experimental group showed significant improvements compared with the control group in single leg stance test {mean difference 1.03 [standard deviation (SD) 1.7], 95% confidence interval (CI) 0.2 to 1.9; P=0.017}, right grip strength [mean difference 1.11 (SD 1.84), 95% CI 0.15 to 2.06; P=0.024] and left grip strength [mean difference 0.90 (SD 1.67), 95% CI 0.03 to 1.77; P=0.043]. Although changes in other outcome measures were not significant between the study groups, there were trends towards greater improvements in the experimental group compared with the control group. This study supports use of the Wii as a feasible, safe and potentially effective therapeutic tool to augment the rehabilitation of young children with developmental delay. The potential application of the Wii to increase the intensity of therapy or as a rehabilitation tool in children's homes and rural settings is an area worthy of investigation. The promising results of this study suggest that further studies are warranted to validate the potential benefits of a low-cost commercially available gaming system as a treatment strategy to supplement rehabilitation of children with disabilities. Copyright © 2012 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

PubMed

Mader, Julia K; Lilly, Leslie C; Aberer, Felix; Korsatko, Stefan; Strock, Ellie; Mazze, Roger S; Damsbo, Peter; Pieber, Thomas R

2014-05-01

This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

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

PubMed

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

2016-12-01

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

Oxcarbazepine in migraine headache: a double-blind, randomized, placebo-controlled study.

PubMed

Silberstein, S; Saper, J; Berenson, F; Somogyi, M; McCague, K; D'Souza, J

2008-02-12

To evaluate the efficacy, safety, and tolerability of oxcarbazepine (1,200 mg/day) vs placebo as prophylactic therapy for patients with migraine headaches. This multicenter, double-blind, randomized, placebo-controlled, parallel-group trial consisted of a 4-week single-blind baseline phase and a 15-week double-blind phase consisting of a 6-week titration period, an 8-week maintenance period, and a 1-week down-titration period, after which patients could enter a 13-week open-label extension phase. During the 6-week titration period, oxcarbazepine was initiated at 150 mg/day and increased by 150 mg/day every 5 days to a maximum tolerated dose of 1,200 mg/day. The primary outcome measure was change from baseline in the number of migraine attacks during the last 28-day period of the double-blind phase. Eighty-five patients were randomized to receive oxcarbazepine and 85 to receive placebo. There was no difference between the oxcarbazepine (-1.30) and placebo groups in mean change in number of migraine attacks from baseline during the last 28 days of double-blind phase (-1.74; p = 0.2274). Adverse events were reported for 68 oxcarbazepine-treated patients (80%) and 55 placebo-treated patients (65%). The majority of adverse events were mild or moderate in severity. The most common adverse events (>or=15% of patients) in the oxcarbazepine-treated group were fatigue (20.0%), dizziness (17.6%), and nausea (16.5%); no adverse event occurred in more than 15% of the placebo-treated patients. Overall, oxcarbazepine was safe and well tolerated; however, oxcarbazepine did not show efficacy in the prophylactic treatment of migraine headaches.

Coformulated bictegravir, Emtricitabine (F), tenofovir alafenamide (TAF) after initial treatment with bictegravir or dolutegravir plus F/TAF.

PubMed

Sax, Paul E; Dejesus, Edwin; Crofoot, Gordon; Ward, Douglas; Benson, Paul; Dretler, Robin; Mills, Anthony; Brinson, Cynthia; Wei, Xuelian; Collins, Sean E; Cheng, Andrew

2018-05-22

: A phase 2, randomized, active-controlled study of initial antiretroviral therapy with bictegravir or dolutegravir in combination with emtricitabine and tenofovir alafenamide showed excellent efficacy. After 60 weeks of blinded treatment, participants switched to a single tablet regimen of bictegravir, emtricitabine and tenofovir alafenamide. Switching maintained viral suppression in all participants who chose to remain on the study through at least 12 weeks in the open-label phase, was safe and well tolerated.

Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain.

PubMed

Moore, R Andrew; Gay-Escoda, C; Figueiredo, R; Tóth-Bagi, Z; Dietrich, T; Milleri, S; Torres-Lagares, D; Hill, C M; García-García, A; Coulthard, P; Wojtowicz, A; Matenko, D; Peñarrocha-Diago, M; Cuadripani, S; Pizà-Vallespir, B; Guerrero-Bayón, C; Bertolotti, M; Contini, M P; Scartoni, S; Nizzardo, A; Capriati, A; Maggi, C A

2015-01-01

Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72%) was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95% confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. Dexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. EudraCT (2010-022798-32); Clinicaltrials.gov (NCT01307020).

Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block.

PubMed

Ashraf, Anam; Raut, Videsh V; Canty, Stephen J; McLauchlan, George J

2013-10-01

We report a prospective blinded randomised trial of local infiltration versus femoral nerve block in patients undergoing primary total knee replacement (TKR), in accordance with the CONSORT statement 2010. Fifty patients in a teaching hospital were consented for the study. The study arms were intraoperative local anaesthesia (150ml 0.2% ropivacaine/1ml 1:1000 adrenaline/30mg ketolorac) and femoral nerve block (30ml 0.2% ropivacaine) with a primary outcome of pain score at 4h post operatively. Secondary outcomes were pain at 2h, pain scores before and after physiotherapy on day one, total opiate administered, time to physiotherapy goals and length of stay. Randomisation was by sealed envelope. The assessor was blinded and the patients partially blinded to the intervention. Ten patients were excluded, eight before randomisation. The trial is complete. Forty patients were analysed for the primary outcome measure. The local infiltration group had significantly lower pain scores at 4h post-operatively; mean [SD] score 2.1 [2.6] versus 6.8 [3.2], p<0.00001 and on post-operative day one prior to physiotherapy; mean score 2.4 [2.3] versus 4.4 [2.3], p<0.05. Total opiate use was also significantly lower in the local infiltration group; mean total 115 [50.3]mg versus 176.5 [103.5]mg, p<0.01. There was no difference in any other outcome. There were no harms as a result of either intervention. Intraoperative local infiltration gives superior pain relief compared to single shot femoral nerve block over the first 24h following primary TKR and minimises post-operative opiate use. Copyright © 2013 Elsevier B.V. All rights reserved.

Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

PubMed

Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

2017-05-01

The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

Visual imagery and functional connectivity in blindness: a single-case study

PubMed Central

Boucard, Christine C.; Rauschecker, Josef P.; Neufang, Susanne; Berthele, Achim; Doll, Anselm; Manoliu, Andrej; Riedl, Valentin; Sorg, Christian; Wohlschläger, Afra; Mühlau, Mark

2016-01-01

We present a case report on visual brain plasticity after total blindness acquired in adulthood. SH lost her sight when she was 27. Despite having been totally blind for 43 years, she reported to strongly rely on her vivid visual imagery. Three-Tesla magnetic resonance imaging (MRI) of SH and age-matched controls was performed. The MRI sequence included anatomical MRI, resting-state functional MRI, and task-related functional MRI where SH was instructed to imagine colours, faces, and motion. Compared to controls, voxel-based analysis revealed white matter loss along SH's visual pathway as well as grey matter atrophy in the calcarine sulci. Yet we demonstrated activation in visual areas, including V1, using functional MRI. Of the four identified visual resting-state networks, none showed alterations in spatial extent; hence, SH's preserved visual imagery seems to be mediated by intrinsic brain networks of normal extent. Time courses of two of these networks showed increased correlation with that of the inferior posterior default mode network, which may reflect adaptive changes supporting SH's strong internal visual representations. Overall, our findings demonstrate that conscious visual experience is possible even after years of absence of extrinsic input. PMID:25690326

Visual imagery and functional connectivity in blindness: a single-case study.

PubMed

Boucard, Christine C; Rauschecker, Josef P; Neufang, Susanne; Berthele, Achim; Doll, Anselm; Manoliu, Andrej; Riedl, Valentin; Sorg, Christian; Wohlschläger, Afra; Mühlau, Mark

2016-05-01

We present a case report on visual brain plasticity after total blindness acquired in adulthood. SH lost her sight when she was 27. Despite having been totally blind for 43 years, she reported to strongly rely on her vivid visual imagery. Three-Tesla magnetic resonance imaging (MRI) of SH and age-matched controls was performed. The MRI sequence included anatomical MRI, resting-state functional MRI, and task-related functional MRI where SH was instructed to imagine colours, faces, and motion. Compared to controls, voxel-based analysis revealed white matter loss along SH's visual pathway as well as grey matter atrophy in the calcarine sulci. Yet we demonstrated activation in visual areas, including V1, using functional MRI. Of the four identified visual resting-state networks, none showed alterations in spatial extent; hence, SH's preserved visual imagery seems to be mediated by intrinsic brain networks of normal extent. Time courses of two of these networks showed increased correlation with that of the inferior posterior default mode network, which may reflect adaptive changes supporting SH's strong internal visual representations. Overall, our findings demonstrate that conscious visual experience is possible even after years of absence of extrinsic input.

Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

PubMed

De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

2017-11-15

Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P < .05 was used to reject the null hypothesis for the primary outcome. Seventy subjects were randomized and sixty-five completed the study. Patients' baseline characteristics and surgical factors were similar between the study groups. There was a clinically significant difference in the global QoR-40 scores between the acetaminophen and the saline groups, median (IQR) of 189 (183 to 194) and 183 (175 to 190), respectively, P = .01. In addition, there was an inverse relationship (Spearman's rho= -0.33) between oral opioid consumption at home (oral morphine equivalents) and 24 hour postoperative quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: Rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study.

PubMed

Sparks, Jeffrey A; Barbhaiya, Medha; Karlson, Elizabeth W; Ritter, Susan Y; Raychaudhuri, Soumya; Corrigan, Cassandra C; Lu, Fengxin; Selhub, Jacob; Chasman, Daniel I; Paynter, Nina P; Ridker, Paul M; Solomon, Daniel H

2017-08-01

The role of low dose methotrexate (LDM) in potential serious toxicities remains unclear despite its common use. Prior observational studies investigating LDM toxicity compared LDM to other active drugs. Prior placebo-controlled clinical trials of LDM in inflammatory conditions were not large enough to investigate toxicity. The Cardiovascular Inflammation Reduction Trial (CIRT) is an ongoing NIH-funded, randomized, double-blind, placebo-controlled trial of LDM in the secondary prevention of cardiovascular disease. We describe here the rationale and design of the CIRT-Adverse Events (CIRT-AE) ancillary study which aims to investigate adverse events within CIRT. CIRT will randomize up to 7000 participants with cardiovascular disease and no systemic rheumatic disease to either LDM (target dose: 15-20mg/week) or placebo for an average follow-up period of 3-5 years; subjects in both treatment arms receive folic acid 1mg daily for 6 days each week. The primary endpoints of CIRT include recurrent cardio vascular events, incident diabetes, and all-cause mortality, and the ancillary CIRT-AE study has been designed to adjudicate other clinically important adverse events including hepatic, gastrointestinal, respiratory, hematologic, infectious, mucocutaneous, oncologic, renal, neurologic, and musculoskeletal outcomes. Methotrexate polyglutamate levels and genome-wide single nucleotide polymorphisms will be examined for association with adverse events. CIRT-AE will comprehensively evaluate potential LDM toxicities among subjects with cardiovascular disease within the context of a large, ongoing, double-blind, placebo-controlled trial. This information may lead to a personalized approach to monitoring LDM in clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial.

PubMed

Niederer, Daniel; Vogt, Lutz; Wippert, Pia-Maria; Puschmann, Anne-Katrin; Pfeifer, Ann-Christin; Schiltenwolf, Marcus; Banzer, Winfried; Mayer, Frank

2016-10-20

Arising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain. A multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed. The control group stays inactive during this period. Outcomes are pain, and pain-associated function as well as motor function in adults with nonspecific low back pain. Each participant is scheduled to five measurement dates: baseline (M1), following centre-based training (M2), following home-based training (M3) and at two follow-up time points 6 months (M4) and 12 months (M5) after M1. All investigations and the assessment of the primary and secondary outcomes are performed in a standardized order: questionnaires - clinical examination - biomechanics (motor function). Subsequent statistical procedures are executed after the examination of underlying assumptions for parametric or rather non-parametric testing. The results and practical relevance of the study will be of clinical and practical relevance not only for researchers and policy makers but also for the general population suffering from nonspecific low back pain. Identification number DRKS00010129. German Clinical Trial registered on 3 March 2016.

Numerical Nonlinear Robust Control with Applications to Humanoid Robots

DTIC Science & Technology

2015-07-01

automatically. While optimization and optimal control theory have been widely applied in humanoid robot control, it is not without drawbacks . A blind... drawback of Galerkin-based approaches is the need to successively produce discrete forms, which is difficult to implement in practice. Related...universal function approx- imation ability, these approaches are not without drawbacks . In practice, while a single hidden layer neural network can

Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

ERIC Educational Resources Information Center

Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

2008-01-01

Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

Telephone-Based Physical Activity Counseling for Major Depression in People with Multiple Sclerosis

ERIC Educational Resources Information Center

Bombardier, Charles H.; Ehde, Dawn M.; Gibbons, Laura E.; Wadhwani, Roini; Sullivan, Mark D.; Rosenberg, Dori E.; Kraft, George H.

2013-01-01

Objective: Physical activity represents a promising treatment for major depressive disorder (MDD) in people with multiple sclerosis (MS). We conducted a single-blind, two-arm randomized controlled trial comparing a 12-week physical activity counseling intervention delivered primarily by telephone (n = 44) to a wait-list control group (N = 48).…

Routine vitamin A supplementation for the prevention of blindness due to measles infection in children.

PubMed

Bello, Segun; Meremikwu, Martin M; Ejemot-Nwadiaro, Regina I; Oduwole, Olabisi

2016-08-31

Reduced vitamin A concentration increases the risk of blindness in children infected with the measles virus. Promoting vitamin A supplementation in children with measles contributes to the control of blindness in children, which is a high priority within the World Health Organization (WHO) VISION 2020 The Right to Sight Program. To assess the efficacy of vitamin A in preventing blindness in children with measles without prior clinical features of vitamin A deficiency. We searched CENTRAL 2015, Issue 11, MEDLINE (1950 to December week 3, 2015), Embase (1974 to December 2015) and LILACS (1985 to December 2015). Randomised controlled trials (RCTs) assessing the efficacy of vitamin A in preventing blindness in well-nourished children diagnosed with measles but with no prior clinical features of vitamin A deficiency. For the original review, two review authors independently assessed studies for eligibility and extracted data on reported outcomes. We contacted trial authors of the included studies for additional information on unpublished data. We included two RCTs which were clinically heterogenous. We presented the continuous outcomes reported as the mean difference (MD) with 95% confidence interval (CI) and dichotomous outcomes as risk ratio (RR) with 95% CI. Due to marked clinical heterogeneity we considered it inappropriate to perform a meta-analysis. For the first publication of this review, two RCTs involving 260 children with measles which compared vitamin A with placebo met the inclusion criteria. Neither study reported blindness or other ocular morbidities as end points. One trial of moderate quality suggested evidence of a significant increase in serum retinol levels in the vitamin A group one week after two doses of vitamin A (MD 9.45 µg/dL, 95% CI 2.19 to 16.71; 17 participants, moderate-quality evidence), but not six weeks after three doses of vitamin A (MD 2.56 µg/dL, 95% CI -5.28 to 10.40; 39 participants, moderate-quality evidence). There was no significant difference in weight gain six weeks (MD 0.39 kg, -0.04 to 0.82; 48 participants, moderate-quality evidence) and six months (MD 0.52 kg, 95% CI -0.08 to 1.12; 36 participants, moderate-quality evidence) after three doses of vitamin A.The second trial found no significant difference in serum retinol levels two weeks after a single dose of vitamin A (MD 2.67 µg/dL, 95% CI -0.29 to 5.63; 155 participants, moderate-quality evidence). Percentage of undernutrition between the two groups did not differ significantly at one week (RR 0.93, 95% CI 0.56 to 1.54, 145 participants) and two weeks (RR 0.82, 95% CI 0.52 to 1.29, 147 participants) after a single dose of vitamin A. No adverse event was reported in either study. We did not find any new RCTS for this second update. We did not find any trials assessing whether or not vitamin A supplementation in children with measles prevents blindness, as neither study reported blindness or other ocular morbidities as end points.

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

Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

2016-01-01

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. 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. 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. ClinicalTrials.gov NCT01496053.

Which is your choice for prolonging the analgesic duration of single-shot interscalene brachial blocks for arthroscopic shoulder surgery? intravenous dexamethasone 5 mg vs. perineural dexamethasone 5 mg randomized, controlled, clinical trial.

PubMed

Chun, Eun Hee; Kim, Youn Jin; Woo, Jae Hee

2016-06-01

The aim of this study was to compare the effect of intravenous (I.V.) dexamethasone with that of perineural dexamethasone on the prolongation of analgesic duration of single-shot interscalene brachial plexus blocks (SISB) in patients undergoing arthroscopic shoulder surgery. We performed a prospective, randomized, double-blind, placebo-controlled study. Patients undergoing elective arthroscopic shoulder surgery with ultrasound-guided SISB were enrolled and randomized into 2 groups. A total volume of 12 mL of the study drug was prepared with a final concentration of 0.5% ropivacaine. In the I.V. group, patients received SISB using ropivacaine 5 mg mL with normal saline (control) with dexamethasone 5 mg I.V. injection. In the perineural group, patients received SISB using ropivacaine 5 mg mL with dexamethasone 5 mg, with normal saline 1 mL I.V. injection. The primary outcome was the time to the first analgesic request, defined as the time between the end of the operation and the first request of analgesics by the patient. The secondary outcomes included patient satisfaction scores, side effects, and neurological symptoms. Patients were randomly assigned to 1 of the 2 groups using a computer-generated randomization table. An anesthesiologist blinded to the group assignments prepared the solutions for injection. The patients and the investigator participating in the study were also blinded to the group assignments. One hundred patients were randomized. Data were analyzed for 99 patients. One case in the I.V. group was converted to open surgery and was therefore not included in the study. Perineural dexamethasone significantly prolonged analgesic duration (median, standard error: 1080 minutes, 117.5 minutes) compared with I.V. dexamethasone (810 minutes, 48.1 minutes) (P = 0.02). There were no significant differences in side effects, neurological symptoms, or changes in blood glucose values between the 2 groups. Our results show that perineural dexamethasone 5 mg is more effective than I.V. dexamethasone 5 mg with regard to analgesic duration of SISB for arthroscopic shoulder surgery.

Single-session tDCS-supported retraining does not improve fine motor control in musician's dystonia.

PubMed

Buttkus, Franziska; Baur, Volker; Jabusch, Hans-Christian; de la Cruz Gomez-Pellin, Maria; Paulus, Walter; Nitsche, Michael A; Altenmüller, Eckart

2011-01-01

Focal dystonia in musicians (MD) is a task-specific movement disorder with a loss of voluntary motor control during instrumental playing. Defective inhibition on different levels of the central nervous system is involved in the pathophysiology. Sensorimotor retraining is a therapeutic approach to MD and aims to establish non-dystonic movements. Transcranial direct current stimulation (tDCS) modulates cortical excitability and alters motor performance. In this study, tDCS of the motor cortex was expected to assist retraining at the instrument. Nine professional pianists suffering from MD were included in a placebo-controlled double-blinded study. Retraining consisted of slow, voluntarily controlled movements on the piano and was combined with tDCS. Patients were treated with three stimulation protocols: anodal tDCS, cathodal tDCS and placebo stimulation. No beneficial effects of single-session tDCS-supported sensorimotor retraining on fine motor control in pianists with MD were found in all three conditions. The main cause of the negative result of this study may be the short intervention time. One retraining session with a duration of 20 min seems not sufficient to improve symptoms of MD. Additionally, a single tDCS session might not be sufficient to modify sensorimotor learning of a highly skilled task in musicians with dystonia.

[Clinical study of tissue-selecting therapy in the treatment of mixed hemorrhoids: a single-blind randomized controlled trail].

PubMed

He, Hongyan; He, Ping; Liu, Ning

2014-06-01

To evaluate the clinical efficacy and safety of tissue-selecting therapy (TST) in treatment of mixed hemorrhoids. A single-blind randomized study was carried out. A total of 120 patients with mixed hemorrhoids from January to December 2012 were prospectively enrolled in the study and equally divided into two groups, TST group and procedure for prolapse and hemorrhoids(PPH) group. Surgical data, efficacy and postoperative complications were compared between the two groups. As compared to PPH group, patients in TST group had shorter operation time [(15.9±5.18) min vs. (22.6±7.1) min, P<0.05], lower scores of rectal urgency (0.5±0.2 vs. 1.5±1.4, P<0.05), and shorter hospital stay [(11.2±3.7) d vs. (14.8±3.7) d, P<0.05]. No anastomotic stricture case was found in TST group, while 11 cases(18.3%) developed anastomotic stricture in PPH group. There were no significant differences in effective rate and pain score of first defecation between the two groups. TST is reliable and safe for mixed hemorrhoids with the advantage of simple, rapid recovery and less complications.

A single blind randomized control trial on support groups for Chinese persons with mild dementia.

PubMed

Young, Daniel K W; Kwok, Timothy C Y; Ng, Petrus Y N

2014-01-01

Persons with mild dementia experience multiple losses and manifest depressive symptoms. This research study aimed to evaluate the effectiveness of a support group led by a social worker for Chinese persons with mild dementia. Participants were randomly assigned to either a ten-session support group or a control group. Standardized assessment tools were used for data collection at pretreatment and post-treatment periods by a research assistant who was kept blind to the group assignment of the participants. Upon completion of the study, 20 treatment group participants and 16 control group participants completed all assessments. At baseline, the treatment and control groups did not show any significant difference on all demographic variables, as well as on all baseline measures; over one-half (59%) of all the participants reported having depression, as assessed by a Chinese Geriatric Depression Scale score ≥8. After completing the support group, the depressive mood of the treatment group participants reduced from 8.83 (standard deviation =2.48) to 7.35 (standard deviation =2.18), which was significant (Wilcoxon signed-rank test; P=0.017, P<0.05), while the control group's participants did not show any significant change. This present study supports the efficacy and effectiveness of the support group for persons with mild dementia in Chinese society. In particular, this present study shows that a support group can reduce depressive symptoms for participants.

Psychological therapy for inpatients receiving acute mental health care: A systematic review and meta-analysis of controlled trials.

PubMed

Paterson, Charlotte; Karatzias, Thanos; Dickson, Adele; Harper, Sean; Dougall, Nadine; Hutton, Paul

2018-04-16

The effectiveness of psychological therapies for those receiving acute adult mental health inpatient care remains unclear, partly because of the difficulty in conducting randomized controlled trials (RCTs) in this setting. The aim of this meta-analysis was to synthesize evidence from all controlled trials of psychological therapy carried out with this group, to estimate its effects on a number of important outcomes and examine whether the presence of randomization and rater blinding moderated these estimates. A systematic review and meta-analysis of all controlled trials of psychological therapy delivered in acute inpatient settings was conducted, with a focus on psychotic symptoms, readmissions or emotional distress (anxiety and depression). Studies were identified through ASSIA, EMBASE, CINAHL, Cochrane, MEDLINE, and PsycINFO using a combination of the key terms 'inpatient', 'psychological therapy', and 'acute'. No restriction was placed on diagnosis. The moderating effect of the use of assessor-blind RCT methodology was examined via subgroup and sensitivity analyses. Overall, psychological therapy was associated with small-to-moderate improvements in psychotic symptoms at end of therapy but the effect was smaller and not significant at follow-up. Psychological therapy was also associated with reduced readmissions, depression, and anxiety. The use of single-blind randomized controlled trial methodology was associated with significantly reduced benefits on psychotic symptoms and was also associated with reduced benefits on readmission and depression; however, these reductions were not statistically significant. The provision of psychological therapy to acute psychiatric inpatients is associated with improvements; however, the use of single-blind RCT methodology was associated with reduced therapy-attributable improvements. Whether this is a consequence of increased internal validity or reduced external validity is unclear. Trials with both high internal and external validity are now required to establish what type, format, and intensity of brief psychological therapy is required to achieve sustained benefits. Clinical implications: This review provides the first meta-analytical synthesis of brief psychological therapy delivered in acute psychiatric inpatient settings. This review suggests that brief psychological therapy may be associated with reduced emotional distress and readmissions. The evidence in this review is of limited quality. The type, format, and intensity of brief psychological therapy required to achieve sustained benefits are yet to be established. © 2018 The British Psychological Society.

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 give insights into study design for clinical assessment of potential MRTPs. Trial registration The study was registered in the Current Controlled Trials database under the reference ISRCTN81286286. PMID:23895296

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

Shepperd, Christopher J; Newland, Nik; Eldridge, Alison; Graff, Don; Meyer, Ingo

2013-07-29

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. 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. Data from this study are expected to improve scientific understanding of the effects of RTP cigarettes on BoE and BoBE, and give insights into study design for clinical assessment of potential MRTPs. The study was registered in the Current Controlled Trials database under the reference ISRCTN81286286.

Effect of propranolol in head tremor: quantitative study following single-dose and sustained drug administration.

PubMed

Calzetti, S; Sasso, E; Negrotti, A; Baratti, M; Fava, R

1992-12-01

The effect of the beta-adrenoceptor antagonist propranolol has been investigated in nine patients suffering from isolated (six patients) or prominent (three patients) essential tremor of the head. In a double-blind, placebo-controlled study the tremorolytic efficacy of propranolol has been assessed by a quantitative accelerometric method after a single oral dose (120 mg) and following 2 weeks of sustained treatment with two different dosage regimens of the drug (120 and 240 mg daily). As compared with placebo, a significant reduction in tremor magnitude was found following a single oral dose but not on sustained administration of the beta-blocker at either dosage. The results suggest that the efficacy of sustained propranolol on isolated or prominent essential head tremor is less predictable and satisfactory than expected on the basis of the single-dose response, as compared with hand tremor.

Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial.

PubMed

Sánchez-Pérez, Arturo; Muñoz-Peñalver, Jesús; Moya-Villaescusa, María José; Sánchez-Matás, Carmen

2018-04-01

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

PubMed

Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

2016-11-16

The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

PubMed

Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

2016-08-01

Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

A double-blind, randomized, placebo-controlled, single-dose study of the cyclooxygenase-2 inhibitor, GW406381, as a treatment for acute migraine.

PubMed

Wentz, A L; Jimenez, T B; Dixon, R M; Aurora, S K; Gold, M

2008-04-01

The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase-2 (COX-2) inhibitor with relatively high CNS penetration, in acute migraine. This was a double-blind, single-dose study of GW406381 compared with placebo and naproxen sodium compared with placebo (protocol number CXA20008). Three hundred and thirty-seven subjects were randomized 1:1:1 to GW406381 (70 mg), naproxen sodium (825 mg), or placebo for the treatment of one migraine headache of moderate or severe intensity in a potential 8-week period. The primary end-point was the proportion of subjects with headache relief [reduction in headache severity score from pre-dose 2 (moderate) or 3 (severe) to 0 (no pain) or 1 (mild)] at 2 h post-dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated with GW406381 (50%, P = 0.032) or naproxen sodium (56%, P = 0.005) than with placebo (35%) reported headache relief at 2 h post-dose. Additional significant benefits were observed on many secondary outcomes, including proportions of subjects pain-free, for both GW406381 and naproxen sodium treatment compared with placebo. Both active treatments were well tolerated. Single-dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tolerated in the treatment of acute migraine.

Efficacy of the Power Balance Silicone Wristband: a single-blind, randomized, triple placebo-controlled study.

PubMed

Pothier, David D; Thiel, Gundula; Khoo, S G; Dillon, Wanda A; Sulway, Shaleen; Rutka, John A

2012-06-01

The Power Balance Silicone Wristband (Power Balance LLC, Laguna Niguel, CA) (power balance band; PBB) consists of a silicone wristband, incorporating two holograms, which is meant to confer improvements in balance on the wearer. Despite its popularity, the PBB has become somewhat controversial, with a number of articles being published in the news media regarding its efficacy. The PBB has not been formally evaluated but remains popular, largely based on anecdotal evidence. This study subjectively and objectively measured the effects of the PBB on balance in normal participants. A prospective, single-blind, randomized, triple placebo-controlled crossover study was undertaken. Twenty participants underwent measurement using the modified Test of Sensory Interaction on Balance (mCTSIB) and gave subjective feedback (visual analogue scale [VAS]) for each of four band conditions: no band, a silicone band, a deactivated PBB, and the PBB. Participants acted as their own controls. The mean of the four mCTSIB conditions (eyes open and closed on both firm and compliant surfaces) was calculated. This mean value and condition 4 of the mCTSIB were compared between band conditions using path length (PL) and root mean square (RMS) as outcome measures. No significant differences were found between band conditions for PL (p  =  .91 and p  =  .94, respectively) and RMS (p  =  .85 and p  =  .96, respectively). VASs also showed no difference between bands (p  =  .25). The PBB appears to have no effect on mCTSIB or VAS measurements of balance.

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

PubMed Central

2013-01-01

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

An interactive sports video game as an intervention for rehabilitation of community-living patients with schizophrenia: A controlled, single-blind, crossover study.

PubMed

Shimizu, Nobuko; Umemura, Tomohiro; Matsunaga, Masahiro; Hirai, Takayoshi

2017-01-01

Hypofrontality is a state of decreased cerebral blood flow in the prefrontal cortex during executive function performance; it is commonly observed in patients with schizophrenia. Cognitive dysfunction, as well as the psychological symptoms of schizophrenia, influences the ability of patients to reintegrate into society. The current study investigated the effects of an interactive sports video game (IVG; Nintendo Wii™ Sports Resort) on frontal lobe function of patients with schizophrenia. A sample of eight patients (6 male and 2 female; mean age = 46.7 years, standard deviation (SD) = 13.7) engaged in an IVG every week for 3 months in a controlled, single-blind, crossover study. Before and after the intervention we examined frontal lobe blood-flow volume using functional near-infrared spectroscopy (fNIRS), and assessed functional changes using the Frontal Assessment Battery, Health-Related Quality of Life scale, and behaviorally-assessed physical function tests. fNIRS revealed that prefrontal activity during IVG performance significantly increased in the IVG period compared with the control period. Furthermore, significant correlations between cerebral blood flow changes in different channels were observed during IVG performance. In addition, we observed intervention-related improvement in health-related quality of life following IVG. IVG intervention was associated with increased prefrontal cortex activation and improved health-related quality of life performance in patients with schizophrenia. Patients with chronic schizophrenia are characterized by withdrawal and a lack of social responsiveness or interest in others. Interventions using IVG may provide a useful low-cost rehabilitation method for such patients, without the need for specialized equipment.

The Efficacy of Daily Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for Burning Mouth Syndrome (BMS): A Randomized Controlled Single-blind Study.

PubMed

Umezaki, Yojiro; Badran, Bashar W; DeVries, William H; Moss, Jkeonye; Gonzales, Theresa; George, Mark S

2016-01-01

Burning mouth syndrome (BMS) is a burning oral sensation without any corresponding abnormal findings. In some cases, BMS is refractory to pharmacologic treatments. Repetitive transcranial magnetic stimulation (rTMS) over left prefrontal cortex induces analgesic effect in both acute and chronic pain. However, its effect for BMS has not been evaluated. The aim of this randomized, controlled, single-blind study was to assess the efficacy of prefrontal rTMS for BMS. Twenty patients with BMS were recruited and randomized to receive 30,000 pulses in total at 10 Hz TMS (n = 12) or sham TMS (n = 8). We assessed the change of BMS pain condition, functional status and mood until 2 months after the beginning of treatment. In the real group, the BMS pain intensity decreased 67%, and 75% of the patients reported >50% pain decrease on final assessment compared to baseline, without heavy side effects. There was significant pain reduction in subjects in the real group immediately after 1 week of treatment, whereas there was none in those in the sham group. Similar tendency was confirmed in change of functional status. Mood and the affective aspect of pain were not changed in this study. BMS pain was significantly improved with 2 weeks of treatment of high frequency rTMS over left DLPFC compared to sham stimulation. Further study is needed to refine and improve TMS as a potential treatment of BMS. Copyright © 2016 Elsevier Inc. All rights reserved.

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study.

PubMed

Bier, Nathalie; Grenier, Sébastien; Brodeur, Catherine; Gauthier, Serge; Gilbert, Brigitte; Hudon, Carol; Lepage, Émilie; Ouellet, Marie-Christine; Viscogliosi, Chantal; Belleville, Sylvie

2015-03-01

Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment (MCI). The MEMO+ study is a randomized, controlled, single-blind trial designed to test the efficacy, specificity, and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI. One hundred and sixty-two participants with MCI will be recruited. They will be randomized into three groups: cognitive training, psychosocial intervention, and no-contact. Each intervention will last for eight weeks (one session per week) and a booster training session will be provided three months after the end of the intervention. Various proximal and distal outcomes will be measured at pre-intervention as well as at one week, three months, and six months post-training. Proximal outcomes include memory and psychological health measures. Distal outcomes focus on self-rated functioning in complex daily activities and strategies used in daily life to enhance function. Socio-demographic factors (age, gender, and education), general cognition, personality traits, engagement in activities, and self-efficacy will be used as moderators. Enrolment began in April 2012 and will be completed by December 2014. This study is likely to have a significant impact on the well-being of persons with MCI by contributing to the development of adapted and scientifically supported cognitive and psychosocial interventions.

Risk Factors Associated with Progression to Blindness from Primary Open-Angle Glaucoma in an African-American Population.

PubMed

Pleet, Alexander; Sulewski, Melanie; Salowe, Rebecca J; Fertig, Raymond; Salinas, Julia; Rhodes, Allison; Merritt Iii, William; Natesh, Vikas; Huang, Jiayan; Gudiseva, Harini V; Collins, David W; Chavali, Venkata Ramana Murthy; Tapino, Paul; Lehman, Amanda; Regina-Gigiliotti, Meredith; Miller-Ellis, Eydie; Sankar, Prithvi; Ying, Gui-Shuang; O'Brien, Joan M

2016-08-01

To determine the risk factors associated with progression to blindness from primary open-angle glaucoma (POAG) in an African-American population. This study examined 2119 patients enrolled in the Primary Open-Angle African-American Glaucoma Genetics (POAAGG) study. A total of 59 eyes were identified as legally blind as a result of POAG (cases) and were age-and sex-matched to 59 non-blind eyes with glaucoma (controls). Chart reviews were performed to record known and suspected risk factors. Cases were diagnosed with POAG at an earlier age than controls (p = 0.005). Of the 59 eyes of cases, 16 eyes (27.1%) presented with blindness at diagnosis. Cases had worse visual acuity (VA) at diagnosis (p < 0.0001), with VA worse than 20/40 conferring a 27 times higher risk of progression to blindness (p = 0.0005). Blind eyes also demonstrated more visual field defects (p = 0.01), higher pre-treatment intraocular pressure (IOP; p < 0.0001), and higher cup-to-disc ratio (p = 0.006) at diagnosis. IOP was less controlled in cases, and those with IOP ≥21 mmHg at more than 20% of follow-up visits were 73 times more likely to become blind (p < 0.0001). Cases missed a greater number of appointments per year (p = 0.003) and had non-adherence issues noted in their charts more often than controls (p = 0.03). However, other compliance data did not significantly differ between groups. Access to care, initial VA worse than 20/40, and poor control of IOP were the major risk factors associated with blindness from POAG. Future studies should examine earlier, more effective approaches to glaucoma screening as well as the role of genetics in these significantly younger patients who progress to blindness.

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty.

PubMed

Culliford, Alfred T; Spector, Jason A; Flores, Roberto L; Louie, Otway; Choi, Mihye; Karp, Nolan S

2007-09-15

Breast reduction is one of the most frequently performed plastic surgical procedures in the United States; more than 160,500 patients underwent the procedure in 2005. Many outpatient reduction mammaplasty patients report the greatest postoperative discomfort in the first 48 hours. The authors' investigated the effect of intraoperative topical application of the long-acting local anesthetic agent bupivacaine (Sensorcaine or Marcaine) on postoperative pain, time to postanesthesia care unit discharge, and postoperative use of narcotic medication. In a prospective, randomized, single-blind trial, intraoperative use of Sensorcaine versus placebo (normal saline) was compared. Postoperative pain was quantified using the visual analogue scale, and time to discharge from the postanesthesia care unit was recorded. Patients documented their outpatient pain medication usage. Of the 37 patients enrolled in the study, 20 were treated with intraoperative topical Sensorcaine and 17 received placebo. Patients treated with Sensorcaine were discharged home significantly faster (2.9 hours versus 3.8 hours, p = 0.002). The control arm consistently had higher pain scores in the postanesthesia care unit (although not statistically significant) than the Sensorcaine group using the visual analogue scale system. Furthermore, patients receiving Sensorcaine required significantly less narcotic medication while recovering at home (mean, 3.5 tablets of Vicodin) than the control group (mean, 6.4 tablets; p = 0.001). There were no complications resulting from Sensorcaine usage. This prospective, randomized, single-blind study demonstrates that a single dose of intraoperative Sensorcaine provides a safe, inexpensive, and efficacious way to significantly shorten the length of postanesthesia care unit stay and significantly decrease postoperative opioid analgesic use in patients undergoing ambulatory reduction mammaplasty.

Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

PubMed

Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

2017-08-15

High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved.

The Efficacy of Plasma Rich in Growth Factors for the Treatment of Alveolar Osteitis: A Randomized Controlled Trial.

PubMed

King, Elizabeth M; Cerajewska, Tanya L; Locke, Matthew; Claydon, Nicholas C A; Davies, Maria; West, Nicola X

2018-06-01

To investigate the efficacy of plasma rich in growth factors (PRGF; BTI Biotechnology Institute, San Antonio, Spain) for the treatment of alveolar osteitis compared with a positive control (Alvogyl; Septodont, Maidstone, Kent, UK). This single-center, single-blinded, randomized, 2-treatment, parallel study was conducted in a UK dental hospital. All healthy adults who presented with alveolar osteitis after tooth extraction over a 3-month period were invited to participate. Each socket was randomized and treated with 1 of 2 treatment modalities, a test treatment (PRGF) or a positive control (Alvogyl). After treatment, patients were reviewed at 3 and 7 days by a second clinician blinded to the treatment given. Outcome measures included pain, exposed bone, inflammation, halitosis, dysgeusia, and quality-of-life assessment. Thirty-eight patients with data from 44 sockets (22 in the PRGF group and 22 in the Alvogyl group) were analyzed. The PRGF group showed significantly faster bone coverage and significantly decreased inflammation and halitosis (P < .05) compared with the control group receiving Alvogyl. There was no significant difference for pain, quality-of-life measures, or dysgeusia between groups. PRGF predictably treated alveolar osteitis after tooth extraction compared with the conventional standard treatment of Alvogyl, which has been used for many years. PRGF could be considered an alternative treatment for alveolar osteitis and indeed appears to have considerable advantages over Alvogyl. Copyright © 2018 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

A Long-Acting Human Growth Hormone With Delayed Clearance (VRS-317): Results of a Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Growth Hormone–Deficient Adults

PubMed Central

Yuen, Kevin C. J.; Conway, Gerard S.; Popovic, Vera; Merriam, George R.; Bailey, Timothy; Hamrahian, Amir H.; Biller, Beverly M. K.; Kipnes, Mark; Moore, Jerome A.; Humphriss, Eric; Cleland, Jeffrey L.

2013-01-01

Background: Administration of daily recombinant human GH (rhGH) poses a considerable challenge to patient compliance. Reduced dosing frequency may improve treatment adherence and potentially overall treatment outcomes. Objectives: This study assessed the safety and tolerability and the potential for achieving IGF-I levels within the target range in adults with GH deficiency after a single dose of the long-acting rhGH analog, VRS-317. Design: This was a randomized, double-blind, placebo-controlled, single ascending dose study. Patients: Fifty adults with growth hormone deficiency (mean age, 45 years) were studied in 5 treatment groups of 10 subjects each (8 active drug and 2 placebo). Setting: The study was conducted in 17 adult endocrinology centers in North America and Europe. Main Outcome Measures: Adverse events, laboratory safety assessments, and VRS-317 pharmacokinetics and pharmacodynamics (IGF-I and IGF binding protein-3) were analyzed. Results: At 0.80 mg/kg, VRS-317 had a mean terminal elimination half-life of 131 hours. Single VRS-317 doses of 0.05, 0.10, 0.20, 0.40, and 0.80 mg/kg (approximately equivalent to daily rhGH doses of 0.3–5.0 μg/kg over 30 d) safely increased the amplitude and duration of IGF-I responses in a dose-dependent manner. After a single 0.80 mg/kg dose, serum IGF-I was maintained in the normal range between −1.5 and 1.5 SD values for a mean of 3 weeks. No unexpected or serious adverse events were observed. Conclusions: The elimination half-life for VRS-317 is 30- to 60-fold longer and stimulates more durable IGF-I responses than previously studied rhGH products. Prolonged IGF-I responses do not come at the expense of overexposure to high IGF-I levels. The pharmacokinetics and pharmacodynamics combined with the observed safety profile indicate the potential for safe and effective monthly dosing. PMID:23585663

Does Transfer Capacitive Resistive Energy Has a Therapeutic Effect on Peyronie's Disease? Randomized, Single-Blind, Sham-Controlled Study on 96 Patients: Fast Pain Relief.

PubMed

Pavone, Carlo; Romeo, Salvatore; D'Amato, Francesco; Usala, Manuela; Letizia Mauro, Giulia; Caruana, Giovanni

2017-01-01

Background/Aims/Objectives: We have investigated the clinical and physiological effects of Transfer Capacitive Resistive Energy (TCARE) therapy on men with Peyronie's disease (PD). Ninety-six men with PD have been randomized in a 2:1 ratio to receive 3 sessions of TCARE therapy or sham therapy. Pain, penile curvature and erectile function have been assessed before the first treatment and up to 9 months after the end of treatment, using the Visual Analogue Scale for the pain, a goniometer to measure the degree of curvature using at-home photography and an International Index of Erectile Function (IIEF-5) questionnaire. A significant pain reduction at the end of the treatment in 51 (79.6%) patients (p < 0.01) of the treated group was observed. No significant improvements in the sham group (p = 0.23) have been observed. No statistical differences in the degree of curvature have been observed in both groups. No statistical improvements have been observed in the IIEF-5 questionnaire. Adverse events have not been reported. This is, to our knowledge, the first randomized, single-blind, sham-controlled study that shows that TCARE has a positive short-term clinical effect on pain in patients with PD. The feasibility and tolerability of this treatment produce an attractive new therapeutic option for men with PD. © 2017 S. Karger AG, Basel.

Single-injection femoral nerve block. Effects on the independence level in functional activities in the early postoperative period in patients with total knee arthroplasty.

PubMed

Tugay, Nazan; Saricaoglu, Fatma; Satilmis, Tulin; Alpar, Ulku; Akarcali, Inci; Citaker, Seyit; Tugay, Umut; Atilla, Bulent; Tokgozoglu, Mazhar

2006-07-01

To investigate the efficacy of single injection femoral nerve block (FNB) on the independence level in functional activities in the early postoperative period in patients with total knee arthroplasty (TKA). We conducted this prospective, randomized, blinded trial in the Department of Orthopedics and Traumatology, Hacettepe University Hospital Ankara, Turkey, between June 2003 and April 2004. Twenty-three patients scheduled for elective TKA were randomly divided into 3 groups. Group I received preemptive single injection FNB, group II received postoperative single injection FNB, and group III served as a control group. Intravenous morphine patient controlled analgesia (PCA) was used following surgery in all groups. Morphine dose and pain score defined by the visual analog scale (VAS) were recorded postoperatively at the 15th minute, 30th minute, 1st, 4th, 6th, 12th, 24th, and 48th hours. A standard rehabilitation protocol was applied for all patients. The independence level in functional activities was assessed during the first 2 postoperative days and at discharge with the Iowa Level of Assistance Scale (ILAS) and the Iowa Ambulation Speed Scale (IASS). Physical therapists that enrolled in the study were blinded to the groups. Pain scores were significantly different between the groups (p<0.05). The preemptive and postoperative FNB group`s VAS scores were both significantly lower than the control group (p<0.05). However, there was no significant difference in VAS scores between preemptive and postoperative FNB groups (p>0.05). There was no statistically significant difference between the groups in any of the functional scores in the first 2 postoperative days, and at discharge (p>0.05). Single injection FNB provided effective analgesia in patients undergoing TKA. However, the independence level in functional activities in the early postoperative period was not influenced by the analgesia method.

Effect of visual experience on structural organization of the human brain: a voxel based morphometric study using DARTEL.

PubMed

Modi, Shilpi; Bhattacharya, Manisha; Singh, Namita; Tripathi, Rajendra Prasad; Khushu, Subash

2012-10-01

To investigate structural reorganization in the brain with differential visual experience using Voxel-Based Morphometry with Diffeomorphic Anatomic Registration Through Exponentiated Lie algebra algorithm (DARTEL) approach. High resolution structural MR images were taken in fifteen normal sighted healthy controls, thirteen totally blind subjects and six partial blind subjects. The analysis was carried out using SPM8 software on MATLAB 7.6.0 platform. VBM study revealed gray matter volume atrophy in the cerebellum and left inferior parietal cortex in total blind subjects and in left inferior parietal cortex, right caudate nucleus, and left primary visual cortex in partial blind subjects as compared to controls. White matter volume loss was found in calcarine gyrus in total blind subjects and Thlamus-somatosensory region in partially blind subjects as compared to controls. Besides, an increase in Gray Matter volume was also found in left middle occipital and middle frontal gyrus and right entorhinal cortex, and an increase in White Matter volume was found in superior frontal gyrus, left middle temporal gyrus and right Heschl's gyrus in totally blind subjects as compared to controls. Comparison between total and partial blind subjects revealed a greater Gray Matter volume in left cerebellum of partial blinds and left Brodmann area 18 of total blind subjects. Results suggest that, loss of vision at an early age can induce significant structural reorganization on account of the loss of visual input. These plastic changes are different in early onset of total blindness as compared to partial blindness. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The role of the dopaminergic system in mood, motivation and cognition in Parkinson's disease: a double blind randomized placebo-controlled experimental challenge with pramipexole and methylphenidate.

PubMed

Drijgers, Rosa L; Verhey, Frans R J; Tissingh, Gerrit; van Domburg, Peter H M F; Aalten, Pauline; Leentjens, Albert F G

2012-09-15

In Parkinson's disease (PD) reduced dopaminergic activity in the mesocorticolimbic pathway is implied in the pathophysiology of several non-motor symptoms related to mood, motivation and cognition. Insight in the pathophysiology of these syndromes may pave the way for more rational treatments. In a double-blind, randomized, placebo controlled, crossover design with three arms, we studied the effects of a direct dopaminergic challenge with the dopamine 2 receptor agonist pramipexole, an indirect challenge with the dopamine reuptake inhibitor methylphenidate, and placebo on measures of mood, motivation and cognition in 23 agonist-naïve PD patients and 23 healthy controls. Acute challenge with pramipexole had a negative effect on mood and fatigue in both patients and controls. In addition, challenge with pramipexole led to increased anger, fatigue, vigor and tension in healthy control subjects, but not in PD patients. Challenge with methylphenidate had a positive effect on anhedonia and vigor in PD patients. Due to its side effects after a single administration, pramipexole is probably less suitable for acute challenge studies. The acute effects of a methylphenidate challenge on anhedonia and vigor in PD patients make this drug an interesting choice for further studies of the treatment of mood and motivational disorders in this population. Copyright © 2012 Elsevier B.V. All rights reserved.

[Design of a multicenter study for assessing the effectiveness of extracorporeal shockwave therapy in epicondylitis humeri radialis].

PubMed

Haake, M; Jensen, K; Prinz, H; Willenberg, T

2000-01-01

Previously published studies concerning, extracorporeal shock-wave therapy (ESWT) in the treatment of lateral epicondylitis do not fulfil the biometric standards of modern clinical research. The objective of the trial is to show that ESWT is effective in the treatment of chronic LE. A prospective, randomized, placebo-controlled, single-blinded, multicenter trial with an independent blinded observer was designed. The effectiveness of ESWT is evaluated by comparison with a control group in which sham-ESWT is performed, both under local anaesthesia. Outcome is determined on the basis of the Roles/Maudsley-Score. Inclusion criteria are a history of at least 6 months of LE and failure of conventional treatment. The therapy includes 3 sessions of low energy ESWT with 2000 impulses (energy flux density 0.07-0.09 mJ/mm2). Sample size is 272 patients. Randomisation started in October 1998 and is planned over a period of two and a half years. Only a randomised clinical trial with adequate control of placebo effects and observer bias can provide the required evidence for the efficiency of ESWT in the treatment of lateral epicondylitis of the elbow.

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Hochwald, Ori; Mainzer, Gur; Borenstein-Levin, Liron; Jubran, Huda; Dinur, Gil; Zucker, Meirav; Mor, Malka; Khoury, Asaad; Kugelman, Amir

2018-05-21

 The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 31 6/7 weeks postmenstrual age.  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12).  There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p  = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.  Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

PubMed

Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

2014-09-06

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

[Effectiveness of Vitex agnus-castus preparations].

PubMed

Gorkow, C; Wuttke, W; März, R W

2002-01-01

The prolactin-inhibiting effect of ACF-preparations, which is due to dopaminergic activities, has been shown in humans too and gives a pharmacological rationale for the clinical effects observed in the different indications (2, 11, 25, 26, 35, 41). Confirmation of efficacy in the treatment of mastalgia has been best endorsed by two recently published double-blind studies conducted according to the principles of GCP (14, 41). One double-blind study, several open and postmarketing surveillance studies have shown that the premenstrual syndrome, or individual symptoms, can be influenced positively (3, 6, 7, 9, 19, 21, 37). Design shortcomings in a second double-blind study should be eliminated in future studies in this indication to improve the body of evidence (18). Hither to there has been one controlled double-blind study of cycle disorders in the case of corpus luteum insufficiency with significant results and a number of non-controlled open studies (1, 4, 15, 16, 20, 24, 26, 27, 32, 35, 36). The high success rates in the open studies indicate therapeutic effects, and it should be possible to reproduce these results under double-blind conditions. The success rates on fertility disorders should be confirmed in controlled double-blind studies (10, 33, 34).

Tumor necrosis factor-α blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study.

PubMed

Nguyen, Christelle; Palazzo, Clémence; Grabar, Sophie; Feydy, Antoine; Sanchez, Katherine; Zee, Nathalie; Quinquis, Laurent; Ben Boutieb, Myriam; Revel, Michel; Lefèvre-Colau, Marie-Martine; Poiraudeau, Serge; Rannou, François

2015-11-19

The aim of this study was to assess the efficacy and safety of tumor necrosis factor (TNF)-α inhibition with infliximab (IFX) in treating recurrent and disabling chronic sciatica pain associated with post-operative peridural lumbar fibrosis. A double-blind, placebo-controlled study randomized 35 patients presenting with sciatica pain associated with post-operative peridural lumbar fibrosis to two groups: IFX (n = 18), a single intravenous injection of 3 mg/kg IFX; and placebo (n = 17), a single saline serum injection. The primary outcome was a 50 % reduction in sciatica pain on a visual analog scale (VAS) at day 10. Secondary outcomes were radicular and lumbar VAS pain at day 0 and radicular and lumbar VAS pain, Québec disability score, drug-sparing effect and tolerance at days 10, 30, 90, and 180. At day 10, the placebo and IFX groups did not differ in the primary outcome (50 % reduction in sciatica pain observed in three (17.6 %) versus five (27.8 %) patients; p = 0.69). The number of patients reaching the patient acceptable symptom state for radicular pain was significantly higher in the placebo than IFX group after injection (12 (70.6 %) versus five (27.8 %) patients; p = 0.01). The two groups were comparable for all other secondary outcomes. Treatment with a single 3 mg/kg IFX injection for post-operative peridural lumbar fibrosis-associated sciatica pain does not significantly reduce radicular symptoms at day 10 after injection. ClinicalTrials.gov NCT00385086 ; registered 4 October 2006 (last updated 15 October 2015).

Wrist-ankle acupuncture (WAA) for primary dysmenorrhea (PD) of young females: study protocol for a randomized controlled trial.

PubMed

Chen, Yingfan; Tian, Sinan; Tian, Jing; Shu, Shi

2017-08-22

Primary dysmenorrhea (PD) is one of the most common health complaints all over the world, specifically among young females. Acupuncture has been employed to relieve the pain-based symptoms and to avoid the side effects of conventional medication, and wrist-ankle acupuncture (WAA) has confirmed analgesic efficacy for various types of pain. The aim of this study is to evaluate the immediate analgesia effect of WAA on PD of young females. This study will carry out a randomized parallel controlled single-blind trial to observe the immediate analgesia effect of WAA in PD of young females. Sixty participants who meet inclusion criteria will be recruited from September 2016 to September 2017 in Changhai hospital of China. They are randomly assigned to WAA therapy or sham acupuncture groups (30 patients for each group), and then receive real or sham acupuncture treatment, respectively. In this trial, the primary outcome measure is simple form of McGill pain questionnaire (SF-MPQ), while expectation and treatment credibility scale (ETCS), safety assessment, the COX menstrual symptom scale (CMSS), questionnaire about the feeling of being punctured are included in the secondary outcomes. This trial will be the first study protocol designed to evaluate the immediate analgesia effect of WAA in PD of young females. The strengths in methodology, including rigorous randomized, sham-controlled, participants-blinded and assessors-blinded, will guarantee the quality of this study. WAA doesn't require any needling sensation, so non-penetrating sham acupuncture can serve as an effective placebo intervention in this trial. Chinese Clinical Trial Registry (identifier: ChiCTR-IOR-16008546 ; registration date: 27 May 2016).

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

PubMed

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

2009-01-01

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

Does Granisetron Eliminate the Gag Reflex? A Crossover, Double-Blind, Placebo-Controlled Pilot Study

PubMed Central

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

2009-01-01

Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon. Selective 5-HT3 antagonists, such as granisetron, may attenuate gagging. In this study, granisetron and placebo were administered intravenously, in a crossover, double-blind manner, to 25 healthy volunteers in 2 different sessions. Gagging levels were recorded before and after administration, as were BP, pulse, and O2 saturation. Recorded results were analyzed with the use of tests for nonparametric values (P = .05). A significant increase in the depth of swab insertion was noted after administration of both placebo and drug. The increase in drug effectiveness correlated with decreased body weight. The true efficacy of granisetron in gagger patients with this treatment protocol has yet to be fully established, although it has been theorized that an increased dosage of granisetron may have a better effect. PMID:19562886

Effect of low oral doses of disopyramide and amiodarone on ventricular and atrial arrhythmias of chagasic patients with advanced myocardial damage.

PubMed

Carrasco, H A; Vicuña, A V; Molina, C; Landaeta, A; Reynosa, J; Vicuña, N; Fuenmayor, A; López, F

1985-12-01

Low-dose (7 mg/kg per day) disopyramide administration to arrhythmic chagasic patients decreased the frequency of ventricular extrasystoles in 4 of 17 patients (24%) and suppressed most complex ventricular arrhythmias in 12 of 15 patients (80%). This assessment was made from 72-h continuous Holter monitoring recorded during the course of this double blind, placebo-controlled randomized crossover study. Seven patients (41%) complained of anticholinergic side effects, but no contractile or conduction system depression was seen. Amiodarone (200 mg) given on a single blind, placebo-controlled basis to 9 of these patients reduced the frequency of ventricular extrasystoles in 6 of 9 patients (67%) and suppressed complex ventricular ectopy in 6 of 7 patients (85%). One patient was unable to tolerate this drug (11%). Both drugs seemed less effective in controlling supraventricular arrhythmias, although disopyramide eliminated paroxysms of supraventricular tachycardia in 9 of 13 (69%) and amiodarone in all 6 patients with this arrhythmia. Amiodarone appears to be a better antiarrhythmic drug for chagasic patients, due to its greater effectiveness and lower incidence of side effects.

Treatment of Xerosis with a Topical Formulation Containing Glyceryl Glucoside, Natural Moisturizing Factors, and Ceramide

PubMed Central

Kausch, Martina; Rippke, Frank; Schoelermann, Andrea M.; Filbry, Alexander W.

2012-01-01

Objective: To assess the effects of Light Formulation, an oil-in-water emulsion, and Rich Formulation, a water-in-oil emulsion, for the treatment of xerosis. Design: Two double-blind, vehicle-controlled trials (both formulations); a double-blind, randomized regression study (Rich Formulation); and a single-blind tolerability study (Light Formulation). The two formulations were applied twice daily for two weeks, for five days in the regression study, and twice daily for two weeks in the tolerability study. Setting: Studies were conducted during winter in Hamburg, Germany. Participants: A total of 169 subjects were enrolled and 154 completed the studies. The majority were between 50 and 80 years of age, women, all with very dry skin. One withdrew because of an incompatibility reaction that reoccurred with the subject's own body lotion after sun exposure. Measurements: Skin hydration and skin barrier function with both formulations over two weeks, long-term moisturization effect after discontinuation of Rich Formulation, and symptom improvement and skin tolerability with Light Formulation. Results: Vehicle-controlled studies of Light and Rich Formulations demonstrated significantly improved hydration at Weeks 1 and 2 versus the untreated site and vehicles, and significantly reduced transepidermal water loss versus untreated site and basic vehicle. Both products significantly decreased visible dryness and tactile roughness. In the regression study, Rich Formulation maintained significant moisturization six days after treatment discontinuation. Light Formulation reduced symptoms of itching, burning, tightness, tingling, and feeling of dryness. Conclusion: These formulations represent a new approach for the treatment of xerosis by addressing multiple key deficiencies in skin hydration. PMID:22916312

Efficacy and safety of a new single-dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double-blind, placebo-controlled study.

PubMed

Ortonne, J P; Korting, H C; Viguié-Vallanet, C; Larnier, C; Savaluny, E

2006-11-01

Tinea pedis is a common dermatophyte infection with frequent recurrences. Terbinafine (presently used as a 1-week topical treatment of tinea pedis) is now available in a novel topical solution (film-forming solution--FFS), developed to allow single application. To demonstrate the efficacy and safety of terbinafine 1% FFS in a randomized, double-blind, placebo-controlled, phase III trial, and to determine relapse or re-infection rate of tinea pedis at 12 weeks. Fifty-four centres (27 in France; 27 in Germany) enrolled 273 evaluable patients (2 : 1 randomization). Patients applied terbinafine 1% FFS or placebo only once between, under and over the toes, soles and sides of both feet. Efficacy assessments included direct microscopy, mycological culture, and clinical signs and symptoms at baseline, and at weeks 1, 6 and 12 after the single drug application. Effective treatment (negative mycology plus absent/minimal symptoms) at week 6 in the terbinafine 1% FFS group was 63%; vehicle was 17% (P

Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy.

PubMed

Moore, R A; McQuay, H J; Tomaszewski, J; Raba, G; Tutunaru, D; Lietuviete, N; Galad, J; Hagymasy, L; Melka, D; Kotarski, J; Rechberger, T; Fülesdi, B; Nizzardo, A; Guerrero-Bayón, C; Cuadripani, S; Pizà-Vallespir, B; Bertolotti, M

2016-01-22

Dexketoprofen trometamol plus tramadol hydrochloride is a new oral combination of two analgesics, which have different mechanisms of action for the treatment of moderate to severe acute pain. Randomised, double-blind, parallel, placebo and active-controlled, single and multiple-dose study to evaluate the analgesic efficacy and safety of dexketoprofen/tramadol 25 mg/75 mg in comparison with the single agents (dexketoprofen 25 mg and tramadol 100 mg) in moderate to severe acute pain after abdominal hysterectomy. Patients received seven consecutive doses of study drug within a 3-day period, each dose separated by an 8-hour interval. A placebo arm was included during the single-dose phase to validate the pain model. Efficacy assessments included pain intensity, pain relief, patient global evaluation and use of rescue medication. The primary endpoint was the mean sum of pain intensity differences over the first 8 h (SPID8). The efficacy analysis included 606 patients, with a mean age of 48 years (range 25-73). The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint (p <0.001). Secondary endpoints were generally supportive of the superiority of the combination for both single and multiple doses. Most common adverse drug reactions (ADRs) were nausea (4.6%) and vomiting (2.3%). All other ADRs were experienced by less than 2% of patients. The study results provided robust evidence of the superiority of dexketoprofen/tramadol 25 mg/75 mg over the single components in the management of moderate to severe acute pain, as confirmed by the single-dose efficacy, repeated-dose sustained effect and good safety profile observed. EU Clinical Trials Register (EudraCT number 2012-004545-32, registered 04 October 2012); Clinicaltrials.gov ( NCT01904149, registered 17 July 2013).

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

PubMed

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

2017-01-01

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

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. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Effect of Acupressure at Spleen 6 Acupuncture Point on the Anxiety Level and Sedative and Analgesics Consumption of Women during Labor: A Randomized, Single-blind Clinical Trial

PubMed Central

Samadi, Parisa; Alipour, Zahra; Lamyian, Minoor

2018-01-01

Background: Labor pain is the most severe pain women would experience, which could lead to loss of emotional control that plays a key role in creating a traumatic delivery experience and psychological disorders. The goal of this study was to evaluate the effect of acupressure on anxiety level and sedative and analgesics consumption in women during labor. Materials and Methods: This study was a randomized, single-blind clinical trial performed at Maryam Hospital in Tehran, Iran. One hundred and thirty-one pregnant women in Labor Ward were selected by convenience sampling. Subjects were randomly allocated to three groups, namely experimental group (pressure group), control group 1(touh group) and, control group 2 (routine care group). The study data were gathered using demographic information form, and assessed with Faces Anxiety Scale (FAS). For participants belonging to the experimental group, pressure was applied to the Spleen 6 acupoint for 30 min, and for those with only light touch was applied to the Spleen 6 acupoint for 30 min. The collected data were analyzed using Statistical Package for the Social Sciences 16 and descriptive statistics. Results: There was a significant difference between the three groups in terms of the mean of anxiety after 30 min of starting the intervention and 30 min after termination of the intervention; the anxiety of the experimental group was significantly decreased (p = 0.03). Sedative and analgesics consumption was significantly lower in the experimental group compared to the other groups (p = 0.006). Conclusions: This study showed that compression of the Spleen 6 acupoint was an effective complementary method to decrease maternal anxiety and analgesic consumption, especially pethidine. PMID:29628954

Safety, Tolerability, and Pharmacokinetic Properties of Intravenous Delafloxacin After Single and Multiple Doses in Healthy Volunteers.

PubMed

Hoover, Randall; Hunt, Thomas; Benedict, Michael; Paulson, Susan K; Lawrence, Laura; Cammarata, Sue; Sun, Eugene

2016-01-01

The objective of this report was to determine the pharmacokinetic properties, safety, and tolerability of single and multiple doses of intravenous delafloxacin. In addition, the absolute bioavailability (BA) of the 450-mg tablet formulation of delafloxacin was determined. Three clinical trials are summarized. The first study was a randomized, double-blind, placebo-controlled, single- (300, 450, 600, 750, 900, and 1200 mg) ascending-dose study of IV delafloxacin in 62 (52 active, 10 placebo) healthy volunteers. The second study was a randomized, double-blind, placebo-controlled study of IV delafloxacin (300 mg) given as a single dose on day 1, followed by twice-daily dosing on days 2 through 14; 12 (8 active, 4 placebo) healthy volunteers were enrolled. The third study was an open-label, randomized, 2-period, 2-sequence crossover study in which 56 healthy volunteers were randomly assigned to 1 of 2 sequences of a single oral dose of delafloxacin (450-mg tablet) or IV delafloxacin (300 mg). Serial blood samples were collected, and plasma pharmacokinetic parameters of delafloxacin were calculated. Delafloxacin Cmax values increased proportionally with increasing single IV dose for the dose range of 300 to 1200 mg, whereas the AUC values increased more than proportionally to dose for the same dose range. The mean terminal half-life of delafloxacin was approximately 12 hours (ranging from 8 to 17 hours). The volume of distribution (Vd) at steady state was approximately 35 L, which is similar to the volume of total body water. There was minimal accumulation of delafloxacin after twice-daily IV administration of 300 mg with an accumulation ratio of 1.09. The delafloxacin total exposure after a single 1-hour IV infusion of 300 mg and a single oral dose of a 450-mg tablet were equivalent with geometric least square mean ratio (90% CI) of 0.8768 (0.8356-0.9200) for AUC0-∞ and 0.8445 (0.8090-0.8815) for AUC0-t, respectively. The Cmax values of delafloxacin were not equivalent for the 2 formulations with a ratio (90% CI) of 0.5516 (0.5150-0.5908), respectively. The mean absolute bioavailability of delafloxacin was 58.8%. Delafloxacin was well tolerated in healthy volunteers after single and multiple IV doses. The total systemic exposure to IV (300 mg) and oral (450 mg) delafloxacin is comparable, supporting that a switch between the 2 formulations is appropriate. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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.

Prevalence of sensitivity to food and drug additives in patients with chronic idiopathic urticaria.

PubMed

Rajan, Jessica P; Simon, Ronald A; Bosso, John V

2014-01-01

Chronic idiopathic urticaria (CIU) is defined as the presence of urticaria most days of the week for a period of 6 weeks or longer. There have been reports of food additive sensitivity in CIU previously, but the prevalence has not been precisely determined. To determine the prevalence of reactions to food and drug additives in patients with CIU. We challenged 100 patients in our allergy/immunology division with CIU to the 11 additives most commonly associated with reactions: tartrazine (FD&C Yellow 5), potassium metabisulfite, monosodium glutamate, aspartame, sodium benzoate, methyl paraben, butylated hydroxy anisole, butylated hydroxy toluene, FD&C Yellow 6, sodium nitrate, sodium nitrite. All of the patients had a history of CIU for longer than 6 weeks, and 43 reported possible history of food or drug additive sensitivity. Single-blind challenges to all of the additives were performed in the clinic and skin scores were recorded. Subjects with positive challenge tests underwent double-blind placebo controlled challenges. Of 100 subjects, only 2 had a positive urticarial response on single-blind challenge. Neither of these patients had a positive urticarial response on double-blind placebo-controlled challenge. There were no gastrointestinal, respiratory, or other symptom, and no patients reported late reactions. We were able to conclude, with 95% confidence intervals that sensitivity to any of the 11 food and drug additives occurs in fewer than 1% of patients with CIU. Food and drug additives appear to be a rare cause of CIU, and avoidance is not recommended. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-12-01

To assess the effect of treatment with febuxostat versus placebo on joint damage in hyperuricemic subjects with early gout (1 or 2 gout flares). In this double-blind, placebo-controlled study, 314 subjects with hyperuricemia (serum uric acid [UA] level of ≥7.0 mg/dl) and early gout were randomized 1:1 to receive once-daily febuxostat 40 mg (increased to 80 mg if the serum UA level was ≥6.0 mg/dl on day 14) or placebo. The primary efficacy end point was the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint. Additional efficacy end points included change from baseline to month 24 in the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores for synovitis, erosion, and edema in the single affected joint, the incidence of gout flares, and serum UA levels. Safety was assessed throughout the study. Treatment with febuxostat did not lead to any notable changes in joint erosion over 2 years. In both treatment groups, the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint was minimal, with no between-group differences. However, treatment with febuxostat significantly improved the RAMRIS synovitis score at month 24 compared with placebo treatment (change from baseline -0.43 versus -0.07; P <0.001), decreased the overall incidence of gout flares (29.3% versus 41.4%; P < 0.05), and improved serum UA control (62.8% versus 5.7%; P < 0.001). No major safety concerns were reported. Urate-lowering therapy with febuxostat improved magnetic resonance imaging-determined synovitis and reduced the incidence of gout flares in subjects with early gout. © 2017 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Comparison of self-citation by peer reviewers in a journal with single-blind peer review versus a journal with open peer review.

PubMed

Levis, Alexander W; Leentjens, Albert F G; Levenson, James L; Lumley, Mark A; Thombs, Brett D

2015-12-01

Some peer reviewers may inappropriately, or coercively request that authors include references to the reviewers' own work. The objective of this study was to evaluate whether, compared to reviews for a journal with single-blind peer review, reviews for a journal with open peer review included (1) fewer self-citations; (2) a lower proportion of self-citations without a rationale; and (3) a lower ratio of proportions of citations without a rationale in self-citations versus citations to others' work. Peer reviews for published manuscripts submitted in 2012 to a single-blind peer review journal, the Journal of Psychosomatic Research, were previously evaluated (Thombs et al., 2015). These were compared to publically available peer reviews of manuscripts published in 2012 in an open review journal, BMC Psychiatry. Two investigators independently extracted data for both journals. There were no significant differences between journals in the proportion of all reviewer citations that were self-citations (Journal of Psychosomatic Research: 71/225, 32%; BMC Psychiatry: 90/315, 29%; p=.50), or in the proportion of self-citations without a rationale (Journal of Psychosomatic Research: 15/71, 21%; BMC Psychiatry: 12/90, 13%; p=.21). There was no significant difference between journals in the proportion of self-citations versus citations to others' work without a rationale (p=.31). Blind and open peer review methodologies have distinct advantages and disadvantages. The present study found that, in reasonably similar journals that use single-blind and open review, there were no substantive differences in the pattern of peer reviewer self-citations. Copyright © 2015 Elsevier Inc. All rights reserved.

Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review

PubMed Central

Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

2015-01-01

While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and blinding credibility. PMID:26536619

Memory strength and lineup presentation moderate effects of administrator influence on mistaken identifications.

PubMed

Zimmerman, David M; Chorn, Jacqueline Austin; Rhead, Lindsey M; Evelo, Andrew J; Kovera, Margaret Bull

2017-12-01

Administrator/witness pairs (N = 313) were randomly assigned to target-absent lineups in a 2 (Suspect/Perpetrator Similarity: High Suspect Similarity vs. Low Suspect Similarity) × 2 (Retention Interval: 30 min vs. 1 week) × 2 (Lineup Presentation: Simultaneous vs. Sequential) × 2 (Administrator Knowledge: Single-Blind vs. Double-Blind) factorial design to test whether suspect similarity and memory strength constrain interpersonal expectancy effects on eyewitness identification accuracy. Administrators who knew which lineup member was the suspect (single-blind) or who administered simultaneous lineups were more likely to emit verbal and nonverbal behaviors that suggested to the witness who the suspect was. Additionally, single-blind administrators exerted more pressure on witnesses to choose the suspect as opposed to fillers. Administrator knowledge interacted with retention interval and lineup presentation to influence mistaken identifications of innocent suspects; witnesses were more likely to mistakenly identify an innocent suspect from single-blind than double-blind lineups when witness retention intervals were long and photographs were presented simultaneously. Contrary to our predictions, suspect/perpetrator similarity did not interact with other manipulated variables to influence identification decisions. Both sequential and double-blind procedures should be used to reduce the use of suggestive behavior during lineup administration. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Evidence for the efficacy of melatonin in the treatment of primary adult sleep disorders.

PubMed

Auld, Fiona; Maschauer, Emily L; Morrison, Ian; Skene, Debra J; Riha, Renata L

2017-08-01

Melatonin is a physiological hormone involved in sleep timing and is currently used exogenously in the treatment of primary and secondary sleep disorders with empirical evidence of efficacy, but very little evidence from randomised, controlled studies. The aim of this meta-analysis was to assess the evidence base for the therapeutic effects of exogenous melatonin in treating primary sleep disorders. An electronic literature review search of MEDLINE (1950-present) Embase (1980- present), PsycINFO (1987- present), and Scopus (1990- present), along with a hand-searching of key journals was performed in July 2013 and then again in May 2015. This identified all studies that compared the effect of exogenous melatonin and placebo in patients with primary insomnia, delayed sleep phase syndrome, non 24-h sleep wake syndrome in people who are blind, and rapid eye movement-behaviour disorder. Meta-analyses were performed to determine the magnitude of effect in studies of melatonin in improving sleep. A total of 5030 studies were identified; of these citations, 12 were included for review based on the inclusion criteria of being: double or single-blind, randomised and controlled. Results from the meta-analyses showed the most convincing evidence for exogenous melatonin use was in reducing sleep onset latency in primary insomnia (p = 0.002), delayed sleep phase syndrome (p < 0.0001), and regulating the sleep-wake patterns in blind patients compared with placebo. These findings highlight the potential importance of melatonin in treating certain first degree sleep disorders. The development of large-scale, randomised, controlled trials is recommended to provide further evidence for therapeutic use of melatonin in a variety of sleep difficulties. Copyright © 2016 Elsevier Ltd. All rights reserved.

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 lasts over time. Mud-bath therapy can represent a useful backup to pharmacologic treatment of knee OA or a valid alternative for patients who do not tolerate pharmacological treatments.

The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

PubMed

Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

2013-11-01

In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial.

PubMed

Sebio García, Raquel; Yáñez-Brage, Maria Isabel; Giménez Moolhuyzen, Esther; Salorio Riobo, Marta; Lista Paz, Ana; Borro Mate, Jose María

2017-08-01

To investigate the effects of a preoperative pulmonary rehabilitation programme in patients with lung cancer undergoing video-assisted thoracic surgery. Randomized, single-blind controlled trial. Teaching hospital. Patients with suspected or confirmed lung cancer undergoing video-assisted thoracic surgery. Participants were randomized to either a prehabilitation group or a control group. Participants in the prehabilitation group underwent a combination of moderate endurance and resistance training plus breathing exercises three to five times per week. The primary outcome of the study was exercise capacity. Secondary outcomes were muscle strength (Senior Fitness Test), health-related quality of life (Short-Form 36) and the postoperative outcomes. Patients were evaluated at baseline (before randomization), presurgery (only the prehabilitation group), after surgery and three months post-operatively. A total of 40 patients were randomized and 22 finished the study (10 in the prehabilitation group and 12 in the control group). Three patients were lost to follow-up at three months. After the training, there was a statistically significant improvement in exercise tolerance (+397 seconds, p = 0.0001), the physical summary component of the SF-36 (+4.4 points, p = 0.008) and muscle strength ( p < 0.01). There were no significant differences between groups after surgery. However, three months postoperatively, significant differences were found in the mean change of exercise capacity ( p = 0.005), physical summary component ( p = 0.001) and upper and lower body strength ( p = 0.045 and p = 0.002). A pulmonary rehabilitation programme before video-assisted thoracic surgery seems to improve patients' preoperative condition and may prevent functional decline after surgery. Clinical Registration Number: NCT01963923 (Registration date 10/10/2013).

A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia.

PubMed

O'Connor, Daniel W; Eppingstall, Barbara; Taffe, John; van der Ploeg, Eva S

2013-11-13

Lavender essential oil shows evidence of sedative properties in neurophysiological and animal studies but clinical trials of its effectiveness as a treatment of agitation in people with dementia have shown mixed results. Study methods have varied widely, however, making comparisons hazardous. To help remedy previous methodological shortcomings, we delivered high grade lavender oil in specified amounts to nursing home residents whose agitated behaviours were recorded objectively. 64 nursing home residents with frequent physically agitated behaviours were entered into a randomized, single-blind cross-over trial of dermally-applied, neurophysiologically active, high purity 30% lavender oil versus an inactive control oil. A blinded observer counted the presence or absence of target behaviours and rated participants' predominant affect during each minute for 30 minutes prior to exposure and for 60 minutes afterwards. Lavender oil did not prove superior to the control oil in reducing the frequency of physically agitated behaviours or in improving participants' affect. Studies of essential oils are constrained by their variable formulations and uncertain pharmacokinetics and so optimal dosing and delivery regimens remain speculative. Notwithstanding this, topically delivered, high strength, pure lavender oil had no discernible effect on affect and behaviour in a well-defined clinical sample. Australian and New Zealand Clinical Trials Registry (ACTRN 12609000569202).

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

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

PubMed

Cambi, Jacopo; Livi, Ludovica; Livi, Walter

2017-05-01

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

The effects of Kinesio Taping on body functions and activity in unilateral spastic cerebral palsy: a single-blind randomized controlled trial.

PubMed

Kaya Kara, Ozgun; Atasavun Uysal, Songul; Turker, Duygu; Karayazgan, Sedef; Gunel, Mintaze Kerem; Baltaci, Gul

2015-01-01

The aim of this study was to investigate the effects of Kinesio Taping (KT) on the body functions and activity of children with unilateral spastic cerebral palsy (CP). This study was designed as a single-blind, randomized, controlled trial. Thirty children with unilateral spastic CP were randomized and split equally between the KT group (eight males, seven females; mean age 9y [SD 2y 3mo] range 7-12y) and the control group (seven males, eight females; mean age 9y 7mo [SD 3y 4mo] range 7-14y) receiving usual care. All participants were evaluated with the Functional Independence Measure for Children (WeeFIM), the Bruininks-Oseretsky Test of Motor Proficiency (BOTMP), the Gross Motor Function Measure (GMFM), short-term muscle power, agility and functional muscle strength tests. Wilcoxon signed-rank and Mann-Whitney U tests were used to evaluate within and between-group differences respectively. The level of significance was accepted as p<0.05. There were significant differences in muscle power sprint (p=0.003), lateral step-up test right (p=0.016), sit to stand (p=0.018), attain stand through half knee right (p=0.003), BOTMP Gross scores (p=0.019), and WeeFIM total (p=0.003) and self-care scores (p=0.022) between the groups (p<0.05). Kinesio Taping is a promising additional approach to increase proprioceptive feedback and improve physical fitness, gross motor function, and activities of daily living in children with CP. © 2014 Mac Keith Press.

Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study.

PubMed

Baldwin, David S; Green, Mary; Montgomery, Stuart A

2014-11-01

'Recurrent brief depression' (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2-4-week single-blind placebo run-in period, a total of 35 patients were randomized to receive double-blind medication for 4 months, but only 16 completed the active treatment period. An intention-to-treat analysis of the 34 evaluable patients found no evidence for the efficacy of moclobemide or imipramine, when compared with placebo, in significantly reducing the severity, duration or frequency of depressive episodes. A total of 28 patients experienced at least one adverse event, and four patients engaged in nonfatal self-harm. Limitations of the study include the small sample size and the high rate of participant withdrawal. The lack of efficacy of these antidepressant drugs and the previous finding of the lack of efficacy of the selective serotonin reuptake inhibitor fluoxetine together indicate that medications other than antidepressant drugs should be investigated as potential treatments for what remains a common, distressing and potentially hazardous condition.

Enhanced Chemosensory Detection of Negative Emotions in Congenital Blindness

PubMed Central

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

2015-01-01

It is generally acknowledged that congenitally blind individuals develop superior sensory abilities in order to compensate for their lack of vision. Substantial research has been done on somatosensory and auditory sensory information processing of the blind. However, relatively little information is available about compensatory plasticity in the olfactory domain. Although previous studies indicate that blind individuals have superior olfactory abilities, no studies so far have investigated their sense of smell in relation to social and affective communication. The current study compares congenitally blind and normal sighted individuals in their ability to discriminate and identify emotions from body odours. A group of 14 congenitally blind and 14 age- and sex-matched sighted control subjects participated in the study. We compared participants' abilities to detect and identify by smelling sweat from donors who had been watching excerpts from emotional movies showing amusement, fear, disgust, or sexual arousal. Our results show that congenitally blind subjects outperformed sighted controls in identifying fear from male donors. In addition, there was a strong tendency that blind individuals were also better in detecting disgust. Our findings reveal that congenitally blind individuals are better at identifying ecologically important emotions and provide new insights into the mechanisms of social and affective communication in blindness. PMID:25878902

Mindfulness-based stress reduction for chronic insomnia in adults older than 75 years: a randomized, controlled, single-blind clinical trial.

PubMed

Zhang, Jia-Xu; Liu, Xiao-Hui; Xie, Xin-Hui; Zhao, Dan; Shan, Mo-Shui; Zhang, Xi-Liang; Kong, Xiao-Ming; Cui, Hong

2015-01-01

To assess the effectiveness of mindfulness-based stress reduction (MBSR) for chronic insomnia and combined depressive or anxiety symptoms of older adults aged 75 years and over. A randomized, controlled, single-blind clinical trial. Participants included 60 adults aged 75 years and over with chronic insomnia. Participants were randomly assigned to the eight-week MBSR group or the wait-list control group. Assessments using the Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Sale (SAS), and Geriatric Depression Scale (GDS) were taken at baseline and post-treatment. For each outcome measure, a repeated measures analysis of variance was used to detect changes across assessments. There was a significant time × group interaction for the PSQI global score (P = .006); the MBSR group had a decrease in the PSQI global score (Cohen׳s d = 1.12), while the control group did not (Cohen׳s d = -0.06). Among the PSQI components, there was a significant time × group interaction for daytime dysfunction (P = .048); Cohen׳s d of the MBSR group was 0.76, while Cohen׳s d of control group was -0.04. There was no significant time × group interaction for the SAS score (P = .116), while for the GDS there was a significant time × group interaction (P = .039); the Cohen׳s d value for the MBSR group was 1.20, and it was 0.12 for the control group. This study demonstrated that the MBSR program could be a beneficial treatment for chronic insomnia in adults aged 75 years and older. Copyright © 2015 Elsevier Inc. All rights reserved.

Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms--a placebo-controlled, double-blind, multicenter trial.

PubMed

Lopatkin, N; Sivkov, A; Walther, C; Schläfke, S; Medvedev, A; Avdeichuk, J; Golubev, G; Melnik, K; Elenberger, N; Engelmann, U

2005-06-01

The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule (PRO 160/120) was investigated in elderly, male patients suffering from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia in a prospective multicenter trial. A total of 257 patients (129 and 128, respectively) were randomized to treatment with PRO 160/120 or placebo (127 and 126 were evaluable for efficacy). Following a single-blind placebo run-in phase of 2 weeks, the patients received 2 x 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks. Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120. Outcome measures for treatment efficacy included the assessment of the patients' LUTS by means of the I-PSS self-rating questionnaire and a quality of life index as well as uroflow and sonographic parameters. Using the International Prostate Symptom Score (I-PSS), patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group (6 points vs 4 points; P=0.003, one tailed) with a tendency in the same direction after 16 weeks. This applied to obstructive as well as to irritative symptoms, and to patients with moderate or severe symptoms at baseline. Patients randomized to placebo showed a marked improvement in LUTS (as measured by the I-PSS) after being switched to PRO 160/120 during the control period (P=0.01, one tailed, in comparison to those who had been treated with PRO 160/120 in the double-blind phase). The tolerability of PRO 160/120 was comparable to the placebo. In conclusion, PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS. PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms. The tolerability of the herbal extract was excellent.

Risk Factors Associated with Progression to Blindness from Primary Open-Angle Glaucoma in an African-American Population

PubMed Central

Pleet, Alexander; Sulewski, Melanie; Salowe, Rebecca J.; Fertig, Raymond; Salinas, Julia; Rhodes, Allison; Merritt, William; Natesh, Vikas; Huang, Jiayan; Gudiseva, Harini V.; Collins, David W.; Chavali, Venkata Ramana Murthy; Tapino, Paul; Lehman, Amanda; Regina-Gigiliotti, Meredith; Miller-Ellis, Eydie; Sankar, Prithvi; Ying, Gui-Shuang; O’Brien, Joan M.

2016-01-01

Purpose To determine the risk factors associated with progression to blindness from primary open-angle glaucoma (POAG) in an African-American population. Methods This study examined 2119 patients enrolled in the Primary Open-Angle African-American Glaucoma Genetics (POAAGG) study. A total of 59 eyes were identified as legally blind as a result of POAG (cases) and were age-and sex-matched to 59 non-blind eyes with glaucoma (controls). Chart reviews were performed to record known and suspected risk factors. Results Cases were diagnosed with POAG at an earlier age than controls (p = 0.005). Of the 59 eyes of cases, 16 eyes (27.1%) presented with blindness at diagnosis. Cases had worse visual acuity (VA) at diagnosis (p < 0.0001), with VA worse than 20/40 conferring a 27 times higher risk of progression to blindness (p = 0.0005). Blind eyes also demonstrated more visual field defects (p = 0.01), higher pretreatment intraocular pressure (IOP; p < 0.0001), and higher cup-to-disc ratio (p = 0.006) at diagnosis. IOP was less controlled in cases, and those with IOP ≥21 mmHg at more than 20% of follow-up visits were 73 times more likely to become blind (p < 0.0001). Cases missed a greater number of appointments per year (p = 0.003) and had non-adherence issues noted in their charts more often than controls (p = 0.03). However, other compliance data did not significantly differ between groups. Conclusion Access to care, initial VA worse than 20/40, and poor control of IOP were the major risk factors associated with blindness from POAG. Future studies should examine earlier, more effective approaches to glaucoma screening as well as the role of genetics in these significantly younger patients who progress to blindness. PMID:27348239

Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials.

PubMed

Weisman, Alanna; Bai, Johnny-Wei; Cardinez, Marina; Kramer, Caroline K; Perkins, Bruce A

2017-07-01

Closed-loop artificial pancreas systems have been in development for several years, including assessment in numerous varied outpatient clinical trials. We aimed to summarise the efficacy and safety of artificial pancreas systems in outpatient settings and explore the clinical and technical factors that can affect their performance. We did a systematic review and meta-analysis of randomised controlled trials comparing artificial pancreas systems (insulin only or insulin plus glucagon) with conventional pump therapy (continuous subcutaneous insulin infusion [CSII] with blinded continuous glucose monitoring [CGM] or unblinded sensor-augmented pump [SAP] therapy) in adults and children with type 1 diabetes. We searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for studies published from 1946, to Jan 1, 2017. We excluded studies not published in English, those involving pregnant women or participants who were in hospital, and those testing adjunct medications other than glucagon. The primary outcome was the mean difference in percentage of time blood glucose concentration remained in target range (3·9-10 mmol/L or 3·9-8 mmol/L, depending on the study), assessed by random-effects meta-analysis. This study is registered with PROSPERO, number 2015:CRD42015026854. We identified 984 reports; after exclusions, 27 comparisons from 24 studies (23 crossover and one parallel design) including a total of 585 participants (219 in adult studies, 265 in paediatric studies, and 101 in combined studies) were eligible for analysis. Five comparisons assessed dual-hormone (insulin and glucagon), two comparisons assessed both dual-hormone and single-hormone (insulin only), and 20 comparisons assessed single-hormone artificial pancreas systems. Time in target was 12·59% higher with artificial pancreas systems (95% CI 9·02-16·16; p<0·0001), from a weighted mean of 58·21% for conventional pump therapy (I 2 =84%). Dual-hormone artificial pancreas systems were associated with a greater improvement in time in target range compared with single-hormone systems (19·52% [95% CI 15·12-23·91] vs 11·06% [6·94 to 15·18]; p=0·006), although six of seven comparisons compared dual-hormone systems to CSII with blinded CGM, whereas 21 of 22 single-hormone comparisons had SAP as the comparator. Single-hormone studies had higher heterogeneity than dual-hormone studies (I 2 79% vs 66%). Bias assessment characteristics were incompletely reported in 12 of 24 studies, no studies masked participants to the intervention assignment, and masking of outcome assessment was not done in 12 studies and was unclear in 12 studies. Artificial pancreas systems uniformly improved glucose control in outpatient settings, despite heterogeneous clinical and technical factors. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study.

PubMed

Zilverstand, Anna; Sorger, Bettina; Slaats-Willemse, Dorine; Kan, Cornelis C; Goebel, Rainer; Buitelaar, Jan K

2017-01-01

Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study's small sample size, potential clinical benefits need to be further investigated in future studies. ISRCTN12390961.

Phase I clinical studies of the advanced glycation end-product (AGE)-breaker TRC4186: safety, tolerability and pharmacokinetics in healthy subjects.

PubMed

Chandra, Kumar P; Shiwalkar, Ajay; Kotecha, Jignesh; Thakkar, Purav; Srivastava, Ambrish; Chauthaiwale, Vijay; Sharma, Sanjay K; Cross, Maurice R; Dutt, Chaitanya

2009-01-01

Advanced glycation end-products (AGEs) have been implicated in the pathogenesis of diabetic complications through a variety of mechanisms including endothelial dysfunction and structural abnormalities in the vasculature and myocardium. Reducing the AGEs burden and their ensuing pro-inflammatory, pro-oxidative and pro-coagulant effect with associated dysfunctional proteins in various target tissues may retard the progression of and even reverse diabetic macro- and microvascular complications. Pyridinium, 3-[[2-(methylsulfonyl) hydrazino] carbonyl]-1-[2-oxo-2-2-thienyl) ethyl]-chloride (TRC4186) has demonstrated AGE-breaking activities in in vitro experiments and improvement in the endothelial and myocardial function in animal models of diabetes mellitus with reduction of AGEs accumulation in tissues over time. The safety of TRC4186 has been established in in vitro and in vivo preclinical studies. Thus, this drug is being developed for the treatment of complications associated with diabetes. This investigation set out to evaluate the safety, tolerability and pharmacokinetics of TRC4186 in healthy human subjects after single and multiple ascending doses, fixed doses in elderly male and female subjects, and with food and different formulations of the compound. Four studies were conducted during phase I clinical development of TRC4186. These were: (i) a randomized, double-blind, placebo-controlled, single-dose, dose-ascending study in healthy male subjects with doses of TRC4186 ranging from 250 to 2500 mg administered as an oral solution (total six doses); (ii) a randomized, double-blind, placebo-controlled, multiple-dose, dose-ascending study in healthy male subjects with three doses of TRC4186 ranging from 500 to 2000 mg twice daily for 6 days with a final single dose on day 7; (iii) a randomized, open-label, three-way crossover study to assess the effect of food (fasted vs fed) and formulation (solution vs tablet) with TRC4186 500 mg; (iv) a randomized, double-blind, placebo-controlled, single-dose, dose-ascending study in elderly male and female subjects at a dose of TRC4186 500 mg followed by TRC4186 1000 mg after a 7-day washout period. The safety and tolerability of TRC4186 were assessed by considering adverse events (AEs), ECG findings, vital signs and laboratory investigation results. TRC4186 was rapidly absorbed, with maximum plasma concentrations (C(max)) attained within 1-4 hours. C(max) and area under the plasma concentration-time curve (AUC) were dose proportional over the range 250-2500 mg for a single dose and 500-2000 mg for multiple doses with twice-daily administration. Steady-state conditions were attained within 6 days at different dose levels. C(max) and AUC were not affected by age, sex, race or type of formulation. The tablet formulation of TRC4186 was bioequivalent with the solution form of the drug under fasting conditions and systemic availability of the tablet formulation was reduced by 40% when administered under fed conditions. Terminal elimination and renal clearance in the elderly male (age 69.1 +/- 6.0 years) were not significantly different compared with younger subjects (age 31 +/- 8.6 years). TRC4186 was safe and well tolerated when administered orally with either a single or multiple doses across the different ages, sexes, races and formulations studied. A dose-proportional increase in plasma TRC4186 concentration was seen, with steady state being achieved within 6 days.

Effects of Nintendo Wii™ Training on Occupational Performance, Balance, and Daily Living Activities in Children with Spastic Hemiplegic Cerebral Palsy: A Single-Blind and Randomized Trial.

PubMed

Atasavun Uysal, Songül; Baltaci, Gül

2016-10-05

This study aimed at assessing how the addition of Nintendo Wii ™ (NW) system to the traditional therapy influences occupational performance, balance, and daily living activities in children with spastic hemiplegic Cerebral Palsy (CP). The present study is a single-blind and randomized trial involving 24 children aged 6-14 years, classified as level I or II on the Gross Motor Function Classification System. The children were allocated into two groups: an intervention and a control group, and their families participated in the study. The activity performance analysis of the children was undertaken by using the Canadian Occupational Performance Measure (COPM), functional balance was measured with the Pediatric Balance Scale (PBS), and activities of daily living were assessed with Pediatric Evaluation of Disability Inventory (PEDI). Twenty-four children with CP were randomly divided into two groups: intervention (n = 12) and control group (n = 12). All children in both groups continued their traditional physiotherapy program twice a week, 45 minutes per session, whereas the participants in the intervention group, additionally, were trained with NW, two other days of the week for 12 weeks, with each session lasting for 30 minutes. Self-care, mobility, PEDI total, PBS, and performance of COPM scores increased in the NW group after intervention. Self-care, mobility, and total PEDI increased in the control group as well. However, there was no statistically significant difference found between the groups, except for PBS (P < 0.05). NW contributed to the implementation of occupational performance, daily living activities, and functional balance. We recommend that NW could be used in the rehabilitation program to engage play-based activities with fun.

Naproxen effects on brain response to painful pressure stimulation in patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled, single-dose study.

PubMed

Giménez, Mónica; Pujol, Jesús; Ali, Zahid; López-Solà, Marina; Contreras-Rodríguez, Oren; Deus, Joan; Ortiz, Héctor; Soriano-Mas, Carles; Llorente-Onaindia, Jone; Monfort, Jordi

2014-11-01

The aim of our study was to investigate the effects of naproxen, an antiinflammatory analgesic drug, on brain response to painful stimulation on the affected knee in chronic osteoarthritis (OA) using functional magnetic resonance imaging (fMRI) in a double-blind, placebo-controlled study. A sample of 25 patients with knee OA received naproxen (500 mg), placebo, or no treatment in 3 separate sessions in a randomized manner. Pressure stimulation was applied to the medial articular interline of the knee during the fMRI pain sequence. We evaluated subjective pain ratings at every session and their association with brain responses to pain. An fMRI control paradigm was included to discard global brain vascular effects of naproxen. We found brain activation reductions under naproxen compared to no treatment in different cortical and subcortical core pain processing regions (p≤0.001). Compared to placebo, naproxen triggered an attenuation of amygdala activation (p=0.001). Placebo extended its attenuation effects beyond the classical pain processing network (p≤0.001). Subjective pain scores during the fMRI painful task differed between naproxen and no treatment (p=0.037). Activation attenuation under naproxen in different regions (i.e., ventral brain, cingulate gyrus) was accompanied by an improvement in the subjective pain complaints (p≤0.002). Naproxen effectively reduces pain-related brain responses involving different regions and the attenuation is related to subjective pain changes. Our current work yields further support to the utility of fMRI to objectify the acute analgesic effects of a single naproxen dose in patients affected by knee OA. The trial was registered at the EuropeanClinicalTrials Database, "EudraCT Number 2008-004501-33".

A Randomized, Double-Blind, Double-Dummy Study to Evaluate the Intranasal Human Abuse Potential and Pharmacokinetics of a Novel Extended-Release Abuse-Deterrent Formulation of Oxycodone

PubMed Central

Kopecky, Ernest A.; Smith, Michael D.; Fleming, Alison B.

2016-01-01

Objective. Evaluate the human abuse potential (HAP) of an experimental, microsphere-in-capsule formulation of extended-release oxycodone (oxycodone DETERx®) (herein “DETERx”). Design. Randomized, double-blind, double-dummy, positive- and placebo-controlled, single-dose, four-phase, four-treatment, crossover study. Setting. Clinical research site. Subjects. There were 39 qualifying subjects (72% male, 85% white, mean age of 27 years) with 36 completing all four Double-blind Treatment Periods. Methods. The four phases encompassed: 1) Screening; 2) Drug Discrimination; 3) Double-blind Treatment; and 4) Follow-up. Drug Discrimination tests ensured that subjects could distinguish placebo from opioid. The four Double-blind Treatments compared DETERx—administered as either a crushed intranasal (IN) or an intact oral (PO) preparation—with immediate-release oxycodone IN (OXY-IR IN) and with an intact IN and PO placebo DETERx control. Results. For primary pharmacokinetic (PK) assessments, abuse quotient (Cmax/Tmax) was lower with DETERx IN than DETERx PO; both treatments were substantially lower than OXY-IR IN (6.24, 8.60, and 69.6 ng/mL/h, respectively). For drug liking, the primary subjective pharmacodynamic (PD) endpoint, both DETERx IN and DETERx PO produced significantly lower scores than OXY-IR IN (P ≤ 0.0001 for each); DETERx IN was less liked than DETERx PO (P ≤ 0.05), mirroring the PK relationships. Objectively assessed pupillometry corroborated the more rapid and significantly greater effect of OXY-IR IN than either DETERx IN or DETERx PO (P ≤ 0.007 for each). Overall safety profiles of DETERx and OXY-IR were comparable and both were well tolerated. Conclusions. Pharmacokinetic and pharmacodynamic outcomes suggest that DETERx IN has relatively low HAP; continued research in larger populations is suggested. PMID:26814256

A tactile-output paging communication system for the deaf-blind

NASA Technical Reports Server (NTRS)

Baer, J. A.

1979-01-01

A radio frequency paging communication system that has coded vibrotactile outputs suitable for use by deaf-blind people was developed. In concept, the system consists of a base station transmitting and receiving unit and many on-body transmitting and receiving units. The completed system has seven operating modes: fire alarm; time signal; repeated single character Morse code; manual Morse code; emergency aid request; operational status test; and message acknowledge. The on-body units can be addressed in three ways: all units; a group of units; or an individual unit. All the functions developed were integrated into a single package that can be worn on the user's wrist. The control portion of the on-body unit is implemented by a microcomputer. The microcomputer is packaged in a custom-designed hybrid circuit to reduce its physical size.

Considerations in the Treatment of the Adult Blind Patient.

ERIC Educational Resources Information Center

Shulman, Dennis G.

1986-01-01

Contends that blindness is not a single clinical determinant, but, rather, that two groups of blind people exist. For those congenitally blind, lack of vision can cause developmental difficulties. For those who later acquire blindness, the premorbid psychodynamics and object relationships are most important in understanding the persons' reactions…

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

Therkelsen, Stig Palm; Hetland, Geir; Lyberg, Torstein; Lygren, Idar; Johnson, Egil

2016-01-01

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. 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. 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 mild to moderate symptoms may have beneficiary effects of AndoSanTM as a safe supplement in addition to conventional medication. ClinicalTrials.gov NCT01496053.

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 mild to moderate symptoms may have beneficiary effects of AndoSanTM as a safe supplement in addition to conventional medication. Trial Registration ClinicalTrials.gov NCT01496053 PMID:27415795

Effect of rhubarb (Rheum emodi) in primary dysmenorrhoea: a single-blind randomized controlled trial.

PubMed

Rehman, Hina; Begum, Wajeeha; Anjum, Farzana; Tabasum, Humyra; Zahid, Shabnam

2015-03-01

The aim of this study was to investigate and evaluate the efficacy of Rheum emodi in the management of primary dysmenorrhoea. A randomized, single-blind, standard controlled trial compared efficacy of R. emodi against mefenamic acid on diagnosed subjects of primary dysmenorrhoea for three consecutive cycles. Experimental group (n=30) received capsules of R. emodi powder two times a day, two days before the expected date of menstruation, and continued first three days of menstruation, while control group (n=15) participants received mefenamic acid capsules three times a day on the same protocol. The primary outcome measures were reduced in severity and duration of pain, assessed by visual analogue scale (VAS) and verbal multidimensional scoring system (VMSS), and secondary outcome measures were overall improvement of dysmenorrhoea and improved in quality of life (QOL). Statistical analysis was done by repeated measures analysis of variance and Chi-square/Fisher Exact test. The menstrual pain was significantly decreased in both groups after three-cycle intervention. Significant changes were observed in VAS (p<0.001) and VMSS (p<0.001) in the experimental group. There is a significant (p<0.001) reduction in duration of pain in both the groups. Associated symptoms and QOL were markedly improved after treatment (p<0.001). It has been clear from the above result that R. emodi is an effective herb in alleviating symptoms of primary dysmenorrhoea. It can serve as an alternative treatment without any apparent side effects. These results deserve further investigations.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

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

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

PubMed

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

2014-02-01

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

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

PubMed Central

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

2014-01-01

Purpose To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Methods This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Results Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Implications Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. PMID:24439640

Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial.

PubMed

Chiu, Hsiu-Ching; Ada, Louise; Lee, Hsin-Min

2014-10-01

To investigate whether Wii Sports Resort training is effective and if any benefits are maintained. Randomized, single-blind trial. Sixty-two hemiplegic children with cerebral palsy (6-13 years). Experimental group undertook six weeks of home-based Wii Sports Resort training plus usual therapy, while the control group received usual therapy. Outcomes were coordination, strength, hand function, and carers' perception of hand function, measured at baseline, six, and 12 weeks by a blinded assessor. There was a trend of mean difference (MD) for the experimental group to have more grip strength by six (MD 4.0 N, 95% confidence interval (CI) -0.8 to 8.8, p = 0.10) and 12 (MD 4.1 N, 95% CI -2.1 to 10.3, p = 0.19) weeks, and to have a higher quantity of hand function according to carers' perception by six (MD 4.5 N, 95% CI -0.7 to 9.7, p = 0.09) and strengthened by 12 (MD 6.4, 95% CI 0.6 to 12.3, p = 0.03) weeks than the control group. There was no difference between groups in coordination and hand function by six or 12 weeks. Wii training did not improve coordination, strength, or hand function. Beyond the intervention, carers perceived that the children used their hands more. © The Author(s) 2014.

Effectiveness of an in-office arginine-calcium carbonate paste on dentine hypersensitivity in periodontitis patients: a double-blind, randomized controlled trial.

PubMed

Pepelassi, Eudoxie; Rahiotis, Christos; Peponi, Eleni; Kakaboura, Afrodite; Vrotsos, Ioannis

2015-01-01

The aim of this single-centre, two-cell, double-blind, randomized controlled clinical study was to evaluate the effectiveness of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing relief on dentine hypersensitivity immediately after scaling and root planing and its sustained relief over a 6-week period. Fifty periodontitis subjects presenting hypersensitivity were subjected to scaling and root planing and in-office application of either 8% arginine and calcium carbonate desensitizing paste (25 subjects, test group) or fluoride-free prophylaxis paste (25 subjects, control group). Air-blast hypersensitivity was assessed using Schiff and Visual Analogue (VAS) scales at baseline, post-scaling, post-application, 2, 4 and 6 weeks. At all evaluation times, the test group presented significant % reduction in hypersensitivity relative to post-scaling (t-test, p < 0.05) (Schiff - Test: 57, 58.6, 60.2, 68; 28.6, 22.2, 23, 23) (VAS - Test: 60, 55.6, 60.1, 68.4; 25.9, 18.2, 20.6, 22.7) and significant % hypersensitivity difference relative to control (ancova, p < 0.05) (Schiff: 38.9, 45.9, 47.4, 57.7; VAS: 49.1, 48.9, 52.6, 61). The single in-office application of the 8% arginine-calcium carbonate desensitizing paste after scaling and root planing provided significant immediate reduction in dentine hypersensitivity, which sustained over a 6-week period. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Differences in Soccer Kick Kinematics between Blind Players and Controls

ERIC Educational Resources Information Center

Giagazoglou, Paraskevi; Katis, Athanasios; Kellis, Eleftherios; Natsikas, Christos

2011-01-01

The purpose of the current study was to examine the kinematic differences during instep soccer kicks between players who were blind and sighted controls. Eleven male soccer players who were blind and nine male sighted performed instep kicks under static and dynamic conditions. The results indicated significantly higher (p less than 0.05) ball…

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma.

PubMed

Kaminski, Rafal; Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome.

A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Meniscal Healing, Clinical Outcomes, and Safety in Patients Undergoing Meniscal Repair of Unstable, Complete Vertical Meniscal Tears (Bucket Handle) Augmented with Platelet-Rich Plasma

PubMed Central

Kulinski, Krzysztof; Kozar-Kaminska, Katarzyna; Wielgus, Monika; Langner, Maciej; Wasko, Marcin K.; Kowalczewski, Jacek; Pomianowski, Stanislaw

2018-01-01

Objective The present study aimed to investigate the effectiveness and safety of platelet-rich plasma (PRP) application in arthroscopic repair of complete vertical tear of meniscus located in the red-white zone. Methods This single center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 37 patients with complete vertical meniscus tears. Patients received an intrarepair site injection of either PRP or sterile 0.9% saline during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the two groups. The secondary endpoints were changes in the International Knee Documentation Committee (IKDC) score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analog scale (VAS) in the two groups at 42 months. Results After 18 weeks, the meniscus healing rate was significantly higher in the PRP-treated group than in the control group (85% versus 47%, P = 0.048). Functional outcomes were significantly better 42 months after treatment than at baseline in both groups. The IKDC score, WOMAC, and KOOS were significantly better in the PRP-treated group than in the control group. No adverse events were reported during the study period. Conclusions The findings of this study indicate that PRP augmentation in meniscus repair results in improvements in both meniscus healing and functional outcome. PMID:29713647

A randomised, controlled, single-blinded study on the impact of a single rhythmical massage (anthroposophic medicine) on well-being and salivary cortisol in healthy adults.

PubMed

Kanitz, Jenny Lena; Reif, Marcus; Rihs, Carolina; Krause, Ingrid; Seifert, Georg

2015-10-01

Rhythmical massage (RM) has evolved from classical massage and is based on the principles of Anthroposophic medicine. The goal of this randomized, single-blinded study was to assess the efficacy of a single RM intervention with either aroma oil (RA) or a neutral oil (RM) compared to a sham massage (SM) on several dimensions of well-being and salivary cortisol in a laboratory setting. 118 healthy adults (mean age: 25.2 years; SD: 4.7) were randomized to one of three groups (RM, RA or SM). After baseline measurements, all subjects were exposed to an experimental stressful situation (Trier Social Stress Test, TSST), before receiving a single massage intervention of about 60 min including a 20-minute rest period. Well-being as the main outcome parameter was assessed by standardized questionnaires (MDBF, Bf-S, B-L) and visual analogue scales (VAS) prior to the beginning of the massage and subsequently. Salivary cortisol and heart rate variability (data are shown elsewhere) were also measured. Participants who received RM or RA showed no statistically significant improvements (MDBF, Bf-S, B-L) compared to the SM group after adjusting for baseline differences observed between the treatment groups. Furthermore, no statistically significant differences were found between the RM and RA groups in any of the analyses. Within a follow-up survey all participants from the RA and 82% from the RM group described the intervention as "relaxing" compared with 42% in the SM group. Salivary cortisol did not differ statistically significantly between the three groups over time. We found no significant effect within this trial. This may be due to the methodological complexity of massage research and especially the sham-controlled design with only one single intervention examined. The influence of the setting, and the expectations of and interaction between participant and practitioner seem to play a role that needs to be verified. Therefore the true potential of rhythmical massage intervention still needs to be validated. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed

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

2012-07-01

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

Does EEG-Neurofeedback Improve Neurocognitive Functioning in Children with Attention-Deficit/Hyperactivity Disorder? A Systematic Review and a Double-Blind Placebo-Controlled Study

ERIC Educational Resources Information Center

Vollebregt, Madelon A.; van Dongen-Boomsma, Martine; Buitelaar, Jan K.; Slaats-Willemse, Dorine

2014-01-01

Background: The number of placebo-controlled randomized studies relating to EEG-neurofeedback and its effect on neurocognition in attention-deficient/hyperactivity disorder (ADHD) is limited. For this reason, a double blind, randomized, placebo-controlled study was designed to assess the effects of EEG-neurofeedback on neurocognitive functioning…

Immediate Effects of Kinesiology Taping of Quadriceps on Motor Performance after Muscle Fatigued Induction.

PubMed

Ahn, Ick Keun; Kim, You Lim; Bae, Young-Hyeon; Lee, Suk Min

2015-01-01

Objectives. The purpose of this cross-sectional single-blind study was to investigate the immediate effects of Kinesiology taping of quadriceps on motor performance after muscle fatigued induction. Design. Randomized controlled cross-sectional design. Subjects. Forty-five subjects participated in this study. Participants were divided into three groups: Kinesiology taping group, placebo taping group, and nontaping group. Methods. Subjects performed short-term exercise for muscle fatigued induction, followed by the application of each intervention. Peak torque test, one-leg single hop test, active joint position sense test, and one-leg static balance test were carried out before and after the intervention. Results. Peak torque and single-leg hopping distance were significantly increased when Kinesiology taping was applied (p < 0.05). But there were no significant effects on active joint position sense and single-leg static balance. Conclusions. We proved that Kinesiology taping is effective in restoring muscle power reduced after muscle fatigued induction. Therefore, we suggest that Kinesiology taping is beneficial for fatigued muscles.

Patellofemoral pain syndrome and its association with hip, ankle, and foot function in 16- to 18-year-old high school students: a single-blind case-control study.

PubMed

Mølgaard, Carsten; Rathleff, Michael Skovdal; Simonsen, Ole

2011-01-01

An increased pronated foot posture is believed to contribute to patellofemoral pain syndrome (PFPS), but the relationship between these phenomena is still controversial. The objectives of this study were to investigate the prevalence of PFPS in high school students and to compare passive internal and external hip rotation, passive dorsiflexion, and navicular drop and drift between healthy high school students and students with PFPS. All 16- to 18-year-old students in a Danish high school were invited to join this single-blind case-control study (N = 299). All of the students received a questionnaire regarding knee pain. The main outcome measurements were prevalence of PFPS, navicular drop and drift, passive ankle dorsiflexion, passive hip rotation in the prone position, and activity level. The case group consisted of all students with PFPS. From the same population, a randomly chosen control group was formed. The prevalence of knee pain was 25%. Of the 24 students with knee pain, 13 were diagnosed as having PFPS. This corresponds to a PFPS prevalence of 6%. Mean navicular drop and drift were higher in the PFPS group versus the control group (navicular drop: 4.2 mm [95% confidence interval (CI), 3.2-5.3 mm] versus 2.9 mm [95% CI, 2.5-3.3 mm]; and navicular drift: 2.6 mm [95% CI, 1.6-3.7 mm] versus 1.4 mm [95% CI, 0.9-2.0 mm]). Higher passive ankle dorsiflexion was also identified in the PFPS group (22.2° [95% CI, 18°-26°] versus 17.7° [95% CI, 15°-20°]). This study demonstrated greater navicular drop, navicular drift, and dorsiflexion in high school students with PFPS compared with healthy students and highlights that foot posture is important to consider as a factor where patients with PFPS diverge from healthy individuals.

Cost effectiveness and cost utility of preventing trachomatous visual impairment: lessons from 30 years of trachoma control in Burma.

PubMed Central

Evans, T G; Ranson, M K; Kyaw, T A; Ko, C K

1996-01-01

AIMS/BACKGROUND: This paper reports on the findings of a cost and effectiveness study of the trachoma control programme (TCP) in Burma. The TCP began in 1964 employing non-surgical interventions (community education and mass treatment with topical antibiotics) and surgical correction of trichiasis. METHODS: Fixed and variable costs of the TCP are assessed over 30 years (1964-93) and apportioned to either surgical or non-surgical interventions. The change in the prevalence of trachoma blindness during this period is used to calculate cases of visual impairment prevented by the TCP. The years of life saved because of premature mortality averted and from living in a handicapped state are added to yield a single measure of utility called handicap adjusted life years (HALYs). RESULTS: The cost effectiveness of the TCP is $54 per case of visual impairment prevented: $193 and $47 for surgical and non-surgical interventions respectively. The cost utility of the TCP is $4 per HALY averted: $10 and $3 for surgical and non-surgical interventions respectively. Results are highly sensitive to the 1965 prevalence of blindness, the choice of discount rate, and the effectiveness of both interventions. CONCLUSIONS: Thirty years of trachoma control in Burma are associated with a remarkable decline in trachomatous blindness. Both surgical and non-surgical interventions are cost effective means of preventing trachomatous visual impairment. Discussion focuses on methodological limitations and implications for research and policy. PMID:8976698

Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

PubMed

Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

2016-12-01

Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring a correct midline perception and, in turn, to improve postural control. Perceptive surfaces represent an alternative to conventional rehabilitation of postural disorders in Parkinson Disease. Further studies are needed to determine if the association of perceptive treatment and active motor training would be useful in improving also gait dexterity.

Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial.

PubMed

Telenius, Elisabeth Wiken; Engedal, Knut; Bergland, Astrid

2015-12-03

Research indicates that exercise can have a positive effect on both physical and mental health in nursing home patients with dementia, however the lasting effect is rarely studied. In a previously published article we investigated the immediate effect of a 12 weeks functional exercise program on physical function and mental health in nursing home residents with dementia. In this paper we studied the long-term effect of this exercise program. We explored the differences between the exercise and control group from baseline to 6 months follow-up and during the detraining period from month 3 to 6. A single blind, randomized controlled trial was conducted and a total of 170 nursing home residents with dementia were included. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. Thirty participants were lost between baseline and six-month follow-up. Linear mixed model analyses for repeated measurements were used to investigate the effect of exercise after detraining period. The exercise group improved their scores on Berg Balance Scale from baseline to 6 months follow-up by 2.7 points in average. The control group deteriorated in the same period and the difference between groups was statistically significant (p = 0.031). The exercise group also scored better on NPI agitation sub-score after 6 months (p = 0.045). The results demonstrate long-time positive effects of a high intensity functional exercise program on balance and indicate a positive effect on agitation, after an intervention period of 12 weeks followed by a detraining period of 12 weeks. Identifier at ClinicalTrials.gov: NCT02262104.

Enhanced verbal abilities in the congenitally blind.

PubMed

Occelli, Valeria; Lacey, Simon; Stephens, Careese; Merabet, Lotfi B; Sathian, K

2017-06-01

Numerous studies have found that congenitally blind individuals have better verbal memory than their normally sighted counterparts. However, it is not known whether this reflects superiority of verbal or memory abilities. In order to distinguish between these possibilities, we tested congenitally blind participants and normally sighted control participants, matched for age and education, on a range of verbal and spatial tasks. Congenitally blind participants were significantly better than sighted controls on all the verbal tasks but the groups did not differ significantly on the spatial tasks. Thus, the congenitally blind appear to have superior verbal, but not spatial, abilities. This may reflect greater reliance on verbal information and the involvement of visual cortex in language processing in the congenitally blind.

Perception of Muscular Effort During Dynamic Elbow Extension in Multiple Sclerosis.

PubMed

Heller, Mario; Retzl, Irene; Kiselka, Anita; Greisberger, Andrea

2016-02-01

To investigate the perception of muscular effort in individuals with multiple sclerosis (MS) and healthy controls during dynamic contractions. Case-control study. MS day care center. Individuals with MS (n=28) and controls (n=28) (N=56). Not applicable. Perceived muscular effort during dynamic elbow extensions was rated at 9 different weight intensities (10%-90% of 1-repetition maximum) in a single-blind, randomized order using the OMNI-Resistance Exercise Scale. Muscle activity of the triceps brachii muscle (lateral head) was measured via surface electromyography and normalized to maximal voluntary excitation. According to OMNI-level ratings, significant main effects were found for the diagnostic condition (F=27.33, P<.001, η(2)=.11), indicating 0.7 (95% confidence interval [CI], 0.3-1.1) lower mean OMNI-level ratings for MS, and for the intensity level (F=46.81, P<.001, η(2)=.46), showing increased OMNI-level ratings for increased intensity levels for both groups. Furthermore, significant main effects were found for the diagnostic condition (F=16.52, P<.001, η(2)=.07), indicating 7.1% (95% CI, -8.6 to 22.8) higher maximal voluntary excitation values for MS, and for the intensity level (F=33.09, P<.001, η(2)=.36), showing higher relative muscle activities for increasing intensity levels in both groups. Similar to controls, individuals with MS were able to differentiate between different intensities of weight during dynamic elbow extensions when provided in a single-blind, randomized order. Therefore, perceived muscular effort might be considered to control resistance training intensities in individuals with MS. However, training intensity for individuals with MS should be chosen at approximately 1 OMNI level lower than recommended, at least for dynamic elbow extension exercises. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Acupressure bands do not improve chemotherapy-induced nausea control in pediatric patients receiving highly emetogenic chemotherapy: A single-blinded, randomized controlled trial.

PubMed

Dupuis, L Lee; Kelly, Kara M; Krischer, Jeffrey P; Langevin, Anne-Marie; Tamura, Roy N; Xu, Ping; Chen, Lu; Kolb, E Anders; Ullrich, Nicole J; Sahler, Olle Jane Z; Hendershot, Eleanor; Stratton, Ann; Sung, Lillian; McLean, Thomas W

2018-03-15

Chemotherapy-induced nausea and vomiting remain common, distressing side effects of chemotherapy. It has been reported that acupressure prevents chemotherapy-induced nausea in adults, but it has not been well studied in children. In this multicenter, prospective, randomized, single-blind, sham-controlled trial, the authors compared acute-phase nausea severity in patients ages 4 to 18 years who were receiving highly emetic chemotherapy using standard antiemetic agents combined with acupressure wrist bands, the most common type of acupressure, versus sham bands. Patients wore acupressure or sham bands continuously on each day of chemotherapy and for up to 7 days afterward. Chemotherapy-induced nausea severity in the delayed phase and chemotherapy-induced vomiting control in the acute and delayed phases also were compared. Of the 187 patients randomized, 165 contributed nausea severity assessments during the acute phase. Acupressure bands did not reduce the severity of chemotherapy-induced nausea in the acute phase (odds ratio [OR], 1.33; 95% confidence limits, 0.89-2.00, in which an OR <1.00 favored acupressure) or in the delayed phase (OR, 1.23; 95% CL, 0.75-2.01). Furthermore, acupressure bands did not improve daily vomiting control during the acute phase (OR, 1.57; 95% CL, 0.95-2.59) or the delayed phase (OR, 0.84; 95% CL, 0.45-1.58). No serious adverse events were reported. Acupressure bands were safe but did not improve chemotherapy-induced nausea or vomiting in pediatric patients who were receiving highly emetic chemotherapy. Cancer 2018;124:1188-96. © 2017 American Cancer Society. © 2017 American Cancer Society.

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

Perioperative Cognitive Protection-Cognitive Exercise and Cognitive Reserve (The Neurobics Trial): A Single-blind Randomized Trial.

PubMed

Humeidan, Michelle L; Otey, Andrew; Zuleta-Alarcon, Alix; Mavarez-Martinez, Ana; Stoicea, Nicoleta; Bergese, Sergio

2015-12-01

The Neurobics Trial is a single-blind, parallel-group, randomized, controlled trial. The main study objective is to compare effectiveness of preoperative cognitive exercise versus no intervention for lowering the incidence of postoperative delirium. Enrollment began March 2015 and is ongoing. Eligible participants include patients older than 60 years of age scheduled for nonemergent, noncardiac, nonneurological surgery at our institution. Patients provide consent and are screened at our Outpatient Preoperative Assessment Clinic to rule out preexisting cognitive dysfunction, significant mental health disorders, and history of surgery requiring general anesthesia in the preceding 6 months. Participants meeting criteria are randomized to complete 1 hour daily of electronic tablet-based cognitive exercise for 10 days before surgery or no preoperative intervention. Compliance with the effective dose of 10 total hours of preoperative exercise is verified on return of the patient for surgery with time logs created by the software application and by patient self-reporting. After surgery, patients are evaluated for delirium in the postanesthesia recovery area, and then twice daily for the remainder of their hospitalization. Additionally, postoperative quality of recovery is assessed daily, along with pain scores and opiate use. More comprehensive cognitive assessments are completed just before discharge for baseline comparison, and quality of recovery is assessed via telephone interview 7, 30, and 90 days post-surgery. The primary outcome is the incidence of delirium during the postoperative hospitalization period. Randomization is computer generated, with allocation concealment in opaque envelopes. All postoperative assessments are completed by blinded study personnel. The study is actively recruiting with 19 patients having provided consent to date, and a total of 264 patients is required for study completion; therefore, no data analysis is currently under way (www.clinicaltrials.gov; NCT02230605). To our knowledge, the Neurobics Trial is the first randomized, controlled study to investigate the effectiveness of a significant preoperative cognitive exercise regimen for the prevention of delirium after noncardiac, nonneurological surgery in elderly patients. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Rupatadine does not potentiate the CNS depressant effects of lorazepam: randomized, double-blind, crossover, repeated dose, placebo-controlled study

PubMed Central

García-Gea, Consuelo; Ballester, Maria Rosa; Martínez, Juan; Antonijoan, Rosa Maria; Donado, Esther; Izquierdo, Iñaki; Barbanoj, Manuel-José

2010-01-01

AIM The main objective was to assess whether benzodiazepine intake when rupatadine plasma concentrations were at steady-state would increase the CNS depressant effects. Rupatadine is a new H1-antihistamine which also inhibits platelet activating factor (PAF) release and has been shown to be clinically effective at doses of 10 mg. METHODS Sixteen healthy young volunteers took part in a crossover, randomized, double-blind, placebo controlled trial comprising two experimental periods (repeated administration for 7 days of rupatadine 10 mg or placebo as single oral daily doses, separated by a washout of 14 days). On days 5 and 7, according to a fully balanced design, a single oral dose of lorazepam 2 mg or placebo was added. CNS effects were evaluated on these days by seven objective tests of psychomotor performance and eight subjective visual analogue scales (VAS) at pre-dose and several times after drug intake. Four treatment conditions were evaluated: placebo, rupatadine 10 mg, lorazepam 2 mg and rupatadine 10 mg + lorazepam 2 mg. RESULTS Significant CNS effects, either impairment of psychomotor performance or subjective sedation, were observed when lorazepam was administered, either alone or in combination with steady state concentrations of rupatadine. No significant differences were found between these two conditions. In addition, rupatadine was not different from placebo. All treatments were well tolerated. CONCLUSION Repeated doses of rupatadine (10 mg orally) did not enhance the CNS depressant effects of lorazepam (2 mg orally, single dose) either in objective psychomotor tasks or in subjective evaluations. PMID:20565458

Just-So Stories: Vaccines, Autism, and the Single-Bullet Disorder

ERIC Educational Resources Information Center

Bearman, Peter

2010-01-01

When should people believe in science, especially in scientific explanations of the causes of health, ill or otherwise? One line of argumentation is that scientific evidence based in robust ecological data, supported by previously tested animal or biological models or double-blinded randomized control trials trumps intuition or just plain "common…

Clobetasol propionate ointment reduces inflammation after cryotherapy.

PubMed

Hindson, T C; Spiro, J; Scott, L V

1985-05-01

A double-blind, randomized, placebo-controlled trial was carried out comparing the effects of clobetasol propionate ointment and the ointment base on the inflammation induced by cryotherapy of basal cell carcinomata and warts. A single application of the steroid was shown to be significantly better at reducing erythema, pain and swelling than the ointment base.

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

NASA Astrophysics Data System (ADS)

Cheng, Xiefeng; Li, Ji

2017-01-01

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

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

ERIC Educational Resources Information Center

Arias, C.; And Others

1993-01-01

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

Vaccines to combat river blindness: expression, selection and formulation of vaccines against infection with Onchocerca volvulus in a mouse model

PubMed Central

Hess, Jessica A.; Zhan, Bin; Bonne-Année, Sandra; Deckman, Jessica M.; Bottazzi, Maria Elena; Hotez, Peter J.; Klei, Thomas R.; Lustigman, Sara; Abraham, David

2014-01-01

Human onchocerciasis is a neglected tropical disease caused by Onchocerca volvulus and an important cause of blindness and chronic disability in the developing world. Although mass drug administration of ivermectin has had a profound effect on control of the disease, additional tools are critically needed including the need for a vaccine against onchocerciasis. The objectives of the present study were to: (i) select antigens with known vaccine pedigrees as components of a vaccine; (ii) produce the selected vaccine antigens under controlled conditions, using two expression systems and in one laboratory and (iii) evaluate their vaccine efficacy using a single immunization protocol in mice. In addition, we tested the hypothesis that joining protective antigens as a fusion protein or in combination, into a multivalent vaccine, would improve the ability of the vaccine to induce protective immunity. Out of eight vaccine candidates tested in this study, Ov-103, Ov-RAL-2 and Ov-CPI-2M were shown to reproducibly induce protective immunity when administered individually, as fusion proteins or in combination. Although there was no increase in the level of protective immunity induced by combining the antigens into one vaccine, these antigens remain strong candidates for inclusion in a vaccine to control onchocerciasis in humans. PMID:24907553

Double-blind, Placebo-controlled Study Assessing the Effect of Chocolate Consumption in Subjects with a History of Acne Vulgaris.

PubMed

Caperton, Caroline; Block, Samantha; Viera, Martha; Keri, Jonette; Berman, Brian

2014-05-01

To assess the effect of chocolate on acne exacerbation in males between the ages of 18 and 35 with a history of acne vulgaris. Double-blind, placebo-controlled, randomized, controlled trial. Single-site, outpatient, research, clinical facility at an academic research institution. Fourteen men between the ages of 18 and 35 were assigned to swallow capsules filled with either unsweetened 100-percent cocoa, hydrolyzed gelatin powder, or a combination of the two, at baseline. Lesions were assessed and photographs were taken at baseline, Day 4, and Day 7. Of the 14 subjects, 13 completed this Institutional Review Board approved study. A statistically significant increase in the mean number of total acneiform lesions (comedones, papules, pustules, nodules) was detected on both Day 4 (p=0.006) and Day 7 (p=0.043) compared to baseline. A small-strength positive Pearson's correlation coefficient existed between the amount of chocolate each subject consumed and the number of lesions each subject developed between baseline and Day 4 (r=0.250), while a medium-strength positive correlation existed between baseline and Day 7 (r=0.314). No serious adverse events occurred. It appears that in acne-prone, male individuals, the consumption of chocolate correlates to an increase in the exacerbation of acne.

A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

PubMed Central

Zywiak, William H.; Edwards, Steven M.; Tidey, Jennifer W.; Swift, Robert M.; Kenna, George A.

2014-01-01

Rationale There is presently no approved single treatment for dual alcohol and nicotine dependencies. Objective This pilot study investigated baclofen effects in alcoholic smokers. Methods This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. Results Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. Conclusions This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies. PMID:24973894

Side effects from intense pulsed light: Importance of skin pigmentation, fluence level and ultraviolet radiation-A randomized controlled trial.

PubMed

Thaysen-Petersen, Daniel; Erlendsson, Andres M; Nash, J F; Beerwerth, Frank; Philipsen, Peter A; Wulf, Hans C; Paasch, Uwe; Haedersdal, Merete

2017-01-01

Intense pulsed light (IPL) is a mainstream treatment for hair removal. Side effects after IPL are known, but risk factors remain to be investigated. The objective of this study was to assess the contribution of skin pigmentation, fluence level, and ultraviolet radiation (UVR) on IPL-induced side effects. The study was a blinded, randomized intra-individual controlled trial including 16 healthy subjects with Fitzpatrick Skin Types (FST) II-V. Three test areas were each divided into four sites, randomized to a single IPL exposure of 22, 34, 46 J/cm 2 or triple stacking of 46 J/cm 2 . Areas were subsequently randomized to no UVR or single solar-simulated UVR exposure of 3 Standard Erythema Dose at 30 minutes or 24 hours after IPL. Each area had a corresponding control, resulting in 15 treatment sites. Follow-up visits were scheduled up to 4 weeks after IPL. Outcome measures were: (i) blinded clinical skin reactions; (ii) objectively measured erythema and pigmentation; (iii) pain measured by visual analog scale (VAS); (iv) histology (H&E, Fontana-Masson); and (v) mRNA-expression of p53. Fifteen subjects with FST II-IV completed the protocol. IPL induced a wide range of skin reactions, including erythema (87% of subjects), purpura (27%), blisters (20%), edema (13%), crusting (13%), hyper- (60%), and hypopigmentation (20%). Darker skin pigmentation and increasing IPL fluence were determinants for IPL-induced side effects (P ≤ 0.002), while a single exposure of UVR did not exacerbate side effects (P ≥ 0.180). Clinical findings were confirmed objectively by reflectance spectrometry and qualitatively by histological changes in skin architecture, inflammatory infiltration, and pigmentation. Marker of cellular DNA damage, that is, p53, did not increase after IPL (P ≥ 0.24). Skin pigmentation and IPL fluence are major determinants of side effects after IPL exposure, while a single exposure to three SED of UVR at 30 minutes or 24 hours after IPL, does not amplify such side effects. Lasers Surg. Med. 49:88-96, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

PubMed Central

2010-01-01

Background Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137 PMID:20594308

Safety and Pharmacokinetics of Multiple 750-Milligram Doses of Intravenous Levofloxacin in Healthy Volunteers

PubMed Central

Chow, Andrew T.; Fowler, Cynthia; Williams, R. Rex; Morgan, Nancy; Kaminski, Susan; Natarajan, Jaya

2001-01-01

The safety and pharmacokinetics of a once-daily high intravenous dose of levofloxacin (750 mg) in 18 healthy volunteers were studied in a double-blind, randomized, placebo-controlled, single-center parallel group study. Levofloxacin was well tolerated, and higher maximum concentration of drug in serum and area under the concentration-time curve values were achieved. For difficult-to-treat infections, high daily doses of levofloxacin may be beneficial, and intravenous administration may be preferred in certain clinical settings, such as when treating patients in intensive care units, warranting further evaluation. PMID:11408234

Safety and pharmacokinetics of multiple 750-milligram doses of intravenous levofloxacin in healthy volunteers.

PubMed

Chow, A T; Fowler, C; Williams, R R; Morgan, N; Kaminski, S; Natarajan, J

2001-07-01

The safety and pharmacokinetics of a once-daily high intravenous dose of levofloxacin (750 mg) in 18 healthy volunteers were studied in a double-blind, randomized, placebo-controlled, single-center parallel group study. Levofloxacin was well tolerated, and higher maximum concentration of drug in serum and area under the concentration-time curve values were achieved. For difficult-to-treat infections, high daily doses of levofloxacin may be beneficial, and intravenous administration may be preferred in certain clinical settings, such as when treating patients in intensive care units, warranting further evaluation.

Highly anisotropic solar-blind UV photodetector based on large-size two-dimensional α-MoO3 atomic crystals

NASA Astrophysics Data System (ADS)

Zhong, Mianzeng; Zhou, Ke; Wei, Zhongming; Li, Yan; Li, Tao; Dong, Huanli; Jiang, Lang; Li, Jingbo; Hu, Wenping

2018-07-01

Orthorhombic MoO3 (α-MoO3) is a typical layered n-type semiconductor with optical band gap over 2.7 eV, which have been widely studied in catalysis, gas sensing, lithium-ion batteries, field-emission, photoelectrical, photochromic and electrochromic devices, supercapacitors and organic solar cells. However, the bottleneck of generation large size atomic thin two-dimensional (2D) α-MoO3 crystals remain challenging this field (normally several micrometers size). Herein, we developed a facile vapor–solid (VS) process for controllable growth of large-size 2D α-MoO3 single crystals with a few nanometers thick and over 300 μm in lateral size. High-performance solar-blind photodetectors were fabricated based on individual 2D α-MoO3 single crystal. The detectors demonstrate outstanding optoelectronic properties under solar-blind UV light (254 nm), with a photoresponsivity of 67.9 A W‑1, external quantum efficiency of 3.3  ×  104%. More important, the devices showed strong in-plane anisotropy in optoelectronic response and transport properties, e.g. the photocurrent along b-axis was found to be 5 times higher than the values along c-axis under 254 nm UV light, and current ON/OFF ratio and mobility anisotropy is about 2 times high. Our work suggests an optimized synthesis routine for 2D crystals, and the great potential of 2D oxides in functional optoelectronics.

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

The DIAMIND study: postpartum SMS reminders to women who have had gestational diabetes mellitus to test for type 2 diabetes: a randomised controlled trial - study protocol.

PubMed

Heatley, Emer; Middleton, Philippa; Hague, William; Crowther, Caroline

2013-04-12

Postpartum follow up of women who have been found to have gestational diabetes during pregnancy is essential because of the strong association of gestational diabetes with subsequent type 2 diabetes. Postal reminders have been shown to increase significantly attendance for oral glucose tolerance testing postpartum. It is possible that a short message service (text) reminder system may also be effective. This trial aims to assess whether a text message reminder system for women who have experienced gestational diabetes in their index pregnancy will increase attendance for oral glucose tolerance testing within six months after birth. Single centre (Women's and Children's Hospital, South Australia), parallel group randomised controlled trial. Women diagnosed with gestational diabetes in their index pregnancy (oral glucose tolerance test with fasting glucose ≥ 5.5 mmol/L and/or two hour glucose ≥ 7.8 mmol/L), with access to a mobile phone, whose capillary blood glucose profile measurements prior to postnatal discharge are all normal (fasting glucose < 6.0 mmol/L, postprandial glucoses < 8.0 mmol/L). Pregestational diabetes mellitus, triplet/higher order multiple birth or stillbirth in the index pregnancy, requirement for interpreter.Trial entry and randomisation: Allocation to intervention will be undertaken using a telephone randomisation service (computer-generated random number sequence generation, with balanced variable blocks, and stratification by insulin requirement).Study groups: Women in the intervention group will receive a text reminder to attend for an oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they do not respond to indicate test completion. Women in the control group will receive a single text message reminder at 6 months postpartum.Blinding: Baseline data collection will be undertaken blinded. Blinding of participants and blinded collection of primary outcome data will not be possible for this study.Primary study outcome: Attendance for the oral glucose tolerance test within 6 months postpartum. 276 subjects will be required to show an 18% absolute increase in the rate of attendance (α=0.05 two tailed, β=80%, 5% loss to follow up) from 37% to 55% in the intervention group. Given the heightened risk of impaired glucose tolerance and type 2 diabetes in women who have had gestational diabetes, ensuring the highest possible rate of attendance for postpartum glucose tolerance testing, so that early diagnosis and intervention can occur, is important. A text message reminder system may prove to be an effective method for achieving improved attendance for such testing. This randomised controlled trial will assess whether such a system will increase rates of attendance for postpartum oral glucose tolerance testing in women who have experienced gestational diabetes. Australian New Zealand Clinical Trials Registry - ACTRN12612000621819.

Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design.

PubMed

Castro-Martín, Eduardo; Ortiz-Comino, Lucía; Gallart-Aragón, Tania; Esteban-Moreno, Bernabé; Arroyo-Morales, Manuel; Galiano-Castillo, Noelia

2017-05-01

To (1) investigate the immediate effects of myofascial induction (MI), with placebo electrotherapy as a control, on perceived pain, cervical/shoulder range of motion (ROM), and mood state in breast cancer survivors (BCSs) with shoulder/arm morbidity; and (2) examine the relationships between pain modifications and cervical/shoulder ROM on the side affected by breast cancer. Randomized, single-blind, placebo-controlled crossover study. Physical therapy laboratory. BCSs (N=21) who had a diagnosis of stage I-IIIA breast cancer and had completed adjuvant therapy (except hormonal treatment). During each session, the BCSs received either an MI (fascial unwinding) intervention focused on the upper limb area following the Pilat approach or placebo pulsed shortwave therapy (control group). Each session lasted 30 minutes, and an adequate washout period of 4 weeks between sessions was established. The visual analog scale (VAS) for pain and anxiety, shoulder-cervical goniometry for ROM, the Profile of Mood States for psychological distress, and the Attitudes Towards Massage Scale were used. An analysis of covariance (ANCOVA) revealed significant time × group interactions for VAS affected arm (P=.031) but not for VAS cervical (P=.332), VAS nonaffected arm (P=.698), or VAS anxiety (P=.266). The ANCOVA also revealed significant interactions for affected shoulder flexion (P<.001), abduction (P<.001), external rotation (P=.004), and internal rotation (P=.001). Significant interactions for affected cervical rotation (P=.022) and affected cervical lateral flexion (P=.038) were also found. A significant negative correlation was found between changes in VAS affected arm and shoulder/arm internal rotation ROM (r=-.46; P=.03). A single MI session decreases pain intensity and improves neck-shoulder ROM to a greater degree than placebo electrotherapy for BCSs experiencing pain. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Teaching Young People Who Are Blind and Have Autism to Make Requests Using a Variation on the Picture Exchange Communication System with Tactile Symbols: A Preliminary Investigation

ERIC Educational Resources Information Center

Lund, Shelley K.; Troha, Jeanette M.

2008-01-01

This study used a single-subject multiple baseline across participants design to evaluate the effectiveness of a modified picture exchange communication system (PECS) teaching protocol with tactile symbols. Three students (two male, one female) aged 12-17 years who had autism and were blind participated in the study. The instructional program…

Spatial memory and integration processes in congenital blindness.

PubMed

Vecchi, Tomaso; Tinti, Carla; Cornoldi, Cesare

2004-12-22

The paper tests the hypothesis that difficulties met by the blind in spatial processing are due to the simultaneous treatment of independent spatial representations. Results showed that lack of vision does not impede the ability to process and transform mental images; however, blind people are significantly poorer in the recall of more than a single spatial pattern at a time than in the recall of the corresponding material integrated into a single pattern. It is concluded that the simultaneous maintenance of different spatial information is affected by congenital blindness, while cognitive processes that may involve sequential manipulation are not.

A placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of single and multiple intravenous infusions of AZD9773 in patients with severe sepsis and septic shock

PubMed Central

2012-01-01

Introduction Tumor necrosis factor-alpha (TNF-α), an early mediator in the systemic inflammatory response to infection, is a potential therapeutic target in sepsis. The primary objective of this study was to determine the safety and tolerability of AZD9773, an ovine, polyclonal, anti-human TNF-α Fab preparation, in patients with severe sepsis. Secondary outcomes related to pharmacokinetic (PK) and pharmacodynamic (PD) parameters. Methods In this double-blind, placebo-controlled, multicenter Phase IIa study, patients were sequentially enrolled into five escalating-dose cohorts (single doses of 50 or 250 units/kg; multiple doses of 250 units/kg loading and 50 units/kg maintenance, 500 units/kg loading and 100 units/kg maintenance, or 750 units/kg loading and 250 units/kg maintenance). In each cohort, patients were randomized 2:1 to receive AZD9773 or placebo. Results Seventy patients received AZD9773 (n = 47) or placebo (n = 23). Baseline characteristics were similar across cohorts. Mean baseline APACHE score was 25.9. PK data demonstrated an approximately proportional increase in concentration with increasing dose and a terminal half-life of 20 hours. For the multiple-dose cohorts, serum TNF-α concentrations decreased to near-undetectable levels within two hours of commencing AZD9773 infusion. This suppression was maintained in most patients for the duration of treatment. AZD9773 was well tolerated. Most adverse events were of mild-to-moderate intensity and considered by the reporting investigator as unrelated to study treatment. Conclusions The safety, PK and PD data support the continued evaluation of AZD9773 in larger Phase IIb/III studies. PMID:22340283

Differential impact of partial cortical blindness on gaze strategies when sitting and walking - an immersive virtual reality study

PubMed Central

Iorizzo, Dana B.; Riley, Meghan E.; Hayhoe, Mary; Huxlin, Krystel R.

2011-01-01

The present experiments aimed to characterize the visual performance of subjects with long-standing, unilateral cortical blindness when walking in a naturalistic, virtual environment. Under static, seated testing conditions, cortically blind subjects are known to exhibit compensatory eye movement strategies. However, they still complain of significant impairment in visual detection during navigation. To assess whether this is due to a change in compensatory eye movement strategy between sitting and walking, we measured eye and head movements in subjects asked to detect peripherally-presented, moving basketballs. When seated, cortically blind subjects detected ~80% of balls, while controls detected almost all balls. Seated blind subjects did not make larger head movements than controls, but they consistently biased their fixation distribution towards their blind hemifield. When walking, head movements were similar in the two groups, but the fixation bias decreased to the point that fixation distribution in cortically blind subjects became similar to that in controls - with one major exception: at the time of basketball appearance, walking controls looked primarily at the far ground, in upper quadrants of the virtual field of view; cortically blind subjects looked significantly more at the near ground, in lower quadrants of the virtual field. Cortically blind subjects detected only 58% of the balls when walking while controls detected ~90%. Thus, the adaptive gaze strategies adopted by cortically blind individuals as a compensation for their visual loss are strongest and most effective when seated and stationary. Walking significantly alters these gaze strategies in a way that seems to favor walking performance, but impairs peripheral target detection. It is possible that this impairment underlies the experienced difficulty of those with cortical blindness when navigating in real life. PMID:21414339

Differential impact of partial cortical blindness on gaze strategies when sitting and walking - an immersive virtual reality study.

PubMed

Iorizzo, Dana B; Riley, Meghan E; Hayhoe, Mary; Huxlin, Krystel R

2011-05-25

The present experiments aimed to characterize the visual performance of subjects with long-standing, unilateral cortical blindness when walking in a naturalistic, virtual environment. Under static, seated testing conditions, cortically blind subjects are known to exhibit compensatory eye movement strategies. However, they still complain of significant impairment in visual detection during navigation. To assess whether this is due to a change in compensatory eye movement strategy between sitting and walking, we measured eye and head movements in subjects asked to detect peripherally-presented, moving basketballs. When seated, cortically blind subjects detected ∼80% of balls, while controls detected almost all balls. Seated blind subjects did not make larger head movements than controls, but they consistently biased their fixation distribution towards their blind hemifield. When walking, head movements were similar in the two groups, but the fixation bias decreased to the point that fixation distribution in cortically blind subjects became similar to that in controls - with one major exception: at the time of basketball appearance, walking controls looked primarily at the far ground, in upper quadrants of the virtual field of view; cortically blind subjects looked significantly more at the near ground, in lower quadrants of the virtual field. Cortically blind subjects detected only 58% of the balls when walking while controls detected ∼90%. Thus, the adaptive gaze strategies adopted by cortically blind individuals as a compensation for their visual loss are strongest and most effective when seated and stationary. Walking significantly alters these gaze strategies in a way that seems to favor walking performance, but impairs peripheral target detection. It is possible that this impairment underlies the experienced difficulty of those with cortical blindness when navigating in real life. Copyright © 2011 Elsevier Ltd. All rights reserved.

The effect of talocrural joint manipulation on range of motion at the ankle.

PubMed

Fryer, Gary A; Mudge, Jacob M; McLaughlin, Patrick A

2002-01-01

To determine whether a single high-velocity, low-amplitude thrust manipulation to the talocrural joint altered ankle range of motion. A randomized, controlled and blinded study. Asymptomatic male and female volunteers (N = 41). Subjects were randomly assigned into either an experimental group (n = 20) or a control group (n = 21). Both ankles of subjects in the experimental group were manipulated by using a single high-velocity, low-amplitude thrust to the talocrural joint. Pretest and posttest measurements of passive dorsiflexion range of motion were taken. No significant changes in dorsiflexion range of motion were detected between manipulated ankles and those of control subjects. A significantly greater pretest dorsiflexion range of motion existed in those ankles in which manipulation produced an audible cavitation. Manipulation of the ankle does not increase dorsiflexion range of motion in asymptomatic subjects. Ankles that displayed a greater pretest range of dorsiflexion were more likely to cavitate, raising the possibility that ligament laxity may be associated with the tendency for ankles to cavitate.

Azelaic acid foam 15% in the treatment of papulopustular rosacea: a randomized, double-blind, vehicle-controlled study.

PubMed

Draelos, Zoe Diana; Elewski, Boni; Staedtler, Gerald; Havlickova, Blanka

2013-12-01

Rosacea is a common chronic inflammatory skin disease that primarily affects facial skin. Its etiology is unknown, and currently there is no cure. Rosacea can be associated with severe symptoms, including transient erythema (flushing), nontransient erythema, papules, pustules, and telangiectases, leading to substantial discomfort and an unattractive appearance. This randomized, double-blind, vehicle-controlled, multicenter, parallel-group study conducted over 12 weeks with a 4-week follow-up period evaluated the efficacy and safety of a new formulation of azelaic acid (AzA) foam in a 15% concentration compared to vehicle alone in patients with papulopustular rosacea (PPR). Primary efficacy variables assessed were investigator global assessment (IGA) dichotomized into success and failure, and nominal change in inflammatory lesion count from baseline to end of treatment. Results indicated that the new foam formulation of AzA is effective and well-tolerated in a population of patients with PPR. Although no single formulation is appropriate for all patients, the development of a new foam formulation in addition to other available vehicles provides patients with options and allows health care providers to match the needs as well as preferences of individual patients and skin types with appropriate delivery modalities.

Nintendo Wii™ Versus Xbox Kinect™ for Assisting People With Parkinson's Disease.

PubMed

Alves, Melissa L M; Mesquita, Beatriz S; Morais, Wenderson S; Leal, Josevan C; Satler, Corina E; Dos Santos Mendes, Felipe A

2018-06-01

This study investigated changes in motor and cognitive skills, anxiety levels, and quality of life perception among patients with Parkinson's Disease (PD) following training with different commercial gaming devices-Nintendo Wii™ and Xbox Kinect™. We used a quasi-experimental, simple blinded clinical trial, dividing 27 patients with PD into three equal groups of nine members: (a) Nintendo Wii™, (b) Xbox Kinect™, and (c) control group. After pretests, experimental group participants spent 10 sessions playing four games of the selected gaming device, while control group participants received no intervention. Only those engaged with the Nintendo Wii™ significantly improved their performance on single and dual task gait tests, decreased anxiety levels, and improved memory, attention, and reversibility. The control group showed no changes on any measures.

Effects of timolol and atenolol on benign essential tremor: placebo-controlled studies based on quantitative tremor recording.

PubMed

Dietrichson, P; Espen, E

1981-08-01

Two different beta-adrenoreceptor antagonists, atenolol and timolol, were separately compared with a placebo in the suppression of essential tremor. In two-week single-blind placebo-controlled studies with cross-over, timolol (5 mg twice daily) and atenolol (100 mg once daily) produced an equal reduction in sitting heart rate and sitting blood pressure. Timolol was effective in reducing tremor while atenolol failed to reduce tremor amplitude. These results indicate that essential tremor can be reduced but not blocked, by the adrenergic blocker timolol with both beta 1 and beta 2 blocking properties; but not by the relatively selective beta 1 blocking drug atenolol. Possibly, the tremor reduction is medicated by a peripheral effect on beta 2 adrenoreceptors.

The effect of massage therapy by patients' companions on severity of pain in the patients undergoing post coronary artery bypass graft surgery: a single-blind randomized clinical trial.

PubMed

Najafi, Sied Saeed; Rast, Fazlola; Momennasab, Marzieh; Ghazinoor, Mahmood; Dehghanrad, Fereshteh; Mousavizadeh, Sied Ali

2014-07-01

Pain on mid sternotomy incision site after Coronary Artery Bypass  Graft  Surgery (CABG) is a common problem that causes sleep disturbance, delayed wound healing, and increased use of analgesic drugs. Massage therapy which is mostly performed by healthcare providers is a non-pharmacological approach for managing this pain. The present study aimed to determine the effect of massage therapy by patient's companion on the severity of pain in post CABG patients. In this randomized single-blind clinical trial, 70 post CABG patients were randomly divided into an intervention and a control group. The intervention group received massage by one of their relatives who was trained by an expert nurse. The control group, on the other hand, received routine care. The pain intensity was assessed by Visual Analogue Scale (VAS) before and immediately, 30, 60, and 120 minutes after the intervention. Then, the data were entered into the SPSS statistical software (version 16) and analyzed using repeated measures ANOVA and post-hoc test (Scheffe). At the beginning of the study, no significant difference was found between the two groups regarding the pain severity. In the intervention group, the pain severity significantly decreased in all the four time points after the intervention (P=0.001). However, no significant difference was observed in this regard in the control group. Massage therapy by patient's companion trained by a nurse was an effective strategy for pain management in post CABG patients. This could also promote the patient's family participation in the process of care. IRCT201208218505N3.

The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial.

PubMed

Guétin, Stéphane; Giniès, Patrick; Siou, Didier Kong A; Picot, Marie-Christine; Pommié, Christelle; Guldner, Elisabeth; Gosp, Anne-Marie; Ostyn, Katelyne; Coudeyre, Emmanuel; Touchon, Jacques

2012-05-01

A music intervention method in the management of pain was recently developed while taking account of recommendations in the scientific literature. The objective of this study was to assess the usefulness of this music intervention to the management of patients with chronic pain. A controlled, single-blind, randomized trial was used. Eighty-seven patients presenting with lumbar pain, fibromyalgia, inflammatory disease, or neurological disease were included in the study. During their hospitalization, the intervention arm (n=44) received at least 2 daily sessions of music listening between D0 and D10, associated with their standard treatment, and then pursued the music intervention at home until D60 using a multimedia player in which the music listening software program had been installed. The control arm received standard treatment only (n=43). The end points measured at D0, D10, D60, and D90 were: pain (VAS), anxiety-depression (HAD) and the consumption of medication. At D60 in the music intervention arm, this technique enabled a more significant reduction (P<0.001) in pain (6.3 ± 1.7 at D0 vs. 3 ± 1.7 at D60) when compared with the arm without music intervention (6.2 ± 1.5 at D0 vs. 4.6 ± 1.7 at D60). In addition, music intervention contributed to significantly reducing both anxiety/depression and the consumption of anxiolytic agents. These results confirm the value of music intervention to the management of chronic pain and anxiety/depression. This music intervention method appears to be useful in managing chronic pain as it enables a significant reduction in the consumption of medication.

The effect of vitamin C and/or E supplementations on type 2 diabetic adult males under metformin treatment: A single-blinded randomized controlled clinical trial.

PubMed

El-Aal, Ali Abd; El-Ghffar, Eman A Abd; Ghali, Asmaa Abu; Zughbur, Mohammed R; Sirdah, Mahmoud M

2018-03-16

Recently, there has been an increasing interest in the influence of antioxidant vitamins on the efficacy of oral hypoglycemic therapy in type 2 diabetic patients (T2DM). This single-blinded randomized controlled clinical trial aimed to investigate the effect of vitamin C and/or E supplementation on the efficacy of oral hypoglycemic therapy in T2DM Palestinian male patients from the Gaza Strip. Forty T2DM male patients aged 40-60 years on metformin treatment were randomly divided into four groups, each group received an additional one of the following daily oral supplements for 90 days: placebo; vitamin C; vitamin E and vitamin C plus vitamin E. After overnight fasting, venous blood specimens were collected from all individuals into K3-EDTA tubes and serum tubes for measuring the biochemical and hematological parameters of the study at baseline and after 90 days of vitamins supplementation. The results revealed that vitamin C and/or E improve fasting blood sugar (FBS), HbA1c, lipid profile, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), reduced glutathione (GSH); and Quantitative Insulin Sensitivity Check Index (QISCI) compared with diabetic patients group that received placebo. This study provided additional evidence on the beneficial effects of supplementing antioxidant vitamins in T2DM which could improve the clinical condition and attenuate or prevent diabetic pathogenesis and complications that, secondly to poor glycemic control, could attribute to the imbalance between the decline in the endogenous antioxidants and increasing production of the reactive oxygen species leading to the oxidant-mediated damage present in the diabetic context. Copyright © 2018 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Enhanced Verbal Abilities in The Congenitally Blind

PubMed Central

Occelli, Valeria; Lacey, Simon; Stephens, Careese; Merabet, Lotfi B.; Sathian, K.

2017-01-01

Numerous studies have found that congenitally blind individuals have better verbal memory than their normally sighted counterparts. However, it is not known whether this reflects superiority of verbal or memory abilities. In order to distinguish between these possibilities, we tested congenitally blind participants and normally sighted control participants, matched for age and education, on a range of verbal and spatial tasks. Congenitally blind participants were significantly better than sighted controls on all the verbal tasks but the groups did not differ significantly on the spatial tasks. Thus, the congenitally blind appear to have superior verbal, but not spatial, abilities. This may reflect greater reliance on verbal information and the involvement of visual cortex in language processing in the congenitally blind. PMID:28280879

Comparative Pharmacodynamics and Plasma Concentrations of D-Threo-Methylphenidate Hydrochloride after Single Doses of D-Threo-Methylphenidate Hydrochloride and D,l-Threo-Methylphenidate Hydrochloride in a Double-Blind, Placebo-Controlled, Crossover Laboratory School Study in Children with Attention-Deficit/hyperactivity Disorder

ERIC Educational Resources Information Center

Quinn, Declan; Wigal, Sharon; Swanson, James; Hirsch, Sharon; Ottolini, Yvonne; Dariani, Maghsoud; Roffman, Mark; Zeldis, Jerome; Cooper, Thomas

2004-01-01

Objective: Methylphenidate has four optical isomers due to two asymmetries (erythro-threo and dextro-levo). The initial commercial formulation eliminated the erythro isomer, but the dextro-levo asymmetry was racemic, with equal amounts of d and l-threo isomers (d,l-MPH). Previous work has suggested that the d-threo isomer methylphenidate (d-MPH)…

Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies

PubMed Central

Conforti, Anita; Bellavite, Paolo; Bertani, Simone; Chiarotti, Flavia; Menniti-Ippolito, Francesca; Raschetti, Roberto

2007-01-01

Background One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal) studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties. The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema), using two treatment administration routes (sub-plantar injection and oral administration). Methods In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement) procedure. In a second phase, some of the remedies (in the same and in different dilutions) were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement) and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170–180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30), saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. Results In the first phase of experiments, some statistically significant effects of homeopathic remedies (Apis, Lachesis and Phosporus) were observed (the reduction in paw volume increase ranging from 10% to 28% at different times since edema induction). In the second phase of experiments, the effects of homeopathic remedies were not confirmed. On the contrary, the unblinded standard allopathic drug indomethacin exhibited its anti-inflammatory effect in both experimental phases (the reduction in paw volume increase ranging from 14% to 40% in the first phase, and from 18% to 38% in the second phase of experiments). Conclusion The discrepancies between single-blind and double-blind methods in animal pharmacological research are noteworthy and should be better investigated, also in non-homeopathic research. PMID:17233886

Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies.

PubMed

Conforti, Anita; Bellavite, Paolo; Bertani, Simone; Chiarotti, Flavia; Menniti-Ippolito, Francesca; Raschetti, Roberto

2007-01-17

One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal) studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties.The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema), using two treatment administration routes (sub-plantar injection and oral administration). In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement) procedure. In a second phase, some of the remedies (in the same and in different dilutions) were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement) and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170-180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30), saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. In the first phase of experiments, some statistically significant effects of homeopathic remedies (Apis, Lachesis and Phosporus) were observed (the reduction in paw volume increase ranging from 10% to 28% at different times since edema induction). In the second phase of experiments, the effects of homeopathic remedies were not confirmed. On the contrary, the unblinded standard allopathic drug indomethacin exhibited its anti-inflammatory effect in both experimental phases (the reduction in paw volume increase ranging from 14% to 40% in the first phase, and from 18% to 38% in the second phase of experiments). The discrepancies between single-blind and double-blind methods in animal pharmacological research are noteworthy and should be better investigated, also in non-homeopathic research.

The AAHKS Clinical Research Award: Liposomal Bupivacaine and Periarticular Injection Are Not Superior to Single-Shot Intra-articular Injection for Pain Control in Total Knee Arthroplasty.

PubMed

Jain, Rajesh K; Porat, Manny D; Klingenstein, Greg G; Reid, Jeremy J; Post, Robert E; Schoifet, Scott D

2016-09-01

Intraoperative injections can help reduce early postoperative pain in total knee arthroplasty. We proposed that liposomal bupivacaine would not be superior to more common and cheaper injections. A single-blinded prospective randomized study with 207 consecutive patients was completed. Patients were randomized to treatment with periarticular liposomal bupivacaine injection, periarticular injection of bupivacaine/morphine, or intra-articular injection of bupivacaine/morphine at the conclusion of the procedure. Postoperative visual analog pain scores and narcotic consumption were recorded and analyzed. There was no significant difference in postoperative visual analog pain scores or narcotic consumption among the 3 study groups. Intra-articular injection of bupivacaine and morphine is as effective for postoperative pain control in total knee arthroplasty as periarticular bupivacaine/morphine injection and liposomal bupivacaine. Use of liposomal bupivacaine in total knee arthroplasty is costly and not justified. Copyright © 2016 Elsevier Inc. All rights reserved.

Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

PubMed Central

Scholey, Andrew; Benson, Sarah; Gibbs, Amy; Perry, Naomi; Sarris, Jerome; Murray, Greg

2017-01-01

Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6), in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171) were randomized (1:1) to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI) score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs) in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in) and/or short duration of treatment may have masked a potential beneficial effect on sleep quality. PMID:28218661

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.

The effect of non-weight bearing group-exercising on females with non-specific chronic low back pain: a randomized single blind controlled pilot study.

PubMed

Masharawi, Youssef; Nadaf, Nedal

2013-01-01

The aim of this study was to investigate the effect of active non-weight-bearing (NWB) group exercising on women with non specific chronic low back pain (NSCLBP). Forty females with NSCLBP were assigned in a randomized control longitudinal single blinded pilot study. 20 of them were assigned to a NWB bi-weekly group exercise class and 20 females were included in the control group. The exercises involved the entire lumbo-pelvic spine aimed at improving lumbar mobility/flexibility and stability. Pain intensity (VAS), back specific disability (Rolland Morris questionnaire-RMQ), and lumbar flexion and extension ranges of motion measurements were taken prior to intervention (t(0)), immediately following 4 weeks of intervention (t(1)) and 8 weeks later (t(fu)). Reliability trials were conducted on 10 females. Non-parametric tests were used for statistical significance (p < 0.05). The following significant changes in outcome measures were indicated at t(1) compared with t(0) and control group (p < 0.001): an increase in lumbar flexion and extension (mean difference = 9.26◦ (+54%) for flexion and 5.95◦ for extension(+98%)); reduction in VAS score (mean difference = 2.32 (+58%)) and RMQ score (mean difference = 4.9 (−34%)). All changes remained significant at t(fu). At t(0), lumbar flexion was correlated with extension (r = 0.547) and VAS (r = −0.581),whereas the RMQ score correlated with VAS score (r = 0.599) and negatively with lumbar extension (r = −0.665). At t(1),lumbar flexion correlated with extension (r = 0.664) and negatively with RMQ score (r = −0.54). At t(fu), changes in VAS score were negatively correlated with changes in lumbar flexion (r = −0.522), while changes in lumbar flexion correlated with extension (r = 0.58). A functional program of NWB group exercising improves functional, painful status, lumbar flexion and extension ranges of motion in women suffering from NSCLBP.

An Examination of Fluoxetine for the Treatment of Selective Mutism Using a Nonconcurrent Multiple-Baseline Single-Case Design Across 5 Cases.

PubMed

Barterian, Justin A; Sanchez, Joel M; Magen, Jed; Siroky, Allison K; Mash, Brittany L; Carlson, John S

2018-01-01

This study examined the utility of fluoxetine in the treatment of 5 children, aged 5 to 14 years, diagnosed with selective mutism who also demonstrated symptoms of social anxiety. A nonconcurrent, randomized, multiple-baseline, single-case design with a single-blind placebo-controlled procedure was used. Parents and the study psychiatrist completed multiple methods of assessment including Direct Behavior Ratings and questionnaires. Treatment outcomes were evaluated by calculating effect sizes for each participant as an individual and for the participants as a group. Information regarding adverse effects with an emphasis on behavioral disinhibition and ratings of parental acceptance of the intervention was gathered. All 5 children experienced improvement in social anxiety, responsive speech, and spontaneous speech with medium to large effect sizes; however, children still met criteria for selective mutism at the end of the study. Adverse events were minimal, with only 2 children experiencing brief occurrences of minor behavioral disinhibition. Parents found the treatment highly acceptable.

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

PubMed

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

2016-12-01

Anxiety and pain are recognized as major problems of burn patients; because pharmaceutical treatments for controlling anxiety and pain symptoms lead to complications and an increase in health costs, nonpharmacological nursing interventions were considered for this group of patients. This led to the present study aimed at comparing the effect of aromatherapy massage with inhalation aromatherapy for anxiety and pain in burn patients. This single-blind clinical trial was carried out on 90 patients with burns <20%. Patients were randomly assigned to one of three groups, namely aromatherapy massage, inhalation aromatherapy, and control group. The patients assigned to the aromatherapy massage group received a massage for half an hour using a blend of lavender and almond oils, while a blend of rose and lavender aroma was used for the inhalation aromatherapy group. Spielberger State Anxiety Inventory was used for measuring anxiety and the visual analog scale (VAS) scale was used for measuring pain. The results showed that three groups were equal in terms of demographics, disease characteristics, and scores of anxiety and pain at the baseline. The mean decreases of anxiety scores were -0.04±5.08, 6.33±12.55, and 6.43±10.60 in the control group, aromatherapy massage group, and inhalation group, respectively (p=0.007). The mean decrease of pain scores were -0.10±0.96, 1.70±1.84, and 0.97±1.56 in the control group, aromatherapy massage group, and inhalation group, respectively (p<0.001). The study results showed the positive effect of aromatherapy massage and inhalation aromatherapy compared with the control group in reducing both anxiety and pain of burn patients. Therefore, both interventions, which are inexpensive, and noninvasive nursing tasks can be proposed for alleviating anxiety and pain of burn patients. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms.

PubMed

Krzysztof, Szwed; Wojciech, Pawliszak; Zbigniew, Serafin; Mariusz, Kowalewski; Remigiusz, Tomczyk; Damian, Perlinski; Magdalena, Szwed; Marta, Tomaszewska; Lech, Anisimowicz; Alina, Borkowska

2017-07-10

Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques. In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis. Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media. NCT03074604; Pre-results. 10-Mar-2017 Original. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia

PubMed Central

2013-01-01

Background Lavender essential oil shows evidence of sedative properties in neurophysiological and animal studies but clinical trials of its effectiveness as a treatment of agitation in people with dementia have shown mixed results. Study methods have varied widely, however, making comparisons hazardous. To help remedy previous methodological shortcomings, we delivered high grade lavender oil in specified amounts to nursing home residents whose agitated behaviours were recorded objectively. Methods 64 nursing home residents with frequent physically agitated behaviours were entered into a randomized, single-blind cross-over trial of dermally-applied, neurophysiologically active, high purity 30% lavender oil versus an inactive control oil. A blinded observer counted the presence or absence of target behaviours and rated participants’ predominant affect during each minute for 30 minutes prior to exposure and for 60 minutes afterwards. Results Lavender oil did not prove superior to the control oil in reducing the frequency of physically agitated behaviours or in improving participants’ affect. Conclusions Studies of essential oils are constrained by their variable formulations and uncertain pharmacokinetics and so optimal dosing and delivery regimens remain speculative. Notwithstanding this, topically delivered, high strength, pure lavender oil had no discernible effect on affect and behaviour in a well-defined clinical sample. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN 12609000569202) PMID:24219098

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

PubMed

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

2015-10-01

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

Randomized, blinded, placebo- and positive-controlled crossover study to determine the effect of multiple doses of apixaban on the QTc interval.

PubMed

Frost, Charles; Nepal, Sunil; Byon, Wonkyung; Moore, Kenneth; Reeves, Richard A; Boyd, Rebecca; LaCreta, Frank

2015-05-01

Apixaban is an oral, direct factor Xa inhibitor indicated for the prevention and treatment of thromboembolic disease. This randomized, blinded, 4-way crossover study investigated the potential effect of apixaban on the QTc interval. Forty healthy subjects (39 completers) each received 3 days of the following treatments: blinded apixaban 10 mg once daily (QD), 50 mg QD (supratherapeutic), matched apixaban placebo QD, and a single dose of open-label moxifloxacin 400 mg on Day 3, preceded by 2 days of placebo QD. Triplicate electrocardiograms obtained over 24 hours on Days -1 (baseline) and 3 were read by a blinded third party. The mean placebo-adjusted, time-matched, Fridericia-corrected change from baseline QTc (ΔΔQTcF) for apixaban and moxifloxacin was estimated at each time point. The maximum ΔΔQTcF was 1.51 milliseconds (one-sided upper 95% confidence interval [CI] 3.71 milliseconds) after apixaban 50 mg QD, 1.36 milliseconds (one-sided upper 95%CI 3.54 milliseconds) after apixaban 10 mg QD, and 10.21 milliseconds (lower 95%CI 8.07 milliseconds) after moxifloxacin. Concentration-response analysis suggested no evidence of a positive relationship between apixaban concentration and ΔQTcF. Apixaban doses up to 50 mg QD for 3 days were well tolerated and did not prolong the QTc interval in healthy subjects. © 2015, The American College of Clinical Pharmacology.

A comparison of the effects of oral vs. intravenous hydration on subclinical acute kidney injury in living kidney donors: a protocol of a randomised controlled trial.

PubMed

Mackinnon, Shona; Aitken, Emma; Ghita, Ryan; Clancy, Marc

2017-01-19

Optimal treatment for established renal failure is living donor kidney transplantation. However this pathway exposes healthy individuals to significant reduction in nephron mass via major surgical procedure. Laparoscopic donor nephrectomy is now the most common method for live donor transplantation, reducing both donor post-operative pain and recovery time. However this procedure exposes kidneys to additional haemodynamic stresses. It has been suggested that donor hydration-particularly the use of preoperative intravenous fluids-may counteract these stresses, reducing subclinical acute kidney injury and ultimately improving long-term renal function. This may be important in both preservation of donor renal function and recipient graft longevity. A prospective single-centre single-blinded randomized controlled trial will be carried out to determine the effects of donor preoperative intravenous fluids. The primary outcome is donor subclinical acute kidney injury (defined as plasma NGAL, >153 ng/ml) on day 1 postoperatively. Secondary outcomes include intraoperative haemodynamics, recipient subclinical acute kidney injury, perioperative complications and donor sleep quality. Donors will be randomised into two groups: the intervention group will receive active pre-hydration consisting of three litres of intravenous Hartmann's solution between midnight and 8 am before morning kidney donation, while the control group will not receive this. Both groups will receive unlimited oral fluids until midnight, as is routine. Plasma NGAL will be measured at pre-specified perioperative time points, intraoperative haemodynamic data will be collected using non-invasive cardiac output monitoring and clinical notes will be used to obtain demographic and clinical data. The researcher will be blinded to the donor fluid hydration status. Blinded statistical analysis will be performed on an intention-to-treat basis. A prospective power calculation estimates a required sample size of 86 patients. This study will provide important data, as there is currently little evidence about the use of donor preoperative fluids in laparoscopic nephrectomy. It is hoped that the results obtained will guide future clinical practice. This study has been approved by the West of Scotland Research Ethics Committee 3 (reference no. 14/WS/1160, 27 January 2015) and is registered with the International Standard Randomised Controlled Trial Number Register (reference no. ISRCTN10199225 , 20 April 2015).

Does Topical Ozone Therapy Improve Patient Comfort After Surgical Removal of Impacted Mandibular Third Molar? A Randomized Controlled Trial.

PubMed

Sivalingam, Varun P; Panneerselvam, Elavenil; Raja, Krishnakumar V B; Gopi, Gayathri

2017-01-01

To assess the influence of topical ozone administration on patient comfort after third molar surgery. A single-blinded randomized controlled clinical trial was designed involving patients who required removal of bilateral impacted mandibular third molars. The predictor variable was the postoperative medication used after third molar surgery. Using the split-mouth design, the study group received topical ozone without postoperative systemic antibiotics, whereas the control group did not receive ozone but only systemic antibiotics. The 2 groups were prescribed analgesics for 2 days. The assessing surgeon was blinded to treatment assignment. The primary outcome variables were postoperative mouth opening, pain, and swelling. The secondary outcome variable was the number of analgesic doses required by each group on postoperative days 3 to 5. Data analysis involved descriptive statistics, paired t tests, and 2-way analysis of variance with repeated measures (P < .05). SPSS 20.0 was used for data analysis. The study sample included 33 patients (n = 33 in each group). The study group showed statistically relevant decreases in postoperative pain, swelling, and trismus. Further, the number of analgesics required was smaller than in the control group. No adverse effects of ozone gel were observed in any patient. Ozone gel was found to be an effective topical agent that considerably improves patient comfort postoperatively and can be considered a substitute of postoperative systemic antibiotics. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

PubMed

Sood, Amit; Sharma, Varun; Schroeder, Darrell R; Gorman, Brian

2014-01-01

To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted. Copyright © 2014. Published by Elsevier Inc.

Short-duration virtual reality simulation training positively impacts performance during laparoscopic colectomy in animal model: results of a single-blinded randomized trial : VR warm-up for laparoscopic colectomy.

PubMed

Araujo, Sergio E A; Delaney, Conor P; Seid, Victor E; Imperiale, Antonio R; Bertoncini, Alexandre B; Nahas, Sergio C; Cecconello, Ivan

2014-09-01

Several studies have demonstrated skills transfer after virtual reality (VR) simulation training in laparoscopic surgery. However, the impact of VR simulation training on transfer of skills related to laparoscopic colectomy remains not investigated. The present study aimed at determining the impact of VR simulation warm-up on performance during laparoscopic colectomy in the porcine model. Fourteen residents naive to laparoscopic colectomy as surgeons were randomly assigned in block to two groups. Seven trainees completed a 2-h VR simulator training in the laparoscopic sigmoid colectomy module (study group). The remaining seven surgeons (control group) underwent no intervention. On the same day, all participants performed a sigmoid colectomy with anastomosis on a pig. All operations were video recorded. Two board-certified expert colorectal surgeons independently assessed performance during the colectomy on the swine. Examiners were blinded to group assignment. The two examiners used a previously validated clinical instrument specific to laparoscopic colectomy. The primary outcome was the generic and specific skills score values. Surgeons undergoing short-duration training on the VR simulator performed significantly better during laparoscopic colectomy on the pig regarding general and specific technical skills evaluation. The average score of generic skills was 17.2 (16.5-18) for the control group and 20.1 (16.5-22) for the study group (p = 0.002). The specific skills average score for the control group was 20.2 (19-21.5) and 24.2 (21-27.5) for the study group (p = 0.001). There was acceptable concordance (Kendall's W) regarding the video assessment of generic (W = 0.78) and specific skills (W = 0.84) between the two examiners. A single short-duration VR simulator practice positively impacted surgeons' generic and specific skills performance required to accomplish laparoscopic colectomy in the swine model.

Underwater Acoustic Source Localisation Among Blind and Sighted Scuba Divers

PubMed Central

Cambi, Jacopo; Livi, Ludovica; Livi, Walter

2017-01-01

Objectives Many blind individuals demonstrate enhanced auditory spatial discrimination or localisation of sound sources in comparison to sighted subjects. However, this hypothesis has not yet been confirmed with regards to underwater spatial localisation. This study therefore aimed to investigate underwater acoustic source localisation among blind and sighted scuba divers. Methods This study took place between February and June 2015 in Elba, Italy, and involved two experimental groups of divers with either acquired (n = 20) or congenital (n = 10) blindness and a control group of 30 sighted divers. Each subject took part in five attempts at an under-water acoustic source localisation task, in which the divers were requested to swim to the source of a sound originating from one of 24 potential locations. The control group had their sight obscured during the task. Results The congenitally blind divers demonstrated significantly better underwater sound localisation compared to the control group or those with acquired blindness (P = 0.0007). In addition, there was a significant correlation between years of blindness and underwater sound localisation (P <0.0001). Conclusion Congenital blindness was found to positively affect the ability of a diver to recognise the source of a sound in an underwater environment. As the correct localisation of sounds underwater may help individuals to avoid imminent danger, divers should perform sound localisation tests during training sessions. PMID:28690888

Virtual Reality Job Interview Training in Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Smith, Matthew J.; Ginger, Emily J.; Wright, Katherine; Wright, Michael A.; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale E.; Bell, Morris D.; Fleming, Michael F.

2014-01-01

The feasibility and efficacy of virtual reality job interview training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n = 16) or treatment-as-usual (TAU) (n = 10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic…

The Effect of Food Stamp Nutrition Education on the Food Insecurity of Low-Income Women Participants

ERIC Educational Resources Information Center

Eicher-Miller, Heather A.; Mason, April C.; Abbott, Angela R.; McCabe, George P.; Boushey, Carol J.

2009-01-01

Objective: To determine the effect of Food Stamp Nutrition Education (FSNE) in Indiana on participants' food insecurity and food insufficiency. Design: A single-blind randomized design. A randomized experimental group completed 5 FSNE lessons as an intervention between a pre- and posttest, whereas a control group completed a pre- and posttest…

A Randomized Controlled Trial of Trauma-Focused Cognitive Behavioral Therapy for Sexually Exploited, War-Affected Congolese Girls

ERIC Educational Resources Information Center

O'Callaghan, Paul; McMullen, John; Shannon, Ciaran; Rafferty, Harry; Black, Alastair

2013-01-01

Objective: To assess the efficacy of trauma-focused cognitive behavioral therapy (TF-CBT) delivered by nonclinical facilitators in reducing posttraumatic stress, depression, and anxiety and conduct problems and increasing prosocial behavior in a group of war-affected, sexually exploited girls in a single-blind, parallel-design, randomized,…

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

NASA Astrophysics Data System (ADS)

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

2017-11-01

The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) ( n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) ( n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 ( p < 0.05). In comparison of difference scores between groups, although there was no statistically significant difference between the two groups at W2 when compared to W0 ( p > 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 ( p < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

Does touch inhibit visual imagery? A case study on acquired blindness.

PubMed

von Trott Zu Solz, Jana; Paolini, Marco; Silveira, Sarita

2017-06-01

In a single-case study of acquired blindness, differential brain activation patterns for visual imagery of familiar objects with and without tactile exploration as well as of tactilely explored unfamiliar objects were observed. Results provide new insight into retrieval of visual images from episodic memory and point toward a potential tactile inhibition of visual imagery. © 2017 The Institute of Psychology, Chinese Academy of Sciences and John Wiley & Sons Australia, Ltd.

Evaluation of Building Energy Saving Through the Development of Venetian Blinds' Optimal Control Algorithm According to the Orientation and Window-to-Wall Ratio

NASA Astrophysics Data System (ADS)

Kwon, Hyuk Ju; Yeon, Sang Hun; Lee, Keum Ho; Lee, Kwang Ho

2018-02-01

As various studies focusing on building energy saving have been continuously conducted, studies utilizing renewable energy sources, instead of fossil fuel, are needed. In particular, studies regarding solar energy are being carried out in the field of building science; in order to utilize such solar energy effectively, solar radiation being brought into the indoors should be acquired and blocked properly. Blinds are a typical solar radiation control device that is capable of controlling indoor thermal and light environments. However, slat-type blinds are manually controlled, giving a negative effect on building energy saving. In this regard, studies regarding the automatic control of slat-type blinds have been carried out for the last couple of decades. Therefore, this study aims to provide preliminary data for optimal control research through the controlling of slat angle in slat-type blinds by comprehensively considering various input variables. The window area ratio and orientation were selected as input variables. It was found that an optimal control algorithm was different among each window-to-wall ratio and window orientation. In addition, through comparing and analyzing the building energy saving performance for each condition by applying the developed algorithms to simulations, up to 20.7 % energy saving was shown in the cooling period and up to 12.3 % energy saving was shown in the heating period. In addition, building energy saving effect was greater as the window area ratio increased given the same orientation, and the effects of window-to-wall ratio in the cooling period were higher than those of window-to-wall ratio in the heating period.

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

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

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). 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 × 10(10) viral particle units (pu), 2·5 × 10(10) pu, 5 × 10(10) pu, or 1 × 10(11) pu; US participants received 1 × 10(10) pu or 1 × 10(11) pu. We randomly allocated Malians in the nested trial (1:1) to receive a single dose of 2 × 10(8) 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 protocol. The primary outcome was safety, measured with occurrence of adverse events for 7 days after vaccination. Both trials are registered with ClinicalTrials.gov, numbers NCT02231866 (US) and NCT02267109 (Malian). Between Oct 8, 2014, and Feb 16, 2015, we randomly allocated 91 participants in Mali (ten [11%] to 1 × 10(10) pu, 35 [38%] to 2·5 × 10(10) pu, 35 [38%] to 5 × 10(10) pu, and 11 [12%] to 1 × 10(11) pu) and 20 in the USA (ten [50%] to 1 × 10(10) pu and ten [50%] to 1 × 10(11) pu), and boosted 52 Malians with MVA-BN-Filo (27 [52%]) or saline (25 [48%]). We identified no safety concerns with either vaccine: seven (8%) of 91 participants in Mali (five [5%] received 5 × 10(10) and two [2%] received 1 × 10(11) pu) and four (20%) of 20 in the USA (all received 1 × 10(11) pu) given ChAd3-EBO-Z had fever lasting for less than 24 h, and 15 (56%) of 27 Malians boosted with MVA-BN-Filo had injection-site pain or tenderness. 1 × 10(11) pu single-dose ChAd3-EBO-Z could suffice for phase 3 efficacy trials of ring-vaccination containment needing short-term, high-level protection to interrupt transmission. MVA-BN-Filo boosting, although a complex regimen, could confer long-lived protection if needed (eg, for health-care workers). Wellcome Trust, Medical Research Council UK, Department for International Development UK, National Cancer Institute, Frederick National Laboratory for Cancer Research, Federal Funds from National Institute of Allergy and Infectious Diseases. Copyright © 2016 Tapia et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

The effect of topical application of pure honey on radiation-induced mucositis: a randomized clinical trial.

PubMed

Motallebnejad, M; Akram, S; Moghadamnia, A; Moulana, Z; Omidi, S

2008-03-01

Radiation-induced mucositis is an early effect of head and neck radiotherapy. Mucositis can cause ulcers, and patients may experience pain and dysphasia which need treatment. The aim of this study is to evaluate the effect of pure natural honey on radiation induced mucositis. In this randomized single blind (examiner blind) clinical trial 40 patients with head and neck cancer requiring radiation to the oropharyngeal mucosa were randomly assigned to two groups. Twenty patients assigned to the study group received honey, while both the study and control groups received standard head and neck radiation therapy based on a standard protocol. In the study group patients were instructed to take 20 ml of honey 15 minutes before radiation therapy, then again at intervals of 15 minutes and six hours after radiation. In the control group patients were instructed to rinse with 20 ml of saline before and after radiation. Patients were evaluated weekly for progression of mucositis using the Oral Mucositis Assessing Scale (OMAS). Data were analyzed using the independent t-test, Mann-Whitney, and Friedman tests. A significant reduction in mucositis among honey-received patients compared with controls (p=0.000) occurred. Within the limits of this study the results showed the application of natural honey is effective in managing radiation induced mucositis. Natural honey is a product with rich nutritional qualities that could be a pleasant, simple, and economic modality for the management of radiation mucositis.

Application and the key technology on high power fiber-optic laser in laser weapon

NASA Astrophysics Data System (ADS)

Qu, Zhou; Li, Qiushi; Meng, Haihong; Sui, Xin; Zhang, Hongtao; Zhai, Xuhua

2014-12-01

The soft-killing laser weapon plays an important role in photoelectric defense technology. It can be used for photoelectric detection, search, blinding of photoelectric sensor and other devices on fire control and guidance devices, therefore it draws more and more attentions by many scholars. High power fiber-optic laser has many virtues such as small volume, simple structure, nimble handling, high efficiency, qualified light beam, easy thermal management, leading to blinding. Consequently, it may be used as the key device of soft-killing laser weapon. The present study introduced the development of high power fiber-optic laser and its main features. Meanwhile the key technology of large mode area (LMA) optical fiber design, the beam combination technology, double-clad fiber technology and pumping optical coupling technology was stated. The present study is aimed to design high doping LMA fiber, ensure single mode output by increasing core diameter and decrease NA. By means of reducing the spontaneous emission particle absorbed by fiber core and Increasing the power density in the optical fiber, the threshold power of nonlinear effect can increase, and the power of single fiber will be improved. Meantime, high power will be obtained by the beam combination technology. Application prospect of high power fiber laser in photoelectric defense technology was also set forth. Lastly, the present study explored the advantages of high power fiber laser in photoelectric defense technology.

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database.

PubMed

Ferreira, Christiane Alves; Loureiro, Carlos Alfredo Salles; Saconato, Humberto; Atallah, Alvaro Nagib

2011-03-01

Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

fMRI Neurofeedback Training for Increasing Anterior Cingulate Cortex Activation in Adult Attention Deficit Hyperactivity Disorder. An Exploratory Randomized, Single-Blinded Study

PubMed Central

Slaats-Willemse, Dorine; Kan, Cornelis C.; Goebel, Rainer; Buitelaar, Jan K.

2017-01-01

Attention Deficit Hyperactivity Disorder (ADHD) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex (dACC). In the current study, we investigated for the first time whether real-time fMRI neurofeedback (rt-fMRI) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning. An exploratory randomized controlled treatment study with blinding of the participants was conducted. Participants with ADHD (n = 7 in the neurofeedback group, and n = 6 in the control group) attended four weekly MRI training sessions (60-min training time/session), during which they performed a mental calculation task at varying levels of difficulty, in order to learn how to up-regulate dACC activation. Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC. Before and after the training, ADHD symptoms and relevant cognitive functioning was assessed. Results showed that both groups achieved a significant increase in dACC activation levels over sessions. While there was no significant difference between the neurofeedback and control group in clinical outcome, neurofeedback participants showed stronger improvement on cognitive functioning. The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients. Due to the study’s small sample size, potential clinical benefits need to be further investigated in future studies. Trial Registration: ISRCTN12390961 PMID:28125735

Validation, Intrarater and Interrater Reliability Study of the Lateral-Anterior Drawer Test for Detecting Posterior Cruciate Ligament Ruptures: Study Protocol of a Prospective Controlled Single-Blinded Cross-Sectional Study.

PubMed

Seeber, Gesine H; Thalhamer, Christoph; Hahne, Julia; Matthijs, Omer

2018-05-29

Commonly used clinical tests for posterior cruciate ligament (PCL) rupture detection exhibit several limitations, thus requiring more precise clinical PCL tests. The lateral-anterior drawer (LAD) test has been proposed as a manually applied testing alternative but not yet been evaluated in vivo. Fifteen patients presenting with an MRI-confirmed acute or chronic unilateral PCL rupture and 15 subjects with no prior knee injury in their medical history will be included in this prospective single-blinded cross-sectional cohort study. Three examiners with different lengths of working experience (range 1-30 years), blinded to MRI outcomes and patient history, will use the LAD test on both knees of each participant to test for PCL integrity. Examiners will independently document the PCL status of each knee on a blank case report form. Fleiss-Kappa values will be calculated to investigate whether the LAD test shows clinically significant interrater and intrarater reliability. Furthermore, LAD test outcomes will be compared with MRI which serves as reference standard to check for concurrent validity. Moreover, LAD test accuracy with respect to tester experience will be evaluated. The study will be conducted in agreement with the World Medical Association Declaration of Helsinki (2013). Ethical permission (EK16-081-0616) to conduct this study was obtained from the review board of the city of Vienna on 1 September 2016. All personal and research data will be used in accordance with the Austrian Federal Data Protection Act and will be anonymised before publication in relevant international peer-reviewed journals. DRKS00013268; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed

Verma, Kushagra; Errico, Thomas J; Vaz, Kenneth M; Lonner, Baron S

2010-04-06

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

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

A double-blind, placebo-controlled oral challenge study with lyophilized larvae and antigen of the fish parasite, Anisakis simplex.

PubMed

Sastre, J; Lluch-Bernal, M; Quirce, S; Arrieta, I; Lahoz, C; Del Amo, A; Fernández-Caldas, E; Marañón, F

2000-06-01

The third-stage larvae of Anisakis simplex may be a hidden source of allergens in fish. The objective was to determine whether the ingestion of lyophilized A. simplex larvae, or antigen, induces clinical symptoms in a group of A. simplex-sensitized patients. Double-blind, placebo-controlled oral challenges were conducted in 11 individuals who had experienced allergic reactions after eating fish. Another patient had chronic urticaria unrelated to the ingestion of fish. All patients had positive skin tests and specific IgE determinations for A. simplex and negative skin tests to a battery of fish species. Conjunctival tests with A. simplex extracts were conducted in all patients and in five controls. The 12 patients received capsules containing either lactose or one, five, or 25 lyophilized larvae of A. simplex at 2-h intervals in a double-blind fashion. The highest single dose was 100 larvae. ECP and tryptase levels in serum were measured before and after the last oral challenge. Lyophilized antigen was also given to five patients. None of the 12 patients experienced a positive reaction after the ingestion of the placebo, the lyophilized larvae, or the antigen. Tryptase and ECP levels before and after challenges did not change significantly. Conjunctival provocation tests were positive in 11 out of the 12 patients and in none of the controls. The ingestion of 100 lyophilized A. simplex larvae, or its equivalent in antigen, does not induce clinical symptoms in individuals with a clinical history and laboratory findings of hypersensitivity to A. simplex. The data suggest that only the ingestion of live larvae may be capable of inducing allergic manifestations.

Protanopia (red color-blindness) in medaka: a simple system for producing color-blind fish and testing their spectral sensitivity.

PubMed

Homma, Noriko; Harada, Yumi; Uchikawa, Tamaki; Kamei, Yasuhiro; Fukamachi, Shoji

2017-02-06

Color perception is important for fish to survive and reproduce in nature. Visual pigments in the retinal photoreceptor cells are responsible for receiving light stimuli, but the function of the pigments in vivo has not been directly investigated in many animals due to the lack of color-blind lines and appropriate color-perception tests. In this study, we established a system for producing color-blind fish and testing their spectral sensitivity. First, we disrupted long-wavelength-sensitive (LWS) opsins of medaka (Oryzias latipes) using the CRISPR/Cas9 system to make red-color-blind lines. Single guide RNAs were designed using the consensus sequences between the paralogous LWSa and LWSb genes to simultaneously introduce double-frameshift mutations. Next, we developed a non-invasive and no-prior-learning test for spectral sensitivity by applying an optomotor response (OMR) test under an Okazaki Large Spectrograph (OLS), termed the O-O test. We constructed an electrical-rotary cylinder with black/white stripes, into which a glass aquarium containing one or more fish was placed under various monochromatic light conditions. The medaka were irradiated by the OLS every 10 nm, from wavelengths of 700 nm to 900 nm, and OMR was evaluated under each condition. We confirmed that the lws - medaka were indeed insensitive to red light (protanopia). While the control fish responded to wavelengths of up to 830 nm (λ = 830 nm), the lws - mutants responded up to λ = 740 nm; however, this difference was not observed after adaptation to dark: both the control and lws - fish could respond up to λ = 820 ~ 830 nm. These results suggest that the lws - mutants lost photopic red-cone vision, but retained scotopic rod vision. Considering that the peak absorption spectra (λ max ) of medaka LWSs are about 560 nm, but the light-adapted control medaka could respond behaviorally to light at λ = 830 nm, red-cone vision could cover an unexpectedly wide range of wavelengths, and behavioral tests could be an effective way to measure spectral sensitivity. Using the CRISPR/Cas9 and O-O systems, the establishment of various other color-blind lines and assessment of their spectra sensitivity could be expected to proceed in the future.

Tonsillitis: MedlinePlus Health Topic

MedlinePlus

... Library of Medicine) Article: The debate continues: a prospective, randomised, single-blind study comparing Coblation... Article: Overnight in-hospital observation following tonsillectomy: retrospective study of post-operative intervention. Article: Immune thrombocytopenia ...

Efficacy of Single-dose and 2-dose Intravenous Administration of Ramosetron in Preventing Postoperative Nausea and Vomiting After Laparoscopic Gynecologic Operation: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial.

PubMed

Lee, Banghyun; Kim, Kidong; Suh, Dong Hoon; Shin, Hyun-Jung; No, Jae Hong; Lee, Jung Ryeol; Jee, Byung Chul; Hwang, Jung Won; Do, Sang Hwan; Kim, Yong Beom

2017-06-01

This randomized trial investigated whether a 2-dose administration of intravenous ramosetron (5-hydroxytryptamine type 3 receptor antagonist) is more effective than a single-dose administration in preventing postoperative nausea and vomiting (PONV) in 89 patients who were scheduled to undergo laparoscopic operation for benign gynecologic diseases and to receive intravenous patient-controlled analgesia for relief of postoperative pain. After assignment at a ratio of 1:1, intravenous ramosetron (0.3 mg) was initially administered at the end of skin closure in all patients. Thereafter, ramosetron (0.3 mg) and placebo were administered to the study and control groups, respectively, at 4 hours after the operation. The baseline and operative characteristics were similar between the groups. The incidence of PONV during the 24-hour period after operation which was assessed as the primary endpoint did not differ between the groups. No serious adverse events occurred in either group. A 2-dose administration of intravenous ramosetron may not be superior to a single-dose administration in preventing PONV in patients undergoing laparoscopic operation for benign gynecologic diseases.

Audible sonar images generated with proprioception for target analysis.

PubMed

Kuc, Roman B

2017-05-01

Some blind humans have demonstrated the ability to detect and classify objects with echolocation using palatal clicks. An audible-sonar robot mimics human click emissions, binaural hearing, and head movements to extract interaural time and level differences from target echoes. Targets of various complexity are examined by transverse displacements of the sonar and by target pose rotations that model movements performed by the blind. Controlled sonar movements executed by the robot provide data that model proprioception information available to blind humans for examining targets from various aspects. The audible sonar uses this sonar location and orientation information to form two-dimensional target images that are similar to medical diagnostic ultrasound tomograms. Simple targets, such as single round and square posts, produce distinguishable and recognizable images. More complex targets configured with several simple objects generate diffraction effects and multiple reflections that produce image artifacts. The presentation illustrates the capabilities and limitations of target classification from audible sonar images.

Differences in change blindness to real-life scenes in adults with autism spectrum conditions.

PubMed

Ashwin, Chris; Wheelwright, Sally; Baron-Cohen, Simon

2017-01-01

People often fail to detect large changes to visual scenes following a brief interruption, an effect known as 'change blindness'. People with autism spectrum conditions (ASC) have superior attention to detail and better discrimination of targets, and often notice small details that are missed by others. Together these predict people with autism should show enhanced perception of changes in simple change detection paradigms, including reduced change blindness. However, change blindness studies to date have reported mixed results in ASC, which have sometimes included no differences to controls or even enhanced change blindness. Attenuated change blindness has only been reported to date in ASC in children and adolescents, with no study reporting reduced change blindness in adults with ASC. The present study used a change blindness flicker task to investigate the detection of changes in images of everyday life in adults with ASC (n = 22) and controls (n = 22) using a simple change detection task design and full range of original scenes as stimuli. Results showed the adults with ASC had reduced change blindness compared to adult controls for changes to items of marginal interest in scenes, with no group difference for changes to items of central interest. There were no group differences in overall response latencies to correctly detect changes nor in the overall number of missed detections in the experiment. However, the ASC group showed greater missed changes for marginal interest changes of location, showing some evidence of greater change blindness as well. These findings show both reduced change blindness to marginal interest changes in ASC, based on response latencies, as well as greater change blindness to changes of location of marginal interest items, based on detection rates. The findings of reduced change blindness are consistent with clinical reports that people with ASC often notice small changes to less salient items within their environment, and are in-line with theories of enhanced local processing and greater attention to detail in ASC. The findings of lower detection rates for one of the marginal interest conditions may be related to problems in shifting attention or an overly focused attention spotlight.

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

ERIC Educational Resources Information Center

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

2007-01-01

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

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

PubMed

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

2016-11-01

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

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

NASA Astrophysics Data System (ADS)

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

2016-11-01

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

Horatio Audio-Describes Shakespeare's "Hamlet": Blind and Low-Vision Theatre-Goers Evaluate an Unconventional Audio Description Strategy

ERIC Educational Resources Information Center

Udo, J. P.; Acevedo, B.; Fels, D. I.

2010-01-01

Audio description (AD) has been introduced as one solution for providing people who are blind or have low vision with access to live theatre, film and television content. However, there is little research to inform the process, user preferences and presentation style. We present a study of a single live audio-described performance of Hart House…

The phototoxic and photoallergy potential of clindamycin phosphate 1.2%/ tretinoin 0.025% gel for facial acne: results of two single-center, evaluator-blinded, randomized, vehicle-controlled phase 1 studies in healthy volunteers.

PubMed

Murray, John; Potts, Aaron

2014-01-01

A fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne. Two-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel. Study 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal. No subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation. Clindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

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

PubMed

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

2016-07-07

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

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

PubMed Central

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

2016-01-01

Introduction In vitro, Vitamin-E-diffused, highly cross-linked polyethylene (PE) has been shown to have superior wear resistance and improved mechanical properties when compared to those of standard highly cross-linked PE liners used in total hip arthroplasty (THA). The aim of the study is to evaluate the safety of a new cemented acetabular cup with Vitamin-E-doped PE regarding migration, head penetration and clinical results. Methods and analysis In this single-centre, double-blinded, randomised controlled trial, we will include 50 patients with primary hip osteoarthritis scheduled for THA and randomise them in a 1:1 ratio to a cemented cup with either argon gas-sterilised PE (control group) or Vitamin-E-diffused PE (vitamin-e group). All patients and the assessor of the primary outcome will be blinded and the same uncemented stem will be used for all participants. The primary end point will be proximal migration of the cup at 2 years after surgery measured with radiostereometry. Secondary end points include proximal migration at other follow-ups, total migration, femoral head penetration, clinical outcome scores and hip-related complications. Patients will be followed up at 3 months and at 1, 2, 5 and 10 years postoperatively. Results Results will be analysed using 95% CIs for the effect size. A regression model will also be used to adjust for stratification factors. Ethics and dissemination The ethical committee at Karolinska Institutet has approved the study. The first results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals when the last patient included has been followed up for 2 years. Trial registration number NCT02254980. PMID:27388352

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

PubMed Central

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

2013-01-01

Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370. PMID:23901031

Systematic review of blinding assessment in randomized controlled trials in schizophrenia and affective disorders 2000-2010.

PubMed

Baethge, Christopher; Assall, Oliver P; Baldessarini, Ross J

2013-01-01

Blinding is an integral part of many randomized controlled trials (RCTs). However, both blinding and blinding assessment seem to be rarely documented in trial reports. Systematic review of articles on RCTs in schizophrenia and affective disorders research during 2000-2010. Among 2,467 publications, 61 (2.5%; 95% confidence interval: 1.9-3.1%) reported assessing participant, rater, or clinician blinding: 5/672 reports on schizophrenia (0.7%; 0.3-1.6%) and 33/1,079 (3.1%; 2.1-4.2%) on affective disorders, without significant trends across the decade. Rarely was blinding assessed at the beginning, in most studies assessment was at the end. Proportion of patients' and raters' correct guesses of study arm averaged 54.4 and 62.0% per study, with slightly more correct guesses in treatment arms than in placebo arms. Three fourths of responders correctly guessed that they received the active agent. Blinding assessment was more frequently reported in papers on psychotherapy and brain stimulation than on drug trials (5.1%, 1.7-11.9%, vs. 8.3%, 4.3-14.4%, vs. 2.1%, 1.5-2.8%). Lack of assessment of blinding was associated with: (a) positive findings, (b) full industrial sponsorship, and (c) diagnosis of schizophrenia. There was a moderate association of treatment success and blinding status of both trial participants (r = 0.51, p = 0.002) and raters (r = 0.55, p = 0.067). Many RCT reports did not meet CONSORT standards regarding documentation of persons blinded (60%) or of efforts to match interventions (50%). Recent treatment trials in major psychiatric disorders rarely reported on or evaluated blinding. We recommend routine documentation of blinding strategies in reports. Copyright © 2013 S. Karger AG, Basel.

Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials.

PubMed

Laurora, Irene; An, Robert

2016-01-01

To evaluate the efficacy of a novel formulation of extended-release/immediate-release (ER) naproxen sodium over 24 h in a dental pain model. Two randomized, double-blind, placebo-controlled trials in moderate to severe pain after extraction of one or two impacted third molars (at least one partial mandibular bony impaction). Treatment comprised oral ER naproxen sodium 660 mg (single dose), placebo (both studies) or immediate-release (IR) naproxen sodium 220 mg tid (study 2). Primary efficacy endpoint: 24-h summed pain intensity difference (SPID). Secondary variables included total pain relief (TOTPAR), use of rescue medication. All treatment-emergent adverse events were recorded. NCT00720057 (study 1), NCT01389284 (study 2). Primary efficacy analyses: pain intensity was significantly lower over 24 h with ER naproxen sodium vs. placebo (p < 0.001), with significant relief from 15 min (study 2). In study 2, ER naproxen sodium was non-inferior to IR naproxen sodium, reducing pain intensity to a comparable extent over 24 h. TOTPAR was significantly greater with ER and IR naproxen sodium vs. placebo at all time points, with generally comparable differences between active treatments. Significantly more placebo patients required rescue medication vs. ER and IR naproxen sodium from 2-24 h post-dose. Once daily ER naproxen sodium was generally safe and well tolerated, with a similar safety profile to IR naproxen sodium tid. The studies were single dose, with limited ability to assess efficacy or safety of multiple doses over time. As the imputed pain score meant that estimated treatment differences may have been biased in favor of ER naproxen sodium, a post hoc analysis evaluated the robustness of the results for pain relief. A single dose of ER naproxen sodium 660 mg significantly reduced moderate to severe dental pain vs. placebo and was comparable to IR naproxen sodium 220 mg tid. Significant pain relief was experienced from 15 min and sustained over 24 h, resulting in a reduced need for rescue medication. ER naproxen sodium 660 mg once daily is a convenient and effective therapy providing 24 h relief of pain.

Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction.

PubMed

Leyden, James; Stephens, Thomas J; Herndon, James H

2012-11-01

Until now, nonablative fractional treatments could only be delivered in an office setting by trained professionals. The goal of this work was to perform clinical testing of a nonablative fractional laser device designed for home-use. This multicenter trial consisted of two clinical studies with slightly varying treatment protocols in which subjects performed at-home treatments of periorbital wrinkles using a handheld nonablative fractional laser. Both studies included an active treatment phase (daily treatments) and a maintenance phase (twice-weekly treatments). In all, 36 subjects were followed up for as long as 5 months after completion of the maintenance phase and 90 subjects were followed up until the completion of the maintenance phase. Evaluations included in-person investigator assessment, independent blinded review of high-resolution images using the Fitzpatrick Wrinkle Scale, and subject self-assessment. All 124 subjects who completed the study were able to use the device following written instructions for use. Treatments were well tolerated with good protocol compliance. Independent blinded evaluations by a panel of physicians showed Fitzpatrick Wrinkle Scale score improvement by one or more grades in 90% of subjects at the completion of the active phase and in 79% of subjects at the completion of the maintenance phase. The most prevalent side effect was transient posttreatment erythema. Lack of a control group and single-blinded study groups were limitations. Safety testing with self-applications by users demonstrated the utility of the device for home use. Independent blinded review of clinical images confirmed the device's proficiency for improving periorbital wrinkles. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Methylphenidate, cognition, and epilepsy: A double-blind, placebo-controlled, single-dose study.

PubMed

Adams, Jesse; Alipio-Jocson, Valerie; Inoyama, Katherine; Bartlett, Victoria; Sandhu, Saira; Oso, Jemima; Barry, John J; Loring, David W; Meador, Kimford

2017-01-31

To evaluate the potential efficacy of immediate-release methylphenidate (MPH) for treating cognitive deficits in epilepsy. This was a double-blind, randomized, single-dose, 3-period crossover study in patients with epilepsy and chronic cognitive complaints comparing the effects of placebo and MPH 10 and 20 mg given 1 week apart. Cognitive outcome was evaluated on the basis of an omnibus z score calculated from performance on the Conners Continuous Performance Test 3 (ability to discriminate between target and nontarget stimuli [d'] and hit reaction time standard deviation), Symbol-Digit Modalities Test, and Medical College of Georgia Paragraph Memory Test. Adverse events and seizure frequency were monitored. An open-label follow-up is reported elsewhere. Thirty-five adult patients with epilepsy participated, of whom 31 finished. Demographics included the following: mean age = 35.3 years (range 20-62 years), 13 men and 18 women, and baseline seizure frequency of 2.8 per month. Epilepsy types were focal (n = 24), generalized (n = 6), or unclassified (n = 1). Mean epilepsy duration was 12.5 years. A statistically significant performance benefit was present at both 10-mg (p = 0.030) and 20-mg (p = 0.034) MPH doses. No seizures were associated with either MPH dose. Adverse effects leading to withdrawal included cognitive "fogginess" (n = 1 on 20 mg), anxiety/agitation (n = 1 on 10 mg), and tachycardia (n = 1). One participant was lost to follow-up after one 20-mg dose without side effect. This single-dose study suggests that MPH may be effective in ameliorating some cognitive deficits in patients with epilepsy. Additional studies are required. NCT02178995. This study provides Class II evidence that single doses of MPH improve cognitive performance on some measures of attention and processing speed in patients with epilepsy and cognitive complaints. © 2016 American Academy of Neurology.

Dexamethasone Prophylaxis to Alleviate Postembolization Syndrome after Transarterial Chemoembolization for Hepatocellular Carcinoma: A Randomized, Double-Blinded, Placebo-Controlled Study.

PubMed

Yang, Hyun; Seon, Jein; Sung, Pil Soo; Oh, Jung Suk; Lee, Hae Lim; Jang, Bohyun; Chun, Ho Jong; Jang, Jeong Won; Bae, Si Hyun; Choi, Jong Young; Yoon, Seung Kew

2017-11-01

To test the hypothesis that prophylactic administration of dexamethasone alleviates postembolization syndrome (PES) after transarterial chemoembolization for the treatment of hepatocellular carcinoma (HCC). This prospective, randomized, double-blinded, placebo-controlled trial was conducted in a single center from August 2015 to June 2016. A total of 88 patients with intermediate-stage HCC were enrolled. After randomization, 44 patients were assigned to the dexamethasone group and the other 44 to the control group. In the dexamethasone group, 12 mg of intravenous dexamethasone was administered before chemoembolization. Nausea, vomiting, fever, pain, and alanine aminotransferase level elevation were evaluated after chemoembolization had been performed with the use of Lipiodol and doxorubicin. The incidences of PES were 78.0% in the dexamethasone group and 97.5% in the control group (P = .008). Mean hospitalization times after chemoembolization were 2.7 days ± 1.44 in the dexamethasone group and 2.9 days ± 1.83 in the control group (P = .553). Mean doses of antiemetic and analgesic agents were lower in the dexamethasone group than the control group (0.2 ± 0.58 vs 1.0 ± 1.89 [P = .029] and 0.6 ± 0.97 vs 1.92 ± 2.54 [P = .006], respectively). Prophylactic administration of dexamethasone was a significant factor that influences PES occurrence after chemoembolization (odds ratio = 10.969, P = .027). This study demonstrates that the prophylactic administration of dexamethasone before chemoembolization is an effective way to reduce PES. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2016-06-01

Drug delivery systems capable of delivering free (unconjugated) curcuminoids is of great therapeutic significance, since the absorption of bioactive and permeable form plays a key factor in mediating the efficacy of a substance which undergoes rapid biotransformation. Considering the recent understanding on the relatively high bioactivities and blood-brain-barrier permeability of free curcuminoids over their conjugated metabolites, the present human study investigated the safety, antioxidant efficacy, and bioavailability of CurQfen (curcumagalactomannoside [CGM]), a food-grade formulation of natural curcumin with fenugreek dietary fiber that has shown to possess improved blood-brain-barrier permeability and tissue distribution in rats. In this randomized double-blinded and placebo-controlled trial, 60 subjects experiencing occupational stress-related anxiety and fatigue were randomized to receive CGM, standard curcumin, and placebo for 30 days (500 mg twice daily). The study demonstrated the safety, tolerance, and enhanced efficacy of CGM in comparison with unformulated standard curcumin. A significant improvement in the quality of life (P < 0.05) with considerable reduction in stress (P < 0.001), anxiety (P < 0.001), and fatigue (P < 0.001) was observed among CGM-treated subjects as compared with the standard curcumin group, when monitored by SF-36, Perceived Stress Scale with 14 items, and Beck Anxiety Inventory scores. Improvement in the quality of life was further correlated with the significant enhancement in endogenous antioxidant markers (P < 0.01) and reduction in lipid peroxidation (P < 0.001). Further comparison of the free curcuminoids bioavailability after a single-dose (500 mg once per day) and repeated-dose (500 mg twice daily for 30 days) oral administration revealed enhanced absorption and improved pharmacokinetics of CGM upon both single- (30.7-fold) and repeated-dose (39.1-fold) administrations.

Rhythmical massage improves autonomic nervous system function: a single-blind randomised controlled trial.

PubMed

Seifert, Georg; Kanitz, Jenny-Lena; Rihs, Carolina; Krause, Ingrid; Witt, Katharina; Voss, Andreas

2018-05-01

Rhythmical massage therapy (RMT) is a massage technique used in anthroposophic medicine. The authors aimed to investigate the physiological action of RMT on the cardiovascular system by analysing heart rate variability (HRV). This study was a randomised, controlled and single-blinded trial, involving 44 healthy women (mean age: (26.20 ± 4.71) years). The subjects were randomised to one of three arms: RMT with aromatic oil (RA), RMT without aromatic oil (RM) or standardised sham massage (SM). In the study the subjects were exposed to a standardised stress situation followed by one of the study techniques and Holter electrocardiograms (ECGs) were recorded for 24 h. HRV parameters were calculated from linear (time and frequency domain) and nonlinear dynamics (symbolic dynamics, Poincare plot analysis) of the 24-h Holter ECG records. Short- and long-term effects of massage on autonomic regulation differed significantly among the three groups. Immediately after an RMT session, stimulation of HRV was found in the groups RA and RM. The use of an aromatic oil produced greater short-term measurable changes in HRV compared with rhythmic massage alone, but after 24 h the effect was no longer distinguishable from the RM group. The lowest stimulation of HRV parameters was measured in the SM group. RMT causes specific and marked stimulation of the autonomic nervous system. Use of a medicinal aromatic oil had only a temporary effect on HRV, indicating that the RM causes the most relevant long-term effect. The effect is relatively specific, as the physiological effects seen in the group of subjects who received only SM were considerably less pronounced. Registration trial DRKS00004164 on DRKS. Copyright © 2018 Shanghai Changhai Hospital. Published by Elsevier B.V. All rights reserved.

The safety and immunogenicity of two hepatitis B vaccine formulations (thiomersal-free and thiomersal-containing) in healthy vietnamese infants: a phase III, prospective, single-blinded, randomized, controlled trial.

PubMed

Hieu, Nguyen Trong; Sarnecki, Michal; Tolboom, Jeroen

2015-01-01

To evaluate the safety and immunogenicity of the thiomersal-free (TF) and thiomersal-containing (TC) formulations of Hepavax-Gene in healthy Vietnamese neonates. A single-blind, randomized, controlled study in Ho Chi Minh City, Vietnam. Healthy infants, born after a normal gestational period (37-42 weeks) to hepatitis B surface antigen-negative mothers, participated in the study. Subjects were randomly allocated in a 1:1 ratio to receive either Hepavax-Gene TC or Hepavax-Gene TF using a standard 0-1-6-month administration schedule. Postvaccination blood samples were taken at months 1, 6 and 7. Parents/legal guardians recorded solicited local and systemic adverse events up to 4 weeks after each vaccination. Very high proportions of subjects were seroprotected. Seroprotection rates at 1, 6 and 7 months were all above 95% using a 10 IU/L cutoff, and were mostly above 90% using a 100 IU/L cutoff. Seroprotection rates between the 2 formulations were equivalent within a 5% margin for either cutoff titer both after 6 and 7 months. There were no significant differences in the number of adverse events reported between the 2 formulations. Safety results were in line with previous reports for Hepavax-Gene. Both formulations of Hepavax-Gene were well tolerated. There were no local adverse events reported in the TF group. No serious adverse events were reported during the study. The thiomersal-free formulation of Hepavax-Gene was noninferior to the thiomersal-containing formulation of Hepavax-Gene in terms of immunogenicity. There was evidence that the thiomersal-free vaccine was associated with fewer local adverse events.

Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder--the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial.

PubMed

Faurholt-Jepsen, Maria; Vinberg, Maj; Christensen, Ellen Margrethe; Frost, Mads; Bardram, Jakob; Kessing, Lars Vedel

2013-01-01

Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms. It has never been tested in a randomised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder. We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder. We developed the MONARCA application for Android-based Smartphones, allowing patients suffering from bipolar disorder to do daily self-monitoring-including an interactive feedback loop between patients and clinicians through a web-based interface. The effect of the application was tested in a parallel-group, single-blind randomised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18-60 years who were given the use of a Smartphone with the MONARCA application (intervention group) or to the use of a cell phone without the application (placebo group) during a 6-month study period. The study was carried out from September 2011. The outcomes were changes in affective symptoms (primary), social functioning, perceived stress, self-rated depressive and manic symptoms, quality of life, adherence to medication, stress and cognitive functioning (secondary and tertiary). Recruitment is ongoing. Ethical permission has been obtained. Positive, neutral and negative findings of the study will be published. The trial is approved by the Regional Ethics Committee in The Capital Region of Denmark (H-2-2011-056) and The Danish Data Protection Agency (2013-41-1710). The trial is registered at ClinicalTrials.gov as NCT01446406.

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

PubMed

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

2015-06-01

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

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Metronidazole Vaginal Gel 1.3% in the Treatment of Bacterial Vaginosis.

PubMed

Schwebke, Jane R; Marrazzo, Jeanne; Beelen, Andrew P; Sobel, Jack D

2015-07-01

Bacterial vaginosis (BV), a prevalent infection in women of reproductive age, is associated with increased risk of upper genital tract and sexually transmitted infections, and complications in pregnancy. Currently approved treatments include metronidazole, which requires once or twice daily intravaginal administration for 5 days or twice daily oral administration for 7 days. This phase 3 study determined the safety and efficacy of single-dose metronidazole vaginal gel (MVG) 1.3%. In this double-blind, vehicle-controlled study, 651 women with clinical diagnosis of BV were randomized 1:1 to receive MVG 1.3% or vehicle vaginal gel. Primary efficacy measure was clinical cure (normal discharge, negative "whiff test," and <20% clue cells) at day 21. Secondary measures included therapeutic cure (both clinical and bacteriological; day 21) and bacteriologic cure (Nugent score <4), clinical cure, and time to resolution of symptoms (day 7). A total of 487 participants were included in the primary analysis. Clinical and therapeutic cure rates (day 21) were higher in participants treated with MVG 1.3% compared with vehicle gel (37.2% vs. 26.6% [P = 0.010] and 16.8% vs. 7.2% [P = 0.001], respectively). Clinical and bacteriologic cure rates (day 7) were also higher in the MVG 1.3% group (46.0% vs. 20.0% [P < 0.001] and 32.7% vs. 6.3% [P < 0.001], respectively). The median time to resolution of symptoms was shorter in the MVG 1.3% (day 6) than vehicle group (not reached). No serious adverse events were reported, and incidence was similar across treatment groups. Single-dose MVG 1.3% was safe and superior to vehicle gel in producing cure among women with BV.

Individual Differences in Susceptibility to Inattentional Blindness

ERIC Educational Resources Information Center

Seegmiller, Janelle K.; Watson, Jason M.; Strayer, David L.

2011-01-01

Inattentional blindness refers to the finding that people do not always see what appears in their gaze. Though inattentional blindness affects large percentages of people, it is unclear if there are individual differences in susceptibility. The present study addressed whether individual differences in attentional control, as reflected by…

Individual differences in susceptibility to inattentional blindness.

PubMed

Seegmiller, Janelle K; Watson, Jason M; Strayer, David L

2011-05-01

Inattentional blindness refers to the finding that people do not always see what appears in their gaze. Though inattentional blindness affects large percentages of people, it is unclear if there are individual differences in susceptibility. The present study addressed whether individual differences in attentional control, as reflected by variability in working memory capacity, modulate susceptibility to inattentional blindness. Participants watched a classic inattentional blindness video (Simons & Chabris, 1999) and were instructed to count passes among basketball players, wherein 58% noticed the unexpected: a person wearing a gorilla suit. When participants were accurate with their pass counts, individuals with higher working memory capacity were more likely to report seeing the gorilla (67%) than those with lesser working memory capacity (36%). These results suggest that variability in attentional control is a potential mechanism underlying the apparent modulation of inattentional blindness across individuals.

Synthetic Influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomised, placebo-controlled Phase I trial.

PubMed

Pleguezuelos, Olga; Robinson, Stuart; Stoloff, Gregory A; Caparrós-Wanderley, Wilson

2012-06-29

Current Influenza vaccines elicit antibody mediated prophylactic immunity targeted to viral capsid antigens. Despite their global use these vaccines must be administered yearly to the population, cannot be manufactured until the circulating viral strain(s) have been identified and have limited efficacy. A need remains for Influenza vaccines addressing these issues and here we report the results of a Phase Ib trial of a novel synthetic Influenza vaccine (FLU-v) targeting T cell responses to NP, M1 and M2. Forty-eight healthy males aged 18-40 were recruited for this single-centre, randomised, double blind study. Volunteers received one single low (250 μg) or high (500 μg) dose of FLU-v, either alone or adjuvanted. Safety, tolerability and basic immunogenicity (IgG and IFN-γ responses) parameters were assessed pre-vaccination and for 21 days post-vaccination. FLU-v was found to be safe and well tolerated with no vaccine associated severe adverse events. Dose-dependent IFN-γ responses >2-fold the pre-vaccination level were detected in 80% and 100% of volunteers receiving, respectively, the low and high dose adjuvanted FLU-v formulations. No formulation tested induced any significant FLU-v antibody response. FLU-v is safe and induces a vaccine-specific cellular immunity. Cellular immune responses are historically known to control and mitigate infection and illness during natural infection. Copyright © 2012 Elsevier Ltd. All rights reserved.

Comparison of photobiomodulation therapy and suprascapular nerve-pulsed radiofrequency in chronic shoulder pain: a randomized controlled, single-blind, clinical trial.

PubMed

Ökmen, Burcu Metin; Ökmen, Korgün

2017-11-01

Shoulder pain can be difficult to treat due to its complex anatomic structure, and different treatment methods can be used. We aimed to examine the efficacy of photobiomodulation therapy (PBMT) and suprascapular nerve (SSN)-pulsed radiofrequency (RF) therapy. In this prospective, randomized, controlled, single-blind study, 59 patients with chronic shoulder pain due to impingement syndrome received PBMT (group H) or SSN-pulsed RF therapy (group P) in addition to exercise therapy for 14 sessions over 2 weeks. Records were taken using visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), and Nottingham Health Profile (NHP) scoring systems for pretreatment (PRT), posttreatment (PST), and PST follow-up at months 1, 3, and 6. There was no statistically significant difference in initial VAS score, SPADI, and NHP values between group H and group P (p > 0.05). Compared to the values of PRT, PST, and PST at months 1, 3, and 6, VAS, SPADI, and NHP values were statistically significantly lower in both groups (p < 0.001). There was no statistically significant difference at all measurement times in VAS, SPADI, and NHP between the two groups. We established that PBMT and SSN-pulsed RF therapy are effective methods, in addition to exercise therapy, in patients with chronic shoulder pain. PBMT seems to be advantageous compared to SSN-pulsed RF therapy, as it is a noninvasive method.

Teaching veterinary radiography by e-learning versus structured tutorial: a randomized, single-blinded controlled trial.

PubMed

Vandeweerd, Jean-Michel E F; Davies, John C; Pinchbeck, Gina L; Cotton, Jo C

2007-01-01

Case-based e-learning may allow effective teaching of veterinary radiology in the field of equine orthopedics. The objective of this study was to investigate the effectiveness of a new case-based e-learning tool, compared with a standard structured tutorial, in altering students' knowledge and skills about interpretation of radiographs of the digit in the horse. It was also designed to assess students' attitudes toward the two educational interventions. A randomized, single-blinded, controlled trial of 96 fourth-year undergraduate veterinary students, involving an educational intervention of either structured tutorial or case-based e-learning, was performed. A multiple-choice examination based on six learning outcomes was carried out in each group after the session, followed by an evaluation of students' attitudes toward their session on a seven-point scale. Text blanks were available to students to allow them to comment on the educational interventions and on their learning outcomes. Students also rated, on a Likert scale from 1 to 7, their performance for each specific learning outcome and their general ability to use a systematic approach in interpreting radiographs. Data were analyzed using the Mann-Whitney test, the t-test, and the equivalence test. There was no significant difference in student achievement on course tests. The results of the survey suggest positive student attitudes toward the e-learning tool and illustrate the difference between objective ratings and subjective assessments by students in testing a new educational intervention.

Effects of psychoeducation on helpful support for complicated grief: a preliminary randomized controlled single-blind study.

PubMed

Nam, I S

2016-01-01

Complicated grief is a distinct psychological response of individuals facing the loss of a loved one and can lead to many types of adverse health outcomes. Although social support may be beneficial, few studies have examined the beneficial effects of helpful support on complicated grief following bereavement. A randomized controlled trial was conducted. Bereaved participants and supporters were randomized to psychoeducation on complicated grief and helpful social support or psychoeducation on complicated grief. The primary outcome was the Inventory of Complicated Grief. The results showed that psychoeducation of supporters of bereaved individuals has significant beneficial effects. Particularly, symptoms of complicated grief were decreased in bereaved individuals with supporters that received psychoeducation. The results highlight the potential of psychoeducation to facilitate helpful social support and reduce complicated grief.

Effects of timolol and atenolol on benign essential tremor: placebo-controlled studies based on quantitative tremor recording.

PubMed Central

Dietrichson, P; Espen, E

1981-01-01

Two different beta-adrenoreceptor antagonists, atenolol and timolol, were separately compared with a placebo in the suppression of essential tremor. In two-week single-blind placebo-controlled studies with cross-over, timolol (5 mg twice daily) and atenolol (100 mg once daily) produced an equal reduction in sitting heart rate and sitting blood pressure. Timolol was effective in reducing tremor while atenolol failed to reduce tremor amplitude. These results indicate that essential tremor can be reduced but not blocked, by the adrenergic blocker timolol with both beta 1 and beta 2 blocking properties; but not by the relatively selective beta 1 blocking drug atenolol. Possibly, the tremor reduction is medicated by a peripheral effect on beta 2 adrenoreceptors. Images PMID:7028921

Acetyl-L-carnitine for alcohol craving and relapse prevention in anhedonic alcoholics: a randomized, double-blind, placebo-controlled pilot trial.

PubMed

Martinotti, Giovanni; Reina, Daniela; Di Nicola, Marco; Andreoli, Sara; Tedeschi, Daniela; Ortolani, Ilaria; Pozzi, Gino; Iannoni, Emerenziana; D'Iddio, Stefania; Janiri, Luigi

2010-01-01

The study aimed to evaluate the efficacy of acetyl-l-carnitine (ALC), at different doses, in relapse prevention and craving in anhedonic detoxified alcohol-dependent subjects. Randomized, double-blind, placebo-controlled, pilot study in 64 alcohol-dependent anhedonic patients: 23 received ALC at a dose of 3 g/day, 21 received ALC at a dosage of 1 g/day and 20 were given placebo. Intensity of alcohol craving was evaluated by Visual Analogue Scale. Subjects were evaluated at the beginning of treatment and after 10, 30, 60 and 90 days. Survival analysis showed that patients treated with ALC remained completely abstinent for longer than those treated with placebo (Z = -2.27; P < 0.05). From the 10th day onwards, a greater reduction of craving was observed in the ALC 1 g group than with placebo (P = 0.035). The two groups did not differ in the percentage of subjects remaining abstinent for the entire study period or the number of subjects who relapsed (defined as five or more standard drinks (four for women) on a single occasion or drinking on five or more days in 1 week). The results of this study suggest that ALC can reduce craving and the time to first drink. ALC use was safe. Further studies are needed to clarify to confirm, over longer periods, these short-term outcome benefits.

Propofol versus thiopental sodium for the treatment of refractory status epilepticus.

PubMed

Prabhakar, Hemanshu; Bindra, Ashish; Singh, Gyaninder Pal; Kalaivani, Mani

2012-08-15

Failure to respond to antiepileptic drugs in uncontrolled seizure activity such as refractory status epilepticus (RSE) has led to the use of anaesthetic drugs. Coma is induced with anaesthetic drugs to achieve complete control of seizure activity. Thiopental sodium and propofol are popularly used for this purpose. Both agents have been found to be effective. However, there is substantial lack of evidence as to which of the two drugs is better in terms of clinical outcome. To compare the efficacy, adverse effects, and short- and long-term outcomes of RSE treated with one of the two anaesthetic agents, thiopental sodium or propofol. We searched the Cochrane Epilepsy Group Specialized Register (10 May 2012), the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4 of 12, The Cochrane Library 2012), and MEDLINE (1946 to May week 1, 2012). We also searched (10 May 2012) ClinicalTrials.gov, The South Asian Database of Controlled Clinical Trials, and IndMED (a bibliographic database of Indian Medical Journals). All randomised or quasi-randomised controlled studies (regardless of blinding) of control of RSE using either thiopental sodium or propofol. Two review authors screened the search results and reviewed abstracts of relevant and eligible trials before retrieving the full text publications. One study was available for review. This study was a small, single-blind, multicentre trial studying adults with RSE and receiving either propofol or thiopental sodium for the control of seizure activity (Rossetti 2011). This study showed a wide confidence interval suggesting that the drugs may differ in efficacy up to more than two-fold. There was no evidence of a difference between the drugs with respect to the outcome measures such as control of seizure activity and functional outcome at three months. There is lack of robust and randomised controlled evidence that can clarify the efficacy of propofol and thiopental sodium over each other in the treatment of RSE. There is a need for large, randomised controlled trials for this serious condition.

Vaccines to combat river blindness: expression, selection and formulation of vaccines against infection with Onchocerca volvulus in a mouse model.

PubMed

Hess, Jessica A; Zhan, Bin; Bonne-Année, Sandra; Deckman, Jessica M; Bottazzi, Maria Elena; Hotez, Peter J; Klei, Thomas R; Lustigman, Sara; Abraham, David

2014-08-01

Human onchocerciasis is a neglected tropical disease caused by Onchocerca volvulus and an important cause of blindness and chronic disability in the developing world. Although mass drug administration of ivermectin has had a profound effect on control of the disease, additional tools are critically needed including the need for a vaccine against onchocerciasis. The objectives of the present study were to: (i) select antigens with known vaccine pedigrees as components of a vaccine; (ii) produce the selected vaccine antigens under controlled conditions, using two expression systems and in one laboratory and (iii) evaluate their vaccine efficacy using a single immunisation protocol in mice. In addition, we tested the hypothesis that joining protective antigens as a fusion protein or in combination, into a multivalent vaccine, would improve the ability of the vaccine to induce protective immunity. Out of eight vaccine candidates tested in this study, Ov-103, Ov-RAL-2 and Ov-CPI-2M were shown to reproducibly induce protective immunity when administered individually, as fusion proteins or in combination. Although there was no increase in the level of protective immunity induced by combining the antigens into one vaccine, these antigens remain strong candidates for inclusion in a vaccine to control onchocerciasis in humans. Copyright © 2014 Australian Society for Parasitology Inc. Published by Elsevier Ltd. All rights reserved.

Double-blind, Placebo-controlled Study Assessing the Effect of Chocolate Consumption in Subjects with a History of Acne Vulgaris

PubMed Central

Caperton, Caroline; Block, Samantha; Viera, Martha; Keri, Jonette

2014-01-01

Objective: To assess the effect of chocolate on acne exacerbation in males between the ages of 18 and 35 with a history of acne vulgaris. Design: Double-blind, placebo-controlled, randomized, controlled trial. Setting: Single-site, outpatient, research, clinical facility at an academic research institution. Participants: Fourteen men between the ages of 18 and 35 were assigned to swallow capsules filled with either unsweetened 100-percent cocoa, hydrolyzed gelatin powder, or a combination of the two, at baseline. Measurements: Lesions were assessed and photographs were taken at baseline, Day 4, and Day 7. Results: Of the 14 subjects, 13 completed this Institutional Review Board approved study. A statistically significant increase in the mean number of total acneiform lesions (comedones, papules, pustules, nodules) was detected on both Day 4 (p=0.006) and Day 7 (p=0.043) compared to baseline. A small-strength positive Pearson’s correlation coefficient existed between the amount of chocolate each subject consumed and the number of lesions each subject developed between baseline and Day 4 (r=0.250), while a medium-strength positive correlation existed between baseline and Day 7 (r=0.314). No serious adverse events occurred. Conclusion: It appears that in acne-prone, male individuals, the consumption of chocolate correlates to an increase in the exacerbation of acne. PMID:24847404

Analysis of Parent, Teacher, and Consultant Speech Exchanges and Educational Outcomes of Students with Autism during COMPASS Consultation

ERIC Educational Resources Information Center

Ruble, Lisa; Birdwhistell, Jessie; Toland, Michael D.; McGrew, John H.

2011-01-01

The significant increase in the numbers of students with autism combined with the need for better trained teachers (National Research Council, 2001) call for research on the effectiveness of alternative methods, such as consultation, that have the potential to improve service delivery. Data from 2 randomized controlled single-blind trials indicate…

Examining the Impact of ABRACADABRA on Early Literacy in Northern Australia: An Implementation Fidelity Analysis

ERIC Educational Resources Information Center

Wolgemuth, Jennifer R.; Abrami, Philip C.; Helmer, Janet; Savage, Robert; Harper, Helen; Lea, Tess

2014-01-01

To address students' poor literacy outcomes, an intervention using a computer-based literacy tool, ABRACADABRA, was implemented in 6 Northern Australia primary schools. A pretest, posttest parallel group, single blind multisite randomized controlled trial was conducted with 308 students between the ages of 4 and 8 years old (M age = 5.8 years, SD…

Single-blind trial addressing the differential effects of two reflexology techniques versus rest, on ankle and foot oedema in late pregnancy.

PubMed

Mollart, L

2003-11-01

This single-blind randomised controlled trial explored the differential effects of two different foot reflexology techniques with a period of rest on oedema-relieving effects and symptom relief in healthy pregnant women with foot oedema. Fifty-five women in the third trimester were randomly assigned to one of the three groups: a period of rest, 'relaxing' reflexology techniques or a specific 'lymphatic' reflexology technique for 15 min with pre- and post-therapy ankle and foot circumference measurements and participant questionnaire. There was no statistically significant difference in the circumference measurements between the three groups; however, the lymphatic technique reflexology group mean circumference measurements were all decreased. A significant reduction in the women's symptom mean measurements in all groups (p<0.0001) was apparent. A 'perceived wellbeing' score revealed the lymphatic technique group (p<0.0001) significantly increased their wellbeing the most, followed closely by relaxing techniques (p<0.001) and then the control rest group (p<0.03). Lymphatic reflexology techniques, relaxing reflexology techniques and a period of rest had a non-significant oedema-relieving effect. From the women's viewpoint, lymphatic reflexology was the preferred therapy with significant increase in symptom relief.

A randomised, double-blind, controlled trial of a killed L. major vaccine plus BCG against zoonotic cutaneous leishmaniasis in Iran.

PubMed

Momeni, A Z; Jalayer, T; Emamjomeh, M; Khamesipour, A; Zicker, F; Ghassemi, R L; Dowlati, Y; Sharifi, I; Aminjavaheri, M; Shafiei, A; Alimohammadian, M H; Hashemi-Fesharki, R; Nasseri, K; Godal, T; Smith, P G; Modabber, F

1999-02-05

Safety and efficacy of killed (autoclaved) L. major promastigotes, ALM, mixed with BCG against zoonotic cutaneous leishmaniasis was tested in healthy volunteers (n = 2453) in a randomized double blind trial vs. BCG as control. Side-effects were similar in both groups but tended to be slightly more frequent and prolonged in the ALM + BCG group. Leishmanin skin test conversion (induration > or =5 mm) was significantly greater in the ALM + BCG than in the BCG group (36.2% vs. 7.9% on day-80 and 33% vs. 19%, after 1 year, respectively). Cumulative incidence rates for 2 years, were similar in both groups (18.0% vs. 18.5%). However, LST responders on day 80 (> or =5 mm) had a significantly lower incidence (35%) of CL during the first year than non-responders. A single dose of ALM + BCG is not sufficiently immunogenic to provide a measurable response when compared to BCG alone. A single dose of this vaccine has been shown to be safe with no evidence of an exacerbating response following natural infection; hence, multiple doses or other adjuvants should be considered to increase its immunogenicity.

MATLAB-based automated patch-clamp system for awake behaving mice

PubMed Central

Siegel, Jennifer J.; Taylor, William; Chitwood, Raymond A.; Johnston, Daniel

2015-01-01

Automation has been an important part of biomedical research for decades, and the use of automated and robotic systems is now standard for such tasks as DNA sequencing, microfluidics, and high-throughput screening. Recently, Kodandaramaiah and colleagues (Nat Methods 9: 585–587, 2012) demonstrated, using anesthetized animals, the feasibility of automating blind patch-clamp recordings in vivo. Blind patch is a good target for automation because it is a complex yet highly stereotyped process that revolves around analysis of a single signal (electrode impedance) and movement along a single axis. Here, we introduce an automated system for blind patch-clamp recordings from awake, head-fixed mice running on a wheel. In its design, we were guided by 3 requirements: easy-to-use and easy-to-modify software; seamless integration of behavioral equipment; and efficient use of time. The resulting system employs equipment that is standard for patch recording rigs, moderately priced, or simple to make. It is written entirely in MATLAB, a programming environment that has an enormous user base in the neuroscience community and many available resources for analysis and instrument control. Using this system, we obtained 19 whole cell patch recordings from neurons in the prefrontal cortex of awake mice, aged 8–9 wk. Successful recordings had series resistances that averaged 52 ± 4 MΩ and required 5.7 ± 0.6 attempts to obtain. These numbers are comparable with those of experienced electrophysiologists working manually, and this system, written in a simple and familiar language, will be useful to many cellular electrophysiologists who wish to study awake behaving mice. PMID:26084901

The short-term effects of trigger point therapy, stretching and medicine ball exercises on accuracy and back swing hip turn in elite, male golfers - A randomised controlled trial.

PubMed

Quinn, Samantha-Lynn; Olivier, Benita; Wood, Wendy-Ann

2016-11-01

This study aimed to compare the effect of myofascial trigger point therapy (MTPT) and stretching, MTPT and medicine ball exercises, and no intervention, on hip flexor length (HFL), golf swing biomechanics and performance in elite, male golfers. Single blind, randomised controlled trial with two experimental groups (stretch group: MTPT and stretching; and the ball group: MTPT, a single stretch and medicine ball exercises) and one control group (no intervention). Professional golf academy. One hundred, elite, male golfers aged 16-25 years. HFL, 3D biomechanical analysis of the golf swing, club head speed (CHS), smash ratio, accuracy and distance at baseline and after the interventions. Backswing hip turn (BSHT) improved in the ball group relative to the control group (p = 0.0248). Accuracy in the ball group and the stretch group improved relative to the control group (Fisher's exact = 0.016). Other performance parameters such as: smash ratio, distance and CHS were not compromised by either intervention. This study advocates the use of MTPT combined with medicine ball exercises over MTPT combined with stretching in the treatment of golfers with shortened hip flexors - even immediately preceding a tournament. Copyright © 2016 Elsevier Ltd. All rights reserved.

Oral challenge test with sodium metabisulfite in steroid-dependent asthmatic patients.

PubMed

Prieto, L; Juyol, M; Paricio, A; Martínez, M A; Palop, J; Castro, J

1988-01-01

Oral challenge tests were carried out with sodium metabisulfite solution doses of 0.5, 1, 10, 25, 50 mg and encapsulated doses of 100 and 200 mg, as well as with lactose-placebo, on 44 non-atopic patients with steroid-dependent bronchial asthma, without clinical evidence of intolerance to these agents. Only those patients with an acceptable and not very labile pulmonary function were tested. A single-blind challenge protocol was performed in 22 patients (sodium metabisulfite solutions at pH 2.2 to 2.6) and the positive responses were confirmed by double-blind challenge. The other 22 were tested directly in a double-blind manner (pH4). Initially, 6/44 presented a positive reaction. However, a careful analysis and the confirmation by double-blind challenge of the positive responses obtained with the single-blind test, allowed us to identify 4 false positive responses. Thus, the true prevalence of sulfite sensitivity in our population is 4.5%. A patient with intolerance to sulfite agents also suffered aspirin-induced asthma. The labile tendency of the pulmonary function of the asthmatic patients may have contributed to some false positive reactions and probably explain the very high prevalence found in some studies. It does not appear that the variations of pH decisively influence the result of the challenge test.

Low-level laser therapy for pain relief after episiotomy: a double-blind randomised clinical trial.

PubMed

Santos, Jaqueline de O; de Oliveira, Sonia M J V; da Silva, Flora M B; Nobre, Moacyr R C; Osava, Ruth H; Riesco, Maria L G

2012-12-01

To evaluate the effectiveness of a low-level laser therapy for pain relief in the perineum following episiotomy during childbirth. Laser irradiation is a painless and non-invasive therapy for perineal pain treatment and its effects have been investigated in several studies, with no clear conclusion on its effectiveness. A double-blind randomised controlled clinical trial. One hundred and fourteen women who underwent right mediolateral episiotomies during vaginal birth in an in-hospital birthing centre in São Paulo, Brazil and reported pain ≥ 3 on a numeric scale (0-10) were randomised into three groups of 38 women each: two experimental groups (treated with red and infrared laser) and a control group. The experimental groups were treated with laser applied at three points directly on the episiotomy after suturing in a single session between 6-56 hours postpartum. We used a diode laser with wavelengths of 660 nm (red laser) and 780 nm (infrared laser). The control group participants underwent all laser procedures, excluding the emission of irradiation. The participants and the pain scores evaluator were blinded to the type of intervention. The perineal pain scores were assessed at three time points: before, immediately after and 30 minutes after low-level laser therapy. The comparison of perineal pain between the three groups showed no significant differences in the three evaluations (p = 0.445), indicating that the results obtained in the groups treated with low-level laser therapy were equivalent to the control group. Low-level laser therapy did not decrease the intensity of perineal pain reported by women who underwent right mediolateral episiotomy. The effect of laser in perineal pain relief was not demonstrated in this study. The dosage may not have been sufficient to provide relief from perineal pain after episiotomy during a vaginal birth. © 2012 Blackwell Publishing Ltd.

Single-treatment skin tightening by radiofrequency and long-pulsed, 1064-nm Nd: YAG laser compared.

PubMed

Key, Douglas J

2007-02-01

To compare single-treatment facial skin tightening achieved with the current radiofrequency (RF) protocol with single-treatment tightening achieved with the long-pulsed, 1064-nm Nd:YAG laser. A total of 12 patients were treated with RF energy on one side of the face and laser energy on the other. Results were evaluated on a numerical scale (0-12 with 12 = greatest enhancement) from pre- and posttreatment photographs by a blinded panel. Upper face improvement (posttreatment score minus pretreatment score) was essentially the same on both sides (30.2 and 31.3% improvement for laser and RF, respectively, P=0.89). Lower face improvement was greater in the laser-treated side (35.7 and 23.8% improvement for laser and RF, respectively), but the difference was not significant (P=0.074). Overall face improvement was significantly greater on the laser-treated side (47.5 and 29.8% improvement for laser and RF, respectively, P=0.028). A single high-fluence treatment with the long-pulse 1064-nm Nd:YAG laser may improve skin laxity more than a single treatment with the RF device. Further controlled split-face or very large non-self controlled studies are needed to conclusively determine the relative efficacies of the two technologies. (c) 2007 Wiley-Liss, Inc.

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

ERIC Educational Resources Information Center

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

2011-01-01

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

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 and a CE Mark in Europe. The Argus II System is the first and only retinal implant to have both approvals. PMID:26162233

Intrauterine instillation of diluted seminal plasma at oocyte pick-up does not increase the IVF pregnancy rate: a double-blind, placebo controlled, randomized study.

PubMed

von Wolff, M; Rösner, S; Germeyer, A; Jauckus, J; Griesinger, G; Strowitzki, T

2013-12-01

Does intrauterine application of diluted seminal plasma (SP) at the time of ovum pick-up improve the pregnancy rate by ≥14% in IVF treatment? Intrauterine instillation of diluted SP at the time of ovum pick-up is unlikely to increase the pregnancy rate by ≥14% in IVF. SP modulates endometrial function, and sexual intercourse around the time of embryo transfer has been suggested to increase the likelihood of pregnancy. A previous randomized double-blind pilot study demonstrated a strong trend towards increased pregnancy rates following the intracervical application of undiluted SP. As this study was not conclusive and as the finding could have been confounded by sexual intercourse, the intrauterine application of diluted SP was investigated in the present trial. A single-centre, prospective, double-blind, placebo-controlled, randomized, superiority trial on women undergoing IVF was conducted from April 2007 until February 2012 at the University Department of Gynaecological Endocrinology and Reproductive Medicine, Heidelberg, Germany. The study was powered to detect an 14% increase in the clinical pregnancy rate and two sequential tests were planned using the Pocock spending function. At the first interim analysis, 279 women had been randomly assigned to intrauterine diluted SP (20% SP in saline from the patients' partner) (n = 138) or placebo (n = 141) at the time of ovum pick-up. The clinical pregnancy rate per randomized patient was 37/138 (26.8%) in the SP group and 41/141 (29.1%) in the placebo group (difference: -2.3%, 95% confidence interval of the difference: -12.7 to +8.2%; P = 0.69). The live birth rate per randomized patient was 28/138 (20.3%) in the SP group and 33/141 (23.4%) in the placebo group (difference: -3.1%, 95% confidence interval of the difference: -12.7 to +6.6%; P = 0.56). It was decided to terminate the trial due to futility at the first interim analysis, at a conditional power of 62%. The confidence interval of the difference remains wide, thus clinically relevant differences cannot reliably be excluded based on this single study. The results of this study cast doubt on the validity of the concept that SP increases endometrial receptivity and thus implantation in humans. Funding was provided by the department's own research facilities. DRKS00004615.

A randomized controlled trial of comprehensive early intervention care in patients with first-episode psychosis in Japan: 1.5-year outcomes from the J-CAP study.

PubMed

Nishida, Atsushi; Ando, Shuntaro; Yamasaki, Syudo; Koike, Shinsuke; Ichihashi, Kayo; Miyakoshi, Yuji; Maekawa, Sanae; Nakamura, Tomohisa; Natsubori, Tatsunobu; Ichikawa, Eriko; Ishigami, Hiroki; Sato, Kojiro; Matsunaga, Asami; Smith, Jo; French, Paul; Harima, Hirohiko; Kishi, Yoshiki; Fujita, Izumi; Kasai, Kiyoto; Okazaki, Yuji

2018-04-08

The first episode of psychosis represents a critical period wherein comprehensive early intervention in psychosis (EIP) may alter the course of illness. However, evidence from randomized controlled trials that have examined the impact of comprehensive EIP care on clinical and functional recovery assessed by independent blinded raters is limited. The objective of this study was to conduct a single-blinded multicenter trial comparing comprehensive EIP care and standard care in young patients with first-episode psychosis (FEP) in Japan (J-CAP Study). A total of 77 participants with FEP (aged 15-35 years) were randomized to receive standard care or specialized comprehensive EIP care and were followed up for 1.5 years (trial no.: UMIN000005092). Function (measured with the Global Assessment of Functioning) and clinical remission (defined by internationally standardized criteria proposed by the Remission in Schizophrenia Working Group) were evaluated by independent raters who were blinded to group assignment. Dropout rate and other secondary outcomes were also examined. The specialized EIP care group had a higher clinical remission rate (odds ratio, 6.3; 95% confidence interval, 1.0-37.9) and lower treatment dropout rate (odds ratio, 0.038; 95% confidence interval, 0.002-0.923) than the standard care group, even after adjusting for baseline characteristics. Functional improvement in the specialized EIP care group was slightly higher than that in the standard care group, but this difference was not statistically significant (p = 0.195). From the results, we conclude that comprehensive EIP care may provide advantages over standard care in patients with FEP. Copyright © 2018. Published by Elsevier Ltd.

Analytical performance study of solar blind non-line-of-sight ultraviolet short-range communication links.

PubMed

Xu, Zhengyuan; Ding, Haipeng; Sadler, Brian M; Chen, Gang

2008-08-15

Motivated by recent advances in solid-state incoherent ultraviolet sources and solar blind detectors, we study communication link performance over a range of less than 1 km with a bit error rate (BER) below 10(-3) in solar blind non-line-of-sight situation. The widely adopted yet complex single scattering channel model is significantly simplified by means of a closed-form expression for tractable analysis. Path loss is given as a function of transceiver geometry as well as atmospheric scattering and attenuation and is compared with experimental data for model validation. The BER performance of a shot-noise-limited receiver under this channel model is demonstrated.

Neovascularization prevalence in the supraspinatus of patients with rotator cuff tendinopathy.

PubMed

Kardouni, Joseph R; Seitz, Amee L; Walsworth, Matthew K; Michener, Lori A

2013-11-01

A high prevalence of neovascularity in lower extremity tendinopathies has been reported. Neovascularity in those with rotator cuff tendinopathy exclusively has not been examined. The objective was to determine the prevalence of neovascularization in patients with rotator cuff tendinopathy compared with asymptomatic controls. Single-blind cross-sectional study. Research laboratory. Participants (n = 40; age = 44.9 years, 23-62 years; 20 females) with rotator cuff tendinopathy (n = 20) but without full-thickness rotator cuff tears, and asymptomatic controls that were age, gender, and hand dominance matched (n = 20) to the patients. The participants laying in supine had their shoulder positioned in internal rotation and extension. Ultrasound images were collected of the supraspinatus tendon and subacromial bursae in the transverse and longitudinal planes using a linear transducer in color Doppler mode. Images were assessed for neovascularization by 2 trained raters who were blinded to group (rotator cuff tendinopathy or asymptomatic group). No statistically significant difference in neovascularization was identified between participants with and without rotator cuff tendinopathy (χ = 0.13, df = 1, P = 0.72). Neovascularization was identified in 6 of 20 patients with rotator cuff tendinopathy (30%) and 5 of 20 asymptomatic control participants (25%). The authors found no differences in neovascularization rate in patients with rotator cuff tendinopathy (30%) and asymptomatic controls (25%). The study indicates that neovascularization is not related to presence of symptomatic tendinopathy in those with rotator cuff tendinopathy. Neovascularization may not be a relevant sonographic finding to aid the clinical assessment of those with rotator cuff tendinopathy.

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

PubMed

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

2013-07-01

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

Single-dose lubiprostone along with split-dose PEG solution without dietary restrictions for bowel cleansing prior to colonoscopy: a randomized, double-blind, placebo-controlled trial.

PubMed

Stengel, Joel Z; Jones, David P

2008-09-01

Proper colonic cleansing prior to colonoscopy is paramount to ensuring complete mucosal visualization and polyp identification. In a double-blind fashion, we compared single-dose lubiprostone (24 microg) versus placebo pretreatment prior to a split-dose polyethylene glycol electrolyte (PEG-E) bowel preparation without dietary restriction to determine the efficacy, safety, and patient tolerability. Two hundred patients referred for outpatient colorectal cancer screening were randomized to receive a single-dose of unlabeled lubiprostone (24 microg) or placebo prior to a split-dose PEG-E bowel preparation without dietary restriction. The patients were surveyed prior to the colonoscopy on the tolerability of the bowel preparation, and any adverse events were recorded. The cleanliness of the colon was graded by the endoscopist during the procedure utilizing the Ottawa bowel preparation scale. One hundred ninety-one patients completed the study (95%). Split-dose PEG-E with lubiprostone pretreatment was found to be more effective at bowel cleansing in each segment of the colon when compared with split-dose PEG-E with placebo (P < 0.001). Patients enrolled in the lubiprostone treatment arm rated the overall experience as more tolerable (P 0.003) and complained of less abdominal bloating (P 0.049). No differences were observed between the groups for treatment-emergent side effects or adverse events (P > 0.05). Single-dose lubiprostone prior to split-dose PEG-E without dietary restriction significantly improves colonic mucosa visualization during colonoscopy and is well tolerated by patients.

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

PubMed

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

2016-06-01

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. 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. 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. 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. 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.

Cerebrovascular accidents in elderly people treated with antipsychotic drugs: a systematic review.

PubMed

Sacchetti, Emilio; Turrina, Cesare; Valsecchi, Paolo

2010-04-01

After 2002, an association between stroke and antipsychotic use was reported in clinical trials and large database studies. This review considers previous quantitative reviews, newly published clinical trials, and recent observational cohort and case-control studies, and focuses on the clinical significance of the risk for stroke, the difference between typical and atypical antipsychotics, the possible at-risk patient profile and the timing of stroke after exposure. A search of MEDLINE covering the period from 1966 to June 2009 was carried out using selected keywords. Inclusion criteria were (i) quantitative reviews on stroke and antipsychotics; (ii) double-blind, placebo-controlled clinical trials involving patients with dementia treated with antipsychotics; and (iii) observational database cohort studies and observational case-control studies investigating the association between stroke and antipsychotics. Clinical trials were excluded if they were single-blind or if patients were affected by dementia and/or other neurological illnesses. Four reviews with aggregate data, 2 meta-analyses, 13 randomized, double-blind, controlled trials, 7 observational cohort studies and 4 observational case-control studies were selected and analysed. The incidence of cerebrovascular accidents (CVAs) was found to be very low in aggregate reviews and meta-analyses (2-4%). When the number collected was sufficiently high, or different drug treatments were grouped together, the higher rate in subjects exposed to antipsychotics was statistically significant. Inspection of other randomized controlled clinical trials, not included in aggregate reviews and meta-analyses, reported similar rates of CVAs. The majority of observational cohort studies compared typical and atypical antipsychotics and no significant class differences were found. A comparison with non-users was carried out in some cohort studies. In case-control studies, the probability of CVAs in users compared with non-users was in the range of 1.3- to 2-fold greater. Preliminary data also indicate that the highest risk of stroke is related to the first weeks of treatment, and a risk profile for stroke is emerging, such as older age, cognitive impairment and vascular illness. Different pathophysiological pathways may be involved, ranging from the facilitation of thrombosis, pre-existing cardiovascular factors, sedation and a common diathesis for stroke of dementia, schizophrenia and affective illness. Before prescribing an antipsychotic, clinicians should weigh all the risk factors for a given patient and consider not only the indications as provided by the regulatory agencies, but also the overall effectiveness of typical and atypical antipsychotics.

A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy.

PubMed

Richardson, J K; Sandman, D; Vela, S

2001-02-01

To determine the effect of a specific exercise regimen on clinical measures of postural stability and confidence in a population with peripheral neuropathy (PN). Prospective, controlled, single blind study. Outpatient clinic of a university hospital. Twenty subjects with diabetes mellitus and electrodiagnostically confirmed PN. Ten subjects underwent a 3-week intervention exercise regimen designed to increase rapidly available distal strength and balance. The other 10 subjects performed a control exercise regimen. Unipedal stance time, functional reach, tandem stance time, and score on the activities-specific balance and confidence (ABC) scale. The intervention subjects, but not the control subjects, showed significant improvement in all 3 clinical measures of balance and nonsignificant improvement on the ABC scale. A brief, specific exercise regimen improved clinical measures of balance in patients with diabetic PN. Further studies are needed to determine if this result translates into a lower fall frequency in this high-risk population.

Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period

PubMed Central

Mofid, Layla S; Casapía, Martín; Montresor, Antonio; Rahme, Elham; Fraser, William D; Marquis, Grace S; Vercruysse, Jozef; Allen, Lindsay H; Gyorkos, Theresa W

2015-01-01

Introduction Soil-transmitted helminth infections are endemic in 114 countries worldwide, and cause the highest burden of disease among all neglected tropical diseases. The WHO includes women of reproductive age as a high-risk group for infection. The primary consequence of infection in this population is anaemia. During lactation, anaemia may contribute to reduced quality and quantity of milk, decreasing the duration of exclusive breastfeeding and lowering the age at weaning. To date, no study has investigated the effects of maternal postpartum deworming on infant or maternal health outcomes. Methods and analysis A single-centre, parallel, double-blind, randomised, placebo-controlled trial will be carried out in Iquitos, Peru, to assess the effectiveness of integrating single-dose 400 mg albendazole into routine maternal postpartum care. A total of 1010 mother-infant pairs will be randomised to either the intervention or control arm, following inhospital delivery and prior to discharge. Participants will be visited in their homes at 1, 6, 12 and 24 months following delivery for outcome ascertainment. The primary outcome is infant mean weight gain between birth and 6 months of age. Secondary outcomes include other infant growth indicators and morbidity, maternal soil-transmitted helminth infection and intensity, anaemia, fatigue, and breastfeeding practices. All statistical analyses will be performed on an intention-to-treat basis. Ethics and dissemination Research ethics board approval has been obtained from the McGill University Health Centre (Canada), the Asociación Civil Impacta Salud y Educación (Peru) and the Instituto Nacional de Salud (Peru). A data safety and monitoring committee is in place to oversee study progression and evaluate adverse events. The results of the analyses will be published in peer-reviewed journals, and presented at national and international conferences. Trial registration number Clinicaltrials.gov: NCT01748929. PMID:26084556

Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period.

PubMed

Mofid, Layla S; Casapía, Martín; Montresor, Antonio; Rahme, Elham; Fraser, William D; Marquis, Grace S; Vercruysse, Jozef; Allen, Lindsay H; Gyorkos, Theresa W

2015-06-17

Soil-transmitted helminth infections are endemic in 114 countries worldwide, and cause the highest burden of disease among all neglected tropical diseases. The WHO includes women of reproductive age as a high-risk group for infection. The primary consequence of infection in this population is anaemia. During lactation, anaemia may contribute to reduced quality and quantity of milk, decreasing the duration of exclusive breastfeeding and lowering the age at weaning. To date, no study has investigated the effects of maternal postpartum deworming on infant or maternal health outcomes. A single-centre, parallel, double-blind, randomised, placebo-controlled trial will be carried out in Iquitos, Peru, to assess the effectiveness of integrating single-dose 400 mg albendazole into routine maternal postpartum care. A total of 1010 mother-infant pairs will be randomised to either the intervention or control arm, following inhospital delivery and prior to discharge. Participants will be visited in their homes at 1, 6, 12 and 24 months following delivery for outcome ascertainment. The primary outcome is infant mean weight gain between birth and 6 months of age. Secondary outcomes include other infant growth indicators and morbidity, maternal soil-transmitted helminth infection and intensity, anaemia, fatigue, and breastfeeding practices. All statistical analyses will be performed on an intention-to-treat basis. Research ethics board approval has been obtained from the McGill University Health Centre (Canada), the Asociación Civil Impacta Salud y Educación (Peru) and the Instituto Nacional de Salud (Peru). A data safety and monitoring committee is in place to oversee study progression and evaluate adverse events. The results of the analyses will be published in peer-reviewed journals, and presented at national and international conferences. Clinicaltrials.gov: NCT01748929. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The 24-hour skin hydration and barrier function effects of a hyaluronic 1%, glycerin 5%, and Centella asiatica stem cells extract moisturizing fluid: an intra-subject, randomized, assessor-blinded study.

PubMed

Milani, Massimo; Sparavigna, Adele

2017-01-01

Moisturizing products are commonly used to improve hydration in skin dryness conditions. However, some topical hydrating products could have negative effects on skin barrier function. In addition, hydrating effects of moisturizers are not commonly evaluated up to 24 hours after a single application. Hyaluronic acid (HA) and glycerin are very well-known substances able to improve skin hydration. Centella asiatica extract (CAE) could exert lenitive, anti-inflammatory and reepithelialization actions. Furthermore, CAE could inhibit hyaluronidase enzyme activity, therefore prolonging the effect of HA. A fluid containing HA 1%, glycerin 5% and stem cells CAE has been recently developed (Jaluronius CS [JCS] fluid). To evaluate and compare the 24-hour effects of JCS fluid on skin hydration and on transepidermal water loss (TEWL) in healthy subjects in comparison with the control site. Twenty healthy women, mean age 40 years, were enrolled in an intra-subject (right vs left), randomized, assessor-blinded, controlled, 1-day trial. The primary end points were the skin hydration and TEWL, evaluated at the volar surface of the forearm and in standardized conditions (temperature- and humidity-controlled room: 23°C and 30% of humidity) using a corneometer and a vapometer device at baseline, 1, 8 and 24 hours after JCS fluid application. Measurements were performed by an operator blinded for the treatments. Skin hydration after 24 hours was significantly higher ( P =0.001; Mann-Whitney U test) in the JCS-treated area in comparison with the control site. JCS induced a significant ( P =0.0001) increase in skin hydration at each evaluation time (+59% after 1 hour, +48% after 8 hours and +29% after 24 hours) in comparison with both baseline ( P =0.0001) and non-treated control site ( P =0.001). TEWL after 24 hours was significantly lower ( P =0.049; Mann-Whitney U test) in the JCS-treated area in comparison with the control site (13±4 arbitrary units [AU] vs 16±6 AU). JCS fluid significantly reduced post-stripping TEWL in comparison with baseline after 1, 8 and 24 hours (-52%, -32% and -48%, respectively). In the control site, TEWL was not reduced in comparison with baseline values at each time point's evaluation. A single application of JCS significantly improves skin hydration for up to 24 hours at the same time as improving skin barrier function.

A multicenter randomized double-blind study on the efficacy and safety of nicergoline in patients with multi-infarct dementia.

PubMed

Herrmann, W M; Stephan, K; Gaede, K; Apeceche, M

1997-01-01

A 6-month double-blind, randomized, placebo-controlled clinical trial preceded by a 3-week single-blind, washout/run-in placebo phase was performed in male and female patients, 55-85 years of age with a clinical diagnosis of mild to moderate multi-infarct dementia according to DSM-III to evaluate the therapeutic efficacy and safety of nicergoline 30 mg b.i.d. Primary endpoints for efficacy were the changes in the Sandoz Clinical Assessment Geriatric Scale (SCAG) and Mini-Mental State Examination (MMSE) scores at the end of the treatment with respect to baseline. Secondary endpoints were Clinical Global Impression, 3 subtests of the Weschsler Adult Intelligence Scale and Blessed A scale for activities of daily living, and all endpoints in 2-month intervals. A total of 252 patients were screened, 136 patients entered the double-blind phase and were evaluated as intent-to-treat (ITT) patients. Fifteen patients were excluded from the efficacy analyses of valid cases (VC) due to protocol violations or because they dropped out of the study prematurely. Confirmatory efficacy analysis after 6 months of treatment revealed superiority of nicergoline treatment with p < 0.01 for both SCAG and MMSE scores (ITT and VC). Subsequent descriptive efficacy analysis resulted in significant differences in favor of nicergoline, in the majority of cases as early as 2 months after start of treatment. Nicergoline was well tolerated and a similar number of adverse events were observed in both the placebo and the nicergoline group.

Measurement-only verifiable blind quantum computing with quantum input verification

NASA Astrophysics Data System (ADS)

Morimae, Tomoyuki

2016-10-01

Verifiable blind quantum computing is a secure delegated quantum computing where a client with a limited quantum technology delegates her quantum computing to a server who has a universal quantum computer. The client's privacy is protected (blindness), and the correctness of the computation is verifiable by the client despite her limited quantum technology (verifiability). There are mainly two types of protocols for verifiable blind quantum computing: the protocol where the client has only to generate single-qubit states and the protocol where the client needs only the ability of single-qubit measurements. The latter is called the measurement-only verifiable blind quantum computing. If the input of the client's quantum computing is a quantum state, whose classical efficient description is not known to the client, there was no way for the measurement-only client to verify the correctness of the input. Here we introduce a protocol of measurement-only verifiable blind quantum computing where the correctness of the quantum input is also verifiable.

Evaluation of a Standardized Extract from Morus alba against α-Glucosidase Inhibitory Effect and Postprandial Antihyperglycemic in Patients with Impaired Glucose Tolerance: A Randomized Double-Blind Clinical Trial

PubMed Central

Hwang, Seung Hwan; Li, Hong Mei; Wang, Zhiqiang

2016-01-01

To evaluate the antihyperglycemic effect of a standardized extract of the leaves of Morus alba (SEMA), the present study was designed to investigate the α-glucosidase inhibitory effect and acute single oral toxicity as well as evaluate blood glucose reduction in animals and in patients with impaired glucose tolerance in a randomized double-blind clinical trial. SEMA was found to inhibit α-glucosidase at a fourfold higher level than the positive control (acarbose), in a concentration-dependent manner. Moreover, blood glucose concentration was suppressed by SEMA in vivo. Clinical signs and weight changes were observed when conducting an evaluation of the acute toxicity of SEMA through a single-time administration, with clinical observation conducted more than once each day. After administration of the SEMA, observation was for 14 days; all of the animals did not die and did not show any abnormal symptoms. In addition, the inhibitory effects of rice coated with SEMA were evaluated in a group of impaired glucose tolerance patients on postprandial glucose and a group of normal persons, and results showed that SEMA had a clear inhibitory effect on postprandial hyperglycemia in both groups. Overall, SEMA showed excellent potential in the present study as a material for improving postprandial hyperglycemia. PMID:27974904

The role of auditory feedback in music-supported stroke rehabilitation: A single-blinded randomised controlled intervention.

PubMed

van Vugt, F T; Kafczyk, T; Kuhn, W; Rollnik, J D; Tillmann, B; Altenmüller, E

2016-01-01

Learning to play musical instruments such as piano was previously shown to benefit post-stroke motor rehabilitation. Previous work hypothesised that the mechanism of this rehabilitation is that patients use auditory feedback to correct their movements and therefore show motor learning. We tested this hypothesis by manipulating the auditory feedback timing in a way that should disrupt such error-based learning. We contrasted a patient group undergoing music-supported therapy on a piano that emits sounds immediately (as in previous studies) with a group whose sounds are presented after a jittered delay. The delay was not noticeable to patients. Thirty-four patients in early stroke rehabilitation with moderate motor impairment and no previous musical background learned to play the piano using simple finger exercises and familiar children's songs. Rehabilitation outcome was not impaired in the jitter group relative to the normal group. Conversely, some clinical tests suggests the jitter group outperformed the normal group. Auditory feedback-based motor learning is not the beneficial mechanism of music-supported therapy. Immediate auditory feedback therapy may be suboptimal. Jittered delay may increase efficacy of the proposed therapy and allow patients to fully benefit from motivational factors of music training. Our study shows a novel way to test hypotheses concerning music training in a single-blinded way, which is an important improvement over existing unblinded tests of music interventions.

Effect of Anodal and Cathodal Transcranial Direct Current Stimulation on DLPFC on Modulation of Inhibitory Control in ADHD.

PubMed

Soltaninejad, Zahra; Nejati, Vahid; Ekhtiari, Hamed

2015-12-20

The purpose of this study was to improve the inhibitory control functions through transcranial direct current stimulation (tDCS) in adolescents with ADHD symptoms. Twenty high school students with ADHD symptoms participated in this single-blinded, crossover, sham-controlled study. All the participants were tested during the application of Stroop and Go/No-Go tasks that is used to measure inhibitory control, using 1.5 mA of tDCS for 15 min over the left dorsolateral prefrontal cortex (DLPFC). Anodal stimulation on left DLPFC had no effect on interference inhibition during the Stroop task and increased the proportion of correct responses in the "Go stage" of the Go/No-Go test compared with sham condition. Cathodal stimulation on the left DLPFC increased the inhibition accuracy in the inhibition stage during Go/No-Go task in comparison with sham. tDCS over the left DLPFC of adolescents who suffer from ADHD symptoms can improve inhibitory control in prepotent response inhibition. © The Author(s) 2015.

A double-blind, placebo-controlled study on the effects of Gotu Kola (Centella asiatica) on acoustic startle response in healthy subjects.

PubMed

Bradwejn, J; Zhou, Y; Koszycki, D; Shlik, J

2000-12-01

Investigations of the pharmacologic profile of medicinal plants have revealed that a number of plants with purported anxiolytic activity bind to cholecystokinin (CCK) receptors. This finding is intriguing in view of the proposed involvement of CCK in the pathophysiology of fear and anxiety. This double-blind, placebo-controlled study was undertaken to evaluate the anxiolytic activity of Gotu Kola (Centella asiatica) in healthy subjects. Gotu Kola has been used for centuries in Ayurvedic and traditional Chinese medicine to alleviate symptoms of depression and anxiety. Recent studies in the rat have shown that long-term pretreatment with Gotu Kola decreases locomotor activity, enhances elevated-plus maze performance, and attenuates the acoustic startle response (ASR). In this study, the authors evaluated the effects of Gotu Kola on the ASR in humans. Subjects were randomly assigned to receive either a single 12-g orally administered dose of Gotu Kola (N = 20) or placebo (N = 20). The results revealed that compared with placebo, Gotu Kola significantly attenuated the peak ASR amplitude 30 and 60 minutes after treatment. Gotu Kola had no significant effect on self-rated mood, heart rate, or blood pressure. These preliminary findings suggest that Gotu Kola has anxiolytic activity in humans as revealed by the ASR. It remains to be seen whether this herb has therapeutic efficacy in the treatment of anxiety syndromes.

The effect of different dosage regimens of tranexamic acid on blood loss in bimaxillary osteotomy: a randomized, double-blind, placebo-controlled study.

PubMed

Apipan, B; Rummasak, D; Narainthonsaenee, T

2018-05-01

The purpose of this study was to compare the effects of three dosage regimens of intravenous tranexamic acid and normal saline placebo on blood loss and the requirement for transfusion during bimaxillary osteotomy. A prospective, randomized, double-blind, placebo-controlled study was performed. Eighty patients scheduled for elective bimaxillary osteotomy were divided into four groups: a placebo group and three groups receiving a single dose of tranexamic acid 10, 15, or 20mg/kg body weight after the induction of anaesthesia. Demographic data, the anaesthetic time, the operative time, and the experience of the surgical team were similar in the four groups. Patients receiving placebo had increased blood loss compared to those receiving tranexamic acid. No significant difference in blood loss was found among those who received 10, 15, or 20mg/kg body weight of tranexamic acid. There was no significant difference in transfusion requirement, amount of 24-h postoperative vacuum drainage, length of hospital stay, or complications among the four groups. Prophylactic tranexamic acid decreased bleeding during bimaxillary osteotomy. Of the three dosages of tranexamic acid studied, the most efficacious and cost-effective dose to reduce bleeding was 10mg/kg body weight. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Shockwave treatment for medial tibial stress syndrome in military cadets: A single-blind randomized controlled trial.

PubMed

Gomez Garcia, Santiago; Ramon Rona, Silvia; Gomez Tinoco, Martha Claudia; Benet Rodriguez, Mikhail; Chaustre Ruiz, Diego Mauricio; Cardenas Letrado, Francia Piedad; Lopez-Illescas Ruiz, África; Alarcon Garcia, Juan Maria

2017-10-01

Medial tibial stress syndrome (MTSS) is a common injury in athletes and soldiers. Several studies have demonstrated the effectiveness of extracorporeal shockwave treatment (ESWT) in athletes with MTSS. To assess whether one session of focused ESWT is effective in the treatment of military cadets with MTSS. A randomized, prospective, controlled, single-blind, parallel-group clinical study. Ib. Military School of Cadets of the Colombian Army. Forty-two military cadets with unilateral chronic MTSS were randomly assigned to either one session of focused electromagnetic ESWT (1500 pulses at 0.20 mJ/mm 2 ) plus a specific exercise programme (muscle stretching and strengthening exercises) or the exercise programme alone. The primary endpoint was change in asymptomatic running test (RT) duration at four weeks from baseline. Secondary endpoints were changes in the visual analogue scale (VAS) after running and modified Roles and Maudsley (RM) score also at four weeks from baseline. ESWT patients were able to run longer. Mean RT after four weeks was 17 min 33 s (SE: 2.36) compared to 4 min 48 s (SE: 1.03) in the exercise-only group (p = 0.000). Mean VAS after running was 2.17 (SE: 0.44) in the ESWT group versus 4.26 (SE: 0.36) in the exercise-only group (p = 0.001). The ESWT group had a significantly higher RM score, with excellent or good results for 82.6% of patients vs. 36.8% in the exercise-only group (p = 0.002). No significant adverse effects of ESWT were observed. A single application of focused shockwave treatment in combination with a specific exercise programme accelerates clinical and functional recovery in military cadets with MTSS. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Photobiomodulation therapy (PBMT) and/or cryotherapy in skeletal muscle restitution, what is better? A randomized, double-blinded, placebo-controlled clinical trial.

PubMed

de Paiva, Paulo Roberto Vicente; Tomazoni, Shaiane Silva; Johnson, Douglas Scott; Vanin, Adriane Aver; Albuquerque-Pontes, Gianna Móes; Machado, Caroline Dos Santos Monteiro; Casalechi, Heliodora Leão; de Carvalho, Paulo de Tarso Camillo; Leal-Junior, Ernesto Cesar Pinto

2016-12-01

Cryotherapy for post-exercise recovery remains widely used despite the lack of quality evidence. Photobiomodulation therapy (PBMT) studies (with both low-level laser therapy and light-emitting diode therapy) have demonstrated positive scientific evidence to suggest its use. The study aims to evaluate PBMT and cryotherapy as a single or combined treatment on skeletal muscle recovery after eccentric contractions of knee extensors. Fifty healthy male volunteers were recruited and randomized into five groups (PBMT, cryotherapy, cryotherapy + PBMT, PMBT + cryotherapy, or placebo) for a randomized, double-blinded, placebo-controlled trial that evaluated exercise performance (maximum voluntary contraction (MVC)), delayed onset muscle soreness (DOMS), and muscle damage (creatine kinase (CK)). Assessments were performed at baseline; immediately after; and at 1, 24, 48, 72, and 96 h. Comparator treatments was performed 3 min after exercise and repeated at 24, 48, and 72 h. PBMT was applied employing a cordless, portable GameDay ™ device (combination of 905 nm super-pulsed laser and 875- and 640-nm light-emitting diodes (LEDs); manufactured by Multi Radiance Medical ™ , Solon - OH, USA), and cryotherapy by flexible rubber ice packs. PBMT alone was optimal for post-exercise recovery with improved MVC, decreased DOMS, and CK activity (p < 0.05) from 24 to 96 h compared to placebo, cryotherapy, and cryotherapy + PBMT. In the PBMT + cryotherapy group, the effect of PBMT was decreased (p > 0.05) but demonstrated significant improvement in MVC, decreased DOMS, and CK activity (p < 0.05). Cryotherapy as single treatment and cryotherapy + PBMT were similar to placebo (p > 0.05). We conclude that PBMT used as single treatment is the best modality for enhancement of post-exercise restitution, leading to complete recovery to baseline levels from 24 h after high-intensity eccentric contractions.

Immediate relief of herniated lumbar disc-related sciatica by ankle acupuncture: A study protocol for a randomized controlled clinical trial.

PubMed

Xiang, Anfeng; Xu, Mingshu; Liang, Yan; Wei, Jinzi; Liu, Sheng

2017-12-01

Around 90% of sciatica cases are due to a herniated intervertebral disc in the lumbar region. Ankle acupuncture (AA) has been reported to be effective in the treatment of acute nonspecific low back pain. This study aims to evaluate the efficacy of a single session of ankle acupuncture for disc-related sciatica. This will be a double-blinded, randomized controlled clinical trial. Patients diagnosed with disc-related sciatica will be randomly divided into 3 parallel groups. The treatment group (n = 30) will receive ankle acupuncture. The 2 control groups will either undergo traditional needle manipulation (n = 30) or sham acupuncture (n = 30) at the same point as the treatment group. The primary outcome will be pain intensity on a visual analog scale (VAS). The secondary outcomes will be paresthesia intensity on a VAS and the Abbreviated Acceptability Rating Profile (AAPR). The success of blinding will be evaluated, and the needle-induced sensation and adverse events will be recorded. All outcomes will be evaluated before, during, and after the treatment. This study will determine the immediate effect and specificity of ankle acupuncture for the treatment of disc-related sciatica. We anticipate that ankle acupuncture might be more effective than traditional needle manipulation or sham acupuncture. ChiCTR-IPR-15007127 (http://www.chictr.org.cn/showprojen.aspx?proj=11989). Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Effect of pre-cooling injection site on pain perception in pediatric dentistry: “A randomized clinical trial”

PubMed Central

Ghaderi, Faezeh; Banakar, Shahin; Rostami, Shima

2013-01-01

Background: Injection of local anesthesia is one of the most important reasons for development of avoidance behavior in children. Efforts have been performed to decrease pain perception of injection. The present research evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. Materials and Methods: A prospective single-blind crossover clinical trial was used to investigate pain perception in 50 healthy pediatric patients who needed bilateral buccal infiltration of local anesthetics for dental treatment. They received a topical anesthetic agent (Benzocaine) on one side (control) for 1 min and topical anesthetic agent plus one minute of ice pack on the other side (trial) prior to the injection. A dentist blind to the study assessed the patients’ reaction during injection. Wilcoxon and Mann-Whitney U tests were used for statistical analysis. Statistical significance was defined at P < 0.05. Results: The means of sound, eye, and motor scales (SEM) were 4.06 ± 1.32 and 5.44 ± 1.79 for the study and control groups, respectively. The means of visual analogue scales (VAS) for the study and control groups were 42.20 ± 12.70 and 58.40 ± 16.83, respectively; with statistically significant differences between the two groups (P < 0.05). Conclusion: Cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients. PMID:24379869

Efficacy of elastic memory chains versus nickel-titanium coil springs in canine retraction: A two-center split-mouth randomized clinical trial.

PubMed

Khanemasjedi, Mashallah; Moradinejad, Mehrnaz; Javidi, Pedram; Niknam, Ozra; Jahromi, Nima Haghighat; Rakhshan, Vahid

2017-12-01

The use of newly-introduced elastic memory chains (EMCs) in space closure is increasingly gaining popularity. However, no clinical studies have evaluated their efficacy. Therefore, this study was conducted. In this two-center split-mouth single-blind randomized controlled trial, 21 jaws were divided into 42 quadrants. The two treatments [canine retraction using EMCs versus nickel-titanium (NiTi) coil springs (as control)] were randomly assigned to two quadrants of each jaw. The premolar space was measured at the baseline, and in the 1st, 2nd, and 3rd months of canine retraction, by a blinded orthodontist. Space closure rates were compared using a paired t-test. The rates of space closure using NiTi springs were 1.93±0.62, 1.71±0.75, and 1.36±0.51mm/month, during the 1st, 2nd, and 3rd months of treatment, respectively. The 3-month average rates of space closure were 1.67±0.39 and 1.89±0.36mm/month in the NiTi and elastic groups, respectively (faster in the elastic group, P=0.022). The application of elastic memory chains is as effective as NiTi springs. Copyright © 2017. Published by Elsevier Masson SAS.

Intranasal fentanyl versus intravenous morphine in the emergency department treatment of severe painful sickle cell crises in children: Study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Children with sickle cell disease (SCD) frequently and unpredictably present to the emergency department (ED) with pain. The painful event is the hallmark acute clinical manifestation of SCD, characterised by sudden onset and is usually bony in origin. This study aims to establish if 1.5mcg/kg of intranasal fentanyl (INF; administered via a Mucosal Atomiser Device, MAD™) is non-inferior to intravenous morphine 0.1 mg/kg in severe SCD-associated pain. Methods/design This study is a randomised,double-blind, double-dummy active control trial of children (weighing more than 10 kg) between 1 year and 21 years of age with severe painful sickle cell crisis. Severe pain is defined as rated seven or greater on a 0 to 10 age-appropriate numeric pain scale or equivalent. The trial will be conducted in a single tertiary urban paediatric ED in Dublin, Ireland. Each patient will receive a single active agent and a single placebo via the intravenous and intranasal routes. All clinical and research staff, patients and parents will be blinded to the treatment allocation. The primary endpoint is severity of pain scored at 10 min from administration of the study medications. Secondary endpoints include pain severity measured at 0, 5, 15, 20, 30, 60 and 120 min after the administration of analgesia, proportion of patients requiring rescue analgesia and incidence of adverse events. The trial ends at 120 min after the administration of the study drugs. A clinically meaningful difference in validated pain scores has been defined as 13 mm. Setting the permitted threshold to 50% of this limit (6 mm) and assuming both treatments are on average equal, a sample size of 30 patients (15 per group) will provide at least 80% power to demonstrate that INF is non-inferior to IV morphine with a level of significance of 0.05. Discussion This clinical trial will inform of the role of INF 1.5mcg/kg via MAD in the acute treatment of severe painful sickle cell crisis in children in the ED setting. Trial registration Current Controlled Trials ISRCTN67469672 and EudraCT no. 2011-005161-20 PMID:22647439

Blinded interpretation of study results can feasibly and effectively diminish interpretation bias.

PubMed

Järvinen, Teppo L N; Sihvonen, Raine; Bhandari, Mohit; Sprague, Sheila; Malmivaara, Antti; Paavola, Mika; Schünemann, Holger J; Guyatt, Gordon H

2014-07-01

Controversial and misleading interpretation of data from randomized trials is common. How to avoid misleading interpretation has received little attention. Herein, we describe two applications of an approach that involves blinded interpretation of the results by study investigators. The approach involves developing two interpretations of the results on the basis of a blinded review of the primary outcome data (experimental treatment A compared with control treatment B). One interpretation assumes that A is the experimental intervention and another assumes that A is the control. After agreeing that there will be no further changes, the investigators record their decisions and sign the resulting document. The randomization code is then broken, the correct interpretation chosen, and the manuscript finalized. Review of the document by an external authority before finalization can provide another safeguard against interpretation bias. We found the blinded preparation of a summary of data interpretation described in this article practical, efficient, and useful. Blinded data interpretation may decrease the frequency of misleading data interpretation. Widespread adoption of blinded data interpretation would be greatly facilitated were it added to the minimum set of recommendations outlining proper conduct of randomized controlled trials (eg, the Consolidated Standards of Reporting Trials statement). Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Brain systems mediating voice identity processing in blind humans.

PubMed

Hölig, Cordula; Föcker, Julia; Best, Anna; Röder, Brigitte; Büchel, Christian

2014-09-01

Blind people rely more on vocal cues when they recognize a person's identity than sighted people. Indeed, a number of studies have reported better voice recognition skills in blind than in sighted adults. The present functional magnetic resonance imaging study investigated changes in the functional organization of neural systems involved in voice identity processing following congenital blindness. A group of congenitally blind individuals and matched sighted control participants were tested in a priming paradigm, in which two voice stimuli (S1, S2) were subsequently presented. The prime (S1) and the target (S2) were either from the same speaker (person-congruent voices) or from two different speakers (person-incongruent voices). Participants had to classify the S2 as either a old or a young person. Person-incongruent voices (S2) compared with person-congruent voices elicited an increased activation in the right anterior fusiform gyrus in congenitally blind individuals but not in matched sighted control participants. In contrast, only matched sighted controls showed a higher activation in response to person-incongruent compared with person-congruent voices (S2) in the right posterior superior temporal sulcus. These results provide evidence for crossmodal plastic changes of the person identification system in the brain after visual deprivation. Copyright © 2014 Wiley Periodicals, Inc.

Effect of study design on the reported effect of cardiac resynchronization therapy (CRT) on quantitative physiological measures: stratified meta-analysis in narrow-QRS heart failure and implications for planning future studies.

PubMed

Jabbour, Richard J; Shun-Shin, Matthew J; Finegold, Judith A; Afzal Sohaib, S M; Cook, Christopher; Nijjer, Sukhjinder S; Whinnett, Zachary I; Manisty, Charlotte H; Brugada, Josep; Francis, Darrel P

2015-01-06

Biventricular pacing (CRT) shows clear benefits in heart failure with wide QRS, but results in narrow QRS have appeared conflicting. We tested the hypothesis that study design might have influenced findings. We identified all reports of CRT-P/D therapy in subjects with narrow QRS reporting effects on continuous physiological variables. Twelve studies (2074 patients) met these criteria. Studies were stratified by presence of bias-resistance steps: the presence of a randomized control arm over a single arm, and blinded outcome measurement. Change in each endpoint was quantified using a standardized effect size (Cohen's d). We conducted separate meta-analyses for each variable in turn, stratified by trial quality. In non-randomized, non-blinded studies, the majority of variables (10 of 12, 83%) showed significant improvement, ranging from a standardized mean effect size of +1.57 (95%CI +0.43 to +2.7) for ejection fraction to +2.87 (+1.78 to +3.95) for NYHA class. In the randomized, non-blinded study, only 3 out of 6 variables (50%) showed improvement. For the randomized blinded studies, 0 out of 9 variables (0%) showed benefit, ranging from -0.04 (-0.31 to +0.22) for ejection fraction to -0.1 (-0.73 to +0.53) for 6-minute walk test. Differences in degrees of resistance to bias, rather than choice of endpoint, explain the variation between studies of CRT in narrow-QRS heart failure addressing physiological variables. When bias-resistance features are implemented, it becomes clear that these patients do not improve in any tested physiological variable. Guidance from studies without careful planning to resist bias may be far less useful than commonly perceived. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Effectiveness of balneotherapy in chronic low back pain -- a randomized single-blind controlled follow-up study.

PubMed

Balogh, Zoltán; Ordögh, József; Gász, Attila; Német, László; Bender, Tamás

2005-08-01

Balneotherapy, a domain of medical science, focuses on utilizing the beneficial effects of medicinal waters. Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime. Although small in number, all controlled studies published on this subject have demonstrated the benefits of balneotherapy. This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain. A single-blind clinical study was carried out to appraise the therapeutic efficacy of reduced sulphurous water on 60 patients with low back pain. 30 subjects took baths in reduced sulphurous mineral water, whereas the other 30 patients used modified tap water of matching odor. Parameters determined at baseline, after balneo-/hydrotherapy, and at the end of the 3-month follow-up period included the results of the Visual Analogue Scale (VAS) score, the modified Oswestry index, mobility of the spine, antalgic posture, tenderness of the paravertebral muscles on palpation, the dose requirements for analgesics, and the efficacy assessed by the investigators and by the patients. Bathing in mineral water resulted in a statistically significant improvement. This was reflected by the VAS (p < 0.01) and manifested by the mitigation of muscle spasm (p < 0.01), the alleviation of local tenderness (p < 0.01), the enhanced flexion-extension and rotation of the spine (p < 0.01) as well as by the improvement of the Schober's index (p < 0.01). All these beneficial changes persisted as long as 3 months after the completion of balneotherapy. By contrast, hydrotherapy with tap water resulted only in the temporary improvement of just a single parameter: the VAS score improved significantly (p < 0.01). Balneotherapy in itself can alleviate low back pain. As demonstrated by this study, the analgesic efficacy and improvement of mobility accomplished by the use of mineral water is significantly superior to that afforded by hydrotherapy with tap water. Our results clearly establish the beneficial effects of mineral water. Moreover, it is a valuable adjunct to other forms of physical treatment as well as to pharmacotherapy.

A clinical trial of single dose rectal and oral administration of diazepam for the prevention of serial seizures in adult epileptic patients.

PubMed Central

Milligan, N M; Dhillon, S; Griffiths, A; Oxley, J; Richens, A

1984-01-01

The clinical anticonvulsant efficacy of single dose rectal and oral administration of diazepam 20 mg was examined in two double-blind placebo-controlled trials in adult epileptic patients. All subjects suffered from drug resistant epilepsy and frequently experienced serial seizures. Diazepam was administered rectally as a new experimental suppository formulation immediately after a seizure and was highly effective in preventing recurrent fits within a 24 h observation period (p less than 0.001). Pharmacokinetic studies revealed a wide range of serum diazepam concentrations 60 min after administration of the suppository (mean serum diazepam level 190 +/- 73 (SD ng/ml). In a similar study oral administration of diazepam 20 mg significantly reduced the incidence of serial seizures compared with a placebo (p less than 0.01) and the mean 60 min serum diazepam level was 273 +/- 190 (SD) ng/ml. PMID:6368753

Premedication with N-acetylcysteine and simethicone improves mucosal visualization during gastroscopy: a randomized, controlled, endoscopist-blinded study.

PubMed

Neale, James R; James, Shirley; Callaghan, James; Patel, Praful

2013-07-01

Diagnostic gastroscopy provides a unique opportunity to diagnose early oesophagogastric neoplasia; however, intraluminal mucus and bile can obscure mucosal visualization. The aim of this study was to determine whether the use of a premedication solution containing the mucolytic agent N-acetylcysteine and the surfactant simethicone improves mucosal visualization within a UK diagnostic gastroscopy service. A total of 75 consecutive patients were recruited from a single (S.J.) endoscopist's diagnostic gastroscopy list. They were randomized into three treatment groups: (a) standard control=clear fluids only for 6 h, nil by mouth for 2 h; (b) water control=standard control+100 ml sterile water (given 20 min before gastroscopy); and (c) solution=standard control+100 ml investigated solution (20 min before gastroscopy). The endoscopist was blinded to patient preparation. Inadequate mucosal visualization was defined as fluid/mucus during gastroscopy that could not be suctioned and required flushing with water. The volume of flush, the site at which it was used and the total procedure times were recorded. All three groups showed no statistical difference for age, sex ratio, procedure priority or indication. The mean volume of flush required to obtain clear mucosa was significantly less in the solution group compared with the other groups. The mean overall procedure time was also less in the solution group compared with the other groups. Premedication with N-acetylcysteine and simethicone markedly improves mucosal visibility during gastroscopy. It also reduces the time taken for the procedure. This low-cost and well-tolerated intervention may improve detection of early neoplasia.

Hydrotherapy vs. conventional land-based exercise for improving walking and balance after stroke: a randomized controlled trial.

PubMed

Zhu, Zhizhong; Cui, Liling; Yin, Miaomiao; Yu, Yang; Zhou, Xiaona; Wang, Hongtu; Yan, Hua

2016-06-01

To investigate the effects of hydrotherapy on walking ability and balance in patients with chronic stroke. Single-blind, randomized controlled pilot trial. Outpatient rehabilitation clinic at a tertiary neurological hospital in China. A total of 28 participants with impairments in walking and controlling balance more than six months post-stroke. After baseline evaluations, participants were randomly assigned to a land-based therapy (control group, n = 14) or hydrotherapy (study group, n = 14). Participants underwent individual sessions for four weeks, five days a week, for 45 minutes per session. After four weeks of rehabilitation, all participants were evaluated by a blinded assessor. Functional assessments included the Functional Reach Test, Berg Balance Scale, 2-minute walk test, and Timed Up and Go Test. After four weeks of treatment, the Berg Balance Scale, functional reach test, 2-minute walk test, and the Timed Up and Go Test scores had improved significantly in each group (P < 0.05). The mean improvement of the functional reach test and 2-minute walk test were significantly higher in the aquatic group than in the control group (P < 0.01). The differences in the mean values of the improvements in the Berg Balance Scale and the Timed Up and Go Test were not statistically significant. The results of this study suggest that a relatively short programme (four weeks) of hydrotherapy exercise resulted in a large improvement in a small group (n = 14) of individuals with relatively high balance and walking function following a stroke. © The Author(s) 2015.

Single blind, randomized, controlled trial of a lightening product with and without iontophoresis versus tretinoin and vehicle for hyperpigmentation.

PubMed

Wanner, Molly; Houston, Neil; Javorsky, Emilia; Yuan, Minsheng; Alora-Palli, Maria; Kimball, Alexa B

2015-01-01

Hyperpigmentation is a common concern and has many causes including lentigines and melasma. Currently available topical products for hyperpigmentation are limited by their potential for irritation, lack of demonstrated efficacy or regulatory concerns. To compare the efficacy of a new skin lightening product with and without iontophoresis to a known effective product (tretinoin) and placebo on hyperpigmentation caused by lentigines and/or melasma. Secondary objectives included an assessment of the product's effects on the appearance of rhytides and roughness. Eighty subjects were randomized into one of four treatment groups: proprietary lightening product, proprietary lightening product with iontophoresis, tretinoin 0.05% cream, or vehicle control. Seventy-four subjects completed all study visits. Blinded assessments of subjects were performed at each visit under ambient and Wood's light. The proprietary skin lightening product improved facial hyperpigmentation versus placebo under ambient light (P= 0.05) and Wood's lamp (P= 0.01) examination. Tretinoin also improved facial hyperpigmentation versus placebo under Wood's lamp (P= 0.01). The proprietary product was better tolerated than tretinoin, with fewer subject reported side effects. The investigational product was effective and may be better tolerated than tretinoin cream.

Blindness enhances tactile acuity and haptic 3-D shape discrimination.

PubMed

Norman, J Farley; Bartholomew, Ashley N

2011-10-01

This study compared the sensory and perceptual abilities of the blind and sighted. The 32 participants were required to perform two tasks: tactile grating orientation discrimination (to determine tactile acuity) and haptic three-dimensional (3-D) shape discrimination. The results indicated that the blind outperformed their sighted counterparts (individually matched for both age and sex) on both tactile tasks. The improvements in tactile acuity that accompanied blindness occurred for all blind groups (congenital, early, and late). However, the improvements in haptic 3-D shape discrimination only occurred for the early-onset and late-onset blindness groups; the performance of the congenitally blind was no better than that of the sighted controls. The results of the present study demonstrate that blindness does lead to an enhancement of tactile abilities, but they also suggest that early visual experience may play a role in facilitating haptic 3-D shape discrimination.

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

Saccharomyces boulardii for the prevention of antibiotic-associated diarrhea in adult hospitalized patients: a single-center, randomized, double-blind, placebo-controlled trial.

PubMed

Pozzoni, Pietro; Riva, Alessia; Bellatorre, Alessandro Giacco; Amigoni, Maria; Redaelli, Elena; Ronchetti, Anna; Stefani, Mariangela; Tironi, Rosangela; Molteni, Edoardo Ennio; Conte, Dario; Casazza, Giovanni; Colli, Agostino

2012-06-01

Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Probiotics were effective in preventing AAD and CDAD in several randomized controlled trials. This study was aimed at testing the effect of Saccharomyces boulardii on the occurrence of AAD and CDAD in hospitalized patients. A single-center, randomized, double-blind, placebo-controlled, parallel-group trial was performed. Patients being prescribed antibiotics or on antibiotic therapy for <48 h were eligible. Exclusion criteria were ongoing diarrhea, recent assumption of probiotics, lack of informed consent, inability to ingest capsules, and severe pancreatitis. Patients received a capsule containing S. boulardii or an indistinguishable placebo twice daily within 48 h of beginning antibiotic therapy, continued treatment for 7 days after antibiotic withdrawal, and were followed for 12 weeks after ending antibiotic treatment. Of 562 consecutive eligible patients, 275 patients aged 79.2 ± 9.8 years (134 on placebo) were randomized and 204 aged 78.4 ± 10.0 years (98 on placebo) completed the follow-up. AAD developed in 13.3% (13/98) of the patients receiving placebo and in 15.1% (16/106) of those receiving S. boulardii (odds ratio for S. boulardii vs. placebo, 1.16; 95% confidence interval (CI), 0.53-2.56). Five cases of CDAD occurred, 2 in the placebo group (2.0%) and 3 in the probiotic group (2.8%; odds ratio for S. boulardii vs. placebo, 1.40; 95% CI, 0.23-8.55). There was no difference in mortality rates (12.7% vs. 15.6%, P=0.60). In elderly hospitalized patients, S. boulardii was not effective in preventing the development of AAD.

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management.

PubMed

Janice Jimenez-Torres, G; Weinstein, Benjamin L; Walker, Cory R; Christopher Fowler, J; Ashford, Philippa; Borckardt, Jeffrey J; Madan, Alok

2017-03-01

Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience. Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial. Eighty-four participants will be randomized (1:1) into a single-blind, 2×12 (group×time) controlled trial. A battery-powered direct and constant current stimulator (Soterix Medical Inc. 2014) delivers anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the right DLPFC. Active tDCS is applied by supplying a 2mA current for 20min/session over 10 sessions. Participants complete self-report and performance-based assessments on a weekly basis just prior to brain stimulation. Self-report assessments are collected via Chronic Pain Tracker version 3.6, an iPad interfaced application. The performance-based pain tolerance task is completed through the cold presser task. Interventions with cross-symptomatic therapeutic potential are absolutely essential in the context of CP, in which psychiatric comorbidity is the norm. Modalities that can be used in tandem with evidence-based, non-opioid therapies have the potential to have a synergistic effect, resulting in increased effectiveness of what have been modestly effective treatments to date. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

PubMed

Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

2016-12-15

The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

Reinforcement control of severe dysfunctional behavior of blind, multihandicapped students.

PubMed

Luiselli, J K; Myles, E; Evans, T P; Boyce, D A

1985-11-01

The effectiveness of reinforcement-based programs with blind, multihandicapped students was examined. In Study 1 the aggressive behavior of a deaf/blind adolescent was eliminated through a differential reinforcement of other behavior (DRO) procedure that was combined with a reinforcer cueing technique and brief time-out. In Study 2 DRO was utilized to reduce stereotypic eye-pressing by a young blind child who was also hearing-impaired. Follow-up observations while treatment procedures remained operative revealed maintenance of intervention effects from 1 to 8 months posttreatment.

Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial.

PubMed

Carr, Robert; Brocklehurst, Peter; Doré, Caroline J; Modi, Neena

2009-01-17

Systemic sepsis is a major cause of death in preterm neonates. There are compelling theoretical reasons why treatment with haemopoietic colony-stimulating factors might reduce sepsis and improve outcomes, and as a consequence these agents have entered into use in neonatal medicine without adequate evidence. We assessed whether granulocyte-macrophage colony stimulating factor (GM-CSF) administered as prophylaxis to preterm neonates at high risk of neutropenia would reduce sepsis, mortality, and morbidity. We undertook a single-blind, multicentre, randomised controlled trial in 26 centres between June, 2000, and June, 2006. 280 neonates of below or equal to 31 weeks' gestation and below the 10th centile for birthweight were randomised within 72 h of birth to receive GM-CSF 10 microg/kg per day subcutaneously for 5 days or standard management. From recruitment to day 28 a detailed daily clinical record form was completed by the treating clinicians. Primary outcome was sepsis-free survival to 14 days from trial entry. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN42553489. Neutrophil counts after trial entry rose significantly more rapidly in infants treated with GM-CSF than in control infants during the first 11 days (difference between neutrophil count slopes 0.34 x 10(9)/L/day; 95% CI 0.12-0.56). There was no significant difference in sepsis-free survival for all infants (93 of 139 treated infants, 105 of 141 control infants; difference -8%, 95% CI -18 to 3). A meta-analysis of this trial and previous published prophylactic trials showed no survival benefit. Early postnatal prophylactic GM-CSF corrects neutropenia but does not reduce sepsis or improve survival and short-term outcomes in extremely preterm neonates.

A single-blind cross over study investigating the efficacy of standard and controlled release levodopa in combination with entacapone in the treatment of end-of-dose effect in people with Parkinson's disease.

PubMed

Iansek, R; Danoudis, M

2011-08-01

To determine the efficacy of standard levodopa combined with controlled release levodopa and entacapone in controlling end-of-dose symptoms in Parkinson's disease. A single-blind cross over design was used to compare the duration of action for three pharmacological combinations: standard levodopa (L/DDC); standard levodopa combined with entacapone (L/DDC/E); and standard levodopa combined with controlled release levodopa (CR) and entacapone (L/DDC/CR/E). Thirty two participants with wearing-off symptoms and inadequate symptom control with L/DDC/E had their optimum dose of L/DDC determined at base line. Entacapone was added to the optimal L/DDC dose and duration of action determined. Levodopa CR dosage was adjusted to match the optimal L/DDC dose for each participant. All participants were then trialed on L/DDC/CR/E and duration of response calculated. Timed Up and Go (TUG) times and magnitude of extra movements were recorded hourly throughout the day over several days to determine the optimum interval between doses for each combination. The UPDRS (Sections 2 and 3), PDQ39 and fatigue scale, the PDF-16, were recorded at base line and when dosage intervals had stabilized on L/DDC/CR/E. Duration of response was greatest with L/DDC/CR/E compared to L/DDC/E (p < 0.001) and number of daily doses were less on L/DDC/CR/E compared to L/DDC/E (p < 0.001). UPDRS, PDQ39 and fatigue scores also improved on L/DDC/CR/E compared to L/DDC (p < 0.001). Dyskinesia increased on L/DDC/CR/E (p = 0.001) however magnitude was mild. Combining standard levodopa and levodopa CR preparations with entacapone is an additional treatment strategy to manage motor fluctuations in advanced PD. Copyright © 2011 Elsevier Ltd. All rights reserved.

The effects of mindfulness-based stress reduction on cardiac patients' blood pressure, perceived stress, and anger: a single-blind randomized controlled trial.

PubMed

Momeni, Javad; Omidi, Abdollah; Raygan, Fariba; Akbari, Hossein

2016-10-01

This study aimed at assessing the effects of mindfulness-based stress reduction (MBSR) on cardiac patients' blood pressure (BP), perceived stress, and anger. In total, 60 cardiac patients were recruited between April and June 2015 from a specialized private cardiac clinic located in Kashan, Iran. Patients were allocated to the intervention and control groups. Patients in the experimental group received MBSR in eight 2.5-hour sessions, while patients in the control group received no psychological therapy. The main outcomes were BP, perceived stress, and anger. Analysis of covariance revealed a significant difference between the study groups regarding the posttest values of systolic BP, perceived stress, and anger (P < .001). However, the study groups did not differ significantly in terms of diastolic BP (P = .061; P = .17). This study reveals that MBSR is effective in reducing cardiac patients' systolic BP, perceived stress, and anger. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Magnitude of blood pressure reduction in the placebo arms of modern hypertension trials: implications for trials of renal denervation.

PubMed

Patel, Hitesh C; Hayward, Carl; Ozdemir, Baris Ata; Rosen, Stuart D; Krum, Henry; Lyon, Alexander R; Francis, Darrel P; di Mario, Carlo

2015-02-01

Early phase studies of novel interventions for hypertension, such as renal sympathetic denervation, are sometimes single-armed (uncontrolled). We explored the wisdom of this by quantifying the blood pressure fall in the placebo arms of contemporary trials of hypertension. We searched Medline up to June 2014 and identified blinded, randomized trials of hypertension therapy in which the control arm received placebo medication or a sham (placebo) procedure. For nonresistant hypertension, we have identified all such trials of drugs licensed by the US Food and Drug Administration since 2000 (5 drugs). This US Food and Drug Administration-related restriction was not applied to resistant hypertension trials. This produced 7451 patients, who were allocated to a blinded control from 52 trials of nonresistant hypertension and 694 patients from 8 trials of resistant hypertension (3 drugs and 2 interventions). Systolic blood pressure fell by 5.92 mm Hg (95% confidence interval, 5.14-6.71; P<0.0001) in the nonresistant cohort and by 8.76 mm Hg (95% confidence interval, 4.83-12.70; P<0.0001) in the resistant cohort. Using metaregression, the falls were larger in trials that did not use ambulatory blood pressure monitoring as an inclusion criterion (z=2.84; P=0.0045), in those with higher baseline blood pressures (z=-0.3; P=0.0001), and in those where the patients were prescribed a continuous background of antihypertensives (z=-2.72; P=0.0065). The nontrivial magnitude of these apparent blood pressure reductions with perfectly ineffective intervention (placebo) illustrates that efficacy explorations of novel therapies for hypertension, once safety is established, should be performed with a randomized, appropriately controlled, and blinded design. © 2014 American Heart Association, Inc.

Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial.

PubMed

Bodes Pardo, Gema; Lluch Girbés, Enrique; Roussel, Nathalie A; Gallego Izquierdo, Tomás; Jiménez Penick, Virginia; Pecos Martín, Daniel

2018-02-01

To assess the effect of a pain neurophysiology education (PNE) program plus therapeutic exercise (TE) for patients with chronic low back pain (CLBP). Single-blind randomized controlled trial. Private clinic and university. Patients with CLBP for ≥6 months (N=56). Participants were randomized to receive either a TE program consisting of motor control, stretching, and aerobic exercises (n=28) or the same TE program in addition to a PNE program (n=28), conducted in two 30- to 50-minute sessions in groups of 4 to 6 participants. The primary outcome was pain intensity rated on the numerical pain rating scale which was completed immediately after treatment and at 1- and 3-month follow-up. Secondary outcome measures were pressure pain threshold, finger-to-floor distance, Roland-Morris Disability Questionnaire, Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, and Patient Global Impression of Change. At 3-month follow-up, a large change in pain intensity (numerical pain rating scale: -2.2; -2.93 to -1.28; P<.001; d=1.37) was observed for the PNE plus TE group, and a moderate effect size was observed for the secondary outcome measures. Combining PNE with TE resulted in significantly better results for participants with CLBP, with a large effect size, compared with TE alone. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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.

Blind Quantum Computing with Weak Coherent Pulses

NASA Astrophysics Data System (ADS)

Dunjko, Vedran; Kashefi, Elham; Leverrier, Anthony

2012-05-01

The universal blind quantum computation (UBQC) protocol [A. Broadbent, J. Fitzsimons, and E. Kashefi, in Proceedings of the 50th Annual IEEE Symposiumon Foundations of Computer Science (IEEE Computer Society, Los Alamitos, CA, USA, 2009), pp. 517-526.] allows a client to perform quantum computation on a remote server. In an ideal setting, perfect privacy is guaranteed if the client is capable of producing specific, randomly chosen single qubit states. While from a theoretical point of view, this may constitute the lowest possible quantum requirement, from a pragmatic point of view, generation of such states to be sent along long distances can never be achieved perfectly. We introduce the concept of ɛ blindness for UBQC, in analogy to the concept of ɛ security developed for other cryptographic protocols, allowing us to characterize the robustness and security properties of the protocol under possible imperfections. We also present a remote blind single qubit preparation protocol with weak coherent pulses for the client to prepare, in a delegated fashion, quantum states arbitrarily close to perfect random single qubit states. This allows us to efficiently achieve ɛ-blind UBQC for any ɛ>0, even if the channel between the client and the server is arbitrarily lossy.

High-Dose Pyridoxine and Magnesium Administration in Children with Autistic Disorder: An Absence of Salutary Effects in a Double-Blind, Placebo-Controlled Study.

ERIC Educational Resources Information Center

Findling, Robert L.; Maxwell, Kathleen; Scotese-Wojtila, Lynette; Huang, Jie; Yamashita, Toyoko; Wiznitzer, Max

1997-01-01

Evaluation of high doses of pyridoxine and magnesium in a 10-week double-blind placebo-controlled trial with 10 patients (mean age 6 years) having autism concluded that the high doses used were ineffective in ameliorating autistic behaviors. (DB)

Ethnicity and Deprivation are Associated With Blindness Among Adults With Primary Glaucoma in Nigeria: Results From the Nigeria National Blindness and Visual Impairment Survey.

PubMed

Kyari, Fatima; Wormald, Richard; Murthy, Gudlavalleti V S; Evans, Jennifer R; Gilbert, Clare E

2016-10-01

We explored the risk factors for glaucoma blindness among adults aged 40 years and above with primary glaucoma in Nigeria. A total of 13,591 participants aged 40 years and above were examined in the Nigeria Blindness Survey; 682 (5.02%; 95 CI, 4.60%-5.47%) had glaucoma by ISGEO's criteria. This was a case-control study (n=890 eyes of 629 persons): glaucoma blind persons were cases and glaucoma not-blind were controls. Education and occupation were used to determine socioeconomic status scores, which were divided into 3 tertiles (affluent, medium, deprived). We assessed sociodemographic, biophysical, and ocular factors by logistic regression analysis for association with glaucoma blindness. Multinomial regression analysis was also performed with nonglaucoma as the reference category. A total of 119/629 (18.9%; 95% CI, 15.9%-22.4%) persons were blind in both eyes; 510 were controls. There was interethnic variation in odds of blindness; age, male sex, socioeconomic status, prior diagnosis of glaucoma, hypertension, intraocular pressure, and lens opacity were associated with glaucoma blindness. Axial length, mean ocular perfusion pressure, and angle-closure glaucoma were associated with blind glaucoma eyes. In multivariate analysis, Igbo ethnicity (OR=2.79; 95% CI, 1.03-7.57) had higher risk as was being male (OR=4.59; 95% CI, 1.73-12.16) and unmarried (OR=2.50; 95% CI, 1.03-6.07). Deprivation (OR=3.57; 95% CI, 1.46-8.72), prior glaucoma diagnosis (OR=5.89; 95% CI, 1.79-19.40), and intraocular pressure (OR=1.07; 95% CI, 1.04-1.09) were also independent risk factors for glaucoma blindness. Approximately 1 in 5 people with primary glaucoma were blind. Male sex, ethnicity and deprivation were strongly associated with blindness. Services for glaucoma need to improve in Nigeria, focusing on poor communities and men.

A single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol.

PubMed

Wyndow, Narelle; Crossley, Kay M; Vicenzino, Bill; Tucker, Kylie; Collins, Natalie J

2017-01-01

Patellofemoral joint osteoarthritis is a common condition, yet information regarding conservative management is lacking. Foot orthoses are an effective intervention for improving pain and function in younger individuals with patellofemoral pain and may be effective in those with patellofemoral osteoarthritis. This pilot study will seek to establish the feasibility of a phase III randomised controlled trial to investigate whether foot orthoses worn in prescribed motion controlled footwear are superior to prescribed motion control footwear alone in the management of patellofemoral osteoarthritis. This phase II pilot clinical trial is designed as a randomized, single-blind, parallel group, two arm, superiority trial. The trial will recruit 44 participants from Queensland and Tasmania, Australia. Volunteers aged 40 years and over must have clinical symptoms and radiographic evidence of patellofemoral osteoarthritis to be eligible for inclusion. Those eligible will be randomized to receive either foot orthoses and prescribed motion control shoes, or prescribed motion control shoes alone, to be worn for a period of 4 months. The feasibility of a phase III clinical trial will be evaluated by assessing factors such as recruitment rate, number of eligible participants, participant compliance with the study protocol, adverse events, and drop-out rate. A secondary aim of the study will be to determine completion rates and calculate effect sizes for patient reported outcome measures such as knee-related symptoms, function, quality of life, kinesiophobia, self-efficacy, general and mental health, and physical activity at 2 and 4 months. Primary outcomes will be reported descriptively while effect sizes and 95% confidence intervals will be calculated for the secondary outcome measures. Data will be analysed using an intention-to-treat principle. The results of this pilot trial will help determine the feasibility of a phase III clinical trial investigating whether foot orthoses plus motion control footwear are superior to motion control footwear alone in individuals with patellofemoral osteoarthritis. A Phase III clinical trial will help guide footwear and foot orthoses recommendations in the clinical management of this disorder. Retrospectively registered with the Australian New Zealand Clinical Trials Registry: ACTRN12615000002583. Date registered: 07/01/15.

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

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.

Supportive text messages for patients with alcohol use disorder and a comorbid depression: a protocol for a single-blind randomised controlled aftercare trial.

PubMed

Hartnett, Dan; Murphy, Edel; Kehoe, Elizabeth; Agyapong, Vincent; McLoughlin, Declan M; Farren, Conor

2017-05-29

Alcohol use disorders (AUDs) and mood disorders commonly co-occur, and are associated with a range of negative outcomes for patients. Mobile phone technology has the potential to provide personalised support for such patients and potentially improve outcomes in this difficult-to-treat cohort. The aim of this study is to examine whether receiving supporting SMS text messages, following discharge from an inpatient dual diagnosis treatment programme, has a positive impact on mood and alcohol abstinence in patients with an AUD and a comorbid mood disorder. The present study is a single-blind randomised controlled trial. Patients aged 18-70 years who meet the criteria for both alcohol dependency syndrome/alcohol abuse and either major depressive disorder or bipolar disorder according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV Axis I will be randomised to receive twice-daily supportive SMS text messages for 6 months plus treatment as usual, or treatment as usual alone, and will be followed-up at 3, 6, 9 and 12 months postdischarge. Primary outcome measures will include changes from baseline in cumulative abstinence duration, which will be expressed as the proportion of days abstinent from alcohol in the preceding 90 days, and changes from baseline in Beck Depression Inventory scores. The trial has received full ethical approval from the St. Patrick's Hospital Research Ethics Committee (protocol 13/14). Results of the trial will be disseminated through peer-reviewed journal articles and at academic conferences. NCT02404662; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effectiveness of different cryotherapies on pain and disease activity in active rheumatoid arthritis. A randomised single blinded controlled trial.

PubMed

Hirvonen, H E; Mikkelsson, M K; Kautiainen, H; Pohjolainen, T H; Leirisalo-Repo, M

2006-01-01

Local cryotherapy is used to relieve pain and inflammation in injuries and inflammatory conditions. Whole-body cryotherapy is an extreme method administered at -110 degrees C for 2 to 3 minutes. The aim of the study was to compare the effect of cryotherapies on pain and inflammation in patients with rheumatoid arthritis (RA). Sixty patients with active seropositive RA were recruited in a randomised controlled single-blinded study to receive whole-body cryotherapy at -110 degrees C, whole-body cryotherapy at -60 degrees C, application of local cold air at -30 degrees C and the use of cold packs locally. In the final analysis, the last 2 groups were pooled. The patients had 2-3 cryotherapy sessions daily for one week plus conventional physiotherapy. Clinical and laboratory variables and patient's and physician's global assessments were used to assess the outcome. Disease activity was calculated by DAS. Pain decreased in all treatment groups, most markedly in the whole-body cryotherapy (-110 degrees C) group. DAS decreased slightly with no statistically significant differences between the groups. No serious or permanent adverse effects were detected. Six of 40 patients (15%) discontinued the whole-body cryotherapy. Pain seemed to decrease more in patients in the whole-body cryotherapy at -110 degrees C than during other cryotherapies, but there were no significant differences in the disease activity between the groups. However, cryotherapy at -110 degrees C is expensive and available only in special centres and may have minor adverse effects. Based on our results, whole-body cryotherapy at -110 degrees C is not superior to local cryotherapy commonly used in RA patients for pain relief and as an adjunct to physiotherapy.

A Controlled, Randomized Double-Blind Study to Evaluate the Safety and Efficacy of Chitosan-N-Acetylcysteine for the Treatment of Dry Eye Syndrome.

PubMed

Schmidl, Doreen; Werkmeister, René; Kaya, Semira; Unterhuber, Angelika; Witkowska, Katarzyna J; Baumgartner, Renate; Höller, Sonja; O'Rourke, Maria; Peterson, Ward; Wolter, Annika; Prinz, Martin; Schmetterer, Leopold; Garhöfer, Gerhard

2017-06-01

This study was designed to evaluate the effect of chitosan-N-acetylcysteine (C-NAC) eye drops on tear film thickness (TFT) in patients with dry eye syndrome (DES). This was a controlled, randomized, double-blind clinical investigation with patients assigned to 2 cohorts. In Cohort I, 21 patients were randomized to receive 1 instillation of C-NAC eye drops in 1 eye and placebo (normal saline solution) in the contralateral eye. In Cohort II, 17 patients were randomized to receive C-NAC eye drops once (QD) or twice (BID) daily for 5 days. TFT was assessed with a custom-built ultrahigh-resolution optical coherence tomography system. In Cohort I, mean TFT increased from 3.9 ± 0.5 μm predose to 4.8 ± 1.1 μm 10 min postdose after treatment with C-NAC. The increase was significantly different from placebo over time (P < 0.0001) and remained stable until 24 h postdose. In Cohort II, TFT increased with QD and BID instillation, with no significant difference between regimens. In both groups, Ocular Surface Disease Index scores improved, fewer patients presented with corneal damage, and symptoms of ocular discomfort/conjunctival redness were reduced. A single instillation of C-NAC significantly increased mean TFT in patients with DES as early as 10 min after instillation and lasted for 24 h. The magnitude of the increase in TFT following a single instillation was comparable with that after instillation twice daily over 5 days. Corneal damage improved in >60% of patients. C-NAC could be a viable treatment option for DES.

Blindness and Glaucoma: A Multicenter Data Review from 7 Academic Eye Clinics.

PubMed

Rossetti, Luca; Digiuni, Maurizio; Montesano, Giovanni; Giovanni, Montesano; Centofanti, Marco; Fea, Antonio M; Iester, Michele; Frezzotti, Paolo; Figus, Michele; Ferreras, Antonio; Oddone, Francesco; Tanga, Lucia; Rolle, Teresa; Battaglino, Valentina; Posarelli, Chiara; Motolese, Ilaria; Mittica, Pietro; Bagaglia, Simone Alex; Menicacci, Cristina; De Cilla', Stefano; Autelitano, Alessandro; Fogagnolo, Paolo

2015-01-01

To evaluate frequency, conversion rate, and risk factors for blindness in glaucoma patients treated in European Universities. This multicenter retrospective study included 2402 consecutive patients with glaucoma in at least one eye. Medical charts were inspected and patients were divided into those blind and the remainder ('controls'). Blindness was defined as visual acuity≤0.05 and/or visual field loss to less than 10°. Unilateral and bilateral blindness were respectively 11.0% and 1.6% at the beginning, and 15.5% and 3.6% at the end of the observation period (7.5±5.5 years, range:1-25 years); conversion to blindness (at least unilateral) was 1.1%/year. 134 eyes (97 patients) developed blindness by POAG during the study. At the first access to study centre, they had mean deviation (MD) of -17.1±8.3 dB and treated intraocular pressure (IOP) of 17.1±6.6 mmHg. During follow-up the IOP decreased by 14% in these eyes but MD deteriorated by 1.1±3.5 dB/year, which was 5-fold higher than controls (0.2±1.6 dB/year). In a multivariate model, the best predictors for blindness by glaucoma were initial MD (p<0.001), initial IOP (p<0.001), older age at the beginning of follow-up (p<0.001), whereas final IOP was found to be protective (p<0.05). In this series of patients, blindness occurred in about 20%. Blindness by glaucoma had 2 characteristics: late diagnosis and/or late referral, and progression of the disease despite in most cases IOP was within the range of normality and target IOP was achieved; it could be predicted by high initial MD, high initial IOP, and old age.

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

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

PubMed Central

2010-01-01

Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581 PMID:20370916

Blindness alters the microstructure of the ventral but not the dorsal visual stream.

PubMed

Reislev, Nina L; Kupers, Ron; Siebner, Hartwig R; Ptito, Maurice; Dyrby, Tim B

2016-07-01

Visual deprivation from birth leads to reorganisation of the brain through cross-modal plasticity. Although there is a general agreement that the primary afferent visual pathways are altered in congenitally blind individuals, our knowledge about microstructural changes within the higher-order visual streams, and how this is affected by onset of blindness, remains scant. We used diffusion tensor imaging and tractography to investigate microstructural features in the dorsal (superior longitudinal fasciculus) and ventral (inferior longitudinal and inferior fronto-occipital fasciculi) visual pathways in 12 congenitally blind, 15 late blind and 15 normal sighted controls. We also studied six prematurely born individuals with normal vision to control for the effects of prematurity on brain connectivity. Our data revealed a reduction in fractional anisotropy in the ventral but not the dorsal visual stream for both congenitally and late blind individuals. Prematurely born individuals, with normal vision, did not differ from normal sighted controls, born at term. Our data suggest that although the visual streams are structurally developing without normal visual input from the eyes, blindness selectively affects the microstructure of the ventral visual stream regardless of the time of onset. We suggest that the decreased fractional anisotropy of the ventral stream in the two groups of blind subjects is the combined result of both degenerative and cross-modal compensatory processes, affecting normal white matter development.

The immediate use of a silicone sheet wound closure device in scar reduction and prevention.

PubMed

Parry, James R; Stupak, Howard D; Johnson, Calvin M

2016-02-01

Silicone has been used successfully postoperatively in the prevention of hypertrophic and other types of adverse scars. The Silicone Suture Plate (SSP) is a new, minimally invasive, sterile wound closure device that is applied intraoperatively to prevent adverse scarring. The SSP device permits immediate application of silicone while concurrently allowing for wound-edge tension redistribution. In this prospective, controlled, single-blinded clinical study, 8 consecutive patients undergoing deep-plane rhytidectomy were selected. SSP devices were placed on the patients' posterior rhytidectomy hairline incision; the mirror-image control site underwent standard suturing techniques. Three blinded, independent raters assessed the treatment and control sides at 6-week and 4-month follow-up visits, using the Objective Scar Assessment Scale (OSAS), a validated scar assessment tool. The 6-week OSAS scores revealed an 18.4% improvement on the side with the SSP device (13.3) when compared to the control side (16.3). The 4-month OSAS scores showed a 27.3% improvement on the treatment side from 12.7 (control) to 9.2 (SSP). These OSAS results were found to be statistically significant when taken as an aggregate of the observers' scores, but not when observers' scores were measured individually (p < 0.05). In our series of patients, we showed promising results with the use of the SSP device. Early silicone application and tissue tension distribution contributed to an overall more aesthetically pleasing scar compared to those seen with standard suturing techniques, although more testing is required.

Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study.

PubMed

Fernando, Disala; Siederer, Sarah; Singh, Sunita; Schneider, Ian; Gupta, Ashutosh; Powell, Marcy; Richards, Duncan; McIntosh, Michelle P; Lambert, Peter; Fowles, Susan

2017-08-01

The utility of intramuscular (IM) oxytocin for the prevention of postpartum hemorrhage in resource-poor settings is limited by the requirement for temperature-controlled storage and skilled staff to administer the injection. We evaluated the safety, tolerability and pharmacokinetics (PK) of a heat-stable, inhaled (IH) oxytocin formulation. This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years. Subjects initially received IM oxytocin 10 international units (IU) on day 1, IH placebo on day 2, and IH oxytocin 50μg on day 3. Subjects were then randomized 4:1 using validated GSK internal software to IH placebo or ascending doses of IH oxytocin (200, 400, 600μg). PK was assessed by comparing systemic exposure (maximum observed plasma concentration, area under the concentration-time curve, and plasma concentrations at 10 and 30min post dose) for IH versus IM oxytocin. Adverse events (AEs), spirometry, laboratory tests, vital signs, electrocardiograms, physical examinations, and cardiac telemetry were assessed. Subjects were recruited between September 14, 2015 and October 12, 2015. Of the 16 subjects randomized following initial dosing, 15 (IH placebo n=3; IH oxytocin n=12) completed the study. IH (all doses) and IM oxytocin PK profiles were comparable in shape. However, systemic exposure with IH oxytocin 400μg most closely matched IM oxytocin 10IU. Systemic exposure was approximately dose proportional for IH oxytocin. No serious AEs were reported. No clinically significant findings were observed for any safety parameters. These data suggest that similar oxytocin systemic exposure can be achieved with IM and IH administration routes, and no safety concerns were identified with either route. The inhalation route may offer the opportunity to increase access to oxytocin for women giving birth in resource-poor settings. Copyright © 2017. Published by Elsevier B.V.

Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study.

PubMed

Morris, Jacqui H; Kelly, Chris; Toma, Madalina; Kroll, Thilo; Joice, Sara; Mead, Gillian; Donnan, Peter; Williams, Brian

2014-09-28

Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness. This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups. Findings will inform sample size calculations for a definitive trial. Thematic analysis of qualitative data will be managed using the Framework Approach. Framework is an analytical approach for qualitative data, commonly used in policy and medical research. If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation. Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.

High-Performance Visible-Blind UV Phototransistors Based on n-Type Naphthalene Diimide Nanomaterials.

PubMed

Song, Inho; Lee, Seung-Chul; Shang, Xiaobo; Ahn, Jaeyong; Jung, Hoon-Joo; Jeong, Chan-Uk; Kim, Sang-Wook; Yoon, Woojin; Yun, Hoseop; Kwon, O-Pil; Oh, Joon Hak

2018-04-11

This study investigates the performance of single-crystalline nanomaterials of wide-band gap naphthalene diimide (NDI) derivatives with methylene-bridged aromatic side chains. Such materials are found to be easily used as high-performance, visible-blind near-UV light detectors. NDI single-crystalline nanoribbons are assembled using a simple solution-based process (without solvent-inclusion problems), which is then applied to organic phototransistors (OPTs). Such OPTs exhibit excellent n-channel transistor characteristics, including an average electron mobility of 1.7 cm 2 V -1 s -1 , sensitive UV detection properties with a detection limit of ∼1 μW cm -2 , millisecond-level responses, and detectivity as high as 10 15 Jones, demonstrating the highly sensitive organic visible-blind UV detectors. The high performance of our OPTs originates from the large face-to-face π-π stacking area between the NDI semiconducting cores, which is facilitated by methylene-bridged aromatic side chains. Interestingly, NDI-based nanoribbon OPTs exhibit a distinct visible-blind near-UV detection with an identical detection limit, even under intense visible light illumination (for example, 10 4 times higher intensity than UV light intensity). Our findings demonstrate that wide-band gap NDI-based nanomaterials are highly promising for developing high-performance visible-blind UV photodetectors. Such photodetectors could potentially be used for various applications including environmental and health-monitoring systems.

Functionally Specific Oscillatory Activity Correlates between Visual and Auditory Cortex in the Blind

ERIC Educational Resources Information Center

Schepers, Inga M.; Hipp, Joerg F.; Schneider, Till R.; Roder, Brigitte; Engel, Andreas K.

2012-01-01

Many studies have shown that the visual cortex of blind humans is activated in non-visual tasks. However, the electrophysiological signals underlying this cross-modal plasticity are largely unknown. Here, we characterize the neuronal population activity in the visual and auditory cortex of congenitally blind humans and sighted controls in a…

A randomised controlled single-blind trial of the effects of Reiki and positive imagery on well-being and salivary cortisol.

PubMed

Bowden, Deborah; Goddard, Lorna; Gruzelier, John

2010-01-15

The study investigated whether participants who received Reiki would show greater health and well-being benefits than a group who received no Reiki. A method of blinding participants to Reiki was also tested, where non-contact Reiki or No-Reiki with random assignment was given to 35 healthy psychology undergraduates whose attention was absorbed in one of three tasks involving self-hypnosis/relaxation. Participants experienced ten 20-min intervention sessions over a period of two and a half to 12 weeks. Reiki was directed by the experimenter who sat behind the participants as they were absorbed in the tasks. Self-report measures of illness symptoms, mood and sleep were assessed pre-post-intervention as was salivary cortisol. While the Reiki group had a tendency towards a reduction in illness symptoms, a substantive increase was seen in the No-Reiki. The Reiki group also had a near-significant comparative reduction in stress, although they also had significantly higher baseline illness symptoms and stress scores. The Reiki blinding was successful - the groups did not differ statistically in their beliefs regarding group membership. The results are suggestive that the Reiki buffered the substantive decline in health in the course of the academic year seen in the No-Reiki group.

Blind Biobanking of the Prostatectomy Specimen: Critical Evaluation of the Existing Techniques and Development of the New 4-Level Tissue Extraction Model With High Sampling Efficacy.

PubMed

Tolkach, Yuri; Eminaga, Okyaz; Wötzel, Fabian; Huss, Sebastian; Bettendorf, Olaf; Eltze, Elke; Abbas, Mahmoud; Imkamp, Florian; Semjonow, Axel

2017-03-01

Fresh tissue is mandatory to perform high-quality translation studies. Several models for tissue extraction from prostatectomy specimens without guidance by frozen sections are already introduced. However, little is known about the sampling efficacy of these models, which should provide representative tissue in adequate volumes, account for multifocality and heterogeneity of tumor, not violate the routine final pathological examination, and perform quickly without frozen section-based histological control. The aim of the study was to evaluate the sampling efficacy of the existing tissue extraction models without guidance by frozen sections ("blind") and to develop an optimized model for tissue extraction. Five hundred thirty-three electronic maps of the tumor distribution in prostates from a single-center cohort of the patients subjected to radical prostatectomy were used for analysis. Six available models were evaluated in silico for their sampling efficacy. Additionally, a novel model achieving the best sampling efficacy was developed. The available models showed high efficacies for sampling "any part" from the tumor (up to 100%), but were uniformly low in efficacy to sample all tumor foci from the specimens (with the best technique sampling only 51.6% of the all tumor foci). The novel 4-level extraction model achieved a sampling efficacy of 93.1% for all tumor foci. The existing "blind" tissue extraction models from prostatectomy specimens without frozen sections control are suitable to target tumor tissues but these tissues do not represent the whole tumor. The novel 4-level model provides the highest sampling efficacy and a promising potential for integration into routine. Prostate 77: 396-405, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

A double-blind, placebo-controlled interaction study between oxcarbazepine and carbamazepine, sodium valproate and phenytoin in epileptic patients.

PubMed Central

McKee, P J; Blacklaw, J; Forrest, G; Gillham, R A; Walker, S M; Connelly, D; Brodie, M J

1994-01-01

1. The effect of carbamazepine (CBZ), sodium valproate (VPA) and phenytoin (PHT) on the pharmacokinetics of oxcarbazepine (OXC) was explored in three groups of 12 epileptic patients taking one of these drug as monotherapy. 2. Each patient took a single 600 mg dose of OXC followed 7 days later by 3 weeks' treatment with OXC 300 mg thrice daily and matched placebo in random order. 3. Seven untreated patients, acting as controls, were prescribed the single OXC dose and 3 weeks' active treatment only. 4. In those patients completing the study, the area under the concentration-time curve (AUC) at steady-state for hydroxycarbazepine (OHCZ), the active metabolite of OXC, was significantly lower in the CBZ-treated group than in controls (P < 0.05). 5. No other differences in AUCs or elimination half-lives for OHCZ were found between treated and untreated patients following single or multiple OXC dosing. 6. Median AUCs of CBZ, VPA and PHT during a dosage interval did not differ significantly after treatment with OXC and placebo. 7. Ten patients completing the study complained of side-effects during treatment with OXC compared with one taking placebo (P < 0.01). 8. There were no important changes in cognitive function testing during administration of OXC compared with placebo. 9. Standard doses of OXC can be given as add-on therapy in epileptic patients receiving CBZ, VPA or PHT without producing a clinically relevant pharmacokinetic interaction. PMID:8148215

Pelvic floor muscle training for urinary incontinence in female stroke patients: a randomized, controlled and blinded trial.

PubMed

Shin, Doo Chul; Shin, Seung Ho; Lee, Myung Mo; Lee, Kyoung Jin; Song, Chang Ho

2016-03-01

To examine the effects of pelvic floor muscle training (PFMT) on the contractility of pelvic floor muscle and lower urinary tract symptoms in female stroke patients. Randomized, single-blind controlled study. Outpatient rehabilitation hospital. Thirty one female patients who were more than three months post-stroke and stress urinary incontinence. The subjects were randomized to either a PFMT group (n = 16), or a control group (n = 15). Both groups received general rehabilitation exercise for 6 weeks, but the PFMT group additionally received PFMT for 6 weeks. Vaginal function test using a perineometer (maximal vaginal squeeze pressure) and intra-vaginal electromyography (activity of pelvic floor muscle), and urinary symptoms and quality of life using a Bristol Female Lower Urinary Tract Symptom questionnaire. After intervention, the maximal vaginal squeeze pressures for the PFMT and control groups were 18.35 (5.24) and 8.46 (3.50) mmHg, respectively. And the activities of pelvic floor muscle of the PFMT and control groups was 12.09 (2.24) ㎶ and 9.33 (3.40) ㎶, respectively. After intervention, the changes of scores for inconvenience in the activity of daily living of the PFMT and control groups were -15.00 (6.25) and -0.17 (1.59), respectively. In addition, the changes of score for lower urinary tract symptom was improved more in the PFMT group (-4.17 (4.00)) than in the control group (-0.25 (1.29)) (P < 0.05). These findings suggest that PFMT is beneficial for the management of urinary incontinence in female stroke patients. © The Author(s) 2015.

The acute effects of baobab fruit ( Adansonia digitata) on satiety in healthy adults.

PubMed

Garvey, Rebecca; Clegg, Miriam; Coe, Shelly

2017-06-01

The baobab fruit is high in both dietary fibre and polyphenols and therefore may increase satiety. The aim of the study was to measure the effects of baobab fruit extract on satiety. The study was conducted on 20 healthy participants. The study was a one-day single-blind crossover design. Participants were randomised to either a test smoothie consisting of 15 g of baobab extract or a control smoothie without the addition of baobab. Subjective ratings of satiety were taken on visual analogue scales immediately pre-consumption and then post-consumption, and energy intake at a post ad libitum meal was recorded. Subjective measures of hunger were reduced following the test smoothie compared with the control ( p < 0.05). There was no significant difference in calorie intake at an ad libitum meal. This research has positive implications for the use of baobab for reducing hunger, possibly having a positive effect on weight maintenance.

Effects of intranasal oxytocin on the attentional bias to emotional stimuli in patients with bulimia nervosa.

PubMed

Kim, Youl-Ri; Eom, Jin-Sup; Leppanen, Jenni; Leslie, Monica; Treasure, Janet

2018-05-01

Bulimia nervosa (BN) is characterized by binge eating and emotional dysregulation including increased negative affectivity (anger, anxiety). The aim of this study was to examine the effect of oxytocin on attentional processes towards anger in patients with BN. The study design consisted of a double-blind, placebo-controlled within-subject crossover, single dose experiment. Sixty-four women (31 patients with BN and 33 healthy comparisons) completed self-reported measures to evaluate emotional difficulties and were administered a single dose of intranasal oxytocin (40IU) or placebo followed by a visual probe detection task to examine attentional orienting to angry or happy faces. Patients with BN reported higher emotional dysregulation and more difficulties in controlling anger compared to the healthy comparison group. Patients with BN and the healthy women exhibited similar attentional bias to angry faces in the placebo condition. Intranasal oxytocin reduced the attentional bias towards angry faces in both the BN patients and the healthy women. We found that a single dose of oxytocin reduced vigilance towards angry faces in patients with BN as well as healthy women. The results showed that patients with BN are not different from healthy women in terms of vigilance towards threat. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of proton pump inhibitors on gastric juice volume, gastric pH and gastric intramucosal pH in critically ill patients : a randomized, double-blind, placebo-controlled study.

PubMed

Gursoy, Olcay; Memiş, Dilek; Sut, Necdet

2008-01-01

This study aimed to determine the effect of administration of a single-dose proton pump inhibitor (PPI) on gastric intramucosal pH (pHi), gastric juice volume and gastric pH in critically ill patients. This prospective, randomized, double-blind, placebo-controlled study included 75 patients who were divided into five groups that received the following treatment: group C (n = 15), saline 100 mL; group O (n = 15), omeprazole 20 mg; group P (n = 15), pantoprazole 40 mg; group E (n = 15), esomeprazole 20 mg; and group R (n = 15), rabeprazole 20 mg. All treatments were administered nasogastrically in 100 mL of physiological saline. Measurements of gastric pHi, gastric juice volume and gastric pH were obtained immediately before and 2, 4 and 6 hours after administration of treatments. In addition, gastric content was aspirated and its volume was recorded. Initial gastric pHi, gastric juice volume and gastric pH values were not statistically significantly different among the groups (p > 0.05). No statistically significant difference in gastric pHi was seen among the groups before or 2, 4 or 6 hours after saline or PPI administration. At hours 2, 4 and 6, gastric pH in the pantoprazole, esomeprazole and rabeprazole groups increased significantly, whereas gastric juice volume decreased significantly, compared with the omeprazole and placebo groups (p < 0.001). No statistically significant differences were seen between the pantoprazole, esomeprazole and rabeprazole groups. This is the first study to show that single-dose pantoprazole, esomeprazole and rabeprazole are associated with greater gastric pH increase and greater gastric juice volume decrease than omeprazole in critically ill patients. Our study also suggests that PPIs do not affect gastric pHi measurements in critically ill patients and can be administered during pH monitoring.

Methodology used in comparative studies assessing programmes of transition from paediatrics to adult care programmes: a systematic review

PubMed Central

Le Roux, E; Mellerio, H; Guilmin-Crépon, S; Gottot, S; Jacquin, P; Boulkedid, R; Alberti, C

2017-01-01

Objective To explore the methodologies employed in studies assessing transition of care interventions, with the aim of defining goals for the improvement of future studies. Design Systematic review of comparative studies assessing transition to adult care interventions for young people with chronic conditions. Data sources MEDLINE, EMBASE, ClinicalTrial.gov. Eligibility criteria for selecting studies 2 reviewers screened comparative studies with experimental and quasi-experimental designs, published or registered before July 2015. Eligible studies evaluate transition interventions at least in part after transfer to adult care of young people with chronic conditions with at least one outcome assessed quantitatively. Results 39 studies were reviewed, 26/39 (67%) published their final results and 13/39 (33%) were in progress. In 9 studies (9/39, 23%) comparisons were made between preintervention and postintervention in a single group. Randomised control groups were used in 9/39 (23%) studies. 2 (2/39, 5%) reported blinding strategies. Use of validated questionnaires was reported in 28% (11/39) of studies. In terms of reporting in published studies 15/26 (58%) did not report age at transfer, and 6/26 (23%) did not report the time of collection of each outcome. Conclusions Few evaluative studies exist and their level of methodological quality is variable. The complexity of interventions, multiplicity of outcomes, difficulty of blinding and the small groups of patients have consequences on concluding on the effectiveness of interventions. The evaluation of the transition interventions requires an appropriate and common methodology which will provide access to a better level of evidence. We identified areas for improvement in terms of randomisation, recruitment and external validity, blinding, measurement validity, standardised assessment and reporting. Improvements will increase our capacity to determine effective interventions for transition care. PMID:28131998

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

PubMed Central

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-01-01

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

PubMed

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-08-23

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in College Students with ADHD

ERIC Educational Resources Information Center

DuPaul, George J.; Weyandt, Lisa L.; Rossi, Joseph S.; Vilardo, Brigid A.; O'Dell, Sean M.; Carson, Kristen M.; Verdi, Genevieve; Swentosky, Anthony

2012-01-01

Objective: To evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) was examined for ADHD participants over five…

A randomized controlled trial of electrocoagulation-enabled biopsy versus conventional biopsy in the diagnosis of endobronchial lesions.

PubMed

Khan, Ajmal; Aggarwal, Ashutosh N; Agarwal, Ritesh; Bal, Amanjit; Gupta, Dheeraj

2011-01-01

Although electrocoagulation at time of endobronchial biopsy can potentially reduce procedure-related bleeding during fiberoptic bronchoscopy (FOB), it can also impair quality of tissue specimen; credible data for either are lacking. To evaluate the impact of hot biopsy on the quality of tissue samples and to quantify the amount of procedure-related bleeding during endobronchial biopsy. In this single-center, prospective, single-blind, randomized controlled study we included adult patients referred for FOB and having endobronchial lesions. Patients were randomized to bronchial biopsy using an electrocoagulation-enabled biopsy forceps, with (EC+ group) or without (EC- group) application of electrocoagulation current (40 W for 10 s in a monopolar mode). Procedure-related bleeding was semi-quantified by observer description, as well as through a visual analogue scale. Overall quality of biopsy specimen and tissue damage were assessed and graded by a pulmonary pathologist blinded to FOB details. 160 patients were randomized to endobronchial biopsy with (n = 81) or without (n = 79) the application of electrocoagulation. There were no severe bleeding episodes in either group, and severity of bleeding in the EC+ and EC- groups was similar (median visual analogue scale scores of 14 and 16, respectively). Histopathological diagnosis was similar in the EC+ and EC- groups (77.8% and 82.3%, respectively). There was no significant difference in tissue quality between the two groups. Use of electrocoagulation-enabled endobronchial biopsy does not alter specimen quality and does not result in any significant reduction in procedure-related bleeding. Copyright © 2010 S. Karger AG, Basel.

An Overwhelming Desire to Be Blind: Similarities and Differences between Body Integrity Identity Disorder and the Wish for Blindness.

PubMed

Gutschke, Katja; Stirn, Aglaja; Kasten, Erich

2017-01-01

The urge to be permanently blind is an extremely rare mental health disturbance. The underlying cause of this desire has not been determined yet, and it is uncertain whether the wish for blindness is a condition that can be included in the context of body integrity identity disorder, a condition where people feel an overwhelming need to be disabled, in many cases by amputation of a limb or through paralysis. The aim of this study is to test the hypothesis that people with a desire for blindness suffer from a greater degree of visual stress in daily activities than people in a healthy visual control group. We created a Likert scale questionnaire to measure visual stress, covering a wide range of everyday situations. The wish for blindness is extremely rare and worldwide only 5 people with an urge to be blind were found to participate in the study (4 female, 1 male). In addition, a control group of 35 (28 female, 7 male) visually healthy people was investigated. Questions addressing issues that may be experienced by participants with a desire to be blind were integrated into the questionnaire. The hypothesis that people with a desire for blindness suffer from a significantly higher visual overload in activities of daily living than visually healthy subjects was confirmed; the significance of visual stress between these groups was p < 0.01. In addition, an interview with the 5 affected participants supported the causal role of visual overload. The desire for blindness seems to originate from visual overload caused by either ophthalmologic or organic brain disturbances. In addition, psychological reasons such as certain personal character traits may play an active role in developing, maintaining, and reinforcing one's desire to be blind.

Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care.

PubMed

Ridd, Matthew J; Garfield, Kirsty; Gaunt, Daisy M; Hollinghurst, Sandra; Redmond, Niamh M; Powell, Kingsley; Wilson, Victoria; Guy, Richard H; Ball, Nicola; Shaw, Lindsay; Purdy, Sarah; Metcalfe, Chris

2016-11-16

To determine the feasibility of a randomised controlled trial of 'leave on' emollients for children with eczema. Single-centre, pragmatic, 4-arm, observer-blinded, parallel, randomised feasibility trial. General practices in the UK. Children with eczema aged 1 month to <5 years. Primary outcome-proportion of parents who reported use of the allocated study emollient every day for the duration of follow-up (12 weeks). Other feasibility outcomes-participant recruitment and retention, data collection and completeness and blinding of observers to allocation. Aveeno lotion, Diprobase cream, Doublebase gel, Hydromol ointment. 197 children were recruited-107 by self-referral (mainly via practice mail-outs) and 90 by inconsultation (clinician consenting and randomising) pathways. Participants recruited inconsultation were younger, had more severe Patient-Oriented Eczema Measure scores and were more likely to withdraw than self-referrals. Parents of 20 (10%) of all the randomised participants reported using the allocated emollient daily for 84 days. The use of other non-study emollients was common. Completeness of data collected by parent-held daily diaries and at monthly study visits was good. Daily diaries were liked (81%) but mainly completed on paper rather than via electronic ('app') form. Major costs drivers were general practitioner consultations and eczema-related prescriptions. Observer unblinding was infrequent, and occurred at the baseline or first follow-up visit through accidental disclosure. It is feasible in a primary care setting to recruit and randomise young children with eczema to emollients, follow them up and collect relevant trial data, while keeping observers blinded to their allocation. However, reported use of emollients (study and others) has design implications for future trials. ISRCTN21828118/EudraCT2013-003001-26. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care

PubMed Central

Ridd, Matthew J; Garfield, Kirsty; Gaunt, Daisy M; Redmond, Niamh M; Powell, Kingsley; Wilson, Victoria; Guy, Richard H; Ball, Nicola; Shaw, Lindsay; Purdy, Sarah; Metcalfe, Chris

2016-01-01

Objectives To determine the feasibility of a randomised controlled trial of ‘leave on’ emollients for children with eczema. Design Single-centre, pragmatic, 4-arm, observer-blinded, parallel, randomised feasibility trial. Setting General practices in the UK. Participants Children with eczema aged 1 month to <5 years. Outcome measures Primary outcome—proportion of parents who reported use of the allocated study emollient every day for the duration of follow-up (12 weeks). Other feasibility outcomes—participant recruitment and retention, data collection and completeness and blinding of observers to allocation. Interventions Aveeno lotion, Diprobase cream, Doublebase gel, Hydromol ointment. Results 197 children were recruited—107 by self-referral (mainly via practice mail-outs) and 90 by inconsultation (clinician consenting and randomising) pathways. Participants recruited inconsultation were younger, had more severe Patient-Oriented Eczema Measure scores and were more likely to withdraw than self-referrals. Parents of 20 (10%) of all the randomised participants reported using the allocated emollient daily for 84 days. The use of other non-study emollients was common. Completeness of data collected by parent-held daily diaries and at monthly study visits was good. Daily diaries were liked (81%) but mainly completed on paper rather than via electronic (‘app’) form. Major costs drivers were general practitioner consultations and eczema-related prescriptions. Observer unblinding was infrequent, and occurred at the baseline or first follow-up visit through accidental disclosure. Conclusions It is feasible in a primary care setting to recruit and randomise young children with eczema to emollients, follow them up and collect relevant trial data, while keeping observers blinded to their allocation. However, reported use of emollients (study and others) has design implications for future trials. Trial registration number ISRCTN21828118/EudraCT2013-003001-26. PMID:27852708

A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life.

PubMed

Cappello, Carmelina; Tremolaterra, Fabrizio; Pascariello, Annalisa; Ciacci, Carolina; Iovino, Paola

2013-03-01

The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria. There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS. This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed. Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p < 0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group. This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.

The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

PubMed Central

Fu, Juanjuan; Ding, Hong; Yang, Haimiao; Huang, Yuhong

2017-01-01

Background Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. Methods/Design This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson's scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson's scale and TCM symptom scale. Ethics and Trial Registration This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349). PMID:29430253

Ginkgo biloba special extract LI 1370 improves dual-task walking in patients with MCI: a randomised, double-blind, placebo-controlled exploratory study.

PubMed

Gschwind, Yves J; Bridenbaugh, Stephanie A; Reinhard, Sarah; Granacher, Urs; Monsch, Andreas U; Kressig, Reto W

2017-08-01

In patients with mild cognitive impairment (MCI), gait instability, particularly in dual-task situations, has been associated with impaired executive function and an increased fall risk. Ginkgo biloba extract (GBE) could be an effective mean to improve gait stability. This study investigated the effect of GBE on spatio-temporal gait parameters of MCI patients while walking under single and dual-task conditions. Fifty patients aged 50-85 years with MCI and associated dual-task-related gait impairment participated in this randomised, double-blind, placebo-controlled, exploratory phase IV drug trial. Intervention group (IG) patients received GBE (Symfona ® forte 120 mg) twice-daily for 6 months while control group (CG) patients received placebo capsules. A 6-month open-label phase with identical GBE dosage followed. Gait was quantified at months 0, 3, 6 and 12. After 6 months, dual-task-related cadence increased in the IG compared to the CG (p = 0.019, d = 0.71). No significant changes, but GBE-associated numerical non-significant trends were found after 6-month treatment for dual-task-related gait velocity and stride time variability. Findings suggest that 120 mg of GBE twice-daily for at least 6 months may improve dual-task-related gait performance in patients with MCI. The observed gait improvements add to the understanding of the self-reported unspecified improvements among MCI patients when treated with standardised GBE.

Exposure of eyes to perfume: a double-blind, placebo-controlled experiment.

PubMed

Elberling, J; Duus Johansen, J; Dirksen, A; Mosbech, H

2006-08-01

Environmental perfume exposure can elicit bothersome respiratory symptoms. Symptoms are induced at exposure levels which most people find tolerable, and the mechanisms are unclear. The aim of the study was to investigate patients with eye and respiratory symptoms related to environmental perfume, by exposing the eyes to perfume in a double-blind, placebo-controlled study.Twenty-one eczema patients with respiratory symptoms elicited by perfume were compared with 21 healthy volunteers in a sex- and age-matched case-control study. The participants completed a symptom questionnaire, and underwent a double-blind, placebo-controlled exposure to perfume. Of the 42 individuals tested, 10 had more eye symptoms (irritation, itching, and tears) during perfume exposure than during placebo exposures, and eight of these individuals (P = 0.07, Fisher's exact test) belonged to the patient group. A true positive eye reaction to perfume was significantly associated with identification of perfume as an active exposure (P < 0.05). In this study, vapor of perfume elicited irritation in the eyes independently of olfaction, but the relative importance of ocular chemoperception in relation to elicitation of respiratory symptoms from common environmental exposures to perfume remains unclear. We investigated the hypothesis of an association between respiratory symptoms related to perfume and ocular perfume sensitivity by exposing the eyes to perfume in a double blind, placebo-controlled experiment. Vapors of perfume provoked symptoms in the relevant eye in some patients and healthy control persons, but under our exposure conditions, ocular chemesthesis failed to elicit respiratory symptoms.

Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial

PubMed Central

Lazzari, Roberta Delasta; Politti, Fabiano; Santos, Cibele Alimedia; Dumont, Arislander Jonathan Lopes; Rezende, Fernanda Lobo; Grecco, Luanda André Collange; Braun Ferreira, Luiz Alfredo; Oliveira, Claudia Santos

2015-01-01

[Purpose] The aim of the present study was to investigate the effects of a single session of transcranial direct current stimulation combined with virtual reality training on the balance of children with cerebral palsy. [Subjetcs and Methods] Children with cerebral palsy between four and 12 years of age were randomly allocated to two groups: an experimental group which performed a single session of mobility training with virtual reality combined with active transcranial direct current stimulation; and a control group which performed a single session of mobility training with virtual reality combined with placebo transcranial direct current stimulation. The children were evaluated before and after the training protocols. Static balance (sway area, displacement, velocity and frequency of oscillations of the center of pressure on the anteroposterior and mediolateral axes) was evaluated using a force plate under four conditions (30-second measurements for each condition): feet on the force plate with the eyes open, and with the eyes closed; feet on a foam mat with the eyes open, and with the eyes closed. [Results] An increase in sway velocity was the only significant difference found. [Conclusion] A single session of anodal transcranial direct current stimulation combined with mobility training elicited to lead to an increase in the body sway velocity of children with cerebral palsy. PMID:25931726

Superior Orthonasal but Not Retronasal Olfactory Skills in Congenital Blindness

PubMed Central

Gagnon, Lea; Ismaili, Abd Rahman Alaoui; Ptito, Maurice; Kupers, Ron

2015-01-01

Sight is undoubtedly important for finding and appreciating food, and cooking. Blind individuals are strongly impaired in finding food, limiting the variety of flavours they are exposed to. We have shown before that compared to sighted controls, congenitally blind individuals have enhanced olfactory but reduced taste perception. In this study we tested the hypothesis that congenitally blind subjects have enhanced orthonasal but not retronasal olfactory skills. Twelve congenitally blind and 14 sighted control subjects, matched in age, gender and body mass index, were asked to identify odours using grocery-available food powders. Results showed that blind subjects were significantly faster and tended to be better at identifying odours presented orthonasally. This was not the case when odorants were presented retronasally. We also found a significant group x route interaction, showing that although both groups performed better for retronasally compared to orthonasally presented odours, this gain was less pronounced for blind subjects. Finally, our data revealed that blind subjects were more familiar with the orthonasal odorants and used the retronasal odorants less often for cooking than their sighted counterparts. These results confirm that orthonasal but not retronasal olfactory perception is enhanced in congenital blindness, a result that is concordant with the reduced food variety exposure in this group. PMID:25822780

Analysis of acute naproxen administration on memory in young adults: A randomized, double-blind, placebo-controlled study.

PubMed

Wilson, Jack H; Criss, Amy H; Spangler, Sean A; Walukevich, Katherine; Hewett, Sandra

2017-10-01

Nonsteroidal anti-inflammatory drugs work by non-selectively inhibiting cyclooxygenase enzymes. Evidence indicates that metabolites of the cyclooxygenase pathway play a critical role in the process of learning and memory. We evaluated whether acute naproxen treatment impairs short-term working memory, episodic memory, or semantic memory in a young, healthy adult population. Participants received a single dose of placebo or naproxen (750 mg) in random order separated by 7-10 days. Two hours following administration, participants completed five memory tasks. The administration of acute high-dose naproxen had no effect on memory in healthy young adults.

A single session, group study of exposure and Eye Movement Desensitization and Reprocessing in treating Posttraumatic Stress Disorder among Vietnam War veterans: preliminary data.

PubMed

Rogers, S; Silver, S M; Goss, J; Obenchain, J; Willis, A; Whitney, R L

1999-01-01

This report summarizes data gathered thus far from an ongoing study. Two groups (total N = 12) of Vietnam War veterans diagnosed with Posttraumatic Stress Disorder (PTSD) received a single session of exposure or Eye Movement Desensitization and Reprocessing (EMDR) focusing on the veterans' most distressing war experience. Group assignment was random, treatment providers were blind to assessment data, and the pre- and posttreatment assessor was blind to treatment assignment. Both groups showed improvement on the Impact of Event Scale. EMDR treatment resulted in greater positive changes in within-session Subjective Units of Discomfort levels and on self-monitored severity of intrusive recollection. A trend toward decreased heart rate reactivity was observed in both groups. Results must be considered carefully due to the small number of subjects used in the study.

Single-Dose Adductor Canal Block With Local Infiltrative Analgesia Compared With Local Infiltrate Analgesia After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Nader, Antoun; Kendall, Mark C; Manning, David W; Beal, Matthew; Rahangdale, Rohit; Dekker, Robert; De Oliveira, Gildasio S; Kamenetsky, Eric; McCarthy, Robert J

A single-dose adductor canal block can provide postoperative analgesia for patients undergoing total knee arthroplasty (TKA). The purpose of this study was to assess postoperative opioid consumption after ultrasound-guided single-injection bupivacaine compared with saline adductor canal block for patients undergoing TKA. After institutional review board approval, written informed consent was obtained from patients (>18 years old) undergoing elective TKA. Subjects were randomized into 2 groups as follows: adductor canal blockade with 10 mL of bupivacaine 0.25% with epinephrine 1:300,000 or 10 mL of normal saline. All patients received a periarticular infiltration mixture intraoperatively with scheduled and patient requested oral and IV analgesics postoperatively for breakthrough pain. Personnel blinded to group allocation recorded pain scores and opioid consumption every 6 hours. Pain burden, area under the numeric rating score for pain, was calculated for 36 hours. The primary outcome was postoperative IV/IM morphine (mg morEq) consumption at 36 hours after surgery. Forty (28 women/12 men) subjects were studied. Postoperative opioid consumption was reduced in the bupivacaine 48 (39 to 61) mg morEq compared with saline 60 (49 to 85) mg morEq, difference -12 (-33 to -2) mg morEq (P = 0.03). Pain burden at rest was decreased in the bupivacaine 71 (37 to 120) score · hours compared with saline 131 (92 to 161) score · hours, difference -60 (-93 to -14) score · hours (P = 0.009). Adductor canal blockade with bupivacaine 0.25% with epinephrine 1:300,000 effectively reduces pain and opioid requirement in the postoperative period after TKA. Adductor canal blockade is an effective pain management adjunct for patients undergoing TKA.

Effect of levodopa in combination with physiotherapy on functional motor recovery after stroke: a prospective, randomised, double-blind study.

PubMed

Scheidtmann, K; Fries, W; Müller, F; Koenig, E

2001-09-08

Functional disability is generally caused by hemiplegia after stroke. Physiotherapy used to be the only way of improving motor function in such patients. However, administration of amphetamines in addition to exercise improves motor recovery in animals, probably by increasing the concentration of norepinephrine in the central nervous system. Our aim was to ascertain whether levodopa could enhance the efficacy of physiotherapy after hemiplegia. We did a prospective, randomised, placebo-controlled, double-blind study in which we enrolled 53 primary stroke patients. For the first 3 weeks patients received single doses of levodopa 100 mg or placebo daily in combination with physiotherapy. For the second 3 weeks patients had only physiotherapy. We quantitatively assessed motor function every week with Rivermead motor assessment (RMA). Six patients were excluded from analyses because of non-neurological complications. Motor recovery was significantly improved after 3 weeks of drug intervention in those on levodopa (RMA improved by 6.4 points) compared with placebo (4.1), and the result was independent of initial degree of impairment (p<0.004). The advantage of the levodopa group was maintained at study endpoint 3 weeks after levodopa was stopped. At the end of the study the total RMA score gain for the levodopa group was 8.2 points compared with 5.7 in the placebo group (p=0.020). A single dose of levodopa is well tolerated and, when given in combination with physiotherapy, enhances motor recovery in patients with hemiplegia. In view of its minimal side-effects, levodopa will be a possible add- on during stroke rehabilitation.

Enhanced perception of pitch changes in speech and music in early blind adults.

PubMed

Arnaud, Laureline; Gracco, Vincent; Ménard, Lucie

2018-06-12

It is well known that congenitally blind adults have enhanced auditory processing for some tasks. For instance, they show supra-normal capacity to perceive accelerated speech. However, only a few studies have investigated basic auditory processing in this population. In this study, we investigated if pitch processing enhancement in the blind is a domain-general or domain-specific phenomenon, and if pitch processing shares the same properties as in the sighted regarding how scores from different domains are associated. Fifteen congenitally blind adults and fifteen sighted adults participated in the study. We first created a set of personalized native and non-native vowel stimuli using an identification and rating task. Then, an adaptive discrimination paradigm was used to determine the frequency difference limen for pitch direction identification of speech (native and non-native vowels) and non-speech stimuli (musical instruments and pure tones). The results show that the blind participants had better discrimination thresholds than controls for native vowels, music stimuli, and pure tones. Whereas within the blind group, the discrimination thresholds were smaller for musical stimuli than speech stimuli, replicating previous findings in sighted participants, we did not find this effect in the current control group. Further analyses indicate that older sighted participants show higher thresholds for instrument sounds compared to speech sounds. This effect of age was not found in the blind group. Moreover, the scores across domains were not associated to the same extent in the blind as they were in the sighted. In conclusion, in addition to providing further evidence of compensatory auditory mechanisms in early blind individuals, our results point to differences in how auditory processing is modulated in this population. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

NASA Astrophysics Data System (ADS)

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

2010-11-01

Single-phase rock-salt MgZnO films with high Zn content were successfully fabricated on the templates of MgO (111)/α-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 Mg0.53Zn0.47O 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.

Working memory training in congenitally blind individuals results in an integration of occipital cortex in functional networks.

PubMed

Gudi-Mindermann, Helene; Rimmele, Johanna M; Nolte, Guido; Bruns, Patrick; Engel, Andreas K; Röder, Brigitte

2018-04-12

The functional relevance of crossmodal activation (e.g. auditory activation of occipital brain regions) in congenitally blind individuals is still not fully understood. The present study tested whether the occipital cortex of blind individuals is integrated into a challenged functional network. A working memory (WM) training over four sessions was implemented. Congenitally blind and matched sighted participants were adaptively trained with an n-back task employing either voices (auditory training) or tactile stimuli (tactile training). In addition, a minimally demanding 1-back task served as an active control condition. Power and functional connectivity of EEG activity evolving during the maintenance period of an auditory 2-back task were analyzed, run prior to and after the WM training. Modality-specific (following auditory training) and modality-independent WM training effects (following both auditory and tactile training) were assessed. Improvements in auditory WM were observed in all groups, and blind and sighted individuals did not differ in training gains. Auditory and tactile training of sighted participants led, relative to the active control group, to an increase in fronto-parietal theta-band power, suggesting a training-induced strengthening of the existing modality-independent WM network. No power effects were observed in the blind. Rather, after auditory training the blind showed a decrease in theta-band connectivity between central, parietal, and occipital electrodes compared to the blind tactile training and active control groups. Furthermore, in the blind auditory training increased beta-band connectivity between fronto-parietal, central and occipital electrodes. In the congenitally blind, these findings suggest a stronger integration of occipital areas into the auditory WM network. Copyright © 2018 Elsevier B.V. All rights reserved.

Acute effect of whole body vibration on postural control in congenitally blind subjects: a preliminary evidence.

PubMed

di Cagno, Alessandra; Giombini, Arrigo; Iuliano, Enzo; Moffa, Stefano; Caliandro, Tiziana; Parisi, Attilio; Borrione, Paolo; Calcagno, Giuseppe; Fiorilli, Giovanni

2017-07-11

The purpose of this study was to investigate the acute effects of whole body vibration at optimal frequency, on postural control in blind subjects. Twenty-four participants, 12 congenital blind males (Experimental Group), and 12 non-disabled males with no visual impairment (Control Groups) were recruited. The area of the ellipse and the total distance of the center of pressure displacements, as postural control parameters, were evaluated at baseline (T0), immediately after the vibration (T1), after 10 min (T10) and after 20 min (T20). Whole body vibration protocol consisted into 5 sets of 1 min for each vibration, with 1 min rest between each set on a vibrating platform. The total distance of center of pressure showed a significant difference (p < 0.05) amongst groups, while the area remained constant. No significant differences were detected among times of assessments, or in the interaction group × time. No impairments in static balance were found after an acute bout of whole body vibration at optimal frequency in blind subjects and, consequently, whole body vibration may be considered as a safe application in individuals who are blind.

Color blindness among multiple sclerosis patients in Isfahan.

PubMed

Shaygannejad, Vahid; Golabchi, Khodayar; Dehghani, Alireza; Ashtari, Fereshteh; Haghighi, Sepehr; Mirzendehdel, Mahsa; Ghasemi, Majid

2012-03-01

Multiple sclerosis (MS) is a disease of young and middle aged individuals with a demyelinative axonal damage nature in central nervous system that causes various signs and symptoms. As color vision needs normal function of optic nerve and macula, it is proposed that MS can alter it via influencing optic nerve. In this survey, we evaluated color vision abnormalities and its relationship with history of optic neuritis and abnormal visual evoked potentials (VEPs) among MS patients. The case group was included of clinically definitive MS patients and the same number of normal population was enrolled as the control group. Color vision of all the participants was evaluated by Ishihara test and then visual evoked potential (VEPs) and history of optic neuritis (ON) was assessed among them. Then, frequency of color blindness was compared between the case and the control group. Finally, color blinded patients were compared to those with the history of ON and abnormal VEPs. 63 MS patients and the same number of normal populations were enrolled in this study. 12 patients had color blindness based on the Ishihara test; only 3 of them were among the control group, which showed a significant different between the two groups (P = 0.013). There was a significant relationship between the color blindness and abnormal VEP (R = 0.53, P = 0.023) but not for the color blindness and ON (P = 0.67). This study demonstrates a significant correlation between color blindness and multiple sclerosis including ones with abnormal prolonged VEP latencies. Therefore, in individuals with acquired color vision impairment, an evaluation for potentially serious underlying diseases like MS is essential.

A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine.

PubMed

Saper, Joel R; Mathew, Ninan T; Loder, Elizabeth W; DeGryse, Ronald; VanDenburgh, Amanda M

2007-09-01

Several randomized, controlled studies have reported benefits of botulinum toxin type A (BoNTA; Allergan Inc., Irvine, CA, USA) over placebo in the treatment of migraine. Some studies reported significant benefits at dosages as low as 16 U, while other studies reported safety, tolerability, and efficacy at dosages up to 260 U. However, the optimal treatment paradigm and patient population have yet to be defined. To compare different injection sites and doses of BoNTA in the prevention of episodic migraine. This was a randomized, double-blind, placebo-controlled study of 232 patients with a history of four to eight moderate to severe migraines per month, with or without aura. Patients were randomized to placebo or one of four BoNTA groups that received injections into different muscle regions: frontal (10 U), temporal (6 U), glabellar (9 U), or all three areas (total dose 25 U). For 3 months following a single treatment, patients recorded migraine-related variables in a daily diary. BoNTA and placebo produced comparable decreases from baseline in the frequency of migraines (P > or = 0.411). In general, no statistically significant differences were observed for any efficacy variable. The overall rates of adverse events (any type) or treatment-related adverse events were similar among the groups. In this exploratory study of episodic migraine patients, low-dose injections of BoNTA into the frontal, temporal, and/or glabellar muscle regions were not more effective than placebo. BoNTA was safe and well tolerated. Future studies may examine higher BoNTA doses, flexible injection sites, multiple treatments, and disallow concomitant prophylactic medications.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

PubMed

Bauhofer, A; Lorenz, W; Stinner, B; Rothmund, M; Koller, M; Sitter, H; Celik, I; Farndon, J R; Fingerhut, A; Hay, J M; Lefering, R; Lorijn, R; Nyström, P O; Schäfer, H; Schein, M; Solomkin, J; Troidl, H; Volk, H D; Wittmann, D H; Wyatt, J

2001-04-01

Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Short-term outcomes of local infiltration anaesthetic in total knee arthroplasty: a randomized controlled double-blinded controlled trial.

PubMed

Mulford, Jonathan S; Watson, Anna; Broe, David; Solomon, Michael; Loefler, Andreas; Harris, Ian

2016-03-01

The primary objective of the study was to determine if local infiltration anaesthetic (LIA) reduced total length of hospital stay in total knee arthroplasty (TKA) patients. The study also examined whether LIA improves early pain management, patient satisfaction and range of motion in TKA patients. We conducted a randomized controlled double-blinded study. Fifty patients undergoing TKA were randomized to receive either placebo or LIA at the time of surgery and on the first day post-operatively. Pain scores, level of satisfaction and range of motion were recorded preoperatively and post-operatively. There was no statistical difference between the groups for length of stay, post-operative pain scores, satisfaction scores or range of motion 6 weeks post-operatively. This randomized double-blinded trial did not demonstrate a decrease in pain or reduction of length of stay due to local infiltration analgesia. © 2015 Royal Australasian College of Surgeons.

Feedback on oral presentations during pediatric clerkships: a randomized controlled trial.

PubMed

Sox, Colin M; Dell, Michael; Phillipi, Carrie A; Cabral, Howard J; Vargas, Gabriela; Lewin, Linda O

2014-11-01

To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students' subsequent presentations. We conducted a single-blind, 3-arm, cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine, University of Maryland School of Medicine, Oregon Health & Science University, and Case Western Reserve University School of Medicine. Blocks of students at each school were randomly assigned to experience either (1) no formal presentation feedback (control) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a (2) single-item (simple) or (3) 18-item (detailed) evaluation form. At the clerkship end, overall quality of subjects' presentations was rated by faculty blinded to randomization status, and subjects reported whether their presentations had improved. Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school. A total of 476 participants were evenly divided into the 3 arms, which had similar characteristics. Compared with controls, presentation quality was significantly associated with participating in detailed (coefficient: 0.38; 95% confidence interval [CI]: 0.07-0.69) but not simple (coefficient: 0.16; 95% CI: -0.12-0.43) feedback sessions. Similarly, student self-report of presentation improvement was significantly associated with participating in detailed (odds ratio: 2.16; 95% CI: 1.11-4.18] but not simple (odds ratio: 1.89; 95% CI: 0.91-3.93) feedback sessions. Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls. Copyright © 2014 by the American Academy of Pediatrics.

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 reduction after 1 Hz-rTMS could either reflect a globally decreased cortical response to the TMS pulse or a specific decrease in inhibition. PMID:23185537

Effectiveness of a new non-hydrogen peroxide bleaching agent after single use - a double-blind placebo-controlled short-term study.

PubMed

Bizhang, Mozhgan; Domin, Julia; Danesh, Gholamreza; Zimmer, Stefan

2017-01-01

Tooth whitening represents perhaps the most common aesthetic procedure in dentistry worldwide. The efficacy of bleaching depends on three aspects: bleaching agent, bleaching method, and tooth color. This in vivo study aimed to examine whitening effects on frontal teeth of the upper and lower jaws using an over-the-counter (OTC) non-hydrogen peroxide bleaching agent in comparison to a placebo after one single use. Forty subjects (25 female; 15 male) participated in this double-blind randomized placebo-controlled trial. The subjects were randomly allocated to two groups (n=20). The test group received the OTC product (iWhite Instant) and the placebo group received an identically composed product except for the active agents. Each subject was treated with a prefilled tray containing iWhite Instant or the placebo for 20 minutes. The tooth shade of the front teeth (upper and lower jaws) was assessed before (E_0), immediately after (E_1) and 24 h after treatment (E_2), using a shade guide (VITA classical). Statistical testing was accomplished using the Mann-Whitney U test (p<0.001). The dropout rate was 0%. There were no significant differences at E_0 between placebo and test groups regarding the tooth color. Differences in tooth color changes immediately after (ΔE1_0) and 24 h after treatment (ΔE2_0) were calculated for both groups. The mean values (standard deviations) of tooth color changes for ΔE1_0 were 2.26 (0.92) in the test group and 0.01 (0.21) in the placebo group. The color changes for ΔE2_0 showed mean values of 2.15 (1.10) in the test group and 0.07 (0.35) in the placebo group. For ΔE1_0 and ΔE2_0 significant differences were found between the groups. In this short-term study, the results showed that a non-hydrogen peroxide bleaching agent has significant whitening effects immediately and 24 h after a single-use treatment.

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 insomnia induced by sleep phase advance. J Clin Sleep Med 2014;10(10):1093-1100. PMID:25317090

A Pilot Study of Pedestrians with Visual Impairments Detecting Traffic Gaps and Surges Containing Hybrid Vehicles

PubMed Central

Emerson, Robert Wall; Naghshineh, Koorosh; Hapeman, Julie; Wiener, William

2010-01-01

The increasing number of hybrid and quiet internal combustion engine vehicles may impact the travel abilities of pedestrians who are blind. Pedestrians who rely on auditory cues for structuring their travel may face challenges in making crossing decisions in the presence of quiet vehicles. This article describes results of initial studies looking at the crossing decisions of pedestrians who are blind at an uncontrolled crossing (no traffic control) and a light controlled intersection. The presence of hybrid vehicles was a factor in each situation. At the uncontrolled crossing, Toyota hybrids were most difficult to detect but crossing decisions were made more often in small gaps ended by a Honda hybrid. These effects were seen only at speed under 20 mph. At the light controlled intersection, parallel surges of traffic were most difficult to detect when made up only of a Ford Escape hybrid. Results suggest that more controlled studies of vehicle characteristics impacting crossing decisions of pedestrians who are blind are warranted. PMID:21379367

A Pilot Study of Pedestrians with Visual Impairments Detecting Traffic Gaps and Surges Containing Hybrid Vehicles.

PubMed

Emerson, Robert Wall; Naghshineh, Koorosh; Hapeman, Julie; Wiener, William

2011-03-01

The increasing number of hybrid and quiet internal combustion engine vehicles may impact the travel abilities of pedestrians who are blind. Pedestrians who rely on auditory cues for structuring their travel may face challenges in making crossing decisions in the presence of quiet vehicles. This article describes results of initial studies looking at the crossing decisions of pedestrians who are blind at an uncontrolled crossing (no traffic control) and a light controlled intersection. The presence of hybrid vehicles was a factor in each situation. At the uncontrolled crossing, Toyota hybrids were most difficult to detect but crossing decisions were made more often in small gaps ended by a Honda hybrid. These effects were seen only at speed under 20 mph. At the light controlled intersection, parallel surges of traffic were most difficult to detect when made up only of a Ford Escape hybrid. Results suggest that more controlled studies of vehicle characteristics impacting crossing decisions of pedestrians who are blind are warranted.

A Functional Neuroimaging Study of Sound Localization: Visual Cortex Activity Predicts Performance in Early-Blind Individuals

PubMed Central

Gougoux, Frédéric; Zatorre, Robert J; Lassonde, Maryse; Voss, Patrice

2005-01-01

Blind individuals often demonstrate enhanced nonvisual perceptual abilities. However, the neural substrate that underlies this improved performance remains to be fully understood. An earlier behavioral study demonstrated that some early-blind people localize sounds more accurately than sighted controls using monaural cues. In order to investigate the neural basis of these behavioral differences in humans, we carried out functional imaging studies using positron emission tomography and a speaker array that permitted pseudo-free-field presentations within the scanner. During binaural sound localization, a sighted control group showed decreased cerebral blood flow in the occipital lobe, which was not seen in early-blind individuals. During monaural sound localization (one ear plugged), the subgroup of early-blind subjects who were behaviorally superior at sound localization displayed two activation foci in the occipital cortex. This effect was not seen in blind persons who did not have superior monaural sound localization abilities, nor in sighted individuals. The degree of activation of one of these foci was strongly correlated with sound localization accuracy across the entire group of blind subjects. The results show that those blind persons who perform better than sighted persons recruit occipital areas to carry out auditory localization under monaural conditions. We therefore conclude that computations carried out in the occipital cortex specifically underlie the enhanced capacity to use monaural cues. Our findings shed light not only on intermodal compensatory mechanisms, but also on individual differences in these mechanisms and on inhibitory patterns that differ between sighted individuals and those deprived of vision early in life. PMID:15678166

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

Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial.

PubMed

Platz, T; Eickhof, C; van Kaick, S; Engel, U; Pinkowski, C; Kalok, S; Pause, M

2005-10-01

To study the effects of augmented exercise therapy time for arm rehabilitation as either Bobath therapy or the impairment-oriented training (Arm BASIS training) in stroke patients with arm severe paresis. Single blind, multicentre randomized control trial. Three inpatient neurorehabilitation centres. Sixty-two anterior circulation ischaemic stroke patients. Random assignment to three group: (A) no augmented exercise therapy time, (B) augmented exercise therapy time as Bobath therapy and (C) augmented exercise therapy time as Arm BASIS training. Fugl-Meyer arm motor score. Secondary measure: Action Research Arm Test (ARA). Ancillary measures: Fugl-Meyer arm sensation and joint motion/pain scores and the Ashworth Scale (elbow flexors). An overall effect of augmented exercise therapy time on Fugl-Meyer scores after four weeks was not corroborated (mean and 95% confidence interval (CI) of change scores: no augmented exercise therapy time (n=20) 8.8, 5.2-12.3; augmented exercise therapy time (n=40) 9.9, 6.8-13.9; p = 0.2657). The group who received the augmented exercise therapy time as Arm BASIS training (n=20) had, however, higher gains than the group receiving the augmented exercise therapy time as Bobath therapy (n=20) (mean and 95% CI of change scores: Bobath 7.2, 2.6-11.8; BASIS 12.6, 8.4-16.8; p = 0.0432). Passive joint motion/pain deteriorated less in the group who received BASIS training (mean and 95% CI of change scores: Bobath -3.2, -5.2 to -1.1; BASIS 0.1, -1.8-2.0; p = 0.0090). ARA, Fugl-Meyer arm sensation, and Ashworth Scale scores were not differentially affected. The augmented exercise therapy time as Arm BASIS training enhanced selective motor control. Type of training was more relevant for recovery of motor control than therapeutic time spent.

Effects of Fluoxetine on Neural Functional Prognosis after Ischemic Stroke: A Randomized Controlled Study in China.

PubMed

He, Yi-Tao; Tang, Bing-Shan; Cai, Zhi-Li; Zeng, Si-Ling; Jiang, Xin; Guo, Yi

2016-04-01

We investigated the effects of fluoxetine on the short-term and long-term neural functional prognoses after ischemic stroke. In this prospective randomized controlled single-blind clinical study in China, eligible patients afflicted with ischemic stroke were randomized into control and treatment groups. Patients in the treatment group received fluoxetine in addition to the basic therapies in the control group over a period of 90 days. The follow-up period was 180 days. We evaluated the effects of fluoxetine on the National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score after ischemic stroke through single- and multiple-factor analysis. The mean NIHSS score on day 180 after treatment was significantly lower in the treatment group than in the control group (P = .009). The mean BI scores on days 90 and 180 were significantly higher in the treatment group (P = .026) than in the control group (P = .011). The improvements in the NIHSS and BI scores on days 90 and 180 compared with baseline in the treatment group were all significantly greater than that in the control group (P = .033, P = .013, P = .013, P = .019, respectively). Treatment with fluoxetine was an independent factor affecting the NIHSS and BI scores on day 180 after treatment. Treatment with fluoxetine for 90 days after ischemic stroke can improve the long-term neural functional outcomes. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Caffeine's Influence on Nicotine's Effects in Nonsmokers

PubMed Central

Blank, Melissa D.; Kleykamp, Bethea A.; Jennings, Janine M.; Eissenberg, Thomas

2011-01-01

Objective To determine if nicotine's effects are influenced by caffeine in nonsmoking, moderate-caffeine consuming individuals (N=20). Methods The first 3 sessions included one of 3 randomly ordered, double-blind caffeine doses (0, 75, or 150 mg, oral [po]) and 2 single-blind nicotine gum doses (2 and 4 mg) in ascending order. The fourth session (single blind) repeated the 0 mg caffeine condition. Results Nicotine increased heart rate and subjective ratings indicative of aversive effects, and decreased reaction times. These effects were independent of caffeine dose and reliable across sessions. Conclusions In nonsmokers, nicotine effects are not influenced by moderate caffeine doses. PMID:17555378

Ablative fractional lasers (CO(2) and Er:YAG): a randomized controlled double-blind split-face trial of the treatment of peri-orbital rhytides.

PubMed

Karsai, Syrus; Czarnecka, Agnieszka; Jünger, Michael; Raulin, Christian

2010-02-01

Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO(2) and Er:YAG lasers. The present study compares these modalities in a randomized controlled double-blind split-face study design. Twenty-eight patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO(2) and one with a fractional Er:YAG laser. The evaluation included the profilometric measurement of wrinkle depth, the Fitzpatrick wrinkle score (both before and 3 months after treatment) as well as the assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment). Both modalities showed a roughly equivalent effect. Wrinkle depth and Fitzpatrick score were reduced by approximately 20% and 10%, respectively, with no appreciable difference between lasers. Side effects and discomfort were slightly more pronounced after Er:YAG treatment in the first few days, but in the later course there were more complaints following CO(2) laser treatment. Patient satisfaction was fair and the majority of patients would have undergone the treatment again without a clear preference for either method. According to the present study, a single ablative fractional treatment session has an appreciable yet limited effect on peri-orbital rhytides. When fractional CO(2) and Er:YAG lasers are used in such a manner that there are comparable post-operative healing periods, comparable cosmetic improvement occurs. Multiple sessions may be required for full effect, which cancels out the proposed advantage of fractional methods, that is, fewer side effects and less down time.

The SyBil-AA real-time fMRI neurofeedback study: protocol of a single-blind randomized controlled trial in alcohol use disorder.

PubMed

Gerchen, Martin Fungisai; Kirsch, Martina; Bahs, Nathalie; Halli, Patrick; Gerhardt, Sarah; Schäfer, Axel; Sommer, Wolfgang H; Kiefer, Falk; Kirsch, Peter

2018-01-17

Alcohol Use Disorder is a highly prevalent mental disorder which puts a severe burden on individuals, families, and society. The treatment of Alcohol Use Disorder is challenging and novel and innovative treatment approaches are needed to expand treatment options. A promising neuroscience-based intervention method that allows targeting cortical as well as subcortical brain processes is real-time functional magnetic resonance imaging neurofeedback. However, the efficacy of this technique as an add-on treatment of Alcohol Use Disorder in a clinical setting is hitherto unclear and will be assessed in the Systems Biology of Alcohol Addiction (SyBil-AA) neurofeedback study. N = 100 patients with Alcohol Use Disorder will be randomized to 5 parallel groups in a single-blind fashion and receive real-time functional magnetic resonance imaging neurofeedback while they are presented pictures of alcoholic beverages. The groups will either downregulate the ventral striatum, upregulate the right inferior frontal gyrus, negatively modulate the connectivity between these regions, upregulate, or downregulate the auditory cortex as a control region. After receiving 3 sessions of neurofeedback training within a maximum of 2 weeks, participants will be followed up monthly for a period of 3 months and relapse rates will be assessed as the primary outcome measure. The results of this study will provide insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback training in the treatment of Alcohol Use Disorder as well as in the involved brain systems. This might help to identify predictors of successful neurofeedback treatment which could potentially be useful in developing personalized treatment approaches. The study was retrospectively registered in the German Clinical Trials Register (trial identifier: DRKS00010253 ; WHO Universal Trial Number (UTN): U1111-1181-4218) on May 10th, 2016.

Phase I, randomized, double-blind, placebo-controlled, single-dose escalation study of the recombinant factor VIIa variant BAY 86-6150 in hemophilia.

PubMed

Mahlangu, J N; Coetzee, M J; Laffan, M; Windyga, J; Yee, T T; Schroeder, J; Haaning, J; Siegel, J E; Lemm, G

2012-05-01

BAY 86-6150 is a new human recombinant factor VIIa variant developed for high procoagulant activity and longer action in people with hemophilia with inhibitors. To investigate the safety, tolerability, pharmacodynamics, pharmacokinetics and immunogenicity of BAY 86-6150 in non-bleeding hemophilia subjects. The study included non-bleeding men (18-65 years of age) with moderate or severe hemophilia A or B with or without inhibitors. Sixteen subjects were randomized 3 : 1 to four cohorts of escalating doses of BAY 86-6150 (6.5, 20, 50 or 90 μg kg(-1) [n = 3 per cohort]) or placebo (n = 1 per cohort); an independent data-monitoring committee reviewed previous cohort data before the next dose escalation. Blood sampling was performed predose and postdose; subjects were monitored for 50 days postdose. At the tested doses, BAY 86-6150 was not associated with clinically significant adverse events or dose-limiting toxicities. BAY 86-6150 pharmacokinetics exhibited a linear dose response, with a half-life of 5-7 h. Subjects demonstrated consistent, dose-dependent thrombin generation ex vivo in platelet-poor plasma (PPP) (mean peak effect, 26-237 nm thrombin from 6.5 to 90 μg kg(-1)). Peak thrombin levels over time paralleled BAY 86-6150, with thrombin kinetics appearing to be slightly shorter; thus, circulating BAY 86-6150 retained activity. There were corresponding decreases in activated partial thromboplastin and prothrombin times. No subject developed de novo anti-BAY 86-6150 neutralizing antibodies during the 50-day follow-up. In this first-in-human, multicenter, randomized, double-blind, placebo-controlled, single-dose escalation study, BAY 86-6150 was tolerated at the highest dose (90 μg kg(-1)), with no safety concerns. Safety and efficacy will be further evaluated in phase II/III studies. © 2012 International Society on Thrombosis and Haemostasis.

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.

PubMed

Mathiassen, Ole N; Vase, Henrik; Bech, Jesper N; Christensen, Kent L; Buus, Niels H; Schroeder, Anne P; Lederballe, Ole; Rickers, Hans; Kampmann, Ulla; Poulsen, Per L; Hansen, Klavs W; Btker, Hans E; Peters, Christian D; Engholm, Morten; Bertelsen, Jannik B; Lassen, Jens F; Langfeldt, Sten; Andersen, Gratien; Pedersen, Erling B; Kaltoft, Anne

2016-08-01

Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ± 18.8 mmHg (RDN) vs. -6.0 ± 13.5 mmHg (SHAM)] and at 6 months [-6.1 ± 18.9 mmHg (RDN) vs. -4.3 ± 15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ± 2.7 (RDN) vs. 7.0 ± 2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

Policy-into-practice for rheumatoid arthritis: randomized controlled trial and cohort study of e-learning targeting improved physiotherapy management.

PubMed

Fary, Robyn E; Slater, Helen; Chua, Jason; Ranelli, Sonia; Chan, Madelynn; Briggs, Andrew M

2015-07-01

To examine the effectiveness of a physiotherapy-specific, web-based e-learning platform, "RAP-el," in best-practice management of rheumatoid arthritis (RA) using a single-blind, randomized controlled trial (RCT) and prospective cohort study. Australian-registered physiotherapists were electronically randomized into intervention and control groups. The intervention group accessed RAP-eL over 4 weeks. Change in self-reported confidence in knowledge and skills was compared between groups at the end of the RCT using linear regression conditioned for baseline scores by a blinded assessor, using intent-to-treat analysis. Secondary outcomes included physiotherapists' satisfaction with RA management and responses to RA-relevant clinical statements and practice-relevant vignettes. Retention was evaluated in a cohort study 8 weeks after the RCT. Eighty physiotherapists were randomized into the intervention and 79 into the control groups. Fifty-six and 48, respectively, provided baseline data. Significant between-group differences were observed for change in confidence in knowledge (mean difference 8.51; 95% confidence interval [95% CI] 6.29, 10.73; effect size 1.62) and skills (mean difference 7.26; 95% CI 5.1, 9.4; effect size 1.54), with the intervention group performing better. Satisfaction in ability to manage RA, 4 of the 6 clinical statements, and responses to vignettes demonstrated significant improvement in the intervention group. Although 8-week scores showed declines in most outcomes, their clinical significance remains uncertain. RAP-eL can improve self-reported confidence, likely practice behaviors and satisfaction in physiotherapists' ability to manage people with RA, and improve their clinical knowledge in several areas of best-practice RA management in the short term. © 2015, American College of Rheumatology.

Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial.

PubMed

Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj

2017-10-01

Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA). Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

Effects of long-term self-massage at the musculotendinous junction on hamstring extensibility, stiffness, stretch tolerance, and structural indices: A randomized controlled trial.

PubMed

Akazawa, Naoki; Okawa, Naomi; Kishi, Masaki; Nakatani, Kiyoshi; Nishikawa, Katsuya; Tokumura, Daichi; Matsui, Yuji; Moriyama, Hideki

2016-09-01

The purpose of this study was to examine the effect of long-term self-massage at the musculotendinous junction on hamstring extensibility, stiffness, stretch tolerance, and structural indices. Single-blind, randomized, controlled trial. Laboratory. Thirty-seven healthy men. The right or left leg of each participant was randomly assigned to the massage group, and the other leg was assigned to the control group. The participants conducted self-massage at the musculotendinous junction for 3 min daily, five times per week, for 12 weeks. Hamstring extensibility, stiffness, stretch tolerance, and structural indices were measured by a blinded examiner prior to the massage intervention and after 6 and 12 weeks of intervention. The maximum hip flexion angle (HFA) and the maximum passive pressure after 6 and 12 weeks of intervention in the massage group were significantly higher than prior to intervention. The visual analog scale (for pain perception) at maximum HFA, the stiffness of the hamstring, and the structural indices did not differ in either group over the 12 week period. Our results suggest that long-term self-massage at the musculotendinous junction increases hamstring extensibility by improving stretch tolerance. However, this intervention does not change hamstring stiffness. University Hospital Medical Information Network registration number UMIN000011233. Copyright © 2016 Elsevier Ltd. All rights reserved.

Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients.

PubMed

Bech, Rune D; Ovesen, Ole; Lindholm, Peter; Overgaard, Søren

2014-04-01

To our knowledge, there is no evidence to support the use of local infiltration analgesia (LIA) for postoperative pain relief after periacetabular osteotomy (PAO). We investigated the effect of wound infiltration with a long-acting local anesthetic (ropivacaine) for postoperative analgesia after PAO. We performed a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov: NCT00815503) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption. All subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site. 26 patients received ropivacaine and 27 received saline. The intervention period was 2 days and the observational period was 4 days. All subjects received patient-controlled opioid analgesia without any restrictions on the total daily dose. Pain was assessed at specific postoperative time points and the daily opioid usage was registered. Infiltration with 75 mL (150 mg) of ropivacaine did not reduce postoperative pain or opioid requirements during the first 4 days. The clinical importance of ropivacaine as single component in postoperative treatment of pain is questionable, and we are planning further studies to explore the potential of LIA in larger volume-and also a multimodal regimen-to treat pain in this category of patients.

Effect of a single dose of dextromethorphan on psychomotor performance and working memory capacity.

PubMed

Al-Kuraishy, Hayder M; Al-Gareeb, Ali I; Ashor, Ammar Waham

2012-04-01

Previous studies show that the prolonged use of dextromethorphan produces cognitive deterioration in humans. The aim of this study was to investigate the effect of a single dose of dextroemthrophan on psychomotor performance and working memory capacity. This is a randomized, double-blind, controlled, and prospective study. Thirty-six (17 women, 19 men) medical students enrolled in the study; half of them (7 women, 11 men) were given placebo, while the other half (10 women, 8 men) received dextromethorphan. The choice reaction time, critical flicker fusion threshold, and N-back working memory task were measured before and after 2 h of taking the drugs. Dextromethorphan showed a significant deterioration in the 3-back working memory task (P<0.05). No significant changes were seen as regards the choice reaction time components (total, recognition, motor) and critical flicker fusion threshold (P>0.05). On the other hand, placebo showed no significant changes as regards the choice reaction time, critical flicker fusion threshold, and N-back working memory task (P>0.05). A single dose of dextromethorphan has no effect on attention and arousal but may significantly impair the working memory capacity.

Safety and Efficacy of Rice Bran Supercritical CO2 Extract for Hair Growth in Androgenic Alopecia: A 16-Week Double-Blind Randomized Controlled Trial.

PubMed

Choi, Jae-Suk; Park, Jae Beom; Moon, Woi-Sook; Moon, Jin-Nam; Son, Sang Wook; Kim, Mi-Ryung

2015-01-01

We conducted a 16-week double-blind randomized controlled single-center trial to evaluate the safety and efficacy of dermal rice bran supercritical CO2 extract (RB-SCE) in the treatment of androgenic alopecia. Fifty alopecia patients were randomly assigned to the experimental and placebo groups. The experimental group received a dermal application of 0.5% RB-SCE (8 mL/d) to the head skin for 16 weeks while the control group received a dermal application of placebo. Changes in hair count, diameter, and density were evaluated with a Folliscope(®). Patient satisfaction was evaluated via questionnaire and clinical photographs were rated by dermatologists. The results showed that RB-SCE significantly increased hair density and hair diameter in male subjects. Patient satisfaction and the evaluation of photographs by dermatologists also confirmed the effectiveness of RB-SCE in the treatment of alopecia. No adverse reactions related to RB-SCE were reported. Therefore, RB-SCE shows promise for use in functional cosmetics and pharmaceuticals.

Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.

PubMed

Fernández, Oscar; Izquierdo, Guillermo; Fernández, Victoria; Leyva, Laura; Reyes, Virginia; Guerrero, Miguel; León, Antonio; Arnaiz, Carlos; Navarro, Guillermo; Páramo, Maria Dolores; Cuesta, Antonio De la; Soria, Bernat; Hmadcha, Abdelkrim; Pozo, David; Fernandez-Montesinos, Rafael; Leal, Maria; Ochotorena, Itziar; Gálvez, Patricia; Geniz, Maria Angeles; Barón, Francisco Javier; Mata, Rosario; Medina, Cristina; Caparrós-Escudero, Carlos; Cardesa, Ana; Cuende, Natividad

2018-01-01

Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded. Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy. Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.

Antihyperalgesic efficacy of 5% lidocaine medicated plaster in capsaicin and sunburn pain models--two randomized, double-blinded, placebo-controlled crossover trials in healthy volunteers.

PubMed

Gustorff, Burkhard; Hauer, David; Thaler, Johannes; Seis, Astrid; Draxler, Julia

2011-12-01

The aim of this research is to analyze analgesic efficacy of the 5% lidocaine medicated plaster in two randomized, double-blinded, placebo-controlled, crossover studies in 16 healthy volunteers using capsaicin and sunburn pain models. Lidocaine and placebo plasters were simultaneously applied to forearms and thighs at contralateral body sites for three alternating 12-h plaster-on/plaster-off periods. Between the second and third plaster-on period, 4.2-cm circular spots on both pretreated thighs were irradiated with three times the individual minimal erythema dose of UVB light. After the last plaster-on period, 20 μl of 0.1% capsaicin was injected intradermally into both forearms. The study was repeated using a single 12-h plaster application. The area of pinprick hyperalgesia was diminished by 53% (p < 0.003) in the capsaicin model and by 84% (p < 0.0001) in the sunburn model; the intensity of mechanical hyperalgesia to rigid filaments (8 - 512 mN) was reduced in both models. Cold pain perception threshold was reduced (19.7°C ± 8.0 vs 21.8°C ± 6.8 for placebo, p < 0.05, sunburn). Similar effects were observed in the 12-h exposure study. No effect was seen on capsaicin-induced spontaneous pain and flare size, or blood flow in the sunburn area, and heat hyperalgesia in either study. Lidocaine plaster effectively treats mechanical hyperalgesia and cold pain.

Development of visual category selectivity in ventral visual cortex does not require visual experience

PubMed Central

van den Hurk, Job; Van Baelen, Marc; Op de Beeck, Hans P.

2017-01-01

To what extent does functional brain organization rely on sensory input? Here, we show that for the penultimate visual-processing region, ventral-temporal cortex (VTC), visual experience is not the origin of its fundamental organizational property, category selectivity. In the fMRI study reported here, we presented 14 congenitally blind participants with face-, body-, scene-, and object-related natural sounds and presented 20 healthy controls with both auditory and visual stimuli from these categories. Using macroanatomical alignment, response mapping, and surface-based multivoxel pattern analysis, we demonstrated that VTC in blind individuals shows robust discriminatory responses elicited by the four categories and that these patterns of activity in blind subjects could successfully predict the visual categories in sighted controls. These findings were confirmed in a subset of blind participants born without eyes and thus deprived from all light perception since conception. The sounds also could be decoded in primary visual and primary auditory cortex, but these regions did not sustain generalization across modalities. Surprisingly, although not as strong as visual responses, selectivity for auditory stimulation in visual cortex was stronger in blind individuals than in controls. The opposite was observed in primary auditory cortex. Overall, we demonstrated a striking similarity in the cortical response layout of VTC in blind individuals and sighted controls, demonstrating that the overall category-selective map in extrastriate cortex develops independently from visual experience. PMID:28507127

Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females—Double isotope sequential single-blind studies in menstruating women

PubMed Central

Önning, Gunilla; Hulthén, Lena

2017-01-01

Background The probiotic strain Lactobacillus plantarum 299v has earlier been shown to increase iron absorption when added to foods. However, it is not known if the same probiotic strain in a freeze-dried format included in a capsule increases the iron absorption. Objective The aim of this study was to test the hypotheses that non-heme iron absorption from a light meal is promoted by a simultaneous intake of freeze-dried Lactobacillus plantarum 299v (Lp299v, DSM 9843). Study design With a single blinded placebo controlled sequential design, iron absorption from a light breakfast meal administered with or without capsules containing 1010 cfu freeze-dried Lp299v was studied in healthy female volunteers of fertile age. The methodology used was a double isotope technique (59Fe and 55Fe). Two studies were performed using the same protocol. Results In study 1, the absorption of iron from a meal without Lp299v was found to be 17.4 ± 13.4%, and from an identical meal with Lp299v was found to be 22.4 ± 17.3% (mean ± SD). This difference was statistically significant (p = 0.040, n = 14). In study 2, the absorption of iron from a meal without Lp299v was found to be 20.9 ± 13.1%, and from an identical meal with Lp299v found to be 24.5 ± 12.0% (mean ± SD, n = 28), which again was statistically significant (p = 0.003). Conclusion Freeze-dried Lp299v enhances the absorption of iron when administered together with a meal with a high iron bioavailability. Trial registration ClinicalTrials.gov Identifier: NCT02131870 PMID:29236734

Increased regional cerebral blood flow but normal distribution of GABAA receptor in the visual cortex of subjects with early-onset blindness.

PubMed

Mishina, Masahiro; Senda, Michio; Kiyosawa, Motohiro; Ishiwata, Kiichi; De Volder, Anne G; Nakano, Hideki; Toyama, Hinako; Oda, Kei-ichi; Kimura, Yuichi; Ishii, Kenji; Sasaki, Touru; Ohyama, Masashi; Komaba, Yuichi; Kobayashi, Shirou; Kitamura, Shin; Katayama, Yasuo

2003-05-01

Before the completion of visual development, visual deprivation impairs synaptic elimination in the visual cortex. The purpose of this study was to determine whether the distribution of central benzodiazepine receptor (BZR) is also altered in the visual cortex in subjects with early-onset blindness. Positron emission tomography was carried out with [(15)O]water and [(11)C]flumazenil on six blind subjects and seven sighted controls at rest. We found that the CBF was significantly higher in the visual cortex for the early-onset blind subjects than for the sighted control subjects. However, there was no significant difference in the BZR distribution in the visual cortex for the subject with early-onset blindness than for the sighted control subjects. These results demonstrated that early visual deprivation does not affect the distribution of GABA(A) receptors in the visual cortex with the sensitivity of our measurements. Synaptic elimination may be independent of visual experience in the GABAergic system of the human visual cortex during visual development.

Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil.

PubMed

Citrome, Leslie

2016-01-01

Aripiprazole monohydrate (AM) and aripiprazole lauroxil (AL) are two different long-acting injectable formulations of aripiprazole. AM 400 mg administered once monthly demonstrated efficacy in an acute, double-blind, placebo-controlled, randomized clinical trial, as well as in a double-blind, placebo-controlled, randomized-withdrawal maintenance study, and in two non-inferiority maintenance studies. AL is a prodrug of aripiprazole and available in 441 mg, 662 mg or 882 mg strengths. AL 441 mg and 882 mg administered once monthly demonstrated efficacy in an acute, double-blind, placebo-controlled, randomized clinical trial. The pharmacokinetic profile of AL also led to approval of dosing intervals of every 6 weeks for the 882 mg dose. The overall tolerability profiles of both products are consistent with what is known about oral aripiprazole.

Comparison of the effectiveness of orthotic intervention, kinesiotaping, and paraffin treatments in patients with carpal tunnel syndrome: A single-blind and randomized controlled study.

PubMed

Mansiz Kaplan, Basak; Akyuz, Gulseren; Kokar, Serdar; Yagci, Ilker

2018-02-17

The aim of the study was to compare different conservative treatments in patients with carpal tunnel syndrome (CTS). A single-blind randomized controlled study. Patients (n = 169) diagnosed with mild or moderate CTS were screened; 110 met study requirements. The patients were randomized into 3 groups. The control (CON) comparison provided to all patients was a fabricated night orthotic which held the wrist in a neutral position. The second group received adjunctive kinesiotaping (KIN) and the third group received paraffin (PARA). All patients were evaluated clinically, electrophysiologically, and ultrasonographically before treatment and at 3 weeks, 3 months, and 6 months. There were 36 patients in CON, 37 in KIN, and 37 in PARA. Pain reduction in KIN was better than the other groups at 3 weeks (mean difference [MD] in CON 2.4 ± 2.5, KIN 3.7 ± 2.0, PARA 2.7 ± 2.3; P < .01) and 6 months (MD in CON 3.4 ± 3.0, KIN 4.9 ± 3.1, PARA 3.7 ± 2.9; P < .05). KIN pain reduction was better than CON at 3 months (MD in CON 3.8 ± 2.8, KIN 5.0 ± 2.5; P < .05). Reduction of the cross-sectional area of median nerve at the level of radioulnar joint was greater for KIN than CON at 3 weeks (MD in CON 0.0 ± 0.5, KIN 0.3 ± 0.7; P < .01) than PARA at 3 months (MD in KIN 0.3 ± 0.8, PARA 0.0 ± 0.8; P < .05) and both groups at 6 months (MD in CON 0.1 ± 0.8, KIN 0.5 ± 0.9, PARA 0.0 ± 1.0 P < .05). Adding KIN to night use of an orthotic was more effective in achieving symptomatic and structural improvements than either the orthotic alone or adjunctive use of paraffin in patients with mild and moderate CTS. Copyright © 2018 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Failing to Prepare Is Preparing to Fail: A Single-Blinded, Randomized Controlled Trial to Determine the Impact of a Preoperative Instructional Video on the Ability of Residents to Perform Laparoscopic Right Colectomy.

PubMed

Crawshaw, Benjamin P; Steele, Scott R; Lee, Edward C; Delaney, Conor P; Mustain, W Conan; Russ, Andrew J; Shanmugan, Skandan; Champagne, Bradley J

2016-01-01

Laparoscopic colorectal resection is an index case for advanced skills training, yet many residents struggle to reach proficiency by graduation. Current methods to reduce the learning curve for residents remain expensive, time consuming, and poorly validated. The purpose of this study was to assess the impact of the addition of a preprocedural instructional video to improve the ability of a general surgery resident to perform laparoscopic right colectomy when compared with standard preparation. This was a single-blinded, randomized control study. Four university-affiliated teaching hospitals were included in the study. General surgery residents in postgraduation years 2 through 5 participated. Residents were randomly assigned to preparation with a narrated instructional video versus standard preparation. Resident performance, scored by a previously validated global assessment scale, was measured. Fifty-four residents were included. Half (n = 27) were randomly assigned to view the training video and half (n = 27) to standard preparation. There were no differences between groups in terms of training level or previous operative experience or in patient demographics (all p > 0.05). Groups were similar in the percentage of the case completed by residents (p = 0.39) and operative time (p = 0.74). Residents in the video group scored significantly higher in total score (mean: 46.8 vs 42.3; p = 0.002), as well as subsections directly measuring laparoscopic skill (vascular control mean: 11.3 vs 9.7, p < 0.001; mobilization mean: 7.6 vs. 7.0, p = 0.03) and overall performance score (mean: 4.0 vs 3.1; p < 0.001). Statistical significance persisted across training levels. There is potential for Hawthorne effect, and the study is underpowered at the individual postgraduate year level. The simple addition of a brief, narrated preprocedural video to general surgery resident case preparation significantly increased trainee ability to successfully perform a laparoscopic right colectomy. In an era of shortened hours and less exposure to cases, incorporating a brief but effective instructional video before surgery may improve the learning curve of trainees and ultimately improve safety.

Effect of joint mobilization techniques for primary total knee arthroplasty: Study protocol for a randomized controlled trial.

PubMed

Xu, Jiao; Zhang, Juan; Wang, Xue-Qiang; Wang, Xuan-Lin; Wu, Ya; Chen, Chan-Cheng; Zhang, Han-Yu; Zhang, Zhi-Wan; Fan, Kai-Yi; Zhu, Qiang; Deng, Zhi-Wei

2017-12-01

Total knee arthroplasty (TKA) has become the most preferred procedure by patients for the relief of pain caused by knee osteoarthritis. TKA patients aim a speedy recovery after the surgery. Joint mobilization techniques for rehabilitation have been widely used to relieve pain and improve joint mobility. However, relevant randomized controlled trials showing the curative effect of these techniques remain lacking to date. Accordingly, this study aims to investigate whether joint mobilization techniques are valid for primary TKA. We will manage a single-blind, prospective, randomized, controlled trial of 120 patients with unilateral TKA. Patients will be randomized into an intervention group, a physical modality therapy group, and a usual care group. The intervention group will undergo joint mobilization manipulation treatment once a day and regular training twice a day for a month. The physical modality therapy group will undergo physical therapy once a day and regular training twice a day for a month. The usual care group will perform regular training twice a day for a month. Primary outcome measures will be based on the visual analog scale, the knee joint Hospital for Special Surgery score, range of motion, surrounded degree, and adverse effect. Secondary indicators will include manual muscle testing, 36-Item Short Form Health Survey, Berg Balance Scale function evaluation, Pittsburgh Sleep Quality Index, proprioception, and muscle morphology. We will direct intention-to-treat analysis if a subject withdraws from the trial. The important features of this trial for joint mobilization techniques in primary TKA are randomization procedures, single-blind, large sample size, and standardized protocol. This study aims to investigate whether joint mobilization techniques are effective for early TKA patients. The result of this study may serve as a guide for TKA patients, medical personnel, and healthcare decision makers. It has been registered at http://www.chictr.org.cn/showproj.aspx?proj=15262 (Identifier:ChiCTR-IOR-16009192), Registered 11 September 2016. We also could provide the correct URL of the online registry in the WHO Trial Registration. http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IOR-16009192.

Impact of autologous blood injections in treatment of mid-portion Achilles tendinopathy: double blind randomised controlled trial.

PubMed

Bell, Kevin J; Fulcher, Mark L; Rowlands, David S; Kerse, Ngaire

2013-04-18

To assess the effectiveness of two peritendinous autologous blood injections in addition to a standardised eccentric calf strengthening programme in improving pain and function in patients with mid-portion Achilles tendinopathy. Single centre, participant and single assessor blinded, parallel group, randomised, controlled trial. Single sports medicine clinic in New Zealand. 53 adults (mean age 49, 53% men) with symptoms of unilateral mid-portion Achilles tendinopathy for at least three months. Participants were excluded if they had a history of previous Achilles tendon rupture or surgery or had undergone previous adjuvant treatments such as injectable therapies, glyceryl trinitrate patches, or extracorporeal shockwave therapy. All participants underwent two unguided peritendinous injections one month apart with a standardised protocol. The treatment group had 3 mL of their own whole blood injected while the control group had no substance injected (needling only). Participants in both groups carried out a standardised and monitored 12 week eccentric calf training programme. Follow-up was at one, two, three and six months. The primary outcome measure was the change in symptoms and function from baseline to six months with the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes were the participant's perceived rehabilitation and their ability to return to sport. 26 participants were randomly assigned to the treatment group and 27 to the control group. In total, 50 (94%) completed the six month study, with 25 in each group. Clear and clinically worthwhile improvements in the VISA-A score were evident at six months in both the treatment (change in score 18.7, 95% confidence interval 12.3 to 25.1) and control (19.9, 13.6 to 26.2) groups. The overall effect of treatment was not significant (P=0.689) and the 95% confidence intervals at all points precluded clinically meaningful benefit or harm. There was no significant difference between groups in secondary outcomes or in the levels of compliance with the eccentric calf strengthening programme. No adverse events were reported. The administration of two unguided peritendinous autologous blood injections one month apart, in addition to a standardised eccentric training programme, provides no additional benefit in the treatment of mid-portion Achilles tendinopathy. Australian New Zealand Clinical Trials Registry ACTRN12610000824066, WHO U1111-1117-2641.

Immediate relief of herniated lumbar disc-related sciatica by ankle acupuncture

PubMed Central

Xiang, Anfeng; Xu, Mingshu; Liang, Yan; Wei, Jinzi; Liu, Sheng

2017-01-01

Abstract Background: Around 90% of sciatica cases are due to a herniated intervertebral disc in the lumbar region. Ankle acupuncture (AA) has been reported to be effective in the treatment of acute nonspecific low back pain. This study aims to evaluate the efficacy of a single session of ankle acupuncture for disc-related sciatica. Method: This will be a double-blinded, randomized controlled clinical trial. Patients diagnosed with disc-related sciatica will be randomly divided into 3 parallel groups. The treatment group (n = 30) will receive ankle acupuncture. The 2 control groups will either undergo traditional needle manipulation (n = 30) or sham acupuncture (n = 30) at the same point as the treatment group. The primary outcome will be pain intensity on a visual analog scale (VAS). The secondary outcomes will be paresthesia intensity on a VAS and the Abbreviated Acceptability Rating Profile (AAPR). The success of blinding will be evaluated, and the needle-induced sensation and adverse events will be recorded. All outcomes will be evaluated before, during, and after the treatment. Discussion: This study will determine the immediate effect and specificity of ankle acupuncture for the treatment of disc-related sciatica. We anticipate that ankle acupuncture might be more effective than traditional needle manipulation or sham acupuncture. Trial registration ChiCTR-IPR-15007127 (http://www.chictr.org.cn/showprojen.aspx?proj=11989) PMID:29390461

A double-blind, randomized, placebo-controlled trial of itopride (100 and 200 mg three times daily) on gastric motor and sensory function in healthy volunteers.

PubMed

Choung, R S; Talley, N J; Peterson, J; Camilleri, M; Burton, D; Harmsen, W S; Zinsmeister, A R

2007-03-01

Itopride, a dopamine D2 antagonist and acetylcholinesterase inhibitor, significantly improved symptoms in patients with functional dyspepsia in one phase II randomized trial. However, the mechanisms by which itopride may improve symptoms are unknown. We aimed to compare the effects of two doses of itopride and placebo on gastric volumes, gastric emptying, small bowel transit and satiation in female and male healthy volunteers. Randomized, double-blind, placebo-controlled study evaluated gastric function before and after 7 days of itopride 100 mg (n = 16) or 200 mg (n = 15) or placebo (n = 15) t.i.d. Validated methods were used to study gastric accommodation (single photon emission computed tomography), gastric emptying and orocecal transit and satiation postnutrient challenge. The three arms were comparable with regard to age, gender and body mass index. There were no statistically significant effects of itopride on gastric emptying, orocecal transit, fasting gastric volume, maximum tolerated volume or aggregate symptom score with nutrient drink challenge. Postprandial (PP) change in gastric volume differed in the three groups (P = 0.019): 625[+/-28 (SEM)], 555(+/-26) and 512(+/-33) in placebo, itopride 100 and 200 mg groups, respectively. In healthy subjects, itopride reduced total PP gastric volume without accelerating gastric emptying or significantly altering gastric motor and sensory function in healthy individuals.

The effect of therapeutic horseback riding on balance in community-dwelling older adults: a pilot study.

PubMed

Homnick, Tamara D; Henning, Kim M; Swain, Charlene V; Homnick, Douglas N

2015-02-01

Equine assisted activities (hippotherapy and therapeutic riding) improve balance in patients with disabilities such as cerebral palsy, but have not been systematically studied in older adults, at risk of falls due to balance deficits. We conducted a 10-week, single blind, controlled trial of the effect of a therapeutic horseback riding course on measures of balance in community-dwelling adults 65 years and older. Nine riders and six controls completed the trial. Controls were age matched to riders and all participants were recruited from the local community. Both groups showed improvements in balance during the trial, but did not reach statistical significance. Sample size was small, participants had relatively high initial balance scores, and controls tended to increase their physical activities, likely influencing outcomes. No adverse events occurred and the supervised therapeutic riding program appeared to be a safe and effective form of exercise to improve balance in older adults. A power analysis was performed to estimate numbers of participants needed for a larger study. © The Author(s) 2012.

Towards evidence-based vitamin D supplementation in infants: vitamin D intervention in infants (VIDI) - study design and methods of a randomised controlled double-blinded intervention study.

PubMed

Helve, Otto; Viljakainen, Heli; Holmlund-Suila, Elisa; Rosendahl, Jenni; Hauta-Alus, Helena; Enlund-Cerullo, Maria; Valkama, Saara; Heinonen, Kati; Räikkönen, Katri; Hytinantti, Timo; Mäkitie, Outi; Andersson, Sture

2017-03-29

Vitamin D is important for bone mass accrual during growth. Additionally, it is considered a requirement for a multitude of processes associated with, for example, the development of immunity. Many countries apply vitamin D supplementation strategies in infants, but the guidelines are not based on scientific evidence and aim at prevention of rickets. It remains unclear whether the recommended doses are sufficient for the wide array of other effects of vitamin D. The VIDI trial performed in Finland is the first large randomised controlled study for evaluation of the effects of different vitamin D supplemental doses in infancy on: 1. bone strength 2. infections and immunity 3. allergy, atopy and asthma 4. cognitive development 5. genetic regulation of mineral homeostasis METHODS/DESIGN: VIDI, a randomised controlled double-blinded single-centre intervention study is conducted in infants from the age of 2 weeks to 24 months. Participants, recruited at Helsinki Maternity Hospital, are randomised to receive daily either 10 μg (400 IU) or 30 μg (1 200 IU) of vitamin D3 supplementation. Both groups are assessed at 6 months of age for calcium homeostasis, and at 12 and 24 months of age for parameters associated with bone strength, growth, developmental milestones, infections, immunity, atopy-related diseases, and genetic factors involved in these functions. The study enables evaluation of short and long term effects of supplemental vitamin D on growth, immune functions and skeletal and developmental parameters in infants, and the effects of genetic factors therein. The results enable institution of evidence-based guidelines for vitamin D supplementation in infancy. ClinicalTrials.gov, NCT01723852 , registration date 6.11.2012.

Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study.

PubMed

Lainé, Fabrice; Laviolle, Bruno; Bardou-Jacquet, Edouard; Fatih, Nadia; Jezequel, Caroline; Collet, Nicolas; Ropert, Martine; Morcet, Jeff; Hamon, Catherine; Reymann, Jean-Michel; Loréal, Olivier

2017-10-01

Hepcidin, secreted by hepatocytes, controls iron metabolism by limiting iron egress in plasma. Hepcidin is upregulated during inflammation through the activation of the signal transducer and activator of transcription 3 (STAT3) transduction pathway, which decreases iron bioavailability and may explain the anemia of chronic inflammatory disease. In vitro, it has been shown that curcumin can decrease hepcidin synthesis by decreasing STAT3 activity. We conducted a proof-of-concept study to assess the effect of curcuma on hepcidin synthesis in human. This was a placebo-controlled, randomized, double-blind, cross-over, two-period study performed in 18 healthy male volunteers. Subjects received a single oral dose of 6 g curcuma containing 2% of curcumin or placebo. Serum hepcidin and iron parameters were assessed repeatedly until 48 h after dosing. When compared with a placebo curcuma decreased hepcidin levels significantly at 6 h (-19%, P = 0.004), 8 h (-17%, P = 0.009), and 12 h (-17%, P = 0.007) and tended to decrease hepcidin at 24 h (-15%, P = 0.076). Curcuma also significantly increased serum ferritin levels at 6 and 8 h (+7% for both times, P = 0.018, 0.030, respectively) and had no effects on serum iron, transferrin, and transferrin saturation. This pilot study showed that curcuma decreases serum hepcidin levels in human and supports the idea that curcuma could be useful in treating hepcidin overproduction during inflammatory processes. Confirmatory studies in patients with chronic inflammation are now required to determine the optimal dose and therapeutic scheme of curcuma. © 2017 Société Française de Pharmacologie et de Thérapeutique.

Effect of a gastro-protective agent, rebamipide, on symptom improvement in patients with functional dyspepsia: a double-blind placebo-controlled study in Japan.

PubMed

Miwa, Hiroto; Osada, Taro; Nagahara, Akihito; Ohkusa, Toshifumi; Hojo, Mariko; Tomita, Toshihiko; Hori, Kazutoshi; Matsumoto, Takayuki; Sato, Nobuhiro

2006-12-01

Although mucosal protective agents have been used frequently for treatment of symptomatic gastritis, there has been no well-controlled study of functional dyspepsia. The aim of this study was to assess the efficacy of a 4-week treatment with rebamipide for the relief of overall dyspeptic symptoms and the improvement in quality of life from an untreated baseline in Japanese patients with functional dyspepsia. In a double-blinded, randomized, placebo-controlled, single-center study, 81 patients with functional dyspepsia were recruited and treated with rebamipide (100 mg, t.i.d.) or placebo for 4 weeks. Symptoms were assessed at baseline and at the end of the study period by a symptom questionnaire. Quality of life was evaluated by the QPD 32. Data was analyzed for symptoms from 38 patients who received rebamipide and 33 patients who received placebo treatment. Overall symptoms were significantly improved in both the rebamipide and placebo treatment groups from the untreated baseline after 4 weeks of treatment, and the mean changes in overall symptoms were not significantly different between the groups. However, the improvement in symptom score was significantly greater in the treatment arm than in the placebo arm for three items, which were bloating, belching, and pain or discomfort that was relieved after a meal. Regarding quality of life, social restriction and pain intensity were significantly improved in the rebamipide treatment group in per-protocol analysis (P = 0.048 and P = 0.031, respectively). Although rebamipide was not significantly better than placebo in reducing overall symptoms by 4 weeks' treatment, it may partially improve the symptoms. It may also be beneficial in improvement of quality of life in Japanese patients with functional dyspepsia.

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

ERIC Educational Resources Information Center

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

2010-01-01

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

Propofol versus thiopental sodium for the treatment of refractory status epilepticus (Review).

PubMed

Prabhakar, Hemanshu; Bindra, Ashish; Singh, Gyaninder Pal; Kalaivani, Mani

2013-07-01

Failure to respond to antiepileptic drugs in uncontrolled seizure activity such as refractory status epilepticus (RSE) has led to the use of anaesthetic drugs. Coma is induced with anaesthetic drugs to achieve complete control of seizure activity. Thiopental sodium and propofol are popularly used for this purpose. Both agents have been found to be effective. However, there is substantial lack of evidence as to which of the two drugs is better in terms of clinical outcome. To compare the efficacy, adverse effects, and short- and long-term outcomes of RSE treated with one of the two anaesthetic agents, thiopental sodium or propofol. We searched the Cochrane Epilepsy Group Specialized Register (10 May 2012), the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4 of 12, The Cochrane Library 2012), and MEDLINE (1946 to May week 1, 2012). We also searched (10 May 2012) ClinicalTrials.gov, The South Asian Database of Controlled Clinical Trials, and IndMED (a bibliographic database of Indian Medical Journals). All randomised or quasi-randomised controlled studies (regardless of blinding) of control of RSE using either thiopental sodium or propofol. Two review authors screened the search results and reviewed abstracts of relevant and eligible trials before retrieving the full text publications. One study was available for review. This study was a small, single-blind, multicentre trial studying adults with RSE and receiving either propofol or thiopental sodium for the control of seizure activity (Rossetti 2011). This study showed a wide confidence interval suggesting that the drugs may differ in efficacy up to more than two-fold. There was no evidence of a difference between the drugs with respect to the outcome measures such as control of seizure activity and functional outcome at three months. There is lack of robust and randomised controlled evidence that can clarify the efficacy of propofol and thiopental sodium over each other in the treatment of RSE. There is a need for large, randomised controlled trials for this serious condition. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

The effect of an interactive cycling training on cognitive functioning in older adults with mild dementia: study protocol for a randomized controlled trial.

PubMed

Karssemeijer, E G A; Bossers, W J R; Aaronson, J A; Kessels, R P C; Olde Rikkert, M G M

2017-03-21

To date there is no cure or an effective disease-modifying drug to treat dementia. Available acetylcholine-esterase inhibiting drugs or memantine only produce small benefits on cognitive and behavioural functioning and their clinical relevance remains controversial. Combined cognitive-aerobic interventions are an appealing alternative or add-on to current pharmacological treatments. The primary aim of this study is to investigate the efficacy of a combined cognitive-aerobic training and a single aerobic training compared to an active control group in older adults with mild dementia. We expect to find a beneficial effect on executive functioning in both training regimes, compared to the control intervention, with the largest effect in the combined cognitive-aerobic group. Secondary, intervention effects on cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty and quality of life are studied. The design is a single-blind, randomized controlled trial (RCT) with three groups: a combined cognitive-aerobic bicycle training (interactive cycling), a single aerobic bicycle training and a control intervention, which consists of stretching and toning exercises. Older adults with mild dementia follow a 12-week training program consisting of three training sessions of 30-40 min per week. The primary study outcome is objective executive functioning measured with a neuropsychological assessment. Secondary measures are objective cognitive functioning in other domains, physical functioning, physical activity levels, activities of daily living, frailty, mood and quality of life. The three groups are compared at baseline, after 6 and 12 weeks of training, and at 24-week follow-up. This study will provide novel information on the effects of an interactive cycling training on executive function in older adults with mild dementia. Furthermore, since this study has both a combined cognitive-aerobic training and a single aerobic training group the effectiveness of the different components of the intervention can be identified. The results of this study may be used for physical and mental activity recommendations in older adults with dementia. The Netherlands National Trial Register NTR5581 . Registered 14 February 2016.

Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

PubMed

Jacq, Olivier; Arnulf, Isabelle; Similowski, Thomas; Attali, Valérie

2017-12-20

Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome. This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. Randomization was computer-generated. Patients each received one active manipulation and one sham manipulation at an interval of 21 days and were evaluated 30 min and 48 h after each session administered by a qualified osteopath. Neither the patients, nor the investigator performing the evaluations were informed about the order of the two techniques (double-blind). The primary endpoint was the percentage of responding patients presenting increased pharyngeal stability defined by a variation of critical closing pressure (Pcrit) of at least -4 cmH 2 O at 30 min. Secondary endpoints were the variation of Pcrit in absolute values, sleepiness and snoring. Others endpoints were lacrimation (Schirmer's test), induced pain, sensations experienced during OMT. Ten patients were included and nine (57 [50; 58] years, comprising 7 men, with an apnoea-hypopnoea index of 31.0 [25.5; 33.2]/h; (values are median [quartiles])) were analysed. Seven patients were analysed for the primary endpoint and nine patients were analysed for secondary endpoints. Five patients responded after active manipulation versus no patients after sham manipulation (p = 0.0209). Active manipulation induced more intense pain (p = 0.0089), increased lacrimation (ns) and more tactile, nociceptive and gustatory sensations (13 versus 1) compared to sham manipulation. No significant difference was observed for the other endpoints. Osteopathic manipulative treatment of the SPG may improve pharyngeal stability in obstructive sleep apnoea syndrome. This trial validates the feasibility of the randomized, controlled, double-blind methodology for evaluation of this osteopathic treatment. Studies on a larger sample size must specify the efficacy on the apnoea-hypopnoea index. The study was retrospectively registered in the clinicaltrial.gov registry under reference NCT01193738 on 1st September 2010 (first inclusion May 19, 2010).

Effects of lithium carbonate on performance and biomedical functions.

DOT National Transportation Integrated Search

1977-07-01

The effects of a single 600-mg dose of lithium carbonate were evaluated in a study of 15 healthy, normal male subjects. Subjects were studied, on two occasions, by utilizing a double-blind design--once receiving the lithium carbonate and once receivi...

High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.

PubMed

Kudo, Taiki; Kawakami, Hiroshi; Hayashi, Tsuyoshi; Yasuda, Ichiro; Mukai, Tsuyoshi; Inoue, Hiroyuki; Katanuma, Akio; Kawakubo, Kazumichi; Ishiwatari, Hirotoshi; Doi, Shinpei; Yamada, Reiko; Maguchi, Hiroyuki; Isayama, Hiroyuki; Mitsuhashi, Tomoko; Sakamoto, Naoya

2014-12-01

EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. Prospective, single-blind, randomized, controlled crossover trial. Seven tertiary referral centers. Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. EUS-FNA by using NNP and HNP. The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. This was a single-blinded, crossover study. Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. ( UMIN000005939.). Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

PubMed

Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

2017-09-01

The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess the efficacy and safety of LCZ696 in Japanese HFrEF patients. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The impact of a computerised test of attention and activity (QbTest) on diagnostic decision-making in children and young people with suspected attention deficit hyperactivity disorder: single-blind randomised controlled trial.

PubMed

Hollis, Chris; Hall, Charlotte L; Guo, Boliang; James, Marilyn; Boadu, Janet; Groom, Madeleine J; Brown, Nikki; Kaylor-Hughes, Catherine; Moldavsky, Maria; Valentine, Althea Z; Walker, Gemma M; Daley, David; Sayal, Kapil; Morriss, Richard

2018-04-26

Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision-making in children with suspected ADHD. Randomised, parallel, single-blind controlled trial in mental health and community paediatric clinics in England. Participants were 6-17 years-old and referred for ADHD diagnostic assessment; all underwent assessment-as-usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within 6-months from baseline. Health economic cost-effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). One hundred and thirty-two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (hazard ratio 1.44, 95% CI 1.04-2.01). At 6-months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (time ratio 0.85, 95% CI 0.77-0.93), increased clinicians' confidence in their diagnostic decisions (odds ratio 1.77, 95% CI 1.09-2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance; however, cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as 'cost neutral'. QbTest may increase the efficiency of ADHD assessment pathway allowing greater patient throughput with clinicians reaching diagnostic decisions faster without compromising diagnostic accuracy. © 2018 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial.

PubMed

Alfawal, Alaa M H; Hajeer, Mohammad Y; Ajaj, Mowaffak A; Hamadah, Omar; Brad, Bassel

2018-02-17

To evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC). Trial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm). 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction. piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side. the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded. Random sequence: Computer-generated random numbers. Allocation concealment: sequentially numbered, opaque, sealed envelopes. Blinding: Single blinded (outcomes' assessor). Seventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05). Piezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction. ClinicalTrials.gov (Identifier: NCT02606331 ).

The addition of a tension night splint to a structured home rehabilitation programme in patients with chronic plantar fasciitis does not lead to significant additional benefits in either pain, function or flexibility: a single-blinded randomised controlled trial

PubMed Central

2017-01-01

Objective To identify any improvements in pain or function in patients with chronic plantar fasciitis following the use of a tension night splint (TNS). Methods Single-blinded randomised controlled trial, with participants split evenly between intervention group (TNS + home exercise programme/HEP) and control group (HEP only). Follow-up at 3 months, with interim data at 6 weeks. Results 40 patients recruited. Mean age 52.1 years, 33% male, mean body mass index 30.8 kg/m2, mean duration of symptoms of 25 months. Improvement in self-reported ‘average pain' in the intervention group from 6.8/10 at baseline to 5.6/10 at 6 weeks, and 5.3/10 at 3 months (both clinically and statistically significant at both time points), compared with control group of 7.1/10 at baseline to 6.2/10 at 6 weeks and 5.6/10 at 3 months (significant only at 3 months). Improvements in self-reported ‘worst pain', ‘pain walking' and ‘pain first thing in the morning' in both groups at all time periods. Improvements were seen in revised Foot Function Index at all time points in both groups, but limited changes seen in flexibility and no significant changes in anxiety or depression Hospital Anxiety and Depression Scale domains or sleep quality in either group. However, no differences were seen between the outcomes seen in the two groups for the majority of the measures studied. Conclusions Improvements in pain and some functional measures seen in both groups, with few, if any, differences seen in outcomes between the intervention group compared with the control group. However, ongoing pain symptoms were reported in both groups, suggesting that ‘help' rather than ‘cure' was obtained for the majority. There is a possibility of earlier benefit seen in the intervention group compared with the control group, but data are unclear and further work may be needed. Trial registration number ClinicalTrials.gov: NCT02546115; results. PMID:29259809

Intervention for phantom limb pain: A randomized single crossover study of mirror therapy.

PubMed

Ramadugu, Shashikumar; Nagabushnam, Satish C; Katuwal, Nagendra; Chatterjee, Kaushik

2017-01-01

Mirror therapy suggested to help relieve phantom limb pain (PLP) by resolving the visual- proprioceptive dissociation in the brain, but studies so far either had shorter follow-up or smaller sample size. In this randomized single crossover trial, 64 amputees with PLP in the age group of 15-75 years of age were distributed into test and control groups by simple randomization method. Of these 28 in control and 32 in test groups, respectively, completed the 4 weeks of mirror therapy and 12 weeks of follow-up assessments. A standardized set of exercises for 15 min/day for 4 and 8 weeks in test and control groups (in the first 4 weeks, the mirror was covered), respectively, was administered under supervision of one of the authors. All were assessed using the visual analog scale and Short-Form McGill Pain Questionnaire on day 0 and at 4, 8, and 12 weeks after therapy. In control group for the initial 4 weeks, the mirror was covered. The assessing author was blinded to the group to which the participants belonged. Significant reduction in PLP was noted in the test group at 4 weeks compared to the control group ( P < 0.0001). Significant reduction was seen in control group also after the switchover and sustained for 12 weeks in both. No harm was reported. Mirror therapy is effective in relieving the intensity, duration, frequency, and overall PLP, and improvement is maintained up to 12 weeks' posttherapy.

Effects of foot reflexology on anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery: A clinical trial.

PubMed

Abbaszadeh, Yaser; Allahbakhshian, Atefeh; Seyyedrasooli, Alehe; Sarbakhsh, Parvin; Goljarian, Sakineh; Safaei, Naser

2018-05-01

This study aimed to investigate the effect of foot reflexology on anxiety and physiological parameters in patients after CABG surgery. This was a single-blind, three-arm, parallel-group, randomized controlled trial with three groups of 40 male patients undergoing CABG. Participants were placed in three groups, named intervention, placebo, and control. Physiological parameters were measured including systolic and diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, percutaneous oxygen saturation, and anxiety of participants. Results showed a statistically significant difference between intervention and control groups in terms of the level of anxiety (p < 0.05). Also, results showed a statistically significant effect on all physiological parameters except heart rate (p < 0.05). This study indicated that foot reflexology may be used by nurses as an adjunct to standard ICU care to reduce anxiety and stabilize physiological parameters such as systolic, diastolic, mean arterial pressure, and heart rate. Copyright © 2018 Elsevier Ltd. All rights reserved.

A spiritual-hypnosis assisted treatment of children with PTSD after the 2002 Bali terrorist attack.

PubMed

Lesmana, C B J; Suryani, L K; Jensen, G D; Tiliopoulos, Niko

2009-07-01

The aim of this study was to assess the effectiveness of a spiritual-hypnosis assisted therapy (SHAT) for treatment of posttraumatic stress disorder (PTSD) in children. All children, age 6-12 years (N=226; 52.7% females), who experienced the terrorist bomb blasts in Bali in 2002, and subsequently were diagnosed with PTSD were studied, through a longitudinal, quasi-experimental (pre-post test), single-blind, randomized control design. Of them, 48 received group SHAT (treatment group), and 178 did not receive any therapy (control group). Statistically significant results showed that SHAT produced a 77.1% improvement rate, at a two-year follow up, compared to 24% in the control group, while at the same time, the mean PTSD symptom score differences were significantly lower in the former group. We conclude that the method of spiritual-hypnosis is highly effective, economic, and easily implemented, and has a potential for therapy of PTSD in other cultures or other catastrophic life-threatening events.

Odour discrimination and identification are improved in early blindness.

PubMed

Cuevas, Isabel; Plaza, Paula; Rombaux, Philippe; De Volder, Anne G; Renier, Laurent

2009-12-01

Previous studies showed that early blind humans develop superior abilities in the use of their remaining senses, hypothetically due to a functional reorganization of the deprived visual brain areas. While auditory and tactile functions have been investigated for long, little is known about the effects of early visual deprivation on olfactory processing. However, blind humans make an extensive use of olfactory information in their daily life. Here we investigated olfactory discrimination and identification abilities in early blind subjects and age-matched sighted controls. Three levels of cuing were used in the identification task, i.e., free-identification (no cue), categorization (semantic cues) and multiple choice (semantic and phonological cues). Early blind subjects significantly outperformed the controls in odour discrimination, free-identification and categorization. In addition, the larger group difference was observed in the free-identification as compared to the categorization and the multiple choice conditions. This indicated that a better access to the semantic information from odour perception accounted for part of the improved olfactory performances in odour identification in the blind. We concluded that early blind subjects have both improved perceptual abilities and a better access to the information stored in semantic memory than sighted subjects.

Blindness and social trust: The effect of early visual deprivation on judgments of trustworthiness.

PubMed

Ferrari, C; Vecchi, T; Merabet, L B; Cattaneo, Z

2017-10-01

Investigating the impact of early visual deprivation on evaluations related to social trust has received little attention to date. This is despite consistent evidence suggesting that early onset blindness may interfere with the normal development of social skills. In this study, we investigated whether early blindness affects judgments of trustworthiness regarding the actions of an agent, with trustworthiness representing the fundamental dimension in the social evaluation. Specifically, we compared performance between a group of early blind individuals with that of sighted controls in their evaluation of trustworthiness of an agent after hearing a pair of two positive or two negative social behaviors (impression formation). Participants then repeated the same evaluation following the presentation of a third (consistent or inconsistent) behavior regarding the same agent (impression updating). Overall, blind individuals tended to give similar evaluations compared to their sighted counterparts. However, they also valued positive behaviors significantly more than sighted controls when forming their impression of an agent's trustworthiness. Moreover, when inconsistent information was provided, blind individuals were more prone to revise their initial evaluation compared to controls. These results suggest that early visual deprivation may have a dramatic effect on the evaluation of social factors such as trustworthiness. Copyright © 2017 Elsevier Inc. All rights reserved.

Validity of false belief tasks in blind children.

PubMed

Brambring, Michael; Asbrock, Doreen

2010-12-01

Previous studies have reported that congenitally blind children without any additional impairment reveal a developmental delay of at least 4 years in perspective taking based on testing first-order false-belief tasks. These authors interpret this delay as a sign of autism-like behavior. However, the delay may be caused by testing blind children with false-belief tasks that require visual experience. Therefore, the present study gave alternative false-belief tasks based on tactile or auditory experience to 45 congenitally blind 4-10-year-olds and 37 sighted 3-6-year-olds. Results showed criterion performance at 80 months (6; 8 years) in blind children compared with 61 months (5; 1 years) in sighted controls. It is concluded that this 19-month (1; 7 year) difference, which is comparable with delays in other developmental areas, is a developmental delay caused by the fact of congenital blindness rather than a sign of a psychopathological disorder of autism-like behavior.

The comparison between limited open carpal tunnel release using direct vision and tunneling technique and standard open carpal tunnel release: a randomized controlled trial study.

PubMed

Suppaphol, Sorasak; Worathanarat, Patarawan; Kawinwongkovit, Viroj; Pittayawutwinit, Preecha

2012-04-01

To compare the operative outcome of carpal tunnel release between limited open carpal tunnel release using direct vision and tunneling technique (group A) with standard open carpal tunnel release (group B). Twenty-eight patients were enrolled in the present study. A single blind randomized control trial study was conducted to compare the postoperative results between group A and B. The study parameters were Levine's symptom severity and functional score, grip and pinch strength, and average two-point discrimination. The postoperative results between two groups were comparable with no statistical significance. Only grip strength at three months follow up was significantly greater in group A than in group B. The limited open carpal tunnel release in the present study is effective comparable to the standard open carpal tunnel release. The others advantage of this technique are better cosmesis and improvement in grip strength at the three months postoperative period.

N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

ERIC Educational Resources Information Center

Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

2013-01-01

Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

Double-Blind Controlled Comparison of Phlebitis Produced by Cephapirin and Cephalothin

PubMed Central

Carrizosa, Jaime; Levison, Matthew E.; Kaye, Donald

1973-01-01

In a double-blind study with each patient as his own control cephapirin and cephalothin were administered to 20 patients in opposite arms for a period of 48 hr each. Neither the incidence of phlebitis nor the degree of phlebitis was significantly different with the two drugs, and there was no difference in the time of onset of pain or phlebitis. PMID:4597719

Impact of adding a second layer to a single unlocked closure of a Cesarean uterine incision: randomized controlled trial.

PubMed

Bennich, G; Rudnicki, M; Wilken-Jensen, C; Lousen, T; Lassen, P D; Wøjdemann, K

2016-04-01

To investigate short- and long-term effects on residual myometrial thickness (RMT) of adding a second layer to a single unlocked closure of a Cesarean uterine incision. This was a randomized double-blind controlled trial. Healthy nulliparous women scheduled for first-time elective Cesarean delivery were operated on using a modified version of the Misgav Ladach surgical technique. The women were examined by transabdominal ultrasound before discharge from the maternity ward and by transvaginal saline contrast sonohysterography at a minimum of 5 months postpartum. Seventy-six nulliparae met the criteria and agreed to participate in the study. Thirty-five women were assigned to the single-layer technique and 38 to the double-layer unlocked closure technique. Groups were comparable regarding gestational age at delivery, duration of surgery and perioperative blood loss. There was no difference in RMT between the two groups, both at time of discharge (mean ± SD, 20.2 ± 8.0 mm vs 21.0 ± 9.7 mm) and after 5 months postpartum (mean, 5.7 ± 2.9 mm vs 5.7 ± 2.2 mm). RMT was approximately half that of the normal myometrium at both examinations. The results of this study suggest that double-layer closure of a Cesarean uterine incision does not increase RMT compared with single-layer closure when an unlocked technique is used. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Effects of Age, Sex, and Race on the Safety and Pharmacokinetics of Single and Multiple Doses of Azilsartan Medoxomil in Healthy Subjects.

PubMed

Harrell, Robert E; Karim, Aziz; Zhang, Wencan; Dudkowski, Caroline

2016-05-01

Azilsartan medoxomil (AZL-M) is an angiotensin II receptor blocker approved to treat hypertension. After oral dosing, AZL-M is quickly hydrolyzed to azilsartan (AZL). The aims of this study were to assess the effects of age, sex, and race on the pharmacokinetics of AZL-M in healthy subjects, as well as safety and tolerability. Sixty-one healthy adults were enrolled in this phase I, single-blind, randomized placebo-controlled study (placebo control was for assessment of safety/tolerability only). Subjects were stratified by age (18-45 vs. 65-85 years), sex, and race (black vs. white) and given oral AZL-M 60 mg (3 × 20 mg capsules) or placebo as a single dose (Day 1) and consecutive daily doses (Days 4-8) (6:2 ratio for AZL-M:placebo per group). Pharmacokinetics were evaluated (AZL-M patients only) on Days 1-3 and 8-9 and safety/tolerability was monitored. Age, sex, and race had no clinically meaningful effect on AZL exposures after single or multiple dosing. Pharmacokinetic parameters remained similar between Days 1 and 8 for each age, sex, and race subgroup. The frequency of adverse events was similar for AZL-M (32%) and placebo (29%). No discontinuations or serious adverse events occurred. Based on these pharmacokinetic and safety/tolerability findings, no AZL-M dose adjustments are required based on age, sex, or race (black/white).

Nonclinical and clinical pharmacology evidence for cardiovascular safety of saxagliptin.

PubMed

Pollack, Pia S; Chadwick, Kristina D; Smith, David M; Billger, Martin; Hirshberg, Boaz; Iqbal, Nayyar; Boulton, David W

2017-09-13

In the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial in patients with type 2 diabetes mellitus (T2D) at high risk of cardiovascular (CV) disease, saxagliptin did not increase the risk for major CV adverse events. However, there was an unexpected imbalance in events of hospitalization for heart failure (hHF), one of six components of the secondary CV composite endpoint, with a greater number of events observed with saxagliptin. Here, we examined findings from nonclinical safety and clinical pharmacology studies of saxagliptin with the aim of identifying any potential signals of myocardial injury. In vitro and in vivo (rat, dog, monkey) safety pharmacology and toxicology studies evaluating the potential effects of saxagliptin and its major active metabolite, 5-hydroxy saxagliptin, on the CV system are reviewed. In addition, results from saxagliptin clinical studies are discussed: one randomized, 2-period, double-blind, placebo-controlled single-ascending-dose study (up to 100 mg); one randomized, double-blind, placebo-controlled, sequential, multiple-ascending-high-dose study (up to 400 mg/day for 14 days); and one randomized, double-blind, 4-period, 4-treatment, cross-over thorough QTc study (up to 40 mg/day for 4 days) in healthy volunteers; as well as one randomized, placebo-controlled, sequential multiple-ascending-dose study in patients with T2D (up to 50 mg/day for 14 days). Neither saxagliptin nor 5-hydroxy saxagliptin affected ligand binding to receptors and ion channels (e.g. potassium channels) or action potential duration in in vitro studies. In animal toxicology studies, no changes in the cardiac conduction system, blood pressure, heart rate, contractility, heart weight, or heart histopathology were observed. In healthy participants and patients with T2D, there were no findings suggestive of myocyte injury or fluid overload. Serum chemistry abnormalities indicative of cardiac injury, nonspecific muscle damage, or fluid homeostasis changes were infrequent and balanced across treatment groups. There were no QTc changes associated with saxagliptin. No treatment-emergent adverse events suggestive of heart failure or myocardial damage were reported. The saxagliptin nonclinical and clinical pharmacology programs did not identify evidence of myocardial injury and/or CV harm that may have predicted or may explain the unexpected imbalance in the rate of hHF observed in SAVOR.

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial

NASA Astrophysics Data System (ADS)

Chary-Valckenaere, Isabelle; Loeuille, Damien; Jay, Nicolas; Kohler, François; Tamisier, Jean-Noë; Roques, Christian-François; Boulange, Michel; Gay, Gérard

2018-02-01

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: `immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial.

PubMed

Song, Jooeun; Paul, Serene S; Caetano, Maria Joana D; Smith, Stuart; Dibble, Leland E; Love, Rachelle; Schoene, Daniel; Menant, Jasmine C; Sherrington, Cathie; Lord, Stephen R; Canning, Colleen G; Allen, Natalie E

2018-03-01

To determine whether 12-week home-based exergame step training can improve stepping performance, gait and complementary physical and neuropsychological measures associated with falls in Parkinson's disease. A single-blinded randomised controlled trial. Community (experimental intervention), university laboratory (outcome measures). Sixty community-dwelling people with Parkinson's disease. Home-based step training using videogame technology. The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment. Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson's disease, number of falls over six months and self-reported mobility and balance. Post intervention, there were no differences between the intervention ( n = 28) and control ( n = 25) groups in the primary or secondary outcomes except for the Timed Up and Go test, where there was a significant difference in favour of the control group ( P = 0.02). Intervention participants reported mobility improvement, whereas control participants reported mobility deterioration-between-group difference on an 11-point scale = 0.9 (95% confidence interval: -1.8 to -0.1, P = 0.03). Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group. Overall, home-based exergame step training was not effective in improving the outcomes assessed. However, the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson's disease.

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial

NASA Astrophysics Data System (ADS)

Chary-Valckenaere, Isabelle; Loeuille, Damien; Jay, Nicolas; Kohler, François; Tamisier, Jean-Noë; Roques, Christian-François; Boulange, Michel; Gay, Gérard

2018-06-01

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: `immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

Brain morphometry in blind and sighted subjects.

PubMed

Maller, Jerome J; Thomson, Richard H; Ng, Amanda; Mann, Collette; Eager, Michael; Ackland, Helen; Fitzgerald, Paul B; Egan, Gary; Rosenfeld, Jeffrey V

2016-11-01

Previous neuroimaging studies have demonstrated structural brain alterations in blind subjects, but most have focused on primary open angle glaucoma or retinopathy of prematurity, used low-field scanners, a limited number of receive channels, or have presented uncorrected results. We recruited 10 blind and 10 age and sex-matched controls to undergo high-resolution MRI using a 3T scanner and a 32-channel receive coil. We evaluated whole-brain morphological differences between the groups as well as manual segmentation of regional hippocampal volumes. There were no hippocampal volume differences between the groups. Whole-brain morphometry showed white matter volume differences between blind and sighted groups including localised larger regions in the visual cortex (occipital gyral volume and thickness) among those with blindness early in life compared to those with blindness later in life. Hence, in our patients, blindness resulted in brain volumetric differences that depend upon duration of blindness. Copyright © 2016 Elsevier Ltd. All rights reserved.

Impact of color blindness on recognition of blood in body fluids.

PubMed

Reiss, M J; Labowitz, D A; Forman, S; Wormser, G P

2001-02-12

Color blindness is a common hereditary X-linked disorder. To investigate whether color blindness affects the ability to detect the presence of blood in body fluids. Ten color-blind subjects and 20 sex- and age-matched control subjects were shown 94 photographs of stool, urine, or sputum. Frank blood was present in 57 (61%) of the photographs. Surveys were done to determine if board-certified internists had ever considered whether color blindness would affect detection of blood and whether an inquiry on color blindness was included in their standard medical interview. Color-blind subjects were significantly less able to identify correctly whether pictures of body fluids showed blood compared with non-color-blind controls (P =.001); the lowest rate of correct identifications occurred with pictures of stool (median of 26 [70%] of 37 for color-blind subjects vs 36.5 [99%] of 37 for controls; P<.001). The more severely color-blind subjects were significantly less accurate than those with less severe color deficiency (P =.009). Only 2 (10%) of the 21 physicians had ever considered the possibility that color blindness might affect the ability of patients to detect blood, and none routinely asked their patients about color blindness. Color blindness impairs recognition of blood in body fluids. Color-blind individuals and their health care providers need to be made aware of this limitation.

Color blindness among multiple sclerosis patients in Isfahan

PubMed Central

Shaygannejad, Vahid; Golabchi, Khodayar; Dehghani, Alireza; Ashtari, Fereshteh; Haghighi, Sepehr; Mirzendehdel, Mahsa; Ghasemi, Majid

2012-01-01

Background: Multiple sclerosis (MS) is a disease of young and middle aged individuals with a demyelinative axonal damage nature in central nervous system that causes various signs and symptoms. As color vision needs normal function of optic nerve and macula, it is proposed that MS can alter it via influencing optic nerve. In this survey, we evaluated color vision abnormalities and its relationship with history of optic neuritis and abnormal visual evoked potentials (VEPs) among MS patients. Materials and Methods: The case group was included of clinically definitive MS patients and the same number of normal population was enrolled as the control group. Color vision of all the participants was evaluated by Ishihara test and then visual evoked potential (VEPs) and history of optic neuritis (ON) was assessed among them. Then, frequency of color blindness was compared between the case and the control group. Finally, color blinded patients were compared to those with the history of ON and abnormal VEPs. Results: 63 MS patients and the same number of normal populations were enrolled in this study. 12 patients had color blindness based on the Ishihara test; only 3 of them were among the control group, which showed a significant different between the two groups (P = 0.013). There was a significant relationship between the color blindness and abnormal VEP (R = 0.53, P = 0.023) but not for the color blindness and ON (P = 0.67). Conclusions: This study demonstrates a significant correlation between color blindness and multiple sclerosis including ones with abnormal prolonged VEP latencies. Therefore, in individuals with acquired color vision impairment, an evaluation for potentially serious underlying diseases like MS is essential. PMID:23267377

Coil geometry effects on scanning single-coil magnetic induction tomography

NASA Astrophysics Data System (ADS)

Feldkamp, Joe R.; Quirk, Stephen

2017-09-01

Alternative coil designs for single coil magnetic induction tomography are considered in this work, with the intention of improving upon the standard design used previously. In particular, we note that the blind spot associated with this coil type, a portion of space along its axis where eddy current generation can be very weak, has an important effect on performance. The seven designs tested here vary considerably in the size of their blind spot. To provide the most discerning test possible, we use laboratory phantoms containing feature dimensions similar to blind spot size. Furthermore, conductivity contrasts are set higher than what would occur naturally in biological systems, which has the effect of weakening eddy current generation at coil locations that straddle the border between high and low conductivity features. Image reconstruction results for the various coils show that coils with smaller blind spots give markedly better performance, though improvements in signal-to-noise ratio could alter that conclusion.

The need for randomization in animal trials: an overview of systematic reviews.

PubMed

Hirst, Jennifer A; Howick, Jeremy; Aronson, Jeffrey K; Roberts, Nia; Perera, Rafael; Koshiaris, Constantinos; Heneghan, Carl

2014-01-01

Randomization, allocation concealment, and blind outcome assessment have been shown to reduce bias in human studies. Authors from the Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies (CAMARADES) collaboration recently found that these features protect against bias in animal stroke studies. We extended the scope the work from CAMARADES to include investigations of treatments for any condition. We conducted an overview of systematic reviews. We searched Medline and Embase for systematic reviews of animal studies testing any intervention (against any control) and we included any disease area and outcome. We included reviews comparing randomized versus not randomized (but otherwise controlled), concealed versus unconcealed treatment allocation, or blinded versus unblinded outcome assessment. Thirty-one systematic reviews met our inclusion criteria: 20 investigated treatments for experimental stroke, 4 reviews investigated treatments for spinal cord diseases, while 1 review each investigated treatments for bone cancer, intracerebral hemorrhage, glioma, multiple sclerosis, Parkinson's disease, and treatments used in emergency medicine. In our sample 29% of studies reported randomization, 15% of studies reported allocation concealment, and 35% of studies reported blinded outcome assessment. We pooled the results in a meta-analysis, and in our primary analysis found that failure to randomize significantly increased effect sizes, whereas allocation concealment and blinding did not. In our secondary analyses we found that randomization, allocation concealment, and blinding reduced effect sizes, especially where outcomes were subjective. Our study demonstrates the need for randomization, allocation concealment, and blind outcome assessment in animal research across a wide range of outcomes and disease areas. Since human studies are often justified based on results from animal studies, our results suggest that unduly biased animal studies should not be allowed to constitute part of the rationale for human trials.

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

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