Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

PubMed

Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

2014-12-01

To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p < 0.05) over the study period in both groups in total; changes (p < 0.05) were seen only in dimension D (group B) and E (both groups) during regular therapy. Physiotherapy may be more effective when provided regularly rather than in blocks.

Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study.

PubMed

Bouvet, L; Loubradou, E; Desgranges, F-P; Chassard, D

2017-11-01

Current fasting guidelines allow oral intake of water up to 2 h before induction of anaesthesia. We assessed whether gum chewing affects gastric emptying of 250 ml water and residual gastric fluid volume measured 2 h after ingestion of water. This prospective randomized observer-blind crossover trial was performed on 20 healthy volunteers who attended two separate study sessions: Control and Chewing gum (chlorophyll flavour, with 2.1 g carbohydrate). Each session started with an ultrasound measurement of the antral area, followed by drinking 250 ml water. Then, volunteers either chewed a sugared gum for 45 min (Chewing gum) or did not (Control). Serial measurements of the antral area were performed during 120 min, and the half-time to gastric emptying (t½), total gastric emptying time, and gastric fluid volume before ingestion of water and 120 min later were calculated. Gastric emptying of water was not different between sessions; the mean (sdsd) t½ was 23 (10) min in the Control session and 21 (7) min in the Chewing gum session (P=0.52). There was no significant difference between sessions in gastric fluid volumes measured before ingestion of water and 120 min later. Chewing gum does not affect gastric emptying of water and does not change gastric fluid volume measured 2 h after ingestion of water. NCT02673307. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com

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

PubMed Central

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

2010-01-01

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

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial

PubMed Central

Miller, Janis M.; Guo, Ying; Ashton-Miller, James A.; DeLancey, John O. L.; Sampselle, Carolyn M.

2014-01-01

Introduction and hypothesis The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. Methods This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. Results No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value=0.57) or in combination with prenatal perineal massage (P value=0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. Conclusions Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups. PMID:22829349

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial.

PubMed

Low, Lisa Kane; Miller, Janis M; Guo, Ying; Ashton-Miller, James A; DeLancey, John O L; Sampselle, Carolyn M

2013-03-01

The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value = 0.57) or in combination with prenatal perineal massage (P value = 0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups.

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma.

PubMed

Gómez-Aguayo, Francisco; Paczka, José A; Leñero-Córdova, Rubén; Jiménez-Román, Jesús; Davila-Villarreal, Jaime; Hartleben, Curt; Baiza-Durán, Leopoldo; Olvera-Montaño, Oscar; García-Velez, Francisco; Muñoz-Villegas, Patricia

2018-06-01

The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months. In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index. A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications-evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also determined to be similar. The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF. Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).

A Randomized Crossover Trial Comparing Autotitrating and Continuous Positive Airway Pressure in Subjects With Symptoms of Aerophagia: Effects on Compliance and Subjective Symptoms

PubMed Central

Shirlaw, Teresa; Hanssen, Kevin; Duce, Brett; Hukins, Craig

2017-01-01

Study Objectives: To assess the benefit and tolerance of autotitrating positive airway pressure (APAP) versus continuous positive airway pressure (CPAP) in subjects who experience aerophagia. Methods: This is the report of a prospective, two-week, double-blinded, randomized crossover trial set in an Australian clinical sleep laboratory in a tertiary hospital. Fifty-six subjects who reported symptoms of aerophagia that they attributed to CPAP were recruited. Full face masks were used by 39 of the 56 subjects recruited. Subjects were randomly and blindly allocated to either CPAP at their treatment recommended pressure or APAP 6–20 cm H2O, in random order. Subjects spent two weeks on each therapy mode. Therapy usage hours, 95th centile pressure, maximum pressure, 95th centile leak, and residual apnea-hypopnea index (AHI) were reported at the end of each two-week treatment period. Functional Outcome of Sleepiness Questionnaire, Epworth Sleepiness Scale, and visual analog scale to measure symptoms of aerophagia were also completed at the end of each 2-week treatment arm. Results: The median pressure (P < .001) and 95th centile pressure (P < .001) were reduced with APAP but no differences in compliance (P = .120) and residual AHI were observed. APAP reduced the symptoms of bloating (P = .011), worst episode of bloating (P = .040), flatulence (P = .010), and belching (P = .001) compared to CPAP. There were no differences in Epworth Sleepiness Scale or Functional Outcome of Sleepiness Questionnaire outcomes between CPAP and APAP. Conclusions: APAP therapy reduces the symptoms of aerophagia while not affecting compliance when compared with CPAP therapy. Clinical Trial Registration: Australian and New Zealand Clinical Trials Registry at https://www.anzctr.org.au, trial number ACTRN12611001250921. Commentary: A commentary on this article appears in this issue on page 859. Citation: Shirlaw T, Hanssen K, Duce B, Hukins C. A randomized crossover trial comparing autotitrating and continuous positive airway pressure in subjects with symptoms of aerophagia: effects on compliance and subjective symptoms. J Clin Sleep Med. 2017;13(7):881–888. PMID:28558864

Skating crossovers on a motorized flywheel: a preliminary experimental design to test effect on speed and on crossovers.

PubMed

Smith, Aynsley M; Krause, David A; Stuart, Michael J; Montelpare, William J; Sorenson, Matthew C; Link, Andrew A; Gaz, Daniel V; Twardowski, Casey P; Larson, Dirk R; Stuart, Michael B

2013-12-01

Ice hockey requires frequent skater crossovers to execute turns. Our investigation aimed to determine the effectiveness of training crossovers on a motorized, polyethylene high-resistance flywheel. We hypothesized that high school hockey players training on the flywheel would perform as well as their peers training on ice. Participants were 23 male high-school hockey players (age 15-19 years). The study used an experimental prospective design to compare players who trained for 9 sessions on the 22-foot flywheel with players who trained for 9 sessions on a similarly sized on-ice circle. Both groups were compared with control subjects who were randomly selected from the same participant pool as those training on ice. All players were tested before and after their 3-week training regimens, and control subjects were asked to not practice crossovers between testing. Group 1 trained in a hockey training facility housing the flywheel, and group 2 trained in the ice hockey arena where testing occurred. Primary outcome measures tested in both directions were: (a) speed (time in seconds) required to skate crossovers for 3 laps of a marked face-off circle, (b) cadence of skating crossovers on the similarly sized circles, and (c) a repeat interval speed test, which measures anaerobic power. No significant changes were found between groups in on-ice testing before and after training. Among the group 1 players, 7 of 8 believed they benefited from flywheel training. Group 2 players, who trained on ice, did not improve performance significantly over group 1 players. Despite the fact that no significant on-ice changes in performance were observed in objective measures, players who trained on the flywheel subjectively reported that the flywheel is an effective cost-effective alternative to training on ice. This is a relevant finding when placed in context with limited availability of on-ice training.

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

A prospective randomized open-label crossover trial of regional citrate anticoagulation vs. anticoagulation free liver dialysis by the Molecular Adsorbents Recirculating System

PubMed Central

2012-01-01

Introduction The Molecular Adsorbent Recycling System (MARS) is used to treat patients with liver failure. Observational data suggest that citrate anticoagulation during MARS is feasible. Comparative studies on the optimal anticoagulation regimen during MARS are lacking. The aim of the current study was to evaluate two heparin-free anticoagulation regimens. Methods We performed a prospective randomized open-label crossover study of regional citrate anticoagulation against no anticoagulation. Ten patients (age 55 ± 11 years) with liver failure undergoing MARS treatment were included. The primary endpoint was completion of MARS sessions. Secondary endpoints included treatment efficacy and safety. Longevity of MARS treatment was plotted as a Kaplan-Meier estimate. Fisher's exact test was used for contingency table analysis. Results Of a total of 27 6-hour sessions, four sessions had to be terminated prematurely, three due to occlusive clotting of the extracorporeal circuit and one due to uncontrollable bleeding from the vascular access site. All four events occurred in the group without anticoagulation. Between group comparison demonstrated citrate anticoagulation to significantly increase the likelihood of completed MARS treatment (Fisher's exact test, P 0.04). This translates into higher bilirubin reduction ratios when citrate was applied (reduction ratio 0.25 vs. 0.15, P 0.02). Systemic ionized calcium concentrations were significantly reduced during citrate anticoagulation (P < 0.001) but remained within a safe range. We observed no major adverse events. Conclusions Regional citrate anticoagulation in patients with liver failure is feasible. Citrate anticoagulation provides superior patency of the extracorporeal circuit. Avoidance of anticoagulation during MARS results in significant loss of treatment efficacy, due to treatment downtime. Additional studies are required to identify the optimal anticoagulation regimen for extracorporeal circulation in patients with liver failure. PMID:22305273

An improved genetic algorithm and its application in the TSP problem

NASA Astrophysics Data System (ADS)

Li, Zheng; Qin, Jinlei

2011-12-01

Concept and research actuality of genetic algorithm are introduced in detail in the paper. Under this condition, the simple genetic algorithm and an improved algorithm are described and applied in an example of TSP problem, where the advantage of genetic algorithm is adequately shown in solving the NP-hard problem. In addition, based on partial matching crossover operator, the crossover operator method is improved into extended crossover operator in order to advance the efficiency when solving the TSP. In the extended crossover method, crossover operator can be performed between random positions of two random individuals, which will not be restricted by the position of chromosome. Finally, the nine-city TSP is solved using the improved genetic algorithm with extended crossover method, the efficiency of whose solution process is much higher, besides, the solving speed of the optimal solution is much faster.

Head elevation and lateral head rotation effect on facemask ventilation efficiency: Randomized crossover trials.

PubMed

Matsunami, Sayuri; Komasawa, Nobuyasu; Konishi, Yuki; Minami, Toshiaki

2017-11-01

We performed two prospective randomized crossover trials to evaluate the effect of head elevation or lateral head rotation to facemask ventilation volume. In the first trial, facemask ventilation was performed with a 12-cm high pillow (HP) and 4-cm low pillow (LP) in 20 female patients who were scheduled to undergo general anesthesia. In the second trial, facemask ventilation was performed with and without lateral head rotation in another 20 female patients. Ventilation volume was measured in a pressure-controlled ventilation (PCV) manner at 10, 15, and 20 cmH 2 O inspiratory pressures. In the first trial evaluating head elevation effect, facemask ventilation volume was significantly higher with a HP than with a LP at 15 and 20 cmH 2 O inspiratory pressure (15 cmH 2 O: HP median 540 [ IQR 480-605] mL, LP 460 [400-520] mL, P=0.006, 20 cmH 2 O: HP 705 [650-800] mL, LP 560 [520-677] mL, P<0.001). In the second trial, lateral head rotation did not significantly increase facemask ventilation volume at all inspiratory pressure. Head elevation increased facemask ventilation volume in normal airway patients, while lateral head rotation did not. Copyright © 2017 Elsevier Inc. All rights reserved.

The Effect of Aromatherapy Abdominal Massage on Alleviating Menstrual Pain in Nursing Students: A Prospective Randomized Cross-Over Study

PubMed Central

Marzouk, Tyseer M. F.; El-Nemer, Amina M. R.; Baraka, Hany N.

2013-01-01

Dysmenorrhea is a common cause of sickness absenteeism from both classes and work. This study investigated the effect of aromatherapy massage on a group of nursing students who are suffering of primary dysmenorrhea. A randomized blind clinical trial of crossover design was used. In the first treatment phase, group 1 (n = 48) received aromatherapy abdominal massage once daily for seven days prior to menstruation using the essential oils (cinnamon, clove, rose, and lavender in a base of almond oil). Group 2 (n = 47) received the same intervention but with placebo oil (almond oil). In the second treatment phase, the two groups switched to alternate regimen. Level and duration of pain and the amount of menstrual bleeding were evaluated at the baseline and after each treatment phase. During both treatment phases, the level and duration of menstrual pain and the amount of menstrual bleeding were significantly lower in the aromatherapy group than in the placebo group. These results suggests that aromatherapy is effective in alleviating menstrual pain, its duration and excessive menstrual bleeding. Aromatherapy can be provided as a nonpharmacological pain relief measure and as a part of nursing care given to girls suffering of dysmenorrhea, or excessive menstrual bleeding. PMID:23662151

A crossover randomized prospective pilot study evaluating a central venous catheter team in reducing catheter-related bloodstream infections in pediatric oncology patients.

PubMed

Secola, Rita; Azen, Colleen; Lewis, Mary Ann; Pike, Nancy; Needleman, Jack; Sposto, Richard; Doering, Lynn

2012-01-01

Treatment for most children with cancer includes the use of a central venous catheter (CVC). CVCs provide reliable venous access for delivery of chemotherapy and supportive care. This advantage is mitigated by an increased risk of bloodstream infections (BSIs). Despite the ubiquitous use of CVCs, few prospective studies have been conducted to address infection prevention strategies in pediatric oncology patients. Prospective, crossover pilot study of a CVC team intervention versus standard care. Two inpatient oncology units in a metropolitan children's hospital. A total of 41 patients/135 admissions for the experimental unit (EU) and 41/129 admissions for the control unit (CU). Patients received a CVC blood draw bundle procedure by a CVC registered nurse (RN) team member (experimental intervention: EU) for 6 months and by the assigned bedside RN (standard care: CU) for 6 months. Feasibility of implementing a CVC RN team; a significant difference in CVC-related BSIs between the team intervention versus standard care and risk factors associated in the development of CVC-related BSIs were determined. There were 7 CVC-related BSIs/1238 catheter days in the EU group (5.7/1000 catheter days) versus 3 CVC-related BSIs/1419 catheter days in the CU group (2.1/1000 catheter days; P = .97). Selected risk factors were not significantly associated with the development of a CVC-related BSI. A CVC team in the care of pediatric oncology patients is feasible; however, a larger cohort will be required to adequately determine the effectiveness of the team reducing CVC-related BSIs.

Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial.

PubMed

Rebello, Candida J; Johnson, William D; Martin, Corby K; Han, Hongmei; Chu, Yi-Fang; Bordenave, Nicolas; van Klinken, B Jan Willem; O'Shea, Marianne; Greenway, Frank L

2016-01-01

Foods that enhance satiety can help consumers to resist environmental cues to eat and help adherence to calorie restriction. The objective of this study was to compare the effect of 2 oat-based breakfast cereals on appetite, satiety, and food intake. Forty-eight healthy individuals, 18 years of age or older, were enrolled in a randomized, crossover trial. Subjects consumed isocaloric servings of either oatmeal or an oat-based ready-to-eat breakfast cereal (RTEC) in random order at least a week apart. Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. Lunch was served 4 hours after breakfast. The physicochemical properties of oat soluble fiber (β-glucan) were determined. Appetite and satiety responses were analyzed by area under the curve. Food intake and β-glucan properties were analyzed using t tests. Oatmeal increased fullness (p = 0.001) and reduced hunger (p = 0.005), desire to eat (p = 0.001), and prospective intake (p = 0.006) more than the RTEC. Energy intake at lunch was lower after eating oatmeal compared to the RTEC (p = 0.012). Oatmeal had higher viscosity (p = 0.03), β-glucan content, molecular weight (p < 0.001), and radius of gyration (p < 0.001) than the RTEC. Oatmeal suppresses appetite, increases satiety, and reduces energy intake compared to the RTEC. The physicochemical properties of β-glucan and sufficient hydration of oats are important factors affecting satiety and subsequent energy intake.

Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilation.

PubMed

Al Shehri, Abdullah M; El-Tahan, Mohamed R; Al Metwally, Roshdi; Qutub, Hatem; El Ghoneimy, Yasser F; Regal, Mohamed A; Zien, Haytham

2014-08-01

To test the effects of pressure-controlled (PCV) and volume-controlled (VCV) ventilation during one-lung ventilation (OLV) for thoracic surgery on right ventricular (RV) function. A prospective, randomized, double-blind, controlled, crossover study. A single university hospital. Fourteen pairs of consecutive patients scheduled for elective thoracotomy. Patients were assigned randomly to ventilate the dependent lung with PCV or VCV mode, each in a randomized crossover order using tidal volume of 6 mL/kg, I: E ratio 1: 2.5, positive end-expiratory pressure (PEEP) of 5 cm H2O and respiratory rate adjusted to maintain normocapnia. Intraoperative changes in RV function (systolic and early diastolic tricuspid annular velocity (TAV), end-systolic volume (ESV), end-diastolic volume (EDV) and fractional area changes (FAC)), airway pressures, compliance and oxygenation index were recorded. The use of PCV during OLV resulted in faster systolic (10.1±2.39 vs. 5.8±1.67 cm/s, respectively), diastolic TAV (9.2±1.99 vs. 4.6±1.42 cm/s, respectively) (p<0.001) and compliance and lower ESV, EDV and airway pressures (p<0.05) than during the use of VCV. Oxygenation indices were similar during the use of VCV and PCV. The use of PCV offers more improved RV function than the use of VCV during OLV for open thoracotomy. These results apply specifically to younger patients with good ventricular and pulmonary functions. © 2014 Elsevier Inc. All rights reserved.

Music and biological stress dampening in mechanically-ventilated patients at the intensive care unit ward-a prospective interventional randomized crossover trial.

PubMed

Beaulieu-Boire, Genevieve; Bourque, Solange; Chagnon, Frederic; Chouinard, Lucie; Gallo-Payet, Nicole; Lesur, Olivier

2013-08-01

To evaluate the impact of slow-tempo music listening periods in mechanically ventilated intensive care unit patients. A randomized crossover study was performed in a 16-bed, adult critical care unit at a tertiary care hospital. Still-sedated patients, mandating at least 3 more days of mechanical ventilation, were included. The intervention consisted in two 1-hour daily periods of music-vs-sham-MP3 listening which were performed on Day 1 or 3 post-inclusion, with a Day 2 wash-out. "Before-after" collection of vital signs, recording of daily sedative drug consumption and measurement of stress and inflammatory blood markers were performed. Of 55 randomized patients, 49 were included in the final analyses. Along with music listening, (i) vital signs did not consistently change, whereas narcotic consumption tended to decrease to a similar sedation (P = .06 vs sham-MP3); (ii) cortisol and prolactin blood concentrations decreased, whereas Adreno Cortico Trophic Hormone (ACTH)/cortisol ratio increased (P = .02; P = .038; and P = .015 vs sham-MP3, respectively), (iii) cortisol responders exhibited reversed associated changes in blood mehionine (MET)-enkephalin content (P = .01). In the present trial, music listening is a more sensitive stress-reliever in terms of biological vs clinical response. The hypothalamus-pituitary adrenal axis stress axis is a quick sensor of music listening in responding mechanically ventilated intensive care unit patients, through a rapid reduction in blood cortisol. Copyright © 2013 Elsevier Inc. All rights reserved.

Electroacupuncture prevents endothelial dysfunction induced by ischemia-reperfusion injury via a cyclooxygenase-2-dependent mechanism: A randomized controlled crossover trial

PubMed Central

Park, Jimin; Woo, Jong Shin; Leem, Jungtae; Park, Jun Hyeong; Lee, Sanghoon; Chung, Hyemoon; Lee, Jung Myung; Kim, Jin-Bae; Kim, Woo-Shik; Kim, Kwon Sam; Kim, Weon

2017-01-01

Objective Exploring clinically effective methods to reduce ischemia-reperfusion (IR) injury in humans is critical. Several drugs have shown protective effects, but studies using other interventions have been rare. Electroacupuncture (EA) has induced similar protection in several animal studies but no study has investigated how the effects could be translated and reproduced in humans. This study aimed to explore the potential effect and mechanisms of EA in IR-induced endothelial dysfunction in humans. Methods This is a prospective, randomized, crossover, sham-controlled trial consisting of two protocols. Protocol 1 was a crossover study to investigate the effect of EA on IR-induced endothelial dysfunction. Twenty healthy volunteers were randomly assigned to EA or sham EA (sham). Flow mediated dilation (FMD) of the brachial artery (BA), nitroglycerin-mediated endothelial independent dilation, blood pressure before and after IR were measured. In protocol 2, seven volunteers were administered COX-2 inhibitor celecoxib (200 mg orally twice daily) for five days. After consumption, volunteers underwent FMD before and after IR identical to protocol 1. Results In protocol 1, baseline BA diameter, Pre-IR BA diameter and FMD were similar between the two groups (p = NS). After IR, sham group showed significantly blunted FMD (Pre-IR: 11.41 ± 3.10%, Post-IR: 4.49 ± 2.04%, p < 0.001). However, EA protected this blunted FMD (Pre-IR: 10.96 ± 5.30%, Post-IR: 9.47 ± 5.23%, p = NS, p < 0.05 compared with sham EA after IR). In protocol 2, this protective effect was completely abolished by pre-treatment with celecoxib (Pre-IR: 11.05 ± 3.27%; Post-IR: 4.20 ± 1.68%, p = 0.001). Conclusion EA may prevent IR-induced endothelial dysfunction via a COX-2 dependent mechanism. PMID:28591155

Increased calcium absorption from synthetic stable amorphous calcium carbonate: Double-blind randomized crossover clinical trial in post-menopausal women

USDA-ARS?s Scientific Manuscript database

Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (C...

Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial

USDA-ARS?s Scientific Manuscript database

Objective: Almonds reduce cardiovascular disease risk via cholesterol reduction, anti-inflammation, glucoregulation, and antioxidation. The objective of this randomized, controlled, cross-over trial was to determine whether the addition of 85 g almonds daily to a National Cholesterol Education Progr...

Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

PubMed

Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

2016-01-01

Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p < 0.05), resulting in a 10 % lower plasma removal rate of the mTPE treatment. Both treatments were comparable in terms of decrease in median (IQR) IgG [pre-mTPE 5.34 (3.48-8.37), post-mTPE 1.96 (1.43-2.84) g/L; pre-cTPE 5.88 (3.42-8.84), post-cTPE 1.89 (1.21-3.52) g/L]. Also the median (IQR) amount of IgG removed in mTPE [13.14 (7.42-16.10) g] was not different from the cTPE treatment [9.30 (6.26-15.69) g]. This was also true for IgM removal. Platelet loss during mTPE was nearly twice as much as with cTPE (15 ± 9 versus 7 ± 9 %, p < 0.05). Although the centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite this lower treatment time, the decline in markers of procedure efficacy was comparable. Especially in centers performing many procedures per year, cTPE in contrast to mTPE can reduce treatment time without compromising treatment efficacy.

Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

PubMed

da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

2017-06-01

The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p < 0.001) improvement in post-test evaluation (average grade 73.9 %). The correct pre-test (p = 0.556) and post-test (p = 0.729) evaluation and the retention of information (p = 0.408) were not different between the two groups. The course in PHO allowed significant acquisition of knowledge to undergraduate students, but the level of information retention was statistically similar between the traditional classroom form and the e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

ERIC Educational Resources Information Center

Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

2004-01-01

Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

The effect of almonds on inflammation and oxidative stress in Chinese patients with type 2 diabetes mellitus: a randomized crossover controlled feeding trial

USDA-ARS?s Scientific Manuscript database

Almond consumption is associated with ameliorations in obesity, hyperlipidemia, hypertension, and hyperglycemia. The hypothesis of this 12-wk randomized, crossover, controlled feeding trial was that almond consumption would ameliorate inflammation and oxidative stress in Chinese patients with type 2...

Prevention of emergency physician migratory contamination in a cluster randomized trial to increase tissue plasminogen activator use in stroke (the INSTINCT trial).

PubMed

Weston, Victoria C; Meurer, William J; Frederiksen, Shirley M; Fox, Allison K; Scott, Phillip A

2014-12-01

Cluster randomized trials (CRTs) are increasingly used to evaluate quality improvement interventions aimed at health care providers. In trials testing emergency department (ED) interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator (tPA) in stroke (the INSTINCT trial). INSTINCT was a prospective, cluster randomized, controlled trial. Twenty-four Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as greater than 10% of EPs affected. Nonadherence, total crossover (contamination+nonadherence), migration distance, and characteristics were determined. Three hundred seven EPs were identified at all sites. Overall, 7 (2.3%) changed study sites. One moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination); and 4 (1.3%) moved from control to intervention (nonadherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. The mobile nature of EPs should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of Ginkgo biloba on visual field and contrast sensitivity in Chinese patients with normal tension glaucoma: a randomized, crossover clinical trial.

PubMed

Guo, Xinxing; Kong, Xiangbin; Huang, Rui; Jin, Ling; Ding, Xiaohu; He, Mingguang; Liu, Xing; Patel, Mehul Chimanlal; Congdon, Nathan G

2014-01-07

We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma. In this prospective, randomized, placebo-controlled crossover study, patients newly diagnosed with normal tension glaucoma, either in a tertiary glaucoma clinic (n = 5) or in a cohort undergoing routine general physical examinations in a primary care clinic (n = 30), underwent two 4-week phases of treatment, separated by a washout period of 8 weeks. Randomization determined whether ginkgo biloba extract (40 mg, 3 times per day) or placebo (identical-appearing tablets) was received first. Primary outcomes were change in contrast sensitivity and mean deviation on 24-2 SITA standard visual field testing, while secondary outcomes included IOP and self-reported adverse events. A total of 35 patients with mean age 63.7 (6.5) years were randomized to the ginkgo biloba extract-placebo (n = 18) or the placebo-ginkgo biloba extract (n = 17) sequence. A total of 28 patients (80.0%, 14 in each group) who completed testing did not differ at baseline in age, sex, visual field mean deviation, contrast sensitivity, IOP, or blood pressure. Changes in visual field and contrast sensitivity did not differ by treatment received or sequence (P > 0.2 for all). Power to have detected a difference in mean defect as large as previously reported was 80%. In contrast to some previous reports, ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients. (http://www.chictr.org number, ChiCTR-TRC-08000724).

Handwashing with soap or alcoholic solutions? A randomized clinical trial of its effectiveness.

PubMed

Zaragoza, M; Sallés, M; Gomez, J; Bayas, J M; Trilla, A

1999-06-01

The effectiveness of an alcoholic solution compared with the standard hygienic handwashing procedure during regular work in clinical wards and intensive care units of a large public university hospital in Barcelona was assessed. A prospective, randomized clinical trial with crossover design, paired data, and blind evaluation was done. Eligible health care workers (HCWs) included permanent and temporary HCWs of wards and intensive care units. From each category, a random sample of persons was selected. HCWs were randomly assigned to regular handwashing (liquid soap and water) or handwashing with the alcoholic solution by using a crossover design. The number of colony-forming units on agar plates from hands printing in 3 different samples was counted. A total of 47 HCWs were included. The average reduction in the number of colony-forming units from samples before handwashing to samples after handwashing was 49.6% for soap and water and 88.2% for the alcoholic solution. When both methods were compared, the average number of colony-forming units recovered after the procedure showed a statistically significant difference in favor of the alcoholic solution (P <.001). The alcoholic solution was well tolerated by HCWs. Overall acceptance rate was classified as "good" by 72% of HCWs after 2 weeks use. Of all HCWs included, 9.3% stated that the use of the alcoholic solution worsened minor pre-existing skin conditions. Although the regular use of hygienic soap and water handwashing procedures is the gold standard, the use of alcoholic solutions is effective and safe and deserves more attention, especially in situations in which the handwashing compliance rate is hampered by architectural problems (lack of sinks) or nursing work overload.

Cap Assisted Upper Endoscopy for Examination of the Major Duodenal Papilla: A Randomized, Blinded, Controlled Crossover Study (CAPPA Study).

PubMed

Abdelhafez, Mohamed; Phillip, Veit; Hapfelmeier, Alexander; Elnegouly, Mayada; Poszler, Alexander; Strobel, Kilian; Born, Peter; Dollhopf, Markus; Kassem, Abdel Meguid; Calavrezos, Lenika; Klare, Peter; Schlag, Christoph; Bajbouj, Monther; Schmid, Roland M; von Delius, Stefan

2017-05-01

Examination of major duodenal papilla (MDP) by standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Cap assisted esophagogastroduodenoscopy (CA-EGD) utilizes a cap fitted to the tip of the endoscope that can depress the mucosal folds and thus might improve visualization of MDP. The aim of this study was to compare CA-EGD to S-EGD for complete examination of the MDP. Prospective, randomized, blinded, controlled crossover study. Subjects scheduled for elective EGD were randomized to undergo S-EGD (group A) or CA-EGD (group B) before undergoing a second examination by the alternate method. Images of the MDP were evaluated by three blinded multicenter-experts. Our primary outcome measure was complete examination of the papilla. Secondary outcome measures were duration and overall diagnostic yield. A total of 101 patients were randomized and completed the study. Complete examination of MDP was achieved in 98 patients using CA-EGD compared to 24 patients using S-EGD (97 vs. 24%, P<0.001). Median duration from intubation of the esophagus until localization of the MDP was shorter with CA-EGD (46. vs. 96 s., P<0.001). In group A, 11 extra lesions and 12 additional incidental findings were detected by secondary CA-EGD, whereas neither were detected by secondary S-EGD in group B (22 vs. 0% and 24 vs. 0%, P<0.001 and P<0.001). CA-EGD enabled complete examination of MDP in almost all cases compared to a low success rate of S-EGD. CA-EGD detected a significant amount of lesions and incidental findings when added to S-EGD. CA-EGD is a safe and effective method for examination of MDP.

Lack of Interaction between Sensing-Intuitive Learning Styles and Problem-First versus Information-First Instruction: A Randomized Crossover Trial

ERIC Educational Resources Information Center

Cook, David A.; Thompson, Warren G.; Thomas, Kris G.; Thomas, Matthew R.

2009-01-01

Background: Adaptation to learning styles has been proposed to enhance learning. Objective: We hypothesized that learners with sensing learning style would perform better using a problem-first instructional method while intuitive learners would do better using an information-first method. Design: Randomized, controlled, crossover trial. Setting:…

Ruxolitinib reduces JAK2 p.V617F allele burden in patients with polycythemia vera enrolled in the RESPONSE study.

PubMed

Vannucchi, Alessandro Maria; Verstovsek, Srdan; Guglielmelli, Paola; Griesshammer, Martin; Burn, Timothy C; Naim, Ahmad; Paranagama, Dilan; Marker, Mahtab; Gadbaw, Brian; Kiladjian, Jean-Jacques

2017-07-01

In patients with polycythemia vera (PV), an elevated JAK2 p.V617F allele burden is associated with indicators of more severe disease (e.g., leukocytosis, splenomegaly, and increased thrombosis risk); however, correlations between allele burden reductions and clinical benefit in patients with PV have not been extensively evaluated in a randomized trial. This exploratory analysis from the multicenter, open-label, phase 3 Randomized Study of Efficacy and Safety in Polycythemia Vera With JAK Inhibitor INCB018424 Versus Best Supportive Care trial evaluated the long-term effect of ruxolitinib treatment on JAK2 p.V617F allele burden in patients with PV. Evaluable JAK2 p.V617F-positive patients randomized to ruxolitinib (n = 107) or best available therapy (BAT) who crossed over to ruxolitinib at week 32 (n = 97) had consistent JAK2 p.V617F allele burden reductions throughout the study. At all time points measured (up to weeks 208 [ruxolitinib-randomized] and 176 [ruxolitinib crossover]), mean changes from baseline over time in JAK2 p.V617F allele burden ranged from -12.2 to -40.0% (ruxolitinib-randomized) and -6.3 to -17.8% (ruxolitinib crossover). Complete or partial molecular response was observed in 3 patients (ruxolitinib-randomized, n = 2; ruxolitinib crossover, n = 1) and 54 patients (ruxolitinib-randomized, n = 33; ruxolitinib crossover, n = 20; BAT, n = 1), respectively. Among patients treated with interferon as BAT (n = 13), the mean maximal reduction in allele burden from baseline was 25.6% after crossover to ruxolitinib versus 6.6% before crossover. Collectively, the data from this exploratory analysis suggest that ruxolitinib treatment for up to 4 years provides progressive reductions in JAK2 p.V617F allele burden in patients with PV who are resistant to or intolerant of hydroxyurea. The relationship between allele burden changes and clinical outcomes in patients with PV remains unclear.

Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial.

PubMed

Muin, Dana A; Wolzt, Michael; Marculescu, Rodrig; Sheikh Rezaei, Safoura; Salama, Mohamed; Fuchs, Carola; Luger, Anton; Bragagna, Elia; Litschauer, Brigitte; Bayerle-Eder, Michaela

2015-09-01

To assess the effect of on-demand intranasal oxytocin administration on female sexual function and activity. Randomized, prospective, double-blind, placebo-controlled, crossover trial with duration of 22 weeks. Academic medical center. Thirty pre-and postmenopausal women with sexual dysfunction. Over 8 weeks, intranasal oxytocin (32 IU) or placebo self-administered by women within 50 minutes before sexual intercourse; after a washout period of 2 weeks, crossover with patients switched to the alternate group for another 8 weeks. Primary outcome parameter: Female Sexual Function Index (FSFI); secondary outcome parameters: Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Interest and Desire Inventory-Female (SIDI-F), and Hamilton depression scale (HDS). After oxytocin and placebo, the FSFI score increased by 26% and 31%, SQOL-F score by 144% and 125%, and SIDI-F score by 29% and 23%, respectively (repeated measures analysis of variance between groups). After oxytocin and placebo, the FSDS score decreased by 36% and 45%, respectively (repeated measures analysis of variance between groups). There was no statistically significant treatment, sequence (placebo first/second), or interaction effect. Long-term intranasal oxytocin and placebo administration both improved sexual function and symptoms of depression in women over time with no treatment, sequence (placebo first/second), or interaction effect. NCT02229721. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Fasting Reduces the Incidence of Delayed-Type Vomiting Associated with Doxorubicin Treatment in Dogs with Lymphoma.

PubMed

Withers, Sita S; Kass, Philip H; Rodriguez, Carlos O; Skorupski, Katherine A; O'Brien, Danielle; Guerrero, Teri A; Sein, Kristen D; Rebhun, Robert B

2014-05-12

Fasting reduces gastrointestinal cellular proliferation rates through G 1 cycle blockade and can promote cellular protection of normal but not cancer cells through altered cell signaling including down-regulation of insulin-like growth factor 1 (IGF-1). Consequently, the purpose of this study was to determine the effects of fasting on delayed-type chemotherapy-induced nausea and vomiting in dogs receiving doxorubicin. This prospective randomized crossover study involved intended administration of two doses of doxorubicin. Cancer-bearing dogs were randomized to be fasted for 24 hours beginning at 6 P.M. the night before the first or second doxorubicin administration, and all treatments were administered within an hour before or after 12 P.M. Dogs were fed normally before the alternate dose. Circulating IGF-1 concentrations were determined from serum samples obtained immediately before each doxorubicin treatment. Data from 35 doses were available from 20 dogs enrolled. Dogs that were fasted exhibited a significantly lower incidence of vomiting, when compared to fed dogs (10% compared to 67%, P = .020). Furthermore, among the 15 dogs that completed crossover dosing, vomiting was abrogated in four of five dogs that experienced doxorubicin-induced vomiting when fed normally (P = .050). No differences in other gastrointestinal, constitutional, or bone marrow toxicities or serum IGF-1 levels were observed. Copyright © 2014 Elsevier Inc. All rights reserved.

Oligofructose promotes satiety in healthy human: a pilot study.

PubMed

Cani, P D; Joly, E; Horsmans, Y; Delzenne, N M

2006-05-01

The administration of a fermentable dietary fibre (oligofructose) in rats increases satietogenic gut peptides and lowered spontaneous energy intake. The aim of the study was to assess the relevance of those effects of oligofructose on satiety and energy intake in humans. Single-blinded, crossover, placebo-controlled design, pilot study. Volunteers included five men and five women aged 21-39 years, BMI ranging from 18.5 to 27.4 kg/m(2), were randomly assigned as described below. Subjects were included in two 2-week experimental phases during which they received either fibre (oligofructose (OFS)) or placebo (dextrine maltose (DM)); a 2-week washout period was included between crossover phases. In total, 8 g OFS or 8 g DM were ingested twice daily (16 g/day in total). Energy intake, hunger, satiety, fullness and prospective food consumption were assessed with analogue scales at the end of each experimental phase. During breakfast, OFS significantly increases the satiety (P=0.04) without any difference on other sensations as compared to DM treatment periods. After lunch, no significant differences are observed between treatment period. At dinner, OFS significantly increases satiety (P=0.04), reduces hunger (P=0.04) and prospective food consumption (P=0.05). The energy intake at breakfast and lunch are significantly lower (P=0.01, 0.03, respectively) after OFS treatment than after DM treatment. Total energy intake per day is 5% lower during OFS than in DM period. Oligofructose treatment increases satiety following breakfast and dinner, reduces hunger and prospective food consumption following dinner. This pilot study presents a rationale to propose oligofructose supplements in the management of food intake in overweight and obese patients.

Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.

PubMed

Kwak, Jung; Anderson, Keith; O'Connell Valuch, Katharine

2018-06-01

Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.

Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study.

PubMed

Holm, Bente; Husted, Henrik; Kehlet, Henrik; Bandholm, Thomas

2012-08-01

To investigate the acute effect of knee joint icing on knee extension strength and knee pain in patients shortly after total knee arthroplasty. A prospective, single-blinded, randomized, cross-over study. A fast-track orthopaedic arthroplasty unit at a university hospital. Twenty patients (mean age 66 years; 10 women) scheduled for primary unilateral total knee arthroplasty. The patients were treated on two days (day 7 and day 10) postoperatively. On one day they received 30 minutes of knee icing (active treatment) and on the other day they received 30 minutes of elbow icing (control treatment). The order of treatments was randomized. Maximal knee extension strength (primary outcome), knee pain at rest and knee pain during the maximal knee extensions were measured 2-5 minutes before and 2-5 minutes after both treatments by an assessor blinded for active or control treatment. The change in knee extension strength associated with knee icing was not significantly different from that of elbow icing (knee icing change (mean (1 SD)) -0.01 (0.07) Nm/kg, elbow icing change -0.02 (0.07) Nm/kg, P = 0.493). Likewise, the changes in knee pain at rest (P = 0.475), or knee pain during the knee extension strength measurements (P = 0.422) were not different between treatments. In contrast to observations in experimental knee effusion models and inflamed knee joints, knee joint icing for 30 minutes shortly after total knee arthroplasty had no acute effect on knee extension strength or knee pain.

Instant Oatmeal Increases Satiety and Reduces Energy Intake Compared to a Ready-to-Eat Oat-Based Breakfast Cereal: A Randomized Crossover Trial

PubMed Central

Rebello, Candida J.; Johnson, William D.; Martin, Corby K.; Han, Hongmei; Chu, Yi-Fang; Bordenave, Nicolas; van Klinken, B. Jan Willem; O'Shea, Marianne; Greenway, Frank L.

2016-01-01

Background: Foods that enhance satiety can help consumers to resist environmental cues to eat and help adherence to calorie restriction. The objective of this study was to compare the effect of 2 oat-based breakfast cereals on appetite, satiety, and food intake. Methods: Forty-eight healthy individuals, 18 years of age or older, were enrolled in a randomized, crossover trial. Subjects consumed isocaloric servings of either oatmeal or an oat-based ready-to-eat breakfast cereal (RTEC) in random order at least a week apart. Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. Lunch was served 4 hours after breakfast. The physicochemical properties of oat soluble fiber (β-glucan) were determined. Appetite and satiety responses were analyzed by area under the curve. Food intake and β-glucan properties were analyzed using t tests. Results: Oatmeal increased fullness (p = 0.001) and reduced hunger (p = 0.005), desire to eat (p = 0.001), and prospective intake (p = 0.006) more than the RTEC. Energy intake at lunch was lower after eating oatmeal compared to the RTEC (p = 0.012). Oatmeal had higher viscosity (p = 0.03), β-glucan content, molecular weight (p < 0.001), and radius of gyration (p < 0.001) than the RTEC. Conclusions: Oatmeal suppresses appetite, increases satiety, and reduces energy intake compared to the RTEC. The physicochemical properties of β-glucan and sufficient hydration of oats are important factors affecting satiety and subsequent energy intake. PMID:26273900

Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

ERIC Educational Resources Information Center

Iriyama, Yae; Murayama, Nobuko

2014-01-01

Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

The role of meal viscosity and oat β-glucan characteristics in human appetite control: a randomized crossover trial.

PubMed

Rebello, Candida J; Chu, Yi-Fang; Johnson, William D; Martin, Corby K; Han, Hongmei; Bordenave, Nicolas; Shi, Yuhui; O'Shea, Marianne; Greenway, Frank L

2014-05-28

Foods that enhance satiety can help consumers to resist environmental cues to eat, and improve the nutritional quality of their diets. Viscosity generated by oat β-glucan, influences gastrointestinal mechanisms that mediate satiety. Differences in the source, processing treatments, and interactions with other constituents in the food matrix affect the amount, solubility, molecular weight, and structure of the β-glucan in products, which in turn influences the viscosity. This study examined the effect of two types of oatmeal and an oat-based ready-to-eat breakfast cereal (RTEC) on appetite, and assessed differences in meal viscosity and β-glucan characteristics among the cereals. Forty-eight individuals were enrolled in a randomized crossover trial. Subjects consumed isocaloric breakfast meals containing instant oatmeal (IO), old-fashioned oatmeal (SO) or RTEC in random order at least a week apart. Each breakfast meal contained 218 kcal (150 kcal cereal, and 68 kcal milk) Visual analogue scales measuring appetite were completed before breakfast, and over four hours, following the meal. Starch digestion kinetics, meal viscosities, and β-glucan characteristics for each meal were determined. Appetite responses were analyzed by area under the curve. Mixed models were used to analyze response changes over time. IO increased fullness (p = 0.04), suppressed desire to eat (p = 0.01) and reduced prospective intake (p < 0.01) more than the RTEC over four hours, and consistently at the 60 minute time-point. SO reduced prospective intake (p = 0.04) more than the RTEC. Hunger scores were not significantly different except that IO reduced hunger more than the RTEC at the 60 minute time-point. IO and SO had higher β-glucan content, molecular weight, gastric viscosity, and larger hydration spheres than the RTEC, and IO had greater viscosity after oral and initial gastric digestion (initial viscosity) than the RTEC. IO and SO improved appetite control over four hours compared to RTEC. Initial viscosity of oatmeal may be especially important for reducing appetite.

The role of meal viscosity and oat β-glucan characteristics in human appetite control: a randomized crossover trial

PubMed Central

2014-01-01

Background Foods that enhance satiety can help consumers to resist environmental cues to eat, and improve the nutritional quality of their diets. Viscosity generated by oat β-glucan, influences gastrointestinal mechanisms that mediate satiety. Differences in the source, processing treatments, and interactions with other constituents in the food matrix affect the amount, solubility, molecular weight, and structure of the β-glucan in products, which in turn influences the viscosity. This study examined the effect of two types of oatmeal and an oat-based ready-to-eat breakfast cereal (RTEC) on appetite, and assessed differences in meal viscosity and β-glucan characteristics among the cereals. Methods Forty-eight individuals were enrolled in a randomized crossover trial. Subjects consumed isocaloric breakfast meals containing instant oatmeal (IO), old-fashioned oatmeal (SO) or RTEC in random order at least a week apart. Each breakfast meal contained 218 kcal (150 kcal cereal, and 68 kcal milk) Visual analogue scales measuring appetite were completed before breakfast, and over four hours, following the meal. Starch digestion kinetics, meal viscosities, and β-glucan characteristics for each meal were determined. Appetite responses were analyzed by area under the curve. Mixed models were used to analyze response changes over time. Results IO increased fullness (p = 0.04), suppressed desire to eat (p = 0.01) and reduced prospective intake (p < 0.01) more than the RTEC over four hours, and consistently at the 60 minute time-point. SO reduced prospective intake (p = 0.04) more than the RTEC. Hunger scores were not significantly different except that IO reduced hunger more than the RTEC at the 60 minute time-point. IO and SO had higher β-glucan content, molecular weight, gastric viscosity, and larger hydration spheres than the RTEC, and IO had greater viscosity after oral and initial gastric digestion (initial viscosity) than the RTEC. Conclusion IO and SO improved appetite control over four hours compared to RTEC. Initial viscosity of oatmeal may be especially important for reducing appetite. PMID:24884934

A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

ERIC Educational Resources Information Center

Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

2012-01-01

Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

Hyperbaric Oxygen Therapy Can Diminish Fibromyalgia Syndrome – Prospective Clinical Trial

PubMed Central

Efrati, Shai; Golan, Haim; Bechor, Yair; Faran, Yifat; Daphna-Tekoah, Shir; Sekler, Gal; Fishlev, Gregori; Ablin, Jacob N.; Bergan, Jacob; Volkov, Olga; Friedman, Mony; Ben-Jacob, Eshel; Buskila, Dan

2015-01-01

Background Fibromyalgia Syndrome (FMS) is a persistent and debilitating disorder estimated to impair the quality of life of 2–4% of the population, with 9:1 female-to-male incidence ratio. FMS is an important representative example of central nervous system sensitization and is associated with abnormal brain activity. Key symptoms include chronic widespread pain, allodynia and diffuse tenderness, along with fatigue and sleep disturbance. The syndrome is still elusive and refractory. The goal of this study was to evaluate the effect of hyperbaric oxygen therapy (HBOT) on symptoms and brain activity in FMS. Methods and Findings A prospective, active control, crossover clinical trial. Patients were randomly assigned to treated and crossover groups: The treated group patients were evaluated at baseline and after HBOT. Patients in the crossover-control group were evaluated three times: baseline, after a control period of no treatment, and after HBOT. Evaluations consisted of physical examination, including tender point count and pain threshold, extensive evaluation of quality of life, and single photon emission computed tomography (SPECT) imaging for evaluation of brain activity. The HBOT protocol comprised 40 sessions, 5 days/week, 90 minutes, 100% oxygen at 2ATA. Sixty female patients were included, aged 21–67 years and diagnosed with FMS at least 2 years earlier. HBOT in both groups led to significant amelioration of all FMS symptoms, with significant improvement in life quality. Analysis of SPECT imaging revealed rectification of the abnormal brain activity: decrease of the hyperactivity mainly in the posterior region and elevation of the reduced activity mainly in frontal areas. No improvement in any of the parameters was observed following the control period. Conclusions The study provides evidence that HBOT can improve the symptoms and life quality of FMS patients. Moreover, it shows that HBOT can induce neuroplasticity and significantly rectify abnormal brain activity in pain related areas of FMS patients. Trial Registration ClinicalTrials.gov NCT01827683 PMID:26010952

Comparison of pain perception during miniscrew placement in orthodontic patients with a visual analog scale survey between compound topical and needle-injected anesthetics: A crossover, prospective, randomized clinical trial.

PubMed

Lamberton, Jordan A; Oesterle, Larry J; Shellhart, W Craig; Newman, Sheldon M; Harrell, Ricky E; Tilliss, Terri; Singh, Neha; Carey, Clifton M

2016-01-01

The use of a compound topical anesthetic (CTA) instead of an injection of a local anesthetic for placing miniscrew implants offers advantages to both the clinician and the patient. The purpose of this crossover, prospective, randomized clinical trial was to compare the clinical effectiveness of a CTA with that of a needle injection of local anesthetic for miniscrew placement. Twenty-four orthodontic patients in a university clinic were recruited; they required bilateral buccal miniscrews for orthodontic anchorage. Eligibility criteria included healthy patients with no special needs; over 8 years of age and 25 pounds; not taking sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines; and not allergic to ester-type local anesthetics or any of the other materials used in the study. A computer generated a randomization list. The allocation was randomized by anesthetic protocol and side of the mouth, and was restricted to achieve balance by treatment and side of the mouth. No allocation concealment was applied. Associated with each randomized number was the subjects' assignment into 1 of 4 groups divided by the side of first miniscrew placement and the type of anesthetic. Blinding was done only for data analysis because of clinical limitations. Each patient received a CTA on one side and an injection of anesthetic on the other before miniscrew placement in a crossover study design. The outcome was assessed by measuring pain levels with a 100-mm visual analog scale at 5 time points. Anesthetic failures occurred when the miniscrew could not be fully comfortably placed with a given anesthetic. Data were organized by visual analog scale time points, and descriptive statistics were calculated. A factorial repeated-measures analysis of variance was used to determine any differences. Twenty-seven patients were assessed for eligibility, and 24 agreed to participate in the study. Patients did not distinguish any differences in pain between the application of the CTA and the injection before or during anesthetic placement, but they experienced more pain with the CTA during miniscrew placement. The mean difference for the entire procedure between the 2 anesthesia types was 24.6 units, and the 95% confidence interval was 18.8 to 30.4, a statistically significant finding (P = 0.0002). The CTA was still viewed as more painful 1 month after the procedures. Significantly more anesthetic failures occurred with the CTA (41.6%) than with the injection (0%). No serious harm was observed in any patient; when significant pain was observed with the CTA, a needle injection of local anesthetic was administered. CTAs provided less predictable, often inadequate, and less comfortable anesthesia than an injection of a local anesthetic for managing patient discomfort during miniscrew placement in buccal sites. This trial was not registered. The protocol was determined and approved by the research committee and institutional review board before the trial. No external funding was used other than the donation of the miniscrews from Rocky Mountain Orthodontics, and no conflict of interest was declared. Copyright © 2016. Published by Elsevier Inc.

Estrogen and cognitive functioning in men with mild cognitive impairment.

PubMed

Sherwin, Barbara B

2002-01-01

Although men do not experience an abrupt cessation of gonadal hormone production at midlife as do women, levels of testosterone (T) decrease gradually with aging. Because estradiol (E2) arises mainly from the conversion of T in men, the availability of E2 also decreases with increasing age. In randomized clinical trials, E2 replacement therapy has been shown to maintain aspects of cognition in postmenopausal women, specifically with regard to verbal memory. The present prospective, randomized, cross-over trial is being undertaken in order to determine whether E2 will enhance verbal memory in men with Mild Cognitive Impairment (MCI). Men with MCI will randomly receive E2 or placebo for the first 3 mo of treatment and will then be crossed-over to the other treatment for an additional 3 mo. A battery of neuropsychological tests will be administered at pretreatment and, again, following each 3-mo treatment phase. It is hypothesized that elderly men with MCI will perform better on tests of explicit memory when they are being treated with E2 compared to their performance under placebo conditions.

The effectiveness of topical colloidal silver in recalcitrant chronic rhinosinusitis: a randomized crossover control trial.

PubMed

Scott, John R; Krishnan, Rohin; Rotenberg, Brian W; Sowerby, Leigh J

2017-11-25

Recalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements. Colloidal silver (CS), a widely used naturopathic agent, has recently shown anti-biofilm properties both in vitro and within a rhinosinusitis animal model. To date, no trials involving humans have been published in world literature. The purpose of this study was to assess the efficacy of CS as a topical nasal spray in patients with refractory CRSsP. A prospective cohort study was conducted using a convenience sample of 20 randomized patients with crossover methodology, comparing nasal sprays with CS versus saline. Patients sprayed twice daily for six weeks with the first intervention and then switched to the second for the next six weeks, with measurements made at baseline and each time point. Primary outcomes were changes in SNOT-22 and Lund-Kennedy (LK) endoscopic scores. All analysis was non-parametric and was conducted using STATA 14. Twenty-two patients were enrolled in the study with 20 completing the entire protocol. Mean 6-week change in SNOT-22 scores were -2.8 and 1.0 for saline and CS, respectively (p = 0.373). Similarly, mean 6-week change in LK scores were -1.4 and -1.1 for saline and CS, respectively (p = 0.794). Significant period effects were observed with the SNOT-22 score between the randomized groups. No participants experienced negative health effects directly attributable to the administration of intranasal CS. Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP. NCT02403479 . Registered on March 1, 2015.

Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

PubMed

Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

2016-12-01

To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). A multivariate mixed-effects model analysis that included patients who completed ≥2 days of the intervention (n=28) demonstrated significant decreases in HR, RR, VAS-A, and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). Providing patient selected music during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients.

PubMed

Bloom, R D; Trofe-Clark, J; Wiland, A; Alloway, R R

2013-01-01

An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving their pre-study twice-daily dose. Pharmacokinetic parameters were compared in 68 patients according to gender, African American ethnicity, the presence or absence of diabetes, and use of steroids. The ratios of tacrolimus AUC0-12 h , Cmax , and C12 with generic vs. reference tacrolimus were calculated using the geometric mean (GM) of dose-normalized values at days 14 and 28. Mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/d. There were no consistent differences in dose-normalized AUC0-12 h , C12 , Cmax, or tmax between the generic and reference preparations within subpopulations. The 90% confidence intervals (CI) for the ratios of dose-normalized AUC0-12 h and C12 with generic vs. reference tacrolimus were within 80-125% for all subpopulations, as were 90% CIs for Cmax other than for females, African Americans, and non-diabetics, which is not unexpected given the wide variability of tacrolimus Cmax and the small subpopulation sizes. These exploratory results suggest that this generic tacrolimus preparation would be expected to offer comparable bioavailability to the reference drug in these patient subpopulations. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Antispasmodic/analgesic associations in primary dysmenorrhea double-blind crossover placebo-controlled clinical trial.

PubMed

de los Santos, A R; Zmijanovich, R; Pérez Macri, S; Martí, M L; Di Girolamo, G

2001-01-01

We studied 125 patients with primary dysmenorrhea in a prospective randomized double-blind crossover study. After an admission pretreatment period without medication, the patients completed three consecutive randomized treatment phases with lysine clonixinate 125 mg plus propinox 10 mg or paracetamol 500 mg plus hyoscine N-butylbromide 10 mg or placebo, according to a fixed-dose schedule of 1 tablet every 6 h, 3 days before onset of menses and for 5 days thereafter. Changes in menstrual pain intensity and duration, amount of bleeding measured according to the number of daily pads used and concomitant symptoms were assessed on the fifth day of each cycle. Every night, the patients recorded the average intensity of menstrual pain during the first 4 days of menstruation in a diary The follow-up visit carried out at day 5 showed significant reduction in pain intensity with both active treatments vs. the other two phases: baseline: 2.72 +/- 0.61; placebo: 1.85 +/- 0.87; lysine clonixinate plus propinox 1.36 +/- 0.81, and paracetamol plus hyosine N-butylbromide: 1.45 +/- 0.87. The patients' diaries showed increasingly lower pain intensities starting from day 1 with the three treatments. Active treatments revealed significantly higher analgesic efficacy from the outset compared with baseline and placebo; however, only the lysine clonixinate plus propinox combination reached a statistically significant difference by days 3 and 4. No changes in duration or intensity of menstrual bleeding or in the incidence of adverse effects were observed during the four study periods.

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

PubMed

Bowers, Alex R; Keeney, Karen; Peli, Eli

2014-02-01

There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition. To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia. Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline. Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks. The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P = .002); participants who discontinued wear reported no difference. Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. clinicaltrials.gov Identifier: NCT00494676.

A Randomized Crossover Trial Comparing Autotitrating and Continuous Positive Airway Pressure in Subjects With Symptoms of Aerophagia: Effects on Compliance and Subjective Symptoms.

PubMed

Shirlaw, Teresa; Hanssen, Kevin; Duce, Brett; Hukins, Craig

2017-07-15

To assess the benefit and tolerance of autotitrating positive airway pressure (APAP) versus continuous positive airway pressure (CPAP) in subjects who experience aerophagia. This is the report of a prospective, two-week, double-blinded, randomized crossover trial set in an Australian clinical sleep laboratory in a tertiary hospital. Fifty-six subjects who reported symptoms of aerophagia that they attributed to CPAP were recruited. Full face masks were used by 39 of the 56 subjects recruited. Subjects were randomly and blindly allocated to either CPAP at their treatment recommended pressure or APAP 6-20 cm H 2 O, in random order. Subjects spent two weeks on each therapy mode. Therapy usage hours, 95th centile pressure, maximum pressure, 95th centile leak, and residual apnea-hypopnea index (AHI) were reported at the end of each two-week treatment period. Functional Outcome of Sleepiness Questionnaire, Epworth Sleepiness Scale, and visual analog scale to measure symptoms of aerophagia were also completed at the end of each 2-week treatment arm. The median pressure ( P < .001) and 95th centile pressure ( P < .001) were reduced with APAP but no differences in compliance ( P = .120) and residual AHI were observed. APAP reduced the symptoms of bloating ( P = .011), worst episode of bloating ( P = .040), flatulence ( P = .010), and belching ( P = .001) compared to CPAP. There were no differences in Epworth Sleepiness Scale or Functional Outcome of Sleepiness Questionnaire outcomes between CPAP and APAP. APAP therapy reduces the symptoms of aerophagia while not affecting compliance when compared with CPAP therapy. Australian and New Zealand Clinical Trials Registry at https://www.anzctr.org.au, trial number ACTRN12611001250921. A commentary on this article appears in this issue on page 859. © 2017 American Academy of Sleep Medicine

A randomized multi-institutional crossover comparison of the GlideScope® Cobalt Video laryngoscope to the flexible fiberoptic bronchoscope in a Pierre Robin manikin.

PubMed

Fiadjoe, John E; Hirschfeld, Matthew; Wu, Stephan; Markley, James; Gurnaney, Harshad; Jawad, Abbas F; Stricker, Paul; Kilbaugh, Todd; Ross, Patrick; Kovatsis, Pete

2015-08-01

The GlideScope Cobalt Video laryngoscope is being used more often in children with challenging laryngoscopy. There are, however, no pediatric trials comparing it to flexible fiberoptic bronchoscopy, the current accepted gold standard. This preliminary manikin study compares the first-attempt intubation success of the GlideScope Cobalt video laryngoscope to the flexible fiberoptic bronchoscope when performed by attending pediatric anesthesiologists at two major pediatric centers. This prospective randomized, crossover study evaluated 120 attempts (60 with each study device) to intubate the AirSim Pierre Robin manikin (PRM) with fiberoptic bronchoscopy and video laryngoscopy (VL). Attending pediatric anesthesiologists from two quaternary pediatric centers were eligible to participate. Each attending anesthesiologist randomly performed a single tracheal intubation attempt with one of the study devices followed by the alternate method. The primary outcome was the first-attempt success rate of tracheal intubation. Blinding was not feasible. We hypothesized that first-attempt success would be higher with fiberoptic bronchoscopy. Thirty anesthesiologists from each center were randomized to use one of the study devices followed by the alternate method. We analyzed all participants' data. There was no overall difference in first-attempt success between VL and fiberoptic bronchoscopy (88.3% vs 85% respectively, P = 0.59). There were significant institutional differences in first-attempt success using VL (76.7% vs 100%). There was no difference in first-attempt success of tracheal intubation using VL vs fiberoptic bronchoscopy when performed by attending anesthesiologists at two large pediatric centers. However, institutional differences exist in success rates with VL across the two centers. Results from single-center device evaluations should be verified by multi-center evaluations. A significant proportion of attending anesthesiologists lack experience with advanced airway devices; targeted education may enhance intubation success and patient safety. © 2015 John Wiley & Sons Ltd.

Anesthetic efficacy of a repeated intraosseous injection following a primary intraosseous injection.

PubMed

Jensen, Joanne; Nusstein, John; Drum, Melissa; Reader, Al; Beck, Mike

2008-02-01

The purpose of this prospective, randomized, single-blinded study was to determine the anesthetic efficacy of a repeated intraosseous injection given 30 minutes after a primary intraosseous injection. Using a crossover design, 55 subjects randomly received a primary X-tip intraosseous injection (Dentsply Inc, York, PA) of 1.4 mL of 2% lidocaine with epinephrine (using the Wand; Milestone Scientific, Deerfield, IL) and a repeated intraosseous or mock injection at 30 minutes in two appointments. The first molar and adjacent teeth were pulp tested every 2 minutes for a total of 120 minutes. Success was defined as obtaining two consecutive 80 readings with the electric pulp tester. Success of the initial intraosseous injection was 100% for the first molar. The repeated intraosseous injection mimicked the initial intraosseous injection in terms of pulpal anesthesia and statistically provided another 15 minutes of pulpal anesthesia. In conclusion, using the methodology presented, repeating the intraosseous injection 30 minutes after an initial intraosseous injection will provide an additional 15 minutes of pulpal anesthesia.

Evaluation of 5 Hour Energy Drink on the Blood Pressure and Electrocardiograph Parameters on Young Healthy Volunteers: A Randomized, Double Blind, Crossover, Placebo-Controlled Trial

DTIC Science & Technology

2014-02-11

Travis AFB CA INSTITUTIONAL REVIEW BOARD (IRB) ()~\\) Non-Exempt Study Final Report p3YVJ (Please 1J!J!£ all information. Use additional pages if...QTc interval after acute and chronic consumption. METHODS: This was a randomized, placebo controlled, crossover study enrolling young healthy volunteers...not on any medications. Subjects received the study drink (5 Hour Energy shot or placebo) twice daily separated by approximately 7 hours for the

Crossover between the Gaussian orthogonal ensemble, the Gaussian unitary ensemble, and Poissonian statistics.

PubMed

Schweiner, Frank; Laturner, Jeanine; Main, Jörg; Wunner, Günter

2017-11-01

Until now only for specific crossovers between Poissonian statistics (P), the statistics of a Gaussian orthogonal ensemble (GOE), or the statistics of a Gaussian unitary ensemble (GUE) have analytical formulas for the level spacing distribution function been derived within random matrix theory. We investigate arbitrary crossovers in the triangle between all three statistics. To this aim we propose an according formula for the level spacing distribution function depending on two parameters. Comparing the behavior of our formula for the special cases of P→GUE, P→GOE, and GOE→GUE with the results from random matrix theory, we prove that these crossovers are described reasonably. Recent investigations by F. Schweiner et al. [Phys. Rev. E 95, 062205 (2017)2470-004510.1103/PhysRevE.95.062205] have shown that the Hamiltonian of magnetoexcitons in cubic semiconductors can exhibit all three statistics in dependence on the system parameters. Evaluating the numerical results for magnetoexcitons in dependence on the excitation energy and on a parameter connected with the cubic valence band structure and comparing the results with the formula proposed allows us to distinguish between regular and chaotic behavior as well as between existent or broken antiunitary symmetries. Increasing one of the two parameters, transitions between different crossovers, e.g., from the P→GOE to the P→GUE crossover, are observed and discussed.

Color-coded prefilled medication syringes decrease time to delivery and dosing errors in simulated prehospital pediatric resuscitations: A randomized crossover trial☆, ☆

PubMed Central

Stevens, Allen D.; Hernandez, Caleb; Jones, Seth; Moreira, Maria E.; Blumen, Jason R.; Hopkins, Emily; Sande, Margaret; Bakes, Katherine; Haukoos, Jason S.

2016-01-01

Background Medication dosing errors remain commonplace and may result in potentially life-threatening outcomes, particularly for pediatric patients where dosing often requires weight-based calculations. Novel medication delivery systems that may reduce dosing errors resonate with national healthcare priorities. Our goal was to evaluate novel, prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape, compared to conventional medication administration, in simulated prehospital pediatric resuscitation scenarios. Methods We performed a prospective, block-randomized, cross-over study, where 10 full-time paramedics each managed two simulated pediatric arrests in situ using either prefilled, color-coded-syringes (intervention) or their own medication kits stocked with conventional ampoules (control). Each paramedic was paired with two emergency medical technicians to provide ventilations and compressions as directed. The ambulance patient compartment and the intravenous medication port were video recorded. Data were extracted from video review by blinded, independent reviewers. Results Median time to delivery of all doses for the intervention and control groups was 34 (95% CI: 28–39) seconds and 42 (95% CI: 36–51) seconds, respectively (difference = 9 [95% CI: 4–14] seconds). Using the conventional method, 62 doses were administered with 24 (39%) critical dosing errors; using the prefilled, color-coded syringe method, 59 doses were administered with 0 (0%) critical dosing errors (difference = 39%, 95% CI: 13–61%). Conclusions A novel color-coded, prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by paramedics during simulated prehospital pediatric resuscitations. PMID:26247145

Eating dark and milk chocolate: a randomized crossover study of effects on appetite and energy intake.

PubMed

Sørensen, L B; Astrup, A

2011-12-05

To compare the effect of dark and milk chocolate on appetite sensations and energy intake at an ad libitum test meal in healthy, normal-weight men. A total of 16 young, healthy, normal-weight men participated in a randomized, crossover study. Test meals were 100 g of either milk (2285 kJ) or dark chocolate (2502 kJ). Visual-analogue scales were used to record appetite sensations before and after the test meal was consumed and subsequently every 30 min for 5 h. An ad libitum meal was served 2 h after the test meal had been consumed. The participants felt more satiated, less hungry, and had lower ratings of prospective food consumption after consumption of the dark chocolate than after the milk chocolate. Ratings of the desire to eat something sweet, fatty or savoury were all lower after consumption of the dark chocolate. Energy intake at the ad libitum meal was 17% lower after consumption of the dark chocolate than after the milk chocolate (P=0.002). If the energy provided by the chocolate is included in the calculation, the energy intake after consumption of the dark chocolate was still 8% lower than after the milk chocolate (P=0.01). The dark chocolate load resulted in an overall energy difference of -584 kJ (95% confidence interval (-1027;-141)) during the test period. In the present study, dark chocolate promotes satiety, lowers the desire to eat something sweet, and suppresses energy intake compared with milk chocolate.

Color-coded prefilled medication syringes decrease time to delivery and dosing errors in simulated prehospital pediatric resuscitations: A randomized crossover trial.

PubMed

Stevens, Allen D; Hernandez, Caleb; Jones, Seth; Moreira, Maria E; Blumen, Jason R; Hopkins, Emily; Sande, Margaret; Bakes, Katherine; Haukoos, Jason S

2015-11-01

Medication dosing errors remain commonplace and may result in potentially life-threatening outcomes, particularly for pediatric patients where dosing often requires weight-based calculations. Novel medication delivery systems that may reduce dosing errors resonate with national healthcare priorities. Our goal was to evaluate novel, prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape, compared to conventional medication administration, in simulated prehospital pediatric resuscitation scenarios. We performed a prospective, block-randomized, cross-over study, where 10 full-time paramedics each managed two simulated pediatric arrests in situ using either prefilled, color-coded syringes (intervention) or their own medication kits stocked with conventional ampoules (control). Each paramedic was paired with two emergency medical technicians to provide ventilations and compressions as directed. The ambulance patient compartment and the intravenous medication port were video recorded. Data were extracted from video review by blinded, independent reviewers. Median time to delivery of all doses for the intervention and control groups was 34 (95% CI: 28-39) seconds and 42 (95% CI: 36-51) seconds, respectively (difference=9 [95% CI: 4-14] seconds). Using the conventional method, 62 doses were administered with 24 (39%) critical dosing errors; using the prefilled, color-coded syringe method, 59 doses were administered with 0 (0%) critical dosing errors (difference=39%, 95% CI: 13-61%). A novel color-coded, prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by paramedics during simulated prehospital pediatric resuscitations. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Addition of Alanyl-Glutamine to Dialysis Fluid Restores Peritoneal Cellular Stress Responses – A First-In-Man Trial

PubMed Central

Boehm, Michael; Herzog, Rebecca; Gruber, Katharina; Lichtenauer, Anton Michael; Kuster, Lilian; Csaicsich, Dagmar; Gleiss, Andreas; Alper, Seth L.; Aufricht, Christoph; Vychytil, Andreas

2016-01-01

Background Peritonitis and ultrafiltration failure remain serious complications of chronic peritoneal dialysis (PD). Dysfunctional cellular stress responses aggravate peritoneal injury associated with PD fluid exposure, potentially due to peritoneal glutamine depletion. In this randomized cross-over phase I/II trial we investigated cytoprotective effects of alanyl-glutamine (AlaGln) addition to glucose-based PDF. Methods In a prospective randomized cross-over design, 20 stable PD outpatients underwent paired peritoneal equilibration tests 4 weeks apart, using conventional acidic, single chamber 3.86% glucose PD fluid, with and without 8 mM supplemental AlaGln. Heat-shock protein 72 expression was assessed in peritoneal effluent cells as surrogate parameter of cellular stress responses, complemented by metabolomics and functional immunocompetence assays. Results AlaGln restored peritoneal glutamine levels and increased the primary outcome heat-shock protein expression (effect 1.51-fold, CI 1.07–2.14; p = 0.022), without changes in peritoneal ultrafiltration, small solute transport, or biomarkers reflecting cell mass and inflammation. Further effects were glutamine-like metabolomic changes and increased ex-vivo LPS-stimulated cytokine release from healthy donor peripheral blood monocytes. In patients with a history of peritonitis (5 of 20), AlaGln supplementation decreased dialysate interleukin-8 levels. Supplemented PD fluid also attenuated inflammation and enhanced stimulated cytokine release in a mouse model of PD-associated peritonitis. Conclusion We conclude that AlaGln-supplemented, glucose-based PD fluid can restore peritoneal cellular stress responses with attenuation of sterile inflammation, and may improve peritoneal host-defense in the setting of PD. PMID:27768727

A randomized cross over study comparing the efficacy of two mandibular advancement appliances in the treatment of mild-moderate obstructive sleep apnea.

PubMed

Al-Dharrab, Ayman

2017-11-01

To compare efficacy, side effects, patient compliance, and preference between two types of custom-made mandibular advancement appliances (MAAs) in the treatment of patients with mild to moderate obstructive sleep apnea (OSA). This prospective, randomized, crossover study of 12 patients with mild to moderate OSA compared a titratable and a non-titratable MAA. Each patient was fitted with both appliances in a random order with a washout period of two weeks. Efficacy, side effects, compliance, and preference were evaluated by a questionnaire. All patients underwent overnight home sleep recordings prior to and after the use of each appliance in order to objectively assess sleep quality in terms of the apnea and hypopnea index (AHI), snoring frequency and oxygen desaturation index. Treatment successes (relief of symptoms and/or reduction of AHI to <10/h) were reported with both types of appliances. No compliance failure was reported, and in most patients, the side effects were mild, and improved with time. Both types of oral appliances were effective treatments for patients with mild to moderate OSA, with fewer side effects and higher patient satisfaction.

Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: the four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs.

PubMed

Diaz, Francisco J; Berg, Michel J; Krebill, Ron; Welty, Timothy; Gidal, Barry E; Alloway, Rita; Privitera, Michael

2013-12-01

Due to concern and debate in the epilepsy medical community and to the current interest of the US Food and Drug Administration (FDA) in revising approaches to the approval of generic drugs, the FDA is currently supporting ongoing bioequivalence studies of antiepileptic drugs, the EQUIGEN studies. During the design of these crossover studies, the researchers could not find commercial or non-commercial statistical software that quickly allowed computation of sample sizes for their designs, particularly software implementing the FDA requirement of using random-effects linear models for the analyses of bioequivalence studies. This article presents tables for sample-size evaluations of average bioequivalence studies based on the two crossover designs used in the EQUIGEN studies: the four-period, two-sequence, two-formulation design, and the six-period, three-sequence, three-formulation design. Sample-size computations assume that random-effects linear models are used in bioequivalence analyses with crossover designs. Random-effects linear models have been traditionally viewed by many pharmacologists and clinical researchers as just mathematical devices to analyze repeated-measures data. In contrast, a modern view of these models attributes an important mathematical role in theoretical formulations in personalized medicine to them, because these models not only have parameters that represent average patients, but also have parameters that represent individual patients. Moreover, the notation and language of random-effects linear models have evolved over the years. Thus, another goal of this article is to provide a presentation of the statistical modeling of data from bioequivalence studies that highlights the modern view of these models, with special emphasis on power analyses and sample-size computations.

The kinetochore prevents centromere-proximal crossover recombination during meiosis

PubMed Central

Vincenten, Nadine; Kuhl, Lisa-Marie; Lam, Isabel; Oke, Ashwini; Kerr, Alastair RW; Hochwagen, Andreas; Fung, Jennifer; Keeney, Scott; Vader, Gerben; Marston, Adèle L

2015-01-01

During meiosis, crossover recombination is essential to link homologous chromosomes and drive faithful chromosome segregation. Crossover recombination is non-random across the genome, and centromere-proximal crossovers are associated with an increased risk of aneuploidy, including Trisomy 21 in humans. Here, we identify the conserved Ctf19/CCAN kinetochore sub-complex as a major factor that minimizes potentially deleterious centromere-proximal crossovers in budding yeast. We uncover multi-layered suppression of pericentromeric recombination by the Ctf19 complex, operating across distinct chromosomal distances. The Ctf19 complex prevents meiotic DNA break formation, the initiating event of recombination, proximal to the centromere. The Ctf19 complex independently drives the enrichment of cohesin throughout the broader pericentromere to suppress crossovers, but not DNA breaks. This non-canonical role of the kinetochore in defining a chromosome domain that is refractory to crossovers adds a new layer of functionality by which the kinetochore prevents the incidence of chromosome segregation errors that generate aneuploid gametes. DOI: http://dx.doi.org/10.7554/eLife.10850.001 PMID:26653857

Energy expenditure in people with transtibial amputation walking with crossover and energy storing prosthetic feet: A randomized within-subject study.

PubMed

McDonald, Cody L; Kramer, Patricia A; Morgan, Sara J; Halsne, Elizabeth G; Cheever, Sarah M; Hafner, Brian J

2018-05-01

Energy storing feet are unable to reduce the energy required for normal locomotion among people with transtibial amputation. Crossover feet, which incorporate aspects of energy storing and running specific feet, are designed to maximize energy return while providing stability for everyday activities. Do crossover prosthetic feet reduce the energy expenditure of walking across a range of speeds, when compared with energy storing feet among people with transtibial amputation due to non-dysvascular causes? A randomized within-subject study was conducted with a volunteer sample of twenty-seven adults with unilateral transtibial amputation due to non-dysvascular causes. Participants were fit with two prostheses. One had an energy storing foot (Össur Variflex) and the other a crossover foot (Össur Cheetah Xplore). Other components, including sockets, suspension, and interface were standardized. Energy expenditure was measured with a portable respirometer (Cosmed K4b2) while participants walked on a treadmill at self-selected slow, comfortable, and fast speeds with each prosthesis. Gross oxygen consumption rates (VO 2  ml/min) were compared between foot conditions. Energy storing feet were used as the baseline condition because they are used by most people with a lower limb prosthesis. Analyses were performed to identify people who may benefit from transition to crossover feet. On average, participants had lower oxygen consumption in the crossover foot condition compared to the energy storing foot condition at each self-selected walking speed, but this difference was not statistically significant. Participants with farther six-minute walk test distances, higher daily step counts, and higher Medicare Functional Classification Levels at baseline were more likely to use less energy in the crossover foot. Crossover feet may be most beneficial for people with higher activity levels and physical fitness. Further research is needed to examine the effect of crossover feet on energy expenditure during high-level activities. Copyright © 2018 Elsevier B.V. All rights reserved.

Spinal Orthoses: The Crucial Role of Comfort on Compliance of Wearing - Monocentric Prospective Pilot Study of Randomized Cross-Over Design.

PubMed

Herget, G W; Patermann, S; Strohm, P C; Zwingmann, J; Eichelberger, P; Südkamp, N P; Hirschmüller, A

2017-01-01

PURPOSE OF THE STUDY Various spine disorders are regularly treated by orthoses, and success of treatment depends on wearing these devices. In this study we examined the compliance, wear comfort, subjective stabilization and side effects associated with spinal orthoses using an individualized questionnaire and the Compact Short Form-12 Health Survey (SF-12). MATERIAL AND METHODS In this prospective pilot study of randomized cross-over design, twelve healthy volunteers with a mean age of 31.2 years wore three different types of orthoses, each for one week: A hyperextension brace (HB), a custom-made semirigid orthosis (SO) and a custom-made rigid orthosis (RO). The daily duration of wearing the orthosis was defined as primary endpoint; contentment was measured using an individualized questionnaire and the standardized SF-12. RESULTS In the study population calculated probability of wearing the HB and RO was between 0.2 und 38.5% (95% confidence interval). No volunteer wore the SO orthosis for the predefined time. The SO and RO each displayed high subjective stabilization, while the RO was more often associated with side effects like skin pressure marks than the SO. The need for rework due to discomfort was mainly necessary with the RO. We observed no substantial differences in feeling compression and sweating. Noteworthy, eight of 12 subjects complained of uncomfortable sternal pressure due to the upper pad of the HB. The SF-12: scores ranged from 52.1 to 48.6 on the physical (PCS), and from 53.7 to 50.8 on the mental component score (MCS), demonstrating an influence on QoL. DISCUSSION AND CONCLUSIONS The design as well as the orthosis itself influence the compliance of wearing and exert a moderate negative, but acceptable impact on QoL. The SO appeared to correlate with the best overall compromise between comfort and subjective stabilization. Further investigations are necessary in patients with spinal diseases, for whom the effect of orthosis wearing may surpass the potential discomfort. Key words: thoracolumbar spine, orthoses, SF-12 - Quality of Life - QoL, comfort, compliance.

Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

PubMed

Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

2016-10-01

Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the educational process. © 2016 Sigma Theta Tau International.

Coronary perfusion pressure and compression quality in maternal cardiopulmonary resuscitation in supine and left-lateral tilt positions: A prospective, crossover study using mannequins and swine models.

PubMed

Dohi, Satoshi; Ichizuka, Kiyotake; Matsuoka, Ryu; Seo, Kohei; Nagatsuka, Masaaki; Sekizawa, Akihiko

2017-09-01

The risk of maternal and fetal mortality is high if cardiopulmonary arrest occurs during pregnancy. To assess the best position for maternal cardiopulmonary resuscitation (CPR), a prospective randomized crossover study was undertaken, involving basic life support mannequin-based simulation (BLS-MS) and a swine model of pulseless electrical activity (an unstable cardiac state) incorporating a fetal mannequin (PEA-FM). The BLS-MS (performed by certified rescuers) served to evaluate the quality of chest compressions in 30° left lateral tilt (LLT) and supine positions. Based on a 5-point scale, each rescuer subjectively graded their experience. The PEA-FM model was used to compare coronary perfusion pressure readings during CPR in supine, supine with left uterine displacement, 30° LLT, and 30° right lateral tilt positions. Compression rate and correctness of hand position, compression depth, and recoil were measures of compression quality (BLS-MS). Compared with LLT position, supine position enabled correct hand position (rate: 0.99 vs 0.88; p<0.05) and compression depth (rate: 0.76 vs 0.36; p<0.001) significantly more often. Moreover, BLS-MS rescuers found chest compressions significantly easier to perform with the mannequin in supine (vs LLT) position (difficulty score: 1.75 vs 3.95; p<0.001). In the PEA-FM study arm, supine position with left uterine displacement and right lateral tilt positions had the highest and lowest recorded coronary perfusion pressure readings, respectively. Supine position with left uterine displacement is optimal for maternal CPR. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

A randomized crossover study comparing the antiplatelet effect of plavix versus generic clopidogrel.

PubMed

Sambu, Nalyaka; Radhakrishnan, Ashwin; Curzen, Nick

2012-12-01

Clopidogrel exists in different salt formulations. All published data that have demonstrated its beneficial effect are based entirely on the hydrogen sulphate salt contained in the branded product Plavix, which had US sales of $6.1 billion in 2010 alone. A number of cheaper generic versions of clopidogrel are increasingly being used in Europe as an alternative to Plavix, mainly for cost reasons. However, there is insufficient evidence to show that their pharmacodynamic effect is equivalent to Plavix. This prospective study investigated whether there is any significant difference in the antiplatelet effect of Plavix versus generic clopidogrel hydrochloride in healthy male volunteers. All participants received loading and maintenance doses of both drugs, in a crossover manner, separated by a 2-week washout period. Adenosine diphosphate (ADP)-induced platelet reactivity was measured using short thrombelastography at multiple timepoints. The results showed interindividual heterogeneity in responses to clopidogrel but no significant difference in ADP-induced platelet reactivity between Plavix versus generic clopidogrel hydrochloride. Our findings suggest comparable inhibition of ADP-induced platelet reactivity with Plavix and generic clopidogrel hydrochloride. This observation is particularly pertinent at a time when the patent for Plavix is expected to expire in the near future leading to the large-scale switch to cheaper generic preparations.

A Randomized Crossover Study of Web-Based Media Literacy to Prevent Smoking

ERIC Educational Resources Information Center

Shensa, Ariel; Phelps-Tschang, Jane; Miller, Elizabeth; Primack, Brian A.

2016-01-01

Feasibly implemented Web-based smoking media literacy (SML) programs have been associated with improving SML skills among adolescents. However, prior evaluations have generally had weak experimental designs. We aimed to examine program efficacy using a more rigorous crossover design. Seventy-two ninth grade students completed a Web-based SML…

The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

PubMed

Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

2015-12-01

A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia

PubMed Central

Bowers, Alex R.; Keeney, Karen; Peli, Eli

2013-01-01

Objective To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia and without visual neglect. Methods Patients recruited at 13 clinics were allocated by minimization into a double-masked, crossover trial with two groups. One group received real (57Δ) oblique and sham (≤ 5Δ) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. A masked data collector at each clinic administered questionnaires after each 4-week crossover period. Main outcome measure The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants who wanted to continue with (said “yes” to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Results Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs. 36%; odds ratio 5.3, 95% CI 1.8 to 21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (p=0.002); participants who discontinued wear reported no difference. Conclusion Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Applications to clinical practice Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. PMID:24201760

Qualitative Analysis of Student Perceptions Comparing Team-based Learning and Traditional Lecture in a Pharmacotherapeutics Course.

PubMed

Remington, Tami L; Bleske, Barry E; Bartholomew, Tracy; Dorsch, Michael P; Guthrie, Sally K; Klein, Kristin C; Tingen, Jeffrey M; Wells, Trisha D

2017-04-01

Objective. To qualitatively compare students' attitudes and perceptions regarding team-based learning (TBL) and lecture. Design. Students were exposed to TBL and lecture in an elective pharmacotherapeutics course in a randomized, prospective, cross-over design. After completing the course, students provided their attitudes and perceptions through a written self-reflection and narrative questions on the end-of-course evaluation. Student responses were reviewed using a grounded theory coding method. Assessment. Students' responses yielded five major themes: impact of TBL on learning, perceptions about TBL learning methods, changes in approaches to learning, building skills for professional practice, and enduring challenges. Overall, students report TBL enhances their learning of course content (knowledge and application), teamwork skills, and lifelong learning skills. Conclusion. Students' attitudes and perceptions support TBL as a viable pedagogy for teaching pharmacotherapeutics.

Qualitative Analysis of Student Perceptions Comparing Team-based Learning and Traditional Lecture in a Pharmacotherapeutics Course

PubMed Central

Bleske, Barry E.; Bartholomew, Tracy; Dorsch, Michael P.; Guthrie, Sally K.; Klein, Kristin C.; Tingen, Jeffrey M.; Wells, Trisha D.

2017-01-01

Objective. To qualitatively compare students’ attitudes and perceptions regarding team-based learning (TBL) and lecture. Design. Students were exposed to TBL and lecture in an elective pharmacotherapeutics course in a randomized, prospective, cross-over design. After completing the course, students provided their attitudes and perceptions through a written self-reflection and narrative questions on the end-of-course evaluation. Student responses were reviewed using a grounded theory coding method. Assessment. Students’ responses yielded five major themes: impact of TBL on learning, perceptions about TBL learning methods, changes in approaches to learning, building skills for professional practice, and enduring challenges. Overall, students report TBL enhances their learning of course content (knowledge and application), teamwork skills, and lifelong learning skills. Conclusion. Students’ attitudes and perceptions support TBL as a viable pedagogy for teaching pharmacotherapeutics. PMID:28496275

A crossover-crossback prospective study of dibutyl-phthalate exposure from mesalamine medications and semen quality in men with inflammatory bowel disease.

PubMed

Nassan, Feiby L; Coull, Brent A; Skakkebaek, Niels E; Williams, Michelle A; Dadd, Ramace; Mínguez-Alarcón, Lidia; Krawetz, Stephen A; Hait, Elizabeth J; Korzenik, Joshua R; Moss, Alan C; Ford, Jennifer B; Hauser, Russ

2016-10-01

Phthalates are widely used chemicals with ubiquitous exposure. Dibutyl-phthalate (DBP), a male reproductive toxicant in animals, is understudied in humans. Some mesalamine medications used to treat inflammatory bowel disease (IBD) have DBP in their coating, whereas other mesalamine formulations do not. Taking advantage of differences in mesalamine formulations, we investigated whether high-DBP exposure from mesalamine medications was associated with decreased semen parameters. 73 men with IBD taking mesalamine participated in a crossover-crossback prospective study. Men taking non-DBP containing mesalamine at baseline i.e., background exposure, crossed-over for four months to high-DBP mesalamine and then crossed-back for four months to their non-DBP mesalamine (B1HB2-arm;Background1-High-Background2) and vice versa for men taking high-DBP mesalamine at baseline (H1BH2-arm;High1-Background-High2). Men provided up to six semen samples (2: baseline, 2: crossover and 2: crossback). We estimated crossover, crossback and carryover effects using linear mixed models adjusted for abstinence time, age, season and duration on high-DBP mesalamine at baseline. Semen parameters in B1HB2-arm (26 men, 133 samples) decreased after high-DBP mesalamine exposure (crossover versus baseline), especially motility parameters, and continued to decrease further even after crossback to non-DBP mesalamine (crossback versus crossover). The cumulative carryover effect of high-DBP (crossback versus baseline) was a decrease of % total sperm motility by 7.61(CI:-13.1, -2.15), % progressive sperm motility by 4.23(CI:-8.05, -0.4) and motile sperm count by 26.0% (CI:-46.2%, 1.7%). However, H1BH2-arm (47 men, 199 samples) had no significant change during crossover or crossback. Men newly exposed to high-DBP mesalamine for four months had a cumulative reduction in several semen parameters, primarily sperm motility, that was more pronounced and statistically significant even after exposure ended for four months. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pilot randomized crossover study comparing the efficacy of transnasal disposable endosheath with standard endoscopy to detect Barrett's esophagus.

PubMed

Shariff, Mohammed K; Varghese, Sibu; O'Donovan, Maria; Abdullahi, Zarah; Liu, Xinxue; Fitzgerald, Rebecca C; di Pietro, Massimiliano

2016-02-01

The transnasal endosheath endoscope is a new disposable technology with potential applicability to the primary care setting. The aim of this study was to evaluate the efficacy of transnasal endosheath endoscopy (TEE) for the detection of Barrett's esophagus, by comparing the diagnostic accuracy of TEE with that of standard endoscopy. This was a prospective, randomized, crossover study performed in a single tertiary referral center. Consecutive patients undergoing surveillance for Barrett's esophagus or referred for diagnostic assessment were recruited. All patients were randomized to undergo TEE followed by standard endoscopy or the reverse. Endoscopy experiences and patient preferences were evaluated using a questionnaire. Endoscopic and histologic diagnosis of Barrett's esophagus, and optical image quality of both endoscopic procedures, were compared. A total of 21 of 25 patients completed the study. TEE had sensitivity and specificity of 100 % for an endoscopic diagnosis of Barrett's esophagus, and of 66.7 % and 100 %, respectively, for the histologic diagnosis of Barrett's esophagus. The mean optical quality of standard endoscopy was significantly better than that of TEE (7.11 ± 0.42 vs. 4.06 ± 0.27; P < 0.0001). However, following endoscopy, patients reported a significantly better experience with TEE compared with standard endoscopy (7.05 ± 0.49 vs. 4.35 ± 0.53; P = 0.0006), with 60 % preferring TEE and 25 % preferring sedated standard endoscopy. In this study, TEE had equal accuracy for an endoscopic diagnosis of Barrett's esophagus compared with standard endoscopy, at the expense of reduced image quality and a lower yield of intestinal metaplasia on biopsy. TEE was better tolerated and preferred by patients. Hence, TEE needs further evaluation in primary care as an initial diagnostic tool. © Georg Thieme Verlag KG Stuttgart · New York.

The administration sequence of propofol and remifentanil does not affect the ED50 and ED95 of rocuronium in rapid sequence induction of anesthesia: a double-blind randomized controlled trial.

PubMed

Ozcelik, M; Guclu, C; Bermede, O; Baytas, V; Altay, N; Karahan, M A; Erdogan, B; Can, O

2016-04-01

The topic of drug administration sequence in rapid sequence induction (RSI) is still an object of interest in terms of rocuronium effectiveness. The aim of this prospective, randomized trial was to evaluate the effect of administration sequence of propofol and remifentanil on ED50 and ED95 of rocuronium in a RSI model. Eighty-four patients were randomized into Group Remifentanil (Group R, n = 43), where induction of general anesthesia started with remifentanil (2 µg/kg) and followed by propofol (2 mg/kg) and rocuronium administrations; and Group Propofol (Group P, n = 41), where induction of general anesthesia started with propofol and followed by remifentanil and rocuronium. First patients in each group were paralyzed by 0.8 mg/kg rocuronium. In case of acceptable intubation as evaluated according to the criteria described by Viby-Mogensen et al, rocuronium dose was decreased by 0.1 mg/kg for the next patient; otherwise, rocuronium dose was increased by 0.1 mg/kg. After three crossover points, increments or decrements in rocuronium dosage were set to 0.05 mg/kg. The process was repeated until a total of ten crossover points were obtained. The ED50 and ED95 doses of rocuronium were similar in Group R (0.182 mg/kg, and 0.244 mg/kg, respectively) and Group P (0.121 mg/kg, and 0.243 mg/kg, respectively) according to 95% CI of the estimates. There was no statistically significant difference in terms of clinically acceptable intubation conditions between the two groups (56.1% in Group R vs. 59% in Group P, p = 0.795). The choice of administration sequence of propofol and remifentanil does not have an impact on estimated ED50 and ED95 of rocuronium in providing acceptable intubation conditions in the RSI technique.

Rationale and design of a randomized controlled trial of allogeneic mesenchymal stem cells in patients with nonischemic cardiomyopathy.

PubMed

Greene, Stephen J; Epstein, Stephen E; Kim, Raymond J; Quyyumi, Arshed A; Cole, Robert T; Anderson, Allen S; Wilcox, Jane E; Skopicki, Hal A; Sikora, Sergey; Verkh, Lev; Tankovich, Nikolai I; Gheorghiade, Mihai; Butler, Javed

2017-04-01

This article describes an ongoing study investigating the safety and efficacy of ischemia-tolerant mesenchymal stem cell (MSC) therapy in patients with nonischemic heart failure and dysfunctional viable myocardium without scarring. This study will follow principles of the previously described mechanistic translational-phase concept whereby the effect of the study agent on laboratory and imaging markers of cardiac structure and function will be tested in a small homogenous cohort with the goal to enhance the understanding of the effect of interventions on cardiac remodeling and performance. This single-blind, placebo-controlled, crossover, multicenter, randomized study will assess the safety, tolerability, and preliminary efficacy of a single intravenous (i.v.) dose of allogeneic ischemia-tolerant MSCs in individuals with heart failure of nonischemic cause, ejection fraction 40% or less, and dysfunctional viable myocardium who have been receiving guideline-directed medical therapy. Eligible patients will have no evidence of baseline replacement scarring on delayed-enhancement cardiac magnetic resonance (CMR). Approximately 20 patients will be randomized in a 1 : 1 ratio to receive an i.v. infusion of ischemia-tolerant MSCs or placebo. At 90 days, the two groups will undergo crossover and received the alternative treatment. The primary endpoint is safety, as evaluated through at least 1-year post-MSC infusion. Additional efficacy endpoints will include measures of cardiac structure and function, as evaluated by serial cine-CMR and transthoracic echocardiography at 90 and 180 days post-initial infusion. This pilot study will explore the safety and effects on cardiac structure and function of i.v. injection of ischemia-tolerant MSCs in a small homogenous cohort of nonischemic heart failure patients with reduced ejection fraction and absent replacement scarring on CMR. This study also represents a prospective mechanistic translational-phase study using baseline and serial CMR imaging in heart failure patients and serves as a potential model for design of future heart failure trials (ClinicalTrials.gov identifier: NCT02467387).

Maintenance treatment for opioid dependence with slow-release oral morphine: a randomized cross-over, non-inferiority study versus methadone

PubMed Central

Beck, Thilo; Haasen, Christian; Verthein, Uwe; Walcher, Stephan; Schuler, Christoph; Backmund, Markus; Ruckes, Christian; Reimer, Jens

2014-01-01

Aims To compare the efficacy of slow-release oral morphine (SROM) and methadone as maintenance medication for opioid dependence in patients previously treated with methadone. Design Prospective, multiple-dose, open label, randomized, non-inferiority, cross-over study over two 11-week periods. Methadone treatment was switched to SROM with flexible dosing and vice versa according to period and sequence of treatment. Setting Fourteen out-patient addiction treatment centres in Switzerland and Germany. Participants Adults with opioid dependence in methadone maintenance programmes (dose ≥50 mg/day) for ≥26 weeks. Measurements The efficacy end-point was the proportion of heroin-positive urine samples per patient and period of treatment. Each week, two urine samples were collected, randomly selected and analysed for 6-monoacetyl-morphine and 6-acetylcodeine. Non-inferiority was concluded if the two-sided 95% confidence interval (CI) in the difference of proportions of positive urine samples was below the predefined boundary of 10%. Findings One hundred and fifty-seven patients fulfilled criteria to form the per protocol population. The proportion of heroin-positive urine samples under SROM treatment (0.20) was non-inferior to the proportion under methadone treatment (0.15) (least-squares mean difference 0.05; 95% CI = 0.02, 0.08; P > 0.01). The 95% CI fell within the 10% non-inferiority margin, confirming the non-inferiority of SROM to methadone. A dose-dependent effect was shown for SROM (i.e. decreasing proportions of heroin-positive urine samples with increasing SROM doses). Retention in treatment showed no significant differences between treatments (period 1/period 2: SROM: 88.7%/82.1%, methadone: 91.1%/88.0%; period 1: P = 0.50, period 2: P = 0.19). Overall, safety outcomes were similar between the two groups. Conclusions Slow-release oral morphine appears to be at least as effective as methadone in treating people with opioid use disorder. PMID:24304412

A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

PubMed

Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

2015-01-01

Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress nor affect predialysis blood pressure. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Comparison of intraosseous and infiltration injections for venous lidocaine blood concentrations and heart rate changes after injection of 2% lidocaine with 1:100,000 epinephrine.

PubMed

Wood, Mark; Reader, Al; Nusstein, John; Beck, Mike; Padgett, David; Weaver, Joel

2005-06-01

The purpose of this prospective, randomized study was to compare the venous blood levels of lidocaine and heart rate changes after intraosseous and infiltration injections of 1.8 ml of 2% lidocaine with 1:100,000 epinephrine. Using a crossover design, 20 subjects randomly received an intraosseous and infiltration injection at two separate appointments. The heart rate was measured using a pulse oximeter. Venous blood samples were collected before the injections and at 2, 5, 10, 15, 20, 25, 30, 45, and 60 min after the injections. The blinded plasma samples were analyzed for lidocaine concentrations using high-performance liquid chromatography (HPLC). The intraosseous injection resulted in a statistically significant increase in heart rate, when compared to the infiltration injection, during solution deposition and for 2 min after the injection. The plasma levels of lidocaine were not statistically different for maxillary anterior intraosseous and infiltration injections when using 1.8 ml of 2% lidocaine with 1:100,000 epinephrine.

Atomoxetine for Hyperactivity in Autism Spectrum Disorders: Placebo-Controlled Crossover Pilot Trial

ERIC Educational Resources Information Center

Arnold, L. Eugene; Aman, Michael G.; Cook, Amelia M.; Witwer, Andrea N.; Hall, Kristy L.; Thompson, Susan; Ramadan, Yaser

2006-01-01

Objective: To explore placebo-controlled efficacy and safety of atomoxetine (ATX) for attention-deficit/hyperactivity disorder (ADHD) symptoms in children with autism spectrum disorders (ASD). Method: Children ages 5 to 15 with ASD and prominent ADHD symptoms were randomly assigned to order in a crossover of clinically titrated ATX and placebo, 6…

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial.

PubMed

Pedersen-Bjergaard, Ulrik; Kristensen, Peter L; Beck-Nielsen, Henning; Nørgaard, Kirsten; Perrild, Hans; Christiansen, Jens S; Jensen, Tonny; Parving, Hans-Henrik; Thorsteinsson, Birger; Tarnow, Lise

2017-01-01

The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4mmol/mol) lower HbA1c. Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p<0.0001)). Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Innovative Strategies for Clinical Microscopy Instruction: Virtual Versus Light Microscopy.

PubMed

McDaniel, M Jane; Russell, Gregory B; Crandall, Sonia J

2018-06-01

The purpose of the study was to compare virtual microscopy with light microscopy to determine differences in learning outcomes and learner attitudes in teaching clinical microscopy to physician assistant (PA) students. A prospective, randomized, crossover design study was conducted with a convenience sample of 67 first-year PA students randomized to 2 groups. One group used light microscopes to find microscopic structures, whereas the other group used instructor-directed video streaming of microscopic elements. At the midpoint of the study, the groups switched instructional strategies. Learning outcomes were assessed via posttest after each section of the study, with comparison of final practical examination results to previous cohorts. Attitudes about the 2 educational strategies were assessed through a postcourse questionnaire with a Likert scale. Analysis of the first posttest demonstrated that students in the video-streamed group had significantly better learning outcomes than those in the light microscopy group (P = .004; Cohen's d = 0.74). Analysis of the posttest after crossover showed no differences between the 2 groups (P = .48). Between the 2 posttests, students first assigned to the light microscopy group scored a 6.6 mean point increase (±10.4 SD; p = .0011), whereas students first assigned to the virtual microscopy group scored a 1.3 mean point increase (±7.1 SD; p = .29). The light microscopy group improved more than the virtual microscopy group (P = .019). Analysis of practical examination data revealed higher scores for the study group compared with 5 previous cohorts of first-year students (P < .0001; Cohen's d = 0.66). Students preferred virtual microscopy to traditional light microscopy. Virtual microscopy is an effective educational strategy, and students prefer this method when learning to interpret images of clinical specimens.

Very low protein diet reduces indoxyl sulfate levels in chronic kidney disease.

PubMed

Marzocco, Stefania; Dal Piaz, Fabrizio; Di Micco, Lucia; Torraca, Serena; Sirico, Maria Luisa; Tartaglia, Domenico; Autore, Giuseppina; Di Iorio, Biagio

2013-01-01

High levels of indoxyl sulfate (IS) are associated with chronic kidney disease (CKD) progression and increased mortality in CKD patients. The aim of this pilot study was to assess whether a very low protein diet (VLPD; 0.3 g/kg bw/day), with a consequent low phosphorus intake, would reduce IS serum levels compared to a low protein diet (LPD; 0.6 g/kg bw/day) in CKD patients not yet on dialysis. This is a post hoc analysis of a preceding cross-over study aimed to analyze FGF23 during VLPD. Here we performed a prospective randomized controlled crossover study in which 32 patients were randomized to receive either a VLPD (0.3 g/kg bw/day) supplemented with ketoanalogues during the first week and an LPD during the second week (group A, n = 16), or an LPD during the first week and a VLPD during the second week (group B, n = 16 patients). IS serum levels were measured at baseline and at the end of each study period. We compared them to 24 hemodialysis patients (HD) and 14 healthy subjects (control). IS serum concentration was significantly higher in the HD (43.4 ± 12.3 µM) and CKD (11.1 ± 6.6 µM) groups compared to the control group (2.9 ± 1.1 µM; p < 0.001). IS levels also correlated with creatinine values in CKD patients (R(2) = 0.42; p < 0.0001). After only 1 week of a VLPD, even preceded by an LPD, CKD patients showed a significant reduction of IS serum levels (37%). VLPD supplemented with ketoanalogues reduced IS serum levels in CKD patients not yet on dialysis. Copyright © 2013 S. Karger AG, Basel.

Spectra Optia granulocyte apheresis collections result in higher collection efficiency of viable, functional neutrophils in a randomized, crossover, multicenter trial.

PubMed

Cancelas, Jose A; Padmanabhan, Anand; Le, Tuan; Ambruso, Daniel R; Rugg, Neeta; Worsham, D Nicole; Pinkard, Susan L; Graminske, Sharon; Buck, Jennifer; Goldberg, Julie; Bill, Jerry

2015-04-01

Granulocyte transfusion from healthy donors is used in the treatment of patients with granulocyte function defects, or transient neutropenia and severe bacterial or fungal infections resistant to maximal antimicrobial treatment. This study evaluated the performance and safety of the newly developed granulocyte collection protocol of the Spectra Optia in a prospective, multicenter, open-label, randomized, paired crossover trial compared with the COBE Spectra apheresis system in a population of 32 evaluable healthy subjects. All subjects received granulocyte-colony-stimulating factor and dexamethasone before collection. Granulocyte procedures from Spectra Optia apheresis procedures had an approximately 23% higher polymorphonuclear (PMN) collection efficiency (CE) than the COBE Spectra collections (mean, 53.7% vs. 43.2%; p < 0.01), while the platelet CE (10.9% vs. 10.8%, respectively) and hematocrit (7.4% vs. 7.4%) were comparable between collections on both devices. Spectra Optia collections generated a higher total PMN yield per liter of blood processed than those produced by the COBE Spectra (with means of 8.6 × 10(10) vs. 6.8 × 10(10) , respectively). Granulocyte viability was more than 99% with both devices, and chemotaxic and bacterial killing activities of circulating versus collected granulocytes were similarly preserved. Fewer operator adjustments were required with Spectra Optia and there was no significant difference in the number or intensity of adverse events between instruments. CE of the granulocyte collection procedure with the Spectra Optia was approximately 10 percentage points higher than with the COBE Spectra, required less operator involvement, and is safe for clinical implementation. © 2014 AABB.

A comparison of the McGrath-MAC and Macintosh laryngoscopes for child tracheal intubation during resuscitation by paramedics. A randomized, crossover, manikin study.

PubMed

Szarpak, Lukasz; Truszewski, Zenon; Czyzewski, Lukasz; Gaszynski, Tomasz; Rodríguez-Núñez, Antonio

2016-08-01

Prehospital tracheal intubation by paramedics during cardiopulmonary resuscitation (CPR) in children is challenging. The potential role of new intubation devices during CPR is unclear. Our objective was to assess the impact of CPR (with and without chest compressions [CCs]) on the success and time to intubation (TTI) with the Macintosh laryngoscope vs the McGrath video laryngoscope on a pediatric manikin. This was an open, prospective, randomized, crossover, manikin trial involving 95 paramedics who performed intubations in a PediaSIM pediatric high-fidelity manikin with Macintosh and McGrath laryngoscopes, with and without concomitant mechanical CCs. Primary outcome was the TTI, and secondary outcome was success of the attempt. Participants rated their best glottic view, the severity of the potential dental trauma, and subjective opinion about the difficulty of the procedure. The median TTI with the Macintosh in the scenario with uninterrupted CC was 33 (interquartile range [IQR], 24-36) seconds, which is significantly longer than TTI in the scenario with interrupted CC (23 [IQR, 20-29] seconds, P < .001). Time to intubation using the McGrath was similar in both scenarios: 20 (IQR, 17-23) seconds vs 19.5 (IQR, 17-22) seconds (P = .083). A statistically significant difference between McGrath and Macintosh was noticed in TTI both in scenario with (P < .001) and without CC (P = .017). McGrath video laryngoscope helps paramedics to intubate a pediatric manikin in a CPR scenario in less time and with fewer attempts than with the classical Macintosh, both in case of ongoing or stopped CC. McGrath use in actual patients could improve CPR quality by paramedics. Copyright © 2015 Elsevier Inc. All rights reserved.

Contrast fluoroscopic evaluation of gastrointestinal transit times with and without the use of falconry hoods in red-tailed hawks (Buteo jamaicensis).

PubMed

Doss, Grayson A; Williams, Jackie M; Mans, Christoph

2017-11-01

OBJECTIVE To evaluate gastrointestinal transit times in red-tailed hawks (Buteo jamaicensis) by use of contrast fluoroscopic imaging and investigate the effect of falconry hooding in these hawks on gastrointestinal transit time. DESIGN Prospective, randomized, blinded, complete crossover study. ANIMALS 9 healthy red-tailed hawks. PROCEDURES Hawks were gavage-fed a 30% weight-by-volume barium suspension (25 mL/kg [11.3 mL/lb]) into the crop. Fluoroscopic images were obtained at multiple time points after barium administration. Time to filling and emptying of various gastrointestinal tract organs and overall transit time were measured. The effect of hooding (hooded vs nonhooded) on these variables was assessed in a randomized complete crossover design. RESULTS In nonhooded birds, overall gastrointestinal transit time ranged from 30 to 180 minutes (mean ± SD, 100 ± 52 min). Time to complete crop emptying ranged from 30 to 180 minutes (83 ± 49 min). Contrast medium was present in the ventriculus in all birds within 5 minutes of administration and in the small intestines within 5 to 15 minutes (median, 5 min). Hooding of red-tailed hawks resulted in a significant delay of complete crop emptying (no hood, 83 ± 49 minutes; hood, 133 ± 48 minutes), but no significant effects of hooding were found on other measured variables. CONCLUSIONS AND CLINICAL RELEVANCE These results indicated that overall gastrointestinal transit times are faster in red-tailed hawks than has been reported for psittacines and that the use of a falconry hood in red-tailed hawks may result in delayed crop emptying. Hooding did not exert significant effects on overall gastrointestinal transit time in this raptorial species.

Eating dark and milk chocolate: a randomized crossover study of effects on appetite and energy intake

PubMed Central

Sørensen, L B; Astrup, A

2011-01-01

Objective: To compare the effect of dark and milk chocolate on appetite sensations and energy intake at an ad libitum test meal in healthy, normal-weight men. Subjects/methods: A total of 16 young, healthy, normal-weight men participated in a randomized, crossover study. Test meals were 100 g of either milk (2285 kJ) or dark chocolate (2502 kJ). Visual-analogue scales were used to record appetite sensations before and after the test meal was consumed and subsequently every 30 min for 5 h. An ad libitum meal was served 2 h after the test meal had been consumed. Results: The participants felt more satiated, less hungry, and had lower ratings of prospective food consumption after consumption of the dark chocolate than after the milk chocolate. Ratings of the desire to eat something sweet, fatty or savoury were all lower after consumption of the dark chocolate. Energy intake at the ad libitum meal was 17% lower after consumption of the dark chocolate than after the milk chocolate (P=0.002). If the energy provided by the chocolate is included in the calculation, the energy intake after consumption of the dark chocolate was still 8% lower than after the milk chocolate (P=0.01). The dark chocolate load resulted in an overall energy difference of −584 kJ (95% confidence interval (−1027;−141)) during the test period. Conclusion: In the present study, dark chocolate promotes satiety, lowers the desire to eat something sweet, and suppresses energy intake compared with milk chocolate. PMID:23455041

Effects of an alveolar recruitment maneuver on subdural pressure, brain swelling, and mean arterial pressure in patients undergoing supratentorial tumour resection: a randomized crossover study.

PubMed

Flexman, Alana M; Gooderham, Peter A; Griesdale, Donald E; Argue, Ruth; Toyota, Brian

2017-06-01

Although recruitment maneuvers have been advocated as part of a lung protective ventilation strategy, their effects on cerebral physiology during elective neurosurgery are unknown. Our objectives were to determine the effects of an alveolar recruitment maneuver on subdural pressure (SDP), brain relaxation score (BRS), and cerebral perfusion pressure among patients undergoing supratentorial tumour resection. In this prospective crossover study, patients scheduled for resection of a supratentorial brain tumour were randomized to undergo either a recruitment maneuver (30 cm of water for 30 sec) or a "sham" maneuver (5 cm of water for 30 sec), followed by the alternative intervention after a 90-sec equilibration period. Subdural pressure was measured through a dural perforation following opening of the cranium. Subdural pressure and mean arterial pressure (MAP) were recorded continuously. The blinded neurosurgeon provided a BRS at baseline and at the end of each intervention. During each treatment, the changes in SDP, BRS, and MAP were compared. Twenty-one patients underwent the study procedure. The increase in SDP was higher during the recruitment maneuver than during the sham maneuver (difference, 3.9 mmHg; 95% confidence interval [CI], 2.2 to 5.6; P < 0.001). Mean arterial pressure decreased further in the recruitment maneuver than in the sham maneuver (difference, -9.0 mmHg; 95% CI, -12.5 to -5.6; P < 0.001). Cerebral perfusion pressure decreased 14 mmHg (95% CI, 4 to 24) during the recruitment maneuver. The BRS did not change with either maneuver. Our results suggest that recruitment maneuvers increase subdural pressure and reduce cerebral perfusion pressure, although the clinical importance of these findings is thus far unknown. This trial was registered with ClinicalTrials.gov, NCT02093117.

A systematic review identifies shortcomings in the reporting of crossover trials in chronic painful conditions.

PubMed

Straube, Sebastian; Werny, Benedikt; Friede, Tim

2015-12-01

To investigate the reporting of study features of interest in abstracts and full texts of journal publications of crossover trials in chronic painful conditions. Systematic review based on a MEDLINE (PubMed) search (January 1990-August 2014). Ninety-eight publications on crossover studies with 3,513 study participants were eligible for inclusion. Double-blind status and randomized allocation to treatment groups are commonly reported in both abstracts and full texts (90 of 98 publications and 82 of 98 publications, respectively). Adverse events are reported in both abstract and full text in 49 of 98 publications and in the full text only in 44 of 98. A breakdown of results by treatment period is provided only in 23 of 98 publications, and if so, is reported only in the full text, never in the abstract. There is a time trend for the reporting of randomization in abstracts; it is more likely to be reported in recent studies (P = 0.0094). No time trends are detected in the reporting of double-blind status (P = 0.1087) and adverse events (P = 0.6084). The reporting of adverse events in the abstract and the reporting of results specified by crossover period in the full texts of journal publications on crossover pain trials should be improved. Copyright © 2015 Elsevier Inc. All rights reserved.

Magnetic versus manual catheter navigation for mapping and ablation of right ventricular outflow tract ventricular arrhythmias: a randomized controlled study.

PubMed

Zhang, Fengxiang; Yang, Bing; Chen, Hongwu; Ju, Weizhu; Kojodjojo, Pipin; Cao, Kejiang; Chen, Minglong

2013-08-01

No randomized controlled study has prospectively compared the performance and clinical outcomes of remote magnetic control (RMC) vs manual catheter control (MCC) during ablation of right ventricular outflow tract (RVOT) ventricular premature complexes (VPC) or ventricular tachycardia (VT). The purpose of this study was to prospectively evaluate the efficacy and safety of using either RMC vs MCC for mapping and ablation of RVOT VPC/VT. Thirty consecutive patients with idiopathic RVOT VPC/VT were referred for catheter ablation and randomized into either the RMC or MCC group. A noncontact mapping system was deployed in the RVOT to identify origins of VPC/VT. Conventional activation and pace-mapping was performed to guide ablation. If ablation performed using 1 mode of catheter control was acutely unsuccessful, the patient crossed over to the other group. The primary endpoints were patients' and physicians' fluoroscopic exposure and times. Mean procedural times were similar between RMC and MCC groups. The fluoroscopic exposure and times for both patients and physicians were much lower in the RMC group than in the MCC group. Ablation was acutely successful in 14 of 15 patients in the MCC group and 10 of 15 in the RMC group. Following crossover, acute success was achieved in all patients. No major complications occurred in either group. During 22 months of follow-up, RVOT VPC recurred in 2 RMC patients. RMC navigation significantly reduces patients' and physicians' fluoroscopic times by 50.5% and 68.6%, respectively, when used in conjunction with a noncontact mapping system to guide ablation of RVOT VPC/VT. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

A Prospective, Randomized, Double-Blind Comparison of 2% Lidocaine With 1 : 100,000 Epinephrine, 4% Prilocaine With 1 : 200,000 Epinephrine, and 4% Prilocaine for Maxillary Infiltrations

PubMed Central

Katz, Steven; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

2010-01-01

Abstract The purpose of this prospective, randomized, double-blind crossover study was to evaluate the anesthetic efficacy of 2% lidocaine with 1 : 100,000 epinephrine, 4% prilocaine with 1 : 200,000 epinephrine, and 4% prilocaine in maxillary lateral incisors and first molars. Sixty subjects randomly received, in a double-blind manner, maxillary lateral incisor and first molar infiltrations of 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine, 1.8 mL of 4% prilocaine with 1 : 200,000 epinephrine, and 1.8 mL of 4% prilocaine, at 3 separate appointments spaced at least 1 week apart. The teeth were pulp-tested in 3-minute cycles for a total of 60 minutes. Anesthetic success (ie, obtaining 2 consecutive 80 readings with the electric pulp tester) and onset of pulpal anesthesia were not significantly different between 2% lidocaine with 1 : 100,000 epinephrine, 4% prilocaine with 1 : 200,000 epinephrine, and 4% prilocaine for the lateral incisor and first molar. For both lateral incisor and first molar, 4% prilocaine with 1 : 200,000 epinephrine and 2% lidocaine with 1 : 100,000 epinephrine were equivalent for incidence of pulpal anesthesia. However, neither anesthetic agent provided an hour of pulpal anesthesia. For both lateral incisor and first molar, 4% prilocaine provided a significantly shorter duration of pulpal anesthesia compared with 2% lidocaine with 1 : 100,000 epinephrine and 4% prilocaine with 1 : 200,000 epinephrine. PMID:20553134

The dynamics of the metabolism of acetate and bicarbonate associated with use of hemodialysates in the ABChD trial: a phase IV, prospective, single center, single blind, randomized, cross-over, two week investigation.

PubMed

Smith, William B; Gibson, Sandy; Newman, George E; Hendon, Kendra S; Askelson, Margarita; Zhao, James; Hantash, Jamil; Flanagan, Brigid; Larkin, John W; Usvyat, Len A; Thadhani, Ravi I; Maddux, Franklin W

2017-08-29

In the United States, hemodialysis (HD) is generally performed via a bicarbonate dialysate. It is not known if small amounts of acid used in dialysate to buffer the bicarbonate can meaningfully contribute to overall buffering administered during HD. We aimed to investigate the metabolism of acetate with use of two different acid buffer concentrates and determine if it effects blood bicarbonate concentrations in HD patients. The Acid-Base Composition with use of hemoDialysates (ABChD) trial was a Phase IV, prospective, single blind, randomized, cross-over, 2 week investigation of peridialytic dynamics of acetate and bicarbonate associated with use of acid buffer concentrates. Eleven prevalent HD patients participated from November 2014 to February 2015. Patients received two HD treatments, with NaturaLyte® and GranuFlo® acid concentrates containing 4 and 8 mEq/L of acetate, respectively. Dialysate order was chosen in a random fashion. The endpoint was to characterize the dynamics of acetate received and metabolized during hemodialysis, and how it effects overall bicarbonate concentrations in the blood and dialysate. Acetate and bicarbonate concentrations were assessed before, at 8 time points during, and 6 time points after the completion of HD. Data from 20 HD treatments for 11 patients (10 NaturaLyte® and 10 GranuFlo®) was analyzed. Cumulative trajectories of arterialized acetate were unique between NaturaLyte® and GranuFlo® (p = 0.003), yet individual time points demonstrated overlap without remarkable differences. Arterialized and venous blood bicarbonate concentrations were similar at HD initiation, but by 240 min into dialysis, mean arterialized bicarbonate concentrations were 30.2 (SD ± 4.16) mEq/L in GranuFlo® and 28.8 (SD ± 4.26) mEq/L in NaturaLyte®. Regardless of acid buffer concentrate, arterial blood bicarbonate was primarily dictated by the prescribed bicarbonate level. Subjects tolerated HD with both acid buffer concentrates without experiencing any related adverse events. A small fraction of acetate was delivered to HD patients with use of NaturaLyte® and GranuFlo® acid buffers; the majority of acetate received was observed to be rapidly metabolized and cleared from the circulation. Blood bicarbonate concentrations appear to be determined mainly by the prescribed concentration of bicarbonate. This trial was registered on ClinicalTrials.gov on 11 Dec 2014 ( NCT02334267 ).

The administration to Indonesians of monosodium L-glutamate in Indonesian foods: an assessment of adverse reactions in a randomized double-blind, crossover, placebo-controlled study.

PubMed

Prawirohardjono, W; Dwiprahasto, I; Astuti, I; Hadiwandowo, S; Kristin, E; Muhammad, M; Kelly, M F

2000-04-01

Monosodium L-glutamate (MSG) has been suggested to cause postprandial symptoms after the ingestion of Chinese or oriental meals. Therefore, we examined whether such symptoms could be elicited in Indonesians ingesting levels of MSG typically found in Indonesian cuisine. Healthy volunteers (n = 52) were treated with capsules of placebo or MSG (1.5 and 3.0 g/person) as part of a standardized Indonesian breakfast. The study used a rigorous, randomized, double-blind, crossover design. The occurrence of symptoms after MSG ingestion did not differ from that after consumption of the placebo.

Linear combinations come alive in crossover designs.

PubMed

Shuster, Jonathan J

2017-10-30

Before learning anything about statistical inference in beginning service courses in biostatistics, students learn how to calculate the mean and variance of linear combinations of random variables. Practical precalculus examples of the importance of these exercises can be helpful for instructors, the target audience of this paper. We shall present applications to the "1-sample" and "2-sample" methods for randomized short-term 2-treatment crossover studies, where patients experience both treatments in random order with a "washout" between the active treatment periods. First, we show that the 2-sample method is preferred as it eliminates "conditional bias" when sample sizes by order differ and produces a smaller variance. We also demonstrate that it is usually advisable to use the differences in posttests (ignoring baseline and post washout values) rather than the differences between the changes in treatment from the start of the period to the end of the period ("delta of delta"). Although the intent is not to provide a definitive discussion of crossover designs, we provide a section and references to excellent alternative methods, where instructors can provide motivation to students to explore the topic in greater detail in future readings or courses. Copyright © 2017 John Wiley & Sons, Ltd.

Comparison of the inhibitory effects of cilostazol, acetylsalicylic acid and ticlopidine on platelet functions ex vivo. Randomized, double-blind cross-over study.

PubMed

Ikeda, Y; Kikuchi, M; Murakami, H; Satoh, K; Murata, M; Watanabe, K; Ando, Y

1987-05-01

A randomized double-blind cross-over study was conducted to determine the inhibitory effects of acetylsalicylic acid (ASA), ticlopidine (TP) and cilostazol (OPC-13013; in the following briefly called CS), a new antithrombotic agent on platelet functions ex vivo. Nine patients with cerebral thrombosis were enrolled in this study. Patients were given each of the three drugs for one week in a complete cross-over design according to a randomization schedule, followed by a wash-out period with a placebo for one week. It was found that CS and TP significantly inhibited platelet aggregation induced by ADP. Collagen- and arachidonic acid-induced platelet aggregation was all inhibited by CS, TP and ASA. Duncan's multiple range test to compare the anti-platelet effects of the three drugs revealed that: CS greater than ASA and TP greater than ASA in inhibiting ADP-induced platelet aggregation and CS greater than TP and ASA greater than TP in inhibiting arachidonic acid-induced platelet aggregation. These results may suggest that CS is superior to ASA and TP in inhibiting platelet aggregation ex vivo.

Dissociable Effects of Subthalamic Stimulation in Obsessive Compulsive Disorder on Risky Reward and Loss Prospects.

PubMed

Voon, Valerie; Droux, Fabien; Chabardes, Stephan; Bougerol, Thierry; Kohl, Sina; David, Olivier; Krack, Paul; Polosan, Mircea

2018-07-01

Our daily decisions involve an element of risk, a behavioral process that is potentially modifiable. Here we assess the role of the associative-limbic subthalamic nucleus (STN) in obsessive compulsive disorder (OCD) testing on and off deep-brain stimulation (DBS) on anticipatory risk taking to obtain rewards and avoid losses. We assessed 12 OCD STN DBS in a randomized double-blind within-subject cross-over design. STN DBS decreased risk taking to rewards (p = 0.02) and greater risk taking to rewards was positively correlated with OCD severity (p = 0.01) and disease duration (p = 0.01). STN DBS was also associated with impaired subjective discrimination of loss magnitude (p < 0.05), an effect mediated by acute DBS rather than chronic DBS. We highlight a role for the STN in mediating dissociable valence prospects on risk seeking. STN stimulation decreases risk taking to rewards and impairs discrimination of loss magnitude. These findings may have implications for behavioral symptoms related to STN DBS and the potential for STN DBS for the treatment of psychiatric disorders. Copyright © 2018. Published by Elsevier Ltd.

The many ways sputum flows - Dealing with high within-subject variability in cystic fibrosis sputum rheology.

PubMed

Radtke, Thomas; Böni, Lukas; Bohnacker, Peter; Fischer, Peter; Benden, Christian; Dressel, Holger

2018-04-21

We evaluated test-retest reliability of sputum viscoelastic properties in clinically stable patients with cystic fibrosis (CF). Data from a prospective, randomized crossover study was used to determine within-subject variability of sputum viscoelasticity (G', storage modulus and G", loss modulus at 1 and 10 rad s -1 ) and solids content over three consecutive visits. Precision of sputum properties was quantified by within-subject standard deviation (SD ws ), coefficient of variation (CV) and intraclass correlation coefficients (ICC). Fifteen clinically stable adults with CF (FEV 1 range 24-94% predicted) were included. No differences between study visits (mean ± SD 8 ± 2 days) were observed for any sputum rheology measure. CV's for G', G" and solids content ranged between 40.3-45.3% and ICC's between 0.21-0.42 indicating poor to fair test-retest reliability. Short-term within-subject variability of sputum properties is high in clinically stable adults with CF. Investigators applying shear rheology experiments in future prospective studies should consider using multiple measurements aiming to increase precision of sputum rheological outcomes. Copyright © 2018 Elsevier B.V. All rights reserved.

Design, Analysis, and Reporting of Crossover Trials for Inclusion in a Meta-Analysis.

PubMed

Li, Tianjing; Yu, Tsung; Hawkins, Barbara S; Dickersin, Kay

2015-01-01

To evaluate the characteristics of the design, analysis, and reporting of crossover trials for inclusion in a meta-analysis of treatment for primary open-angle glaucoma and to provide empirical evidence to inform the development of tools to assess the validity of the results from crossover trials and reporting guidelines. We searched MEDLINE, EMBASE, and Cochrane's CENTRAL register for randomized crossover trials for a systematic review and network meta-analysis we are conducting. Two individuals independently screened the search results for eligibility and abstracted data from each included report. We identified 83 crossover trials eligible for inclusion. Issues affecting the risk of bias in crossover trials, such as carryover, period effects and missing data, were often ignored. Some trials failed to accommodate the within-individual differences in the analysis. For a large proportion of the trials, the authors tabulated the results as if they arose from a parallel design. Precision estimates properly accounting for the paired nature of the design were often unavailable from the study reports; consequently, to include trial findings in a meta-analysis would require further manipulation and assumptions. The high proportion of poorly reported analyses and results has the potential to affect whether crossover data should or can be included in a meta-analysis. There is pressing need for reporting guidelines for crossover trials.

Comparative Study of Assisted Ambulation and Perceived Exertion With the Wheeled Knee Walker and Axillary Crutches in Healthy Subjects.

PubMed

Kocher, Benjamin K; Chalupa, Robyn L; Lopez, Donna M; Kirk, Kevin L

2016-11-01

Functional limitations after lower extremity surgery often require the use of an assistive device for ambulation during rehabilitation and recovery. There are no known objective data evaluating the wheeled knee walker as an assistive device for protected ambulation. The purpose of this study was to compare assisted ambulation and perceived exertion with the wheeled knee walker and the axillary crutches in healthy participants. A prospective, randomized crossover study was performed using 24 healthy volunteers. Each participant performed a 6-minute walk test (6MWT) using each assistive device in a crossover manner. Preactivity and postactivity heart rates were recorded. The self-selected walking velocity (SSWV) was calculated and the participant's rating of perceived exertion was recorded using the OMNI Rating of Perceived Exertion (OMNI-RPE). Participant's preference for assistive device was identified. The 6MWT, SSWV, and the Omni-RPE were evaluated using paired t tests and determined to be statistically significant for the wheeled knee walker compared with axillary crutches. Evaluation of the preactivity and postactivity heart rates demonstrated a statistically significant difference for the wheeled knee walker compared with axillary crutches. The wheeled knee walker was preferred by 88% of participants. The wheeled knee walker provided increased assisted ambulation and had a lower rating of perceived exertion than axillary crutches on level surfaces in healthy participants. Level III, comparative study. © The Author(s) 2016.

The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial.

PubMed

Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

2014-01-01

Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration: ClinicalTrials.gov NCT01449383.

The Influence of Whole Grain Products and Red Meat on Intestinal Microbiota Composition in Normal Weight Adults: A Randomized Crossover Intervention Trial

PubMed Central

Foerster, Jana; Maskarinec, Gertraud; Reichardt, Nicole; Tett, Adrian; Narbad, Arjan; Blaut, Michael; Boeing, Heiner

2014-01-01

Intestinal microbiota is related to obesity and serum lipid levels, both risk factors for chronic diseases constituting a challenge for public health. We investigated how a diet rich in whole grain (WG) products and red meat (RM) influences microbiota. During a 10-week crossover intervention study, 20 healthy adults consumed two isocaloric diets, one rich in WG products and one high in RM. Repeatedly data on microbiota were assessed by 16S rRNA based denaturing gradient gel electrophoresis (DGGE). A blood sample and anthropometric data were collected. Mixed models and logistic regression were used to investigate effects. Microbiota showed interindividual variability. However, dietary interventions modified microbiota appearance: 8 bands changed in at least 4 participants during the interventions. One of the bands appearing after WG and one increasing after RM remained significant in regression models and were identified as Collinsella aerofaciens and Clostridium sp. The WG intervention lowered obesity parameters, while the RM diet increased serum levels of uric acid and creatinine. The study showed that diet is a component of major relevance regarding its influence on intestinal microbiota and that WG has an important role for health. The results could guide investigations of diet and microbiota in observational prospective cohort studies. Trial registration ClinicalTrials.gov NCT01449383 PMID:25299601

Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial.

PubMed

North, Richard B; Kidd, David H; Farrokhi, Farrokh; Piantadosi, Steven A

2005-01-01

Persistent or recurrent radicular pain after lumbosacral spine surgery is often associated with nerve root compression and is treated by repeated operation or, as a last resort, by spinal cord stimulation (SCS). We conducted a prospective, randomized, controlled trial to test our hypothesis that SCS is more likely than reoperation to result in a successful outcome by standard measures of pain relief and treatment outcome, including subsequent use of health care resources. For an average of 3 years postoperatively, disinterested third-party interviewers followed 50 patients selected for reoperation by standard criteria and randomized to SCS or reoperation. If the results of the randomized treatment were unsatisfactory, patients could cross over to the alternative. Success was based on self-reported pain relief and patient satisfaction. Crossover to the alternative procedure was an outcome measure. Use of analgesics, activities of daily living, and work status were self-reported. Among 45 patients (90%) available for follow-up, SCS was more successful than reoperation (9 of 19 patients versus 3 of 26 patients, P <0.01). Patients initially randomized to SCS were significantly less likely to cross over than were those randomized to reoperation (5 of 24 patients versus 14 of 26 patients, P=0.02). Patients randomized to reoperation required increased opiate analgesics significantly more often than those randomized to SCS (P <0.025). Other measures of activities of daily living and work status did not differ significantly. SCS is more effective than reoperation as a treatment for persistent radicular pain after lumbosacral spine surgery, and in the great majority of patients, it obviates the need for reoperation.

A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: a Prospective, Randomized, Controlled Trial.

PubMed

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Stark, Renée G; Altenhofer, Julia; Henze, Kerstin; Parhofer, Klaus G

2017-10-06

Studies indicate a positive association between walnut intake and improvements in plasma lipids. We evaluated the effect of an isocaloric replacement of macronutrients with walnuts and the time point of consumption on plasma lipids. We included 194 healthy subjects (134 females, age 63 ± 7 years, BMI 25.1 ± 4.0 kg/m²) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (8 weeks each). Ninety-six subjects first followed a walnut-enriched diet (43 g walnuts/day) and then switched to a nut-free diet. Ninety-eight subjects followed the diets in reverse order. Subjects were also randomized to either reduce carbohydrates ( n = 62), fat ( n = 65), or both ( n = 67) during the walnut diet, and instructed to consume walnuts either as a meal or as a snack. The walnut diet resulted in a significant reduction in fasting cholesterol (walnut vs. -8.5 ± 37.2 vs. -1.1 ± 35.4 mg/dL; p = 0.002), non-HDL cholesterol (-10.3 ± 35.5 vs. -1.4 ± 33.1 mg/dL; p ≤ 0.001), LDL-cholesterol (-7.4 ± 32.4 vs. -1.7 ± 29.7 mg/dL; p = 0.029), triglycerides (-5.0 ± 47.5 vs. 3.7 ± 48.5 mg/dL; p = 0.015) and apoB (-6.7 ± 22.4 vs. -0.5 ± 37.7; p ≤ 0.001), while HDL-cholesterol and lipoprotein (a) did not change significantly. Neither macronutrient replacement nor time point of consumption significantly affected the effect of walnuts on lipids. Thus, 43 g walnuts/d improved the lipid profile independent of the recommended macronutrient replacement and the time point of consumption.

A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: A Prospective, Randomized, Controlled Trial

PubMed Central

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Stark, Renée G.; Altenhofer, Julia; Parhofer, Klaus G.

2017-01-01

Studies indicate a positive association between walnut intake and improvements in plasma lipids. We evaluated the effect of an isocaloric replacement of macronutrients with walnuts and the time point of consumption on plasma lipids. We included 194 healthy subjects (134 females, age 63 ± 7 years, BMI 25.1 ± 4.0 kg/m2) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (8 weeks each). Ninety-six subjects first followed a walnut-enriched diet (43 g walnuts/day) and then switched to a nut-free diet. Ninety-eight subjects followed the diets in reverse order. Subjects were also randomized to either reduce carbohydrates (n = 62), fat (n = 65), or both (n = 67) during the walnut diet, and instructed to consume walnuts either as a meal or as a snack. The walnut diet resulted in a significant reduction in fasting cholesterol (walnut vs. control: −8.5 ± 37.2 vs. −1.1 ± 35.4 mg/dL; p = 0.002), non-HDL cholesterol (−10.3 ± 35.5 vs. −1.4 ± 33.1 mg/dL; p ≤ 0.001), LDL-cholesterol (−7.4 ± 32.4 vs. −1.7 ± 29.7 mg/dL; p = 0.029), triglycerides (−5.0 ± 47.5 vs. 3.7 ± 48.5 mg/dL; p = 0.015) and apoB (−6.7 ± 22.4 vs. −0.5 ± 37.7 mg/dL; p ≤ 0.001), while HDL-cholesterol and lipoprotein (a) did not change significantly. Neither macronutrient replacement nor time point of consumption significantly affected the effect of walnuts on lipids. Thus, 43 g walnuts/day improved the lipid profile independent of the recommended macronutrient replacement and the time point of consumption. PMID:28984822

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

2013-12-01

Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

A crossover-crossback prospective study of dibutyl-phthalate exposure from mesalamine medications and serum reproductive hormones in men.

PubMed

Nassan, Feiby L; Coull, Brent A; Skakkebaek, Niels E; Andersson, Anna-Maria; Williams, Michelle A; Mínguez-Alarcón, Lidia; Krawetz, Stephen A; Hall, Janet E; Hait, Elizabeth J; Korzenik, Joshua R; Ford, Jennifer B; Moss, Alan C; Hauser, Russ

2018-01-01

Phthalates, such as dibutyl phthalate (DBP), are endocrine disruptors used in some medication coatings e.g., mesalamine to treat inflammatory bowel disease (IBD). Taking advantage of different mesalamine formulations with/without DBP, we assessed whether DBP from mesalamine (>1000x background) altered serum hormones. Men (N=73) with IBD participated in a crossover-crossback prospective study and provided up to 6 serum samples (2:baseline, 2:crossover, 2:crossback). Men on non-DBP mesalamine (background) at baseline crossed-over for 4 months to DBP-mesalamine (high) and then crossed-back for 4 months to non-DBP mesalamine (B 1 HB 2 -arm) and vice versa for men on DBP-mesalamine at baseline (H 1 BH 2 -arm). We divided H 1 BH 2 -arm at the median (H 1 <3yrs or H 1 ≥3yrs). We estimated crossover and crossback % changes in serum reproductive hormones using multivariable linear mixed effect models. When B 1 HB 2 -arm (26 men,134 samples) crossed-over, luteinizing hormone decreased 13.9% (95% confidence interval(CI): -23.6,-3.0) and testosterone, inhibin-B, and follicle-stimulating hormone (FSH) marginally decreased; after crossback all increased 8-14%. H 1 BH 2 -arm, H 1 ≥3yrs (25 men,107samples) had no changes at crossover or crossback whereas in H 1 BH 2 -arm,H 1 <3yrs (22 men,100 samples) after crossover, inhibin-B increased 13.2% (CI: 4.2,22.9), FSH decreased 9.9% (CI: -17.9,-1.1) and after crossback, inhibin-B further increased 11.3%, and FSH marginally increased. High-DBP exposure may disrupt pituitary-gonadal hormones that largely reversed after exposure removal, but only in men with no or short previous high-exposure history. Paradoxically, men with longer duration of high-DBP exposure, exposure removal did not change hormone levels, suggesting that long-term high-DBP exposure may alter the pituitary-gonadal axis and make it insensitive to exposure changes. Copyright © 2017 Elsevier Inc. All rights reserved.

The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.

PubMed

Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

2016-01-01

To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.

Meals based on vegetable protein sources (beans and peas) are more satiating than meals based on animal protein sources (veal and pork) – a randomized cross-over meal test study

PubMed Central

Kristensen, Marlene D.; Bendsen, Nathalie T.; Christensen, Sheena M.; Astrup, Arne; Raben, Anne

2016-01-01

Background Recent nutrition recommendations advocate a reduction in protein from animal sources (pork, beef) because of environmental concerns. Instead, protein from vegetable sources (beans, peas) should be increased. However, little is known about the effect of these vegetable protein sources on appetite regulation. Objective To examine whether meals based on vegetable protein sources (beans/peas) are comparable to meals based on animal protein sources (veal/pork) regarding meal-induced appetite sensations. Design In total, 43 healthy, normal-weight, young men completed this randomized, double-blind, placebo-controlled, three-way, cross-over meal test. The meals (all 3.5 MJ, 28 energy-% (E%) fat) were either high protein based on veal and pork meat, HP-Meat (19 E% protein, 53 E% carbohydrate, 6 g fiber/100 g); high protein based on legumes (beans and peas), HP-Legume (19 E% protein, 53 E% carbohydrate, 25 g fiber/100 g); or low-protein based on legumes, LP-Legume (9 E% protein, 62 E% carbohydrate, 10 g fiber/100 g). Subjective appetite sensations were recorded at baseline and every half hour using visual analog scales until the ad libitum meal 3 h after the test meal. Repeated measurements analyses and summary analyses were performed using ANCOVA (SAS). Results HP-Legume induced lower composite appetite score, hunger, prospective food consumption, and higher fullness compared to HP-Meat and LP-Legume (p<0.05). Furthermore, satiety was higher after HP-Legume than HP-Meat (p<0.05). When adjusting for palatability, HP-Legume still resulted in lower composite appetite scores, hunger, prospective consumption, and higher fullness compared to HP-Meat (p<0.05). Furthermore, HP-Legume induced higher fullness than LP-Legume (p<0.05). A 12% and 13% lower energy intake, respectively, was seen after HP-Legume compared to HP-Meat or LP-Legume (p<0.01). Conclusion Vegetable-based meals (beans/peas) influenced appetite sensations favorably compared to animal-based meals (pork/veal) with similar energy and protein content, but lower fiber content. Interestingly, a vegetable-based meal with low protein content was as satiating and palatable as an animal-based meal with high protein content. PMID:27765144

Meals based on vegetable protein sources (beans and peas) are more satiating than meals based on animal protein sources (veal and pork) - a randomized cross-over meal test study.

PubMed

Kristensen, Marlene D; Bendsen, Nathalie T; Christensen, Sheena M; Astrup, Arne; Raben, Anne

2016-01-01

Recent nutrition recommendations advocate a reduction in protein from animal sources (pork, beef) because of environmental concerns. Instead, protein from vegetable sources (beans, peas) should be increased. However, little is known about the effect of these vegetable protein sources on appetite regulation. To examine whether meals based on vegetable protein sources (beans/peas) are comparable to meals based on animal protein sources (veal/pork) regarding meal-induced appetite sensations. In total, 43 healthy, normal-weight, young men completed this randomized, double-blind, placebo-controlled, three-way, cross-over meal test. The meals (all 3.5 MJ, 28 energy-% (E%) fat) were either high protein based on veal and pork meat, HP-Meat (19 E% protein, 53 E% carbohydrate, 6 g fiber/100 g); high protein based on legumes (beans and peas), HP-Legume (19 E% protein, 53 E% carbohydrate, 25 g fiber/100 g); or low-protein based on legumes, LP-Legume (9 E% protein, 62 E% carbohydrate, 10 g fiber/100 g). Subjective appetite sensations were recorded at baseline and every half hour using visual analog scales until the ad libitum meal 3 h after the test meal. Repeated measurements analyses and summary analyses were performed using ANCOVA (SAS). HP-Legume induced lower composite appetite score, hunger, prospective food consumption, and higher fullness compared to HP-Meat and LP-Legume ( p <0.05). Furthermore, satiety was higher after HP-Legume than HP-Meat ( p <0.05). When adjusting for palatability, HP-Legume still resulted in lower composite appetite scores, hunger, prospective consumption, and higher fullness compared to HP-Meat ( p <0.05). Furthermore, HP-Legume induced higher fullness than LP-Legume ( p <0.05). A 12% and 13% lower energy intake, respectively, was seen after HP-Legume compared to HP-Meat or LP-Legume ( p <0.01). Vegetable-based meals (beans/peas) influenced appetite sensations favorably compared to animal-based meals (pork/veal) with similar energy and protein content, but lower fiber content. Interestingly, a vegetable-based meal with low protein content was as satiating and palatable as an animal-based meal with high protein content.

Chorionic gonadotropin in weight control. A double-blind crossover study.

PubMed

Young, R L; Fuchs, R J; Woltjen, M J

1976-11-29

Two hundred two patients participated in a double-blind random cross-over study of the effectiveness of human chorionic gonadotropin (HCG) vs placebo in a wieght reduction program. Serial measurements were made of weight, skin-fold thickness, dropout rates, reasons for dropping out, and patient subjective response. There was no statistically significant difference between those receiving HCG vs placebo during any phase of this study (P greater than .1).

Flexible chain molecules in the marginal and concentrated regimes: universal static scaling laws and cross-over predictions.

PubMed

Laso, Manuel; Karayiannis, Nikos Ch

2008-05-07

We present predictions for the static scaling exponents and for the cross-over polymer volumetric fractions in the marginal and concentrated solution regimes. Corrections for finite chain length are made. Predictions are based on an analysis of correlated fluctuations in density and chain length, in a semigrand ensemble in which mers and solvent sites exchange identities. Cross-over volumetric fractions are found to be chain length independent to first order, although reciprocal-N corrections are also estimated. Predicted scaling exponents and cross-over regimes are compared with available data from extensive off-lattice Monte Carlo simulations [Karayiannis and Laso, Phys. Rev. Lett. 100, 050602 (2008)] on freely jointed, hard-sphere chains of average lengths from N=12-500 and at packing densities from dilute ones up to the maximally random jammed state.

Acceptability of potential rectal microbicide delivery systems for HIV prevention: a randomized crossover trial.

PubMed

Pines, Heather A; Gorbach, Pamina M; Weiss, Robert E; Hess, Kristen; Murphy, Ryan; Saunders, Terry; Brown, Joelle; Anton, Peter A; Cranston, Ross D

2013-03-01

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use.

Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: A Randomized Crossover Trial

PubMed Central

Gorbach, Pamina M.; Weiss, Robert E.; Hess, Kristen; Murphy, Ryan; Saunders, Terry; Brown, Joelle; Anton, Peter A.; Cranston, Ross D.

2012-01-01

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use. PMID:23114512

Small dead space heat and moisture exchangers do not impede gas exchange during noninvasive ventilation: a comparison with a heated humidifier.

PubMed

Boyer, Alexandre; Vargas, Frederic; Hilbert, Gilles; Gruson, Didier; Mousset-Hovaere, Maud; Castaing, Yves; Dreyfuss, Didier; Ricard, Jean Damien

2010-08-01

Adverse respiratory and gasometrical effects have been described in patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV) with standard heat and moisture exchangers (HME). We decided to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared with heated humidifier (HH). Prospective randomized crossover study. A 16-bed medical intensive care unit (ICU). Fifty patients receiving NIV for ARF. The effects of HME and HH on respiratory rate, minute ventilation, EtCO(2), oxygen saturation, airway occlusion pressure at 0.1 s, ABG, and comfort perception were compared during two randomly determined NIV periods of 30 min. The relative impact of HME and HH on these parameters was successively compared with or without addition of a flex tube (40 and 10 patients, respectively). No difference was observed between HME and HH regarding any of the studied parameters, whether or not a flex tube was added. If one decides to humidify patients' airways during NIV, one may do so with small dead space HME or HH without altering respiratory parameters.

A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

PubMed Central

2012-01-01

Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial.

PubMed

Spence, Jessica; Belley-Côté, Emilie; Lee, Shun Fu; Bangdiwala, Shrikant; Whitlock, Richard; LeManach, Yannick; Syed, Summer; Lamy, Andre; Jacobsohn, Eric; MacIsaac, Sarah; Devereaux, P J; Connolly, Stuart

2018-07-01

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia.

PubMed

Miyakita, Hideshi; Yokoyama, Eiji; Onodera, Yasutada; Utsunomiya, Takuji; Tokunaga, Masatoshi; Tojo, Takanori; Fujii, Noriteru; Yanada, Shuichi

2010-10-01

To compare the efficacy and safety of silodosin and tamsulosin in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) by a randomized crossover method. BPH patients with the complaint of LUTS were included in this study, and were randomly divided into two groups: a silodosin-preceding group (4 weeks of twice-daily administration of silodosin at 4 mg, followed by 4 weeks of once-daily administration of tamsulosin at 0.2 mg) or a tamsulosin-preceding group (4 weeks' administration of tamsulosin, followed by 4 weeks' administration of silodosin). No drug withdrawal period was provided when switching the drug. In the first treatment period, both drugs significantly improved the International Prostate Symptom Score total score, but the improvement by silodosin was significantly superior to that by tamsulosin. After crossover treatment, significant improvement was observed only with silodosin treatment. Moreover, intergroup comparison of changes revealed that silodosin showed significant improvement of straining and nocturia with first and crossover treatments, respectively, compared with tamsulosin. Silodosin also significantly improved quality of life (QOL) score in both treatment periods, while tamsulosin significantly improved QOL score only in the first treatment period. The most frequent adverse drug reaction was ejaculatory disorder with silodosin; however, the incidence of dizziness with silodosin was similar to that with tamsulosin. In BPH/LUTS patients, silodosin exhibits excellent efficacy in improving subjective symptoms in both initial and crossover treatment, and it appears to improve the QOL of patients. © 2010 The Japanese Urological Association.

Effects of coarse-graining on the scaling behavior of long-range correlated and anti-correlated signals.

PubMed

Xu, Yinlin; Ma, Qianli D Y; Schmitt, Daniel T; Bernaola-Galván, Pedro; Ivanov, Plamen Ch

2011-11-01

We investigate how various coarse-graining (signal quantization) methods affect the scaling properties of long-range power-law correlated and anti-correlated signals, quantified by the detrended fluctuation analysis. Specifically, for coarse-graining in the magnitude of a signal, we consider (i) the Floor, (ii) the Symmetry and (iii) the Centro-Symmetry coarse-graining methods. We find that for anti-correlated signals coarse-graining in the magnitude leads to a crossover to random behavior at large scales, and that with increasing the width of the coarse-graining partition interval Δ, this crossover moves to intermediate and small scales. In contrast, the scaling of positively correlated signals is less affected by the coarse-graining, with no observable changes when Δ < 1, while for Δ > 1 a crossover appears at small scales and moves to intermediate and large scales with increasing Δ. For very rough coarse-graining (Δ > 3) based on the Floor and Symmetry methods, the position of the crossover stabilizes, in contrast to the Centro-Symmetry method where the crossover continuously moves across scales and leads to a random behavior at all scales; thus indicating a much stronger effect of the Centro-Symmetry compared to the Floor and the Symmetry method. For coarse-graining in time, where data points are averaged in non-overlapping time windows, we find that the scaling for both anti-correlated and positively correlated signals is practically preserved. The results of our simulations are useful for the correct interpretation of the correlation and scaling properties of symbolic sequences.

Effects of coarse-graining on the scaling behavior of long-range correlated and anti-correlated signals

PubMed Central

Xu, Yinlin; Ma, Qianli D.Y.; Schmitt, Daniel T.; Bernaola-Galván, Pedro; Ivanov, Plamen Ch.

2014-01-01

We investigate how various coarse-graining (signal quantization) methods affect the scaling properties of long-range power-law correlated and anti-correlated signals, quantified by the detrended fluctuation analysis. Specifically, for coarse-graining in the magnitude of a signal, we consider (i) the Floor, (ii) the Symmetry and (iii) the Centro-Symmetry coarse-graining methods. We find that for anti-correlated signals coarse-graining in the magnitude leads to a crossover to random behavior at large scales, and that with increasing the width of the coarse-graining partition interval Δ, this crossover moves to intermediate and small scales. In contrast, the scaling of positively correlated signals is less affected by the coarse-graining, with no observable changes when Δ < 1, while for Δ > 1 a crossover appears at small scales and moves to intermediate and large scales with increasing Δ. For very rough coarse-graining (Δ > 3) based on the Floor and Symmetry methods, the position of the crossover stabilizes, in contrast to the Centro-Symmetry method where the crossover continuously moves across scales and leads to a random behavior at all scales; thus indicating a much stronger effect of the Centro-Symmetry compared to the Floor and the Symmetry method. For coarse-graining in time, where data points are averaged in non-overlapping time windows, we find that the scaling for both anti-correlated and positively correlated signals is practically preserved. The results of our simulations are useful for the correct interpretation of the correlation and scaling properties of symbolic sequences. PMID:25392599

Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.

PubMed

Stalmans, Ingeborg; Oddone, Francesco; Cordeiro, Maria Francesca; Hommer, Anton; Montesano, Giovanni; Ribeiro, Luisa; Sunaric-Mégevand, Gordana; Rossetti, Luca

2016-06-01

The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study.

PubMed

Nitikman, Michael; Mulpuri, Kishore; Reilly, Christopher W

2017-03-01

Modern technology puts into question the effectiveness of using pen and paper as a means of collecting information from web-enabled patients. This study aimed to validate and test the reliability of using the Internet as a method of administering health-related quality of life questionnaires in a pediatric spine population. A prospective randomized crossover study was conducted. Patients aged 11 to 18 with idiopathic scoliosis were invited to participate, and informed consent was obtained from a scoliosis outpatient clinic setting. Participants were randomized to one of 4 groups determining the method of questionnaire administration [Scoliosis Research Society 30 (SRS-30) and Pediatric Outcomes Data Collection Instrument (PODCI)]. Both questionnaires were completed at 2 separate timepoints and 2 weeks apart to prevent recall bias. Groups included: Paper/Paper, Paper/Internet, Internet/Paper, and Internet/Internet. Paired-samples t tests were used to determine the test-retest reliability of each group. Analysis was stratified for surveys returned within or outside of the allotted 4-week timeframe following enrollment. Of the 96 participants who completed and returned both sets of questionnaires, 26 were allocated to the Paper/Paper group (27%), 20 to the Paper/Internet group (21%), 26 to the Internet/Paper group (27%), and 24 to the Internet/Internet group (25%). The second iteration of questionnaires was returned on time by 69 of the participants (71.2%). Of the late questionnaires, 18 (67%) were paper forms. Overall, no differences were observed between Internet-administered compared with pen and paper-administered questionnaires (P=0.206). No differences were observed within any group individually for either the SRS-30 or PODCI questionnaire. In addition, no significant differences were observed within groups for surveys returned within or outside of the 4-week timeframe. Eighty-four percent of the participants who completed both paper and Internet versions of the questionnaires reported a preference of the Internet. Internet administration of both the SRS-30 and PODCI questionnaires is a valid and reliable method of acquiring health-related quality of life information in this population LEVEL OF EVIDENCE:: Level II-therapeutic study.

Effects of the pure flavonoids epicatechin and quercetin on vascular function and cardiometabolic health: a randomized, double-blind, placebo-controlled, crossover trial.

PubMed

Dower, James I; Geleijnse, Johanna M; Gijsbers, Lieke; Zock, Peter L; Kromhout, Daan; Hollman, Peter C H

2015-05-01

Prospective cohort studies showed inverse associations between the intake of flavonoid-rich foods (cocoa and tea) and cardiovascular disease (CVD). Intervention studies showed protective effects on intermediate markers of CVD. This may be due to the protective effects of the flavonoids epicatechin (in cocoa and tea) and quercetin (in tea). We investigated the effects of supplementation of pure epicatechin and quercetin on vascular function and cardiometabolic health. Thirty-seven apparently healthy men and women aged 40-80 y with a systolic blood pressure (BP) between 125 and 160 mm Hg at screening were enrolled in a randomized, double-blind, placebo-controlled, crossover trial. CVD risk factors were measured before and after 4 wk of daily flavonoid supplementation. Participants received (-)-epicatechin (100 mg/d), quercetin-3-glucoside (160 mg/d), or placebo capsules for 4 wk in random order. The primary outcome was the change in flow-mediated dilation from pre- to postintervention. Secondary outcomes included other markers of CVD risk and vascular function. Epicatechin supplementation did not change flow-mediated dilation significantly (1.1% absolute; 95% CI: -0.1%, 2.3%; P = 0.07). Epicatechin supplementation improved fasting plasma insulin (Δ insulin: -1.46 mU/L; 95% CI: -2.74, -0.18 mU/L; P = 0.03) and insulin resistance (Δ homeostasis model assessment of insulin resistance: -0.38; 95% CI: -0.74, -0.01; P = 0.04) and had no effect on fasting plasma glucose. Epicatechin did not change BP (office BP and 24-h ambulatory BP), arterial stiffness, nitric oxide, endothelin 1, or blood lipid profile. Quercetin-3-glucoside supplementation had no effect on flow-mediated dilation, insulin resistance, or other CVD risk factors. Our results suggest that epicatechin may in part contribute to the cardioprotective effects of cocoa and tea by improving insulin resistance. It is unlikely that quercetin plays an important role in the cardioprotective effects of tea. This study was registered at clinicaltrials.gov as NCT01691404. © 2015 American Society for Nutrition.

Clinical follow-up after cessation of chronic electrical neuromodulation in patients with severe coronary artery disease: a prospective randomized controlled study on putative involvement of sympathetic activity.

PubMed

Jessurun, G A; DeJongste, M J; Hautvast, R W; Tio, R A; Brouwer, J; van Lelieveld, S; Crijns, H J

1999-10-01

The present study assessed the reoccurrence of myocardial ischemia after withholding electrical neurostimulation. After randomization, in the study or withdrawal group, spinal cord stimulation (SCS) was set active during the first 4 weeks, followed by 4 weeks of withholding stimulation. In the control group, SCS was switched off during 4 weeks before the end of the study. The control group had no crossover period. Measurements were done at baseline, then after 4 and 8 weeks. The first periods at 4 weeks of each sequence of both groups were compared. In addition, a comparison of clinical variables was performed between the study group 4 weeks after withholding stimulation and the control group 4 weeks following randomization. A total number of 24 patients with refractory angina and an implanted spinal cord stimulator were included in the study (n = 12) and control group. Angina pectoris complaints, nitroglycerin intake, ischemia, and heart rate variability using 48-hour ambulatory electrocardiographic monitoring were assessed. In addition, neurohormonal status and symptom-limited aerobic capacity were evaluated. There was no increase of anginal complaints or ischemia after withholding stimulation. Neurohormonal levels and aerobic capacity were not altered. We conclude that there is no adverse clinical rebound phenomenon after withholding neurostimulation in patients with refractory angina pectoris.

Modafinil for the Improvement of Patient Outcomes Following Traumatic Brain Injury.

PubMed

Borghol, Amne; Aucoin, Michael; Onor, Ifeanyichukwu; Jamero, Dana; Hawawini, Fadi

2018-04-01

Objective : The authors sought to assess the literature evidence on the efficacy of modafinil use in patients with fatigue or excessive daytime sleepiness (EDS) secondary to traumatic brain injury (TBI). Method of Research : A literature search of Medline and PubMed was performed using the EBSCOhost database. Primary literature, observational studies, meta-analyses, case reports, and systematic reviews were assessed for content regarding modafinil and psychostimulant use in patients with TBI. Of the 23 articles collected, three randomized, controlled studies, three observational studies, one case report, and two systematic reviews gave a description of modafinil use in TBI patients. Results and Conclusion : Modafinil is a central nervous system stimulant with well-established effectiveness in the treatment of narcolepsy and shift-work sleep disorder. There is conflicting evidence about the benefits of modafinil in the treatment of fatigue and EDS secondary to TBI. One randomized, controlled study states that modafinil does not significantly improve patient wakefulness, while another concludes that modafinil corrects EDS but not fatigue. An observational study provides evidence that modafinil increases alertness in fatigued patients with past medical history of brainstem diencephalic stroke or multiple sclerosis. Modafinil appears to have the potential to improve wakefulness in patients with TBI. A prospective, double-blinded, randomized, crossover trial of modafinil for the management of fatigue in ischemic stroke patients is currently being conducted, and further studies demonstrating consistent results are needed before making a conclusive decision.

Application of Crossover Design for Conducting Rigorous Extension Evaluations

ERIC Educational Resources Information Center

Jayaratne, K. S. U.; Bird, Carolyn L.; McClelland, Jacquelyn W.

2013-01-01

With the increasing demand for accountability of Extension programming, Extension professionals need to apply rigorous evaluation designs. Randomized designs are useful to eliminate selection biases of program participants and to improve the accuracy of evaluation. However, randomized control designs are not practical to apply in Extension program…

Melatonin improves sleep in children with epilepsy: randomized, double-blind cross-over study

PubMed Central

Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

2015-01-01

Objective Insomnia, especially maintenance insomnia is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, cross-over study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Methods Eleven pre-pubertal, developmentally normal children aged 6–11 years with epilepsy were randomized by software algorithm to receive placebo or 9 mg sustained release melatonin for 4 weeks, followed by a 1-week washout and 4-week crossover condition. The pharmacy performed blinding; patients, parents and study staff other than a statistician were blinded. Primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. Secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on EEG and reaction time measures on psychomotor vigilance task. Statistical tests appropriate for cross-over designs were used for analysis. Results Data were analyzed from ten subjects who completed the study. Melatonin decreased sleep latency (Mean difference (MD): 11.4 min, p= 0.02) and WASO (MD 22 min, p=0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, Slow-wave sleep duration and REM latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. Conclusion Sustained-release melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed but the study was too small to allow any conclusions to be drawn in this regard. PMID:25862116

New and old ways to control meiotic recombination.

PubMed

Phadnis, Naina; Hyppa, Randy W; Smith, Gerald R

2011-10-01

The unique segregation of homologs, rather than sister chromatids, at the first meiotic division requires the formation of crossovers (COs) between homologs by meiotic recombination in most species. Crossovers do not form at random along chromosomes. Rather, their formation is carefully controlled, both at the stage of formation of DNA double-strand breaks (DSBs) that can initiate COs and during the repair of these DSBs. Here, we review control of DSB formation and two recently recognized controls of DSB repair: CO homeostasis and CO invariance. Crossover homeostasis maintains a constant number of COs per cell when the total number of DSBs in a cell is experimentally or stochastically reduced. Crossover invariance maintains a constant CO density (COs per kb of DNA) across much of the genome despite strong DSB hotspots in some intervals. These recently uncovered phenomena show that CO control is even more complex than previously suspected. Copyright © 2011 Elsevier Ltd. All rights reserved.

Statistical crossover characterization of the heterotic localized-extended transition.

PubMed

Ugajin, Ryuichi

2003-07-01

We investigated the spectral statistics of a quantum particle in a superlattice consisting of a disordered layer and a clean layer, possibly accompanied by random magnetic fields. Because a disordered layer has localized states and a clean layer has extended states, our quantum system shows a heterotic phase of an Anderson insulator and a normal metal. As the ratio of the volume of these two layers changes, the spectral statistics change from Poissonian to one of the Gaussian ensembles which characterize quantum chaos. A crossover distribution specified by two parameters is introduced to distinguish the transition from an integrable system to a quantum chaotic system during the heterotic phase from an Anderson transition in which the degree of random potentials is homogenous.

Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study.

PubMed

Shrier, Ian; Raglin, John S; Levitan, Emily B; Mittleman, Murray A; Steele, Russell J; Powell, Janette

2014-06-11

Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show "O". Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology.

Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study

PubMed Central

2014-01-01

Background Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. Methods We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show “O”. Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. Results The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. Conclusion A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology. PMID:24920527

Protein from Meat or Vegetable Sources in Meals Matched for Fiber Content has Similar Effects on Subjective Appetite Sensations and Energy Intake-A Randomized Acute Cross-Over Meal Test Study.

PubMed

Nielsen, Lone V; Kristensen, Marlene D; Klingenberg, Lars; Ritz, Christian; Belza, Anita; Astrup, Arne; Raben, Anne

2018-01-16

Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy intake and appetite sensations, compared to macronutrient-balanced, iso-caloric meals based on animal protein (veal/pork or eggs). Thirty-five healthy men were enrolled in this acute cross-over study. On each test day, participants were presented with one of four test meals (~3550 kilojoules (kJ) 19% of energy from protein), based on fava beans/split peas (28.5 g fiber), pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber), or eggs without supplementation of fiber (6.0 g fiber). Subjective appetite sensations were recorded at baseline and every half hour until the ad libitum meal three hours later. There were no differences in ad libitum energy intake across test meals ( p > 0.05). Further, no differences were found across meals for hunger, satiety, fullness, prospective food consumption, or composite appetite score (all p > 0.05). Iso-caloric, macronutrient-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations.

Protein from Meat or Vegetable Sources in Meals Matched for Fiber Content has Similar Effects on Subjective Appetite Sensations and Energy Intake—A Randomized Acute Cross-Over Meal Test Study

PubMed Central

Nielsen, Lone V.; Kristensen, Marlene D.; Klingenberg, Lars; Belza, Anita

2018-01-01

Higher-protein meals decrease hunger and increase satiety compared to lower-protein meals. However, no consensus exists about the different effects of animal and vegetable proteins on appetite. We investigated how a meal based on vegetable protein (fava beans/split peas) affected ad libitum energy intake and appetite sensations, compared to macronutrient-balanced, iso-caloric meals based on animal protein (veal/pork or eggs). Thirty-five healthy men were enrolled in this acute cross-over study. On each test day, participants were presented with one of four test meals (~3550 kilojoules (kJ) 19% of energy from protein), based on fava beans/split peas (28.5 g fiber), pork/veal or eggs supplemented with pea fiber to control for fiber content (28.5 g fiber), or eggs without supplementation of fiber (6.0 g fiber). Subjective appetite sensations were recorded at baseline and every half hour until the ad libitum meal three hours later. There were no differences in ad libitum energy intake across test meals (p > 0.05). Further, no differences were found across meals for hunger, satiety, fullness, prospective food consumption, or composite appetite score (all p > 0.05). Iso-caloric, macronutrient-balanced, fiber-matched meals based on vegetable protein (fava beans/split peas) or animal protein (veal/pork or eggs) had similar effects on ad libitum energy intake and appetite sensations. PMID:29337861

12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial.

PubMed

Bakris, George L; Townsend, Raymond R; Flack, John M; Brar, Sandeep; Cohen, Sidney A; D'Agostino, Ralph; Kandzari, David E; Katzen, Barry T; Leon, Martin B; Mauri, Laura; Negoita, Manuela; O'Neill, William W; Oparil, Suzanne; Rocha-Singh, Krishna; Bhatt, Deepak L

2015-04-07

Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Clinical Trials

MedlinePlus

... pill that has no medicine in it. Most times participants do not know which they are receiving. Other clinical trials involve a crossover design, where participants are randomly assigned to take a ...

Evaluation of quality of life using a tablet PC-based survey in cancer patients treated with radiotherapy: a multi-institutional prospective randomized crossover comparison of paper and tablet PC-based questionnaires (KROG 12-01).

PubMed

Kim, Haeyoung; Park, Hee Chul; Yoon, Sang Min; Kim, Tae Hyun; Kim, Jinsung; Kang, Min Kyu; Jung, Jinhong; Kim, Sang-Won; Yea, Ji Woon; Park, Sung Ho; Park, Young Suk

2016-10-01

This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use. Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated. The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys. A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy.

Effects of expiratory ribcage compression before endotracheal suctioning on arterial blood gases in patients receiving mechanical ventilation.

PubMed

Kohan, Mahmoud; Rezaei-Adaryani, Morteza; Najaf-Yarandi, Akram; Hoseini, Fatemeh; Mohammad-Taheri, Nahid

2014-09-01

To investigate the effects of expiratory ribcage compression (ERCC) before endotracheal suctioning on the arterial blood gases (ABG) in patients receiving mechanical ventilation. Endotracheal suctioning is one of the most frequently used methods for airway clearance in patients receiving mechanical ventilation. Chest physiotherapy techniques such as ERCC before endotracheal suctioning can be used as a means to facilitate mobilizing and removing airway secretions and improving alveolar ventilation. A prospective, randomized, controlled cross-over design. A randomized controlled cross-over trial with a convenience sample of 70 mechanically ventilated patients was conducted from 2006 to 2007. The patients received endotracheal suctioning with (experiment-period) or without (control-period) an antecedent 5-min expiratory ribcage. All the patients experienced both periods with at least a 3-h washed-out interval between the two periods. ABG were measured 5 min before and 25 min after endotracheal suctioning. The statistical tests showed that the levels of partial pressure of oxygen (PaO2 )/fraction of inspired oxygen (FiO2 ), partial pressure of carbon dioxide (PaCO2 ) and arterial oxygen saturation (SaO2 ) in the experimental period at 25 min after the intervention were significantly different from the control period. The tests also revealed that the levels of these variables at 25 min after suctioning were also significantly different from baseline values. However, these differences were clinically significant only for PaO2 /FiO2 . By improving the levels of PaO2 /FiO2 , ERCC can reduce the patients' need for oxygen and hence it can at least reduce the side effects of oxygen therapy. Improving PaO2 /FiO2 levels means less need for oxygen therapy. Hence, by applying ERCC we can at least minimize the side effects of oxygen therapy. © 2014 British Association of Critical Care Nurses.

Lung volume changes during cleaning of closed endotracheal suction catheters: a randomized crossover study using electrical impedance tomography.

PubMed

Corley, Amanda; Sharpe, Nicola; Caruana, Lawrence R; Spooner, Amy J; Fraser, John F

2014-04-01

Airway suctioning in mechanically ventilated patients is required to maintain airway patency. Closed suction catheters (CSCs) minimize lung volume loss during suctioning but require cleaning post-suction. Despite their widespread use, there is no published evidence examining lung volumes during CSC cleaning. The study objectives were to quantify lung volume changes during CSC cleaning and to determine whether these changes were preventable using a CSC with a valve in situ between the airway and catheter cleaning chamber. This prospective randomized crossover study was conducted in a metropolitan tertiary ICU. Ten patients mechanically ventilated via volume-controlled synchronized intermittent mandatory ventilation (SIMV-VC) and requiring manual hyperinflation (MHI) were included in this study. CSC cleaning was performed using 2 different brands of CSC (one with a valve [Ballard Trach Care 72, Kimberly-Clark, Roswell, Georgia] and one without [Portex Steri-Cath DL, Smiths Medical, Dublin, Ohio]). The maneuvers were performed during both SIMV-VC and MHI. Lung volume change was measured via impedance change using electrical impedance tomography. A mixed model was used to compare the estimated means. During cleaning of the valveless CSC, significant decreases in lung impedance occurred during MHI (-2563 impedance units, 95% CI 2213-2913, P < .001), and significant increases in lung impedance occurred during SIMV (762 impedance units, 95% CI 452-1072, P < .001). In contrast, cleaning of the CSC with a valve in situ resulted in non-significant lung volume changes and maintenance of normal ventilation during MHI and SIMV-VC, respectively (188 impedance units, 95% CI -136 to 511, P = .22; and 22 impedance units, 95% CI -342 to 299, P = .89). When there is no valve between the airway and suction catheter, cleaning of the CSC results in significant derangements in lung volume. Therefore, the presence of such a valve should be considered essential in preserving lung volumes and uninterrupted ventilation in mechanically ventilated patients.

Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series.

PubMed

Sweet, Jennifer; Badjatiya, Anish; Tan, Daniel; Miller, Jonathan

2016-04-01

Spinal cord stimulation (SCS) traditionally is thought to require paresthesia, but there is evidence that paresthesia-free stimulation using high-density (HD) parameters might also be effective. The purpose of this study is to evaluate relative effectiveness of conventional, subthreshold HD, and sham stimulation on pain intensity and quality of life. Fifteen patients with response to conventional stimulation (60 Hz/350 μsec) were screened with a one-week trial of subthreshold HD (1200 Hz/200 μsec/amplitude 90% paresthesia threshold) and enrolled if there was at least 50% reduction on visual analog scale (VAS) for pain. Subjects were randomized into two groups and treated with four two-week periods of conventional, subthreshold HD, and sham stimulation in a randomized crossover design. Four of 15 patients responded to subthreshold HD stimulation. Mean VAS during conventional, subthreshold HD, and sham stimulation was 5.32 ± 0.63, 2.29 ± 0.41, and 6.31 ± 1.22, respectively. There was a significant difference in pain scores during the blinded crossover study of subthreshold HD vs. sham stimulation (p < 0.05, Student's t-test). Post hoc analysis revealed that subjects reported significantly greater attention to pain during conventional stimulation compared with subthreshold HD stimulation (p < 0.05, Student's t-test). All subjects reported a positive impression of change for subthreshold HD stimulation compared with conventional stimulation, and there was a trend toward greater likelihood for response to subthreshold HD stimulation in comparison with sham stimulation (p = 0.07, Fisher's exact test). At the end of the trial, all subjects elected to continue to receive subthreshold HD stimulation rather than conventional stimulation. Paresthesia are not necessary for pain relief using commercially available SCS devices, and may actually increase attention to pain. Subthreshold HD SCS represents a viable alternative to conventional stimulation among patients who are confirmed to have a clinical response to it. © 2015 International Neuromodulation Society.

Solving the surgeon ergonomic crisis with surgical exosuit.

PubMed

Liu, Shanglei; Hemming, Daniel; Luo, Ran B; Reynolds, Jessica; Delong, Jonathan C; Sandler, Bryan J; Jacobsen, Garth R; Horgan, Santiago

2018-01-01

The widespread adoption of laparoscopic surgery has put new physical demands on the surgeon leading to increased musculoskeletal disorders and injuries. Shoulder, back, and neck pains are among the most common complaints experienced by laparoscopic surgeons. Here, we evaluate the feasibility and efficacy of a non-intrusive progressive arm support exosuit worn by surgeons under the sterile gown to reduce pain and fatigue during surgery. This is a prospective randomized crossover study approved by the Internal Review Board (IRB). The study involves three phases of testing. In each phase, general surgery residents or attendings were randomized to wearing the surgical exosuit at the beginning or at the crossover point. The first phase tests for surgeon manual dexterity wearing the device using the Minnesota Dexterity test, the Purdue Pegboard test, and the Fundamentals of Laparoscopic Surgery (FLS) modules. The second phase tests the effect of the device on shoulder pain and fatigue while operating the laparoscopic camera. The third phase rates surgeon experience in the operating room between case-matched operating days. Twenty subjects were recruited for this study. Surgeons had the similar dexterity scores and FLS times whether or not they wore the exosuit (p value ranges 0.15-0.84). All exosuit surgeons completed 15 min of holding laparoscopic camera compared to three non-exosuit surgeons (p < 0.02). Exosuit surgeons experienced significantly less fatigue at all time periods and arm pain (3.11 vs 5.88, p = 0.019) at 10 min. Surgeons wearing the exosuit during an operation experienced significant decrease in shoulder pain and 85% of surgeons reported some form of pain reduction at the end of the operative day. The progressive arm support exosuit can be a minimally intrusive device that laparoscopic surgeons wear to reduce pain and fatigue of surgery without significantly interfering with operative skills or manual dexterity.

Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Vaney, C; Heinzel-Gutenbrunner, M; Jobin, P; Tschopp, F; Gattlen, B; Hagen, U; Schnelle, M; Reif, M

2004-08-01

Cannabis may alleviate some symptoms associated with multiple sclerosis (MS). This study investigated the effect of an orally administered standardized Cannabis sativa plant extract in MS patients with poorly controlled spasticity. During their inpatient rehabilitation programme, 57 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled crossover study of cannabis-extract capsules standardized to 2.5 mg tetrahydrocannabinol (THC) and 0.9 mg cannabidiol (CBD) each. Patients in group A started with a drug escalation phase from 15 to maximally 30 mg THC by 5 mg per day if well tolerated, being on active medication for 14 days before starting placebo. Patients in group B started with placebo for seven days, crossed to the active period (14 days) and closed with a three-day placebo period (active drug dose escalation and placebo sham escalation as in group A). Measures used included daily self-report of spasm frequency and symptoms, Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test, paced auditory serial addition test (PASAT), and the digit span test. In the 50 patients included into the intention-to-treat analysis set, there were no statistically significant differences associated with active treatment compared to placebo, but trends in favour of active treatment were seen for spasm frequency, mobility and getting to sleep. In the 37 patients (per-protocol set) who received at least 90% of their prescribed dose, improvements in spasm frequency (P = 0.013) and mobility after excluding a patient who fell and stopped walking were seen (P = 0.01). Minor adverse events were slightly more frequent and severe during active treatment, and toxicity symptoms, which were generally mild, were more pronounced in the active phase. A standardized Cannabis sativa plant extract might lower spasm frequency and increase mobility with tolerable side effects in MS patients with persistent spasticity not responding to other drugs.

Impact of food on the pharmacokinetics of first-line anti-TB drugs in treatment-naive TB patients: a randomized cross-over trial.

PubMed

Saktiawati, Antonia M I; Sturkenboom, Marieke G G; Stienstra, Ymkje; Subronto, Yanri W; Sumardi; Kosterink, Jos G W; van der Werf, Tjip S; Alffenaar, Jan-Willem C

2016-03-01

Concomitant food intake influences pharmacokinetics of first-line anti-TB drugs in healthy volunteers. However, in treatment-naive TB patients who are starting with drug treatment, data on the influence of food intake on the pharmacokinetics are absent. This study aimed to quantify the influence of food on the pharmacokinetics of isoniazid, rifampicin, ethambutol and pyrazinamide in TB patients starting anti-TB treatment. A prospective randomized cross-over pharmacokinetic study was conducted in treatment-naive adults with drug-susceptible TB. They received isoniazid, rifampicin and ethambutol intravenously and oral pyrazinamide on day 1, followed by oral administration of these drugs under fasted and fed conditions on two consecutive days. Primary outcome was the bioavailability while fasting and with concomitant food intake. This study was registered with clinicaltrials.gov identifier NCT02121314. Twenty subjects completed the study protocol. Absolute bioavailability in the fasted state and the fed state was 93% and 78% for isoniazid, 87% and 71% for rifampicin and 87% and 82% for ethambutol. Food decreased absolute bioavailability of isoniazid and rifampicin by 15% and 16%, respectively. Pyrazinamide AUC0-24 was comparable for the fasted state (481 mg·h/L) and the fed state (468 mg·h/L). Food lowered the maximum concentrations of isoniazid, rifampicin and pyrazinamide by 42%, 22% and 10%, respectively. Time to maximum concentration was delayed for isoniazid, rifampicin and pyrazinamide. The pharmacokinetics of ethambutol were unaffected by food. Food decreased absolute bioavailability and maximum concentration of isoniazid and rifampicin, but not of ethambutol or pyrazinamide, in treatment-naive TB patients. In patients prone to low drug exposure, this may further compromise treatment efficacy and increase the risk of acquired drug resistance. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial.

PubMed

Souday, Vincent; Koning, Nick J; Perez, Bruno; Grelon, Fabien; Mercat, Alain; Boer, Christa; Seegers, Valérie; Radermacher, Peter; Asfar, Pierre

2016-01-01

To test the hypothesis whether enriched air nitrox (EAN) breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression. Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2) in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes). Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler. Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P < 0.001). Three decompression incidents, all presenting as cutaneous itching, occurred in the air versus zero in the EAN group (P = 0.217). Weak correlations were observed between bubble scores and age or body mass index, respectively. EAN breathing markedly reduces venous gas bubble emboli after decompression in volunteers selected for susceptibility for intravascular bubble formation. When using similar diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing. ISRCTN 31681480.

Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

ERIC Educational Resources Information Center

Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

2010-01-01

To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

Native whey induces higher and faster leucinemia than other whey protein supplements and milk: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Resistance exercise and protein intake are both strong stimuli for muscle protein synthesis. The potential for a protein to acutely increase muscle protein synthesis seems partly dependent on absorption kinetics and the amino acid composition. The aim of this double-blinded randomized cross-over stu...

The Sonoma Water Evaluation Trial (SWET): A randomized drinking water intervention trial to reduce gastrointestinal illness in older adults

EPA Science Inventory

Objectives. We estimate the risk of highly credible gastrointestinal illness (HCGI) among adults 55 and older in a community drinking tap water meeting current U.S. standards. Methods. We conducted a randomized, triple-blinded, crossover trial in 714 households (988 indiv...

Cannabis for dyskinesia in Parkinson disease: a randomized double-blind crossover study.

PubMed

Carroll, C B; Bain, P G; Teare, L; Liu, X; Joint, C; Wroath, C; Parkin, S G; Fox, P; Wright, D; Hobart, J; Zajicek, J P

2004-10-12

The long-term treatment of Parkinson disease (PD) may be complicated by the development of levodopa-induced dyskinesia. Clinical and animal model data support the view that modulation of cannabinoid function may exert an antidyskinetic effect. The authors conducted a randomized, double-blind, placebo-controlled crossover trial to examine the hypothesis that cannabis may have a beneficial effect on dyskinesia in PD. A 4-week dose escalation study was performed to assess the safety and tolerability of cannabis in six PD patients with levodopa-induced dyskinesia. Then a randomized placebo-controlled crossover study (RCT) was performed, in which 19 PD patients were randomized to receive oral cannabis extract followed by placebo or vice versa. Each treatment phase lasted for 4 weeks with an intervening 2-week washout phase. The primary outcome measure was a change in Unified Parkinson's Disease Rating Scale (UPDRS) (items 32 to 34) dyskinesia score. Secondary outcome measures included the Rush scale, Bain scale, tablet arm drawing task, and total UPDRS score following a levodopa challenge, as well as patient-completed measures of a dyskinesia activities of daily living (ADL) scale, the PDQ-39, on-off diaries, and a range of category rating scales. Seventeen patients completed the RCT. Cannabis was well tolerated, and had no pro- or antiparkinsonian action. There was no evidence for a treatment effect on levodopa-induced dyskinesia as assessed by the UPDRS, or any of the secondary outcome measures. Orally administered cannabis extract resulted in no objective or subjective improvement in dyskinesias or parkinsonism.

Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials

PubMed Central

Flaherty, Keith T; Hennig, Michael; Lee, Sandra J; Ascierto, Paolo A; Dummer, Reinhard; Eggermont, Alexander M M; Hauschild, Axel; Kefford, Richard; Kirkwood, John M; Long, Georgina V; Lorigan, Paul; Mackensen, Andreas; McArthur, Grant; O'Day, Steven; Patel, Poulam M; Robert, Caroline; Schadendorf, Dirk

2015-01-01

Summary Background Recent phase 3 trials have shown an overall survival benefit in metastatic melanoma. We aimed to assess whether progression-free survival (PFS) could be regarded as a reliable surrogate for overall survival through a meta-analysis of randomised trials. Methods We systematically reviewed randomised trials comparing treatment regimens in metastatic melanoma that included dacarbazine as the control arm, and which reported both PFS and overall survival with a standard hazard ratio (HR). We correlated HRs for overall survival and PFS, weighted by sample size or by precision of the HR estimate, assuming fixed and random effects. We did sensitivity analyses according to presence of crossover, trial size, and dacarbazine dose. Findings After screening 1649 reports and meeting abstracts published before Sept 8, 2013, we identified 12 eligible randomised trials that enrolled 4416 patients with metastatic melanoma. Irrespective of weighting strategy, we noted a strong correlation between the treatment effects for PFS and overall survival, which seemed independent of treatment type. Pearson correlation coefficients were 0.71 (95% CI 0.29–0.90) with a random-effects assumption, 0.85 (0.59–0.95) with a fixed-effects assumption, and 0.89 (0.68–0.97) with sample-size weighting. For nine trials without crossover, the correlation coefficient was 0.96 (0.81–0.99), which decreased to 0.93 (0.74–0.98) when two additional trials with less than 50% crossover were included. Inclusion of mature follow-up data after at least 50% crossover (in vemurafenib and dabrafenib phase 3 trials) weakened the PFS to overall survival correlation (0.55, 0.03–0.84). Inclusion of trials with no or little crossover with the random-effects assumption yielded a conservative statement of the PFS to overall survival correlation of 0.85 (0.51–0.96). Interpretation PFS can be regarded as a robust surrogate for overall survival in dacarbazine-controlled randomised trials of metastatic melanoma; we postulate that this association will hold as treatment standards evolve and are adopted as the control arm in future trials. Funding None. PMID:24485879

Comparison of EUS-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study

PubMed Central

DeWitt, John; Cho, Chang-Min; Lin, Jingmei; Al-Haddad, Mohammad; Canto, Marcia Irene; Salamone, Ashley; Hruban, Ralph H.; Messallam, Ahmed A.; Khashab, Mouen A.

2015-01-01

Background and study aims: The optimal core biopsy needle for endoscopic ultrasound (EUS) is unknown. The principle aim of this study is to compare outcomes of EUS-fine-needle biopsy (EUS-FNB) with a new 19-gauge EUS histology needle (ProCore, Cook Medical Inc., Winston-Salem, North Carolina, United States) to a conventional 19-gauge Tru-Cut biopsy (EUS-TCB) needle (19G, Quick-Core, Cook Medical Inc.). Patients and methods: Patients referred for EUS who require possible histologic biopsy were prospectively randomized to EUS-FNB or EUS-TCB. With the initial needle, ≤ 3 biopsies were obtained until either technical failure or an adequate core was obtained. Patients with suspected inadequate biopsies were crossed over to the other needle and similarly ≤ 3 passes were obtained until adequate cores or technical failure occurred. Technical success, diagnostic histology, accuracy and complication rates were evaluated. Results: Eighty-five patients (mean 58 years; 43 male) were randomized to FNB (n = 44) and TCB (n = 41) with seven patients excluded. Procedure indication, biopsy site, mass size, number of passes, puncture site, overall technical success and adverse events were similar between the two groups. FNB specimens had a higher prevalence of diagnostic histology (85 % vs. 57 %; P = 0.006), accuracy (88 % vs. 62 %; P = 0.02), mean total length (19.4 vs. 4.3 mm; P = 0.001), mean complete portal triads from liver biopsies (10.4 vs. 1.3; P = 0.0004) and required fewer crossover biopsies compared to those of TCB (2 % vs. 65 %; P = 0.0001). Overall technical success and complication rates were comparable. Conclusion: EUS-FNB using a 19-gauge FNB needle is superior to 19-gauge EUS-TCB needle. PMID:26528504

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

PubMed Central

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

2016-01-01

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

No effects of MRI scan on male reproduction hormones.

PubMed

Møllerløkken, Ole J; Moen, Bente E; Baste, Valborg; Magerøy, Nils; Oftedal, Gunnhild; Neto, Emanuel; Ersland, Lars; Bjørge, Line; Torjesen, Peter A; Mild, Kjell Hansson

2012-08-01

Magnetic resonance imaging (MRI) is increasing around the world and the possible adverse effects on reproductive health of electromagnetic fields (EMFs) in MRI are not previously studied. A prospective randomized balanced cross-over study using a head scan in real MRI with whole-body transmitting coil and sham MRI among 24 healthy male volunteers was conducted. Serum-blood samples of inhibin B, testosterone, prolactine, thyreotropine, luteinizing hormone, follicle stimulating hormone, sex-hormone binding globuline and estradiol were taken before and after the different scans. Neither immediately after, nor after 11 days were there seen any differences in the hormone levels comparing real and sham MRI. The lack of effects of EMF on male reproductive hormones should be reassuring to the public and especially for men examined in MRI. Adverse effects on other endpoints than male reproduction or possible chronic effect of multiple MRI scans have not been investigated in this study. Copyright © 2012 Elsevier Inc. All rights reserved.

Polyphenols from cocoa and vascular health-a critical review.

PubMed

Rimbach, Gerald; Melchin, Mona; Moehring, Jennifer; Wagner, Anika E

2009-11-20

Cocoa is a rich source of dietary polyphenols. In vitro as well as cell culture data indicate that cocoa polyphenols may exhibit antioxidant and anti-inflammatory, as well as anti-atherogenic activity. Several molecular targets (e.g., nuclear factor kappa B, endothelial nitric oxide synthase, angiotensin converting enzyme) have been recently identified which may partly explain potential beneficial cardiovascular effects of cocoa polyphenols. However cocoa polyphenol concentrations, as used in many cell culture studies, are not physiologically achievable. Bioavailability studies indicate that plasma concentrations of cocoa polyphenols following dietary intake are low and in the nanomolar range. Human studies regarding the effect of cocoa polyphenols on vascular health are often underpowered and lack a rigorous study design. If dietary cocoa polyphenol intake is due to chocolate its high energy content needs to be taken into account. In order to determine potential health benefits of cocoa polyphenols large scale, long term, randomized, placebo controlled studies, (ideally with a cross-over design) as well as prospective studies are warranted.

Polyphenols from Cocoa and Vascular Health—A Critical Review

PubMed Central

Rimbach, Gerald; Melchin, Mona; Moehring, Jennifer; Wagner, Anika E.

2009-01-01

Cocoa is a rich source of dietary polyphenols. In vitro as well as cell culture data indicate that cocoa polyphenols may exhibit antioxidant and anti-inflammatory, as well as anti-atherogenic activity. Several molecular targets (e.g., nuclear factor kappa B, endothelial nitric oxide synthase, angiotensin converting enzyme) have been recently identified which may partly explain potential beneficial cardiovascular effects of cocoa polyphenols. However cocoa polyphenol concentrations, as used in many cell culture studies, are not physiologically achievable. Bioavailability studies indicate that plasma concentrations of cocoa polyphenols following dietary intake are low and in the nanomolar range. Human studies regarding the effect of cocoa polyphenols on vascular health are often underpowered and lack a rigorous study design. If dietary cocoa polyphenol intake is due to chocolate its high energy content needs to be taken into account. In order to determine potential health benefits of cocoa polyphenols large scale, long term, randomized, placebo controlled studies, (ideally with a cross-over design) as well as prospective studies are warranted. PMID:20057946

Molecular adsorbent recirculating system and single-pass albumin dialysis in liver failure--a prospective, randomised crossover study.

PubMed

Sponholz, Christoph; Matthes, Katja; Rupp, Dina; Backaus, Wolf; Klammt, Sebastian; Karailieva, Diana; Bauschke, Astrid; Settmacher, Utz; Kohl, Matthias; Clemens, Mark G; Mitzner, Steffen; Bauer, Michael; Kortgen, Andreas

2016-01-04

The aim of extracorporeal albumin dialysis (ECAD) is to reduce endogenous toxins accumulating in liver failure. To date, ECAD is conducted mainly with the Molecular Adsorbents Recirculating System (MARS). However, single-pass albumin dialysis (SPAD) has been proposed as an alternative. The aim of this study was to compare the two devices with a prospective, single-centre, non-inferiority crossover study design with particular focus on reduction of bilirubin levels (primary endpoint) and influence on paraclinical and clinical parameters (secondary endpoints) associated with liver failure. Patients presenting with liver failure were screened for eligibility and after inclusion were randomly assigned to be started on either conventional MARS or SPAD (with 4% albumin and a dialysis flow rate of 700 ml/h). Statistical analyses were based on a linear mixed-effects model. Sixty-nine crossover cycles of ECAD in 32 patients were completed. Both systems significantly reduced plasma bilirubin levels to a similar extent (MARS: median -68 μmol/L, interquartile range [IQR] -107.5 to -33.5, p = 0.001; SPAD: -59 μmol/L, -84.5 to +36.5, p = 0.001). However, bile acids (MARS: -39 μmol/L, -105.6 to -8.3, p < 0.001; SPAD: -9 μmol/L, -36.9 to +11.4, p = 0.131), creatinine (MARS: -24 μmol/L, -46.5 to -8.0, p < 0.001; SPAD: -2 μmol/L, -9.0 to +7.0/L, p = 0.314) and urea (MARS: -0.9 mmol/L, -1.93 to -0.10, p = 0.024; SPAD: -0.1 mmol/L, -1.0 to +0.68, p = 0.523) were reduced and albumin-binding capacity was increased (MARS: +10%, -0.8 to +20.9%, p < 0.001; SPAD: +7%, -7.5 to +15.5%, p = 0.137) only by MARS. Cytokine levels of interleukin (IL)-6 and IL-8 and hepatic encephalopathy were altered by neither MARS nor SPAD. Both procedures were safe for temporary extracorporeal liver support. While in clinical practice routinely assessed plasma bilirubin levels were reduced by both systems, only MARS affected other paraclinical parameters (i.e., serum bile acids, albumin-binding capacity, and creatinine and urea levels). Caution should be taken with regard to metabolic derangements and electrolyte disturbances, particularly in SPAD using regional citrate anti-coagulation. German Clinical Trials Register ( www.drks.de) DRKS00000371. Registered 8 April 2010.

Dual Fractal Dimension and Long-Range Correlation of Chinese Stock Prices

NASA Astrophysics Data System (ADS)

Chen, Chaoshi; Wang, Lei

2012-03-01

The recently developed modified inverse random midpoint displacement (mIRMD) and conventional detrended fluctuation analysis (DFA) algorithms are used to analyze the tick-by-tick high-frequency time series of Chinese A-share stock prices and indexes. A dual-fractal structure with a crossover at about 10 min is observed. The majority of the selected time series show visible persistence within this time threshold, but approach a random walk on a longer time scale. The phenomenon is found to be industry-dependent, i.e., the crossover is much more prominent for stocks belonging to cyclical industries than for those belonging to noncyclical (defensive) industries. We have also shown that the sign series show a similar dual-fractal structure, while like generally found, the magnitude series show a much longer time persistence.

Persistent-random-walk approach to anomalous transport of self-propelled particles

NASA Astrophysics Data System (ADS)

Sadjadi, Zeinab; Shaebani, M. Reza; Rieger, Heiko; Santen, Ludger

2015-06-01

The motion of self-propelled particles is modeled as a persistent random walk. An analytical framework is developed that allows the derivation of exact expressions for the time evolution of arbitrary moments of the persistent walk's displacement. It is shown that the interplay of step length and turning angle distributions and self-propulsion produces various signs of anomalous diffusion at short time scales and asymptotically a normal diffusion behavior with a broad range of diffusion coefficients. The crossover from the anomalous short-time behavior to the asymptotic diffusion regime is studied and the parameter dependencies of the crossover time are discussed. Higher moments of the displacement distribution are calculated and analytical expressions for the time evolution of the skewness and the kurtosis of the distribution are presented.

Response-Order Effects in Survey Methods: A Randomized Controlled Crossover Study in the Context of Sport Injury Prevention.

PubMed

Chan, Derwin K; Ivarsson, Andreas; Stenling, Andreas; Yang, Sophie X; Chatzisarantis, Nikos L; Hagger, Martin S

2015-12-01

Consistency tendency is characterized by the propensity for participants responding to subsequent items in a survey consistent with their responses to previous items. This method effect might contaminate the results of sport psychology surveys using cross-sectional design. We present a randomized controlled crossover study examining the effect of consistency tendency on the motivational pathway (i.e., autonomy support → autonomous motivation → intention) of self-determination theory in the context of sport injury prevention. Athletes from Sweden (N = 341) responded to the survey printed in either low interitem distance (IID; consistency tendency likely) or high IID (consistency tendency suppressed) on two separate occasions, with a one-week interim period. Participants were randomly allocated into two groups, and they received the survey of different IID at each occasion. Bayesian structural equation modeling showed that low IID condition had stronger parameter estimates than high IID condition, but the differences were not statistically significant.

The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye

PubMed Central

Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

2016-01-01

Purpose To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. Methods The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). Results At 3 months, the treatment group had greater mean improvement in MGS (P<0.0001) and dry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (P<0.0001) and dry eye symptoms from 44.1±20.4 to 21.6±21.3 (P<0.0001); 89% of the crossover group had received only one VTP treatment with sustained mean improvement in MGS from 6.3±3.6 to 18.4±11.1 (P<0.0001) and dry eye symptoms from 49.1±21.0 to 24.0±23.2 (P<0.0001). Greater mean improvement in MGS was associated with less severe baseline MGS (P=0.0017) and shorter duration of time between diagnosis and treatment (P=0.0378). Conclusion A single VTP treatment can deliver a sustained mean improvement in meibomian gland function and mean reduction in dry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes. PMID:27555745

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

PubMed

Werner, Gerald S; Martin-Yuste, Victoria; Hildick-Smith, David; Boudou, Nicolas; Sianos, Georgios; Gelev, Valery; Rumoroso, Jose Ramon; Erglis, Andrejs; Christiansen, Evald Høj; Escaned, Javier; di Mario, Carlo; Hovasse, Thomas; Teruel, Luis; Bufe, Alexander; Lauer, Bernward; Bogaerts, Kris; Goicolea, Javier; Spratt, James C; Gershlick, Anthony H; Galassi, Alfredo R; Louvard, Yves

2018-05-02

The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. NCT01760083.

Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis.

PubMed

Davis, Tim; Loudermilk, Eric; DePalma, Michael; Hunter, Corey; Lindley, David; Patel, Nilesh; Choi, Daniel; Soloman, Marc; Gupta, Anita; Desai, Mehul; Buvanendran, Asokumar; Kapural, Leonardo

2018-01-01

Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection. ClinicalTrials.gov (NCT02343003).

Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis

PubMed Central

Davis, Tim; Loudermilk, Eric; DePalma, Michael; Hunter, Corey; Lindley, David; Patel, Nilesh; Choi, Daniel; Soloman, Marc; Gupta, Anita; Desai, Mehul; Buvanendran, Asokumar; Kapural, Leonardo

2018-01-01

Background and Objectives Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. Methods This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. Results There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. Conclusions This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection. Clinical Trial Registration: ClinicalTrials.gov (NCT02343003). PMID:29095245

Orange pomace improves postprandial glycemic responses: an acute, randomized, placebo-controlled, double-blind, crossover trial in overweight men

USDA-ARS?s Scientific Manuscript database

Orange pomace (OP), a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-co...

Supervised Home Training of Dialogue Skills in Chronic Aphasia: A Randomized Parallel Group Study

ERIC Educational Resources Information Center

Nobis-Bosch, Ruth; Springer, Luise; Radermacher, Irmgard; Huber, Walter

2011-01-01

Purpose: The aim of this study was to prove the efficacy of supervised self-training for individuals with aphasia. Linguistic and communicative performance in structured dialogues represented the main study parameters. Method: In a cross-over design for randomized matched pairs, 18 individuals with chronic aphasia were examined during 12 weeks of…

Neuronal effects of nicotine during auditory selective attention.

PubMed

Smucny, Jason; Olincy, Ann; Eichman, Lindsay S; Tregellas, Jason R

2015-06-01

Although the attention-enhancing effects of nicotine have been behaviorally and neurophysiologically well-documented, its localized functional effects during selective attention are poorly understood. In this study, we examined the neuronal effects of nicotine during auditory selective attention in healthy human nonsmokers. We hypothesized to observe significant effects of nicotine in attention-associated brain areas, driven by nicotine-induced increases in activity as a function of increasing task demands. A single-blind, prospective, randomized crossover design was used to examine neuronal response associated with a go/no-go task after 7 mg nicotine or placebo patch administration in 20 individuals who underwent functional magnetic resonance imaging at 3T. The task design included two levels of difficulty (ordered vs. random stimuli) and two levels of auditory distraction (silence vs. noise). Significant treatment × difficulty × distraction interaction effects on neuronal response were observed in the hippocampus, ventral parietal cortex, and anterior cingulate. In contrast to our hypothesis, U and inverted U-shaped dependencies were observed between the effects of nicotine on response and task demands, depending on the brain area. These results suggest that nicotine may differentially affect neuronal response depending on task conditions. These results have important theoretical implications for understanding how cholinergic tone may influence the neurobiology of selective attention.

Subcutaneous Midazolam with and without Ketamine for Sedation In Children Undergoing Dental Treatment: A Pilot Study.

PubMed

Flores-Castillo, D; Martínez-Rider, R; Ruiz-Rodríguez, S; Garrocho-Rangel, A; Lara-Guevara, J; Pozos-Guillén, A

2015-01-01

The objective of this study was to evaluate the efficacy of subcutaneous (SC) sedation using midazolam with and without ketamine in non-cooperative pediatric patients undergoing dental treatment. A prospective, randomized, controlled, double-blind, crossover pilot clinical trial was carried out in 13 children, aged between 17-46 months, ASA l, Frankl 1. Two sedation schemes were administered SC: Midazolam alone (M), and a combination of Midazolam-Ketamine (MK). Both regimens were administered to the same patient in two consecutive treatment sessions, in accordance with a random assignment. Overall behavior, movement, and crying were assessed according to the modified Houpt scale. Heart rate, blood pressure, blood oxygen saturation, and possible side effects were also monitored. The percentage of non-crying children was always higher in the treatment with MK compared with the treatment with M, but without a significant statistical difference. Regarding variable body movement, the percentage of children without movement was higher in the MK group, although only up to minute 10; no significant differences were found at 20, 30, and 40 minutes, and from minute 40, body movement was lower in the M group. Midazolam alone and the midazolam-ketamine combination administered subcutaneously resulted in a safe and efficient pharmacological method for providing moderate sedation to non-cooperative pediatric patients undergoing dental treatment.

Performance of three multipurpose disinfecting solutions with a silicone hydrogel contact lens.

PubMed

García-Porta, Nery; Rico-del-Viejo, Laura; Ferreira-Neves, Helena; Peixoto-de-Matos, Sofia C; Queirós, Antonio; González-Méijome, José M

2015-01-01

To evaluate the clinical performance of a silicone hydrogel (Si-Hy) soft contact lens (CL) in combination with three different multipurpose disinfecting solutions (MPDSs). This was a prospective, randomized, single-masked, crossover, and comparative study in which 31 habitual soft CL wearers were randomly assigned to one of the three MPDSs (Synergi, COMPLETE RevitaLens, and OPTI-FREE PureMoist) for 1 month with a 1-week wash-out period between each exposure. All subjects were successfully refitted with a Si-Hy CL (Biofinity). Subjects were then scheduled for follow-up visits after 1 month of lens wear, being evaluated at 2 and 8 hours after lens insertion. Visual Analogue Scales (VAS) were used to gauge comfort rating. The tarsal conjunctiva showed a significantly different degree of lid redness between the MPDSs at the 2-hour visit (P < 0.05, Kruskal-Wallis test), being lower for COMPLETE RevitaLens compared to the other two MPDSs (Mann-Whitney U test). Furthermore, a significantly different degree of lid roughness at the 8-hour visit was seen (P < 0.05, Kruskal-Wallis test), being higher for Synergi (Mann-Whitney U test). The subjective comfort was similar with the three MPDSs. Tarsal conjunctival response should be also considered in the context of the clinical performance of MPDs at the ocular surface.

Impact of prestorage leucoreduction of autologous whole blood on length of hospital stay with a subgroup analysis in bilateral hip arthroplasty.

PubMed

Sawamura, Y; Ohto, H; Ikeda, K; Kanno, T; Suzuki, Y; Gonda, K; Tasaki, T; Nollet, K E; Takahashi, H; Aota, S

2018-06-20

Although prestorage leucoreduction (LR) of blood components for transfusion has gained favour around the world, evidence of its beneficial clinical effects is ambiguous. To reveal whether leucocytes and/or platelets in transfused blood are related to transfusion-related adverse effects, a prospective randomized crossover study was performed on patients who donated autologous blood prior to elective surgery. Among 1487 primary enrolees, a total of 192 patients undergoing two-stage, bilateral total hip arthroplasty were randomized to receive autologous blood that was either prestorage leucoreduced, or not, for the first procedure. For the second procedure, each patient was crossed over to receive alternatively processed autologous blood. Length of hospital stay served as a primary end-point, with perioperative infectious/thrombotic complications, pre- and postoperative laboratory values, and body temperature serving as secondary endpoints. No significant differences emerged between prestorage LR and non-LR cohorts in length of hospital stay, as well as perioperative infectious/thrombotic complications, postoperative body temperature and duration of fever. Postoperative laboratory values including white blood cell counts and C-reactive protein levels had no significant differences. This study could not prove any superiority of prestorage LR over non-LR for autologous whole blood among patients who underwent total hip arthroplasty. © 2018 International Society of Blood Transfusion.

Comparisons of the Pentax-AWS, Glidescope, and Macintosh Laryngoscopes for Intubation Performance during Mechanical Chest Compressions in Left Lateral Tilt: A Randomized Simulation Study of Maternal Cardiopulmonary Resuscitation

PubMed Central

Lee, Sanghyun; Kim, Wonhee; Kang, Hyunggoo; Oh, Jaehoon; Lim, Tae Ho; Lee, Yoonjae; Kim, Changsun; Cho, Jun Hwi

2015-01-01

Purpose. Rapid advanced airway management is important in maternal cardiopulmonary resuscitation (CPR). This study aimed to compare intubation performances among Pentax-AWS (AWS), Glidescope (GVL), and Macintosh laryngoscope (MCL) during mechanical chest compression in 15° and 30° left lateral tilt. Methods. In 19 emergency physicians, a prospective randomized crossover study was conducted to examine the three laryngoscopes. Primary outcomes were the intubation time and the success rate for intubation. Results. The median intubation time using AWS was shorter than that of GVL and MCL in both tilt degrees. The time to visualize the glottic view in GVL and AWS was significantly lower than that of MCL (all P < 0.05), whereas there was no significant difference between the two video laryngoscopes (in 15° tilt, P = 1; in 30° tilt, P = 0.71). The progression of tracheal tube using AWS was faster than that of MCL and GVL in both degrees (all P < 0.001). Intubations using AWS and GVL showed higher success rate than that of Macintosh laryngoscopes. Conclusions. The AWS could be an appropriate laryngoscope for airway management of pregnant women in tilt CPR considering intubation time and success rate. PMID:26161426

Effects of ampicillin/sulbactam and enrofloxacin on the blood pressure of isoflurane anesthetized dogs.

PubMed

Moorer, Jeremiah D; Towle-Millard, Heather A; Gross, Marjorie E; Payton, Mark E

2013-01-01

A blinded, prospective, randomized crossover study was performed to determine the effects of ampicillin Na/sulbactam Na and enrofloxacin on the blood pressure (BP) of healthy anesthetized dogs. Eight dogs were anesthetized three different times. They randomly received enrofloxacin, ampicillin Na/sulbactam Na, and saline. Systolic, diastolic, and mean arterial BPs (SAP, DAP, and MAP, respectively), heart rate (HR), O2 saturation of hemoglobin, end-tidal CO2 (ETCO2) concentration, inspired isoflurane concentration, end-tidal isoflurane (ETiso) concentration, respiratory rate, electrocardiogram, and body temperature were measured for 20 min prior to administration of treatment, during administration over 30 min, and for 30 min after administration. There was no significant difference in the SAP or ETiso. There was no significant change in the arterial pressure values over time in the enrofloxacin and ampicillin Na/sulbactam Na groups. The control group's MAP increased over time and was increased compared with the enrofloxacin group at times 25, 35, 45, and 55. The statistical difference between the enrofloxacin and the control groups was due to an increase in the MAP in the control group, not a decrease in the enrofloxacin group's BP. Neither enrofloxacin nor ampicillin Na/sulbactam Na caused hypotension in healthy dogs anesthetized with isoflurane and fentanyl.

Circular Data Images for Directional Data

NASA Technical Reports Server (NTRS)

Morpet, William J.

2004-01-01

Directional data includes vectors, points on a unit sphere, axis orientation, angular direction, and circular or periodic data. The theoretical statistics for circular data (random points on a unit circle) or spherical data (random points on a unit sphere) are a recent development. An overview of existing graphical methods for the display of directional data is given. Cross-over occurs when periodic data are measured on a scale for the measurement of linear variables. For example, if angle is represented by a linear color gradient changing uniformly from dark blue at -180 degrees to bright red at +180 degrees, the color image will be discontinuous at +180 degrees and -180 degrees, which are the same location. The resultant color would depend on the direction of approach to the cross-over point. A new graphical method for imaging directional data is described, which affords high resolution without color discontinuity from "cross-over". It is called the circular data image. The circular data image uses a circular color scale in which colors repeat periodically. Some examples of the circular data image include direction of earth winds on a global scale, rocket motor internal flow, earth global magnetic field direction, and rocket motor nozzle vector direction vs. time.

Comparisons on efficacy of elcatonin and limaprost alfadex in patients with lumbar spinal stenosis and concurrent osteoporosis: a preliminary study using a crossover design.

PubMed

Kanchiku, Tsukasa; Imajo, Yasuaki; Suzuki, Hidenori; Yoshida, Yuichiro; Taguchi, Toshihiko; Tominaga, Toshikatsu; Toyoda, Koichiro

2014-08-01

Multicenter prospective study with a crossover design. The objective of this study is to compare the efficacy of limaprost alfadex (LP) and elcatonin (EL) for lumbar spinal stenosis (LSS) patients with concurrent osteoporosis. It has been increasingly important to improve quality of life by establishing appropriate conservative treatments for LSS patients with concurrent osteoporosis who will presumably continue to increase due to the percentage of the aging elevations, however there is no prospective study. A total of 19 patients with LSS and concurrent osteoporosis were enrolled in this study. The patients were divided into two groups and compared using a crossover design. The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and short-form (SF)-8 health survey scale were used for clinical evaluations. There was a significant improvement of buttock-leg pain and numbness in the EL group. A significant improvement of impaired walking function was noted for the LP group according to the JOABPEQ while the rest of the items in the JOABPEQ showed no significant differences. The SF-8 health survey revealed that somatic pains and physical summary scores in the EL group and physical functioning and physical summary scores in the LP group tended to improve but not to any statistically significant extents. Concomitant uses of EL may be useful in patients who do not respond satisfactorily to the treatments of LP for 6-8 weeks.

A Candidate Gene Analysis of Methylphenidate Response in Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

McGough, James J.; McCracken, James T.; Loo, Sandra K.; Manganiello, Marc; Leung, Michael C.; Tietjens, Jeremy R.; Trinh, Thao; Baweja, Shilpa; Suddath, Robert; Smalley, Susan L.; Hellemann, Gerhard; Sugar, Catherine A.

2009-01-01

Objective: This study examines the potential role of candidate genes in moderating treatment effects of methylphenidate (MPH) in attention-deficit/hyperactivity disorder (ADHD). Method: Eighty-two subjects with ADHD aged 6 to 17 years participated in a prospective, double-blind, placebo-controlled, multiple-dose, crossover titration trial of…

Hydrophilic-coated catheters for intermittent catheterisation reduce urethral micro trauma: a prospective, randomised, participant-blinded, crossover study of three different types of catheters.

PubMed

Stensballe, J; Looms, D; Nielsen, P N; Tvede, M

2005-12-01

To compare two hydrophilic-coated (SpeediCath and LoFric and one uncoated gel-lubricated catheter (InCare Advance Plus) concerning withdrawal friction force and urethral micro trauma. 49 healthy male volunteers participated in this prospective, randomised, blinded, crossover study of three different bladder catheters. The withdrawal friction force was measured, and urine analysis of blood, nitrite and leucocytes, microbiological analysis of urine cultures and subjective evaluation of the catheters were performed. 40 participants completed the study and were included in the analysis. SpeediCath exerted a significantly lower mean withdrawal friction force and work than the gel-lubricated uncoated catheter, whereas LoFric exerted a significantly higher mean friction force than both of the other catheters. The hydrophilic catheters caused less microscopic haematuria and less pain than the gel-lubricated uncoated catheter. Furthermore, 93% of the participants preferred the hydrophilic catheters. Hydrophilic-coated catheters perform better than uncoated catheters with regard to haematuria and preference. SpeediCath, but not LoFric, exerts less withdrawal friction force than InCare Advance Plus.

High-resolution endoscopy plus chromoendoscopy or narrow-band imaging in Barrett's esophagus: a prospective randomized crossover study.

PubMed

Kara, M A; Peters, F P; Rosmolen, W D; Krishnadath, K K; ten Kate, F J; Fockens, P; Bergman, J J G H

2005-10-01

High-resolution endoscopy (HRE) may improve the detection of early neoplasia in Barrett's esophagus. Indigo carmine chromoendoscopy (ICC) and narrow-band imaging (NBI) may be useful techniques to complement HRE. The aim of this study was to compare HRE-ICC with HRE-NBI for the detection of high-grade dysplasia or early cancer (HGD/EC) in patients with Barrett's esophagus. Twenty-eight patients with Barrett's esophagus underwent HRE-ICC and HRE-NBI (separated by 6 - 8 weeks) in a randomized sequence. The two procedures were performed by two different endoscopists, who were blinded to the findings of the other examination. Targeted biopsies were taken from all detected lesions, followed by four-quadrant biopsies at 2-cm intervals. Biopsy evaluation was supervised by a single expert pathologist, who was blinded to the imaging technique used. Fourteen patients were diagnosed with HGD/EC. The sensitivity for HGD/EC was 93 % and 86 % for HRE-ICC and HRE-NBI, respectively. Targeted biopsies had a sensitivity of 79 % with HRE alone. HGD was diagnosed from random biopsies alone in only one patient. ICC and NBI detected a limited number of additional lesions occult to HRE, but these lesions did not alter the sensitivity for identifying patients with HGD/EC. In most patients with high-grade dysplasia or early cancer in Barrett's esophagus, subtle lesions can be identified with high-resolution endoscopy. Indigo carmine chromoendoscopy and narrow-band imaging are comparable as adjuncts to high-resolution endoscopy.

Bach music in preterm infants: no 'Mozart effect' on resting energy expenditure.

PubMed

Keidar, H Rosenfeld; Mandel, D; Mimouni, F B; Lubetzky, R

2014-02-01

To study whether Johan Sebastian Bach music has a lowering effect on resting energy expenditure (REE) similar to that of Wolfgang Amadeus Mozart music. Prospective, randomized clinical trial with cross-over in 12 healthy, appropriate weights for gestational age (GA), gavage fed, metabolically stable, preterm infants. Infants were randomized to a 30-min period of either Mozart or Bach music or no music over 3 consecutive days. REE was measured every minute by indirect calorimetry. Three REE measurements were performed in each of 12 infants at age 20±15.8 days. Mean GA was 30.17±2.44 weeks and mean birthweight was 1246±239 g. REE was similar during the first 10-min of all three randomization periods. During the next 10-min period, infants exposed to music by Mozart had a trend toward lower REE than when not exposed to music. This trend became significant during the third 10-min period. In contrast, music by Bach or no music did not affect significantly REE during the whole study. On average, the effect size of Mozart music upon REE was a reduction of 7.7% from baseline. Mozart music significantly lowers REE in preterm infants, whereas Bach music has no similar effect. We speculate that 'Mozart effect' must be taken into account when incorporating music in the therapy of preterm infants, as not all types of music may have similar effects upon REE and growth.

A randomized controlled trial oftransfusion-related acute lung injury: is plasma from multiparous blood donors dangerous?

PubMed

Palfi, M; Berg, S; Ernerudh, J; Berlin, G

2001-03-01

Transfusion-related acute lung injury (TRALI) and other posttransfusion reactions may be caused by granulocyte and/or HLA antibodies, which are often present in blood from multiparous donors. The purpose of this study was to compare the effects of plasma from multiparous donors with those of plasma from donors with no history of transfusion or pregnancy (control plasma) in a prospective, randomized, double-blind, crossover study. Intensive care patients, judged to need at least 2 units of plasma, were randomly assigned to receive a unit of control plasma and, 4 hours later, a plasma unit from a multiparous donor (> or = 3 live births) or to receive the plasma units in opposite order. The patients were closely monitored, and body temperature, blood pressure, and heart rate were recorded. Blood samples for analysis of blood gases, TNFalpha, IL-1 receptor antagonist, soluble E selectin, and C3d complement factor were collected at least on four occasions (before and after the transfusion of each unit). Transfusion of plasma from multiparous donors was associated with significantly lower oxygen saturation and higher TNFalpha concentrations than transfusion of control plasma. The mean arterial pressure increased significantly after the transfusion of control plasma, whereas plasma from multiparous donors had no effect on it. Five posttransfusion reactions were observed in 100 patients, in four cases after the transfusion of plasma from multiparous donors. Plasma from multiparous blood donors may impair pulmonary function in intensive care unit patients.

Coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone improves postprandial endothelial dysfunction in patients with borderline and stage 1 hypertension.

PubMed

Kajikawa, Masato; Maruhashi, Tatsuya; Hidaka, Takayuki; Nakano, Yukiko; Kurisu, Satoshi; Matsumoto, Takeshi; Iwamoto, Yumiko; Kishimoto, Shinji; Matsui, Shogo; Aibara, Yoshiki; Yusoff, Farina Mohamad; Kihara, Yasuki; Chayama, Kazuaki; Goto, Chikara; Noma, Kensuke; Nakashima, Ayumu; Watanabe, Takuya; Tone, Hiroshi; Hibi, Masanobu; Osaki, Noriko; Katsuragi, Yoshihisa; Higashi, Yukihito

2018-01-12

The purpose of this study was to evaluate acute effects of coffee with a high content of chlorogenic acids and different hydroxyhydroquinone contents on postprandial endothelial dysfunction. This was a single-blind, randomized, placebo-controlled, crossover-within-subject clinical trial. A total of 37 patients with borderline or stage 1 hypertension were randomized to two study groups. The participants consumed a test meal with a single intake of the test coffee. Subjects in the Study 1 group were randomized to single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone or coffee with a high content of chlorogenic acids and a high content of hydroxyhydroquinone with crossover. Subjects in the Study 2 group were randomized to single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone or placebo coffee with crossover. Endothelial function assessed by flow-mediated vasodilation and plasma concentration of 8-isoprostanes were measured at baseline and at 1 and 2 h after coffee intake. Compared with baseline values, single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone, but not coffee with a high content of chlorogenic acids and high content of hydroxyhydroquinone or placebo coffee, significantly improved postprandial flow-mediated vasodilation and decreased circulating 8-isoprostane levels. These findings suggest that a single intake of coffee with a high content of chlorogenic acids and low content of hydroxyhydroquinone is effective for improving postprandial endothelial dysfunction. URL for Clinical Trial: https://upload.umin.ac.jp ; Registration Number for Clinical Trial: UMIN000013283.

Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.

PubMed

Semler, Matthew W; Wanderer, Jonathan P; Ehrenfeld, Jesse M; Stollings, Joanna L; Self, Wesley H; Siew, Edward D; Wang, Li; Byrne, Daniel W; Shaw, Andrew D; Bernard, Gordon R; Rice, Todd W

2017-05-15

Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown. To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids. This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction. Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P < 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98). An electronic health record-embedded, cluster-randomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt. Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).

Chest Compression With Personal Protective Equipment During Cardiopulmonary Resuscitation: A Randomized Crossover Simulation Study.

PubMed

Chen, Jie; Lu, Kai-Zhi; Yi, Bin; Chen, Yan

2016-04-01

Following a chemical, biological, radiation, and nuclear incident, prompt cardiopulmonary resuscitation (CPR) procedure is essential for patients who suffer cardiac arrest. But CPR when wearing personal protection equipment (PPE) before decontamination becomes a challenge for healthcare workers (HCW). Although previous studies have assessed the impact of PPE on airway management, there is little research available regarding the quality of chest compression (CC) when wearing PPE.A present randomized cross-over simulation study was designed to evaluate the effect of PPE on CC performance using mannequins.The study was set in one university medical center in the China.Forty anesthesia residents participated in this randomized cross-over study.Each participant performed 2 min of CC on a manikin with and without PPE, respectively. Participants were randomized into 2 groups that either performed CC with PPE first, followed by a trial without PPE after a 180-min rest, or vice versa.CPR recording technology was used to objectively quantify the quality of CC. Additionally, participants' physiological parameters and subjective fatigue score values were recorded.With the use of PPE, a significant decrease of the percentage of effective compressions (41.3 ± 17.1% with PPE vs 67.5 ± 15.6% without PPE, P < 0.001) and the percentage of adequate compressions (67.7 ± 18.9% with PPE vs 80.7 ± 15.5% without PPE, P < 0.001) were observed. Furthermore, the increases in heart rate, mean arterial pressure, and subjective fatigue score values were more obvious with the use of PPE (all P < 0.01).We found significant deterioration of CC performance in HCW with the use of a level-C PPE, which may be a disadvantage for enhancing survival of cardiac arrest.

Individual eigenvalue distributions of crossover chiral random matrices and low-energy constants of SU(2) × U(1) lattice gauge theory

NASA Astrophysics Data System (ADS)

Yamamoto, Takuya; Nishigaki, Shinsuke M.

2018-02-01

We compute individual distributions of low-lying eigenvalues of a chiral random matrix ensemble interpolating symplectic and unitary symmetry classes by the Nyström-type method of evaluating the Fredholm Pfaffian and resolvents of the quaternion kernel. The one-parameter family of these distributions is shown to fit excellently the Dirac spectra of SU(2) lattice gauge theory with a constant U(1) background or dynamically fluctuating U(1) gauge field, which weakly breaks the pseudoreality of the unperturbed SU(2) Dirac operator. The observed linear dependence of the crossover parameter with the strength of the U(1) perturbations leads to precise determination of the pseudo-scalar decay constant, as well as the chiral condensate in the effective chiral Lagrangian of the AI class.

Influence diagnostics for count data under AB-BA crossover trials.

PubMed

Hao, Chengcheng; von Rosen, Dietrich; von Rosen, Tatjana

2017-12-01

This paper aims to develop diagnostic measures to assess the influence of data perturbations on estimates in AB-BA crossover studies with a Poisson distributed response. Generalised mixed linear models with normally distributed random effects are utilised. We show that in this special case, the model can be decomposed into two independent sub-models which allow to derive closed-form expressions to evaluate the changes in the maximum likelihood estimates under several perturbation schemes. The performance of the new influence measures is illustrated by simulation studies and the analysis of a real dataset.

Spin dynamics of random Ising chain in coexisting transverse and longitudinal magnetic fields

NASA Astrophysics Data System (ADS)

Liu, Zhong-Qiang; Jiang, Su-Rong; Kong, Xiang-Mu; Xu, Yu-Liang

2017-05-01

The dynamics of the random Ising spin chain in coexisting transverse and longitudinal magnetic fields is studied by the recursion method. Both the spin autocorrelation function and its spectral density are investigated by numerical calculations. It is found that system's dynamical behaviors depend on the deviation σJ of the random exchange coupling between nearest-neighbor spins and the ratio rlt of the longitudinal and the transverse fields: (i) For rlt = 0, the system undergoes two crossovers from N independent spins precessing about the transverse magnetic field to a collective-mode behavior, and then to a central-peak behavior as σJ increases. (ii) For rlt ≠ 0, the system may exhibit a coexistence behavior of a collective-mode one and a central-peak one. When σJ is small (or large enough), system undergoes a crossover from a coexistence behavior (or a disordered behavior) to a central-peak behavior as rlt increases. (iii) Increasing σJ depresses effects of both the transverse and the longitudinal magnetic fields. (iv) Quantum random Ising chain in coexisting magnetic fields may exhibit under-damping and critical-damping characteristics simultaneously. These results indicate that changing the external magnetic fields may control and manipulate the dynamics of the random Ising chain.

Arousability and Fall Risk During Forced Awakenings From Nocturnal Sleep Among Healthy Males Following Administration of Zolpidem 10 mg and Doxepin 6 mg: A Randomized, Placebo-Controlled, Four-Way Crossover Trial.

PubMed

Drake, Christopher L; Durrence, Heith; Cheng, Philip; Roth, Thomas; Pillai, Vivek; Peterson, Edward L; Singh, Meeta; Tran, Kieulinh Michelle

2017-07-01

To examine and compare the arousability threshold and fall risk upon awakening of doxepin (6 mg) versus zolpidem (10 mg). A total of 52 healthy adult males were included in a double-blind, placebo-controlled, four-way crossover study. The experimental procedure included four nights with polysomnography in the lab (zolpidem, doxepin, and their respective placebo conditions). Arousability was measured using an auditory awakening threshold delivered at the peak-plasma concentration for the active hypnotics and at matched times for the respective placebo conditions. Fall risk during the night was measured following awakening using the Berg Balance Scale and the Tandem Walk Task. Both arousability and fall risk were lower in the doxepin condition compared to the zolpidem condition. Furthermore, arousability and fall risk for doxepin did not differ significantly from the placebo conditions. A significantly greater proportion of participants in the zolpidem condition (63.5%) did not wake until receiving the loudest tone (110 dB) as compared to the doxepin (17.6%) and placebo conditions (17.3%, 5.8%). Results suggest that zolpidem has greater risks for balance and awakening threshold compared with low-dose doxepin. Future prospective studies should extend results to clinical samples with population-level risk of injury and arousability. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

An Ecological Approach of Constraint Induced Movement Therapy for 2-3-Year-Old Children: A Randomized Control Trial

ERIC Educational Resources Information Center

Eliasson, Ann-Christin; Shaw, Karin; Berg, Elisabeth; Krumlinde-Sundholm, Lena

2011-01-01

The aim was to evaluate the effect of Eco-CIMT in young children with unilateral cerebral palsy in a randomized controlled crossover design. The training was implemented within the regular pediatric services, provided by the child's parents and/or preschool teacher and supervised by the child's regular therapist. Methods: Twenty-five children…

Random-walk diffusion and drying of porous materials

NASA Astrophysics Data System (ADS)

Mehrafarin, M.; Faghihi, M.

2001-12-01

Based on random-walk diffusion, a microscopic model for drying is proposed to explain the characteristic features of the drying-rate curve of porous materials. The constant drying-rate period is considered as a normal diffusion process. The transition to the falling-rate regime is attributed to the fractal nature of porous materials which results in crossover to anomalous diffusion.

Balloon-Assisted Tracking Use Reduces Radial Artery Access Failure in an Experienced Radial Center and is Feasible During Primary PCI for STEMI.

PubMed

Obaid, Daniel; Hailan, Ahmed; Chase, Alexander; Dorman, Stephen; Jenkins, Geraint; Raybould, Adrian; Ramsey, Mark; Thomas, Phillip; Smith, David; Ionescu, Adrian

2017-07-01

This prospective study assesses balloon-assisted tracking (BAT) in reducing radial access failure during percutaneous coronary intervention (PCI). Arterial spasm prevents PCI from the radial artery in a small percentage of cases. A total of 2223 consecutive patients undergoing PCI from the radial approach were analyzed. Radial access failure mode and requirement for crossover to femoral access during a 12-month run-in period were compared with the following 14-month period with routine BAT usage. During the 14-month study period, 1334 radial PCIs were attempted. Twenty-six patients switched to femoral at an early stage, while 76 encountered radial spasm and underwent successful BAT in 69 cases (91%), giving a total crossover rate to femoral of 33/1334 (2.5%). Utilizing BAT rather than a femoral puncture reduced our institution's radial-femoral crossover rate from 7.6% to 2.5% (P<.01), which is also significantly lower than the radial-femoral crossover rate in the 12 months before BAT implementation (6.1%; P<.01). Mean procedure times were similar for those requiring BAT compared with conventional radial access (51.3 ± 21.3 min vs 47.9 ± 23.7 min; P=.23), and those crossing straight to femoral (BAT not attempted) (60.7 ± 31.9 min; P=.10). Mean first device/balloon time for the BAT-assisted primary PCI cases (22.6 ± 9.4 min) was similar to cases that had radial difficulties and converted to femoral without attempting BAT (25.8 ± 13.4 min; P=.54). BAT allowed catheter passage despite radial spasm in 91% of cases, significantly reducing the institution's rate of femoral crossover. During radial spasm in primary PCI, using BAT did not delay reperfusion compared with femoral crossover.

Nocturnal, every-other-day, online haemodiafiltration: an effective therapeutic alternative.

PubMed

Maduell, Francisco; Arias, Marta; Durán, Carlos E; Vera, Manel; Fontseré, Néstor; Azqueta, Manel; Rico, Nayra; Pérez, Nuria; Sentis, Alexis; Elena, Montserrat; Rodriguez, Néstor; Arcal, Carola; Bergadá, Eduardo; Cases, Aleix; Bedini, Jose Luis; Campistol, Josep M

2012-04-01

Longer and more frequent dialysis sessions have demonstrated excellent survival and clinical advantages, while online haemodiafiltration (OL-HDF) provides the most efficient form of dialysis treatment. The aim of this study was to evaluate the beneficial effects of a longer (nocturnal) and more frequent (every-other-day) dialysis schedule with OL-HDF at the same or the highest convective volume. This prospective, in-centre crossover study was carried out in 26 patients, 18 males and 8 females, 49.2±14 years old, on 4-5 h thrice-weekly post-dilution OL-HDF, switched to nocturnal every-other-day OL-HDF. Patient inclusion criteria consisted of stable patients with good vascular access and with good prospects for improved occupational, psychological and social rehabilitation. Patients were randomly assigned into two groups: Group A received the same convective volume as previously for 6 months followed by a higher convective volume for a further 6 months, while Group B received the same schedule in reverse order. Nocturnal every-other-day OL-HDF was well tolerated and 56% of patients who were working during the baseline period continued to work throughout the study with practically no absenteeism. The convective volume was 26.7±2 L at baseline, 27.5±2 with the unchanged volume and 42.9±4 L with the higher volume. eKt/V increased from 1.75±0.4 to 3.37±0.9. Bicarbonate, blood urea nitrogen (BUN) and creatinine values decreased, while phosphate levels fell markedly with a 90% reduction in phosphate binders. Blood pressure and left ventricular hypertrophy (LVH) improved and the use of anti-hypertensive drugs decreased. In both groups, BUN, creatinine and β2-microglobulin reduction ratios improved. Different removal patterns were observed for myoglobin, prolactin and α1-acid glycoprotein. Nocturnal every-other-day OL-HDF could be an excellent therapeutic alternative since good tolerance and occupational rehabilitation, marked improvement in dialysis dose, nutritional status, LVH, phosphate and hypertension control and a substantial reduction in drug requirements were observed. In this crossover study, different removal patterns of large solutes were identified.

A Randomized Crossover Trial of Dietary Sodium Restriction in Stage 3–4 CKD

PubMed Central

Padilla, Robin L.; Gillespie, Brenda W.; Heung, Michael; Hummel, Scott L.; Derebail, Vimal Kumar; Pitt, Bertram; Levin, Nathan W.; Zhu, Fansan; Abbas, Samer R.; Liu, Li; Kotanko, Peter; Klemmer, Philip

2017-01-01

Background and objectives Patients with chronic kidney disease (CKD) are often volume expanded and hypertensive. Few controlled studies have assessed the effects of a sodium-restricted diet (SRD) in CKD. Design, setting, participants, & measurements We conducted a randomized crossover trial to evaluate the effect of SRD (target <2 g sodium per day) versus usual diet on hydration status (by bioelectrical impedance spectroscopy) and blood pressure (BP) between May of 2009 and May of 2013. A total of 58 adults with stage 3–4 CKD were enrolled from two academic sites: University of Michigan (n=37) and University of North Carolina at Chapel Hill (n=21); 60% were men, 43% were diabetic, 93% were hypertensive, and mean age was 61 years. Participants followed SRD or usual diet for 4 weeks, followed by a 2-week washout period and a 4-week crossover phase. During the SRD, dieticians provided counseling every 2 weeks, using motivational interviewing techniques. Results Whole-body extracellular volume and calf intracellular volume decreased by 1.02 L (95% confidence interval [95% CI], −1.48 to −0.56; P<0.001) and −0.06 L (95% CI, −0.12 to −0.01; P=0.02), respectively, implying decreased fluid content on the SRD compared with usual diet. Significant reductions in urinary sodium (−57.3 mEq/24 h; 95% CI, −81.8 to −32.9), weight (−2.3 kg; 95% CI, −3.2 to −1.5), and 24-hour systolic BP (−10.8 mmHg; 95% CI, −17.0 to −4.6) were also observed (all P<0.01). Albumin-to-creatinine ratio did not change significantly and mean serum creatinine increased slightly (0.1 mg/dl; 95% CI, −0.01 to 0.2; P=0.06). No period or carryover effects were observed. Results were similar when analyzed from phase 1 only before crossover, although P values were modestly larger because of the loss of power. Conclusions In this randomized crossover trial, implementation of SRD in patients with CKD stage 3–4 resulted in clinically and statistically significant improvement in BP and hydration status. This simple dietary intervention merits a larger trial in CKD to evaluate effects on major clinical outcomes. PMID:28209636

Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial.

PubMed

Hecking, Manfred; Antlanger, Marlies; Winnicki, Wolfgang; Reiter, Thomas; Werzowa, Johannes; Haidinger, Michael; Weichhart, Thomas; Polaschegg, Hans-Dietrich; Josten, Peter; Exner, Isabella; Lorenz-Turnheim, Katharina; Eigner, Manfred; Paul, Gernot; Klauser-Braun, Renate; Hörl, Walter H; Sunder-Plassmann, Gere; Säemann, Marcus D

2012-06-08

Data generated with the body composition monitor (BCM, Fresenius) show, based on bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated with poor survival. However, removing excess fluid by lowering dry weight can be accompanied by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that, in comparison to conventional hemodialysis, blood volume-monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) will decrease complications when ultrafiltration volumes are systematically increased in fluid-overloaded hemodialysis patients. BCM measurements yield results on fluid overload (in liters), relative to extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel-group, crossover, randomized, controlled clinical trial, we use BCM measurements, routinely introduced in our three maintenance hemodialysis centers shortly prior to the start of the study, to recruit sixty hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, 'final' dry weight is set to normohydration weight -7% of ECW postdialysis, and reached by reducing the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase). In case of intradialytic complications, dry weight reduction is decreased, according to a prespecified algorithm. A comparison of intra- and post-dialytic complications among study groups constitutes the primary endpoint. In addition, we will assess relative weight reduction, changes in residual renal function, quality of life measures, and predialysis levels of various laboratory parameters including C-reactive protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary outcome parameters). Patients are not requested to revert to their initial degree of fluid overload after each study phase. Therefore, the crossover design of the present study merely serves the purpose of secondary endpoint evaluation, for example to determine patient choice of treatment modality. Previous studies on blood volume monitoring have yielded inconsistent results. Since we include only patients with BCM-determined fluid overload, we expect a benefit for all study participants, due to strict fluid management, which decreases the mortality risk of hemodialysis patients. ClinicalTrials.gov, NCT01416753.

Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Data generated with the body composition monitor (BCM, Fresenius) show, based on bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated with poor survival. However, removing excess fluid by lowering dry weight can be accompanied by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that, in comparison to conventional hemodialysis, blood volume-monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) will decrease complications when ultrafiltration volumes are systematically increased in fluid-overloaded hemodialysis patients. Methods/design BCM measurements yield results on fluid overload (in liters), relative to extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel-group, crossover, randomized, controlled clinical trial, we use BCM measurements, routinely introduced in our three maintenance hemodialysis centers shortly prior to the start of the study, to recruit sixty hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, ‘final’ dry weight is set to normohydration weight −7% of ECW postdialysis, and reached by reducing the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase). In case of intradialytic complications, dry weight reduction is decreased, according to a prespecified algorithm. A comparison of intra- and post-dialytic complications among study groups constitutes the primary endpoint. In addition, we will assess relative weight reduction, changes in residual renal function, quality of life measures, and predialysis levels of various laboratory parameters including C-reactive protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary outcome parameters). Discussion Patients are not requested to revert to their initial degree of fluid overload after each study phase. Therefore, the crossover design of the present study merely serves the purpose of secondary endpoint evaluation, for example to determine patient choice of treatment modality. Previous studies on blood volume monitoring have yielded inconsistent results. Since we include only patients with BCM-determined fluid overload, we expect a benefit for all study participants, due to strict fluid management, which decreases the mortality risk of hemodialysis patients. Trial registration ClinicalTrials.gov, NCT01416753 PMID:22682149

Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial

PubMed Central

Morgan, Sara J.; McDonald, Cody L.; Halsne, Elizabeth G.; Cheever, Sarah M.; Salem, Rana; Kramer, Patricia A.

2018-01-01

Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p < .001). Participants also exhibited longer sound side steps in XF compared to ESF (p < .001). Most participants (89%) reported an overall preference for XF; others (11%) reported no preference. Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of mobility activities. Trial registration: ClinicalTrials.gov NCT02440711 PMID:29414988

Low-dose lisinopril in normotensive men with idiopathic oligospermia and infertility: a 5-year randomized, controlled, crossover pilot study.

PubMed

Mbah, A U; Ndukwu, G O; Ghasi, S I; Shu, E N; Ozoemena, F N; Mbah, J O; Onodugo, O D; Ejim, E C; Eze, M I; Nkwo, P O; Okonkwo, P O

2012-04-01

The outcomes of drug treatment for male infertility remain conjectural, with controversial study results. Our pilot study employed a randomized, placebo-controlled, crossover methodology with intention-to-treat analysis. Thirty-three men with idiopathic oligospermia were randomized to start either daily oral lisinopril 2.5 mg (n = 17) or daily oral placebo (n = 16). Lisinopril was found to cause a normalization of seminal parameters in 53.6% of the participants. Although the mean ejaculate volume was unchanged (P ≥ 0.093), the total sperm cell count and the percentage of motile sperm cells increased (P ≤ 0.03 and P < 0.001, respectively), whereas the percentage of sperm cells with abnormal morphology decreased (P ≤ 0.04). The pregnancy rate was 48.5%, and there was no serious adverse drug event. It is concluded, albeit cautiously, that prolonged treatment with 2.5 mg/day of oral lisinopril may be well tolerated in normotensive men with idiopathic oligospermia, may improve sperm quantity and quality, and may enhance fertility in approximately half of those treated.

Tolerance of beta blocked hypertensives during orthostatic and altitude stress.

DOT National Transportation Integrated Search

1992-04-01

To evaluate the effects of orthostatic, altitude, and pharmacologic stresses upon civil aviation-specific performance, a double-blind, randomized, crossover trial of atenolol, 100mg, was designed and executed. Hypertensive males are females qualifyin...

Background Material for the Human Studies Review Board's Review of Ezratty 2014

EPA Pesticide Factsheets

Journal article and details of EPA's science and ethics reviews of the study by Ezratty et al. from 2014: Repeated Nitrogen Dioxide Exposures and Eosinophilic Airway Inflammation in Asthmatics: A Randomized Crossover Study.

Peer Assessment Enhances Student Learning: The Results of a Matched Randomized Crossover Experiment in a College Statistics Class.

PubMed

Sun, Dennis L; Harris, Naftali; Walther, Guenther; Baiocchi, Michael

2015-01-01

Feedback has a powerful influence on learning, but it is also expensive to provide. In large classes it may even be impossible for instructors to provide individualized feedback. Peer assessment is one way to provide personalized feedback that scales to large classes. Besides these obvious logistical benefits, it has been conjectured that students also learn from the practice of peer assessment. However, this has never been conclusively demonstrated. Using an online educational platform that we developed, we conducted an in-class matched-set, randomized crossover experiment with high power to detect small effects. We establish that peer assessment causes a small but significant gain in student achievement. Our study also demonstrates the potential of web-based platforms to facilitate the design of high-quality experiments to identify small effects that were previously not detectable.

Breath-stacking and incentive spirometry in Parkinson's disease: Randomized crossover clinical trial.

PubMed

Ribeiro, Rhayssa; Brandão, Daniella; Noronha, Jéssica; Lima, Cibelle; Fregonezi, Guilherme; Resqueti, Vanessa; Dornelas de Andrade, Arméle

2018-05-01

Patients with Parkinson's disease often exhibit respiratory disorders and there are no Respiratory Therapy protocols which are suggested as interventions in Parkinson's patients. The aim of this study is to evaluate the effects of Breathing-Stacking (BS) and incentive spirometer (IS) techniques in volume variations of the chest wall in patients with Parkinson's Disease (PD). 14 patients with mild-moderate PD were included in this randomized cross-over study. Volume variations of the chest wall were assessed before, immediately after, then 15 and 30 min after BS and IS performance by optoelectronic plethysmography. Tidal volume (VT) and minute ventilation (MV) significantly increased after BS and IS techniques (p < 0.05). There was greater involvement of pulmonary and abdominal compartments after IS. The results suggest that these re-expansion techniques can be performed to immediately improve volume. Copyright © 2018 Elsevier B.V. All rights reserved.

Impact of the Cognitive-Functional (Cog-Fun) Intervention on Executive Functions and Participation Among Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Trial.

PubMed

Hahn-Markowitz, Jeri; Berger, Itai; Manor, Iris; Maeir, Adina

We examined the effect of the Cognitive-Functional (Cog-Fun) occupational therapy intervention on executive functions and participation among children with attention deficit hyperactivity disorder (ADHD). We used a randomized, controlled study with a crossover design. One hundred and seven children age 7-10 yr diagnosed with ADHD were allocated to treatment or wait-list control group. The control group received treatment after a 3-mo wait. Outcome measures included the Behavior Rating Inventory of Executive Function (BRIEF) and the Canadian Occupational Performance Measure (COPM). Significant improvements were found on both the BRIEF and COPM after intervention with large treatment effects. Before crossover, significant Time × Group interactions were found on the BRIEF. This study supports the effectiveness of the Cog-Fun intervention in improving executive functions and participation among children with ADHD. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Explicit Bias Toward High-Income-Country Research: A Randomized, Blinded, Crossover Experiment Of English Clinicians.

PubMed

Harris, Matthew; Marti, Joachim; Watt, Hillary; Bhatti, Yasser; Macinko, James; Darzi, Ara W

2017-11-01

Unconscious bias may interfere with the interpretation of research from some settings, particularly from lower-income countries. Most studies of this phenomenon have relied on indirect outcomes such as article citation counts and publication rates; few have addressed or proven the effect of unconscious bias in evidence interpretation. In this randomized, blinded crossover experiment in a sample of 347 English clinicians, we demonstrate that changing the source of a research abstract from a low- to a high-income country significantly improves how it is viewed, all else being equal. Using fixed-effects models, we measured differences in ratings for strength of evidence, relevance, and likelihood of referral to a peer. Having a high-income-country source had a significant overall impact on respondents' ratings of relevance and recommendation to a peer. Unconscious bias can have far-reaching implications for the diffusion of knowledge and innovations from low-income countries.

A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.

PubMed

Rao, Sunil V; Hess, Connie N; Barham, Britt; Aberle, Laura H; Anstrom, Kevin J; Patel, Tejan B; Jorgensen, Jesse P; Mazzaferri, Ernest L; Jolly, Sanjit S; Jacobs, Alice; Newby, L Kristin; Gibson, C Michael; Kong, David F; Mehran, Roxana; Waksman, Ron; Gilchrist, Ian C; McCourt, Brian J; Messenger, John C; Peterson, Eric D; Harrington, Robert A; Krucoff, Mitchell W

2014-08-01

This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparisons on Efficacy of Elcatonin and Limaprost Alfadex in Patients with Lumbar Spinal Stenosis and Concurrent Osteoporosis: A Preliminary Study Using a Crossover Design

PubMed Central

Imajo, Yasuaki; Suzuki, Hidenori; Yoshida, Yuichiro; Taguchi, Toshihiko; Tominaga, Toshikatsu; Toyoda, Koichiro

2014-01-01

Study Design Multicenter prospective study with a crossover design. Purpose The objective of this study is to compare the efficacy of limaprost alfadex (LP) and elcatonin (EL) for lumbar spinal stenosis (LSS) patients with concurrent osteoporosis. Overview of Literature It has been increasingly important to improve quality of life by establishing appropriate conservative treatments for LSS patients with concurrent osteoporosis who will presumably continue to increase due to the percentage of the aging elevations, however there is no prospective study. Methods A total of 19 patients with LSS and concurrent osteoporosis were enrolled in this study. The patients were divided into two groups and compared using a crossover design. The Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and short-form (SF)-8 health survey scale were used for clinical evaluations. Results There was a significant improvement of buttock-leg pain and numbness in the EL group. A significant improvement of impaired walking function was noted for the LP group according to the JOABPEQ while the rest of the items in the JOABPEQ showed no significant differences. The SF-8 health survey revealed that somatic pains and physical summary scores in the EL group and physical functioning and physical summary scores in the LP group tended to improve but not to any statistically significant extents. Conclusions Concomitant uses of EL may be useful in patients who do not respond satisfactorily to the treatments of LP for 6-8 weeks. PMID:25187864

Diagnostic stability of autism spectrum disorder in toddlers prospectively identified in a community-based setting: Behavioural characteristics and predictors of change over time.

PubMed

Barbaro, Josephine; Dissanayake, Cheryl

2017-10-01

Autism spectrum disorder diagnoses in toddlers have been established as accurate and stable across time in high-risk siblings and clinic-referred samples. Few studies have investigated diagnostic stability in children prospective identified in community-based settings. Furthermore, there is a dearth of evidence on the individual behaviours that predict diagnostic change over time. The stability and change of autism spectrum disorder diagnoses were investigated from 24 to 48 months in 77 children drawn from the Social Attention and Communication Study. Diagnostic stability was high, with 88.3% overall stability and 85.5% autism spectrum disorder stability. The behavioural markers at 24 months that contributed to diagnostic shift off the autism spectrum by 48 months included better eye contact, more directed vocalisations, the integration of gaze and directed vocalisations/gestures and higher non-verbal developmental quotient. These four variables correctly predicted 88.7% of children into the autism spectrum disorder-stable and autism spectrum disorder-crossover groups overall, with excellent prediction for the stable group (96.2%) and modest prediction for the crossover group (44.4%). Furthermore, non-verbal developmental quotient at 24 months accounted for the significant improvement across time in 'Social Affect' scores on the Autism Diagnostic Observation Schedule for both groups and was the only unique predictor of diagnostic crossover. These findings contribute to the body of evidence on the feasibility of diagnoses at earlier ages to facilitate children's access to interventions to promote positive developmental outcomes.

Bayesian analysis of time-series data under case-crossover designs: posterior equivalence and inference.

PubMed

Li, Shi; Mukherjee, Bhramar; Batterman, Stuart; Ghosh, Malay

2013-12-01

Case-crossover designs are widely used to study short-term exposure effects on the risk of acute adverse health events. While the frequentist literature on this topic is vast, there is no Bayesian work in this general area. The contribution of this paper is twofold. First, the paper establishes Bayesian equivalence results that require characterization of the set of priors under which the posterior distributions of the risk ratio parameters based on a case-crossover and time-series analysis are identical. Second, the paper studies inferential issues under case-crossover designs in a Bayesian framework. Traditionally, a conditional logistic regression is used for inference on risk-ratio parameters in case-crossover studies. We consider instead a more general full likelihood-based approach which makes less restrictive assumptions on the risk functions. Formulation of a full likelihood leads to growth in the number of parameters proportional to the sample size. We propose a semi-parametric Bayesian approach using a Dirichlet process prior to handle the random nuisance parameters that appear in a full likelihood formulation. We carry out a simulation study to compare the Bayesian methods based on full and conditional likelihood with the standard frequentist approaches for case-crossover and time-series analysis. The proposed methods are illustrated through the Detroit Asthma Morbidity, Air Quality and Traffic study, which examines the association between acute asthma risk and ambient air pollutant concentrations. © 2013, The International Biometric Society.

Self-Administered Computer Therapy for Apraxia of Speech: Two-Period Randomized Control Trial With Crossover.

PubMed

Varley, Rosemary; Cowell, Patricia E; Dyson, Lucy; Inglis, Lesley; Roper, Abigail; Whiteside, Sandra P

2016-03-01

There is currently little evidence on effective interventions for poststroke apraxia of speech. We report outcomes of a trial of self-administered computer therapy for apraxia of speech. Effects of speech intervention on naming and repetition of treated and untreated words were compared with those of a visuospatial sham program. The study used a parallel-group, 2-period, crossover design, with participants receiving 2 interventions. Fifty participants with chronic and stable apraxia of speech were randomly allocated to 1 of 2 order conditions: speech-first condition versus sham-first condition. Period 1 design was equivalent to a randomized controlled trial. We report results for this period and profile the effect of the period 2 crossover. Period 1 results revealed significant improvement in naming and repetition only in the speech-first group. The sham-first group displayed improvement in speech production after speech intervention in period 2. Significant improvement of treated words was found in both naming and repetition, with little generalization to structurally similar and dissimilar untreated words. Speech gains were largely maintained after withdrawal of intervention. There was a significant relationship between treatment dose and response. However, average self-administered dose was modest for both groups. Future software design would benefit from incorporation of social and gaming components to boost motivation. Single-word production can be improved in chronic apraxia of speech with behavioral intervention. Self-administered computerized therapy is a promising method for delivering high-intensity speech/language rehabilitation. URL: http://orcid.org/0000-0002-1278-0601. Unique identifier: ISRCTN88245643. © 2016 American Heart Association, Inc.

An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial.

PubMed

Son, Mi Ju; Im, Hwi-Jin; Ku, Boncho; Lee, Jun-Hwan; Jung, So Young; Kim, Young-Eun; Lee, Sung Bae; Kim, Jun Young; Son, Chang-Gue

2018-01-01

Introduction: Gongjin-dan (GJD) is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans. Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted. Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration ( p = 0.25), but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels ( p = 0.14). Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07) and the Fatigue Severity Scale (FSS, p = 0.13) questionnaires. BFI and FSS scores in the first stage (before the crossover), however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05) after GJD treatment (relative to placebo). GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire ( p = 0.06), with a significant improvement specifically in the condition "Getting To Sleep" ( p = 0.02). Five participants experienced minor adverse events, but no adverse events were specific to the GJD administration period. Conclusions: This trial produced the first clinical evidence that GJD might have anti-fatigue properties, especially under sleep deprivation; however, the investigation of cortisol-mediated mechanisms requires further larger-scale studies in the future. World Health Organization International Clinical Trials Registry Platform KCT0001681 (http://apps.who.int/trialsearch/Trial2.aspx?TrialID=KCT0001681).

Testing equality and interval estimation in binary responses when high dose cannot be used first under a three-period crossover design.

PubMed

Lui, Kung-Jong; Chang, Kuang-Chao

2015-01-01

When comparing two doses of a new drug with a placebo, we may consider using a crossover design subject to the condition that the high dose cannot be administered before the low dose. Under a random-effects logistic regression model, we focus our attention on dichotomous responses when the high dose cannot be used first under a three-period crossover trial. We derive asymptotic test procedures for testing equality between treatments. We further derive interval estimators to assess the magnitude of the relative treatment effects. We employ Monte Carlo simulation to evaluate the performance of these test procedures and interval estimators in a variety of situations. We use the data taken as a part of trial comparing two different doses of an analgesic with a placebo for the relief of primary dysmenorrhea to illustrate the use of the proposed test procedures and estimators.

Comparative study of 2 electric and 2 manual toothbrushes in patients with fixed orthodontic appliances.

PubMed

Thienpont, V; Dermaut, L R; Van Maele, G

2001-10-01

The objective of this prospective single-blind crossover clinical trial was to evaluate the efficacy of 4 toothbrushes in 33 children undergoing fixed appliance orthodontic therapy. The toothbrushes included in this study were the Braun Oral-B 3D Plaque Remover (Kronberg, Germany), the Philips-Jordan HP 510 (Philips Domestic Appliances, Groningen, The Netherlands), the Lactona orthodontic toothbrush (Bergen op Zoom, The Netherlands), and the Oral-B Advantage Control Grip (Braun); the first 2 are electric, and the last 2 are manual. Every patient tested each type of toothbrush in a randomly designed sequence. Plaque and gingival scores were recorded at baseline and after every 4-week test period. All patients received professional prophylaxis after each clinical evaluation. The data were analyzed with the Friedman test, which showed no significant differences among the 4 brushes for any of the parameters measured. The Wilcoxon signed rank test, comparing the plaque and the gingival scores between the upper and lower jaw for each brush, indicated that plaque removal was more efficient in the lower jaw than in the upper.

Celecoxib, a specific COX-2 inhibitor, has no significant effect on methotrexate pharmacokinetics in patients with rheumatoid arthritis.

PubMed

Karim, A; Tolbert, D S; Hunt, T L; Hubbard, R C; Harper, K M; Geis, G S

1999-12-01

To determine the effects of celecoxib, a specific inhibitor of cyclooxygenase 2 (COX-2) on the renal clearance and plasma pharmacokinetic profile of stable methotrexate (MTX) doses in patients with rheumatoid arthritis (RA). Fourteen adult female patients with RA taking a stable weekly dose of MTX (5 to 15 mg/wk) for a minimum of 3 months were randomized to receive concomitantly either celecoxib (200 mg BID) or placebo for a period of 7 days in a single blind, 2 period crossover study of MTX pharmacokinetics and renal clearance. The plasma pharmacokinetic profile of MTX did not change significantly when celecoxib or a placebo was coadministered. The mean renal clearance of MTX alone, 7.98+/-2.18 l/h, was virtually unchanged by coadministration of celecoxib (7.94+/-1.61 l/h) or placebo (7.97+/-1.19 l/h). Celecoxib has no significant effect on the pharmacokinetics or renal clearance of MTX in patients with RA, although these results should be confirmed in prospective studies of elderly and renally impaired patients.

Consumption of high-fat meal containing cheese compared with vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomized controlled cross-over study

USDA-ARS?s Scientific Manuscript database

Dietary recommendations suggest decreased consumption of SFA to minimize CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomized...

An in silico approach helped to identify the best experimental design, population, and outcome for future randomized clinical trials.

PubMed

Bajard, Agathe; Chabaud, Sylvie; Cornu, Catherine; Castellan, Anne-Charlotte; Malik, Salma; Kurbatova, Polina; Volpert, Vitaly; Eymard, Nathalie; Kassai, Behrouz; Nony, Patrice

2016-01-01

The main objective of our work was to compare different randomized clinical trial (RCT) experimental designs in terms of power, accuracy of the estimation of treatment effect, and number of patients receiving active treatment using in silico simulations. A virtual population of patients was simulated and randomized in potential clinical trials. Treatment effect was modeled using a dose-effect relation for quantitative or qualitative outcomes. Different experimental designs were considered, and performances between designs were compared. One thousand clinical trials were simulated for each design based on an example of modeled disease. According to simulation results, the number of patients needed to reach 80% power was 50 for crossover, 60 for parallel or randomized withdrawal, 65 for drop the loser (DL), and 70 for early escape or play the winner (PW). For a given sample size, each design had its own advantage: low duration (parallel, early escape), high statistical power and precision (crossover), and higher number of patients receiving the active treatment (PW and DL). Our approach can help to identify the best experimental design, population, and outcome for future RCTs. This may be particularly useful for drug development in rare diseases, theragnostic approaches, or personalized medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

Energy expenditure in growing preterm infants receiving massage therapy.

PubMed

Lahat, Sharon; Mimouni, Francis B; Ashbel, Gina; Dollberg, Shaul

2007-08-01

Massage therapy has been consistently shown to increase weight gain in preterm infants. The mechanism of this presumed improved metabolic efficiency is unknown. We conducted the following trial to test the hypothesis that massage therapy reduces energy expenditure in growing healthy preterm infants. A prospective, randomized, cross-over design study was conducted in 10 healthy, appropriate weights for gestational age, gavage fed preterm infants. Each infant was studied twice: after a period of either 5 days of massage therapy, or after a period of 5 days without massage therapy. Infants were randomized to 5 days of massage followed by 5 days of no massage (n = 5) or the opposite sequence (n = 5). During the massage therapy period, massage was provided daily for three 15 minute periods at the beginning of each 3 hour period every morning. Metabolic measurements were performed by indirect calorimetry, using the Deltatrac II Metabolic cart. Energy expenditure was significantly lower in infants after the 5 day massage therapy period (59.6 +/- 3.6 Kcal/Kg/ 24 hours) than after the period without (63.1 +/- 5.4 Kcal/Kg/ 24 hours) (p = 0.05). Energy expenditure is significantly lowered by 5 days of massage therapy in metabolically and thermally stable preterm infants. This decrease in energy expenditure may be in part responsible for the enhanced growth caused by massage therapy.

The comparison of the diuretic and natriuretic efficacy of continuous and bolus intravenous furosemide in patients with chronic kidney disease.

PubMed

Sanjay, Srinivas; Annigeri, Rajeev A; Seshadri, Rajagopalan; Rao, Budithi Subba; Prakash, Kowdle C; Mani, Muthu Krishna

2008-06-01

To compare natriuretic, kaliuretic, diuretic and free water clearance efficacy of continuous versus bolus intravenous furosemide administration in patients with chronic renal insufficiency. In a prospective randomized cross-over trial, 42 patients of chronic renal insufficiency were randomized to receive the same dose of intravenous furosemide as bolus and continuous infusion. The effects of bolus and intravenous administration of furosemide on the volume of urine, sodium and potassium excretion were assessed. Mean age was 53.6 +/- 14 years and 23 (55%) were male. The mean modification of diet in renal disease glomerular filtration rate was 20.5 +/- 17 mL/min per 1.73 m(2). The urinary excretion of sodium in intravenous bolus and infusion was 98.1 +/- 78 and 114.4 +/- 100 mmol, respectively (P = 0.001). Total urinary volume following bolus and infusion of furosemide was 1064 +/- 627 and 1170 +/- 764 mL, respectively (0.001). The excretion of potassium was similar in bolus (15.8 +/- 16.6) and infusion (14.3 +/- 9) administration (P = 0.11). The fractional excretion of sodium was higher following infusion (16.63 +/- 16.1) than bolus administration (12.87 +/- 9) of furosemide (P = 0.016). Continuous intravenous infusion of furosemide has significantly better natriuretic and diuretic effect than bolus administration of the same dose of the drug in patients with advanced chronic renal insufficiency.

Performance of Three Multipurpose Disinfecting Solutions with a Silicone Hydrogel Contact Lens

PubMed Central

García-Porta, Nery; Rico-del-Viejo, Laura; Ferreira-Neves, Helena; Peixoto-de-Matos, Sofia C.; Queirós, Antonio; González-Méijome, José M.

2015-01-01

Purpose. To evaluate the clinical performance of a silicone hydrogel (Si-Hy) soft contact lens (CL) in combination with three different multipurpose disinfecting solutions (MPDSs). Methods. This was a prospective, randomized, single-masked, crossover, and comparative study in which 31 habitual soft CL wearers were randomly assigned to one of the three MPDSs (Synergi, COMPLETE RevitaLens, and OPTI-FREE PureMoist) for 1 month with a 1-week wash-out period between each exposure. All subjects were successfully refitted with a Si-Hy CL (Biofinity). Subjects were then scheduled for follow-up visits after 1 month of lens wear, being evaluated at 2 and 8 hours after lens insertion. Visual Analogue Scales (VAS) were used to gauge comfort rating. Results. The tarsal conjunctiva showed a significantly different degree of lid redness between the MPDSs at the 2-hour visit (P < 0.05, Kruskal-Wallis test), being lower for COMPLETE RevitaLens compared to the other two MPDSs (Mann-Whitney U test). Furthermore, a significantly different degree of lid roughness at the 8-hour visit was seen (P < 0.05, Kruskal-Wallis test), being higher for Synergi (Mann-Whitney U test). The subjective comfort was similar with the three MPDSs. Conclusion. Tarsal conjunctival response should be also considered in the context of the clinical performance of MPDs at the ocular surface. PMID:25918703

A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.

PubMed

Alloway, R R; Sadaka, B; Trofe-Clark, J; Wiland, A; Bloom, R D

2012-10-01

Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken to compare twice-daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC(0-12h) and peak concentration (C(max) ) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97-108%, p = 0.486) for AUC(0-12h) and 1.09 (90% CI 101-118%, p = 0.057) for C(max) . Mean (SD) C(0) was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients

PubMed Central

Alloway, R R; Sadaka, B; Trofe-Clark, J; Wiland, A; Bloom, R D

2012-01-01

Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken to compare twice-daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC0–12h and peak concentration (Cmax) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97–108%, p = 0.486) for AUC0–12h and 1.09 (90% CI 101–118%, p = 0.057) for Cmax. Mean (SD) C0 was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines. PMID:22759200

The effects of anticholinergic drugs on attention span and short-term memory skills in children.

PubMed

Giramonti, Karla M; Kogan, Barry A; Halpern, Leslie F

2008-01-01

Studies have shown cognitive problems in adults treated with anticholinergics. It is unclear if children are also susceptible to anticholinergic adverse effects. This study evaluates the effects of long-acting oxybutynin and tolterodine on short-term memory and attention in children with urgency and urge incontinence. Children with urgency or urge incontinence were recruited to take part in a prospective, randomized double-blinded placebo controlled trial using long-acting oxybutynin or tolterodine. Patients underwent a baseline test of their memory/recall ability and attention span using a standardized developmental/neuropsychological assessment tool. They were then randomized to either medication or placebo with retesting in 2 weeks, at which time they were crossed. They were retested after the second 2 weeks. Fourteen children (9 boys and 5 girls), ranging in age from 5 to 11 (M = 7.7) participated in the study. Attention and memory scores increased over time in all children, however, the analyses showed no significant negative effects of anticholinergic medications on attention or memory. Indeed, though not statistically significant, trends were for improvement in test scores in both areas. Our results in a double blinded cross-over trial suggest that long-acting oxybutynin and tolterodine do not have a deleterious effect on children's attention and memory. Other cognitive functions may be affected. (c) 2007 Wiley-Liss, Inc

Effect of the alpha-glucosidase inhibitor acarbose on control of glycemia in dogs with naturally acquired diabetes mellitus.

PubMed

Nelson, R W; Robertson, J; Feldman, E C; Briggs, C

2000-04-15

To evaluate effect of acarbose on control of glycemia in dogs with diabetes mellitus. Prospective randomized crossover controlled trial. 5 dogs with naturally acquired diabetes mellitus. Dogs were treated with acarbose and placebo for 2 months each: in 1 of 2 randomly assigned treatment sequences. Dogs that weighed < or = 10 kg (22 lb; n = 3) or > 10 kg (2) were given 25 or 50 mg of acarbose, respectively, at each meal for 2 weeks, then 50 or 100 mg of acarbose, respectively, at each meal for 6 weeks, with a 1-month interval between treatments. Caloric intake, type of insulin, and frequency of insulin administration were kept constant, and insulin dosage was adjusted as needed to maintain control of glycemia. Serum glucose concentrations, blood glycosylated hemoglobin concentration, and serum fructosamine concentration were determined. Significant differences in mean body weight and daily insulin dosage among dogs treated with acarbose and placebo were not found. Mean preprandial serum glucose concentration, 8-hour mean serum glucose concentration, and blood glycosylated hemoglobin concentration were significantly lower in dogs treated with insulin and acarbose, compared with insulin and placebo. Semisoft to watery feces developed in 3 dogs treated with acarbose. Acarbose may be useful as an adjunctive treatment in diabetic dogs in which cause for poor glycemic control cannot be identified, and insulin treatment alone is ineffective.

[Acute and persistent antiproteinuric effect of a low-protein diet in chronic kidney disease].

PubMed

Di Iorio, B R; Cucciniello, E; Martino, R; Frallicciardi, A; Tortoriello, R; Struzziero, G

2009-01-01

This study aimed to evaluate the anti-proteinuric effect of a very-low-protein diet supplemented with essential amino acids and keto analogs in patients with moderate to advanced chronic kidney disease and proteinuria already treated with both ACE inhibitors and angiotensin-receptor blockers. The study was a prospective randomized controlled cross-over trial comparing a very-low-protein diet (VLpD) and a low-protein diet (LpD). We enrolled 32 consecutive patients between June 2000 and June 2005. They were randomized to receive a VpLD (group A) or an LpD (group B) for 6 months; thereafter, patients of both groups were switched to the other diet (group A to LpD; group B to VpLD) for a further 6 months. Finally, all patients were randomized again within each group to receive either LpD or VLpD and were followed for another year. The VLpD group showed a significant reduction of urinary protein excretion during the diet period, with a nadir at the fourth month of treatment; the amount of urinary protein reduction was about 58%. Serum advanced glycation end products (AGE) significantly decreased in 10 patients (5 of group A, 5 of group B; -18% and -19%, respectively) during VLpD. Univariate analysis showed that proteinuria correlated indirectly with VpLD and directly with AGE. This study demonstrates that in patients with moderate to advanced chronic kidney disease and severe proteinuria, a VLpD reduces both proteinuria and serum AGE, even in the presence of complete inhibition of the renin-angiotensin system.

The effects of uncoated paper on skin moisture and transepidermal water loss in bedridden patients.

PubMed

Shin, Yong Soon; Kim, Hyun Jung; Moon, Nam-Kyung; Ahn, Young Hee; Kim, Kyoung-Ok

2012-09-01

The aims of this study were to measure skin moisture and transepidermal water loss after application of uncoated paper and to compare skin moisture and transepidermal water loss after use of uncoated paper and disposable underpads. The study was a cross-over, prospective, open-labeled, randomized trial. Bedridden patients aged≥18 years at a medical center in Korea were included. Treatment order was randomly assigned using block randomization, with a block size of 4 and an assignment rate of one-by-one. Skin moisture was measured using a Corneometer 825 and transepidermal water loss was measured using a Tewameter 300. Skin moisture after application of an uncoated paper was significantly lower than observed after application of a disposable underpad (mean 40.6 and SD 13.1 vs. mean 64.6 and SD 23.7, p<0.001). Transepidermal water loss also showed greater health scores after using uncoated paper (mean 11.1 and SD 5.7 g/m2/hour) than after applying a disposable underpad (mean 23.2 and SD 11.1 g/m2 /hour, p<0.001). There were no statistical between-group differences in room temperature, relative humidity, and body temperature. We found that uncoated paper was helpful in avoiding excessive moisture without adverse effects. As indicated by the results of this study, uncoated paper can be applied to bed-ridden patients who required incontinence care. Nurses may consider using uncoated paper as one of nursing methods in the routine care of bed-ridden patients for moisture control. © 2012 Blackwell Publishing Ltd.

Ulcerative colitis patients with an inflammatory response upon mesalazine cannot be desensitized: a randomized study.

PubMed

Buurman, Dorien J; De Monchy, Jan G R; Schellekens, Reinout C A; van der Waaij, Laurens A; Kleibeuker, Jan H; Dijkstra, Gerard

2015-04-01

Mesalazine is a key drug in the treatment of ulcerative colitis (UC). Intolerance to mesalazine has been described, including fever and gastrointestinal symptoms. Several case reports reported successful desensitization of patients with mesalazine intolerance. The aim was to assess the number of UC patients who are persistently intolerant to mesalazine after single-blinded rechallenge and to test the effectiveness of a rapid desensitization protocol in UC patients demonstrated mesalazine intolerance. This is a prospective, single-blind randomized study in UC patients who discontinued mesalazine because of intolerance. Patients with severe reactions were excluded. Eligible patients underwent a skin patch test with mesalazine followed by a single-blinded randomized crossover rechallenge with 500 mg mesalazine or placebo. Patients with symptoms upon rechallenge were admitted to the hospital for 3 days oral desensitization. Nine of the 37 identified UC patients who discontinued mesalazine because of intolerance were included. All nine patients had negative patch tests, seven patients had symptoms (fever, nausea, vomiting and diarrhea) within 2 h upon rechallenge. Four of these seven patients participated in the desensitization protocol and in none a successful desensitization could be performed. All four had an inflammatory intolerance reaction with rise in C-reactive protein. There were no elevations in serum tryptase or urinary-methylhistamine levels observed and no signs of immediate type allergic reactions, like urticaria, bronchial obstruction or anaphylaxis. We recommend not to rechallenge UC patients with an inflammatory response upon mesalazine and these patients will not benefit from a rapid desensitization protocol.

Randomized Trial of Desktop Humidifier for Dry Eye Relief in Computer Users.

PubMed

Wang, Michael T M; Chan, Evon; Ea, Linda; Kam, Clifford; Lu, Yvonne; Misra, Stuti L; Craig, Jennifer P

2017-11-01

Dry eye is a frequently reported problem among computer users. Low relative humidity environments are recognized to exacerbate signs and symptoms of dry eye, yet are common in offices of computer operators. Desktop USB-powered humidifiers are available commercially, but their efficacy for dry eye relief has not been established. This study aims to evaluate the potential for a desktop USB-powered humidifier to improve tear-film parameters, ocular surface characteristics, and subjective comfort of computer users. Forty-four computer users were enrolled in a prospective, masked, randomized crossover study. On separate days, participants were randomized to 1 hour of continuous computer use, with and without exposure to a desktop humidifier. Lipid-layer grade, noninvasive tear-film breakup time, and tear meniscus height were measured before and after computer use. Following the 1-hour period, participants reported whether ocular comfort was greater, equal, or lesser than that at baseline. The desktop humidifier effected a relative difference in humidity between the two environments of +5.4 ± 5.0% (P < .001). Participants demonstrated no significant differences in lipid-layer grade and tear meniscus height between the two environments (all P > .05). However, a relative increase in the median noninvasive tear-film breakup time of +4.0 seconds was observed in the humidified environment (P < .001), which was associated with a higher proportion of subjects reporting greater comfort relative to baseline (36% vs. 5%, P < .001). Even with a modest increase in relative humidity locally, the desktop humidifier shows potential to improve tear-film stability and subjective comfort during computer use.Trial registration no: ACTRN12617000326392.

Effect of a High-Protein, High-Fiber Beverage Preload on Subjective Appetite Ratings and Subsequent Ad Libitum Energy Intake in Overweight Men and Women: A Randomized, Double-Blind Placebo-Controlled, Crossover Study.

PubMed

Sharafi, Mastaneh; Alamdari, Nima; Wilson, Michael; Leidy, Heather J; Glynn, Erin L

2018-06-01

Dietary protein and fiber have been shown to independently improve subjective measures of appetite control. The aim of this study was to determine the acute effects of a high-protein, high-fiber (HP/HFb) beverage taken as a preload compared with an isocaloric lower-protein, lower-fiber (LP/LFb) placebo beverage on subjective appetite ratings and subsequent energy intake at an ad libitum meal in healthy adults. A total of 50 overweight/obese men and women [ n  = 25 men, 25 women; age 30 ± 2 y; body mass index (BMI) 29.6 ± 0.3 kg/m 2 ] received a 160 kcal HP/HFb beverage containing 17 g protein and 6 g fiber on one occasion and an isocaloric LP/LFb placebo beverage containing 1 g protein and 3 g fiber on another occasion in a randomized, double-blind, crossover design. Thirty min after consumption of the beverage preload, an ad libitum pizza meal was provided to be consumed over a 30-min period. Visual analog scales (VAS) were used to assess subjective appetite ratings throughout the testing period. The Revised Restraint Scale (RRS) was used to classify participants as restrained or unrestrained eaters. HP/HFb led to greater reductions in postprandial desire to eat and hunger compared with LP/LFb (both, P  < 0.05) but did not significantly affect postprandial fullness or prospective food consumption. Subsequent meal energy intake tended to be lower after HP/HFb compared with LP/LFb ( P  = 0.09). A subanalysis showed lower energy intake after HP/HFb in older participants (≥25 y) compared with LP/LFb, which was not observed in the younger participants (<25 y). Compared with LP/LFb, a HP/HFb beverage preload reduced hunger, desire to eat, and tended to reduce subsequent food intake. Dietary restraint and age appear to influence subsequent energy intake and should be taken into account when designing nutrition interventions for weight reduction and/or maintenance. This trial was registered at clinicaltrials.gov as NCT02979717.

Orally Formulated Artemisinin in Healthy Fasting Vietnamese Male Subjects: A Randomized, Four-Sequence, Open-Label, Pharmacokinetic Crossover Study

PubMed Central

Hien, Tran Tinh; Hanpithakpong, Warunee; Truong, Nguyen Thanh; Dung, Nguyen Thi; Toi, Pham Van; Farrar, Jeremy; Lindegardh, Niklas; Tarning, Joel; Ashton, Michael

2011-01-01

Background Artemisinin derivatives are used in antimalarial drug combination therapy. Artemisinin and piperaquine have recently been proven to be prospective candidates for combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Objective The goal of this study was to evaluate the relative bioavailability and to characterize the pharmacokinetic properties of a new micronized powder formulation of artemisinin against the previous standard Vietnamese formulation when administered as a single oral dose or in combination with piperaquine. Methods This was a single-center, randomized, 4-sequence, open-label, crossover study conducted in 15 healthy male Vietnamese volunteers under fasting conditions with a washout period of 3 weeks between study visits. A single oral dose of 160 or 500 mg of artemisinin was administered alone or in combination with piperaquine. Potential adverse events were monitored daily by the clinician and by using laboratory test results. Frequent blood samples were drawn for 12 hours after dose. Artemisinin was quantified in plasma using LC-MS/MS. Pharmacokinetic parameters were computed from the plasma concentration–time profiles using a noncompartmental analysis method. Results Pharmacokinetic parameters Tmax, Cmax, AUC0-∞, Vd/F, CL/F, and t1/2 (mean [SD]) for the new formulation of artemisinin were 1.83 (0.88) hours, 178 (97) ng/mL, 504 (210) h × ng/mL, 1270 (780) L, 401 (260) L/h, and 2.21 (0.29) hours, respectively. The mean percentage of the test/reference formulation ratio for the logarithmically transformed values of Cmax, AUC0–last, and AUC0–∞ were 121% (90% CI, 92.5–158), 122% (90% CI, 101–148), and 120% (90% CI, 98.0–146), respectively. Conclusions This single-dose study found that the dose-normalized Cmax, AUC0–last, and AUC0–∞ mean geometric differences between the test and reference formulations were relatively small (<40%) and will probably not have a clinical impact in the treatment of malaria infections. PMID:21665048

Functional short- and long-term effects of nasal CPAP with and without humidification on the ciliary function of the nasal respiratory epithelium.

PubMed

Sommer, J Ulrich; Kraus, Marius; Birk, Richard; Schultz, Johannes D; Hörmann, Karl; Stuck, Boris A

2014-03-01

Continuous positive airway pressure (CPAP) is the gold standard in the treatment of obstructive sleep apnea (OSA), but its impact on ciliary function is unclear to date. Furthermore, CPAP is associated with numerous side effects related to the nose and upper airway. Humidified CPAP is used to relieve these symptoms, but again, little is known regarding its effect on ciliary function of the nasal respiratory epithelium. In this prospective, randomized, crossover trial, 31 patients with OSA (AHI >15/h) were randomized to two treatment arms: nasal continuous positive airway pressure (nCPAP) with humidification or nCPAP without humidification for one night in each modality to assess short-term effects of ciliary beat frequency (CBF) and mucus transport time (MTT) and consecutively for 8 weeks in each modality to assess long-term effects in a crossover fashion. The baseline CBF was 4.8 ± 0.6 Hz, and baseline MTT was 540 ± 221 s. After one night of CPAP with and without humidification, ciliary function increased moderately yet with statistical significance (p <0.05). The short-term groups with and without humidification did not differ statistically significant. Regarding long-term effects of CPAP, a statistically significant increase in ciliary function above the baseline level and above the short-term level was shown without humidification (7.2 ± 0.4 Hz; 402 ± 176 s; p <0.01). The increase above baseline level was even more pronounced with humidification (9.3 ± 0.7 Hz; 313 ± 95 s; p <0.01). There was a statistically significant difference between both groups at long-term assessment with regard to CBF (p <0.01). Independent of airway humidification, nCPAP has moderate effects on short-term ciliary function of the nasal respiratory epithelium. However, a significant increase in ciliary function-both in terms of an increased CBF and a decreased MTT-was detected after long-term use. The effect was more pronounced when humidification was used during nCPAP.

Effect of rosuvastatin on risk markers for venous thromboembolism in cancer.

PubMed

Ades, S; Douce, D; Holmes, C E; Cory, S; Prior, S; Butenas, S; Callas, P; Cushman, M

2018-06-01

Essentials Statins lower venous thromboembolism risk in general but have not been studied in cancer patients. We completed a randomized trial of rosuvastatin vs. placebo among cancer patients on chemotherapy. Rosuvastatin did not significantly lower prothrombotic biomarkers including D-dimer. The role of statins in venous thrombosis prevention in cancer patients remains unknown. Background Statin therapy is associated with lower risk of venous thromboembolism (VTE) but has not been prospectively evaluated in patients with advanced cancer. Objectives We determined if statin administration in this high-risk population reduces the risk of VTE, based on established and emerging biomarkers. Patients/Methods This double-blind, crossover, randomized controlled trial among patients with advanced cancer receiving systemic therapy allocated participants to rosuvastatin 20 mg daily or placebo for 3-4 weeks prior to crossover to the alternative therapy, with a 3-5-week washout. D-dimer, C-reactive protein (CRP), soluble (s)P-selectin, factor VIII (FVIII), thrombin generation and exploratory biomarkers focusing on endogenous thrombin potential, including tissue factor (TF), activated factor IX (FIXa) and activated factor XI (FXIa), were measured at the start and end of both treatment periods. The primary outcome was change in D-dimer with rosuvastatin compared with placebo. Results Of 38 enrolled participants, 24 (63%) completed the study. Rosuvastatin did not cause statistically significant changes in D-dimer levels or any other biomarker. CRP levels decreased by 40%; 4.3 mg L -1 (95% confidence interval, -11.0 to +2.5 mg L -1 ) compared with placebo. In post-hoc analysis, participants who received rosuvastatin initially during their first line of treatment had a 13% decrease in D-dimer. Circulating TF, FIXa and FXIa were detected in 26%, 68% and 71% of cancer patients despite not being found in healthy individuals. Conclusions Rosuvastatin did not cause favorable changes in biomarkers of VTE risk in advanced cancer patients receiving chemotherapy. The role of statin therapy as thromboprophylaxis in the cancer population remains uncertain. © 2018 International Society on Thrombosis and Haemostasis.

Decomposing Multifractal Crossovers

PubMed Central

Nagy, Zoltan; Mukli, Peter; Herman, Peter; Eke, Andras

2017-01-01

Physiological processes—such as, the brain's resting-state electrical activity or hemodynamic fluctuations—exhibit scale-free temporal structuring. However, impacts common in biological systems such as, noise, multiple signal generators, or filtering by transport function, result in multimodal scaling that cannot be reliably assessed by standard analytical tools that assume unimodal scaling. Here, we present two methods to identify breakpoints or crossovers in multimodal multifractal scaling functions. These methods incorporate the robust iterative fitting approach of the focus-based multifractal formalism (FMF). The first approach (moment-wise scaling range adaptivity) allows for a breakpoint-based adaptive treatment that analyzes segregated scale-invariant ranges. The second method (scaling function decomposition method, SFD) is a crossover-based design aimed at decomposing signal constituents from multimodal scaling functions resulting from signal addition or co-sampling, such as, contamination by uncorrelated fractals. We demonstrated that these methods could handle multimodal, mono- or multifractal, and exact or empirical signals alike. Their precision was numerically characterized on ideal signals, and a robust performance was demonstrated on exemplary empirical signals capturing resting-state brain dynamics by near infrared spectroscopy (NIRS), electroencephalography (EEG), and blood oxygen level-dependent functional magnetic resonance imaging (fMRI-BOLD). The NIRS and fMRI-BOLD low-frequency fluctuations were dominated by a multifractal component over an underlying biologically relevant random noise, thus forming a bimodal signal. The crossover between the EEG signal components was found at the boundary between the δ and θ bands, suggesting an independent generator for the multifractal δ rhythm. The robust implementation of the SFD method should be regarded as essential in the seamless processing of large volumes of bimodal fMRI-BOLD imaging data for the topology of multifractal metrics free of the masking effect of the underlying random noise. PMID:28798694

Randomized Crossover Comparison of the Short-Term Efficacy and Safety of Single Half-Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PubMed

Takeshita, Hideki; Moriyama, Shingo; Arai, Yoshiaki; Washino, Satoshi; Saito, Kimitoshi; Chiba, Koji; Horiuchi, Susumu; Noro, Akira

2016-01-01

To compare the efficacy and safety of single half-dose silodosin and single full-dose tamsulosin in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). Japanese men aged ≥50 years with LUTS/BPH and an International Prostate Symptom Score (IPSS) of ≥8 were enrolled in the randomized crossover study and divided into silodosin-preceding (S-T) and tamsulosin-preceding (T-S) groups. The S-T group received 4 mg silodosin once daily for 4 weeks followed by 0.2 mg tamsulosin once daily for 4 weeks. The T-S group received the reverse treatment sequence. A washout period prior to drug crossover was not included. Subjective and objective efficacy parameters including IPSS, quality of life (QOL) index, uroflowmetry, and safety were compared between the two groups. Thirty of 34 men (S-T group n = 16; T-S group n = 14) completed the study. Both drugs significantly improved all IPSS items and QOL index in the first treatment period. Subjective improvement in nocturia by silodosin was observed in both the first and crossover treatment periods. Objective improvement in maximum flow rate by silodosin was only observed in the first treatment period. Adverse events occurred more frequently with silodosin than with tamsulosin; however, none of the adverse events required treatment discontinuation. Ejaculation disorders occurred in three participants (10%) and were associated with silodosin use. Single half-dose silodosin has a similar efficacy to full-dose tamsulosin in Japanese men with LUTS/BPH and thus, may represent an effective, safe, and affordable treatment option. © 2015 Wiley Publishing Asia Pty Ltd.

Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up.

PubMed

Cappellini, M Domenica; Bejaoui, Mohamed; Agaoglu, Leyla; Canatan, Duran; Capra, Marcello; Cohen, Alan; Drelichman, Guillermo; Economou, Marina; Fattoum, Slaheddine; Kattamis, Antonis; Kilinc, Yurdanur; Perrotta, Silverio; Piga, Antonio; Porter, John B; Griffel, Louis; Dong, Victor; Clark, Joan; Aydinok, Yesim

2011-07-28

Patients with β-thalassemia require lifelong iron chelation therapy from early childhood to prevent complications associated with transfusional iron overload. To evaluate long-term efficacy and safety of once-daily oral iron chelation with deferasirox, patients aged ≥ 2 years who completed a 1-year, phase 3, randomized trial entered a 4-year extension study, either continuing on deferasirox (deferasirox cohort) or switching from deferoxamine to deferasirox (crossover cohort). Of 555 patients who received ≥ 1 deferasirox dose, 66.8% completed the study; 43 patients (7.7%) discontinued because of adverse events. In patients with ≥ 4 years' deferasirox exposure who had liver biopsy, mean liver iron concentration significantly decreased by 7.8 ± 11.2 mg Fe/g dry weight (dw; n = 103; P < .001) and 3.1 ± 7.9 mg Fe/g dw (n = 68; P < .001) in the deferasirox and crossover cohorts, respectively. Median serum ferritin significantly decreased by 706 ng/mL (n = 196; P < .001) and 371 ng/mL (n = 147; P < .001), respectively, after ≥ 4 years' exposure. Investigator-assessed, drug-related adverse events, including increased blood creatinine (11.2%), abdominal pain (9.0%), and nausea (7.4%), were generally mild to moderate, transient, and reduced in frequency over time. No adverse effect was observed on pediatric growth or adolescent sexual development. This first prospective study of long-term deferasirox use in pediatric and adult patients with β-thalassemia suggests treatment for ≤ 5 years is generally well tolerated and effectively reduces iron burden. This trial was registered at www.clinicaltrials.gov as #NCT00171210.

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

PubMed Central

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

2017-01-01

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

Study for every other day administration of vonoprazan in maintenance treatment of erosive GERD: study protocol for a multicentre randomised cross-over study.

PubMed

Kato, Mototsugu; Ito, Noriko; Demura, Mamiko; Kubo, Kimitoshi; Mabe, Katsuhiro; Harada, Naohiko

2018-01-01

The first drug selected for treatment of gastro-oesophageal reflux disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), but recently, a potassium-competitive acid blocker (P-CAB) was put on the market in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the usefulness of every other day administration or discontinuous administration is expected. This study is a prospective, multicentre, open-label, two-period randomised cross-over study to compare the efficacy and safety of PPI every other day administration and P-CAB every other day administration in 120 patients who receive erosive GERD maintenance therapy with PPI. Patients will be randomly allocated to receive 4 weeks P-CAB or PPI followed by 4 weeks cross over, where those on P-CAB will receive PPI and vice versa. The primary endpoint is proportion of asymptomatic patients. Secondary endpoints are suppressive effect of GERD symptoms, proportion of asymptomatic patients at each time point, safety and cost-saving effect of P-CAB every other day administration, compliance with every other day administration, and proportion of asymptomatic patients at the first month of study drug administration. This study was approved by the National Hospital Organization Central Review Board for Clinical Trials (5 December 2017). If P-CAB every other day administration is established as one of GERD maintenance therapies, there is merit in both medical cost reduction and the safety to alleviate elevation in serum gastrin. UMIN000034701.

Study for every other day administration of vonoprazan in maintenance treatment of erosive GERD: study protocol for a multicentre randomised cross-over study

PubMed Central

Kato, Mototsugu; Ito, Noriko; Demura, Mamiko; Kubo, Kimitoshi; Mabe, Katsuhiro; Harada, Naohiko

2018-01-01

Introduction The first drug selected for treatment of gastro-oesophageal reflux disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), but recently, a potassium-competitive acid blocker (P-CAB) was put on the market in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the usefulness of every other day administration or discontinuous administration is expected. Methods and analysis This study is a prospective, multicentre, open-label, two-period randomised cross-over study to compare the efficacy and safety of PPI every other day administration and P-CAB every other day administration in 120 patients who receive erosive GERD maintenance therapy with PPI. Patients will be randomly allocated to receive 4 weeks P-CAB or PPI followed by 4 weeks cross over, where those on P-CAB will receive PPI and vice versa. The primary endpoint is proportion of asymptomatic patients. Secondary endpoints are suppressive effect of GERD symptoms, proportion of asymptomatic patients at each time point, safety and cost-saving effect of P-CAB every other day administration, compliance with every other day administration, and proportion of asymptomatic patients at the first month of study drug administration. Ethics and dissemination This study was approved by the National Hospital Organization Central Review Board for Clinical Trials (5 December 2017). Discussion If P-CAB every other day administration is established as one of GERD maintenance therapies, there is merit in both medical cost reduction and the safety to alleviate elevation in serum gastrin. Trial registration number UMIN000034701. PMID:29527318

The effects of topical diclofenac, topical flurbiprofen, and humidity on corneal sensitivity in normal dogs.

PubMed

Dorbandt, Daniel M; Labelle, Amber L; Mitchell, Mark A; Hamor, Ralph E

2017-03-01

To determine the immediate and chronic effects of topical 0.1% diclofenac and 0.03% flurbiprofen on corneal sensitivity in normal canine eyes. Eighteen normal, nonbrachycephalic dogs. A prospective, randomized, masked, crossover study was performed. To determine the immediate effects associated with treatment, the study drug was instilled into the eye every 5 min for five doses, and corneal sensitivity of treated and untreated eyes was obtained prior to treatment and every 15 min post-treatment for 60 min. To determine the chronic effects, the study drug was instilled every 12 h for 30 days, and corneal sensitivity of treated and untreated eyes was obtained prior to treatment on days 0 and 30. A washout period of at least 30 days occurred between drug crossover. Ambient temperature and humidity were measured throughout the study. After multiple instillations, there was no difference in corneal sensitivity between eyes over time for diclofenac (P = 0.67) or flurbiprofen (P = 0.54), with a median sensitivity of 25 mm (1.8 g/mm 2 ). After chronic dosing, there was no difference in corneal sensitivity between eyes over time for diclofenac (P = 0.82) or flurbiprofen (P = 0.56), with a median sensitivity of 35 mm (1.0 g/mm 2 ). Decreasing ambient humidity was associated with an increase in sensitivity measurements (P = 0.0001). Neither diclofenac nor flurbiprofen had an effect on corneal sensitivity after multiple-drops or twice-daily dosing for 30 days. Ambient humidity may have an effect on corneal sensitivity measurements, with a longer filament length eliciting a blink response at lower humidity. © 2016 American College of Veterinary Ophthalmologists.

A randomized double-blind placebo-controlled crossover-style trial of buspirone in functional dysphagia and ineffective esophageal motility.

PubMed

Aggarwal, Nitin; Thota, Prashanthi Nagavenkata; Lopez, Rocio; Gabbard, Scott

2018-02-01

Studies suggest that Ineffective Esophageal Motility (IEM) is the manometric correlate of Functional Dysphagia (FD). Currently, there is no accepted therapy for either condition. Buspirone is a serotonin modulating medication and has been shown to augment esophageal peristaltic amplitude in healthy volunteers. We aimed to determine if buspirone improves manometric parameters and symptoms in patients with overlapping IEM/FD. We performed a prospective, double-blind, placebo-controlled, crossover-style trial of 10 patients with IEM/FD. The study consisted of two 2-week treatment arms with a 2-week washout period. Outcomes measured at baseline, end of week 2, and week 6 include high resolution esophageal manometry (HREM), the Mayo Dysphagia Questionnaire-14 (MDQ-14), and the GERD-HRQL. The mean age of our 10 patients was 53 ± 9 years and 70% were female. After treatment with buspirone, 30% of patients had normalization of IEM on manometry; however, there was 30% normalization in the placebo group as well. Comparing buspirone to placebo, there was no statistically significant difference in the HREM parameters measured. There was also no statistically significant difference in symptom outcomes for buspirone compared to placebo. Of note, patients had a statistically significant decrease in the total GERD-HRQL total score when treated with placebo compared to baseline levels. Despite previous data demonstrating improved esophageal motility in healthy volunteers, our study shows no difference in terms of HREM parameters or symptom scores in IEM/FD patients treated with buspirone compared to placebo. Further research is necessary to identify novel agents for this condition. © 2017 John Wiley & Sons Ltd.

The Toronto outcome measure for craniofacial prosthetics: reliability and validity of a condition-specific quality-of-life instrument.

PubMed

Anderson, James D; Johnston, Dennis A; Haugh, Gil S; Kiat-Amnuay, Sudarat; Gettleman, Lawrence

2013-01-01

The purpose of this study was to refine the Toronto Outcome Measure for Craniofacial Prosthetics (TOMCP), present evidence for its reliability and validity, and use the instrument to explore differences in quality of life between prostheses made with chlorinated polyethylene (CPE) (experimental) and silicone (control). As part of a multicenter prospective controlled randomized double-blind single-crossover clinical trial of the two materials, the TOMCP was administered at the start and end of two 4-month study arms, during which 42 patients wore prostheses made from one material then the other. Reliability was assessed at the crossover. To determine validity of the TOMCP, the Linear Analogue Self-Assessment (LASA-12) and the Short-Form 8 (SF-8) were also administered with the TOMCP. The TOMCP was reduced by removing items that were unreliable, had poorly distributed answers, showed increased internal consistency after their removal, or were too highly correlated with more than one other item. The tests of reliability and validity were then repeated. Finally, the reduced instrument was used to test for differences in quality of life between prostheses made of the two materials. The item reduction tactics pared the 52-item instrument down to 27 items. The correlations of both TOMCP versions with the LASA-12 and the SF-8 were found to be statistically significant, providing evidence of the validity of the TOMCP. The instrument revealed significantly better quality of life with silicone rather than CPE prostheses. Both versions of the TOMCP were found to be reliable and valid. The instrument was able to show differences in quality of life between two materials.

Modified Veress needle decompression of tension pneumothorax: a randomized crossover animal study.

PubMed

Lubin, Dafney; Tang, Andrew L; Friese, Randall S; Martin, Matthew; Green, D J; Jones, Trevor; Means, Russell R; Ginwalla, Rashna; O'Keeffe, Terence S; Joseph, Bellal A; Wynne, Julie L; Kulvatunyou, Narong; Vercruysse, Gary; Gries, Lynn; Rhee, Peter

2013-12-01

The current prehospital standard of care using a large bore intravenous catheter for tension pneumothorax (tPTX) decompression is associated with a high failure rate. We developed a modified Veress needle (mVN) for this condition. The purpose of this study was to evaluate the effectiveness and safety of the mVN as compared with a 14-gauge needle thoracostomy (NT) in a swine tPTX model. tPTX was created in 16 adult swine via thoracic CO2 insufflation to 15 mm Hg. After tension physiology was achieved, defined as a 50% reduction of cardiac output, the swine were randomized to undergo either mVN or NT decompression. Failure to restore 80% baseline systolic blood pressure within 5 minutes resulted in crossover to the alternate device. The success rate of each device, death, and need for crossover were analyzed using χ. Forty-three tension events were created in 16 swine (24 mVN, 19 NT) at 15 mm Hg of intrathoracic pressure with a mean CO2 volume of 3.8 L. tPTX resulted in a 48% decline of systolic blood pressure from baseline and 73% decline of cardiac output, and 42% had equalization of central venous pressure with pulmonary capillary wedge pressure. All tension events randomized to mVN were successfully rescued within a mean (SD) of 70 (86) seconds. NT resulted in four successful decompressions (21%) within a mean (SD) of 157 (96) seconds. Four swine (21%) died within 5 minutes of NT decompression. The persistent tension events where the swine survived past 5 minutes (11 of 19 NTs) underwent crossover mVN decompression, yielding 100% rescue. Neither the mVN nor the NT was associated with inadvertent injuries to the viscera. Thoracic insufflation produced a reliable and highly reproducible model of tPTX. The mVN is vastly superior to NT for effective and safe tPTX decompression and physiologic recovery. Further research should be invested in the mVN for device refinement and replacement of NT in the field.

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial.

PubMed

Nel, Annaléne; Martins, Janine; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides.

Modafinil Improves Real Driving Performance in Patients with Hypersomnia: A Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial

PubMed Central

Philip, Pierre; Chaufton, Cyril; Taillard, Jacques; Capelli, Aurore; Coste, Olivier; Léger, Damien; Moore, Nicholas; Sagaspe, Patricia

2014-01-01

Study Objective: Patients with excessive daytime sleepiness (EDS) are at high risk for driving accidents, and physicians are concerned by the effect of alerting drugs on driving skills of sleepy patients. No study has up to now investigated the effect of modafinil (a reference drug to treat EDS in patients with hypersomnia) on on-road driving performance of patients suffering from central hypersomnia. The objective is to evaluate in patients with central hypersomnia the effect of a wake-promoting drug on real driving performance and to assess the relationship between objective sleepiness and driving performance. Design and Participants: Randomized, crossover, double-blind placebo-controlled trial conducted among 13 patients with narcolepsy and 14 patients with idiopathic hypersomnia. Patients were randomly assigned to receive modafinil (400 mg) or placebo for 5 days prior to the driving test. Each condition was separated by at least 3 weeks of washout. Measurements: Mean number of Inappropriate Line Crossings, Standard Deviation of Lateral Position of the vehicle and mean sleep latency in the Maintenance of Wakefulness Test were assessed. Results: Modafinil reduced the mean number of Inappropriate Line Crossings and Standard Deviation of Lateral Position of the vehicle compared to placebo (F(1,25) = 4.88, P < 0.05 and F(1,25) = 3.87, P = 0.06 tendency). Mean sleep latency at the Maintenance of Wakefulness Test significantly correlated with the mean number of Inappropriate Line Crossings (r = -0.41, P < 0.001). Conclusions: Modafinil improves driving performance in patients with narcolepsy and idiopathic hypersomnia. The Maintenance of Wakefulness Test is a suitable clinical tool to assess fitness to drive in this population. Citation: Philip P; Chaufton C; Taillard J; Capelli A; Coste O; Léger D; Moore N; Sagaspe P. Modafinil improves real driving performance in patients with hypersomnia: a randomized double-blind placebo-controlled crossover clinical trial. SLEEP 2014;37(3):483-487. PMID:24587570

Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial

PubMed Central

Nel, Annaléne; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

2018-01-01

Background Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. Objectives This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. Methods 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. Results No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. Conclusions The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides. PMID:29813074

Omega-3/Omega-6 Fatty Acids for Attention Deficit Hyperactivity Disorder: A Randomized Placebo-Controlled Trial in Children and Adolescents

ERIC Educational Resources Information Center

Johnson, Mats; Ostlund, Sven; Fransson, Gunnar; Kadesjo, Bjorn; Gillberg, Christopher

2009-01-01

Objective: The aim of the study was to assess omega 3/6 fatty acids (eye q) in attention deficit hyperactivity disorder (ADHD). Method: The study included a randomized, 3-month, omega 3/6 placebo-controlled, one-way crossover trial with 75 children and adolescents (8-18 years), followed by 3 months with omega 3/6 for all. Investigator-rated ADHD…

Genetic algorithms applied to the scheduling of the Hubble Space Telescope

NASA Technical Reports Server (NTRS)

Sponsler, Jeffrey L.

1989-01-01

A prototype system employing a genetic algorithm (GA) has been developed to support the scheduling of the Hubble Space Telescope. A non-standard knowledge structure is used and appropriate genetic operators have been created. Several different crossover styles (random point selection, evolving points, and smart point selection) are tested and the best GA is compared with a neural network (NN) based optimizer. The smart crossover operator produces the best results and the GA system is able to evolve complete schedules using it. The GA is not as time-efficient as the NN system and the NN solutions tend to be better.

No evidence for differential dose effects of hydrocortisone on intrusive memories in female patients with complex post-traumatic stress disorder--a randomized, double-blind, placebo-controlled, crossover study.

PubMed

Ludäscher, Petra; Schmahl, Christian; Feldmann, Robert E; Kleindienst, Nikolaus; Schneider, Miriam; Bohus, Martin

2015-10-01

Post-traumatic stress disorder is characterized by intrusive traumatic memories. Presently, a controversial debate is ongoing regarding whether reduced cortisol secretion in post-traumatic stress disorder promotes an automatic retrieval of trauma-associated memories. Hence, a pharmacological elevation of cortisol was proposed to decrease post-traumatic stress disorder symptoms, particularly intrusions. The present study investigated the impact of two different doses of hydrocortisone on automatic memory retrieval using a randomized, double-blind, placebo-controlled, crossover study in 30 inpatients with post-traumatic stress disorder. All participants were female and received various psychotropic medications. They were randomly assigned to one of two groups within a crossover design: they received either 1 week placebo followed by 1 week hydrocortisone 10/d, followed by 1 week placebo, followed by hydrocortisone 30 mg/d (15 participants) or 1 week hydrocortisone 30 mg/d, followed by 1 week placebo, followed by 1 week hydrocortisone 10 mg/d, followed by 1 week placebo (15 participants). The outcome measures were the frequency and the intensity of intrusions, the overall symptomatology of post-traumatic stress disorder and the general psychopathology. We did not find any differences in the frequency and the intensity of post-traumatic stress disorder-related intrusions between the 10 mg hydrocortisone, the 30 mg hydrocortisone and the placebo condition. All effect sizes for the hydrocortisone condition vs. placebo were very small. Additionally, the overall symptomatology of post-traumatic stress disorder and the general psychopathology did not differ between the hydrocortisone therapies and placebo. Our results do not show any effect of the hydrocortisone administration on intrusions in complex post-traumatic stress disorder. © The Author(s) 2015.

Small Amounts of Gluten in Subjects With Suspected Nonceliac Gluten Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.

PubMed

Di Sabatino, Antonio; Volta, Umberto; Salvatore, Chiara; Biancheri, Paolo; Caio, Giacomo; De Giorgio, Roberto; Di Stefano, Michele; Corazza, Gino R

2015-09-01

There is debate over the existence of nonceliac gluten sensitivity (NCGS) intestinal and extraintestinal symptoms in response to ingestion of gluten-containing foods by people without celiac disease or wheat allergy. We performed a randomized, double-blind, placebo-controlled, cross-over trial to determine the effects of administration of low doses of gluten to subjects with suspected NCGS. We enrolled 61 adults without celiac disease or a wheat allergy who believed ingestion of gluten-containing food to be the cause of their intestinal and extraintestinal symptoms. Participants were assigned randomly to groups given either 4.375 g/day gluten or rice starch (placebo) for 1 week, each via gastrosoluble capsules. After a 1-week gluten-free diet, participants crossed over to the other group. The primary outcome was the change in overall (intestinal and extraintestinal) symptoms, determined by established scoring systems, between gluten and placebo intake. A secondary outcome was the change in individual symptom scores between gluten vs placebo. According to the per-protocol analysis of data from the 59 patients who completed the trial, intake of gluten significantly increased overall symptoms compared with placebo (P = .034). Abdominal bloating (P = .040) and pain (P = .047), among the intestinal symptoms, and foggy mind (P = .019), depression (P = .020), and aphthous stomatitis (P = .025), among the extraintestinal symptoms, were significantly more severe when subjects received gluten than placebo. In a cross-over trial of subjects with suspected NCGS, the severity of overall symptoms increased significantly during 1 week of intake of small amounts of gluten, compared with placebo. Clinical trial no: ISRCTN72857280. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

A randomized, single-blind cross-over design evaluating the effectiveness of an individually defined, targeted physical therapy approach in treatment of children with cerebral palsy.

PubMed

Franki, Inge; Van den Broeck, Christine; De Cat, Josse; Tijhuis, Wieke; Molenaers, Guy; Vanderstraeten, Guy; Desloovere, Kaat

2014-10-01

A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program. A randomized, single-blind cross-over design. Ten ambulant children with bilateral spastic cerebral palsy, age four to nine years. Participants were randomly assigned into a ten-week individually defined, targeted or a general program, followed by a cross-over. Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis. General outcome parameters were Gross Motor Function Measure-88 scores, time and distance parameters, gait profile score and movement analysis profiles. Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function. No significant changes were observed regarding gross motor function. Only after individualized therapy, step- and stride-length increased significantly (p = 0.022; p = 0.017). Change in step-length was higher after the individualized program (p = 0.045). Within-group effects were found for the pelvis in transversal plane after the individualized program (p = 0.047) and in coronal plane after the general program (p = 0.047). Between-program differences were found for changes in the knee in sagittal plane, in the advantage of the individual program (p = 0.047). A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program, respectively. Functional goal attainment was higher after the individual therapy program compared with the general program (48 to 43.5). The results indicate slightly favorable effects towards the individualized program. To detect clinically significant changes, future studies require a minimal sample size of 72 to 90 participants. © The Author(s) 2014.

Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patients' Global Perceived Effect in Intrathecal Therapy for Pain: A Randomized Double-Blind Crossover Study.

PubMed

Eldabe, Sam; Duarte, Rui V; Madzinga, Grace; Batterham, Alan M; Brookes, Morag E; Gulve, Ashish P; Perruchoud, Christophe; Raphael, Jon H; Lorenzana, David; Buchser, Eric

2017-05-01

Intrathecal drug delivery (ITDD) is commonly used for intractable pain management. A paucity of good-quality studies in chronic noncancer patients and concerns over increased dosages have focused interest on different modes of administration. The aim of this international multicenter randomized double-blind crossover trial was to compare the efficacy of the same daily dose of drugs administered by intermittent boluses vs simple continuous infusion. Eligible patients implanted with a programmable ITDD device were randomized to receive two weeks of either intermittent boluses or a simple continuous flow in period 1, followed by a crossover to the alternative mode of administration. The primary outcome measure was the Patients' Global Impression of Change (PGIC) scale. The mean proportion of positive responders (at least "minimally improved") was 38.4% in the continuous condition vs 37.3% in the bolus (difference in proportions = 1.1%, 95% confidence interval [CI] = -21.8-24.0%, P  = 0.93). The mean PGIC in the continuous condition was 3.8 vs 3.9 in the bolus (mean difference = -0.1, -0.6-0.4, P  = 0.72). Exploratory analyses revealed a tendency for the mean proportion of positive responders to be higher at low vs high flow rates for both bolus and continuous administrations. Two patients were withdrawn from the study due to adverse events during the bolus phase, both with symptoms of increased pain, and one patient with additional symptoms of numbness and urinary retention. The mean PGIC and proportion of positive responders was not substantially different after intermittent bolus vs continuous administration. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study

PubMed Central

Jenkins, Tim M; Smart, Trevor S; Hackman, Frances; Cooke, Carol; Tan, Keith KC

2012-01-01

Background: Detecting the efficacy of novel analgesic agents in neuropathic pain is challenging. There is a critical need for study designs with the desirable characteristics of assay sensitivity, low placebo response, reliable pain recordings, low cost, short duration of exposure to test drug and placebo, and relevant and recruitable population. Methods: We designed a proof-of-concept, double-blind, randomized, placebo-controlled, crossover study in patients with post-traumatic peripheral neuropathic pain (PTNP) to evaluate whether such a study design had the potential to detect efficacious agents. Pregabalin, known to be efficacious in neuropathic pain, was used as the active analgesic. We also assessed physical activity throughout the study. Results: Twenty-five adults (20–70 years of age) with PTNP for ≥3 months entered a screening week and were then randomized to one of the two following treatment sequences: (1) pregabalin followed by placebo or (2) placebo followed by pregabalin. These 2-week treatment periods were separated by a 2-week washout period. Patients on pregabalin treatment received escalating doses to a final dosage of 300 mg/day (days 5–15). In an attempt to minimize placebo response, patients received placebo treatment during the screening week and the 2-week washout period. Average daily pain scores (primary endpoint) were significantly reduced for pregabalin versus placebo, with a mean treatment difference of −0.81 (95% confidence interval: −1.45 to −0.17; P = 0.015). Conclusion: The efficacy of pregabalin was similar to that identified in a large, parallel group trial in PTNP. Therefore, this efficient crossover study design has potential utility for future proof-of-concept studies in neuropathic pain. PMID:22888270

Promising effects of oxytocin on social and food-related behaviour in young children with Prader-Willi syndrome: a randomized, double-blind, controlled crossover trial.

PubMed

Kuppens, R J; Donze, S H; Hokken-Koelega, A C S

2016-12-01

Prader-Willi syndrome (PWS) is known for hyperphagia with impaired satiety and a specific behavioural phenotype with stubbornness, temper tantrums, manipulative and controlling behaviour and obsessive-compulsive features. PWS is associated with hypothalamic and oxytocinergic dysfunction. In humans without PWS, intranasal oxytocin administration had positive effects on social and eating behaviour, and weight balance. To evaluate the effects of intranasal oxytocin compared to placebo administration on social behaviour and hyperphagia in children with PWS. Randomized, double-blind, placebo-controlled, crossover study in a PWS Reference Center in the Netherlands. Crossover intervention with twice daily intranasal oxytocin (dose range 24-48 IU/day) and placebo administration, both during 4 weeks, in 25 children with PWS (aged 6 to 14 years). In the total group, no significant effects of oxytocin on social behaviour or hyperphagia were found, but in the 17 children younger than 11 years, parents reported significantly less anger (P = 0·001), sadness (P = 0·005), conflicts (P = 0·010) and food-related behaviour (P = 0·011), and improvement of social behaviour (P = 0·018) during oxytocin treatment compared with placebo. In the eight children older than 11 years, the items happiness (P = 0·039), anger (P = 0·042) and sadness (P = 0·042) were negatively influenced by oxytocin treatment compared to placebo. There were no side effects or adverse events. This randomized, double-blind, placebo-controlled study suggests that intranasal oxytocin administration has beneficial effects on social behaviour and food-related behaviour in children with PWS younger than 11 years of age, but not in those older than 11 years of age. © 2016 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial.

PubMed

Ross, Stephen; Bossis, Anthony; Guss, Jeffrey; Agin-Liebes, Gabrielle; Malone, Tara; Cohen, Barry; Mennenga, Sarah E; Belser, Alexander; Kalliontzi, Krystallia; Babb, James; Su, Zhe; Corby, Patricia; Schmidt, Brian L

2016-12-01

Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks. Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60-80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression. In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress. ClinicalTrials.gov Identifier: NCT00957359. © The Author(s) 2016.

Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial

PubMed Central

Ross, Stephen; Bossis, Anthony; Guss, Jeffrey; Agin-Liebes, Gabrielle; Malone, Tara; Cohen, Barry; Mennenga, Sarah E; Belser, Alexander; Kalliontzi, Krystallia; Babb, James; Su, Zhe; Corby, Patricia; Schmidt, Brian L

2016-01-01

Background: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. Methods: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks. Results: Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60–80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression. Conclusions: In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress. Trial Registration: ClinicalTrials.gov Identifier: NCT00957359 PMID:27909164

Test equality in binary data for a 4 × 4 crossover trial under a Latin-square design.

PubMed

Lui, Kung-Jong; Chang, Kuang-Chao

2016-10-15

When there are four or more treatments under comparison, the use of a crossover design with a complete set of treatment-receipt sequences in binary data is of limited use because of too many treatment-receipt sequences. Thus, we may consider use of a 4 × 4 Latin square to reduce the number of treatment-receipt sequences when comparing three experimental treatments with a control treatment. Under a distribution-free random effects logistic regression model, we develop simple procedures for testing non-equality between any of the three experimental treatments and the control treatment in a crossover trial with dichotomous responses. We further derive interval estimators in closed forms for the relative effect between treatments. To evaluate the performance of these test procedures and interval estimators, we employ Monte Carlo simulation. We use the data taken from a crossover trial using a 4 × 4 Latin-square design for studying four-treatments to illustrate the use of test procedures and interval estimators developed here. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Antioxidants intake and dry eye syndrome: a crossover, placebo-controlled, randomized trial.

PubMed

Drouault-Holowacz, Sophie; Bieuvelet, Séverine; Burckel, André; Rigal, Danièle; Dubray, Claude; Lichon, Jean-Louis; Bringer, Paul; Pilon, Francois; Chiambaretta, Frédéric

2009-01-01

To assess whether an orally administered antioxidant dietary supplement could improve the objective clinical signs and alleviate the subjective symptoms of dry eye syndrome. Twenty-four subjects diagnosed with dry eye syndrome were randomized in a crossover, double-blind, controlled, randomized study to receive a placebo or an antioxidants combination (Oxybiane) for 12 weeks. In all subjects, break-up time (BUT) test, Schirmer test, ocular symptoms (sore eyes, burning, itching, sensation of foreign object in the eye, photophobia, sticky eyes, and redness), visual comfort, and general well-being were evaluated weekly. After 12 weeks of supplementation with Oxybiane, both the BUT scores (27.3%+/-8.4% with Oxybiane versus 3.61%+/-4.3% with the placebo, p=0.017) and the Schirmer scores (26.9%+/-14.2% with Oxybiane versus -4.7%+/-3.4% with the placebo, p=0.037) were significantly increased. A significantly improvement was also observed considering subjective clinical symptoms such as burning (p=0.031), itching (p=0.027), sensation of foreign body in eye (p=0.030), and redness (p=0.043). CONCLUSIONS. Supplementation with oral antioxidants can improve both tear stability and quantity but also subjective clinical signs.

Ebselen does not improve oxidative stress and vascular function in patients with diabetes: a randomized, crossover trial.

PubMed

Beckman, Joshua A; Goldfine, Allison B; Leopold, Jane A; Creager, Mark A

2016-12-01

Oxidative stress is a key driver of vascular dysfunction in diabetes mellitus. Ebselen is a glutathione peroxidase mimetic. A single-site, randomized, double-masked, placebo-controlled, crossover trial was carried out in 26 patients with type 1 or type 2 diabetes to evaluate effects of high-dose ebselen (150 mg po twice daily) administration on oxidative stress and endothelium-dependent vasodilation. Treatment periods were in random order of 4 wk duration, with a 4-wk washout between treatments. Measures of oxidative stress included nitrotyrosine, plasma 8-isoprostanes, and the ratio of reduced to oxidized glutathione. Vascular ultrasound of the brachial artery and plethysmographic measurement of blood flow were used to assess flow-mediated and methacholine-induced endothelium-dependent vasodilation of conduit and resistance vessels, respectively. Ebselen administration did not affect parameters of oxidative stress or conduit artery or forearm arteriolar vascular function compared with placebo treatment. There was no difference in outcome by diabetes type. Ebselen, at the dose and duration evaluated, does not improve the oxidative stress profile, nor does it affect endothelium-dependent vasodilation in patients with diabetes mellitus. Copyright © 2016 the American Physiological Society.

A Feasibility Randomized Controlled Crossover Trial of Home-Based Warm Footbath to Improve Sleep in the Chronic Phase of Traumatic Brain Injury.

PubMed

Chiu, Hsiao-Yean; Lin, En-Yuan; Chiu, Hsiao-Ting; Chen, Pin-Yuan

2017-12-01

Sleep disturbance is a common complaint after traumatic brain injury (TBI). The aim of this study was to examine the effects of a home-based warm footbath intervention on sleep in patients with TBI. This was a randomized controlled crossover study, and 23 adults with TBI were recruited and randomized to receive first a 30-minute, 41°C warm footbath and then a usual care, or vice versa, with each lasting 3 days and separated by a 3-day washout. Sleep efficiency, sleep onset latency (SOL), total sleep time, and wake after sleep onset (WASO) were assessed by actigraphy. We found that home-based warm footbath significantly had a reduced SOL (difference, -5.11 minutes) and a suppressed WASO (difference, -2.57 minutes) compared with those of usual care, but not in sleep efficiency and total sleep time. No adverse effect was reported. This study suggested that home-based warm footbath is practical and effective in relieving post-TBI sleep disturbances, particular in SOL and WASO. Nurses can use home-based warm footbath as an effective intervention for management of sleep disturbances after TBI.

Normal and tumoral melanocytes exhibit q-Gaussian random search patterns.

PubMed

da Silva, Priscila C A; Rosembach, Tiago V; Santos, Anésia A; Rocha, Márcio S; Martins, Marcelo L

2014-01-01

In multicellular organisms, cell motility is central in all morphogenetic processes, tissue maintenance, wound healing and immune surveillance. Hence, failures in its regulation potentiates numerous diseases. Here, cell migration assays on plastic 2D surfaces were performed using normal (Melan A) and tumoral (B16F10) murine melanocytes in random motility conditions. The trajectories of the centroids of the cell perimeters were tracked through time-lapse microscopy. The statistics of these trajectories was analyzed by building velocity and turn angle distributions, as well as velocity autocorrelations and the scaling of mean-squared displacements. We find that these cells exhibit a crossover from a normal to a super-diffusive motion without angular persistence at long time scales. Moreover, these melanocytes move with non-Gaussian velocity distributions. This major finding indicates that amongst those animal cells supposedly migrating through Lévy walks, some of them can instead perform q-Gaussian walks. Furthermore, our results reveal that B16F10 cells infected by mycoplasmas exhibit essentially the same diffusivity than their healthy counterparts. Finally, a q-Gaussian random walk model was proposed to account for these melanocytic migratory traits. Simulations based on this model correctly describe the crossover to super-diffusivity in the cell migration tracks.

Short-term effects of a green coffee extract-, Garcinia c ambogia- and L-carnitine-containing chewing gum on snack intake and appetite regulation.

PubMed

Bobillo, Cecilia; Finlayson, Graham; Martínez, Ana; Fischman, Daniela; Beneitez, Analisa; Ferrero, Alejandro J; Fernández, Belisario E; Mayer, Marcos A

2018-03-01

Different studies have assessed the influence of chewing gum to aid control of appetite and reduce food intake. The aims of the present study were to evaluate the effects of chewing gum on satiety, food hedonics and snack intake and to explore the potential effects of the combination of Garcinia c ambogia, green coffee extract and L-carnitine on satiety, when administered in a gum format. This was a prospective study in which 57 subjects randomly received three kinds of treatments, in a crossover design: (1) active gum; (2) placebo gum; and (3) no gum. Food preferences and appetite sensations were evaluated by means of the Leeds Food Preference Questionnaire and visual analog scales. There was a significant reduction in low-fat sweet snack intake with placebo gum and the active gum compared to no gum and a reduction in high-fat sweet snack intake with the active gum compared to placebo gum and no gum. Total caloric intake was only reduced in the active gum condition. Both the active and placebo gum conditions significantly reduced hunger and prospective food consumption and increased fullness compared to no gum and were associated with a reduced wanting for sweet food in the LFPQ, consistent in a reduction in the relative preference for sweet snacks versus savoury snacks. This study supports the notion that chewing gum containing nutraceutical products might aid in the control over snack intake and reduce hunger sensations.

Clinical comparison of a new manual toothbrush on breath volatile sulfur compounds.

PubMed

Williams, Malcolm I; Vazquez, Joe; Cummins, Diane

2004-10-01

The objective of this randomized, crossover study was to compare the effectiveness of a newly designed manual toothbrush (Colgate 360 degrees) to two commercially available manual toothbrushes (Oral-B Indicator and Oral-B CrossAction) and a battery-powered toothbrush (Crest SpinBrush PRO) for their ability to reduce overnight volatile sulfur compounds (VSC) associated with oral malodor. The study followed a four-period crossover design. Following a washout period, prospective subjects arrived at the testing facility without eating, drinking, or performing oral hygiene for baseline evaluation of breath VSC levels. For each phase of the study, subjects were given one of the test tooth-brushes and a tube of regular toothpaste to take home, and they were instructed to brush their teeth in their customary manner for 1 minute. When using the Colgate 360 degrees toothbrush, subjects were instructed to clean their tongue with the implement on the back of the brush head for 10 seconds. The following morning, subjects reported to the testing facility, again without performing oral hygiene, eating, or drinking, for the overnight evaluation. After a minimum 2-day washout period, subjects repeated the same regimen using the other toothbrushes. The levels of breath VSC were evaluated instrumentally using a gas chromatograph equipped with a flame photometric detector. Measurements were taken in duplicate and then averaged. The levels of VSC were expressed as parts per billion (ppb) in mouth air. Sixteen men and women completed the study. At baseline, the mean levels of VSC in mouth air for the 4 toothbrushes were 719.8 ppb+/-318.4 ppb, 592.8 ppb+/-264.6 ppb, 673.8 ppb+/-405.9 ppb, and 656.2 ppb+/-310.2 ppb for the Colgate 360 degrees, Oral-B Indicator, Crest SpinBrush PRO, and Oral-B CrossAction, respectively. Overnight, the mean breath VSC levels after using the four toothbrushes were lower than those observed at baseline. The respective mean levels of breath VSC were 266.5 ppb+/-269.9 ppb, 545.2 ppb+/-346.1 ppb, 567 ppb+/-335.7 ppb, and 554.6 ppb+/-398.4 ppb. Only the Colgate 360 degrees toothbrush provided a statistically significant reduction (P < .05) in breath VSC vs baseline. Additionally, the Colgate 360 degrees toothbrush was statistically significantly better (P < .05) than the three commercial toothbrushes in reducing breath VSC. Therefore, the results of this randomized, crossover clinical study indicate that a newly designed manual toothbrush with a tongue-cleaning implement on the back of the brush head was significantly more effective than three commercially available toothbrushes in reducing morning breath VSC associated with oral malodor.

Glycemic effect of nutritive sweeteners: Honey, sugar and high fructose corn syrup

USDA-ARS?s Scientific Manuscript database

Controversy currently exists over whether all nutritive sweeteners produce similar metabolic effects. Using a randomized, crossover design we evaluated the effects of chronic consumption of 3 nutritive sweeteners (honey, sucrose and high fructose corn syrup (HFCS)) on glucose tolerance in overweigh...

Randomized pharmacokinetic cross-over study comparing two curcumin preparations in plasma and rectal tissue of healthy human volunteers

PubMed Central

Asher, Gary N.; Xie, Ying; Moaddel, Ruin; Sanghvi, Mitesh; Dossou, Katina S.S.; Kashuba, Angela D. M.; Sandler, Robert S.; Hawke, Roy L.

2016-01-01

Curcumin is poorly absorbed driving interest in new preparations. However, little is known about pharmacokinetics and tissue bioavailability between formulations. In this randomized, crossover study we evaluated the relationship between steady-state plasma and rectal tissue curcuminoid concentrations using standard and phosphatidylcholine curcumin extracts. There was no difference in the geometric mean plasma AUCs when adjusted for the 10-fold difference in curcumin dose between the two formulations. Phosphatidylcholine curcumin extract yielded only 20–30% plasma demethoxycurcumin and bisdemethoxycurcumin conjugates compared to standard extract, yet yielded 20-fold greater hexahydrocurcumin. When adjusting for curcumin dose, tissue curcumin concentrations were 5-fold greater for the phosphatidylcholine extract. Improvements in curcuminoid absorption due to phosphatidylcholine are not uniform across the curcuminoids. Furthermore, curcuminoid exposures in the intestinal mucosa are most likely due to luminal exposure rather than plasma disposition. Finally, once-daily dosing is sufficient to maintain detectable curcuminoids at steady-state in both plasma and rectal tissues. PMID:27503249

Walnut consumption increases activation of the insula to highly desirable food cues: A randomized, double-blind, placebo-controlled, cross-over fMRI study.

PubMed

Farr, Olivia M; Tuccinardi, Dario; Upadhyay, Jagriti; Oussaada, Sabrina M; Mantzoros, Christos S

2018-01-01

The use of walnuts is recommended for obesity and type 2 diabetes, although the mechanisms through which walnuts may improve appetite control and/or glycaemic control remain largely unknown. To determine whether short-term walnut consumption could alter the neural control of appetite using functional magnetic resonance imaging, we performed a randomized, placebo-controlled, double-blind, cross-over trial of 10 patients who received, while living in the controlled environment of a clinical research center, either walnuts or placebo (using a validated smoothie delivery system) for 5 days each, separated by a wash-out period of 1 month. Walnut consumption decreased feelings of hunger and appetite, assessed using visual analog scales, and increased activation of the right insula to highly desirable food cues. These findings suggest that walnut consumption may increase salience and cognitive control processing of highly desirable food cues, leading to the beneficial metabolic effects observed. © 2017 John Wiley & Sons Ltd.

Cardiovascular benefits from ancient grain bread consumption: findings from a double-blinded randomized crossover intervention trial.

PubMed

Sereni, Alice; Cesari, Francesca; Gori, Anna Maria; Maggini, Niccolò; Marcucci, Rossella; Casini, Alessandro; Sofi, Francesco

2017-02-01

Ancient grain varieties have been shown to have some beneficial effects on health. Forty-five clinically healthy subjects were included in a randomized, double-blinded crossover trial aimed at evaluating the effect of a replacement diet with bread derived from ancient grain varieties versus modern grain variety on cardiovascular risk profile. After 8 weeks of intervention, consumption of bread obtained by the ancient varieties showed a significant amelioration of various cardiovascular parameters. Indeed, the ancient varieties were shown to result in a significant reduction of total cholesterol, low-density lipoprotein (LDL)-cholesterol and blood glucose, whereas no significant differences during the phase with the modern variety were reported. Moreover, a significant increase in circulating endothelial progenitor cells were reported after the consumption of products made from the ancient "Verna" variety. The present results suggest that a dietary consumption of bread obtained from ancient grain varieties was effective in reducing cardiovascular risk factors.

Comparison of lorazepam and zopiclone for insomnia in patients with stroke and brain injury: a randomized, crossover, double-blinded trial.

PubMed

Li Pi Shan, Rodney S; Ashworth, Nigel L

2004-06-01

To determine if lorazepam or zopiclone is more effective in providing a restful night of sleep and to assess the effects of these medications on cognition. A randomized, double-blinded, crossover trial was performed at a tertiary care rehabilitation inpatient unit in a teaching hospital. A total of 18 brain-injured and stroke patients, aged 20-78 yrs, were administered lorazepam, 0.5-1.0 mg, orally at bedtime as needed for 7 days and zopiclone, 3.75-7.5 mg, orally at bedtime as needed for 7 days. Total sleep time and characteristics of sleep were measured. Effects on cognition were also measured using the Folstein Mini Mental Status Exam. There was no difference in average sleep duration or in subjective measures of sleep. Cognition as assessed by the Mini Mental Status Exam revealed no difference in the zopiclone arm compared with the lorazepam arm. Zopiclone is equally effective as lorazepam in the treatment of insomnia in stroke and brain-injured patients.

Lactobacillus salivarius WB21--containing tablets for the treatment of oral malodor: a double-blind, randomized, placebo-controlled crossover trial.

PubMed

Suzuki, Nao; Yoneda, Masahiro; Tanabe, Kazunari; Fujimoto, Akie; Iha, Kosaku; Seno, Kei; Yamada, Kazuhiko; Iwamoto, Tomoyuki; Masuo, Yosuke; Hirofuji, Takao

2014-04-01

This study evaluated the effect of probiotic intervention using lactobacilli on oral malodor. We conducted a 14-day, double-blind, placebo-controlled, randomized crossover trial of tablets containing Lactobacillus salivarius WB21 (2.0 × 10(9) colony-forming units per day) or placebo taken orally by patients with oral malodor. Organoleptic test scores significantly decreased in both the probiotic and placebo periods compared with the respective baseline scores (P < .001 and P = .002), and no difference was detected between periods. In contrast, the concentration of volatile sulfur compounds (VSCs) (P = .019) and the average probing pocket depth (P = .001) decreased significantly in the probiotic period compared with the placebo period. Bacterial quantitative analysis found significantly lower levels of ubiquitous bacteria (P = .003) and Fusobacterium nucleatum (P = .020) in the probiotic period. These results indicated that daily oral consumption of tablets containing probiotic lactobacilli could help to control oral malodor and malodor-related factors. Copyright © 2014 Elsevier Inc. All rights reserved.

Fecal blood loss caused by two differently microencapsulated acetylsalicylic acid preparations in patients with rheumatoid arthritis. A prospective crossover study.

PubMed

Dirksen, A; Rasmussen, S N; Manthorpe, R

1982-01-01

In an investigator-blind crossover study, fecal blood loss determined by 51Cr-labelled red cells was measured in 17 male patients with rheumatoid arthritis and one with anchylosing spondylitis. In two periods, each of one week's duration and separated by a 3-week wash-out period, the patients received microencapsulated acetylsalicylic acid (ASA) 3 g daily--either iwht time-dependent (Acetard) or with pH-depeendent release (Reumyl). With the exception of one patient, who suffered clinically significant bleeding, both preparations produced only moderate bleeding. The bleeding provoked by ASA with pH-dependent release (median blood loss in ml/day: first period 1.6; last period 2.6) was less than with time-dependent release (first period 1.8; last period 3.5).

Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design

PubMed Central

Kim, Myoung Kwon; Shin, Young Jun

2017-01-01

Background The objective of this study was to investigate the immediate effect on gait function when ankle balance taping is applied to amateur soccer players with lateral ankle sprain. Material/Methods A cross-over randomized design was used. Twenty-two soccer players with an ankle sprain underwent 3 interventions in a random order. Subjects were randomly assigned to ankle balance taping, placebo taping, and no taping groups. The assessment was performed using the GAITRite portable walkway system, which records the location and timing of each footfall during ambulation. Results Significant differences were found in the velocity, step length, stride length, and H-H base support among the 3 different taping methods (p<0.05). The ankle balance taping group showed significantly greater velocity, step length, and stride length in comparison to the placebo and no taping group. The ankle balance taping group showed a statistically significant decrease (p<0.05) in the H-H base support compared to the placebo and no taping groups, and the placebo group showed significantly greater velocity in comparison to the no taping group (p<0.05). Conclusions We conclude that ankle balance taping that uses kinesiology tape instantly increased the walking ability of amateur soccer players with lateral ankle sprain. Therefore, ankle balance taping is a useful alternative to prevent and treat ankle sprain of soccer players. PMID:29158472

Phytochemical pharmacokinetics and bioactivity of oat and barley flour: a randomized crossover trial

USDA-ARS?s Scientific Manuscript database

While dietary fiber plays an important role in the health benefits associated with whole grain consumption, other ingredients concentrated in the outer bran layer, including alkylresorcinols, lignans, phenolic acids, phytosterols, and tocols, may also contribute to these outcomes. To determine the a...

Almond consumption improved glycemic control and lipid profiles in patients with type 2 diabetes mellitus

USDA-ARS?s Scientific Manuscript database

Almond consumption is associated with ameliorations in obesity, hyperlipidemia, hypertension, and hyperglycemia. The hypothesis of this 12-wk randomized crossover clinical trial was that almond consumption would improve glycemic control and decrease risk to cardiovascular disease in 20 Chinese type ...

Exercising Attention within the Classroom

ERIC Educational Resources Information Center

Hill, Liam; Williams, Justin H. G.; Aucott, Lorna; Milne, June; Thomson, Jenny; Greig, Jessie; Munro, Val; Mon-Williams, Mark

2010-01-01

Aim: To investigate whether increased physical exercise during the school day influenced subsequent cognitive performance in the classroom. Method: A randomized, crossover-design trial (two weeks in duration) was conducted in six mainstream primary schools (1224 children aged 8-11y). No data on sex was available. Children received a…

Crossover and maximal fat-oxidation points in sedentary healthy subjects: methodological issues.

PubMed

Gmada, N; Marzouki, H; Haboubi, M; Tabka, Z; Shephard, R J; Bouhlel, E

2012-02-01

Our study aimed to assess the influence of protocol on the crossover point and maximal fat-oxidation (LIPOX(max)) values in sedentary, but otherwise healthy, young men. Maximal oxygen intake was assessed in 23 subjects, using a progressive maximal cycle ergometer test. Twelve sedentary males (aged 20.5±1.0 years) whose directly measured maximal aerobic power (MAP) values were lower than their theoretical maximal values (tMAP) were selected from this group. These individuals performed, in random sequence, three submaximal graded exercise tests, separated by three-day intervals; work rates were based on the tMAP in one test and on MAP in the remaining two. The third test was used to assess the reliability of data. Heart rate, respiratory parameters, blood lactate, the crossover point and LIPOX(max) values were measured during each of these tests. The crossover point and LIPOX(max) values were significantly lower when the testing protocol was based on tMAP rather than on MAP (P<0.001). Respiratory exchange ratios were significantly lower with MAP than with tMAP at 30, 40, 50 and 60% of maximal aerobic power (P<0.01). At the crossover point, lactate and 5-min postexercise oxygen consumption (EPOC(5 min)) values were significantly higher using tMAP rather than MAP (P<0.001). During the first 5 min of recovery, EPOC(5 min) and blood lactate were significantly correlated (r=0.89; P<0.001). Our data show that, to assess the crossover point and LIPOX(max) values for research purposes, the protocol must be based on the measured MAP rather than on a theoretical value. Such a determination should improve individualization of training for initially sedentary subjects. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial

PubMed Central

Nazari, Mohammad; Taghizadeh, Ali; Bazzaz, Mojtaba Mousavi; Rakhshandeh, Hassan; Shokri, Sadegh

2017-01-01

Background Chemotherapy induced nausea and vomiting (CINV) is a side effect, and has negative effect on quality of life and continuation of chemotherapy. Despite new regimen and drugs, the problems still remain and standard guidelines, effective treatment and supportive care for refractory CINV are still not yet established. Persian medicine, the old Iranian medical school, offer Persumac (prepared from Rhus Coriaria and Bunium Persicum Boiss). Objective The specific objectives were to assess the effect of Persumac on the number and severity of nausea and vomiting in refractory CINV in acute and delayed phase. Methods This randomized, double blind, crossover clinical trial study was carried out on 93 patients with breast cancer and refractory CINV, who received outpatient high emetogenic chemotherapy in Imam Reza hospital, Mashhad, Iran from October 2015 to May 2016. The study has three stages: in stage I patients received a questionaire and completed it after chemotherapy. In stage II they were randomly divided into intervention group with Persumac and control group with placebo (lactose were used). In stage III, wash out and crossover was conducted. Both groups in all stages received standard antiemetic therapy for CINV. The following were set as the inclusion criteria of the study: female, Age ≥18 years, clinical diagnosis of breast cancer, history of refractory CINV, normal blood tests and at least three courses of chemotherapy remaining. Exclusion criteria of this study were: Total or upper abdominal radiation therapy along with chemotherapy, drugs/therapy for nausea and vomiting not prescribed in this study, hypersensitivity to Sumac or Bunium Persicum, use of sumac and Bunium Persicum in seven days prior to the intervention, clinical diagnosis of digestion disorders, non-chemotherapy induced nausea and vomiting, milk allergy, loss of two consecutive or three intermittent doses of Persumac or placebo. Outcomes were gathered by Persian questionnaire. Number and severity of nausea and vomiting was measured with a self-reporting tool; visual analog scale. Results Demographic data and other characters in both groups have no significant diffrence. Eighty of 93 eligible patients in stage I completed the study and in stage II, eleven declined participation for stage III (crossover). P value of carry over, period and treatment effects demonstrated that they had not affected the results before and after crossover. The mean severity of nausea in acute phase was in stage I: 4.83 ± 1.40, stage II: 4.54 ± 2.0 and stage III: 4.15 ± 0.92 in sequence AB (first Persumac and then placebo in crossover), and in sequence BA (first placebo and then Persumac in crossover) was respectively 4.83 ± 1.40, 4.54 ± 2.0, 4.15 ± 0.92 with p value of carry over effect: 0.03 and period effect: 0.22. Except for severity of nausea in acute phase, the mean number and severity of nausea and vomiting scores significantly decreased in acute and delayed phase of CINV. Conclusion Persumac may control the refractory CINV. The implicable and clinical importance of this research is that another option exists for refractory CINV. Higher doses, different cancers, patients with more various features, and more complete methodology and tools can provide appropriate designs for new research on this topic. Trial registration This trial was registered at the Clinical Trials.gov ID: NCT02787707. Funding This study is part of a Ph.D. thesis and under grant; No: 930735 of Research Chancellery of MUMS. PMID:28243404

Deep brain stimulation for treatment-resistant major depressive disorder: a comparison of two targets and long-term follow-up

PubMed Central

Raymaekers, S; Luyten, L; Bervoets, C; Gabriëls, L; Nuttin, B

2017-01-01

We previously found that electrical stimulation in the anterior limb of the internal capsule/bed nucleus of the stria terminalis (IC/BST) alleviates depressive symptoms in severe treatment-resistant obsessive-compulsive disorder (OCD) patients. Here we tested the hypothesis that electrical stimulation in either IC/BST or in the inferior thalamic peduncle (ITP) effectively reduces depressive symptoms in treatment-resistant major depressive disorder (TRD). In a double-blind crossover design, the effects of electrical stimulation at both targets were compared in TRD patients. The 17-item Hamilton Depression Rating scale (HAM-D) was the primary outcome measure. During the first crossover, patients received IC/BST stimulation versus no stimulation in random order (2 × 1 weeks). During the second crossover (3 × 2 months), patients received IC/BST versus ITP versus no stimulation. Patients and evaluators were blinded for stimulation conditions. All patients (n=7) were followed up for at least 3 years (3–8 years) after implantation. Six patients completed the first crossover and five patients completed the second. During the first crossover, mean (s.d.) HAM-D scores were 21.5 (2.7) for no stimulation and 11.5 (8.8) for IC/BST stimulation. During the second crossover, HAM-D scores were 15.4 (7.5) for no stimulation, 7.6 (3.8) for IC/BST stimulation and 11.2 (7.5) for ITP stimulation. The final sample size was too small to statistically analyze this second crossover. At last follow-up, only one patient preferred ITP over IC/BST stimulation. Two patients, with a history of suicide attempts before implantation, committed suicide during the follow-up phases of this study. Our data indicate that, in the long term, both ITP and IC/BST stimulation may alleviate depressive symptoms in patients suffering from TRD. PMID:29087373

Deep brain stimulation for treatment-resistant major depressive disorder: a comparison of two targets and long-term follow-up.

PubMed

Raymaekers, S; Luyten, L; Bervoets, C; Gabriëls, L; Nuttin, B

2017-10-31

We previously found that electrical stimulation in the anterior limb of the internal capsule/bed nucleus of the stria terminalis (IC/BST) alleviates depressive symptoms in severe treatment-resistant obsessive-compulsive disorder (OCD) patients. Here we tested the hypothesis that electrical stimulation in either IC/BST or in the inferior thalamic peduncle (ITP) effectively reduces depressive symptoms in treatment-resistant major depressive disorder (TRD). In a double-blind crossover design, the effects of electrical stimulation at both targets were compared in TRD patients. The 17-item Hamilton Depression Rating scale (HAM-D) was the primary outcome measure. During the first crossover, patients received IC/BST stimulation versus no stimulation in random order (2 × 1 weeks). During the second crossover (3 × 2 months), patients received IC/BST versus ITP versus no stimulation. Patients and evaluators were blinded for stimulation conditions. All patients (n=7) were followed up for at least 3 years (3-8 years) after implantation. Six patients completed the first crossover and five patients completed the second. During the first crossover, mean (s.d.) HAM-D scores were 21.5 (2.7) for no stimulation and 11.5 (8.8) for IC/BST stimulation. During the second crossover, HAM-D scores were 15.4 (7.5) for no stimulation, 7.6 (3.8) for IC/BST stimulation and 11.2 (7.5) for ITP stimulation. The final sample size was too small to statistically analyze this second crossover. At last follow-up, only one patient preferred ITP over IC/BST stimulation. Two patients, with a history of suicide attempts before implantation, committed suicide during the follow-up phases of this study. Our data indicate that, in the long term, both ITP and IC/BST stimulation may alleviate depressive symptoms in patients suffering from TRD.

Lysine clonixinate vs naproxen sodium for the acute treatment of migraine: a double-blind, randomized, crossover study.

PubMed

Krymchantowski, Abouch Valenty; Peixoto, Patricia; Higashi, Rafael; Silva, Ariovaldo; Schutz, Vivian

2005-12-14

The process of inflammation is crucial in migraine, and several nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of migraine attacks. Despite their efficacy, the routine use of NSAIDs is limited by side effects as well as incomplete efficacy in some patients. Among the available options, lysine clonixinate (LC) and naproxen sodium (NS) have proved effective in migraine. The aim of this study was to compare the efficacy and tolerability of oral formulations of LC and NS in the treatment of moderate or severe migraine attacks, with a double-blind, crossover design. Seventy subjects (62 women, 8 men) between ages 18 and 71 years (mean age, 41) with migraine according to the criteria of the International Headache Society were prospectively enrolled. The patients were randomized into 2 groups and each participant treated 2 migraine attacks. Group 1 treated the first attack with LC and the second attack with NS. Group 2 treated 2 attacks in a counterbalanced order. Doses were 250 mg of LC or 550 mg of NS, which were encapsulated for equal appearance. Headache intensity, nausea, photophobia, and side effects were evaluated at baseline, 1 hour, and 2 hours after drug administration. Rescue drugs were allowed after 2 hours for those who didn't respond, and this was also compared between groups. Sixty patients (54 women, 6 men) completed the study. At 1 hour, 13.6% patients who used LC were pain-free compared with 11.9% who used NS (P = .78). At 2 hours, 35.6% patients who took LC and 32.2% who took NS were pain-free (P = .69). At baseline, 52.5% of the patients randomized to group 1 reported nausea, compared with 33.9% in group 2, and both drugs eliminated nausea: At both 1 hour and 2 hours, nausea diminished significantly for those taking LC, but only after 2 hours for those who took NS (P < .0001). Both drugs eliminated photophobia at 1 hour and 2 hours; however, LC was superior to NS in reducing photophobia at 2 hours (P = .027). Ten patients who took LC and 8 who took NS required rescue drugs after 2 hours. Twelve patients who used LC and 16 who took NS reported side effects. Although this study did not include a placebo arm, which impairs any definitive efficacy claims, we found LC and NS to be similarly effective and well tolerated in patients presenting moderate or severe attacks of migraine.

Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.

PubMed

Feil, Katharina; Adrion, Christine; Teufel, Julian; Bösch, Sylvia; Claassen, Jens; Giordano, Ilaria; Hengel, Holger; Jacobi, Heike; Klockgether, Thomas; Klopstock, Thomas; Nachbauer, Wolfgang; Schöls, Ludger; Stendel, Claudia; Uslar, Ellen; van de Warrenburg, Bart; Berger, Ingrid; Naumann, Ivonne; Bayer, Otmar; Müller, Hans-Helge; Mansmann, Ulrich; Strupp, Michael

2017-01-10

Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA. An investigator-initiated, multicenter, European, randomized, double-blind, placebo-controlled, 2-treatment 2-period crossover phase III trial will be carried out. In total, 108 adult patients who meet the clinical criteria of CA of different etiologies (hereditary or non-hereditary, non-acquired) presenting with a SARA total score of at least 3 points will be randomly assigned in a 1:1 ratio to one of two different treatment sequences, either acetyl-DL-leucine (up to 5 g per day) followed by placebo or vice versa. Each sequence consists of two 6-week treatment periods, separated by a 4-week wash-out period. A follow-up examination is scheduled 4 weeks after the end of treatment. The primary efficacy outcome is the absolute change in the SARA total score. Secondary objectives are to demonstrate that acetyl-DL-leucine is effective in improving (1) motor function measured by the Spinocerebellar Ataxia Functional Index (SCAFI) and SARA subscore items and (2) QoL (EuroQoL 5 dimensions and 5 level version, EQ-5D-5 L), depression (Beck Depression Inventory, BDI-II) and fatigue (Fatigue Severity Score, FSS). Furthermore, the incidence of adverse events will be investigated. The results of this trial will inform whether symptomatic treatment with the modified amino-acid acetyl-DL-leucine is a worthy candidate for a new drug therapy to relieve ataxia symptoms and to improve patient care. If superiority of the experimental drug to placebo can be established it will also be re-purposing of an agent that has been previously used for the symptomatic treatment of dizziness. The trial was prospectively registered at www.clinicaltrialsregister.eu (EudraCT no. 2015-000460-34) and at https://www.germanctr.de (DRKS-ID: DRKS00009733 ).

Dynamical instability of a driven-dissipative electron-hole condensate in the BCS-BEC crossover region

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hanai, Ryo; Littlewood, Peter B.; Ohashi, Yoji

2017-09-01

We present a stability analysis on a driven-dissipative electron-hole condensate in the BCS (Bardeen-Cooper-Schrieffer)-BEC (Bose-Einstein-condensation)-crossover region. Extending the combined BCS-Leggett theory with the generalized random phase approximation (GRPA) to the non-equilibrium case by employing the Keldysh formalism, we show that the pumping-and-decay of carriers causes a depairing effect on excitons. This phenomenon gives rise to an attractive interaction between excitons in the BEC regime, as well as a supercurrent that anomalously flows anti-parallel to ∇θ(r) (where θ(r) is the phase of the condensate) in the BCS regime, both leading to dynamical instabilities of an exciton-BEC.

Food processing and structure impact the metabolizable energy of almonds

USDA-ARS?s Scientific Manuscript database

The measured metabolizable energy (ME) of whole almonds has been shown to be less than predicted by Atwater factors. However, data are lacking on the effects of processing (roasting, chopping or grinding) on the ME of almonds. A 5-period randomized, crossover study in healthy individuals (n=18) was ...

Bioavailability of enteric-coated microencapsulated calcium during pregnancy: A randomized crossover trial in Bangladesh

USDA-ARS?s Scientific Manuscript database

Prenatal calcium and iron supplements are recommended in settings of low dietary calcium intake and high prevalence of anemia. However, calcium administration may inhibit iron absorption. To overcome calcium-iron interactions, we developed a multi-micronutrient powder containing iron (60 mg), folic ...

Differential effects of estrogen and progestin on apolipoprotein B100 and B48 kinetics in postmenopausal women

USDA-ARS?s Scientific Manuscript database

The distinct effects of the estrogen and progestin components of hormonal therapy on the metabolism of apolipoprotein (apo) B-containing lipoproteins have not been studied. We enrolled eight healthy postmenopausal women in a placebo-controlled, randomized, double-blind, crossover study. Each subject...

Genetic Algorithm Phase Retrieval for the Systematic Image-Based Optical Alignment Testbed

NASA Technical Reports Server (NTRS)

Rakoczy, John; Steincamp, James; Taylor, Jaime

2003-01-01

A reduced surrogate, one point crossover genetic algorithm with random rank-based selection was used successfully to estimate the multiple phases of a segmented optical system modeled on the seven-mirror Systematic Image-Based Optical Alignment testbed located at NASA's Marshall Space Flight Center.

Enhanced bioavailability of EPA from emulsified fish oil preparations versus capsular triacylglycerol

USDA-ARS?s Scientific Manuscript database

Pre-emulsified fish oil supplements, an alternative to capsular triacylglycerol, may enhance the uptake of LCn3 fatty acids it contains. A randomized, Latin-square crossover design was used to compare the effects of four fish oil supplement preparations on phospholipid (PLFA) and chylomicron fatty ...

Digestive and physiological effects of a wheat bran extract, arabino-xylan-oligosaccharide, in breakfast cereal

USDA-ARS?s Scientific Manuscript database

We assessed whether a wheat bran extract containing arabino-xylan-oligosaccharide (AXOS) elicited a prebiotic effect and influenced other physiologic parameters when consumed in ready-to-eat cereal at two dose levels. This double-blind, randomized, controlled, crossover trial evaluated the effects o...

Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system.

PubMed

Ryan, F; Byrne, S; O'Shea, S

2009-08-01

Increased frequency of prothrombin time testing, facilitated by patient self-testing (PST) of the International Normalized Ratio (INR) can improve the clinical outcomes of oral anticoagulation therapy (OAT). However, oversight of this type of management is often difficult and time-consuming for healthcare professionals. This study reports the first randomized controlled trial of an automated direct-to-patient expert system, enabling remote and effective management of patients on OAT. A prospective, randomized controlled cross-over study was performed to test the hypothesis that supervised PST using an internet-based, direct-to-patient expert system could provide improved anticoagulation control as compared with that provided by an anticoagulation management service (AMS). During the 6 months of supervised PST, patients measured their INR at home using a portable meter and entered this result, along with other information, onto the internet web page. Patients received instant feedback from the system as to what dose to take and when the next test was due. During the routine care arm, patients attended the AMS at least every 4-6 weeks and were dosed by the anticoagulation pharmacist or physician. The primary outcome variable was the difference in the time in therapeutic range (TTR) between both arms. One hundred and sixty-two patients were enrolled (male 61.6%, mean age 58.7 years), and 132 patients (81.5%) completed both arms. TTR was significantly higher during PST management than during AMS management (median TTR 74% vs 58.6%; z=5.67, P < 0.001). The use of an internet-based, direct-to-patient expert system for the management of PST improves the control of OAT as compared with AMS management.

Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial.

PubMed

Jaillette, Emmanuelle; Brunin, Guillaume; Girault, Christophe; Zerimech, Farid; Chiche, Arnaud; Broucqsault-Dedrie, Céline; Fayolle, Cyril; Minacori, Franck; Alves, Isabelle; Barrailler, Stephanie; Robriquet, Laurent; Tamion, Fabienne; Delaporte, Emmanuel; Thellier, Damien; Delcourte, Claire; Duhamel, Alain; Nseir, Saad

2015-09-25

Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs. BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015. ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).

Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

PubMed

Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

2017-03-01

Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Impact of hydrophilic catheters on urinary tract infections in people with spinal cord injury: systematic review and meta-analysis of randomized controlled trials.

PubMed

Li, Li; Ye, Wenqin; Ruan, Hong; Yang, Baoyan; Zhang, Shuqi; Li, Li

2013-04-01

To identify randomized controlled trials comparing the use of hydrophilic and nonhydrophilic catheters for intermittent catheterization (IC) in patients with spinal cord injury (SCI), and to perform a meta-analysis evaluating the occurrence of hematuria and urinary tract infection (UTI). We searched the following electronic databases to identify studies: EMBASE (1991 to August 2011), PubMed (1991 to August 2011), Cochrane Library (no date restriction), China National Knowledge Infrastructure (no date restriction), and the Chinese Biomedical Literature Database (no date restriction). Randomized controlled trials, parallel-control, crossover-control, and prospective cohort studies that assessed morbidity associated with the use of hydrophilic catheters and nonhydrophilic catheters in patients after SCI were included. Data extraction was performed using standardized forms of the Cochrane Collaboration. Methodologic quality was independently assessed by 2 reviewers using the Downs and Black instrument. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for dichotomous data. Five studies involving 508 subjects; 462 subjects completed the study and were included in this meta-analysis. There was a significantly lower incidence (OR=.36; 95% CI, 24%-54%; P<.0001) of reported UTIs in the hydrophilic-treated group compared with the nonhydrophilic-treated group. Hematuria was also reported significantly less in the hydrophilic catheter group than in the nonhydrophilic catheter group (OR=.57; 95% CI, 35%-92%; P=.001). This meta-analysis found UTIs and hematuria less frequently associated with the use of hydrophilic-coated catheters for IC in patients with SCI. These findings support the use of hydrophilic catheters in this patient population. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effect of a plasma sodium biofeedback system applied to HFR on the intradialytic cardiovascular stability. Results from a randomized controlled study

PubMed Central

Locatelli, Francesco; Stefoni, Sergio; Petitclerc, Thierry; Colì, Luigi; Di Filippo, Salvatore; Andrulli, Simeone; Fumeron, Christine; Frascà, Giovanni Maria; Sagripanti, Sibilla; Savoldi, Silvana; Serra, Andrea; Stallone, Carmine; Aucella, Filippo; Gesuete, Antonio; Scarlatella, Antonio; Quarello, Francesco; Mesiano, Paola; Ahrenholz, Peter; Winkler, Roland; Mandart, Lise; Fort, Joan; Tielemans, Christian; Navino, Carlo

2012-01-01

Background Intradialytic hypotension (IDH) is still a major clinical problem for haemodialysis (HD) patients. Haemodiafiltration (HDF) has been shown to be able to reduce the incidence of IDH. Methods Fifty patients were enrolled in a prospective, randomized, crossover international study focussed on a variant of traditional HDF, haemofiltration with endogenous reinfusion (HFR). After a 1-month run-in period on HFR, the patients were randomized to two treatments of 2 months duration: HFR (Period A) or HFR-Aequilibrium (Period B), followed by a 1-month HFR wash-out period and then switched to the other treatment. HFR-Aequilibrium (HFR-Aeq) is an evolution of the haemofiltration with endogenous reinfusion (HFR) dialysis therapy, with dialysate sodium concentration and ultrafiltration rate profiles elaborated by an automated procedure. The primary end point was the frequency of IDH. Results Symptomatic hypotension episodes were significantly lower on HFR-Aeq versus HFR (23 ± 3 versus 31 ± 4% of sessions, respectively, P l= l0.03), as was the per cent of clinical interventions (17 ± 3% of sessions with almost one intervention on HFR-Aeq versus 22 ± 2% on HFR, P <0.01). In a post-hoc analysis, the effect of HFR-Aeq was greater on more unstable patients (35 ± 3% of sessions with hypotension on HFR-Aeq versus 71 ± 3% on HFR, P <0.001). No clinical or biochemical signs of Na/water overload were registered during the treatment with HFR-Aeq. Conclusions HFR-Aeq, a profiled dialysis supported by the Natrium sensor for the pre-dialysis Na+ measure, can significantly reduce the burden of IDH. This could have an important impact in every day dialysis practice. PMID:22561583

Randomized Crossover Study of Training Benefits of High Fidelity ECMO Simulation versus Porcine Animal Model An Interim Report

DTIC Science & Technology

2017-02-25

59 MDW/SGVU SUBJECT: Professional Presentation Approval 24 FEB 2017 1. Your paper, entitled Randomized C rossover Study of T raining Benefits of...WHASC) internship and residency programs. 3. Please know that if you are a Graduate Health Sciences Education student and your department has told you...source for your study [e.g .. 59 MOW CRD Graduate Health Sciences Education (GHSE) (SGS O&M): SGS R&D; Tri-Service Nursing Research Program (TSNRP

Prone versus supine position in mechanically ventilated children: a pilot study.

PubMed

Sawhney, Ashu; Kumar, Nirmal; Sreenivas, Vishnubhatla; Gupta, Sangeeta; Tyagi, Vineet; Puliyel, Jacob M

2005-05-01

It is known that mechanically ventilated patients in the prone position have improved oxygenation compared with those supine. We did a prospective, randomized, controlled trial to evaluate the effect of prone position during mechanical ventilation, on survival in critically ill children. Forty-two children needing mechanical ventilation for various illnesses were randomized to receive initial ventilation for four hours prone or supine by drawing lots. Initial severity of illness and blood gases in all children were noted. In a crossover design, after the initial four hours the children were turned over and ventilated in the alternate posture for an hour. Oxygenation parameters and mean airway pressures were noted at one hour, four hours, and five hours. Mortality, duration of ventilation, and the above parameters were compared in the two groups. Initial PRISM scores were similar in the two groups. Mortality in the prone group was less than in the supine group. The odds ratio of mortality was 0.20 (95% CI 0.05-0.75). Duration of ventilation was similar in the two groups. The oxygenation index was significantly lower in the prone group at one, four, and five hours after onset of ventilation. Prone position in the first few hours of ventilation significantly improves gas exchange and oxygenation, reduces the mean airway pressures required to ventilate children, and may cause significant improvement in survival. Our study protocol allowed ventilator settings to be changed as needed during ventilation.

Effect of dietary insoluble fiber on control of glycemia in dogs with naturally acquired diabetes mellitus.

PubMed

Nelson, R W; Duesberg, C A; Ford, S L; Feldman, E C; Davenport, D J; Kiernan, C; Neal, L

1998-02-01

To evaluate the effect of a high insoluble-fiber (HF) diet containing 12% cellulose in dry matter and a low insoluble-fiber (LF) diet on control of glycemia in dogs with naturally acquired insulin-dependent diabetes mellitus. Prospective randomized crossover controlled trial. 11 dogs with naturally acquired diabetes mellitus. Dogs were fed HF and LF diets for 8 months each in 1 of 2 randomly assigned diet sequences. Caloric intake and insulin treatment were adjusted as needed to maintain stable body weight and control of glycemia, respectively. After a 2-month adaptation period, control of glycemia was evaluated every 6 weeks for 6 months. Variables assessed included serum glucose concentration measured during the preprandial state, blood glycosylated hemoglobin concentration, serum glucose concentration measured every 2 hours for 24 hours beginning at the time of the morning insulin injection, 24-hour mean serum glucose concentration, mean serum glucose concentration fluctuation from the 24-hour mean serum glucose concentration, and 24-hour urinary excretion of glucose. Significant differences in mean daily caloric intake, body weight, or daily insulin dosage among dogs fed HF and LF diets were not found. Mean preprandial serum glucose concentration, most postprandial serum glucose concentrations, 24-hour mean serum glucose concentration, and 24-hour urinary excretion of glucose were significantly lower in dogs fed the HF diet, compared with the LF diet. Results of this study support feeding of commercially available insoluble fiber diets to dogs with naturally acquired diabetes mellitus.

Effects of insoluble and soluble dietary fiber on glycemic control in dogs with naturally occurring insulin-dependent diabetes mellitus.

PubMed

Kimmel, S E; Michel, K E; Hess, R S; Ward, C R

2000-04-01

To evaluate the effects of diets differing in type and quantity of fiber on glycemic control in dogs with naturally occurring insulin-dependent diabetes mellitus. Prospective randomized crossover controlled trial. 7 dogs with well-regulated naturally occurring insulin-dependent diabetes mellitus. Dogs were fed 1 of 3 diets for 1 month each in 1 of 6 randomized diet sequences. Diets included a low-fiber diet (LF) and 2 high-fiber diets; 1 contained only insoluble fiber (HIF), and 1 contained soluble fiber in addition to insoluble fiber (HSF). Caloric intake was unchanged throughout the study. Glycemic control was assessed after each feeding trial by measuring serum fructosamine concentration and performing 5 serial measurements of blood glucose concentration every 2 hours after the morning feeding and insulin injection. Significant differences were not detected in body weight, required insulin dosage, or albumin concentration among dogs fed the HIF, HSF, and LF diets. Mean and maximum blood glucose concentrations and area under the blood glucose curve were significantly lower in dogs fed the HIF diet, compared with values in the same dogs fed the HSF or LF diet. Fructosamine concentration was significantly lower in dogs fed the HIF or HSF diet, compared with values in the same dogs fed the LF diet. In dogs with naturally occurring insulin-dependent diabetes mellitus, a dry, high insoluble-fiber diet may aid in glycemic control.

Optimal chest compression rate in cardiopulmonary resuscitation: a prospective, randomized crossover study using a manikin model.

PubMed

Lee, Seong Hwa; Ryu, Ji Ho; Min, Mun Ki; Kim, Yong In; Park, Maeng Real; Yeom, Seok Ran; Han, Sang Kyoon; Park, Seong Wook

2016-08-01

When performing cardiopulmonary resuscitation (CPR), the 2010 American Heart Association guidelines recommend a chest compression rate of at least 100 min, whereas the 2010 European Resuscitation Council guidelines recommend a rate of between 100 and 120 min. The aim of this study was to examine the rate of chest compression that fulfilled various quality indicators, thereby determining the optimal rate of compression. Thirty-two trainee emergency medical technicians and six paramedics were enrolled in this study. All participants had been trained in basic life support. Each participant performed 2 min of continuous compressions on a skill reporter manikin, while listening to a metronome sound at rates of 100, 120, 140, and 160 beats/min, in a random order. Mean compression depth, incomplete chest recoil, and the proportion of correctly performed chest compressions during the 2 min were measured and recorded. The rate of incomplete chest recoil was lower at compression rates of 100 and 120 min compared with that at 160 min (P=0.001). The numbers of compressions that fulfilled the criteria for high-quality CPR at a rate of 120 min were significantly higher than those at 100 min (P=0.016). The number of high-quality CPR compressions was the highest at a compression rate of 120 min, and increased incomplete recoil occurred with increasing compression rate. However, further studies are needed to confirm the results.

Extra virgin olive oil phenols and markers of oxidation in Greek smokers: a randomized cross-over study.

PubMed

Moschandreas, J; Vissers, M N; Wiseman, S; van Putte, K P; Kafatos, A

2002-10-01

To examine the effect of a low phenol olive oil and high phenol olive oil on markers of oxidation and plasma susceptibility to oxidation in normolipaemic smokers. Randomized single-blind cross-over trial with two intervention periods. The Medical School and University Hospital of the University of Crete, Heraklion, Crete, Greece. Twenty-five healthy males and females completed the study. Each intervention was of three weeks duration and intervention periods were separated by a two week washout. Seventy grams of extra virgin olive oil was supplied to each subject per day in the intervention periods. The olive oils supplied differed in their phenol content by 18.6 mg/day. Two fasting venous blood samples were taken at the end of each intervention period. The markers of antioxidant capacity measured in fasting plasma samples (total plasma resistance to oxidation, concentrations of protein carbonyl as a marker of protein oxidation, malondialdehyde and lipid hydroperoxides as markers of lipid oxidation and the ferric reducing ability of plasma) did not differ significantly between the low and high phenol olive oil diets. No effect of olive oil phenols on markers of oxidation in smokers was detected. It may be that the natural concentrations of phenols in olive oil are too low to produce an effect in the post-absorptive phase. Possible reasons for period effects and interactions between diet and administration period need attention to aid further cross-over trials of this kind. Unilever Research Vlaardingen, The Netherlands.

Impact of dry ejaculation caused by highly selective alpha1A-blocker: randomized, double-blind, placebo-controlled crossover pilot study in healthy volunteer men.

PubMed

Shimizu, Fumitaka; Taguri, Masataka; Harada, Yoshiko; Matsuyama, Yutaka; Sase, Kazuhiro; Fujime, Makoto

2010-03-01

Dry ejaculation with loss of seminal emission is reported in patients who have been administered silodosin, an alpha1A-adrenoceptor antagonist. We investigated the impact of dry ejaculation caused by orally administered silodosin on orgasmic function. In a double-blind crossover study, 50 healthy volunteer men were randomly assigned to receive either a single dose of 4-mg silodosin or placebo with 3 days of washout before crossover. Subjects masturbated 4 hours after administering agents. Numerical rating scale (NRS) score from 0 (highest) to 10 (lowest) for subjective quality of orgasm, the subjective number of contractions of the bulbocavernosus/pelvic floor muscles, and the amount of semen were examined. Results. After the administration of silodosin, the NRS score worsened by 1.3 points (P = 0.003), the number of contractions of the bulbocavernosus/pelvic floor muscles decreased by about 1 (P = 0.003), and there was a decrease of 1.8 mL in the amount of semen produced (P < 0.0001). Eleven men overall (22%) on silodosin administration had less than a 50% decrease from baseline in the amount of semen. Silodosin may adversely affect the subjective orgasmic function by causing an abnormal ejaculation with decreased (or no) semen discharge and a decrease in the number of bulbocavernosus/pelvic floor muscle contractions. Semen passing through the urethra and sufficient rhythmic contraction of the muscle of the pelvic floor may contribute to the subjective pleasure of orgasm.

Switching to nilotinib versus imatinib dose escalation in patients with chronic myeloid leukaemia in chronic phase with suboptimal response to imatinib (LASOR): a randomised, open-label trial.

PubMed

Cortes, Jorge E; De Souza, Carmino Antonio; Ayala, Manuel; Lopez, Jose Luis; Bullorsky, Eduardo; Shah, Sandip; Huang, Xiaojun; Babu, K Govind; Abdulkadyrov, Kudrat; de Oliveira, José Salvador Rodrigues; Shen, Zhi-Xiang; Sacha, Tomasz; Bendit, Israel; Liang, Zhizhou; Owugah, Tina; Szczudlo, Tomasz; Khanna, Sadhvi; Fellague-Chebra, Rafik; le Coutre, Philipp D

2016-12-01

Optimal management of patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response remains undetermined. This study aimed to investigate the safety and efficacy of switching to nilotinib vs imatinib dose escalation for patients with suboptimal cytogenetic response on imatinib. We did a phase 3, open-label, randomised trial in patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response to imatinib according to the 2009 European LeukemiaNet criteria, in Latin America, Europe, and Asia (59 hospitals and care centres in 12 countries). Eligible patients were aged 18 years or older with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase and Eastern Cooperative Oncology Group performance status of 0-2. Before enrolment, all patients had received 3-18 months of imatinib 400 mg once daily and had a suboptimal cytogenetic response according to 2009 ELN recommendations, established through bone marrow cytogenetics. By use of an interactive response technology using fixed blocks, we randomly assigned patients (1:1) to switch to nilotinib 400 mg twice per day or an escalation of imatinib dose to 600 mg once per day (block size of 4). Investigators and participants were not blinded to study treatment. Crossover was allowed for loss of response or intolerance at any time, or for patients with no complete cytogenetic response at 6 months. The primary endpoint was complete cytogenetic response at 6 months in the intention-to-treat population. Efficacy endpoints were based on the intention-to-treat population, with all patients assessed according to the treatment group to which they were randomised (regardless of crossover); the effect of crossover was assessed in post-hoc analyses, in which responses achieved after crossover were excluded. We present the final results at 24 months' follow-up. This study is registered with ClinicalTrials.gov (NCT00802841). Between July 7, 2009, and Aug 29, 2012, we enrolled 191 patients. 96 patients were randomly assigned to nilotinib and 95 patients were randomly assigned to imatinib. Complete cytogenetic response at 6 months was achieved by 48 of 96 patients in the nilotinib group (50%, 95·18% CI 40-61) and 40 of 95 in the imatinib group (42%, 32-53%; difference 7·9% in favour of nilotinib; 95% CI -6·2 to 22·0, p=0·31). Excluding responses achieved after crossover, 48 (50%) of 96 patients in the nilotinib group and 34 (36%) of 95 patients in the imatinib group achieved complete cytogenic response at 6 months (nominal p=0·058). Grade 3-4 non-haematological adverse events occurring in more than one patient were headache (nilotinib group, n=2 [2%, including 1 after crossover to imatinib]; imatinib group, n=1 [1%]), blast cell crisis (nilotinib group, n=1 [1%]; imatinib group, n=1 [1%]), and QT prolongation (nilotinib group, n=1 [1%]; imatinib group, n=1 [1%, after crossover to nilotinib]). Serious adverse events on assigned treatment were reported in 11 (11%) of 96 patients in the nilotinib group and nine (10%) of 93 patients in the imatinib group. Seven (7%) of 96 patients died in the nilotinib group and five (5%) of 93 patients died in the imatinib group; no deaths were treatment-related. While longer-term analyses are needed to establish whether the clinical benefits observed with switching to nilotinib are associated with improved long-term survival outcomes, our results suggest that patients with suboptimal cytogenetic response are more likely to achieve improved cytogenetic and molecular responses with switching to nilotinib than with imatinib dose escalation, although the difference was not statistically significant when responses achieved after crossover were included. Novartis Pharmaceuticals. Copyright © 2016 Elsevier Ltd. All rights reserved.

Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery

Increased calcium absorption from synthetic stable amorphous calcium carbonate: double-blind randomized crossover clinical trial in postmenopausal women.

PubMed

Vaisman, Nachum; Shaltiel, Galit; Daniely, Michal; Meiron, Oren E; Shechter, Assaf; Abrams, Steven A; Niv, Eva; Shapira, Yami; Sagi, Amir

2014-10-01

Calcium supplementation is a widely recognized strategy for achieving adequate calcium intake. We designed this blinded, randomized, crossover interventional trial to compare the bioavailability of a new stable synthetic amorphous calcium carbonate (ACC) with that of crystalline calcium carbonate (CCC) using the dual stable isotope technique. The study was conducted in the Unit of Clinical Nutrition, Tel Aviv Sourasky Medical Center, Israel. The study population included 15 early postmenopausal women aged 54.9 ± 2.8 (mean ± SD) years with no history of major medical illness or metabolic bone disorder, excess calcium intake, or vitamin D deficiency. Standardized breakfast was followed by randomly provided CCC or ACC capsules containing 192 mg elemental calcium labeled with 44Ca at intervals of at least 3 weeks. After swallowing the capsules, intravenous CaCl2 labeled with 42Ca on was administered on each occasion. Fractional calcium absorption (FCA) of ACC and CCC was calculated from the 24-hour urine collection following calcium administration. The results indicated that FCA of ACC was doubled (± 0.96 SD) on average compared to that of CCC (p < 0.02). The higher absorption of the synthetic stable ACC may serve as a more efficacious way of calcium supplementation. © 2014 American Society for Bone and Mineral Research.

A Phase 1, Open-Label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 (Trifluridine/Tipiracil) Tablets Relative to an Oral Solution Containing Equivalent Amounts of Trifluridine and Tipiracil.

PubMed

Becerra, Carlos R; Yoshida, Kenichiro; Mizuguchi, Hirokazu; Patel, Manish; Von Hoff, Daniel

2017-06-01

TAS-102 (trifluridine/tipiracil) is composed of an antineoplastic thymidine-based nucleoside analogue trifluridine (FTD), and a thymidine phosphorylase inhibitor, tipiracil (TPI), at a molar ratio of 1:0.5 (weight ratio, 1:0.471). A phase 1 study evaluated relative bioavailability of TAS-102 tablets compared with an oral solution containing equivalent amounts of FTD and TPI. In an open-label, 2-sequence, 3-period, crossover bioavailability study (part 1), patients 18 years or older with advanced solid tumors were randomized to receive TAS-102 tablets (60 mg; 3 × 20-mg tablets) on day 1 and TAS-102 oral solution (60 mg) on days 8 and 15, or the opposite sequence. In an extension (part 2), all patients received TAS-102 tablets. Of the 46 patients treated in the crossover study, 38 were evaluable in the crossover bioavailability pharmacokinetic population. For area under the concentration-time curve (AUC) 0-∞ and AUC 0-last for FTD and TPI, and maximum plasma concentration (C max ) for TPI, the 90% confidence intervals (CIs) of the geometric mean ratios were within the 0.80 to 1.25 boundary for demonstration of bioequivalence; for FTD C max , the lower limit of the 90%CI was 0.786. The most frequently reported treatment-related grade 3 or 4 adverse events were neutropenia (7 patients) and decreased neutrophil count (3 patients). Although the lower limit of the 90%CI for the geometric mean ratio of FTD C max was slightly lower than 0.80, the bioavailability of the TAS-102 tablet is considered clinically similar to that of a TAS-102 oral solution. TAS-102 was well tolerated in this population of patients with advanced solid tumors. © 2016, The American College of Clinical Pharmacology.

Influence of two different flap designs on the sequelae of mandibular third molar surgery.

PubMed

Erdogan, Ozgür; Tatlı, Ufuk; Ustün, Yakup; Damlar, Ibrahim

2011-09-01

The aim of this study was to compare the influence of triangular and envelope flaps on trismus, pain, and facial swelling after mandibular third molar surgery. Twenty healthy patients with bilateral, symmetrically impacted mandibular third molars were included in this double-blinded, prospective, cross-over, randomized study. The patients were operated with envelope flap on one side and triangular flap on the other side. Trismus was determined by measuring maximum interincisal opening, and facial swelling was evaluated using a tape measuring method. Pain was determined using visual analog scale (VAS) and recording the number of pain pills taken. The facial swelling measurements and VAS scores were lower in the envelope flap group compared to the triangular flap group. There was no significant difference between the two flap designs in operation time, maximum interincisal opening, and the number of analgesics taken. Envelope flap yields to less facial swelling and reduced VAS scores in comparison to triangular flap. There is no clinical difference in trismus between the two flap designs. Despite the higher VAS scores with triangular flap, no additional doses of analgesics were required in triangular flap.

Effect of a viscous fiber-containing nutrition bar on satiety of patients with type 2 diabetes.

PubMed

Chow, Jomay; Choe, Yong S; Noss, Michael J; Robinson, Kay J; Dugle, Janis E; Acosta, Sonja H; Garleb, Keith A

2007-06-01

To assess the satiety-promoting effect of a novel viscous fiber-containing nutrition bar, overweight and obese adult subjects with type 2 diabetes (n=99) were randomized into a double blind, crossover study. They were fed a 300kcal lunch consisting of viscous fiber-containing nutrition bars (VF) or commercial nutrition control bars designed for people with diabetes (CH). VF resulted in a 27.1% increase in fullness (p<0.05), a 15.8% decrease in prospective consumption (p<0.001), and a 14.2% decrease in hunger (p<0.001) in the 120-240min post-lunch areas under the curve (AUC) compared to CH, but no differences were observed for nausea or thirst (p>0.05). Similar results were noted for 0-300min AUC values. VF were associated with greater frequencies and intensities of abdominal distention (p<0.001) and flatulence (p<0.001), and greater frequency of stools (p<0.001) compared to CH, but there were no differences in mean or maximum (loosest) stool consistency (p>0.05). Overall, these results suggest that VF could be a useful tool in weight management of type 2 diabetes.

Recombinant granulocyte colony-stimulating factor administered enterally to neonates is not absorbed.

PubMed

Calhoun, Darlene A; Maheshwari, Akhil; Christensen, Robert D

2003-08-01

Granulocyte colony-stimulating factor (G-CSF) is present in liquids swallowed by the fetus and neonate; specifically, amniotic fluid, colostrum, and human milk. The swallowed G-CSF has local effects on enteric cells, which express the G-CSF receptor. However, some portion of the G-CSF ingested by the fetus and neonate might be absorbed into the circulation and have systemic actions, such as stimulating neutrophil production. To assess this possibility we sought to determine if circulating G-CSF concentrations of neonates increase after enteral administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF). This was a single-center, prospective, blinded, randomized, 2 x 2 crossover study, with each infant receiving 1 dose of rhG-CSF (100 microg/kg) and 1 dose of placebo. Plasma G-CSF concentrations were measured at 2 and 4 hours after administration of the test solution. No significant change in plasma G-CSF concentration was observed after the enteral administration of rhG-CSF. On this basis, we conclude that orally administered rhG-CSF is not absorbed in significant quantities, and we speculate that the G-CSF swallowed by the fetus and neonate has local but not systemic effects.

Effects of high fructose corn syrup and sucrose on the pharmacokinetics of fructose and acute metabolic and hemodynamic responses in healthy subjects

PubMed Central

Le, MyPhuong T.; Frye, Reginald F.; Rivard, Christopher J.; Cheng, Jing; McFann, Kim K.; Segal, Mark S.; Johnson, Richard J.; Johnson, Julie A.

2011-01-01

Objective It is unclear whether high fructose corn syrup (HFCS), which contains a higher amount of fructose and provides an immediate source of free fructose, induces greater systemic concentrations of fructose as compared to sucrose. It is also unclear whether exposure to higher levels of fructose leads to increased fructose-induced adverse effects. The objective was to prospectively compare the effects of HFCS- versus sucrose-sweetened soft drinks on acute metabolic and hemodynamic effects. Materials/Methods Forty men and women consumed 24 oz of HFCS- or sucrose-sweetened beverages in a randomized crossover design study. Blood and urine samples were collected over 6 hr. Blood pressure, heart rate, fructose, and a variety of other metabolic biomarkers were measured. Results Fructose area under the curve and maximum concentration, dose normalized glucose area under the curve and maximum concentration, relative bioavailability of glucose, changes in postprandial concentrations of serum uric acid, and systolic blood pressure maximum levels were higher when HFCS-sweetened beverages were consumed as compared to sucrose-sweetened beverages. Conclusions Compared to sucrose, HFCS leads to greater fructose systemic exposure and significantly different acute metabolic effects. PMID:22152650

Effects of high-fructose corn syrup and sucrose on the pharmacokinetics of fructose and acute metabolic and hemodynamic responses in healthy subjects.

PubMed

Le, Myphuong T; Frye, Reginald F; Rivard, Christopher J; Cheng, Jing; McFann, Kim K; Segal, Mark S; Johnson, Richard J; Johnson, Julie A

2012-05-01

It is unclear whether high-fructose corn syrup (HFCS), which contains a higher amount of fructose and provides an immediate source of free fructose, induces greater systemic concentrations of fructose as compared with sucrose. It is also unclear whether exposure to higher levels of fructose leads to increased fructose-induced adverse effects. The objective was to prospectively compare the effects of HFCS- vs sucrose-sweetened soft drinks on acute metabolic and hemodynamic effects. Forty men and women consumed 24 oz of HFCS- or sucrose-sweetened beverages in a randomized crossover design study. Blood and urine samples were collected over 6 hours. Blood pressure, heart rate, fructose, and a variety of other metabolic biomarkers were measured. Fructose area under the curve and maximum concentration, dose-normalized glucose area under the curve and maximum concentration, relative bioavailability of glucose, changes in postprandial concentrations of serum uric acid, and systolic blood pressure maximum levels were higher when HFCS-sweetened beverages were consumed as compared with sucrose-sweetened beverages. Compared with sucrose, HFCS leads to greater fructose systemic exposure and significantly different acute metabolic effects. Copyright © 2012 Elsevier Inc. All rights reserved.

Acetylcysteine reduces plasma homocysteine concentration and improves pulse pressure and endothelial function in patients with end-stage renal failure.

PubMed

Scholze, Alexandra; Rinder, Christiane; Beige, Joachim; Riezler, Reiner; Zidek, Walter; Tepel, Martin

2004-01-27

Increased oxidative stress, elevated plasma homocysteine concentration, increased pulse pressure, and impaired endothelial function constitute risk factors for increased mortality in patients with end-stage renal failure. We investigated the metabolic and hemodynamic effects of intravenous administration of acetylcysteine, a thiol-containing antioxidant, during a hemodialysis session in a prospective, randomized, placebo-controlled crossover study in 20 patients with end-stage renal failure. Under control conditions, a hemodialysis session reduced plasma homocysteine concentration to 58+/-22% predialysis (mean+/-SD), whereas in the presence of acetylcysteine, the plasma homocysteine concentration was significantly more reduced to 12+/-7% predialysis (P<0.01). The reduction of plasma homocysteine concentration was significantly correlated with a reduction of pulse pressure. A 10% decrease in plasma homocysteine concentration was associated with a decrease of pulse pressure by 2.5 mm Hg. Analysis of the second derivative of photoplethysmogram waveform showed changes of arterial wave reflectance during hemodialysis in the presence of acetylcysteine, indicating improved endothelial function. Acetylcysteine-dependent increase of homocysteine removal during a hemodialysis session improves plasma homocysteine concentration, pulse pressure, and endothelial function in patients with end-stage renal failure.

The Effects of Food Labelling on Postexercise Energy Intake in Sedentary Women.

PubMed

Lafrenière, Jacynthe; McNeil, Jessica; Provencher, Véronique; Doucet, Éric

2017-01-01

Food labelling has been previously reported to influence energy intake (EI). Whether food labels influence postexercise EI remains to be determined. We assessed how food labelling and exercise (Ex) interact to influence food perception and postexercise EI. In this randomized crossover design, 14 inactive women participated in 4 experimental conditions: Ex (300 kcal at 70% of VO 2peak ) and lunch labelled as low in fat (LF), Ex and lunch labelled as high in fat (HF), Rest and LF, and Rest and HF. The lunch was composed of a plate of pasta, yogurt, and oatmeal cookies, which had the same nutritional composition across the 4 experimental conditions. EI at lunch and for the 48-hour period covering the testing day and the following day was assessed. Furthermore, perceived healthiness of the meal and appetite ratings were evaluated. There were no effects of exercise and food labelling on EI. However, meals labelled as LF were perceived as heathier, and this label was associated with higher prospective food consumption. Initial beliefs about food items had a stronger effect on healthiness perception than the different food labels and explain the positive correlation with the amount of food consumed ( ρ = 0.34, P < 0.001).

A Systematic Review of the Efficacy of Bioactive Compounds in Cardiovascular Disease: Phenolic Compounds

PubMed Central

Rangel-Huerta, Oscar D.; Pastor-Villaescusa, Belen; Aguilera, Concepcion M.; Gil, Angel

2015-01-01

The prevalence of cardiovascular diseases (CVD) is rising and is the prime cause of death in all developed countries. Bioactive compounds (BAC) can have a role in CVD prevention and treatment. The aim of this work was to examine the scientific evidence supporting phenolic BAC efficacy in CVD prevention and treatment by a systematic review. Databases utilized were Medline, LILACS and EMBASE, and all randomized controlled trials (RCTs) with prospective, parallel or crossover designs in humans in which the effects of BAC were compared with that of placebo/control were included. Vascular homeostasis, blood pressure, endothelial function, oxidative stress and inflammatory biomarkers were considered as primary outcomes. Cohort, ecological or case-control studies were not included. We selected 72 articles and verified their quality based on the Scottish Intercollegiate Guidelines Network, establishing diverse quality levels of scientific evidence according to two features: the design and bias risk of a study. Moreover, a grade of recommendation was included, depending on evidence strength of antecedents. Evidence shows that certain polyphenols, such as flavonols can be helpful in decreasing CVD risk factors. However, further rigorous evidence is necessary to support the BAC effect on CVD prevention and treatment. PMID:26132993

Antibiotic rotation strategies to reduce antimicrobial resistance in Gram-negative bacteria in European intensive care units: study protocol for a cluster-randomized crossover controlled trial.

PubMed

van Duijn, Pleun J; Bonten, Marc J M

2014-07-10

Intensive care units (ICU) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria (ARGNB) because of high rates of antibiotic usage, rapid patient turnover, immunological susceptibility of acutely ill patients, and frequent contact between healthcare workers and patients, facilitating cross-transmission.Antibiotic stewardship programs are considered important to reduce antibiotic resistance, but the effectiveness of strategies such as, for instance, antibiotic rotation, have not been determined rigorously. Interpretation of available studies on antibiotic rotation is hampered by heterogeneity in implemented strategies and suboptimal study designs. In this cluster-randomized, crossover trial the effects of two antibiotic rotation strategies, antibiotic mixing and cycling, on the prevalence of ARGNB in ICUs are determined. Antibiotic mixing aims to create maximum antibiotic heterogeneity, and cycling aims to create maximum antibiotic homogeneity during consecutive periods. This is an open cluster-randomized crossover study of mixing and cycling of antibiotics in eight ICUs in five European countries. During cycling (9 months) third- or fourth-generation cephalosporins, piperacillin-tazobactam and carbapenems will be rotated during consecutive 6-week periods as the primary empiric treatment in patients suspected of infection caused by Gram-negative bacteria. During mixing (9 months), the same antibiotics will be rotated for each consecutive antibiotic course. Both intervention periods will be preceded by a baseline period of 4 months. ICUs will be randomized to consecutively implement either the mixing and then cycling strategy, or vice versa. The primary outcome is the ICU prevalence of ARGNB, determined through monthly point-prevalence screening of oropharynx and perineum. Secondary outcomes are rates of acquisition of ARGNB, bacteremia and appropriateness of therapy, length of stay in the ICU and ICU mortality. Results will be adjusted for intracluster correlation, and patient- and ICU-level variables of case-mix and infection-prevention measures using advanced regression modeling. This trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs. ClinicalTrials.gov NCT01293071 December 2010.

Cardiovascular Benefits of Wearing Particulate-Filtering Respirators: A Randomized Crossover Trial

PubMed Central

Shi, Jingjin; Lin, Zhijing; Chen, Renjie; Wang, Cuicui; Yang, Changyuan; Cai, Jing; Lin, Jingyu; Xu, Xiaohui; Ross, Jennifer A.; Zhao, Zhuohui; Kan, Haidong

2016-01-01

Background: Practical approaches to protect individuals from ambient particulate matter (PM) are urgently needed in developing countries. Evidence on the health benefits of wearing particulate-filtering respirators is limited. Objectives: We evaluated the short-term cardiovascular health effects of wearing respirators in China. Methods: A randomized crossover trial was performed in 24 healthy young adults in Shanghai, China in 2014. The subjects were randomized into two groups and wore particulate-filtering respirators for 48 hr alternating with a 3-week washout interval. Heart rate variability (HRV) and ambulatory blood pressure (BP) were continuously monitored during the 2nd 24 hr in each intervention. Circulating biomarkers were measured at the end of each intervention. Linear mixed-effect models were applied to evaluate the effects of wearing respirators on health outcomes. Results: During the intervention periods, the mean daily average concentration of PM with an aerodynamic diameter < 2.5 μm (PM2.5) was 74.2 μg/m3. Compared with the absence of respirators, wearing respirators was associated with a decrease of 2.7 mmHg [95% confidence interval (CI): 0.1, 5.2 mmHg] in systolic BP and increases of HRV parameters, including 12.5% (95% CI: 3.8%, 21.2%) in high frequency (HF) power, 10.9% (95% CI: 1.8%, 20.0%) in the root mean square of the successive differences, and 22.1% (95% CI: 3.6%, 40.7%) in the percentage of normal RR intervals with duration > 50 msec different from the previous normal RR interval (pNN50). The presence of respirators was also associated with a decrease of 7.8% (95% CI: 3.5%, 12.1%) in the ratio of low frequency (LF)/HF power. Conclusions: Short-term wearing of particulate-filtering respirators may produce cardiovascular benefits by improving autonomic nervous function and reducing BP. Citation: Shi J, Lin Z, Chen R, Wang C, Yang C, Cai J, Lin J, Xu X, Ross JA, Zhao Z, Kan H. 2017. Cardiovascular benefits of wearing particulate-filtering respirators: a randomized crossover trial. Environ Health Perspect 125:175–180; http://dx.doi.org/10.1289/EHP73 PMID:27562361

The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

PubMed Central

2010-01-01

Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601 PMID:20487567

Appetite and food intake after consumption of sausages with 10% fat and added wheat or rye bran.

PubMed

Vuholm, Stine; Arildsen Jakobsen, Louise Margrethe; Vejrum Sørensen, Karina; Kehlet, Ursula; Raben, Anne; Kristensen, Mette

2014-02-01

The use of dietary fibers as fat-replacers in sausages gives less energy-dense and thereby healthier foods. Also, dietary fibers have been shown to induce satiety. The objectives of this study were to investigate if appetite sensations and energy intake was affected by (1) addition of dietary fibers to sausages, (2) type of dietary fibers and (3) the food matrix of the dietary fibers. In this randomized cross-over study 25 young men were served four test meals; wheat bran sausages, rye bran sausages, rye bran bread and wheat flour sausages. The test meals were served as breakfast after an overnight fast. Appetite sensations were evaluated by visual analogue scales (VAS) assessed every 30 min for 240 min followed by an ad libitum lunch meal where energy intake was calculated. Both rye bran and wheat bran sausages increased satiety (P < 0.01) and fullness (P < 0.02) and decreased hunger (P < 0.001) and prospective consumption (P < 0.001) compared to wheat flour sausages. Furthermore, rye bran sausages increased satiety (P < 0.05) and fullness (P < 0.02) and decreased prospective consumption (P < 0.01) compared to rye bran bread. No differences in subsequent energy intake were observed. In conclusion, wheat and rye bran added to sausages decreased appetite sensations and thereby has a potential added health benefit beyond the role as fat-replacer. The satisfying effect of dietary fibers appears to be more pronounced when added to sausages than when added to bread, stressing the importance of food matrix and food processing.

Patterns of physical activity in children with haemophilia.

PubMed

Broderick, C R; Herbert, R D; Latimer, J; van Doorn, N

2013-01-01

The current widespread use of prophylaxis in developed countries has enabled greater participation in physical activity. However, there are no data available on leisure-time physical activity in Australian children with haemophilia. The data reported here were obtained from a case-crossover study nested in a prospective cohort study of 104 boys with moderate and severe haemophilia followed for one year. Each child's physical activity was assessed using a modifiable physical activity questionnaire (Kriska's MAQ) administered at baseline, and a one-week prospective activity diary at a randomly determined time. Children were aged 4-18 years. The median time spent in sport or leisure-time physical activity in the preceding year was 7.9 h/week (IQR 4.6 to 12.9). The median time spent in vigorous physical activity was 3.8 h/week (IQR 1.6 to 6.4) and in moderate and vigorous physical activity 6.4 h/week (IQR 3.7 to 10.0). The median small-screen time was 2.5 h/day (IQR 0.5 to 2.5). Forty-five per cent of all children and 61% of children over the age of 10 years played at least one competitive sport. Averaged across one week, 43% of all children met the Australian government physical activity guidelines for children and 36% met the guidelines for small-screen time. This study provides the first data regarding leisure-time physical activity in children with haemophilia living in Australia. The majority of Australian children with haemophilia are not meeting the national physical activity and small-screen time guidelines. © 2012 Blackwell Publishing Ltd.

A single meal containing raw, crushed garlic influences expression of immunity- and cancer-related genes in whole blood of humans

USDA-ARS?s Scientific Manuscript database

Preclinical and epidemiological studies suggest that garlic intake is inversely associated with the progression of cancer and cardiovascular disease. To probe mechanisms of garlic action in humans, we conducted a randomized crossover feeding trial in which 17 volunteers consumed a garlic-containing...

Differential Effects of Methylphenidate on Attentional Functions in Children with Attention-Deficit-Hyperactivity Disorder

ERIC Educational Resources Information Center

Konrad, Kerstin; Gunther, Thomas; Hanisch, Charlotte; Herpertz-Dahlmann, Beate

2004-01-01

Objective: To examine the effects of methylphenidate on different attentional functions and behavior in children with attention-deficit-hyperactivity disorder (ADHD). Method: A total of 60 ADHD children aged between 8 and 12 years completed a randomized, double-blind, placebo-controlled, within-subject crossover trial with two doses of…

Simulated Driving Changes in Young Adults with ADHD Receiving Mixed Amphetamine Salts Extended Release and Atomoxetine

ERIC Educational Resources Information Center

Kay, Gary G.; Michaels, M. Alex; Pakull, Barton

2009-01-01

Background: Psychostimulant treatment may improve simulated driving performance in young adults with attention-deficit/hyperactivity disorder (ADHD). Method: This was a randomized, double-blind, placebo-controlled, crossover study of simulated driving performance with mixed amphetamine salts--extended release (MAS XR) 50 mg/day (Cohort 1) and…

Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

PubMed

Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

2016-01-01

It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

Aged Garlic Extract Improves Adiponectin Levels in Subjects with Metabolic Syndrome: A Double-Blind, Placebo-Controlled, Randomized, Crossover Study

PubMed Central

Gómez-Arbeláez, Diego; Lahera, Vicente; Oubiña, Pilar; Valero-Muñoz, Maria; de las Heras, Natalia; Rodríguez, Yudy; García, Ronald Gerardo; Camacho, Paul Anthony; López-Jaramillo, Patricio

2013-01-01

Background. Garlic (Allium sativum) has been shown to have important benefits in individuals at high cardiovascular risk. The aim of the present study was to evaluate the effects of the administration of aged garlic extract (AGE) on the risk factors that constitute the cluster of metabolic syndrome (MS). Methods and Design. Double-blind, crossover, randomized, placebo-controlled clinical trial to assess the effect of 1.2 g/day of AGE (Kyolic), for 24 weeks of treatment (12 weeks of AGE and 12 weeks of placebo), on subjects with MS. Results. The administration of AGE increased the plasma levels of adiponectin (P = 0.027). No serious side effects associated with the intervention were reported. Conclusion. The present results have shown for the first time that the administration of AGE for 12 weeks increased plasma adiponectin levels in patients with MS. This suggests that AGE might be a useful, novel, nonpharmacological therapeutic intervention to increase adiponectin and to prevent cardiovascular (CV) complications in individuals with MS. PMID:23533302

Randomized Pharmacokinetic Crossover Study Comparing 2 Curcumin Preparations in Plasma and Rectal Tissue of Healthy Human Volunteers.

PubMed

Asher, Gary N; Xie, Ying; Moaddel, Ruin; Sanghvi, Mitesh; Dossou, Katina S S; Kashuba, Angela D M; Sandler, Robert S; Hawke, Roy L

2017-02-01

Curcumin is poorly absorbed, which is interest in new preparations. However, little is known about variations in its pharmacokinetics and tissue bioavailability between formulations. In this randomized, crossover study we evaluated the relationship between steady-state plasma and rectal tissue curcuminoid concentrations using standard and phosphatidylcholine curcumin extracts. There was no difference in the geometric mean plasma AUCs when adjusted for the 10-fold difference in curcumin dose between the 2 formulations. Phosphatidylcholine curcumin extract yielded only 20% to 30% plasma demethoxycurcumin and bisdemethoxycurcumin conjugates compared to standard extract, yet yielded 20-fold greater hexahydrocurcumin. When adjusting for curcumin dose, tissue curcumin concentrations were 5-fold greater for the phosphatidylcholine extract. Improvements in curcuminoid absorption due to phosphatidylcholine are not uniform across the curcuminoids. Furthermore, curcuminoid exposures in the intestinal mucosa are most likely due to luminal exposure rather than to plasma disposition. Finally, once-daily dosing is sufficient to maintain detectable curcuminoids at steady state in both plasma and rectal tissues. © 2016, The American College of Clinical Pharmacology.

Can inhibitory and facilitatory kinesiotaping techniques affect motor neuron excitability? A randomized cross-over trial.

PubMed

Yoosefinejad, Amin Kordi; Motealleh, Alireza; Abbasalipur, Shekoofeh; Shahroei, Mahan; Sobhani, Sobhan

2017-04-01

The aim of this study was to investigate the immediate effects of facilitatory and inhibitory kinesiotaping on motor neuron excitability. Randomized cross-over trial. Twenty healthy people received inhibitory and facilitatory kinesiotaping on two testing days. The H- and M-waves of the lateral gasterocnemius were recorded before and immediately after applying the two modes of taping. The Hmax/Mmax ratio (a measure of motor neuron excitability) was determined and analyzed. The mean Hmax/Mmax ratios were -0.013 (95% CI: -0.033 to 0.007) for inhibitory taping and 0.007 (95% CI: -0.013 to 0.027) for facilitatory taping. The mean difference between groups was -0.020 (95% CI: -0.048 to 0.008). The statistical model revealed no significant differences between the two interventions (P = 0.160). Furthermore, there were no within-group differences in Hmax/Mmax ratio for either group. Our findings did not disclose signs of immediate change in motor neuron excitability in the lateral gasterocnemius. Copyright © 2016. Published by Elsevier Ltd.

Influence of heat and moisture exchanger respiratory load on transcutaneous oxygenation in laryngectomized individuals: a randomized crossover study.

PubMed

Zuur, J Karel; Muller, Sara H; Sinaasappel, Michiel; Hart, Guus A M; van Zandwijk, Nico; Hilgers, Frans J M

2007-12-01

High-resistance heat and moisture exchangers (HMEs) have been reported to increase transcutaneous oxygenation (tcpO(2)) values in laryngectomized individuals and to negatively influence patient compliance. The goal of the present study was to validate earlier published results on short-term transcutaneous oxygenation changes by high-resistance HMEs. We conducted a randomized crossover study, monitoring the influence of an HME on tcpO(2) over a 2-hour time interval in 20 subjects. No evidence of an immediate HME effect (95% CI: -14.9-13.3 mm Hg, p = .91), or a time-dependent HME effect (95% CI: -.121 - .172 mm Hg/minute, p = .74), on tcpO(2) was found. After fitting the statistical model without time dependency, again no evidence of HME presence was seen (95% CI: -.5 mm Hg - 3.6 mm Hg, p = .15). In contrast to earlier suggestions, there is no evidence of increased tcpO(2) levels by high-resistance HMEs in laryngectomized individuals. Thus, using such HMEs has no added clinical value in this respect.

Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males-a randomized controlled cross-over study.

PubMed

Ranawana, Viren; Muller, Adelaide; Henry, C Jeya K

2013-04-01

Polydextrose is a low-calorie highly branched-chain glucose polymer that is poorly digested in the upper gastrointestinal tract and therefore demonstrates fibre-like properties. Fibre has been shown to increase satiety and possibly reduce food intake. Therefore, the objective of the current study was to examine the effects of polydextrose on short-term satiety and energy intake. In a repeated-measures randomized blind cross-over design, 26 healthy males consumed a 400-g fruit smoothie containing 12 g (3 %) of polydextrose, and a buffet lunch 60 min after the smoothie. Motivational ratings for satiety and palatability and lunch energy intake were measured. The effects of the polydextrose-containing smoothie were compared against a polydextrose-free control smoothie. Polydextrose did not significantly alter the taste and palatability of the fruit smoothie. Consuming the polydextrose-containing smoothie resulted in a significantly lower energy intake at lunch (102 kcal less) compared to the control. Polydextrose may be a good fortificant for reducing short-term food intake.

The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial.

PubMed

Yatawara, C J; Einfeld, S L; Hickie, I B; Davenport, T A; Guastella, A J

2016-09-01

Interventions for autism are limited. The synthetic hormone oxytocin may provide a potential treatment to improve core social and behavioral difficulties in autism, but its efficacy has yet to be evaluated in young children who potentially may benefit to a greater extent. We investigated the efficacy, tolerability and safety of oxytocin treatment in young children with autism using a double-blind, randomized, placebo-controlled, crossover, clinical trial. Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment. Compared with placebo, oxytocin led to significant improvements on the primary outcome of caregiver-rated social responsiveness. Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation. This study is the first clinical trial to support the potential of oxytocin as an early intervention for young children with autism to help improve social interaction deficits.

The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial

PubMed Central

Yatawara, C J; Einfeld, S L; Hickie, I B; Davenport, T A; Guastella, A J

2016-01-01

Interventions for autism are limited. The synthetic hormone oxytocin may provide a potential treatment to improve core social and behavioral difficulties in autism, but its efficacy has yet to be evaluated in young children who potentially may benefit to a greater extent. We investigated the efficacy, tolerability and safety of oxytocin treatment in young children with autism using a double-blind, randomized, placebo-controlled, crossover, clinical trial. Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment. Compared with placebo, oxytocin led to significant improvements on the primary outcome of caregiver-rated social responsiveness. Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation. This study is the first clinical trial to support the potential of oxytocin as an early intervention for young children with autism to help improve social interaction deficits. PMID:26503762

Bupivacaine 0.5 % versus articaine 4 % for the removal of lower third molars. A crossover randomized controlled trial

PubMed Central

Sancho-Puchades, Manuel; Vílchez-Pérez, Miguel A.; Paredes-García, Jordi; Berini-Aytés, Leonardo; Gay-Escoda, Cosme

2012-01-01

Objective: To compare the anesthetic action of 0.5% bupivacaine in relation to 4% articaine, both with 1:200,000 epinephrine, in the surgical removal of lower third molars. As a secondary objective hemodynamic changes using both anesthetics were analyzed. Study Design: Triple-blind crossover randomized clinical trial. Eighteen patients underwent bilateral removal of impacted lower third molars using 0.5% bupivacaine or 4% articaine in two different appointments. Preoperative, intraoperative and postoperative variables were recorded. Differences were assessed with McNemar tests and repeated measures ANOVA tests. Results: Both solutions exhibited similar latency times and intraoperative efficacy. Statistical significant lower pain levels were observed with bupivacaine between the fifth (p=0.011) and the ninth (p=0.007) postoperative hours. Bupivacaine provided significantly longer lasting soft tissue anesthesia (p<0.05). Systolic blood pressure and heart rate values were significantly higher with articaine. Conclusions: Bupivacaine could be a valid alternative to articaine especially due to its early postoperative pain prevention ability. Key words:Bupivacaine, articaine, third molar, anesthesia, postoperative pain. PMID:22143739

SGEM Hot Off the Press: ultrasound during critical care simulation: a randomized crossover study.

PubMed

McKenna, Paul; Thoma, Brent; Milne, Ken; Bond, Chris

2017-01-01

As part of the Canadian Journal of Emergency Medicine's (CJEM) developing social media strategy, 1 we are collaborating with the Skeptics' Guide to Emergency Medicine (SGEM) to summarize and critically appraise the current emergency medicine (EM) literature using evidence-based medicine principles. In the "Hot Off the Press" series, we select original research manuscripts published in CJEM to be featured on the SGEM website/podcast 2 and discussed by the study authors and the online EM community. A similar collaboration is underway between the SGEM and Academic Emergency Medicine. What follows is a summary of the selected article the immediate post-publication synthesis from the SGEM podcast, commentary by the first author, and the subsequent discussion from the SGEM blog and other social media. Through this series, we hope to enhance the value, accessibility, and application of important, clinically relevant EM research. In this, the third SGEM HOP hosted collaboratively with CJEM, we discuss Olszynski et al.'s randomized crossover study evaluating the use of ultrasound simulator devices during critical care simulation. 3.

Crossover transition in flowing granular chains

NASA Astrophysics Data System (ADS)

Ulrich, Xialing; Fried, Eliot; Shen, Amy Q.

2009-09-01

We report on the dynamical and statistical behavior of flowing collections of granular chains confined two-dimensionally (2D) within a rotating tumbler. Experiments are conducted with systems of chains of fixed length, but various lengths are considered. The dynamics are punctuated by cascades of chains along a free-surface cascades, which drive the development of mixed porous/laminar packing arrangements in bulk. We investigate the conformation of the system, as characterized by the porosity of the flow region occupied by the chains and the mean-square end-to-end distance of the chains during flow. Both of these measures show crossover transitions from a 2D self-avoiding walk to a 2D random walk when the chain length becomes long enough to allow self-contact.

A Prospective Randomized, Double-Blind, Two-Period Crossover Pharmacokinetic Trial Comparing Green Coffee Bean Extract-A Botanically Sourced Caffeine-With a Synthetic USP Control.

PubMed

Morton, Kayce; Knight, Katelin; Kalman, Douglas; Hewlings, Susan

2018-04-16

Coffee is a primary dietary source of the chlorogenic acids (CGAs) of phenolic compounds. Coffee contains caffeine and other phytonutrients, including CGAs. Caffeine on its own has been well characterized and descried pharmacokinetically in the literature, less so for CGAs. The purpose of this double-blind crossover study was to determine the comparative pharmacokinetics of CGAs with caffeine (natural extract) with synthetic caffeine (US Pharmacopeia [USP] standard). Sixteen healthy male subjects were randomly assigned to take 1 dose of product 1, 60 mg of botanically sourced caffeine from 480 mg of green coffee bean extract, or product 2, 60 mg of synthetic USP caffeine, with 5 days between. Blood analysis was done to determine the levels of CGA compounds, more specifically 3-, 4-, and 5-caffeoylquinic acid (CQA), and serum caffeine. The natural caffeine extract exhibited mean peak concentrations (C max ) of 3-CQA (11.4 ng/mL), 4-CQA (6.84 ng/mL), and 5-CQA (7.20 ng/mL). The mean systemic 4-hour exposure (AUC 0-4 h ) was 3-CQA (27.3 ng·h/mL), 4-CQA (16.1 ng·h/mL), and 5-CQA (15.7 ng·h/mL). The median t max was 3-CQA (1.00 hour), 4-CQA (1.00 hour), and 5-CQA (1.50 hours). The t max of caffeine was 0.75 hours (natural extract) and 0.63 hours (synthetic caffeine). C max and AUC 0-4 h of serum caffeine were statistically equivalent between products. The geometric least-squares mean ratios (GMRs) of C max and AUC 0-4 h of caffeine were 97.77% (natural extract) and 98.33% (synthetic caffeine). It would appear that CGA compounds from the natural caffeine extract are bioavailable, and 3-CGA may be the compound most absorbed. In addition, caffeine sourced from natural extract versus synthetic were statistically similar for pharmacokinetic parameters. There were no adverse events or safety concerns. © 2018 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

Carbamezapine for pain management in Guillain-Barré syndrome patients in the intensive care unit.

PubMed

Tripathi, M; Kaushik, S

2000-03-01

To evaluate carbamezapine (CBZ) for neuritic pain relief in Guillain-Barré syndrome (GBS) patients in the intensive care unit (ICU). Prospective, double-blind, randomly allocated cross-over study days. ICU in a tertiary care university hospital. Twelve consecutive, conscious adult (22-54 yrs) patients with GBS during recovery from the muscular weakness and receiving pressure-support ventilation in the ICU. All patients complained of severe backache and/or leg cramps and tenderness in muscles, and they required opioids for pain relief. CBZ (100 mg every 8 hrs) or equivalent placebo was given to nursing staff in coded powder form. Medication was given to patients through a nasogastric feeding tube. The same coded medicine was given for 3 days, and after a 1-day omission, a second set of coded powder was given for the next 3 days in a randomized, double-blind, crossover fashion. Pethidine (1 mg x kg(-1)) was given intravenously in between, if the pain score was >2. Group 1 (n = 6) patients were given a placebo on the first 3 days, followed by CBZ. Group 2 (n = 6) patients were given CBZ on the first 3 days, followed by a placebo. In these two study periods of different medications, we observed and scored pain (1, no pain; 5, severe pain), sedation (1, alert; 6, asleep, does not respond to verbal command), and total pethidine requirement per day. In group 1 patients, a significant (p < .001) improvement in the sedation score and a low requirement for pethidine was observed 3 days later, when CBZ was started. However, in group 2 patients, a gradual increase in the pethidine requirement and a high sedation score were noteworthy in the later days of placebo medication. Observations were also analyzed for CBZ days vs. placebo days. Overall, the pain score (1.7 +/- 0.8) during the CBZ period of both regimens was significantly (p < .001) lower than during the placebo days (3.1 +/- 0.9). Significantly higher doses of pethidine (3.7 +/- 0.9 mg/kg/day) were used on the placebo days than on the CBZ days (1.7 +/- 1.0 mg/kg/day). The pain in GBS has a dual origin, and we recommend CBZ as an adjuvant to treat pain in GBS patients, during the recovery phase in the ICU, to reduce the narcotic requirement.

Effect of a High-Protein, High-Fiber Beverage Preload on Subjective Appetite Ratings and Subsequent Ad Libitum Energy Intake in Overweight Men and Women: A Randomized, Double-Blind Placebo-Controlled, Crossover Study

PubMed Central

Sharafi, Mastaneh; Alamdari, Nima; Wilson, Michael; Leidy, Heather J; Glynn, Erin L

2018-01-01

Abstract Background Dietary protein and fiber have been shown to independently improve subjective measures of appetite control. Objective The aim of this study was to determine the acute effects of a high-protein, high-fiber (HP/HFb) beverage taken as a preload compared with an isocaloric lower-protein, lower-fiber (LP/LFb) placebo beverage on subjective appetite ratings and subsequent energy intake at an ad libitum meal in healthy adults. Methods A total of 50 overweight/obese men and women [n = 25 men, 25 women; age 30 ± 2 y; body mass index (BMI) 29.6 ± 0.3 kg/m2] received a 160 kcal HP/HFb beverage containing 17 g protein and 6 g fiber on one occasion and an isocaloric LP/LFb placebo beverage containing 1 g protein and 3 g fiber on another occasion in a randomized, double-blind, crossover design. Thirty min after consumption of the beverage preload, an ad libitum pizza meal was provided to be consumed over a 30-min period. Visual analog scales (VAS) were used to assess subjective appetite ratings throughout the testing period. The Revised Restraint Scale (RRS) was used to classify participants as restrained or unrestrained eaters. Results HP/HFb led to greater reductions in postprandial desire to eat and hunger compared with LP/LFb (both, P < 0.05) but did not significantly affect postprandial fullness or prospective food consumption. Subsequent meal energy intake tended to be lower after HP/HFb compared with LP/LFb (P = 0.09). A subanalysis showed lower energy intake after HP/HFb in older participants (≥25 y) compared with LP/LFb, which was not observed in the younger participants (<25 y). Conclusions Compared with LP/LFb, a HP/HFb beverage preload reduced hunger, desire to eat, and tended to reduce subsequent food intake. Dietary restraint and age appear to influence subsequent energy intake and should be taken into account when designing nutrition interventions for weight reduction and/or maintenance. This trial was registered at clinicaltrials.gov as NCT02979717.

Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.

PubMed

Safarinejad, Mohammad Reza

2005-01-01

To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months. 558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P < 0.001). Both IPSS and Qmax showed greater improvement with drug than with placebo. The IPSS went from 19.8 down to 11.8 with Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P < 0.05). In Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P < 0.05). No appreciable change was seen in the placebo group. Serum PSA and testosterone levels were unchanged in both groups. A modest decrease in prostate size as measured by transrectal ultrasonography (TRUS) was seen in Urtica dioica group (from 40.1 cc initially to 36.3 cc; P < 0.001). There was no change in the prostate volume at the end of study with placebo. At 18-month follow-up, only patients who continued therapy, had a favorable treatment variables value. No side effects were identified in either group. In the present study, Urtica dioica have beneficial effects in the treatment of symptomatic BPH. Further clinical trials should be conducted to confirm these results before concluding that Urtica dioica is effective.

A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial

PubMed Central

Melzer, Itshak; Elbar, Ori; Tsedek, Irit; Oddsson, Lars IE

2008-01-01

Background Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136). Methods/Design The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65–88) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training). Voluntary step reaction times and postural stability using stabiliogram diffusion analysis will be tested before and after the 12 weeks of training. Discussion This study will determine whether a water-based balance training program that includes perturbation exercises, in a group setting, can improve speed of voluntary stepping responses and improve balance control. Results will help guide the development of more cost-effective interventions that can prevent the occurrence of falls in the elderly. PMID:18706103

Mobile Application vs Paper Pictorial Blood Assessment Chart to Track Menses in Young Women: A Randomized Cross-over Design.

PubMed

Jacobson, Amanda E; Vesely, Sara K; Haamid, Fareeda; Christian-Rancy, Myra; O'Brien, Sarah H

2018-04-01

Heavy menstrual bleeding is a common symptom reported by approximately 30% of women. The Pictorial Blood Assessment Chart (PBAC) score is often used to quantify severity of menstrual bleeding. However, the traditional PBAC paper diary might be subject to recall bias and compliance issues, especially in adolescents. We developed a mobile application (app) version of the PBAC score and evaluated patient satisfaction and compliance with app reporting vs paper reporting. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: This study was a randomized cross-over study of 25 postmenarchal female adolescents and young women ages 13-21 years. Participants agreed to track bleeding in 2 consecutive menstrual cycles and were randomized to use the PBAC paper diary or mobile app format first. At the end of each cycle, a satisfaction survey and system usability scale (app only) was used to assess the acceptability of the format used. Twenty-five participants had a median age of 15 years. Cross-over analysis showed that satisfaction level was significantly higher for the app (P < .001). Twenty of 25 (80%) participants preferred the app over the paper diary. For the app, 20 of 25 participants (80%) had high compliance for reporting bleeding, with a mean of 2 app entries per day. Participants' PBAC scores did not vary significantly between the paper diary (median, 95) and mobile app (median, 114). All paper diaries met definition for high compliance. There was no significant period or carryover effect. This study showed that a PBAC app compared with the paper diary was the preferred method of recording menstrual bleeding in adolescents and showed feasibility as a research data collection tool. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

The Effects of Aroma Foot Massage on Blood Pressure and Anxiety in Japanese Community-Dwelling Men and Women: A Crossover Randomized Controlled Trial

PubMed Central

Tomooka, Kiyohide; Ohira, Tetsuya; Ogino, Keiki; Tanigawa, Takeshi

2016-01-01

Objectives The aim of this study was to investigate the effects of aroma foot massage on blood pressure, anxiety, and health-related quality of life (QOL) in Japanese community-dwelling men and women using a crossover randomized controlled trial. Methods Fifty-seven eligible participants (5 men and 52 women) aged 27 to 72 were randomly divided into 2 intervention groups (group A: n = 29; group B: n = 28) to participate in aroma foot massages 12 times during the 4-week intervention period. Systolic and diastolic blood pressure (SBP and DBP, respectively), heart rate, state anxiety, and health-related QOL were measured at the baseline, 4-week follow-up, and 8-week follow-up. The effects of the aroma foot massage intervention on these factors and the proportion of participants with anxiety were analyzed using a linear mixed-effect model for a crossover design adjusted for participant and period effects. Furthermore, the relationship between the changes in SBP and state anxiety among participants with relieved anxiety was assessed using a linear regression model. Results Aroma foot massage significantly decreased the mean SBP (p = 0.02), DBP (p = 0.006), and state anxiety (p = 0.003) as well as the proportion of participants with anxiety (p = 0.003). Although it was not statistically significant (p = 0.088), aroma foot massage also increased the score of mental health-related QOL. The change in SBP had a significant and positive correlation with the change in state anxiety (p = 0.01) among participants with relieved anxiety. Conclusion The self-administered aroma foot massage intervention significantly decreased the mean SBP and DBP as well as the state anxiety score, and tended to increase the mental health-related QOL scores. The results suggest that aroma foot massage may be an easy and effective way to improve mental health and blood pressure. Trial Registration University Hospital Medical Information Network 000014260 PMID:27010201

The Effects of Aroma Foot Massage on Blood Pressure and Anxiety in Japanese Community-Dwelling Men and Women: A Crossover Randomized Controlled Trial.

PubMed

Eguchi, Eri; Funakubo, Narumi; Tomooka, Kiyohide; Ohira, Tetsuya; Ogino, Keiki; Tanigawa, Takeshi

2016-01-01

The aim of this study was to investigate the effects of aroma foot massage on blood pressure, anxiety, and health-related quality of life (QOL) in Japanese community-dwelling men and women using a crossover randomized controlled trial. Fifty-seven eligible participants (5 men and 52 women) aged 27 to 72 were randomly divided into 2 intervention groups (group A: n = 29; group B: n = 28) to participate in aroma foot massages 12 times during the 4-week intervention period. Systolic and diastolic blood pressure (SBP and DBP, respectively), heart rate, state anxiety, and health-related QOL were measured at the baseline, 4-week follow-up, and 8-week follow-up. The effects of the aroma foot massage intervention on these factors and the proportion of participants with anxiety were analyzed using a linear mixed-effect model for a crossover design adjusted for participant and period effects. Furthermore, the relationship between the changes in SBP and state anxiety among participants with relieved anxiety was assessed using a linear regression model. Aroma foot massage significantly decreased the mean SBP (p = 0.02), DBP (p = 0.006), and state anxiety (p = 0.003) as well as the proportion of participants with anxiety (p = 0.003). Although it was not statistically significant (p = 0.088), aroma foot massage also increased the score of mental health-related QOL. The change in SBP had a significant and positive correlation with the change in state anxiety (p = 0.01) among participants with relieved anxiety. The self-administered aroma foot massage intervention significantly decreased the mean SBP and DBP as well as the state anxiety score, and tended to increase the mental health-related QOL scores. The results suggest that aroma foot massage may be an easy and effective way to improve mental health and blood pressure. University Hospital Medical Information Network 000014260.

Randomized, Double-Blinded, Placebo-Controlled Crossover Trial of Treating Erectile Dysfunction with Sildenafil After Radiotherapy and Short-Term Androgen Deprivation Therapy: Results of RTOG 0215

PubMed Central

Bruner, Deborah Watkins; James, Jennifer L.; Bryan, Charlene J.; Pisansky, Thomas M.; Rotman, Marvin; Corbett, Thomas; Speight, Joycelyn; Byhardt, Roger; Sandler, Howard; Bentzen, Søren; Kachnic, Lisa; Berk, Lawrence

2013-01-01

Introduction Erectile dysfunction (ED) may be the most commonly observed adverse event (AE) associated with the combination of radiation therapy (RT) and androgen deprivation therapy (ADT). A significant number of men are trying phosphodiesterase type 5 inhibitors (PDE5s) such as sildenafil to treat ED, yet sildenafil studies to date shed little light on the response to ED after ADT. Aim The purpose of this trial was to evaluate sildenafil in the treatment of ED in prostate cancer patients previously treated with external beam RT and neoadjuvant and concurrent ADT. Methods In this randomized, double-blinded crossover trial, eligible patients received RT/ADT for intermediate risk prostate cancer and currently had ED as defined by the International Index of Erectile Function (IIEF). Patients were randomized to 12 weeks of sildenafil or placebo followed by 1 week of no treatment then 12 weeks of the alternative. Treatment differences were evaluated using a marginal model for binary crossover data. Main Outcome Measures The primary end point was improved erectile function, as measured by the IIEF. Results The study accrued 115 patients and 61 (55%) completed all three IIEF assessments. Sildenafil effect was significant (P = 0.009) with a difference in probabilities of erectile response of 0.17 (95% confidence interval: 0.06, 0.29), and 0.21 (0.06, 0.38) for patients receiving ≤120 days of ADT. However, as few as 21% of patients had a treatment-specific response, only improving during sildenafil but not during the placebo phase. Conclusions This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer. PMID:21235716

Repeated Nitrogen Dioxide Exposures and Eosinophilic Airway Inflammation in Asthmatics: A Randomized Crossover Study

PubMed Central

Guillossou, Gaëlle; Neukirch, Catherine; Dehoux, Monique; Koscielny, Serge; Bonay, Marcel; Cabanes, Pierre-André; Samet, Jonathan M.; Mure, Patrick; Ropert, Luc; Tokarek, Sandra; Lambrozo, Jacques; Aubier, Michel

2014-01-01

Background: Nitrogen dioxide (NO2), a ubiquitous atmospheric pollutant, may enhance the asthmatic response to allergens through eosinophilic activation in the airways. However, the effect of NO2 on inflammation without allergen exposure is poorly studied. Objectives: We investigated whether repeated peaks of NO2, at various realistic concentrations, induce changes in airway inflammation in asthmatics. Methods: Nineteen nonsmokers with asthma were exposed at rest in a double-blind, crossover study, in randomized order, to 200 ppb NO2, 600 ppb NO2, or clean air once for 30 min on day 1 and twice for 30 min on day 2. The three series of exposures were separated by 2 weeks. The inflammatory response in sputum was measured 6 hr (day 1), 32 hr (day 2), and 48 hr (day 3) after the first exposure, and compared with baseline values measured twice 10–30 days before the first exposure. Results: Compared with baseline measurements, the percentage of eosinophils in sputum increased by 57% after exposure to 600 ppb NO2 (p = 0.003) but did not change significantly after exposure to 200 ppb. The slope of the association between the percentage of eosinophils and NO2 exposure level was significant (p = 0.04). Eosinophil cationic protein in sputum was highly correlated with eosinophil count and increased significantly after exposure to 600 ppb NO2 (p = 0.001). Lung function, which was assessed daily, was not affected by NO2 exposure. Conclusions: We observed that repeated peak exposures of NO2 performed without allergen exposure were associated with airway eosinophilic inflammation in asthmatics in a dose-related manner. Citation: Ezratty V, Guillossou G, Neukirch C, Dehoux M, Koscielny S, Bonay M, Cabanes PA, Samet JM, Mure P, Ropert L, Tokarek S, Lambrozo J, Aubier M. 2014. Repeated nitrogen dioxide exposures and eosinophilic airway inflammation in asthmatics: a randomized crossover study. Environ Health Perspect 122:850–855; http://dx.doi.org/10.1289/ehp.1307240 PMID:24747297

Efficacy and safety of 10-mg azilsartan compared with 8-mg candesartan cilexetil in Japanese patients with hypertension: a randomized crossover non-inferiority trial.

PubMed

Takahara, Mitsuyoshi; Shiraiwa, Toshihiko; Shindo, Megumi; Arai, Akie; Kusuda, Yuko; Katakami, Naoto; Kaneto, Hideaki; Matsuoka, Taka-Aki; Shimomura, Iichiro

2014-09-01

We investigated whether 10 mg per day of azilsartan, one-half of the normal dosage, would be non-inferior to 8 mg per day of candesartan cilexetil for controlling blood pressure in Japanese patients with hypertension. In this open-label, randomized, crossover trial, 309 hypertensive Japanese adults treated with 8-mg candesartan cilexetil were randomized into two arms and received either 10-mg azilsartan or 8-mg candesartan cilexetil in a crossover manner. The primary efficacy outcome was systolic blood pressure, and the margin of non-inferiority was set to be 2.5 mm Hg. The participants were 67±11 years old, and 180 (58%) were male. The baseline systolic and diastolic blood pressure levels were 127.1±13.2 and 69.7±11.2 mm Hg, respectively. During the study period, the difference in systolic blood pressure between the treatments with 10-mg azilsartan and 8-mg candesartan cilexetil was -1.7 mm Hg, with the two-sided 95% confidence interval (CI) ranged from -3.2 to -0.2 mm Hg. The upper boundary of the 95% CI was below the margin of 2.5 mm Hg, confirming the non-inferiority of 10-mg azilsartan to 8-mg candesartan cilexetil. The difference also reached significance (P=0.037). The corresponding difference in diastolic blood pressure was -1.4 (95% CI: -2.4 to -0.4) mm Hg (P=0.006). Treatment with 10-mg azilsartan was similar to 8-mg candesartan cilexetil in its association with rare adverse events. In conclusion, 10-mg azilsartan was non-inferior to 8-mg candesartan cilexetil for controlling systolic blood pressure in Japanese hypertensive patients already being treated with 8-mg candesartan cilexetil.

A Randomized, Double Crossover Study to Investigate the Influence of Saline Infusion on Sleep Apnea Severity in Men

PubMed Central

Yadollahi, Azadeh; Gabriel, Joseph M.; White, Laura H.; Taranto Montemurro, Luigi; Kasai, Takatoshi; Bradley, T. Douglas

2014-01-01

Study Objectives: Obstructive sleep apnea (OSA) is commoner in patients with fluid-retaining states than in those without fluid retention, in men than in women, and worsens with aging. In men, OSA severity is related to the amount of fluid shifting out of the legs overnight, but a cause-effect relationship is not established. Our objective was to test the hypothesis that mimicking fluid overload during sleep would increase severity of OSA more in older (≥ 40 years) than in younger men (< 40 years). Design: Randomized, single-blind, double crossover study. Setting: Research sleep laboratory. Patients or Participants: Seven older and 10 younger men with non-severe or no sleep apnea, matched for body mass index. Interventions: During the control arm, normal saline was infused to keep the vein open. During intervention, subjects received an intravenous bolus of normal saline (22 mL/kg body weight) after sleep onset while they were wearing compression stockings to prevent fluid accumulation in the legs. Measurements and Results: Compared to younger men, infusion of similar amounts of saline in older men caused a greater increase in neck circumference (P < 0.05) and in the AHI (32.2 ± 22.1 vs. 2.2 ± 7.1, P = 0.002). Conclusions: Older men are more susceptible to the adverse effects of intravenous fluid loading on obstructive sleep apnea severity than younger men. This may be due to age-related differences in the amount of fluid accumulating in the neck or upper airway collapsibility in response to intravenous fluid loading. These possibilities remain to be tested in future studies. Citation: Yadollahi A, Gabriel JM, White LH, Taranto Montemurro L, Kasai T, Bradley TD. A randomized, double crossover study to investigate the influence of saline infusion on sleep apnea severity in men. SLEEP 2014;37(10):1699-1705. PMID:25197812

Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction.

PubMed

Polly, David W; Swofford, John; Whang, Peter G; Frank, Clay J; Glaser, John A; Limoni, Robert P; Cher, Daniel J; Wine, Kathryn D; Sembrano, Jonathan N

2016-01-01

Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period. In this Level 1 multicenter prospective randomized controlled trial, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months. This study was approved by a local or central IRB before any subjects were enrolled. All patients provided study-specific informed consent prior to participation.

Crossover Effects Among Parental Hostility and Parent-Child Relationships During the Preschool Period.

PubMed

Newland, Rebecca P; Ciciolla, Lucia; Crnic, Keith A

2015-07-01

Parental hostility may have widespread effects across members of the family, whereby one parent's hostility might disrupt the other parent's ability to maintain a positive relationship with his or her children. The present study prospectively examined crossover effects of parental hostility on parent-child relationship quality in a sample of 210 families. At child ages 3, 4, and 5, mothers and fathers completed questionnaires assessing feelings of hostility. In addition, mother-child and father-child dyadic relationship quality were coded at each age during naturalistic home observations. Results from structural equation analyses indicated that mother and father hostility were relatively stable over the two year period. Further, results were consistent with notions of fathering vulnerability, such that the father-child relationship might be especially susceptible to parental hostility. Possible compensatory processes, wherein mothers may compensate for father hostility, were also explored. Child and parent gender add further complexity to the results, as the father-son relationship appears most susceptible to crossover effects of parental hostility, whereas the father-daughter relationship might be somewhat protected in the early childhood period. Findings from the current investigation highlight the need for broader perspectives on family functioning, considering influences across family subsystems and the effects of both parent and child gender.

Proton pump inhibitors and vascular function: A prospective cross-over pilot study.

PubMed

Ghebremariam, Yohannes T; Cooke, John P; Khan, Fouzia; Thakker, Rahul N; Chang, Peter; Shah, Nigam H; Nead, Kevin T; Leeper, Nicholas J

2015-08-01

Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. We conducted a controlled, open-label, cross-over pilot study among 21 adults aged 18 and older who are healthy (n=11) or have established clinical cardiovascular disease (n=10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2-week washout period, participants were crossed over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = -0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow-mediated vasodilation during the course of this study. In conclusion, in this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies. © The Author(s) 2015.

Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial.

PubMed

Lillicrap, Thomas; Krishnamurthy, Venkatesh; Attia, John; Nilsson, Michael; Levi, Christopher R; Parsons, Mark W; Bivard, Andrew

2016-08-17

Fatigue is a common symptom in stroke survivors for which there is currently no proven therapy. Modafinil is a wakefulness-promoting agent with established benefits in other disease models. We aim to test if modafinil will improve patient's self-reported fatigue scores when compared to placebo and if therapy results in increased quality of life. MIDAS is a phase II, single-centre, prospective, double-blinded, randomised, crossover trial of modafinil for the treatment of persistent fatigue in survivors of ischaemic stroke. The inclusion criteria will require an average score of 12 or more across all domains of the Multi-dimensional Fatigue Inventory (MFI-20) and the diagnosis of a stroke more than 6 months prior. Patients will be randomised 1:1 to receive either modafinil 200 mg daily or placebo for a period of 6 weeks, after which a crossover will occur where patients who are on modafinil will begin taking placebo and vice versa. The primary outcome will be improvement in fatigue as measured by the MFI-20. Secondary outcomes will include changes in the Fatigue Severity Scale, improved cognition measured using the Montreal Cognitive Assessment, improvement in mood as determined by the Depression, Anxiety and Stress Scale and improvement in each patient's stroke-specific quality of life score. All participants will also undergo magnetic resonance imaging (MRI) at baseline, crossover and study conclusion to measure cerebral blood flow on arterial spin labelling and brain activity on resting state functional MRI. This study will comply with the CONSORT guidelines. The projected sample size requirement is 36 participants in a crossover trial giving a power of 80 % and a type-1 error rate of 0.05. MIDAS seeks to enhance the quality of life in stroke survivors by assisting or resolving stroke-associated fatigue. ACTRN12615000350527 , registered on the 17 April 2015. Protocol version 3, approved 16 June 2015.

Non-equilibrium many-body dynamics following a quantum quench

NASA Astrophysics Data System (ADS)

Vyas, Manan

2017-12-01

We study analytically and numerically the non-equilibrium dynamics of an isolated interacting many-body quantum system following a random quench. We model the system Hamiltonian by Embedded Gaussian Orthogonal Ensemble (EGOE) of random matrices with one plus few-body interactions for fermions. EGOE are paradigmatic models to study the crossover from integrability to chaos in interacting many-body quantum systems. We obtain a generic formulation, based on spectral variances, for describing relaxation dynamics of survival probabilities as a function of rank of interactions. Our analytical results are in good agreement with numerics.

A Randomized Crossover Design to Assess Learning Impact and Student Preference for Active and Passive Online Learning Modules.

PubMed

Prunuske, Amy J; Henn, Lisa; Brearley, Ann M; Prunuske, Jacob

Medical education increasingly involves online learning experiences to facilitate the standardization of curriculum across time and space. In class, delivering material by lecture is less effective at promoting student learning than engaging students in active learning experience and it is unclear whether this difference also exists online. We sought to evaluate medical student preferences for online lecture or online active learning formats and the impact of format on short- and long-term learning gains. Students participated online in either lecture or constructivist learning activities in a first year neurologic sciences course at a US medical school. In 2012, students selected which format to complete and in 2013, students were randomly assigned in a crossover fashion to the modules. In the first iteration, students strongly preferred the lecture modules and valued being told "what they need to know" rather than figuring it out independently. In the crossover iteration, learning gains and knowledge retention were found to be equivalent regardless of format, and students uniformly demonstrated a strong preference for the lecture format, which also on average took less time to complete. When given a choice for online modules, students prefer passive lecture rather than completing constructivist activities, and in the time-limited environment of medical school, this choice results in similar performance on multiple-choice examinations with less time invested. Instructors need to look more carefully at whether assessments and learning strategies are helping students to obtain self-directed learning skills and to consider strategies to help students learn to value active learning in an online environment.

Improving Nurses' Peripheral Intravenous Catheter Insertion Knowledge, Confidence, and Skills Using a Simulation-Based Blended Learning Program: A Randomized Trial.

PubMed

Keleekai, Nowai L; Schuster, Catherine A; Murray, Connie L; King, Mary Anne; Stahl, Brian R; Labrozzi, Laura J; Gallucci, Susan; LeClair, Matthew W; Glover, Kevin R

2016-12-01

Peripheral intravenous catheter (PIVC) insertion is one of the most common invasive procedures performed in a hospital, but most nurses receive little formal training in this area. Blended PIVC insertion training programs that incorporate deliberate simulated practice have the potential to improve clinical practice and patient care. The study was a randomized, wait-list control group with crossover using nurses on three medical/surgical units. Baseline PIVC knowledge, confidence, and skills assessments were completed for both groups. The intervention group then received a 2-hour PIVC online course, followed by an 8-hour live training course using a synergistic mix of three simulation tools. Both groups were then reassessed. After crossover, the wait-list group received the same intervention and both groups were reassessed. At baseline, both groups were similar for knowledge, confidence, and skills. Compared with the wait-list group, the intervention group had significantly higher scores for knowledge, confidence, and skills upon completing the training program. After crossover, the wait-list group had similarly higher scores for knowledge, confidence, and skills than the intervention group. Between the immediate preintervention and postintervention periods, the intervention group improved scores for knowledge by 31%, skills by 24%, and decreased confidence by 0.5%, whereas the wait-list group improved scores for knowledge by 28%, confidence by 16%, and skills by 15%. Results demonstrate significant improvements in nurses' knowledge, confidence, and skills with the use of a simulation-based blended learning program for PIVC insertion. Transferability of these findings from a simulated environment into clinical practice should be further explored.

Exercise training, vascular function, and functional capacity in middle-aged subjects.

PubMed

Maiorana, A; O'Driscoll, G; Dembo, L; Goodman, C; Taylor, R; Green, D

2001-12-01

The aim of this study was to investigate the effect of 8 wk of exercise training on functional capacity, muscular strength, body composition, and vascular function in sedentary but healthy subjects by using a randomized, crossover protocol. After familiarization sessions, 19 subjects aged 47 +/- 2 yr (mean +/- SE) undertook a randomized, crossover design study of the effect of 8 wk of supervised circuit training consisting of combined aerobic and resistance exercise. Peak oxygen uptake (.VO(2peak)), sum of 7 maximal voluntary contractions and the sum of 8 skinfolds and 5 segment girths were determined at entry, crossover, and 16 wk. Endothelium-dependent and -independent vascular function were determined by forearm strain-gauge plethysmography and intrabrachial infusions of acetylcholine (ACh) and sodium nitroprusside (SNP) in 16 subjects. Training did not alter ACh or SNP responses. .VO(2peak), (28.6 +/- 1.1 to 32.6 +/- 1.3 mL.kg(-1).min(-1), P < 0.001), exercise test duration (17.4 +/- 1.1 to 22.1 +/- 1.2 min, P < 0.001), and muscular strength (465 +/- 27 to 535 +/- 27 kg, P < 0.001) significantly increased after the exercise program, whereas skinfolds decreased (144 +/- 10 vs 134 +/- 9 mm, P < 0.001). These results suggest that moderate intensity circuit training designed to minimize the involvement of the arms improves functional capacity, body composition, and strength in healthy, middle-aged subjects without significantly influencing upper limb vascular function. This finding contrasts with previous studies in subjects with type 2 diabetes and heart failure that employed an identical training program.

Muscle activation levels of the gluteus maximus and medius during standing hip-joint strengthening exercises using elastic-tubing resistance.

PubMed

Youdas, James W; Adams, Kady E; Bertucci, John E; Brooks, Koel J; Nelson, Meghan M; Hollman, John H

2014-02-01

No published studies have compared muscle activation levels simultaneously for the gluteus maximus and medius muscles of stance and moving limbs during standing hip-joint strengthening while using elastic-tubing resistance. To quantify activation levels bilaterally of the gluteus maximus and medius during resisted lower-extremity standing exercises using elastic tubing for the cross-over, reverse cross-over, front-pull, and back-pull exercise conditions. Repeated measures. Laboratory. 26 active and healthy people, 13 men (25 ± 3 y) and 13 women (24 ± 1 y). Subjects completed 3 consecutive repetitions of lower-extremity exercises in random order. Surface electromyographic (EMG) signals were normalized to peak activity in the maximum voluntary isometric contraction (MVIC) trial and expressed as a percentage. Magnitudes of EMG recruitment were analyzed with a 2 × 4 repeated-measures ANOVA for each muscle (α = .05). For the gluteus maximus an interaction between exercise and limb factor was significant (F3,75 = 21.5; P < .001). The moving-limb gluteus maximus was activated more than the stance limb's during the back-pull exercise (P < .001), and moving-limb gluteus maximus muscle recruitment was greater for the back-pull exercise than for the cross-over, reverse cross-over, and front-pull exercises (P < .001). For the gluteus medius an interaction between exercise and limb factor was significant (F3,75 = 3.7; P < .03). Gluteus medius muscle recruitment (% MVIC) was greater in the stance limb than moving limb when performing the front-pull exercise (P < .001). Moving-limb gluteus medius muscle recruitment was greater for the reverse cross-over exercise than for the cross-over, front-pull, and back-pull exercises (P < .001). From a clinical standpoint there is no therapeutic benefit to selectively activate the gluteus maximus and gluteus medius muscles on the stance limb by resisting sagittal- and frontal-plane hip movements on the moving limb using resistance supplied by elastic tubing.

Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children

ERIC Educational Resources Information Center

Aman, Michael G.; Hollway, Jill A.; Leone, Sarah; Masty, Jessica; Lindsay, Ronald; Nash, Patricia; Arnold, L. Eugene

2009-01-01

This study was designed to explore the placebo-controlled effects of risperidone on cognitive-motor processes, dyskinetic movements, and behavior in children receiving maintenance risperidone therapy. Sixteen children aged 4-14 years with disruptive behavior were randomly assigned to drug order in a crossover study of risperidone and placebo for 2…

Time Course of Treatment Effect of OROS[R] Methylphenidate in Children with ADHD

ERIC Educational Resources Information Center

Armstrong, Robert B.; Damaraju, C. V.; Ascher, Steve; Schwarzman, Lesley; O'Neill, James; Starr, H. Lynn

2012-01-01

Objective: The authors evaluated the time course of the treatment effect of Osmotic-Release Oral System methylphenidate (OROS[R] MPH) HCl (Concerta[R], Raritan, NJ) CII in children with ADHD. Method: Data were combined from two double-blind, randomized, placebo-controlled, cross-over, analog classroom studies in children (9-12 years) with ADHD.…

Acute Exercise and Academic Achievement in High School Youth

ERIC Educational Resources Information Center

Harveson, Andrew; Hannon, James; Brusseau, Timothy; Podlog, Les; Chase, Ben; Kang, Kyoung-doo

2018-01-01

The purpose of this study was to compare the acute effects of Aerobic Exercise (AE), Resistance Exercise (RE), and a nonexercise (NE) control on measures of academic achievement (AA) and cognition in 10th grade males and females. This study utilized a randomized crossover design. Tenth grade males and females performed three exercise trials (AE,…

Covert Modeling vs. Behavior Rehearsal in the Training and Generalization of Assertive Behaviors: A Crossover Design.

ERIC Educational Resources Information Center

Zielinski, Joseph J.; Williams, Leslie J.

1979-01-01

Twenty-four underassertive adults were randomly assigned to two treatment orders that included covert modeling and behavior rehearsal. No measurable difference in treatments was found, but participants preferred and had greater expectations of behavior rehearsal. Skill generalization to untrained situations occurred on 8 of 11 behavioral measures.…

Chronic dietary fiber supplementation with wheat dextrin does not inhibit calcium and magnesium absorption in premenopausal and postmenopausal women

USDA-ARS?s Scientific Manuscript database

This placebo-controlled, randomized, crossover clinical study examined the effect of chronic wheat dextrin intake on calcium and magnesium absorption. Forty premenopausal and post menopausal women (mean +/- SD age 49.9 +/- 9.8 years)consumed wheat dextrin or placebo (15 g/day) for 2 weeks prior to 4...

Increased cytokine production by monocytes from human subjects who consumed grape powder was not mediated by differences in dietary intake patterns

USDA-ARS?s Scientific Manuscript database

Recently, in a randomized, double-blind cross-over study, we reported that consumption of grape powder by obese human subjects increased the production of the pro-inflammatory cytokines interleukin-1' and interleukin-6 by ex vivo-derived peripheral blood monocytes after exposure to bacterial lipopol...

Dietary Protein and Calcium Interact to Influence Calcium Retention: A Controlled Feeding Study

USDA-ARS?s Scientific Manuscript database

Objective: To test the effect of dietary protein on Ca (Ca) retention at low and high Ca intakes. Methods: In a randomized, controlled feeding study with a 2x2 factorial crossover design, healthy post-menopausal women (n=27), consumed either ~675 or ~1510 mg Ca/d, with both low and high protein (pro...

Evaluation of 5 Hour Energy Drink on the Blood Pressure and Electrocardiograph Parameters on Young Healthy Volunteers: A Randomized, Double Blind, Crossover, Placebo-Controlled Trial (Presentation)

DTIC Science & Technology

2014-02-11

other substances. • There have been reports of atrial fibrillation , Takotsubo cardiomyopathy and sudden cardiac deaths in healthy individuals...baseline cardiac rhythm, history of atrial or ventricular arrhythmia, baseline corrected QT (QTc) interval greater than 440 milliseconds (msec

Examining the Impact of Technology on Primary Students' Revision of Written Work

ERIC Educational Resources Information Center

Lisy, Jennifer Garrette

2015-01-01

Few studies have examined the revision processes of second grade students and even fewer have explored the impact of digital writing on young students' revisions. This study utilized a within subject crossover trial using randomized block assignment (AB | BA) for counterbalancing. This study sought to determine (1) whether revising on paper versus…

Low settings of the ventricular pacing output in patients dependent on a pacemaker: are they really safe?

PubMed

Schuchert, Andreas; Frese, Jens; Stammwitz, Ekkehard; Novák, Miroslav; Schleich, Arthur; Wagner, Stefan M; Meinertz, Thomas

2002-06-01

It is generally acknowledged that pacemaker output must be adjusted with a 100% voltage safety margin above the pacing threshold to avoid ineffective pacing, especially in patients dependent on pacemakers. The aim of this prospective crossover study was to assess the beat-to-beat safety of low outputs in patients who are dependent on a pacemaker between 2 follow-up examinations. The study included 12 patients who had received a DDD pacemaker with an automatic beat-to-beat capture verification function. The ventricular output at 0.4 milliseconds pulse duration was programmed independently of the actual pacing threshold in a crossover randomization to 1.0 V, 1.5 V, and 2.5 V for 6 weeks each. At each follow-up, the diagnostic counters were interrogated and the pacing threshold at 0.4 milliseconds was determined in 0.1-V steps. The diagnostic pacemaker counters depict the frequency of back-up pulses delivered because of a loss of capture. During the randomization to 1.0-V output, we evaluated whether the adjustment of the output under consideration of the >100% voltage safety margin reduced the frequency of back-up pulses. Pacing thresholds at the randomization to 1.0-V, 1.5-V, and 2.5-V output were not significantly different, with 0.7 +/- 0.3 V at 2.5-V output, 0.6 +/- 0.2 V at 1.5-V output, and 0.6 +/- 0.2 V at 1.0-V output. The frequency of back-up pulses was similar at 2.5-V and 1.5-V output, 2.2% +/- 1.9% and 2.0% +/- 2.0%, respectively. The frequency of back-up pulses significantly increased at 1.0-V output to 5.8% +/- 6.4% (P <.05). Back-up pulses >5% of the time between the 2 follow-ups were observed in no patient at 2.5 V, in 1 patient at 1.5 V, and in 5 patients at 1.0 V. At the randomization to the 1.0-V output, 6 patients had pacing thresholds of 0.5 V or less, and 6 patients had pacing thresholds >0.5 V. The frequency of back-up pulses in the 2 groups was not significantly different, 6.4% +/- 8.6% and 5.7% +/- 2.6%. The frequency of back-up pulses was significantly higher at 1.0-V output than at 1.5-V and 2.5-V output. This also applied to patients with pacing thresholds of < or =0.5 V. Fixed low outputs seem not to be absolutely safe between 2 follow-ups in patients who are dependent on a pacemaker, even when the output has a 100% voltage safety margin above the pacing threshold. When patients with pacemakers programmed to a low ventricular output have symptoms of ineffective pacing, an intermittent increase of the pacing threshold should be carefully ruled out.

Effect of Oral Coadministration of Ascorbic Acid with Ling Zhi Preparation on Pharmacokinetics of Ganoderic Acid A in Healthy Male Subjects: A Randomized Crossover Study

PubMed Central

Tawasri, Patcharanee; Ampasavate, Chadarat; Tharatha, Somsak

2016-01-01

The objective of this randomized, open-label, single-dose, two-phase crossover study was to determine the effect of ascorbic acid on pharmacokinetics of ganoderic acid A, an important biologically active triterpenoid compound with anticancer activities, following oral administration of water extract of fruiting bodies of Ling Zhi in 12 healthy male subjects. Each subject was randomized to receive either one of the two regimens: (1) a single dose of 3,000 mg of the Ling Zhi preparation or (2) a single dose of 3,000 mg of the Ling Zhi preparation in combination with 2,500 mg of ascorbic acid. After a washout period of at least two weeks, subjects were switched to receive the alternate regimen. Blood samples were collected in each phase immediately before dosing and at specific time points for 8 hours after dosing. Plasma ganoderic acid A concentrations were quantified using liquid chromatography-mass spectrometry (LC-MS). The pharmacokinetic parameters analyzed were maximal plasma concentration (C max), time to reach peak concentration (T max), area under the plasma concentration-time curve (AUC), and half-life (t 1/2). An oral coadministration of ascorbic acid with Ling Zhi preparation did not significantly alter the pharmacokinetic parameters of ganoderic acid A in healthy male subjects. PMID:27747224

Acute Garcinia mangostana (mangosteen) supplementation does not alleviate physical fatigue during exercise: a randomized, double-blind, placebo-controlled, crossover trial.

PubMed

Chang, Chih-Wei; Huang, Tzu-Zung; Chang, Wen-Hsin; Tseng, Yi-Chun; Wu, Yu-Tse; Hsu, Mei-Chich

2016-01-01

The purple mangosteen (Garcinia mangostana), known as the "queen of fruit," is widely consumed and unique not only because of its outstanding appearance and flavor but also its remarkable and diverse pharmacological effects. The aim of the present study is to evaluate the effect of acute mangosteen supplementation on physical fatigue during exercise. A randomized, double-blind, placebo-controlled, crossover study was carried out by 12 healthy adults. The participants were randomly assigned to receive acute oral administration of either 250 mL of the mangosteen-based juice (supplementation treatment; 305 mg of α-mangostin and 278 mg of hydroxycitric acid) or a placebo (control treatment) 1 h before cycle ergometer exercise. Time to exhaustion, heart rate, Borg Rating of Perceived Exertion score, blood biochemical markers (namely ammonia, cortisol, creatine kinase, aspartate aminotransferase, alanine aminotransferase, glucose, and lactate), muscle dynamic stiffness, and Profile of Mood States (POMS) were evaluated and recorded. The results showed all parameters we examined were significantly altered by the exercise challenge, which demonstrated they directly reflected the condition of fatigue. However, there were no differences between the two treatments besides a positive impact on the POMS examination. The occurrence of physical fatigue depends on multiple underlying mechanisms. We concluded that acute mangosteen supplementation had no impact on alleviating physical fatigue during exercise.

Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial.

PubMed

Chinwong, Surarong; Chinwong, Dujrudee; Mangklabruks, Ampica

2017-01-01

This open-label, randomized, controlled, crossover trial assessed the effect of daily virgin coconut oil (VCO) consumption on plasma lipoproteins levels and adverse events. The study population was 35 healthy Thai volunteers, aged 18-25. At entry, participants were randomly allocated to receive either (i) 15 mL VCO or (ii) 15 mL 2% carboxymethylcellulose (CMC) solution (as control), twice daily, for 8 weeks. After 8 weeks, participants had an 8-week washout period and then crossed over to take the alternative regimen for 8 weeks. Plasma lipoproteins levels were measured in participants at baseline, week-8, week-16, and week-24 follow-up visits. Results . Of 32 volunteers with complete follow-up (16 males and 16 females), daily VCO intake significantly increased high-density lipoprotein cholesterol by 5.72 mg/dL ( p = 0.001) compared to the control regimen. However, there was no difference in the change in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels between the two regimens. Mild diarrhea was reported by some volunteers when taking VCO, but no serious adverse events were reported. Conclusion . Daily consumption of 30 mL VCO in young healthy adults significantly increased high-density lipoprotein cholesterol. No major safety issues of taking VCO daily for 8 weeks were reported.

Comparison of Ventilation With One-Handed Mask Seal With an Intraoral Mask Versus Conventional Cuffed Face Mask in a Cadaver Model: A Randomized Crossover Trial.

PubMed

Amack, Andrew J; Barber, Gary A; Ng, Patrick C; Smith, Thomas B; April, Michael D

2017-01-01

We compare received minute volume with an intraoral mask versus conventional cuffed face mask among medics obtaining a 1-handed mask seal on a cadaver model. This study comprised a randomized crossover trial of adult US Army combat medic volunteers participating in a cadaver laboratory as part of their training. We randomized participants to obtain a 1-handed mask seal during ventilation of a fresh unembalmed cadaver, first using either an intraoral airway device or conventional cuffed face mask. Participants obtained a 1-handed mask seal while a ventilator delivered 10 standardized 750-mL breaths during 1 minute. After a 5-minute rest period, they repeated the study with the alternative mask. The primary outcome measure was received minute volume as measured by a respirometer. Of 27 recruited participants, all completed the study. Median received minute volume was higher with the intraoral mask compared with conventional cuffed mask by 1.7 L (95% confidence interval 1.0 to 1.9 L; P<.001). The intraoral mask resulted in greater received minute volume received compared with conventional cuffed face mask during ventilation with a 1-handed mask seal in a cadaver model. The intraoral mask may prove a useful airway adjunct for ventilation. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Analgesic Effect of Topical Sodium Diclofenac before Retinal Photocoagulation for Diabetic Retinopathy: A Randomized Double-masked Placebo-controlled Intraindividual Crossover Clinical Trial.

PubMed

Ramezani, Alireza; Entezari, Morteza; Shahbazi, Mohammad Mehdi; Semnani, Yosef; Nikkhah, Homayoun; Yaseri, Mehdi

2017-04-01

To evaluate the analgesic effect of topical sodium diclofenac 0.1% before retinal laser photocoagulation for diabetic retinopathy. Diabetic patients who were candidates for peripheral laser photocoagulation were included in a randomized, placebo-controlled, intraindividual, two-period, and crossover clinical trial. At the first session and based on randomization, one eye received topical sodium diclofenac 0.1% and the other eye received an artificial tear drop (as placebo) three times before laser treatment. At the second session, eyes were given the alternate drug. Patients scored their pain using visual analogue scale (max, 10 cm) at both sessions. Patients and the surgeon were blinded to the drops given. Difference of pain level was the main outcome measure. A total of 200 eyes of 100 patients were enrolled. Both treatments were matched regarding the applied laser. Pain sensation based on visual analogue scale was 5.6 ± 3.0 in the treated group and 5.5 ± 3.0 in the control group. The calculated treatment effect was 0.15 (95% confidence interval, -0.27 to 0.58; p = 0.486). The estimated period effect was 0.24 ( p = 0.530) and the carryover effect was not significant ( p = 0.283). Pretreatment with topical sodium diclofenac 0.1% does not have any analgesic effect during peripheral retinal laser photocoagulation in diabetic patients.

Clomiphene citrate before and after withdrawal bleeding for induction of ovulation in women with polycystic ovary syndrome: Randomized cross-over trial.

PubMed

Elbohoty, Ahmed E H; Amer, Mohamed; Abdelmoaz, Mohamed

2016-08-01

To compare the ovarian response to early versus late clomiphene citrate (CC) in women with polycystic ovary syndrome (PCOS). This cross-over randomized controlled clinical trial included 90 infertile amenorrheic women with PCOS. After inducing withdrawal bleeding, patients were randomly divided into two equal groups to receive ovulation induction with CC 100 mg/day for 5 days. Group I started treatment the next day after finishing medroxyprogesterone acetate course for a menstrual cycle, and after a washout period of another menstrual cycle, the treatment was shifted to start on day 2 of withdrawal bleeding. Group II received a reversed protocol: late then early treatment. Women were followed up on transvaginal ultrasonography to monitor follicular growth, endometrial thickness and evidence of ovulation. Human chorionic gonadotropin 10 000 IU was given i.m. to trigger ovulation when at least one mature follicle measured ≥18 mm at day 14. In all cases, early induction protocol resulted in significantly higher proportion of ovulating patients, thicker endometrium and higher number of follicles 14-17 mm in diameter, ≥ 18 mm in diameter and total number of follicles (P < 0.001 for all comparisons). In women with PCOS, early initiation of CC before withdrawal bleeding or during the last days of the luteal phase can achieve a better ovulatory response. © 2016 Japan Society of Obstetrics and Gynecology.

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

PubMed

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

2017-01-01

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

Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

PubMed

Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

2017-01-01

We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

The effect of recommending a CPP-ACPF product on salivary and plaque pH levels in orthodontic patients: a randomized cross-over clinical trial.

PubMed

Heshmat, Haleh; Banava, Sepideh; Mohammadi, Ebrahim; Kharazifard, Mohammad Javad; Mojtahedzadeh, Faramarz

2014-11-01

Along with their re-mineralizing capacity, calcium phosphopeptide-amorphous calcium phosphate products combined with fluoride (CPP-ACPF) could also be beneficial by neutralizing acidic salivary and plaque pH. The purpose was to evaluate the effect of CPP-ACPF on salivary and plaque pH in orthodontic patients. As a triple-blind, cross-over randomized trial, 30 orthodontic patients with fixed appliances (age range = 15.70 ± 4.08 years) were recruited and randomly assigned to two groups. A CPP-ACPF paste (MI Paste Plus, GC America, Alsip, IL) was used by group 1 (n = 15) and a placebo by group 2 (n = 15) for 1 month. After a 1 month washout period, patients used the alternative paste for another month. Plaque and salivary pH levels were measured at all before and after periods. By applying MI Paste Plus, the plaque pH increased from 5.81 ± 0.45 to 6.60 ± 0.38 (p < 0.05), whereas the before and after salivary pH recordings, which were 6.72 ± 0.43 and 6.71 ± 0.38, respectively, remained statistically unchanged (p > 0.05). MI Paste Plus can be clinically beneficial in increasing plaque pH levels, but has no effect on the salivary pH.

The effects of intermittent use of the SGLT-2 inhibitor, dapagliflozin, in overweight patients with type 2 diabetes in Japan: a randomized, crossover, controlled clinical trial.

PubMed

Kato, Kanako; Suzuki, Kunihiro; Aoki, Chie; Sagara, Masaaki; Niitani, Takafumi; Wakamatsu, Sho; Yanagi, Kazunori; Aso, Yoshimasa

2017-06-01

This study examined the effects of short-term administration of the sodium glucose cotransporter 2 (SGLT-2) inhibitor, dapagliflozin, on visceral fat area (VFA) in Japanese patients with type 2 diabetes. In this randomized, crossover, controlled clinical trial, overweight patients with type 2 diabetes were randomized to treatment with 5 mg dapagliflozin for the first (n = 27) or second 12-week study period (n = 29). The parameters evaluated at baseline and after 12 and 24 weeks included blood pressure, hemoglobin A1c (HbA1c), body composition, VFA, and subcutaneous fat area (SFA). In both groups, dapagliflozin administration improved the levels of HbA1c, body weight, blood pressure, total fat mass, and VFA. Cessation of dapagliflozin, however, reversed the improvements in HbA1c, blood pressure, body weight, and SFA levels, whereas reductions in VFA and total fat mass levels were somewhat maintained even after 12 weeks without treatment. Dapagliflozin led to decreases in VFA and, consequently, body weight after a short treatment period. However, these effects were largely reversed by the cessation of dapagliflozin, suggesting that this agent should be administered continuously to maintain clinical usefulness in overweight patients with type 2 diabetes.

Dietary nitrate supplementation in COPD: an acute, double-blind, randomized, placebo-controlled, crossover trial.

PubMed

Kerley, Conor P; Cahill, Kathleen; Bolger, Kenneth; McGowan, Aisling; Burke, Conor; Faul, John; Cormican, Liam

2015-01-30

The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity. We hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects. Eleven COPD subjects were randomly assigned to consume either a high nitrate or a matched, low nitrate beverage in a double-blind, randomized, placebo-controlled, crossover design. ISWT distance was measured both before and 3 h after the beverage and change was recorded. After a 7-day washout, ISWT distances were re-measured before and 3 h after the alternate beverage and changes were recorded. We observed an increase in ISWT distance after consuming the high nitrate juice (25 m) compared with a reduction after the low nitrate juice (14 m) (p < 0.01). This improvement in exercise capacity was associated with significant increases in serum nitrate (p < 0.000005) and nitrite (p < 0.01) levels and a significant lowering of resting blood pressure (<0.05). In patients with stable COPD, the acute consumption of dietary nitrate increased serum nitrate/nitrite levels and exercise capacity and was associated with a decrease in resting blood pressure. Nitrate consumption might alter exercise capacity in COPD patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Daily Consumption of Virgin Coconut Oil Increases High-Density Lipoprotein Cholesterol Levels in Healthy Volunteers: A Randomized Crossover Trial

PubMed Central

2017-01-01

This open-label, randomized, controlled, crossover trial assessed the effect of daily virgin coconut oil (VCO) consumption on plasma lipoproteins levels and adverse events. The study population was 35 healthy Thai volunteers, aged 18–25. At entry, participants were randomly allocated to receive either (i) 15 mL VCO or (ii) 15 mL 2% carboxymethylcellulose (CMC) solution (as control), twice daily, for 8 weeks. After 8 weeks, participants had an 8-week washout period and then crossed over to take the alternative regimen for 8 weeks. Plasma lipoproteins levels were measured in participants at baseline, week-8, week-16, and week-24 follow-up visits. Results. Of 32 volunteers with complete follow-up (16 males and 16 females), daily VCO intake significantly increased high-density lipoprotein cholesterol by 5.72 mg/dL (p = 0.001) compared to the control regimen. However, there was no difference in the change in total cholesterol, low-density lipoprotein cholesterol, and triglyceride levels between the two regimens. Mild diarrhea was reported by some volunteers when taking VCO, but no serious adverse events were reported. Conclusion. Daily consumption of 30 mL VCO in young healthy adults significantly increased high-density lipoprotein cholesterol. No major safety issues of taking VCO daily for 8 weeks were reported. PMID:29387131

Preemptive Use of Naproxen on Tooth Sensitivity Caused by In-Office Bleaching: A Triple-Blind, Crossover, Randomized Clinical Trial.

PubMed

Fernandes, M T; Vaez, S C; Lima, C M; Nahsan, F P; Loguércio, A D; Faria-E-Silva, A L

A triple-blind, randomized, crossover clinical trial evaluated prior use of nonsteroidal anti-inflammatory naproxen on sensitivity reported by patients undergoing in-office tooth bleaching. Fifty patients were subjected to two sessions of in-office tooth bleaching with 35% hydrogen peroxide in a single application of 40 minutes for two sessions, with an interval of seven days between applications. One hour prior to the procedure, each patient randomly received a single dose of naproxen (500 mg) or placebo. The patient's sensitivity level was evaluated during and immediately after the bleaching using two scales (verbal and visual analog); the verbal scale only was repeated after 24 hours. The effectiveness of the bleaching procedures was evaluated with the Bleachedguide scale. Relative risk to sensitivity was calculated and adjusted by session, while comparison of overall risk was performed by the McNemar test. Data on the sensitivity level for both scales and shade were subjected to the Friedman, Wilcoxon, and Mann-Whitney tests (α=0.05). The use of naproxen only decreased the absolute risk and intensity of tooth sensitivity reported immediately after the second session. On the other hand, no measurable effect was observed during or 24 hours after either session. The sequence of drug administration did not affect the bleaching effectiveness. Preemptive use of naproxen only reduced tooth sensitivity reported by patients immediately after the second session of bleaching.

1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

PubMed

Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

2007-12-01

Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

A single dose of cocaine enhances prospective memory performance.

PubMed

Hutten, Nadia Rpw; Kuypers, Kim Pc; van Wel, Janelle Hp; Theunissen, Eef L; Toennes, Stefan W; Verkes, Robbert-Jan; Ramaekers, Johannes G

2018-06-01

Prospective memory is the ability to recall intended actions or events at the right time or in the right context. While cannabis is known to impair prospective memory, the acute effect of cocaine is unknown. In addition, it is not clear whether changes in prospective memory represent specific alterations in memory processing or result from more general effects on cognition that spread across multiple domains such as arousal and attention. The main objective of the study was, therefore, to determine whether drug-induced changes in prospective memory are memory specific or associated with more general drug-induced changes in attention and arousal. A placebo-controlled, three-way, cross-over study including 15 regular poly-drug users was set up to test the influence of oral cocaine (300 mg) and vaporised cannabis (300+150 'booster' µg/kg bodyweight) on an event-based prospective memory task. Attentional performance was assessed using a divided attention task and subjective arousal was assessed with the Profile of Mood States questionnaire. Results showed that cocaine enhanced prospective memory, attention and arousal. Mean performance of prospective memory and attention, as well as levels of arousal were lowest during treatment with cannabis as compared with placebo and cocaine as evinced by a significantly increased trend across treatment conditions. Prospective memory performance was only weakly positively associated to measures of attention and arousal. Together, these results indicate that cocaine enhancement of prospective memory performance cannot be fully explained by parallel changes in arousal and attention levels, and is likely to represent a direct change in the neural network underlying prospective memory.

Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design.

PubMed

Antunes, Thaiany Pedrozo Campos; Oliveira, Acary Souza Bulle de; Crocetta, Tania Brusque; Antão, Jennifer Yohanna Ferreira de Lima; Barbosa, Renata Thais de Almeida; Guarnieri, Regiani; Massetti, Thais; Monteiro, Carlos Bandeira de Mello; Abreu, Luiz Carlos de

2017-03-01

Physical and mental changes associated with aging commonly lead to a decrease in communication capacity, reducing social interactions and increasing loneliness. Computer classes for older adults make significant contributions to social and cognitive aspects of aging. Games in a virtual reality (VR) environment stimulate the practice of communicative and cognitive skills and might also bring benefits to older adults. Furthermore, it might help to initiate their contact to the modern technology. The purpose of this study protocol is to evaluate the effects of practicing VR games during computer classes on the level of loneliness of students of an elderly reference center. This study will be a prospective longitudinal study with a randomised cross-over design, with subjects aged 50 years and older, of both genders, spontaneously enrolled in computer classes for beginners. Data collection will be done in 3 moments: moment 0 (T0) - at baseline; moment 1 (T1) - after 8 typical computer classes; and moment 2 (T2) - after 8 computer classes which include 15 minutes for practicing games in VR environment. A characterization questionnaire, the short version of the Short Social and Emotional Loneliness Scale for Adults (SELSA-S) and 3 games with VR (Random, MoviLetrando, and Reaction Time) will be used. For the intervention phase 4 other games will be used: Coincident Timing, Motor Skill Analyser, Labyrinth, and Fitts. The statistical analysis will compare the evolution in loneliness perception, performance, and reaction time during the practice of the games between the 3 moments of data collection. Performance and reaction time during the practice of the games will also be correlated to the loneliness perception. The protocol is approved by the host institution's ethics committee under the number 52305215.3.0000.0082. Results will be disseminated via peer-reviewed journal articles and conferences. This clinical trial is registered at ClinicalTrials.gov identifier: NCT02798081.

[Deficient lactose digestion and intolerance in a group of patients with chronic nonspecific ulcerative colitis: a controlled, double-blind, cross-over clinical trial].

PubMed

Cabrera-Acosta, G A; Milke-García, M P; Ramírez-Iglesias, M T; Uscanga, L

2012-01-01

Despite the fact that the frequency of hypolactasia and lactose intolerance is similar in both chronic idiopathic ulcerative colitis patients and the general population, the elimination of dairy products from the patient's diet is a habitual recommendation. Hypolactasia is common in Mexico, but its relation to chronic idiopathic ulcerative colitis has not been established. To evaluate lactose digestion and lactose intolerance in persons with chronic idiopathic ulcerative colitis. Thirty-nine patients with confirmed chronic idiopathic ulcerative colitis diagnosis were included in the study (mean: 31 years, range: 15 to 38). Twenty-two patients presented with rectosigmoid involvement and the remaining patients with pancolitis. No patient showed inflammatory activity according to the Truelove-Witts criteria and all consumed dairy products before diagnosis. A prospective, controlled, double-blind, cross-over study was designed. Patients randomly received 12.5 g of lactose or maltose in 250 cc water- each test 72 hours apart - and ydrogen was measured in exhaled air before disaccharide ingestion and then every 30 minutes for 3 hours. Digestion was considered deficient when there was an increase in hydrogen of at least 20 ppm. Symptom intensities were evaluated by Visual Analog Scales before, during, and after the hydrogen test. Differences between the groups were contrasted with the Mann-Whitney U and the Wilcoxon tests. Eighteen patients (46%) presented with deficient lactose digestion. No significant differences were found in the symptoms, extension, or progression of chronic idiopathic ulcerative colitis between patients that could digest and those that could not digest lactose. No patient had symptom exacerbation with the disaccharides used. Lactose digestion deficiency frequency is similar in subjects with chronic idiopathic ulcerative colitis and in healthy individuals in Mexico. We do not know whether higher doses could have some effect, but symptoms in patients with inactive chronic idiopathic ulcerative colitis were not modified using 12.5 g of lactose/day.

Cardiac index in term pregnant women in the sitting, lateral, and supine positions: an observational, crossover study.

PubMed

Armstrong, Sarah; Fernando, Roshan; Columb, Malachy; Jones, Tanya

2011-08-01

Aortocaval compression may affect maternal hemodynamic indices and fetal well-being in various maternal positions. There has been much debate regarding the optimal position for performing neuraxial blockade for labor analgesia and cesarean delivery. We hypothesized that in pregnant women at term, cardiac index (CI) may be improved in the lateral positions as compared with the flexed sitting position. Our primary outcome was to measure CI as assessed by suprasternal Doppler. A prospective, observational, crossover study was conducted in 25 ASA physical status I/II women with uncomplicated pregnancies presenting for elective cesarean delivery at term. Hemodynamic indices were measured in 4 positions in random order: supine with a 15-degree left tilt, sitting with neck and hips flexed, and flexed left lateral and flexed right lateral positions. Maternal CIs were measured using a noninvasive suprasternal Doppler device and upper arm noninvasive arterial blood pressure. Umbilical Dopplers were performed simultaneously to measure the fetal heart rate and umbilical artery pulsatility and resistivity indices. CI differed by position (P = 0.01); it was higher in the right lateral position compared with the sitting and supine positions (by 8.8% and 8.1%, respectively) and in the left lateral compared with sitting position (by 7.8%) (P < 0.05). Maternal stroke volume index, heart rate, and systolic blood pressure were higher in the lateral positions compared with the sitting and supine-tilt positions. We found no significant differences in fetal heart rate, pulsatility index, or resistivity index among positions. Positioning for neuraxial anesthesia may influence maternal hemodynamic variables. We found no difference in healthy fetal blood flow indices among positions, suggesting that these changes are not clinically significant. This study provides new physiological information on the changes that occur in a group in whom it has not been practical to study previously. Further study is necessary to determine whether these changes are significant in the presence of neuraxial anesthesia or in the high-risk parturient.

Maraviroc Intensification Improves Endothelial Function in Abacavir-Treated Patients, an Open-Label Randomized Cross-Over Pilot Study.

PubMed

Krikke, Maaike; Tesselaar, Kiki; Arends, Joop E; Drylewicz, Julia; Otto, Sigrid A; van Lelyveld, Steven F L; Visseren, Frank J L; Hoepelman, Andy I M

2016-09-01

The increased risk of abacavir in cardiovascular disease (CVD) in HIV-infected patients is still being debated. Maraviroc, a CCR5 blocker, has been shown to decrease immune activation and monocyte infiltration in atherosclerotic plaques in murine experiments. Therefore, we examined the effect of maraviroc intensification on flow-mediated dilatation (FMD) in abacavir-treated HIV-infected patients and its effect on immunological and inflammatory parameters. A open-label prospective crossover study with a duration of 16 weeks: 8 weeks of intervention (maraviroc intensification) and 8 weeks of control (unchanged cART regimen). FMD, HIV-specific variables, expression of HIV co-receptors, markers of inflammation and coagulation and cellular markers of immune activation were measured at weeks 0, 8 and 16. The changes (Δ) in these variables were compared between intervention and control periods using non-parametric tests. To evaluate the relation with the change in FMD, linear regression modeling was used. Twenty-one male patients with suppressed plasma HIV-RNA, on cART, had a known HIV infection for 9.2 years (IQR 6.9-13.5) with abacavir use for 6.5 years (2.8-9.3). A significantly increased FMD of 0.73% (IQR -0.25 to 1.70) was seen after maraviroc intensification compared to a decrease of -0.42% (IQR -1.89 to 0.25; p = 0.049) in the control period. There was a negative relation between ΔFMD with ΔD-dimer (β -22.70, 95% CI -39.27; -6.13, p = 0.011) and ΔCD95+ CD4+ T cells (β -0.16, 95% CI -0.28; -0.04, p = 0.013), adjusted for age and duration of HIV. Maraviroc intensification modestly improves endothelial function in HIV-infected patients on an abacavir-containing regimen. NCT01389063.

PM₁₀ exposure and non-accidental mortality in Asian populations: a meta-analysis of time-series and case-crossover studies.

PubMed

Park, Hye Yin; Bae, Sanghyuk; Hong, Yun-Chul

2013-01-01

We investigated the association between particulate matter less than 10 µm in aerodynamic diameter (PM₁₀) exposure and non-accidental mortality in Asian populations by meta-analysis, using both time-series and case-crossover analysis. Among the 819 published studies searched from PubMed and EMBASE using key words related to PM₁₀ exposure and non-accidental mortality in Asian countries, 8 time-series and 4 case-crossover studies were selected for meta-analysis after exclusion by selection criteria. We obtained the relative risk (RR) and 95% confidence intervals (CI) of non-accidental mortality per 10 µg/m³ increase of daily PM₁₀ from each study. We used Q statistics to test the heterogeneity of the results among the different studies and evaluated for publication bias using Begg funnel plot and Egger test. Testing for heterogeneity showed significance (p<0.001); thus, we applied a random-effects model. RR (95% CI) per 10 µg/m³ increase of daily PM₁₀ for both the time-series and case-crossover studies combined, time-series studies relative risk only, and case-crossover studies only, were 1.0047 (1.0033 to 1.0062), 1.0057 (1.0029 to 1.0086), and 1.0027 (1.0010 to 1.0043), respectively. The non-significant Egger test suggested that this analysis was not likely to have a publication bias. We found a significant positive association between PM₁₀ exposure and non-accidental mortality among Asian populations. Continued investigations are encouraged to contribute to the health impact assessment and public health management of air pollution in Asian countries.

Patient profiling can identify patients with adult spinal deformity (ASD) at risk for conversion from nonoperative to surgical treatment: initial steps to reduce ineffective ASD management.

PubMed

Passias, Peter G; Jalai, Cyrus M; Line, Breton G; Poorman, Gregory W; Scheer, Justin K; Smith, Justin S; Shaffrey, Christopher I; Burton, Douglas C; Fu, Kai-Ming G; Klineberg, Eric O; Hart, Robert A; Schwab, Frank; Lafage, Virginie; Bess, Shay

2018-02-01

Non-operative management is a common initial treatment for patients with adult spinal deformity (ASD) despite reported superiority of surgery with regard to outcomes. Ineffective medical care is a large source of resource drain on the health system. Characterization of patients with ASD likely to elect for operative treatment from non-operative management may allow for more efficient patient counseling and cost savings. This study aimed to identify deformity and disability characteristics of patients with ASD who ultimately convert to operative treatment compared with those who remain non-operative and those who initially choose surgery. A retrospective review was carried out. A total of 510 patients with ASD (189 non-operative, 321 operative) with minimum 2-year follow-up comprised the patient sample. Oswestry Disability Index (ODI), Short-Form 36 Health Assessment (SF-36), Scoliosis Research Society questionnaire (SRS-22r), and spinopelvic radiographic alignment were the outcome measures. Demographic, radiographic, and patient-reported outcome measures (PROMs) from a cohort of patients with ASD prospectively enrolled into a multicenter database were evaluated. Patients were divided into three treatment cohorts: Non-operative (NON=initial non-operative treatment and remained non-operative), Operative (OP=initial operative treatment), and Crossover (CROSS=initial non-operative treatment with subsequent conversion to operative treatment). NON and OP groups were propensity score-matched (PSM) to CROSS for baseline demographics (age, body mass index, Charlson Comorbidity Index). Time to crossover was divided into early (<1 year) and late (>1 year). Outcome measures were compared across and within treatment groups at four time points (baseline, 6 weeks, 1 year, and 2 years). Following PSM, 118 patients were included (NON=39, OP=38, CROSS=41). Crossover rate was 21.7% (41/189). Mean time to crossover was 394 days. All groups had similar baseline sagittal alignment, but CROSS had larger pelvic incidence and lumbar lordosis (PI-LL) mismatch than NON (11.9° vs. 3.1°, p=.032). CROSS and OP had similar baseline PROM scores; however, CROSS had worse baseline ODI, PCS, SRS-22r (p<.05). At time of crossover, CROSS had worse ODI (35.7 vs. 27.8) and SRS Satisfaction (2.6 vs. 3.3) compared with NON (p<.05). Alignment remained similar for CROSS from baseline to conversion; however, PROMs (ODI, PCS, SRS Activity/Pain/Total) worsened (p<.05). Early and late crossover evaluation demonstrated CROSS-early (n=25) had worsening ODI, SRS Activity/Pain at time of crossover (p<.05). From time of crossover to 2-year follow-up, CROSS-early had less SRS Appearance/Mental improvement compared with OP. Both CROSS-early/late had worse baseline, but greater improvements, in ODI, PCS, SRS Pain/Total compared with NON (p<.05). Baseline alignment and disability parameters increased crossover odds-Non with Schwab T/L/D curves and ODI≥40 (odds ratio [OR]: 3.05, p=.031), and Non with high PI-LL modifier grades ("+"/'++') and ODI≥40 (OR: 5.57, p=.007) were at increased crossover risk. High baseline and increasing disability over time drives conversion from non-operative to operative ASD care. CROSS patients had similar spinal deformity but worse PROMs than NON. CROSS achieved similar 2-year outcome scores as OP. Profiling at first visit for patients at risk of crossover may optimize physician counseling and cost savings. Copyright © 2017. Published by Elsevier Inc.

Use of a Metronome in Cardiopulmonary Resuscitation: A Simulation Study.

PubMed

Zimmerman, Elise; Cohen, Naiomi; Maniaci, Vincenzo; Pena, Barbara; Lozano, Juan Manuel; Linares, Marc

2015-11-01

Determine whether the use of a metronome improves chest compression rate and depth during cardiopulmonary resuscitation (CPR) on a pediatric manikin. A prospective, simulation-based, crossover, randomized controlled trial was conducted. Participants included pediatric residents, fellows, nurses, and medical students who were randomly assigned to perform chest compressions on a pediatric manikin with and without an audible metronome. Each participant performed 2 rounds of 2 minutes of chest compressions separated by a 15-minute break. A total of 155 participants performed 2 rounds of chest compressions (74 with the metronome on during the first round and 81 with the metronome on during the second round of CPR). There was a significant improvement in the mean percentage of compressions delivered within an adequate rate (90-100 compressions per minute) with the metronome on compared with off (72% vs 50%; mean difference [MD] 22%; 95% confidence interval [CI], 15% to 29%). No significant difference was noted in the mean percentage of compressions within acceptable depth (38-51 mm) (72% vs 70%; MD 2%; 95% CI, -2% to 6%). The metronome had a larger effect among medical students (73% vs 55%; MD 18%; 95% CI, 8% to 28%) and pediatric residents and fellows (84% vs 48%; MD 37%; 95% CI, 27% to 46%) but not among pediatric nurses (46% vs 48%; MD -3%; 95% CI, -19% to 14%). The rate of chest compressions during CPR can be optimized by the use of a metronome. These findings will help medical professionals comply with the American Heart Association guidelines. Copyright © 2015 by the American Academy of Pediatrics.

Influence of body position on the displacement of nasal prongs in preterm newborns receiving continuous positive airway pressure

PubMed Central

Brunherotti, Marisa Afonso Andrade; Martinez, Francisco Eulógio

2015-01-01

Abstract Objective: To evaluate the influence of body position on the displacement of nasal prongs in preterm infants. Methods: This prospective, randomized, crossover study enrolled infants born at a mean gestational age of 29.7±2 weeks, birth weight of 1353±280g and 2.9±2.2 days of life, submitted to continuous positive airway pressure by nasal prongs. The main outcome was the number of times that the nasal prongs were displaced following infant positioning in the following body positions: prone, right lateral, left lateral, and supine, according to a pre-established random order. Moreover, cardiorespiratory variables (respiratory rate, heart rate, and oxygen saturation) were evaluated for each body position. Data for each position were collected every 10 min, over a period of 60 min. An occurrence was defined when the nasal prongs were displaced from the nostrils after 3 min in the desired position, requiring intervention of the examiner. Results: Among the 16 studied infants, the occurrence of nasal prong displacement was only observed in the prone position (9 infants - 56.2%) and in the left lateral position (2 infants - 12.5%). The number of times that the prongs were displaced was 11 in the prone position (7 within the first 10min) and 2 in the left lateral position (1 within the first 10min). No clinically significant changes were observed in the cardiorespiratory variables. Conclusions: Maintenance of the nasal prongs to provide adequate noninvasive respiratory support was harder in the prone position. PMID:26116326

Vildagliptin reduces plasma stromal cell-derived factor-1α in patients with type 2 diabetes compared with glimepiride.

PubMed

Park, Kyeong Seon; Kwak, SooHeon; Cho, Young Min; Park, Kyong Soo; Jang, Hak C; Kim, Seong Yeon; Jung, Hye Seung

2017-03-01

Dipeptidyl peptidase-4 inhibitors might have pleiotropic protective effects on cardiovascular disease (CVD), in contrast to sulfonylureas. Therefore, we compared various CVD risk factors between vildagliptin and glimepiride. We carried out a randomized, prospective and crossover trial. A total of 16 patients with type 2 diabetes whose glycated hemoglobin was >7% were randomized to add vildagliptin or glimepiride. After 12-week treatment, each drug was replaced with the other for another 12 weeks. Before and after each treatment, glucose homeostasis and CVD risk factors were assessed, and the continuous glucose monitoring system was applied to calculate glycemic variability. The mean age of the participants was 60 years, 31% were men, body mass index 25.5 kg/m 2 and HbA1c 8.41%. Both vildagliptin and glimepiride significantly decreased glycated hemoglobin and glycemic variability indices. Despite the improved glucose homeostasis, favorable change of CVD markers was not prominent in both the arms, along with significant weight gain. Only plasma stromal cell-derived factor (SDF)-1α decreased by 30% in the vildagliptin arm. According to regression analyses, the reduction of SDF-1α was independently associated with vildagliptin usage and serum interleukin-6 changes, but white blood cells were not related with the SDF-1α changes. Compared with glimepiride, vildagliptin arrestingly decreased plasma SDF-1α, and its clinical implications should be further investigated. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

More pistachio nuts for improving the blood lipid profile. Systematic review of epidemiological evidence.

PubMed

Lippi, Giuseppe; Cervellin, Gianfranco; Mattiuzzi, Camilla

2016-05-06

Recent evidence suggests that regular intake of nuts may be associated with reduction of all-cause mortality, especially cardiovascular deaths. Among all types of nuts, pistachio displays the most favorable dietary composition. Therefore, we searched Medline and ISI Web of Science to identify interventional studies which evaluated changes of conventional blood lipids after replacing part of normal caloric intake with pistachio nuts in humans. Overall, 9 studies were finally included in our systematical literature review (4 randomized crossover, 3 randomized controlled and 3 prospective). In 6/9 (67%) interventional studies total cholesterol and low-density lipoprotein cholesterol (LDL-C) decreased, whereas high-density lipoprotein cholesterol (HDL-C) increased. In all studies total cholesterol/HDL-C ratio (7/7; 100%) and LDL-C/HDL-C ratio (6/6; 100%) decreased after replacing caloric intake with pistachio nuts for not less than 3 weeks. A significant reduction of triglycerides could only be observed in 2 out of 8 studies (25%). Even more importantly, in no interventional study the intake of pistachio nuts was associated with unfavorable changes of the lipid profile. The results of our literature search provide solid evidence that intake of pistachio nuts may exerts favorable effects on the traditional blood profile, provided that their consumption does not increase the habitual or recommended daily caloric intake. It seems also reasonable to suggest that further studies aimed to investigate the favorable effects of nuts on human diseases should distinguish between one type and the others, since the different nuts exhibit unique dietary composition and may hence produce distinctive biological effects in humans.

Anesthetic efficacy of 1.8 mL versus 3.6 mL of 4% articaine with 1:100,000 epinephrine as a primary buccal infiltration of the mandibular first molar.

PubMed

Martin, Matthew; Nusstein, John; Drum, Melissa; Reader, Al; Beck, Mike

2011-05-01

No study has compared 1.8 mL and 3.6 mL 4% articaine with 1:100,000 epinephrine in a mandibular buccal infiltration of the first molar. The authors conducted a prospective, randomized, single-blind, crossover study comparing the degree of pulpal anesthesia obtained with 1.8 mL and 3.6 mL 4% articaine with 1:100,000 epinephrine as a primary infiltration in the mandibular first molar. Eighty-six asymptomatic adult subjects randomly received a primary mandibular buccal first molar infiltration of 1.8 mL or 3.6 mL 4% articaine with 1:100,000 epinephrine in two separate appointments. The authors used an electric pulp tester to test the first molar for anesthesia in 3-minute cycles for 90 minutes after the injections. Compared with the 1.8-mL volume of 4% articaine with 1:100,000 epinephrine, the 3.6-mL volume showed a statistically higher success rate (70% vs 50%). The anesthetic efficacy of 3.6 mL 4% articaine with 1:100,000 epinephrine is better than 1.8 mL of the same anesthetic solution in a primary mandibular buccal infiltration of the first molar. However, the success rate of 70% is not high enough to support its use as a primary injection technique in the mandibular first molar. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

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.

Comparative study on the sedative effects of morphine, methadone, butorphanol or tramadol, in combination with acepromazine, in dogs.

PubMed

Monteiro, Eduardo Raposo; Junior, Adolfo Rodrigues; Assis, Hemir Martins Quirilos; Campagnol, Daniela; Quitzan, Juliany Gomes

2009-01-01

To compare the effects of morphine (MOR), methadone (MET), butorphanol (BUT) and tramadol (TRA), in combination with acepromazine, on sedation, cardiorespiratory variables, body temperature and incidence of emesis in dogs. Prospective randomized, blinded, experimental trial. Six adult mixed-breed male dogs weighing 12.0 +/- 4.3 kg. Dogs received intravenous administration (IV) of acepromazine (0.05 mg kg(-1)) and 15 minutes later, one of four opioids was randomly administered IV in a cross-over design, with at least 1-week intervals. Dogs then received MOR 0.5 mg kg(-1); MET 0.5 mg kg(-1); BUT 0.15 mg kg(-1); or TRA 2.0 mg kg(-1). Indirect systolic arterial pressure (SAP), heart rate (HR), respiratory rate (f(R)), rectal temperature, pedal withdrawal reflex and sedation were evaluated at regular intervals for 90 minutes. Acepromazine administration decreased SAP, HR and temperature and produced mild sedation. All opioids further decreased temperature and MOR, BUT and TRA were associated with further decreases in HR. Tramadol decreased SAP whereas BUT decreased f(R) compared with values before opioid administration. Retching was observed in five of six dogs and vomiting occurred in one dog in MOR, but not in any dog in the remaining treatments. Sedation scores were greater in MET followed by MOR and BUT. Tramadol was associated with minor changes in sedation produced by acepromazine alone. When used with acepromazine, MET appears to provide better sedation than MOR, BUT and TRA. If vomiting is to be avoided, MET, BUT and TRA may be better options than MOR.

Under-humidification and over-humidification during moderate induced hypothermia with usual devices.

PubMed

Lellouche, François; Qader, Siham; Taille, Solenne; Lyazidi, Aissam; Brochard, Laurent

2006-07-01

In mechanically ventilated patients with induced hypothermia, the efficacy of heat and moisture exchangers and heated humidifiers to adequately humidify the airway is poorly known. The aim of the study was to assess the efficacy of different humidification devices during moderate hypothermia. Prospective, cross-over randomized study. Medical Intensive Care Unit in a University Hospital. Nine adult patients hospitalized after cardiac arrest in whom moderate hypothermia was induced (33 degrees C for 24[Symbol: see text]h). Patients were ventilated at admission (period designated "normothermia") with a heat and moisture exchanger, and were randomly ventilated during hypothermia with a heat and moisture exchanger, a heated humidifier, and an active heat and moisture exchanger. Core temperature, inspired and expired gas absolute and relative humidity were measured. Each system demonstrated limitations in its ability to humidify gases in the specific situation of hypothermia. Performances of heat and moisture exchangers were closely correlated to core temperature (r (2)[Symbol: see text]=[Symbol: see text]0.84). During hypothermia, heat and moisture exchangers led to major under-humidification, with absolute humidity below 25[Symbol: see text]mgH(2)O/l. The active heat and moisture exchanger slightly improved humidification. Heated humidifiers were mostly adequate but led to over-humidification in some patients, with inspiratory absolute humidity higher than maximal water content at 33 degrees C with a positive balance between inspiratory and expiratory water content. These results suggest that in the case of moderate hypothermia, heat and moisture exchangers should be used cautiously and that heated humidifiers may lead to over-humidification with the currently recommended settings.

Nurse- vs nomogram-directed glucose control in a cardiovascular intensive care unit.

PubMed

Chant, Clarence; Mustard, Mary; Thorpe, Kevin E; Friedrich, Jan O

2012-07-01

Paper-based nomograms are reasonably effective for achieving glycemic control but have low adherence and are less adaptive than nurses' judgment. To compare efficacy (glucose control) and safety (hypoglycemia) achieved by use of a paper nomogram versus nurses' judgment. Prospective, randomized, open-label, crossover trial in an intensive care unit in postoperative patients with glucose concentrations greater than 8 mmol/L. Consenting nurses with at least 1 year of experience were randomized to use either their judgment or a validated paper-based nomogram for glucose control. After completion of 2 study shifts, the nurses used the alternative method for the next 2 study shifts. Glucose target level and safety and efficacy boundaries were the same for both methods. The primary end point was area under glucose time curve per hour. Thirty-four nurses contributed 95 shifts of data (44 nomogram-directed, 51 nurse-directed). Adherence to the nomogram was higher in the nomogram group than hypothetical adherence in the nurse-directed group for correct adjustments in insulin infusion (70% vs 37%; P < .001) and glucose checks (58% vs 43%; P = .008). The primary end point did not differ between the 2 groups (mean, 9.0 mmol/L; SD, 3.5 vs mean, 8.3 mmol/L; SD, 2.1; P = .08). Glucose variability, amount of time patients were hypoglycemic or hyperglycemic, and number of glucose checks performed were similar in the 2 groups. In an intensive care unit where nurses generally accepted the need for tight glucose control, nurse-directed control was as effective and as safe as nomogram-based control.

Intravenous Insulin Decreases Protein Breakdown in Infants on Extracorporeal Membrane Oxygenation

PubMed Central

Agus, Michael S.D.; Javid, Patrick J.; Ryan, Daniel P.; Jaksic, Tom

2010-01-01

Background/Purpose Infants requiring extracorporeal membrane oxygenation (ECMO) have the highest rates of protein catabolism ever reported. Recent investigations have found that such extreme protein breakdown is refractory to conventional nutritional management. In this pilot study, the authors sought to use the anabolic hormone insulin to reduce the profound protein degradation in this cohort. Methods Four parenterally fed infants on ECMO were enrolled in a prospective, randomized, crossover trial. Subjects were administered an insulin infusion using a 4-hour hyperinsulinemic euglycemic clamp followed by a control saline infusion on consecutive days in random order. Whole-body protein flux and breakdown were quantified using a primed continuous infusion of the stable isotope l-[1-13C]leucine. Statistical analyses were performed using paired t tests. Results Serum insulin levels were increased 15-fold during the insulin clamp compared with the saline control (407 ± 103 v 26 ± 12 µU/mL; P < .05). During the insulin infusion, infants had decreased rates of total leucine flux (214 ± 25 v 298 ± 38 µmol/kg/h; P < .05) and leucine flux derived from protein breakdown (156 ± 40 v 227 ± 54 µmol/kg/h; P < .05) when compared with saline control. Overall, insulin administration produced a 32% reduction in protein breakdown (P < .05). Conclusions In this pilot study, the anabolic hormone insulin markedly reduced protein breakdown in critically ill infants on ECMO. Because elevated protein breakdown correlates with mortality and morbidity, the administration of intravenous insulin may ultimately have broad applicability to the metabolic management of critically ill infants. PMID:15185208

Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study.

PubMed

Bingler, Michael; Erickson, Lori A; Reid, Kimberly J; Lee, Brian; O'Brien, James; Apperson, Johnathan; Goggin, Kathy; Shirali, Girish

2018-05-01

Interstage outcomes for infants with single ventricle remain suboptimal. We have previously described a tablet PC-based platform Cardiac High Acuity Monitoring Program (CHAMP) for remote monitoring which provides immediate access to data, videos, and instant alerts to our single ventricle care team. This study compares traditional three-ring binder monitoring (Binder) to CHAMP using a randomized crossover design to evaluate mortality, resource utilization, and caregiver experience. At discharge, all single ventricle infants were monitored using Binder and randomized to receive CHAMP at either one or two months postdischarge. One month after randomization, caregivers could choose either Binder or CHAMP for the remainder of the interstage period. Caregivers experience was recorded using surveys. Enrollment included 31 single ventricle infants from May 2014 to June 2015. There was no interstage mortality over 4,911 total interstage days (median: 144/patient). Of 73 readmissions, 45 were unplanned. Of the initial 23 unplanned readmissions, 13 were found to have been based on data obtained exclusively through CHAMP (as instant alerts or based on data review) rather than caregiver concerns. Due to concerns regarding patient safety, additional enrollment was stopped. The CHAMP use was associated with significantly fewer unplanned intensive care unit days/100 interstage days, shorter delays in care, lower resource utilization at readmissions, and lower incidence of interstage growth failure and was preferred by a majority of caregivers. These findings suggest that CHAMP may offer benefits over Binder (improved interstage outcomes, delays in care, and caregiver experience). These findings should be tested across multiple centers in larger populations.

Formulation and in vitro examination of furosemide containing suppositories and preliminary experiences of their clinical use.

PubMed

Regdon, G; Fazekas, T; Regdon, G; Selmeczi, B

1996-02-01

Rectal suppositories containing furosemide (4-chloro-N-furfuryl-5-sulfamoylanthranilic acid) and furosemide sodium were formulated with various suppository bases. The in vitro drug release of Massa Estarinum 299 proved to be the best from the vehicle having various physical-chemical properties. The diuretic effect of the two suppositories was compared in a prospective, crossover clinical trial including 8 patients. Both preparations have induced an increase of urine flow, which was comparable to the diuretic effect of the tablet.

Dietary supplementation with purified citrus limonin glucoside does not alter ex vivo functions of circulating T lymphocytes or monocytes in overweight/obese human adults

USDA-ARS?s Scientific Manuscript database

Overweight/obesity is associated with chronic inflammation and impairs both innate and adaptive immune responses. Limonoids found in citrus fruits have shown health benefits in human and animal studies. In a double-blind, randomized, crossover study, 10 overweight/obese human subjects were fed pur...

Influence of Caffeine Ingestion on Perceived Mood States, Concentration, and Arousal Levels during a 75-Min University Lecture

ERIC Educational Resources Information Center

Peeling, Peter; Dawson, Brian

2007-01-01

This investigation aimed to assess the effect of a caffeine supplement on perceived mood state, concentration, and arousal during a 75-min university lecture. Methods. This randomized, blind, cross-over design investigation ran over a course of 2 consecutive weeks. During "week" 1, 10 third-year Human Movement and Exercise Science…

Choosing an Appropriate Physical Exercise to Reduce Stereotypic Behavior in Children with Autism Spectrum Disorders: A Non-Randomized Crossover Study

ERIC Educational Resources Information Center

Tse, C. Y. Andy; Pang, C. L.; Lee, Paul H.

2018-01-01

Considerable evidence has shown that physical exercise could be an effective treatment in reducing stereotypical autism spectrum disorder (ASD) behaviors in children. The present study seeks to examine the underlying mechanism by considering the theoretical operant nature of stereotypy. Children with ASD (n = 30) who exhibited hand-flapping and…

Aniracetam tested in chronic psychosyndrome after long-term exposure to organic solvents. A randomized, double-blind, placebo-controlled cross-over study with neuropsychological tests.

PubMed

Somnier, F E; Ostergaard, M S; Boysen, G; Bruhn, P; Mikkelsen, B O

1990-01-01

In order to examine if the nootropic drug, aniracetam, was capable of improving cognitive performance, 44 subjects suffering from chronic psychosyndrome after long-term exposure to organic solvents were included in a randomized, double-blind, placebo-controlled, cross-over study. The treatment periods were 3 months with aniracetam 1 g daily and 3 months with placebo. Neuropsychological tests as well as a physical and neurological examination were performed at entry into the study and after each treatment period, together with an evaluation of the subjects' overall condition. Neither the doctors' nor the subjects' own assessment of the overall condition indicated that the trial medication had had any effect. No significant changes in neuropsychological symptoms were observed. A statistically significant difference in favour of antiracetam was found in only 1 of the 19 neuropsychological test measures, namely a test for constructional ability. However, in another test on visuo-spatial function, a statistically significant result was found in favour of placebo. Thus, aniracetam was found to be ineffective in the treatment of subjects suffering from chronic psychosyndrome after long-term exposure to organic solvents.

A pilot study assessing the effectiveness of a glycerin suppository in controlled colostomy emptying.

PubMed

McClees, Nancy; Mikolaj, Eda L; Carlson, Sharon L; Pryor-McCann, Joan

2004-01-01

The focus of this research was to explore another way for the patient to manage their colostomy. It was hoped that by inserting a glycerin suppository into the colostomy one would be able to evacuate the lower large intestine more effectively and efficiently. To determine if persons with a sigmoid colostomy could obtain fecal continence by instituting a daily self-administered bowel-stimulating suppository. Randomized crossover comparative study comparing usual ostomy emptying practice with emptying with a glycerine suppository to stimulate controlled emptying. Adult males and females with a sigmoid colostomy were studied in their homes. The instruments included a profile questionnaire, a take-home diary, crossover and end-of-study questionnaires, and an exit questionnaire. Subjects were randomized to their usual pouching method or to the experimental suppository method for 14 days each. There was no difference in fecal output, fecal volume, or flatus between the 2 groups. The action of the suppository was affected by its failure to remain in the bowel for an adequate amount of time. Further research is needed to determine if an adjunct device/method to hold the suppository in place would produce successful results.

Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.

PubMed

Udani, Jay K

2013-01-01

Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35-65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood.

Effects of SuperUlam on Supporting Concentration and Mood: A Randomized, Double-Blind, Placebo-Controlled Crossover Study

PubMed Central

Udani, Jay K

2013-01-01

Background. SuperUlam is a proprietary blend of natural ingredients aimed at supporting brain health. We aimed to evaluate the effect of SuperUlam on attention and mood in healthy adults. Methods. Twenty healthy individuals aged 35–65 were enrolled in this randomized, double-blind, placebo-controlled, crossover study. Study duration was 3 weeks and consisted of 3 visits. Measurement of cognitive function included computer-based testing of reaction time, complex attention, working memory, sustained attention, and executive functioning. Mood testing was performed via the profile of mood states (POMS) survey and the Chalder fatigue scale. Results. Cognitive function testing demonstrated a significant improvement from baseline in executive functioning, cognitive flexibility, reaction time, and working memory in the product group only (P < 0.05). When comparing the study product to placebo, the data demonstrated a significant decrease in tension, depression, and anger (P < 0.05). There was no significant difference between the product and placebo in the other measures of mood, including vigor, fatigue, confusion, and total mood disturbance. No adverse events were reported. Conclusions. Supplementation with SuperUlam is safe to consume with potential benefits to cognitive function and mood. PMID:24371452

Automatic Molecular Design using Evolutionary Techniques

NASA Technical Reports Server (NTRS)

Globus, Al; Lawton, John; Wipke, Todd; Saini, Subhash (Technical Monitor)

1998-01-01

Molecular nanotechnology is the precise, three-dimensional control of materials and devices at the atomic scale. An important part of nanotechnology is the design of molecules for specific purposes. This paper describes early results using genetic software techniques to automatically design molecules under the control of a fitness function. The fitness function must be capable of determining which of two arbitrary molecules is better for a specific task. The software begins by generating a population of random molecules. The population is then evolved towards greater fitness by randomly combining parts of the better individuals to create new molecules. These new molecules then replace some of the worst molecules in the population. The unique aspect of our approach is that we apply genetic crossover to molecules represented by graphs, i.e., sets of atoms and the bonds that connect them. We present evidence suggesting that crossover alone, operating on graphs, can evolve any possible molecule given an appropriate fitness function and a population containing both rings and chains. Prior work evolved strings or trees that were subsequently processed to generate molecular graphs. In principle, genetic graph software should be able to evolve other graph representable systems such as circuits, transportation networks, metabolic pathways, computer networks, etc.

Synbiotic Lactobacillus acidophilus NCFM and cellobiose does not affect human gut bacterial diversity but increases abundance of lactobacilli, bifidobacteria and branched-chain fatty acids: a randomized, double-blinded cross-over trial.

PubMed

van Zanten, Gabriella C; Krych, Lukasz; Röytiö, Henna; Forssten, Sofia; Lahtinen, Sampo J; Abu Al-Soud, Waleed; Sørensen, Søren; Svensson, Birte; Jespersen, Lene; Jakobsen, Mogens

2014-10-01

Probiotics, prebiotics, and combinations thereof, that is synbiotics, have been reported to modulate gut microbiota of humans. In this study, effects of a novel synbiotic on the composition and metabolic activity of human gut microbiota were investigated. Healthy volunteers (n = 18) were enrolled in a double-blinded, randomized, and placebo-controlled cross-over study and received synbiotic [Lactobacillus acidophilus NCFM (10(9) CFU) and cellobiose (5 g)] or placebo daily for 3 weeks. Fecal samples were collected and lactobacilli numbers were quantified by qPCR. Furthermore, 454 tag-encoded amplicon pyrosequencing was used to monitor the effect of synbiotic on the composition of the microbiota. The synbiotic increased levels of Lactobacillus spp. and relative abundances of the genera Bifidobacterium, Collinsella, and Eubacterium while the genus Dialister was decreased (P < 0.05). No other effects were found on microbiota composition. Remarkably, however, the synbiotic increased concentrations of branched-chain fatty acids, measured by gas chromatography, while short-chain fatty acids were not affected. © 2014 Federation of European Microbiological Societies. Published by John Wiley & Sons Ltd. All rights reserved.

Safety of a new compact male intermittent catheter: randomized, cross-over, single-blind study in healthy male volunteers.

PubMed

Bagi, Per; Hannibalsen, Jane; Permild, Rikke; Stilling, Sine; Looms, Dagnia K

2011-01-01

A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference -0.27; 95% confidence interval -0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p < 0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved. Copyright © 2011 S. Karger AG, Basel.

Increased Erythrocyte Eicosapentaenoic Acid and Docosahexaenoic Acid Are Associated With Improved Attention and Behavior in Children With ADHD in a Randomized Controlled Three-Way Crossover Trial.

PubMed

Milte, Catherine M; Parletta, Natalie; Buckley, Jonathan D; Coates, Alison M; Young, Ross M; Howe, Peter R C

2015-11-01

To investigate effects of omega-3 polyunsaturated fatty acids (n-3 PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) on attention, literacy, and behavior in children with ADHD. Ninety children were randomized to consume supplements high in EPA, DHA, or linoleic acid (control) for 4 months each in a crossover design. Erythrocyte fatty acids, attention, cognition, literacy, and Conners' Parent Rating Scales (CPRS) were measured at 0, 4, 8, 12 months. Fifty-three children completed the treatment. Outcome measures showed no significant differences between the three treatments. However, in children with blood samples (n = 76-46), increased erythrocyte EPA + DHA was associated with improved spelling (r = .365, p < .001) and attention (r = -.540, p < .001) and reduced oppositional behavior (r = -.301, p < .003), hyperactivity (r = -.310, p < .001), cognitive problems (r = -.326, p < .001), Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) hyperactivity (r = -.270, p = .002) and DSM-IV inattention (r = -.343, p < .001). Increasing erythrocyte DHA and EPA via dietary supplementation may improve behavior, attention, and literacy in children with ADHD. © The Author(s) 2013.

Randomly diluted xy and resistor networks near the percolation threshold

NASA Astrophysics Data System (ADS)

Harris, A. B.; Lubensky, T. C.

1987-05-01

A formulation based on that of Stephen for randomly diluted systems near the percolation threshold is analyzed in detail. By careful consideration of various limiting procedures, a treatment of xy spin models and resistor networks is given which shows that previous calculations (which indicate that these systems having continuous symmetry have the same crossover exponents as the Ising model) are in error. By studying the limit wherein the energy gap goes to zero, we exhibit the mathematical mechanism which leads to qualitatively different results for xy-like as contrasted to Ising-like systems. A distinctive feature of the results is that there is an infinite sequence of crossover exponents needed to completely describe the probability distribution for R(x,x'), the resistance between sites x and x'. Because of the difference in symmetry between the xy model and the resistor network, the former has an infinite sequence of crossover exponents in addition to those of the resistor network. The first crossover exponent φ1=1+ɛ/42 governs the scaling behavior of R(x,x') with ||x-x'||≡r: [R(x,x')]c~xφ1/ν, where [ ]c indicates a conditional average, subject to x and x' being in the same cluster, ν is the correlation length exponent for percolation, and ɛ=6-d, where d is the spatial dimensionality. We give a detailed analysis of the scaling properties of the bulk conductivity and the anomalous diffusion constant introduced by Gefen et al. Our results show conclusively that the Alexander-Orbach conjecture, while numerically quite accurate, is not exact, at least in high spatial dimension. We also evaluate various amplitude ratios associated with susceptibilities, χn involving the nth power of the resistance R(x,x'), e.g., &χ2χ0/χ21=2[1+(19ɛ/420)]. In an appendix we outline how the calculation can be extended to treat the diluted m-component spin model for m>2. As expected, the results for φ1 remain valid for m>2. The techniques described here have led to several recent calculations of various infinite families of exponents.

The effects of the DDS-1 strain of lactobacillus on symptomatic relief for lactose intolerance - a randomized, double-blind, placebo-controlled, crossover clinical trial.

PubMed

Pakdaman, Michael N; Udani, Jay K; Molina, Jhanna Pamela; Shahani, Michael

2016-05-20

Lactose intolerance is a form of lactose maldigestion where individuals experience symptoms such as diarrhea, abdominal cramping, flatulence, vomiting and bowel sounds following lactose consumption. Lactobacillus acidophilus is a species of bacteria known for its sugar fermenting properties. Preclinical studies have found that Lactobacillus acidophilus supplementation may assist in breaking down lactose; however, no human clinical trials exist evaluating its efficacy in alleviating symptoms related to lactose intolerance. The aim of this randomized, double-blind, placebo-controlled, crossover study was to evaluate the effect of a proprietary strain of Lactobacillus acidophilus on relieving discomfort related to lactose intolerance. The study enrolled healthy volunteers between 18 and 75 years of age who complained of lactose intolerance. Screening visits included a lactose challenge visit to confirm eligibility based on a score of 10 or higher on subjective assessment of the following symptoms after lactose challenge: diarrhea, abdominal cramping, vomiting, audible bowel sounds, flatulence, and overall symptoms. Qualified subjects participated in a 2-arm crossover design, with each arm consisting of 4 weeks of intervention of either active or placebo product, with a 2-week washout period during crossover. The study product consisted of the DDS-1 strain of Lactobacillus acidophilus (Nebraska Cultures, Walnut Creek, California). The placebo was formulated from maltodextrin. Study participants were instructed to take the product once daily for 4 weeks. Data collected included subjective symptom scores related to lactose intolerance. Longitudinal comparison between the DDS-1 group and placebo group demonstrated statistically significant reductions in abdominal symptom scores during the 6-h Lactose Challenge at week 4 for diarrhea (p = 0.033), abdominal cramping (p = 0.012), vomiting (p = 0.0002), and overall symptom score (p = 0.037). No adverse events were reported. The present study has found that this unique DDS-1 strain of Lactobacillus acidophilus, manufactured by Nebraska Cultures, is safe to consume and improves abdominal symptom scores compared to placebo with respect to diarrhea, cramping, and vomiting during an acute lactose challenge.

The effect of small solar powered 'Bͻkͻͻ' net fans on mosquito net use: results from a randomized controlled cross-over trial in southern Ghana.

PubMed

Briët, Olivier J T; Yukich, Joshua O; Pfeiffer, Constanze; Miller, William; Jaeger, Mulako S; Khanna, Nitin; Oppong, Samuel; Nardini, Peter; Ahorlu, Collins K; Keating, Joseph

2017-01-03

Long-lasting insecticidal nets (LLINs) are ineffective malaria transmission prevention tools if they are unused. Discomfort due to heat is the most commonly reported reason for not using nets, but this problem is largely unaddressed. With increasing rural electrification and the dropping price of solar power, fans could improve comfort inside nets and be affordable to populations in malaria endemic areas. Here, results are presented from a pilot randomized controlled cross-over study testing the effect of fans on LLIN use. Eighty-three households from two rural communities in Greater Accra, Ghana, randomized into three groups, participated in a 10-month cross-over trial. After a screening survey to identify eligible households, all households received new LLINs. Bͻkͻͻ net fan systems (one fan per member) were given to households in Group 1 and water filters were given to households in Group 2. At mid-point, Group 1 and 2 crossed over interventions. Households in Group 1 and 2 participated in fortnightly surveys on households' practices related to nets, fans and water filters, while households in Group 3 were surveyed only at screening, mid-point and study end. Entomological and weather data were collected throughout the study. Analysis took both 'per protocol' (PP) and 'intention to treat' (ITT) approaches. The mid- and end-point survey data from Group 1 and 2 were analysed using Firth logistic regressions. Fortnightly survey data from all groups were analysed using logistic regressions with random effects. Provision of fans to households appeared to increase net use in this study. Although the increase in net use explained by fans was not significant in the primary analyses (ITT odds ratio 3.24, p > 0.01; PP odds ratio = 1.17, p > 0.01), it was significant in secondary PP analysis (odds ratio = 1.95, p < 0.01). Net use was high at screening and even higher after provision of new LLINs and with follow up. Fan use was 90-100% depending on the fortnightly visit. This pilot study could not provide definitive evidence that fans increase net use. A larger study with additional statistical power is needed to assess this association across communities with diverse environmental and socio-demographic characteristics.

A Randomized Crossover Trial Evaluating Continuous Positive Airway Pressure Versus Mandibular Advancement Device on Health Outcomes in Veterans With Posttraumatic Stress Disorder

PubMed Central

El-Solh, Ali A.; Homish, Gregory G.; Ditursi, Guy; Lazarus, John; Rao, Nithin; Adamo, David; Kufel, Thomas

2017-01-01

Study Objectives: Despite the overall improvement in posttraumatic stress disorder (PTSD) symptomatology with continuous positive airway pressure (CPAP) therapy, adherence to CPAP is far worse in veterans with PTSD compared to the general population with obstructive sleep apnea (OSA). The aim of this study was to compare the efficacy, adherence, and preference of CPAP versus mandibular advancement device (MAD) and the effect of these treatments on health outcomes in veterans with PTSD. Methods: Forty-two subjects with PTSD and newly diagnosed OSA by polysomnography were treated in a randomized, crossover trial of 12 weeks with CPAP alternating with MAD separated by a 2-week washout period. The primary outcome was the difference in titration residual apnea-hypopnea index (AHI) between CPAP and MAD. Secondary outcome measures included PTSD Checklist and health-related quality of life (Medical Outcomes Study 36-Item Short Form and Pittsburgh Sleep Quality Index). Results: Analyses were limited to the 35 subjects (mean age 52.7 ± 11.6 years) who completed the trial, regardless of compliance with their assigned treatment. CPAP was more efficacious in reducing AHI and improving nocturnal oxygenation than MAD (P < .001 and P = .04, respectively). Both treatments reduced PTSD severity and ameliorated scores of the Medical Outcomes Study Short Form 36 and Pittsburgh Sleep Quality Index, although no differences were detected between the CPAP and MAD arms. The reported adherence to MAD was significantly higher than CPAP (P < .001), with 58% preferring MAD to CPAP. Conclusions: Although CPAP is more efficacious than MAD at improving sleep apnea, both treatment modalities imparted comparable benefits for veterans with PTSD in relation to PTSD severity and health-related quality of life. MAD offers a viable alternative for veterans with OSA and PTSD who are nonadherent to CPAP. Clinical Trial Registration: Title: A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder; URL: https://www.clinicaltrials.gov/ct/show/NCT01569022; Identifier: NCT01569022 Citation: El-Solh AA, Homish GG, Ditursi G, Lazarus J, Rao N, Adamo D, Kufel T. A randomized crossover trial evaluating continuous positive airway pressure versus mandibular advancement device on health outcomes in veterans with posttraumatic stress disorder. J Clin Sleep Med. 2017;13(11):1327–1335 PMID:29065960

The patient general satisfaction of mandibular single-implant overdentures and conventional complete dentures: Study protocol for a randomized crossover trial.

PubMed

Kanazawa, Manabu; Tanoue, Mariko; Miyayasu, Anna; Takeshita, Shin; Sato, Daisuke; Asami, Mari; Lam, Thuy Vo; Thu, Khaing Myat; Oda, Ken; Komagamine, Yuriko; Minakuchi, Shunsuke; Feine, Jocelyne

2018-05-01

Mandibular overdentures retained by a single implant placed in the midline of edentulous mandible have been reported to be more comfortable and function better than complete dentures. Although single-implant overdentures are still more costly than conventional complete dentures, there are a few studies which investigated whether mandibular single-implant overdentures are superior to complete dentures when patient general satisfaction is compared. The aim of this study is to assess patient general satisfaction with mandibular single-implant overdentures and complete dentures. This study is a randomized crossover trial to compare mandibular single-implant overdentures and complete dentures in edentulous individuals. Participant recruitment is ongoing at the time of this submission. Twenty-two participants will be recruited. New mandibular complete dentures will be fabricated. A single implant will be placed in the midline of the edentulous mandible. The mucosal surface of the complete denture around the implant will be relieved for 3 months. The participants will then be randomly allocated into 2 groups according to the order of the interventions; group 1 will receive single-implant overdentures first and will wear them for 2 months, followed by complete dentures for 2 months. Group 2 will receive the same treatments in a reverse order. After experiencing the 2 interventions, the participants will choose one of the mandibular prostheses, and yearly follow-up visits are planned for 5 years. The primary outcome of this trial is patient ratings of general satisfaction on 100 mm visual analog scales. Assessments of the prostheses and oral health-related quality of life will also be recorded as patient-reported outcomes. The secondary outcomes are cost and time for treatment. Masticatory efficiency and cognitive capacity will also be recorded. Furthermore, qualitative research will be performed to investigate the factors associated with success of these mandibular denture types. Clinical outcomes, such as implant survival rate, marginal bone loss, and prosthodontic complications, will also be recorded. The results of this randomized crossover trial will clarify whether mandibular single implants and overdentures for edentulous individuals provide better patient general satisfaction when compared to conventional complete dentures. This clinical trial was registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000017883).

The effect of deep muscle relaxation on the force required during Latissimus Dorsi dissection for breast reconstructive surgery: results of a prospective, double-blinded observational pilot study.

PubMed

Ledowski, T; Goodwin-Walters, A; Quinn, P; Calvert, M

2017-02-21

The use of neuromuscular blocking agents has previously been suggested to facilitate the dissection of the latissimus dorsi muscle during breast reconstructive surgery. The aim of this study was to quantify the influence of deep muscle relaxation on the force required to lift the latissimus dorsi muscle during flap preparation. After ethics approval and written informed consent 15 patients scheduled for elective breast reconstruction with a latissimus dorsi pedicled flap (muscle flap, not myocutaneous flap) under general anaesthesia were prospectively included. Midway through the muscle dissection a sterile cotton tape was slung around the mid portion of the muscle and connected with a sterile strain gauge stably positioned just above the patient. Thereafter, the muscle was lifted by moving the strain gauge vertically upwards until a muscle tension similar to that created manually during muscle dissection was achieved. The force (N) and distance required to tension the muscle were recorded and the tension released. In a randomized and blinded crossover design either rocuronium (0.6 mg.kg -1 ) or normal saline were given intravenously, and the tension protocol was repeated 2 min after each drug administration. Muscle relaxation significantly reduced the force for flap tensioning (median [percentiles] - 22 [-32/-13] %; P = 0.011) in 10/15 patients. However, in the remaining 5 patients no significant effect was measured. Normal saline had no effect on the measured force. Deep muscle relaxation significantly reduces the force required to manually elevate the latissimus dorsi muscle during its dissection in the majority of but not all patients. The study was retrospectively registered on [17.6.2014] with the Australian and New Zealand Clinical Trials Registry. ACTRN12614000637640.

A randomized, double-blind, crossover, placebo-controlled comparative clinical trial of arginine aspartate plus adenosine monophosphate for the intermittent treatment of male erectile dysfunction.

PubMed

Neuzillet, Y; Hupertan, V; Cour, F; Botto, H; Lebret, T

2013-03-01

Efficacy and safety of l-arginine aspartate 8 g combined with 200 mg of adenosine monophosphate (AA) with placebo (PL) alone for intermittent treatment of mild-to-moderate erectile dysfunction (ED) were compared. The study design was a double-blind, PL-controlled, two-way crossover randomized clinical trial with 26 patients. Efficacy was assessed by International Index of Erectile Function (IIEF) and two additional validated questionnaires [the Erection Hardness Score (EHS) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). During each crossover period, separated by a 2-week wash-out period, drugs were administered orally, 1-2 h before sexual intercourse. Primary endpoint was a change in the IIEF. Secondary endpoints were patient and investigator assessments of treatment success. Investigators' and patients' assessment of efficacy was significantly improved by the combination vs. PL (p = 0.01 and p = 0.04 respectively]. EHS and EDITS questionnaires were both improved by the combination (p = 0.015 and p = 0.017 respectively). There was no significant difference in terms of tolerance between AA and PL or severe adverse events. ED patients demonstrated significant improvements in all IIEF domains with the exception of the Sexual Desire and Orgasmic Domains when treated with AA compared with PL. This pilot phase II study showed that the on-demand oral administration at a high dosage of l-arginine aspartate-adenosine monophosphate combination may be effective in patients with mild-to-moderate ED, is very well tolerated and could be tested as a safe first-line therapy in a larger size phase III study. © 2012 American Society of Andrology and European Academy of Andrology.

Mud-bath therapy and oral glucosamine sulfate in patients with knee osteoarthritis: a randomized, controlled, crossover study.

PubMed

Peluso, Rosario; Caso, Francesco; Costa, Luisa; Sorbo, Dario; Carraturo, Nello; Di Minno, Matteo Nicola Dario; Carraturo, Federica; Oriente, Alfonso; Balestrieri, Umberto; Minicucci, Annamaria; Del Puente, Antonio; Scarpa, Raffaele

2016-01-01

To evaluate the efficacy and safety of combined treatment of mud-bath therapy and glucosamine crystalline sulfate (GlcN-S) in patients with knee osteoarthritis (OA). This study was a randomised, controlled, crossover investigation. Patients were randomly assigned (1:1) by the investigators to two groups, named group 1 and 2. Group 1 included twenty-three patients receiving oral GlcN-S treatment from the beginning of the study (T0) to the end of the 3rd month of treatment (T3) and a combined treatment of both mud-bath therapy and GlcN-S from T3 to the end of the study at six months (T6). Group 2 included twenty-two patients receiving a combined treatment of both mud-bath therapy and GlcN-S from T0 to T3 and that discontinued mud-bath therapy, receiving GlcN-S treatment alone, from T3 to T6. Primary endpoints of the study consisted of evaluating OA severity and activity at baseline and at follow-up visits. All 45 patients, eligible for the study, completed the period of the crossover. In group 1, no significant difference was shown in the comparison from T0 to T3, while from T3 to T6 most variables were significantly improved. In group 2, instead, the comparison between T0 and T3 showed a significant difference in different parameters. When comparing T3 and T6, despite an improvement of all the variables, no significant difference was shown. The association of GlcN-S and mud-bath therapy has a positive and safe role in improving pain, function and quality of life in knee OA patients.

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

PubMed

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

2017-07-01

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

A Randomized, Crossover Trial of a Novel Sound-to-Sleep Mattress Technology in Children with Autism and Sleep Difficulties.

PubMed

Frazier, Thomas W; Krishna, Jyoti; Klingemier, Eric; Beukemann, Mary; Nawabit, Rawan; Ibrahim, Sally

2017-01-15

This preliminary study investigated the tolerability and efficacy of a novel mattress technology-the Sound-To-Sleep (STS) system-in the treatment of sleep problems in children with autism. After screening, 45 children, ages 2.5 to 12.9 years, were randomized to order of mattress technology use (On-Off vs. Off-On). Treatment conditions (On vs. Off) lasted two weeks with immediate crossover. Tolerability, including study discontinuation and parent-report of mattress tolerance and ease of use, was tracked throughout the study. Efficacy assessments were obtained at baseline, prior to crossover, and end of study and included measures of autism traits, other psychopathology symptoms, sensory abnormalities, communication difficulties, quality of life, sleep diary parameters, and single-blinded actigraphy-derived sleep parameters. Statistical analyses evaluated differences in tolerability and efficacy when the STS system was on versus off. STS system use was well tolerated (n = 2, 4.4% dropout) and resulted in parent-reported sleep quality improvements (STS off mean = 4.3, 95% CI = 4.05-4.54 vs. on mean = 4.9, 95%CI = 4.67-5.14). The technology was described by parents as very easy to use and child tolerance was rated as good. Parent-diary outcomes indicated improvements in falling asleep and reduced daytime challenging behavior. Actigraphy-derived sleep parameters indicated improved sleep duration and sleep efficiency. Improvements in child and family quality of life were identified on parent questionnaires. A future large sample phase 2 trial of the STS system is warranted and would benefit from extended study duration, an objective primary efficacy outcome, and careful attention to methodological issues that promote compliance with the intervention and study procedures. © 2017 American Academy of Sleep Medicine

Crossover Control Study of the Effect of Personal Care Products Containing Triclosan on the Microbiome

PubMed Central

Poole, Angela C.; Pischel, Lauren; Ley, Catherine; Suh, Gina; Goodrich, Julia K.; Haggerty, Thomas D.; Ley, Ruth E.

2016-01-01

ABSTRACT Commonly prescribed antibiotics are known to alter human microbiota. We hypothesized that triclosan and triclocarban, components of many household and personal care products (HPCPs), may alter the oral and gut microbiota, with potential consequences for metabolic function and weight. In a double-blind, randomized, crossover study, participants were given triclosan- and triclocarban (TCS)-containing or non-triclosan/triclocarban (nTCS)-containing HPCPs for 4 months and then switched to the other products for an additional 4 months. Blood, stool, gingival plaque, and urine samples and weight data were obtained at baseline and at regular intervals throughout the study period. Blood samples were analyzed for metabolic and endocrine markers and urine samples for triclosan. The microbiome in stool and oral samples was then analyzed. Although there was a significant difference in the amount of triclosan in the urine between the TCS and nTCS phases, no differences were found in microbiome composition, metabolic or endocrine markers, or weight. Though this study was limited by the small sample size and imprecise administration of HPCPs, triclosan at physiologic levels from exposure to HPCPs does not appear to have a significant or important impact on human oral or gut microbiome structure or on a panel of metabolic markers. IMPORTANCE Triclosan and triclocarban are commonly used commercial microbicides found in toothpastes and soaps. It is unknown what effects these chemicals have on the human microbiome or on endocrine function. From this randomized crossover study, it appears that routine personal care use of triclosan and triclocarban neither exerts a major influence on microbial communities in the gut and mouth nor alters markers of endocrine function in humans. PMID:27303746

Impact of Interactive e-Learning Modules on Appropriateness of Imaging Referrals: A Multicenter, Randomized, Crossover Study.

PubMed

Velan, Gary M; Goergen, Stacy K; Grimm, Jane; Shulruf, Boaz

2015-11-01

Health care expenditure on diagnostic imaging investigations is increasing, and many tests are ordered inappropriately. Validated clinical decision rules (CDRs) for certain conditions are available to aid in assessing the need for imaging. However, awareness and utilization of CDRs are lacking. This study compared the efficacy and perceived impact of interactive e-learning modules versus static versions of CDRs, for learning about appropriate imaging referrals. A multicenter, randomized, crossover trial was performed; participants were volunteer medical students and recent graduates. In week 1, group 1 received an e-learning module on appropriate imaging referrals for pulmonary embolism; group 2 received PDF versions of relevant CDRs, and an online quiz with feedback. In week 2, the groups crossed over, focusing on imaging referrals for cervical spine trauma in adults. Online assessments were administered to both groups at the end of each week, and participants completed an online questionnaire at the end of the trial. Group 1 (e-learning module) performed significantly better on the pulmonary embolism knowledge assessment. After the crossover, participants in group 2 (e-learning module) were significantly more likely to improve their scores in the assessment of cervical spine trauma knowledge. Both groups gave positive evaluations of the e-learning modules. Interactive e-learning was significantly more effective for learning in this cohort, compared with static CDRs. We believe that the authentic clinical scenarios, feedback, and integration provided by the e-learning modules contributed to their impact. This study has implications for implementation of e-learning tools to facilitate appropriate referrals for imaging investigations in clinical practice. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

Oral antioxidant therapy for marginal dry eye.

PubMed

Blades, K J; Patel, S; Aidoo, K E

2001-07-01

To assess the efficacy of an orally administered antioxidant dietary supplement for managing marginal dry eye. A prospective, randomised, placebo controlled trial with cross-over. Eye Clinic, Department of Vision Sciences, Glasgow Caledonian University. Forty marginal dry eye sufferers composed of 30 females and 10 males (median age 53 y; range 38-69 y). Baseline assessments were made of tear volume sufficiency (thread test), tear quality (stability), ocular surface status (conjunctival impression cytology) and dry eye symptoms (questionnaire). Each subject was administered courses of active treatment, placebo and no treatment, in random order for 1 month each and results compared to baseline. Tear stability and ocular surface status were significantly improved following active treatment (P<0.05). No changes from baseline were detected following administration of placebo and no treatment (P>0.05). Absolute increase in tear stability correlated with absolute change in goblet cell population density. Tear volume was not improved following any treatment period and dry eye symptom responses were subject to placebo effect. Oral antioxidants improved both tear stability and conjunctival health, although it is not yet understood whether increased ocular surface health mediates increased tear stability or vice versa. This study was supported by a PhD scholarship funded by the Department of Vision Sciences, Glasgow Caledonian University, Scotland. Antioxidant supplements and placebos were kindly donated by Vitabiotics.

Bee pollen and honey for the alleviation of hot flushes and other menopausal symptoms in breast cancer patients.

PubMed

Münstedt, Karsten; Voss, Benjamin; Kullmer, Uwe; Schneider, Ursula; Hübner, Jutta

2015-07-01

Hot flushes, night sweats, pain during sexual intercourse, hair loss, forgetfulness, depression and sleeping disturbances are common problems among breast cancer patients undergoing antihormonal treatment. The aim of this study was to investigate whether bee pollen can alleviate menopausal symptoms in patients receiving tamoxifen and aromatase inhibitors/inactivators. We compared a pollen-honey mixture with pure honey (placebo) in a prospective, randomized crossover trial in breast cancer patients receiving antihormonal treatment. The menopausal complaints were assessed using the Menopause Rating Scale (MRS). A total of 46 patients were recruited; 68.3% (28/41) of the patients reported an improvement in their symptoms while taking honey, compared with 70.9% (22/31) who reported an improvement with pollen (the difference was non-significant). The results were confirmed by significant improvements in the postmenopausal complaints in the two groups in a pre-post analysis in the MRS and its 3 subscales. This study provided evidence that honey and bee pollen may improve the menopausal symptoms of breast cancer patients on antihormonal treatment. Of note, honey, which was intended to be used as a placebo, produced similar effects as pollen and they both exceeded the extent of a placebo effect in this setting (~25%).

Traditional Nurse Triage vs. Physician Tele-Presence in a Pediatric Emergency Department

PubMed Central

Marconi, Greg P.; Chang, Todd; Pham, Phung K.; Grajower, Daniel N.; Nager, Alan L.

2014-01-01

Objectives To compare traditional nurse triage (TNT) in a Pediatric Emergency Department (PED) to physician tele-presence (PTP). Methods Prospective, 2×2 crossover study with random assignment using a sample of walk-in patients seeking care in a PED at a large, tertiary care children’s hospital, from May 2012 to January 2013. Outcomes of triage times, documentation errors, triage scores, and survey responses were compared between TNT and PTP. Comparison between PTP to actual treating PED physicians regarding the accuracy of ordering blood and urine tests, throat cultures, and radiologic imaging was also studied. Results Paired samples t-tests showed a statistically significant difference in triage time between TNT and PTP (p=0.03), but no significant difference in documentation errors (p=0.10). Triage scores of TNT were 71% accurate, compared to PTP, which were 95% accurate. Both parents and children had favorable scores regarding PTP and the majority indicated they would prefer PTP again at their next PED visit. PTP diagnostic ordering was comparable to the actual PED physician ordering, showing no statistical differences. Conclusions Utilizing physician tele-presence technology to remotely perform triage is a feasible alternative to traditional nurse triage, with no clinically significant differences in time, triage scores, errors and patient and parent satisfaction. PMID:24445223

Dexmedetomidine preserves attention/calculation when used for cooperative and short-term intensive care unit sedation.

PubMed

Goodwin, Haley E; Gill, Randeep S; Murakami, Peter N; Thompson, Carol B; Lewin, John J; Mirski, Marek A

2013-12-01

Differential effects on cognition were recently demonstrated between dexmedetomidine (DEX) and propofol (PRO) when used for cooperative sedation. Propofol was found to reduce cognition, whereas DEX improved cognition. To further discriminate these effects, we evaluated the effect of PRO vs DEX in selected areas of cognition. This is a post hoc analysis of the Acute Neurologic Intensive Care Unit Sedation Trial and an investigator-initiated, prospective, randomized, double-blinded, crossover study, comparing the effect of PRO and DEX on cognition measure by the Johns Hopkins Adapted Cognitive Exam (ACE). A linear model analysis accounting for within-patient correlation of measures was used to estimate differences in ACE subscales between drugs. Propofol diminished adjusted scores on all ACE subscales (P < .05), whereas DEX improved adjusted scores selectively for attention/calculation (3.55; 95% confidence interval, 1.49-5.61; P < .01). The positive and significant difference in ACE scores between agents was present across subscales. Our findings indicate that DEX improved ACE attention/calculation subscale in awake patients receiving cooperative sedation. This is in contrast to the deterioration in all mean ACE subscale scores observed using PRO, suggesting DEX preserved cognitive function with specific preservation of focus and attention and allows for greater cognition compared with PRO across all cognitive domains. © 2013.

Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach

PubMed Central

Baker, Karen; Stolar, Marilyn; Miller-Davis, Claiborne; Ames, Nancy; Yates, Jan; Bolle, Jacques; Pereira, Donna; St. Germain, Diane; Handel, Daniel; Berger, Ann

2012-01-01

Purpose To prospectively compare outcomes and processes of hospital-based early palliative care with standard care in surgical oncology patients (N = 152). Methods A randomized, mixed methods, longitudinal study evaluated the effectiveness of a hospital-based Pain and Palliative Care Service (PPCS). Interviews were conducted presurgically and at follow-up visits up to 1 year. Primary outcome measures included the Gracely Pain Intensity and Unpleasantness Scales and the Symptom Distress Scale. Qualitative interviews assessed social support, satisfaction with care, and communication with providers. Survival analysis methods explored factors related to treatment crossover and study discontinuation. Models for repeated measures within subjects over time explored treatment and covariate effects on patient-reported pain and symptom distress. Results None of the estimated differences achieved statistical significance; however, for those who remained on study for 12 months, the PPCS group performed better than their standard of care counterparts. Patients identified consistent communication, emotional support, and pain and symptom management as positive contributions delivered by the PPCS. Conclusions It is unclear whether lower pain perceptions despite greater symptom distress were clinically meaningful; however, when coupled with the patients’ perceptions of their increased resources and alternatives for pain control, one begins to see the value of an integrated PPCS. PMID:22101861

Association of habitual high-fat intake and desire for protein and sweet food.

PubMed

Tatano, Hiroshi; Yamanaka-Okumura, Hisami; Zhou, Bei; Adachi, Chisaki; Kawakami, Yuka; Katayama, Takafumi; Masuda, Masashi; Takeda, Eiji; Taketani, Yutaka

2016-01-01

Reducing dietary calorie density (CD) is useful in body weight management. This study investigates the association between dietary habits and preferences for different CDs. We conducted a randomized crossover study of 232 healthy subjects who consumed packed lunch boxes containing a control, high-meat and low-rice, low-vegetable, medium-fat and low-vegetable, high-fat, and high-fat and low-vegetable meals over six sessions. The subjective levels of sensory properties were assessed over time using a visual analog scale and the area under the curve. Subjects were assessed for dietary habits using a brief-type self-administered diet history questionnaire (BDHQ) and were divided into two groups based on a daily fat energy ratio ≥ 25% (high fat [HF], n=116) and < 25% (normal, n=116) that was matched for age, body mass index, and sex ratio. Our findings indicate that the desire for sweetness was higher in the HF group than in the normal group, regardless of the meals consumed. Particularly, among the 500-kcal low-CD meals, a high-protein meal provided greater fullness and satisfaction and lower prospective consumption in the HF group than in the normal group. Therefore, our study demonstrates that postprandial appetite sensation is associated with dietary habits of fat intake. J. Med. Invest. 63: 241-247, August, 2016.

The Effects of Food Labelling on Postexercise Energy Intake in Sedentary Women

PubMed Central

Lafrenière, Jacynthe; McNeil, Jessica

2017-01-01

Food labelling has been previously reported to influence energy intake (EI). Whether food labels influence postexercise EI remains to be determined. We assessed how food labelling and exercise (Ex) interact to influence food perception and postexercise EI. In this randomized crossover design, 14 inactive women participated in 4 experimental conditions: Ex (300 kcal at 70% of VO2peak) and lunch labelled as low in fat (LF), Ex and lunch labelled as high in fat (HF), Rest and LF, and Rest and HF. The lunch was composed of a plate of pasta, yogurt, and oatmeal cookies, which had the same nutritional composition across the 4 experimental conditions. EI at lunch and for the 48-hour period covering the testing day and the following day was assessed. Furthermore, perceived healthiness of the meal and appetite ratings were evaluated. There were no effects of exercise and food labelling on EI. However, meals labelled as LF were perceived as heathier, and this label was associated with higher prospective food consumption. Initial beliefs about food items had a stronger effect on healthiness perception than the different food labels and explain the positive correlation with the amount of food consumed (ρ = 0.34, P < 0.001). PMID:28626589

Recovery from desflurane anesthesia in horses with and without post-anesthetic xylazine.

PubMed

Aarnes, Turi K; Bednarski, Richard M; Bertone, Alicia L; Hubbell, John A E; Lerche, Phillip

2014-04-01

The objective of this study was to compare recovery from desflurane anesthesia in horses with or without post-anesthetic xylazine. Six adult horses were anesthetized on 2 occasions, 14 d apart using a prospective, randomized crossover design. Horses were sedated with xylazine, induced to lateral recumbency with ketamine and diazepam, and anesthesia was maintained with desflurane. One of 2 treatments was administered intravenously at the end of anesthesia: xylazine [0.2 mg/kg body weight (BW)] or an equivalent volume of saline. Recovery parameters were recorded and assessed by 2 blinded observers. A Wilcoxon signed-rank test was used to analyze recovery data. Heart rate, arterial blood pressures, and arterial blood gas data were analyzed using 2-way analysis of variance (ANOVA) for repeated measures. Values of P < 0.05 were considered significant. Duration of anesthesia was not different between groups. Administration of xylazine at the end of desflurane anesthesia was associated with significantly longer times to first movement, endotracheal tube removal, first attempt to achieve sternal recumbency, sternal recumbency, first attempt to stand, and standing. Number of attempts to stand and quality of recovery scores were not different between groups. Administering xylazine after desflurane anesthesia resulted in longer recovery times. Recovery scores were not significantly different between groups.

Recovery from desflurane anesthesia in horses with and without post-anesthetic xylazine

PubMed Central

Aarnes, Turi K.; Bednarski, Richard M.; Bertone, Alicia L.; Hubbell, John A.E.; Lerche, Phillip

2014-01-01

The objective of this study was to compare recovery from desflurane anesthesia in horses with or without post-anesthetic xylazine. Six adult horses were anesthetized on 2 occasions, 14 d apart using a prospective, randomized crossover design. Horses were sedated with xylazine, induced to lateral recumbency with ketamine and diazepam, and anesthesia was maintained with desflurane. One of 2 treatments was administered intravenously at the end of anesthesia: xylazine [0.2 mg/kg body weight (BW)] or an equivalent volume of saline. Recovery parameters were recorded and assessed by 2 blinded observers. A Wilcoxon signed-rank test was used to analyze recovery data. Heart rate, arterial blood pressures, and arterial blood gas data were analyzed using 2-way analysis of variance (ANOVA) for repeated measures. Values of P < 0.05 were considered significant. Duration of anesthesia was not different between groups. Administration of xylazine at the end of desflurane anesthesia was associated with significantly longer times to first movement, endotracheal tube removal, first attempt to achieve sternal recumbency, sternal recumbency, first attempt to stand, and standing. Number of attempts to stand and quality of recovery scores were not different between groups. Administering xylazine after desflurane anesthesia resulted in longer recovery times. Recovery scores were not significantly different between groups. PMID:24688171

[Effect of subglottic air insufflation on subglottic pressure during swallowing].

PubMed

Clarett, M; Andreu, M F; Salvati, I G; Donnianni, M C; Montes, G S; Rodríguez, M G

2014-04-01

To determine whether there are differences between subglottic pressure during swallowing with and without air insufflation via a subglottic catheter in tracheostomized patients. A prospective, randomized cross-over study was made. Adult Intensive Care Units. Patients requiring mechanical ventilation and tracheostomy with a subglottic catheter, and with tolerance to deflation of the balloon and a speaking valve placed over the opening of the tracheostomy tube. Subglottic pressure was measured during swallowing of a thickened solution with and without the delivery of airflow through the subglottic catheter. Subglottic pressure during swallowing. Twelve out of 14 patients showed higher subglottic pressure values during swallowing with air insufflation. Two patients showed no differences between both conditions. Median (Med) values of subglottic pressure for the first, second and third swallow were 5, 4 and 4.5 cmH2O (Med 4.5 cmH2O) without air insufflation, and 8, 5.5 and 7.5 cmH2O (Med 5.5 cmH2O) with air insufflation, respectively (Wilcoxon, Z=-3.078; p=.002). In a group of tracheostomized patients, air insufflation via a subglottic catheter increased subglottic pressure levels measured during swallowing. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

Comparison of Combined Endoscopic Ultrasonography and Endoscopic Secretin Testing With the Traditional Secretin Pancreatic Function Test in Patients With Suspected Chronic Pancreatitis: A Prospective Crossover Study.

PubMed

Kothari, Darshan; Ketwaroo, Gyanprakash; Sawhney, Mandeep S; Freedman, Steven D; Sheth, Sunil G

2017-07-01

We aimed to determine the feasibility and accuracy of a combined endoscopic ultrasonography (EUS) with a shortened pancreatic function testing (sEUS) for structural and functional assessment using a single instrument in patients with suspected chronic pancreatitis (CP). We completed a prospective crossover study, enrolling patients with suspected CP. Patients who underwent both traditional 1-hour secretin pancreatic function test (sPFT) and sEUS were included in the analysis. We compared study results for test concordance and for correlation of peak bicarbonate concentrations. Eleven (64.7%) of 17 patients had concordant sPFT and sEUS findings when the cutoff for peak bicarbonate was 80 mEq/L. Six patients had discordant findings with a negative sPFT and positive sEUS. This poor concordance suggests that sEUS is an unreliable functional test. Lowering the sEUS cutoff to 70 mEq/L resulted in improved concordance (64.7% vs 70.6%). Finally, there was no significant correlation between peak bicarbonate concentrations (r = 0.47; 95% confidence interval, -0.02 to 0.79) in these 2 functional tests. We demonstrate poor concordance between sPFT and sEUS suggesting that a combined shortened functional and structural test using a single instrument may not be a feasible test for diagnosis of suspected CP when a cutoff of 80 mEq/L is used.

Notes on testing equality and interval estimation in Poisson frequency data under a three-treatment three-period crossover trial.

PubMed

Lui, Kung-Jong; Chang, Kuang-Chao

2016-10-01

When the frequency of event occurrences follows a Poisson distribution, we develop procedures for testing equality of treatments and interval estimators for the ratio of mean frequencies between treatments under a three-treatment three-period crossover design. Using Monte Carlo simulations, we evaluate the performance of these test procedures and interval estimators in various situations. We note that all test procedures developed here can perform well with respect to Type I error even when the number of patients per group is moderate. We further note that the two weighted-least-squares (WLS) test procedures derived here are generally preferable to the other two commonly used test procedures in the contingency table analysis. We also demonstrate that both interval estimators based on the WLS method and interval estimators based on Mantel-Haenszel (MH) approach can perform well, and are essentially of equal precision with respect to the average length. We use a double-blind randomized three-treatment three-period crossover trial comparing salbutamol and salmeterol with a placebo with respect to the number of exacerbations of asthma to illustrate the use of these test procedures and estimators. © The Author(s) 2014.

Between-Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial.

PubMed

Burmeister Getz, E; Carroll, K J; Mielke, J; Benet, L Z; Jones, B

2017-03-01

We previously demonstrated pharmacokinetic differences among manufacturing batches of a US Food and Drug Administration (FDA)-approved dry powder inhalation product (Advair Diskus 100/50) large enough to establish between-batch bio-inequivalence. Here, we provide independent confirmation of pharmacokinetic bio-inequivalence among Advair Diskus 100/50 batches, and quantify residual and between-batch variance component magnitudes. These variance estimates are used to consider the type I error rate of the FDA's current two-way crossover design recommendation. When between-batch pharmacokinetic variability is substantial, the conventional two-way crossover design cannot accomplish the objectives of FDA's statistical bioequivalence test (i.e., cannot accurately estimate the test/reference ratio and associated confidence interval). The two-way crossover, which ignores between-batch pharmacokinetic variability, yields an artificially narrow confidence interval on the product comparison. The unavoidable consequence is type I error rate inflation, to ∼25%, when between-batch pharmacokinetic variability is nonzero. This risk of a false bioequivalence conclusion is substantially higher than asserted by regulators as acceptable consumer risk (5%). © 2016 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of The American Society for Clinical Pharmacology and Therapeutics.

Unsedated transnasal small-caliber esophagogastroduodenoscopy in elderly and bedridden patients.

PubMed

Yuki, Mika; Amano, Yuji; Komazawa, Yoshinori; Fukuhara, Hiroyuki; Shizuku, Toshihiro; Yamamoto, Shun; Kinoshita, Yoshikazu

2009-11-28

To evaluate the safety of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) for elderly and critically ill bedridden patients. One prospective randomized comparative study and one crossover comparative study between transnasal small-caliber EGD and transoral conventional EGD was done (Study 1). For the comparative study, we enrolled 240 elderly patients aged > 65 years old. For the crossover analysis, we enrolled 30 bedridden patients with percutaneous endoscopic gastrostomy (PEG) (Study 2). We evaluated cardiopulmonary effects by measuring arterial oxygen saturation (SpO(2)) and calculating the rate-pressure product (RPP) (pulse rate x systolic blood pressure/100) at baseline, 2 and 5 min after endoscopic intubation in Study 1. To assess the risk for endoscopy-related aspiration pneumonia during EGD, we also measured blood leukocyte counts and serum C-reactive protein (CRP) levels before and 3 d after EGD in Study 2. In Study 1, we observed significant decreases in SpO(2) during conventional transoral EGD, but not during transnasal small-caliber EGD (0.24% vs -0.24% after 2 min, and 0.18% vs -0.29% after 5 min, P = 0.034, P = 0.044). Significant differences of the RPP were not found between conventional transoral and transnasal small-caliber EGD. In Study 2, crossover analysis showed statistically significant increases of the RPP at 2 min after intubation and the end of endoscopy (26.8 and 34.6 vs 3.1 and 15.2, P = 0.044, P = 0.046), and decreases of SpO(2) (-0.8% vs -0.1%, P = 0.042) during EGD with transoral conventional in comparison with transnasal small-caliber endoscopy. Thus, for bedridden patients with PEG feeding, who were examined in the supine position, transoral conventional EGD more severely suppressed cardiopulmonary function than transnasal small-caliber EGD. There were also significant increases in the markers of inflammation, blood leukocyte counts and serum CRP values, in bedridden patients after transoral conventional EGD, but not after transnasal small-caliber EGD performed with the patient in the supine position. Leukocyte count increased from 6053 +/- 1975/L to 6900 +/- 3392/L (P = 0.0008) and CRP values increased from 0.93 +/- 0.24 to 2.49 +/- 0.91 mg/dL (P = 0.0005) at 3 d after transoral conventional EGD. Aspiration pneumonia, possibly caused by the endoscopic examination, was found subsequently in two of 30 patients after transoral conventional EGD. Transnasal small-caliber EGD is a safer method than transoral conventional EGD in critically ill, bedridden patients who are undergoing PEG feeding.

Unsedated transnasal small-caliber esophagogastroduodenoscopy in elderly and bedridden patients

PubMed Central

Yuki, Mika; Amano, Yuji; Komazawa, Yoshinori; Fukuhara, Hiroyuki; Shizuku, Toshihiro; Yamamoto, Shun; Kinoshita, Yoshikazu

2009-01-01

AIM: To evaluate the safety of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) for elderly and critically ill bedridden patients. METHODS: One prospective randomized comparative study and one crossover comparative study between transnasal small-caliber EGD and transoral conventional EGD was done (Study 1). For the comparative study, we enrolled 240 elderly patients aged > 65 years old. For the crossover analysis, we enrolled 30 bedridden patients with percutaneous endoscopic gastrostomy (PEG) (Study 2). We evaluated cardiopulmonary effects by measuring arterial oxygen saturation (SpO2) and calculating the rate-pressure product (RPP) (pulse rate × systolic blood pressure/100) at baseline, 2 and 5 min after endoscopic intubation in Study 1. To assess the risk for endoscopy-related aspiration pneumonia during EGD, we also measured blood leukocyte counts and serum C-reactive protein (CRP) levels before and 3 d after EGD in Study 2. RESULTS: In Study 1, we observed significant decreases in SpO2 during conventional transoral EGD, but not during transnasal small-caliber EGD (0.24% vs -0.24% after 2 min, and 0.18% vs -0.29% after 5 min, P = 0.034, P = 0.044). Significant differences of the RPP were not found between conventional transoral and transnasal small-caliber EGD. In Study 2, crossover analysis showed statistically significant increases of the RPP at 2 min after intubation and the end of endoscopy (26.8 and 34.6 vs 3.1 and 15.2, P = 0.044, P = 0.046), and decreases of SpO2 (-0.8% vs -0.1%, P = 0.042) during EGD with transoral conventional in comparison with transnasal small-caliber endoscopy. Thus, for bedridden patients with PEG feeding, who were examined in the supine position, transoral conventional EGD more severely suppressed cardiopulmonary function than transnasal small-caliber EGD. There were also significant increases in the markers of inflammation, blood leukocyte counts and serum CRP values, in bedridden patients after transoral conventional EGD, but not after transnasal small-caliber EGD performed with the patient in the supine position. Leukocyte count increased from 6053 ± 1975/L to 6900 ± 3392/L (P = 0.0008) and CRP values increased from 0.93 ± 0.24 to 2.49 ± 0.91 mg/dL (P = 0.0005) at 3 d after transoral conventional EGD. Aspiration pneumonia, possibly caused by the endoscopic examination, was found subsequently in two of 30 patients after transoral conventional EGD. CONCLUSION: Transnasal small-caliber EGD is a safer method than transoral conventional EGD in critically ill, bedridden patients who are undergoing PEG feeding. PMID:19938199

Efficacy of homeopathically potentized antimony on blood coagulation. A randomized placebo controlled crossover trial.

PubMed

Heusser, Peter; Berger, Sarah; Stutz, Monika; Hüsler, André; Haeberli, André; Wolf, Ursula

2009-02-01

Homeopathically potentized antimony 6x is traditionally used in anthroposophic medicine for an alleged pro-coagulatory effect in bleeding disorders. However, the scientific evidence base is yet insufficient. Results of a previous in vitro study suggested a slight increase of maximal clot firmness (MCF) and a tendency towards a shorter clotting time (CT). The objective of this study was to investigate the pro-coagulatory effects of antimony in vivo, and possible unexpected or adverse events. A randomized placebo controlled double blind crossover study was carried out in 30 healthy volunteers (15 males, 15 females). Each participant received intravenously 10 ml of antimony 6x and placebo in a randomized order at an interval of 1 month. Thrombelastography (TEG) was carried out immediately before and 30 and 60 min after the injection. Statistically significant pro-coagulatory effects were observed 30 min after injection for CT in men (p = 0.0306), and for MCF in men and women combined (p = 0.0476). The effect of antimony was significantly larger on test day 1 than on test day 2, whereas the effect of placebo was similar on both test days. No unexpected adverse or adverse events causally related to antimony were observed. This study adds evidence to the hypothesis that homeopathically potentized antimony may be efficacious in vivo. The consistency of the results with previous in vitro results indicates an effect on MCF and CT. The in vivo application of antimony 6x is safe. Copyright (c) 2009 S. Karger AG, Basel.

How to deal with morning bad breath: A randomized, crossover clinical trial.

PubMed

Oliveira-Neto, Jeronimo M; Sato, Sandra; Pedrazzi, Vinícius

2013-11-01

The absence of a protocol for the treatment of halitosis has led us to compare mouthrinses with mechanical oral hygiene procedures for treating morning breath by employing a hand-held sulfide monitor. To compare the efficacy of five modalities of treatment for controlling morning halitosis in subjects with no dental or periodontal disease. This is a five-period, randomized, crossover clinical trial. Twenty volunteers were randomly assigned to the trial. Testing involved the use of a conventional tongue scraper, a tongue scraper joined to the back of a toothbrush's head, two mouthrinses (0.05% cetylpyridinium chloride and 0.12% chlorhexidine digluconate) and a soft-bristled toothbrush and fluoride toothpaste for practicing oral hygiene. Data analysis was performed using SPSS version 17 for Windows and NCSS 2007 software (P < 0.05). The products and the periods were compared with each other using the Friedman's test. When significant differences (P < 0.05) were determined, the products and periods were compared in pairs by using the Wilcoxon's test and by adjusting the original significance level (0.05) for multiple comparisons by using the Bonferroni's method. The toothbrush's tongue scraper was able to significantly reduce bad breath for up to 2 h. Chlorhexidine reduced bad breath only at the end of the second hour, an effect that lasted for 3 h. Mechanical tongue cleaning was able to immediately reduce bad breath for a short period, whereas chlorhexidine and mechanical oral hygiene reduced bad breath for longer periods, achieving the best results against morning breath.

Distractive Auditory Stimuli in the Form of Music in Individuals With COPD: A Systematic Review.

PubMed

Lee, Annemarie L; Desveaux, Laura; Goldstein, Roger S; Brooks, Dina

2015-08-01

Music has been used as a distractive auditory stimulus (DAS) in patients with COPD, but its effects are unclear. This systematic review aimed to establish the effect of DAS on exercise capacity, symptoms, and health-related quality of life (HRQOL) under three conditions: (1) during exercise training, (2) during exercise testing, and (3) for symptom management at rest. Randomized controlled or crossover trials as well as cohort studies of DAS during exercise training, during formal exercise testing, and for symptom management among individuals with COPD were identified from a search of seven databases. Two reviewers independently assessed study quality. Weighted mean differences (WMDs) with 95% CIs were calculated using a random-effects model. Thirteen studies (12 of which were randomized controlled or crossover trials) in 415 participants were included. DAS increased exercise capacity when applied over at least 2 months of exercise training (WMD, 98 m; 95% CI, 47-150 m). HRQOL improved only after a training duration of 3 months. Less dyspnea was noted with DAS during exercise training, but this was not consistently observed in short-term exercise testing or as a symptom management strategy at rest. DAS appears to reduce symptoms of dyspnea and fatigue when used during exercise training, with benefits observed in exercise capacity and HRQOL. When applied during exercise testing, the effects on exercise capacity and symptoms and as a strategy for symptom management at rest are inconsistent.

Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study.

PubMed Central

Poon, R. T.; Chow, L. W.

1998-01-01

A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory. PMID:9635849

Exposure to bisphenol A from drinking canned beverages increases blood pressure: randomized crossover trial.

PubMed

Bae, Sanghyuk; Hong, Yun-Chul

2015-02-01

Bisphenol A (BPA) is a chemical used in plastic bottles and inner coating of beverage cans, and its exposure is almost ubiquitous. BPA has been associated with hypertension and decreased heart rate variability in the previous studies. The aim of the present study was to determine whether increased BPA exposure from consumption of canned beverage actually affects blood pressure and heart rate variability. We conducted a randomized crossover trial with noninstitutionalized adults, who were aged ≥60 years and recruited from a local community center. A total of 60 participants visited the study site 3 times, and they were provided the same beverage in 2 glass bottles, 2 cans, or 1 can and 1 glass bottle at a time. The sequence of the beverage was randomized. We then measured urinary BPA concentration, blood pressure, and heart rate variability 2 hours after the consumption of each beverage. The paired t test and mixed model were used to compare the differences. The urinary BPA concentration increased after consuming canned beverages by >1600% compared with that after consuming glass bottled beverages. Systolic blood pressure adjusted for daily variance increased by ≈4.5 mm Hg after consuming 2 canned beverages compared with that after consuming 2 glass bottled beverages, and the difference was statistically significant. The parameters of the heart rate variability did not show statistically significant differences.The present study demonstrated that consuming canned beverage and consequent increase of BPA exposure increase blood pressure acutely. © 2014 American Heart Association, Inc.

kinesiotaping reduces pain and modulates sensory function in patients with focal dystonia: a randomized crossover pilot study.

PubMed

Pelosin, Elisa; Avanzino, Laura; Marchese, Roberta; Stramesi, Paola; Bilanci, Martina; Trompetto, Carlo; Abbruzzese, Giovanni

2013-10-01

Pain is one of the most common and disabling "nonmotor" symptoms in patients with dystonia. No recent study evaluated the pharmacological or physical therapy approaches to specifically treat dystonic pain symptoms. To evaluate the effectiveness of KinesioTaping in patients with cervical dystonia (CD) and focal hand dystonia (FHD) on self-reported pain (primary objective) and on sensory functions (secondary objective). Twenty-five dystonic patients (14 with CD and 11 FHD) entered a randomized crossover pilot study. The patients were randomized to 14-day treatment with KinesioTaping or ShamTaping over neck (in CD) or forearm muscles (in FHD), and after a 30-day washout period, they received the other treatment. The were 3 visual analog scales (VASs) for usual pain, worst pain, and pain relief. Disease severity changes were evaluated by means of the Toronto Western Spasmodic Torticollis Rating Scale (CD) and the Writer's Cramp Rating Scale (FHD). Furthermore, to investigate possible KinesioTaping-induced effects on sensory functions, we evaluated the somatosensory temporal discrimination threshold. Treatment with KinesioTape induced a decrease in the subjective sensation of pain and a modification in the ability of sensory discrimination, whereas ShamTaping had no effect. A significant, positive correlation was found in both groups of patients between the improvement in the subjective sensation of pain and the reduction of somatosensory temporal discrimination threshold values induced by KinesioTaping. These preliminary results suggest that KinesioTaping may be useful in treating pain in patients with dystonia.

Metformin vs myoinositol: which is better in obese polycystic ovary syndrome patients? A randomized controlled crossover study.

PubMed

Tagliaferri, Valeria; Romualdi, Daniela; Immediata, Valentina; De Cicco, Simona; Di Florio, Christian; Lanzone, Antonio; Guido, Maurizio

2017-05-01

Due to the central role of metabolic abnormalities in the pathophysiology of polycystic ovary syndrome (PCOS), insulin sensitizing agents have been proposed as a feasible treatment option. To investigate which is the more effective between metformin and myoinositol (MYO) on hormonal, clinical and metabolic parameters in obese patients with PCOS. Crossover randomized controlled study. Thirty-four PCOS obese women (age: 25·62 ± 4·7 years; BMI: 32·55 ± 5·67 kg/m 2 ) were randomized to receive metformin (850 mg twice a day) or MYO (1000 mg twice a day) for 6 months. After a 3 month washout, the same subjects received the other compound for the following 6 months. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile at baseline and after 6 months of treatment were performed. Both metformin and MYO significantly reduced the insulin response to OGTT and improved insulin sensitivity. Metformin significantly decreased body weight and improved menstrual pattern and Ferriman-Gallwey score. Metformin treatment was also associated with a significant decrease in LH and oestradiol levels, androgens and anti-müllerian hormone levels. None of these clinical and hormonal changes were observed during MYO administration. Both treatments improved the glyco-insulinaemic features of obese PCOS patients, but only metformin seems to exert a beneficial effect on the endocrine and clinical features of the syndrome. © 2017 John Wiley & Sons Ltd.

A randomized, crossover comparison of injected buffered lidocaine, lidocaine cream, and no analgesia for peripheral intravenous cannula insertion.

PubMed

McNaughton, Candace; Zhou, Chuan; Robert, Linda; Storrow, Alan; Kennedy, Robert

2009-08-01

We compare pain and anxiety associated with peripheral intravenous (IV) cannula insertion after pretreatment with no local anesthesia, 4% lidocaine cream, or subcutaneously injected, buffered 1% lidocaine. In a randomized, crossover design, 3 peripheral IVs were inserted in each of 70 medical students or nurses. In random order, insertion sites were pretreated with nothing, lidocaine cream, or injected, buffered lidocaine. After each IV insertion, subjects recorded pain, anxiety, and preference (as patient and provider) for each technique on a 10-point numeric rating scale. Higher scores indicated greater pain, anxiety, and preference. Median pain scores (interquartile range [IQR]) were 7 (4 to 8) without local anesthesia, 3 (2 to 5) with lidocaine cream, and 1 (1 to 2) with injected, buffered lidocaine. Median anxiety scores (IQR) were 4 (2 to 7) without local anesthesia, 2 (1 to 4) with lidocaine cream, and 2 (1 to 3) with injected, buffered lidocaine. There was no detectable difference in anxiety scores between lidocaine cream and injected, buffered lidocaine. Most IV placement attempts were successful, regardless of technique. Seventy percent of subjects indicated they would "always" request buffered lidocaine for peripheral IV insertion. In adult health care providers, pain and anxiety associated with peripheral IV insertion is significantly reduced by using topical lidocaine cream or injected, buffered lidocaine. Injected, buffered lidocaine reduces IV insertion pain more than lidocaine cream, without affecting success. Adults desire the use of local anesthetic techniques for IV insertion for themselves and for their patients.

Feasibility and preliminary efficacy of the effects of flavanoid-rich purple grape juice on the vascular health of childhood cancer survivors: a randomized, controlled crossover trial.

PubMed

Blair, Cindy K; Kelly, Aaron S; Steinberger, Julia; Eberly, Lynn E; Napurski, Char; Robien, Kim; Neglia, Joseph P; Mulrooney, Daniel A; Ross, Julie A

2014-12-01

Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment, yet few interventions have been evaluated to reduce this risk. Purple grape juice (pGJ), a rich source of flavonoids with antioxidant properties, has been shown in adults to reduce oxidative stress and improve endothelial function. We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors (ages 10-21 years). In a randomized controlled crossover trial consisting of two, 4 week intervention periods, each preceded by a 4 week washout period, subjects received in random order 6 ounces twice daily of pGJ and clear apple juice (cAJ; similar in calories but lower in flavonoids). Measurements were obtained before and after each supplementation period; change was evaluated using mixed effects ANOVA. pGJ did not improve endothelial function, measured using digital reactive hyperemia, compared with cAJ (mean change: pGJ 0.06, cAJ 0.22; difference of mean change [95% CI]: -0.16 [-0.42 - 0.11], P = 0.25). No significant changes in plasma concentrations of oxidized-LDL, myeloperoxidase, or high sensitivity C-reactive protein were observed. After 4 weeks of daily consumption of flavonoid-rich pGJ, no measurable change in vascular function was observed in these childhood cancer survivors. © 2014 Wiley Periodicals, Inc.

Ass's milk in children with atopic dermatitis and cow's milk allergy: crossover comparison with goat's milk.

PubMed

Vita, Daniela; Passalacqua, Giovanni; Di Pasquale, Giuseppe; Caminiti, Lucia; Crisafulli, Giuseppe; Rulli, Imma; Pajno, Giovanni B

2007-11-01

Cow milk allergy is a common disease of infancy, often associated with atopic dermatitis (AD). Avoidance of cow milk (CM) implies the use of alternative dietary supports such as mammalian milks. In this study, we assessed the tolerability and clinical effect of ass's milk (AM), when compared with the largely used goat's milk (GM) in a single-blind, controlled, randomized crossover. Twenty-eight children with AD and ascertained allergy to CM were enrolled. The children were randomized to AM or GM for 6 months, then switched to the other milk for further 3 months. The SCORAD index (SI) and a visual analog scale (VAS) were evaluated blindly. After termination of the study, food challenges with GM and AM were performed. An SDS-PAGE analysis of different milks was performed. Two children from the GM group dropped out after randomization and 26 completed the study. Ass milk invariantly led to a significant improvement of SI and VAS of symptoms (p < 0.03 vs. baseline and inter-group), whereas GM had no measurable clinical effect. At the end of the study 23 of 26 children had a positive food challenge with GM and one of 26 with AM. Ass's milk had a protein profile closer to human milk than GM. Ass milk is better tolerated and more effective than GM in reducing symptoms of AD. It may represent a better substitute of CM than the currently used GM.

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.

The Gluten-Free, Casein-Free Diet in Autism: Results of a Preliminary Double Blind Clinical Trial

ERIC Educational Resources Information Center

Elder, Jennifer Harrison; Shankar, Meena; Shuster, Jonathan; Theriaque, Douglas; Burns, Sylvia; Sherrill, Lindsay

2006-01-01

This study tested the efficacy of a gluten-free and casein-free (GFCF) diet in treating autism using a randomized, double blind repeated measures crossover design. The sample included 15 children aged 2-16 years with autism spectrum disorder. Data on autistic symptoms and urinary peptide levels were collected in the subjects' homes over the 12…

Low to moderate alcohol consumption on serum vitamin D and other indicators of bone health in postmenopausal women in a controlled feeding study

USDA-ARS?s Scientific Manuscript database

Heavy alcohol drinking adversely affects vitamin D status and bone health. However, data from randomized, placebo-controlled trials (RCTs) on the effects of low to moderate alcohol consumption on vitamin D status and bone health in humans is unavailable. The objective of this cross-over RCT was to e...

Advanced Cancer Detection Center

DTIC Science & Technology

2007-10-01

therapy in children: A Phase II randomized double blinded cross-over study (HLMCC 0708) • Risperidone for the Treatment of Cerebellar Mutism Syndrome...each question, the participant selects the answer by using the left and right arrow keys and then pressing the Choose button. The next question is...transformed to a quantitative scale measure for transmission. Numeric responses can be entered directly or can be selected from a list of

Efficacy and safety of mini-dose glucagon for treatment of nonsevere hypoglycemia in adults with type 1 diabetes

USDA-ARS?s Scientific Manuscript database

The purpose of this study was to evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). This was a randomized crossover trial (two 3-week periods) conducted at five U.S. diabetes clinics. Twenty adults with T1D using an insulin pump and continuous gluc...

The Effect of Repetitive Rhythmic Precision Grip Task-Oriented Rehabilitation in Chronic Stroke Patients: A Pilot Study

ERIC Educational Resources Information Center

Dispa, Delphine; Lejeune, Thierry; Thonnard, Jean-Louis

2013-01-01

Most chronic stroke patients present with difficulty in the manipulation of objects. The aim of this study was to test whether an intensive program of precision grip training could improve hand functioning of patients at more than 6 months after a stroke. This was a cross-over study; hence, at inclusion, the patients were randomly divided into two…

Randomized crossover study evaluating the effect of a hand sanitizer dispenser on the frequency of hand hygiene among anesthesiology staff in the operating room.

PubMed

Munoz-Price, L Silvia; Patel, Zalak; Banks, Shawn; Arheart, Kristopher; Eber, Scott; Lubarsky, David A; Birnbach, David J

2014-06-01

Forty anesthesia providers were evaluated with and without hand sanitizer dispensers present on the anesthesia machine. Having a dispenser increased the frequency of hand hygiene only from 0.5 to 0.8 events per hour (P = .01). Other concomitant interventions are needed to further increase hand hygiene frequency among anesthesia providers.

Differential Impact of Unguided versus Guided Use of a Multimedia Introduction to Equine Obstetrics in Veterinary Education

ERIC Educational Resources Information Center

Govaere Jan, L. J.; de Kruif, Aart; Valcke, Martin

2012-01-01

In view of supporting the study of the complex domain of equine obstetrics, a Foal"in"Mare multimedia package with 3D designs has been developed. The present study centers on questions as to the most optimal implementation of the multimedia package in veterinary education. In a pretest-posttest cross-over design, students were randomly assigned to…

Quality of resuscitation: flight attendants in an airplane simulator use a new mechanical resuscitation device--a randomized simulation study.

PubMed

Fischer, Henrik; Neuhold, Stephanie; Hochbrugger, Eva; Steinlechner, Barbara; Koinig, Herbert; Milosevic, Ljubisa; Havel, Christof; Frantal, Sophie; Greif, Robert

2011-04-01

Cardiopulmonary resuscitation (CPR) during flight is challenging and has to be sustained for long periods. In this setting a mechanical-resuscitation-device (MRD) might improve performance. In this study we compared the quality of resuscitation of trained flight attendants practicing either standard basic life support (BLS) or using a MRD in a cabin-simulator. Prospective, open, randomized and crossover simulation study. Study participants, competent in standard BLS were trained to use the MRD to deliver both chest compressions and ventilation. 39 teams of two rescuers resuscitated a manikin for 12 min in random order, standard BLS or mechanically assisted resuscitation. Primary outcome was "absolute hands-off time" (sum of all periods during which no hand was placed on the chest minus ventilation time). Various parameters describing the quality of chest compression and ventilation were analysed as secondary outcome parameters. Use of the MRD led to significantly less "absolute hands-off time" (164±33 s vs. 205±42 s, p<0.001). The quality of chest compression was comparable among groups, except for a higher compression rate in the standard BLS group (123±14 min(-1) vs. 95±11 min(-1), p<0.001). Tidal volume was higher in the standard BLS group (0.48±0.14 l vs. 0.34±0.13 l, p<0.001), but we registered fewer gastric inflations in the MRD group (0.4±0.3% vs. 16.6±16.9%, p<0.001). Using the MRD resulted in significantly less "absolute hands-off time", but less effective ventilation. The translation of higher chest compression rate into better outcome, as shown in other studies previously, has to be investigated in another human outcome study. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Effect of metronome rates on the quality of bag-mask ventilation during metronome-guided 30:2 cardiopulmonary resuscitation: A randomized simulation study.

PubMed

Na, Ji Ung; Han, Sang Kuk; Choi, Pil Cho; Shin, Dong Hyuk

2017-01-01

Metronome guidance is a feasible and effective feedback technique to improve the quality of cardiopulmonary resuscitation (CPR). The rate of the metronome should be set between 100 to 120 ticks/minute and the speed of ventilation may have crucial effect on the quality of ventilation. We compared three different metronome rates (100, 110, 120 ticks/minute) to investigate its effect on the quality of ventilation during metronome-guided 30:2 CPR. This is a prospective, randomized, crossover observational study using a RespiTrainer○ r . To simulate 30 chest compressions, one investigator counted from 1 to 30 in cadence with the metronome rate (1 count for every 1 tick), and the participant performed 2 consecutive ventilations immediately following the counting of 30. Thirty physicians performed 5 sets of 2 consecutive (total 10) bag-mask ventilations for each metronome rate. Participants were instructed to squeeze the bag over 2 ticks (1.0 to 1.2 seconds depending on the rate of metronome) and deflate the bag over 2 ticks. The sequence of three different metronome rates was randomized. Mean tidal volume significantly decreased as the metronome rate was increased from 110 ticks/minute to 120 ticks/minute (343±84 mL vs. 294±90 mL, P =0.004). Peak airway pressure significantly increased as metronome rate increased from 100 ticks/minute to 110 ticks/minute (18.7 vs. 21.6 mmHg, P =0.006). In metronome-guided 30:2 CPR, a higher metronome rate may adversely affect the quality of bag-mask ventilations. In cases of cardiac arrest where adequate ventilation support is necessary, 100 ticks/minute may be better than 110 or 120 ticks/minute to deliver adequate tidal volume during audio tone guided 30:2 CPR.

Effect of metronome rates on the quality of bag-mask ventilation during metronome-guided 30:2 cardiopulmonary resuscitation: A randomized simulation study

PubMed Central

Na, Ji Ung; Han, Sang Kuk; Choi, Pil Cho; Shin, Dong Hyuk

2017-01-01

BACKGROUND: Metronome guidance is a feasible and effective feedback technique to improve the quality of cardiopulmonary resuscitation (CPR). The rate of the metronome should be set between 100 to 120 ticks/minute and the speed of ventilation may have crucial effect on the quality of ventilation. We compared three different metronome rates (100, 110, 120 ticks/minute) to investigate its effect on the quality of ventilation during metronome-guided 30:2 CPR. METHODS: This is a prospective, randomized, crossover observational study using a RespiTrainer○r. To simulate 30 chest compressions, one investigator counted from 1 to 30 in cadence with the metronome rate (1 count for every 1 tick), and the participant performed 2 consecutive ventilations immediately following the counting of 30. Thirty physicians performed 5 sets of 2 consecutive (total 10) bag-mask ventilations for each metronome rate. Participants were instructed to squeeze the bag over 2 ticks (1.0 to 1.2 seconds depending on the rate of metronome) and deflate the bag over 2 ticks. The sequence of three different metronome rates was randomized. RESULTS: Mean tidal volume significantly decreased as the metronome rate was increased from 110 ticks/minute to 120 ticks/minute (343±84 mL vs. 294±90 mL, P=0.004). Peak airway pressure significantly increased as metronome rate increased from 100 ticks/minute to 110 ticks/minute (18.7 vs. 21.6 mmHg, P=0.006). CONCLUSION: In metronome-guided 30:2 CPR, a higher metronome rate may adversely affect the quality of bag-mask ventilations. In cases of cardiac arrest where adequate ventilation support is necessary, 100 ticks/minute may be better than 110 or 120 ticks/minute to deliver adequate tidal volume during audio tone guided 30:2 CPR. PMID:28458759

Is hydroxychloroquine effective in treating primary Sjogren's syndrome: a systematic review and meta-analysis.

PubMed

Wang, Shi-Qin; Zhang, Li-Wei; Wei, Pan; Hua, Hong

2017-05-12

To systematically review and assess the efficacy and safety of hydroxychloroquine (HCQ) for treating primary Sjogren's syndrome (pSS). Five electronic databases (Pubmed, EMBASE, Web of science, Ovid, Cochrane Library) were searched for randomized controlled trials and retrospective or prospective studies published in English that reported the effect of HCQ on pSS. The subjective symptoms (sicca symptoms, fatigue and pain) and the objective indexes (erythrocyte sedimentation rate and Schirmer test) were assessed as main outcome measures. A meta-analysis and descriptive study on the efficacy and safety of HCQ were conducted. The estimate of the effect of HCQ treatment was expressed as a proportion together with 95% confidence interval, and plotted on a forest plot. Four trials with totals of 215 SS patients, including two randomized controlled trials, one double blind crossover trial and one retrospective open-label study, were analyzed in this review. For dry mouth and dry eyes, the effectiveness of HCQ treatment was essentially the same as placebo treatment. For fatigue, the effectiveness of HCQ was lower than placebo. The efficacy of HCQ in treating pain associated with pSS was superior to that of the placebo. There was no significant difference between HCQ-treated groups and controls in terms of Schirmer test results, but HCQ could reduce the erythrocyte sedimentation rate compare with placebo. A descriptive safety assessment showed that gastrointestinal adverse effects were the most common adverse effects associated with HCQ. This systematic review showed that there is no significant difference between HCQ and placebo in the treatment of dry mouth and dry eye in pSS. Well-designed, randomized, controlled trials are needed to provide higher-quality evidence to confirm our findings, and future studies should focus on some other index or extraglandular measures, such as cutaneous manifestations, to further explore the therapeutic effect of HCQ in pSS.

Reversal of apixaban anticoagulation by four-factor prothrombin complex concentrates in healthy subjects: a randomized three-period crossover study.

PubMed

Song, Y; Wang, Z; Perlstein, I; Wang, J; LaCreta, F; Frost, R J A; Frost, C

2017-11-01

Essentials Prothrombin complex concentrates (PCCs) may reverse the effect of factor Xa (FXa) inhibitors. We conducted an open-label, randomized, placebo-controlled, three-period crossover study in 15 subjects. Both PCCs rapidly reversed apixaban-mediated decreases in mean endogenous thrombin potential. Four-factor PCC administration had no effect on apixaban pharmacokinetics or anti-FXa activity. Background Currently, there is no approved reversal agent for direct activated factor Xa (FXa) inhibitors; however, several agents are under investigation, including prothrombin complex concentrates (PCCs). Objective This open-label, randomized, placebo-controlled, three-period crossover study assessed the effect of two four-factor PCCs on apixaban pharmacodynamics and pharmacokinetics in 15 healthy subjects. Methods Subjects received apixaban 10 mg twice daily for 3 days. On day 4, 3 h after apixaban, subjects received a 30-min infusion of 50 IU kg -1 Cofact, Beriplex P/N (Beriplex), or saline. Change in endogenous thrombin potential (ETP), measured with a thrombin generation assay (TGA), was the primary endpoint. Secondary endpoints included changes in other TGA parameters, prothrombin time (PT), International Normalized Ratio (INR), activated partial thromboplastin time, anti-FXa activity, apixaban pharmacokinetics, and safety. Results Apixaban-related changes in ETP and several other pharmacodynamic measures occurred following apixaban administration. Both PCCs reversed apixaban's effect on ETP; the differences in adjusted mean change from pre-PCC baseline to end of infusion were 425 nm min (95% confidence interval [CI] 219.8-630.7 nm min; P < 0.001) for Cofact, and 91 nm min (95% CI - 31.3 to 212.4 nm min; P > 0.05) for Beriplex. Both PCCs returned ETP to pre-apixaban baseline levels 4 h after PCC infusion, versus 45 h for placebo. For both PCCs, mean ETP peaked 21 h after PCC initiation, and then slowly decreased over the following 48 h. Both PCCs reversed apixaban's effect on TGA peak height, PT, and INR. Apixaban pharmacokinetic and anti-FXa profiles were consistent across treatments. Conclusions Cofact and Beriplex reversed apixaban's steady-state effects on several coagulation assessments. © 2017 International Society on Thrombosis and Haemostasis.

Effect of sodium chloride- and sodium bicarbonate-rich mineral water on blood pressure and metabolic parameters in elderly normotensive individuals: a randomized double-blind crossover trial.

PubMed

Schorr, U; Distler, A; Sharma, A M

1996-01-01

To examine the effect of sodium chloride- and sodium bicarbonate-rich mineral water on blood pressure and parameters of glucose and lipid metabolism in elderly normotensive individuals. We examined 21 healthy men and women aged 60-72 years in a randomized, placebo-controlled, double-blind crossover trial. After reducing dietary salt intake to below 100 mmol/day, study participants were randomly assigned to drink 1.5 l daily of a sodium chloride-rich (sodium 84.5 mmol/l, chloride 63.7 mmol/l, bicarbonate 21.9 mmol/l), a sodium bicarbonate-rich (sodium 39.3 mmol/l, chloride 6.5 mmol/l, bicarbonate 48.8 mmol/l) and a low-sodium (placebo: sodium, chloride and bicarbonate < 0.02 mmol/l) mineral water for 4 weeks each in a three-phase crossover order. Each phase was separated by a 2-week washout period in which the study participants remained on a low-salt diet. Compliance was assessed by biweekly urinary electrolyte excretion and five study participants were excluded from analysis for failing to complete the trial or to fulfil the compliance criteria. Mean arterial blood pressure was significantly lower during the periods of consuming low-sodium -7.0 +/- 7.2 mmHg, P < 0.001) or sodium bicarbonate-rich (-5.7 +/- 6.4 mmHg, P < 0.05) water than at baseline. In contrast, blood pressure during the phase of drinking sodium chloride-rich water was identical to that at baseline. Ambulatory 24 h blood pressure, oral glucose tolerance and plasma lipids were not affected by the different regimens. Urinary calcium excretion was significantly reduced by drinking low-sodium or sodium bicarbonate-rich water but was unchanged under the sodium chloride-rich water. Consumption of sodium chloride-rich mineral water can abolish the blood pressure reduction induced by dietary salt restriction in elderly individuals. Sodium bicarbonate-rich mineral water in conjunction with a low-salt diet may have a beneficial effect on calcium homeostasis.

Effects of supervised exercise on progression-free survival in lymphoma patients: an exploratory follow-up of the HELP Trial.

PubMed

Courneya, Kerry S; Friedenreich, Christine M; Franco-Villalobos, Conrado; Crawford, Jennifer J; Chua, Neil; Basi, Sanraj; Norris, Mary K; Reiman, Tony

2015-02-01

Few randomized controlled trials in exercise oncology have examined survival outcomes. Here, we report an exploratory follow-up of progression-free survival (PFS) from the Healthy Exercise for Lymphoma Patients (HELP) Trial. The HELP Trial randomized 122 lymphoma patients between 2005 and 2008 to either control (n = 62) or 12 weeks of supervised aerobic exercise (n = 60). PFS events were abstracted from medical records in 2013. In addition to the randomized comparison, we explored the effects of exercise adherence (<80 % vs. ≥80 %) and control group crossover (no vs. yes). After a median follow-up of 61 months (interquartile range 36-67), the adjusted 5-year PFS was 64.8 % for the exercise group compared with 65.0 % for the control group (Hazard ratio [HR] 1.01, 95 % CI 0.51-2.01, p = 0.98). In the secondary analysis, the adjusted 5-year PFS was 59.0 % in the control group without crossover compared with 69.2 % for the control group with crossover (HR 0.68, 95 % CI 0.22-2.06, p = 0.49), 67.7 % for the exercise group with <80 % adherence (HR 0.72, 95 % CI 0.28-1.85, p = 0.50), and 68.4 % for the exercise group with ≥80 % adherence (HR 0.70, 95 % CI 0.32-1.56, p = 0.39). In a post hoc analysis combining the three groups that received supervised exercise, the adjusted 5-year PFS for the supervised exercise groups was 68.5 % compared with 59.0 % for the group that received no supervised exercise (HR 0.70, 95 % CI 0.35-1.39, p = 0.31). This exploratory follow-up of the HELP Trial suggests that supervised aerobic exercise may be associated with improved PFS in lymphoma patients. Larger trials designed to answer this question are needed.

Case-based or non-case-based questions for teaching postgraduate physicians: a randomized crossover trial.

PubMed

Cook, David A; Thompson, Warren G; Thomas, Kris G

2009-10-01

The comparative efficacy of case-based (CB) and non-CB self-assessment questions in Web-based instruction is unknown. The authors sought to compare CB and non-CB questions. The authors conducted a randomized crossover trial in the continuity clinics of two academic residency programs. Four Web-based modules on ambulatory medicine were developed in both CB (periodic questions based on patient scenarios) and non-CB (questions matched for content but lacking patient scenarios) formats. Participants completed two modules in each format (sequence randomly assigned). Participants also completed a pretest of applied knowledge for two modules (randomly assigned). For the 130 participating internal medicine and family medicine residents, knowledge scores improved significantly (P < .0001) from pretest (mean: 53.5; SE: 1.1) to posttest (75.1; SE: 0.7). Posttest knowledge scores were similar in CB (75.0; SE: 0.1) and non-CB formats (74.7; SE: 1.1); the 95% CI was -1.6, 2.2 (P = .76). A nearly significant (P = .062) interaction between format and the presence or absence of pretest suggested a differential effect of question format, depending on pretest. Overall, those taking pretests had higher posttest knowledge scores (76.7; SE: 1.1) than did those not taking pretests (73.0; SE: 1.1; 95% CI: 1.7, 5.6; P = .0003). Learners preferred the CB format. Time required was similar (CB: 42.5; SE: 1.8 minutes, non-CB: 40.9; SE: 1.8 minutes; P = .22). Our findings suggest that, among postgraduate physicians, CB and non-CB questions have similar effects on knowledge scores, but learners prefer CB questions. Pretests influence posttest scores.

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

PubMed

Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

2017-06-06

Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

A randomized, controlled trial of bright light therapy for agitated behaviors in dementia patients residing in long-term care.

PubMed

Lyketsos, C G; Lindell Veiel, L; Baker, A; Steele, C

1999-07-01

Agitated behaviors are common in dementia patients residing in chronic care settings. Their occurrence may be associated with lack of adequate exposure to sunlight and with circadian rhythm disturbances. Prior research has suggested that bright light therapy (BLT) may reduce agitated behaviors in dementia patients. The aim of this study was to test the efficacy of BLT in a randomized, controlled, crossover clinical trial. Fifteen patients with dementia and agitated behaviors residing in a chronic care facility were randomized in a crossover design to morning BLT for 1 hour per day or to a control condition with dim light exposure. Patients were treated in either condition for 4 weeks, followed by 1 week on no treatment, prior to being crossed over to the other condition. Eight out of 15 patients completed the entire study. The rest completed at least 2 weeks of study. Patients randomized to the BLT condition exhibited a statistically significant improvement in nocturnal sleep from a mean of 6.4 hours/night to 8.1 hours/night 4 weeks later (p<0.05). The sleep of patients in the control condition did not improve significantly. There were no other significant differences between baseline and follow-up, nor between BLT and control treated patients on the other outcome measures, which included the Behavioral Pathology in Alzheimer Disease scale (Behave-AD) and the Cornell Scale for Depression in Dementia. Patients with dementia in chronic care who exhibit agitated behaviors sleep more hours at night when administered morning BLT. However, BLT does not lead to improvements in agitated behaviors in institutionalized patients with dementia with non-disturbed sleep-wake cycles. Copyright 1999 John Wiley & Sons, Ltd.

Single-case experimental design yielded an effect estimate corresponding to a randomized controlled trial.

PubMed

Shadish, William R; Rindskopf, David M; Boyajian, Jonathan G

2016-08-01

We reanalyzed data from a previous randomized crossover design that administered high or low doses of intravenous immunoglobulin (IgG) to 12 patients with hypogammaglobulinaemia over 12 time points, with crossover after time 6. The objective was to see if results corresponded when analyzed as a set of single-case experimental designs vs. as a usual randomized controlled trial (RCT). Two blinded statisticians independently analyzed results. One analyzed the RCT comparing mean outcomes of group A (high dose IgG) to group B (low dose IgG) at the usual trial end point (time 6 in this case). The other analyzed all 12 time points for the group B patients as six single-case experimental designs analyzed together in a Bayesian nonlinear framework. In the randomized trial, group A [M = 794.93; standard deviation (SD) = 90.48] had significantly higher serum IgG levels at time six than group B (M = 283.89; SD = 71.10) (t = 10.88; df = 10; P < 0.001), yielding a mean difference of MD = 511.05 [standard error (SE) = 46.98]. For the single-case experimental designs, the effect from an intrinsically nonlinear regression was also significant and comparable in size with overlapping confidence intervals: MD = 495.00, SE = 54.41, and t = 495.00/54.41 = 9.10. Subsequent exploratory analyses indicated that how trend was modeled made a difference to these conclusions. The results of single-case experimental designs accurately approximated results from an RCT, although more work is needed to understand the conditions under which this holds. Copyright © 2016 Elsevier Inc. All rights reserved.

Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial.

PubMed

Nourbakhsh, Bardia; Revirajan, Nisha; Waubant, Emmanuelle

2018-01-01

Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used fatigue medications in patients with MS. The study is a randomized, placebo-controlled, crossover, four-sequence, four-period, double-blind, multicenter trial of three commonly used medications for the treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS. Adult patients with MS, with an Expanded Disability Status Scale of <7.0 are eligible to participate. Participants will be randomized to one of four predefined sequences of medication administration. Each sequence comprises four 6-week periods of treatment with one of the 3 study drugs or placebo, and three 2-week washout periods between medication periods. 136 participants will be randomized over two years in two academic centers in the United States starting in the Summer 2017. Complete enrollment is expected by early 2019. The primary outcome of the study is the modified fatigue impact scale (MFIS) score while participants receive the maximally tolerated dose of each study medication (or placebo). Safety and tolerability of the medications and heterogeneity of treatment effect will also be assessed. Results of the proposed study will provide evidence-based and personalized treatment options for patients affected by MS-related fatigue. Clinicaltrials.gov registration number: NCT03185065. Copyright © 2017 Elsevier Inc. All rights reserved.

The Effect of Head Massage on the Regulation of the Cardiac Autonomic Nervous System: A Pilot Randomized Crossover Trial.

PubMed

Fazeli, Mir Sohail; Pourrahmat, Mir-Masoud; Liu, Mailan; Guan, Ling; Collet, Jean-Paul

2016-01-01

To evaluate the effect of a single 10-minute session of Chinese head massage on the activity of the cardiac autonomic nervous system via measurement of heart rate variability (HRV). In this pilot randomized crossover trial, each participant received both head massage and the control intervention in a randomized fashion. The study was conducted at Children's & Women's Health Centre of British Columbia between June and November 2014. Ten otherwise healthy adults (6 men and 4 women) were enrolled in this study. The intervention comprised 10 minutes of head massage therapy (HMT) in a seated position compared with a control intervention of sitting quietly on the same chair with eyes closed for an equal amount of time (no HMT). The primary outcome measures were the main parameters of HRV, including total power (TP), high frequency (HF), HF as a normalized unit, pre-ejection period, and heart rate (HR). A single short session (10 minutes) of head massage demonstrated an increase in TP continuing up to 20 minutes after massage and reaching statistical significance at 10 minutes after massage (relative change from baseline, 66% for HMT versus -6.6% for no HMT; p = 0.017). The effect on HF also peaked up to 10 minutes after massage (59.4% for HMT versus 4% for no HMT; p = 0.139). Receiving head massage also decreased HR by more than three-fold compared to the control intervention. This study shows the potential benefits of head massage by modulating the cardiac autonomic nervous system through an increase in the total variability and a shift toward higher parasympathetic nervous system activity. Randomized controlled trials with larger sample size and multiple sessions of massage are needed to substantiate these findings.

Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.

PubMed

Goebel, Andreas; Baranowski, Andrew; Maurer, Konrad; Ghiai, Artemis; McCabe, Candy; Ambler, Gareth

2010-02-02

Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients. To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions. A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259) University College London Hospitals Pain Management Centre. Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment. IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days. The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment. 13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported. The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation. IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed. Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.

Comparison of deferral rates using a computerized versus written blood donor questionnaire: a randomized, cross-over study [ISRCTN84429599

PubMed Central

Sellors, John W; Hayward, Robert; Swanson, Graham; Ali, Anita; Haynes, R Brian; Bourque, Ronald; Moore, Karen-Ann; Lohfeld, Lynne; Dalby, Dawn; Howard, Michelle

2002-01-01

Background Self-administered computer-assisted blood donor screening strategies may elicit more accurate responses and improve the screening process. Methods Randomized crossover trial comparing responses to questions on a computerized hand-held tool (HealthQuiz, or HQ), to responses on the standard written instrument (Donor Health Assessment Questionnaire, or DHAQ). Randomly selected donors at 133 blood donation clinics in the area of Hamilton, Canada participated from 1995 to 1996. Donors were randomized to complete either the HQ or the DHAQ first, followed by the other instrument. In addition to responses of 'yes' and 'no' on both questionnaires, the HQ provided a response option of 'not sure'. The primary outcome was the number of additional donors deferred by the HQ. Results A total of 1239 donors participated. Seventy-one potential donors were deferred as a result of responses to the questionnaires; 56.3% (40/71) were deferred by the DHAQ, and an additional 43.7% (31/71) were deferred due to risks identified by the HQ but not by the DHAQ. Fourteen donors self-deferred; 11 indicated on the HQ that they should not donate blood on that day but did not use the confidential self-exclusion option on the DHAQ, and three used the self-exclusion option on the DHAQ but did not indicate that they should not donate blood on the HQ. The HQ identified a blood contact or risk factor for HIV/AIDS or sexually transmitted infection that was not identified by the DHAQ in 0.1% to 2.7% of donors. Conclusion A self-administered computerized questionnaire may increase risk reporting by blood donors. PMID:12191432

Two Universality Classes for the Many-Body Localization Transition

NASA Astrophysics Data System (ADS)

Khemani, Vedika; Sheng, D. N.; Huse, David A.

2017-08-01

We provide a systematic comparison of the many-body localization (MBL) transition in spin chains with nonrandom quasiperiodic versus random fields. We find evidence suggesting that these belong to two separate universality classes: the first dominated by "intrinsic" intrasample randomness, and the second dominated by external intersample quenched randomness. We show that the effects of intersample quenched randomness are strongly growing, but not yet dominant, at the system sizes probed by exact-diagonalization studies on random models. Thus, the observed finite-size critical scaling collapses in such studies appear to be in a preasymptotic regime near the nonrandom universality class, but showing signs of the initial crossover towards the external-randomness-dominated universality class. Our results provide an explanation for why exact-diagonalization studies on random models see an apparent scaling near the transition while also obtaining finite-size scaling exponents that strongly violate Harris-Chayes bounds that apply to disorder-driven transitions. We also show that the MBL phase is more stable for the quasiperiodic model as compared to the random one, and the transition in the quasiperiodic model suffers less from certain finite-size effects.

Is there any alternative to standard chest compression techniques in infants? A randomized manikin trial of the new "2-thumb-fist" option.

PubMed

Ladny, Jerzy R; Smereka, Jacek; Rodríguez-Núñez, Antonio; Leung, Steve; Ruetzler, Kurt; Szarpak, Lukasz

2018-02-01

Pediatric cardiac arrest is a fatal emergent condition that is associated with high mortality, permanent neurological injury, and is a socioeconomic burden at both the individual and national levels. The aim of this study was to test in an infant manikin a new chest compression (CC) technique ("2 thumbs-fist" or nTTT) in comparison with standard 2-finger (TFT) and 2-thumb-encircling hands techniques (TTEHT). This was prospective, randomized, crossover manikin study. Sixty-three nurses who performed a randomized sequence of 2-minute continuous CC with the 3 techniques in random order. Simulated systolic (SBP), diastolic (DBP), mean arterial pressure (MAP), and pulse pressures (PP, SBP-DBP) in mm Hg were measured. The nTTT resulted in a higher median SBP value (69 [IQR, 63-74] mm Hg) than TTEHT (41.5 [IQR, 39-42] mm Hg), (P < .001) and TFT (26.5 [IQR, 25.5-29] mm Hg), (P <.001). The simulated median value of DBP was 20 (IQR, 19-20) mm Hg with nTTT, 18 (IQR, 17-19) mm Hg with TTEHT and 23.5 (IQR, 22-25.5) mm Hg with TFT. DBP was significantly higher with TFT than with TTEHT (P <.001), as well as with TTEHT than nTTT (P <.001). Median values of simulated MAP were 37 (IQR, 34.5-38) mm Hg with nTTT, 26 (IQR, 25-26) mm Hg with TTEHT and 24.5 (IQR,23.5-26.5) mm Hg with TFT. A statistically significant difference was noticed between nTTT and TFT (P <.001), nTTT and TTEHT (P <.001), and between TTEHT and TFT (P <.001). Sixty-one subjects (96.8%) preferred the nTTT over the 2 standard methods. The new nTTT technique achieved higher SBP and MAP compared to the standard CC techniques in our infant manikin model. nTTT appears to be a suitable alternative or complementary to the TFT and TTEHT.

Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction

PubMed Central

Swofford, John; Whang, Peter G.; Frank, Clay J.; Glaser, John A.; Limoni, Robert P.; Cher, Daniel J.; Wine, Kathryn D.; Sembrano, Jonathan N.

2016-01-01

Background Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. Objective To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. Methods One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. Results In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period. Conclusions In this Level 1 multicenter prospective randomized controlled trial, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months. This study was approved by a local or central IRB before any subjects were enrolled. All patients provided study-specific informed consent prior to participation. PMID:27652199

Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

PubMed

Beksinska, Mags E; Smit, Jenni; Greener, Ross; Todd, Catherine S; Lee, Mei-ling Ting; Maphumulo, Virginia; Hoffmann, Vivian

2015-02-01

In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting. We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273. Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time. MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.

Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study.

PubMed

Yao, James C; Pavel, Marianne; Lombard-Bohas, Catherine; Van Cutsem, Eric; Voi, Maurizio; Brandt, Ulrike; He, Wei; Chen, David; Capdevila, Jaume; de Vries, Elisabeth G E; Tomassetti, Paola; Hobday, Timothy; Pommier, Rodney; Öberg, Kjell

2016-11-10

Purpose Everolimus improved median progression-free survival by 6.4 months in patients with advanced pancreatic neuroendocrine tumors (NET) compared with placebo in the RADIANT-3 study. Here, we present the final overall survival (OS) data and data on the impact of biomarkers on OS from the RADIANT-3 study. Methods Patients with advanced, progressive, low- or intermediate-grade pancreatic NET were randomly assigned to everolimus 10 mg/day (n = 207) or placebo (n = 203). Crossover from placebo to open-label everolimus was allowed on disease progression. Ongoing patients were unblinded after final progression-free survival analysis and could transition to open-label everolimus at the investigator's discretion (extension phase). OS analysis was performed using a stratified log-rank test in the intent-to-treat population. The baseline levels of chromogranin A, neuron-specific enolase, and multiple soluble angiogenic biomarkers were determined and their impact on OS was explored. Results Of 410 patients who were enrolled between July 2007 and March 2014, 225 received open-label everolimus, including 172 patients (85%) randomly assigned initially to the placebo arm. Median OS was 44.0 months (95% CI, 35.6 to 51.8 months) for those randomly assigned to everolimus and 37.7 months (95% CI, 29.1 to 45.8 months) for those randomly assigned to placebo (hazard ratio, 0.94; 95% CI, 0.73 to 1.20; P = .30). Elevated baseline chromogranin A, neuron-specific enolase, placental growth factor, and soluble vascular endothelial growth factor receptor 1 levels were poor prognostic factors for OS. The most common adverse events included stomatitis, rash, and diarrhea. Conclusion Everolimus was associated with a median OS of 44 months in patients with advanced, progressive pancreatic NET, the longest OS reported in a phase III study for this population. Everolimus was associated with a survival benefit of 6.3 months, although this finding was not statistically significant. Crossover of patients likely confounded the OS results.

Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

PubMed

Spertus, John A; Maron, David J; Cohen, David J; Kolm, Paul; Hartigan, Pam; Weintraub, William S; Berman, Daniel S; Teo, Koon K; Shaw, Leslee J; Sedlis, Steven P; Knudtson, Merril; Aslan, Mihaela; Dada, Marcin; Boden, William E; Mancini, G B John

2013-07-01

In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown. We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]). Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.

Hyperbaric Oxygen Environment Can Enhance Brain Activity and Multitasking Performance

PubMed Central

Vadas, Dor; Kalichman, Leonid; Hadanny, Amir; Efrati, Shai

2017-01-01

Background: The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, <10% of the brain is active at any given time, it utilizes almost all the oxygen delivered. In order to perform complex tasks or more than one task (multitasking), the oxygen supply is shifted from one brain region to another, via blood perfusion modulation. The aim of the present study was to evaluate whether a hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enhance the performance of complex and/or multiple activities. Methods: A prospective, double-blind randomized control, crossover trial including 22 healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multitasking). Participants were randomized to perform the tasks in two environments: (a) normobaric air (1 ATA 21% oxygen) (b) HBO (2 ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance. Results: Compared to the performance at normobaric conditions, both cognitive and motor single tasks scores were significantly enhanced by HBO environment (p < 0.001 for both). Multitasking performance was also significantly enhanced in HBO environment (p = 0.006 for the cognitive part and p = 0.02 for the motor part). Conclusions: The improvement in performance of both single and multi-tasking while in an HBO environment supports the hypothesis which according to, oxygen is indeed a rate limiting factor for brain activity. Hyperbaric oxygenation can serve as an environment for brain performance. Further studies are needed to evaluate the optimal oxygen levels for maximal brain performance. PMID:29021747

Plasma variations in stress markers: Clinical trial of two anesthetics used in regional block in the extraction of impacted inferior third molars

PubMed Central

Arteagoitia, Iciar; Zumarraga, Mercedes; Dávila, Ricardo; Barbier, Luis; Santamaría, Gorka

2014-01-01

Objectives: Was to evaluate the effect of different regional anesthetics (articaine with epinephrine versus prilocaine with felypressin) on stress in the extraction of impacted lower third molars in healthy subjects. Sutdy Desing: A prospective single-blind, split-mouth cross-over randomized study was designed, with a control group. The experimental group consisted of 24 otherwise healthy male volunteers, with two impacted lower third molars which were surgically extracted after inferior alveolar nerve block (regional anesthesia), with a fortnight’s interval: the right using 4% articaine with 1:100.000 epinephrine, and the left 3% prilocaine with 1:1.850.000 felypressin. Patients were randomized for the first surgical procedure. To analyze the variation in four stress markers, homovanillic acid, 3-methoxy-4-hydroxyphenylglycol, prolactin and cortisol, 10-mL blood samples were obtained at t = 0, 5, 60, and 120 minutes. The control group consisted of 12 healthy volunteers, who did not undergo either extractions or anesthetic procedures but from whom blood samples were collected and analyzed in the same way. Results: Plasma cortisol increased in the experimental group (multiple range test, P<0.05), the levels being significantly higher in the group receiving 3% prilocaine with 1:1.850,000 felypressin (signed rank test, p<0.0007). There was a significant reduction in homovanillic acid over time in both groups (multiple range test, P<0.05). No significant differences were observed in homovanillic acid, 3-methoxy-4-hydroxyphenylglycol or prolactin concentrations between the experimental and control groups. Conclusions: The effect of regional anesthesia on stress is lower when 4% articaine with 1:100,000 epinephrine is used in this surgical procedure. Key words:Stress markets, epinephrine versus felypressin. PMID:24316704

Equivalence of nasal and oronasal masks during initial CPAP titration for obstructive sleep apnea syndrome.

PubMed

Teo, Ming; Amis, Terence; Lee, Sharon; Falland, Karina; Lambert, Stephen; Wheatley, John

2011-07-01

Continuous positive airway pressure (CPAP) titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. There is little evidence regarding the equivalence of different mask interfaces used to initiate treatment. We hypothesized that oronasal breathing when using an oronasal mask increases upper airway collapsibility and that a higher pressure may be required to maintain airway patency. We also assessed patient preferences for the 2 mask interfaces. Prospective, randomized, cross-over design with 2 consecutive CPAP titration nights. Accredited laboratory in a university hospital. Twenty-four treatment-naive subjects with obstructive sleep apnea syndrome and respiratory disturbance index of greater than 15 events per hour. CPAP titration was performed using an auto-titrating machine with randomization to a nasal or oronasal mask, followed by a second titration night using the alternate mask style. There was no significant difference in the mean pressures determined between nasal and oronasal masks, although 43% of subjects had nasal-to-oronasal mask-pressure differences of 2 cm H(2)O or more. Residual respiratory events, arousals, and measured leak were all greater with the oronasal mask. Seventy-nine percent of subjects preferred the nasal mask. Patients with obstructive sleep apnea syndrome can generally switch between nasal and oronasal masks without changing machine pressure, although there are individual differences that may be clinically significant. Measured leak is greater with the oronasal mask. Most patients with obstructive sleep apnea syndrome prefer a nasal mask as the interface for initiation of CPAP. Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN: ACTRN12611000243910. URL: http://www.ANZCTR.org.au/ACTRN12611000243910.aspx

Influence of face mask design on bag-valve-mask ventilation performance: a randomized simulation study.

PubMed

Na, J U; Han, S K; Choi, P C; Cho, J H; Shin, D H

2013-10-01

Different face mask designs can influence bag-valve-mask (BVM) ventilation performance during resuscitation. We compared a single-use, air-cushioned face mask (AM) with a reusable silicone face mask (SM) for quality of BVM ventilation on a manikin simulating cardiac arrest. Thirty-two physicians were recruited, and a prospective, randomized, crossover observational study was conducted after an American Heart Association-accredited basic life support provider course and standardized practice time were completed. Participants performed 12 cycles of BVM ventilation with both the AM and SM on a SmartMan lung simulator. Mean tidal volume was significantly higher in ventilations performed using the AM vs. the SM (548 ± 159 ml vs. 439 ± 163 ml, P < 0.01). In addition, the proportion of low-volume ventilation was significantly lower with the AM than the SM [6/12 (2-11) vs. 9/12 (5-12), P = 0.03]. Bag-valve-AM ventilation volume was not affected by the physical characteristics of the rescuers, except for sex. In contrast, bag-valve-SM ventilation volume was affected by most of the characteristics tested, including sex, height, weight, hand width, hand length, and grip power. The AM seems to be a more efficient face mask than the SM at delivering sufficient ventilation volumes. The performance of the AM did not seem to be associated with the physical characteristics of the rescuers, whereas that of the SM was affected by these factors. The SM may not be an appropriate face mask for performing one-person BVM ventilation during resuscitation for rescuers who are smaller in stature, have a smaller hand size, or have weaker grip power. © 2013 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Efficacy of palonosetron and 1-day dexamethasone in moderately emetogenic chemotherapy compared with fosaprepitant, granisetron, and dexamethasone: a prospective randomized crossover study.

PubMed

Kitayama, Hiromitsu; Tsuji, Yasushi; Sugiyama, Junko; Doi, Ayako; Kondo, Tomohiro; Hirayama, Michiaki

2015-12-01

Although palonosetron (PALO) and NK1 receptor antagonist both reduce chemotherapy-induced nausea and vomiting, no comparison trial in moderately emetogenic chemotherapy (MEC) had been reported. The purpose of this study was to find out which drug combinations are preferable for patients receiving MEC. Chemotherapy-naive patients receiving MEC were randomized to two groups; group A first received PALO therapy [PALO plus 1-day dexamethasone (DEX)], and group B first received fosaprepitant (FAPR) therapy [FAPR, granisetron (GRAN), and DEX]. Patients were re-allocated to the other therapy, respectively, for the second cycle of chemotherapy. We administered intravenous PALO (0.75 mg) and DEX (9.9 mg) to the PALO therapy group, and FAPR (150 mg), DEX (4.95 mg), and GRAN (3 mg) to the FAPR therapy group, on Day 1. Complete response (CR) was the primary endpoint; complete control (CC), total control (CT), and the therapy chosen by the patients for their third and following cycles of antiemetic therapy were the secondary endpoints. We evaluated CR, CC, and TC in the acute phase, in the delayed phase, and over the whole period. A total of 35 patients and 70 cycles of therapy was evaluable for analysis. No significant difference was found at all evaluation points. Overall CR rates for PALO and FAPR therapy were 74 vs 69 % (P = 0.567), CC rates 66 vs 69 % (P = 0.521), and TC rates 46 vs 60 % (P = 0.235), respectively. Patients also showed no clear preference for their third and following cycles of chemotherapy, choosing both regimens almost equally often (PALO 10 vs FAPR 13). PALO and 1-day DEX is almost equivalent to FAPR, GRAN, and DEX for MEC.

Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure.

PubMed

Colombo, Davide; Cammarota, Gianmaria; Bergamaschi, Valentina; De Lucia, Marta; Corte, Francesco Della; Navalesi, Paolo

2008-11-01

Neurally adjusted ventilatory assist (NAVA) is a new mode wherein the assistance is provided in proportion to diaphragm electrical activity (EAdi). We assessed the physiologic response to varying levels of NAVA and pressure support ventilation (PSV). ICU of a University Hospital. Fourteen intubated and mechanically ventilated patients. DESIGN AND PROTOCOL: Cross-over, prospective, randomized controlled trial. PSV was set to obtain a VT/kg of 6-8 ml/kg with an active inspiration. NAVA was matched with a dedicated software. The assistance was decreased and increased by 50% with both modes. The six assist levels were randomly applied. Arterial blood gases (ABGs), tidal volume (VT/kg), peak EAdi, airway pressure (Paw), neural and flow-based timing. Asynchrony was calculated using the asynchrony index (AI). There was no difference in ABGs regardless of mode and assist level. The differences in breathing pattern, ventilator assistance, and respiratory drive and timing between PSV and NAVA were overall small at the two lower assist levels. At the highest assist level, however, we found greater VT/kg (9.1 +/- 2.2 vs. 7.1 +/- 2 ml/kg, P < 0.001), and lower breathing frequency (12 +/- 6 vs. 18 +/- 8.2, P < 0.001) and peak EAdi (8.6 +/- 10.5 vs. 12.3 +/- 9.0, P < 0.002) in PSV than in NAVA; we found mismatch between neural and flow-based timing in PSV, but not in NAVA. AI exceeded 10% in five (36%) and no (0%) patients with PSV and NAVA, respectively (P < 0.05). Compared to PSV, NAVA averted the risk of over-assistance, avoided patient-ventilator asynchrony, and improved patient-ventilator interaction.

Sedative music facilitates deep sleep in young adults.

PubMed

Chen, Chih-Kuang; Pei, Yu-Cheng; Chen, Ning-Hung; Huang, Li-Ting; Chou, Shih-Wei; Wu, Katie P; Ko, Pei-Chih; Wong, Alice M K; Wu, Chih-Kuan

2014-04-01

To investigate the effect of sedative music on the different stages of the sleep cycle in young adults with various sleep latencies by using polysomnography (PSG). Prospective, randomized, controlled, crossover study. Sleep center of a teaching hospital. Young adults with different sleep latencies. Poor sleepers (Pittsburgh Sleep Quality Index score ≥5) were excluded. Each participant stayed one night in the sleep center for adaptation and on each of the following two nights was assigned to (1) music and (2) control (without music) conditions in random order. In the music condition, sedative music composed by certified music therapists was played on a compact disc player for the first hour the participant was in bed. Sleep measures recorded with PSG, including sleep latency and durations of sleep stages. Twenty-four young adults (mean±standard deviation, 24.5±2.6 years) participated. They were classified into the short sleep latency (SL) group if the baseline SL of the adaptation night was shorter than 10 minutes or into the long SL group if the baseline SL was 10 minutes or longer. Sedative music did not alter the SL in either group. Sedative music reduced stage II sleep in both SL groups (main effect of music, p=0.03; interaction effect, p=0.87) but increased the duration of deep sleep (stages III and IV) only in the long SL group (main effect of music, p=0.15; interaction effect, p=0.02). In participants with long SL, sedative music improved the quality of sleep by prolonging the duration of deep sleep. This effect provides an alternative and noninvasive way to improve sleep in selected persons experiencing sleep problems.

Elemental Diets May Reduce the Risk of Aspiration Pneumonia in Bedridden Gastrostomy-Fed Patients

PubMed Central

Horiuchi, Akira; Nakayama, Yoshiko; Sakai, Ryosei; Suzuki, Manabu; Kajiyama, Masashi; Tanaka, Naoki

2013-01-01

OBJECTIVES: Our clinical experience suggested that elemental diets were associated with a reduction in aspiration pneumonia among bedridden patients with percutaneous endoscopic gastrostomy (PEG). We compared the effects of elemental and standard liquid diets on the risk of clinical aspiration pneumonia and gastric emptying in bedridden patients receiving PEG feedings. METHODS: Study 1: consecutive bedridden PEG patients received elemental diets or standard liquid diets in the same fashion. The frequency of defecation, diet aspirated from the trachea, and aspiration pneumonia during hospitalization were prospectively recorded. Study 2: a randomized, crossover trial using elemental or standard liquid diets containing 13C sodium acetate as a tracer given to bedridden PEG patients who had experienced aspiration pneumonia. 13C breath tests were performed to estimate gastric emptying. RESULTS: Study 1: 127 patients were enrolled, 60 with elemental and 67 with standard liquid diets. The diet was aspirated from the trachea in none (0%) with the elemental diet vs. 8 (11.9%) with standard liquid diets (P=0.0057); aspiration pneumonia developed none with the elemental diet vs. 5 (7.5%) with standard liquid diets (P=0.031) (number needed to treat 14, 95% confidence interval 7–85). Study 2: 19 patients were enrolled. The elemental diet was associated with a significant increase in the 10, 30 or 50% emptying (excretion) time (P<0.001) and increased the area under the curve (% dose/h) compared with the standard liquid diet (P<0.05). CONCLUSIONS: Elemental diets were associated with more rapid gastric empting and fewer episodes of aspiration than standard liquid diets in bedridden PEG patients. They may be preferred for bedridden PEG patients especially who have experienced aspiration pneumonia. Properly performed randomized-controlled trials are needed to prove this potential benefit. PMID:23399554

Effects of an acidic beverage (Coca-Cola) on absorption of ketoconazole.

PubMed Central

Chin, T W; Loeb, M; Fong, I W

1995-01-01

Absorption of ketoconazole is impaired in patients with achlorhydria. The purpose of this study was to determine the effectiveness of a palatable acidic beverage (Coca-Cola Classic, pH 2.5) in improving the absorption of ketoconazole in the presence of drug-induced achlorhydria. A prospective, randomized, three-way crossover design with a 1-week wash-out period between each treatment was employed. Nine healthy nonsmoking, nonobese volunteers between 22 and 41 years old were studied. Each subject was randomized to receive three treatments: (A) ketoconazole 200-mg tablet with water (control), (B) omeprazole (60 mg) followed by ketoconazole (200 mg) taken with water, and (C) omeprazole (60 mg) followed by ketoconazole (200 mg) taken with 240 ml of Coca-Cola Classic. The pH values of gastric aspirates were checked after omeprazole was administered to confirm attainment of a pH of > 6. Multiple serum samples were obtained for measurements of ketoconazole concentrations by high-pressure liquid chromatography. The mean area under the ketoconazole concentration-time curve from zero to infinity for the control treatment (17.9 +/- 13.1 mg.h/liter) was significantly greater than that for treatment B (3.5 +/- 5.1 mg.h/liter; 16.6% +/- 15.0% of control). The mean peak concentration was highest for the control treatment (4.1 +/- 1.9 micrograms/ml), for which the mean peak concentration showed a significant increase over that for treatment B. The absorption of ketoconazole was reduced in the presence of omeprazole-induced achlorhydria. However, drug absorption was significantly increased, to approximately 65% of the mean for the control treatment, when the drug was taken with an acidic beverage, such as Coca-Cola. PMID:7486898

Hyperbaric Oxygen Environment Can Enhance Brain Activity and Multitasking Performance.

PubMed

Vadas, Dor; Kalichman, Leonid; Hadanny, Amir; Efrati, Shai

2017-01-01

Background: The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, <10% of the brain is active at any given time, it utilizes almost all the oxygen delivered. In order to perform complex tasks or more than one task (multitasking), the oxygen supply is shifted from one brain region to another, via blood perfusion modulation. The aim of the present study was to evaluate whether a hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enhance the performance of complex and/or multiple activities. Methods: A prospective, double-blind randomized control, crossover trial including 22 healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multitasking). Participants were randomized to perform the tasks in two environments: (a) normobaric air (1 ATA 21% oxygen) (b) HBO (2 ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance. Results: Compared to the performance at normobaric conditions, both cognitive and motor single tasks scores were significantly enhanced by HBO environment ( p < 0.001 for both). Multitasking performance was also significantly enhanced in HBO environment ( p = 0.006 for the cognitive part and p = 0.02 for the motor part). Conclusions: The improvement in performance of both single and multi-tasking while in an HBO environment supports the hypothesis which according to, oxygen is indeed a rate limiting factor for brain activity. Hyperbaric oxygenation can serve as an environment for brain performance. Further studies are needed to evaluate the optimal oxygen levels for maximal brain performance.

Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation.

PubMed

Johannsson, G; Nilsson, A G; Bergthorsdottir, R; Burman, P; Dahlqvist, P; Ekman, B; Engström, B E; Olsson, T; Ragnarsson, O; Ryberg, M; Wahlberg, J; Biller, B M K; Monson, J P; Stewart, P M; Lennernäs, H; Skrtic, S

2012-02-01

Patients with treated adrenal insufficiency (AI) have increased morbidity and mortality rate. Our goal was to improve outcome by developing a once-daily (OD) oral hydrocortisone dual-release tablet with a more physiological exposure-time cortisol profile. The aim was to compare pharmacokinetics and metabolic outcome between OD and the same daily dose of thrice-daily (TID) dose of conventional hydrocortisone tablets. We conducted an open, randomized, two-period, 12-wk crossover multicenter trial with a 24-wk extension at five university hospital centers. The trial enrolled 64 adults with primary AI; 11 had concomitant diabetes mellitus (DM). The same daily dose of hydrocortisone was administered as OD dual-release or TID. We evaluated cortisol pharmacokinetics. Compared with conventional TID, OD provided a sustained serum cortisol profile 0-4 h after the morning intake and reduced the late afternoon and the 24-h cortisol exposure. The mean weight (difference = -0.7 kg, P = 0.005), systolic blood pressure (difference = -5.5 mm Hg, P = 0.0001) and diastolic blood pressure (difference: -2.3 mm Hg; P = 0.03), and glycated hemoglobin (absolute difference = -0.1%, P = 0.0006) were all reduced after OD compared with TID at 12 wk. Compared with TID, a reduction in glycated hemoglobin by 0.6% was observed in patients with concomitant DM during OD (P = 0.004). The OD dual-release tablet provided a more circadian-based serum cortisol profile. Reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during OD treatment. In particular, glucose metabolism improved in patients with concomitant DM.

The effects of control of thermal balance on vascular stability in hemodialysis patients: results of the European randomized clinical trial.

PubMed

Maggiore, Quirino; Pizzarelli, Francesco; Santoro, Antonio; Panzetta, Giovanni; Bonforte, Giuseppe; Hannedouche, Thierry; Alvarez de Lara, Maria Antonia; Tsouras, Ioannis; Loureiro, Alfredo; Ponce, Pedro; Sulkovà, Sylvie; Van Roost, Guido; Brink, Hans; Kwan, Jonathan T C

2002-08-01

Many reports note that the use of cool dialysate has a protective effect on blood pressure during hemodialysis (HD) treatments. However, formal clinical trials in which dialysate temperature is tailored to the body temperature of appropriately selected hypotension-prone patients are lacking. We investigated the effect of thermal control of dialysate on hemodynamic stability in hypotension-prone patients selected from 27 centers in nine European countries. Patients were eligible for the study if they had symptomatic hypotensive episodes in 25% or more of their HD sessions, assessed during a prospective screening phase over 1 month. The study is designed as a randomized crossover trial with two phases and two treatment arms, each phase lasting 4 weeks. We used a device allowing the regulation of thermal balance (Blood Temperature Monitor; Fresenius Medical Care, Bad Homberg, Germany), by which we compared a procedure aimed at preventing any transfer of thermal energy between dialysate and extracorporeal blood (thermoneutral dialysis) with a procedure aimed at keeping body temperature unchanged (isothermic dialysis). One hundred sixteen HD patients were enrolled, and 95 patients completed the study. During thermoneutral dialysis (energy flow rate: DeltaE = -0.22 +/- 0.29 kJ/kg x h), 6 of 12 treatments (median) were complicated by hypotension, whereas during isothermic dialysis (energy flow rate: DeltaE = -0.90 +/- 0.35 kJ/kg x h), the median decreased to 3 of 12 treatments (P < 0.001). Systolic and diastolic blood pressures and heart rate were more stable during the latter procedure. Isothermic dialysis was well tolerated by patients. Results show that active control of body temperature can significantly improve intradialytic tolerance in hypotension-prone patients. Copyright 2002 by the National Kidney Foundation, Inc.

Comparison of three different inhalant anesthetic agents (isoflurane, sevoflurane, desflurane) in red-tailed hawks (Buteo jamaicensis).

PubMed

Granone, Tiffany D; de Francisco, Olga N; Killos, Maria B; Quandt, Jane E; Mandsager, Ron E; Graham, Lynelle F

2012-01-01

To compare isoflurane, sevoflurane and desflurane for inhalant anesthesia in red-tailed hawks (Buteo jamaicensis) in terms of the speed and characteristics of induction; cardiovascular and respiratory parameters while anesthetized; and speed and quality of recovery. Prospective, cross over, randomized experimental study. 12 healthy adult red-tailed hawks. Anesthesia was induced with isoflurane, sevoflurane or desflurane in oxygen via face mask in a crossover, randomized design with a 1 week washout period between each treatment. Hawks were tracheally intubated, allowed to breathe spontaneously, and instrumented for cardiopulmonary monitoring. Data collected included heart rate, respiratory rate, end-tidal CO(2) , inspired and expired agent, SpO(2,) temperature, systolic blood pressure, time to intubation and time to recovery (tracking). Recovery was subjectively scored on a 4 point scale as well as a summary evaluation, by a single blinded observer. No significant difference in time to induction and time to extubation was noted with the administration of isoflurane, sevoflurane or desflurane. Time to the ability of the bird to follow a moving object with its eyes (tracking) was significantly faster with the administration of sevoflurane and desflurane. All recoveries were scored 1 or 2 and were assessed as good to excellent. No significant difference was noted in heart rate, blood pressure and temperature among the three inhalants. Administration of isoflurane resulted in lower respiratory rates. Overall, although isoflurane remains the most common inhaled anesthetic in avian practice, sevoflurane and desflurane both offer faster time to tracking, while similar changes in cardiopulmonary function were observed with each agent during anesthesia of healthy red-tailed hawks. © 2011 The Authors. Veterinary Anaesthesia and Analgesia. © 2011 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesiologists.

Comparison of cotrimoxazole vs. second-generation cephalosporins for prevention of urinary tract infections in children.

PubMed

Antachopoulos, Charalampos; Ioannidou, Maria; Tratselas, Athanasios; Iosifidis, Elias; Katragkou, Aspasia; Kadiltzoglou, Paschalis; Kollios, Konstantinos; Roilides, Emmanuel

2016-12-01

Antimicrobial prophylaxis is recommended for the prevention of urinary tract infections (UTI) in high-risk children. However, there is growing concern about the use of β-lactams as prophylaxis and subsequent development of antibiotic resistance. In this prospective, randomized, crossover controlled trial we compared cotrimoxazole (SXT) and second-generation cephalosporins (2GC) as UTI prophylaxis in children ranging in age from 1 to 60 months. Eligible patients were 1:1 randomized to receive either SXT or 2GC for the initial 6-month period (1 course), then switched to the other antimicrobial agent class for the subsequent course, with switching continuing after each course until the end of the study. Urethral orifice cultures (UOCs) were obtained at the time of switching antimicrobial prophylaxis. Among 97 children (mean age 13.6 months) on prophylaxis, breakthrough UTIs occurred during 13.3 % (10/75) of SXT courses and 10.3 % (8/78) of 2GC courses (p = 0.62). 2GC failed earlier than SXT (mean ± standard error: 0.81 ± 0.1 vs. 2.37 ± 0.36 months, respectively; p = 0.028). Pseudomonas aeruginosa and Enterococcus spp. were more frequently isolated after 2GC courses than after SXT courses [22.6 vs. 4.8 % (p = 0.02) and 20.7 vs. 4.8 % (p = 0.035), respectively]. Prophylaxis with 2GC significantly increased resistance to both 2GC and SXT, while SXT prophylaxis did not affect susceptibility to 2GC. While SXT and 2GC appear to be equally efficacious as UTI prophylaxis in children, the latter exert a broader effect on patients' flora and development of bacterial resistance, suggesting that SXT may be more appropriate for UTI prophylaxis than 2GC.

A Prospective, Randomized, Double-Blind Study of the Anesthetic Efficacy of Sodium Bicarbonate Buffered 2% Lidocaine With 1 : 100,000 Epinephrine in Inferior Alveolar Nerve Blocks

PubMed Central

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

2010-01-01

Abstract The authors, using a crossover design, randomly administered, in a double-blind manner, inferior alveolar nerve (IAN) blocks using a buffered 2% lidocaine with 1 : 100,000 epinephrine/sodium bicarbonate formulation and an unbuffered 2% lidocaine with 1 : 100,000 epinephrine formulation at 2 separate appointments spaced at least 1 week apart. An electric pulp tester was used in 4-minute cycles for 60 minutes to test for anesthesia of the first and second molars, premolars, and lateral and central incisors. Anesthesia was considered successful when 2 consecutive 80 readings were obtained within 15 minutes, and the 80 reading was continuously sustained for 60 minutes. For the buffered 2% lidocaine with 1 : 100,000 epinephrine/sodium bicarbonate formulation, successful pulpal anesthesia ranged from 10–71%. For the unbuffered 2% lidocaine with 1 : 100,000 epinephrine formulation, successful pulpal anesthesia ranged from 10–72%. No significant differences between the 2 anesthetic formulations were noted. The buffered lidocaine formulation did not statistically result in faster onset of pulpal anesthesia or less pain during injection than did the unbuffered lidocaine formulation. We concluded that buffering a 2% lidocaine with 1 : 100,000 epinephrine with sodium bicarbonate, as was formulated in the current study, did not statistically increase anesthetic success, provide faster onset, or result in less pain of injection when compared with unbuffered 2% lidocaine with 1 : 100,000 epinephrine for an IAN block. PMID:20553136

Effects of Alanyl-Glutamine Treatment on the Peritoneal Dialysis Effluent Proteome Reveal Pathomechanism-Associated Molecular Signatures*

PubMed Central

Herzog, Rebecca; Boehm, Michael; Unterwurzacher, Markus; Wagner, Anja; Parapatics, Katja; Májek, Peter; Mueller, André C.; Lichtenauer, Anton; Bennett, Keiryn L.; Alper, Seth L.; Vychytil, Andreas; Aufricht, Christoph; Kratochwill, Klaus

2018-01-01

Peritoneal dialysis (PD) is a modality of renal replacement therapy in which the high volumes of available PD effluent (PDE) represents a rich source of biomarkers for monitoring disease and therapy. Although this information could help guide the management of PD patients, little is known about the potential of PDE to define pathomechanism-associated molecular signatures in PD. We therefore subjected PDE to a high-performance multiplex proteomic analysis after depletion of highly-abundant plasma proteins and enrichment of low-abundance proteins. A combination of label-free and isobaric labeling strategies was applied to PDE samples from PD patients (n = 20) treated in an open-label, randomized, two-period, cross-over clinical trial with standard PD fluid or with a novel PD fluid supplemented with alanyl-glutamine (AlaGln). With this workflow we identified 2506 unique proteins in the PDE proteome, greatly increasing coverage beyond the 171 previously-reported proteins. The proteins identified range from high abundance plasma proteins to low abundance cellular proteins, and are linked to larger numbers of biological processes and pathways, some of which are novel for PDE. Interestingly, proteins linked to membrane remodeling and fibrosis are overrepresented in PDE compared with plasma, whereas the proteins underrepresented in PDE suggest decreases in host defense, immune-competence and response to stress. Treatment with AlaGln-supplemented PD fluid is associated with reduced activity of membrane injury-associated mechanisms and with restoration of biological processes involved in stress responses and host defense. Our study represents the first application of the PDE proteome in a randomized controlled prospective clinical trial of PD. This novel proteomic workflow allowed detection of low abundance biomarkers to define pathomechanism-associated molecular signatures in PD and their alterations by a novel therapeutic intervention. PMID:29208752

The effect of pre-anaesthetic fasting time and type of food on gastric content volume and acidity in dogs.

PubMed

Savvas, Ioannis; Rallis, Timoleon; Raptopoulos, Dimitris

2009-11-01

To investigate the effect of pre-anaesthetic fasting time and variety of food on gastric content (GC) volume and pH in dogs. Randomized, cross-over, prospective experimental study. Fifteen mongrel dogs (nine females and six males 1-4 years old, weighing 10-24.5 kg). Each dog received the same seven treatments in random order: dry food 3 hours before anaesthesia (BA) (treatment 3D), canned food (half daily rate) 3 hours BA (treatment 3C), 0% fat cow milk 3 hours BA (treatment 3M), dry food 10 hours BA (treatment 10D), canned food 10 hours BA (treatment 10C), low fat canned food 10 hours BA (treatment 10F) and low protein canned food 10 hours BA (treatment 10P). All animals were pre-medicated with propionyl promazine and anaesthesia was induced with thiopental sodium and maintained with halothane. GC was aspirated using an orogastric catheter and its volume and pH were measured. Treatment 10F had significantly lower GC pH than all the 3-hour treatments. Treatments 10D and 10P had significantly lower pH than treatments 3D and 3C. Treatment 3M had significantly lower pH than the other 3-hour treatments. Treatment 3D had significantly greater gastric volume than treatments 3M, 10C, 10F and 10P. Canned food at half the daily rate administered 3 hours before anaesthesia did not increase significantly the GC volume compared to the other types of food used. The GC pH was also high. This type of food fed 3 hours before induction of anaesthesia may be of benefit in reduction of the incidence of gastro-oesophageal reflux during anaesthesia in dogs.

The comfort of breathing: a study with volunteers assessing the influence of various modes of assisted ventilation.

PubMed

Russell, W C; Greer, J R

2000-11-01

To assess the subjective feeling of comfort of healthy volunteers breathing on various modes of ventilation used in intensive care. A randomized, prospective, double-blinded, crossover trial using volunteers. An intensive care unit (ICU) in a teaching hospital. We compared, by using healthy volunteers, the subjective feeling of comfort of three modes of ventilation used during the weaning phase of critical illness. We used healthy volunteers to avoid other distracting influences of intensive care that may confound the primary feeling of comfort. The modes we compared were synchronized intermittent mandatory ventilation, assisted spontaneous breathing, and biphasic positive airway pressure. The imposed ventilation was comparable with 50% of the volunteers' normal respiratory effort. The volunteers breathed via a mouthpiece through a ventilator circuit, and the modes of ventilation were introduced in a randomized manner. We measured visual analog scores for comfort for the three modes of ventilation and collected a ranking order and open-ended comments. We demonstrated that at the level of support we imposed, assisted spontaneous breathing was the most comfortable mode of ventilation and that synchronized intermittent mandatory ventilation was the most uncomfortable. These results were strongly supported by both the ranking scale and comments of the volunteers. Assisted spontaneous breathing was the most comfortable mode of ventilation because the pattern was primarily determined by the volunteer. Synchronized intermittent mandatory ventilation was the most uncomfortable because the ventilatory pattern was imposed on the volunteers, leading to ventilator-volunteer dyssynchrony. We also conclude there is wide individual variation in the subjective feeling of comfort. Whereas the mode of ventilation in ICUs is based primarily on the physiologic needs of the patient, the feeling of comfort may be considered when choosing an appropriate mode of ventilation during the weaning phase of critical illness.

Elemental diets may reduce the risk of aspiration pneumonia in bedridden gastrostomy-fed patients.

PubMed

Horiuchi, Akira; Nakayama, Yoshiko; Sakai, Ryosei; Suzuki, Manabu; Kajiyama, Masashi; Tanaka, Naoki

2013-05-01

Our clinical experience suggested that elemental diets were associated with a reduction in aspiration pneumonia among bedridden patients with percutaneous endoscopic gastrostomy (PEG). We compared the effects of elemental and standard liquid diets on the risk of clinical aspiration pneumonia and gastric emptying in bedridden patients receiving PEG feedings. Study 1: consecutive bedridden PEG patients received elemental diets or standard liquid diets in the same fashion. The frequency of defecation, diet aspirated from the trachea, and aspiration pneumonia during hospitalization were prospectively recorded. Study 2: a randomized, crossover trial using elemental or standard liquid diets containing (13)C sodium acetate as a tracer given to bedridden PEG patients who had experienced aspiration pneumonia. (13)C breath tests were performed to estimate gastric emptying. Study 1: 127 patients were enrolled, 60 with elemental and 67 with standard liquid diets. The diet was aspirated from the trachea in none (0%) with the elemental diet vs. 8 (11.9%) with standard liquid diets (P=0.0057); aspiration pneumonia developed none with the elemental diet vs. 5 (7.5%) with standard liquid diets (P=0.031) (number needed to treat 14, 95% confidence interval 7-85). Study 2: 19 patients were enrolled. The elemental diet was associated with a significant increase in the 10, 30 or 50% emptying (excretion) time (P<0.001) and increased the area under the curve (% dose/h) compared with the standard liquid diet (P<0.05). Elemental diets were associated with more rapid gastric empting and fewer episodes of aspiration than standard liquid diets in bedridden PEG patients. They may be preferred for bedridden PEG patients especially who have experienced aspiration pneumonia. Properly performed randomized-controlled trials are needed to prove this potential benefit.

AN INTERVENTION TO ASSIST MEN WHO HAVE SEX WITH MEN DISCLOSE THEIR SEROSTATUS TO CASUAL SEX PARTNERS

PubMed Central

Serovich, Julianne M.; Reed, Sandra; Grafsky, Erika L.; Andrist, David

2009-01-01

This article reports pilot data from a newly developed disclosure intervention and associated measures specifically tailored for disclosure to casual sexual partners. Treatment consisted of a four-session, theoretically driven intervention focusing on the costs and benefits of disclosure. Using a randomized control, crossover design 77 men were randomized into one of three conditions (wait-list control, facilitator only, and computer and facilitator). Results of the study suggest that facilitated administration of the pilot intervention was effective in reducing mean scores on the HIV disclosure behavior and attitude scales and that these reductions were both statistically and practically significant. PMID:19519236