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…

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

ERIC Educational Resources Information Center

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

2013-01-01

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

Why caution is recommended with post-hoc individual patient matching for estimation of treatment effect in parallel-group randomized controlled trials: the case of acute stroke trials.

PubMed

Jafari, Nahid; Hearne, John; Churilov, Leonid

2013-11-10

A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on the trade-off between the quality of individual matches and the overall percentage of matching. Using acute stroke trials as a context, we utilize exact optimization and simulation techniques to investigate a complex relationship between the overall percentage of individual post-hoc matching, the size of the respective RCT, and the quality of matching on variables highly prognostic for a good functional outcome after stroke, as well as the dispersion in these variables. It is empirically confirmed that a high percentage of individual post-hoc matching can only be achieved when the differences in prognostic baseline variables between individually matched subjects within the same pair are sufficiently large and that the unmatched subjects are qualitatively different to the matched ones. It is concluded that the post-hoc individual matching as a technique for treatment effect estimation in parallel-group RCTs should be exercised with caution because of its propensity to introduce significant bias and reduce validity. If used with appropriate caution and thorough evaluation, this approach can complement other viable alternative approaches for estimating the treatment effect. Copyright © 2013 John Wiley & Sons, Ltd.

Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

PubMed

Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

2017-08-17

A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

Safety and Efficacy of ABT-089 in Pediatric Attention-Deficit/Hyperactivity Disorder: Results from Two Randomized Placebo-Controlled Clinical Trials

ERIC Educational Resources Information Center

Wilens, Timothy E.; Gault, Laura M.; Childress, Ann; Kratochvil, Christopher J.; Bensman, Lindsey; Hall, Coleen M.; Olson, Evelyn; Robieson, Weining Z.; Garimella, Tushar S.; Abi-Saab, Walid M.; Apostol, George; Saltarelli, Mario D.

2011-01-01

Objective: To assess the safety and efficacy of ABT-089, a novel alpha[subscript 4]beta[subscript 2] neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD). Method: Two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of children 6 through 12 years…

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

[Effect of Xinling Wan in treatment of stable angina pectoris: a randomized, double-blinded, placebo parallel-controlled, multicenter trial].

PubMed

Gao, Jian-Wei; Gao, Xue-Min; Zou, Ting; Zhao, Tian-Meng; Wang, Dong-Hua; Wu, Zong-Gui; Ren, Chang-Jie; Wang, Xing; Geng, Nai-Zhi; Zhao, Ming-Jun; Liang, Qiu-Ming; Feng, Xing; Yang, Bai-Song; Shi, Jun-Ling; Hua, Qi

2018-03-01

To evaluate the effectiveness and safety of Xinling Wan on patients with stable angina pectoris, a randomized, double-blinded, placebo parallel-controlled, multicenter clinical trial was conducted. A total of 232 subjects were enrolled and randomly divided into experiment group and placebo group. The experiment group was treated with Xinling Wan (two pills each time, three times daily) for 4 weeks, and the placebo group was treated with placebo. The effectiveness evaluation showed that Xinling Wan could significantly increase the total duration of treadmill exercise among patients with stable angina pectoris. FAS analysis showed that the difference value of the total exercise duration was between experiment group (72.11±139.32) s and placebo group (31.25±108.32) s. Xinling Wan could remarkably increase the total effective rate of angina pectoris symptom score, and the analysis showed that the total effective rate was 78.95% in experiment group and 42.61% in placebo group. The reduction of nitroglycerin dose was (2.45±2.41) tablets in experiment group and (0.50±2.24) tablets in placebo group on the basis of FAS analysis. The decrease of symptom integral was (4.68±3.49) in experiment group and (3.19±3.31) in placebo group based on FAS analysis. Besides, Xinling Wan could decrease the weekly attack time and the duration of angina pectoris. PPS analysis results were similar to those of FAS analysis. In conclusion, Xinling Wan has an obvious therapeutic effect in treating stable angina pectoris, with a good safety and a low incidence of adverse event and adverse reaction in experiment group. Copyright© by the Chinese Pharmaceutical Association.

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

PubMed

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

2015-12-01

A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p < 0.0001, respectively]. The overall incidence rates of treatment-emergent adverse events were similar among the treatment groups. Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings. © 2015 John Wiley & Sons Ltd.

Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials.

PubMed

Scott, JoAnna M; deCamp, Allan; Juraska, Michal; Fay, Michael P; Gilbert, Peter B

2017-04-01

Stepped wedge designs are increasingly commonplace and advantageous for cluster randomized trials when it is both unethical to assign placebo, and it is logistically difficult to allocate an intervention simultaneously to many clusters. We study marginal mean models fit with generalized estimating equations for assessing treatment effectiveness in stepped wedge cluster randomized trials. This approach has advantages over the more commonly used mixed models that (1) the population-average parameters have an important interpretation for public health applications and (2) they avoid untestable assumptions on latent variable distributions and avoid parametric assumptions about error distributions, therefore, providing more robust evidence on treatment effects. However, cluster randomized trials typically have a small number of clusters, rendering the standard generalized estimating equation sandwich variance estimator biased and highly variable and hence yielding incorrect inferences. We study the usual asymptotic generalized estimating equation inferences (i.e., using sandwich variance estimators and asymptotic normality) and four small-sample corrections to generalized estimating equation for stepped wedge cluster randomized trials and for parallel cluster randomized trials as a comparison. We show by simulation that the small-sample corrections provide improvement, with one correction appearing to provide at least nominal coverage even with only 10 clusters per group. These results demonstrate the viability of the marginal mean approach for both stepped wedge and parallel cluster randomized trials. We also study the comparative performance of the corrected methods for stepped wedge and parallel designs, and describe how the methods can accommodate interval censoring of individual failure times and incorporate semiparametric efficient estimators.

Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

PubMed

Kawashima, Makoto; Sato, Shinichi; Furukawa, Fukumi; Matsunaga, Kayoko; Akamatsu, Hirohiko; Igarashi, Atsuyuki; Tsunemi, Yuichiro; Hayashi, Nobukazu; Yamamoto, Yuki; Nagare, Toshitaka; Katsuramaki, Tsuneo

2017-07-01

A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end-point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd.

A Randomized Double-Blinded Trial on the Effects of Ultrasound Transducer Orientation on Teaching and Learning Ultrasound-Guided Regional Anesthesia.

PubMed

Lam, Nicholas C K; Baker, Elizabeth B; Fishburn, Steven J; Hammer, Angie R; Petersen, Timothy R; Mariano, Edward R

2016-07-01

Learning ultrasound-guided regional anesthesia skills, especially needle/ beam alignment, can be especially difficulty for trainees, who can often become frustrated. We hypothesized that teaching novices to orient the transducer and needle perpendicular to their shoulders will improve performance on a standardized task, compared to holding the transducer and needle parallel to the shoulders. This study compared the effects of transducer orientation on trainees' ability to complete a standardized ultrasound-guided nerve block simulation. The time to task completion and percentage of the attempt time without adequate needle visualization were measured. Participants were right-handed healthy adults with no previous ultrasound experience and were randomly assigned to training in either transducer and needle alignment in a coronal plane, parallel to the shoulders (parallel group) or transducer and needle alignment in a sagittal plane, perpendicular to the shoulders (perpendicular group). Participants used ultrasound to direct a needle to 3 targets in a standardized gelatin phantom and repeated this task 3 times. Their efforts were timed and evaluated by an assessor, who was blinded to group assignment. Data were analyzed on 28 participants. The perpendicular group was able to complete the task more quickly (P < .001) and with a smaller proportion of time lost to inadequate needle visualization (P < .001). Ultrasound-guided regional anesthesia trainees complete a standardized task more quickly and efficiently when instructed to hold the transducer and needle in an orientation perpendicular to their shoulders.

Early High-dosage Atorvastatin Treatment Improved Serum Immune-inflammatory Markers and Functional Outcome in Acute Ischemic Strokes Classified as Large Artery Atherosclerotic Stroke: A Randomized Trial.

PubMed

Tuttolomondo, Antonino; Di Raimondo, Domenico; Pecoraro, Rosaria; Maida, Carlo; Arnao, Valentina; Della Corte, Vittoriano; Simonetta, Irene; Corpora, Francesca; Di Bona, Danilo; Maugeri, Rosario; Iacopino, Domenico Gerardo; Pinto, Antonio

2016-03-01

Statins have beneficial effects on cerebral circulation and brain parenchyma during ischemic stroke and reperfusion. The primary hypothesis of this randomized parallel trial was that treatment with 80 mg/day of atorvastatin administered early at admission after acute atherosclerotic ischemic stroke could reduce serum levels of markers of immune-inflammatory activation of the acute phase and that this immune-inflammatory modulation could have a possible effect on prognosis of ischemic stroke evaluated by some outcome indicators. We enrolled 42 patients with acute ischemic stroke classified as large arteries atherosclerosis stroke (LAAS) randomly assigned in a randomized parallel trial to the following groups: Group A, 22 patients treated with atorvastatin 80 mg (once-daily) from admission day until discharge; Group B, 20 patients not treated with atorvastatin 80 mg until discharge, and after discharge, treatment with atorvastatin has been started. At 72 hours and at 7 days after acute ischemic stroke, subjects of group A showed significantly lower plasma levels of tumor necrosis factor-α, interleukin (IL)-6, vascular cell adhesion molecule-1, whereas no significant difference with regard to plasma levels of IL-10, E-Selectin, and P-Selectin was observed between the 2 groups. At 72 hours and 7 days after admission, stroke patients treated with atorvastatin 80 mg in comparison with stroke subjects not treated with atorvastatin showed a significantly lower mean National Institutes of Health Stroke Scale and modified Rankin scores. Our findings provide the first evidence that atorvastatin acutely administered immediately after an atherosclerotic ischemic stroke exerts a lowering effect on immune-inflammatory activation of the acute phase of stroke and that its early use is associated to a better functional and prognostic profile.

Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

PubMed Central

Tay, Lee; Leon, Francisco; Vratsanos, George; Raymond, Ralph; Corbo, Michael

2007-01-01

The effect of abatacept, a selective T-cell co-stimulation modulator, on vaccination has not been previously investigated. In this open-label, single-dose, randomized, parallel-group, controlled study, the effect of a single 750 mg infusion of abatacept on the antibody response to the intramuscular tetanus toxoid vaccine (primarily a memory response to a T-cell-dependent peptide antigen) and the intramuscular 23-valent pneumococcal vaccine (a less T-cell-dependent response to a polysaccharide antigen) was measured in 80 normal healthy volunteers. Subjects were uniformly randomized to receive one of four treatments: Group A (control group), subjects received vaccines on day 1 only; Group B, subjects received vaccines 2 weeks before abatacept; Group C, subjects received vaccines 2 weeks after abatacept; and Group D, subjects received vaccines 8 weeks after abatacept. Anti-tetanus and anti-pneumococcal (Danish serotypes 2, 6B, 8, 9V, 14, 19F and 23F) antibody titers were measured 14 and 28 days after vaccination. While there were no statistically significant differences between the dosing groups, geometric mean titers following tetanus or pneumococcal vaccination were generally lower in subjects who were vaccinated 2 weeks after receiving abatacept, compared with control subjects. A positive response (defined as a twofold increase in antibody titer from baseline) to tetanus vaccination at 28 days was seen, however, in ≥ 60% of subjects across all treatment groups versus 75% of control subjects. Similarly, over 70% of abatacept-treated subjects versus all control subjects (100%) responded to at least three pneumococcal serotypes, and approximately 25–30% of abatacept-treated subjects versus 45% of control subjects responded to at least six serotypes. PMID:17425783

White Matter Microstructural Correlates of Superior Long-term Skill Gained Implicitly under Randomized Practice

PubMed Central

Song, Sunbin; Sharma, Nikhil; Buch, Ethan R.

2012-01-01

We value skills we have learned intentionally, but equally important are skills acquired incidentally without ability to describe how or what is learned, referred to as implicit. Randomized practice schedules are superior to grouped schedules for long-term skill gained intentionally, but its relevance for implicit learning is not known. In a parallel design, we studied healthy subjects who learned a motor sequence implicitly under randomized or grouped practice schedule and obtained diffusion-weighted images to identify white matter microstructural correlates of long-term skill. Randomized practice led to superior long-term skill compared with grouped practice. Whole-brain analyses relating interindividual variability in fractional anisotropy (FA) to long-term skill demonstrated that 1) skill in randomized learners correlated with FA within the corticostriatal tract connecting left sensorimotor cortex to posterior putamen, while 2) skill in grouped learners correlated with FA within the right forceps minor connecting homologous regions of the prefrontal cortex (PFC) and the corticostriatal tract connecting lateral PFC to anterior putamen. These results demonstrate first that randomized practice schedules improve long-term implicit skill more than grouped practice schedules and, second, that the superior skill acquired through randomized practice can be related to white matter microstructure in the sensorimotor corticostriatal network. PMID:21914632

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

DTIC Science & Technology

2010-09-30

a novel hypocretiniorexin antagonist, almorexant (ALM), to a standard hypnotic , zolpidem (ZOL), and placebo (PBO) on neurocognitive performance at...Placebo-Controlled, Randomized, Parallel- Group Study Comparing the Effect of a Novel HypocretiniOrexin Antagonist (Almorexant) Versus a Standard Hypnotic ...Group Study Comparing the Effect of a Novel HypocretiniOrexin Antagonist (Almorexant) Versus a Standard Hypnotic (Zolpidem) and Placebo on

Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

PubMed

Isacsson, Göran; Nohlert, Eva; Fransson, Anette M C; Bornefalk-Hermansson, Anna; Wiman Eriksson, Eva; Ortlieb, Eva; Trepp, Livia; Avdelius, Anna; Sturebrand, Magnus; Fodor, Clara; List, Thomas; Schumann, Mohamad; Tegelberg, Åke

2018-05-16

The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA. To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective. In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy. Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively). The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive. In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude. Registered with ClinicalTrials.gov (#NCT02148510).

Reductions of intimate partner violence resulting from supplementing children with omega-3 fatty acids: A randomized, double-blind, placebo-controlled, stratified, parallel-group trial.

PubMed

Portnoy, Jill; Raine, Adrian; Liu, Jianghong; Hibbeln, Joseph R

2018-05-20

Omega-3 supplementation has been found to reduce externalizing behavior in children. Reciprocal models of parent-child behavior suggest that improving child behavior could lead to improvements in parent behavior, however no study has examined whether omega-3 supplementation in children could reduce intimate partner violence or child maltreatment by their adult caregivers. In this randomized, double-blind, placebo-controlled, stratified, parallel group trial, a community sample of children were randomized to receive either a fruit drink containing 1 gm of omega-3 fats (Smartfish Recharge; Omega-3 group, n = 100) or the same fruit drink without omega-3's (Placebo group, n = 100). Child participants, adult caregivers, and research staff were blinded to group assignment. Adult caregivers reported inter-partner and child-directed physical assault and psychological aggression at baseline, 6 months (end of treatment) and 12 months (6 months post-treatment) using the Conflicts Tactics Scale. Caregivers of children in the omega-3 group reported long-term reductions in psychological aggression in a group × time interaction. Improvements in adult psychological aggression were correlated with improvements in child externalizing behavior scores. No differences were reported for child maltreatment. This study is the first to show that omega-3 supplementation in children can reduce inter-partner psychological aggression among adult caregivers not receiving supplements. Findings suggest that improving child behavior through omega-3 supplementation could have long-term benefits to the family system as a whole. © 2018 Wiley Periodicals, Inc.

Effects of Intravenous Patient-Controlled Sufentanil Analgesia and Music Therapy on Pain and Hemodynamics After Surgery for Lung Cancer: A Randomized Parallel Study.

PubMed

Wang, Yichun; Tang, Haoke; Guo, Qulian; Liu, Jingshi; Liu, Xiaohong; Luo, Junming; Yang, Wenqian

2015-11-01

Postoperative pain is caused by surgical injury and trauma; is stressful to patients; and includes a series of physiologic, psychological, and behavioral reactions. Effective postoperative analgesia helps improve postoperative pain, perioperative safety, and hospital discharge rates. This study aimed to observe the influence of postoperative intravenous sufentanil patient-controlled analgesia combined with music therapy versus sufentanil alone on hemodynamics and analgesia in patients with lung cancer. This was a randomized parallel study performed in 60 patients in American Society of Anesthesiologists class I or II undergoing lung cancer resection at the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University. Patients were randomly assigned to a music therapy (MT) group and a control (C) group. The MT group underwent preoperative and postoperative music intervention while the C group did not. Both groups received intravenous patient-controlled sufentanil analgesia. The primary outcome was the visual analogue scale (VAS) score at 24 hours after surgery. The secondary outcomes included hemodynamic changes (systolic blood pressure, diastolic blood pressure, heart rate), changes on the Self-Rating Anxiety Scale (SAS), total consumption of sufentanil, number of uses, sedation, and adverse effects. The postoperative sufentanil dose and analgesia frequency were recorded. Compared with the C group, the MT group had significantly lower VAS score, systolic and diastolic blood pressure, heart rate, and SAS score within 24 hours after surgery (p < 0.01). In addition, postoperative analgesia frequency and sufentanil dose were reduced in the MT group (p < 0.01). Combined music therapy and sufentanil improves intravenous patient-controlled analgesia effects compared with sufentanil alone after lung cancer surgery. Lower doses of sufentanil could be administered to more effectively improve patients' cardiovascular parameters.

Prospective Randomized Phase II Parallel Study of Vinorelbine Maintenance Therapy versus Best Supportive Care in Advanced Non-Small Cell Lung Cancer.

PubMed

Khosravi, Adnan; Esfahani-Monfared, Zahra; Seifi, Sharareh; Khodadad, Kian

2017-01-01

Maintenance strategy has been used to improve survival in non-small cell lung cancer (NSCLC). We investigated whether switch maintenance therapy with vinorelbine improved progression free survival (PFS) after first-line chemotherapy with gemcitabine plus carboplatin. In this single blind, parallel, phase 2, randomized trial, patients with NSCLC pathology, age >18 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2, and advanced stage (IIIB and IV) were treated with up to 6 cycles of gemcitabine 1250 mg/m 2 (day 1 and 8) plus carboplatin AUC 5 (day 1) every 3 weeks. Patients who did not show progression after first-line chemotherapy were randomly assigned to receive switch maintenance with vinorelbine (25 mg/m 2 , day 1, 15) or the best supportive care until disease progression. A total of 100 patients were registered, of whom 34 had a non-progressive response to first-line chemotherapy and randomly received maintenance vinorelbine (n=19) or best supportive care (n=15). The hazard ratio of PFS in the vinorelbine group relative to the best supportive care group was 1.097 (95% confidence interval = 0.479-2.510; P-value =0.827). There was no significant difference between the overall survival for the two groups (P=0.068). Switch maintenance strategies are beneficial, but defining the right candidates for treatment is a problem. Moreover, the trial designs do not always reflect the real-world considerations. Switch maintenance therapy with vinorelbine, though had tolerable toxicity, did not improve PFS in patients with NSCLC. Therefore, other agents should be considered in this setting.

[Meta analysis of parallel versus perpendicular double plating for distal humerus fracture of type C in adults].

PubMed

Li, B B; Lin, F; Cai, L H; Chen, Y; Lin, Z J

2017-08-01

Objective: To evaluate the effects of parallel versus perpendicular double plating for distal humerus fracture of type C. Methods: A standardized comprehensive literature search was performed by PubMed, Embase, Cochrane library, CMB, CNKI and Medline datebase.Randomized controlled studies on comparison between parallel versus perpendicular double plating for distal humerus fracture of type C before December 2015 were enrolled in the study.All date were analyzed by the RevMan 5.2 software. Results: Six studies, including 284 patients, met the inclusion criteria.There were 155 patients in perpendicular double plating group, 129 patients in parallel double plating group.The results of Meta-analysis indicated that there were statistically significant difference between the two groups in complications ( OR =2.59, 95% CI : 1.03 to 6.53, P =0.04). There was no significant difference between the two groups in surgical duration ( MD =-1.84, 95% CI : -9.06 to 5.39, P =0.62), bone union time ( MD =0.09, 95% CI : -0.06 to 0.24, P =0.22), Mayo Elbow Performance Score ( MD =0.09, 95% CI : -0.06 to 0.24, P =0.22), Range of Motions ( MD =-0.92, 95% CI : -4.65 to 2.81, P =0.63) and the rate of excellent and good results ( OR =0.64, 95% CI : 0.27 to 1.52, P =0.31). Conclusion: Both perpendicular and parallel double plating are effective in distal humerus fracture of type C, parallel double plating has less complications.

Isoflavones, calcium, vitamin D and inulin improve quality of life, sexual function, body composition and metabolic parameters in menopausal women: result from a prospective, randomized, placebo-controlled, parallel-group study.

PubMed

Vitale, Salvatore Giovanni; Caruso, Salvatore; Rapisarda, Agnese Maria Chiara; Cianci, Stefano; Cianci, Antonio

2018-03-01

Menopause results in metabolic changes that contribute to increase risk of cardiovascular diseases: increase in low density lipoprotein (LDL) and triglycerides and decrease in high density lipoprotein (HDL), weight gain are associated with a correspondent increase in incidence of hypertension and diabetes. The aim of this study was to evaluate the effect of a preparation of isoflavones, calcium vitamin D and inulin in menopausal women. We performed a prospective, randomized, placebo-controlled, parallel-group study. A total of 50 patients were randomized to receive either oral preparations of isoflavones (40 mg), calcium (500 mg) vitamin D (300 UI) and inulin (3 g) or placebo (control group). Pre- and post-treatment assessment of quality of life and sexual function were performed through Menopause-Specific Quality of Life Questionnaire (MENQOL) and Female Sexual Function Index (FSFI); evaluations of anthropometric indicators, body composition through bioelectrical impedance analyser, lumbar spine and proximal femur T-score and lipid profile were performed. After 12 months, a significant reduction in MENQOL vasomotor, physical and sexual domain scores ( p < 0.05) and a significant increase in all FSFI domain scores ( p < 0.05) were observed in treatment group. Laboratory tests showed significant increase in serum levels of HDL ( p < 0.05). No significant changes of lumbar spine and femur neck T-score ( p > 0.05) were found in the same group. According to our data analysis, isoflavones, calcium, vitamin D and inulin may exert favourable effects on menopausal symptoms and signs.

[Effect of urapidil combined with phentolamine on hypertension during extracorporeal circulation].

PubMed

Wang, Fangjun; Chen, Bin; Liu, Yang; Tu, Faping

2014-08-01

To study the effect of urapidil combined with phentolamine in the management of hypertension during extracorporeal circulation. Ninety patients undergoing aortic and mitral valve replacement were randomly divided into 3 equal groups to receive treatment with phentolamine (group A), urapidil (group B), or both (group C) during extracorporeal circulation. The mean arterial pressure (MAP) before and after drug administration, time interval of two administrations, spontaneous recovery of heart beat after aorta unclamping, ventricular arrhythmia, changes of ST-segment 1 min after the recovery of heart beat, ante-parallel cycle time, aorta clamping time, post-parallel cycle time, dopamine dose after cardiac resuscitation, and perioperative changes of plasma TNF-α and IL-6 levels were recorded. There was no significant difference in MAP between the 3 groups before or after hypotensive drug administration (P>0.05). The time interval of two hypotensive drug administrations was longer in group C than in groups A and B (P<0.05). The incidence of spontaneous recovery of heart beat after aorta unclamping, incidence of ventricular arrhythmia, changes of ST-segment 1 min after the recovery of heart beat, ante-parallel cycle time, aorta clamping time, and post-parallel cycle time were all comparable between the 3 groups. The dose of dopamine administered after cardiac resuscitation was significantly larger in group B than in groups A or group C (P<0.05). The plasma levels of TNF-α and IL-6 were significantly increased after CPB and after the operation in all the groups, but were lowed in group C than in groups A and B at the end of CPB and at 2 h and 12 after the operation. Urapidil combined with phentolamine can control hypertension during extracorporeal circulation without causing hypotension.

Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial.

PubMed

Yang, Wenying; Zhu, Lvyun; Meng, Bangzhu; Liu, Yu; Wang, Wenhui; Ye, Shandong; Sun, Li; Miao, Heng; Guo, Lian; Wang, Zhanjian; Lv, Xiaofeng; Li, Quanmin; Ji, Qiuhe; Zhao, Weigang; Yang, Gangyi

2016-01-01

The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject-driven and investigator-driven groups, respectively. Subject-titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.

Reporting of participant flow diagrams in published reports of randomized trials.

PubMed

Hopewell, Sally; Hirst, Allison; Collins, Gary S; Mallett, Sue; Yu, Ly-Mee; Altman, Douglas G

2011-12-05

Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.

The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study.

PubMed

Ghali, Jalal K; Orlandi, Cesare; Abraham, William T

2012-06-01

Volume overload is the dominant feature of decompensated heart failure (HF) and it often results in adverse clinical outcomes. Vasopressin receptor antagonists such as lixivaptan may provide effective volume unloading. This study assessed weight loss after 1 day and 8 weeks of treatment with lixivaptan in outpatients with HF and volume overload. This phase II, 8-week, multicentre, double-blind, parallel-group study randomized participants (2:1) to receive lixivaptan 100 mg or placebo once daily (in addition to standard HF therapy). Body weight and cardiovascular assessments were made at baseline, Day 1 (not cardiovascular), Weeks 1, 2, 4, and 8, and 7 days post-treatment. The Trail-making Test, part B (TMT-B) and the Medical Outcomes Survey 6-item cognitive function scale (MOS-6) were assessed at baseline and Week 4. The study randomized 170 participants (lixivaptan, n = 111; placebo, n = 59). Most (97.1%) were receiving pharmacological therapy for HF at baseline. Demographic characteristics were generally similar between the two groups. Body weight decreased significantly from baseline to Day 1 with lixivaptan vs. placebo (least-square mean change ± standard error: - 0.38 ± 0.08 kg vs. +0.13 ± 0.11 kg; P < 0.001) and at Weeks 1, 2, and 4 (P < 0.01). Cardiovascular changes were generally similar in both groups, though orthopnoea and dyspnoea improved in the lixivaptan group vs. placebo. The TMT-B and MOS-6 showed no significant differences between groups. Lixivaptan was well tolerated-thirst and polyuria occurred more frequently vs. placebo. In outpatients with HF and volume overload, lixivaptan 100 mg once daily, when added to standard therapy, reduced body weight, improved dyspnoea and orthopnoea, and was well tolerated. NCT01055912.

Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial.

PubMed

Braendvik, Siri Merete; Koret, Teija; Helbostad, Jorunn L; Lorås, Håvard; Bråthen, Geir; Hovdal, Harald Olav; Aamot, Inger Lise

2016-12-01

The most effective treatment approach to improve walking in people with multiple sclerosis (MS) is not known. The aim of this trial was to assess the efficacy of treadmill training and progressive strength training on walking in people with MS. A single blinded randomized parallel group trial was carried out. Eligible participants were adults with MS with Expanded Disability Status Scale score ≤6. A total of 29 participants were randomized and 28 received the allocated exercise intervention, treadmill (n = 13) or strength training (n = 15). Both groups exercised 30 minutes, three times a week for 8 weeks. Primary outcome was The Functional Ambulation Profile evaluated by the GAITRite walkway. Secondary outcomes were walking work economy and balance control during walking, measured by a small lightweight accelerometer connected to the lower back. Testing was performed at baseline and the subsequent week after completion of training. Two participants were lost to follow-up, and 11 (treadmill) and 15 (strength training) were left for analysis. The treadmill group increased their Functional Ambulation Profile score significantly compared with the strength training group (p = .037). A significant improvement in walking work economy (p = .024) and a reduction of root mean square of vertical acceleration (p = .047) also favoured the treadmill group. The results indicate that task-specific training by treadmill walking is a favourable approach compared with strength training to improve walking in persons with mild and moderate MS. Implications for Physiotherapy practice, this study adds knowledge for the decision of optimal treatment approaches in people with MS. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Design paper: the DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression.

PubMed

Krogh, Jesper; Petersen, Lone; Timmermann, Michael; Saltin, Bengt; Nordentoft, Merete

2007-01-01

In western countries, the yearly incidence of depression is estimated to be 3-5% and the lifetime prevalence is 17%. In patient populations with chronic diseases the point prevalence may be 20%. Depression is associated with increased risk for various conditions such as osteoporoses, cardiovascular diseases, and dementia. WHO stated in 2000 that depression was the fourth leading cause of disease burden in terms of disability. In 2000 the cost of depression in the US was estimated to 83 billion dollars. A predominance of trials suggests that physical exercise has a positive effect on depressive symptoms. However, a meta-analysis from 2001 stated: "The effectiveness of exercise in reducing symptoms of depression cannot be determined because of a lack of good quality research on clinical populations with adequate follow-up." The major objective for this randomized trial is to compare the effect of non-aerobic, aerobic, and relaxation training on depressive symptoms using the blindly assessed Hamilton depression scale (HAM-D(17)) as primary outcome. The secondary outcome is the effect of the intervention on working status (i.e., lost days from work, employed/unemployed) and the tertiary outcomes consist of biological responses. The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are recruited through general practitioners and psychiatrist and randomized to three different interventions: 1) non-aerobic, -- progressive resistance training, 2) aerobic training, -- cardio respiratory fitness, and 3) relaxation training with minimal impact on strength or cardio respiratory fitness. Training for all three groups takes place twice a week for 4 months. Evaluation of patients' symptoms takes place four and 12 months after inclusion. The trial is designed to include 45 patients in each group. Statistical analysis will be done as intention to treat (all randomized patients). Results from the DEMO trial will be reported according to the CONSORT guidelines in 2008-2009.

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

PubMed

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

2018-01-01

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

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

PubMed Central

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

2018-01-01

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

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally.

PubMed

Solomon, Todd M; Leech, Jarrett; deBros, Guy B; Murphy, Cynthia A; Budson, Andrew E; Vassey, Elizabeth A; Solomon, Paul R

2016-03-01

Alpha BRAIN® is a nootropic supplement that purports to enhance cognitive functioning in healthy adults. The goal of this study was to investigate the efficacy of this self-described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double blind, placebo-controlled design. A total of 63-treatment naïve individuals between 18 and 35 years of age completed the randomized, double-blind, placebo controlled trial. All participants completed a 2-week placebo run in before receiving active product, Alpha BRAIN® or new placebo, for 6 weeks. Participants undertook a battery of neuropsychological tests at randomization and at study completion. Primary outcome measures included a battery of neuropsychological tests and measures of sleep. Compared with placebo, Alpha BRAIN® significantly improved on tasks of delayed verbal recall and executive functioning. Results also indicated significant time-by-group interaction in delayed verbal recall for the Alpha BRAIN® group. The use of Alpha BRAIN® for 6 weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN®, and the results merit further study. Copyright © 2016 John Wiley & Sons, Ltd.

The role of prophylactic internal iliac artery ligation in abnormally invasive placenta undergoing caesarean hysterectomy: a randomized control trial.

PubMed

Hussein, Ahmed M; Dakhly, Dina Mohamed Refaat; Raslan, Ayman N; Kamel, Ahmed; Abdel Hafeez, Ali; Moussa, Manal; Hosny, Ahmed Samir; Momtaz, Mohamed

2018-04-25

To identify the role of bilateral internal iliac artery (IIA) ligation on reducing blood loss in abnormally invasive placenta (AIP) undergoing caesarean hysterectomy. In this parallel-randomized control trial, 57 pregnant females with ultrasound features suggestive of AIP were enrolled. They were randomized into two groups; IIA group (n = 29 cases) performed bilateral IIA ligation followed by caesarean hysterectomies, while Control group (n = 28 cases) underwent caesarean hysterectomy only. The main outcome was the difference in the estimated intraoperative blood loss between the two groups. There was no significant difference between the two groups regarding the intraoperative estimated blood loss (1632 ± 804 versus 1698 ± 1251, p value .83). The operative procedure duration (minutes) (223 ± 66 versus 171 ± 41.4, p value .001) varied significantly between the two groups. Bilateral internal iliac artery ligation, in cases of AIP undergoing caesarean hysterectomy, is not recommended for routine practice to minimize blood loss intraoperatively.

Comparative Evaluation of the Efficacy of Probiotic, Herbal and Chlorhexidine Mouthwash on Gingival Health: A Randomized Clinical Trial

PubMed Central

Dodamani, Arun Suresh; Karibasappa, Gundabaktha; Khairnar, Mahesh Ravindra; Naik, Rahul Gaybarao; Jadhav, Harish Chaitram

2017-01-01

Introduction Due to inherent limitations of Chlorhexidine (CHX), search for an effective and potentially safe anti-plaque agent has led to emergence of alternative products. Aim The present study evaluated the comparative efficacy of probiotic, herbal and CHX mouthwashes on gingival health of healthy individuals. Materials and Methods The present study was randomized parallel group controlled trial. A group of 45 healthy subjects in the age group of 18-21 years received complete supragingival scaling at baseline and study variables viz., Oral Hygiene Index – Simplified (OHI-S), Plaque Index (PI) and Gingival Index (GI) were recorded. Subjects were then randomly divided into three groups (15 in each group) and were randomly intervened with three different mouthwashes i.e., HiOra mouthwash, CHX mouthwash and Probiotic mouthwash. Variables were again recorded on the seventh and 14th day after use of mouthwashes and data obtained was subjected to statistical analysis. Results There was no significant difference in the efficacy of CHX, HiOra regular and probiotic mouthwashes on plaque accumulation, gingival health and oral hygiene status. Conclusion Herbal and probiotic mouthwashes can prove to be effective alternatives to CHX with minimal side effects. PMID:28511500

A Parallel Randomized Clinical Trial Examining the Return of Urinary Continence after Robot-Assisted Radical Prostatectomy with or without a Small Intestinal Submucosa Bladder Neck Sling.

PubMed

Bahler, Clinton D; Sundaram, Chandru P; Kella, Naveen; Lucas, Steven M; Boger, Michelle A; Gardner, Thomas A; Koch, Michael O

2016-07-01

Urinary continence is a driver of quality of life after radical prostatectomy. In this study we evaluated the impact of a biological bladder neck sling on the return of urinary continence after robot-assisted radical prostatectomy. This study compared early continence in patients undergoing robot-assisted radical prostatectomy with a sling and without a sling in a 2-group, 1:1, parallel, randomized controlled trial. Patients were blinded to group assignment. The primary outcome was defined as urinary continence (0 to 1 pad per day) at 1 month postoperatively. Inclusion criteria were organ confined prostate cancer and a prostate specific antigen less than 15 ng/ml. Exclusion criteria were any prior surgery on the prostate, a history of neurogenic bladder and history of pelvic radiation. A chi-squared test was used for the primary outcome. A total of 147 patients were randomized (control 74, sling 73) and 92% were available for primary end point analysis at 1 month. There were no significant differences in baseline or perioperative data except that operating room time was 20.1 minutes longer for the sling group (p=0.04). The continence rate was similar between the control and sling groups at 1 month (47.1% vs 55.2%, p=0.34) and 12 months (86.7% vs 94.5%, p=0.15), respectively. Adverse events were similar between the control and sling groups (10.8% vs 13.7%, p=0.59). The application of an absorbable urethral sling at robot-assisted radical prostatectomy was well tolerated with no increase in obstructive symptoms in this randomized trial. However, the sling failed to show a significant improvement in continence. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Ten-day quadruple therapy comprising low-dose rabeprazole, bismuth, amoxicillin and tetracycline is an effective and safe first-line treatment for Helicobacter pylori infection in population with high antibiotic resistance: a prospective, multicenter, randomized, parallel-controlled clinical trial in China.

PubMed

Xie, Yong; Zhu, Zhenhua; Wang, Jiangbin; Zhang, Lingxia; Zhang, Zhenyu; Lu, Hong; Zeng, Zhirong; Chen, Shiyao; Liu, Dongsheng; Lv, Nonghua

2018-06-18

Objectives: To investigate the efficacy and safety of 10-day bismuth quadruple therapy with amoxicillin, tetracycline or clarithromycin and different doses of rabeprazole for first-line treatment of Helicobacter pylori infection. Methods: This multicenter, randomized, parallel-controlled clinical trial was conducted between March 2013 and August 2014. A total of 431 H. pylori -infected patients with duodenal ulcers were enrolled and randomized into four treatment groups (1:1:1:1) for 10 days: 1. LR-BAC Group, which received rabeprazole 10 mg b.i.d., bismuth, amoxicillin and clarithromycin; 2. LR-BAT Group, which received rabeprazole 10mg b.i.d., bismuth, amoxicillin and tetracycline; 3. HR-BAC Group, which received rabeprazole 20 mg b.i.d., and bismuth, amoxicillin and clarithromycin; and 4. HR-BAT Group, which received rabeprazole 20 mg b.i.d., bismuth, amoxicillin, tetracycline. Antimicrobial susceptibility was assessed by the E-test method. The primary outcome was H. pylori eradication at 4 weeks after the treatment. Results: The per-protocol (PP) eradication rates in the LR-BAC, LR-BAT, HR-BAC, and HR-BAT groups were 94.1%, 91.9%, 94.8% and 91.9%, respectively, while the intention-to-treat (ITT) eradication rates in those groups were 87.2%, 87.2%, 87.7% and 86%, respectively. There was no significant difference between four groups in PP analysis( P =0.799) and ITT analysis( P =0.985). The efficacies of four treatment therapy were not affected by antibiotics resistance. The adverse events in four treatment groups were similar, CNS and gastrointestinal symptoms were the most common reported. Conclusions: Bismuth-containing quadruple therapy with low-dose rabeprazole, amoxicillin and tetracycline is a good option for first-line treatment of H. pylori infection in population with high antibiotic resistance. Copyright © 2018 Xie et al.

Evaluation of pulsing magnetic field effects on paresthesia in multiple sclerosis patients, a randomized, double-blind, parallel-group clinical trial.

PubMed

Afshari, Daryoush; Moradian, Nasrin; Khalili, Majid; Razazian, Nazanin; Bostani, Arash; Hoseini, Jamal; Moradian, Mohamad; Ghiasian, Masoud

2016-10-01

Evidence is mounting that magnet therapy could alleviate the symptoms of multiple sclerosis (MS). This study was performed to test the effects of the pulsing magnetic fields on the paresthesia in MS patients. This study has been conducted as a randomized, double-blind, parallel-group clinical trial during the April 2012 to October 2013. The subjects were selected among patients referred to MS clinic of Imam Reza Hospital; affiliated to Kermanshah University of Medical Sciences, Iran. Sixty three patients with MS were included in the study and randomly were divided into two groups, 35 patients were exposed to a magnetic pulsing field of 4mT intensity and 15-Hz frequency sinusoidal wave for 20min per session 2 times per week over a period of 2 months involving 16 sessions and 28 patients was exposed to a magnetically inactive field (placebo) for 20min per session 2 times per week over a period of 2 months involving 16 sessions. The severity of paresthesia was measured by the numerical rating scale (NRS) at 30, 60days. The study primary end point was NRS change between baseline and 60days. The secondary outcome was NRS change between baseline and 30days. Patients exposing to magnetic field showed significant paresthesia improvement compared with the group of patients exposing to placebo. According to our results pulsed magnetic therapy could alleviate paresthesia in MS patients .But trials with more patients and longer duration are mandatory to describe long-term effects. Copyright © 2016 Elsevier B.V. All rights reserved.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules in Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Greenhill, Laurence L.; Muniz, Rafael; Ball, Roberta R.; Levine, Alan; Pestreich, Linda; Jiang, Hai

2006-01-01

Objective: The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD). Method: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with…

Randomization and Data-Analysis Items in Quality Standards for Single-Case Experimental Studies

ERIC Educational Resources Information Center

Heyvaert, Mieke; Wendt, Oliver; Van den Noortgate, Wim; Onghena, Patrick

2015-01-01

Reporting standards and critical appraisal tools serve as beacons for researchers, reviewers, and research consumers. Parallel to existing guidelines for researchers to report and evaluate group-comparison studies, single-case experimental (SCE) researchers are in need of guidelines for reporting and evaluating SCE studies. A systematic search was…

Isoflavones, calcium, vitamin D and inulin improve quality of life, sexual function, body composition and metabolic parameters in menopausal women: result from a prospective, randomized, placebo-controlled, parallel-group study

PubMed Central

Caruso, Salvatore; Rapisarda, Agnese Maria Chiara; Cianci, Stefano; Cianci, Antonio

2018-01-01

Introduction Menopause results in metabolic changes that contribute to increase risk of cardiovascular diseases: increase in low density lipoprotein (LDL) and triglycerides and decrease in high density lipoprotein (HDL), weight gain are associated with a correspondent increase in incidence of hypertension and diabetes. The aim of this study was to evaluate the effect of a preparation of isoflavones, calcium vitamin D and inulin in menopausal women. Material and methods We performed a prospective, randomized, placebo-controlled, parallel-group study. A total of 50 patients were randomized to receive either oral preparations of isoflavones (40 mg), calcium (500 mg) vitamin D (300 UI) and inulin (3 g) or placebo (control group). Pre- and post-treatment assessment of quality of life and sexual function were performed through Menopause-Specific Quality of Life Questionnaire (MENQOL) and Female Sexual Function Index (FSFI); evaluations of anthropometric indicators, body composition through bioelectrical impedance analyser, lumbar spine and proximal femur T-score and lipid profile were performed. Results After 12 months, a significant reduction in MENQOL vasomotor, physical and sexual domain scores (p < 0.05) and a significant increase in all FSFI domain scores (p < 0.05) were observed in treatment group. Laboratory tests showed significant increase in serum levels of HDL (p < 0.05). No significant changes of lumbar spine and femur neck T-score (p > 0.05) were found in the same group. Conclusions According to our data analysis, isoflavones, calcium, vitamin D and inulin may exert favourable effects on menopausal symptoms and signs. PMID:29725283

Dietary supplementation with rice bran fermented with Lentinus edodes increases interferon-γ activity without causing adverse effects: a randomized, double-blind, placebo-controlled, parallel-group study.

PubMed

Choi, Ji-Young; Paik, Doo-Jin; Kwon, Dae Young; Park, Yongsoon

2014-04-22

The purpose of this study was to investigate the hypothesis that dietary supplementation with rice bran fermented with Lentinus edodes (rice bran exo-biopolymer, RBEP), a substance known to contain arabinoxylan, enhances natural killer (NK) cell activity and modulates cytokine production in healthy adults. This study was designed in a randomized, double-blind, placebo-controlled, and parallel-group format. Eighty healthy participants with white blood cell counts of 4,000-8,000 cells/μL were randomly assigned to take six capsules per day of either 3 g RBEP or 3 g placebo for 8 weeks. Three participants in the placebo group were excluded after initiation of the protocol; no severe adverse effects from RBEP supplementation were reported. NK cell activity of peripheral blood mononuclear cells was measured using nonradioactive cytotoxicity assay kits and serum cytokine concentrations included interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-2, IL-4, IL-10, and IL-12 were measured by Bio-Plex cytokine assay kit. This study was registered with the Clinical Research Information Service (KCT0000536). Supplementation of RBEP significantly increased IFN-γ production compared with the placebo group (P = 0.012). However, RBEP supplementation did not affect either NK cell activity or cytokine levels, including IL-2, IL-4, IL-10, IL-12, and TNF-α, compared with the placebo group. The data obtained in this study indicate that RBEP supplementation increases IFN-γ secretion without causing significant adverse effects, and thus may be beneficial to healthy individuals. This new rice bran-derived product may therefore be potentially useful to include in the formulation of solid and liquid foods designed for treatment and prevention of pathological states associated with defective immune responses.

Early High-dosage Atorvastatin Treatment Improved Serum Immune-inflammatory Markers and Functional Outcome in Acute Ischemic Strokes Classified as Large Artery Atherosclerotic Stroke

PubMed Central

Tuttolomondo, Antonino; Di Raimondo, Domenico; Pecoraro, Rosaria; Maida, Carlo; Arnao, Valentina; Corte, Vittoriano Della; Simonetta, Irene; Corpora, Francesca; Di Bona, Danilo; Maugeri, Rosario; Iacopino, Domenico Gerardo; Pinto, Antonio

2016-01-01

Abstract Statins have beneficial effects on cerebral circulation and brain parenchyma during ischemic stroke and reperfusion. The primary hypothesis of this randomized parallel trial was that treatment with 80 mg/day of atorvastatin administered early at admission after acute atherosclerotic ischemic stroke could reduce serum levels of markers of immune-inflammatory activation of the acute phase and that this immune-inflammatory modulation could have a possible effect on prognosis of ischemic stroke evaluated by some outcome indicators. We enrolled 42 patients with acute ischemic stroke classified as large arteries atherosclerosis stroke (LAAS) randomly assigned in a randomized parallel trial to the following groups: Group A, 22 patients treated with atorvastatin 80 mg (once-daily) from admission day until discharge; Group B, 20 patients not treated with atorvastatin 80 mg until discharge, and after discharge, treatment with atorvastatin has been started. At 72 hours and at 7 days after acute ischemic stroke, subjects of group A showed significantly lower plasma levels of tumor necrosis factor-α, interleukin (IL)-6, vascular cell adhesion molecule-1, whereas no significant difference with regard to plasma levels of IL-10, E-Selectin, and P-Selectin was observed between the 2 groups. At 72 hours and 7 days after admission, stroke patients treated with atorvastatin 80 mg in comparison with stroke subjects not treated with atorvastatin showed a significantly lower mean National Institutes of Health Stroke Scale and modified Rankin scores. Our findings provide the first evidence that atorvastatin acutely administered immediately after an atherosclerotic ischemic stroke exerts a lowering effect on immune-inflammatory activation of the acute phase of stroke and that its early use is associated to a better functional and prognostic profile. PMID:27043681

Effect of Probiotic Curd on Salivary pH and Streptococcus mutans: A Double Blind Parallel Randomized Controlled Trial.

PubMed

Srivastava, Shivangi; Saha, Sabyasachi; Kumari, Minti; Mohd, Shafaat

2016-02-01

Dairy products like curd seem to be the most natural way to ingest probiotics which can reduce Streptococcus mutans level and also increase salivary pH thereby reducing the dental caries risk. To estimate the role of probiotic curd on salivary pH and Streptococcus mutans count, over a period of 7 days. This double blind parallel randomized clinical trial was conducted at the institution with 60 caries free volunteers belonging to the age group of 20-25 years who were randomly allocated into two groups. Test Group consisted of 30 subjects who consumed 100ml of probiotic curd daily for seven days while an equal numbered Control Group were given 100ml of regular curd for seven days. Saliva samples were assessed at baseline, after ½ hour 1 hour and 7 days of intervention period using pH meter and Mitis Salivarius Bacitracin agar to estimate salivary pH and S. mutans count. Data was statistically analysed using Paired and Unpaired t-test. The study revealed a reduction in salivary pH after ½ hour and 1 hour in both the groups. However after 7 days, normal curd showed a statistically significant (p< 0.05) reduction in salivary pH while probiotic curd showed a statistically significant (p< 0.05) increase in salivary pH. Similarly with regard to S. mutans colony counts probiotic curd showed statistically significant reduction (p< 0.05) as compared to normal curd. Short-term consumption of probiotic curds showed marked salivary pH elevation and reduction of salivary S. mutans counts and thus can be exploited for the prevention of enamel demineralization as a long-term remedy keeping in mind its cost effectiveness.

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

PubMed Central

Kim, Jinyoung; Cho, Jae-Heung

2017-01-01

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere's disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck's Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions' questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017. PMID:29387128

Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan.

PubMed

Chen, Yeung-Jen; Chiang, Chao-Ching; Huang, Peng-Ju; Huang, Jason; Karcher, Keith; Li, Honglan

2015-11-01

To evaluate the efficacy and safety of tapentadol immediate-release (IR) for treating acute pain following orthopedic bunionectomy surgery in a Taiwanese population. This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group bridging study in which Taiwanese patients (N = 60) with moderate-to-severe pain following bunionectomy were randomized (1:1:1) to receive tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours over a 72 hour period. The primary endpoint was the sum of pain intensity difference over 48 hours (SPID48), analyzed using analysis of variance. Out of 60 patients randomized (mainly women [96.7%]; median age 44 years), 41 (68.3%) completed the treatment. Mean SPID48 values were significantly higher for tapentadol IR (p ≤ 0.006: 50 mg, p ≤ 0.004: 75 mg) compared with placebo. Between-group differences in LS means of SPID48 (vs. placebo) were tapentadol IR 50 mg: 105.6 (95% CI: 32.0; 179.2); tapentadol IR 75 mg: 126.6 (95% CI: 49.5; 203.7). Secondary endpoints including SPID at 12, 24, and 72 hours, time to first use of rescue medication, cumulative distribution of responder rates, total pain relief and sum of total pain relief and sum of pain intensity difference at 12, 24, 48, and 72 hours, and patient global impression of change showed numerically better results supporting that tapentadol IR (50 and 75 mg) was more efficacious than placebo in relieving acute pain. The most frequent treatment emergent adverse events reported in ≥ 10% patients in either group were dizziness, nausea, and vomiting. A limitation of this study may possibly include more controlled patient monitoring through 4-6 hour dosing intervals, which reflects optimal conditions and thus may not approximate real-world clinical practice. However, all treatment groups would be equally affected by such bias of frequent monitoring, if any, since it was a randomized and double-blind study. Tapentadol IR treatment significantly relieved acute postoperative pain and was well tolerated in a Taiwanese population. ClinicalTrials.gov identifier: NCT01813890.

Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial.

PubMed

Voogt, Carmen V; Poelen, Evelien A P; Kleinjan, Marloes; Lemmers, Lex A C J; Engels, Rutger C M E

2011-04-14

The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N=454: web-based brief alcohol intervention) or control condition (N=454: no intervention). The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief alcohol intervention. We expect a reduction of mean weekly alcohol consumption and frequency of binge drinking in the experimental condition compared to the control condition as a direct result of the intervention. If the website is effective, it will be implemented in alcohol prevention initiatives, which will facilitate the implementation of the protocol. Netherlands Trial Register NTR2665.

The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

PubMed

Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

2015-11-01

In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. Copyright © 2015 Elsevier Inc. All rights reserved.

The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

PubMed

Hosomi, Naohisa; Nagai, Yoji; Kohriyama, Tatsuo; Ohtsuki, Toshiho; Aoki, Shiro; Nezu, Tomohisa; Maruyama, Hirofumi; Sunami, Norio; Yokota, Chiaki; Kitagawa, Kazuo; Terayama, Yasuo; Takagi, Makoto; Ibayashi, Setsuro; Nakamura, Masakazu; Origasa, Hideki; Fukushima, Masanori; Mori, Etsuro; Minematsu, Kazuo; Uchiyama, Shinichiro; Shinohara, Yukito; Yamaguchi, Takenori; Matsumoto, Masayasu

2015-09-01

Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients. This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints. Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events. Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis. This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

Text Messages Promoting Mental Imagery Increase Self-Reported Physical Activity in Older Adults: A Randomized Controlled Study.

PubMed

Robin, Nicolas; Toussaint, Lucette; Coudevylle, Guillaume R; Ruart, Shelly; Hue, Olivier; Sinnapah, Stephane

2018-06-22

This study tested whether text messages prompting adults 50 years of age and older to perform mental imagery would increase aerobic physical activity (APA) duration using a randomized parallel trial design. Participants were assigned to an Imagery 1, Imagery 2, or placebo group. For 4 weeks, each group was exposed to two conditions (morning text message vs. no morning text message). In the morning message condition, the imagery groups received a text message with the instruction to mentally imagine performing an APA, and the placebo group received a placebo message. All participants received an evening text message of "Did you do your cardio today? If yes, what did you do?" for 3 days per week. Participants of the imagery groups reported significantly more weekly minutes of APA in the morning text message condition compared with the no morning message condition. Electronic messages were effective at increasing minutes of APA.

Randomized controlled trial of video self-modeling following speech restructuring treatment for stuttering.

PubMed

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-08-01

In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech restructuring treatment. Post treatment, participants were randomly assigned to 2 trial arms: standard maintenance and standard maintenance plus VSM. Participants in the latter arm viewed stutter-free videos of themselves each day for 1 month. The addition of VSM did not improve speech outcomes, as measured by percent syllables stuttered, at either 1 or 6 months postrandomization. However, at the latter assessment, self-rating of worst stuttering severity by the VSM group was 10% better than that of the control group, and satisfaction with speech fluency was 20% better. Quality of life was also better for the VSM group, which was mildly to moderately impaired compared with moderate impairment in the control group. VSM intervention after treatment was associated with improvements in self-reported outcomes. The clinical implications of this finding are discussed.

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: a 3-year randomized clinical trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele

2012-02-01

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.

Oral sumatriptan for migraine in children and adolescents: a randomized, multicenter, placebo-controlled, parallel group study.

PubMed

Fujita, Mitsue; Sato, Katsuaki; Nishioka, Hiroshi; Sakai, Fumihiko

2014-04-01

The objective of this article is to evaluate the efficacy and tolerability of two doses of oral sumatriptan vs placebo in the acute treatment of migraine in children and adolescents. Currently, there is no approved prescription medication in Japan for the treatment of migraine in children and adolescents. This was a multicenter, outpatient, single-attack, double-blind, randomized, placebo-controlled, parallel-group study. Eligible patients were children and adolescents aged 10 to 17 years diagnosed with migraine with or without aura (ICHD-II criteria 1.1 or 1.2) from 17 centers. They were randomized to receive sumatriptan 25 mg, 50 mg or placebo (1:1:2). The primary efficacy endpoint was headache relief by two grades on a five-grade scale at two hours post-dose. A total of 178 patients from 17 centers in Japan were enrolled and randomized to an investigational product in double-blind fashion. Of these, 144 patients self-treated a single migraine attack, and all provided a post-dose efficacy assessment and completed the study. The percentage of patients in the full analysis set (FAS) population who report pain relief at two hours post-treatment for the primary endpoint was higher in the placebo group than in the pooled sumatriptan group (38.6% vs 31.1%, 95% CI: -23.02 to 8.04, P  = 0.345). The percentage of patients in the FAS population who reported pain relief at four hours post-dose was higher in the pooled sumatriptan group (63.5%) than in the placebo group (51.4%) but failed to achieve statistical significance ( P  = 0.142). At four hours post-dose, percentages of patients who were pain free or had complete relief of photophobia or phonophobia were numerically higher in the sumatriptan pooled group compared to placebo. Both doses of oral sumatriptan were well tolerated. No adverse events (AEs) were serious or led to study withdrawal. The most common AEs were somnolence in 6% (two patients) in the sumatriptan 25 mg treatment group and chest discomfort in 7% (three patients) in the sumatriptan 50 mg treatment group. There was no statistically significant improvement between the sumatriptan pooled group and the placebo group for pain relief at two hours. Oral sumatriptan was well tolerated.

Comparison of immunogenicity between inactivated and live attenuated hepatitis A vaccines: a single-blind, randomized, parallel-group clinical trial among children in Xinjiang Uighur Autonomous Region, China.

PubMed

Liu, Xue-En; Wushouer, Fuerhati; Gou, Aili; Kuerban, Mahemuti; Li, Xinlan; Sun, Yubo; Zhang, Jiamin; Liu, Yan; Li, Jie; Zhuang, Hui

2013-07-01

To compare immunogenicity among an inactivated hepatitis A vaccine (Healive(®)) with one-dose and two-dose regimens, and three kinds of live attenuated vaccines in children. A single-blind, randomized, parallel-group clinical trial was conducted among healthy children aged 1.5-6 y in Xinjiang Uighur Autonomous Region, China. Subjects were randomly assigned to 5 groups. Two groups were administered one-dose or two-dose inactivated vaccine and the remaining groups were immunized with one of three kinds of attenuated vaccines, respectively. Serum samples were collected at 6- and 12-mo follow-ups. Anti-HAV IgG was measured with a microparticle enzyme immunoassay. No significant differences were observed in seroconversion rates (seroprotection rates) among the five groups at 6 or 12 mo (p>0.05). The geometric mean concentration (GMC) of anti-HAV IgG was significantly higher in the two-dose Healive(®) group than in the one-dose Healive(®) group and the attenuated vaccine groups at 12 mo (932.4 vs. 112.7, 135.8, 203.3, 212.8 mIU/ml, respectively, p<0.05). In the one-dose Healive(®) group, the GMC was significantly lower than that in the attenuated vaccine B and C groups at 6 mo (152.6 vs. 212, 204 mIU/ml, p<0.05) and at 12 mo (112.7 vs. 203.3, 212.8, p<0.05), but was similar to the attenuated vaccine A group at 12 mo (112.7 vs. 135.8 mIU/ml, p>0.05). The GMCs were significantly higher in the 1-2 y of age group than in the 3-6 y of age group for all types of vaccines except the attenuated vaccine C (p<0.05) at 12 mo. A higher GMC of anti-HAV IgG was induced in the two-dose Healive(®) than in the one-dose and the attenuated vaccines at 12 mo. The attenuated vaccine B or C produced higher GMCs than the one-dose Healive(®) at 6-12 mo after vaccination.

Effectiveness of supervised oral health maintenance in hearing impaired and mute children- A parallel randomized controlled trial

PubMed Central

Pareek, Sonia; Nagaraj, Anup; Yousuf, Asif; Ganta, Shravani; Atri, Mansi; Singh, Kushpal

2015-01-01

Context: Individuals with special needs may have great limitations in oral hygiene performance due to their potential motor, sensory, and intellectual disabilities. Thus, oral health care utilization is low among the disabled people. Hearing disorders affect the general behavior and impair the level of social functioning. Objectives: The present study was conducted to assess the dental health outcomes following supervised tooth brushing among institutionalized hearing impaired and mute children in Jaipur, Rajasthan. Materials and Methods: The study followed a single-blind, parallel, and randomized controlled design. A total of 315 students were divided into three groups of 105 children each. Group A included resident students, who underwent supervised tooth brushing under the supervision of their parents. The non-resident students were further divided into two groups: Group B and Group C. Group B children were under the supervision of a caregiver and Group C children were under the supervision of both investigator and caregiver. Results: There was an average reduction in plaque score during the subsequent second follow-up conducted 3 weeks after the start of the study and in the final follow-up conducted at 6 weeks. There was also a marked reduction in the gingival index scores in all the three groups. Conclusion: The program of teacher and parent supervised toothbrushing with fluoride toothpaste can be safely targeted to socially deprived communities and can enable a significant reduction in plaque and gingival scores. Thus, an important principle of oral health education is the active involvement of parents and caregivers. PMID:26236676

Measuring the Effects of an Animal-Assisted Intervention for Pediatric Oncology Patients and Their Parents: A Multisite Randomized Controlled Trial [Formula: see text].

PubMed

McCullough, Amy; Ruehrdanz, Ashleigh; Jenkins, Molly A; Gilmer, Mary Jo; Olson, Janice; Pawar, Anjali; Holley, Leslie; Sierra-Rivera, Shirley; Linder, Deborah E; Pichette, Danielle; Grossman, Neil J; Hellman, Cynthia; Guérin, Noémi A; O'Haire, Marguerite E

2018-05-01

This multicenter, parallel-group, randomized trial examined the effects of an animal-assisted intervention on the stress, anxiety, and health-related quality of life for children diagnosed with cancer and their parents. Newly diagnosed patients, aged 3 to 17 years (n = 106), were randomized to receive either standard care plus regular visits from a therapy dog (intervention group), or standard care only (control group). Data were collected at set points over 4 months of the child's treatment. Measures included the State-Trait Anxiety Inventory™, Pediatric Quality of Life Inventory, Pediatric Inventory for Parents, and child blood pressure and heart rate. All instruments were completed by the child and/or his/her parent(s). Children in both groups experienced a significant reduction in state anxiety ( P < .001). Parents in the intervention group showed significantly decreased parenting stress ( P = .008), with no changes in stress among parents in the control group. However, no significant differences between groups over time on any measures were observed. Animal-assisted interventions may provide certain benefits for parents and families during the initial stages of pediatric cancer treatment.

Dose Response Effects of Lisdexamfetamine Dimesylate Treatment in Adults with ADHD: An Exploratory Study

ERIC Educational Resources Information Center

Faraone, Stephen V.; Spencer, Thomas J.; Kollins, Scott H.; Glatt, Stephen J.; Goodman, David

2012-01-01

Objective: To explore dose-response effects of lisdexamfetamine dimesylate (LDX) treatment for ADHD. Method: This was a 4-week, randomized, double-blinded, placebo-controlled, parallel-group, forced-dose titration study in adult participants, aged 18 to 55 years, meeting "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.)…

Impact of a Community-Based Intervention on Serving and Intake of Vegetables among Low-Income, Rural Appalachian Families

ERIC Educational Resources Information Center

Wenrich, Tionni R.; Brown, J. Lynne; Wilson, Robin Taylor; Lengerich, Eugene J.

2012-01-01

Objective: To evaluate the effectiveness of a community-based intervention promoting the serving and eating of deep-orange, cruciferous, and dark-green leafy vegetables. Design: Randomized, parallel-group, community-based intervention with a baseline/postintervention/3-month follow-up design. Setting and Participants: Low-income food preparers (n…

Enhancing Self-Determination in Health: Results of an RCT of the Ask Project, a School-Based Intervention for Adolescents with Intellectual Disability

ERIC Educational Resources Information Center

McPherson, Lyn; Ware, Robert S.; Carrington, Suzanne; Lennox, Nicholas

2017-01-01

Background: Adolescents with intellectual disability have high levels of unrecognized disease and inadequate health screening/promotion which might be addressed by improving health advocacy skills. Methods: A parallel-group cluster randomized controlled trial was conducted to investigate whether a health intervention package, consisting of…

Comprehensive assessment of long-term effects of reducing intake of energy phase 2 (CALERIE Phase 2) screening and recruitment: Methods and results

USDA-ARS?s Scientific Manuscript database

The Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE) study is a systematic investigation of sustained 25% calorie restriction (CR) in non-obese humans. CALERIE is a multicenter (3 clinical sites, one coordinating center), parallel group, randomized con...

Interventions to Reduce Distress in Adult Victims of Rape and Sexual Violence: A Systematic Review

ERIC Educational Resources Information Center

Regehr, Cheryl; Alaggia, Ramona; Dennis, Jane; Pitts, Annabel; Saini, Michael

2013-01-01

Objectives: This article presents a systematic evaluation of the effectiveness of interventions aimed at reducing distress in adult victims of rape and sexual violence. Method: Studies were eligible for the review if the assignment of study participants to experimental or control groups was by random allocation or parallel cohort design. Results:…

Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial.

PubMed

Gnessi, Lucio; Bacarea, Vladimir; Marusteri, Marius; Piqué, Núria

2015-10-30

There is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea. However, few data from clinical trials are available. A randomized, controlled, open-label, parallel group, multicentre, clinical trial was performed to evaluate the efficacy and safety of xyloglucan, in comparison with diosmectite and Saccharomyces in adult patients with acute diarrhea due to different causes. Patients were randomized to receive a 3-day treatment. Symptoms (stools type, nausea, vomiting, abdominal pain and flatulence) were assessed by a self-administered ad-hoc questionnaire 1, 3, 6, 12, 24, 48 and 72 h following the first dose administration. Adverse events were also recorded. A total of 150 patients (69.3 % women and 30.7 % men, mean age 47.3 ± 14.7 years) were included (n = 50 in each group). A faster onset of action was observed in the xyloglucan group compared with the diosmectite and S. bouliardii groups. At 6 h xyloglucan produced a statistically significant higher decrease in the mean number of type 6 and 7 stools compared with diosmectite (p = 0.031). Xyloglucan was the most efficient treatment in reducing the percentage of patients with nausea throughout the study period, particularly during the first hours (from 26 % at baseline to 4 % after 6 and 12 h). An important improvement of vomiting was observed in all three treatment groups. Xyloglucan was more effective than diosmectite and S. bouliardii in reducing abdominal pain, with a constant improvement observed throughout the study. The clinical evolution of flatulence followed similar patterns in the three groups, with continuous improvement of the symptom. All treatments were well tolerated, without reported adverse events. Xyloglucan is a fast, efficacious and safe option for the treatment of acute diarrhea. EudraCT number 2014-001814-24 (date: 2014-04-28) ISRCTN number: 90311828.

Reporting of participant flow diagrams in published reports of randomized trials

PubMed Central

2011-01-01

Background Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. Methods A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Results Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Conclusions Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. PMID:22141446

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Effect of Kangfuxin Solution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

PubMed Central

Luo, Yangkun; Feng, Mei; Fan, Zixuan; Zhu, Xiaodong; Jin, Feng; Li, Rongqing; Wu, Jingbo; Yang, Xia; Jiang, Qinghua; Bai, Hongfang; Huang, Yecai; Lang, Jinyi

2016-01-01

Objective. To evaluate the efficacy and safety of Kangfuxin Solution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients. Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive either Kangfuxin Solution (test group) or compound borax gargle (control group) during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the Verbal Rating Scale (VRS). Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P = 0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in test group (P < 0.01), and the accumulated radiation dose was also higher in test group comparing to the control group (P < 0.05). The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P < 0.01). No significant adverse events were observed. Conclusion. Kangfuxin Solution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application. PMID:27375766

Donepezil and flight simulator performance: effects on retention of complex skills.

PubMed

Yesavage, J A; Mumenthaler, M S; Taylor, J L; Friedman, L; O'Hara, R; Sheikh, J; Tinklenberg, J; Whitehouse, P J

2002-07-09

We report a randomized, double-blind, parallel group, placebo-controlled study to test the effects of the acetylcholinesterase inhibitor, donepezil (5 mg/d for 30 days), on aircraft pilot performance in 18 licensed pilots with mean age of 52 years. After 30 days of treatment, the donepezil group showed greater ability to retain the capacity to perform a set of complex simulator tasks than the placebo group, p < 0.05. Donepezil appears to have beneficial effects on retention of training on complex aviation tasks in nondemented older adults.

Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial.

PubMed

Tao, Jing; Rao, Ting; Lin, Lili; Liu, Wei; Wu, Zhenkai; Zheng, Guohua; Su, Yusheng; Huang, Jia; Lin, Zhengkun; Wu, Jinsong; Fang, Yunhua; Chen, Lidian

2015-02-25

Balance dysfunction after stroke limits patients' general function and participation in daily life. Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals' balance function and reduce the risk of falls. But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate. Considering the difficulties for stroke patients to complete the whole exercise, the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization, parallel-controlled design. A single-blind, cluster-randomized, parallel-controlled trial will be conducted. A total of 10 community health centers (5 per arm) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group. Each community health centers will be asked to enroll 25 eligible patients into the trial. 60 minutes per each session, 1 session per day, 5 times per week and the total training round is 12 weeks. Primary and secondary outcomes will be measured at baseline and 4-weeks, 8-weeks, 12-weeks, 6-week follow-up, 12-week follow-up after randomization. Safety and economic evaluation will also be assessed. This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke. If the outcome is positive, this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients. Chinese Clinical Trial Registry: ChiCTR-TRC-13003641. Registration date: 22 August, 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .

Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.

PubMed

Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu; Ravelomanana, Noro Lantoniaina Rosa; Tabala, Martine; Okitolonda, Emile W

2017-04-26

Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation. The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .

Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial.

PubMed

Klarskov, Pia; Bang, Lia E; Schultz-Larsen, Peter; Gregers Petersen, Hans; Benee Olsen, David; Berg, Ronan M G; Abrahamsen, Henrik; Wiinberg, Niels

2018-01-17

To compare the effect of a conventional to an intensive blood pressure monitoring regimen on blood pressure in hypertensive patients in the general practice setting. Randomized controlled parallel group trial with 12-month follow-up. One hundred and ten general practices in all regions of Denmark. One thousand forty-eight patients with essential hypertension. Conventional blood pressure monitoring ('usual group') continued usual ad hoc blood pressure monitoring by office blood pressure measurements, while intensive blood pressure monitoring ('intensive group') supplemented this with frequent home blood pressure monitoring and 24-hour ambulatory blood pressure monitoring. Mean day- and night-time systolic and diastolic 24-hour ambulatory blood pressure. Change in systolic and diastolic office blood pressure and change in cardiovascular risk profile. Of the patients, 515 (49%) were allocated to the usual group, and 533 (51%) to the intensive group. The reductions in day- and night-time 24-hour ambulatory blood pressure were similar (usual group: 4.6 ± 13.5/2.8 ± 82 mmHg; intensive group: 5.6 ± 13.0/3.5 ± 8.2 mmHg; P = 0.27/P = 0.20). Cardiovascular risk scores were reduced in both groups at follow-up, but more so in the intensive than in the usual group (P = 0.02). An intensive blood pressure monitoring strategy led to a similar blood pressure reduction to conventional monitoring. However, the intensive strategy appeared to improve patients' cardiovascular risk profile through other effects than a reduction of blood pressure. Clinical Trials NCT00244660. © The Author 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.

PubMed

Katakami, Naoto; Mita, Tomoya; Yoshii, Hidenori; Shiraiwa, Toshihiko; Yasuda, Tetsuyuki; Okada, Yosuke; Umayahara, Yutaka; Kaneto, Hideaki; Osonoi, Takeshi; Yamamoto, Tsunehiko; Kuribayashi, Nobuichi; Maeda, Kazuhisa; Yokoyama, Hiroki; Kosugi, Keisuke; Ohtoshi, Kentaro; Hayashi, Isao; Sumitani, Satoru; Tsugawa, Mamiko; Ohashi, Makoto; Taki, Hideki; Nakamura, Tadashi; Kawashima, Satoshi; Sato, Yasunori; Watada, Hirotaka; Shimomura, Iichiro

2017-10-01

Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker. The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function. This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD. Kowa Co., Ltd. UMIN000017607.

The clinical efficacy of reminiscence therapy in patients with mild-to-moderate Alzheimer disease: Study protocol for a randomized parallel-design controlled trial.

PubMed

Li, Mo; Lyu, Ji-Hui; Zhang, Yi; Gao, Mao-Long; Li, Wen-Jie; Ma, Xin

2017-12-01

Alzheimer disease (AD) is one of the most common diseases among the older adults. Currently, various nonpharmacological interventions are used for the treatment of AD. Such as reminiscence therapy is being widely used in Western countries. However, it is often used as an empirical application in China; the evidence-based efficacy of reminiscence therapy in AD patients remains to be determined. Therefore, the aim of this research is to assess the effectives of reminiscence therapy for Chinese elderly. This is a randomized parallel-design controlled trial. Mild and moderate AD patients who are in the Beijing Geriatric Hospital, China will be randomized into control and intervention groups (n = 45 for each group). For the intervention group, along with conventional drug therapy, participants will be exposed to a reminiscence therapy of 35 to 45 minutes, 2 times/wk for 12 consecutive weeks. Patients in the control group will undergo conventional drug therapy only. The primary outcome measure will be the differences in Alzheimer disease Assessment Scale-Cognitive Section Score. The secondary outcome measures will be the differences in the Cornell scale for depression in dementia, Neuropsychiatric Inventory score, and Barthel Index scores at baseline, at 4 and 12 weeks of treatment, and 12 weeks after treatment. The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval no. 2015-010). Findings will be disseminated through presentation at scientific conferences and in academic journals. Chinese Clinical Trial Registry identifier ChiCTR-INR-16009505. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Renoprotective effects of febuxostat in hyperuricemic patients with chronic kidney disease: a parallel-group, randomized, controlled trial.

PubMed

Tanaka, Kenichi; Nakayama, Masaaki; Kanno, Makoto; Kimura, Hiroshi; Watanabe, Kimio; Tani, Yoshihiro; Hayashi, Yoshimitsu; Asahi, Koichi; Terawaki, Hiroyuki; Watanabe, Tsuyoshi

2015-12-01

Hyperuricemia is associated with the onset of chronic kidney disease (CKD) and renal disease progression. Febuxostat, a novel, non-purine, selective xanthine oxidase inhibitor, has been reported to have a stronger effect on hyperuricemia than conventional therapy with allopurinol. However, few data are available regarding the clinical effect of febuxostat in patients with CKD. A prospective, randomized, open-label, parallel-group trial was conducted in hyperuricemic patients with stage 3 CKD. Patients were randomly assigned to treatment with febuxostat (n = 21) or to continue conventional therapy (n = 19). Treatment was continued for 12 weeks. The efficacy of febuxostat was determined by monitoring serum uric acid (UA) levels, blood pressures, renal function, and urinary protein levels. In addition, urinary liver-type fatty acid-binding protein (L-FABP), urinary albumin, urinary beta 2 microglobulin (β2MG), and serum high sensitivity C-reactive protein were measured before and 12 weeks after febuxostat was added to the treatment. Febuxostat resulted in a significantly greater reduction in serum UA (-2.2 mg/dL) than conventional therapy (-0.3 mg/dL, P < 0.001). Serum creatinine and estimated glomerular filtration rate changed little during the study period in each group. However, treatment with febuxostat for 12 weeks reduced the urinary levels of L-FABP, albumin, and β2MG, whereas the levels of these markers did not change in the control group. Febuxostat reduced serum UA levels more effectively than conventional therapy and might have a renoprotective effect in hyperuricemic patients with CKD. Further studies should clarify whether febuxostat prevents the progression of renal disease and improves the prognosis of CKD.

A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment.

PubMed

Serpell, M; Ratcliffe, S; Hovorka, J; Schofield, M; Taylor, L; Lauder, H; Ehler, E

2014-08-01

Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study. In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated. At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05-3.70]. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment. These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified. © 2014 European Pain Federation - EFIC®

The efficacy of traditional acupuncture on patients with chronic neck pain: study protocol of a randomized controlled trial.

PubMed

Yang, Yiling; Yan, Xiaoxia; Deng, Hongmei; Zeng, Dian; Huang, Jianpeng; Fu, Wenbin; Xu, Nenggui; Liu, Jianhua

2017-07-10

A large number of randomized trials on the use of acupuncture to treat chronic pain have been conducted. However, there is considerable controversy regarding the effectiveness of acupuncture. We designed a randomized trial involving patients with chronic neck pain (CNP) to investigate whether acupuncture is more effective than a placebo in treating CNP. A five-arm, parallel, single-blinded, randomized, sham-controlled trial was designed. Patients with CNP of more than 3 months' duration are being recruited from Guangdong Provincial Hospital of Chinese Medicine (China). Following examination, 175 patients will be randomized into one of five groups (35 patients in each group) as follows: a traditional acupuncture group (group A), a shallow-puncture group (group B), a non-acupoint acupuncture group (group C), a non-acupoint shallow-puncture group (group D) and a sham-puncture group (group E). The interventions will last for 20 min and will be carried out twice a week for 5 weeks. The primary outcome will be evaluated by changes in the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes will be measured by the pain threshold, the Short Form McGill Pain Questionnaire-2 (SF-MPQ-2), the 36-Item Short-Form Health Survey (SF-36) and diary entries. Analysis of the data will be performed at baseline, at the end of the intervention and at 3 months' follow-up. The safety of acupuncture will be evaluated at each treatment period. The purpose of this trial is to determine whether traditional acupuncture is more effective for chronic pain relief than sham acupuncture in adults with CNP, and to determine which type of sham acupuncture is the optimal control for clinical trials. Chinese Clinical Trial Registry: ChiCTR-IOR-15006886 . Registered on 2 July 2015.

The effect of pheniramine on fentanyl-induced cough: a randomized, double blinded, placebo controlled clinical study.

PubMed

Arslan, Zakir; Çalık, Eyup Serhat; Kaplan, Bekir; Ahiskalioglu, Elif Oral

2016-01-01

There are many studies conducted on reducing the frequency and severity of fentayl-induced cough during anesthesia induction. We propose that pheniramine maleate, an antihistaminic, may suppress this cough. We aim to observe the effect of pheniramine on fentanyl-induced cough during anesthesia induction. This is a double-blinded, prospective, three-arm parallel, randomized clinical trial of 120 patients with ASA (American Society of Anesthesiologists) physical status III and IV who aged ≥18 and scheduled for elective open heart surgery during general anesthesia. Patients were randomly assigned to three groups of 40 patients, using computer-generated random numbers: placebo group, pheniramine group, and lidocaine group. Cough incidence differed significantly between groups. In the placebo group, 37.5% of patients had cough, whereas the frequency was significantly decreased in pheniramine group (5%) and lidocaine group (15%) (Fischer exact test, p=0.0007 and p=0.0188, respectively). There was no significant change in cough incidence between pheniramine group (5%) and lidocaine group (15%) (Fischer exact test, p=0.4325). Cough severity did also change between groups. Post Hoc tests with Bonferroni showed that mean cough severity in placebo differed significantly than that of pheniramine group and lidocaine group (p<0.0001 and p=0.009, respectively). There was no significant change in cough severity between pheniramine group and lidocaine group (p=0.856). Intravenous pheniramine is as effective as lidocaine in preventing fentayl-induced cough. Our results emphasize that pheniramine is a convenient drug to decrease this cough. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

Inference of median difference based on the Box-Cox model in randomized clinical trials.

PubMed

Maruo, K; Isogawa, N; Gosho, M

2015-05-10

In randomized clinical trials, many medical and biological measurements are not normally distributed and are often skewed. The Box-Cox transformation is a powerful procedure for comparing two treatment groups for skewed continuous variables in terms of a statistical test. However, it is difficult to directly estimate and interpret the location difference between the two groups on the original scale of the measurement. We propose a helpful method that infers the difference of the treatment effect on the original scale in a more easily interpretable form. We also provide statistical analysis packages that consistently include an estimate of the treatment effect, covariance adjustments, standard errors, and statistical hypothesis tests. The simulation study that focuses on randomized parallel group clinical trials with two treatment groups indicates that the performance of the proposed method is equivalent to or better than that of the existing non-parametric approaches in terms of the type-I error rate and power. We illustrate our method with cluster of differentiation 4 data in an acquired immune deficiency syndrome clinical trial. Copyright © 2015 John Wiley & Sons, Ltd.

Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: a randomized comparison of efficacy and safety in subjects with scalp psoriasis.

PubMed

Reygagne, P; Mrowietz, U; Decroix, J; de Waard-van der Spek, F B; Acebes, L Olmos; Figueiredo, A; Caputo, R; Poncet, M; Arsonnaud, S

2005-02-01

Scalp involvement in psoriatic patients represents a common issue. Treatment of the hairy skin requires adequate pharmaceutical formulations; hence, a new specific shampoo formulation of clobetasol propionate 0.05% was developed by Galderma R&D, Inc. For this multicenter, randomized, investigator-masked, parallel group study, 151 subjects with moderate to severe scalp psoriasis were randomized to 4 weeks of treatment with clobetasol propionate shampoo or calcipotriol solution. Clobetasol propionate demonstrated significantly superior efficacy to calcipotriol solution (total severity score: mean difference 0.51, 95% CI 0.05-0.97, p = 0.028; global severity score: mean difference 0.43, 95% CI 0.08-0.78, p = 0.016). Adverse events were more common in the calcipotriol group than in the clobetasol propionate shampoo group. Telangiectasia and skin atrophy did not differ significantly between treatments; however, a burning sensation was significantly more common in the calcipotriol solution group. Short contact therapy of scalp psoriasis with this new shampoo formulation of clobetasol propionate was significantly more effective and better tolerated than calcipotriol solution for the treatment of scalp psoriasis.

An overview of confounding. Part 1: the concept and how to address it.

PubMed

Howards, Penelope P

2018-04-01

Confounding is an important source of bias, but it is often misunderstood. We consider how confounding occurs and how to address confounding using examples. Study results are confounded when the effect of the exposure on the outcome, mixes with the effects of other risk and protective factors for the outcome. This problem arises when these factors are present to different degrees among the exposed and unexposed study participants, but not all differences between the groups result in confounding. Thinking about an ideal study where all of the population of interest is exposed in one universe and is unexposed in a parallel universe helps to distinguish confounders from other differences. In an actual study, an observed unexposed population is chosen to stand in for the unobserved parallel universe. Differences between this substitute population and the parallel universe result in confounding. Confounding by identified factors can be addressed analytically and through study design, but only randomization has the potential to address confounding by unmeasured factors. Nevertheless, a given randomized study may still be confounded. Confounded study results can lead to incorrect conclusions about the effect of the exposure of interest on the outcome. © 2018 Nordic Federation of Societies of Obstetrics and Gynecology.

Myorelaxant Effect of Bee Venom Topical Skin Application in Patients with RDC/TMD Ia and RDC/TMD Ib: A Randomized, Double Blinded Study

PubMed Central

Baron, Stefan

2014-01-01

The aim of the study was the evaluation of myorelaxant action of bee venom (BV) ointment compared to placebo. Parallel group, randomized double blinded trial was performed. Experimental group patients were applying BV for 14 days, locally over masseter muscles, during 3-minute massage. Placebo group patients used vaseline for massage. Muscle tension was measured twice (TON1 and TON2) in rest muscle tonus (RMT) and maximal muscle contraction (MMC) on both sides, right and left, with Easy Train Myo EMG (Schwa-medico, Version 3.1). Reduction of muscle tonus was statistically relevant in BV group and irrelevant in placebo group. VAS scale reduction was statistically relevant in both groups: BV and placebo. Physiotherapy is an effective method for myofascial pain treatment, but 0,0005% BV ointment gets better relief in muscle tension reduction and analgesic effect. This trial is registered with Clinicaltrials.gov NCT02101632. PMID:25050337

A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

PubMed Central

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

2015-01-01

Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

EFFECT OF A DENTIFRICE CONTAINING ALOE VERA ON PLAQUE AND GINGIVITIS CONTROL. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

PubMed Central

de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

2008-01-01

The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) – dentifrice containing Aloe vera - or the control group (n=15) – fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice. PMID:19089263

Effect of a dentifrice containing Aloe vera on plaque and gingivitis control. A double-blind clinical study in humans.

PubMed

de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

2008-01-01

The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) - dentifrice containing Aloe vera - or the control group (n=15) - fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice.

Reducing the Mental Health-Related Stigma of Social Work Students: A Cluster RCT

ERIC Educational Resources Information Center

Rubio-Valera, Maria; Aznar-Lou, Ignacio; Vives-Collet, Mireia; Fernández, Ana; Gil-Girbau, Montserrat; Serrano-Blanco, Antoni

2018-01-01

The aim of this study was to evaluate the impact of a social contact and education intervention to improve attitudes to mental illness in first-year social work students. This was a 3-month cluster randomized controlled trial with two parallel arms: intervention (87) and control group (79). The intervention was a workshop led by an OBERTAMENT…

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

ERIC Educational Resources Information Center

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

2014-01-01

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

Habit Reversal versus Object Manipulation Training for Treating Nail Biting: A Randomized Controlled Clinical Trial

PubMed Central

Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

2013-01-01

Objective This is a parallel, three group, randomized, controlled clinical trial, with outcomes evaluated up to three months after randomization for children and adolescents with chronic nail biting. The current study investigates the efficacy of habit reversal training (HRT) and compares its effect with object manipulation training (OMT) considering the limitations of the current literature. Method Ninety one children and adolescents with nail biting were randomly allocated to one of the three groups. The three groups were HRT (n = 30), OMT (n = 30), and wait-list or control group (n = 31). The mean length of nail was considered as the main outcome. Results The mean length of the nails after one month in HRT and OMT groups increased compared to the waiting list group (P < 0.001, P < 0.001, respectively). In long term, both OMT and HRT increased the mean length of nails (P < 0.01), but HRT was more effective than OMT (P < 0.021). The parent-reported frequency of nail biting did show similar results as to the mean length of nails assessment in long term. The number of children who completely stopped nail biting in HRT and OMT groups during three months was 8 and 7, respectively. This number was zero during one month for the wait-list group. Conclusion This trial showed that HRT is more effective than wait-list and OMT in increasing the mean length of nails of children and adolescents in long terms. PMID:24130603

A randomized clinical trial with two doses of an enteral diabetes-specific suplements in elderly patients with diabetes mellitus type 2.

PubMed

de Luis, D A; Izaola, O; de la Fuente, B; Terroba, M C; Cuellar, L; Cabezas, G

2013-06-01

The aim of our study was to investigate whether two different daily doses of a high monounsaturated fatty acid (MUFA) specific diabetes enteral formula could improve nutritional variables as well as metabolic parameters. We conducted a randomized, open-label, multicenter, parallel group study. 27 patients with diabetes mellitus type 2 with recent weight loss were randomized to one of two study groups: group 1 (two cans per day) and group 2 (three cans per day) for a ten week period. A significative decrease of HbA1c was detected in both groups. The decrease 0.98% (confidence interval 95% 0.19-1.88) was higher in group 2 than group 1 0.60% (confidence interval 95% 0.14-1.04). A significant increase of weight, body mass index, fat mass, albumin, prealbumin and transferrin was observed in both groups without statistical differences in this improvement between both groups. The increase of weight 4.59kg (confidence interval 95% 1.71-9.49) was higher in group 2 than group 1 1.46% (confidence interval 95% 0.39-2.54). Gastrointestinal tolerance (diarrhea episodes) with both formulas was good, without statistical differences (7.60% vs 7.14%: ns). A high monounsaturated fatty acid diabetes-specific supplement improved HbA1c and nutritional status. These improvements were higher with three supplements than with two per day.

Evaluation of the effectiveness of low-dose aspirin and omega 3 in treatment of asymmetrically intrauterine growth restriction: A randomized clinical trial.

PubMed

Ali, Mohammed K; Amin, Maggy E; Amin, Ahmed F; Abd El Aal, Diaa Eldeen M

2017-03-01

To test the effect of aspirin and omega 3 on fetal weight as well as feto-maternal blood flow in asymmetrical intrauterine growth restriction (IUGR). This study is a clinically registered (NCT02696577), open, parallel, randomized controlled trial, conducted at Assiut Woman's Health Hospital, Egypt including 80 pregnant women (28-30 weeks) with IUGR. They were randomized either to group I: aspirin or group II: aspirin plus omega 3. The primary outcome was the fetal weight after 6 weeks of treatment. Secondary outcomes included Doppler blood flow changes in both uterine and umbilical arteries, birth weight, time and method of delivery and admission to NICU. The outcome variables were analyzed using paired and unpaired t-test. The estimated fetal weight increased significant in group II more than group I (p=0.00). The uterine and umbilical arteries blood flow increased significantly in group II (p<0.05). The birth weight in group II was higher than that observed in group I (p<0.05). The using of aspirin with omega 3 is more effective than using aspirin only in increasing fetal weight and improving utero-placental blood flow in IUGR. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Yusof, Barakatun-Nisak Mohd

2016-02-27

Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT02322268.

Effects of a whole body vibration (WBV) exercise intervention for institutionalized older people: a randomized, multicentre, parallel, clinical trial.

PubMed

Sitjà-Rabert, Mercè; Martínez-Zapata, Ma José; Fort Vanmeerhaeghe, Azahara; Rey Abella, Ferran; Romero-Rodríguez, Daniel; Bonfill, Xavier

2015-02-01

To assess the efficacy of an exercise program on a whole-body vibration platform (WBV) in improving body balance and muscle performance and preventing falls in institutionalized elderly people. A multicentre randomized parallel assessor-blinded clinical trial was conducted in elderly persons living in nursing homes. Participants were randomized to an exercise program performed either on a whole body vibratory platform (WBV plus exercise group) or on a stationary surface (exercise group). The exercise program for both groups consisted of static and dynamic exercises (balance and strength training over a 6-week training period of 3 sessions per week). The frequency applied on the vibratory platform was 30 to 35 Hz and amplitude was 2 to 4 mm. The primary outcome measurement was static/dynamic body balance. Secondary outcomes were muscle strength and number of falls. Efficacy was analyzed on an intention-to-treat basis and per protocol. The effects of the intervention were evaluated using the t test, Mann-Whitney test, or chi-square test, depending on the type of outcome. Follow-up measurements were collected 6 weeks and 6 months after randomization. A total of 159 participants from 10 centers were included: 81 in the WBV plus exercise group and 78 in the control group. Mean age was 82 years, and 67.29% were women. The Tinetti test score showed a significant overall improvement in both groups (P < .001). No significant differences were found between groups at week 6 (P = .890) or month 6 (P = .718). The Timed Up and Go test did not improve (P = .599) in either group over time, and no significant differences were found between groups at week 6 (P = .757) or month 6 (P = .959). Muscle performance results from the 5 Sit-To-Stand tests improved significantly across time (P = .001), but no statistically significant differences were found between groups at week 6 (P = .709) or month 6 (P = .841). A total of 57 falls (35.8%) were recorded during the follow-up period, with no differences between groups (P = .406). Exercise program on a vibratory platform provides benefits similar to those with exercise program on a stationary surface in relation to body balance, gait, functional mobility, and muscle strength in institutionalized elderly people. Longer studies in larger samples are needed to assess falls. Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

The Effect of Gromwell (Lithospermum erythrorhizon) Extract on the Stratum Corneum Hydration and Ceramides Content in Atopic Dermatitis Patients.

PubMed

Cho, Hee Ryung; Cho, Yunhi; Kim, Juyoung; Seo, Dae Bang; Kim, Sung Han; Lee, Sang Jun; Kim, Nack In

2008-06-01

A disruption of the balance between the water content of the stratum corneum (SC) and skin surface lipids may lead to the clinical manifestation of dryness of skin in patients with atopic dermatitis (AD). To determine whether supplementation of gromwell (Lithospermum erythrorhizon), one of herbs used in East Asia in remedies for various abnormal skin conditions, may improve the SC level of hydration and ceramides, major lipid in SC in patients with AD. A total of 28 subjects with AD were randomly assigned into two groups: either gromwell group received dextrose contained capsules with 1.5 g of gromwell extracts or placebo group received only dextrose contained capsules for 10 weeks. In contrast to no alteration of SC hydration and ceramides in placebo group, the SC hydration in gromwell group was significantly increased in parallel with an increase of SC ceramides. Furthermore, % increase of SC hydration in gromwell group bore a positive correlation with the clinical severity, which suggests that the increase of SC hydration in gromwell group was more effective as AD was more severe. Supplementation of gromwell improves SC hydration in parallel with an increase of ceramides in part.

The benefits of giving a massage on the mental state of massage therapists: a randomized, controlled trial.

PubMed

Jensen, Anne M; Ramasamy, Adaikalavan; Hotek, Judith; Roel, Brian; Riffe, Drew

2012-12-01

The objective of this study was to determine whether giving a massage had an impact of the mental state of the massage therapist. The design of this study was a randomized, controlled, blinded study with two parallel groups. This study was conducted at an accredited school of therapeutic massage in Dallas, Texas. The study comprised healthy female and male final-term massage students between ages 18 and 65 years. The participants were randomized into two groups: (1) the experimental group who gave a 1-hour Swedish massage to a massage client (Massage group), or (2) the control group who sat in a room doing normal, daily activities (Control group). Both these activities were a normal part of the daily routine for these massage students. The primary outcomes were the change in the Depression Anxiety and Stress Scale (DASS) scores pre- and postparticipation. Twenty-two (22) participants were randomized in this trial. The baseline characteristics were comparable between the two groups. A statistically significant advantage for the massage group was found relative to the control group in subjective anxiety (DASS Anxiety Subscale, p=0.014). There were no significant differences between the groups with regard to total DASS score (p=0.540), subjective depressive symptoms (DASS Depression Subscale, p=0.472) and subjective stress-related symptoms (DASS Stress Subscale, p=0.919). There were no adverse events reported by any participant. This study shows that massage therapists themselves may benefit from giving a therapeutic massage by experiencing less subjective anxiety following the giving of a massage.

Efficacy of vitamins C, E, and their combination for treatment of restless legs syndrome in hemodialysis patients: a randomized, double-blind, placebo-controlled trial.

PubMed

Sagheb, Mohammad Mahdi; Dormanesh, Banafshe; Fallahzadeh, Mohammad Kazem; Akbari, Hamideh; Sohrabi Nazari, Sahar; Heydari, Seyed Taghi; Behzadi, Saeed

2012-05-01

Restless legs syndrome (RLS) is a common disorder in hemodialysis patients that leads to insomnia and impaired quality of life. Because high oxidative stress has been implicated in the pathogenesis of RLS, we sought to evaluate the efficacy of vitamins C and E and their combination in reducing the severity of RLS symptoms in hemodialysis patients in this randomized, double-blind, placebo-controlled, four-arm parallel trial. Sixty stable hemodialysis patients who had all four diagnostic criteria for RLS developed by the International Restless Legs Syndrome Group with no acute illness or history of renal stone were randomly allocated to four fifteen-patient parallel groups to receive vitamin C (200 mg) and vitamin E (400 mg), vitamin C (200 mg) and placebo, vitamin E (400 mg) and placebo, and double placebo daily for eight weeks. International Restless Legs Scale (IRLS) scores were measured for all patients at baseline and at the end of treatment phase. The primary outcome was absolute change in IRLS sum score from baseline to the end of treatment phase. Means of IRLS sum score decreased significantly in the vitamins C and E (10.3 ± 5.3, 95% CI: 7.4-13.3), vitamin C and placebo (10 ± 3.5, 95% CI: 8.1-11.9), and vitamin E and placebo groups (10.1 ± 6, 95% CI: 6.8-13.5) compared with the double placebo group (3.1 ± 3, 95% CI: 1.5-4.8), (P<0.001); however, no differences were observed between these treatment groups. Vitamins C and E and their combination are safe and effective treatments for reducing the severity of RLS in hemodialysis patients over the short-term. Copyright © 2012 Elsevier B.V. All rights reserved.

Parallel Algorithms for Switching Edges in Heterogeneous Graphs.

PubMed

Bhuiyan, Hasanuzzaman; Khan, Maleq; Chen, Jiangzhuo; Marathe, Madhav

2017-06-01

An edge switch is an operation on a graph (or network) where two edges are selected randomly and one of their end vertices are swapped with each other. Edge switch operations have important applications in graph theory and network analysis, such as in generating random networks with a given degree sequence, modeling and analyzing dynamic networks, and in studying various dynamic phenomena over a network. The recent growth of real-world networks motivates the need for efficient parallel algorithms. The dependencies among successive edge switch operations and the requirement to keep the graph simple (i.e., no self-loops or parallel edges) as the edges are switched lead to significant challenges in designing a parallel algorithm. Addressing these challenges requires complex synchronization and communication among the processors leading to difficulties in achieving a good speedup by parallelization. In this paper, we present distributed memory parallel algorithms for switching edges in massive networks. These algorithms provide good speedup and scale well to a large number of processors. A harmonic mean speedup of 73.25 is achieved on eight different networks with 1024 processors. One of the steps in our edge switch algorithms requires the computation of multinomial random variables in parallel. This paper presents the first non-trivial parallel algorithm for the problem, achieving a speedup of 925 using 1024 processors.

Parallel Algorithms for Switching Edges in Heterogeneous Graphs☆

PubMed Central

Khan, Maleq; Chen, Jiangzhuo; Marathe, Madhav

2017-01-01

An edge switch is an operation on a graph (or network) where two edges are selected randomly and one of their end vertices are swapped with each other. Edge switch operations have important applications in graph theory and network analysis, such as in generating random networks with a given degree sequence, modeling and analyzing dynamic networks, and in studying various dynamic phenomena over a network. The recent growth of real-world networks motivates the need for efficient parallel algorithms. The dependencies among successive edge switch operations and the requirement to keep the graph simple (i.e., no self-loops or parallel edges) as the edges are switched lead to significant challenges in designing a parallel algorithm. Addressing these challenges requires complex synchronization and communication among the processors leading to difficulties in achieving a good speedup by parallelization. In this paper, we present distributed memory parallel algorithms for switching edges in massive networks. These algorithms provide good speedup and scale well to a large number of processors. A harmonic mean speedup of 73.25 is achieved on eight different networks with 1024 processors. One of the steps in our edge switch algorithms requires the computation of multinomial random variables in parallel. This paper presents the first non-trivial parallel algorithm for the problem, achieving a speedup of 925 using 1024 processors. PMID:28757680

A parallel randomized trial on the effect of a healthful diet on inflammageing and its consequences in European elderly people: design of the NU-AGE dietary intervention study.

PubMed

Berendsen, Agnes; Santoro, Aurelia; Pini, Elisa; Cevenini, Elisa; Ostan, Rita; Pietruszka, Barbara; Rolf, Katarzyna; Cano, Noël; Caille, Aurélie; Lyon-Belgy, Noëlle; Fairweather-Tait, Susan; Feskens, Edith; Franceschi, Claudio; de Groot, C P G M

2013-01-01

The proportion of European elderly is expected to increase to 30% in 2060. Combining dietary components may modulate many processes involved in ageing. So, it is likely that a healthful diet approach might have greater favourable impact on age-related decline than individual dietary components. This paper describes the design of a healthful diet intervention on inflammageing and its consequences in the elderly. The NU-AGE study is a parallel randomized one-year trial in 1250 apparently healthy, independently living European participants aged 65-80 years. Participants are randomised into either the diet group or control group. Participants in the diet group received dietary advice aimed at meeting the nutritional requirements of the ageing population. Special attention was paid to nutrients that may be inadequate or limiting in diets of elderly, such as vitamin D, vitamin B12, and calcium. C-reactive protein is measured as primary outcome. The NU-AGE study is the first dietary intervention investigating the effect of a healthful diet providing targeted nutritional recommendations for optimal health and quality of life in apparently healthy European elderly. Results of this intervention will provide evidence on the effect of a healthful diet on the prevention of age related decline. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial.

PubMed

Liu, Tai-Wa; Ng, Gabriel Y F; Ng, Shamay S M

2018-03-07

The consequences of falls are devastating for patients with stroke. Balance problems and fear of falling are two major challenges, and recent systematic reviews have revealed that habitual physical exercise training alone cannot reduce the occurrence of falls in stroke survivors. However, recent trials with community-dwelling healthy older adults yielded the promising result that interventions with a cognitive behavioral therapy (CBT) component can simultaneously promote balance and reduce the fear of falling. Therefore, the aim of the proposed clinical trial is to evaluate the effectiveness of a combination of CBT and task-oriented balance training (TOBT) in promoting subjective balance confidence, and thereby reducing fear-avoidance behavior, improving balance ability, reducing fall risk, and promoting independent living, community reintegration, and health-related quality of life of patients with stroke. The study will constitute a placebo-controlled single-blind parallel-group randomized controlled trial in which patients are assessed immediately, at 3 months, and at 12 months. The selected participants will be randomly allocated into one of two parallel groups (the experimental group and the control group) with a 1:1 ratio. Both groups will receive 45 min of TOBT twice per week for 8 weeks. In addition, the experimental group will receive a 45-min CBT-based group intervention, and the control group will receive 45 min of general health education (GHE) twice per week for 8 weeks. The primary outcome measure is subjective balance confidence. The secondary outcome measures are fear-avoidance behavior, balance ability, fall risk, level of activities of daily living, community reintegration, and health-related quality of life. The proposed clinical trial will compare the effectiveness of CBT combined with TOBT and GHE combined with TOBT in promoting subjective balance confidence among chronic stroke patients. We hope our results will provide evidence of a safe, cost-effective, and readily transferrable therapeutic approach to clinical practice that reduces fear-avoidance behavior, improves balance ability, reduces fall risk, promotes independence and community reintegration, and enhances health-related quality of life. ClinicalTrials.gov, NCT02937532 . Registered on 17 October 2016.

Forecasting Three-Month Outcomes in a Laboratory School Comparison of Mixed Amphetamine Salts Extended Release (Adderall XR) and Atomoxetine (Strattera) in School-Aged Children with ADHD

ERIC Educational Resources Information Center

Faraone, Stephen V.; Wigal, Sharon B.; Hodgkins, Paul

2007-01-01

Objective: Compare observed and forecasted efficacy of mixed amphetamine salts extended release (MAS-XR; Adderall) with atomoxetine (Strattera) in ADHD children. Method: The authors analyze data from a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study of children ages 6 to 12 with ADHD combined…

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

PubMed Central

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

2014-01-01

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

Effectiveness of peer-led dissonance-based eating disorder prevention groups: results from two randomized pilot trials.

PubMed

Stice, Eric; Rohde, Paul; Durant, Shelley; Shaw, Heather; Wade, Emily

2013-05-01

The present preliminary trials tested whether undergraduate peer leaders can effectively deliver a dissonance-based eating disorder prevention program, which could facilitate broad dissemination of this efficacious intervention. In Study 1, female undergraduates (N=171) were randomized to peer-led groups, clinician-led groups, or an educational brochure control condition. In Study 2, which improved a design limitation of Study 1 by using completely parallel outcome measures across conditions, female undergraduates (N=148) were randomized to either immediate peer-led groups or a waitlist control condition. In Study 1, participants in peer- and clinician-led groups showed significantly greater pre-post reductions in risk factors and eating disorder symptoms than controls (M d=.64 and .98 respectively), though clinician- versus peer-led groups had higher attendance and competence ratings, and produced stronger effects at posttest (M d=.32) and at 1-year follow-up (M d=.26). In Study 2, participants in peer-led groups showed greater pre-post reductions in all outcomes than waitlist controls (M d=.75). Results provide novel evidence that dissonance-based eating disorder prevention groups led by undergraduate peers are feasible and produce greater reductions in eating disorder risk factors and symptoms than minimal-intervention control conditions, but indicate that effects are smaller for peer- versus clinician-led groups. Copyright © 2013 Elsevier Ltd. All rights reserved.

The effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among adolescents aged 15 to 20 years with a low educational background: study protocol for a randomized controlled trial.

PubMed

Voogt, Carmen V; Poelen, Evelien A P; Lemmers, Lex A C J; Engels, Rutger C M E

2012-06-15

The serious negative health consequences of heavy drinking among adolescents is cause for concern, especially among adolescents aged 15 to 20 years with a low educational background. In the Netherlands, there is a lack of alcohol prevention programs directed to the drinking patterns of this specific target group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that aims to reduce alcohol use among heavy drinking adolescents aged 15 to 20 years with a low educational background. The effectiveness of the What Do You Drink (WDYD) web-based brief alcohol intervention will be tested among 750 low-educated, heavy drinking adolescents. It will use a two-arm parallel group cluster randomized controlled trial. Classes of adolescents from educational institutions will be randomly assigned to either the experimental (n = 375: web-based brief alcohol intervention) or control condition (n = 375: no intervention). Primary outcomes measures will be: 1) the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking, 2) reductions in mean weekly alcohol consumption, and 3) frequency of binge drinking. The secondary outcome measures include the alcohol-related cognitions, attitudes, self-efficacy, and subjective norms, which will be measured at baseline and at one and six months after the intervention. This study protocol presents the study design of a two-arm parallel-group randomized controlled trial to evaluate the effectiveness of the WDYD web-based brief alcohol intervention. We hypothesized a reduction in mean weekly alcohol consumption and in the frequency of binge drinking in the experimental condition, resulting from the web-based brief alcohol intervention, compared to the control condition. Netherlands Trial Register NTR2971.

Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial.

PubMed

Shi, Jing; Feng, Yongliang; Gao, Linying; Feng, Dan; Yao, Tian; Shi, Shan; Zhang, Yawei; Liang, Xiaofeng; Wang, Suping

2017-04-25

To explore whether the immunization with high-dose (60μg) hepatitis B vaccines in patients receiving methadone maintenance treatment (MMT) could yield a superior protection against hepatitis B infection than did the standard dose (20μg). We conducted a randomized, double-blinded, parallel-controlled trial in MMT patients. Patients with serologically negative hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) were randomized in a ratio of 1:1 to receive three intramuscular injections of 20μg or 60μg recombinant hepatitis B vaccine at months 0, 1, and 6. Serum HBsAg and anti-HBs were measured at months 7 and 12 post-vaccination to assess the immunogenicity. A total of 196 MMT patients were randomized and 195 received at least one injection (98 and 97 in 20 and 60μg vaccine groups, respectively). The 60μg vaccine group showed a seroconversion of anti-HBs of 87.3%, high-level response rate of 56.3%, and GMC of 742.9mIU/mL at month 7. While these results were numerically higher than the 20μg group, a statistical difference was not found. HIV infection and concomitant drug abuse were negatively associated with the robust immune responses. 7.7% of MMT patients receiving at least one dose of vaccine reported solicited adverse reactions within 7days after vaccination, 2.6% reported unsolicited adverse reactions within 28days after vaccination. None of the MMT patients reported serious adverse events or became HBsAg positive during the follow-up. The three-dose regimen of 60μg recombinant hepatitis B vaccine at months 0, 1, and 6 can yield a similar immunogenicity among MMT patients as compared to the 20μg vaccine. ClinicalTrials.gov identifier: NCT02991599. Copyright © 2017. Published by Elsevier Ltd.

Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial

PubMed Central

2011-01-01

Background Institutionalized older persons have a poor functional capacity. Including physical exercise in their routine activities decreases their frailty and improves their quality of life. Whole-body vibration (WBV) training is a type of exercise that seems beneficial in frail older persons to improve their functional mobility, but the evidence is inconclusive. This trial will compare the results of exercise with WBV and exercise without WBV in improving body balance, muscle performance and fall prevention in institutionalized older persons. Methods/Design An open, multicentre and parallel randomized clinical trial with blinded assessment. 160 nursing home residents aged over 65 years and of both sexes will be identified to participate in the study. Participants will be centrally randomised and allocated to interventions (vibration or exercise group) by telephone. The vibration group will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm) over a six-week training period (3 sessions/week). The exercise group will perform the same exercise protocol but without a vibration stimuli platform. The primary outcome measure is the static/dynamic body balance. Secondary outcomes are muscle strength and, number of new falls. Follow-up measurements will be collected at 6 weeks and at 6 months after randomization. Efficacy will be analysed on an intention-to-treat (ITT) basis and 'per protocol'. The effects of the intervention will be evaluated using the "t" test, Mann-Witney test, or Chi-square test, depending on the type of outcome. The final analysis will be performed 6 weeks and 6 months after randomization. Discussion This study will help to clarify whether WBV training improves body balance, gait mobility and muscle strength in frail older persons living in nursing homes. As far as we know, this will be the first study to evaluate the efficacy of WBV for the prevention of falls. Trial Registration ClinicalTrials.gov: NCT01375790 PMID:22192313

Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial.

PubMed

Mendes, D A; Veiga, D F; Veiga-Filho, J; Loyola, A B A T; Paiva, L F; Novo, N F; Sabino-Neto, M; Ferreira, L M

2018-06-01

Concepts regarding the best way to treat a surgical wound vary, in literature, ranging from no dressing use to dressing maintenance for 24 to 48 hours or until suture removal. This study aimed to evaluate the influence of the length of dressing maintenance after breast augmentation with implants on cutaneous colonization and surgical site infection. This is a two-arm, parallel group, randomized clinical trial. Eighty patients who were candidates for augmentation mammoplasty with silicone implants were randomly allocated to two groups, in which the dressing was removed on postoperative day 1 (group A, n = 40) or postoperative day 6 (group B, n = 40). Cutaneous colonization was examined by culturing samples collected before and after dressing removal. The criteria defined by the Centers for Disease Control and Prevention were used to assess surgical site infection. No significant difference regarding cutaneous colonization was observed between groups before dressing application. On postoperative day 6, significantly more bacterial growth was observed in group A (p = 0.01). No surgical site infection occurred. We concluded that maintaining the dressing for 6 days led to a lower cutaneous colonization but did not influence surgical site infection rates. Copyright © 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Randomized controlled pilot study to compare Homeopathy and Conventional therapy in Acute Otitis Media.

PubMed

Sinha, M N; Siddiqui, V A; Nayak, C; Singh, Vikram; Dixit, Rupali; Dewan, Deepti; Mishra, Alok

2012-01-01

To compare the effectiveness of Homeopathy and Conventional therapy in Acute Otitis Media (AOM). A randomized placebo-controlled parallel group pilot study of homeopathic vs conventional treatment for AOM was conducted in Jaipur, India. Patients were randomized by a computer generated random number list to receive either individualized homeopathic medicines in fifty millesimal (LM) potencies, or conventional treatment including analgesics, antipyretics and anti-inflammatory drugs. Patients who did not improve were prescribed antibiotics at the 3rd day. Outcomes were assessed by the Acute Otitis Media-Severity of Symptoms (AOM-SOS) Scale and Tympanic Membrane Examination over 21 days. 81 patients were included, 80 completed follow-up: 41 for conventional and 40 for homeopathic treatment. In the Conventional group, all 40 (100%) patients were cured, in the Homeopathy group, 38 (95%) patients were cured while 02 (5%) patients were lost to the last two follow-up. By the 3rd day of treatment, 4 patients were cured in Homeopathy group but in Conventional group only one patient was cured. In the Conventional group antibiotics were prescribed in 39 (97.5%), no antibiotics were required in the Homeopathy group. 85% of patients were prescribed six homeopathic medicines. Individualized homeopathy is an effective conventional treatment in AOM, there were no significant differences between groups in the main outcome. Symptomatic improvement was quicker in the Homeopathy group, and there was a large difference in antibiotic requirements, favouring homeopathy. Further work on a larger scale should be conducted. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Treatment with a barrier-strengthening moisturizer prevents relapse of hand-eczema. An open, randomized, prospective, parallel group study.

PubMed

Lodén, Marie; Wirén, Karin; Smerud, Knut; Meland, Nils; Hønnås, Helge; Mørk, Gro; Lützow-Holm, Claus; Funk, Jörgen; Meding, Birgitta

2010-11-01

Hand eczema influences the quality of life. Management strategies include the use of moisturizers. In the present study the time to relapse of eczema during treatment with a barrier-strengthening moisturizer (5% urea) was compared with no treatment (no medical or non-medicated preparations) in 53 randomized patients with successfully treated hand eczema. The median time to relapse was 20 days in the moisturizer group compared with 2 days in the no treatment group (p = 0.04). Eczema relapsed in 90% of the patients within 26 weeks. No difference in severity was noted between the groups at relapse. Dermatology Life Quality Index (DLQI) increased significantly in both groups; from 4.7 to 7.1 in the moisturizer group and from 4.1 to 7.8 in the no treatment group (p < 0.01) at the time of relapse. Hence, the application of moisturizers seems to prolong the disease-free interval in patients with controlled hand eczema. Whether the data is applic-able to moisturizers without barrier-strengthening properties remains to be elucidated.

Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial.

PubMed

Lobre, Wendy D; Callegari, Brent J; Gardner, Gary; Marsh, Curtis M; Bush, Anneke C; Dunn, William J

2016-07-01

To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n  =  29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α  =  .05. During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P  =  .002) and biting pain (P  =  .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

Effect of Herbal and Fluoride Mouth Rinses on Streptococcus mutans and Dental Caries among 12–15-Year-Old School Children: A Randomized Controlled Trial

PubMed Central

Shenoy Panchmal, Ganesh; Kumar, Vijaya; Jodalli, Praveen S.; Sonde, Laxminarayan

2017-01-01

To assess and compare the effect of herbal and fluoride mouth rinses on Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries, a parallel group placebo controlled randomized trial was conducted among 240 schoolchildren (12–15 years old). Participants were randomly divided and allocated into Group I (0.2% fluoride group), Group II (herbal group), and Group III (placebo group). All received 10 ml of respective mouth rinses every fortnight for a period of one year. Intergroup and intragroup comparison were done for Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries. Streptococcus mutans count showed a statistically significant difference between Group I and Group III (p = 0.035) and also between Group II and Group III (p = 0.039). Glucan concentration levels showed a statistically significant difference (p = 0.024) between Group II and Group III at 12th month. Mean DMF scores showed no statistical difference between the three groups (p = 0.139). No difference in the level of significance was seen in the intention-to-treat and per-protocol analysis. The present study showed that both herbal and fluoride mouth rinses, when used fortnightly, were equally effective and could be recommended for use in school-based health education program to control dental caries. Trial registration number is CTRI/2015/08/006070. PMID:28352285

Rehabilitation for improved cognition in patients with stress-related exhaustion disorder: RECO - a randomized clinical trial.

PubMed

Malmberg Gavelin, Hanna; Eskilsson, Therese; Boraxbekk, Carl-Johan; Josefsson, Maria; Stigsdotter Neely, Anna; Slunga Järvholm, Lisbeth

2018-04-25

Stress-related exhaustion has been associated with selective and enduring cognitive impairments. However, little is known about how to address cognitive deficits in stress rehabilitation and how this influences stress recovery over time. The aim of this open-label, parallel randomized controlled trial (ClinicalTrials.gov: NCT03073772) was to investigate the long-term effects of 12 weeks cognitive or aerobic training on cognitive function, psychological health, and work ability for patients diagnosed with exhaustion disorder (ED). One-hundred-and-thirty-two patients (111 women) participating in multimodal stress rehabilitation were randomized to receive additional cognitive training (n = 44), additional aerobic training (n = 47), or no additional training (n = 41). Treatment effects were assessed before, immediately after and one-year post intervention. The primary outcome was global cognitive function. Secondary outcomes included domain-specific cognition, self-reported burnout, depression, anxiety, fatigue and work ability, aerobic capacity, and sick-leave levels. Intention-to-treat analysis revealed a small but lasting improvement in global cognitive functioning for the cognitive training group, paralleled by a large improvement on a trained updating task. The aerobic training group showed improvements in aerobic capacity and episodic memory immediately after training, but no long-term benefits. General improvements in psychological health and work ability were observed, with no difference between interventional groups. Our findings suggest that cognitive training may be a viable method to address cognitive impairments for patients with ED, whereas the effects of aerobic exercise on cognition may be more limited when performed during a restricted time period. The implications for clinical practice in supporting patients with ED to adhere to treatment are discussed.

Intranasal Midazolam versus Rectal Diazepam for the Management of Canine Status Epilepticus: A Multicenter Randomized Parallel-Group Clinical Trial.

PubMed

Charalambous, M; Bhatti, S F M; Van Ham, L; Platt, S; Jeffery, N D; Tipold, A; Siedenburg, J; Volk, H A; Hasegawa, D; Gallucci, A; Gandini, G; Musteata, M; Ives, E; Vanhaesebrouck, A E

2017-07-01

Intranasal administration of benzodiazepines has shown superiority over rectal administration for terminating emergency epileptic seizures in human trials. No such clinical trials have been performed in dogs. To evaluate the clinical efficacy of intranasal midazolam (IN-MDZ), via a mucosal atomization device, as a first-line management option for canine status epilepticus and compare it to rectal administration of diazepam (R-DZP) for controlling status epilepticus before intravenous access is available. Client-owned dogs with idiopathic or structural epilepsy manifesting status epilepticus within a hospital environment were used. Dogs were randomly allocated to treatment with IN-MDZ (n = 20) or R-DZP (n = 15). Randomized parallel-group clinical trial. Seizure cessation time and adverse effects were recorded. For each dog, treatment was considered successful if the seizure ceased within 5 minutes and did not recur within 10 minutes after administration. The 95% confidence interval was used to detect the true population of dogs that were successfully treated. The Fisher's 2-tailed exact test was used to compare the 2 groups, and the results were considered statistically significant if P < .05. IN-MDZ and R-DZP terminated status epilepticus in 70% (14/20) and 20% (3/15) of cases, respectively (P = .0059). All dogs showed sedation and ataxia. IN-MDZ is a quick, safe and effective first-line medication for controlling status epilepticus in dogs and appears superior to R-DZP. IN-MDZ might be a valuable treatment option when intravenous access is not available and for treatment of status epilepticus in dogs at home. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study.

PubMed

Bartlett, Jimmy D; Holland, Edward J; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

2008-08-01

To compare the ocular comfort and tolerability of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; TobraDex) in healthy volunteers. In this multicenter, randomized, double-masked, parallel-group study, healthy volunteers (n = 306) were randomized to receive LE/T or DM/T four times per day for 28 days. Subjects recorded subjective ratings for seven comfort/tolerability parameters using an electronic patient diary (EPD). The primary endpoint was the difference at week 4 from the ratings of an artificial tear at baseline in comfort/tolerability parameters between treatment groups, using a noninferiority paradigm. ClinicalTrials. gov, NCT 00532961. The 97.5% confidence intervals for the lower bound were within -10 for all of the seven comfort/ tolerability parameters evaluated (pain, stinging/burning, irritation, itchiness, foreign-body sensation, dryness, and light sensitivity). Secondary analysis revealed small but significant within-treatment differences in pain favoring LE/T over tears and in light sensitivity favoring tears over DM/T (p < 0.01). Small between-treatment differences in the changes from baseline tear ratings to individual study visits favored LE/T for pain, stinging/burning, irritation, itchiness, foreign-body sensation, and light sensitivity at visit 4 (p < or = 0.04); for pain, stinging/burning, and foreignbody sensation at visit 5 (p < or = 0.03), and for dryness and light sensitivity at visit 6 (p < or = 0.05). LE/T satisfied all conditions of noninferiority to DM/T in comfort and tolerability. Subjects receiving LE/T were more likely to report better ocular comfort/tolerability ratings relative to baseline artificial tears than subjects receiving DM/T. The study population consisted of healthy volunteers.

Comparison of anti-plaque efficacy between a low and high cost dentifrice: A short term randomized double-blind trial

PubMed Central

Ganavadiya, Rahul; Shekar, B. R. Chandra; Goel, Pankaj; Hongal, Sudheer G.; Jain, Manish; Gupta, Ruchika

2014-01-01

Objective: The aim of this study was to compare the anti-plaque efficacy of a low and high cost commercially available tooth paste among 13-20 years old adolescents in a Residential Home, Bhopal, India. Materials and Methods: The study was randomized double-blind parallel clinical trial conducted in a Residential Home, Bhopal, India. A total of 65 patients with established dental plaque and gingivitis were randomly assigned to either low cost or high cost dentifrice group for 4 weeks. The plaque and gingival scores at baseline and post-intervention were assessed and compared. Statistical analysis was performed using paired t-test and the independent sample t-test. The statistical significance was fixed at 0.05. Results: Results indicated a significant reduction in plaque and gingival scores in both groups post-intervention compared with the baseline. Difference between the groups was not significant. No adverse events were reported and both the dentifrices were well-tolerated. Conclusion: Low cost dentifrice is equally effective to the high cost dentifrice in reducing plaque and gingival inflammation. PMID:25202220

Oscillations and chaos in neural networks: an exactly solvable model.

PubMed Central

Wang, L P; Pichler, E E; Ross, J

1990-01-01

We consider a randomly diluted higher-order network with noise, consisting of McCulloch-Pitts neurons that interact by Hebbian-type connections. For this model, exact dynamical equations are derived and solved for both parallel and random sequential updating algorithms. For parallel dynamics, we find a rich spectrum of different behaviors including static retrieving and oscillatory and chaotic phenomena in different parts of the parameter space. The bifurcation parameters include first- and second-order neuronal interaction coefficients and a rescaled noise level, which represents the combined effects of the random synaptic dilution, interference between stored patterns, and additional background noise. We show that a marked difference in terms of the occurrence of oscillations or chaos exists between neural networks with parallel and random sequential dynamics. Images PMID:2251287

A double blind parallel group placebo controlled comparison of sedative and mnesic effects of etifoxine and lorazepam in healthy subjects [corrected].

PubMed

Micallef, J; Soubrouillard, C; Guet, F; Le Guern, M E; Alquier, C; Bruguerolle, B; Blin, O

2001-06-01

This paper describes the psychomotor and mnesic effects of single oral doses of etifoxine (50 and 100 mg) and lorazepam (2 mg) in healthy subjects. Forty-eight healthy subjects were included in this randomized double blind, placebo controlled parallel group study [corrected]. The effects of drugs were assessed by using a battery of subjective and objective tests that explored mood and vigilance (Visual Analog Scale), attention (Barrage test), psychomotor performance (Choice Reaction Time) and memory (digit span, immediate and delayed free recall of a word list). Whereas vigilance, psychomotor performance and free recall were significantly impaired by lorazepam, neither dosage of etifoxine (50 and 100 mg) produced such effects. These results suggest that 50 and 100 mg single dose of etifoxine do not induce amnesia and sedation as compared to lorazepam.

Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp.

PubMed

Buechner, Stanislaw A

2014-06-01

This study investigated the non-inferiority of efficacy and tolerance of 2% miconazole nitrate shampoo in comparison with 2% ketoconazole shampoo in the treatment of scalp seborrheic dermatitis. A randomized, double-blind, comparative, parallel group, multicenter study was done. A total of 274 patients (145 miconazole, 129 ketoconazole) were enrolled. Treatment was twice-weekly for 4 weeks. Safety and efficacy assessments were made at baseline and at weeks 2 and 4. Assessments included symptoms of erythema, itching, scaling ['Symptom Scale of Seborrhoeic Dermatitis' (SSSD)], disease severity and global change [Clinical Global Impressions (CGIs) and Patient Global Impressions (PGIs)]. Miconazole shampoo is at least as effective and safe as ketoconazole shampoo in treating scalp seborrheic dermatitis scalp.

Effect of flashlight guidance on manual ventilation performance in cardiopulmonary resuscitation: A randomized controlled simulation study.

PubMed

Kim, Ji Hoon; Beom, Jin Ho; You, Je Sung; Cho, Junho; Min, In Kyung; Chung, Hyun Soo

2018-01-01

Several auditory-based feedback devices have been developed to improve the quality of ventilation performance during cardiopulmonary resuscitation (CPR), but their effectiveness has not been proven in actual CPR situations. In the present study, we investigated the effectiveness of visual flashlight guidance in maintaining high-quality ventilation performance. We conducted a simulation-based, randomized, parallel trial including 121 senior medical students. All participants were randomized to perform ventilation during 2 minutes of CPR with or without flashlight guidance. For each participant, we measured mean ventilation rate as a primary outcome and ventilation volume, inspiration velocity, and ventilation interval as secondary outcomes using a computerized device system. Mean ventilation rate did not significantly differ between flashlight guidance and control groups (P = 0.159), but participants in the flashlight guidance group exhibited significantly less variation in ventilation rate than participants in the control group (P<0.001). Ventilation interval was also more regular among participants in the flashlight guidance group. Our results demonstrate that flashlight guidance is effective in maintaining a constant ventilation rate and interval. If confirmed by further studies in clinical practice, flashlight guidance could be expected to improve the quality of ventilation performed during CPR.

Effectiveness and Patient Acceptability of Stellate Ganglion Block (SGB) for Treatment of Posttraumatic Stress Disorder (PTSD) Symptoms among Active Duty Military Members

DTIC Science & Technology

PTSD) symptoms. We will conduct two parallel studies: a randomized, controlled trial (RCT) to evaluate the effectiveness of SGB for treating PTSD, and a...study, individuals enrolled in the RCT will be asked to participate either in a focus group or an interview with their spouse. In addition, we will...conduct focus groups and key informant interviews with providers: those who refer individuals to the study, and those who provide SGB to service members.

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

PubMed

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

2015-01-01

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

The impact of group music therapy on depression and cognition in elderly persons with dementia: a randomized controlled study.

PubMed

Chu, Hsin; Yang, Chyn-Yng; Lin, Yu; Ou, Keng-Liang; Lee, Tso-Ying; O'Brien, Anthony Paul; Chou, Kuei-Ru

2014-04-01

The aims of this study were to determine the effectiveness of group music therapy for improving depression and delaying the deterioration of cognitive functions in elderly persons with dementia. The study had a prospective, parallel-group design with permuted-block randomization. Older persons with dementia (N = 104) were randomly assigned to the experimental or control group. The experimental group received 12 sessions of group music therapy (two 30-min sessions per week for 6 weeks), and the control group received usual care. Data were collected 4 times: (1) 1 week before the intervention, (2) the 6th session of the intervention, (3) the 12th session of the intervention, and (4) 1 month after the final session. Group music therapy reduced depression in persons with dementia. Improvements in depression occurred immediately after music therapy and were apparent throughout the course of therapy. The cortisol level did not significantly decrease after the group music therapy. Cognitive function significantly improved slightly at the 6th session, the 12th session, and 1 month after the sessions ended; in particular, short-term recall function improved. The group music therapy intervention had the greatest impact in subjects with mild and moderate dementia. The group music intervention is a noninvasive and inexpensive therapy that appeared to reduce elders' depression. It also delayed the deterioration of cognitive functions, particularly short-term recall function. Group music therapy may be an appropriate intervention among elderly persons with mild and moderate dementia.

A pilot randomized double-blind placebo-controlled trial on topical chamomile (Matricaria chamomilla L.) oil for severe carpal tunnel syndrome.

PubMed

Hashempur, Mohammad Hashem; Lari, Zeinab Nasiri; Ghoreishi, Parissa Sadat; Daneshfard, Babak; Ghasemi, Mohammad Sadegh; Homayouni, Kaynoosh; Zargaran, Arman

2015-11-01

To assess the effectiveness of standardized topical Chamomile (Matricaria chamomilla L.) oil in patients with severe carpal tunnel syndrome, as a complementary treatment. A pilot randomized double-blind placebo-controlled trial was conducted. Twenty six patients with documented severe carpal tunnel syndrome were treated in two parallel groups with a night splint plus topical chamomile oil or placebo. They were instructed to use their prescribed oil for 4 weeks, twice daily. Symptomatic and functional status of the patients and their electrodiagnostic parameters were evaluated when enrolled and after the trial period, as our outcome measures. A significant improvement of symptomatic and functional status of patients in the chamomile oil group was observed (p = 0.019 and 0.016, respectively) compared with those in the placebo group. However, electrodiagnostic parameters showed no significant changes between the two groups. Chamomile oil improved symptomatic and functional status of patients with severe carpal tunnel syndrome. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy of aloe vera gel as an adjuvant treatment of oral submucous fibrosis.

PubMed

Alam, Sarwar; Ali, Iqbal; Giri, K Y; Gokkulakrishnan, S; Natu, Subodh S; Faisal, Mohammad; Agarwal, Anshita; Sharma, Himanshu

2013-12-01

Definitive therapy is not defined for the management of oral submucous fibrosis (OSMF). This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF. A double-blind, placebo-controlled, parallel-group randomized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment (submucosal injection of hyaluronidase and dexamethasone, n = 30) and surgical treatment (n = 30) categories. Each category was randomly divided into groups A (with aloe vera, n = 15 per category) and B (without aloe vera, n = 15 per category). Follow-up assessment for various symptoms was performed, and results were analyzed using paired and unpaired Student t tests. The group receiving aloe vera had a significant improvement in most symptoms of OSMF (P < .01) compared with the non-aloe vera group, in both the medicinal and surgical categories. Aloe vera gel was effective as an adjuvant in treatment of OSMF. Copyright © 2013 Elsevier Inc. All rights reserved.

A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems.

PubMed

Stocks, Jennifer Dugan; Taneja, Baldeo K; Baroldi, Paolo; Findling, Robert L

2012-04-01

To evaluate safety and tolerability of four doses of immediate-release molindone hydrochloride in children with attention-deficit/hyperactivity disorder (ADHD) and serious conduct problems. This open-label, parallel-group, dose-ranging, multicenter trial randomized children, aged 6-12 years, with ADHD and persistent, serious conduct problems to receive oral molindone thrice daily for 9-12 weeks in four treatment groups: Group 1-10 mg (5 mg if weight <30 kg), group 2-20 mg (10 mg if <30 kg), group 3-30 mg (15 mg if <30 kg), and group 4-40 mg (20 mg if <30 kg). The primary outcome measure was to evaluate safety and tolerability of molindone in children with ADHD and serious conduct problems. Secondary outcome measures included change in Nisonger Child Behavior Rating Form-Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem subscale scores, change in Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) subscale scores from baseline to end point, and Swanson, Nolan, and Pelham rating scale-revised (SNAP-IV) ADHD-related subscale scores. The study randomized 78 children; 55 completed the study. Treatment with molindone was generally well tolerated, with no clinically meaningful changes in laboratory or physical examination findings. The most common treatment-related adverse events (AEs) included somnolence (n=9), weight increase (n=8), akathisia (n=4), sedation (n=4), and abdominal pain (n=4). Mean weight increased by 0.54 kg, and mean body mass index by 0.24 kg/m(2). The incidence of AEs and treatment-related AEs increased with increasing dose. NCBRF-TIQ subscale scores improved in all four treatment groups, with 34%, 34%, 32%, and 55% decreases from baseline in groups 1, 2, 3, and 4, respectively. CGI-S and SNAP-IV scores improved over time in all treatment groups, and CGI-I scores improved to the greatest degree in group 4. Molindone at doses of 5-20 mg/day (children weighing <30 kg) and 20-40 mg (≥ 30 kg) was well tolerated, and preliminary efficacy results suggest that molindone produces dose-related behavioral improvements over 9-12 weeks. Additional double-blind, placebo-controlled trials are needed to further investigate molindone in this pediatric population.

Random number generators for large-scale parallel Monte Carlo simulations on FPGA

NASA Astrophysics Data System (ADS)

Lin, Y.; Wang, F.; Liu, B.

2018-05-01

Through parallelization, field programmable gate array (FPGA) can achieve unprecedented speeds in large-scale parallel Monte Carlo (LPMC) simulations. FPGA presents both new constraints and new opportunities for the implementations of random number generators (RNGs), which are key elements of any Monte Carlo (MC) simulation system. Using empirical and application based tests, this study evaluates all of the four RNGs used in previous FPGA based MC studies and newly proposed FPGA implementations for two well-known high-quality RNGs that are suitable for LPMC studies on FPGA. One of the newly proposed FPGA implementations: a parallel version of additive lagged Fibonacci generator (Parallel ALFG) is found to be the best among the evaluated RNGs in fulfilling the needs of LPMC simulations on FPGA.

Hemostatic Agents in Periapical Surgery: A Randomized Study of Gauze Impregnated in Epinephrine versus Aluminum Chloride.

PubMed

Menéndez-Nieto, Isabel; Cervera-Ballester, Juan; Maestre-Ferrín, Laura; Blaya-Tárraga, Juan Antonio; Peñarrocha-Oltra, David; Peñarrocha-Diago, Miguel

2016-11-01

Adequate bleeding control is essential for the success of periapical surgery. The aim of this study was to evaluate the effects of 2 hemostatic agents on the outcome of periapical surgery and their relationship with patient and teeth parameters. A prospective study was designed with 2 randomized parallel groups, depending on the hemostatic agent used: gauze impregnated in epinephrine (epinephrine group) and aluminum chloride (aluminum chloride group). The analysis of the hemorrhage control was judged before and after the application of the hemostatic agents by the surgeon, and 2 examiners independently recorded it as adequate (complete hemorrhage control) or inadequate (incomplete hemorrhage control). Ninety-nine patients with a periradicular lesion were enrolled in this study and divided into 2 groups: gauze impregnated in epinephrine in 48 patients (epinephrine group) or aluminum chloride in 51 (aluminum chloride group). In epinephrine group adequate hemostasis was achieved in 25 cases, and in aluminum chloride group it was achieved in 37 cases (P < .05). The outcome was better in the aluminum chloride group than in the gauze impregnated in epinephrine group. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov

2010-11-19

The Objectives of the Study is to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg; Plus Acarbose 50 mg Tablets) Thrice Daily Versus Acarbose 50 mg Thrice Daily Over 16 Weeks in; Subjects With Type 2 Diabetes Mellitus.

A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy

PubMed Central

Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

2016-01-01

Objective: The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. Methods: In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σsetup) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. Results: 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σsetup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. Conclusion: UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial. PMID:27710100

A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy.

PubMed

Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

2016-12-01

The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σ setup ) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σ setup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol.

PubMed

Kwon, Hyo-Jung; Kim, Jong-In; Lee, Myeong Soo; Choi, Jun-Yong; Kang, Sungkeel; Chung, Jie-Yoon; Kim, Young-Jin; Lee, Seung-Hoon; Lee, Sanghoon; Nam, Dongwoo; Kim, Yong-Suk; Lee, Jae-Dong; Choi, Do-Young

2011-03-09

Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales.

Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial.

PubMed

Gulluoglu, Bahadir M; Guler, Sertac Ata; Ugurlu, M Umit; Culha, Gulcan

2013-01-01

To assess the impact of prophylactic antibiotics on the prevention of surgical site infection (SSI) and the cost-effectiveness of this prophylaxis for breast cancer surgery in overweight or obese women. SSI is higher than expected after breast surgery. Obesity was found to be one of the risk factors. The trial was designed as a phase IV randomized, controlled, parallel-group efficacy trial. It was conducted at a tertiary university hospital. Overweight or obese women with clinically early-stage breast cancer who had been assigned to undergo surgery were eligible. Patients were randomly allocated to either a prophylaxis or a control group by using a computer-generated list. The prophylaxis group received 1 g ampicillin-sulbactam intravenously at anesthesia. The control group received no intervention. Patients and observers were blinded to the assignments. The primary outcome was the comparison of SSI incidences of the 2 groups. Patients were monitored for 30 days. A total of 369 patients were included in final analysis, out of which 187 were allocated for prophylaxis and 182 were randomly assigned to the control group. Analysis was done according to the intention-to-treat principle. Prophylaxis significantly reduced the SSI rate (4.8%) in the prophylaxis group when compared with that in the control group [13.7%; relative risk (RR) 0.35; 95% CI: 0.17-0.73]. No adverse reaction was observed. The mean SSI-related cost (20.26 USD) was found to be significantly higher in the control group when compared with that (8.48 USD) in the prophylaxis group. Antibiotic prophylaxis significantly decreased SSI incidence after elective surgery and was shown to be cost-effective in obese breast cancer patients. ClinicalTrials.gov Identifier: NCT00356148.

Sonographic evaluation of the fetal spine position and success rate of manual rotation of the fetus in occiput posterior position: A randomized controlled trial.

PubMed

Masturzo, Bianca; Farina, Antonio; Attamante, Lorenza; Piazzese, Annalisa; Rolfo, Alessandro; Gaglioti, Pietro; Todros, Tullia

2017-10-01

To evaluate whether sonographic (US) diagnosis of the fetal spine position could increase the success rate of manual rotation of the fetal occiput (MRFO) in second-stage arrest in persistent occiput posterior position (OPP). In this randomized controlled parallel single-center trial, 58 nulliparous in second-stage arrest of labor with fetus in cephalic presentation and OPP diagnosed by US were randomly assigned to group A where the fetal spine position was not known by the operator or to group B where the operator knew it. The main outcome was the success of MRFO in the two groups. Secondary outcomes were perineal injuries, blood loss, duration of expulsive period, and neonatal APGAR at 5 minutes. A priori knowledge of the spine position improves the success of the MRFO (41.4% group A versus 82.8% group B, p value < 0.001), the percentage of spontaneous deliveries (27.6% group A versus 69% group B, p value = 0.01), and maternal outcome (intact perineum and blood loss). No differences were detected on the neonatal side. MRFO is a safe and useful procedure that should be performed in second-stage arrest in OPP. A better performance was observed when supported by the US knowledge of the spine position. © 2017 Wiley Periodicals, Inc. J Clin Ultrasound 45:472-476, 2017. © 2017 Wiley Periodicals, Inc.

Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial.

PubMed

Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj

2017-10-01

Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA). Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

Open-Label, Randomized, Parallel-Group Controlled Clinical Trial of Massage for Treatment of Depression in HIV-Infected Subjects

PubMed Central

Gertsik, Lev; Favreau, Joya T.; Smith, Shawnee I.; Mirocha, James M.; Rao, Uma; Daar, Eric S.

2013-01-01

Abstract Objectives The study objectives were to determine whether massage therapy reduces symptoms of depression in subjects with human immunodeficiency virus (HIV) disease. Design Subjects were randomized non-blinded into one of three parallel groups to receive Swedish massage or to one of two control groups, touch or no intervention for eight weeks. Settings/location The study was conducted at the Department of Psychiatry and Behavioral Neurosciences at Cedars-Sinai Medical Center in Los Angeles, California, which provided primary clinical care in an institutional setting. Subjects Study inclusion required being at least 16 years of age, HIV-seropositive, with a diagnosis of major depressive disorder. Subjects had to be on a stable neuropsychiatric, analgesic, and antiretroviral regimen for >30 days with no plans to modify therapy for the duration of the study. Approximately 40% of the subjects were currently taking antidepressants. All subjects were medically stable. Fifty-four (54) subjects were randomized, 50 completed at least 1 week (intent-to-treat; ITT), and 37 completed the study (completers). Interventions Swedish massage and touch subjects visited the massage therapist for 1 hour twice per week. The touch group had a massage therapist place both hands on the subject with slight pressure, but no massage, in a uniform distribution in the same pattern used for the massage subjects. Outcome measures The primary outcome measure was the Hamilton Rating Scale for Depression score, with the secondary outcome measure being the Beck Depression Inventory. Results For both the ITT and completers analyses, massage significantly reduced the severity of depression beginning at week 4 (p≤0.04) and continuing at weeks 6 (p≤0.03) and 8 (p≤0.005) compared to no intervention and/or touch. Conclusions The results indicate that massage therapy can reduce symptoms of depression in subjects with HIV disease. The durability of the response, optimal “dose” of massage, and mechanisms by which massage exerts its antidepressant effects remain to be determined. PMID:23098696

Parallel point-multiplication architecture using combined group operations for high-speed cryptographic applications

PubMed Central

Saeedi, Ehsan; Kong, Yinan

2017-01-01

In this paper, we propose a novel parallel architecture for fast hardware implementation of elliptic curve point multiplication (ECPM), which is the key operation of an elliptic curve cryptography processor. The point multiplication over binary fields is synthesized on both FPGA and ASIC technology by designing fast elliptic curve group operations in Jacobian projective coordinates. A novel combined point doubling and point addition (PDPA) architecture is proposed for group operations to achieve high speed and low hardware requirements for ECPM. It has been implemented over the binary field which is recommended by the National Institute of Standards and Technology (NIST). The proposed ECPM supports two Koblitz and random curves for the key sizes 233 and 163 bits. For group operations, a finite-field arithmetic operation, e.g. multiplication, is designed on a polynomial basis. The delay of a 233-bit point multiplication is only 3.05 and 3.56 μs, in a Xilinx Virtex-7 FPGA, for Koblitz and random curves, respectively, and 0.81 μs in an ASIC 65-nm technology, which are the fastest hardware implementation results reported in the literature to date. In addition, a 163-bit point multiplication is also implemented in FPGA and ASIC for fair comparison which takes around 0.33 and 0.46 μs, respectively. The area-time product of the proposed point multiplication is very low compared to similar designs. The performance (1Area×Time=1AT) and Area × Time × Energy (ATE) product of the proposed design are far better than the most significant studies found in the literature. PMID:28459831

Parallel point-multiplication architecture using combined group operations for high-speed cryptographic applications.

PubMed

Hossain, Md Selim; Saeedi, Ehsan; Kong, Yinan

2017-01-01

In this paper, we propose a novel parallel architecture for fast hardware implementation of elliptic curve point multiplication (ECPM), which is the key operation of an elliptic curve cryptography processor. The point multiplication over binary fields is synthesized on both FPGA and ASIC technology by designing fast elliptic curve group operations in Jacobian projective coordinates. A novel combined point doubling and point addition (PDPA) architecture is proposed for group operations to achieve high speed and low hardware requirements for ECPM. It has been implemented over the binary field which is recommended by the National Institute of Standards and Technology (NIST). The proposed ECPM supports two Koblitz and random curves for the key sizes 233 and 163 bits. For group operations, a finite-field arithmetic operation, e.g. multiplication, is designed on a polynomial basis. The delay of a 233-bit point multiplication is only 3.05 and 3.56 μs, in a Xilinx Virtex-7 FPGA, for Koblitz and random curves, respectively, and 0.81 μs in an ASIC 65-nm technology, which are the fastest hardware implementation results reported in the literature to date. In addition, a 163-bit point multiplication is also implemented in FPGA and ASIC for fair comparison which takes around 0.33 and 0.46 μs, respectively. The area-time product of the proposed point multiplication is very low compared to similar designs. The performance ([Formula: see text]) and Area × Time × Energy (ATE) product of the proposed design are far better than the most significant studies found in the literature.

Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial.

PubMed

Mundt, Torsten; Al Jaghsi, Ahmad; Schwahn, Bernd; Hilgert, Janina; Lucas, Christian; Biffar, Reiner; Schwahn, Christian; Heinemann, Friedhelm

2016-07-30

Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00007589 ( www.germanctr.de ) on January 13(th), 2015.

Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin: A Randomized Open Parallel-Group Study.

PubMed

Nyström, Thomas; Padro Santos, Irene; Hedberg, Fredric; Wardell, Johan; Witt, Nils; Cao, Yang; Bojö, Leif; Nilsson, Bo; Jendle, Johan

2017-01-01

We aimed to investigate the effect of liraglutide treatment on heart function in type 2 diabetes (T2D) patients with subclinical heart failure. Randomized open parallel-group trial. 62 T2D patients (45 male) with subclinical heart failure were randomized to either once daily liraglutide 1.8 mg, or glimepiride 4 mg, both add on to metformin 1 g twice a day. Mitral annular systolic (s') and early diastolic (e') velocities were measured at rest and during bicycle ergometer exercise, using tissue Doppler echocardiography. The primary endpoint was 18-week treatment changes in longitudinal functional reserve index (LFRI diastolic/systolic ). Clinical characteristics between groups (liraglutide = 33 vs. glimepiride = 29) were well matched. At baseline left ventricle ejection fraction (53.7 vs. 53.6%) and global longitudinal strain (-15.3 vs. -16.5%) did not differ between groups. There were no significant differences in mitral flow velocities between groups. For the primary endpoint, there was no treatment change [95% confidence interval] for: LFRI diastolic (-0.18 vs. -0.53 [-0.28, 2.59; p  = 0.19]), or LFRI systolic (-0.10 vs. -0.18 [-1.0, 1.7; p  = 0.54]); for the secondary endpoints, there was a significant treatment change in respect of body weight (-3.7 vs. -0.2 kg [-5.5, -1.4; p  = 0.001]), waist circumference (-3.1 vs. -0.8 cm [-4.2, -0.4; p  = 0.019]), and heart rate (HR) (6.3 vs. -2.3 bpm [-3.0, 14.2; p  = 0.003]), with no such treatment change in hemoglobin A1c levels (-11.0 vs. -9.2 mmol/mol [-7.0, 2.6; p  = 0.37]), between groups. 18-week treatment of liraglutide compared with glimepiride did not improve LFRI diastolic/systolic , but however increased HR. There was a significant treatment change in body weight reduction in favor for liraglutide treatment.

Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain.

PubMed

Johnson, Jeremy R; Burnell-Nugent, Mary; Lossignol, Dominique; Ganae-Motan, Elena Doina; Potts, Richard; Fallon, Marie T

2010-02-01

This study compared the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract, with placebo, in relieving pain in patients with advanced cancer. In total, 177 patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, entered a two-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. Patients were randomized to THC:CBD extract (n = 60), THC extract (n = 58), or placebo (n = 59). The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THC:CBD compared with placebo (improvement of -1.37 vs. -0.69), whereas the THC group showed a nonsignificant change (-1.01 vs. -0.69). Twice as many patients taking THC:CBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo (23 [43%] vs. 12 [21%]). The associated odds ratio was statistically significant, whereas the number of THC group responders was similar to placebo (12 [23%] vs. 12 [21%]) and did not reach statistical significance. There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups. No significant group differences were found in the NRS sleep quality or nausea scores or the pain control assessment. However, the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire showed a worsening in nausea and vomiting with THC:CBD compared with placebo (P = 0.02), whereas THC had no difference (P = 1.0). Most drug-related adverse events were mild/moderate in severity. This study shows that THC:CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids. Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial.

PubMed

Migliorati, Marco; Amorfini, Leonardo; Signori, Alessio; Biavati, Armando Silvestrini; Benedicenti, Stefano

2015-10-01

The aesthetic outcome of an implant-supported restoration is first of all dependent on the soft tissue volume. Because the labial bone plate resorbs in every direction after tooth extraction, even when an implant is placed immediately, most patients end up with compromised aesthetics. In this parallel-designed, randomized clinical trial, participants were randomly assigned to the test group (immediate load post-extractive implant treated with subepithelial connective tissue graft placed using the tunnel technique in the labial area) and control group (immediate load post-extractive implant treated without raising a flap) with an allocation ratio of 1:1. Both groups received deproteinized bovine bone mineral. Patients were observed at baseline, crown insertion, 1-year follow-up, and 2-year follow-up. Clinical, radiological and aesthetic parameters were recorded to assess primary treatment outcomes. A random permuted block system was blindly generated ensuring uniformity of the patient allocation during the trial by randomly distributing three participants to the test and three participants to the control group every six treated patients. At the 2-year examination, all 47 implants were successfully integrated, demonstrating stability and healthy peri-implant soft tissues as documented by standard clinical parameters. The results showed a soft tissue remodeling of -10% in thickness and -18% in highness in the non-grafted group, whereas in the grafted group there was a gain of 35% in thickness and a slight reduction of -11% in highness. Test group reported an increase of aesthetic result (mean pink aesthetic score [PES] 8) compared with control group (mean PES 6.65). This prospective study demonstrates the effectiveness of placing a soft tissue graft at the time of immediate implant placement in the aesthetic zone. At the 2-year follow-up, test group revealed a better aesthetic outcomes and stable facial soft tissues compared with control group. © 2013 Wiley Periodicals, Inc.

A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

PubMed

Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

2018-06-01

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

Venlafaxine versus methylphenidate in pediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial.

PubMed

Zarinara, Ali-Reza; Mohammadi, Mohammad-Reza; Hazrati, Nazanin; Tabrizi, Mina; Rezazadeh, Shams-Ali; Rezaie, Farzin; Akhondzadeh, Shahin

2010-11-01

The present report aimed to investigate the efficacy and tolerability of venlafaxine compared to methylphenidate in children and adolescents with Attention Deficit/Hyperactivity Disorder (ADHD). This was a 6-week, parallel group, randomized clinical trial. Thirty-eight patients (27 boys and 11 girls) with a DSM-IV-TR diagnosis of ADHD were the study population of this trial. All study subjects were randomly assigned to receive treatment using capsules of venlafaxine at doses of 50-75 mg/day depending on weight (50 mg/day for <30 kg and 75 mg/day for >30 kg (group 1) or methylphenidate at a dose of 20-30 mg/day depending on weight (group 2) for a 6-week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent Attention Deficit/Hyperactivity Disorder Rating Scale-IV. No significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores (df = 1; F = 1.77; p = 0.19 and df = 1; F = 1.64; p = 0.20, respectively). Side effects of headaches and insomnia were observed more frequently in the methylphenidate group. The results suggest that venlafaxine may be useful for the treatment of ADHD. In addition, a tolerable side-effect profile is one of the advantages of venlafaxine in the treatment of ADHD. Copyright © 2010 John Wiley & Sons, Ltd.

Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

PubMed Central

2011-01-01

Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010 PMID:21388554

Randomized Clinical Trial of Virtual Reality Simulation Training for Transvaginal Gynecologic Ultrasound Skills.

PubMed

Chao, Coline; Chalouhi, Gihad E; Bouhanna, Philippe; Ville, Yves; Dommergues, Marc

2015-09-01

To compare the impact of virtual reality simulation training and theoretical teaching on the ability of inexperienced trainees to produce adequate virtual transvaginal ultrasound images. We conducted a randomized controlled trial with parallel groups. Participants included inexperienced residents starting a training program in Paris. The intervention consisted of 40 minutes of virtual reality simulation training using a haptic transvaginal simulator versus 40 minutes of conventional teaching including a conference with slides and videos and answers to the students' questions. The outcome was a 19-point image quality score calculated from a set of 4 images (sagittal and coronal views of the uterus and left and right ovaries) produced by trainees immediately after the intervention, using the same simulator on which a new virtual patient had been uploaded. Experts assessed the outcome on stored images, presented in a random order, 2 months after the trial was completed. They were blinded to group assignment. The hypothesis was an improved outcome in the intervention group. Randomization was 1 to 1. The mean score was significantly greater in the simulation group (n = 16; mean score, 12; SEM, 0.8) than the control group (n = 18; mean score, 9; SEM, 1.0; P= .0302). The quality of virtual vaginal images produced by inexperienced trainees was greater immediately after a single virtual reality simulation training session than after a single theoretical teaching session. © 2015 by the American Institute of Ultrasound in Medicine.

Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial.

PubMed

Fritel, Xavier; de Tayrac, Renaud; Bader, Georges; Savary, Denis; Gueye, Ameth; Deffieux, Xavier; Fernandez, Hervé; Richet, Claude; Guilhot, Joëlle; Fauconnier, Arnaud

2015-08-01

To compare, in an unselected population of nulliparous pregnant women, the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence (UI). In a randomized controlled trial in two parallel groups, 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy. The physiotherapy group received prenatal individually supervised exercises. Both groups received written instructions about how to perform exercises at home. Women were blindly assessed at baseline, end of pregnancy, and 2 and 12 months postpartum. The primary outcome measured was UI severity, assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score (range 0-21; 1-5 is slight UI) at 12 months postpartum; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires. To give a 1-point difference in UI severity score, we needed 91 women in each group (standard deviation 2.4, α=0.05, β=0.20, and bilateral analysis). Between February 2008 and June 2010, 140 women were randomized in the physiotherapy group and 142 in the control group. No difference was observed between the two groups in UI severity, prevalence, or pelvic floor troubles at baseline, end of pregnancy, and at 2 and 12 months postpartum. At 12 months postpartum, the primary outcome was available for 190 women (67.4%); mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group (P=.38). Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI. ClinicalTrials.gov; www.clinicaltrials.gov, NCT00551551. I.

Effect of a herbal extract powder (YY-312) from Imperata cylindrica Beauvois, Citrus unshiu Markovich, and Evodia officinalis Dode on body fat mass in overweight adults: a 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial.

PubMed

Cho, Young-Gyu; Jung, Ji-Hye; Kang, Jae-Heon; Kwon, Jin Soo; Yu, Seung Pil; Baik, Tae Gon

2017-07-28

YY-312 is a herbal extract powder from Imperata cylindrica Beauvois, Citrus unshiu Markovich, and Evodia officinalis Dode, which have health promoting effects, including body fat reduction. We aimed to evaluate the efficacy and safety of YY-312 for body fat reduction in overweight adults. This was a 12-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial performed in overweight Korean adults aged 19-60 years with a body mass index of 25.0-29.9 kg/m 2 . The daily dose of YY-312 was 2400 mg (containing 1800 mg of active herbal extract and 600 mg of cyclodextrin). Primary outcomes were reductions in body fat mass (BFM) and body fat percentage (BF%) after 12 weeks. Secondary outcomes included reductions in body weight and waist circumference (WC) after 12 weeks. After 12 weeks, BFM (1.6 kg vs. 0.1 kg; P = 0.023) and BF% (1.5% vs. -0.2%; P = 0.018) decreased significantly more in the YY-312 group than in the placebo group, as did body weight (2.7 kg vs. 1.0 kg; P = 0.014) and WC (2.2 cm vs. 0.8 cm; P = 0.049). All safety parameters were within normal limits; no serious adverse events occurred in either group. In a 12-week clinical trial in overweight adults, YY-312 resulted in significantly greater reduction in body fat vs. placebo, while being safe and well tolerated. cris.nih.go.kr: ( KCT0001225 ).

Comparison of the therapeutic efficacy and safety of combined oral tranexamic acid and topical hydroquinone 4% treatment vs. topical hydroquinone 4% alone in melasma: a parallel-group, assessor- and analyst-blinded, randomized controlled trial with a short-term follow-up.

PubMed

Lajevardi, Vahideh; Ghayoumi, Afsaneh; Abedini, Robabeh; Hosseini, Hamed; Goodarzi, Azadeh; Akbari, Zahra; Hedayat, Kosar

2017-06-01

Melasma's high prevalence and profound psychological impact on patients necessitate efficacious, economical, and safe therapeutic interventions. Adjunctive therapies such as tranexamic acid (TA) can enhance the therapeutic effect of standard treatments like hydroquinone 4% cream (HQ). To conduct an assessor- and analyst-blinded, parallel, superiority, randomized controlled trial to compare the clinical efficacy and safety of oral TA plus HQ vs. HQ alone in melasma treatment. A total of 100 eligible patients with symmetric facial melasma were assigned to the intervention (250 mg thrice daily oral TA plus HQ 4% cream nightly) or the control group (HQ 4% cream only). Following 3 months of treatment, MASI (melasma area and severity index) score reduction was calculated as the primary outcome measure. After a 3-month follow-up, relapse was also assessed. A total of 88 patients completed the study. At the end of the 6-month period, the overall mean of the MASI score in the intervention group was 1.8 points lower than in the controls (95% confidence interval, 0.36-3.24, P = 0.015) but the relapse rate was not significantly different (30% vs. 26% in the treatment vs. control group, respectively). Side effect occurrence was also similar, but treatment satisfaction was higher in the intervention group than the controls, with 82.2% vs. 34.95 of patients reporting moderate-to-complete satisfaction, respectively (P < 0.001). Oral TA can enhance the efficacy of hydroquinone 4% cream in melasma treatment, but the high incidence of relapse suggests that treatment effects may be temporary, warranting more investigation. © 2016 Wiley Periodicals, Inc.

Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial.

PubMed

Syed, Maaz Hussain; Khandelwal, Prakash Narayan; Thawani, Vijay R; Katare, S S

2017-01-01

To evaluate the efficacy and safety of atorvastatin (ATN) 80 mg in the prevention of contrast medium- induced nephropathy (CIN) in high risk patients undergoing angiograph. This was a prospective, double-blind, two-arm, parallel group RCT. A total of 216 patients undergoing coronary angiography were screened, and 188 eligible patients were randomized to two treatment arms. Patients in Group A received tablet N-acetylcysteine (NAC) 1200 mg once daily, and patients in Group B received tablet atorvastatin 80 mg + NAC 1200 mg once daily, for 3 days before, and 2 days after angiography. A total of 160 patients completed the trial. Postprocedure, nine and two CIN cases were found in Group A and B, respectively. The mean change in serum creatinine was 0.086 ± 0.168 in Group A and 0.021 ± 0.083 in Group B, which was statistically significant ( P = 0.0289). Postprocedure, the estimated glomerular filteration rate was reduced by 19.52 in Group A and 13.55 in Group B ( P = 0.003). This trial indicates the positive role of statins in preventive strategy against CIN along with NAC.

Efficacy of Atorvastatin in Prevention of Contrast-induced Nephropathy in High-risk Patients Undergoing Angiography: A Double-blind Randomized Controlled Trial

PubMed Central

Syed, Maaz Hussain; Khandelwal, Prakash Narayan; Thawani, Vijay R.; Katare, S. S.

2017-01-01

Objective: To evaluate the efficacy and safety of atorvastatin (ATN) 80 mg in the prevention of contrast medium- induced nephropathy (CIN) in high risk patients undergoing angiograph. Materials and Methods: This was a prospective, double-blind, two-arm, parallel group RCT. A total of 216 patients undergoing coronary angiography were screened, and 188 eligible patients were randomized to two treatment arms. Patients in Group A received tablet N-acetylcysteine (NAC) 1200 mg once daily, and patients in Group B received tablet atorvastatin 80 mg + NAC 1200 mg once daily, for 3 days before, and 2 days after angiography. Results: A total of 160 patients completed the trial. Postprocedure, nine and two CIN cases were found in Group A and B, respectively. The mean change in serum creatinine was 0.086 ± 0.168 in Group A and 0.021 ± 0.083 in Group B, which was statistically significant (P = 0.0289). Postprocedure, the estimated glomerular filteration rate was reduced by 19.52 in Group A and 13.55 in Group B (P = 0.003). Conclusion: This trial indicates the positive role of statins in preventive strategy against CIN along with NAC. PMID:28706398

The Effect of Gromwell (Lithospermum erythrorhizon) Extract on the Stratum Corneum Hydration and Ceramides Content in Atopic Dermatitis Patients

PubMed Central

Cho, Hee Ryung; Cho, Yunhi; Kim, Juyoung; Seo, Dae Bang; Kim, Sung Han; Lee, Sang Jun

2008-01-01

Background A disruption of the balance between the water content of the stratum corneum (SC) and skin surface lipids may lead to the clinical manifestation of dryness of skin in patients with atopic dermatitis (AD). Objective To determine whether supplementation of gromwell (Lithospermum erythrorhizon), one of herbs used in East Asia in remedies for various abnormal skin conditions, may improve the SC level of hydration and ceramides, major lipid in SC in patients with AD. Methods A total of 28 subjects with AD were randomly assigned into two groups: either gromwell group received dextrose contained capsules with 1.5 g of gromwell extracts or placebo group received only dextrose contained capsules for 10 weeks. Results In contrast to no alteration of SC hydration and ceramides in placebo group, the SC hydration in gromwell group was significantly increased in parallel with an increase of SC ceramides. Furthermore, % increase of SC hydration in gromwell group bore a positive correlation with the clinical severity, which suggests that the increase of SC hydration in gromwell group was more effective as AD was more severe. Conclusion Supplementation of gromwell improves SC hydration in parallel with an increase of ceramides in part. PMID:27303161

Early application of tail nerve electrical stimulation-induced walking training promotes locomotor recovery in rats with spinal cord injury.

PubMed

Zhang, S-X; Huang, F; Gates, M; Shen, X; Holmberg, E G

2016-11-01

This is a randomized controlled prospective trial with two parallel groups. The objective of this study was to determine whether early application of tail nerve electrical stimulation (TANES)-induced walking training can improve the locomotor function. This study was conducted in SCS Research Center in Colorado, USA. A contusion injury to spinal cord T10 was produced using the New York University impactor device with a 25 -mm height setting in female, adult Long-Evans rats. Injured rats were randomly divided into two groups (n=12 per group). One group was subjected to TANES-induced walking training 2 weeks post injury, and the other group, as control, received no TANES-induced walking training. Restorations of behavior and conduction were assessed using the Basso, Beattie and Bresnahan open-field rating scale, horizontal ladder rung walking test and electrophysiological test (Hoffmann reflex). Early application of TANES-induced walking training significantly improved the recovery of locomotor function and benefited the restoration of Hoffmann reflex. TANES-induced walking training is a useful method to promote locomotor recovery in rats with spinal cord injury.

A comparative study on the effects of systemic manual acupuncture, periauricular electroacupuncture, and digital electroacupuncture to treat tinnitus: A randomized, paralleled, open-labeled exploratory trial.

PubMed

Kim, Bong Hyun; Kim, Kyuseok; Nam, Hae Jeong

2017-01-31

Many previous studies of electroacupuncture used combined therapy of electroacupuncture and systemic manual acupuncture, so it was uncertain which treatment was effective. This study evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. A randomized, parallel, open-labeled exploratory trial was conducted. Subjects aged 20-75 years who had suffered from idiopathic tinnitus for > 2 weeks were recruited from May 2013 to April 2014. The subjects were divided into three groups by systemic manual acupuncture group (MA), periauricular electroacupuncture group (PE), and distal electroacupuncture group (DE). The groups were selected by random drawing. Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of eight sessions over 4 weeks. Outcomes were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud , and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. Thirty-nine subjects were eligible and their data were analyzed. No difference in THI and VAS loudness scores was observed in between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. There was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS uncomfortable . KCT0001991 by CRIS (Clinical Research Information Service), 2016-8-1, retrospectively registered.

Effect of NICU Department Orientation Program on Mother’s Anxiety: a Randomized Clinical Trial

PubMed Central

Valizadeh, Leila; Hosseini, Mohammad Bager; Heydarpoor Damanabad, Zhilla; Rahkar Farshi, Mahni; Asgari Jafarabadi, Mohammad; Ranjbar Kochaksaraie, Fatemeh

2016-01-01

Introduction: Neonatal intensive care unit induces the high level of anxiety for mothers. The aim of this study was to evaluate the effectiveness of NICU orientation program on the anxiety of mothers who had preterm newborns hospitalized in NICU. Methods: This study was a randomized clinical trial (three parallel groups). Participants included 99 mothers with preterm newborns hospitalized in NICU of Al- Zahra hospital, affiliated to Tabriz University of Medical Sciences in 2015. Mothers were randomly assigned to one of three groups (film, booklet, and control). Mothers completed the State- Trait Anxiety Inventory before entering to the NICU, and then mothers in the experiment groups became familiar with the NICU environment through watching a film or reading booklet. After the first NICU visit, all mothers completed the STAI and Cattell's Anxiety Questionnaires. Data were analyzed using SPSS ver. 13 software. Results: There was no significant difference between three groups regarding state- trait anxiety before the intervention. After the first NICU visit, a significant reduction in maternal state anxiety was seen in the both experiment groups. There was no statistical significant difference regarding trait anxiety. Data obtained from Cattell's anxiety questionnaire after intervention, showed significant difference in state anxiety between groups. Conclusion: Employing film and booklet orientation strategy after preterm delivery can reduce the mother’s anxiety and beneficent for the mother, baby, family and health care system. PMID:27752486

Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

PubMed

Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

2013-08-01

Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

Parallelization of a Monte Carlo particle transport simulation code

NASA Astrophysics Data System (ADS)

Hadjidoukas, P.; Bousis, C.; Emfietzoglou, D.

2010-05-01

We have developed a high performance version of the Monte Carlo particle transport simulation code MC4. The original application code, developed in Visual Basic for Applications (VBA) for Microsoft Excel, was first rewritten in the C programming language for improving code portability. Several pseudo-random number generators have been also integrated and studied. The new MC4 version was then parallelized for shared and distributed-memory multiprocessor systems using the Message Passing Interface. Two parallel pseudo-random number generator libraries (SPRNG and DCMT) have been seamlessly integrated. The performance speedup of parallel MC4 has been studied on a variety of parallel computing architectures including an Intel Xeon server with 4 dual-core processors, a Sun cluster consisting of 16 nodes of 2 dual-core AMD Opteron processors and a 200 dual-processor HP cluster. For large problem size, which is limited only by the physical memory of the multiprocessor server, the speedup results are almost linear on all systems. We have validated the parallel implementation against the serial VBA and C implementations using the same random number generator. Our experimental results on the transport and energy loss of electrons in a water medium show that the serial and parallel codes are equivalent in accuracy. The present improvements allow for studying of higher particle energies with the use of more accurate physical models, and improve statistics as more particles tracks can be simulated in low response time.

Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial.

PubMed

Winter, Michiel M; van der Bom, Teun; de Vries, Leonie C S; Balducci, Anna; Bouma, Berto J; Pieper, Petronella G; van Dijk, Arie P J; van der Plas, Mart N; Picchio, Fernando M; Mulder, Barbara J M

2012-06-01

To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Multi-centre parallel randomized controlled trial. Patients with a systemic RV due to congenitally or surgically corrected transposition of the great arteries. Fifty-four adult patients with a systemic RV, were randomized using unmarked opaque envelopes to an intervention group (n = 28) with three training sessions per week for 10 consecutive weeks, and a control group (n = 26). Randomization was stratified by participating centre. At baseline, and follow-up, we determined maximal exercise capacity (V'O(2peak)), serum NT-proBNP levels, and quality of life by means of the SF-36, and the TAAQOL Congenital Heart Disease questionnaires. The final analysis was performed by linear regression, taking into account the stratified randomization. Forty-six patients were analysed (male 50%, age 32 ± 11 years, intervention group n = 24, control group n = 22). Analysis at 10 weeks showed a significant difference in V'O(2peak) (3.4 mL/kg/min, 95% CI: 0.2 to 6.7; P = 0.04) and resting systolic blood pressure (-7.6 mmHg, 95% CI: -14.0 to -1.3; P = 0.03) in favour of the exercise group. No significant changes were found in serum NT-proBNP levels or quality of life in the intervention group or in the control group nor between groups. None of the patients in the intervention group had to discontinue the training programme due to adverse events. In adult patients with a systemic RV exercise training improve exercise capacity. We recommend to revise restrictive guidelines, and to encourage patients to become physically active. ( The study was registered at http://trialregister.nl. Identifier: NTR1909.).

The efficacy of early treatment of seasonal allergic rhinitis with benifuuki green tea containing O-methylated catechin before pollen exposure: an open randomized study.

PubMed

Maeda-Yamamoto, Mari; Ema, Kaori; Monobe, Manami; Shibuichi, Ikuo; Shinoda, Yuki; Yamamoto, Tomohiro; Fujisawa, Takao

2009-09-01

We previously reported that 'benifuuki' green tea containing O-methylated catechin significantly relieved the symptoms of perennial or seasonal rhinitis compared with a placebo green tea that did not contain O-methylated catechin in randomized double-blind clinical trials. In this study we assessed the effects of 'benifuuki' green tea on clinical symptoms of seasonal allergic rhinitis. An open-label, single-dose, randomized, parallel-group study was performed on 38 subjects with Japanese cedar pollinosis. The subjects were randomly assigned to long-term (December 27, 2006-April 8, 2007, 1.5 months before pollen exposure) or short-term (February 15, 2007: after cedar pollen dispersal--April 8, 2007) drinking of a 'benifuuki' tea drink containing 34 mg O-methylated catechin per day. Each subject recorded their daily symptom scores in a diary. The primary efficacy variable was the mean weekly nasal symptom medication score during the study period. The nasal symptom medication score in the long-term intake group was significantly lower than that of the short-term intake group at the peak of pollen dispersal. The symptom scores for throat pain, nose-blowing, tears, and hindrance to activities of daily living were significantly better in the long-term group than the short-term group. In particular, the differences in the symptom scores for throat pain and nose-blowing between the 2 groups were marked. We conclude that drinking 'benifuuki' tea for 1.5 months prior to the cedar pollen season is effective in reducing symptom scores for Japanese cedar pollinosis.

Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

PubMed Central

Dubbert, Patricia M.

2017-01-01

Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7) years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS)) and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life) were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9) compared to the control group (0.5; 95% CI, −0.3–1.3) at 8 weeks (average intergroup difference (95% CI), 5.5 (4.3–6.7), p < 0.001) after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045. PMID:28261500

Acupuncture for the sequelae of Bell's palsy: a randomized controlled trial.

PubMed

Kwon, Hyo-Jung; Choi, Jun-Yong; Lee, Myeong Soo; Kim, Yong-Suk; Shin, Byung-Cheul; Kim, Jong-In

2015-06-03

Incomplete recovery from facial palsy results in social and physical disabilities, and the medical options for the sequelae of Bell's palsy are limited. Acupuncture is widely used for Bell's palsy patients in East Asia, but its efficacy is unclear. We performed a randomized controlled trial including participants with the sequelae of Bell's palsy with the following two parallel arms: an acupuncture group (n = 26) and a waiting list group (n = 13). The acupuncture group received acupuncture treatments for 8 weeks, whereas the waiting list group did not receive acupuncture treatments during the 8-week period after randomization. The primary outcome measure was change in the Facial Disability Index (FDI) social and well-being subscale at week 8. We also analyzed changes in the FDI physical function subscale, the House-Brackmann score, the Sunnybrook Facial Nerve Grading system, lip mobility and stiffness at 5 and 8 weeks after randomization. An intention-to-treat analysis was applied. The acupuncture group exhibited greater improvements in the FDI social score (mean difference, 23.54; 95% confidence interval, 12.99 to 34.08) and better results on the FDI physical function subscale (mean difference, 21.54; 95% confidence interval, 7.62 to 35.46), Sunnybrook Facial Nerve Grading score (mean difference, 14.77; 95% confidence interval, 5.05 to 24.49), and stiffness scale (mean difference, -1.58; 95% confidence interval,-2.26 to -0.89) compared with the waiting list group after 8 weeks. No severe adverse event occurred in either group. Compared with the waiting list group, acupuncture had better therapeutic effects on the social and physical aspects of sequelae of Bell's palsy. Current Controlled Trials ISRCTN43104115.

Effect of Store and Forward Teledermatology on Quality of Life

PubMed Central

Whited, John D.; Warshaw, Erin M.; Edison, Karen E.; Kapur, Kush; Thottapurathu, Lizy; Raju, Srihari; Cook, Bethany; Engasser, Holly; Pullen, Samantha; Parks, Patricia; Sindowski, Tom; Motyka, Danuta; Brown, Rodney; Moritz, Thomas E.; Datta, Santanu K.; Chren, Mary-Margaret; Marty, Lucinda; Reda, Domenic J.

2013-01-01

Importance Although research on quality of life and dermatologic conditions is well represented in the literature, information on teledermatology’s effect on quality of life is virtually absent. Objective To determine the effect of store and forward teledermatology on quality of life. Design Two-site, parallel-group, superiority randomized controlled trial. Setting Dermatology clinics and affiliated sites of primary care at 2 US Department of Veterans Affairs medical facilities. Participants Patients being referred to a dermatology clinic were randomly assigned, stratified by site, to teledermatology or the conventional consultation process. Among the 392 patients who met the inclusion criteria and were randomized, 326 completed the allocated intervention and were included in the analysis. Interventions Store and forward teledermatology (digital images and a standardized history) or conventional text-based consultation processes were used to manage the dermatology consultations. Patients were followed up for 9 months. Main Outcome Measures The primary end point was change in Skindex-16 scores, a skin-specific quality-of-life instrument, between baseline and 9 months. A secondary end point was change in Skindex-16 scores between baseline and 3 months. Results Patients in both randomization groups demonstrated a clinically significant improvement in Skindex-16 scores between baseline and 9 months with no significant difference by randomization group (P=.66, composite score). No significant difference in Skindex-16 scores by randomization group between baseline and 3 months was found (P=.39, composite score). Conclusions Compared with the conventional consultation process, store and forward teledermatology did not result in a statistically significant difference in skin-related quality of life at 3 or 9 months after referral. Trial Registration clinicaltrials.gov Identifier: NCT00488293 PMID:23426111

Pomegranate supplementation improves cognitive and functional recovery following ischemic stroke: A randomized trial.

PubMed

Bellone, John A; Murray, Jeffrey R; Jorge, Paolo; Fogel, Travis G; Kim, Mary; Wallace, Desiree R; Hartman, Richard E

2018-02-13

We tested whether supplementing with pomegranate polyphenols can enhance cognitive/functional recovery after stroke. In this parallel, block-randomized clinical trial, we administered commercially-available pomegranate polyphenol or placebo pills twice per day for one week to adult inpatients in a comprehensive rehabilitation setting starting approximately 2 weeks after stroke. Pills contained 1 g of polyphenols derived from whole pomegranate, equivalent to levels in approximately 8 oz of juice. Placebo pills were similar to the pomegranate pills except that they contained only lactose. Of the 163 patients that were screened, 22 were eligible and 16 were randomized (8 per group). We excluded one subject per group from the neuropsychological analyses since they were lost to follow-up, but we included all subjects in the analysis of functional data since outcome data were available. Clinicians and subjects were blinded to group assignment. Neuropsychological testing (primary outcome: Repeatable Battery for the Assessment of Neuropsychological Status) and functional independence scores were used to determine changes in cognitive and functional ability. Pomegranate-treated subjects demonstrated more neuropsychological and functional improvement and spent less time in the hospital than placebo controls. Pomegranate polyphenols enhanced cognitive and functional recovery after stroke, justifying pursuing larger clinical trials.

Role of 3D animation in periodontal patient education: a randomized controlled trial.

PubMed

Cleeren, Gertjan; Quirynen, Marc; Ozcelik, Onur; Teughels, Wim

2014-01-01

This randomized controlled parallel trial investigates the effect of 3D animation on the increase and recall of knowledge on periodontitis by patients with periodontitis. The effects of a 3D animation (3D animation group) were compared with narration and drawing (control group) for periodontal patient education. A total of 68 periodontitis patients were stratified according to educational level and then randomly allocated to control or 3D animation groups. All patients received: (1) a pre-test (baseline knowledge), (2) a patient education video (3D animation or control video), (3) a post-test (knowledge immediately after looking at the video), and (4) a follow-up test (knowledge recall after 2 weeks). Each test contained 10 multiple-choice questions. There was no significant difference in baseline knowledge. Patients receiving the 3D animations had significantly higher scores for both the post-test and the follow-up test, when compared with patients receiving sketch animations. 3D animations are more effective than real-time drawings for periodontal patient education in terms of knowledge recall. 3D animations may be a powerful tool for assisting in the information process. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chocolate flavanols and skin photoprotection: a parallel, double-blind, randomized clinical trial.

PubMed

Mogollon, Jaime Andres; Boivin, Catherine; Lemieux, Simone; Blanchet, Claudine; Claveau, Joël; Dodin, Sylvie

2014-06-27

Solar ultraviolet (UV) radiation has deleterious effects on the skin, including sunburn, photoaging and cancer. Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage. We investigated the influence of 12-week high-flavanol chocolate (HFC) consumption on skin sensitivity to UV radiation, measured by minimal erythema dose (MED). We also evaluated skin elasticity and hydration. In this 2-group, parallel, double-blind, randomized controlled trial, 74 women aged 20-65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City, for randomization to either HFC (n = 33) or low-flavanol chocolate (LFC) (n = 41). A blocked randomisation (4), considering date of entry, skin type and age as factors, generated a sequentially-numbered allocation list. Study participants and research assistants were blinded. Totally, 30 g of chocolate were consumed daily for 12 weeks, followed by a 3-week washout period. MED was assessed at baseline and at 6, 9, 12 and 15 weeks. Main outcome was changes in MED at week 12. 33 participants in the HFC group and 41 in the LFC group were analyzed with 15 weeks of follow-up. Both groups showed similarly-increased MED at 12 weeks (HFC: 0.0252 ± 0.1099 J/cm2 [mean ± standard deviation (SD)]; LFC: 0.0151 ± 0.1118; mean difference (MD): 0.0100 J/cm2; 95% confidence interval (CI): -0.0417 to 0.0618). However, after 3-week washout, the HFC group presented decreased MED (-0.0248 ± 0.1145) whereas no effect was seen in the LFC group (0.0168 ± 0.1698) (MD: -0.0417; 95% CI: -0.1106 to 0.0272). Net temple elasticity increased slightly but significantly by 0.09 ± 0.12 mm in the HFC group at 12 weeks compared to 0.02 ± 0.12 mm in the LFC group (MD: 0.06; 95% CI: 0.01 to 0.12 ). No significant adverse events were reported. Our study failed to demonstrate a statistically-significant protective effect of HFC vs. LFC consumption on skin sensitivity to UV radiation as measured by MED. ClinicalTrials.gov identifier: NCT01444625.

Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial.

PubMed

Smaïl-Faugeron, Violaine; Muller-Bolla, Michèle; Sixou, Jean-Louis; Courson, Frédéric

2015-07-10

Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the computerised QuickSleeper system, in children and adolescents. Inclusion criteria are patients 7-15 years old with at least 2 first permanent molars belonging to the same dental arch (for the split-mouth RCT) or with a first permanent molar (for the parallel-arm RCT) requiring conservative or endodontic treatment limited to pulpotomy. The setting of this study is the Department of Paediatric Dentistry at 3 University dental hospitals in France. The primary outcome measure will be pain reported by the patient on a visual analogue scale concerning the insertion of the needle and the injection/infiltration. Secondary outcomes are latency, need for additional anaesthesia during the treatment and pain felt during the treatment. We will use a computer-generated permuted-block randomisation sequence for allocation to anaesthesia groups. The random sequences will be stratified by centre (and by dental arch for the parallel-arm RCT). Only participants will be blinded to group assignment. Data will be analysed by the intent-to-treat principle. In all, 160 patients will be included (30 in the split-mouth RCT, 130 in the parallel-arm RCT). This protocol has been approved by the French ethics committee for the protection of people (Comité de Protection des Personnes, Ile de France I) and will be conducted in full accordance with accepted ethical principles. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. ClinicalTrials.gov NCT02084433. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial.

PubMed

Na, Sang-Hoon; Lee, Hae-Young; Hong Baek, Sang; Jeon, Hui-Kyung; Kang, Jin-Ho; Kim, Yoon-Nyun; Park, Chang-Gyu; Ryu, Jae-Kean; Rhee, Moo-Yong; Kim, Moo-Hyun; Hong, Taek-Jong; Choi, Dong-Ju; Cho, Seong-Wook; Cha, Dong-Hun; Jeon, Eun-Seok; Kim, Jae-Joong; Shin, Joon-Han; Park, Sung-Ha; Lee, Seung-Hwan; John, Sung-Hee; Shin, Eun-Seok; Kim, Nam-Ho; Lee, Sung-Yun; Kwan, Jun; Jeong, Myung-Ho; Kim, Sang-Wook; Jeong, Jin-Ok; Kim, Dong-Woon; Lee, Nam-Ho; Park, Woo-Jung; Ahn, Jeong-Cheon; Won, Kyung-Heon; Uk Lee, Seung; Cho, Jang-Hyun; Kim, Soon-Kil; Ahn, Taehoon; Hong, Sukkeun; Yoo, Sang-Yong; Kim, Song-Yi; Kim, Byung-Soo; Juhn, Jae-Hyeon; Kim, Sun-Young; Lee, Yu-Jeong; Oh, Byung-Hee

2015-08-01

The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2). Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P < 0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P < 0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups. Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Effectiveness of a theory-based mobile phone text message intervention for improving protective behaviors of pregnant women against air pollution: a randomized controlled trial.

PubMed

Jasemzadeh, Mehrnoosh; Khafaie, Morteza Abdullatif; Jaafarzadeh, Nematallah; Araban, Marzieh

2018-03-01

Health impact of exposure to air pollution is a public health concern. The aim of this study was to investigate an extended parallel process model (EPPM)-based mobile phone text message intervention for improving protective behaviors against air pollution among pregnant women. In this randomized controlled trial (IRCT2016102810804N8), 130 pregnant women were randomly assigned into either experimental or control groups. A valid and reliable questionnaire was used to collect data. Experimental group received mobile phone intervention on a daily basis for 2 months. Control group received usual care, only. Data were analyzed using SPSS 15 applying t test, chi-square, and Wilcoxon and Mann-Whitney U test. Although before intervention, there were no significant differences between different structures of EPPM (P > 0.05), after intervention, there were statistically significant differences between perceived severity, response efficacy, self-efficacy, and protective behaviors between two groups (P < 0.05). Implementing EPPM based-mobile phone intervention could promote protective behaviors against air pollution among pregnant women. The present study might be used as a framework for evidence-based health promotion regarding air pollution risk communication and self-care behaviors. IRCT2016102810804N8.

Eight Weeks of Cosmos caudatus (Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial.

PubMed

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Barakatun-Nisak, Mohd Yusof

2015-01-01

Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications. Cosmos caudatus is reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness of C. caudatus on glycemic status in patients with type 2 diabetes. Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g of C. caudatus daily for eight weeks while diabetic controls abstained from taking C. caudatus. Both groups received the standard lifestyle advice. Results. After 8 weeks of supplementation, C. caudatus significantly reduced serum insulin (-1.16 versus +3.91), reduced HOMA-IR (-1.09 versus +1.34), and increased QUICKI (+0.05 versus -0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (-0.76% versus -0.37%). C. caudatus was safe to consume. Conclusions. C. caudatus supplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes.

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

A randomized trial of specialized versus standard neck physiotherapy in cervical dystonia.

PubMed

Counsell, Carl; Sinclair, Hazel; Fowlie, Jillian; Tyrrell, Elaine; Derry, Natalie; Meager, Peter; Norrie, John; Grosset, Donald

2016-02-01

Anecdotal reports suggested that a specialized physiotherapy technique developed in France (the Bleton technique) improved primary cervical dystonia. We evaluated the technique in a randomized trial. A parallel-group, single-blind, two-centre randomized trial compared the specialized outpatient physiotherapy programme given by trained physiotherapists up to once a week for 24 weeks with standard physiotherapy advice for neck problems. Randomization was by a central telephone service. The primary outcome was the change in the total Toronto Western Spasmodic Torticollis Rating (TWSTR) scale, measured before any botulinum injections that were due, between baseline and 24 weeks evaluated by a clinician masked to treatment. Analysis was by intention-to-treat. 110 patients were randomized (55 in each group) with 24 week outcomes available for 84. Most (92%) were receiving botulinum toxin injections. Physiotherapy adherence was good. There was no difference between the groups in the change in TWSTR score over 24 weeks (mean adjusted difference 1.44 [95% CI -3.63, 6.51]) or 52 weeks (mean adjusted difference 2.47 [-2.72, 7.65]) nor in any of the secondary outcome measures (Cervical Dystonia Impact Profile-58, clinician and patient-rated global impression of change, mean botulinum toxin dose). Both groups showed large sustained improvements compared to baseline in the TWSTR, most of which occurred in the first four weeks. There were no major adverse events. Subgroup analysis suggested a centre effect. There was no statistically or clinically significant benefit from the specialized physiotherapy compared to standard neck physiotherapy advice but further trials are warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine.

PubMed

Kario, Kazuomi; Hoshide, Satoshi

2014-06-01

The ACS1 (Azilsartan Circadian and Sleep Pressure - the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm.

Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine

PubMed Central

Hoshide, Satoshi

2014-01-01

Objective The ACS1 (Azilsartan Circadian and Sleep Pressure – the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. Materials and methods The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). Conclusion The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm. PMID:24637789

A randomized clinical trial of histamine 2 receptor antagonism in treatment-resistant schizophrenia.

PubMed

Meskanen, Katarina; Ekelund, Heidi; Laitinen, Jarmo; Neuvonen, Pertti J; Haukka, Jari; Panula, Pertti; Ekelund, Jesper

2013-08-01

Histamine has important functions as regulator of several other key neurotransmitters. Patients with schizophrenia have lower histamine H1 receptor levels. Since a case report in 1990 of an effect of the H2 antagonist famotidine on negative symptoms in schizophrenia, some open-label trials have been performed, but no randomized controlled trial. Recently, it was shown that clozapine is a full inverse agonist at the H2 receptor. We performed a researcher-initiated, academically financed, double-blind, placebo-controlled, parallel-group, randomized trial with the histamine H2 antagonist famotidine in treatment-resistant schizophrenia. Thirty subjects with schizophrenia were randomized to have either famotidine (100 mg twice daily, n = 16) or placebo (n = 14) orally, added to their normal treatment regimen for 4 weeks. They were followed up weekly with the Scale for the Assessment of Negative Symptoms (SANS), the PANSS (Positive and Negative Syndrome Scale), and Clinical Global Impression (CGI) Scale. In the famotidine group, the SANS score was reduced by 5.3 (SD, 13.1) points, whereas in the placebo group the SANS score was virtually unchanged (mean change, +0.2 [SD, 9.5]). The difference did not reach statistical significance (P = 0.134) in Mann-Whitney U analysis. However, the PANSS Total score and the General subscore as well as the CGI showed significantly (P < 0.05) greater change in the famotidine group than in the placebo group. No significant adverse effects were observed. This is the first placebo-controlled, randomized clinical trial showing a beneficial effect of histamine H2 antagonism in schizophrenia. H2 receptor antagonism may provide a new alternative for the treatment of schizophrenia.

Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers.

PubMed

de Hoon, Jan; Van Hecken, Anne; Vandermeulen, Corinne; Herbots, Marissa; Kubo, Yumi; Lee, Ed; Eisele, Osa; Vargas, Gabriel; Gabriel, Kristin

2018-01-01

Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg. Blood pressure was measured pre-dose and at prespecified times post-dose. The primary endpoint was individual time-weighted averages of mean arterial pressure, measured from 0 hours to 2.5 hours after the first dose of sumatriptan. Pharmacokinetic parameters for sumatriptan were evaluated by calculating geometric mean ratios (erenumab and sumatriptan/placebo and sumatriptan). Adverse events and anti-erenumab antibodies were also evaluated. Results A total of 34 subjects were randomized and included in the analysis. Least squares mean (standard error) time-weighted averages of mean arterial pressure were 87.4 (1.0) mmHg for the placebo and sumatriptan group and 87.4 (1.2) mmHg for the erenumab and sumatriptan group. Mean difference in mean arterial pressure between groups was -0.04 mmHg (90% confidence interval: -2.2, 2.1). Geometric mean ratio estimates for maximum plasma concentration of sumatriptan was 0.95 (90% confidence interval: 0.82, 1.09), area under the plasma concentration-time curve (AUC) from time 0 to 6 hours was 0.98 (90% confidence interval: 0.93, 1.03), and AUC from time 0 to infinity was 1.00 (90% confidence interval: 0.96, 1.05). No clinically relevant safety findings for co-administration of sumatriptan and erenumab were identified. Conclusion Co-administration of erenumab and sumatriptan had no additional effect on resting blood pressure or on pharmacokinetics of sumatriptan. ClinicalTrials.gov, NCT02741310.

Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland.

PubMed

Haziza, Christelle; de La Bourdonnaye, Guillaume; Skiada, Dimitra; Ancerewicz, Jacek; Baker, Gizelle; Picavet, Patrick; Lüdicke, Frank

2016-11-30

The Tobacco Heating System (THS) 2.2, a candidate Modified Risk Tobacco Product (MRTP), is designed to heat tobacco without burning it. Tobacco is heated in order to reduce the formation of harmful and potentially harmful constituents (HPHC), and reduce the consequent exposure, compared with combustible cigarettes (CC). In this 5-day exposure, controlled, parallel-group, open-label clinical study, 160 smoking, healthy subjects were randomized to three groups and asked to: (1) switch from CCs to THS 2.2 (THS group; 80 participants); (2) continue to use their own non-menthol CC brand (CC group; 41 participants); or (3) to refrain from smoking (smoking abstinence (SA) group; 39 participants). Biomarkers of exposure, except those associated with nicotine exposure, were significantly reduced in the THS group compared with the CC group, and approached the levels observed in the SA group. Increased product consumption and total puff volume were reported in the THS group. However, exposure to nicotine was similar to CC at the end of the confinement period. Reduction in urge-to-smoke was comparable between the THS and CC groups and THS 2.2 product was well tolerated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Massage and Reiki used to reduce stress and anxiety: Randomized Clinical Trial

PubMed Central

Kurebayashi, Leonice Fumiko Sato; Turrini, Ruth Natalia Teresa; de Souza, Talita Pavarini Borges; Takiguchi, Raymond Sehiji; Kuba, Gisele; Nagumo, Marisa Toshi

2016-01-01

ABTRACT Objective: to evaluate the effectiveness of massage and reiki in the reduction of stress and anxiety in clients at the Institute for Integrated and Oriental Therapy in Sao Paulo (Brazil). Method: clinical tests randomly done in parallel with an initial sample of 122 people divided into three groups: Massage + Rest (G1), Massage + Reiki (G2) and a Control group without intervention (G3). The Stress Systems list and the Trace State Anxiety Inventory were used to evaluate the groups at the start and after 8 sessions (1 month), during 2015. Results: there were statistical differences (p = 0.000) according to the ANOVA (Analysis of Variance) for the stress amongst the groups 2 and 3 (p = 0.014) with a 33% reductions and a Cohen of 0.78. In relation to anxiety-state, there was a reduction in the intervention groups compared with the control group (p < 0.01) with a 21% reduction in group 2 (Cohen of 1.18) and a 16% reduction for group 1 (Cohen of 1.14). Conclusion: Massage + Reiki produced better results amongst the groups and the conclusion is for further studies to be done with the use of a placebo group to evaluate the impact of the technique separate from other techniques. RBR-42c8wp PMID:27901219

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

PubMed Central

Johari, Sarika; Gandhi, Tejal

2016-01-01

Background: Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment. Aims and Objectives: This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse. Settings and Design: Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design. Materials and Methods: The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10) were treated with drug Mesalamine (Group I), monoherbal tablet (Group II) and combination of both (Group III) respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study. Statistical Analysis Used: Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6. Results: All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with diarrhea and flatulence after drug withdrawal. Conclusion: Thus, monoherbal formulation alone and with Mesalamine was efficacious than Mesalamine alone in UC. PMID:28182023

Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study

PubMed Central

2014-01-01

Background Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. Methods We performed a meta-epidemiological study. We systematically reviewed meta- analyses including both split-mouth and parallel-arm RCTs with binary or continuous outcomes published up to February 2013. Two independent authors selected studies and extracted data. We used a two-step approach to quantify the differences between split-mouth and parallel-arm RCTs: for each meta-analysis. First, we derived ratios of odds ratios (ROR) for dichotomous data and differences in standardized mean differences (∆SMD) for continuous data; second, we pooled RORs or ∆SMDs across meta-analyses by random-effects meta-analysis models. Results We selected 18 systematic reviews, for 15 meta-analyses with binary outcomes (28 split-mouth and 28 parallel-arm RCTs) and 19 meta-analyses with continuous outcomes (28 split-mouth and 28 parallel-arm RCTs). Effect estimates did not differ between split-mouth and parallel-arm RCTs (mean ROR, 0.96, 95% confidence interval 0.52–1.80; mean ∆SMD, 0.08, -0.14–0.30). Conclusions Our study did not provide sufficient evidence for a difference in intervention effect estimates derived from split-mouth and parallel-arm RCTs. Authors should consider including split-mouth RCTs in their meta-analyses with suitable and appropriate analysis. PMID:24886043

Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial

PubMed Central

2015-01-01

Objectives: Flare-up during root canal treatment of non vital teeth is a common clinical incident. The aim of the present study was to assess the effect of prophylactic use of antibiotics to avoid flare up during root canal treatment of the teeth having asymptomatic necrotic pulp. Materials and Methods: A randomized double blind clinical trial with parallel design was conducted on 100 subjects with asymptomatic non vital teeth. They were randomly divided into two groups. The first group (50 participants) was given two gram amoxicillin one hour before the first visit of root canal treatment; the second group (50 participants) did not receive any treatment (control group). In both groups, root canal treatment was performed in two visits. The flare up was assessed by the pain visual analogue scale and based on the swelling criteria. The data were processed and analyzed using SPSS statistical software 17. A p-value of 0.05 or less was considered statistically significant. Results: A total of 80% of participants in the experimental group had flare up while 12% of participants had flare up in the control group. Prophylactic Amoxicillin had no effect on inter-appointment flare up (p > 0.05). There was no relationship between flare up and patient’s age, gender and tooth type (p > 0.05). Conclusion: Prophylactic use of Amoxicillin in asymptomatic non vital teeth before root canal treatment had no effect on the incidence of flare-up. PMID:25954695

Cancer information and anxiety: applying the extended parallel process model.

PubMed

Evans, Ruth Ec; Beeken, Rebecca J; Steptoe, Andrew; Wardle, Jane

2012-05-01

There is concern that public education about testicular cancer (TC) may cause unnecessary anxiety. Psychological theory suggests that if threat (eg, TC) information is accompanied with threat control strategies (eg, testicular self-examination; TSE) anxiety is less likely. Male students (N=443) were randomized to either a TC or TC +TSE information group or a no information control group, and assessed at three time points. Anxiety levels did not differ between the groups and exposure to TC+TSE resulted in greater perceived message benefit, increased intention to self-examine and lower message denigration. This suggests TC information is not anxiogenic, but inclusion of TSE information may improve acceptance of disease awareness information.

Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery

PubMed Central

Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

2003-01-01

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. PMID:12562974

Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery.

PubMed

Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

2003-02-01

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.

Immediate effect of subliminal priming with positive reward stimuli on standing balance in healthy individuals: A randomized controlled trial.

PubMed

Aoyama, Yasuhiro; Uchida, Hiroyuki; Sugi, Yasuyuki; Kawakami, Akinobu; Fujii, Miki; Kiso, Kanae; Kono, Ryota; Takebayashi, Takashi; Hirao, Kazuki

2017-07-01

Information received subconsciously can influence exercise performance; however, it remains unclear whether subliminal or supraliminal reward is more effective in improving standing balance ability when priming stimuli are subconsciously delivered. The present study aimed to compare the effects of subliminal priming-plus-subliminal reward stimuli (experimental) with subliminal priming-plus-supraliminal reward stimuli (control) on standing balance ability. This was a single-blind (outcome assessor), parallel-group, randomized controlled trial involving healthy young adults recruited from a university in Japan. Assessments were conducted at baseline and immediately after intervention. The primary outcome was the functional reach test (FRT) measurement. The secondary outcome was one-leg standing time (OLST) with eyes closed. Of the 52 participants screened, 25 were randomly assigned to experimental and control groups each. Both interventions were effective for improving the FRT between the baseline and intervention; however, smaller improvements were observed in the experimental group. We found a large between-groups effect size immediately after the intervention for the FRT (d = -0.92). In contrast, there were no differences in improvements in OLST between the 2 groups (d = -0.06); furthermore, neither intervention was found to be effective for this parameter. We concluded that subliminal priming with conscious reward stimuli results in improvements in immediate-term forward reach ability, which is superior to that achieved by subliminal priming with subconscious reward stimuli.

Effects of tactile-kinesthetic stimulation on low birth weight neonates.

PubMed

Aliabadi, Faranak; Askary, Reihaneh K

2013-06-01

Low Birth Weight [LBW] (1500gr ≤ Birth Weight ≤ 2499 gr) is one of the most serious health problems in neonates. These neonates need complementary interventions (e.g. tactile-kinesthetic stimulation) to promote development. This study was conducted to determine the effect of Tactile-Kinesthetic Stimulation (TKS) on physical and behavioral development of Low Birth Weight neonates. This was a randomized controlled trial with equal randomization (1:1 for two groups) and parallel group design. Forty LBW neonates were randomly allocated into test (n = 20) and control (n = 20) groups. TKS was provided for three 15 minute periods per day for 10 consecutive days to the test group, with the massages consisting of moderate pressure strokes in supine and prone position and kinesthetic exercises consisting of flexion and extension of limbs. All measurements were taken before and after completion of the study with the same equipment (Philips electronic weighing scale with an accuracy of ±5 grams and Brazelton Neonatal Behavioral Assessment) and by the same person. There was a trend towards increased daily weight gain, but without statistical significance. On the Brazelton scale, the test group showed statistically significant improved scores on the 'motor' (P-value <0.001) and 'regulation of state' (P-value = 0.039) clusters after the 10 days TKS. TKS has no adverse effects on physiologic parameters and gives better adaptive behavior of LBW neonates compared to those without TKS.

Effect of Two Frequencies of Whole-Body Vibration Training on Balance and Flexibility of the Elderly: A Randomized Controlled Trial.

PubMed

Tseng, Shiuan-Yu; Hsu, Pi-Shan; Lai, Chung-Liang; Liao, Wan-Chun; Lee, Meng-Chih; Wang, Chun-Hou

2016-10-01

The aim of this study was to investigate the effects of whole-body vibration training with different frequencies on the balance and flexibility of the healthy elderly. The participants were recruited from hospital volunteers and the community; all of them were healthy subjects, all over 65 years of age. The study involved three randomized groups in a parallel and single-blind design. The main outcome variables included the limits of stability test and the sit and reach test, which were measured at pre-training, Month 1 (Mid-training), Month 3 (Post-training), and Month 6 (Follow-up). A total of 45 subjects, with a mean age of 69.6 ± 3.9 years, were randomly divided into three groups. There was significant interaction in the performance of the limits of stability and sit and reach tests in the different groups at the four different time points (F = 25.218, P < 0.001, F = 12.235, P < 0.001, respectively). There was a significant difference in balance performance between the vibration groups at the frequencies of 20 Hz and 40 Hz and the control group at Month 1, Month 3, and Month 6 (P < 0.001). Whole-body vibration training at 20 Hz has significant benefit to the balance and flexibility of the elderly who do not engage in habitual exercise.

An efficient parallel-processing method for transposing large matrices in place.

PubMed

Portnoff, M R

1999-01-01

We have developed an efficient algorithm for transposing large matrices in place. The algorithm is efficient because data are accessed either sequentially in blocks or randomly within blocks small enough to fit in cache, and because the same indexing calculations are shared among identical procedures operating on independent subsets of the data. This inherent parallelism makes the method well suited for a multiprocessor computing environment. The algorithm is easy to implement because the same two procedures are applied to the data in various groupings to carry out the complete transpose operation. Using only a single processor, we have demonstrated nearly an order of magnitude increase in speed over the previously published algorithm by Gate and Twigg for transposing a large rectangular matrix in place. With multiple processors operating in parallel, the processing speed increases almost linearly with the number of processors. A simplified version of the algorithm for square matrices is presented as well as an extension for matrices large enough to require virtual memory.

Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus: a 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial.

PubMed

Hong, S; Park, C-Y; Han, K A; Chung, C H; Ku, B J; Jang, H C; Ahn, C W; Lee, M-K; Moon, M K; Son, H S; Lee, C B; Cho, Y-W; Park, S-W

2016-05-01

We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n = 142) were randomized 2 : 1 into two different treatment groups as follows: 99 received teneligliptin (20 mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24 weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21 mmol/l (-1.72, -0.70), respectively (all p < 0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24 weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

The Influence of Two Different Doses of Magnesium Sulfate on Intraocular Pressure Variations after Injection of Succinylcholine and Endotracheal Intubation: A Prospective, Randomized, Parallel Three-Arm, Double-blind, Placebo-controlled Clinical Trial.

PubMed

Yassin, Hany Mahmoud; Abdel Moneim, Ahmed Tohamy; Mostafa Bayoumy, Ahmed Sherin; Bayoumy, Hasan Metwally; Taher, Sameh Galal

2017-01-01

The use of succinylcholine for rapid sequence induction in patients with open globe injuries may be detrimental to the eye. The aim of this study is to determine if the premedication with magnesium sulfate (MgSO 4 ) could attenuate the increase in intraocular pressure (IOP) associated with succinylcholine injection and intubation. Operation theaters in a tertiary care University Hospital between December 2014 and July 215. This was a prospective, randomized, parallel three-arm, double-blind, placebo-controlled clinical trial. One hundred and thirteen patients' physical status ASA Classes I and II underwent elective cataract surgery under general anesthesia. These patients allocated into three groups: Group C (control group) received 100 ml normal saline, Group M1 received 30 mg/kg MgSO 4 in 100 ml normal saline, and Group M2 received 50 mg/kg MgSO 4 in 100 ml normal saline. IOP, mean arterial pressure (MAP), and heart rate (HR) reported at 5-time points related to study drug administration. In addition, any adverse effects related to MgSO 4 were recorded. Intragroup and between-groups differences were examined by analysis of variance test. We noticed a significant decrease in IOP in M1 ( n = 38) and M2 ( n = 37) groups as compared with C group ( n = 38) after study drugs infusion, 2 and 5 min after intubation, P < 0.001. While the difference between M1 and M2 groups was insignificant, P = 0.296 and P = 0.647, respectively. There was a significant decrease in MAP and HR in M1 and M2 groups as compared with C group 2 and 5 min after intubation, P = 0.01. While the difference between M1 and M2 groups was insignificant, P = 1. MgSO 4 30 mg/kg as well as 50 mg/kg effectively prevented the rise in IOP, MAP, and HR associated with rapid sequence induction by succinylcholine and endotracheal intubation.

Trial protocol: a parallel group, individually randomized clinical trial to evaluate the effect of a mobile phone application to improve sexual health among youth in Stockholm County.

PubMed

Nielsen, Anna; De Costa, Ayesha; Bågenholm, Aspasia; Danielsson, Kristina Gemzell; Marrone, Gaetano; Boman, Jens; Salazar, Mariano; Diwan, Vinod

2018-02-05

Genital Chlamydia trachomatis infection is a major public health problem worldwide affecting mostly youth. Sweden introduced an opportunistic screening approach in 1982 accompanied by treatment, partner notification and case reporting. After an initial decline in infection rate till the mid-90s, the number of reported cases has increased over the last two decades and has now stabilized at a high level of 37,000 reported cases in Sweden per year (85% of cases in youth). Sexual risk-taking among youth is also reported to have significantly increased over the last 20 years. Mobile health (mHealth) interventions could be particularly suitable for youth and sexual health promotion as the intervention is delivered in a familiar and discrete way to a tech savvy at-risk population. This paper presents a protocol for a randomized trial to study the effect of an interactive mHealth application (app) on condom use among the youth of Stockholm. 446 youth resident in Stockholm, will be recruited in this two arm parallel group individually randomized trial. Recruitment will be from Youth Health Clinics or via the trial website. Participants will be randomized to receive either the intervention (which comprises an interactive app on safe sexual health that will be installed on their smart phones) or a control group (standard of care). Youth will be followed up for 6 months, with questionnaire responses submitted periodically via the app. Self-reported condom use over 6 months will be the primary outcome. Secondary outcomes will include presence of an infection, Chlamydia tests during the study period and proxy markers of safe sex. Analysis is by intention to treat. This trial exploits the high mobile phone usage among youth to provide a phone app intervention in the area of sexual health. If successful, the results will have implications for health service delivery and health promotion among the youth. From a methodological perspective, this trial is expected to provide information on the strength and challenges of implementing a partially app (internet) based trial in this context. ISRCTN 13212899, date of registration June 22, 2017.

A parallel Monte Carlo code for planar and SPECT imaging: implementation, verification and applications in (131)I SPECT.

PubMed

Dewaraja, Yuni K; Ljungberg, Michael; Majumdar, Amitava; Bose, Abhijit; Koral, Kenneth F

2002-02-01

This paper reports the implementation of the SIMIND Monte Carlo code on an IBM SP2 distributed memory parallel computer. Basic aspects of running Monte Carlo particle transport calculations on parallel architectures are described. Our parallelization is based on equally partitioning photons among the processors and uses the Message Passing Interface (MPI) library for interprocessor communication and the Scalable Parallel Random Number Generator (SPRNG) to generate uncorrelated random number streams. These parallelization techniques are also applicable to other distributed memory architectures. A linear increase in computing speed with the number of processors is demonstrated for up to 32 processors. This speed-up is especially significant in Single Photon Emission Computed Tomography (SPECT) simulations involving higher energy photon emitters, where explicit modeling of the phantom and collimator is required. For (131)I, the accuracy of the parallel code is demonstrated by comparing simulated and experimental SPECT images from a heart/thorax phantom. Clinically realistic SPECT simulations using the voxel-man phantom are carried out to assess scatter and attenuation correction.

A double-blind, randomized, multiple-dose, parallel-group study to characterize the occurrence of diarrhea following two different dosing regimens of neratinib, an irreversible pan-ErbB receptor tyrosine kinase inhibitor.

PubMed

Abbas, Richat; Hug, Bruce A; Leister, Cathie; Sonnichsen, Daryl

2012-07-01

Neratinib, a potent, low-molecular-weight, orally administered, irreversible, pan-ErbB receptor tyrosine kinase inhibitor has antitumor activity in ErbB2 + breast cancer. The objective of this study was to characterize the onset, severity, and duration of diarrhea after administration of neratinib 240 mg once daily (QD) and 120 mg twice daily (BID) for ≤14 days in healthy subjects. A randomized, double-blind, parallel-group, inpatient study was conducted in 50 subjects given oral neratinib either 240 mg QD or 120 mg BID with food for ≤14 days. The primary endpoint was the proportion of subjects with diarrhea of at least moderate severity (grade 2; 5-7 loose stools/day). In subjects with grade 2 diarrhea, fecal analytes were determined. Pharmacokinetic profiles were characterized for neratinib on Days 1 and 7. No severe (grade 3) diarrhea was reported. By Day 4, all subjects had grade 1 diarrhea. Grade 2 diarrhea occurred in 11/22 evaluable subjects (50 % [90 % confidence interval (CI): 28-72 %]) in the QD group and 17/23 evaluable subjects (74 % [90 % CI: 52-90 %]) in the BID group (P = 0.130). In fecal analyses, 18 % tested positive for hemoglobin and 46 % revealed fecal lactoferrin. Specimen pH was neutral to slightly alkaline. In pharmacokinetic analyses, Day 1 peak plasma concentration and Day 7 steady-state exposure were higher with the QD regimen than the BID regimen. In an exploratory analysis, ABCG2 genotype showed no correlation with severity or onset of diarrhea. Incidences and onsets of at least grade 1 and at least grade 2 diarrhea were not improved on BID dosing compared with QD dosing.

The effect of a corticosteroid cream and a barrier-strengthening moisturizer in hand eczema. A double-blind, randomized, prospective, parallel group clinical trial.

PubMed

Lodén, M; Wirén, K; Smerud, K T; Meland, N; Hønnås, H; Mørk, G; Lützow-Holm, C; Funk, J; Meding, B

2012-05-01

Hand eczema is a common and persistent disease with a relapsing course. Clinical data suggest that once daily treatment with corticosteroids is just as effective as twice daily treatment. The aim of this study was to compare once and twice daily applications of a strong corticosteroid cream in addition to maintenance therapy with a moisturizer in patients with a recent relapse of hand eczema. The study was a parallel, double-blind, randomized, clinical trial on 44 patients. Twice daily application of a strong corticosteroid cream (betamethasone valerate 0.1%) was compared with once daily application, where a urea-containing moisturizer was substituted for the corticosteroid cream in the morning. The investigator scored the presence of eczema and the patients judged the health-related quality of life (HRQoL) using the Dermatology Life Quality Index (DLQI), which measures how much the patient's skin problem has affected his/her life over the past week. The patients also judged the severity of their eczema daily on a visual analogue scale. Both groups improved in terms of eczema and DLQI. However, the clinical scoring demonstrated that once daily application of corticosteroid was superior to twice daily application in diminishing eczema, especially in the group of patients with lower eczema scores at inclusion. Twice daily use of corticosteroids was not superior to once daily use in treating eczema. On the contrary, the clinical assessment showed a larger benefit from once daily treatment compared with twice daily, especially in the group of patients with a moderate eczema at inclusion. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

"A Vegetarian vs. Conventional Hypocaloric Diet: The Effect on Physical Fitness in Response to Aerobic Exercise in Patients with Type 2 Diabetes." A Parallel Randomized Study.

PubMed

Veleba, Jiri; Matoulek, Martin; Hill, Martin; Pelikanova, Terezie; Kahleova, Hana

2016-10-26

It has been shown that it is possible to modify macronutrient oxidation, physical fitness and resting energy expenditure (REE) by changes in diet composition. Furthermore, mitochondrial oxidation can be significantly increased by a diet with a low glycemic index. The purpose of our trial was to compare the effects of a vegetarian (V) and conventional diet (C) with the same caloric restriction (-500 kcal/day) on physical fitness and REE after 12 weeks of diet plus aerobic exercise in 74 patients with type 2 diabetes (T2D). An open, parallel, randomized study design was used. All meals were provided for the whole study duration. An individualized exercise program was prescribed to the participants and was conducted under supervision. Physical fitness was measured by spiroergometry and indirect calorimetry was performed at the start and after 12 weeks Repeated-measures ANOVA (Analysis of variance) models with between-subject (group) and within-subject (time) factors and interactions were used for evaluation of the relationships between continuous variables and factors. Maximal oxygen consumption (VO 2max ) increased by 12% in vegetarian group (V) (F = 13.1, p < 0.001, partial η ² = 0.171), whereas no significant change was observed in C (F = 0.7, p = 0.667; group × time F = 9.3, p = 0.004, partial η ² = 0.209). Maximal performance (Watt max) increased by 21% in V (F = 8.3, p < 0.001, partial η ² = 0.192), whereas it did not change in C (F = 1.0, p = 0.334; group × time F = 4.2, p = 0.048, partial η ² = 0.116). Our results indicate that V leads more effectively to improvement in physical fitness than C after aerobic exercise program.

A Randomized, Rater-Blinded, Parallel Trial of Intensive Speech Therapy in Sub-Acute Post-Stroke Aphasia: The SP-I-R-IT Study

ERIC Educational Resources Information Center

Martins, Isabel Pavao; Leal, Gabriela; Fonseca, Isabel; Farrajota, Luisa; Aguiar, Marta; Fonseca, Jose; Lauterbach, Martin; Goncalves, Luis; Cary, M. Carmo; Ferreira, Joaquim J.; Ferro, Jose M.

2013-01-01

Background: There is conflicting evidence regarding the benefits of intensive speech and language therapy (SLT), particularly because intensity is often confounded with total SLT provided. Aims: A two-centre, randomized, rater-blinded, parallel study was conducted to compare the efficacy of 100 h of SLT in a regular (RT) versus intensive (IT)…

Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial.

PubMed

Mogollon, Jaime Andres; Bujold, Emmanuel; Lemieux, Simone; Bourdages, Mélodie; Blanchet, Claudine; Bazinet, Laurent; Couillard, Charles; Noël, Martin; Dodin, Sylvie

2013-04-08

Several randomized clinical trials (RCTs) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation (FMD) and blood pressure (BP). However, no RCTs have evaluated these outcomes in pregnant women. The objective of this 2-group, parallel, double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP. Forty-four healthy, pregnant women were randomized to the high-flavanol (n = 23) or low-flavanol (n = 21) chocolate consumption for 12 weeks. At randomization (0, 60, 120 and 180 min after a single 40-g dose of chocolate), 6 and 12 weeks after daily 20-g chocolate intake, we evaluated plasma concentrations of flavanols and theobromine, as well as the FMD and BP. Plasma epicatechin was significantly increased (p < 0.001) 180 min after the consumption of 40-g high-flavanol chocolate compared to low-flavanol chocolate. Theobromine concentrations were significantly higher 180 min and 12 weeks after the intake of experimental chocolate or low-flavanol chocolate (p < 0.001). FMD was not different between the 2 groups at all pre-defined time periods. No other significant within-group or between-group changes were observed. These results confirm the feasibility of a large-scale RCT comparing daily consumption of flavanol-rich chocolate to an equivalent placebo during pregnancy and demonstrate higher plasma epicatechin and theobromine concentration in the intervention group after acute ingestion ClinicalTrials.gov Identifier: NCT01659060.

Bupropion and Naltrexone for Smoking Cessation: A Double-Blind Randomized Placebo-Controlled Clinical Trial

PubMed Central

Mooney, Marc E.; Schmitz, Joy M.; Allen, Sharon; Grabowski, John; Pentel, Paul; Oliver, Andrew; Hatsukami, Dorothy K.

2016-01-01

Combination of non-nicotine pharmacotherapies has been under-examined for cigarette smoking cessation. A randomized, double-blind, parallel-group double-dummy study evaluated two medications, bupropion (BUP) and naltrexone (NTX), in treatment-seeking cigarette smokers (N = 121) over a 7-week treatment intervention with 6-month follow-up. Smokers were randomized to either BUP (300 mg/day) + Placebo (PBO) or BUP (300 mg/day) + NTX (50 mg/day). The primary outcome was biochemically-verified (saliva cotinine, carbon monoxide) 7-day, point-prevalence abstinence. BUP+NTX was associated with significantly higher point-prevalence abstinence rates after 7-weeks of treatment (BUP+NTX, 54.1%; BUP+PBO, 33.3%), p = 0.0210, but not at 6-month follow-up (BUP+NTX, 27.9%; BUP+PBO, 15.0%), p = 0.09. Continuous abstinence rates did not differ, p = 0.0740 (BUP+NTX, 26.2%; BUP+PBO, 13.3%). Those receiving BUP+NTX reported reduced nicotine withdrawal, p = 0.0364. The BUP+NTX combination was associated with elevated rates of some side effects, but with no significant difference in retention between the groups. PMID:27213949

Effect of Garlic and Lemon Juice Mixture on Lipid Profile and Some Cardiovascular Risk Factors in People 30-60 Years Old with Moderate Hyperlipidaemia: A Randomized Clinical Trial.

PubMed

Aslani, Negar; Entezari, Mohammad Hasan; Askari, Gholamreza; Maghsoudi, Zahra; Maracy, Mohammad Reza

2016-01-01

This study was performed to effects of garlic and lemon juice mixture on lipid profile and some cardiovascular risk factors in people 30-60 years old with moderate hyperlipidemia. In a parallel-designed randomized controlled clinical trial, a total of 112 hyperlipidemic patients 30-60 years, were recruited from Isfahan Cardiovascular Research Center. People were selected and randomly divided into four groups. Control blood samples were taken and height, weight, and blood pressure were recorded. (1) Received 20 g of garlic daily, plus 1 tablespoon lemon juice, (2) received 20 g garlic daily, (3) received 1 tablespoon of lemon juice daily, and (4) did not receive garlic or lemon juice. A study technician was done the random allocations using a random numbers table. All participants presented 3 days of dietary records and 3 days of physical activity records during 8 weeks. Blood samples were obtained at study baseline and after 8 weeks of intervention. Results showed a significant decrease in total cholesterol (changes from baseline: 40.8 ± 6.1, P < 0.001), low-density lipoprotein-cholesterol (29.8 ± 2.6, P < 0.001), and fibrinogen (111.4 ± 16.1, P < 0.001) in the Group 1, in comparison with other groups. A greater reduction in systolic and diastolic blood pressure was observed in Group 1 compared with the Groups 3 and 4 (37 ± 10, P = 0.01) (24 ± 1, P = 0.02); respectively. Furthermore, a great reduction in body mass index was observed in the mixed group compared with the lemon juice and control groups (1.6 ± 0.1, P = 0.04). Administration of garlic plus lemon juice resulted in an improvement in lipid levels, fibrinogen and blood pressure of patients with hyperlipidemia.

Wheel of Wellness Counseling in Community Dwelling, Korean Elders: A Randomized, Controlled Trial.

PubMed

Kwon, So Hi

2015-06-01

The purpose of this study was to investigate the effects of Wheel of Wellness counseling on wellness lifestyle, depression, and health-related quality of life in community dwelling elderly people. A parallel, randomized controlled, open label, trial was conducted. Ninety-three elderly people in a senior welfare center were randomly assigned to two groups: 1) A Wheel of Wellness counseling intervention group (n=49) and 2) a no-treatment control group (n=44). Wheel of Wellness counseling consisted of structured, individual counseling based on the Wheel of Wellness model and provided once a week for four weeks. Wellness lifestyle, depression, and health-related quality of life were assessed pre-and post-test in both groups. Data from 89 participants were analyzed. For participants in the experimental group, there was a significant improvement on all of the wellness-lifestyle subtasks except realistic beliefs. Perceived wellness and depression significantly improved after the in the experimental group (n=43) compared to the control group (n=46) from pre- to post-test in the areas of sense of control (p=.033), nutrition (p=.017), exercise (p=.039), self-care (p<.001), stress management (p=.017), work (p=.011), perceived wellness (p=.019), and depression (p=.031). One participant in the intervention group discontinued the intervention due to hospitalization and three in the control group discontinued the sessions. Wheel of Wellness counseling was beneficial in enhancing wellness for the community-dwelling elderly people. Research into long-term effects of the intervention and health outcomes is recommended.

Far infrared emitting plaster in knee osteoarthritis: a single blinded, randomised clinical trial.

PubMed

Bagnato, G L; Miceli, G; Atteritano, M; Marino, N; Bagnato, G F

2012-12-20

Therapeutic approach of osteoarthritis (OA) still represents a challenge in clinical practice. The aim of the study is to assess the efficacy of far infrared (FIR) emitting plaster in the treatment of knee OA. This is a randomized, single-blind, placebo-controlled, parallel group with equal randomization (1:1), clinical trial. Patients affected by knee OA were randomly allocated to 1 of 2 treatment groups, either placebo plaster or far infrared emitting plaster. Primary endpoint was to assess pain improvement from baseline to 1 months posttreatment in the visual analogue score (VAS). Secondary end point was to evaluate pain score after 1 week of treatment and to compare ultrasonographic findings after 1 month of treatment. Each group comprised 30 (in the FIR group) and 30 (in the placebo group) completers. VAS scores of the placebo and the FIR group were significantly lower at 1 week post-treatment (95% confidence interval CI = -1.14 to 0.31; P<0.05) and at the end of the study (95% confidence interval CI = -2.57 to -0.89; P=0.01). Effect size was -0.43 after one week of treatment and -1.38 after one month of treatment. The mean decrease in VAS values was ≥ 20% in the FIR group. The number of patients from the FIR group with joint effusion was lower (40%) compared to baseline (80%), while no changes were seen among the placebo group. Far infrared emitting plaster could be considered an effective non-pharmacological choice for the therapeutic management of knee OA.

Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial.

PubMed

Rossignol, Patrick; Dorval, Marc; Fay, Renaud; Ros, Joan Fort; Loughraieb, Nathalie; Moureau, Frédérique; Laville, Maurice

2013-06-01

Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting.The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical implications for patient care. ClinicalTrials.gov NCT01318486.

Effect of Weight Maintenance on Symptoms of Knee Osteoarthritis in Obese Patients: A Twelve-Month Randomized Controlled Trial

PubMed Central

Christensen, Robin; Henriksen, Marius; Leeds, Anthony R; Gudbergsen, Henrik; Christensen, Pia; Sørensen, Tina J; Bartels, Else M; Riecke, Birgit F; Aaboe, Jens; Frederiksen, Rikke; Boesen, Mikael; Lohmander, L Stefan; Astrup, Arne; Bliddal, Henning

2015-01-01

Objective To compare results of obese patients with knee osteoarthritis (OA) who, after an intensive weight loss regimen, received 1 year of either dietary support (D), a knee-exercise program (E), or “no attention” (C; control group). Methods We conducted a randomized, 2-phase, parallel-group trial. A total of 192 obese participants with knee OA were enrolled; the mean age was 62.5 years and 81% were women with a mean entry weight of 103.2 kg. In phase 1, all participants were randomly assigned to 1 of 3 groups and began a dietary regimen of 400–810 and 1,250 kcal/day for 16 weeks (2 8-week phases) to achieve a major weight loss. Phase 2 consisted of 52 weeks' maintenance in either group D, E, or C. Outcomes were changes from randomization in pain on a 100-mm visual analog scale, weight, and response according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria. Results Mean weight loss for phase 1 was 12.8 kg. After 1 year on maintenance therapy, the D group sustained a lower weight (11.0 kg, 95% confidence interval [95% CI] 9.0, 12.8 kg) than those in the E (6.2, 95% CI 4.4, 8.1 kg) and C (8.2, 95% CI 6.4, 10.1 kg) groups (P = 0.002 by analysis of covariance [ANCOVA]). Adherence was low in the E group. All groups had statistically significant pain reduction (D: 6.1; E: 5.6; and C: 5.5 mm) with no difference between groups (P = 0.98 by ANCOVA). In each group 32 (50%), 26 (41%), and 33 (52%) participants responded to treatment in the D, E, and C groups, respectively, with no statistically significant difference in the number of responders (P = 0.41). Conclusion A significant weight reduction with a 1-year maintenance program improves knee OA symptoms irrespective of maintenance program. PMID:25370359

Impact of Attending Physicians' Comments on Residents' Workloads in the Emergency Department: Results from Two J(^o^)PAN Randomized Controlled Trials.

PubMed

Kuriyama, Akira; Umakoshi, Noriyuki; Fujinaga, Jun; Kaihara, Toshie; Urushidani, Seigo; Kuninaga, Naoki; Ichikawa, Motohiro; Ienaga, Shinichiro; Sasaki, Akira; Ikegami, Tetsunori

2016-01-01

To examine whether peppy comments from attending physicians increased the workload of residents working in the emergency department (ED). We conducted two parallel-group, assessor-blinded, randomized trials at the ED in a tertiary care hospital in western Japan. Twenty-five residents who examined either ambulatory (J(^o^)PAN-1 Trial) or transferred patients (J(^o^)PAN-2 Trial) in the ED on weekdays. Participants were randomly assigned to groups that either received a peppy message such as "Hope you have a quiet day!" (intervention group) or did not (control group) from the attending physicians. Both trials were conducted from June 2014 through March 2015. For each trial, residents rated the number of patients examined during and the busyness and difficulty of their shifts on a 5-point Likert scale. A total of 169 randomizations (intervention group, 81; control group, 88) were performed for the J(^o^)PAN-1 Trial, and 178 (intervention group, 85; control group, 93) for the J(^o^)PAN-2 Trial. In the J(^o^)PAN-1 trial, no differences were observed in the number of ambulatory patients examined during their shifts (5.5 and 5.7, respectively, p = 0.48), the busyness of their shifts (2.8 vs 2.8; p = 0.58), or the difficulty of their shifts (3.1 vs 3.1, p = 0.94). However, in the J(^o^)PAN-2 trial, although busyness (2.8 vs 2.7; p = 0.40) and difficulty (3.1 vs 3.2; p = 0.75) were similar between groups, the intervention group examined more transferred patients than the control group (4.4 vs 3.9; p = 0.01). Peppy comments from attending physicians had a minimal jinxing effect on the workload of residents working in the ED. University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000017193 and UMIN000017194.

Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study.

PubMed

Bousser, M G; Amarenco, P; Chamorro, A; Fisher, M; Ford, I; Fox, K; Hennerici, M G; Mattle, H P; Rothwell, P M

2009-01-01

Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged > or =55 years, having suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or =8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2-4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event. Copyright 2009 S. Karger AG, Basel.

Impact on quality of life of a nursing intervention programme for patients with chronic non-cancer pain: an open, randomized controlled parallel study protocol.

PubMed

Morales-Fernandez, Angeles; Morales-Asencio, Jose Miguel; Canca-Sanchez, Jose Carlos; Moreno-Martin, Gabriel; Vergara-Romero, Manuel

2016-05-01

To determine the effect of a nurse-led intervention programme for patients with chronic non-cancer pain. Chronic non-cancer pain is a widespread health problem and one that is insufficiently controlled. Nurses can play a vital role in pain management, using best practices in the assessment and management of pain under a holistic approach where the patient plays a proactive role in addressing the disease process. Improving the quality of life, reducing disability, achieving acceptance of health status, coping and breaking the vicious circle of pain should be the prime objectives of our care management programme. Open randomized parallel controlled study. The experimental group will undertake one single initial session, followed by six group sessions led by nurses, aimed at empowering patients for the self-management of pain. Healthy behaviours will be encouraged, such as sleep and postural hygiene, promotion of physical activity and healthy eating. Educational interventions on self-esteem, pain-awareness, communication and relaxing techniques will be carried out. As primary end points, quality of life, perceived level of pain, anxiety and depression will be evaluated. Secondary end points will be coping and satisfaction. Follow-up will be performed at 12 and 24 weeks. The study was approved by the Ethics and Research Committee Costa del Sol. If significant effects were detected, impact on quality of life through a nurse-led programme would offer a complementary service to existing pain clinics for a group of patients with frequent unmet needs. © 2016 John Wiley & Sons Ltd.

GASPRNG: GPU accelerated scalable parallel random number generator library

NASA Astrophysics Data System (ADS)

Gao, Shuang; Peterson, Gregory D.

2013-04-01

Graphics processors represent a promising technology for accelerating computational science applications. Many computational science applications require fast and scalable random number generation with good statistical properties, so they use the Scalable Parallel Random Number Generators library (SPRNG). We present the GPU Accelerated SPRNG library (GASPRNG) to accelerate SPRNG in GPU-based high performance computing systems. GASPRNG includes code for a host CPU and CUDA code for execution on NVIDIA graphics processing units (GPUs) along with a programming interface to support various usage models for pseudorandom numbers and computational science applications executing on the CPU, GPU, or both. This paper describes the implementation approach used to produce high performance and also describes how to use the programming interface. The programming interface allows a user to be able to use GASPRNG the same way as SPRNG on traditional serial or parallel computers as well as to develop tightly coupled programs executing primarily on the GPU. We also describe how to install GASPRNG and use it. To help illustrate linking with GASPRNG, various demonstration codes are included for the different usage models. GASPRNG on a single GPU shows up to 280x speedup over SPRNG on a single CPU core and is able to scale for larger systems in the same manner as SPRNG. Because GASPRNG generates identical streams of pseudorandom numbers as SPRNG, users can be confident about the quality of GASPRNG for scalable computational science applications. Catalogue identifier: AEOI_v1_0 Program summary URL:http://cpc.cs.qub.ac.uk/summaries/AEOI_v1_0.html Program obtainable from: CPC Program Library, Queen’s University, Belfast, N. Ireland Licensing provisions: UTK license. No. of lines in distributed program, including test data, etc.: 167900 No. of bytes in distributed program, including test data, etc.: 1422058 Distribution format: tar.gz Programming language: C and CUDA. Computer: Any PC or workstation with NVIDIA GPU (Tested on Fermi GTX480, Tesla C1060, Tesla M2070). Operating system: Linux with CUDA version 4.0 or later. Should also run on MacOS, Windows, or UNIX. Has the code been vectorized or parallelized?: Yes. Parallelized using MPI directives. RAM: 512 MB˜ 732 MB (main memory on host CPU, depending on the data type of random numbers.) / 512 MB (GPU global memory) Classification: 4.13, 6.5. Nature of problem: Many computational science applications are able to consume large numbers of random numbers. For example, Monte Carlo simulations are able to consume limitless random numbers for the computation as long as resources for the computing are supported. Moreover, parallel computational science applications require independent streams of random numbers to attain statistically significant results. The SPRNG library provides this capability, but at a significant computational cost. The GASPRNG library presented here accelerates the generators of independent streams of random numbers using graphical processing units (GPUs). Solution method: Multiple copies of random number generators in GPUs allow a computational science application to consume large numbers of random numbers from independent, parallel streams. GASPRNG is a random number generators library to allow a computational science application to employ multiple copies of random number generators to boost performance. Users can interface GASPRNG with software code executing on microprocessors and/or GPUs. Running time: The tests provided take a few minutes to run.

Randomized controlled clinical trial evaluating multiplex polymerase chain reaction for pathogen identification and therapy adaptation in critical care patients with pulmonary or abdominal sepsis.

PubMed

Tafelski, Sascha; Nachtigall, Irit; Adam, Thomas; Bereswill, Stefan; Faust, Jana; Tamarkin, Andrey; Trefzer, Tanja; Deja, Maria; Idelevich, Evgeny A; Wernecke, Klaus-Dieter; Becker, Karsten; Spies, Claudia

2015-06-01

To determine whether a multiplex polymerase chain reaction (PCR)-based test could reduce the time required for initial pathogen identification in patients in an intensive care unit (ICU) setting. This double-blind, parallel-group randomized controlled trial** enrolled adults with suspected pulmonary or abdominal sepsis caused by an unknown pathogen. Both the intervention and control groups underwent the standard blood culture (BC) testing, but additional pathogen identification, based on the results of a LightCycler® SeptiFast PCR test, were provided in the intervention group. The study enrolled 37 patients in the control group and 41 in the intervention group. Baseline clinical and demographic characteristics were similar in both groups. The PCR-based test identified a pathogen in 10 out of 41 (24.4%) patients in the intervention group, with a mean duration from sampling to providing the information to the ICU of 15.9 h. In the control group, BC results were available after a significantly longer period (38.1 h). The LightCycler® SeptiFast PCR test demonstrated a significant reduction in the time required for initial pathogen identification, compared with standard BC. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Mometasone furoate nasal spray relieves the ocular symptoms of seasonal allergic rhinoconjunctivitis.

PubMed

Igarashi, Tsutomu; Nakazato, Yuri; Kunishige, Tomoyuki; Fujita, Miho; Yamada, Yumi; Fujimoto, Chiaki; Okubo, Kimihiro; Takahashi, Hiroshi

2012-01-01

Recent studies have examined the effects of intranasal corticosteroids (INSs) in relieving the ocular symptoms of seasonal allergic rhinoconjunctivitis (SAR) and perennial allergic rhinitis. However, because most of these studies were based on subjective assessments by patients, the associated factors and mechanism of action are unknown. A single-center, randomized, double-blind, parallel-group study was carried out in which patients with SAR were randomly assigned to an INS mometasone furoate nasal spray (MFNS) group or to a placebo group and treated once daily for 4 weeks. Substance P concentrations in tears were measured, ocular and nasal symptoms were recorded by patients in an allergy diary, and findings were recorded by an ophthalmologist. There was no significant difference between treatment groups in the mean change from baseline of substance P concentration in tears after 4 weeks of treatment, but the mean change tended to increase in the placebo group and tended to decrease in the MFNS group (P = 0.089). All ocular and nasal symptom scores, except eye tearing, were significantly lower in the MFNS group than in the placebo group. Furthermore, substance P concentrations were strongly correlated with ocular and nasal symptom scores. In patients with SAR, INSs tend to decrease the substance P concentration in tears, which is correlated with the severity of ocular and nasal symptoms.

Intensive Language Action Therapy in Chronic Aphasia: A Randomized Clinical Trial Examining Guidance by Constraint

PubMed Central

Stanek,, Edward J.; Stokes, Polly; Li, Minming; Andrianopoulos, Mary

2016-01-01

Purpose Intensive language action therapy (ILAT) can be effective in overcoming learned nonuse in chronic aphasia. It is suggested that all three guiding principles (constraint, communication embedding, massed practice) are essential to ILAT's success. We examined whether one of these, guidance by constraint, is critical. Method Twenty-four participants with aphasia (PWAs) were assigned to ILAT or a modified version of promoting aphasic communicative effectiveness (PACE) in a randomized block, single-blind, parallel-group treatment study. Blocking was by severity (mild/moderate, moderate to severe, severe). Both groups received intensive treatment in the context of therapeutic language action games. Whereas the ILAT group was guided toward spoken responses, the PACE group could choose any response modality. Results All participants, whether assigned to ILAT or PACE groups, improved on the primary outcome measure, picture naming. There was a Severity × Treatment interaction, with the largest effects estimated for PWAs with mild/moderate and moderate to severe aphasia. Regardless of severity, the ILAT group outperformed the PACE group on untrained pictures, suggesting some benefit of ILAT to generalization. However, this difference was not statistically significant. Conclusion Although the groups differed in subtle ways, including better generalization to untrained pictures for ILAT, the study was inconclusive on the influence of guidance by constraint. PMID:27997954

Dietary supplementation with docosahexaenoic acid (DHA) improves seminal antioxidant status and decreases sperm DNA fragmentation.

PubMed

Martínez-Soto, Juan Carlos; Domingo, Joan Carles; Cordobilla, Begoña; Nicolás, María; Fernández, Laura; Albero, Pilar; Gadea, Joaquín; Landeras, José

2016-12-01

The purpose of this study was to evaluate the effect of docosahexaenoic acid (DHA) dietary supplementation on semen quality, fatty acid composition, antioxidant capacity, and DNA fragmentation. In this randomized, double blind, placebo-controlled, parallel-group study, 74 subjects were recruited and randomly assigned to either the placebo group (n=32) or to the DHA group (n=42) to consume three 500-mg capsules of oil per day over 10 weeks. The placebo group received 1,500 mg/day of sunflower oil and the DHA group 1,500 mg/day of DHA-enriched oil. Seminal parameters (semen volume, sperm concentration, motility, morphology, and vitality), total antioxidant capacity, deoxyribonucleic acid fragmentation, and lipid composition were evaluated prior to the treatment and after 10 weeks. Finally, 57 subjects were included in the study with 25 in the placebo group and 32 in the DHA group. No differences were found in traditional sperm parameters or lipid composition of the sperm membrane after treatment. However, an increase in DHA and Omega-3 fatty acid content in seminal plasma, an improvement in antioxidant status, and a reduction in the percentage of spermatozoa with deoxyribonucleic acid damage were observed in the DHA group after 10 weeks of treatment.

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

PubMed

Suzuki, Kazuyuki; Endo, Ryujin; Takikawa, Yasuhiro; Moriyasu, Fuminori; Aoyagi, Yutaka; Moriwaki, Hisataka; Terai, Shuji; Sakaida, Isao; Sakai, Yoshiyuki; Nishiguchi, Shuhei; Ishikawa, Toru; Takagi, Hitoshi; Naganuma, Atsushi; Genda, Takuya; Ichida, Takafumi; Takaguchi, Koichi; Miyazawa, Katsuhiko; Okita, Kiwamu

2018-05-01

The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH 3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH 3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia. © 2017 The Japan Society of Hepatology.

Multidisciplinary intensive functional restoration versus outpatient active physiotherapy in chronic low back pain: a randomized controlled trial.

PubMed

Roche-Leboucher, Ghislaine; Petit-Lemanac'h, Audrey; Bontoux, Luc; Dubus-Bausière, Valérie; Parot-Shinkel, Elsa; Fanello, Serge; Penneau-Fontbonne, Dominique; Fouquet, Natacha; Legrand, Erick; Roquelaure, Yves; Richard, Isabelle

2011-12-15

Randomized parallel group comparative trial with a 1-year follow-up period. To compare in a population of patients with chronic low back pain, the effectiveness of a functional restoration program (FRP), including intensive physical training and a multidisciplinary approach, with an outpatient active physiotherapy program at 1-year follow-up. Controlled studies conducted in the United States and in Northern Europe showed a benefit of FRPs, especially on return to work. Randomized studies have compared these programs with standard care. A previously reported study presented the effectiveness at 6 months of both functional restoration and active physiotherapy, with a significantly greater reduction of sick-leave days for functional restoration. A total of 132 patients with low back pain were randomized to either FRP (68 patients) or active individual therapy (64 patients). One patient did not complete the FRP; 19 patients were lost to follow-up (4 in the FRP group and 15 in the active individual treatment group). The number of sick-leave days in 2 years before the program was similar in both groups (180 ± 135.1 days in active individual treatment vs. 185 ± 149.8 days in FRP, P = 0.847). In both groups, at 1-year follow-up, intensity of pain, flexibility, trunk muscle endurance, Dallas daily activities and work and leisure scores, and number of sick-leave days were significantly improved compared with baseline. The number of sick-leave days was significantly lower in the FRP group. Both programs are efficient in reducing disability and sick-leave days. The FRP is significantly more effective in reducing sick-leave days. Further analysis is required to determine if this overweighs the difference in costs of both programs.

Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise -Associated Hyponatremia.

PubMed

Bridges, Eileen; Altherwi, Tawfeeq; Correa, José A; Hew-Butler, Tamara

2018-01-23

To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon. Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either "oral" or "IV." Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada. Twenty race finishers with mild to moderately symptomatic EAH. Age, sex, race finish time, and 9 clinical symptoms. Time from treatment to discharge. We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention. The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms. Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.

Applying the Transtheoretical Model to evaluate the effect of a call-recall program in enhancing Pap smear practice: a cluster randomized trial.

PubMed

Abdullah, Fauziah; Su, Tin Tin

2013-01-01

The objective of this study was to evaluate the effect of a call-recall approach in enhancing Pap smear practice by changes of motivation stage among non-compliant women. A cluster randomized controlled trial with parallel and un-blinded design was conducted between January and November 2010 in 40 public secondary schools in Malaysia among 403 female teachers who never or infrequently attended for a Pap test. A cluster randomization was applied in assigning schools to both groups. An intervention group received an invitation and reminder (call-recall program) for a Pap test (20 schools with 201 participants), while the control group received usual care from the existing cervical screening program (20 schools with 202 participants). Multivariate logistic regression was performed to determine the effect of the intervention program on the action stage (Pap smear uptake) at 24 weeks. In both groups, pre-contemplation stage was found as the highest proportion of changes in stages. At 24 weeks, an intervention group showed two times more in the action stage than control group (adjusted odds ratio 2.44, 95% CI 1.29-4.62). The positive effect of a call-recall approach in motivating women to change the behavior of screening practice should be appreciated by policy makers and health care providers in developing countries as an intervention to enhance Pap smear uptake. Copyright © 2013 Elsevier Inc. All rights reserved.

Aerobic training for improved memory in patients with stress-related exhaustion: a randomized controlled trial.

PubMed

Eskilsson, Therese; Slunga Järvholm, Lisbeth; Malmberg Gavelin, Hanna; Stigsdotter Neely, Anna; Boraxbekk, Carl-Johan

2017-09-02

Patients with stress-related exhaustion suffer from cognitive impairments, which often remain after psychological treatment or work place interventions. It is important to find effective treatments that can address this problem. Therefore, the aim of this study was to investigate the effects on cognitive performance and psychological variables of a 12-week aerobic training program performed at a moderate-vigorous intensity for patients with exhaustion disorder who participated in a multimodal rehabilitation program. In this open-label, parallel, randomized and controlled trial, 88 patients diagnosed with exhaustion disorder participated in a 24-week multimodal rehabilitation program. After 12 weeks in the program the patients were randomized to either a 12-week aerobic training intervention or to a control group with no additional training. Primary outcome measure was cognitive function, and secondary outcome measures were psychological health variables and aerobic capacity. In total, 51% patients in the aerobic training group and 78% patients in the control group completed the intervention period. The aerobic training group significantly improved in maximal oxygen uptake and episodic memory performance. No additional improvement in burnout, depression or anxiety was observed in the aerobic group compared with controls. Aerobic training at a moderate-vigorous intensity within a multimodal rehabilitation program for patients with exhaustion disorder facilitated episodic memory. A future challenge would be the clinical implementation of aerobic training and methods to increase feasibility in this patient group. ClinicalTrials.gov: NCT03073772 . Retrospectively registered 21 February 2017.

Randomized controlled trial for assessment of Internet of Things system to guide intensive glucose control in diabetes outpatients: Nagoya Health Navigator Study protocol.

PubMed

Onoue, Takeshi; Goto, Motomitsu; Kobayashi, Tomoko; Tominaga, Takashi; Ando, Masahiko; Honda, Hiroyuki; Yoshida, Yasuko; Tosaki, Takahiro; Yokoi, Hisashi; Kato, Sawako; Maruyama, Shoichi; Arima, Hiroshi

2017-08-01

The Internet of Things (IoT) allows collecting vast amounts of health-relevant data such as daily activity, body weight (BW), and blood pressure (BP) automatically. The use of IoT devices to monitor diabetic patients has been studied, but could not evaluate IoT-dependent effects because health data were not measured in control groups. This multicenter, open-label, randomized, parallel group study will compare the impact of intensive health guidance using IoT and conventional medical guidance on glucose control. It will be conducted in outpatients with type 2 diabetes for a period of 6 months. IoT devices to measure amount of daily activity, BW, and BP will be provided to IoT group patients. Healthcare professionals (HCPs) will provide appropriate feedback according to the data. Non-IoT control, patients will be given measurement devices that do not have a feedback function. The primary outcome is glycated hemoglobin at 6 months. The study has already enrolled 101 patients, 50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides. This will be the first randomized, controlled study to evaluate IoT-dependent effects of intensive feedback from HCPs. The results will validate a new method of health-data collection and provision of feedback suitable for diabetes support with increased effectiveness and low cost.

Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention study.

PubMed

Hoppe, Michael; Ross, Alastair B; Svelander, Cecilia; Sandberg, Ann-Sofie; Hulthén, Lena

2018-05-23

To investigate the effects of eating wholegrain rye bread with high or low amounts of phytate on iron status in women under free-living conditions. In this 12-week, randomized, parallel-design intervention study, 102 females were allocated into two groups, a high-phytate-bread group or a low-phytate-bread group. These two groups were administered: 200 g of blanched wholegrain rye bread/day, or 200 g dephytinized wholegrain rye bread/day. The bread was administered in addition to their habitual daily diet. Iron status biomarkers and plasma alkylresorcinols were analyzed at baseline and post-intervention. Fifty-five females completed the study. In the high-phytate-bread group (n = 31) there was no change in any of the iron status biomarkers after 12 weeks of intervention (p > 0.05). In the low-phytate bread group (n = 24) there were significant decreases in both ferritin (mean = 12%; from 32 ± 7 to 27 ± 6 µg/L, geometric mean ± SEM, p < 0.018) and total body iron (mean = 12%; from 6.9 ± 1.4 to 5.4 ± 1.1 mg/kg, p < 0.035). Plasma alkylresorcinols indicated that most subjects complied with the intervention. In Swedish females of reproductive age, 12 weeks of high-phytate wholegrain bread consumption had no effect on iron status. However, consumption of low-phytate wholegrain bread for 12 weeks resulted in a reduction of markers of iron status. Although single-meal studies clearly show an increase in iron bioavailability from dephytinization of cereals, medium-term consumption of reduced phytate bread under free-living conditions suggests that this strategy does not work to improve iron status in healthy women of reproductive age.

Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

PubMed

Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

2017-09-01

The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess the efficacy and safety of LCZ696 in Japanese HFrEF patients. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Self-monitoring Using Mobile Phones in the Early Stages of Adolescent Depression: Randomized Controlled Trial

PubMed Central

Reid, Sophie Caroline; Crooke, Alexander Hew Dale; Khor, Angela; Hearps, Stephen John Charles; Jorm, Anthony Francis; Sanci, Lena; Patton, George

2012-01-01

Background The stepped-care approach, where people with early symptoms of depression are stepped up from low-intensity interventions to higher-level interventions as needed, has the potential to assist many people with mild depressive symptoms. Self-monitoring techniques assist people to understand their mental health symptoms by increasing their emotional self-awareness (ESA) and can be easily distributed on mobile phones at low cost. Increasing ESA is an important first step in psychotherapy and has the potential to intervene before mild depressive symptoms progress to major depressive disorder. In this secondary analysis we examined a mobile phone self-monitoring tool used by young people experiencing mild or more depressive symptoms to investigate the relationships between self-monitoring, ESA, and depression. Objectives We tested two main hypotheses: (1) people who monitored their mood, stress, and coping strategies would have increased ESA from pretest to 6-week follow-up compared with an attention comparison group, and (2) an increase in ESA would predict a decrease in depressive symptoms. Methods We recruited patients aged 14 to 24 years from rural and metropolitan general practices. Eligible participants were identified as having mild or more mental health concerns by their general practitioner. Participants were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored) or the attention comparison group (where only daily activities were monitored), and both groups self-monitored for 2 to 4 weeks. Randomization was carried out electronically via random seed generation, by an in-house computer programmer; therefore, general practitioners, participants, and researchers were blinded to group allocation at randomization. Participants completed pretest, posttest, and 6-week follow-up measures of the Depression Anxiety Stress Scale and the ESA Scale. We estimated a parallel process latent growth curve model (LGCM) using Mplus to test the indirect effect of the intervention on depressive symptoms via the mediator ESA, and calculated 95% bias-corrected bootstrapping confidence intervals (CIs). Results Of the 163 participants assessed for eligibility, 118 were randomly assigned and 114 were included in analyses (68 in the intervention group and 46 in the comparison group). A parallel process LGCM estimated the indirect effect of the intervention on depressive symptoms via ESA and was shown to be statistically significant based on the 95% bias-corrected bootstrapping CIs not containing zero (–6.366 to –0.029). The proportion of the maximum possible indirect effect estimated was κ2 =.54 (95% CI .426–.640). Conclusions This study supported the hypothesis that self-monitoring increases ESA, which in turn decreases depressive symptoms for young people with mild or more depressive symptoms. Mobile phone self-monitoring programs are ideally suited to first-step intervention programs for depression in the stepped-care approach, particularly when ESA is targeted as a mediating factor. Trial Registration ClinicalTrials.gov NCT00794222; http://clinicaltrials.gov/ct2/show/NCT00794222 (Archived by WebCite at http://www.webcitation.org/65lldW34k) PMID:22732135

Efficient, massively parallel eigenvalue computation

NASA Technical Reports Server (NTRS)

Huo, Yan; Schreiber, Robert

1993-01-01

In numerical simulations of disordered electronic systems, one of the most common approaches is to diagonalize random Hamiltonian matrices and to study the eigenvalues and eigenfunctions of a single electron in the presence of a random potential. An effort to implement a matrix diagonalization routine for real symmetric dense matrices on massively parallel SIMD computers, the Maspar MP-1 and MP-2 systems, is described. Results of numerical tests and timings are also presented.

Effects of conventional vs high-dose rocuronium on the QTc interval during anesthesia induction and intubation in patients undergoing coronary artery surgery: a randomized, double-blind, parallel trial

PubMed Central

Öztürk, T.; Ağdanlı, D.; Bayturan, Ö.; Çıkrıkcı, C.; Keleş, G.T.

2015-01-01

Myocardial ischemia, as well as the induction agents used in anesthesia, may cause corrected QT interval (QTc) prolongation. The objective of this randomized, double-blind trial was to determine the effects of high- vs conventional-dose bolus rocuronium on QTc duration and the incidence of dysrhythmias following anesthesia induction and intubation. Fifty patients about to undergo coronary artery surgery were randomly allocated to receive conventional-dose (0.6 mg/kg, group C, n=25) or high-dose (1.2 mg/kg, group H, n=25) rocuronium after induction with etomidate and fentanyl. QTc, heart rate, and mean arterial pressure were recorded before induction (T0), after induction (T1), after rocuronium (just before laryngoscopy; T2), 2 min after intubation (T3), and 5 min after intubation (T4). The occurrence of dysrhythmias was recorded. In both groups, QTc was significantly longer at T3 than at baseline [475 vs 429 ms in group C (P=0.001), and 459 vs 434 ms in group H (P=0.005)]. The incidence of dysrhythmias in group C (28%) and in group H (24%) was similar. The QTc after high-dose rocuronium was not significantly longer than after conventional-dose rocuronium in patients about to undergo coronary artery surgery who were induced with etomidate and fentanyl. In both groups, compared with baseline, QTc was most prolonged at 2 min after intubation, suggesting that QTc prolongation may be due to the nociceptive stimulus of intubation. PMID:25714880

A randomized study of new sling exercise treatment vs traditional physiotherapy for patients with chronic whiplash-associated disorders with unsettled compensation claims.

PubMed

Vikne, John; Oedegaard, Arit; Laerum, Even; Ihlebaek, Camilla; Kirkesola, Gitle

2007-04-01

Many patients with chronic whiplash-associated disorders have reduced neuromuscular control of the neck and head. It has been proposed that a new sling exercise therapy may promote neuromuscular control of the neck. To compare the effects of traditional physiotherapy vs traditional physiotherapy combined with a new sling exercise therapy on discomfort and function in patients with chronic whiplash-associated disorders who have unsettled compensation claims; and to investigate possible additional effects of guided, long-term home training. A randomized multi-centre trial with 4 parallel groups. A total of 214 patients were assigned randomly to 4 treatment groups, and received either traditional physiotherapy with or without home training, or new sling exercise therapy with or without home training. Outcome measures were pain, disability, psychological distress, sick leave and physical tests. A total of 171 patients (80%) completed the study. There were no important statistical or clinical differences between the groups after 4 months of treatment. There was a small statistically significant effect at 12-month follow-up in both groups with home training regarding pain during rest (p = 0.05) and reported fatigue in the final week (p = 0.02). No statistically significant differences were found between the traditional physiotherapy group and the new sling exercise group, with or without home training. Since the groups were not compared with a control group without treatment, we cannot conclude that the studied treatments are effective for patients with whiplash-associated disorder, only that they did not differ in our study.

Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

PubMed

Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2014-06-01

Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

Effect of rotator cuff strengthening as an adjunct to standard care in subjects with adhesive capsulitis: A randomized controlled trial.

PubMed

Rawat, Pallavi; Eapen, Charu; Seema, Kulathuran Pillai

Randomized controlled trial. To study the effect of adding rotator cuff (RC) muscles strengthening to joint mobilization and transcutaneous electrical nerve stimulation (TENS) in patients with adhesive capsulitis. A prospective, parallel-group, randomised clinical trial was conducted on 42 patients. One group received TENS and joint mobilization and in the other group RC muscles strengthening was added. Treatment was given for 12 sessions within 4 weeks. When compared between the groups statistically significant changes were seen in all the outcome measures in the group that received RC muscle strengthening exercises vs TENS and mobilization. VAS 12.76 ± 1.04 vs 4.05 ± 1.32; SPADI 34.66 ± 6.69 vs 54.29 ± 12.17; PFPS 3.06 ± 0.80 vs 4.70 ± 0.81; and ROM (elevation >125 vs >110 degrees and rotations >70 vs >48 degrees). Addition of a structured RC strengthening program to TENS and joint mobilization in the treatment of adhesive capsulitis resulted in improvement in pain, ROM and function. 1b. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Simple and flexible SAS and SPSS programs for analyzing lag-sequential categorical data.

PubMed

O'Connor, B P

1999-11-01

This paper describes simple and flexible programs for analyzing lag-sequential categorical data, using SAS and SPSS. The programs read a stream of codes and produce a variety of lag-sequential statistics, including transitional frequencies, expected transitional frequencies, transitional probabilities, adjusted residuals, z values, Yule's Q values, likelihood ratio tests of stationarity across time and homogeneity across groups or segments, transformed kappas for unidirectional dependence, bidirectional dependence, parallel and nonparallel dominance, and significance levels based on both parametric and randomization tests.

Ecologically optimizing exercise maintenance in men and women post-cardiac rehabilitation: Protocol for a randomized controlled trial of efficacy with economics (ECO-PCR).

PubMed

Reid, Robert; Blanchard, Chris M; Wooding, Evyanne; Harris, Jennifer; Krahn, Murray; Pipe, Andrew; Chessex, Caroline; Grace, Sherry L

2016-09-01

Exercise-based cardiac rehabilitation (CR) participation results in increased cardio-metabolic fitness, which is associated with reduced mortality. However, many graduates fail to maintain exercise post-program. ECO-PCR investigates the efficacy and cost-effectiveness of a social ecologically-based intervention to increase long-term exercise maintenance following the completion of CR. A three-site, 2-group, parallel randomized controlled trial is underway. 412 male and 192 female (N=604) supervised CR participants are being recruited just before CR graduation. Participants are randomized (1:1 concealed allocation) to intervention or usual care. A 50-week exercise facilitator intervention has been designed to assist CR graduates in the transition from structured, supervised exercise to self-managed home- or community-based (e.g., Heart Wise Exercise programs) exercise. The intervention consists of 8 telephone contacts over the 50week period: 3 individual and 5 group. Assessments occur at CR graduation, and 26, 52 and 78weeks post-randomization. The primary outcome is change in minutes of accelerometer-measured moderate to vigorous-intensity physical activity (MVPA) from CR graduation to 52weeks post-randomization. Secondary measures include exercise capacity, quality of life, and cardiovascular risk factors. Analyses will be undertaken based on intention-to-treat. For the primary outcome, an analysis of variance will be computed to test the change in minutes of MVPA in each group between CR graduation and 52week follow-up (2 [arm]×2 [time]). Secondary objectives will be assessed using mixed-model repeated measures analyses to compare differences between groups over time. Mean costs and quality-adjusted life years for each arm will be estimated. Copyright © 2016 Elsevier Inc. All rights reserved.

Randomized controlled study comparing the hemodynamic response to laryngoscopy and endotracheal intubation with McCoy, Macintosh, and C-MAC laryngoscopes in adult patients

PubMed Central

Buhari, Faiza Sulaiman; Selvaraj, Venkatesh

2016-01-01

Background and Aims: Earlier studies have shown that the type of laryngoscope blade influences the degree of hemodynamic response to endotracheal intubation. The aim of the study was to evaluate the hemodynamic response to oral endotracheal intubation with C-MAC laryngoscopy and McCoy laryngoscopy compared to that of Macintosh laryngoscopy in adult patients under general anesthesia. Material and Methods: This is a prospective randomized parallel group study. Ninety American Society of Anesthesiologists I patients were randomly allotted into three groups. Group A – Macintosh laryngoscopy (control group). Group B – laryngoscopy with McCoy laryngoscope. Group C – laryngoscopy with C-MAC video laryngoscope. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were monitored at baseline (just before induction), just before intubation (T0), 1 min (T1), 3 min (T3), 5 min (T5), and 10 min (T10) after intubation. Intergroup comparison of study parameters was done by unpaired sample t-test for normal data and Mann-Whitney U-test for skewed data. For within-group comparison, the repeated measures of ANOVA for normal data and Friedman followed by Wilcoxon signed rank test for skewed data were performed. Results: In C-MAC group, the HR was significantly higher than the Macintosh group at 3 min after intubation, whereas SBP, DBP, and MAP were significantly higher at 1 min. McCoy group showed a similar response compared to Macintosh group at all time intervals. Conclusion: C-MAC video laryngoscope has a comparatively greater hemodynamic response than Macintosh laryngoscope. PMID:28096584

Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

PubMed Central

Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

2016-01-01

Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

Comparison of Intralesional Triamcinolone Acetonide, 5-Fluorouracil, and Their Combination for the Treatment of Keloids

PubMed Central

Srivastava, Sunil; Patil, Aditya Nanasaheb; Prakash, Chaitra; Kumari, Hiranmayi

2017-01-01

Objective: Despite the myriad options available, there is no universally accepted treatment for keloids. Our objective was to compare three regimens and establish superiority in terms of objective and subjective outcomes. Approach: In this randomized parallel group study, 60 patients were enrolled and randomly allocated to three groups. Patients received intralesional injections of triamcinolone acetonide (TAC) in Group TAC, 5-fluorouracil (5FU) in Group 5FU, and a combination in Group T + F every 3 weeks till 24 weeks or till the keloid resolved. Results: There was a reduction in all parameters at every successive assessment in all three groups. Improvement in terms of height, vascularity, and pliability was fastest with 5FU, TAC, and T + F group, respectively, which was statistically significant. Decrease in pigmentation was significantly faster with T+F. Reduction in pruritus, however, was significantly faster with 5FU than the other groups, but the difference in reduction of pain among the three groups was not significant. Telangiectasias and skin atrophy were seen most commonly in TAC group, while skin ulceration was a common problem in 5FU group. Conclusion: TAC, 5FU, and their combination are all effective in keloid scars. A combination of TAC +5FU seems to offer the balanced benefit of faster and more efficacious response with lesser adverse effects when compared to individual drugs. PMID:29098115

Beyond silence: protocol for a randomized parallel-group trial comparing two approaches to workplace mental health education for healthcare employees.

PubMed

Moll, Sandra; Patten, Scott Burton; Stuart, Heather; Kirsh, Bonnie; MacDermid, Joy Christine

2015-04-16

Mental illness is a significant and growing problem in Canadian healthcare organizations, leading to tremendous personal, social and financial costs for individuals, their colleagues, their employers and their patients. Early and appropriate intervention is needed, but unfortunately, few workers get the help that they need in a timely way due to barriers related to poor mental health literacy, stigma, and inadequate access to mental health services. Workplace education and training is one promising approach to early identification and support for workers who are struggling. Little is known, however, about what approach is most effective, particularly in the context of healthcare work. The purpose of this study is to compare the impact of a customized, contact-based education approach with standard mental health literacy training on the mental health knowledge, stigmatized beliefs and help-seeking/help-outreach behaviors of healthcare employees. A multi-centre, randomized, two-group parallel group trial design will be adopted. Two hundred healthcare employees will be randomly assigned to one of two educational interventions: Beyond Silence, a peer-led program customized to the healthcare workplace, and Mental Health First Aid, a standardized literacy based training program. Pre, post and 3-month follow-up surveys will track changes in knowledge (mental health literacy), attitudes towards mental illness, and help-seeking/help-outreach behavior. An intent-to-treat, repeated measures analysis will be conducted to compare changes in the two groups over time in terms of the primary outcome of behavior change. Linear regression modeling will be used to explore the extent to which knowledge, and attitudes predict behavior change. Qualitative interviews with participants and leaders will also be conducted to examine process and implementation of the programs. This is one of the first experimental studies to compare outcomes of standard mental health literacy training to an intervention with an added anti-stigma component (using best-practices of contact-based education). Study findings will inform recommendations for designing workplace mental health education to promote early intervention for employees with mental health issues in the context of healthcare work. May 2014 - ClinicalTrials.gov: NCT02158871.

SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa.

PubMed

Amstutz, Alain; Nsakala, Bienvenu Lengo; Vanobberghen, Fiona; Muhairwe, Josephine; Glass, Tracy Renée; Achieng, Beatrice; Sepeka, Mamorena; Tlali, Katleho; Sao, Lebohang; Thin, Kyaw; Klimkait, Thomas; Battegay, Manuel; Labhardt, Niklaus Daniel

2018-02-12

The World Health Organization (WHO) recommends viral load (VL) measurement as the preferred monitoring strategy for HIV-infected individuals on antiretroviral therapy (ART) in resource-limited settings. The new WHO guidelines 2016 continue to define virologic failure as two consecutive VL ≥1000 copies/mL (at least 3 months apart) despite good adherence, triggering switch to second-line therapy. However, the threshold of 1000 copies/mL for defining virologic failure is based on low-quality evidence. Observational studies have shown that individuals with low-level viremia (measurable but below 1000 copies/mL) are at increased risk for accumulation of resistance mutations and subsequent virologic failure. The SESOTHO trial assesses a lower threshold for switch to second-line ART in patients with sustained unsuppressed VL. In this multicenter, parallel-group, open-label, randomized controlled trial conducted in Lesotho, patients on first-line ART with two consecutive unsuppressed VL measurements ≥100 copies/mL, where the second VL is between 100 and 999 copies/mL, will either be switched to second-line ART immediately (intervention group) or not be switched (standard of care, according to WHO guidelines). The primary endpoint is viral resuppression (VL < 50 copies/mL) 9 months after randomization. We will enrol 80 patients, giving us 90% power to detect a difference of 35% in viral resuppression between the groups (assuming two-sided 5% alpha error). For our primary analysis, we will use a modified intention-to-treat set, with those lost to care, death, or crossed over considered failure to resuppress, and using logistic regression models adjusted for the prespecified stratification variables. The SESOTHO trial challenges the current WHO guidelines, assessing an alternative, lower VL threshold for patients with unsuppressed VL on first-line ART. This trial will provide data to inform future WHO guidelines on VL thresholds to recommend switch to second-line ART. ClinicalTrials.gov ( NCT03088241 ), registered May 05, 2017.

Eight Weeks of Cosmos caudatus (Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial

PubMed Central

Cheng, Shi-Hui; Ismail, Amin; Anthony, Joseph; Ng, Ooi Chuan; Hamid, Azizah Abdul; Barakatun-Nisak, Mohd Yusof

2015-01-01

Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications. Cosmos caudatus is reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness of C. caudatus on glycemic status in patients with type 2 diabetes. Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g of C. caudatus daily for eight weeks while diabetic controls abstained from taking C. caudatus. Both groups received the standard lifestyle advice. Results. After 8 weeks of supplementation, C. caudatus significantly reduced serum insulin (−1.16 versus +3.91), reduced HOMA-IR (−1.09 versus +1.34), and increased QUICKI (+0.05 versus −0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (−0.76% versus −0.37%). C. caudatus was safe to consume. Conclusions. C. caudatus supplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes. PMID:26713097

Aerobic training and l-arginine supplementation promotes rat heart and hindleg muscles arteriogenesis after myocardial infarction.

PubMed

Ranjbar, Kamal; Rahmani-Nia, Farhad; Shahabpour, Elham

2016-09-01

Arteriogenesis is a main defense mechanism to prevent heart and local tissues dysfunction in occlusive artery disease. TGF-β and angiostatin have a pivotal role in arteriogenesis. We tested the hypothesis that aerobic training and l-arginine supplementation promotes cardiac and skeletal muscles arteriogenesis after myocardial infarction (MI) parallel to upregulation of TGF-β and downregulation of angiostatin. For this purpose, 4 weeks after LAD occlusion, 50 male Wistar rats were randomly distributed into five groups: (1) sham surgery without MI (sham, n = 10), (2) control-MI (Con-MI, n = 10), (3) l-arginine-MI (La-MI, n = 10), (4) exercise training-MI (Ex-MI, n = 10), and (5) exercise and l-arginine-MI (Ex + La-MI). Exercise training groups running on a treadmill for 10 weeks with moderate intensity. Rats in the l-arginine-treated groups drank water containing 4 % l-arginine. Arteriolar density with different diameters (11-25, 26-50, 51-75, and 76-150 μm), TGF-β, and angiostatin gene expression were measured in cardiac (area at risk) and skeletal (soleus and gastrocnemius) muscles. Smaller arterioles decreased in cardiac after MI. Aerobic training and l-arginine increased the number of cardiac arterioles with 11-25 and 26-50 μm diameters parallel to TGF-β overexpression. In gastrocnemius muscle, the number of arterioles/mm(2) was only increased in the 11 to 25 μm in response to training with and without l-arginine parallel to angiostatin downregulation. Soleus arteriolar density with different size was not different between experimental groups. Results showed that 10 weeks aerobic exercise training and l-arginine supplementation promotes arteriogenesis of heart and gastrocnemius muscles parallel to overexpression of TGF-β and downregulation of angiostatin in MI rats.

The efficacy of fractional carbon dioxide (CO2) laser combined with luliconazole 1% cream for the treatment of onychomycosis: A randomized, controlled trial.

PubMed

Zhou, Bing Rong; Lu, Yan; Permatasari, Felicia; Huang, He; Li, Jin; Liu, Juan; Zhang, Jia An; Luo, Dan; Xu, Yang

2016-11-01

To evaluate the efficacy of fractional carbon dioxide (CO2) laser combined with luliconazole 1% cream for the treatment of onychomycosis and to compare it with that of fractional CO2 laser alone. This was a randomized, parallel group, 2-arm, positive-controlled, single-center, superiority trial with a 1:2 allocation ratio. Sixty patients with clinical and mycological diagnosis of onychomycosis were enrolled from the Dermatology Department of the First Affiliated Hospital of Nanjing Medical University in Nanjing, China from March 2015 to May 2015. Patients were randomized following simple randomization procedures (computerized random number generator) into 2 groups; L group only received 12 sessions of laser treatment at 2-week interval for 6 months, while L + D group received 12 sessions of laser treatment at 2-week interval combined with luliconazole 1% cream once daily for 6 months. This was not a blind trial. The main outcome measures were the clinical efficacy rate (CER) assessed from the percentage of fully and >60% normal-appearing nails and the mycological clearance rate (MCR) assessed from the percentage of nails with negative fungal microscopy. There were no changes to trial outcome measures after the trial commenced. A total of 60 patients (N = 233 nails) completed treatments and follow-up, and were randomized and divided into 2 groups: L group (31 patients, N = 108 nails) and L + D group (29 patients, N = 115 nails). The CER and MCR of L + D group were 69.6% and 57.4%, respectively. L + D group showed significantly higher CER (69.6% vs 50.9%; χ = 8.1, P = 0.004) and MCR (57.4% vs 38.9%; χ = 7.6, P = 0.006) compared with those in L group. Some patients experienced mild pain during laser treatment, but there was no bleeding or oozing during or after treatment. There were no adverse effects reported during the observation period. Fractional CO2 laser treatment combined with 1% luliconazole cream for 6 months was an effective and safe method for the treatment of onychomycosis, and had a higher efficacy than fractional CO2 laser treatment alone.

A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data.

PubMed

Meirik, Olav; Brache, Vivian; Orawan, Kiriwat; Habib, Ndema Abu; Schmidt, Johannes; Ortayli, Nuriye; Culwell, Kelly; Jackson, Emily; Ali, Moazzam

2013-01-01

Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8% and 0.2%; and at follow-up, 27.2% and 26.7% of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1% of IUDs were expelled. Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A. Copyright © 2013 Elsevier Inc. All rights reserved.

Papillary vs Nonpapillary Puncture in Percutaneous Nephrolithotomy: A Prospective Randomized Trial.

PubMed

Kallidonis, Panagiotis; Kyriazis, Iason; Kotsiris, Dimitrios; Koutava, Adamantia; Kamal, Wissam; Liatsikos, Evangelos

2017-04-01

Literature suggests that the percutaneous punctures for percutaneous nephrolithotomy (PCNL) must be performed at the papilla of the renal calix and a puncture at the infundibulum or the direction of the pelvis is not advisable because of increased hemorrhagic risk. A prospective randomized study was conducted to investigate the safety in terms of blood loss of the infundibular approach for PCNL. Patients with renal stones with an accumulative size of at least 2 cm were randomly assigned to one of two parallel groups to undergo PCNL with either papillary (Group 1) or infundibular (Group 2) renal access. The primary outcome measures were the reduction in hemoglobin on first postoperative day and the need for transfusion during the first postoperative month. Secondary endpoints included the operative and fluoroscopy time, number of accesses performed, overall complication rate, hospitalization time, and complications up to 3 months. In total, 27 and 28 patients were enrolled in Groups 1 and 2, respectively. Patient age, body mass index, and stone size were similar among the groups (p = 0.672, 0.256, and 0.889, respectively). Reduction in hemoglobin and transfusion rate did not differ among Groups 1 and 2 (p = 0.916, p = 1.0, respectively). Operative time was higher in the case of Group 1 (p = 0.027). The overall complications rate was 7.4% for Group 1 and 7.14% for Group 2. Hospitalization time was not significantly different in the study groups (p = 0.724). The infundibular approach for PCNL to the posterior middle renal calices is not associated with higher blood loss or transfusion rate in comparison with the respective approach to the fornix of the papilla when the currently described technique is performed.

Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: a randomized, controlled trial.

PubMed

Porta-Roda, Oriol; Vara-Paniagua, Jesús; Díaz-López, Miguel A; Sobrado-Lozano, Pilar; Simó-González, Marta; Díaz-Bellido, Paloma; Reula-Blasco, María C; Muñoz-Garrido, Francisco

2015-08-01

To compare the efficacy and safety of Kegel exercises performed with or without, vaginal spheres as treatment for women with urinary incontinence. Multicentre parallel-group, open, randomized controlled trial. Women were allocated to either a pelvic floor muscle-training program consisting of Kegel exercises performed twice daily, 5 days/week at home, over 6 months with vaginal spheres, or to the same program without spheres. The primary endpoint was women's report of urinary incontinence at 6 months using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF). Secondary outcome measures were the 1 hr pad-test, King's Health Questionnaire (KHQ) and a five-point Likert scale for subjective evaluation. Adherence was measured with the Morisky-Green test. Thirty-seven women were randomized to the spheres group and 33 to the control group. The primary endpoint was evaluated in 65 women (35 in the spheres group vs. 30 controls). ICIQ-UI-SF results improved significantly at 1-month follow-up in the spheres group (P < 0.01) and at 6 months in the controls. The 1 hr pad-test improved in the spheres group but not in the control group. No significant differences were found in the KHQ results or in the subjective evaluation of efficacy and safety. Adherence was higher in the spheres group but differences were not significant. Mild transient side effects were reported in four patients in the spheres group and one in the control group. Both treatments improved urinary incontinence but women who performed the exercises with vaginal spheres showed an earlier improvement. Vaginal spheres were well tolerated and safe. © 2014 Wiley Periodicals, Inc.

Long-Term Effect of Pravastatin on Carotid Intima–Media Complex Thickness

PubMed Central

Toyoda, Kazunori; Minematsu, Kazuo; Yasaka, Masahiro; Nagai, Yoji; Aoki, Shiro; Nezu, Tomohisa; Hosomi, Naohisa; Kagimura, Tatsuo; Origasa, Hideki; Kamiyama, Kenji; Suzuki, Rieko; Ohtsuki, Toshiho; Maruyama, Hirofumi; Kitagawa, Kazuo; Uchiyama, Shinichiro; Matsumoto, Masayasu

2018-01-01

Background and Purpose— The effect of statins on progression of carotid intima–media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. This study aimed to determine the effect of low-dose pravastatin on carotid IMT in Japanese patients with noncardioembolic ischemic stroke. Methods— This is a substudy of the J-STARS trial (Japan Statin Treatment Against Recurrent Stroke), a multicenter, randomized, open-label, parallel-group trial to examine whether pravastatin reduces stroke recurrence. Patients were randomized to receive pravastatin (10 mg daily, usual dose in Japan; pravastatin group) or not to receive any statins (control group). The primary outcome was IMT change of the common carotid artery for a 5-year observation period. IMT change was compared using mixed-effects models for repeated measures. Results— Of 864 patients registered in this substudy, 71 without baseline ultrasonography were excluded, and 388 were randomly assigned to the pravastatin group and 405 to the control group. Baseline characteristics were not significantly different, except National Institutes of Health Stroke Scale scores (median, 0 [interquartile range, 0–2] versus 1 [interquartile range, 0–2]; P=0.019) between the 2 groups. Baseline IMT (mean±SD) was 0.887±0.155 mm in the pravastatin group and 0.887±0.152 mm in the control group (P=0.99). The annual change in the IMT at 5-year visit was significantly reduced in the pravastatin group as compared with that in the control group (0.021±0.116 versus 0.040±0.118 mm; P=0.010). Conclusions— The usual Japanese dose of pravastatin significantly reduced the progression of carotid IMT at 5 years in patients with noncardioembolic stroke. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00361530. PMID:29191850

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

PubMed Central

Seiler, CM; Fröhlich, BE; Veit, JA; Gazyakan, E; Wente, MN; Wollermann, C; Deckert, A; Witte, S; Victor, N; Buchler, MW; Knaebel, HP

2006-01-01

Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery) is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min) when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice. PMID:16948853

Effectiveness of Goal-Setting Telephone Follow-Up on Health Behaviors of Patients with Ischemic Stroke: A Randomized Controlled Trial.

PubMed

Wan, Li-Hong; Zhang, Xiao-Pei; Mo, Miao-Miao; Xiong, Xiao-Ni; Ou, Cui-Ling; You, Li-Ming; Chen, Shao-Xian; Zhang, Min

2016-09-01

Adopting healthy behaviors is critical for secondary stroke prevention, but many patients fail to follow national guidelines regarding diet, exercise, and abstinence from risk factors. Compliance often decreases with time after hospital discharge, yet few studies have examined programs promoting long-term adherence to health behaviors. Goal setting and telephone follow-up have been proven to be effective in other areas of medicine, so this study evaluated the effectiveness of a guideline-based, goal-setting telephone follow-up program for patients with ischemic stroke. This was a multicenter, assessor-blinded, parallel-group, randomized controlled trial. Ninety-one stroke patients were randomized to either a control group or an intervention group. Intervention consisted of predischarge education and 3 goal-setting follow-up sessions conducted by phone. Data were collected at baseline and during the third and sixth months after hospital discharge. Six months after discharge, patients in the intervention group exhibited significantly higher medication adherence than patients in the control group. There were no statistically significant differences in physical activity, nutrition, low-salt diet adherence, blood pressure monitoring, smoking abstinence, unhealthy use of alcohol, and modified Rankin Scale (mRS) scores between the 2 groups. Goal-setting telephone follow-up intervention for ischemic stroke patients is feasible and leads to improved medication adherence. However, the lack of group differences in other health behavior subcategories and in themRS score indicates a need for more effective intervention strategies to help patients reach guideline-recommended targets. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A Proposed Solution to the Problem with Using Completely Random Data to Assess the Number of Factors with Parallel Analysis

ERIC Educational Resources Information Center

Green, Samuel B.; Levy, Roy; Thompson, Marilyn S.; Lu, Min; Lo, Wen-Juo

2012-01-01

A number of psychometricians have argued for the use of parallel analysis to determine the number of factors. However, parallel analysis must be viewed at best as a heuristic approach rather than a mathematically rigorous one. The authors suggest a revision to parallel analysis that could improve its accuracy. A Monte Carlo study is conducted to…

Satisfiability Test with Synchronous Simulated Annealing on the Fujitsu AP1000 Massively-Parallel Multiprocessor

NASA Technical Reports Server (NTRS)

Sohn, Andrew; Biswas, Rupak

1996-01-01

Solving the hard Satisfiability Problem is time consuming even for modest-sized problem instances. Solving the Random L-SAT Problem is especially difficult due to the ratio of clauses to variables. This report presents a parallel synchronous simulated annealing method for solving the Random L-SAT Problem on a large-scale distributed-memory multiprocessor. In particular, we use a parallel synchronous simulated annealing procedure, called Generalized Speculative Computation, which guarantees the same decision sequence as sequential simulated annealing. To demonstrate the performance of the parallel method, we have selected problem instances varying in size from 100-variables/425-clauses to 5000-variables/21,250-clauses. Experimental results on the AP1000 multiprocessor indicate that our approach can satisfy 99.9 percent of the clauses while giving almost a 70-fold speedup on 500 processors.

Resistance training for hot flushes in postmenopausal women: Randomized controlled trial protocol.

PubMed

Berin, Emilia; Hammar, Mats L; Lindblom, Hanna; Lindh-Åstrand, Lotta; Spetz Holm, Anna-Clara E

2016-03-01

Hot flushes and night sweats affect 75% of all women after menopause and is a common reason for decreased quality of life in mid-aged women. Hormone therapy is effective in ameliorating symptoms but cannot be used by all women due to contraindications and side effects. Engagement in regular exercise is associated with fewer hot flushes in observational studies, but aerobic exercise has not proven effective in randomized controlled trials. It remains to be determined whether resistance training is effective in reducing hot flushes and improves quality of life in symptomatic postmenopausal women. The aim of this study is to investigate the effect of standardized resistance training on hot flushes and other health parameters in postmenopausal women. This is an open, parallel-group, randomized controlled intervention study conducted in Linköping, Sweden. Sixty symptomatic and sedentary postmenopausal women with a mean of at least four moderate to severe hot flushes per day or 28 per week will be randomized to an exercise intervention or unchanged physical activity (control group). The intervention consists of 15 weeks of standardized resistance training performed three times a week under supervision of a physiotherapist. The primary outcome is hot flush frequency assessed by self-reported hot flush diaries, and the difference in change from baseline to week 15 will be compared between the intervention group and the control group. The intention is that this trial will contribute to the evidence base regarding effective treatment for hot flushes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The effect of three ergonomics training programs on the prevalence of low-back pain among workers of an Iranian automobile factory: a randomized clinical trial.

PubMed

Aghilinejad, M; Bahrami-Ahmadi, A; Kabir-Mokamelkhah, E; Sarebanha, S; Hosseini, H R; Sadeghi, Z

2014-04-01

Many workers suffer from low-back pain. Type and severity of spinal complaints have relationship with work load. Lack of adherence to ergonomics recommendations among the important causes of low-back pain. To assess the effect of 3 ergonomics training programs on the prevalence of lowback pain among workers of an Iranian automobile factory. In a parallel-design 4-arm randomized clinical trial, 760 active workers of an automobile factory were studied. 503 workers were found eligible and randomized into 3 intervention groups (n=252), and a control group (n=251). The intervention groups consisted of 3 arms: 84 workers were educated by pamphlet, 84 by lectures, and 84 by workshop. Nordic questionnaire was used to determine the prevalence of spinal complaint before and 1-year after the interventions. The trial is registered with the Iranian Randomized Clinical Trial Registry, number IRCT2013061213182N2. Out of 503 workers, 52 lost to follow-up leaving 451 workers for analyses. The prevalence of low-back pain at the baseline was not significantly different among the studied arms. 1-year after the interventions, the prevalence did not change significantly from the baseline values for the lecture and pamphlet group. However, the prevalence of LBP experienced during the last year significantly (p=0.036) decreased from 42% to 23% in participant took part in the workshop. Training of automobile factory workers in ergonomics is more effective by running workshop than giving lecture or disseminating pamphlet.

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

PubMed

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

2018-06-01

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

Recommending Oral Probiotics to Reduce Winter Antibiotic Prescriptions in People With Asthma: A Pragmatic Randomized Controlled Trial.

PubMed

Smith, Timothy D H; Watt, Hilary; Gunn, Laura; Car, Josip; Boyle, Robert J

2016-09-01

Evidence from studies mainly in children has shown that orally administered probiotics may prevent respiratory tract infections and associated antibiotic use. We evaluated whether advice to take daily probiotics can reduce antibiotic prescribing for winter respiratory tract infections in people with asthma. We conducted a randomized controlled, parallel-group pragmatic study for participants aged 5 years and older with asthma in a UK primary care setting. The intervention was a postal leaflet with advice to take daily probiotics from October 2013 to March 2014, compared with a standard winter advice leaflet. Primary outcome was the proportion of participants prescribed antibiotics for respiratory tract infections. There were 1,302 participants randomly assigned to a control group (n = 650) or intervention group (n = 652). There was no significant difference in the primary outcome measure, with 27.7% receiving antibiotics in the intervention group and 26.9% receiving antibiotics in the control group (odds ratio = 1.04; 95% CI, 0.82-1.34). Uptake of probiotics was low, but outcomes were similar in those who accessed probiotics (adjusted odds ratio = 1.08; 95% CI, 0.69-1.69, compared with controls). We also found no evidence of an effect on respiratory tract infections or asthma exacerbations. In this pragmatic community-based trial in people with asthma, we found no evidence that advising use of winter probiotics reduces antibiotic prescribing. © 2016 Annals of Family Medicine, Inc.

Bistatic scattering from a three-dimensional object above a two-dimensional randomly rough surface modeled with the parallel FDTD approach.

PubMed

Guo, L-X; Li, J; Zeng, H

2009-11-01

We present an investigation of the electromagnetic scattering from a three-dimensional (3-D) object above a two-dimensional (2-D) randomly rough surface. A Message Passing Interface-based parallel finite-difference time-domain (FDTD) approach is used, and the uniaxial perfectly matched layer (UPML) medium is adopted for truncation of the FDTD lattices, in which the finite-difference equations can be used for the total computation domain by properly choosing the uniaxial parameters. This makes the parallel FDTD algorithm easier to implement. The parallel performance with different number of processors is illustrated for one rough surface realization and shows that the computation time of our parallel FDTD algorithm is dramatically reduced relative to a single-processor implementation. Finally, the composite scattering coefficients versus scattered and azimuthal angle are presented and analyzed for different conditions, including the surface roughness, the dielectric constants, the polarization, and the size of the 3-D object.

Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial.

PubMed

Beck, Emma; Bo, Sune; Gondan, Matthias; Poulsen, Stig; Pedersen, Liselotte; Pedersen, Jesper; Simonsen, Erik

2016-07-12

Evidence-based outpatient psychotherapeutic programs are first-line treatment of borderline personality disorder (BPD). Early and effective treatment of BPD is crucial to the prevention of its individual, psychosocial, and economic consequences. However, in spite of recent advantages in diagnosing adolescent BPD, there is a lack of cost-effective evidence-based treatment programs for adolescents. Mentalization-based treatment is an evidence-based program for BPD, originally developed for adults. We will investigate whether a specifically designed mentalization-based treatment in groups is an efficacious treatment for adolescents with BPD or subthreshold BPD compared to treatment as usual. The trial is a four-center, two-armed, parallel-group, assessor-blinded randomized clinical superiority trial. One hundred twelve patients aged 14 to 17 referred to Child and Adolescent Psychiatric Clinics in Region Zealand are randomized to 1 year of either mentalization-based treatment in groups or treatment as usual. Patients will be included if they meet at least four DSM-5 criteria for BPD. The primary outcome is self-reported borderline features at discharge. Secondary outcomes will include self-harm, depression, BPD criteria, externalizing and internalizing symptoms, and social functioning, together with parental reports on borderline features, externalizing and internalizing symptoms. Measures of attachment and mentalization will be included as mediational variables. Follow-up assessment will take place at 3 and 12 months after end of treatment. This is the first randomized controlled trial to test the efficacy of a group-based mentalization-based treatment for adolescents with BPD or subthreshold BPD. If the results confirm our hypothesis, this trial will add to the treatment options of cost-effective treatment of adolescent BPD. Clinicaltrials.gov NCT02068326 , February 19, 2014.

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

PubMed

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

2016-11-16

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

Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial

PubMed Central

Ferrer, Assumpta; Formiga, Francesc; Sanz, Héctor; de Vries, Oscar J; Badia, Teresa; Pujol, Ramón

2014-01-01

Background The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. Methods A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Results Sixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94–1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03–2.09) and that functional impairment (HR 1.42, 95% CI 0.97–2.12), previous falls (HR 1.09, 95% CI 0.74–1.60), and cognitive impairment (HR 1.08, 95% CI 0.72–1.60) had no effect on the assessment. Conclusion This multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study. PMID:24596458

Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial

PubMed Central

2013-01-01

Background Several randomized clinical trials (RCTs) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation (FMD) and blood pressure (BP). However, no RCTs have evaluated these outcomes in pregnant women. The objective of this 2-group, parallel, double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP. Methods Forty-four healthy, pregnant women were randomized to the high-flavanol (n = 23) or low-flavanol (n = 21) chocolate consumption for 12 weeks. At randomization (0, 60, 120 and 180 min after a single 40-g dose of chocolate), 6 and 12 weeks after daily 20-g chocolate intake, we evaluated plasma concentrations of flavanols and theobromine, as well as the FMD and BP. Results Plasma epicatechin was significantly increased (p < 0.001) 180 min after the consumption of 40-g high-flavanol chocolate compared to low-flavanol chocolate. Theobromine concentrations were significantly higher 180 min and 12 weeks after the intake of experimental chocolate or low-flavanol chocolate (p < 0.001). FMD was not different between the 2 groups at all pre-defined time periods. No other significant within-group or between-group changes were observed. Conclusion These results confirm the feasibility of a large-scale RCT comparing daily consumption of flavanol-rich chocolate to an equivalent placebo during pregnancy and demonstrate higher plasma epicatechin and theobromine concentration in the intervention group after acute ingestion Trial registration ClinicalTrials.gov Identifier: NCT01659060 PMID:23565841

Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

PubMed

Park, Won; Yoo, Dae Hyun; Jaworski, Janusz; Brzezicki, Jan; Gnylorybov, Andriy; Kadinov, Vladimir; Sariego, Irmgadt Goecke; Abud-Mendoza, Carlos; Escalante, William Jose Otero; Kang, Seong Wook; Andersone, Daina; Blanco, Francisco; Hong, Seung Suh; Lee, Sun Hee; Braun, Jürgen

2016-01-20

CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, infections and infusion-related reactions. CT-P13 and RP have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to RP; no differences in immunogenicity were observed. ClinicalTrials.gov identifier: NCT01220518 . Registered 4 October 2010.

Chocolate flavanols and skin photoprotection: a parallel, double-blind, randomized clinical trial

PubMed Central

2014-01-01

Background Solar ultraviolet (UV) radiation has deleterious effects on the skin, including sunburn, photoaging and cancer. Chocolate flavanols are naturally-occurring antioxidant and anti-inflammatory molecules that could play a role in preventing cutaneous UV damage. We investigated the influence of 12-week high-flavanol chocolate (HFC) consumption on skin sensitivity to UV radiation, measured by minimal erythema dose (MED). We also evaluated skin elasticity and hydration. Methods In this 2-group, parallel, double-blind, randomized controlled trial, 74 women aged 20–65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City, for randomization to either HFC (n = 33) or low-flavanol chocolate (LFC) (n = 41). A blocked randomisation (4), considering date of entry, skin type and age as factors, generated a sequentially-numbered allocation list. Study participants and research assistants were blinded. Totally, 30 g of chocolate were consumed daily for 12 weeks, followed by a 3-week washout period. MED was assessed at baseline and at 6, 9, 12 and 15 weeks. Main outcome was changes in MED at week 12. Results 33 participants in the HFC group and 41 in the LFC group were analyzed with 15 weeks of follow-up. Both groups showed similarly-increased MED at 12 weeks (HFC: 0.0252 ± 0.1099 J/cm2 [mean ± standard deviation (SD)]; LFC: 0.0151 ± 0.1118; mean difference (MD): 0.0100 J/cm2; 95% confidence interval (CI): -0.0417 to 0.0618). However, after 3-week washout, the HFC group presented decreased MED (-0.0248 ± 0.1145) whereas no effect was seen in the LFC group (0.0168 ± 0.1698) (MD: -0.0417; 95% CI: -0.1106 to 0.0272). Net temple elasticity increased slightly but significantly by 0.09 ± 0.12 mm in the HFC group at 12 weeks compared to 0.02 ± 0.12 mm in the LFC group (MD: 0.06; 95% CI: 0.01 to 0.12 ). No significant adverse events were reported. Conclusion Our study failed to demonstrate a statistically-significant protective effect of HFC vs. LFC consumption on skin sensitivity to UV radiation as measured by MED. Trial registration ClinicalTrials.gov identifier: NCT01444625 PMID:24970388

Medium-Chain Triglycerides in Combination with Leucine and Vitamin D Benefit Cognition in Frail Elderly Adults: A Randomized Controlled Trial.

PubMed

Abe, Sakiko; Ezaki, Osamu; Suzuki, Motohisa

2017-01-01

The combined supplementation of medium-chain triglycerides (MCTs), L-leucine-rich amino acids, and cholecalciferol (vitamin D 3 ) increase muscle strength and function in frail elderly individuals. However, their effects on cognition are unknown. We enrolled 38 elderly nursing home residents (mean age±SD, 86.6±4.8 y) in a 3-mo randomized, controlled, parallel group trial. The participants were randomly allocated to 3 groups: the first group received a L-leucine (1.2 g)- and cholecalciferol (20 μg)-enriched supplement with 6 g of MCT (LD+MCT); the second group received the same supplement with 6 g of long-chain triglycerides (LD+LCT); and the third group did not receive any supplements (control). Cognition was assessed at baseline and after the 3-mo intervention. The difference in changes among the groups was assessed with ANCOVA, adjusting for age and the baseline value as covariates. After 3 mo, the Mini-Mental State Examination (MMSE) score in the LD+MCT group increased by 10.6% (from 16.6 to 18.4 points, p<0.05). After 3 mo, the Nishimura geriatric rating scale for mental status (NM scale) score in the LD+MCT group increased by 30.6% (from 24.6 to 32.2 points, p<0.001), whereas that in the LD+LCT and control groups decreased by 11.2% (from 31.2 to 27.7 points, p<0.05) and 26.1% (from 27.2 to 20.1 points, p<0.001), respectively. The combined supplementation of MCTs (6 g), L-leucine-rich amino acids, and cholecalciferol may improve cognitive function in frail elderly individuals.

Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

PubMed

Kim, Gangmi

2015-10-14

Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery. This study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle. The AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy. The trial was registered in Clinical Research Information Service (CRiS), Republic of Korea ( KCT0001486 ) on 14 May 2015.

Independent exercise for glottal incompetence to improve vocal problems and prevent aspiration pneumonia in the elderly: a randomized controlled trial.

PubMed

Fujimaki, Yoko; Tsunoda, Koichi; Kobayashi, Rika; Tonghyo, Chong; Tanaka, Fujinobu; Kuroda, Hiroyuki; Numata, Tsutomu; Ishii, Toyota; Kuroda, Reiko; Masuda, Sawako; Hashimoto, Sho; Misawa, Hayato; Shindo, Naoko; Mori, Takahiro; Mori, Hiroko; Uchiyama, Naoki; Kamei, Yuichirou; Tanaka, Masashi; Hamaya, Hironobu; Funatsuki, Shingo; Usui, Satoko; Ito, Ikuno; Hamada, Kohei; Shindo, Akihito; Tokumaru, Yutaka; Morita, Yoko; Ueha, Rumi; Nito, Takaharu; Kikuta, Shu; Sekimoto, Sotaro; Kondo, Kenji; Sakamoto, Takashi; Itoh, Kenji; Yamasoba, Tatsuya; Matsumoto, Sumio

2017-08-01

To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Parallel-arm, individual randomized controlled trial. Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly ( p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference ( p < 0.001). The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. gov Identifier-UMIN000015567.

Comparison of efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial.

PubMed

Mahatme, Mohini Sachin; Dakhale, Ganesh Natthuji; Tadke, Kanchan; Hiware, Sachin Keshaorao; Dudhgaonkar, S D; Wankhede, Sumit

2016-01-01

Allergic rhinitis (AR) is a global health problem. Almost 10%-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, and intranasal corticosteroids are the pillars in the management of AR. The combination therapy of montelukast with antihistaminic provides enhancing and complimentary effects, thereby reducing the symptoms effectively, but there are scanty data regarding the comparisons of combinations. Therefore, we aimed to compare the efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine combination in patients of AR. Seventy patients with AR participated in a prospective, randomized, double-blind, parallel, active-controlled, comparative 4-week trial. The patients between the age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent AR were included in the study. The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetirizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter. Evaluation of TNSS revealed significant difference ( P < 0.05) when compared from baseline to 4 th week in both groups. The mean change of TNSS, i.e., 9.46 was significant ( P < 0.05) in montelukast-fexofenadine group. The cost-effectiveness ratio was less in montelukast-levocetirizine group than in montelukast-fexofenadine group. The decrease in TNSS was more in montelukast-fexofenadine group, but the cost-effectiveness is more with montelukast-levocetirizine combination.

Efficacy of Crest Herbal Toothpaste in “Clearing Internal Heat”: A Randomized, Double-Blind Clinical Study

PubMed Central

Chen, Jia-Xu; Liu, Yue-Yun; Wang, Shao-Xian; Li, Xiao-Hong

2013-01-01

Objective. Evaluation of the efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat.” Methods. This was a randomized, double-blind, controlled parallel design clinical test of a product that was already on the market. 72 subjects were randomly assigned to control group (group A with Colgate Herbal Salty Toothpaste) or treatment group (group B with Crest Herbal Crystal Toothpaste) with ratio of 1 : 2. Subjects were instructed to brush with 1g toothpaste for 2 minutes each time, 2 times per day in a 4-aweek test period; measurement with the rating scale on the efficacy of “clearing internal heat” for the herbal toothpaste was done at baseline, 2 weeks, and 4 weeks of toothpaste usage. Results. The rating scale on efficacy of “clearing internal heat” for the herbal toothpaste reveals that the primitive points of 72-case intention-to-treat (ITT) analysis and 67-case per-protocol (PP) analysis for subjects in group A and subjects in group B were found to be reduced progressively with statistical significance (P < 0.05). The overall effective rates for group A and group B were, respectively, 62.50%, 56.25% (ITT) and 62.50%, 60.64% (PP). The statistical results indicated that the symptoms of fire-heat for both groups of subjects have been improved after application of toothpaste. Conclusion. The efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat” was confirmed by the trial as compared to Colgate Herbal Salty Toothpaste. And its efficacy was objectively evaluated by the rating scale on efficacy of “clearing internal heat.” PMID:24228064

Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study.

PubMed

Falk Delgado, Alberto; Falk Delgado, Anna

2017-07-26

Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.

Pacifier and swaddling effective in impeding premature infant's pain score and heart rate.

PubMed

Efendi, Defi; Rustina, Yeni; Gayatri, Dewi

2018-02-01

To assess the effectiveness of pacifier and swaddling on premature infant's pain score, hearthrate, and oxygen saturation during an invasive procedure. This randomized control trial involv 30 premature infants who were randomly assigned into control (n=15) and intervention (n=15) groups using parallel design. Infants in the intervention group received pacifier and swaddling when they were undergoing invasive procedures. The outcome indicators of the two-day intervention were pain score, hearth rate, and oxygen saturation. The Premature Infant Pain Profile (PIPP) was used in this study to measure infants' pain. The paired t-test results showed that the pain score and heart rate were significantly increased following the procedure in the control group (p=0.003; p=0.013 < 0.05); meanwhile, there was no significant increase in the intervention group (p=0.256; p=0.783 > 0.005). There was no significant different in oxygen saturation in the control group (p=0.270) and in the intervention (p=0.370) group before and after the procedure. Providing pacifier and swaddling can impede the increase of premature infants' pain score and hearth rate during an invasive procedures, therefore it can be implemented as an alternative to pain management in premature infants. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Protocol: Testing the Relevance of Acupuncture Theory in the Treatment of Myofascial Pain in the Upper Trapezius Muscle.

PubMed

Elsdon, Dale S; Spanswick, Selina; Zaslawski, Chris; Meier, Peter C

2017-01-01

A protocol for a prospective single-blind parallel four-arm randomized placebo-controlled trial with repeated measures was designed to test the effects of various acupuncture methods compared with sham. Eighty self-selected participants with myofascial pain in the upper trapezius muscle were randomized into four groups. Group 1 received acupuncture to a myofascial trigger point (MTrP) in the upper trapezius. Group 2 received acupuncture to the MTrP in addition to relevant distal points. Group 3 received acupuncture to the relevant distal points only. Group 4 received a sham treatment to both the MTrP and distal points using a deactivated acupuncture laser device. Treatment was applied four times within 2 weeks with outcomes measured throughout the trial and at 2 weeks and 4 weeks posttreatment. Outcome measurements were a 100-mm visual analog pain scale, SF-36, pressure pain threshold, Neck Disability Index, the Upper Extremity Functional Index, lateral flexion in the neck, McGill Pain Questionnaire, Massachusetts General Hospital Acupuncture Sensation Scale, Working Alliance Inventory (short form), and the Credibility Expectance Questionnaire. Two-way analysis of variance (ANOVA) with repeated measures were used to assess the differences between groups. Copyright © 2017 Medical Association of Pharmacopuncture Institute. Published by Elsevier B.V. All rights reserved.

A Randomized Clinical Trial on Treatment of Chronic Constipation by Traditional Persian Medicine Recommendations Compared to Allopathic Medicine: A Pilot Study

PubMed Central

Fattahi, Mohammad Reza; Alorizi, Seyed Morteza Emami; Nimrouzi, Majid; Zarshenas, Mohammad M.; Parvizi, Mohammad Mahdi

2017-01-01

Background: The aim of this study was to compare the efficacy and side effects of lactulose plus traditional Persian medicine with only lactulose on the functional chronic constipation. Methods: Participants included 20 patients (10 in each group) aged 18–80 years, with major inclusion criteria of ROME III. They were assigned into two parallel therapeutic groups, including the intervention group (lactulose plus traditional Persian medicine [TPM] advices) and control group (only lactulose) through a block randomization. Weekly follow-up was done for 1 month for both groups. Results: After the intervention, the frequency of bowel habit increased significantly in patients of both groups (P = 0.001), and the frequency of hard stool defecation, sensation of painful defecation, sensation of incomplete evacuation, sensation of anorectal obstruction, and manual maneuver for evacuation were decreased significantly in patients of both groups (P < 0.001 for all comparisons and 0.025 for manual maneuver). However, the only significant difference between the two groups was more reduction in the sensation of painful defecation in the lactulose group versus lactulose plus TPM advices (P = 0.014). Conclusions: Based on the pilot study, no significant difference was shown between TPM with lactulose and lactulose only in the management of chronic functional constipation. However, the easy recommendations of TPM can be useful in improving chronic constipation. PMID:28757927

Probucol in Albuminuric Type 2 Diabetes Mellitus Patients on Renin-Angiotensin System Blockade: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Jin, Sang-Man; Han, Kyung Ah; Yu, Jae Myung; Sohn, Tae Seo; Choi, Sung Hee; Chung, Choon Hee; Park, Ie Byung; Rhee, Eun Jung; Baik, Sei Hyun; Park, Tae Sun; Lee, In-Kyu; Ko, Seung-Hyun; Hwang, You-Cheol; Cha, Bong Soo; Lee, Hyoung Woo; Nam, Moon-Suk; Lee, Moon-Kyu

2016-10-01

To determine the effect of probucol on urine albumin excretion in type 2 diabetes mellitus patients with albuminuria using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. This was a 16-week, phase II, randomized, placebo-controlled, parallel-group study in type 2 diabetes mellitus patients with a urinary albumin/creatinine ratio of ≥300 mg/g using angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, conducted in 17 tertiary referral hospitals. Eligible patients were randomized to probucol 250 mg/d (n=44), probucol 500 mg/d (n=41), and placebo (n=41) groups in a ratio of 1:1:1 after block randomization procedures, keeping the treatment assignment blinded to the investigators, patients, and study assistants. The primary end point was change in the geometric mean of urinary albumin/creatinine ratio from baseline to week 16 (ClinicalTrials.gov identifier NCT01726816). The study was started on November 8, 2012, and completed on March 24, 2014. The least squares mean change±SE from baseline in urinary albumin/creatinine ratio at week 16 was -7.2±639.5 mg/g in the probucol 250 mg/d group (n=43; P=0.2077 versus placebo group), 9.3±587.4 mg/g in the probucol 500 mg/d group (n=40; P=0.1975 versus placebo group), and 259.0±969.1 mg/g in the placebo group (n=41). Although the majority of subjects were on statins, probucol treatment significantly lowered total cholesterol and low-density lipoprotein cholesterol levels. QT prolongation occurred in one and two subjects in control and probucol 250 mg/d groups, respectively. Four months of probucol up to 500 mg/d failed to reduce urinary albumin excretion. © 2016 American Heart Association, Inc.

Social Desirability Bias in the Reporting of Alcohol Consumption: A Randomized Trial.

PubMed

Kypri, Kypros; Wilson, Amanda; Attia, John; Sheeran, Paschal; Miller, Peter; McCambridge, Jim

2016-05-01

To investigate reporting of alcohol consumption, we manipulated the contexts of questions in ways designed to induce social desirability bias. We undertook a two-arm, parallel-group, individually randomized trial at an Australian public university. Students were recruited by email to a web-based "Research Project on Student Health Behavior." Respondents answered nine questions about their physical activity, diet, and smoking. They were unknowingly randomized to a group presented with either (A) three questions about their alcohol consumption or (B) seven questions about their alcohol dependence and problems (under a prominent header labeled "Alcohol Use Disorders Identification Test"), followed by the same three alcohol consumption questions from (A). A total of 3,594 students (mean age = 27, SD = 10) responded and were randomized: 1,778 to Group A and 1,816 to Group B. Outcome measures were the number of days they drank alcohol, the typical number of drinks they consumed per drinking day, and the number of days they consumed six or more drinks. The primary analysis included participants with any alcohol consumption in the preceding 4 weeks (1,304 in Group A; 1,340 in Group B) using between-group, two-tailed t tests. In Groups A and B, respectively, means (and SDs) of the number of days drinking were 5.89 (5.92) versus 6.06 (6.12), p = .49; typical number of drinks per drinking day: 4.02 (3.87) versus 3.82 (3.76), p = .17; and number of days consuming six or more drinks: 1.69 (2.94) versus 1.67 (3.25), p = .56. We could not reject the null hypothesis because earlier questions about alcohol dependence and problems showed no sign of biasing the respondents' subsequent reports of alcohol consumption. These data support the validity of university students' reporting of alcohol consumption in web-based studies.

Serum galactomannan versus a combination of galactomannan and polymerase chain reaction-based Aspergillus DNA detection for early therapy of invasive aspergillosis in high-risk hematological patients: a randomized controlled trial.

PubMed

Aguado, José María; Vázquez, Lourdes; Fernández-Ruiz, Mario; Villaescusa, Teresa; Ruiz-Camps, Isabel; Barba, Pere; Silva, Jose T; Batlle, Montserrat; Solano, Carlos; Gallardo, David; Heras, Inmaculada; Polo, Marta; Varela, Rosario; Vallejo, Carlos; Olave, Teresa; López-Jiménez, Javier; Rovira, Montserrat; Parody, Rocío; Cuenca-Estrella, Manuel

2015-02-01

The benefit of the combination of serum galactomannan (GM) assay and polymerase chain reaction (PCR)-based detection of serum Aspergillus DNA for the early diagnosis and therapy of invasive aspergillosis (IA) in high-risk hematological patients remains unclear. We performed an open-label, controlled, parallel-group randomized trial in 13 Spanish centers. Adult patients with acute myeloid leukemia and myelodysplastic syndrome on induction therapy or allogeneic hematopoietic stem cell transplant recipients were randomized (1:1 ratio) to 1 of 2 arms: "GM-PCR group" (the results of serial serum GM and PCR assays were provided to treating physicians) and "GM group" (only the results of serum GM were informed). Positivity in either assay prompted thoracic computed tomography scan and initiation of antifungal therapy. No antimold prophylaxis was permitted. Overall, 219 patients underwent randomization (105 in the GM-PCR group and 114 in the GM group). The cumulative incidence of "proven" or "probable" IA (primary study outcome) was lower in the GM-PCR group (4.2% vs 13.1%; odds ratio, 0.29 [95% confidence interval, .09-.91]). The median interval from the start of monitoring to the diagnosis of IA was lower in the GM-PCR group (13 vs 20 days; P = .022), as well as the use of empirical antifungal therapy (16.7% vs 29.0%; P = .038). Patients in the GM-PCR group had higher proven or probable IA-free survival (P = .027). A combined monitoring strategy based on serum GM and Aspergillus DNA was associated with an earlier diagnosis and a lower incidence of IA in high-risk hematological patients. Clinical Trials Registration. NCT01742026. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

[Clinical study on the effect of anti-gingivitis IgY toothpaste in control of gingivitis and dental plaque].

PubMed

Zhang, Wei; Feng, Xi-Ping; Tao, Dan-Ying; Chen, Jian-Fen

2016-08-01

To observe the effect of anti-gingivitis IgY toothpaste in control of gingivitis and plaque. The study was a double-blind, randomized, parallel-controlled clinical trail with a total of 100 subjects who were divided into two groups, experimental group and control group. The subjects in experimental group used anti-gingivitis IgY toothpaste to brush twice daily for 3 minutes, and the subjects in control group used none anti-gingivitis IgY toothpaste. The examiner recorded GI, PI and BOP index of all subjects at the baseline, 6-weeks and 12-weeks. SPSS21.0 software package was used for statistical analysis. Twelve weeks later, there were significant differences in GI and BOP between the two groups. Yet no significant difference was found in PI. Anti-gingivitis IgY toothpaste is effective in control of gingivitis.

Comprehensive, Individualized, Person-Centered Management of Community-Residing Persons with Moderate-to-Severe Alzheimer Disease: A Randomized Controlled Trial.

PubMed

Reisberg, Barry; Shao, Yongzhao; Golomb, James; Monteiro, Isabel; Torossian, Carol; Boksay, Istvan; Shulman, Melanie; Heller, Sloane; Zhu, Zhaoyin; Atif, Ayesha; Sidhu, Jaskirat; Vedvyas, Alok; Kenowsky, Sunnie

2017-01-01

The aim was to examine added benefits of a Comprehensive, Individualized, Person-Centered Management (CI-PCM) program to memantine treatment. This was a 28-week, clinician-blinded, randomized, controlled, parallel-group study, with a similar study population, similar eligibility criteria, and a similar design to the memantine pivotal trial of Reisberg et al. [N Engl J Med 2003;348:1333-1341]. Twenty eligible community-residing Alzheimer disease (AD) subject-caregiver dyads were randomized to the CI-PCM program (n = 10) or to usual community care (n = 10). Primary outcomes were the New York University Clinician's Interview-Based Impression of Change Plus Caregiver Input (NYU-CIBIC-Plus), assessed by one clinician set, and an activities of daily living inventory, assessed by a separate clinician set at baseline and at weeks 4, 12, and 28. Primary outcomes showed significant benefits of the CI-PCM program at all post-baseline evaluations. Improvement on the NYU-CIBIC-Plus in the management group at 28 weeks was 2.9 points over the comparator group. The memantine 2003 trial showed an improvement of 0.3 points on this global measure in memantine-treated versus placebo-randomized subjects at 28 weeks. Hence, globally, the management program intervention benefits were 967% greater than memantine treatment alone. These results are approximately 10 times those usually observed with both nonpharmacological and pharmacological treatments and indicate substantial benefits with the management program for advanced AD persons. © 2017 S. Karger AG, Basel.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial.

PubMed

Alfawal, Alaa M H; Hajeer, Mohammad Y; Ajaj, Mowaffak A; Hamadah, Omar; Brad, Bassel

2018-02-17

To evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC). Trial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm). 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction. piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side. the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded. Random sequence: Computer-generated random numbers. Allocation concealment: sequentially numbered, opaque, sealed envelopes. Blinding: Single blinded (outcomes' assessor). Seventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05). Piezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction. ClinicalTrials.gov (Identifier: NCT02606331 ).

Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.

PubMed

Ley, Chit Moy; Ni, Qing; Liao, Xing; Gao, Huai-Lin; Robinson, Nicola

2016-10-01

To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes. This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. This RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain.

A Randomized Controlled Trial Evaluating Efficacy of Promoting a Home-Based HIV Self-Testing with Online Counseling on Increasing HIV Testing Among Men Who Have Sex with Men.

PubMed

Wang, Zixin; Lau, Joseph T F; Ip, Mary; Ho, Shara P Y; Mo, Phoenix K H; Latkin, Carl; Ma, Yee Ling; Kim, Yoona

2018-01-01

We developed an innovative home-based HIV self-testing (HIVST) service that included mailing of a free HIVST kit, and providing online real-time instructions and pre-test/post-test counseling (HIVST-OIC). The present parallel-group and non-blinded randomized controlled trial was conducted to evaluate the efficacy of promoting HIVST-OIC in increasing HIV testing rate among 430 men who have sex with men (MSM), with access to online live-chat applications in Hong Kong. At month 6, as compared to the control group, the intervention group reported significantly higher prevalence of HIV testing of any type (89.8 vs. 50.7%; relative risk (RR): 1.77; p < 0.001). Among those who have taken up any HIV testing in the last six months, significant between-group difference was found in multiple male sex partnerships (34.2 vs. 47.7%, RR: 0.72; p = 0.021). HIVST-OIC has a strong potential in increasing prevalence of HIV testing and reducing sexual risk behaviors. Implementation research is warranted.

Sample size re-estimation and other midcourse adjustments with sequential parallel comparison design.

PubMed

Silverman, Rachel K; Ivanova, Anastasia

2017-01-01

Sequential parallel comparison design (SPCD) was proposed to reduce placebo response in a randomized trial with placebo comparator. Subjects are randomized between placebo and drug in stage 1 of the trial, and then, placebo non-responders are re-randomized in stage 2. Efficacy analysis includes all data from stage 1 and all placebo non-responding subjects from stage 2. This article investigates the possibility to re-estimate the sample size and adjust the design parameters, allocation proportion to placebo in stage 1 of SPCD, and weight of stage 1 data in the overall efficacy test statistic during an interim analysis.

A Behavior-Based Intervention That Prevents Sexual Assault: the Results of a Matched-Pairs, Cluster-Randomized Study in Nairobi, Kenya.

PubMed

Baiocchi, Michael; Omondi, Benjamin; Langat, Nickson; Boothroyd, Derek B; Sinclair, Jake; Pavia, Lee; Mulinge, Munyae; Githua, Oscar; Golden, Neville H; Sarnquist, Clea

2017-10-01

The study's design was a cluster-randomized, matched-pairs, parallel trial of a behavior-based sexual assault prevention intervention in the informal settlements. The participants were primary school girls aged 10-16. Classroom-based interventions for girls and boys were delivered by instructors from the same settlements, at the same time, over six 2-h sessions. The girls' program had components of empowerment, gender relations, and self-defense. The boys' program promotes healthy gender norms. The control arm of the study received a health and hygiene curriculum. The primary outcome was the rate of sexual assault in the prior 12 months at the cluster level (school level). Secondary outcomes included the generalized self-efficacy scale, the distribution of number of times victims were sexually assaulted in the prior period, skills used, disclosure rates, and distribution of perpetrators. Difference-in-differences estimates are reported with bootstrapped confidence intervals. Fourteen schools with 3147 girls from the intervention group and 14 schools with 2539 girls from the control group were included in the analysis. We estimate a 3.7 % decrease, p = 0.03 and 95 % CI = (0.4, 8.0), in risk of sexual assault in the intervention group due to the intervention (initially 7.3 % at baseline). We estimate an increase in mean generalized self-efficacy score of 0.19 (baseline average 3.1, on a 1-4 scale), p = 0.0004 and 95 % CI = (0.08, 0.39). This innovative intervention that combined parallel training for young adolescent girls and boys in school settings showed significant reduction in the rate of sexual assault among girls in this population.

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial.

PubMed

Kim, Jung-Eun; Seo, Byung-Kwan; Choi, Jin-Bong; Kim, Hyeong-Jun; Kim, Tae-Hun; Lee, Min-Hee; Kang, Kyung-Won; Kim, Joo-Hee; Shin, Kyung-Min; Lee, Seunghoon; Jung, So-Young; Kim, Ae-Ran; Shin, Mi-Suk; Jung, Hee-Jung; Park, Hyo-Ju; Kim, Sung-Phil; Baek, Yong-Hyeon; Hong, Kwon-Eui; Choi, Sun-Mi

2015-07-26

The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone. A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks. Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P <0.001) and 13 weeks (Group A, P = 0.037; B, P <0.001). Group B showed significantly lower BDI scores than Group C at 13 weeks (P = 0.007). NRS scores from the treatment groups were significantly reduced compared to control at 5 (Group A and B, P <0.001) and 13 weeks (Group A, P = 0.011; B, P = 0.002). Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients. Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.

Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up

PubMed Central

Morales, Alicia; Gandolfo, Alessandro; Bravo, Joel; Carvajal, Paola; Silva, Nora; Godoy, Claudia; Garcia-Sesnich, Jocelyn; Hoare, Anilei; Diaz, Patricia; Gamonal, Jorge

2018-01-01

ABSTRACT Objective The aim of this double-blind, placebo-controlled and parallel- arm randomized clinical trial was to evaluate the effects of Lactobacillus rhamnosus SP1-containing probiotic sachet and azithromycin tablets as an adjunct to nonsurgical therapy in clinical parameters and in presence and levels of Tannerella forsythia, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Material and Methods Forty-seven systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically and microbiologically at baseline for 3, 6 and 9 months after therapy. Subgingival plaque samples were collected from four periodontal sites with clinical attachment level ≥1 mm, probing pocket depth ≥4 mm and bleeding on probing, one site in each quadrant. Samples were cultivated and processed using the PCR technique. Patients received nonsurgical therapy including scaling and root planing (SRP) and were randomly assigned to a probiotic (n=16), antibiotic (n = 16) or placebo (n = 15) group. L. rhamnosus SP1 was taken once a day for 3 months. Azithromycin 500mg was taken once a day for 5 days. Results All groups showed improvements in clinical and microbiological parameters at all time points evaluated. Probiotic and antibiotic groups showed greater reductions in cultivable microbiota compared with baseline. The placebo group showed greater reduction in number of subjects with P. gingivalis compared with baseline. However, there were no significant differences between groups. Conclusions The adjunctive use of L. rhamnosus SP1 sachets and azithromycin during initial therapy resulted in similar clinical and microbiological improvements compared with the placebo group. PMID:29364340

A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.

PubMed

Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A

2015-04-14

Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.

A double-blind, randomized comparative study to investigate the morphine to hydromorphone conversion ratio in Japanese cancer patients

PubMed Central

Inoue, Satoshi; Saito, Yoji; Tsuneto, Satoru; Aruga, Etsuko; Ogata, Takeshi; Uemori, Mitsutoshi

2018-01-01

Abstract Objective To confirm the morphine to hydromorphone conversion ratio for hydromorphone (DS-7113b) immediate-release tablets in cancer patients who achieved pain control with oral morphine. Methods This was a multicenter, active-controlled, randomized, double-blind, parallel-group, comparative study (July 2013 to December 2014) at 39 Japanese sites. Seventy-one patients (aged >20 years) who had achieved pain control with morphine 60 mg/day and 90 mg/day were randomly allocated 1:1 to hydromorphone immediate-release tablets at a dose converted at a hydromorphone:morphine ratio of 1:5 or 1:8, respectively, and treated for up to 5 days. The efficacy was evaluated as the pain control ratio. Results The pain control ratio in the full analysis set was 83.3% (25/30) in the conversion ratio 1:5 group and 95.0% (38/40) in the conversion ratio 1:8 group, and both groups demonstrated highly successful pain control. The incidence of adverse events was 46.7% (14/30) in the conversion ratio 1:5 group and 58.5% (24/41) in the 1:8 group; the difference was not clinically relevant. Frequently observed adverse events (incidence ≥5%) were nausea, vomiting, diarrhea, somnolence and dyspnea. Conclusions A high pain control ratio was maintained by a switch at either conversion ratio, and no notable difference was observed in the incidence of adverse events. A switch from morphine to hydromorphone is effective at a dose converted at ratios of 1:5 and 1:8. PMID:29635632

Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study.

PubMed

Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

2014-07-15

To determine the feasibility and pilot a sleep education program in New Zealand high school students. A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention (n = 15) or to a usual curriculum control group (n = 14). The sleep education program involved four 50-minute classroom-based education sessions with interactive groups. Students completed a 7-day sleep diary, a sleep questionnaire (including sleep hygiene, knowledge and problems) at baseline, post-intervention (4 weeks) and 10 weeks follow-up. An overall treatment effect was observed for weekend sleep duration (F 1,24 = 5.21, p = 0.03). Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to those in the control group. No differences were found between groups for sleep duration on weekday nights. No significant differences were observed between groups for any of the secondary outcomes (sleep hygiene, sleep problems, or sleep knowledge). A sleep education program appears to increase weekend sleep duration in the short term. Although this program was feasible, most schools are under time and resource pressure, thus alternative methods of delivery should be assessed for feasibility and efficacy. Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes. A commentary on this article appears in this issue on page 793.

Mirror therapy in children with hemiparesis: a randomized observer-blinded trial.

PubMed

Bruchez, Roselyn; Jequier Gygax, Marine; Roches, Sylvie; Fluss, Joel; Jacquier, David; Ballabeni, Pierluigi; Grunt, Sebastian; Newman, Christopher J

2016-09-01

To determine the efficacy of mirror therapy in children with hemiparesis. The design was an observer-blinded parallel-group randomized controlled trial (International Standard Randomised Controlled Trial Number 48748291). Randomization was computer-generated, 1:1 allocation to mirror therapy or comparison groups. The settings were home-based intervention and tertiary centre assessments. Participants were 90 children with hemiparesis aged 7 to 17 years. Intervention was 15 minutes per day of simultaneous arm training, 5 days a week, for 5 weeks. The mirror therapy group used a mirror; those in the comparison group looked at their paretic limb. Assessments comprised measures of upper limb strength, function (Melbourne Assessment 2), daily performance (ABILHAND-Kids), and sensory function at weeks 0 (T0 ), 5 (T1 ), and 10 (T2 ). There were no significant differences in outcomes and their progression over time between the mirror therapy and comparison groups. Post-hoc intention-to-treat analyses showed significant improvements in both groups for grasp strength (T0 -T1 +12.6%), pinch strength (T0 -T2 +9.1%), upper limb function in terms of accuracy (T0 -T2 +2.7%) and fluency (T0 -T2 +5.0%), as well as daily performance (T0 -T2 +16.6%). Per protocol analyses showed additional improvements in dexterity (T0 -T2 +4.0%). The use of the mirror illusion during therapy had no significant effect on treatment outcomes. However, 5 weeks of daily simultaneous arm training significantly improved paretic upper limb strength, function, and daily use. © 2016 Mac Keith Press.

Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial.

PubMed

Al-Sibaie, Salma; Hajeer, Mohammad Y

2014-06-01

No randomized controlled trial has tried to compare treatment outcomes between the sliding en-masse retraction of upper anterior teeth supported by mini-implants and the two-step sliding retraction technique employing conventional anchorage devices. To evaluate skeletal, dental, and soft tissue changes following anterior teeth retraction. Parallel-groups randomized controlled trial on patients with class II division 1 malocclusion treated at the University of Al-Baath Dental School in Hamah, Syria between July 2011 and May 2013. One hundred and thirty-three patients with an upper dentoalveolar protrusion were evaluated and 80 patients fulfilled the inclusion criteria. Randomization was performed using computer-generated tables; allocation was concealed using sequentially numbered opaque and sealed envelopes. Fifty-six participants were analysed (mean age 22.34 ± 4.56 years). They were randomly distributed into two groups with 28 patients in each group (1:1 allocation ratio). Following first premolar extraction, space closure was accomplished using either the en-masse technique with mini-implants or the two-step technique with transpalatal arches (TPAs). The antero-posterior displacements of upper incisal edges and upper first molars were measured on lateral cephalograms at three assessment times. Assessor blinding was employed. A bodily retraction (-4.42 mm; P < 0.001) with a slight intrusion (-1.53 mm; P < 0.001) of the upper anterior teeth was achieved in the mini-implants group, whereas upper anterior teeth retraction was achieved by controlled palatal tipping in the TPA group. When retracting anterior teeth in patients with moderate to severe protrusion, the en-masse retraction based on mini-implants anchorage gave superior results compared to the two-step retraction based on conventional anchorage in terms of speed, dental changes, anchorage loss, and aesthetic outcomes.

Losartan/hydrochlorothiazide combination vs. high-dose losartan in patients with morning hypertension--a prospective, randomized, open-labeled, parallel-group, multicenter trial.

PubMed

Ueda, Tamenobu; Kai, Hisashi; Imaizumi, Tsutomu

2012-07-01

The treatment of morning hypertension has not been established. We compared the efficacy and safety of a losartan/hydrochlorothiazide (HCTZ) combination and high-dose losartan in patients with morning hypertension. A prospective, randomized, open-labeled, parallel-group, multicenter trial enrolled 216 treated outpatients with morning hypertension evaluated by home blood pressure (BP) self-measurement. Patients were randomly assigned to receive a combination therapy of 50 mg losartan and 12.5 mg HCTZ (n=109) or a high-dose therapy with 100 mg losartan (n=107), each of which were administered once every morning. Primary efficacy end points were morning systolic BP (SBP) level and target BP achievement rate after 3 months of treatment. At baseline, BP levels were similar between the two therapy groups. Morning SBP was reduced from 150.3±10.1 to 131.5±11.5 mm Hg by combination therapy (P<0.001) and from 151.0±9.3 to 142.5±13.6 mm Hg by high-dose therapy (P<0.001). The morning SBP reduction was greater in the combination therapy group than in the high-dose therapy group (P<0.001). Combination therapy decreased evening SBP from 141.6±13.3 to 125.3±13.1 mm Hg (P<0.001), and high-dose therapy decreased evening SBP from 138.9±9.9 to 131.4±13.2 mm Hg (P<0.01). Although both therapies improved target BP achievement rates in the morning and evening (P<0.001 for both), combination therapy increased the achievement rates more than high-dose therapy (P<0.001 and P<0.05, respectively). In clinic measurements, combination therapy was superior to high-dose therapy in reducing SBP and improving the achievement rate (P<0.001 and P<0.01, respectively). Combination therapy decreased urine albumin excretion (P<0.05) whereas high-dose therapy reduced serum uric acid. Both therapies indicated strong adherence and few adverse effects (P<0.001). In conclusion, losartan/HCTZ combination therapy was more effective for controlling morning hypertension and reducing urine albumin than high-dose losartan.

A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.

PubMed

Lomax, A; Patel, S; Wang, N; Kakar, K; Kakar, A; Bosma, M L

2017-11-01

In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events. Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701). This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use. © 2016 The Authors. International Journal of Dental Hygiene Published by John Wiley & Sons Ltd.

Efficacy and Safety of Levosulpiride Versus Haloperidol Injection in Patients With Acute Psychosis: A Randomized Double-Blind Study.

PubMed

Lavania, Sagar; Praharaj, Samir Kumar; Bains, Hariender Singh; Sinha, Vishal; Kumar, Abhinav

2016-01-01

Injectable antipsychotics are frequently required for controlling agitation and aggression in acute psychosis. No study has examined the use of injectable levosulpiride for this indication. To compare the efficacy and safety of injectable levosulpiride and haloperidol in patients with acute psychosis. This was a randomized, double-blind, parallel-group study in which 60 drug-naive patients having acute psychosis were randomly assigned to receive either intramuscular haloperidol (10-20 mg/d) or levosulpiride (25-50 mg/d) for 5 days. All patients were rated on Brief Psychiatric Rating Scale (BPRS), Overt Agitation Severity Scale (OASS), Overt Aggression Scale-Modified (OAS-M) scores, Simpson Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS). Repeated-measures ANOVA for BPRS scores showed significant effect of time (P < 0.001) and a trend toward greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.076). Repeated-measures ANOVA for OASS showed significant effect of time (P < 0.001) but no group × time interaction. Repeated-measures ANOVA for OAS-M scores showed significant effect of time (P < 0.001) and greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.032). Lorazepam requirement was much lower in haloperidol group as compared with those receiving levosulpiride (P = 0.022). Higher rates of akathisia and extrapyramidal symptoms were noted in the haloperidol group. Haloperidol was more effective than levosulpiride injection for psychotic symptoms, aggression, and severity of agitation in acute psychosis, but extrapyramidal adverse effects were less frequent with levosulpiride as compared with those receiving haloperidol.

Effect of low-level laser therapy on pain and perineal healing after episiotomy: A triple-blind randomized controlled trial.

PubMed

Alvarenga, Marina B; de Oliveira, Sonia Maria Junqueira Vasconcellos; Francisco, Adriana A; da Silva, Flora Maria B; Sousa, Marcelo; Nobre, Moacyr Roberto

2017-02-01

Episiotomy is associated with perineal pain and healing complications. The low-level laser therapy (LLLT) reduces pain and inflammation and stimulates the healing process. This study aimed to assess the effect of LLLT on pain and perineal healing after an episiotomy. A randomized, triple-blind, parallel clinical trial with 54 postpartum women who had a spontaneous birth with a right mediolateral episiotomy. The women were randomized into two groups: the experimental group (applications of LLLT n = 29) or the placebo group (simulated LLLT applications n = 25). Three sessions of real or sham irradiation were performed at 6-10 hours after normal birth, and the 2nd and 3rd applications were performed at 20-24 hours and 40-48 hours after the first session, respectively. Perineal pain was recorded using a Numeric Scale ranging from 0 to 10 (0 = absence and 10 = worst pain). Perineal healing was assessed using the redness, oedema, ecchymosis, discharge, and approximation (REEDA) scale. Both groups were assessed four times: in each of the three LLLT sessions and at 7-10 days after normal birth. The groups were compared using the Student's t, Mann-Whitney, and Chi-square tests. There was no significant difference between the groups regarding perineal healing after LLLT. The perineal pain scores were statistically higher in the experimental group in the first assessment and after the third LLLT. There was no significant difference between the groups related to the perineal pain scores 7-10 days after normal birth. The use of LLLT does not provide any benefit for treating postpartum perineal trauma using these specific protocol and parameters. Lasers Surg. Med. 49:181-188, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Efficacy of motivational interviewing and cognitive behavioral therapy for anxiety and depression symptoms following traumatic brain injury.

PubMed

Ponsford, J; Lee, N K; Wong, D; McKay, A; Haines, K; Alway, Y; Downing, M; Furtado, C; O'Donnell, M L

2016-04-01

Anxiety and depression are common following traumatic brain injury (TBI), often co-occurring. This study evaluated the efficacy of a 9-week cognitive behavioral therapy (CBT) program in reducing anxiety and depression and whether a three-session motivational interviewing (MI) preparatory intervention increased treatment response. A randomized parallel three-group design was employed. Following diagnosis of anxiety and/or depression using the Structured Clinical Interview for DSM-IV, 75 participants with mild-severe TBI (mean age 42.2 years, mean post-traumatic amnesia 22 days) were randomly assigned to an Adapted CBT group: (1) MI + CBT (n = 26), or (2) non-directive counseling (NDC) + CBT (n = 26); or a (3) waitlist control (WC, n = 23) group. Groups did not differ in baseline demographics, injury severity, anxiety or depression. MI and CBT interventions were guided by manuals adapted for individuals with TBI. Three CBT booster sessions were provided at week 21 to intervention groups. Using intention-to-treat analyses, random-effects regressions controlling for baseline scores revealed that Adapted CBT groups (MI + CBT and NDC + CBT) showed significantly greater reduction in anxiety on the Hospital Anxiety and Depression Scale [95% confidence interval (CI) -2.07 to -0.06] and depression on the Depression Anxiety and Stress Scale (95% CI -5.61 to -0.12) (primary outcomes), and greater gains in psychosocial functioning on Sydney Psychosocial Reintegration Scale (95% CI 0.04-3.69) (secondary outcome) over 30 weeks post-baseline relative to WC. The group receiving MI + CBT did not show greater gains than the group receiving NDC + CBT. Findings suggest that modified CBT with booster sessions over extended periods may alleviate anxiety and depression following TBI.

Physical therapy for urinary incontinence in postmenopausal women with osteoporosis or low bone density: a randomized controlled trial.

PubMed

Sran, Meena; Mercier, Joanie; Wilson, Penny; Lieblich, Pat; Dumoulin, Chantale

2016-03-01

To assess the effectiveness of 12 weekly physical therapy sessions for urinary incontinence (UI) compared with a control intervention, for reducing the number of UI episodes measured with the 7-day bladder diary, at 3 months and 1 year postrandomization. A single parallel-group randomized controlled trial was conducted at one outpatient public health center, in postmenopausal women aged 55 years and over with osteoporosis or low bone density and UI. Women were randomized to physical therapy (PT) for UI or osteoporosis education. The primary outcome measure was number of leakage episodes on the 7-day bladder diary, assessed at baseline, after treatment and at 1 year. The secondary outcome measures included the pad test and disease-specific quality of life and self-efficacy questionnaires assessed at the same timepoints. Forty-eight women participated (24 per group). Two participants dropped out of each group and one participant was deceased before 3-month follow-up. Intention-to-treat analysis was undertaken. At 3 months and 1 year, there was a statistically significant difference in the number of leakage episodes on the 7-day bladder diary (3 mo: P = 0.04; 1 y: P = 0.01) in favor of the PT group. The effect size was 0.34 at 1 year. There were no harms reported. After a 12-week course of PT once per week for UI, PT group participants had a 75% reduction in weekly median number of leakage episodes, whereas the control group's condition had no improvement. At 1 year, the PT group participants maintained this improvement, whereas the control group's incontinence worsened.

Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension.

PubMed

Lee, Sang Eun; Kim, Yong-Jin; Lee, Hae-Young; Yang, Han-Mo; Park, Chang-Gyu; Kim, Jae-Joong; Kim, Soon-Kil; Rhee, Moo-Yong; Oh, Byung-Hee

2012-03-01

Angiotensin receptor blockers (ARBs) is an effective and well tolerated first-line antihypertensive drug. Fimasartan is a newly developed ARB that has not been compared with other ARBs with regard to its efficacy and tolerability. The goal of this study was to determine the noninferiority of fimasartan to losartan with regard to its efficacy and tolerability in adult Korean patients with mild-to-moderate hypertension. This was a randomized, multicenter, double-blind, parallel group, dose escalation, Phase III, noninferiority clinical trial. Patients aged 18 to 70 years with mild-to-moderate hypertension were randomized to receive either fimasartan 60/120 mg daily or losartan 50/100 mg daily with optional titration. Antihypertensive efficacy and tolerability were evaluated for 12 weeks. The primary end point was noninferiority of improvement in mean siDBP from baseline to week 12 for fimasartan compared with losartan. The incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs) were evaluated to assess their tolerability. In addition, some patients whose blood pressure reached goal levels participated in a 24-week extension study for additional assessment of tolerability and efficacy. Five hundred six patients were randomly allocated to receive fimasartan (n = 256) or losartan (n = 250). There was no significant difference in baseline demographic characteristics between the 2 treatment groups (fimasartan-treated group-mean age, 53.96 [8.79] years; mean weight, 70.58 [11.73] kg; male, 68.02%; losartan-treated group-mean age, 53.58 [9.61] years; mean weight, 69.80 [11.08] kg; male, 70.17%). At week 12, siDBP was significantly decreased from baseline in both groups (-11.26 [7.53] mm Hg in the fimasartan group and -8.56 [7.72] mm Hg in the losartan group [P < 0.0001]). The between-group difference was 2.70 mm Hg (P = 0.0002), and the lower limit of the 2-sided 95% CI (1.27 mm Hg) was higher than the prespecified noninferiority margin (-2.5 mm Hg). The incidence of ADRs were 7.84% and 10.40% in the fimasartan and losartan groups, respectively (χ(2) test, P = 0.3181). The efficacy of fimasartan was maintained over 24 weeks, and its tolerability was comparable with losartan in the extension study. In this study with eligible adult Korean patients who had mild-to-moderate hypertension, the reduction of siDBP after 12 weeks of treatment with fimasartan 60/120 mg was noninferior to that of losartan 50/100 mg. By post hoc comparison, between-group differences in siDBP were significant in favor of fimasartan, suggesting superiority to losartan. There was no statistically significant difference in tolerability between the groups. This efficacy and tolerability were maintained throughout the additional 12-week extension study. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Growth of healthy term infants fed partially hydrolyzed whey-based infant formula: a randomized, blinded, controlled trial.

PubMed

Borschel, Marlene W; Choe, Yong S; Kajzer, Janice A

2014-12-01

Partially hydrolyzed formulas (pHF) represent a significant percentage of the infant formula market. A new whey-based, palm olein oil (PO)-free pHF was developed and a masked, randomized, parallel growth study was conducted in infants fed this formula or a commercially available whey-based pHF with PO. Infants between 0 and 8 days were to be enrolled and studied to 119 days of age. Growth and tolerance of infants were evaluated. Mean weight gain from 14 to 119 days of age was similar between groups. There were no significant differences between groups in weight, length, head circumference (HC), or length or HC gains. Infants fed the new PO-free pHF had significantly softer stools than those fed the PO-containing formula except at 119 days of age. This study demonstrates that whereas growth of infants fed different formulas during the first 4 months of life may be similar, infants may tolerate individual formulas differently. © The Author(s) 2014.

The Effect of Topical Rosa damascena (Rose) Oil on Pregnancy-Related Low Back Pain: A Randomized Controlled Clinical Trial.

PubMed

Shirazi, Mahbobeh; Mohebitabar, Safieh; Bioos, Sodabeh; Yekaninejad, Mir Saeed; Rahimi, Roja; Shahpiri, Zahra; Malekshahi, Farhad; Nejatbakhsh, Fatemeh

2017-01-01

The study aimed to assess the efficacy of topical rose oil in women with pregnancy-related low back pain. A randomized controlled clinical trial was conducted on 120 women with pregnancy-related low back pain. Patients were allocated to 3 parallel groups to receive topical rose oil (in the carrier of almond oil), placebo (carrier oil), or no intervention. All groups were followed for 4 weeks. All participants were evaluated by Visual Analog Scale and the Roland-Morris Disability Questionnaires to assess the pain intensity and its impact on daily activities before and after the intervention. Significant decrease in pain intensity compared to carrier oil or no intervention was observed. The rose oil also improves the functional ability of these patients in contrast with no intervention, while its effect on function is not significant compared to carrier oil. Rose oil reduced pregnancy-related low back pain intensity without any significant adverse effect. © The Author(s) 2016.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Effects and Safety of Gyejibongnyeong-Hwan on Dysmenorrhea Caused by Blood Stagnation: A Randomized Controlled Trial

PubMed Central

Park, Jeong-Su; Park, Sunju; Cheon, Chun-Hoo; Jo, Seong-Cheon; Cho, Han Baek; Lim, Eun-Mee; Lim, Hyung Ho; Shin, Yong-Cheol; Ko, Seong-Gyu

2013-01-01

Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration. Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group. Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles. Trial Registration. This trial is registered with Current Controlled Trials no. ISRCTN30426947. PMID:24191165

[Compliancy of pre-exposure prophylaxis for HIV infection in men who have sex with men in Chengdu].

PubMed

Xu, J Y; Mou, Y C; Ma, Y L; Zhang, J Y

2017-05-10

Objective: To evaluate the compliancy of HIV pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) in Chengdu, Sichuan province, and explore the influencing factors. Methods: From 1 July 2013 to 30 September 2015, a random, open, multi-center and parallel control intervention study was conducted in 328 MSM enrolled by non-probability sampling in Chengdu. The MSM were divided into 3 groups randomly, i.e. daily group, intermittent group (before and after exposure) and control group. Clinical follow-up and questionnaire survey were carried out every 3 months. Their PrEP compliances were evaluated respectively and multivariate logistic regression analysis was conducted to identify the related factors. Results: A total of 141 MSM were surveyed, in whom 59(41.8 % ) had good PrEP compliancy. The PrEP compliancy rate was 69.0 % in daily group, higher than that in intermittent group (14.3 % ), the difference had significance ( χ (2)=45.29, P <0.001). Multivariate logistic analysis indicated that type of PrEP was the influencing factors of PrEP compliancy. Compared with daily group, the intermittent group had worse PrEP compliancy ( OR =0.07, 95 %CI : 0.03-0.16). Conclusion: The PrEP compliance of the MSM in this study was poor, the compliancy would be influenced by the type of PrEP.

Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support—Results of a Prospective, Randomized, Comparative Study

PubMed Central

Pirard, Céline; Loumaye, Ernest; Wyns, Christine

2015-01-01

Background. The aim of this pilot study was to evaluate intranasal buserelin for luteal phase support and compare its efficacy with standard vaginal progesterone in IVF/ICSI antagonist cycles. Methods. This is a prospective, randomized, open, parallel group study. Forty patients underwent ovarian hyperstimulation with human menopausal gonadotropin under pituitary inhibition with gonadotropin-releasing hormone antagonist, while ovulation trigger and luteal support were achieved using intranasal GnRH agonist (group A). Twenty patients had their cycle downregulated with buserelin and stimulated with hMG, while ovulation trigger was achieved using 10,000 IU human chorionic gonadotropin with luteal support by intravaginal progesterone (group B). Results. No difference was observed in estradiol levels. Progesterone levels on day 5 were significantly lower in group A. However, significantly higher levels of luteinizing hormone were observed in group A during the entire luteal phase. Pregnancy rates (31.4% versus 22.2%), implantation rates (22% versus 15.4%), and clinical pregnancy rates (25.7% versus 16.7%) were not statistically different between groups, although a trend towards higher rates was observed in group A. No luteal phase lasting less than 10 days was recorded in either group. Conclusion. Intranasal administration of buserelin is effective for providing luteal phase support in IVF/ICSI antagonist protocols. PMID:25945092

The studies of FT-IR and CD spectroscopy on catechol oxidase I from tobacco

NASA Astrophysics Data System (ADS)

Xiao, Hourong; Xie, Yongshu; Liu, Qingliang; Xu, Xiaolong; Shi, Chunhua

2005-10-01

A novel copper-containing enzyme named COI (catechol oxidase I) has been isolated and purified from tobacco by extracting acetone-emerged powder with phosphate buffer, centrifugation at low temperature, ammonium sulfate fractional precipitation, and column chromatography on DEAE-sephadex (A-50), sephadex (G-75), and DEAE-celluse (DE-52). PAGE, SDS-PAGE were used to detect the enzyme purity, and to determine its molecular weight. Then the secondary structures of COI at different pH, different temperatures and different concentrations of guanidine hydrochloride (GdnHCl) were studied by the FT-IR, Fourier self-deconvolution spectra, and circular dichroism (CD). At pH 2.0, the contents of both α-helix and anti-parallel β-sheet decrease, and that of random coil increases, while β-turn is unchanged compared with the neutral condition (pH 7.0). At pH 11.0, the results indicate that the contents of α-helix, anti-parallel β-sheet and β-turn decrease, while random coil structure increases. According to the CD measurements, the relative average fractions of α-helix, anti-parallel β-sheet, β-turn/parallel β-sheet, aromatic residues and disulfide bond, and random coil/γ-turn are 41.7%, 16.7%, 23.5%, 11.3%, and 6.8% at pH 7.0, respectively, while 7.2%, 7.7%, 15.2%, 10.7%, 59.2% at pH 2.0, and 20.6%, 9.5%, 15.2%, 10.5%, 44.2% at pH 11.0. Both α-helix and random coil decrease with temperature increasing, and anti-parallel β-sheet increases at the same time. After incubated in 6 mol/L guanidine hydrochloride for 30 min, the fraction of α-helix almost disappears (only 1.1% left), while random coil/γ-turn increases to 81.8%, which coincides well with the results obtained through enzymatic activity experiment.

Exercise counseling to enhance smoking cessation outcomes: the Fit2Quit randomized controlled trial.

PubMed

Maddison, Ralph; Roberts, Vaughan; McRobbie, Hayden; Bullen, Christopher; Prapavessis, Harry; Glover, Marewa; Jiang, Yannan; Brown, Paul; Leung, William; Taylor, Sue; Tsai, Midi

2014-10-01

Regular exercise has been proposed as a potential smoking cessation aid. This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks. A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone. There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01). Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.).

Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

PubMed

Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

2014-07-01

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Dismembered Pyeloplasty in Infants 6 Months Old or Younger With and Without External Trans-anastomotic Nephrostent: A Prospective Randomized Study.

PubMed

Nasser, Farouk M; Shouman, Ahmed M; ElSheemy, Mohammed S; Lotfi, Mohammed A; Aboulela, Waseem; El Ghoneimy, Mohamed; Abdelwahhab, Mohammad; Shoukry, Ahmed I; Ghoneima, Waleed; Morsi, Hany; Badawy, Hesham

2017-03-01

To compare the outcome of dismembered pyeloplasty in infants with and without external nephro-ureteric stent (ENUS) for treatment of congenital ureteropelvic junction obstruction. This is a parallel, randomized comparative study between October 2013 and September 2014. Thirty infants ≤6 months old with ureteropelvic junction obstruction indicated for dismembered pyeloplasty were randomly assigned (block randomization, closed envelope method) into two groups: group A (stentless) and group B (ENUS). Infants with solitary kidney, gross pyuria, huge pelvis, vesicoureteric reflux, or other renal anomalies were excluded. Operative data, complications, and ultrasonographic and nuclear scintigraphy criteria were compared after at least 18 months of follow-up using Student t, Mann-Whitney U, Kruskal-Wallis, chi-square, and Fisher exact tests when appropriate. Occurrence of urinary leakage was the primary outcome. Included patients completed the study with intention-to-treat analysis. All children had normal renal function. The mean operative time was 85.3 ± 6.3 (60-90) minutes in group A and 92.6 ± 15.3 (70-120) minutes in group B (P = .2). Although there was a significant postoperative improvement in each group in split renal function and anterior-posterior renal pelvis diameter, there was no significant difference between both groups. The mean hospital stay for group A and group B was 5.9 ± 2 (4-10) days versus 3.5 ± 0.8 (2-5) days, respectively (P < .001). Postoperative urinary leakage was reported only in group A (40%). All complications were managed by double J insertion. Auxiliary interventions were higher in group A. The overall success rate was 93.4%. Redo pyeloplasty was performed in one case in each group. ENUS significantly reduces hospital stay and complications. It saves the infant hazards of auxiliary interventions under general anesthesia for management of leakage or double J removal if placed at time of pyeloplasty. Copyright © 2016 Elsevier Inc. All rights reserved.

Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study).

PubMed

Nakamura, T; Fukunaga, M; Nakano, T; Kishimoto, H; Ito, M; Hagino, H; Sone, T; Taguchi, A; Tanaka, S; Ohashi, M; Ota, Y; Shiraki, M

2017-01-01

In a 2-year randomized, placebo-controlled study of 665 Japanese patients with primary osteoporosis, once-yearly administration of zoledronic acid (5 mg) reduced the risk of new morphometric vertebral fractures. The purpose of this study was to determine the efficacy and safety of once-yearly intravenous infusion of ZOL in Japanese patients with primary osteoporosis. This was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study (ZONE Study). Subjects were 665 Japanese patients between the ages of 65 and 89 years who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months. The 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). The 24-month cumulative incidence of new morphometric vertebral fracture was 3.3 % in the ZOL group versus 9.7 % in the placebo group (log-rank test: p = 0.0029; hazard ratio: 0.35; 95 % confidence interval: 0.17-0.72). The cumulative incidence of any clinical fracture, clinical vertebral fracture, and non-vertebral fracture was significantly reduced in the ZOL group by 54, 70, and 45 %, respectively, compared to the placebo group. At 24 months, ZOL administration increased bone mineral density in the lumbar spine, femoral neck, and total hip (t test: p < 0.0001). No new adverse events or osteonecrosis of the jaw were observed in this study. Once-yearly administration of ZOL 5 mg to Japanese patients with primary osteoporosis reduced the risk of new morphometric vertebral fractures and was found to be safe.

Efficacy of a virtual assistance-based lifestyle intervention in reducing risk factors for Type 2 diabetes in young employees in the information technology industry in India: LIMIT, a randomized controlled trial.

PubMed

Limaye, T; Kumaran, K; Joglekar, C; Bhat, D; Kulkarni, R; Nanivadekar, A; Yajnik, C

2017-04-01

To investigate a virtual assistance-based lifestyle intervention to reduce risk factors for Type 2 diabetes in young employees in the information technology industry in India. LIMIT (Lifestyle Modification in Information Technology) was a parallel-group, partially blinded, randomized controlled trial. Employees in the information technology industry with ≥3 risk factors (family history of cardiometabolic disease, overweight/obesity, high blood pressure, impaired fasting glucose, hypertriglyceridaemia, high LDL cholesterol and low HDL cholesterol) from two industries were randomized to a control or an intervention (1:1) group. After initial lifestyle advice, the intervention group additionally received reinforcement through mobile phone messages (three per week) and e-mails (two per week) for 1 year. The primary outcome was change in prevalence of overweight/obesity, analysed by intention to treat. Of 437 employees screened (mean age 36.2 ± 9.3 years; 74.8% men), 265 (61.0%) were eligible and randomized into control (n=132) or intervention (n=133) group. After 1 year, the prevalence of overweight/obesity reduced by 6.0% in the intervention group and increased by 6.8% in the control group (risk difference 11.2%; 95% CI 1.2-21.1; P=0.042). There were also significant improvements in lifestyle measurements, waist circumference, and total and LDL cholesterol in the intervention group. The number-needed-to-treat to prevent one case of overweight/obesity in 1 year was 9 (95% CI 5-82), with an incremental cost of INR10665 (£112.30) per case treated/prevented. A total of 98% of participants found the intervention acceptable. A virtual assistance-based lifestyle intervention was effective, cost-effective and acceptable in reducing risk factors for diabetes in young employees in the information technology industry, and is potentially scalable. © 2016 Diabetes UK.

A Randomized Trial of the Amikacin Fosfomycin Inhalation System for the Adjunctive Therapy of Gram-Negative Ventilator-Associated Pneumonia: IASIS Trial.

PubMed

Kollef, Marin H; Ricard, Jean-Damien; Roux, Damien; Francois, Bruno; Ischaki, Eleni; Rozgonyi, Zsolt; Boulain, Thierry; Ivanyi, Zsolt; János, Gál; Garot, Denis; Koura, Firas; Zakynthinos, Epaminondas; Dimopoulos, George; Torres, Antonio; Danker, Wayne; Montgomery, A Bruce

2017-06-01

Clinical failures in ventilator-associated pneumonia (VAP) caused by gram-negative bacteria are common and associated with substantial morbidity, mortality, and resource utilization. We assessed the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS) for the treatment of gram-negative bacterial VAP in a randomized double-blind, placebo-controlled, parallel group, phase 2 study between May 2013 and March 2016. We compared standard of care in each arm plus 300 mg amikacin/120 mg fosfomycin or placebo (saline), delivered by aerosol twice daily for 10 days (or to extubation if < 10 days) via the investigational eFlow Inline System (PARI GmbH). The primary efficacy end point was change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of AFIS/placebo, using the subset of patients with microbiologically proven baseline infections with gram-negative bacteria. There were 143 patients randomized: 71 to the AFIS group, and 72 to the placebo group. Comparison of CPIS change from baseline between treatment groups was not different (P = .70). The secondary hierarchical end point of no mortality and clinical cure at day 14 or earlier was also not significant (P = .68) nor was the hierarchical end point of no mortality and ventilator-free days (P = .06). The number of deaths in the AFIS group was 17 (24%) and 12 (17%) in the placebo group (P = .32). The AFIS group had significantly fewer positive tracheal cultures on days 3 and 7 than placebo. In this trial of adjunctive aerosol therapy compared with standard of care IV antibiotics in patients with gram-negative VAP, the AFIS was ineffective in improving clinical outcomes despite reducing bacterial burden. ClinicalTrials.gov; No.: NCT01969799; URL: www.clinicaltrials.gov. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Method and apparatus for routing data in an inter-nodal communications lattice of a massively parallel computer system by semi-randomly varying routing policies for different packets

DOEpatents

Archer, Charles Jens; Musselman, Roy Glenn; Peters, Amanda; Pinnow, Kurt Walter; Swartz, Brent Allen; Wallenfelt, Brian Paul

2010-11-23

A massively parallel computer system contains an inter-nodal communications network of node-to-node links. Nodes vary a choice of routing policy for routing data in the network in a semi-random manner, so that similarly situated packets are not always routed along the same path. Semi-random variation of the routing policy tends to avoid certain local hot spots of network activity, which might otherwise arise using more consistent routing determinations. Preferably, the originating node chooses a routing policy for a packet, and all intermediate nodes in the path route the packet according to that policy. Policies may be rotated on a round-robin basis, selected by generating a random number, or otherwise varied.

Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial.

PubMed

Powers, William J; Clarke, William R; Grubb, Robert L; Videen, Tom O; Adams, Harold P; Derdeyn, Colin P

2011-11-09

Patients with symptomatic atherosclerotic internal carotid artery occlusion (AICAO) and hemodynamic cerebral ischemia are at high risk for subsequent stroke when treated medically. To test the hypothesis that extracranial-intracranial (EC-IC) bypass surgery, added to best medical therapy, reduces subsequent ipsilateral ischemic stroke in patients with recently symptomatic AICAO and hemodynamic cerebral ischemia. Parallel-group, randomized, open-label, blinded-adjudication clinical treatment trial conducted from 2002 to 2010. Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada. The majority were academic medical centers. Patients with arteriographically confirmed AICAO causing hemispheric symptoms within 120 days and hemodynamic cerebral ischemia identified by ipsilateral increased oxygen extraction fraction measured by PET. Of 195 patients who were randomized, 97 were randomized to receive surgery and 98 to no surgery. Follow-up for the primary end point until occurrence, 2 years, or termination of trial was 99% complete. No participant withdrew because of adverse events. Anastomosis of superficial temporal artery branch to a middle cerebral artery cortical branch for the surgical group. Antithrombotic therapy and risk factor intervention were recommended for all participants. For all participants who were assigned to surgery and received surgery, the combination of (1) all stroke and death from surgery through 30 days after surgery and (2) ipsilateral ischemic stroke within 2 years of randomization. For the nonsurgical group and participants assigned to surgery who did not receive surgery, the combination of (1) all stroke and death from randomization to randomization plus 30 days and (2) ipsilateral ischemic stroke within 2 years of randomization. The trial was terminated early for futility. Two-year rates for the primary end point were 21.0% (95% CI, 12.8% to 29.2%; 20 events) for the surgical group and 22.7% (95% CI, 13.9% to 31.6%; 20 events) for the nonsurgical group (P = .78, Z test), a difference of 1.7% (95% CI, -10.4% to 13.8%). Thirty-day rates for ipsilateral ischemic stroke were 14.4% (14/97) in the surgical group and 2.0% (2/98) in the nonsurgical group, a difference of 12.4% (95% CI, 4.9% to 19.9%). Among participants with recently symptomatic AICAO and hemodynamic cerebral ischemia, EC-IC bypass surgery plus medical therapy compared with medical therapy alone did not reduce the risk of recurrent ipsilateral ischemic stroke at 2 years. clinicaltrials.gov Identifier: NCT00029146.

Type I and Type II Error Rates and Overall Accuracy of the Revised Parallel Analysis Method for Determining the Number of Factors

ERIC Educational Resources Information Center

Green, Samuel B.; Thompson, Marilyn S.; Levy, Roy; Lo, Wen-Juo

2015-01-01

Traditional parallel analysis (T-PA) estimates the number of factors by sequentially comparing sample eigenvalues with eigenvalues for randomly generated data. Revised parallel analysis (R-PA) sequentially compares the "k"th eigenvalue for sample data to the "k"th eigenvalue for generated data sets, conditioned on"k"-…

The Distinction of Hot Herbal Compress, Hot Compress, and Topical Diclofenac as Myofascial Pain Syndrome Treatment.

PubMed

Boonruab, Jurairat; Nimpitakpong, Netraya; Damjuti, Watchara

2018-01-01

This randomized controlled trial aimed to investigate the distinctness after treatment among hot herbal compress, hot compress, and topical diclofenac. The registrants were equally divided into groups and received the different treatments including hot herbal compress, hot compress, and topical diclofenac group, which served as the control group. After treatment courses, Visual Analog Scale and 36-Item Short Form Health survey were, respectively, used to establish the level of pain intensity and quality of life. In addition, cervical range of motion and pressure pain threshold were also examined to identify the motional effects. All treatments showed significantly decreased level of pain intensity and increased cervical range of motion, while the intervention groups exhibited extraordinary capability compared with the topical diclofenac group in pressure pain threshold and quality of life. In summary, hot herbal compress holds promise to be an efficacious treatment parallel to hot compress and topical diclofenac.

Considering Horn's Parallel Analysis from a Random Matrix Theory Point of View.

PubMed

Saccenti, Edoardo; Timmerman, Marieke E

2017-03-01

Horn's parallel analysis is a widely used method for assessing the number of principal components and common factors. We discuss the theoretical foundations of parallel analysis for principal components based on a covariance matrix by making use of arguments from random matrix theory. In particular, we show that (i) for the first component, parallel analysis is an inferential method equivalent to the Tracy-Widom test, (ii) its use to test high-order eigenvalues is equivalent to the use of the joint distribution of the eigenvalues, and thus should be discouraged, and (iii) a formal test for higher-order components can be obtained based on a Tracy-Widom approximation. We illustrate the performance of the two testing procedures using simulated data generated under both a principal component model and a common factors model. For the principal component model, the Tracy-Widom test performs consistently in all conditions, while parallel analysis shows unpredictable behavior for higher-order components. For the common factor model, including major and minor factors, both procedures are heuristic approaches, with variable performance. We conclude that the Tracy-Widom procedure is preferred over parallel analysis for statistically testing the number of principal components based on a covariance matrix.

Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study.

PubMed

Triratana, Terdphong; Kraivaphan, Petcharat; Amornchat, Cholticha; Mateo, Luis R; Morrison, Boyce M; Dibart, Serge; Zhang, Yun-Po

2015-04-01

To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

Zinc-rich oysters as well as zinc-yeast- and astaxanthin-enriched food improved sleep efficiency and sleep onset in a randomized controlled trial of healthy individuals.

PubMed

Saito, Hitomi; Cherasse, Yoan; Suzuki, Rina; Mitarai, Makoto; Ueda, Fumitaka; Urade, Yoshihiro

2017-05-01

Zinc is an essential mineral that plays an important role in the body. We previously reported that orally feeding zinc-enriched yeast to mice induces nonrapid-eye-movement sleep. In addition, astaxanthin, an antioxidant abundant in seafood such as salmon and krill, is able to chelate minerals and may promote zinc absorption, which in return may also improve sleep. The purpose of our study was to examine the effect of zinc-rich and astaxanthin-containing food on sleep in humans. We conducted a randomized, double-blinded, placebo-controlled parallel group trial of 120 healthy subjects and recorded their night activity by actigraphy for 12 weeks. These subjects were divided into four groups: placebo, zinc-rich food, zinc-, and astaxanthin-rich food, and placebo supplemented with zinc-enriched yeast and astaxanthin oil. Compared with the placebo group, the zinc-rich food group efficiently decreased the time necessary to fall asleep and improved sleep efficiency, whereas the group that ingested zinc-enriched yeast and astaxanthin oil significantly improved the sleep onset latency. Actigraphic sleep monitoring demonstrated that eating zinc-rich food improved sleep onset latency as well as improved the sleep efficiency in healthy individuals. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis.

PubMed

Langford, R M; Mares, J; Novotna, A; Vachova, M; Novakova, I; Notcutt, W; Ratcliffe, S

2013-04-01

Central neuropathic pain (CNP) occurs in many multiple sclerosis (MS) patients. The provision of adequate pain relief to these patients can very difficult. Here we report the first phase III placebo-controlled study of the efficacy of the endocannabinoid system modulator delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (USAN name, nabiximols; Sativex, GW Pharmaceuticals, Salisbury, Wiltshire, UK), to alleviate CNP. Patients who had failed to gain adequate analgesia from existing medication were treated with THC/CBD spray or placebo as an add-on treatment, in a double-blind manner, for 14 weeks to investigate the efficacy of the medication in MS-induced neuropathic pain. This parallel-group phase of the study was then followed by an 18-week randomized-withdrawal study (14-week open-label treatment period plus a double-blind 4-week randomized-withdrawal phase) to investigate time to treatment failure and show maintenance of efficacy. A total of 339 patients were randomized to phase A (167 received THC/CBD spray and 172 received placebo). Of those who completed phase A, 58 entered the randomized-withdrawal phase. The primary endpoint of responder analysis at the 30 % level at week 14 of phase A of the study was not met, with 50 % of patients on THC/CBD spray classed as responders at the 30 % level compared to 45 % of patients on placebo (p = 0.234). However, an interim analysis at week 10 showed a statistically significant treatment difference in favor of THC/CBD spray at this time point (p = 0.046). During the randomized-withdrawal phase, the primary endpoint of time to treatment failure was statistically significant in favor of THC/CBD spray, with 57 % of patients receiving placebo failing treatment versus 24 % of patients from the THC/CBD spray group (p = 0.04). The mean change from baseline in Pain Numerical Rating Scale (NRS) (p = 0.028) and sleep quality NRS (p = 0.015) scores, both secondary endpoints in phase B, were also statistically significant compared to placebo, with estimated treatment differences of -0.79 and 0.99 points, respectively, in favor of THC/CBD spray treatment. The results of the current investigation were equivocal, with conflicting findings in the two phases of the study. While there were a large proportion of responders to THC/CBD spray treatment during the phase A double-blind period, the primary endpoint was not met due to a similarly large number of placebo responders. In contrast, there was a marked effect in phase B of the study, with an increased time to treatment failure in the THC/CBD spray group compared to placebo. These findings suggest that further studies are required to explore the full potential of THC/CBD spray in these patients.

Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

PubMed

Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R; Ramstad, Erica; Magnusson, Frederik Løgstrup; Krogh, Helle B; Groth, Camilla; Gillies, Donna; Zwi, Morris; Skoog, Maria; Gluud, Christian; Simonsen, Erik

2017-01-01

To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found.

The effectiveness of a dentifrice without sodium lauryl sulphate on dental plaque and gingivitis - a randomized controlled clinical trial.

PubMed

Sälzer, S; Rosema, Nam; Hennequin-Hoenderdos, N L; Slot, D E; Timmer, C; Dörfer, C E; Van der Weijden, G A

2017-08-01

The purpose of the study was to evaluate the effect on dental plaque and gingivitis of a dentifrice without sodium lauryl sulphate (SLS) compared to two SLS-containing dentifrices. For this double-blind, parallel study, 90 volunteers having moderate gingival inflammation (≥40%) were randomly divided among three groups: one group using non-SLS dentifrice containing enzymes, colostrum and low concentrations of zinc and two control groups each using different SLS-containing dentifrices. Dental plaque scores (Turesky modification of Quigley & Hein) and gingivitis scores (Bleeding On Marginal Probing) were assessed at baseline, after 2 and 4 weeks. Eighty-nine participants provided evaluable data. A slight decrease in gingivitis scores was observed for all groups over 4 weeks, which was statistically significant for the non-SLS group. Mean values for dental plaque scores did not show major differences over 4 weeks. For both parameters, no significant differences between groups could be observed at any time point. Patient appreciation was in favour of the SLS groups especially regarding the foaming effect. No significant differences could be observed with respect to the effect on plaque and gingivitis between SLS-containing and SLS-free dentifrice containing enzymes, colostrum and low concentration zinc. Patients enjoyed the duration of taste and the 'foaming effect' of SLS-containing dentifrices better. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial.

PubMed

Kingston, Dawn; McDonald, Sheila; Biringer, Anne; Austin, Marie-Paule; Hegadoren, Kathy; McDonald, Sarah; Giallo, Rebecca; Ohinmaa, Arto; Lasiuk, Gerri; MacQueen, Glenda; Sword, Wendy; Lane-Smith, Marie; van Zanten, Sander Veldhuyzen

2014-01-02

Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed. The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening. ClinicalTrials.gov Identifier: NCT01899534.

The efficacy of lymphatic drainage and traditional massage in the prophylaxis of migraine: a randomized, controlled parallel group study.

PubMed

Happe, Svenja; Peikert, Andreas; Siegert, Rudolf; Evers, Stefan

2016-10-01

This study aimed at examining the efficacy of lymphatic drainage (LD) and traditional massage (TM) in the prophylactic treatment of migraine using controlled prospective randomized clinical trial of 64 patients (57 women, 45 ± 10 years) with migraine with and without aura. Patients were randomized into three groups: LD (n = 21); TM (n = 21); waiting group (WG, n = 22). After a 4-week-baseline, a treatment period of 8 weeks was applied followed by a 4-week observation period. The patients filled in a headache diary continuously; every 4 weeks they filled in the German version of the CES-D and the German version of the Headache Disability Inventory. The main outcome measure was migraine frequency per month. At the end of the observation period, the number of migraine attacks and days decreased in the LD group by 1.8 and 3.1, respectively, in the TM group by 1.3 and 2.4, and in the WG by 0.4 and 0.2, respectively. The differences between LD and WG were significant (p = 0.006 and p = 0.015, respectively) as well as the differences between TM und WG (p = 0.042 and p = 0.016, respectively). There was a significant decrease in the amount of analgesic intake in the LD group compared to the two other groups (p = 0.004). TM and LD resulted in a reduction of migraine attack frequency. The analgesic intake only decreased significantly during LD intervention. Useful effects were identified for LD and TM as compared to WG for the prophylaxis of migraine. LD was more efficacious in some parameters than TM.

Dietary tartary buckwheat intake attenuates insulin resistance and improves lipid profiles in patients with type 2 diabetes: a randomized controlled trial.

PubMed

Qiu, Ju; Liu, Yanping; Yue, Yanfen; Qin, Yuchang; Li, Zaigui

2016-12-01

Tartary buckwheat (TB) is rich in protein, dietary fiber, and flavonoids and has been reported to affect type 2 diabetes mellitus (T2DM) in animal experiments, but limited information on the benefit of TB as a whole food in T2DM patients is available. Thus, we tested the hypothesis that a daily replacement of a portion of the staple food with TB will improve risk factors of T2DM, including fasting glucose, insulin resistance, and lipid profile. In a parallel, randomized, open-label, controlled trial, 165 T2DM patients were randomly assigned to a control diet group (DC group; systematic diet plans and intensive nutritional education) or a TB intervention group (TB group; daily replacement of a portion of staple food with TB food). Blood samples and diet information were collected at baseline and after 4 weeks of intervention. The TB group decreased fasting insulin (2.46-2.39 Ln mU/L), total cholesterol (5.08-4.79 mmol/L), and low-density lipoprotein cholesterol (3.00-2.80 mmol/L) compared with the DC group at 4 weeks (P<.05). No significant differences in blood glucose or glycated hemoglobin levels were noted between the TB and DC groups. In addition, subgroup analyses based on daily TB intake dose showed a reduction in insulin, total cholesterol, and low-density lipoprotein cholesterol, but also insulin resistance was observed when TB intake dose was greater than 110 g/d. These results support the hypothesis that TB may improve insulin resistance and lipid profile in T2DM patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

PubMed

Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

2015-10-01

The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial

PubMed Central

Haj-Younis, Samiha; Khattab, Tarek Z.; Hajeer, Mohammad Y.; Farah, Hassan

2016-01-01

ABSTRACT Objective: To compare speech performance and levels of oral impairment between two types of lingual brackets. Methods: A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years) with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio). Either STb (Ormco) or 7th Generation (Ormco) lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0), one week following premolar extraction prior to bracket placement (T1), within 24 hours of bracket bonding (T2), one month after (T3), and three months after (T4) bracket placement. Patients′ acceptance was assessed by means of standardized questionnaires. Results: After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. Conclusions: 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment. PMID:27653268

A comparison between two lingual orthodontic brackets in terms of speech performance and patients' acceptance in correcting Class II, Division 1 malocclusion: a randomized controlled trial.

PubMed

Haj-Younis, Samiha; Khattab, Tarek Z; Hajeer, Mohammad Y; Farah, Hassan

2016-01-01

To compare speech performance and levels of oral impairment between two types of lingual brackets. A parallel-group randomized controlled trial was carried out on patients with Class II, Division 1 malocclusion treated at the University of Hama School of Dentistry in Hama, Syria. A total of 46 participants (mean age: 22.3 ± 2.3 years) with maxillary dentoalveolar protrusion were randomly distributed into two groups with 23 patients each (1:1 allocation ratio). Either STb (Ormco) or 7th Generation (Ormco) lingual brackets were applied. Fricative sound/s/ spectrograms were analyzed directly before intervention (T0), one week following premolar extraction prior to bracket placement (T1), within 24 hours of bracket bonding (T2), one month after (T3), and three months after (T4) bracket placement. Patients' acceptance was assessed by means of standardized questionnaires. After bracket placement, significant deterioration in articulation was recorded at all assessment times in the 7th Generation group, and up to T3 in the STb group. Significant intergroup differences were detected at T2 and T3. No statistically significant differences were found between the two groups in reported tongue irritation levels, whereas chewing difficulty was significantly higher in the 7th Generation group one month after bracket placement. 7th Generation brackets have more interaction with sound production than STb ones. Although patients in both groups complained of some degree of oral impairment, STb appliances appeared to be more comfortable than the 7th Generation ones, particularly within the first month of treatment.

Clinical efficacy of a xenogeneic collagen matrix in augmenting keratinized mucosa around implants: a randomized controlled prospective clinical trial.

PubMed

Lorenzo, Ramón; García, Virginia; Orsini, Marco; Martin, Conchita; Sanz, Mariano

2012-03-01

The aim of this controlled randomized clinical trial was to evaluate the efficacy of a xenogeneic collagen matrix (CM) to augment the keratinized tissue around implants supporting prosthetic restorations at 6 months when compared with the standard treatment, the connective tissue autograft, CTG). This randomized longitudinal parallel controlled clinical trial studied 24 patients with at least one location with minimal keratinized tissue (≤1 mm). The 6-month width of keratinized tissue. As secondary outcomes the esthetic outlook, the maintenance of peri-implant mucosal health and the patient morbidity were assessed pre-operatively and 1, 3, and 6 months post-operatively. At 6 months, Group CTG attained a mean width of keratinized tissue of 2.75 (1.5) mm, while the corresponding figure in Group CM was 2.8 (0.4) mm, the inter-group differences not being statistically significant. The surgical procedure in both groups did not alter significantly the mucosal health in the affected abutments. There was a similar esthetic result and significant increase in the vestibular depth in both groups as a result of the surgery. In the CM group it changed from 2.2 (3.3) to 5.1 (2.5) mm at 6 months. The patients treated with the CM referred less pain, needed less pain medication, and the surgical time was shorter, although these differences were not statistically significant when compared with the CTG group. These results prove that this new CM was as effective and predictable as the CTG for attaining a band of keratinized tissue. © 2011 John Wiley & Sons A/S.

Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials.

PubMed

Lebwohl, Mark; Dinehart, Scott; Whiting, David; Lee, Peter K; Tawfik, Naji; Jorizzo, Joseph; Lee, James H; Fox, Terry L

2004-05-01

The immune system plays a critical role in the development and pathogenesis of actinic keratosis (AK). Imiquimod has been shown to stimulate the cutaneous immune response and be effective for the treatment of nonmelanoma skin cancers. Two phase III, randomized, double-blind, vehicle-controlled studies evaluated the efficacy of imiquimod 5% cream compared with vehicle in the treatment of AK lesions on the face and balding scalp. A total of 436 participants at 24 centers in the United States and Canada were randomized to either imiquimod 5% or vehicle cream. Study cream was applied one time per day, 2 days per week for 16 weeks. Clearance of AK lesions was clinically assessed at an 8-week posttreatment visit. The complete clearance rate was 45.1% for the imiquimod group and 3.2% for the vehicle group. The difference in complete clearance rates (imiquimod minus vehicle) was 41.9% with a 95% confidence interval of 34.9% to 49%. The partial (> or =75%) clearance rate was 59.1% for the imiquimod group and 11.8% for the vehicle group. The difference in partial clearance rates (imiquimod minus vehicle) was 47.3% with a 95% confidence interval of 39.5% to 55.1%. The median percent reduction in AK lesions was 83.3% for the imiquimod group and 0% for the vehicle group. Local skin reactions were common. Severe erythema was reported by 17.7% of participants who received imiquimod and 2.3% of participants who received vehicle. Overall, imiquimod was very well tolerated. Imiquimod 5% cream used 2 times per week for 16 weeks is an effective and well-tolerated treatment for AK.

Effectiveness of a decision-training aid on referral prioritization capacity: a randomized controlled trial.

PubMed

Harries, Priscilla; Tomlinson, Christopher; Notley, Elizabeth; Davies, Miranda; Gilhooly, Kenneth

2012-01-01

In the community mental health field, occupational therapy students lack the capacity to prioritize referrals effectively. The purpose of this study was to test the effectiveness of a clinical decision-training aid on referral prioritization capacity. A double-blind, parallel-group, randomized controlled trial was conducted using a judgment analysis approach. Each participant used the World Wide Web to prioritize referral sets at baseline, immediate posttest, and 2-wk follow-up. The intervention group was provided with training after baseline testing; control group was purely given instructions to continue with the task. One hundred sixty-five students were randomly allocated to intervention (n = 87) or control (n = 81). Intervention. Written and graphical descriptions were given of an expert consensus standard explaining how referral information should be used to prioritize referrals. Participants' prioritization ratings were correlated with the experts' ratings of the same referrals at each stage of testing, as well as to examine the effect on mean group scores, regression weights, and the lens model indices. At baseline, no differences were found between control and intervention on rating capacity or demographic characteristics. Comparison of the difference in mean correlation baseline scores of the control and intervention group compared with immediate posttest showed a statistically significant result that was maintained at 2-wk follow-up. The effect size was classified as large. At immediate posttest and follow-up, the intervention group improved rating capacity, whereas the control group's capacity remained poor. The results of this study indicate that the decision-training aid has a positive effect on referral prioritization capacity. This freely available, Web-based decision-training aid will be a valuable adjunct to the education of these novice health professionals internationally.

Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial.

PubMed

Hong, Shou-Hai; Ding, Sha-Sha; Wu, Fei; Bi, Ying; Xu, Fu; Wan, Yi-Jia; Xuan, Li-Hua

2017-03-06

Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thus generating different acupuncture responses or effects. Evidence has demonstrated that acupuncture is effective for functional dyspepsia (FD). However, the effects of different stimulating parameters of MA manipulations on FD remain unclear. This study is a randomized controlled trial with a four-arm, parallel-group structure. Patients with FD with epigastric pain syndrome (EPS) will be included and randomly allocated into four groups: three MA manipulation groups (separately treated with a frequency of 1 Hz, 2 Hz, or 3 Hz) and a control group. All groups will receive omeprazole as a basic treatment and acupuncture: in the MA manipulation groups, the needles will be manipulated manually with three different frequencies on the basis when de qi is reached, while in the control group, the needles will be inserted without any manipulation. All patients will receive acupuncture treatment of five consecutive sessions per week for 2 weeks and be followed up at 4, 8, and 12 weeks. The primary outcomes of the study include patients' response to the treatment. The secondary outcomes include dyspeptic symptoms, quality of life, mental status, fasting serum gastrin, motilin, and ghrelin concentrations, and adverse events. The protocol was approved by the Ethics committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (2016-K-057-01). The aim of this study is to evaluate the efficacy and safety of MA manipulations with different stimulating parameters (different frequencies) on EPS in patients with FD. Chinese Clinical Trial Registry, ChiCTR-IOR-16008189 . Registered on 30 March 2016.

Effect of 0.3% Hydroxypropyl Methylcellulose/Dextran Versus 0.18% Sodium Hyaluronate in the Treatment of Ocular Surface Disease in Glaucoma Patients: A Randomized, Double-Blind, and Controlled Study.

PubMed

Prabhasawat, Pinnita; Ruangvaravate, Ngamkae; Tesavibul, Nattaporn; Thewthong, Maneerat

2015-01-01

To compare the efficacy and safety of 0.3% hydroxypropyl methylcellulose/dextran (HPMC/dextran) and 0.18% sodium hyaluronate (SH) in the treatment of ocular surface disease in patients using antiglaucoma drugs containing preservatives. This was a double-blind, randomized, parallel-group study in 70 glaucoma patients with Ocular Surface Disease Index (OSDI) score greater than 20 points and/or presence of ocular signs. Patients were randomized to receive either preservative-free 0.3% HPMC/dextran (n=35) or preservative-free 0.18% SH (n=35). Treatment was 1 drop in each eye, 4 times a day. Data were collected at baseline, at day 7 and day 28. The groups were homogeneous at baseline. At day 28, both treatments showed significant improvements (P<0.05) in the mean OSDI score, lid skin and lid margin inflammation, conjunctival injection, and expressibility of meibomian glands, corneal staining score, fluorescein tear breakup time (FBUT), and Schirmer I test. However, the mean OSDI score, lid margin inflammation and conjunctival injection showed significant improvements (P<0.05) in the SH group at days 7 and 28, compared to the HPMC/dextran group. FBUT and the Schirmer I test also showed significant improvements (P<0.05) in the SH group compared to the HPMC/dextran group, at day 28. No adverse reactions were observed in either group. Preservative-free artificial tear, 0.3% HPMC/dextran, and 0.18% SH, caused a significant relief of the ocular surface disease in glaucoma patients. However, 0.18% SH led to a greater improvement in ocular signs and symptoms than 0.3% HPMC/dextran.

Impact evaluation of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial.

PubMed

Knowlden, Adam P; Sharma, Manoj; Cottrell, Randall R; Wilson, Bradley R A; Johnson, Marcus Lee

2015-04-01

The family and home environment is an influential antecedent of childhood obesity. The purpose of this study was to pilot test The Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention; a newly developed, theory-based, online program for prevention of childhood obesity. The two-arm, parallel group, randomized, participant-blinded trial targeted mothers with children between 4 and 6 years of age. Measures were collected at baseline, 4 weeks, and 8 weeks to evaluate programmatic effects on constructs of social cognitive theory (SCT) and obesity-related behaviors. Process evaluation transpired concurrently with each intervention session. Fifty-seven participants were randomly assigned to receive either experimental EMPOWER (n = 29) or active control Healthy Lifestyles (n = 28) intervention. Significant main effects were identified for child physical activity, sugar-free beverage consumption, and screen time, indicating that both groups improved in these behaviors. A significant group-by-time interaction was detected for child fruit and vegetable (FV) consumption as well as the SCT construct of environment in the EMPOWER cohort. An increase of 1.613 cups of FVs (95% confidence interval = [0.698, 2.529]) was found in the experimental group, relative to the active control group. Change score analysis found changes in the home environment accounted for 31.4% of the change in child FV intake for the experimental group. Child physical activity, sugar-free beverage consumption, and screen time improved in both groups over the course of the trial. Only the theory-based intervention was efficacious in increasing child FV consumption. The EMPOWER program was robust for inducing change in the home environment leading to an increase in child FV intake (Cohen's f = 0.160). © 2014 Society for Public Health Education.

Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women: a randomized controlled trial.

PubMed

Fathi, Yasamin; Faghih, Shiva; Zibaeenezhad, Mohammad Javad; Tabatabaei, Sayed Hamid Reza

2016-02-01

Controversy exists regarding whether increasing dairy intake without energy restriction would lead to weight loss. We aimed to compare the potential weight-reducing effects of kefir drink (a probiotic dairy product) and milk in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. One hundred and forty-four subjects were assessed for eligibility in this single-center, multi-arm, parallel-group, randomized controlled trial. Of these, seventy-five eligible women aged 25-45 years were randomly assigned to three groups, labeled as control, milk, and kefir, to receive an outpatient dietary regimen for 8 weeks. Subjects in the control group received a diet providing a maintenance level of energy intake, containing 2 servings/day of low-fat dairy products, while those in the milk and kefir groups received a weight maintenance diet, containing 2 additional servings/day (a total of 4 servings/day) of dairy products from low-fat milk or commercial kefir drink, respectively. Anthropometric outcomes including weight, body mass index (BMI), and waist circumference (WC) were measured every 2 weeks. Fifty-eight subjects completed the study. Using analysis of covariance models in the intention-to-treat population (n = 75), we found that at 8 weeks, subjects in the kefir and milk groups had significantly greater reductions in weight, BMI, and WC compared to those in the control group (all p < 0.01). However, no such significant differences were found between the kefir and milk groups. Kefir drink leads to a similar weight loss, compared with milk, in a dairy-rich non-energy-restricted diet in overweight or obese premenopausal women. However, further studies are warranted.

Neuroendocrine and Inflammatory Responses to Losartan and Continuous Positive Airway Pressure in Patients with Hypertension and Obstructive Sleep Apnea. A Randomized Controlled Trial.

PubMed

Thunström, Erik; Manhem, Karin; Yucel-Lindberg, Tülay; Rosengren, Annika; Lindberg, Caroline; Peker, Yüksel

2016-11-01

Blood pressure reduction in response to antihypertensive agents is less for patients with obstructive sleep apnea (OSA). Increased sympathetic and inflammatory activity, as well as alterations in the renin-angiotensin-aldosterone system, may play a role in this context. To address the cardiovascular mechanisms involved in response to an angiotensin II receptor antagonist, losartan, and continuous positive airway pressure (CPAP) as add-on treatment for hypertension and OSA. Newly diagnosed hypertensive patients with or without OSA (allocated in a 2:1 ratio for OSA vs. no OSA) were treated with losartan 50 mg daily during a 6-week two-center, open-label, prospective, case-control, parallel-design study. In the second 6-week, sex-stratified, open-label, randomized, parallel-design study, all subjects with OSA continued to receive losartan and were randomly assigned to either CPAP as add-on therapy or to no CPAP (1:1 ratio for CPAP vs. no CPAP). Study subjects without OSA were followed in parallel while they continued to take losartan. Blood samples were collected at baseline, after 6 weeks, and after 12 weeks for analysis of renin, aldosterone, noradrenaline, adrenaline, and inflammatory markers. Fifty-four patients with OSA and 35 without OSA were included in the first 6-week study. Losartan significantly increased renin levels and reduced aldosterone levels in the group without OSA. There was no significant decrease in aldosterone levels among patients with OSA. Add-on CPAP treatment tended to lower aldosterone levels, but reductions were more pronounced in measures of sympathetic activity. No significant changes in inflammatory markers were observed following treatment with losartan and CPAP. Hypertensive patients with OSA responded to losartan treatment with smaller reductions in aldosterone compared with hypertensive patients without OSA. Sympathetic system activity seemed to respond primarily to add-on CPAP treatment in patients with newly discovered hypertension and OSA. Clinical trial registered with www.clinicaltrials.gov (NCT00701428).

Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

PubMed

Mohammed, Shama; Glennerster, Rachel; Khan, Aamir J

2016-01-01

The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes. To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. We conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day. Public and private sector tuberculosis clinics in Karachi, Pakistan. Newly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group. The primary outcome was clinically recorded treatment success based upon intention-to-treat. We found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment. In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact. The trial was registered with ClinicalTrials.gov, NCT01690754.

Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial.

PubMed

Chen, Bo; Hu, Shu-xiang; Liu, Bao-hu; Zhao, Tian-yi; Li, Bo; Liu, Yan; Li, Ming-yue; Pan, Xing-fang; Guo, Yong-ming; Chen, Ze-lin; Guo, Yi

2015-05-12

Many patients experience nausea and vomiting during chemotherapy treatment. Evidence demonstrates that electroacupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting (CINV). However, the acupoint or matching acupoint with the best efficacy for controlling CINV still remains unidentified. This study consists of a randomized controlled trial (RCT) with four parallel arms: a control group and three electroacupuncture groups (one with Neiguan (PC6), one with Zhongwan (CV12), and one with both PC6 and CV12). The control group received standard antiemetic only, while the other three groups received electroacupuncture stimulation with different acupoints besides the standard antiemetic. The intervention is done once daily from the first day (day 1) to the fourth day (day 4) during chemotherapy treatment. The primary outcome measures include frequency of nausea, vomiting and retching. The secondary outcome measures are the grade of constipation and diarrhea, electrogastrogram, assessment of quality of life, assessment of anxiety and depression, and other adverse effects during the chemotherapy. Assessments are scheduled from one day pre-chemotherapy (day 0) to the fifth day of chemotherapy (day 5). Follow-ups are done from day 6 to day 21. The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV. The register number of randomized controlled trial is NCT02195908 . The date of registration was 21 July 2014.

Annurca (Malus pumila Miller cv. Annurca) apple as a functional food for the contribution to a healthy balance of plasma cholesterol levels: results of a randomized clinical trial.

PubMed

Tenore, Gian Carlo; Caruso, Domenico; Buonomo, Giuseppe; D'Urso, Emanuela; D'Avino, Maria; Campiglia, Pietro; Marinelli, Luciana; Novellino, Ettore

2017-05-01

Recent human studies have evaluated the effect of daily apple consumption on plasma cholesterol level, which is recognized as an important risk factor for cardiovascular disease (CVD). Nevertheless, slightly significant effects have been generally registered although consuming more than two apples a day for several weeks. This study describes the influence of daily consumption of Annurca apples on the cholesterol levels of mildly hypercholesterolaemic healthy subjects. A monocentric, randomized, parallel-group, placebo-controlled, 4-month study was conducted. The subjects (n = 250) were randomly assigned to five treatment groups (each one of 50 subjects: 28 men and 22 women). Four groups were administered one apple per day among the following: Red Delicious, Granny Smith, Fuji, Golden Delicious. The fifth group was asked to consume two Annurca apples per day, since the weight of this cultivar is on average half that of the commercial ones considered in this study. Comparing results, Annurca led to the most significant outcome, allowing a reduction in total and low-density lipoprotein cholesterol levels by 8.3% and 14.5%, respectively, and an increase in high-density lipoprotein cholesterol levels by 15.2% (all P < 0.001). Our data would reasonably indicate Annurca apple as a useful tool to contribute to the prevention of CVD risk through normal diet. © 2016 Society of Chemical Industry. © 2016 Society of Chemical Industry.

Comparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study.

PubMed

Lee, Mi Young; Choi, Dong Seop; Lee, Moon Kyu; Lee, Hyoung Woo; Park, Tae Sun; Kim, Doo Man; Chung, Choon Hee; Kim, Duk Kyu; Kim, In Joo; Jang, Hak Chul; Park, Yong Soo; Kwon, Hyuk Sang; Lee, Seung Hun; Shin, Hee Kang

2014-01-01

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528).

Comparison of Acarbose and Voglibose in Diabetes Patients Who Are Inadequately Controlled with Basal Insulin Treatment: Randomized, Parallel, Open-Label, Active-Controlled Study

PubMed Central

Lee, Mi Young; Lee, Moon Kyu; Lee, Hyoung Woo; Park, Tae Sun; Kim, Doo Man; Chung, Choon Hee; Kim, Duk Kyu; Kim, In Joo; Jang, Hak Chul; Park, Yong Soo; Kwon, Hyuk Sang; Lee, Seung Hun; Shin, Hee Kang

2014-01-01

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528) PMID:24431911

Immediate relief of herniated lumbar disc-related sciatica by ankle acupuncture: A study protocol for a randomized controlled clinical trial.

PubMed

Xiang, Anfeng; Xu, Mingshu; Liang, Yan; Wei, Jinzi; Liu, Sheng

2017-12-01

Around 90% of sciatica cases are due to a herniated intervertebral disc in the lumbar region. Ankle acupuncture (AA) has been reported to be effective in the treatment of acute nonspecific low back pain. This study aims to evaluate the efficacy of a single session of ankle acupuncture for disc-related sciatica. This will be a double-blinded, randomized controlled clinical trial. Patients diagnosed with disc-related sciatica will be randomly divided into 3 parallel groups. The treatment group (n = 30) will receive ankle acupuncture. The 2 control groups will either undergo traditional needle manipulation (n = 30) or sham acupuncture (n = 30) at the same point as the treatment group. The primary outcome will be pain intensity on a visual analog scale (VAS). The secondary outcomes will be paresthesia intensity on a VAS and the Abbreviated Acceptability Rating Profile (AAPR). The success of blinding will be evaluated, and the needle-induced sensation and adverse events will be recorded. All outcomes will be evaluated before, during, and after the treatment. This study will determine the immediate effect and specificity of ankle acupuncture for the treatment of disc-related sciatica. We anticipate that ankle acupuncture might be more effective than traditional needle manipulation or sham acupuncture. ChiCTR-IPR-15007127 (http://www.chictr.org.cn/showprojen.aspx?proj=11989). Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery.

PubMed

Masket, Samuel; Hovanesian, John A; Levenson, Jeffrey; Tyson, Farrell; Flynn, William; Endl, Michael; Majmudar, Parag A; Modi, Satish; Chu, Ralph; Raizman, Michael B; Lane, Stephen S; Kim, Terry

2014-12-01

To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. Twenty-four ophthalmic clinical practices in the United States. Prospective randomized parallel-arm controlled multicenter subject-masked study. Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress. Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double- Blind Randomized Controlled Clinical Trial.

PubMed

Jafarpour-Sadegh, Farnaz; Montazeri, Vahid; Adili, Ali; Esfehani, Ali; Rashidi, Mohammad-Reza; Mesgari, Mehran; Pirouzpanah, Saeed

2015-01-01

Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

Protection of xenon against postoperative oxygen impairment in adults undergoing Stanford Type-A acute aortic dissection surgery: Study protocol for a prospective, randomized controlled clinical trial.

PubMed

Jin, Mu; Cheng, Yi; Yang, Yanwei; Pan, Xudong; Lu, Jiakai; Cheng, Weiping

2017-08-01

The available evidence shows that hypoxemia after Stanford Type-A acute aortic dissection (AAD) surgery is a frequent cause of several adverse consequences. The pathogenesis of postoperative hypoxemia after AAD surgery is complex, and ischemia/reperfusion and inflammation are likely to be underlying risk factors. Xenon, recognized as an ideal anesthetic and anti-inflammatory treatment, might be a possible treatment for these adverse effects. The trial is a prospective, double-blind, 4-group, parallel, randomized controlled, a signal-center clinical trial. We will recruit 160 adult patients undergoing Stanford type-A AAD surgery. Patients will be allocated a study number and will be randomized on a 1:1:1:1 basis to receive 1 of the 3 treatment options (pulmonary inflated with 50% xenon, 75% xenon, or 100% xenon) or no treatment (control group, pulmonary inflated with 50% nitrogen). The aims of this study are to clarify the lung protection capability of xenon and its possible mechanisms in patients undergoing the Stanford type-A AAD surgery. This trial uses an innovative design to account for the xenon effects of postoperative oxygen impairment, and it also delineates the mechanism for any benefit from xenon. The investigational xenon group is considered a treatment intervention, as it includes 3 groups of pulmonary static inflation with 50%, 75%, and 100% xenon. It is suggested that future trials might define an appropriate concentration of xenon for the best practice intervention.

Efficacy of the resilience and adjustment intervention after traumatic brain injury: a randomized controlled trial.

PubMed

Kreutzer, Jeffrey S; Marwitz, Jennifer H; Sima, Adam P; Mills, Ana; Hsu, Nancy H; Lukow, Herman R

2018-05-24

Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group. The manualized treatment was delivered in seven 1-h sessions. The Connor-Davidson Resilience Scale (CD-RISC) was the primary outcome measure. Secondary measures included the Mayo Portland Adaptability Inventory-4 (MPAI-4), Brief Symptom Inventory-18 (BSI-18) and 13-Item Stress Test. After adjusting for injury severity, education and time postinjury, the RAI group (N = 75) demonstrated a significantly greater increase in resilience (effect size = 1.03) compared to the WLC group (N = 73). Participants in the RAI group demonstrated more favourable scores on the MPAI-4 Adjustment and Ability Indices, BSI-18 and the 13-item Stress Test. However, only the CD-RISC and BSI-18 demonstrated a clinically significant difference. In addition, RAI participants demonstrated maintenance of gains from pre-treatment to 3-month follow-up; however, only the BSI-18 maintained a clinically significant difference. Investigation provided evidence that a resilience-focused intervention can improve psychological health and adjustment after TBI. Additional research is needed to ascertain the longer term benefits of intervention and the efficacy of alternative delivery methods (e.g., via telephone, Internet).

High-frequency TENS in post-episiotomy pain relief in primiparous puerpere: a randomized, controlled trial.

PubMed

Pitangui, Ana Carolina Rodarti; de Sousa, Ligia; Gomes, Flávia Azevedo; Ferreira, Cristine Homsi Jorge; Nakano, Ana Márcia Spanó

2012-07-01

We evaluated the effectiveness of high-frequency transcutaneous electrical nerve stimulation (TENS) as a pain relief resource for primiparous puerpere who had experienced natural childbirth with an episiotomy. A controlled, randomized clinical study was conducted in a Brazilian maternity ward. Forty puerpere were randomly divided into two groups: TENS high frequency and a no treatment control group. Post-episiotomy pain was assessed in the resting and sitting positions and during ambulation. An 11-point numeric rating scale was performed in three separate evaluations (at the beginning of the study, after 60 min and after 120 min). The McGill pain questionnaire was employed at the beginning and 60 min later. TENS with 100 Hz frequency and 75 µs pulse for 60 min was employed without causing any pain. Four electrodes ware placed in parallel near the episiotomy site, in the area of the pudendal and genitofemoral nerves. An 11-point numeric rating scale and McGill pain questionnaire showed a significant statistical difference in pain reduction in the TENS group, while the control group showed no alteration in the level of discomfort. Hence, high-frequency TENS treatment significantly reduced pain intensity immediately after its use and 60 min later. TENS is a safe and viable non-pharmacological analgesic resource to be employed for pain relief post-episiotomy. The routine use of TENS post-episiotomy is recommended. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

Effects of royal jelly supplementation on glycemic control and oxidative stress factors in type 2 diabetic female: a randomized clinical trial.

PubMed

Pourmoradian, Samira; Mahdavi, Reza; Mobasseri, Majid; Faramarzi, Elnaz; Mobasseri, Mehrnoosh

2014-05-01

It has been proposed that royal jelly has antioxidant properties and may improve oxidative stress and glycemic control. Therefore, we investigated the effects of royal jelly supplementation in diabetic females. In this pilot, parallel design randomized clinical trial, 50 female volunteers with type 2 diabetes were randomly allocated to the supplemented (25, cases) and placebo (25, cases) groups, based on random block procedure produced by Random Allocation Software, given a daily dose of 1,000 mg royal jelly soft gel or placebo, respectively, for 8 weeks. Before and after intervention, glycemic control indices, antioxidant and oxidative stress factors were measured. After royal jelly supplementation, the mean fasting blood glucose decreased remarkably (163.05±42.51 mg/dL vs. 149.68±42.7 mg/dL). Royal jelly supplementation resulted in significant reduction in the mean serum glycosylated hemoglobin levels (8.67%±2.24% vs. 7.05%±1.45%, P=0.001) and significant elevation in the mean insulin concentration (70.28±29.16 pmol/L vs. 86.46±27.50 pmol/L, P=0.01). Supplementation significantly increased erythrocyte superoxidase dismutase and glutathione peroxidase activities and decreased malondialdehyde levels (P<0.05). At the end of study, the mean total antioxidant capacity elevated insignificantly in both groups. On the basis of our findings, it seems that royal jelly supplementation may be beneficial in controlling diabetes outcomes. Further studies with larger sample size are warranted.

Can sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials?

PubMed

Ivanova, Anastasia; Zhang, Zhiwei; Thompson, Laura; Yang, Ying; Kotz, Richard M; Fang, Xin

2016-01-01

Sequential parallel comparison design (SPCD) was proposed for trials with high placebo response. In the first stage of SPCD subjects are randomized between placebo and active treatment. In the second stage placebo nonresponders are re-randomized between placebo and active treatment. Data from the population of "all comers" and the subpopulations of placebo nonresponders then combined to yield a single p-value for treatment comparison. Two-way enriched design (TED) is an extension of SPCD where active treatment responders are also re-randomized between placebo and active treatment in Stage 2. This article investigates the potential uses of SPCD and TED in medical device trials.

Effect of Brief Mindfulness Practice on Self-Reported Affect, Craving, and Smoking: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment.

PubMed

Ruscio, Aimee C; Muench, Christine; Brede, Emily; Waters, Andrew J

2016-01-01

Despite efficacious pharmacological and behavioral treatments, most smokers attempt to quit without assistance and fail to quit. Mindfulness practice may be useful in smoking cessation. This ecological momentary assessment (EMA) study was a pilot parallel group randomized controlled trial of a brief mindfulness practice (Brief-MP) intervention on self-reported smoking behavior delivered to smokers on a Personal Digital Assistant (PDA) in the field. Adult community smokers (N = 44) were randomly assigned to a Brief-MP (n = 24) or Control (sham meditation; n = 20) group. Participants were instructed to smoke as much or as little as they liked. Participants carried a PDA for 2 weeks and were instructed to initiate 20 minutes of meditation (or control) training on the PDA daily, completing an assessment of cognitive and affective processes immediately afterwards. Additionally, they completed assessments at random times up to four times per day. Primary outcome variables were negative affect, craving, and cigarettes smoked per day, all self-reported. Thirty-seven participants provided EMA data totaling 1874 assessments. Linear Mixed Model analyses on EMA data revealed that Brief-MP (vs. Control) reduced overall negative affect, F(1, 1798) = 13.8, P = .0002; reduced craving immediately post-meditation, (Group × Assessment Type interaction, F(2, 1796) = 12.3, P = .0001); and reduced cigarettes smoked per day over time (Group × Day interaction, F(1, 436) = 5.50, P = .01). Brief-MP administered in the field reduced negative affect, craving, and cigarette use, suggesting it may be a useful treatment. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Prevention of Hypoglycemia With Predictive Low Glucose Insulin Suspension in Children With Type 1 Diabetes: A Randomized Controlled Trial.

PubMed

Battelino, Tadej; Nimri, Revital; Dovc, Klemen; Phillip, Moshe; Bratina, Natasa

2017-06-01

To investigate whether predictive low glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with the sensor-augmented insulin pump in children with type 1 diabetes. This randomized, two-arm, parallel, controlled, two-center open-label study included 100 children and adolescents with type 1 diabetes and glycated hemoglobin A 1c ≤10% (≤86 mmol/mol) and using continuous subcutaneous insulin infusion. Patients were randomly assigned to either an intervention group with PLGM features enabled (PLGM ON) or a control group (PLGM OFF), in a 1:1 ratio, all using the same type of sensor-augmented insulin pump. The primary end point was the number of hypoglycemic events below 65 mg/dL (3.6 mmol/L), based on sensor glucose readings, during a 14-day study treatment. The analysis was performed by intention to treat for all randomized patients. The number of hypoglycemic events below 65 mg/dL (3.6 mmol/L) was significantly smaller in the PLGM ON compared with the PLGM OFF group (mean ± SD 4.4 ± 4.5 and 7.4 ± 6.3, respectively; P = 0.008). This was also true when calculated separately for night ( P = 0.025) and day ( P = 0.022). No severe hypoglycemic events occurred; however, there was a significant increase in time spent above 140 mg/dL (7.8 mmol/L) in the PLGM ON group ( P = 0.0165). The PLGM insulin suspension was associated with a significantly reduced number of hypoglycemic events. Although this was achieved at the expense of increased time in moderate hyperglycemia, there were no serious adverse effects in young patients with type 1 diabetes. © 2017 by the American Diabetes Association.

The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial

PubMed Central

Qasemzadeh, Mohammad Javad; Fathi, Mahdi; Tashvighi, Maryam; Gharehbeglou, Mohammad; Yadollah-Damavandi, Soheila; Parsa, Yekta; Rahimi, Ebrahim

2014-01-01

Objectives. Pneumonia is one of the common mortality causes in young children. Some studies have shown beneficial effect of zinc supplements on treatment of pneumonia. The present study aimed to investigate the effects of short courses of zinc administration on recovery from this disease in hospitalized children. Methods. In a parallel Double-Blind Randomized Controlled Trial at Ayatollah Golpaygani Hospital in Qom, 120 children aged 3–60 months with pneumonia were randomly assigned 1 : 1 to receive zinc or placebo (5 mL every 12 hours) along with the common antibiotic treatments until discharge. Primary outcome was recovery from pneumonia which included the incidence and resolving clinical symptoms and duration of hospitalization. Results. The difference between two groups in all clinical symptoms at admittance and the variables affecting the disease such as age and sex were not statistically significant (P < 0.05) at baseline. Compared to the placebo group, the treatment group showed a statistically significant decrease in duration of clinical symptoms (P = 0.044) and hospitalization (P = 0.004). Conclusions. Supplemental administration of zinc can expedite the healing process and results in faster resolution of clinical symptoms in children with pneumonia. In general, zinc administration, along with common antibiotic treatments, is recommended in this group of children. It can also reduce the drug resistance caused by multiple antibiotic therapies. This trial is approved by Medical Ethic Committee of Islamic Azad University in Iran (ID Number: 8579622-Q). This study is also registered in AEARCTR (The American Economic Association's Registry for Randomized Controlled Trials). This trial is registered with RCT ID: AEARCTR-0000187. PMID:24955282

Early versus delayed invasive strategy for intermediate- and high-risk acute coronary syndromes managed without P2Y12 receptor inhibitor pretreatment: Design and rationale of the EARLY randomized trial.

PubMed

Lemesle, Gilles; Laine, Marc; Pankert, Mathieu; Puymirat, Etienne; Cuisset, Thomas; Boueri, Ziad; Maillard, Luc; Armero, Sébastien; Cayla, Guillaume; Bali, Laurent; Motreff, Pascal; Peyre, Jean-Pascal; Paganelli, Franck; Kerbaul, François; Roch, Antoine; Michelet, Pierre; Baumstarck, Karine; Bonello, Laurent

2018-01-01

According to recent literature, pretreatment with a P2Y 12 ADP receptor antagonist before coronary angiography appears no longer suitable in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) due to an unfavorable risk-benefit ratio. Optimal delay of the invasive strategy in this specific context is unknown. We hypothesize that without P2Y 12 ADP receptor antagonist pretreatment, a very early invasive strategy may be beneficial. The EARLY trial (Early or Delayed Revascularization for Intermediate- and High-Risk Non-ST-Segment Elevation Acute Coronary Syndromes?) is a prospective, multicenter, randomized, controlled, open-label, 2-parallel-group study that plans to enroll 740 patients. Patients are eligible if the diagnosis of intermediate- or high-risk NSTE-ACS is made and an invasive strategy intended. Patients are randomized in a 1:1 ratio. In the control group, a delayed strategy is adopted, with the coronary angiography taking place between 12 and 72 hours after randomization. In the experimental group, a very early invasive strategy is performed within 2 hours. A loading dose of a P2Y 12 ADP receptor antagonist is given at the time of intervention in both groups. Recruitment began in September 2016 (n = 558 patients as of October 2017). The primary endpoint is the composite of cardiovascular death and recurrent ischemic events at 1 month. The EARLY trial aims to demonstrate the superiority of a very early invasive strategy compared with a delayed strategy in intermediate- and high-risk NSTE-ACS patients managed without P2Y 12 ADP receptor antagonist pretreatment. © 2018 Wiley Periodicals, Inc.

Twice-weekly aripiprazole for treating children and adolescents with tic disorder, a randomized controlled clinical trial.

PubMed

Ghanizadeh, Ahmad

2016-01-01

Treating tic disorder is challenging. No trial has ever examined whether twice weekly aripiprazole is effective for treating tic disorders. Participants of this 8-week randomized controlled parallel-group clinical trial were a clinical sample of 36 children and adolescents with tic disorder. Yale global tic severity scale was used to assess the outcome. Both groups received daily dosage of aripiprazole for the first 14 days. Then, one group received daily dose of aripiprazole while the other group received twice weekly dosage of aripiprazole for the next 46 days. The patients were assessed at baseline, week 2, 4, and 8. Tic scores decreased in both group significantly 22.8 (18.5) versus 22.0 (11.6). Moreover, there was no between group difference. The final mean (SD) score of motor and vocal tics in the group treated with daily treatment was not significantly different from the twice weekly group (Cohen's d = 0.36). The odds ratios for sedation and increased appetite were 3.05 and 3, respectively. For the first time, current findings support that twice weekly aripiprazole efficacy was not different from that of daily treatment. The rate of drowsiness in the twice weekly treatment group was less than that of the daily treatment group. This trial was registered at http://www.irct.ir. The registration number of this trial was: IRCT201312263930N32. http://www.irct.ir/searchresult.php?id=3930&number=32.

Effect of visual method vs plaque disclosure in enhancing oral hygiene in adolescents and young adults: a single-blind randomized controlled trial.

PubMed

Peng, Yiran; Wu, Ruixian; Qu, Wenwen; Wu, Wanhong; Chen, Jiangyue; Fang, Jie; Chen, Yangxi; Farella, Mauro; Mei, Li

2014-03-01

Enamel demineralization and gingival inflammation are the most prevalent consequences of biofilm formation in orthodontics. Our hypothesis was that educating patients about the severe consequences of biofilm accumulation could enhance their oral hygiene while wearing fixed appliances. This study was designed as a randomized controlled 4-arm parallel trial. A total of 148 participants in Chengdu, China, matching the eligibility criteria of 11 to 25 years of age, at least 20 natural teeth, and a treatment plan that included conventional stainless steel brackets, were randomly assigned to 4 intervention groups based on computer-generated random sequencing using simple randomization without blocking. In group A (n = 37), the subjects were shown images illustrating the severe consequences of biofilm formation, including enamel demineralization and gingival inflammation; subjects in group B (n = 40) were given biofilm disclosing tablets; those in group C (n = 38) received a combination of A and B; the subjects in group D (n = 33) served as the controls. The investigators were blinded to the allocations, and the researcher managing the random sequence did not participate in allocation or measurement. All groups received routine oral hygiene instructions. Plaque index and gingival index scores were recorded at each appointment during a 6-month follow-up. Eighteen participants were lost during follow-up, resulting in a total of 130 participants after the trial (group A, 35; group B, 32; group C, 34; group D, 29). No adverse events were recorded. Groups A and C exhibited a significantly lower plaque index scores (parameter-estimate [95% confidence interval] = -1.20 [-1.76 to -0.63] for group A, and -1.12 [-1.69 to -0.56] for group C) and gingival index scores (-0.13 [-0.21 to -0.04], and -0.19 [-0.28 to -0.10]), respectively, compared with group D (P <0.001 for all), whereas no significant difference was found between groups B and D, or between groups A and C (P >0.05). The adults had significantly lower plaque index (0.48 [0.13-0.84], P <0.001) and gingival index (0.06 [0.01-0.11], P = 0.018) scores than did the teenagers, and the female subjects had significantly higher gingival index (-0.06 [-0.11 to -0.01], P = 0.040) scores than did the male subjects. The use of images showing the severe consequences of biofilm accumulation enhanced the oral hygiene of patients treated with fixed appliances. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Evaluation of the accuracy of the Rotating Parallel Ray Omnidirectional Integration for instantaneous pressure reconstruction from the measured pressure gradient

NASA Astrophysics Data System (ADS)

Moreto, Jose; Liu, Xiaofeng

2017-11-01

The accuracy of the Rotating Parallel Ray omnidirectional integration for pressure reconstruction from the measured pressure gradient (Liu et al., AIAA paper 2016-1049) is evaluated against both the Circular Virtual Boundary omnidirectional integration (Liu and Katz, 2006 and 2013) and the conventional Poisson equation approach. Dirichlet condition at one boundary point and Neumann condition at all other boundary points are applied to the Poisson solver. A direct numerical simulation database of isotropic turbulence flow (JHTDB), with a homogeneously distributed random noise added to the entire field of DNS pressure gradient, is used to assess the performance of the methods. The random noise, generated by the Matlab function Rand, has a magnitude varying randomly within the range of +/-40% of the maximum DNS pressure gradient. To account for the effect of the noise distribution pattern on the reconstructed pressure accuracy, a total of 1000 different noise distributions achieved by using different random number seeds are involved in the evaluation. Final results after averaging the 1000 realizations show that the error of the reconstructed pressure normalized by the DNS pressure variation range is 0.15 +/-0.07 for the Poisson equation approach, 0.028 +/-0.003 for the Circular Virtual Boundary method and 0.027 +/-0.003 for the Rotating Parallel Ray method, indicating the robustness of the Rotating Parallel Ray method in pressure reconstruction. Sponsor: The San Diego State University UGP program.

Exploring the role of quantitative feedback in inhaler technique education: a cluster-randomised, two-arm, parallel-group, repeated-measures study.

PubMed

Toumas-Shehata, Mariam; Price, David; Basheti, Iman Amin; Bosnic-Anticevich, Sinthia

2014-11-13

Feedback is a critical component of any educational intervention. When it comes to feedback associated with inhaler technique education, there is a lack of knowledge on its role or its potential to solve the major issue of poor inhaler technique. This study aims to explore the role of feedback in inhaler technique education and its impact on the inhaler technique of patients over time. A parallel-group, repeated-measures study was conducted in the community pharmacy in which the effectiveness of current best practice inhaler technique education utilising qualitative visual feedback (Group 1) was compared with a combination of qualitative and quantitative visual feedback (Group 2). The impact of these two interventions on inhaler technique maintenance was evaluated. Community pharmacists were randomly allocated to recruit people with asthma who were using a dry powder inhaler. At Visit 1 their inhaler technique was evaluated and education delivered and they were followed up at Visit 2 (1 month later). Both educational interventions resulted in an increase in the proportion of patients with correct inhaler technique: from 4% to 51% in Group 1 and from 6% to 83% in Group 2 (Pearson's Chi-Squared, P=0.03, n=49, and Pearson's Chi-Squared, P=0.01, n=48, respectively). The magnitude of improvement was statistically significantly higher for Group 2 compared with Group 1 (n=97, P=0.02, Pearson's Chi-Square test). The nature of feedback has an impact on the effectiveness of inhaler technique education with regard to correct inhaler technique maintenance over time.

Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

PubMed Central

Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

2015-01-01

Objective To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. Methods This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Results Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Conclusion Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention. PMID:25926725

A randomized, double-blind, clinical trial comparing the efficacy and safety of Crocus sativus L. with fluoxetine for improving mild to moderate depression in post percutaneous coronary intervention patients.

PubMed

Shahmansouri, Nazila; Farokhnia, Mehdi; Abbasi, Seyed-Hesammeddin; Kassaian, Seyed Ebrahim; Noorbala Tafti, Ahmad-Ali; Gougol, Amirhossein; Yekehtaz, Habibeh; Forghani, Saeedeh; Mahmoodian, Mehran; Saroukhani, Sepideh; Arjmandi-Beglar, Akram; Akhondzadeh, Shahin

2014-02-01

A significant correlation exists between coronary artery diseases and depression. The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression after performing percutaneous coronary intervention (PCI). In this randomized double-blind parallel-group study, 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoexetine (40mg/day) or saffron (30mg/day) capsule for six weeks. Participants were evaluated by Hamilton depression rating scale (HDRS) at weeks 3 and 6 and the adverse events were systemically recorded. By the study endpoint, no significant difference was detected between two groups in reduction of HDRS scores (P=0.62). Remission and response rates were not significantly different as well (P=1.00 and P=0.67; respectively). There was no significant difference between two groups in the frequency of adverse events during this trial. Relatively small sample size and short observational period were the major limitations of this study. Short-term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression. © 2013 Published by Elsevier B.V.

Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial.

PubMed

Trabal, Joan; Forga, Maria; Leyes, Pere; Torres, Ferran; Rubio, Jordi; Prieto, Esther; Farran-Codina, Andreu

2015-01-01

To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults. This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15) or a placebo (control group [CG], n=15), plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation. Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes. Our combined analysis showed moderate changes in isometric leg muscle strength and certain components of functional status. The magnitude of changes found on these outcomes should be qualified as a positive effect of the concomitant intervention.

An exploratory study on the efficacy and safety of a BCAA preparation used in combination with cardiac rehabilitation for patients with chronic heart failure.

PubMed

Takata, Munenori; Amiya, Eisuke; Watanabe, Masafumi; Hosoya, Yumiko; Nakayama, Atsuko; Fujiwara, Takayuki; Taya, Masanobu; Oguri, Gaku; Hyodo, Kanako; Takayama, Naoko; Takano, Nami; Mashiko, Tomoe; Uemura, Yukari; Komuro, Issei

2017-07-27

Sarcopenia is generally complicated with patients with chronic heart failure (CHF) and its presence negatively affects the course of heart failure, however effective nutritional intervention had not been elucidated yet. The primary objective of this study is to explore whether the addition of a branched-chain amino acid (BCAA) preparation for cardiac rehabilitation (CR) of patients with CHF further improves cardiopulmonary functions, skeletal muscle functions, and metabolism in comparison with conventional CR. This is a randomized, parallel-group comparative study. The elderly patients that were participated in CR and complicated with left ventricular systolic or diastolic dysfunction are randomized into two groups, CR + BCAA and CR. 20 weeks later, the second randomization is performed, which divide subjects into two groups with and without BCAA intervention without CR. Primary outcome measure is the rate of change of the anaerobic threshold workload from baseline to post-intervention. Secondary outcome include parameters of exercise capacity, cardiac function and psychological status. In the current study the effect of a promising new intervention, BCAA, will be assessed to determine whether its addition to CR improve exercise capacity in patients with heart failure, who are generally complicated with sarcopenia. This clinical trial was registered with the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR; JPRN-UMIN R000022440 ).

Parallel Mitogenome Sequencing Alleviates Random Rooting Effect in Phylogeography.

PubMed

Hirase, Shotaro; Takeshima, Hirohiko; Nishida, Mutsumi; Iwasaki, Wataru

2016-04-28

Reliably rooted phylogenetic trees play irreplaceable roles in clarifying diversification in the patterns of species and populations. However, such trees are often unavailable in phylogeographic studies, particularly when the focus is on rapidly expanded populations that exhibit star-like trees. A fundamental bottleneck is known as the random rooting effect, where a distant outgroup tends to root an unrooted tree "randomly." We investigated whether parallel mitochondrial genome (mitogenome) sequencing alleviates this effect in phylogeography using a case study on the Sea of Japan lineage of the intertidal goby Chaenogobius annularis Eighty-three C. annularis individuals were collected and their mitogenomes were determined by high-throughput and low-cost parallel sequencing. Phylogenetic analysis of these mitogenome sequences was conducted to root the Sea of Japan lineage, which has a star-like phylogeny and had not been reliably rooted. The topologies of the bootstrap trees were investigated to determine whether the use of mitogenomes alleviated the random rooting effect. The mitogenome data successfully rooted the Sea of Japan lineage by alleviating the effect, which hindered phylogenetic analysis that used specific gene sequences. The reliable rooting of the lineage led to the discovery of a novel, northern lineage that expanded during an interglacial period with high bootstrap support. Furthermore, the finding of this lineage suggested the existence of additional glacial refugia and provided a new recent calibration point that revised the divergence time estimation between the Sea of Japan and Pacific Ocean lineages. This study illustrates the effectiveness of parallel mitogenome sequencing for solving the random rooting problem in phylogeographic studies. © The Author 2016. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

“A Vegetarian vs. Conventional Hypocaloric Diet: The Effect on Physical Fitness in Response to Aerobic Exercise in Patients with Type 2 Diabetes.” A Parallel Randomized Study

PubMed Central

Veleba, Jiri; Matoulek, Martin; Hill, Martin; Pelikanova, Terezie; Kahleova, Hana

2016-01-01

It has been shown that it is possible to modify macronutrient oxidation, physical fitness and resting energy expenditure (REE) by changes in diet composition. Furthermore, mitochondrial oxidation can be significantly increased by a diet with a low glycemic index. The purpose of our trial was to compare the effects of a vegetarian (V) and conventional diet (C) with the same caloric restriction (−500 kcal/day) on physical fitness and REE after 12 weeks of diet plus aerobic exercise in 74 patients with type 2 diabetes (T2D). An open, parallel, randomized study design was used. All meals were provided for the whole study duration. An individualized exercise program was prescribed to the participants and was conducted under supervision. Physical fitness was measured by spiroergometry and indirect calorimetry was performed at the start and after 12 weeks Repeated-measures ANOVA (Analysis of variance) models with between-subject (group) and within-subject (time) factors and interactions were used for evaluation of the relationships between continuous variables and factors. Maximal oxygen consumption (VO2max) increased by 12% in vegetarian group (V) (F = 13.1, p < 0.001, partial η2 = 0.171), whereas no significant change was observed in C (F = 0.7, p = 0.667; group × time F = 9.3, p = 0.004, partial η2 = 0.209). Maximal performance (Watt max) increased by 21% in V (F = 8.3, p < 0.001, partial η2 = 0.192), whereas it did not change in C (F = 1.0, p = 0.334; group × time F = 4.2, p = 0.048, partial η2 = 0.116). Our results indicate that V leads more effectively to improvement in physical fitness than C after aerobic exercise program. PMID:27792174

Emergency skill training--a randomized controlled study on the effectiveness of the 4-stage approach compared to traditional clinical teaching.

PubMed

Greif, Robert; Egger, Lars; Basciani, Reto M; Lockey, Andrew; Vogt, Andreas

2010-12-01

The "4-stage approach" has been widely accepted for practical skill training replacing the traditional 2 stages ("see one, do one"). However, the superior effectiveness of the 4-stage approach was never proved. To evaluate whether skill training with the 4-stage approach results in shorter performance time needed for a successful percutaneous needle-puncture cricothyroidotomy, and consequently in a reduced number of attempts needed to perform the skill in <60s compared to traditional teaching. Randomized controlled single-blinded parallel group study at the University Hospital Bern. With IRB approval and informed consent 128 undergraduate medical students were randomized in four groups: traditional teaching, no stage 2, no stage 3, and 4-stage approach for the training of cricothyroidotomy. Everyone watched a video of the cricothyroidotomy as stage 1 followed by skill training in the respective teaching group. Participants had to perform the cricothyroidotomy 10 times on skin-covered pig larynxes. Performance time was measured from skin palpation to trachea ventilation. Study participants filled out a self-rating on competency during the training. Performance time for each attempt was comparable in all groups and improved similarly to reach a performance time of <60 s. Self-rating revealed that all groups felt equally competent throughout. Even if the 4-stage approach is widely accepted and used as a didactic method for skill teaching we could not find evidence that its use or omitting stage 2 or 3 results in superior learning of an emergency skill compared to traditional teaching. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Providing additional money to food-insecure households and its effect on food expenditure: a randomized controlled trial.

PubMed

Smith, Claire; Parnell, Winsome Ruth; Brown, Rachel Clare; Gray, Andrew Robert

2013-08-01

Financial constraint is the underpinning determinant of household food insecurity; however, there has been little research examining the impact that increasing the ‘money available’ to food-insecure households could have on food purchasing. The main objective of the present study was to examine the effect of additional money (in the form of supermarket vouchers) on food expenditure in food-insecure households with children. A parallel randomized controlled trial with a 4-week baseline phase followed by a 4-week intervention phase. Households were randomized to either receive vouchers (coupons) for 4 weeks or a control group that did not receive any vouchers. Dunedin, New Zealand. Low-income households with children ≥ 18 years) reporting food insecurity (n 214). The mean monetary value of the vouchers received by households was $NZ 17?00 per week. The voucher group spent ≥ NZ 15.20 (95% CI 1.46, 28.94) more per week on food during the intervention phase compared with the control group (P50.030). There were no differences in expenditure between the voucher and the control group for the food groups ‘fruit and vegetables’ (mean difference: ≥ NZ 0?46; 95% CI 21.97, 2.89; P50.709), ‘meat and poultry’ (mean difference: ≥ NZ 0.29; 95% CI 23.07, 3.64; P50.866) and ‘dairy’ (mean difference: ≥ NZ 0.82; 95% CI 20.75, 2.42; P50.302). Providing money via supermarket vouchers to food-insecure resulted in an increase in overall expenditure on food.

Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

PubMed

Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

2017-03-01

To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

Does the bracket–ligature combination affect the amount of orthodontic space closure over three months? A randomized controlled trial

PubMed Central

Wong, Henry; Collins, Jill; Tinsley, David; Sandler, Jonathan; Benson, Philip

2013-01-01

Objective: To investigate the effect of bracket–ligature combination on the amount of orthodontic space closure over three months. Design: Randomized clinical trial with three parallel groups. Setting: A hospital orthodontic department (Chesterfield Royal Hospital, UK). Participants: Forty-five patients requiring upper first premolar extractions. Methods: Informed consent was obtained and participants were randomly allocated into one of three groups: (1) conventional pre-adjusted edgewise brackets and elastomeric ligatures; (2) conventional pre-adjusted edgewise brackets and Super Slick® low friction elastomeric ligatures; (3) Damon 3MX® passive self-ligating brackets. Space closure was undertaken on 0·019×0·025-inch stainless steel archwires with nickel–titanium coil springs. Participants were recalled at four weekly intervals. Upper alginate impressions were taken at each visit (maximum three). The primary outcome measure was the mean amount of space closure in a 3-month period. Results: A one-way ANOVA was undertaken [dependent variable: mean space closure (mm); independent variable: group allocation]. The amount of space closure was very similar between the three groups (1 mm per 28 days); however, there was a wide variation in the rate of space closure between individuals. The differences in the amount of space closure over three months between the three groups was very small and non-significant (P = 0·718). Conclusion: The hypothesis that reducing friction by modifying the bracket/ligature interface increases the rate of space closure was not supported. The major determinant of orthodontic tooth movement is probably the individual patient response. PMID:23794696

Autologous hematopoietic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a randomized clinical trial.

PubMed

van Laar, Jacob M; Farge, Dominique; Sont, Jacob K; Naraghi, Kamran; Marjanovic, Zora; Larghero, Jérôme; Schuerwegh, Annemie J; Marijt, Erik W A; Vonk, Madelon C; Schattenberg, Anton V; Matucci-Cerinic, Marco; Voskuyl, Alexandre E; van de Loosdrecht, Arjan A; Daikeler, Thomas; Kötter, Ina; Schmalzing, Marc; Martin, Thierry; Lioure, Bruno; Weiner, Stefan M; Kreuter, Alexander; Deligny, Christophe; Durand, Jean-Marc; Emery, Paul; Machold, Klaus P; Sarrot-Reynauld, Francoise; Warnatz, Klaus; Adoue, Daniel F P; Constans, Joël; Tony, Hans-Peter; Del Papa, Nicoletta; Fassas, Athanasios; Himsel, Andrea; Launay, David; Lo Monaco, Andrea; Philippe, Pierre; Quéré, Isabelle; Rich, Éric; Westhovens, Rene; Griffiths, Bridget; Saccardi, Riccardo; van den Hoogen, Frank H; Fibbe, Willem E; Socié, Gérard; Gratwohl, Alois; Tyndall, Alan

2014-06-25

High-dose immunosuppressive therapy and autologous hematopoietic stem cell transplantation (HSCT) have shown efficacy in systemic sclerosis in phase 1 and small phase 2 trials. To compare efficacy and safety of HSCT vs 12 successive monthly intravenous pulses of cyclophosphamide. The Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial, a phase 3, multicenter, randomized (1:1), open-label, parallel-group, clinical trial conducted in 10 countries at 29 centers with access to a European Group for Blood and Marrow Transplantation-registered transplant facility. From March 2001 to October 2009, 156 patients with early diffuse cutaneous systemic sclerosis were recruited and followed up until October 31, 2013. HSCT vs intravenous pulse cyclophosphamide. The primary end point was event-free survival, defined as time from randomization until the occurrence of death or persistent major organ failure. A total of 156 patients were randomly assigned to receive HSCT (n = 79) or cyclophosphamide (n = 77). During a median follow-up of 5.8 years, 53 events occurred: 22 in the HSCT group (19 deaths and 3 irreversible organ failures) and 31 in the control group (23 deaths and 8 irreversible organ failures). During the first year, there were more events in the HSCT group (13 events [16.5%], including 8 treatment-related deaths) than in the control group (8 events [10.4%], with no treatment-related deaths). At 2 years, 14 events (17.7%) had occurred cumulatively in the HSCT group vs 14 events (18.2%) in the control group; at 4 years, 15 events (19%) had occurred cumulatively in the HSCT group vs 20 events (26%) in the control group. Time-varying hazard ratios (modeled with treatment × time interaction) for event-free survival were 0.35 (95% CI, 0.16-0.74) at 2 years and 0.34 (95% CI, 0.16-0.74) at 4 years. Among patients with early diffuse cutaneous systemic sclerosis, HSCT was associated with increased treatment-related mortality in the first year after treatment. However, HCST conferred a significant long-term event-free survival benefit. isrctn.org Identifier: ISRCTN54371254.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis.

PubMed

Gerent, Aline Rejane Muller; Almeida, Juliano Pinheiro; Fominskiy, Evgeny; Landoni, Giovanni; de Oliveira, Gisele Queiroz; Rizk, Stephanie Itala; Fukushima, Julia Tizue; Simoes, Claudia Marques; Ribeiro, Ulysses; Park, Clarice Lee; Nakamura, Rosana Ely; Franco, Rafael Alves; Cândido, Patricia Inês; Tavares, Cintia Rosa; Camara, Ligia; Dos Santos Rocha Ferreira, Graziela; de Almeida, Elisangela Pinto Marinho; Filho, Roberto Kalil; Galas, Filomena Regina Barbosa Gomes; Hajjar, Ludhmila Abrahão

2018-05-23

Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. We hypothesized that using cardiac index (CI)-guided GDHT in the postoperative period for patients undergoing high-risk surgery for cancer treatment would reduce 30-day mortality and postoperative complications. A randomized, parallel-group, superiority trial was performed in a tertiary oncology hospital. All adult patients undergoing high-risk cancer surgery who required intensive care unit admission were randomly allocated to a CI-guided GDHT group or to a usual care group. In the GDHT group, postoperative therapy aimed at CI ≥ 2.5 L/min/m 2 using fluids, inotropes and red blood cells during the first 8 postoperative hours. The primary outcome was a composite endpoint of 30-day all-cause mortality and severe postoperative complications during the hospital stay. A meta-analysis was also conducted including all randomized trials of postoperative GDHT published from 1966 to May 2017. A total of 128 patients (64 in each group) were randomized. The primary outcome occurred in 34 patients of the GDHT group and in 28 patients of the usual care group (53.1% vs 43.8%, absolute difference 9.4 (95% CI, - 7.8 to 25.8); p = 0.3). During the 8-h intervention period more patients in the GDHT group received dobutamine when compared to the usual care group (55% vs 16%, p < 0.001). A meta-analysis of nine randomized trials showed no differences in postoperative mortality (risk ratio 0.85, 95% CI 0.59-1.23; p = 0.4; p for heterogeneity = 0.7; I 2  = 0%) and in the overall complications rate (risk ratio 0.88, 95% CI 0.71-1.08; p = 0.2; p for heterogeneity = 0.07; I 2  = 48%), but a reduced hospital length of stay in the GDHT group (mean difference (MD) - 1.6; 95% CI - 2.75 to - 0.46; p = 0.006; p for heterogeneity = 0.002; I 2  = 74%). CI-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery. www.clinicaltrials.gov , NCT01946269 . Registered on 16 September 2013.

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

PubMed

Huo, Jian; Liu, Li-Sha; Jian, Wen-Yuan; Zeng, Jie-Ping; Duan, Jun-Guo; Lu, Xue-Jing; Yin, Shuo

2018-06-18

Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

[Treatment of combined hyperlipidemia patients by jiangzhi tongluo soft capsule combined atorvastatin calcium tablet: a clinical study].

PubMed

Xie, Ying; He, Yu-Bin; Zhang, Shi-Xin; Pan, Ai-Qun; Zhang, Jun; Guan, Xiao-Hong; Wang, Jin-Xue; Guo, Wen-Sheng

2014-09-01

To evaluate the efficacy and safety of using Jiangzhi Tongluo Soft Capsule (JTSC) combined with Atorvastatin Calcium Tablet (ACT) or ACT alone in treatment of combined hyperlipidemia. A randomized, double blinded, parallel control, and multi-center clinical research design was adopted. Totally 138 combined hyperlipidemia patients were randomly assigned to the combined treatment group (A) and the atorvastatin treatment group (B) by random digit table, 69 in each group. All patients took ACT 20 mg per day. Patients in the A group took JTSC 100 mg each time, 3 times per day. Those in the B group took JTSC simulated agent, 100 mg each time, 3 times per day. The treatment period for all was 8 weeks. Serum levels of triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), and high density lipoprotein cholesterol (HDL-C) were observed before treatment, at week 4 and 8 after treatment; and safety was assessed as well. At week 4 and 8 after treatment serum TG decreased by 26.69% and 33.29% respectively in the A group (both P < 0.01), while it was decreased by 25.7% and 22.98% respectively in the B group (both P < 0.01). At week 8 decreased serum TG was obviously higher in the A group than in the B group (P < 0.05). Compared with before treatment, serum levels of LDL-C and TC levels decreased significantly in the two groups (all P < 0.01). There was no statistical difference in the drop-out value and the drop-out rate of serum LDL-C and TC levels (P > 0.05). At week 8 the serum HDL-C level showed an increasing tendency in the two groups. No obvious increase in peptase or creatase occurred in the two groups after treatment. JTSC combined with ACT could lower the serum TG level of combined hyperlipidemia patients with safety.

A sweep algorithm for massively parallel simulation of circuit-switched networks

NASA Technical Reports Server (NTRS)

Gaujal, Bruno; Greenberg, Albert G.; Nicol, David M.

1992-01-01

A new massively parallel algorithm is presented for simulating large asymmetric circuit-switched networks, controlled by a randomized-routing policy that includes trunk-reservation. A single instruction multiple data (SIMD) implementation is described, and corresponding experiments on a 16384 processor MasPar parallel computer are reported. A multiple instruction multiple data (MIMD) implementation is also described, and corresponding experiments on an Intel IPSC/860 parallel computer, using 16 processors, are reported. By exploiting parallelism, our algorithm increases the possible execution rate of such complex simulations by as much as an order of magnitude.

Effects of Silybum marianum (L.) Gaertn. (silymarin) extract supplementation on antioxidant status and hs-CRP in patients with type 2 diabetes mellitus: a randomized, triple-blind, placebo-controlled clinical trial.

PubMed

Ebrahimpour Koujan, Soraiya; Gargari, Bahram Pourghassem; Mobasseri, Majid; Valizadeh, Hadi; Asghari-Jafarabadi, Mohammad

2015-02-15

Diabetes is a serious metabolic disorder and oxidative stress and inflammation contribute to its pathogenesis and complications. Since Silybum marianum (L.) Gaertn. (silymarin) extract is an antioxidant with anti-inflammatory properties, this randomized clinical trial was conducted to evaluate the effects of silymarin supplementation on oxidative stress indices and hs-CRP in type 2 diabetes mellitus patients. For the present paralleled, randomized, triple-blinded, placebo-controlled clinical trial, 40 type 2 diabetes patients aged 25-50 yr old and on stable medication were recruited from the Iranian Diabetes Society and endocrinology clinics in East Azarbayjan (Tabriz, Iran) and randomly assigned into two groups. Patients in the silymarin treatment group received 140 mg, thrice daily of dried extracts of Silybum marianum (n = 20) and those in the placebo group (n = 20) received identical placebos for 45 days. Data pertaining to height, weight, waist circumference and BMI, as well as food consumption, were collected at base line and at the conclusion of the study. Fasting blood samples were obtained and antioxidant indices and hs-CRP were assessed at baseline, as well as at the end of the trial. All 40 patients completed the study and did not report any adverse effects or symptoms with the silymarin supplementation. Silymarin supplementation significantly increased superoxide dismutase (SOD), glutathione peroxidase (GPX) activity and total antioxidant capacity (TAC) compared to patients taking the placebo, by 12.85%, 30.32% and 8.43%, respectively (p < 0.05). There was a significant reduction in hs-CRP levels by 26.83% (p < 0.05) in the silymarin group compared to the placebo group. Malondialdehyde (MDA) concentration significantly decreased by 12.01% (p < 0.05) in the silymarin group compared to the baseline. Silymarin supplementation improves some antioxidant indices (SOD, GPX and TAC) and decrease hs-CRP levels in T2DM patients. Copyright © 2015. Published by Elsevier GmbH.

Randomized multicentre trial comparing external and internal pancreatic stenting during pancreaticoduodenectomy.

PubMed

Jang, J-Y; Chang, Y R; Kim, S-W; Choi, S H; Park, S J; Lee, S E; Lim, C-S; Kang, M J; Lee, H; Heo, J S

2016-05-01

There is no consensus on the best method of preventing postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). This multicentre, parallel group, randomized equivalence trial investigated the effect of two ways of pancreatic stenting after PD on the rate of POPF. Patients undergoing elective PD or pylorus-preserving PD with duct-to-mucosa pancreaticojejunostomy were enrolled from four tertiary referral hospitals. Randomization was stratified according to surgeon with a 1 : 1 allocation ratio to avoid any related technical factors. The primary endpoint was clinically relevant POPF rate. Secondary endpoints were nutritional index, remnant pancreatic volume, long-term complications and quality of life 2 years after PD. A total of 328 patients were randomized to the external (164 patients) or internal (164) stent group between August 2010 and January 2014. The rates of clinically relevant POPF were 24·4 per cent in the external and 18·9 per cent in the internal stent group (risk difference 5·5 per cent). As the 90 per cent confidence interval (-2·0 to 13·0 per cent) did not fall within the predefined equivalence limits (-10 to 10 per cent), the clinically relevant POPF rates in the two groups were not equivalent. Similar results were observed for patients with soft pancreatic texture and high fistula risk score. Other postoperative outcomes were comparable between the two groups. Five stent-related complications occurred in the external stent group. Multivariable analysis revealed that soft pancreatic texture, non-pancreatic disease and high body mass index (23·3 kg/m 2 or above) predicted clinically relevant POPF. External stenting after PD was associated with a higher rate of clinically relevant POPF than internal stenting. Registration number: NCT01023594 (https://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

Estimation of treatment efficacy with complier average causal effects (CACE) in a randomized stepped wedge trial.

PubMed

Gruber, Joshua S; Arnold, Benjamin F; Reygadas, Fermin; Hubbard, Alan E; Colford, John M

2014-05-01

Complier average causal effects (CACE) estimate the impact of an intervention among treatment compliers in randomized trials. Methods used to estimate CACE have been outlined for parallel-arm trials (e.g., using an instrumental variables (IV) estimator) but not for other randomized study designs. Here, we propose a method for estimating CACE in randomized stepped wedge trials, where experimental units cross over from control conditions to intervention conditions in a randomized sequence. We illustrate the approach with a cluster-randomized drinking water trial conducted in rural Mexico from 2009 to 2011. Additionally, we evaluated the plausibility of assumptions required to estimate CACE using the IV approach, which are testable in stepped wedge trials but not in parallel-arm trials. We observed small increases in the magnitude of CACE risk differences compared with intention-to-treat estimates for drinking water contamination (risk difference (RD) = -22% (95% confidence interval (CI): -33, -11) vs. RD = -19% (95% CI: -26, -12)) and diarrhea (RD = -0.8% (95% CI: -2.1, 0.4) vs. RD = -0.1% (95% CI: -1.1, 0.9)). Assumptions required for IV analysis were probably violated. Stepped wedge trials allow investigators to estimate CACE with an approach that avoids the stronger assumptions required for CACE estimation in parallel-arm trials. Inclusion of CACE estimates in stepped wedge trials with imperfect compliance could enhance reporting and interpretation of the results of such trials.

Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers.

PubMed

Udani, Jay K; Singh, Betsy B; Barrett, Marilyn L; Singh, Vijay J

2010-08-26

Arabinogalactan from Larch tree (Larix spp.) bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia) vaccine in healthy adults. This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g) at the screening visit (V1-Day 0) and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2). They were monitored the following day (V3-Day 31), as well as 21 days (V4-Day 51) and 42 days (V5-Day 72) after vaccination. Responses by the adaptive immune system (antigen specific) were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and salivary IgA levels. Responses by the innate immune system (non-specific) were measured via white blood cell counts, inflammatory cytokines and the complement system. Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F) at both Day 51 (p = 0.006 and p = 0.002) and at Day 72 (p = 0.008 and p = 0.041). These same subtypes (18C and 23F) also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001) and at Day 72 (p = 0.012 and p = 0.003). Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There was no effect from the vaccine or arabinogalactan on salivary IgA, white blood cell count, inflammatory cytokines or complement. The proprietary arabinogalactan extract (ResistAid), tested in this randomized, double-blind, placebo-controlled, parallel-group pilot study, increased the antibody response of healthy volunteers to the 23-valent pneumococcal vaccine compared to placebo. ISRCTN98817459.

Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

PubMed Central

2010-01-01

Background Arabinogalactan from Larch tree (Larix spp.) bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia) vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g) at the screening visit (V1-Day 0) and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2). They were monitored the following day (V3-Day 31), as well as 21 days (V4-Day 51) and 42 days (V5-Day 72) after vaccination. Responses by the adaptive immune system (antigen specific) were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and salivary IgA levels. Responses by the innate immune system (non-specific) were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F) at both Day 51 (p = 0.006 and p = 0.002) and at Day 72 (p = 0.008 and p = 0.041). These same subtypes (18C and 23F) also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001) and at Day 72 (p = 0.012 and p = 0.003). Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There was no effect from the vaccine or arabinogalactan on salivary IgA, white blood cell count, inflammatory cytokines or complement. Conclusions The proprietary arabinogalactan extract (ResistAid™), tested in this randomized, double-blind, placebo-controlled, parallel-group pilot study, increased the antibody response of healthy volunteers to the 23-valent pneumococcal vaccine compared to placebo. Trial Registration ISRCTN98817459 PMID:20796315

Efficacy and tolerability of a fixed-dose combination of metoprolol extended release/amlodipine in patients with mild-to-moderate hypertension: a randomized, parallel-group, multicentre comparison with losartan plus amlodipine.

PubMed

Pareek, Anil; Chandurkar, Nitin B; Sharma, Ravishankar; Tiwari, Dharmendra; Gupta, Bhagwan S

2010-01-01

Epidemiological studies and clinical trials have shown that prevention of cardiovascular disease, the ultimate goal of hypertension treatment, requires a sufficient reduction in blood pressure. The primary objective of this study was to compare the mean decrease in systolic (SBP) and diastolic (DBP) blood pressure between metoprolol extended release (XL)/amlodipine fixed-dose combination and losartan plus amlodipine combination in patients with mild-to-moderate essential hypertension. The secondary objectives of this study were to compare the proportion of responders in the two treatment groups and to evaluate the tolerability of the study medications. This was a randomized, parallel-group, multicentre comparative study conducted at the outpatient departments of three teaching hospitals in India. Patients with mild-to-moderate hypertension (defined as DBP 90-109 mmHg) aged between 18 and 75 years were enrolled in this study and followed up for 12 weeks. Response to study treatments was evaluated in terms of mean decrease in SBP and DBP and the response rate (reduction to SBP <140 mmHg and DBP <90 mmHg). Out of 152 patients who underwent a 1-week placebo washout, 148 eligible patients were randomized to receive either metoprolol XL 25 mg/amlodipine 2.5 mg fixed-dose combination (76 patients) or losartan 25 mg plus amlodipine 2.5 mg (72 patients). The two treatment groups were similar with respect to demographic and baseline characteristics. Non-responders after 4 weeks of therapy were escalated to metoprolol XL 50 mg/amlodipine 5 mg fixed-dose combination or losartan 50 mg plus amlodipine 5 mg, respectively. The study was completed by 66 patients in each group, of whom 43 patients in each group responded to the starting doses. After 4 weeks' therapy, both treatments were associated with significant decreases in SBP and DBP from baseline (p < 0.001) and were comparable with respect to mean decrease in SBP (p = 0.304), mean decrease in DBP (p = 0.630) and response rate (p = 1.0). Also, both the step-up therapies were comparable with respect to mean decrease in SBP (p = 0.484), mean decrease in DBP (p = 0.650) and response rate (p = 0.134) at week 12. Both treatments were well tolerated in the studied population. Metoprolol XL/amlodipine fixed-dose combination was found to be as effective and well tolerated as losartan plus amlodipine in the treatment of essential hypertension.

Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study.

PubMed

Park, Won; Lee, Sang Joon; Yun, Jihye; Yoo, Dae Hyun

2015-01-01

To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima(®), Inflectra(®)]) with two formulations of the reference medicinal product (RMP) (Remicade(®)) from either Europe (EU-RMP) or the USA (US-RMP). This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71). The primary objective was to compare the PK profiles for the three formulations. Assessments of comparative safety and tolerability were secondary objectives. Baseline demographics were well balanced across the three groups. Primary end points (Cmax, AUClast and AUCinf) were equivalent between all formulations (CT-P13 vs EU-RMP; CT-P13 vs US-RMP; EU-RMP vs US-RMP). All other PK end points supported the high similarity of the three treatments. Tolerability profiles of the formulations were similar. The PK profile of CT-P13 is highly similar to EU-RMP and US-RMP. All three formulations were equally well tolerated.

Lack of significant anti-inflammatory activity with clindamycin in the treatment of rosacea: results of 2 randomized, vehicle-controlled trials.

PubMed

Martel, Philippe; Jarratt, Michael; Weiss, Jonathan; Carlavan, Isabelle

2017-07-01

Rosacea is a chronic inflammatory skin disease of the face. The objective of the studies described here was to evaluate the efficacy of clindamycin in the treatment of rosacea. Two multicenter, randomized, vehicle-controlled, phase 2 studies were conducted in participants with moderate to severe rosacea. Study A was a 12-week dose-comparison, 5-arm, parallel group comparison of clindamycin cream 1% or vehicle once or twice daily and clindamycin cream 0.3% once daily. Study B was a 2-arm comparison of twice daily clindamycin gel 1% versus vehicle gel. A total of 629 participants (study A, N=416; study B, N=213) were randomized. The results of these studies indicated that clindamycin cream 0.3% and 1% and clindamycin gel 1% were no more effective than the vehicle in the treatment of moderate to severe rosacea, suggesting clindamycin has no intrinsic anti-inflammatory activity in rosacea.

TemperSAT: A new efficient fair-sampling random k-SAT solver

NASA Astrophysics Data System (ADS)

Fang, Chao; Zhu, Zheng; Katzgraber, Helmut G.

The set membership problem is of great importance to many applications and, in particular, database searches for target groups. Recently, an approach to speed up set membership searches based on the NP-hard constraint-satisfaction problem (random k-SAT) has been developed. However, the bottleneck of the approach lies in finding the solution to a large SAT formula efficiently and, in particular, a large number of independent solutions is needed to reduce the probability of false positives. Unfortunately, traditional random k-SAT solvers such as WalkSAT are biased when seeking solutions to the Boolean formulas. By porting parallel tempering Monte Carlo to the sampling of binary optimization problems, we introduce a new algorithm (TemperSAT) whose performance is comparable to current state-of-the-art SAT solvers for large k with the added benefit that theoretically it can find many independent solutions quickly. We illustrate our results by comparing to the currently fastest implementation of WalkSAT, WalkSATlm.

The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie; O'Dwyer, Siobhan T; Murfield, Jenny; Johnston, Amy; Sung, Billy

2013-02-18

Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses' stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities. This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ≥ two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants' perceptions of the intervention. The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial η2=0.22) and anxiety (p= 0.02, partial η2=0.31), with the foot massage group experiencing greatest decreases immediately after the session. The qualitative interviews suggest the foot massage was well tolerated and although taking staff away from their work resulted in some participants feeling guilty about taking time out, a 10-min foot massage was feasible during a working shift. This pilot trial provides data to support the feasibility of the study in terms of recruitment and consent, the intervention and completion rates. Although the outcome data should be treated with caution, the pilot demonstrated the foot massage intervention showed trends in improved mood, reduced anxiety and lower blood pressure in long-term care staff working with older people with dementia. A larger study is needed to build on these promising, but preliminary, findings. ACTRN: ACTRN12612000659808.

A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component.

PubMed

Atkinson, J Hampton; Slater, Mark A; Capparelli, Edmund V; Patel, Shetal M; Wolfson, Tanya; Gamst, Anthony; Abramson, Ian S; Wallace, Mark S; Funk, Stephen D; Rutledge, Thomas R; Wetherell, Julie L; Matthews, Scott C; Zisook, Sidney; Garfin, Steven R

2016-07-01

Gabapentin is prescribed for analgesia in chronic low back pain, yet there are no controlled trials supporting this practice. This randomized, 2-arm, 12-week, parallel group study compared gabapentin (forced titration up to 3600 mg daily) with inert placebo. The primary efficacy measure was change in pain intensity from baseline to the last week on treatment measured by the Descriptor Differential Scale; the secondary outcome was disability (Oswestry Disability Index). The intention-to-treat analysis comprised 108 randomized patients with chronic back pain (daily pain for ≥6 months) whose pain did (43%) or did not radiate into the lower extremity. Random effects regression models which did not impute missing scores were used to analyze outcome data. Pain intensity decreased significantly over time (P < 0.0001) with subjects on gabapentin or placebo, reporting reductions of about 30% from baseline, but did not differ significantly between groups (P = 0.423). The same results pertained for disability scores. In responder analyses of those who completed 12 weeks (N = 72), the proportion reporting at least 30% or 50% reduction in pain intensity, or at least "Minimal Improvement" on the Physician Clinical Global Impression of Change did not differ significantly between groups. There were no significant differences in analgesia between participants with radiating (n = 46) and nonradiating (n = 62) pain either within or between treatment arms. There was no significant correlation between gabapentin plasma concentration and pain intensity. Gabapentin appears to be ineffective for analgesia in chronic low back pain with or without a radiating component.

Outcome of patients after lower limb fracture with partial weight bearing postoperatively treated with or without anti-gravity treadmill (alter G®) during six weeks of rehabilitation - a protocol of a prospective randomized trial.

PubMed

Henkelmann, Ralf; Schneider, Sebastian; Müller, Daniel; Gahr, Ralf; Josten, Christoph; Böhme, Jörg

2017-03-14

Partial or complete immobilization leads to different adjustment processes like higher risk of muscle atrophy or a decrease of general performance. The present study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau (group 1)or ankle fractures (group 2) with six weeks of partial weight bearing of 20 kg. This prospective randomized study will include a total of 60 patients for each group according to predefined inclusion and exclusion criteria. 1:1 randomization will be performed centrally via fax supported by the Clinical Trial Centre Leipzig (ZKS Leipzig). Patients in the treatment arm will be treated with an anti-gravity treadmill (alter G®) instead of physiotherapy. The protocol is designed parallel to standard physiotherapy with a frequency of two to three times of training with the treadmill per week with duration of 20 min for six weeks. Up to date no published randomized controlled trial with an anti-gravity treadmill is available. The findings of this study can help to modify rehabilitation of patients with partial weight bearing due to their injury or postoperative protocol. It will deliver interesting results if an anti-gravity treadmill is useful in rehabilitation in those patients. Further ongoing studies will identify different indications for an anti-gravity treadmill. Thus, in connection with those studies, a more valid statement regarding safety and efficacy is possible. NCT02790229 registered on May 29, 2016.

Docosahexaenoic acid for reading, working memory and behavior in UK children aged 7-9: A randomized controlled trial for replication (the DOLAB II study).

PubMed

Montgomery, Paul; Spreckelsen, Thees F; Burton, Alice; Burton, Jennifer R; Richardson, Alexandra J

2018-01-01

Omega-3 fatty acids are central to brain-development of children. Evidence from clinical trials and systematic reviews demonstrates the potential of long-chain Omega-3 supplementation for learning and behavior. However, findings are inconclusive and in need of robust replication studies since such work is lacking. Replication of the 2012 DOLAB 1 study findings that a dietary supplementation with the long-chain omega-3 docosahexaenoic acid (DHA) had beneficial effects on the reading, working memory, and behavior of healthy schoolchildren. Parallel group, fixed-dose, randomized (minimization, 30% random element), double-blind, placebo-controlled trial (RCT). Mainstream primary schools (n = 84) from five counties in the UK in 2012-2015. Healthy children aged 7-9 underperforming in reading (<20th centile). 1230 invited, 376 met study criteria. 600 mg/day DHA (from algal oil), placebo: taste/color matched corn/soybean oil; for 16 weeks. Age-standardized measures of reading, working memory, and behavior, parent-rated and as secondary outcome teacher-rated. 376 children were randomized. Reading, working memory, and behavior change scores showed no consistent differences between intervention and placebo group. Some behavioral subscales showed minor group differences. This RCT did not replicate results of the earlier DOLAB 1 study on the effectiveness of nutritional supplementation with DHA for learning and behavior. Possible reasons are discussed, particularly regarding the replication of complex interventions. www.controlled-trials.com (ISRCTN48803273) and protocols.io (https://dx.doi.org/10.17504/protocols.io.k8kczuw).

A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component

PubMed Central

Atkinson, J. Hampton; Slater, Mark A.; Capparelli, Edmund V.; Patel, Shetal M.; Wolfson, Tanya; Gamst, Anthony; Abramson, Ian S.; Wallace, Mark S.; Funk, Stephen D.; Rutledge, Thomas R.; Wetherell, Julie Loebach; Matthews, Scott C.; Zisook, Sidney; Garfin, Steven R.

2016-01-01

Gabapentin is prescribed for analgesia in chronic low back pain, yet there are no controlled trials supporting this practice. This randomized, two-arm, 12-week, parallel group study compared gabapentin (forced titration up to 3600 mg daily) to inert placebo. The primary efficacy measure was change in pain intensity from baseline to the last week on treatment measured by the Descriptor Differential Scale; the secondary outcome was disability (Oswestry Disability Index). The intention-to-treat analysis comprised 108 randomized chronic back pain patients (daily pain for ≥ 6 months) whose pain did (43%) or did not radiate into the lower extremity. Random effects regression models which did not impute missing scores were used to analyze outcome data. Pain intensity decreased significantly over time (p < .0001) with subjects on gabapentin or placebo reporting reductions of about 30% from baseline, but did not differ significantly between groups (p = .423). The same results pertained for disability scores. In responder analyses of those who completed 12 weeks (N=72), the proportion reporting at least 30% or 50% reduction in pain intensity, or at least “Minimal Improvement” on the Physician Clinical Global Impression of Change did not differ significantly between groups. There were no significant differences in analgesia between participants with radiating (n = 46) and non-radiating (n = 62) pain either within or between treatment arms. There was no significant correlation between gabapentin plasma concentration and pain intensity. Gabapentin appears to be ineffective for analgesia in chronic low back pain with or without a radiating component. PMID:26963844

The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

PubMed Central

Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

2014-01-01

Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight. This trial was registered at clinicaltrails.gov as NCT01781780. PMID:24898236

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial.

PubMed

Crétel-Durand, Elodie; Nouguerède, Emilie; Le Caer, Hervé; Rousseau, Frédérique; Retornaz, Frédérique; Guillem, Olivier; Couderc, Anne-Laure; Greillier, Laurent; Norguet, Emmanuelle; Cécile, Maud; Boulahssass, Rabia; Le Caer, Francoise; Tournier, Sandrine; Butaud, Chantal; Guillet, Pierre; Nahon, Sophie; Poudens, Laure; Kirscher, Sylvie; Loubière, Sandrine; Diaz, Nadine; Dhorne, Jean; Auquier, Pascal; Baumstarck, Karine

2017-04-12

Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy. This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected). The randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study. ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.

Pre-operative use of dexamethasone does not reduce incidence or intensity of bleaching-induced tooth sensitivity. A triple-blind, parallel-design, randomized clinical trial.

PubMed

da Costa Poubel, Luiz Augusto; de Gouvea, Cresus Vinicius Deppes; Calazans, Fernanda Signorelli; Dip, Etyene Castro; Alves, Wesley Veltri; Marins, Stella Soares; Barcelos, Roberta; Barceleiro, Marcos Oliveira

2018-04-25

This study evaluated the effect of the administration of pre-operative dexamethasone on tooth sensitivity stemming from in-office bleaching. A triple-blind, parallel-design, randomized clinical trial was conducted on 70 volunteers who received dexamethasone or placebo capsules. The drugs were administered in a protocol of three daily 8-mg doses of the drug, starting 48 h before the in-office bleaching treatment. Two bleaching sessions with 37.5% hydrogen peroxide gel were performed with a 1-week interval. Tooth sensitivity (TS) was recorded on visual analog scales (VAS) and numeric rating scales (NRS) in different periods up to 48 h after bleaching. The color evaluations were also performed. The absolute risk of TS and its intensity were evaluated by using Fisher's exact test. Comparisons of the TS intensity (NRS and VAS data) were performed by using the Mann-Whitney U test and a two-way repeated measures ANOVA and Tukey's test, respectively. In both groups, a high risk of TS (Dexa 80% x Placebo 94%) was detected. No significant difference was observed in terms of TS intensity. A whitening of approximately 3 shade guide units of the VITA Classical was detected in both groups, which were statistically similar. It was concluded that the administration pre-operatively of dexamethasone, in the proposed protocol, does not reduce the incidence or intensity of bleaching-induced tooth sensitivity. The use of dexamethasone drug before in-office bleaching treatment does not reduce incidence or intensity of tooth sensitivity. NCT02956070.

Effect of continuous oral suctioning on the development of ventilator-associated pneumonia: a pilot randomized controlled trial.

PubMed

Chow, Meyrick C M; Kwok, Shu-Man; Luk, Hing-Wah; Law, Jenny W H; Leung, Bartholomew P K

2012-11-01

Both continuous and intermittent aspiration of subglottic secretions by means of specially designed endotracheal tubes containing a separate dorsal lumen that opens into the subglottic region have been shown to be useful in reducing ventilator-associated pneumonia (VAP). However, the high cost of these tubes restricts their use. The aim of this pilot randomized controlled trial was to test the effect of a low-cost device (saliva ejector) for continuous oral suctioning (COS) on the incidence of VAP in patients receiving mechanical ventilation. The study was conducted in the six-bed medical-surgical ICU of a hospital with over 400 beds that provides comprehensive medical services to the public. The design of this study was a parallel-group randomized controlled trial. While both the experimental and control groups used the conventional endotracheal tube, the saliva ejector was only applied to patients assigned to the experimental group. The device was put between the patient's cheek and teeth, and then connected to 100mmHg of suction for the continuous drainage of saliva. Fourteen patients were randomized to receive COS and 13 patients were randomized to the control group. The two groups were similar in demographics, reasons for intubation, co-morbidity, and risk factors for acquiring VAP. VAP was found in 3 patients (23.1%; 71 episodes of VAP per 1000 ventilation days) receiving COS and in 10 patients (83.3%; 141 episodes of VAP per 1000 ventilation days) in the control group (relative risk, 0.28; 95% confidence interval, 0.10-0.77; p=0.003). The duration of mechanical ventilation in the experimental group was 3.2 days (SD 1.3), while that in the control group was 5.9 days (SD 2.8) (p=0.009); and the length of ICU stay was 4.8 days (SD 1.6) versus 9.8 days (SD 6.3) for the experimental and control groups, respectively (p=0.019). Continuous clearance of oral secretion by the saliva ejector may have an important role to play in reducing the rate of VAP, decreasing the duration of mechanical ventilation, and shortening the length of stay of patients in the ICU. Copyright © 2012 Elsevier Ltd. All rights reserved.

Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms

PubMed Central

FALLAH, Razieh; SALOR, Fahimah; AKHAVAN KARBASI, Sedighah; MOTAGHIPISHEH, Hadi

2014-01-01

Objective Infantile spasms (IS) are among the most catastrophic epileptic syndromes of infancy. The purpose of this study was to compare efficacy and safety of topiramate (TPM) and nitrazepam (NZP) as first-line drugs in the treatment of IS. Materials & Methods In a parallel single-blinded randomized clinical trial, 50 patients with IS referred to Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran, were evaluated from September 2008 to March 2010. Patients were randomly assigned to two groups to be treated with TPM or with NZP for 6 months. The primary endpoint was efficacy in cessation of all spasms or reduction of more than 50% in weekly seizure frequency, which was evaluated before and 6 months after the drug use. Secondary outcome was clinical sideeffects of the drugs. Results Twenty boys (40%) and 30 girls (60%) with the mean age of 9.4±3.8 months were evaluated. Cessation of all spasms occurred in 12 (48%) infants in TPM group and 4(16%) in NZP group. Eight (32%) children in TPM group and 7 (28%) in NZP group had more than 50% reduction in spasms frequency. So, TPM was more effective. Side effects were seen in 32% of TPM and in 36% of NZP groups. Conclusion Topiramate is an effective and safe drug, which might be considered as the firstline drug for the treatment of ISs. PMID:24665322

Effect of alignment of easy axes on dynamic magnetization of immobilized magnetic nanoparticles

NASA Astrophysics Data System (ADS)

Yoshida, Takashi; Matsugi, Yuki; Tsujimura, Naotaka; Sasayama, Teruyoshi; Enpuku, Keiji; Viereck, Thilo; Schilling, Meinhard; Ludwig, Frank

2017-04-01

In some biomedical applications of magnetic nanoparticles (MNPs), the particles are physically immobilized. In this study, we explore the effect of the alignment of the magnetic easy axes on the dynamic magnetization of immobilized MNPs under an AC excitation field. We prepared three immobilized MNP samples: (1) a sample in which easy axes are randomly oriented, (2) a parallel-aligned sample in which easy axes are parallel to the AC field, and (3) an orthogonally aligned sample in which easy axes are perpendicular to the AC field. First, we show that the parallel-aligned sample has the largest hysteresis in the magnetization curve and the largest harmonic magnetization spectra, followed by the randomly oriented and orthogonally aligned samples. For example, 1.6-fold increase was observed in the area of the hysteresis loop of the parallel-aligned sample compared to that of the randomly oriented sample. To quantitatively discuss the experimental results, we perform a numerical simulation based on a Fokker-Planck equation, in which probability distributions for the directions of the easy axes are taken into account in simulating the prepared MNP samples. We obtained quantitative agreement between experiment and simulation. These results indicate that the dynamic magnetization of immobilized MNPs is significantly affected by the alignment of the easy axes.

Social support and education groups for single mothers: a randomized controlled trial of a community-based program.

PubMed

Lipman, Ellen L; Boyle, Michael H

2005-12-06

Members of families headed by single mothers are at increased risk of psychosocial disadvantage and mental health problems. We assessed the effect of a community-based program of social support and education groups for single mothers of young children on maternal well-being and parenting. We recruited 116 single mothers of children 3 to 9 years old through community advertisements. Eligible mothers were randomly assigned either to participate in a 10-week program of group sessions (1.5 hours per week) offering social support and education, with a parallel children's activity group, or to receive a standard list of community resources and the option to participate in group sessions at the end of the follow-up period. Interviewers blinded to the randomization collected assessment data from all mothers at baseline and at 3 follow-up visits (immediately after the intervention and at 3 and 6 months after the intervention). Outcome measures were self-reported mood, self-esteem, social support and parenting. Between February 2000 and April 2003, the program was offered to 9 groups of single mothers. Most of the mothers in the trial reported high levels of financial and mental health problems. In the short term (after the intervention), mothers in the intervention group had improved scores for mood (p < 0.01, standardized effect = 0.55) and self-esteem (p < 0.05, standardized effect = 0.29) compared with mothers in the control group; scores for the other 2 measures did not differ between the groups. Growth curve analysis of program effects over the follow-up period showed improvement in all 4 outcomes, with no significant difference between the intervention and control groups. This community-based program of group sessions offering social support and education to low-income single mothers had positive short-term effects on mood and self-esteem but not on social support and parenting. Longer follow-up showed attenuation of these effects.

Yogurt supplemented with probiotics can protect the healthy elderly from respiratory infections: A randomized controlled open-label trial.

PubMed

Pu, Fangfang; Guo, Yue; Li, Ming; Zhu, Hong; Wang, Shijie; Shen, Xi; He, Miao; Huang, Chengyu; He, Fang

2017-01-01

To evaluate whether yogurt supplemented with a probiotic strain could protect middle-aged and elderly people from acute upper respiratory tract infections (URTI) using a randomized, blank-controlled, parallel-group design. Two hundred and five volunteers aged ≥45 years were randomly divided into two groups. The subjects in the intervention group were orally administered 300 mL/d of yogurt supplemented with a probiotic strain, Lactobacillus paracasei N1115 (N1115), 3.6×10 7 CFU/mL for 12 weeks, while those in the control group retained their normal diet without any probiotic supplementation. The primary outcome was the incidence of URTI, and changes in serum protein, immunoglobulins, and the profiles of the T-lymphocyte subsets (total T-cells [CD3 + ], T-helper cells [CD4 + ], and T-cytotoxic-suppressor cells [CD8 + ]) during the intervention were the secondary outcomes. Compared to the control group, the number of persons diagnosed with an acute URTI and the number of URTI events significantly decreased in the intervention group ( P =0.038, P =0.030, respectively). The risk of URTI in the intervention group was evaluated as 55% of that in the control group (relative risk =0.55, 95% CI: 0.307-0.969). The change in the percentage of CD3 + cells in the intervention group was significantly higher than in the control group ( P =0.038). However, no significant differences were observed in the total protein, albumin, globulin, and prealbumin levels in both groups ( P >0.05). The study suggested that yogurt with selected probiotic strains such as N1115 may reduce the risk of acute upper tract infections in the elderly. The enhancement of the T-cell-mediated natural immune defense might be one of the important underlying mechanisms for probiotics to express their anti-infective effects.

Yogurt supplemented with probiotics can protect the healthy elderly from respiratory infections: A randomized controlled open-label trial

PubMed Central

Pu, Fangfang; Guo, Yue; Li, Ming; Zhu, Hong; Wang, Shijie; Shen, Xi; He, Miao; Huang, Chengyu; He, Fang

2017-01-01

Purpose To evaluate whether yogurt supplemented with a probiotic strain could protect middle-aged and elderly people from acute upper respiratory tract infections (URTI) using a randomized, blank-controlled, parallel-group design. Patients and methods Two hundred and five volunteers aged ≥45 years were randomly divided into two groups. The subjects in the intervention group were orally administered 300 mL/d of yogurt supplemented with a probiotic strain, Lactobacillus paracasei N1115 (N1115), 3.6×107 CFU/mL for 12 weeks, while those in the control group retained their normal diet without any probiotic supplementation. The primary outcome was the incidence of URTI, and changes in serum protein, immunoglobulins, and the profiles of the T-lymphocyte subsets (total T-cells [CD3+], T-helper cells [CD4+], and T-cytotoxic-suppressor cells [CD8+]) during the intervention were the secondary outcomes. Results Compared to the control group, the number of persons diagnosed with an acute URTI and the number of URTI events significantly decreased in the intervention group (P=0.038, P=0.030, respectively). The risk of URTI in the intervention group was evaluated as 55% of that in the control group (relative risk =0.55, 95% CI: 0.307–0.969). The change in the percentage of CD3+ cells in the intervention group was significantly higher than in the control group (P=0.038). However, no significant differences were observed in the total protein, albumin, globulin, and prealbumin levels in both groups (P>0.05). Conclusion The study suggested that yogurt with selected probiotic strains such as N1115 may reduce the risk of acute upper tract infections in the elderly. The enhancement of the T-cell-mediated natural immune defense might be one of the important underlying mechanisms for probiotics to express their anti-infective effects. PMID:28848330

Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study.

PubMed

Okubo, Kimihiro; Gotoh, Minoru; Asako, Mikiya; Nomura, Yasuyuki; Togawa, Michinori; Saito, Akihiro; Honda, Takayuki; Ohashi, Yoshihiro

2017-01-01

Bilastine, a novel non-sedating second-generation H 1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10-13). A total of 765 patients were randomly allocated to receive bilastine, fexofenadine, or placebo (256, 254, and 255 patients, respectively). The mean change in TNSS from baseline at Week 2 was significantly decreased by bilastine (-0.98) compared to placebo (-0.63, P = 0.023). Bilastine and fexofenadine showed no significant difference in the primary endpoint. However, the mean change in TNSS from baseline on Day 1 was more significantly decreased by bilastine (-0.99) than by placebo (-0.28, P < 0.001) or fexofenadine (-0.62, P = 0.032). The active drugs also improved instantaneous TNSS 1 h after the first and before the second drug administration on Day 1 (P < 0.05). The study drugs were well tolerated. After 2-week treatment period, bilastine 20 mg once daily was effective and tolerable in Japanese patients with PAR, and exhibited a rapid onset of action. Copyright © 2016 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

Comparison of in-vivo failure of single-thread and dual-thread temporary anchorage devices over 18 months: A split-mouth randomized controlled trial.

PubMed

Durrani, Owais Khalid; Shaheed, Sohrab; Khan, Arsalan; Bashir, Ulfat

2017-10-01

The purpose of this study was to compare the in-vivo failure rates of single-thread and dual-thread temporary anchorage device (TAD) designs over 18 months. Thirty patients with skeletal Class II Division 1 malocclusion requiring anchorage from TADs for retraction of maxillary incisors into the extracted premolar space were recruited in this parallel group, split-mouth, randomized controlled trial. A block randomization sequence was generated with Random Allocation Software (version 2.0; Isfahan, Iran) with the allocations concealed in sequentially numbered, opaque, sealed envelopes. A total of 60 TADs (diameter, 2 mm; length, 10 mm) were placed in the maxillary arches of these patients with random allocation of the 2 types to the left and the right sides in a 1:1 ratio. All TADs were placed between the roots of the second premolar and the first molar and were immediately loaded. Patients were followed for a minimum of 12 months and a maximum of 18 months for the failure of the TADs. Data were analyzed blindly on an intention-to-treat basis. Four TADs (13.3%) failed in the single-thread group, and 6 TADs (20%) failed in the dual-thread group. The McNemar test showed an insignificant difference (P = 0.72) between the 2 groups. An odds ratio of 1.6 (95% confidence interval, 0.39-6.97) showed no significant associations among the variables. Most TADs failed in the first month after insertion (50%). The failure rate of dual-thread TADs compared with single-thread TADs is statistically insignificant when placed in the maxilla for retraction of the anterior segment. Registration: The trial was not registered before commencement. The protocol was not published before the trial. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

A benefit-finding intervention for family caregivers of persons with Alzheimer disease: study protocol of a randomized controlled trial

PubMed Central

2012-01-01

Background Caregivers of relatives with Alzheimer’s disease are highly stressed and at risk for physical and psychiatric conditions. Interventions are usually focused on providing caregivers with knowledge of dementia, skills, and/or support, to help them cope with the stress. This model, though true to a certain extent, ignores how caregiver stress is construed in the first place. Besides burden, caregivers also report rewards, uplifts, and gains, such as a sense of purpose and personal growth. Finding benefits through positive reappraisal may offset the effect of caregiving on caregiver outcomes. Design Two randomized controlled trials are planned. They are essentially the same except that Trial 1 is a cluster trial (that is, randomization based on groups of participants) whereas in Trial 2, randomization is based on individuals. Participants are randomized into three groups - benefit finding, psychoeducation, and simplified psychoeducation. Participants in each group receive a total of approximately 12 hours of training either in group or individually at home. Booster sessions are provided at around 14 months after the initial treatment. The primary outcomes are caregiver stress (subjective burden, role overload, and cortisol), perceived benefits, subjective health, psychological well-being, and depression. The secondary outcomes are caregiver coping, and behavioral problems and functional impairment of the care-recipient. Outcome measures are obtained at baseline, post-treatment (2 months), and 6, 12, 18 and 30 months. Discussion The emphasis on benefits, rather than losses and difficulties, provides a new dimension to the way interventions for caregivers can be conceptualized and delivered. By focusing on the positive, caregivers may be empowered to sustain caregiving efforts in the long term despite the day-to-day challenges. The two parallel trials will provide an assessment of whether the effectiveness of the intervention depends on the mode of delivery. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org/en/) identifier number ChiCTR-TRC-10000881. PMID:22747914

Sternotomy or drainage for a hemopericardium after penetrating trauma: a randomized controlled trial.

PubMed

Nicol, Andrew J; Navsaria, Pradeep H; Hommes, Martijn; Ball, Chad G; Edu, Sorin; Kahn, Delawir

2014-03-01

To determine if stable patients with a hemopericardium detected after penetrating chest trauma can be safely managed with pericardial drainage alone. The current international practice is to perform a sternotomy and cardiac repair if a hemopericardium is detected after penetrating chest trauma. The experience in Cape Town, South Africa, on performing a mandatory sternotomy in hemodynamically stable patients was that a sternotomy was unnecessary and the cardiac injury, if present, had sealed. A single-center parallel-group randomized controlled study was completed. All hemodynamically stable patients with a hemopericardium confirmed at subxiphoid pericardial window (SPW), and no active bleeding, were randomized. The primary outcome measure was survival to discharge from hospital. Secondary outcomes were complications and postoperative hospital stay. Fifty-five patients were randomized to sternotomy and 56 to pericardial drainage and wash-out only. Fifty-one of the 55 patients (93%) randomized to sternotomy had either no cardiac injury or a tangential injury. There were only 4 patients with penetrating wounds to the endocardium and all had sealed. There was 1 death postoperatively among the 111 patients (0.9%) and this was in the sternotomy group. The mean intensive care unit (ICU) stay for a sternotomy was 2.04 days (range, 0-25 days) compared with 0.25 days (range, 0-2) for the drainage (P < 0.001). The estimated mean difference highlighted a stay of 1.8 days shorter in the ICU for the drainage group (95% CI: 0.8-2.7). Total hospital stay was significantly shorter in the SPW group (P < 0.001; 95% CI: 1.4-3.3). SPW and drainage is effective and safe in the stable patient with a hemopericardium after penetrating chest trauma, with no increase in mortality and a shorter ICU and hospital stay. (ClinicalTrials.gov Identifier: NCT00823160).

A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy

PubMed Central

Lee, Hee Yeon; Lee, Kyung Hee; Kim, Bong-Seog; Song, Hong Suk; Yang, Sung Hyun; Kim, Joon Hee; Kim, Yeul Hong; Kim, Jong Gwang; Kim, Sang-We; Kim, Dong-Wan; Kim, Si-Young; Park, Hee Sook

2014-01-01

Purpose This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting. Materials and Methods This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6. Results Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events. Conclusion In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups. PMID:24520219

EFFECTS OF A DIETARY SUPPLEMENT ON THE INCIDENCE OF ACUTE RESPIRATORY INFECTIONS IN SUSCEPTIBLE ADULTS: A RANDOMIZED CONTROLLED TRIAL.

PubMed

Bernal-Orozco, María Fernanda; Posada-Falomir, Margarita; Ortega-Orozco, Rafael; Silva-Villanueva, Elvia Elaonor; Macedo-Ojeda, Gabriela; Márquez-Sandoval, Yolanda Fabiola; Vizmanos-Lamotte, Barbara

2015-08-01

although supplementation of specific micronutrients may improve immunologic factors, few studies about the combination of micronutrients with plant extracts on the occurrence of acute respiratory infections (ARI) have been published. to assess the effect of a nutritional supplement with micronutrients and plant extracts on the incidence of ARI in susceptible adults between January and April, 2012. a randomized, double-blind, parallel, placebo- controlled clinical trial was performed. Participants were adults susceptible to ARI who were healthy at the time of evaluation, signed informed consent forms and were not taking medication. They completed a medical history; weight, height, vital signs and laboratory analyses were assessed. Subjects were randomly assigned for consumption of the supplement or a placebo, for a 90 days period. Subjects made daily diary entries indicating the presence ARI symptoms. Those who became ill notified researchers and the attending physician confirmed the presence of an infection. Fisher's exact test was used to compare the proportion of ill subjects between groups. Relative risk and risk difference were also calculated (p < 0.05 significant). of 59 included subjects, 45 (25 women) completed the study (21 in the supplemented group and 24 in the placebo group). There were no significant differences at baseline between groups. After the intervention, the supplemented group had a lower incidence of ARI compared with the placebo group (57.1% vs. 91.7%, p = 0.013, RR = 0.62, 95%CI 0.42, 0.92). the consumption of a supplement with vitamins, minerals and plant extracts may decrease the incidence of ARI in susceptible adults. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Elearning approaches to prevent weight gain in young adults: A randomized controlled study.

PubMed

Nikolaou, Charoula Konstantia; Hankey, Catherine Ruth; Lean, Michael Ernest John

2015-12-01

Preventing obesity among young adults should be a preferred public health approach given the limited efficacy of treatment interventions. This study examined whether weight gain can be prevented by online approaches using two different behavioral models, one overtly directed at obesity and the other covertly. A three-group parallel randomized controlled intervention was conducted in 2012-2013; 20,975 young adults were allocated a priori to one control and two "treatment" groups. Two treatment groups were offered online courses over 19 weeks on (1) personal weight control ("Not the Ice Cream Van," NTICV) and, (2) political, environmental, and social issues around food ("Goddess Demetra," "GD"). Control group received no contact. The primary outcome was weight change over 40 weeks. Within-group 40-week weight changes were different between groups (P < 0.001): Control (n = 2,134): +2.0 kg (95% CI = 1.5, 2.3 kg); NTICV (n = 1,810): -1.0 kg (95% CI = -1.3, -0.5); and GD (n = 2,057): -1.35 kg (95% CI = -1.4 to -0.7). Relative risks for weight gain vs. NTICV = 0.13 kg (95% CI = 0.10, 0.15), P < 0.0001; GD = 0.07 kg (95% CI = 0.05, 0.10), P < 0.0001. Both interventions were associated with prevention of the weight gain observed among control subjects. This low-cost intervention could be widely transferable as one tool against the obesity epidemic. Outside the randomized controlled trial setting, it could be enhanced using supporting advertising and social media. © 2015 The Obesity Society.

A Randomized Controlled Trial of the Impact of a Family-Based Adolescent Depression Intervention on both Youth and Parent Mental Health Outcomes.

PubMed

Poole, Lucinda A; Knight, Tess; Toumbourou, John W; Lubman, Dan I; Bertino, Melanie D; Lewis, Andrew J

2018-01-01

This paper presents findings from a multi-centre, double-blind, randomized controlled trial that tested the hypothesis that parent and youth mental health improvements would be superior in a family-based intervention for adolescent depression (BEST MOOD) compared to a treatment-as-usual supportive parenting program (PAST). Eligible participants were families with a young person aged between 12 and 18 years who met diagnostic criteria for a depressive disorder (major, minor or dysthymic). Participating families (N = 64; 73.4% of youth were female) were recruited in Victoria, Australia and allocated to treatment condition using a block randomization procedure (parallel design) with two levels of blinding. This paper reports on the trial's secondary outcomes on youth and parent mental health. General linear mixed models were used to examine the longitudinal effect of treatment group on outcome. Data were analyzed according to intention-to-treat; 31 families were analyzed in BEST MOOD, and 33 families in PAST. Parents in the BEST MOOD group experienced significantly greater reductions in stress and depressive symptoms than parents in the PAST group at 3-month follow-up. A greater reduction in parental anxiety was observed in the BEST MOOD group (d = 0.35) compared with PAST (d = 0.02), although the between-group difference was not significant. Both groups of youth showed similar levels of improvement in depressive symptoms at post-treatment (d = 0.83 and 0.80 respectively), which were largely sustained at a 3-month follow-up. The family-based BEST MOOD intervention appeared superior to treatment-as-usual (PAST) in demonstrating greater reductions in parental stress and depression. Both interventions produced large reductions in youth depressive symptoms.

Reduction of visceral fat by liraglutide is associated with ameliorations of hepatic steatosis, albuminuria, and micro-inflammation in type 2 diabetic patients with insulin treatment: a randomized control trial.

PubMed

Bouchi, Ryotaro; Nakano, Yujiro; Fukuda, Tatsuya; Takeuchi, Takato; Murakami, Masanori; Minami, Isao; Izumiyama, Hajime; Hashimoto, Koshi; Yoshimoto, Takanobu; Ogawa, Yoshihiro

2017-03-31

Liraglutide, an analogue of human glucagon-like peptide 1, reduces cardiovascular events in patients with type 2 diabetes; however, it has still been unknown by which mechanisms liraglutide could reduce cardiovascular events. Type 2 diabetic patients with insulin treatment were enrolled in this randomized, open-label, comparative study. Participants were randomly assigned to liraglutide plus insulin (liraglutide group) and insulin treatment (control group) at 1:1 allocation. Primary endpoint was the change in viscera fat are (VFA, cm 2 ) at 24 weeks. Liver attenuation index (LAI) measured by abdominal computed tomography, urinary albumin-to-creatinine ratio (ACR, mg/g), and C-reactive protein (CRP) levels, skeletal muscle index (SMI), and quality of life (QOL) related to diabetes treatment were also determined. Seventeen patients (8; liraglutide group, 9; control group, mean age 59 ± 13 years; 53% female) completed this study. Liraglutide treatment significantly reduced VFA at 24 weeks; whereas, SFA was unchanged. ACR, LAI, and CRP levels were significantly reduced by liraglutide at 24 weeks and there was no difference in SMI between the two groups. Changes in VFA from baseline to 24 weeks were significantly associated with those in LAI, albuminuria, and HbA1c. Liraglutide treatment significantly improved QOL scores associated with anxiety and dissatisfaction with treatment and satisfaction with treatment. No severe adverse events were observed in both groups. Our data suggest that liraglutide could reduce visceral adiposity in parallel with attenuation of hepatic fat accumulation, albuminuria and micro-inflammation and improve QOL related to diabetes care in insulin-treated patients with type 2 diabetes.

Transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures: A randomized controlled study with patient-reported outcome.

PubMed

Galal, Sherif; Safwat, Wael

2017-01-01

The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.

Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial.

PubMed

Zhong, Toni; Ojha, M; Bagher, Shaghayegh; Butler, Kate; Srinivas, Coimbatore; McCluskey, Stuart A; Clarke, Hance; O'Neill, Anne C; Novak, Christine B; Hofer, Stefan O P

2014-11-01

The analgesic efficacy of the transversus abdominis plane peripheral nerve block following abdominal tissue breast reconstruction has not been studied in a randomized controlled trial. The authors conducted a double-blind, placebo-controlled, 1:1 allocation, two-arm parallel group, superiority design, randomized controlled trial in patients undergoing microsurgical abdominally based breast reconstruction. Intraoperatively, epidural catheters were inserted under direct vision through the triangle of Petit on both sides of the abdomen into the transversus abdominis plane just before rectus fascial closure. Patients received either bupivacaine (study group) or saline (placebo group) through the catheters for 2 postoperative days. All patients received hydromorphone by means of a patient-controlled analgesic pump. The primary outcome was the difference in the parenteral opioid consumption on each postoperative day between the groups. The secondary outcome measures included the following: total in-hospital opioid; antinausea medication; pain, nausea, and sedation scores; Quality of Recovery Score; time to ambulation; and hospital stay duration. Between September of 2011 and June of 2013, 93 patients were enrolled: 49 received bupivacaine and 44 received saline. There were 11 postoperative complications (13 percent); none were related to the catheter. Primary outcomes were completed by 85 of 93 patients (91.3 percent); the mean parenteral morphine consumption was significantly reduced on postoperative day 1 in the bupivacaine group (20.7±20.1 mg) compared with 30.0±19.1 mg in the control group (p=0.02). There were no significant differences in secondary outcomes. Following abdominally based breast reconstruction, transversus abdominis plane peripheral nerve block is safe and significantly reduces morphine consumption in the early postoperative period. Therapeutic, II.

Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial.

PubMed

Claessen, Femke M A P; Mellema, Jos J; Stoop, Nicky; Lubberts, Bart; Ring, David; Poolman, Rudolf W

2016-01-01

Patient-reported outcome measures (PROMs) are influenced by psychosocial factors, but it is unknown whether we can influence PROM scores by modifying the mindset of the patient. We assessed whether priming affects scores on PROMs. In all, 168 patients with musculoskeletal illness participated in this double-blinded, randomized, controlled, parallel study between July 2014 and October 2014 in a level I trauma center. Inclusion criteria were patients aged 18 years or older with English fluency and literacy and the ability to provide informed consent. Priming was performed by means of the Pain Catastrophizing Scale (PCS). The patients were randomized (1:1:1) into 3 groups: intervention group I was negatively primed with the original PCS; intervention group II was positively primed with a positively phrased PCS group; and control group III was not primed. Assessments were performed using PROMs on the domain of physical function, depression, and pain. Bivariate and multivariable regression analyses were conducted. The intervention and control groups were well balanced in demographic and condition-specific characteristics. The positive PCS was independently associated with higher PROM scores in the physical function domain (Patient-Reported Outcome Measurement Information System Upper Extremity Function: coefficient = 4.7, partial R(2) = 0.042; CI: 1.2-8.2; p < 0.010). Patients primed with a positively phrased version of the PCS reported less functional disability as compared with patients who were either negatively primed or not primed at all. This suggests that by influencing the mindset, PROMs can be influenced, resulting in better outcome if positively primed. Level 1 therapeutic study. NCT02209259. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip: a randomized controlled trial.

PubMed

Brantingham, James W; Parkin-Smith, Gregory; Cassa, Tammy Kay; Globe, Gary A; Globe, Denise; Pollard, Henry; deLuca, Katie; Jensen, Muffit; Mayer, Stephan; Korporaal, Charmaine

2012-02-01

To determine the short-term effectiveness of full kinematic chain manual and manipulative therapy (MMT) plus exercise compared with targeted hip MMT plus exercise for symptomatic mild to moderate hip osteoarthritis (OA). Parallel-group randomized trial with 3-month follow-up. Two chiropractic outpatient teaching clinics. Convenience sample of eligible participants (N=111) with symptomatic hip OA were consented and randomly allocated to receive either the experimental or comparison treatment, respectively. Participants in the experimental group received full kinematic chain MMT plus exercise while those in the comparison group received targeted hip MMT plus exercise. Participants in both groups received 9 treatments over a 5-week period. Western Ontario and McMasters Osteoarthritis Index (WOMAC), Harris hip score (HHS), and Overall Therapy Effectiveness, alongside estimation of clinically meaningful outcomes. Total dropout was 9% (n=10) with 7% of total data missing, replaced using a multiple imputation method. No statistically significant differences were found between the 2 groups for any of the outcome measures (analysis of covariance, P=.45 and P=.79 for the WOMAC and HHS, respectively). There were no statistically significant differences in the primary or secondary outcome scores when comparing full kinematic chain MMT plus exercise with targeted hip MMT plus exercise for mild to moderate symptomatic hip OA. Consequently, the nonsignificant findings suggest that there would also be no clinically meaningful difference between the 2 groups. The results of this study provides guidance to musculoskeletal practitioners who regularly use MMT that the full kinematic chain approach does not appear to have any benefit over targeted treatment. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Psychological adjustment and levels of self esteem in children with visual-motor integration difficulties influences the results of a randomized intervention trial.

PubMed

Lahav, Orit; Apter, Alan; Ratzon, Navah Z

2013-01-01

This study evaluates how much the effects of intervention programs are influenced by pre-existing psychological adjustment and self-esteem levels in kindergarten and first grade children with poor visual-motor integration skills, from low socioeconomic backgrounds. One hundred and sixteen mainstream kindergarten and first-grade children, from low socioeconomic backgrounds, scoring below the 25th percentile on a measure of visual-motor integration (VMI) were recruited and randomly divided into two parallel intervention groups. One intervention group received directive visual-motor intervention (DVMI), while the second intervention group received a non-directive supportive intervention (NDSI). Tests were administered to evaluate visual-motor integration skills outcome. Children with higher baseline measures of psychological adjustment and self-esteem responded better in NDSI while children with lower baseline performance on psychological adjustment and self-esteem responded better in DVMI. This study suggests that children from low socioeconomic backgrounds with low VMI performance scores will benefit more from intervention programs if clinicians choose the type of intervention according to baseline psychological adjustment and self-esteem measures. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

PubMed

Lindholm, Asa; Bixo, Marie; Björn, Inger; Wölner-Hanssen, Pål; Eliasson, Mats; Larsson, Anders; Johnson, Owe; Poromaa, Inger Sundström

2008-05-01

To examine the efficacy of sibutramine together with brief lifestyle modification for weight reduction in obese women with polycystic ovary syndrome (PCOS). Investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial. Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice. Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study. Sibutramine 15 mg once daily together with brief lifestyle modification was compare with placebo together with brief lifestyle modification. The primary endpoint was to assess weight loss. Secondary endpoints included the efficacy of sibutramine for treatment of menstrual pattern and cardiovascular risk factors. After 6 months the sibutramine group had lost 7.8 +/- 5.1 kg compared with a weight loss of 2.8 +/- 6.2 kg in the placebo group. Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels. Sibutramine in combination with lifestyle intervention results in significant weight reduction in obese patients with PCOS. In addition to the weight loss, sibutramine seems to have beneficial effects on metabolic and cardiovascular risk factors.

Shampoo-clay heals diaper rash faster than calendula officinalis.

PubMed

Adib-Hajbaghery, Mohsen; Mahmoudi, Mansoreh; Mashaiekhi, Mahdi

2014-06-01

Diaper rash is one of the most common skin disorders of infancy and childhood. Some studies have shown that Shampoo-clay was effective to treat chronic dermatitis. Then, it is supposed that it may be effective in diaper rash; however, no published studies were found in this regard. This study aimed to compare the effects of Shampoo-clay (S.C) and Calendula officinalis (C.O) to improve infantile diaper rash. A randomized, double blind, parallel controlled, non-inferiority trial was conducted on 60 outpatient infants referred to health care centers or pediatric clinics in Khomein city and diagnosed with diaper rash. Patients were randomly assigned into two treatment groups including S.C group (n = 30) and C.O group (n = 30) by using one to one allocation ratio. The rate of complete recovery in three days was the primary outcome. Data was collected using a checklist and analyzed using t-test, Chi-square and Fisher's exact tests and risk ratio. Totally, 93.3% of lesions in the S.C group healed in the first 6 hours, while this rate was 40% in C.O group (P < 0.001). The healing ratio for improvement in the first 6 hours was 7 times more in the S.C group. In addition, 90% of infants in the SC group and 36.7% in the C.O group were improved completely in the first 3 days (P < 0.001). S.C was effective to heal diaper rash, and also had faster effects compared to C.O.

Tissue welding tonsillectomy provides an enhanced recovery compared to that after monopolar electrocautery technique in adults: a prospective randomized clinical trial.

PubMed

Silvola, Juha; Salonen, Aarre; Nieminen, Jouko; Kokki, Hannu

2011-02-01

We have compared tonsillectomy (TE) with tissue welding (TW) technology using a specially designed forceps versus conventional monopolar electrocautery to evaluate whether this new technology may improve recovery after TE. This was a single-blind, randomized clinical trial with two parallel groups. Sixty healthy adult day-surgery patients were allocated into the TW-TE group (n = 31) and the monopolar electrocautery-TE group (n = 29). We recorded intraoperative events and short- and long-term recovery for 2 weeks postoperatively. The patients and study nurses evaluating patients during recovery were blinded to the operation method used. All patients in the TW-TE group completed the study as per protocol, but in the monopolar electrocautery-TE group, there was one drop-out in the hospital and another after discharge. There was no difference in the perioperative parameters and early recovery between the two groups. After discharge, recovery was significantly faster in the TW group than in the monopolar group: (1) the duration of postoperative pain was 2 days shorter, and (2) activities of normal daily living were less affected, and (3) the need for hospital contacts after discharge, and (4) the incidence of postoperative bleeding was less in the TW group than that in the monopolar group. No patients in the TW group developed secondary bleeding versus three patients in the monopolar group requiring electrocautery to control bleeding. In conclusion; our results indicate that, TW technique may provide reduced pain, faster recovery, and fewer complications compared to electrocautery TE.

Football to tackle overweight in children.

PubMed

Faude, O; Kerper, O; Multhaupt, M; Winter, C; Beziel, K; Junge, A; Meyer, T

2010-04-01

The present study aimed at analyzing the efficacy of a 6-month football training program compared with a standard exercise program on health and fitness parameters in overweight children. The study design was a 6-month, two-arm, parallel-group randomized trial. Twenty-two overweight children were randomly assigned to two groups (age=10.8+/-1.2 years, height=1.56+/-0.08 m, weight= 65.1+/-11.4 kg). One group conducted a football training program, and the other group an established standard sports program. Both interventions took place three times per week from mid-May to mid-November. Before, after 3 months and after the training period, comprehensive testing was conducted: anthropometric characteristics, cycling ergometry, psychometric monitoring as well as several motor ability tests. Maximal performance capacity increased and submaximal heart rate during cycling ergometry decreased significantly. Several motor skills as well as self-esteem also improved considerably. Body composition and other psychometric variables remained nearly unchanged. No relevant differences were observed between both exercise programs. It can be concluded that a 6-month football training is as efficacious in improving the physical capacity, health-related fitness parameters and self-esteem of overweight children as a standard exercise program. These results provide further evidence that playing football has significant health effects.

Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial.

PubMed

Gezginci, Elif; Iyigun, Emine; Yilmaz, Sercan

The purpose of this study was to compare the effect of 3 instructional methods for behavioral therapy on lower urinary tract symptom (LUTS) severity and health-related quality of life (HRQOL) in women with overactive bladder. Single-center, parallel-group, randomized, clinical trial. The sample comprised 60 women diagnosed with overactive bladder. The study setting was a university-based female urology clinic in Ankara, Turkey; data were collected from November 2012 to May 2013. Eligible participants were ambulatory women 18 years or older with predominant overactive bladder and urge urinary incontinence (UI) symptoms, with or without stress UI symptoms. Subjects were randomized into 4 groups based on educational intervention; group 1 received structured verbal instruction plus a leaflet, group 2 received structured verbal instruction, group 3 received a leaflet alone, and group 4 received usual care that included unstructured verbal counseling about continence care. The primary outcome measures were Incontinence Impact Questionnaire-7 (IIQ-7) and Urinary Distress Inventory-6 (UDI-6) scores. We also measured changes in UI-specific HRQOL scores via the Urinary Incontinence Quality of Life Instrument (I-QOL). All outcomes were measured before and 6 to 8 weeks after the interventions. The Wilcoxon test was used to identify differences in LUTS severity and HRQOL before and after the educational intervention. The Kruskall-Wallis test was used to compare differences among the groups. The severity of LUTS and UI-specific quality of life assessed by the IIQ-7, UDI-6, and I-QOL scores significantly improved after training in all 4 groups (P < .05). The group that received structured verbal instruction plus an educational leaflet achieved significantly lower LUTS scores and significantly higher UI-specific HRQOL when compared to the other groups (P < .05). Findings suggest that structured verbal instruction plus educational leaflet is the most effective method of bladder training in women with overactive bladder and urge UI.

Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.

PubMed

Klein-Laansma, Christien T; Jong, Mats; von Hagens, Cornelia; Jansen, Jean Pierre C H; van Wietmarschen, Herman; Jong, Miek C

2018-03-22

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated. A multicenter, randomized, controlled pragmatic trial with parallel groups. The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany. Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized. Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences. Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03). With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial

PubMed Central

Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-01-01

BACKGROUND: Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. METHODS: In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 109 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0–6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. RESULTS: A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference −0.001, 95% confidence interval [CI] −0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI −0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI −0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. INTERPRETATION: Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596 PMID:29255098

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial.

PubMed

Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-12-18

Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 10 9 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0-6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference -0.001, 95% confidence interval [CI] -0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI -0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI -0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596. © 2017 Joule Inc. or its licensors.

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

PubMed

Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

2013-01-05

Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people. ClinicalTrials.gov Identifier NCT00671099.

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Effect of vitamin C on inflammation and metabolic markers in hypertensive and/or diabetic obese adults: a randomized controlled trial

PubMed Central

Ellulu, Mohammed S; Rahmat, Asmah; Patimah, Ismail; Khaza’ai, Huzwah; Abed, Yehia

2015-01-01

Background Obesity is well associated as being an interfering factor in metabolic diseases such as hypertension and diabetes by increasing the secretion of proinflammatory markers from adipose tissue. Having healthy effects, vitamin C could work as an anti-inflammatory agent through its antioxidant capacity. Registration Registration number: FPSK_Mac [13]04. Objective The aim of the study reported here was to identify the effect of vitamin C on reducing the levels of inflammatory markers in hypertensive and/or diabetic obese adults. Subjects and methods Sixty-four obese patients, who were hypertensive and/or diabetic and had high levels of inflammatory markers, from primary health care centers in Gaza City, Palestine, were enrolled into one of two groups in an open-label, parallel, randomized controlled trial. A total of 33 patients were randomized into a control group and 31 patients were randomized into an experimental group. The experimental group was treated with 500 mg vitamin C twice a day. Results In the experimental group, vitamin C significantly reduced the levels of high-sensitivity C-reactive protein (hs-CRP), interleukin 6 (IL-6), fasting blood glucose (FBG), and triglyceride (TG) after 8 weeks of treatment (overall: P<0.001); no changes appeared in total cholesterol (TC). In the control group, there were significant reductions in FBG and TG (P=0.001 and P=0.026, respectively), and no changes in hs-CRP, IL-6, or TC. On comparing the changes in the experimental group with those in the control group at the endpoint, vitamin C was found to have achieved clinical significance in treating effectiveness for reducing hs-CRP, IL-6, and FBG levels (P=0.01, P=0.001, and P<0.001, respectively), but no significant changes in TC or TG were found. Conclusion Vitamin C (500 mg twice daily) has potential effects in alleviating inflammatory status by reducing hs-CRP, IL-6, and FBG in hypertensive and/or diabetic obese patients. PMID:26170625

Effect of the emotional freedom technique on perceived stress, quality of life, and cortisol salivary levels in tension-type headache sufferers: a randomized controlled trial.

PubMed

Bougea, Anastasia M; Spandideas, Nick; Alexopoulos, Evangelos C; Thomaides, Thomas; Chrousos, George P; Darviri, Christina

2013-01-01

To evaluate the short-term effects of the emotional freedom technique (EFT) on tension-type headache (TTH) sufferers. We used a parallel-group design, with participants randomly assigned to the emotional freedom intervention (n = 19) or a control arm (standard care n = 16). The study was conducted at the outpatient Headache Clinic at the Korgialenio Benakio Hospital of Athens. Thirty-five patients meeting criteria for frequent TTH according to International Headache Society guidelines were enrolled. Participants were instructed to use the EFT method twice a day for two months. Study measures included the Perceived Stress Scale, the Multidimensional Health Locus of Control Scale, and the Short-Form questionnaire-36. Salivary cortisol levels and the frequency and intensity of headache episodes were also assessed. Within the treatment arm, perceived stress, scores for all Short-Form questionnaire-36 subscales, and the frequency and intensity of the headache episodes were all significantly reduced. No differences in cortisol levels were found in any group before and after the intervention. EFT was reported to benefit patients with TTH. This randomized controlled trial shows promising results for not only the frequency and severity of headaches but also other lifestyle parameters. Copyright © 2013 Elsevier Inc. All rights reserved.

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics.

PubMed

Russo, Rennie; Coultas, David; Ashmore, Jamile; Peoples, Jennifer; Sloan, John; Jackson, Bradford E; Uhm, Minyong; Singh, Karan P; Blair, Steven N; Bae, Sejong

2015-03-01

To describe the recruitment methods, study participation rate, and baseline characteristics of a representative sample of outpatients with COPD eligible for pulmonary rehabilitation participating in a trial of a lifestyle behavioral intervention to increase physical activity. A patient registry was developed for recruitment using an administrative database from primary care and specialty clinics of an academic medical center in northeast Texas for a parallel group randomized trial. The registry was comprised of 5582 patients and over the course of the 30 month recruitment period 325 patients were enrolled for an overall study participation rate of 35.1%. After a 6-week COPD self-management education period provided to all enrolled patients, 305 patients were randomized into either usual care (UC; n=156) or the physical activity self-management intervention (PASM; n=149). There were no clinically significant differences in demographics, clinical characteristics, or health status indicators between the randomized groups. The results of this recruitment process demonstrate the successful use of a patient registry for enrolling a representative sample of outpatients eligible for pulmonary rehabilitation with COPD from primary and specialty care. Moreover, this approach to patient recruitment provides a model for future studies utilizing administrative databases and electronic health records. Published by Elsevier Inc.

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

PubMed

Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

2013-08-01

Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.

PubMed

Stern, Matthew B; Marek, Kenneth L; Friedman, Joseph; Hauser, Robert A; LeWitt, Peter A; Tarsy, Daniel; Olanow, C Warren

2004-08-01

Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (+/-SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (+/-1.3), -3.6 (+/-1.7), -3.6 (+/-1.2), and -0.5 (+/-0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. Copyright 2004 Movement Disorder Society

Butterbur root extract and music therapy in the prevention of childhood migraine: an explorative study.

PubMed

Oelkers-Ax, Rieke; Leins, Anne; Parzer, Peter; Hillecke, Thomas; Bolay, Hans V; Fischer, Jochen; Bender, Stephan; Hermanns, Uta; Resch, Franz

2008-04-01

Migraine is very common in school-aged children, but despite a number of pharmacological and non-pharmacological options for prophylaxis, randomized controlled evidence in children is small. Evidence-based prophylactic drugs may have considerable side effects. This study was to assess efficacy of a butterbur root extract (Petadolex) and music therapy in primary school children with migraine. Prospective, randomized, partly double-blind, placebo-controlled, parallel-group trial. Following a 8-week baseline patients were randomized and received either butterbur root extract (n=19), music therapy (n=20) or placebo (n=19) over 12 weeks. All participants received additionally headache education ("treatment as usual") from the baseline onwards. Reduction of headache frequency after treatment (8-week post-treatment) as well as 6 months later (8-week follow-up) was the efficacy variable. Data analysis of subjects completing the respective study phase showed that during post-treatment, only music therapy was superior to placebo (p=0.005), whereas in the follow-up period both music therapy and butterbur root extract were superior to placebo (p=0.018 and p=0.044, respectively). All groups showed a substantial reduction of attack frequency already during baseline. Butterbur root extract and music therapy might be superior to placebo and may represent promising treatment approaches in the prophylaxis of paediatric migraine.

Evaluation of Oral Robenacoxib for the Treatment of Postoperative Pain and Inflammation in Cats: Results of a Randomized Clinical Trial

PubMed Central

King, Stephen; Roberts, Elizabeth S.; Roycroft, Linda M.; King, Jonathan N.

2012-01-01

The efficacy and safety of robenacoxib were assessed for the control of postoperative pain and inflammation in cats. The study was a multicenter, prospective, randomized, blinded, and parallel group clinical trial. A total of 249 client-owned cats scheduled for forelimb onychectomy plus either ovariohysterectomy or castration surgeries were included. All cats received butorphanol prior to anesthesia and forelimb four-point regional nerve blocks with bupivacaine after induction of general anesthesia. Cats were randomized to receive daily oral tablet robenacoxib, at a mean (range) dosage of 1.84 (1.03–2.40) mg/kg (n = 167), or placebo (n = 82), once prior to surgery and for two days postoperatively. Significantly (P < 0.05) fewer robenacoxib cats received additional analgesia rescue therapy (16.5%) than placebo cats (46.3%). Pain elicited on palpation of the soft tissue incision site, behavior following social interaction, and posture assessed during the first 8 hours after extubation were significantly (P < 0.05) improved in cats receiving robenacoxib. Frequency of reported adverse clinical signs, hematology, serum chemistry and urinalysis variables, and body weight changes weresimilar between groups. In conclusion, robenacoxib was effective and well tolerated in the control of postoperative pain and inflammation in cats undergoing onychectomy with ovariohysterectomy or castration. PMID:23738129

Methods for sample size determination in cluster randomized trials

PubMed Central

Rutterford, Clare; Copas, Andrew; Eldridge, Sandra

2015-01-01

Background: The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. Methods: We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. Results: We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. Conclusions: There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. PMID:26174515

Teaching of evidence-based medicine to medical students in Mexico: a randomized controlled trial

PubMed Central

2012-01-01

Background Evidence-Based Medicine (EBM) is an important competency for the healthcare professional. Experimental evidence of EBM educational interventions from rigorous research studies is limited. The main objective of this study was to assess EBM learning (knowledge, attitudes and self-reported skills) in undergraduate medical students with a randomized controlled trial. Methods The educational intervention was a one-semester EBM course in the 5th year of a public medical school in Mexico. The study design was an experimental parallel group randomized controlled trial for the main outcome measures in the 5th year class (M5 EBM vs. M5 non-EBM groups), and quasi-experimental with static-groups comparisons for the 4th year (M4, not yet exposed) and 6th year (M6, exposed 6 months to a year earlier) groups. EBM attitudes, knowledge and self-reported skills were measured using Taylor’s questionnaire and a summative exam which comprised of a 100-item multiple-choice question (MCQ) test. Results 289 Medical students were assessed: M5 EBM=48, M5 non-EBM=47, M4=87, and M6=107. There was a higher reported use of the Cochrane Library and secondary journals in the intervention group (M5 vs. M5 non-EBM). Critical appraisal skills and attitude scores were higher in the intervention group (M5) and in the group of students exposed to EBM instruction during the previous year (M6). The knowledge level was higher after the intervention in the M5 EBM group compared to the M5 non-EBM group (p<0.001, Cohen's d=0.88 with Taylor's instrument and 3.54 with the 100-item MCQ test). M6 Students that received the intervention in the previous year had a knowledge score higher than the M4 and M5 non-EBM groups, but lower than the M5 EBM group. Conclusions Formal medical student training in EBM produced higher scores in attitudes, knowledge and self-reported critical appraisal skills compared with a randomized control group. Data from the concurrent groups add validity evidence to the study, but rigorous follow-up needs to be done to document retention of EBM abilities. PMID:23131115

Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

PubMed

Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

2015-08-01

Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic cluster headache with verapamil

PubMed Central

2013-01-01

Background Episodic cluster headache (ECH) is a primary headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of cluster attacks in the beginning of a cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a cluster episode. Methods and design PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with episodic cluster headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German headache clinics that specialize in the treatment of ECH. Discussion PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of cluster attacks in the beginning of a cluster episode as compared to monotherapy with verapamil. Trial registration German Clinical Trials Register DRKS00004716 PMID:23889923

GPURFSCREEN: a GPU based virtual screening tool using random forest classifier.

PubMed

Jayaraj, P B; Ajay, Mathias K; Nufail, M; Gopakumar, G; Jaleel, U C A

2016-01-01

In-silico methods are an integral part of modern drug discovery paradigm. Virtual screening, an in-silico method, is used to refine data models and reduce the chemical space on which wet lab experiments need to be performed. Virtual screening of a ligand data model requires large scale computations, making it a highly time consuming task. This process can be speeded up by implementing parallelized algorithms on a Graphical Processing Unit (GPU). Random Forest is a robust classification algorithm that can be employed in the virtual screening. A ligand based virtual screening tool (GPURFSCREEN) that uses random forests on GPU systems has been proposed and evaluated in this paper. This tool produces optimized results at a lower execution time for large bioassay data sets. The quality of results produced by our tool on GPU is same as that on a regular serial environment. Considering the magnitude of data to be screened, the parallelized virtual screening has a significantly lower running time at high throughput. The proposed parallel tool outperforms its serial counterpart by successfully screening billions of molecules in training and prediction phases.

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

PubMed Central

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

2001-01-01

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

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

PubMed

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

2001-07-01

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

Comparison of structured and unstructured physical activity training on predicted VO2max and heart rate variability in adolescents - a randomized control trial.

PubMed

Sharma, Vivek Kumar; Subramanian, Senthil Kumar; Radhakrishnan, Krishnakumar; Rajendran, Rajathi; Ravindran, Balasubramanian Sulur; Arunachalam, Vinayathan

2017-05-01

Physical inactivity contributes to many health issues. The WHO-recommended physical activity for adolescents encompasses aerobic, resistance, and bone strengthening exercises aimed at achieving health-related physical fitness. Heart rate variability (HRV) and maximal aerobic capacity (VO2max) are considered as noninvasive measures of cardiovascular health. The objective of this study is to compare the effect of structured and unstructured physical training on maximal aerobic capacity and HRV among adolescents. We designed a single blinded, parallel, randomized active-controlled trial (Registration No. CTRI/2013/08/003897) to compare the physiological effects of 6 months of globally recommended structured physical activity (SPA), with that of unstructured physical activity (USPA) in healthy school-going adolescents. We recruited 439 healthy student volunteers (boys: 250, girls: 189) in the age group of 12-17 years. Randomization across the groups was done using age and gender stratified randomization method, and the participants were divided into two groups: SPA (n=219, boys: 117, girls: 102) and USPA (n=220, boys: 119, girls: 101). Depending on their training status and gender the participants in both SPA and USPA groups were further subdivided into the following four sub-groups: SPA athlete boys (n=22) and girls (n=17), SPA nonathlete boys (n=95) and girls (n=85), USPA athlete boys (n=23) and girls (n=17), and USPA nonathlete boys (n=96) and girls (n=84). We recorded HRV, body fat%, and VO2 max using Rockport Walk Fitness test before and after the intervention. Maximum aerobic capacity and heart rate variability increased significantly while heart rate, systolic blood pressure, diastolic blood pressure, and body fat percentage decreased significantly after both SPA and USPA intervention. However, the improvement was more in SPA as compared to USPA. SPA is more beneficial for improving cardiorespiratory fitness, HRV, and reducing body fat percentage in terms of magnitude than USPA in adolescent individuals irrespective of their gender and sports activities.

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

PubMed

Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2013-07-06

The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. NCT01857882.

Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials

PubMed Central

Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R.; Ramstad, Erica; Magnusson, Frederik Løgstrup; Krogh, Helle B.; Groth, Camilla; Gillies, Donna; Zwi, Morris; Skoog, Maria; Gluud, Christian; Simonsen, Erik

2017-01-01

Objectives To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. Methods and findings We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23) and weight (RR 3.89, 95% CI 1.43 to 10.59). In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04). We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes. Conclusion Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found. PMID:28617801

Vocal warm-up and breathing training for teachers: randomized clinical trial

PubMed Central

Pereira, Lílian Paternostro de Pina; Masson, Maria Lúcia Vaz; Carvalho, Fernando Martins

2015-01-01

OBJECTIVE To compare the effectiveness of two speech therapy interventions, vocal warm-up and breathing training, focusing on teachers’ voice quality. METHODS A single-blind, randomized, parallel clinical trial was conducted. The research included 31 20 to 60-year old teachers from a public school in Salvador, BA, Northeasatern Brazil, with minimum workloads of 20 hours a week, who have or have not reported having vocal alterations. The exclusion criteria were the following: being a smoker, excessive alcohol consumption, receiving additional speech therapy assistance while taking part in the study, being affected by upper respiratory tract infections, professional use of the voice in another activity, neurological disorders, and history of cardiopulmonary pathologies. The subjects were distributed through simple randomization in groups vocal warm-up (n = 14) and breathing training (n = 17). The teachers’ voice quality was subjectively evaluated through the Voice Handicap Index (Índice de Desvantagem Vocal, in the Brazilian version) and computerized voice analysis (average fundamental frequency, jitter, shimmer, noise, and glottal-to-noise excitation ratio) by speech therapists. RESULTS Before the interventions, the groups were similar regarding sociodemographic characteristics, teaching activities, and vocal quality. The variations before and after the intervention in self-assessment and acoustic voice indicators have not significantly differed between the groups. In the comparison between groups before and after the six-week interventions, significant reductions in the Voice Handicap Index of subjects in both groups were observed, as wells as reduced average fundamental frequencies in the vocal warm-up group and increased shimmer in the breathing training group. Subjects from the vocal warm-up group reported speaking more easily and having their voices more improved in a general way as compared to the breathing training group. CONCLUSIONS Both interventions were similar regarding their effects on the teachers’ voice quality. However, each contribution has individually contributed to improve the teachers’ voice quality, especially the vocal warm-up. PMID:26465664

Creatine Supplementation Associated or Not with Strength Training upon Emotional and Cognitive Measures in Older Women: A Randomized Double-Blind Study

PubMed Central

Alves, Christiano Robles Rodrigues; Merege Filho, Carlos Alberto Abujabra; Benatti, Fabiana Braga; Brucki, Sonia; Pereira, Rosa Maria R.; de Sá Pinto, Ana Lucia; Lima, Fernanda Rodrigues; Roschel, Hamilton; Gualano, Bruno

2013-01-01

Purpose To assess the effects of creatine supplementation, associated or not with strength training, upon emotional and cognitive measures in older woman. Methods This is a 24-week, parallel-group, double-blind, randomized, placebo-controlled trial. The individuals were randomly allocated into one of the following groups (n=14 each): 1) placebo, 2) creatine supplementation, 3) placebo associated with strength training or 4) creatine supplementation associated with strength training. According to their allocation, the participants were given creatine (4 x 5 g/d for 5 days followed by 5 g/d) or placebo (dextrose at the same dosage) and were strength trained or not. Cognitive function, assessed by a comprehensive battery of tests involving memory, selective attention, and inhibitory control, and emotional measures, assessed by the Geriatric Depression Scale, were evaluated at baseline, after 12 and 24 weeks of the intervention. Muscle strength and food intake were evaluated at baseline and after 24 weeks. Results After the 24-week intervention, both training groups (ingesting creatine supplementation and placebo) had significant reductions on the Geriatric Depression Scale scores when compared with the non-trained placebo group (p = 0.001 and p = 0.01, respectively) and the non-trained creatine group (p < 0.001 for both comparison). However, no significant differences were observed between the non-trained placebo and creatine (p = 0.60) groups, or between the trained placebo and creatine groups (p = 0.83). Both trained groups, irrespective of creatine supplementation, had better muscle strength performance than the non-trained groups. Neither strength training nor creatine supplementation altered any parameter of cognitive performance. Food intake remained unchanged. Conclusion Creatine supplementation did not promote any significant change in cognitive function and emotional parameters in apparently healthy older individuals. In addition, strength training per se improved emotional state and muscle strength, but not cognition, with no additive effects of creatine supplementation. Trial Registration Clinicaltrials.gov NCT01164020 PMID:24098469

The effectiveness of wet-cupping for nonspecific low back pain in Iran: a randomized controlled trial.

PubMed

Farhadi, Khosro; Schwebel, David C; Saeb, Morteza; Choubsaz, Mansour; Mohammadi, Reza; Ahmadi, Alireza

2009-01-01

To determine the efficacy of wet-cupping for treating persistent nonspecific low back pain. Wet-cupping therapy is one of the oldest known medical techniques. It is still used in several contemporary societies. Very minimal empirical study has been conducted on its efficacy. Randomized controlled trial with two parallel groups. Patients in the experimental group were offered the option of referral to the wet-cupping service; all accepted that option. The control group received usual care. Medical clinic in Kermanshah, Iran. In total, 98 patients aged 17-68 years with nonspecific low back pain; 48 were randomly assigned to experimental group and 50 to the control group. Patients in the experimental group were prescribed a series of three staged wet-cupping treatments, placed at 3 days intervals (i.e., 0, 3, and 6 days). Patients in the control group received usual care from their general practitioner. Three outcomes assessed at baseline and again 3 months following intervention: the McGill Present Pain Index, Oswestry Pain Disability Index, and the Medication Quantification Scale. Wet-cupping care was associated with clinically significant improvement at 3-month follow-up. The experimental group who received wet-cupping care had significantly lower levels of pain intensity ([95% confidence interval (CI) 1.72-2.60] mean difference=2.17, p<0.01), pain-related disability (95% CI=11.18-18.82, means difference=14.99, p<0.01), and medication use (95% CI=3.60-9.50, mean difference=6.55, p<0.01) than the control group. The differences in all three measures were maintained after controlling for age, gender, and duration of lower back pain in regression models (p<0.01). Traditional wet-cupping care delivered in a primary care setting was safe and acceptable to patients with nonspecific low back pain. Wet-cupping care was significantly more effective in reducing bodily pain than usual care at 3-month follow-up.

Prevention of hand eczema: effect of an educational program versus treatment as usual - results of the randomized clinical PREVEX trial.

PubMed

Fisker, Maja H; Ebbehøj, Niels E; Vejlstrup, Søren Grove; Lindschou, Jane; Gluud, Christian; Winkel, Per; Bonde, Jens Peter; Agner, Tove

2018-03-01

Objective Occupational hand eczema has adverse health and socioeconomic impacts for the afflicted individuals and society. Prevention and treatment strategies are needed. This study aimed to assess the effectiveness of an educational intervention on sickness absence, quality of life and severity of hand eczema. Methods PREVEX (PreVention of EXema) is an individually randomized, parallel-group superiority trial investigating the pros and cons of one-time, 2-hour, group-based education in skin-protective behavior versus treatment as usual among patients with newly notified occupational hand eczema, with follow-up after one year. Co-primary outcomes were total sickness absence, health-related quality of life (HR-QoL), and self-reported severity of hand eczema. Results Patients (N=1668) with notified occupational skin diseases from July 2012 to November 2014 were invited to participate in the trial. Of these, 756 were randomized to the intervention (N= 376) versus control (N=380) group. The intervention group had 21% fewer sickness absence days compared with the control group [95% confidence interval (CI) -55-40%, P=0.43]. We found no significant difference in the change of HR-QoL for the intervention compared with the control group (4% lower in the intervention group, 95% CI -18-13%, P=0.67). The ordinal odds of scoring worse on self-reported hand eczema severity was 15% lower in the intervention compared with the control group (95% CI -39-18%, P=0.34). Post-hoc sub-group analyses indicated that the effect of the intervention on severity differed between occupations, being detrimental to healthcare workers and beneficial in all other occupations. Conclusion The educational skincare program had no marked effect on the primary outcomes sickness absence, HR-QoL, and severity of hand eczema when compared with treatment as usual.

Autogenic training to reduce anxiety in nursing students: randomized controlled trial.

PubMed

Kanji, Nasim; White, Adrian; Ernst, Edzard

2006-03-01

This paper reports a study to determine the effectiveness of autogenic training in reducing anxiety in nursing students. Nursing is stressful, and nursing students also have the additional pressures and uncertainties shared with all academic students. Autogenic training is a relaxation technique consisting of six mental exercises and is aimed at relieving tension, anger and stress. Meta-analysis has found large effect sizes for autogenic trainings intervention comparisons, medium effect sizes against control groups, and no effects when compared with other psychological therapies. A controlled trial with 50 nursing students found that the number of certified days off sick was reduced by autogenic training compared with no treatment, and a second trial with only 18 students reported greater improvement in Trait Anxiety, but not State Anxiety, compared with untreated controls. A randomized controlled trial with three parallel arms was completed in 1998 with 93 nursing students aged 19-49 years. The setting was a university college in the United Kingdom. The treatment group received eight weekly sessions of autogenic training, the attention control group received eight weekly sessions of laughter therapy, and the time control group received no intervention. The outcome measures were the State-Trait Anxiety Inventory, the Maslach Burnout Inventory, blood pressure and pulse rate completed at baseline, 2 months (end of treatment), and 5, 8, and 11 months from randomization. There was a statistically significantly greater reduction of State (P<0.001) and Trait (P<0.001) Anxiety in the autogenic training group than in both other groups immediately after treatment. There were no differences between the groups for the Maslach Burnout Inventory. The autogenic training group also showed statistically significantly greater reduction immediately after treatment in systolic (P<0.01) and diastolic (P<0.05) blood pressure, and pulse rate (P<0.002), than the other two groups. CONCLUSION. Autogenic training has at least a short-term effect in alleviating stress in nursing students.

Kefir drink causes a significant yet similar improvement in serum lipid profile, compared with low-fat milk, in a dairy-rich diet in overweight or obese premenopausal women: A randomized controlled trial.

PubMed

Fathi, Yasamin; Ghodrati, Naeimeh; Zibaeenezhad, Mohammad-Javad; Faghih, Shiva

Controversy exists as to whether the lipid-lowering properties of kefir drink (a fermented probiotic dairy product) in animal models could be replicated in humans. To assess and compare the potential lipid-lowering effects of kefir drink with low-fat milk in a dairy-rich diet in overweight or obese premenopausal women. In this 8-week, single-center, multiarm, parallel-group, outpatient, randomized controlled trial, 75 eligible Iranian women aged 25 to 45 years were randomly allocated to kefir, milk, or control groups. Women in the control group received a weight-maintenance diet containing 2 servings/d of low-fat dairy products, whereas subjects in the milk and kefir groups received a similar diet containing 2 additional servings/d (a total of 4 servings/d) of dairy products from low-fat milk or kefir drink, respectively. At baseline and study end point, serum levels/ratios of total cholesterol (TC), low- and high-density lipoprotein cholesterol (LDLC and HDLC), triglyceride, Non-HDLC, TC/HDLC, LDLC/HDLC, and triglyceride/LDLC were measured as outcome measures. After 8 weeks, subjects in the kefir group had significantly lower serum levels/ratios of lipoproteins than those in the control group (mean between-group differences were -10.4 mg/dL, -9.7 mg/dL, -11.5 mg/dL, -0.4, and -0.3 for TC, LDLC, non-HDLC, TC/HDLC, and LDLC/HDLC, respectively; all P < .05). Similar results were observed in the milk group. However, no such significant differences were found between the kefir and milk groups. Kefir drink causes a significant yet similar improvement in serum lipid profile, compared with low-fat milk, in a dairy-rich diet in overweight or obese premenopausal women. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

PubMed

Buhagiar, Mark A; Naylor, Justine M; Harris, Ian A; Xuan, Wei; Kohler, Friedbert; Wright, Rachael J; Fortunato, Renee

2013-12-17

Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required. The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty. U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.

Switching from sulphonylurea to a sodium-glucose cotransporter2 inhibitor in the fasting month of Ramadan is associated with a reduction in hypoglycaemia.

PubMed

Wan Seman, W J; Kori, N; Rajoo, S; Othman, H; Mohd Noor, N; Wahab, N A; Sukor, N; Mustafa, N; Kamaruddin, N A

2016-06-01

The aim of the present study was to assess the hypoglycaemia risk and safety of dapagliflozin compared with sulphonylurea during the fasting month of Ramadan. In this 12-week, randomized, open-label, two-arm parallel group study, 110 patients with type 2 diabetes who were receiving sulphonylurea and metformin were randomized either to receive 10 mg (n = 58) of dapagliflozin daily or to continue receiving sulphonylurea (n = 52). The primary outcome was to compare the effects of dapagliflozin and sulphonylurea on the proportions of patients with at least one episode of hypoglycaemia during Ramadan, as well as to assess the safety of dapagliflozin when used to treat patients observing Ramadan. A lower proportion of patients had reported or documented hypoglycaemia in the dapagliflozin group than in the sulphonylurea group: 4 (6.9%) versus 15 (28.8%); p = 0.002. The relative risk of any reported or documented hypoglycaemia in the 4th week of Ramadan was significantly lower in the dapagliflozin group: RR=0.24, 95%CI: 0.09, 0.68; p=0.002. No significance differences were observed between the two groups regarding postural hypotension (13.8 vs 3.8%; p = 0.210) or urinary tract infections (10.3 vs 3.8%; p = 0.277). In conclusion, fewer patients exhibited hypoglycaemia in the dapagliflozin group than in the sulphonylurea group. © 2016 John Wiley & Sons Ltd.

Effectiveness of hormone therapy for treating dry eye syndrome in postmenopausal women: a randomized trial.

PubMed

Piwkumsribonruang, Narongchai; Somboonporn, Woraruk; Luanratanakorn, Patanaree; Kaewrudee, Srinaree; Tharnprisan, Piangjit; Soontrapa, Sugree

2010-06-01

The efficacy of hormone therapy (HT) on dry eye syndrome remains debatable. To study the efficacy of HT on dry eye syndrome. A randomized controlled, double blind, parallel group, community-based study in 42 post-menopausal patients was conducted. The patients had dry eye syndrome and were not taking any medications. They were assigned to one of two groups. Group A comprised 21 patients given transdermal 17 beta-estradiol (50 mg/day) and medroxy progesterone acetate (2.5 mg/day) continuously for three months and group B comprised 21 patients given both transdermal and oral placebo. Participants in the study were included for final analysis. The improvement of dry eye symptoms were measured by visual analog scale, tear secretion, intraocular pressure, corneal thickness, and tear breakup time determined before treatment and at 6 and 12 weeks of treatment. At 12 weeks, the number of patients who reported improvement of dry eye symptoms was greater in the HT group than that in the placebo group. However, the difference was not statistically significant (RR 0.25, 95% CI 0.04-2.80 and 0.60, 95% CI 0.33-2.03 in right and left eye, respectively). For other parameters, there was no significant difference between the two groups. According to the present study, there is no strong evidence to support the use of HT for treating dry eye syndrome. The limited number of participants included in the present study may have contributed to the insignificant effects.

Prospective randomized comparison of rotational angiography with three-dimensional reconstruction and computed tomography merged with electro-anatomical mapping: a two center atrial fibrillation ablation study.

PubMed

Anand, Rishi; Gorev, Maxim V; Poghosyan, Hermine; Pothier, Lindsay; Matkins, John; Kotler, Gregory; Moroz, Sarah; Armstrong, James; Nemtsov, Sergei V; Orlov, Michael V

2016-08-01

To compare the efficacy and accuracy of rotational angiography with three-dimensional reconstruction (3DATG) image merged with electro-anatomical mapping (EAM) vs. CT-EAM. A prospective, randomized, parallel, two-center study conducted in 36 patients (25 men, age 65 ± 10 years) undergoing AF ablation (33 % paroxysmal, 67 % persistent) guided by 3DATG (group 1) vs. CT (group 2) image fusion with EAM. 3DATG was performed on the Philips Allura Xper FD 10 system. Procedural characteristics including time, radiation exposure, outcome, and navigation accuracy were compared between two groups. There was no significant difference between the groups in total procedure duration or time spent for various procedural steps. Minor differences in procedural characteristics were present between two centers. Segmentation and fusion time for 3DATG or CT-EAM was short and similar between both centers. Accuracy of navigation guided by either method was high and did not depend on left atrial size. Maintenance of sinus rhythm between the two groups was no different up to 24 months of follow-up. This study did not find superiority of 3DATG-EAM image merge to guide AF ablation when compared to CT-EAM fusion. Both merging techniques result in similar navigation accuracy.

Effects of a Proprietary Freeze-Dried Water Extract of Eurycoma longifolia (Physta) and Polygonum minus on Sexual Performance and Well-Being in Men: A Randomized, Double-Blind, Placebo-Controlled Study

PubMed Central

Udani, Jay K.; George, Annie A.; Musthapa, Mufiza; Pakdaman, Michael N.; Abas, Azreena

2014-01-01

Background. Physta is a proprietary product containing a freeze-dried water extract of Eurycoma longifolia (tongkat ali), which is traditionally used as an energy enhancer and aphrodisiac. We aim to evaluate a 300 mg combination of Physta and Polygonum minus, an antioxidant, with regard to sexual performance and well-being in men. Methods. Men that aged 40–65 years were screened for this 12-week randomized, double-blind, placebo-controlled, parallel-group study. Outcome measures included validated questionnaires that aimed to evaluate erectile function, satisfaction with intervention, sexual intercourse performance, erectile hardness, mood, and overall quality of life. Results. 12 subjects in the active group and 14 in the placebo group completed the study. Significant improvements were noted in scores for the Sexual Intercourse Attempt diary, Erection Hardness Scale, Sexual Health Inventory of Men, and Aging Male Symptom scale (P < 0.05 for all). Three adverse events were reported in the active group and four in the placebo group, none of which were attributed to study product. Laboratory evaluations, including liver and kidney function testing, showed no clinically significant abnormality. Conclusion. Supplementation for twelve weeks with Polygonum minus and the proprietary Eurycoma longifolia extract, Physta, was well tolerated and more effective than placebo in enhancing sexual performance in healthy volunteers. PMID:24550993

Effects of a Proprietary Freeze-Dried Water Extract of Eurycoma longifolia (Physta) and Polygonum minus on Sexual Performance and Well-Being in Men: A Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Udani, Jay K; George, Annie A; Musthapa, Mufiza; Pakdaman, Michael N; Abas, Azreena

2014-01-01

Background. Physta is a proprietary product containing a freeze-dried water extract of Eurycoma longifolia (tongkat ali), which is traditionally used as an energy enhancer and aphrodisiac. We aim to evaluate a 300 mg combination of Physta and Polygonum minus, an antioxidant, with regard to sexual performance and well-being in men. Methods. Men that aged 40-65 years were screened for this 12-week randomized, double-blind, placebo-controlled, parallel-group study. Outcome measures included validated questionnaires that aimed to evaluate erectile function, satisfaction with intervention, sexual intercourse performance, erectile hardness, mood, and overall quality of life. Results. 12 subjects in the active group and 14 in the placebo group completed the study. Significant improvements were noted in scores for the Sexual Intercourse Attempt diary, Erection Hardness Scale, Sexual Health Inventory of Men, and Aging Male Symptom scale (P < 0.05 for all). Three adverse events were reported in the active group and four in the placebo group, none of which were attributed to study product. Laboratory evaluations, including liver and kidney function testing, showed no clinically significant abnormality. Conclusion. Supplementation for twelve weeks with Polygonum minus and the proprietary Eurycoma longifolia extract, Physta, was well tolerated and more effective than placebo in enhancing sexual performance in healthy volunteers.

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

PubMed Central

Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

PubMed

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-08-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.

A noninferiority confirmatory trial of prasugrel versus clopidogrel in Japanese patients with non-cardioembolic stroke: rationale and study design for a randomized controlled trial - PRASTRO-I trial.

PubMed

Nagao, Takehiko; Toyoda, Kazunori; Kitagawa, Kazuo; Kitazono, Takanari; Yamagami, Hiroshi; Uchiyama, Shinichiro; Tanahashi, Norio; Matsumoto, Masayasu; Minematsu, Kazuo; Nagata, Izumi; Nishikawa, Masakatsu; Nanto, Shinsuke; Abe, Kenji; Ikeda, Yasuo; Ogawa, Akira

2018-04-01

This comparison of PRAsugrel and clopidogrel in Japanese patients with ischemic STROke (PRASTRO)-I trial investigates the noninferiority of prasugrel to clopidogrel sulfate in the prevention of recurrence of primary events (ischemic stroke, myocardial infarction, and death from other vascular causes), and the long-term safety of prasugrel in Japanese patients with non-cardioembolic stroke. This was an active-controlled, randomized, double-blind, double-dummy, parallel-group study conducted between July 2011 and March 2016 at multiple centers around Japan. Patients had to meet eligibility criteria before receiving 3.75 mg prasugrel or 75 mg clopidogrel orally once daily for a period of 96-104 weeks. A total of 3747 patients were included in this trial; 1598 in the 3.75 mg prasugrel group and 1551 in the 75 mg clopidogrel group completed the study. During the study period, 287 (15.2%) patients in the prasugrel group and 311 (16.7%) in the clopidogrel group discontinued treatment. Baseline characteristics, safety, and efficacy results are forthcoming and will be published separately. This article presents the study design and rationale for a trial investigating the noninferiority of prasugrel to clopidogrel sulfate with regards to the inhibitory effect on primary events in patients with non-cardioembolic stroke.

Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors.

PubMed

Colen, Sascha; van den Bekerom, Michel P J; Bellemans, Johan; Mulier, Michiel

2010-11-16

Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate. Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine.The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS), Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment) and intake of pain rescue medication (number per week). In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered. This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine. NCT01079455.

Simulation can contribute a part of cardiorespiratory physiotherapy clinical education: two randomized trials.

PubMed

Blackstock, Felicity C; Watson, Kathryn M; Morris, Norman R; Jones, Anne; Wright, Anthony; McMeeken, Joan M; Rivett, Darren A; O'Connor, Vivienne; Peterson, Raymond F; Haines, Terry P; Watson, Geoffrey; Jull, Gwendolen Anne

2013-02-01

Simulated learning environments (SLEs) are used worldwide in health professional education, including physiotherapy, to train certain attributes and skills. To date, no randomized controlled trial (RCT) has evaluated whether education in SLEs can partly replace time in the clinical environment for physiotherapy cardiorespiratory practice. Two independent single-blind multi-institutional RCTs were conducted in parallel using a noninferiority design. Participants were volunteer physiotherapy students (RCT 1, n = 176; RCT 2, n = 173) entering acute care cardiorespiratory physiotherapy clinical placements. Two SLE models were investigated as follows: RCT 1, 1 week in SLE before 3 weeks of clinical immersion; RCT 2, 2 weeks of interspersed SLE/clinical immersion (equivalent to 1 SLE week) within the 4-week clinical placement. Students in each RCT were stratified on academic grade and randomly allocated to an SLE plus clinical immersion or clinical immersion control group. The primary outcome was competency to practice measured in 2 clinical examinations using the Assessment of Physiotherapy Practice. Secondary outcomes were student perception of experience and clinical educator and patient rating of student performance. There were no significant differences in student competency between the SLE and control groups in either RCT, although students in the interspersed group (RCT 2) achieved a higher score in 5 of 7 Assessment of Physiotherapy Practice standards (all P < 0.05). Students rated the SLE experience positively. Clinical educators and patients reported comparability between groups. An SLE can replace clinical time in cardiorespiratory physiotherapy practice. Part education in the SLE satisfied clinical competency requirements, and all stakeholders were satisfied.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

PubMed

Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

PubMed

Leem, Jungtae; Lee, Seung Min Kathy; Park, Jun Hyeong; Lee, Suji; Chung, Hyemoon; Lee, Jung Myung; Kim, Weon; Lee, Sanghoon; Woo, Jong Shin

2017-07-11

The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture. This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit. The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure. Clinical Research Information Service: KCT0002249 .

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

PubMed

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Effect of Aromatherapy Massage on Chemotherapy-Induced Peripheral Neuropathic Pain and Fatigue in Patients Receiving Oxaliplatin: An Open Label Quasi-Randomized Controlled Pilot Study.

PubMed

Izgu, Nur; Ozdemir, Leyla; Bugdayci Basal, Fatma

2017-12-02

Patients receiving oxaliplatin may experience peripheral neuropathic pain and fatigue. Aromatherapy massage, a nonpharmacological method, may help to control these symptoms. The aim of this open-label, parallel-group, quasi-randomized controlled pilot study was to investigate the effect of aromatherapy massage on chemotherapy-induced peripheral neuropathic pain and fatigue in patients receiving oxaliplatin. Stratified randomization was used to allocate 46 patients to 2 groups: intervention (n = 22) and control (n = 24). Between week 1 and week 6, participants in the intervention group (IG) received aromatherapy massage 3 times a week. There was no intervention in weeks 7 and 8. The control group (CG) received routine care. Neuropathic pain was identified using the Douleur Neuropathique 4 Questions; severity of painful paresthesia was assessed with the numerical rating scale; fatigue severity was identified with the Piper Fatigue Scale. At week 6, the rate of neuropathic pain was significantly lower in the IG, when compared with the CG. The severity of painful paresthesia based on numerical rating scale in the IG was significantly lower than that in the CG at weeks 2, 4, and 6. At week 8, fatigue severity in the IG was significantly lower when compared with CG (P < .05). Aromatherapy massage may be useful in the management of chemotherapy-induced peripheral neuropathic pain and fatigue. This pilot study suggests that aromatherapy massage may be useful to relieve neuropathic pain and fatigue. However, there is a need for further clinical trials to validate the results of this study.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

PubMed Central

Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

2014-01-01

Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

Effects of professional oral health care on elderly: randomized trial.

PubMed

Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M

2014-11-01

To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P < 0.05). Moreover, DPI significantly improved in the intervention group (Intervention, 57% [8/14]; Control, 13% [2/16]: Fisher's, two-tailed, P < 0.05). The improvement in DPI extended for 3 months after intervention. None of side effects were reported. The short-term professional oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Management of Neuropathic Chronic Pain with Methadone Combined with Ketamine: A Randomized, Double Blind, Active-Controlled Clinical Trial.

PubMed

Rigo, Flavia Karine; Trevisan, Gabriela; Godoy, Maria C; Rossato, Mateus Fortes; Dalmolin, Gerusa D; Silva, Mariane A; Menezes, Mirian S; Caumo, Wolnei; Ferreira, Juliano

2017-03-01

Methadone and ketamine are used in neuropathic pain management. However, the benefits of both drugs association are uncertain in the treatment of neuropathic pain. Our primary objective was test the hypothesis that oral methadone combined with oral ketamine is more effective than oral methadone or ketamine alone in reducing neuropathic pain. We conducted a randomized, double blind, active-controlled parallel-group clinical trial. Forty-two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive oral methadone (n = 14), ketamine (n = 14), or methadone plus ketamine (n = 14) over a 3-month period. During these 90 days, we observed pain scores using a visual analogical scale (VAS), allodynia, burning/shooting pain, and some side effects. All treatments were effective in reducing pain scores by at least 40%. However, a significant improvement in pain was observed only in the ketamine alone group compared with both the methadone or methadone/ketamine groups. No significant differences were observed among the treatment groups for the reduction of burning or shooting pain, while ketamine alone was more effective than methadone or methadone/ketamine for the reduction of allodynia. Formal assessment for awareness of the allocation was not performed, some co-intervention bias may have occurred, our results could be only relevant to the patient population investigated and the use of VAS as the primary outcome detect changes in pain intensity but not to assess neuropathic pain symptoms. This study indicates that ketamine was better than methadone or methadone/ketamine for treating neuropathic pain.Key words: Multimodal analgesia, refractory pain, NMDA receptor, opioid.

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.

Daily corticosteroids reduce infection-associated relapses in frequently relapsing nephrotic syndrome: a randomized controlled trial.

PubMed

Gulati, Ashima; Sinha, Aditi; Sreenivas, Vishnubhatla; Math, Aparna; Hari, Pankaj; Bagga, Arvind

2011-01-01

Relapses of nephrotic syndrome often follow minor infections, commonly of the upper respiratory tract. Daily administration of maintenance prednisolone during intercurrent infections was examined to determine whether the treatment reduces relapse rates in children with frequently relapsing nephrotic syndrome. In a randomized controlled trial (nonblind, parallel group, tertiary-care hospital), 100 patients with idiopathic, frequently relapsing nephrotic syndrome eligible for therapy with prolonged low-dose, alternate-day prednisolone with or without levamisole were randomized to either receive their usual dose of alternate-day prednisolone daily for 7 days during intercurrent infections (intervention group) or continue alternate-day prednisolone (controls). Primary outcome was assessed by comparing the rates of infection-associated relapses at 12-month follow-up. Secondary outcomes were the frequency of infections and the cumulative amount of prednisolone received in both groups. Patients in the intervention group showed significantly lower infection-associated (rate difference, 0.7 episodes/patient per year; 95% confidence intervals [CI] 0.3, 1.1) and lower total relapse rates (0.9 episodes/patient per year, 95% CI 0.4, 1.4) without increase in steroid toxicity. Poisson regression, adjusted for occurrence of infections, showed that daily administration of prednisolone during infections independently resulted in 59% reduction in frequency of relapses (rate ratio, 0.41; 95% CI 0.3, 0.6). For every six patients receiving this intervention, one showed a reduction of relapse frequency to less than three per year. Daily administration of maintenance doses of prednisolone, during intercurrent infections, significantly reduces relapse rates and the proportion of children with frequently relapsing nephrotic syndrome.

Sunscreen use and intentional exposure to ultraviolet A and B radiation: a double blind randomized trial using personal dosimeters

PubMed Central

Autier, P; Doré, J-F; Reis, A C; Grivegnée, A; Ollivaud, L; Truchetet, F; Chamoun, E; Rotmensz, N; Severi, G; Césarini, J-P

2000-01-01

A previous randomized trial found that sunscreen use could extend intentional sun exposure, thereby possibly increasing the risk of cutaneous melanoma. In a similarly designed trial, we examined the effect of the use of sunscreens having different sun protection factor (SPF) on actual exposure to ultraviolet B (UVB) and ultraviolet A (UVA) radiation. In June 1998, 58 European participants 18–24 years old were randomized to receive a SPF 10 or 30 sunscreens and were asked to complete daily records of their sun exposure during their summer holidays of whom 44 utilized a personal UVA and UVB dosimeter in a standard way during their sunbathing sessions. The median daily sunbathing duration was 2.4 hours in the SPF 10 group and 3.0 hours in the SPF 30 group (P = 0.054). The increase in daily sunbathing duration was paralleled by an increase in daily UVB exposure, but not by changes in UVA or UVB accumulated over all sunbathing sessions, or in daily UVA exposure. Of all participants, those who used the SPF 30 sunscreen and had no sunburn spent the highest number of hours in sunbathing activities. Differences between the two SPF groups in total number of sunbathing hours, daily sunbathing duration, and daily UVB exposure were largest among participants without sunburn during holidays. Among those with sunburn, the differences between the two groups tended to reduce. In conclusion, sunscreens used during sunbathing tended to increase the duration of exposures to doses of ultraviolet radiation below the sunburn threshold. © 2000 Cancer Research Campaign PMID:11027441

Dietary Wolfberry Extract Modifies Oxidative Stress by Controlling the Expression of Inflammatory mRNAs in Overweight and Hypercholesterolemic Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Lee, You Jin; Ahn, Youngsook; Kwon, Oran; Lee, Mee Youn; Lee, Choong Hwan; Lee, Sungyoung; Park, Taesung; Kwon, Sung Won; Kim, Ji Yeon

2017-01-18

In the present study, we evaluated the antioxidative and anti-inflammatory effects of an aqueous extract of wolfberry fruit (WBE) in mild hypercholesterolemic and overweight subjects. This study was a double-blind randomized trial of two parallel groups of free-living subjects (n = 53). The participants consumed the contents of an 80 mL pouch containing 13.5 g WBE or placebo after one meal per day over an 8-week period. Following 8 weeks of WBE supplementation, we observed a slight but significant decrease in erythrocyte superoxide dismutase activity and an increase in catalase activity. Furthermore, to assess endogenous DNA damage in lymphocytes, the alkaline comet assay was performed, showing that the percentage of DNA in the tail was significantly decreased by 8-week WBE intake. Additionally, the proportion of significantly deregulated mRNAs related to oxidative or inflammatory stress was considerably higher in the WBE intake group. The present data indicate that WBE intake has antioxidative and anti-inflammatory effects in overweight and hypercholesterolemic subjects by modulating mRNA expression.

Neurophysiological study on the effect of various short durations of deep breathing: A randomized controlled trial.

PubMed

Cheng, Kok Suen; Han, Ray P S; Lee, Poh Foong

2018-02-01

The study aims to study the effects of short duration deep breathing on the EEG power with topography based on parallel group randomized controlled trial design which was lacking in prior reports. 50 participants were split into 4 groups: control (CONT), deep breathing (DB) for 5 (DB5), 7 (DB7), and 9 (DB9) minutes. EEG recordings were obtained during baseline, deep breathing session, after deep breathing, and a follow-up session after 7 days of consecutive practice. Frontal theta power of DB5 and DB9 was significantly larger than that of CONT after the deep breathing session (p = 0.027 and p = 0.006, respectively) and the profound finding showed that the theta topography obtained a central-focused distribution for DB7 and DB9. The result obtained was consistent with previous literature, albeit for certain deep breathing durations only, indicating a possible linkage between the deep breathing duration and the neurophysiology of the brain. Copyright © 2017 Elsevier B.V. All rights reserved.

Parallel and Serial Grouping of Image Elements in Visual Perception

ERIC Educational Resources Information Center

Houtkamp, Roos; Roelfsema, Pieter R.

2010-01-01

The visual system groups image elements that belong to an object and segregates them from other objects and the background. Important cues for this grouping process are the Gestalt criteria, and most theories propose that these are applied in parallel across the visual scene. Here, we find that Gestalt grouping can indeed occur in parallel in some…

Lipid modifying action of atorvastatin in comparison to combination of atorvastatin and nicotinic acid in patients with ischaemic heart disease.

PubMed

Santanu, Guha; Suhrita, Paul; Mookerjee, Soura; Tania, Kundu; Mita, Saha; Pramit, Ghosh; Sharmila, Guha; Miraj, Mandal; Debdutta, Majumder

2011-01-01

The current study is a prospective, randomized controlled study with two parallel treatment groups done to assess the tolerability and efficacy of a combination of atorvastatin (10 mg) and extended release nicotinic acid (1G) in comparison to atorvastatin (20 mg) alone in modulating the lipid profile in patients of Ischemic Heart Disease in our population. Patients were randomly allocated into two equal groups (n = 216) as per selection criteria. Group A received Atorvastatin 20 mg while Group B received combination of Atorvastatin -10 mg and extended release nicotinic acid (1G), both once daily at bed time, for a period of 24 weeks. Final end-of-study assessment and evaluation of tolerability and efficacy was done after 24 weeks. Comparison between the groups was performed with paired t-test. A p value < 0.05 was considered to be statistically significant. There was significant reduction in cholesterol, LDL & triglycerides in both the groups. Mean values of cholesterol and LDL were comparable in both groups where as there was increased reduction of triglycerides in Group B. Mean value of HDL cholesterol significantly increased only in group B thus the total cholesterol: HDL ratio was decreased more favorably. SGPT level was not significantly altered in either of the groups. In the Indian perspective, where HDL is low and the LDL values are not very high, a combination of low dose atorvastatin with nicotinic acid may influence the lipid profile more favorably and reduce the cholesterol/HDL ratio in comparison to atorvastatin alone and is also fairly well tolerated.

Influence of case-based e-learning on students' performance in point-of-care ultrasound courses: a randomized trial.

PubMed

Hempel, Dorothea; Sinnathurai, Sivajini; Haunhorst, Stephanie; Seibel, Armin; Michels, Guido; Heringer, Frank; Recker, Florian; Breitkreutz, Raoul

2016-08-01

Theoretical knowledge, visual perception, and sensorimotor skills are key elements in ultrasound education. Classroom-based presentations are used routinely to teach theoretical knowledge, whereas visual perception and sensorimotor skills typically require hands-on training (HT). We aimed to compare the effect of classroom-based lectures versus a case-based e-learning (based on clinical cases only) on the hands-on performance of trainees during an emergency ultrasound course. This is a randomized, controlled, parallel-group study. Sixty-two medical students were randomized into two groups [group 1 (G1) and group 2 (G2)]. G1 (n=29) was subjected to a precourse e-learning, based on 14 short screencasts (each 5 min), an on-site discussion (60 min), and a standardized HT session on the day of the course. G2 (n=31) received classroom-based presentations on the day of the course before an identical HT session. Both groups completed a multiple-choice (MC) pretest (test A), a practical postcourse test (objective structured clinical exam), and MC tests directly after the HT (test B) and 1 day after the course (test C). The Mann-Whitney U-test was used for statistical analysis. G1 performed markedly better in test A (median 84.2, 25%; 75% percentile: 68.5; 92.2) compared with G2 (65.8; 53.8; 80.4), who had not participated in case-based e-learning (P=0.0009). No differences were found in the objective structured clinical exam, test B, and test C. e-learning exclusively based on clinical cases is an effective method of education in preparation for HT sessions and can reduce attendance time in ultrasound courses.

A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial.

PubMed

Kalfon, Pierre; Baumstarck, Karine; Estagnasie, Philippe; Geantot, Marie-Agnès; Berric, Audrey; Simon, Georges; Floccard, Bernard; Signouret, Thomas; Boucekine, Mohamed; Fromentin, Mélanie; Nyunga, Martine; Sossou, Achille; Venot, Marion; Robert, René; Follin, Arnaud; Audibert, Juliette; Renault, Anne; Garrouste-Orgeas, Maïté; Collange, Olivier; Levrat, Quentin; Villard, Isabelle; Thevenin, Didier; Pottecher, Julien; Patrigeon, René-Gilles; Revel, Nathalie; Vigne, Coralie; Azoulay, Elie; Mimoz, Olivier; Auquier, Pascal

2017-12-01

Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items. This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients. Clinicaltrials.gov Identifier NCT02442934.

Does flushing the endometrial cavity with follicular fluid after oocyte retrieval affect pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection? A randomized controlled trial.

PubMed

Hashish, N M; Badway, H S; Abdelmoty, H I; Mowafy, A; Youssef, M A F M

2014-05-01

Follicular fluid of mature oocytes is rich in growth factors and cytokines that may exert paracrine and autocrine effects on implantation. The aim of this study was to investigate if flushing the endometrial cavity with follicular fluid after oocyte retrieval improved pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection (ICSI). One hundred subfertile women undergoing ICSI between April 2012 and September 2012 at the centre for reproductive medicine, Cairo University, Egypt were enrolled in this open label, parallel randomized controlled study. Patients were randomized into two groups at the start of treatment using a computer-generated programme and sealed opaque envelopes: the follicular fluid group (n=50) and the control group (n=50). Inclusion criteria were: age 20-38 years; basal follicle-stimulating hormone <10mIU/ml; body mass index <35kg/m(2); and ostradiol >1000pg/ml and <4000pg/ml on the day of human chorionic gonadotrophin administration. Exclusion criteria were: evidence of endometriosis; uterine myoma; hydrosalpinges; endocrinological disorders; history of implantation failure in previous in-vitro fertilization/ICSI cycles; and severe male factor infertility. Clinical pregnancy and implantation rates were higher in the follicular fluid group compared with the control group [354% (17/48) vs 319% (15/47); p=0718] and (18.6% vs 11.3%; p=0.153), respectively. However, the difference was not statistically significant. Flushing the endometrial cavity with follicular fluid after oocyte retrieval neither improved nor adversely affected clinical pregnancy and implantation rates in subfertile women undergoing ICSI. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial.

PubMed

Arguisuelas, María D; Lisón, Juan Francisco; Sánchez-Zuriaga, Daniel; Martínez-Hurtado, Isabel; Doménech-Fernández, Julio

2017-05-01

Double-blind, randomized parallel sham-controlled trial with concealed allocation and intention-to treat analysis. To investigate the effects of an isolate myofascial release (MFR) protocol on pain, disability, and fear-avoidance beliefs in patients with chronic low back pain (CLBP). MFR is a form of manual medicine widely used by physiotherapists in the management of different musculoskeletal pathologies. Up to this moment, no previous studies have reported the effects of an isolated MFR treatment in patients with CLBP. Fifty-four participants, with nonspecific CLBP, were randomized to MFR group (n = 27) receiving four sessions of myofascial treatment, each lasting 40 minutes, and to control group (n = 27) receiving a sham MFR. Variables studied were pain measured by means Short Form McGill Pain Questionnaire (SF-MPQ) and visual analog scale (VAS), disability measured with Roland Morris Questionnaire, and fear-avoidance beliefs measured with Fear-Avoidance Beliefs Questionnaire. Subjects receiving MFR displayed significant improvements in pain (SF-MPQ) (mean difference -7.8; 95% confidence interval [CI]: -14.5 to -1.1, P = 0.023) and sensory SF-MPQ subscale (mean difference -6.1; 95% CI: -10.8 to -1.5, P = 0.011) compared to the sham group, but no differences were found in VAS between groups. Disability and the Fear-Avoidance Beliefs Questionnaire score also displayed a significant decrease in the MFR group (P < 0.05) as compared to sham MFR. MFR therapy produced a significant improvement in both pain and disability. Because the minimal clinically important differences in pain and disability are, however, included in the 95% CI, we cannot know whether this improvement is clinically relevant. 2.

Role of reflexology and antiepileptic drugs in managing intractable epilepsy--a randomized controlled trial.

PubMed

Dalal, Krishna; Devarajan, Elanchezhiyan; Pandey, Ravindra Mohan; Subbiah, Vivekanandan; Tripathi, Manjari

2013-01-01

This report is based on the results of a randomized parallel controlled trial conducted to determine the efficacy of reflexology therapy in managing intractable epilepsy. Subjects who failed epilepsy surgery or were not candidates for epilepsy surgery or were non-responders of antiepileptic drugs (AEDs) took part in this study. The trial was completed by 77 subjects randomly assigned to 2 arms: control (AEDs) and reflexology (AEDs + reflexology therapy). The hypothesis was that hand reflexology therapy could produce results similar to those of vagus nerve stimulation, and foot reflexology therapy could maintain homeostasis in the functional status of individual body parts. Reflexology therapy was applied by family members. The follow-up period was 1.5 years. Quality of life in epilepsy patients was assessed with the QOLIE-31 instrument. In the reflexology group, the median baseline seizure frequency decreased from 9.5 (range 2-120) to 2 (range 0-110) with statistical significance (p < 0.001). In the control arm, the decrease was less than 25% with a baseline value of 16 (range 2-150). The pretherapy QOLIE-31 scores in the control group and the reflexology group were 41.05 ± 7 and 43.6 ± 8, respectively. Posttherapy data were 49.07 ± 6 and 65.4 ± 9, respectively (p < 0.002). The reflexology method allowed detection of knee pain in 85% of the reflexology group patients (p < 0.001), and 85.3% of patients derived 81% relief from it (p < 0.001). 4 reflexology group patients reported nausea/vomiting (n = 1), change in voice (n = 2), and hoarseness (n = 1). Reflexology therapy together with AEDs may help reducing seizure frequency and improving quality of life in individuals with epilepsy. Copyright © 2013 S. Karger AG, Basel.

Effect of short-term hazelnut consumption on DNA damage and oxidized LDL in children and adolescents with primary hyperlipidemia: a randomized controlled trial.

PubMed

Guaraldi, Federica; Deon, Valeria; Del Bo', Cristian; Vendrame, Stefano; Porrini, Marisa; Riso, Patrizia; Guardamagna, Ornella

2018-07-01

Children with primary hyperlipidemia are prone to develop premature atherosclerosis, possibly associated with increased oxidative stress. Nutritional therapy is the primary strategy in the treatment of hyperlipidemia and associated conditions. Dietary interventions with bioactive-rich foods, such as nuts, may contribute to the modulation of both lipid profile and the oxidative/antioxidant status. Our study aimed to assess the impact of a dietary intervention with hazelnuts on selected oxidative stress markers in children and adolescents with primary hyperlipidemia. A single-blind, 8-week, randomized, controlled, three-arm, parallel-group study was performed. Children and adolescents diagnosed with primary hyperlipidemia (n=60) received dietary guidelines and were randomized into three groups: group 1 received hazelnuts with skin (HZN+S), and group 2 hazelnuts without skin (HZN-S), at equivalent doses (15-30 g/day, based on body weight); group 3 (controls) received only dietary recommendations (no nuts). At baseline and after 8 weeks, plasma oxidized low-density lipoprotein (ox-LDL) concentrations, oxidative levels of DNA damage in PBMCs and potential correlation with changes in serum lipids were examined. A reduction of endogenous DNA damage by 18.9%±51.3% (P=.002) and 23.1%±47.9% (P=.007) was observed after HZN+S and HZN-S, respectively. Oxidatively induced DNA strand breaks decreased by 16.0%±38.2% (P=.02) following HZN+S treatment. Ox-LDL levels did not change after HZN+S intervention but positively correlated with total cholesterol and LDL cholesterol. A short-term hazelnut intervention improves cell DNA protection and resistance against oxidative stress but not ox-LDL in hyperlipidemic pediatric patients. The trial was registered at ISRCTN.com, ID no. ISRCTN12261900. Copyright © 2018 Elsevier Inc. All rights reserved.

Randomized trial of amino acid mixture combined with physical activity promotion for abdominal fat reduction in overweight adults.

PubMed

Ueda, Keisuke; Sasai, Hiroyuki; Tsujimoto, Takehiko; Sanbongi, Chiaki; Ikegami, Shuji; Kobayashi, Hiroyuki; Shioya, Nobuhiko; Suzuki, Satoru; Nakata, Yoshio

2018-01-01

The purpose of this study was to test the efficacy of arginine, alanine, and phenylalanine mixture (A-mix) ingestion at 1,500 mg/day in combination with the promotion of physical activity for abdominal fat reduction in overweight adults. A placebo-controlled, double-blind, parallel-group, randomized trial for 12 weeks combined with a 4-week follow-up period was conducted at a single center in Minato-ku, Tokyo, Japan, between December 2016 and May 2017. Data were analyzed between June and August 2017. The study participants were 200 overweight adults within the age range of 20-64 years. The participants were randomly assigned to the A-mix group (n=100) or a placebo group (n=100) and were administered 500 mL of test beverage containing 1,500 or 0 mg of A-mix, respectively, for 12 weeks. All participants maintained a physically active lifestyle between week 0 and week 12 through monthly sessions of physical activity. The primary outcomes were the 12-week changes in the abdominal total, subcutaneous, and visceral fat areas, as assessed by computed tomography. Of the 200 enrolled participants, 199 (99%) accomplished the 12-week intervention and 4-week follow-up period. The per-protocol-based analysis for 194 participants demonstrated that the abdominal total fat area decreased significantly in the A-mix group compared with that in the placebo group (difference, 10.0 cm 2 ; 95% confidence interval [CI]: 0.4-19.6 cm 2 ; P =0.041). Comparable outcomes were obtained for the abdominal subcutaneous fat area (difference, 7.4 cm 2 ; 95% CI: 0.1-14.7 cm 2 ; P =0.047). No study-related unfavorable events occurred. A-mix supplementation in combination with physical activity promotion facilitated abdominal fat reduction in overweight adults.

Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Papakostas, George I; Fava, Maurizio; Baer, Lee; Swee, Michaela B; Jaeger, Adrienne; Bobo, William V; Shelton, Richard C

2015-12-01

The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram. This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures. Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group. Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.

Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial.

PubMed

Costello, John M; Dunbar-Masterson, Carolyn; Allan, Catherine K; Gauvreau, Kimberlee; Newburger, Jane W; McGowan, Francis X; Wessel, David L; Mayer, John E; Salvin, Joshua W; Dionne, Roger E; Laussen, Peter C

2014-07-01

We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0-24]; milrinone, 18 [0-23]; placebo, 20 [0-23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. http://www.clinicaltrials.gov. Unique identifier: NCT00543309. © 2014 American Heart Association, Inc.

A double-blind randomized controlled trial to assess the efficacy of daylight photodynamic therapy with methyl-aminolevulinate vs. Placebo and daylight in patients with facial photodamage.

PubMed

Sanclemente, G; Mancilla, G A; Hernandez, G

2016-04-01

Daylight PDT (dPDT) is easy to use and does not require light equipment. Such therapy has been exhaustively proved to be successful in the treatment of actinic keratosis, but its use in skin photodamage remains unclear. To evaluate dPDT's efficacy in skin facial photodamage. This was a parallel-group double-blind, randomized placebo-controlled trial. Sixty participants with symmetric facial photodamage were allocated to topical methyl aminolevulinate (MAL) and daylight vs. matching placebo and daylight. Primary outcome was global photodamage improvement/failure 1 month after the third session. Secondary outcomes included: pain evaluation; specific photodamage severity scores; sun irradiance quantification and Skindex-29 scores. Adverse events were also investigated. Primary analysis included all randomized patients. All patients sun-exposed for 120min in 3 sessions. The risk of failure was lower in the MAL-dPDT group than in the placebo plus daylight group (RR: 0.18; 95% CI: 0.08-0.41). Mean solar irradiance (W/m(2)) during the first, second and third sessions was 480.82, 430.07 and 435.84, respectively. Items 5 and 14 of Skindex-29 in the MAL-dPDT group showed statistical significant differences. Two patients in the MAL-dPDT group had serious and non-serious events not directly related to the product. dPDT with MAL was un-painful, effective and safe for the treatment of facial photodamage. Herpes simplex prophylaxis should be considered before sessions. Copyright © 2015 AEDV. Published by Elsevier España, S.L.U. All rights reserved.

Effect of Sirolimus on Native Total Kidney Volume After Transplantation in Patients with Autosomal Dominant Polycystic Kidney Disease: A Randomized Controlled Pilot Study.

PubMed

Davis, S; Gralla, J; Chan, L; Wiseman, A; Edelstein, C L

2018-06-01

The mammalian target of rapamycin (mTOR) pathway has been shown to be central to cyst formation and growth in patients with autosomal dominant polycystic kidney disease (ADPKD). Drugs that suppress mTOR signaling are frequently used as antiproliferative agents for maintenance immunosuppression in patients who have undergone kidney transplantation. The aim of this study was to determine the effect of sirolimus, an mTOR inhibitor, on cyst volume regression in patients with ADPKD who have undergone renal transplantation. In this single-center, prospective, open-label, parallel-group, randomized trial, 23 adult patients with ADPKD who successfully underwent renal transplantation from 2008 to 2012 were subsequently randomized (on a 1:1 basis) to a maintenance immunosuppression regimen with either sirolimus (sirolimus, tacrolimus, prednisone) or mycophenolate (mycophenolate, tacrolimus, prednisone). Total kidney volumes were measured by means of high-resolution magnetic resonance imaging within 2 weeks after transplantation and at 1 year. The primary end point was change in total kidney volume at 1 year. Sixteen patients completed the 1-year study (8 patients in each group). There was a decrease in kidney volume in both the sirolimus group (percentage change from baseline, 20.5%; P < .001) and mycophenolate group (percentage change from baseline, 17%; P = .048), but there was no significant difference in percentage change of total kidney volume between the groups (P = .665). In ADPKD patients at 1 year after kidney transplantation, there was a similar decrease in polycystic kidney volume in patients receiving an immunosuppression regimen containing sirolimus compared with patients receiving mycophenolate. Copyright © 2018 Elsevier Inc. All rights reserved.

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

PubMed Central

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-01-01

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

PubMed

Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

2016-08-23

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

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.

Prebiotic effect of an infant formula supplemented with galacto-oligosaccharides: randomized multicenter trial.

PubMed

Giovannini, Marcello; Verduci, Elvira; Gregori, Dario; Ballali, Simonetta; Soldi, Sara; Ghisleni, Diana; Riva, Enrica

2014-01-01

The objective of the study was to investigate the effects of a galacto-oligosaccharides (GOS)-supplemented formula on the intestinal microbiota in healthy term infants, with a specific consideration for gastrointestinal symptoms as colic, stool frequency and consistency, regurgitation. This was a randomized, double-blind, controlled, parallel-group clinical trial performed simultaneously by 6 centers in Italy. Three groups were considered: breastfed, formula-fed, and GOS-supplemented formula-fed infants. Formula-fed infants were randomized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding. The nutritional composition of the 2 formulas were identical, apart from the supplemented GOS (0.4 g/100 mL) in the study formula. Four different types of bacteria were evaluated in order to assess the efficacy of GOS-supplemented formula on infants: Bifidobacterium, Lactobacillus, and Clostridium, Escherichia coli. A total of 199 breastfed infants and 163 formula-fed infants were recruited. When considering stool frequency and consistency, GOS-supplemented formula presented normal and soft stools in the majority of episodes (89%). In the supplemented group the incidence of colic was lower with respect to the control group. A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic. In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one. The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth, resulting in a significantly lower presence of colic.

Effect of intravenous ascorbic acid infusion on blood loss during laparoscopic myomectomy: a randomized, double-blind, placebo-controlled trial.

PubMed

Lee, Banghyun; Kim, Kidong; Cho, Hye Yon; Yang, Eun Joo; Suh, Dong Hoon; No, Jae Hong; Lee, Jung Ryeol; Hwang, Jung Won; Do, Sang Hwan; Kim, Yong Beom

2016-04-01

Most interventions aimed at reducing bleeding during myomectomy lack sufficient evidence regarding their effectiveness. Recently, it was reported that intraoperative ascorbic acid administration effectively reduced blood loss during abdominal myomectomy. Therefore, this study aimed to investigate whether intravenous ascorbic acid infusion would affect intraoperative blood loss in women undergoing laparoscopic myomectomy. A randomized, double-blind, parallel-group, placebo-controlled trial including 50 women undergoing laparoscopic myomectomy was conducted. Women with ≤4 myomas, ≤9cm in maximum diameter were eligible. The study:control group ratio was 1:1. Starting 30minutes before anesthesia, 2g of ascorbic acid or a placebo were administered for 2hours intraoperatively. Intraoperative blood loss, the primary endpoint, was calculated as the difference between the volume of fluids acquired from suction and that used for irrigation of the abdominal cavity during surgery using constant values. Among the 50 randomized women, 1 and 3 in the study and control groups, respectively, were excluded due to withdrawal of consent, cancelation of surgery, or non-measurement of the primary endpoint. The baseline and operative characteristics were similar between the study and control groups, as was the intraoperative blood loss (193±204mL vs. 159±193mL, P=0.52). In addition, the operating time (95±29min vs. 110±52min; P=0.50) and decrease in hemoglobin level after surgery (1.9±1.31g/dL vs. 1.4±1.4g/dL; P=0.24) were similar between the study and control groups. Intravenous ascorbic acid infusion did not reduce intraoperative blood loss in women undergoing laparoscopic myomectomy. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01715597. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Postpartum pelvic floor muscle training and pelvic organ prolapse--a randomized trial of primiparous women.

PubMed

Bø, Kari; Hilde, Gunvor; Stær-Jensen, Jette; Siafarikas, Franziska; Tennfjord, Merete Kolberg; Engh, Marie Ellstrøm

2015-01-01

Pelvic organ prolapse (POP) is a common and distressing condition. The aim of the present study was to evaluate the effect of pelvic floor muscle training (PFMT) on prevention and treatment of symptoms and signs of POP in primiparous postpartum women. This was a parallel group assessor blind randomized controlled trial. One hundred seventy-five primiparous postpartum women, mean age 29.8 years (standard deviation 4.1), stratified on major levator ani defects or no defect diagnosed by 3-/4-dimensional ultrasound, participated in a 4-month PFMT starting at 6-8 weeks' postpartum or control. All participants had thorough individual instruction and assessment of ability to perform correct pelvic floor muscle contractions. The PFMT group followed a supervised, weekly group training program and performed 3 sets of 8-12 daily maximal contractions at home. Main outcome was POP stage II or greater assessed by POP quantification and bladder neck position assessed by 3-/4- dimensional transperineal ultrasonography. Secondary outcome was symptoms of vaginal bulge using International Consultation on Incontinence Vaginal Symptoms questionnaire. Ninety-six percent of the intervention group adhered to ≥80% of both group and home training sessions. At postintervention, there was no significant risk difference in POP (rational ratio, 1.62; 95% confidence interval, 0.55-4.75), bladder neck position or symptoms of vaginal bulging. No effect was found of postpartum PFMT on POP in primiparous women. More randomized controlled trials are needed before strong conclusions can be drawn on the effect of PFMT on POP in the particular population. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial.

PubMed

Scheltens, Philip; Twisk, Jos W R; Blesa, Rafael; Scarpini, Elio; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Swinkels, Sophie H N; Stam, Cornelis J; de Waal, Hanneke; Wurtman, Richard J; Wieggers, Rico L; Vellas, Bruno; Kamphuis, Patrick J G H

2012-01-01

Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and extend previous findings in drug-naïve patients with mild AD. Patients were randomized 1:1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary outcome was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks. Electroencephalography (EEG) measures served as secondary outcomes as marker for synaptic connectivity. Assessments were done at baseline, 12, and 24 weeks. The NTB memory domain Z-score was significantly increased in the active versus the control group over the 24-week intervention period (p = 0.023; Cohen's d = 0.21; 95% confidence interval [-0.06]-[0.49]). A trend for an effect was observed on the NTB total composite z-score (p = 0.053). EEG measures of functional connectivity in the delta band were significantly different between study groups during 24 weeks in favor of the active group. Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events. This study demonstrates that Souvenaid is well tolerated and improves memory performance in drug-naïve patients with mild AD. EEG outcomes suggest that Souvenaid has an effect on brain functional connectivity, supporting the underlying hypothesis of changed synaptic activity.

Comparison of the Effects of Religious Cognitive Behavioral Therapy (RCBT), Cognitive Behavioral Therapy (CBT), and Sertraline on Depression and Anxiety in Patients after Coronary Artery Bypass Graft Surgery: Study Protocol for a Randomized Controlled Trial.

PubMed

Hosseini, Seyed Hamzeh; Rafiei, Alireza; Gaemian, Ali; Tirgari, Abdolhakim; Zakavi, Aliasghar; Yazdani, Jamshid; Bolhari, Jafar; Golzari, Mahmood; Esmaeili Douki, Zahra; Vaezzadeh, Nazanin

2017-07-01

Objective: The present study aimed at comparing the effects of Religious Cognitive Behavioral Therapy (RCBT), Cognitive Behavioral Therapy (CBT), and sertraline on depression, anxiety, biomarker levels, and quality of life in patients after coronary artery bypass graft (CABG) surgery. Method: This was a randomized controlled trial with parallel groups. A total of 160 patients after CABG surgery will be screened for anxiety and depression according to clinical interviews based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and Hospital Anxiety Depression Scale (HADS) scores (≥ 8). To assess religious attitude, Golriz and Baraheni's Religious Attitude questionnaire will be used. Participants will be randomly allocated to 4 groups of 40 including 3 intervention groups (RCBT, CBT, and sertraline) and 1 control group (usual care). RCBT and CBT programs will consist of 12 one-hour weekly sessions. The participants in the pharmacological intervention group will receive 25-200 mg/d of sertraline for 3 months. The Short Form-36 Health Survey (SF-36) will be administered to assess the patients' quality of life. Blood samples will be taken and biomarker levels will be determined using the enzyme-linked immunosorbent assay (ELISA). The primary outcome will be reduction in anxiety and depression scores after the interventions. The secondary outcomes will be increase in quality of life scores and normalized biomarker levels after the interventions. Discussion: If RCBT is found to be more effective than the other methods; it can be used to improve patients' health status after CABG surgery. Irct ID: IRCT201404122898N5.

J-pouch versus Roux-en-Y reconstruction after gastrectomy: functional assessment and quality of life (randomized trial).

PubMed

Zonča, Pavel; Malý, Tomáš; Ihnát, Peter; Peteja, Matus; Kraft, Otakar; Kuca, Kamil

2017-01-01

The aim of this study was to evaluate the quality of life and functional emptying of J-pouch versus Roux-en-Y reconstruction after total gastrectomy for malignancy. This study was designed as a prospective, nonblinded, randomized, parallel clinical trial (Trial Number: MN Ostrava, 200604). With informed consent, patients undergoing gastrectomy for malignancy were randomized to J-pouch or Roux-en-Y reconstruction. The time taken for a test semisolid meal labeled with 99m Tc-sulfur colloid to exit the reconstructed parts was measured by dynamic scintigraphy 1 year after resection. Quality of life was measured using the Eypasch questionnaire at the same time as functional emptying assessment. This trial was investigator-initiated. In all, 72 patients were included into the study. The time taken for the test meal to exit the postgastrectomy reconstruction was 16.5±10.0 minutes (mean ± standard deviation) in the Roux-en-Y group and 89.4±37.8 minutes in the "J-pouch" group; the difference was statistically significant ( P <0.001). Emptying of the J-pouch appeared to be a linear decreasing function compared to the exponential pattern seen in the Roux-en-Y group. The quality of life measurement showed scores of 106±18.8 points (mean ± standard deviation) in the Roux-en-Y group compared to 122±22.5 points in the J-pouch group; the difference was statistically significant ( P =0.0016). There were no important adverse events. After total gastrectomy, a J-pouch reconstruction empties more slowly and is associated with higher quality of life compared to Roux-en-Y reconstruction. Whether these two observations have a direct causative link remains unanswered.

Effects of Different Doses of Irbesartan Combined With Spironolactone on Urinary Albumin Excretion Rate in Elderly Patients With Early Type 2 Diabetic Nephropathy.

PubMed

Chen, Yingying; Liu, Peng; Chen, Xia; Li, Yanan; Zhang, Fengmei; Wang, Yangang

2018-05-01

There is a lack of research on the effect of low dose of angiotensin receptor blockers combined with spironolactone, and the effect of high dose of angiotensin receptor blockers alone on the urinary albumin excretion rate (UAER) in elderly patients with early type 2 diabetic nephropathy (DN). We conducted a prospective, randomized, open-label, parallel-controlled study that included 244 elderly patients with early DN and mild-to-moderate essential hypertension. Patients were randomly divided into 4 groups: low-dose irbesartan (group A), high-dose irbesartan (group B), low-dose irbesartan combined with spironolactone (group C) and high-dose irbesartan combined with spironolactone (group D). Changes in UAER, serum potassium and blood pressure were compared. There were no statistical differences in the baseline characteristics among groups. Furthermore, no significant difference in blood pressure before and after treatment was found among different groups. After 72-week treatment, UAER in group D was lower compared to group A and B (P < 0.05). Meanwhile, compared with group B, UAER in group C decreased significantly (P < 0.05). Additionally, significantly higher serum potassium was found in group D compared to other groups (P < 0.05). Also, group D had the highest count of patients who withdrew from the study due to hyperkalemia compared to other groups (P < 0.05). Our results indicate high-dose irbesartan combined with spironolactone may be more efficient in reducing UAER in elderly patients with early DN, but this treatment could cause hyperkalemia. Low-dose irbesartan combined with spironolactone was shown to be safer and more effective in decreasing UAER compared to high-dose irbesartan. Copyright © 2018 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

Comparison between an instructor-led course and training using a voice advisory manikin in initial cardiopulmonary resuscitation skill acquisition.

PubMed

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

2016-09-01

We compared training using a voice advisory manikin (VAM) with an instructor-led (IL) course in terms of acquisition of initial cardiopulmonary resuscitation (CPR) skills, as defined by the 2010 resuscitation guidelines. This study was a randomized, controlled, blinded, parallel-group trial. We recruited 82 first-year emergency medical technician students and distributed them randomly into two groups: the IL group (n=41) and the VAM group (n=37). In the IL-group, participants were trained in "single-rescuer, adult CPR" according to the American Heart Association's Basic Life Support course for healthcare providers. In the VAM group, all subjects received a 20-minute lesson about CPR. After the lesson, each student trained individually with the VAM for 1 hour, receiving real-time feedback. After the training, all subjects were evaluated as they performed basic CPR (30 compressions, 2 ventilations) for 4 minutes. The proportion of participants with a mean compression depth ≥50 mm was 34.1% in the IL group and 27.0% in the VAM group, and the proportion with a mean compression depth ≥40 mm had increased significantly in both groups compared with ≥50 mm (IL group, 82.9%; VAM group, 86.5%). However, no significant differences were detected between the groups in this regard. The proportion of ventilations of the appropriate volume was relatively low in both groups (IL group, 26.4%; VAM group, 12.5%; P=0.396). Both methods, the IL training using a practice-while-watching video and the VAM training, facilitated initial CPR skill acquisition, especially in terms of correct chest compression.

Paging memory from random access memory to backing storage in a parallel computer

DOEpatents

Archer, Charles J; Blocksome, Michael A; Inglett, Todd A; Ratterman, Joseph D; Smith, Brian E

2013-05-21

Paging memory from random access memory (`RAM`) to backing storage in a parallel computer that includes a plurality of compute nodes, including: executing a data processing application on a virtual machine operating system in a virtual machine on a first compute node; providing, by a second compute node, backing storage for the contents of RAM on the first compute node; and swapping, by the virtual machine operating system in the virtual machine on the first compute node, a page of memory from RAM on the first compute node to the backing storage on the second compute node.

Cognitive Behavior Therapy to Treat Sleep Disturbance and Fatigue After Traumatic Brain Injury: A Pilot Randomized Controlled Trial.

PubMed

Nguyen, Sylvia; McKay, Adam; Wong, Dana; Rajaratnam, Shantha M; Spitz, Gershon; Williams, Gavin; Mansfield, Darren; Ponsford, Jennie L

2017-08-01

To evaluate the efficacy of adapted cognitive behavioral therapy (CBT) for sleep disturbance and fatigue in individuals with traumatic brain injury (TBI). Parallel 2-group randomized controlled trial. Outpatient therapy. Adults (N=24) with history of TBI and clinically significant sleep and/or fatigue complaints were randomly allocated to an 8-session adapted CBT intervention or a treatment as usual (TAU) condition. Cognitive behavior therapy. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) posttreatment and at 2-month follow-up. Secondary measures included the Insomnia Severity Index, Fatigue Severity Scale, Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale, and Hospital Anxiety and Depression Scale. At follow-up, CBT recipients reported better sleep quality than those receiving TAU (PSQI mean difference, 4.85; 95% confidence interval [CI], 2.56-7.14). Daily fatigue levels were significantly reduced in the CBT group (BFI difference, 1.54; 95% CI, 0.66-2.42). Secondary improvements were significant for depression. Large within-group effect sizes were evident across measures (Hedges g=1.14-1.93), with maintenance of gains 2 months after therapy cessation. Adapted CBT produced greater and sustained improvements in sleep, daily fatigue levels, and depression compared with TAU. These pilot findings suggest that CBT is a promising treatment for sleep disturbance and fatigue after TBI. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy of an orlistat-resveratrol combination for weight loss in subjects with obesity: A randomized controlled trial.

PubMed

Arzola-Paniagua, María Angélica; García-Salgado López, Enrique Raúl; Calvo-Vargas, Cesar G; Guevara-Cruz, Martha

2016-07-01

To evaluate the efficacy of an orlistat-resveratrol (O-R) combination in subjects with obesity over a 6-month period. This study was a double-blind, parallel, randomized controlled clinical trial. Patients fulfilling the selection criteria (age from 20 to 60 years and body mass index (BMI) ≥30 and ≤39.9 kg/m(2) ) consumed an energy-reduced diet with 500 fewer calories than their usual diet for 2 weeks. Then the participants were randomly assigned to four groups, placebo, resveratrol, orlistat, or O-R, and they consumed the energy-reduced diet for 6 months. The study consisted of seven visits. During each visit, a 24-h recall was performed, along with measurements of anthropometric and serum biochemical parameters. A total of 161 participants were selected. Of these, 84 participants completed the study. A significant weight loss of -6.82 kg (95% CI -8.37 to -5.26) was observed in the O-R group compared with -3.50 kg (-5.05 to -1.95, P = 0.021) in the placebo group. In contrast, the -6.02 kg (-7.68 to -4.36) orlistat and -4.68 kg (-6.64 to -2.71) resveratrol monotherapy losses did not significantly differ from the placebo. Significant decreases in BMI, waist circumference, fat mass, triglycerides, leptin, and leptin/adiponectin ratio were observed with the O-R combination. The O-R combination was the most effective weight loss treatment. © 2016 The Obesity Society.

Effect of Deploying Trained Community Based Reproductive Health Nurses (CORN) on Long-Acting Reversible Contraception (LARC) Use in Rural Ethiopia: A Cluster Randomized Community Trial.

PubMed

Zerfu, Taddese Alemu; Ayele, Henok Taddese; Bogale, Tariku Nigatu

2018-06-01

To investigate the effect of innovative means to distribute LARC on contraceptive use, we implemented a three arm, parallel groups, cluster randomized community trial design. The intervention consisted of placing trained community-based reproductive health nurses (CORN) within health centers or health posts. The nurses provided counseling to encourage women to use LARC and distributed all contraceptive methods. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where the new service providers were deployed, health post or health center. We calculated difference-in-difference (DID) estimates to assess program impacts on LARC use. After nine months of intervention, the use of LARC methods increased significantly by 72.3 percent, while the use of short acting methods declined by 19.6 percent. The proportion of women using LARC methods increased by 45.9 percent and 45.7 percent in the health post and health center based intervention arms, respectively. Compared to the control group, the DID estimates indicate that the use of LARC methods increased by 11.3 and 12.3 percentage points in the health post and health center based intervention arms. Given the low use of LARC methods in similar settings, deployment of contextually trained nurses at the grassroots level could substantially increase utilization of these methods. © 2018 The Population Council, Inc.

Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial.

PubMed

Trevisanuto, Daniele; Cavallin, Francesco; Nguyen, Loi Ngoc; Nguyen, Tien Viet; Tran, Linh Dieu; Tran, Chien Dinh; Doglioni, Nicoletta; Micaglio, Massimo; Moccia, Luciano

2015-08-01

To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. Registered with ClinicalTrials.gov: NCT01963936. Copyright © 2015 Elsevier Inc. All rights reserved.

Electroacupuncture for patients with diarrhea-predominant irritable bowel syndrome or functional diarrhea: A randomized controlled trial.

PubMed

Zheng, Hui; Li, Ying; Zhang, Wei; Zeng, Fang; Zhou, Si-Yuan; Zheng, Hua-Bin; Zhu, Wen-Zeng; Jing, Xiang-Hong; Rong, Pei-Jing; Tang, Chun-Zhi; Wang, Fu-Chun; Liu, Zhi-Bin; Wang, Shi-Jun; Zhou, Mei-Qi; Liu, Zhi-Shun; Zhu, Bing

2016-06-01

Diarrhea-predominant irritable bowel syndrome (IBS-D) and functional diarrhea (FD) are highly prevalent, and the effectiveness of acupuncture for managing IBS-D and FD is still unknown.The aim of this study was to compare the effectiveness of electroacupuncture with loperamide.It was a prospective, randomized, parallel group controlled trial.A total of 448 participants were randomly assigned to He electroacupuncture group (n = 113), Shu-Mu electroacupuncture group (n = 111), He-Shu-Mu electroacupuncture group (n = 112), or loperamide group (n = 112). Participants in the 3 acupuncture groups received 16 sessions of electroacupuncture during a 4-week treatment phase, whereas participants in the loperamide group received oral loperamide 2 mg thrice daily. The primary outcome was the change from baseline in stool frequency at the end of the 4-weeks treatment. The secondary outcomes were the Bristol scale, the MOS 36-item short form health survey (SF-36), the weekly average number of days with normal defecations and the proportion of adverse events.Stool frequency was significantly reduced at the end of the 4-week treatment in the 4 groups (mean change from baseline, 5.35 times/week). No significant difference was found between the 3 electroacupuncture groups and the loperamide group in the primary outcome (He vs. loperamide group [mean difference 0.6, 95% CI, -1.2 to 2.4]; Shu-Mu vs. loperamide group [0.4, 95% CI, -1.4 to 2.3]; He-Shu-Mu vs. loperamide group [0.0, 95% CI, -1.8 to 1.8]). Both electroacupuncture and loperamide significantly improved the mean score of Bristol scale and increased the weekly average number of days with normal defecations and the mean scores of SF-36; they were equivalent in these outcomes. However, the participants in electroacupuncture groups did not report fewer adverse events than those in the loperamide group. Similar results were found in a subgroup analysis of separating patients with IBS-D and FD patients.Electroacupuncture is equivalent to loperamide for reducing stool frequency in IBS-D and FD patients. Further studies on cost effectiveness of acupuncture are warranted.

Comparison of peri-implant bone loss between conventional drilling with irrigation versus low-speed drilling without irrigation.

PubMed

Pellicer-Chover, H; Peñarrocha-Oltra, D; Aloy-Prosper, A; Sanchis-Gonzalez, J-C; Peñarrocha-Diago, M-A; Peñarrocha-Diago, M

2017-11-01

To compare the technique of high speed drilling with irrigation and low speed drilling without irrigation in order to evaluate the success rate and peri-implant bone loss at 12 months of follow-up. A randomized, controlled, parallel-group clinical trial was carried out in patients requiring dental implants to rehabilitate their unitary edentulism. Patients were recruited from the Oral Surgery Unit of the University of Valencia (Spain) between September 2014 and August 2015. Patients who met the inclusion criteria were randomized to two groups: group A (high-speed drilling with irrigation) and group B (low-speed drilling without irrigation). The success rate and peri-implant bone loss were recorded at 12 months of follow-up. Twenty-five patients (9 men and 16 women) with 30 implants were enrolled in the study: 15 implants in group A and 15 implants in group B. The mean bone loss of the implants in group A and group B was 0.83 ± 0.73 mm and 0.62 ± 0.70 mm, respectively (p> 0.05). In the maxilla, the bone loss was 1.04 ± 0.63 mm in group A and 0.71 ± 0.36 mm in group B (p> 0.05), while bone loss in the mandible was 0.59 ± 0.80 mm in group A and 0.69 ± 0.77 mm in group B (p> 0.05). The implant success rate at 12 months was 93.3% in group A and 100% in group B. Within the limitations of the study, the low-speed drilling technique presented peri-implant bone loss outcomes similar to those of the conventional drilling technique at 12 months of follow-up.

Effectiveness of a Self-monitoring Device for Urinary Sodium-to-Potassium Ratio on Dietary Improvement in Free-Living Adults: a Randomized Controlled Trial.

PubMed

Iwahori, Toshiyuki; Ueshima, Hirotsugu; Ohgami, Naoto; Yamashita, Hideyuki; Miyagawa, Naoko; Kondo, Keiko; Torii, Sayuki; Yoshita, Katsushi; Shiga, Toshikazu; Ohkubo, Takayoshi; Arima, Hisatomi; Miura, Katsuyuki

2018-01-05

Reducing the urinary sodium-to-potassium ratio is important for reducing both blood pressure and risk of cardiovascular disease. Among free-living Japanese individuals, we carried out a randomized trial to clarify the effect of lifestyle modification for lowering urinary sodium-to-potassium ratio using a self-monitoring device. This was an open, prospective, parallel randomized, controlled trial. Ninety-two individuals were recruited from Japanese volunteers. Participants were randomly allocated into intervention and control groups. A month-long dietary intervention on self-monitoring urinary sodium-to-potassium ratio was carried out using monitors (HEU-001F, OMRON Healthcare Co., Ltd., Kyoto, Japan). All participants had brief dietary education and received a leaflet as usual care. Monitors were handed out to the intervention group, but not to the control group. The intervention group was asked to measure at least one spot urine sodium-to-potassium ratio daily, and advised to lower their sodium-to-potassium ratio toward the target of less than 1. Outcomes included changes in 24-hour urinary sodium-to-potassium ratio, sodium excretion, potassium excretion, blood pressure, and body weight in both groups. Mean measurement frequency of monitoring was 2.8 times/day during the intervention. Changes in urinary sodium-to-potassium ratio were -0.55 in the intervention group and -0.06 in the control group (P = 0.088); respective sodium excretion changes were -18.5 mmol/24 hours and -8.7 mmol/24 hours (P = 0.528); and corresponding potassium excretion was 2.6 mmol/24 hours and -1.5 mmol/24 hours (P = 0.300). No significant reductions were observed in either blood pressure or body weight after the intervention. Providing the device to self-monitor a sodium-to-potassium ratio did not achieve the targeted reduction of the ratio in "pure self-management" settings, indicating further needs to study an effective method to enhance the synergetic effect of dietary programs and self-monitoring practice to achieve the reduction. However, we cannot deny the possibility of reducing sodium-to-potassium ratio using a self-monitoring device.

Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial

PubMed Central

Mendelow, A. David; Rowan, Elise N.; Francis, Richard; McColl, Elaine; McNamee, Paul; Chambers, Iain R.; Unterberg, Andreas; Boyers, Dwayne; Mitchell, Patrick M.

2015-01-01

Abstract Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, −4.4–25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed. PMID:25738794