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Sample records for controlled randomized study

  1. Celiac Patients: A Randomized, Controlled Clinical Study

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    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  2. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

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    SOFIA VON HUMBOLDT

    2013-01-01

    Full Text Available El objetivo del estudio que se informa fue ex- plorar si una intervención individual de terapia centrada en la persona (TCP en personas adul- tas mayores puede promover su sentido de cohe- rencia, en comparación con un grupo control (lista de espera. Se plantea que los participantes asignados al azar a TCP informarían mejoras en SDC de pre y post-intervención en comparación con el grupo control. Un grupo de 87 participantes de 65 a 86 años (M = 72.4; DE = 5.15 fue evaluado con la Escala de Sentido de Coherencia (ESDC y el cuestio- nario sociodemográfico en tres momentos dife- rentes: al inicio del estudio (t1, post-tratamiento (t2 y a los 12 meses de seguimiento (t3. Los resultados indicaron que los participan- tes en TCP evidenciaron un aumento significa- tivo en cuanto a su SDC (16.7%, mientras que en el grupo control se encontró una disminu- ción significativa (-2.7%, entre el inicio del es- tudio y el momento de seguimiento. El tamaño del efecto en el grupo TCP fue alto (η2p = .776. En concreto, tanto en la post-intervención como en el momento del seguimiento, los participan- tes que se sometieron a TCP tenían un SDC sig- nificativamente mayor (M = 3.84, DE = .219 Se encontraron diferencias significativas entre el grupo de intervención y el grupo control en la post-intervención y en el seguimiento. Se concluye que los cambios en SDC fueron positivos y mantenidos, por lo tanto, los resul- tados sugieren que la TCP es favorable a la me- jora de SDC. Por otra parte, ya que la SDC se asocia con el bienestar relacionado con la salud de las poblaciones de mayor edad, hay que en- fatizar el desarrollo de SDC en la vejez.

  3. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

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    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  4. A Systematic Review of Randomized Controlled Studies of Art Therapy

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    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  5. A Systematic Review of Randomized Controlled Studies of Art Therapy

    Science.gov (United States)

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  6. Coblation tonsillectomy: a double blind randomized controlled study.

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    Timms, M S; Temple, R H

    2002-06-01

    Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.

  7. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

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    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  8. Partner randomized controlled trial: study protocol and coaching intervention

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    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  9. Hypnosis versus diazepam for embryo transfer: a randomized controlled study.

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    Catoire, Patrick; Delaunay, Laurent; Dannappel, Thomas; Baracchini, Dominique; Marcadet-Fredet, Sabine; Moreau, Olivier; Pacaud, Luc; Przyrowski, Daniel; Marret, Emmanuel

    2013-04-01

    Levitas et al. (2006) showed in a cohort study that hypnosis during embryo transfer (ET) increased pregnancy ratio by 76%. In order to evaluate hypnosis during ET in a general population, the authors performed a randomized prospective controlled study comparing diazepam (usual premedication) administered before ET plus muscle relaxation versus hypnosis plus placebo in 94 patients. Additionally, the authors studied anxiety pre and post ET. Anxiety scores were not different in the two groups before and after ET. No difference in pregnancy and birth ratio was found in the two groups. Hypnosis during ET is as effective as diazepam in terms of pregnancy ratio and anxiolytic effects, but with fewer side effects and should be routinely available.

  10. Study on Multi-array Shaker Random Vibration Test Control

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    Gao Chun-hua

    2013-07-01

    Full Text Available Some basic algorithms and theories are discussed for 9-shaker random vibration test control in this paper. A correct algorithm RMS is presented without considering influence of cross spectrum. The algorithm can make the control spectrum of convergence stably and fastly. In order to solve the problem of multiple-point input and output synthetically weighting control,  Finite Markov Chains and Algorithmic is set forth for the first time to form the main control matrix. Finally through Matlab simulation and the results show that the method can meet the engineering demand.  

  11. Working on asymmetry in Parkinson's disease: randomized, controlled pilot study.

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    Ricciardi, Lucia; Ricciardi, Diego; Lena, Francesco; Plotnik, Meir; Petracca, Martina; Barricella, Simona; Bentivoglio, Anna Rita; Modugno, Nicola; Bernabei, Roberto; Fasano, Alfonso

    2015-08-01

    Posture, gait and balance problems are very disabling symptoms in Parkinson's disease (PD). An increased stride-to-stri de variability, reduction of automaticity and asymmetry of lower limbs function characterize parkinsonian gait. These features predispose to freezing of gait (FOG), which often leads to falls. The aim of this study was to evaluate how the modulation of asymmetry through physiotherapy might improve gait and reduce FOG, thus preventing falls. Twenty-eight PD patients entered a double-blind pilot feasibility controlled study and were evaluated at baseline and after 3 months of a rehabilitative program (performed twice a week) by means of the motor part of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Gait and Falls Questionnaire, Tinetti balance and gait scale, Short Physical Performance Battery (SPPB), European Quality of Life questionnaire. Patients were randomly assigned to three treatment arms: (1) worst side improvement; (2) best side improvement; (3) standard therapy. All study arms showed a significant improvement of the Tinetti and SPPB scores. BSI led to a greater improvement than ST in terms of UPDRS-III (p = 0.01); Tinetti total score (p = 0.05) and Tinetti gait subscore (p = 0.01). Our study confirms the efficacy of physical therapy in the treatment of PD and, more importantly, suggests that specific intervention tailored on individual feature (e.g., asymmetry of motor condition) might be even more effective than standard rehabilitative programs.

  12. Randomized controlled study of CBT in bronchial asthma

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    Grover Naveen

    2007-01-01

    Full Text Available The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured interview schedule, Asthma Symptom Checklist, Asthma di-ary, Asthma Bother Profile, Hospital Anxiety & Depression Scale, AQLQ and Peak Expiratory Flow Rate. Within group comparison showed significant improvement in both groups at the post assessment. Between group comparisons showed that CBT group reported significantly greater change than that of SM group. Cognitive behavior therapy helps in improving the managment of asthma.

  13. [Chuzhen therapy for sub-health: a randomized controlled study].

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    Hu, You-Ping; Xu, Zhen-Jie; Wu, Jia; Xing, Lin; Zhang, Lei-Xiao; Zhang, Jin-Xing; Tan, Hui; Mao, Shi-Zhi; Zhou, Cong-Quan

    2012-11-01

    To observe the effect on intervention of sub-health with pestle needle (Chuzhen). Randomized controlled trail was adopted for this research. One hundred and fifty-three cases were randomly divided into two groups of a Chuzhen group (79 cases) and a massage group (74 cases). Acupoint of Bazhen (Baihui Bazhen, Shendao Bazhen, Zhiyang Bazhen, Mingmen Bazhen, Yaoyangguan Bazhen), Hechelu on the head, the neck and the lumbar area were adopted in Chuzhen group. While regular whole-body massage was applied in the massage group. The human sub-health score, the cornell medical index (CMI) and thermal texture maps system (TTM) technology of the two groups before and after the intervention were observed. 1) After treatment, sub-health condition score, the CMI score, the M-R score and the TTM index were all increased in both groups (all P0.05). 3) The sub-health condition score in Chuzhen group was higher than that in the massage group (P<0.01). Chuzhen therapy has definite effect on intervention of sub-health, which is better than regular general massage.

  14. Prenatal emotion management improves obstetric outcomes: a randomized control study.

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    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.

  15. [Randomized controlled study on acupuncture treatment for chronic fatigue syndrome].

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    Chen, Xing-Hua; Li, Lu-Qian; Zhang, Wen; Yang, Juan; Dai, Yi-Shuang; Xu, Dong-Hua; Tang, Chun-Zhi

    2010-07-01

    To observe the therapeutic effect of acpuncture treatment for chronic fatigue syndrome (CFS). Nighty cases of CFS were randomly divided into an observation group and a control group, 45 cases in each group. The observation group was treated with acupunture at Renying (ST 9), Fengfu (GV 16), Baihui (GV 20); the control group was treated with 250 mL 5% Glucose injectio combined with 20 mL Shenmai injectio. Fatigue Scale (FS) was used to compare the scores between the two groups after treatment. The total scores in the observation group were 9.37 +/- 2.33 and 5.41 +/- 1.96 before and after treatment respectively, and in the control group, they were 9.08 +/- 2.27 and 7.34 +/- 2.03 respectively. FS brainwork integral, physical fatigue integral, and total integral all decreased after treatment in two groups (all P < 0.001), and it decreased much more obviously in the observation group (P < 0.05, P < 0.01). Both of the acpuncture treatment and Shenmai injectio are able to decrease fatigue scale score, improve the fatigue symptoms of CFS patients, and the effect of acupucture treatment is obviously superior to that of Shenmai injectio.

  16. Study protocol: The Adherence and Intensification of Medications (AIM study - a cluster randomized controlled effectiveness study

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    Selby Joe

    2010-10-01

    Full Text Available Abstract Background Many patients with diabetes have poor blood pressure (BP control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. Methods In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL, medication adherence determined from pharmacy refill data, and medication intensification rates. Discussion Integration of the three intervention elements - proactive identification, adherence counseling and medication intensification - is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. Trial Registration The ClinicalTrials.gov registration number is NCT

  17. A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

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    Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

    2012-01-01

    This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

  18. Fetal response to abbreviated relaxation techniques. A randomized controlled study.

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    Fink, Nadine S; Urech, Corinne; Isabel, Fornaro; Meyer, Andrea; Hoesli, Irène; Bitzer, Johannes; Alder, Judith

    2011-02-01

    stress during pregnancy can have adverse effects on the course of pregnancy and on fetal development. There are few studies investigating the outcome of stress reduction interventions on maternal well-being and obstetric outcome. this study aims (1) to obtain fetal behavioral states (quiet/active sleep, quiet/active wakefulness), (2) to investigate the effects of maternal relaxation on fetal behavior as well as on uterine activity, and (3) to investigate maternal physiological and endocrine parameters as potential underlying mechanisms for maternal-fetal relaxation-transferral. the behavior of 33 fetuses was analyzed during laboratory relaxation/quiet rest (control group, CG) and controlled for baseline fetal behavior. Potential associations between relaxation/quiet rest and fetal behavior (fetal heart rate (FHR), FHR variation, FHR acceleration, and body movements) and uterine activity were studied, using a computerized cardiotocogram (CTG) system. Maternal heart rate, blood pressure, cortisol, and norepinephrine were measured. intervention (progressive muscle relaxation, PMR, and guided imagery, GI) showed changes in fetal behavior. The intervention groups had higher long-term variation during and after relaxation compared to the CG (p=.039). CG fetuses had more FHR acceleration, especially during and after quiet rest (p=.027). Women in the PMR group had significantly more uterine activity than women in the GI group (p=.011) and than CG women. Maternal heart rate, blood pressure, and stress hormones were not associated with fetal behavior. this study indicates that the fetus might participate in maternal relaxation and suggests that GI is superior to PMR. This could especially be true for women who tend to direct their attention to body sensations such as abdominal activity. 2010 Elsevier Ltd. All rights reserved.

  19. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies

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    Shobha Misra

    2012-01-01

    Full Text Available Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  20. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies.

    Science.gov (United States)

    Misra, Shobha

    2012-07-01

    Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  1. Transcutaneus electrical nerve stimulation for overactive bladder increases rectal motor activity in children: a randomized controlled study

    DEFF Research Database (Denmark)

    Jønsson, Iben; Hagstrøm, Søren; Siggaard, Charlotte

    Transcutaneus electrical nerve stimulation for overactive bladder increases rectal motor activity in children: a randomized controlled study......Transcutaneus electrical nerve stimulation for overactive bladder increases rectal motor activity in children: a randomized controlled study...

  2. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

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    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  3. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study.

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    De Vito, Andrea; Agnoletti, Vanni; Berrettini, Stefano; Piraccini, Emanuele; Criscuolo, Armando; Corso, Ruggero; Campanini, Aldo; Gambale, Giorgio; Vicini, Claudio

    2011-03-01

    Understanding the sites of pharyngeal collapse is mandatory for surgical treatment decision-making in obstructive sleep-apnea-hypopnea syndrome patients. Drug-induced sleep endoscopy (DISE) allows for the direct observation of the upper airway during sedative-induced sleep. In order to re-create snoring and apnea patterns related to a spontaneous sleep situation, the authors used a target-controlled infusion (TCI) sleep endoscopy (DISE-TCI), comparing this technique to conventional DISE, in which sedation was reached by a manual bolus injection. The authors conducted a prospective, randomized, unicenter study. The apneic event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plans of DISE-TCI technique. From January 2009 to June 2009, 40 OSAHS patients were included in the study and randomized allocated in two groups: the bolus injection conventional DISE group and the DISE-TCI group. We recorded the complete apnea event at the oropharynx and hypopharynx levels in 4 patients of the conventional DISE group (20%) and in 17 patients of the DISE-TCI group (85%) (P DISE group because of severe desaturation that resulted from the first bolus of propofol (1 mg/kg) (P = 0.4872 ns). We recorded the instability of the sedation plan in 13 patients from the conventional DISE group (65%) and 1 patient from the DISE-TCI group (5%) (P = 0.0001). Our results suggest that the DISE-TCI technique should be the first choice in performing sleep endoscopy because of its increased accuracy, stability and safety.

  4. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

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    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  5. Pain after microlaparoscopic cholecystectomy. A randomized double-blind controlled study

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R;

    2000-01-01

    BACKGROUND: Laparoscopic cholecystectomy (LC) is traditionally performed with two 10-mm and two 5-mm trocars. The effect of smaller port incisions on pain has not been established in controlled studies. METHODS: In a double-blind controlled study, patients were randomized to LC or cholecystectomy......: The study was discontinued after inclusion of 26 patients because five of the 13 patients (38%) randomized to micro-LC were converted to LC. In the remaining 21 patients, overall pain and incisional pain intensity during the first 3 h postoperatively increased in the LC group (n = 13) compared...

  6. Effect of yoga on quality of life of CLBP patients: A randomized control study

    OpenAIRE

    Tekur Padmini; Chametcha Singphow; Hongasandra Ramarao; Raghuram Nagarathna

    2010-01-01

    Context: In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP), 12 to 16 weeks of intervention were found effective in reducing pain and disability. Aim: To study the efficacy of a residential short term intensive yoga program on quality of life in CLBP. Materials and Methods: About 80 patients with CLBP (females 37) registered for a week long treatment at SVYASA Holistic Health Centre in Bengaluru, India. They were randomized into two groups (40 each). T...

  7. Neostigmine Decreases Bupivacaine Use by Patient-Controlled Epidural Analgesia During Labor: A Randomized Controlled Study

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    Ross, Vernon H.; Pan, Peter H.; Owen, Medge D; Seid, Melvin H.; Harris, Lynne; Clyne, Brittany; Voltaire, Misa; Eisenach, James C.

    2009-01-01

    Background Intrathecal neostigmine produces analgesia, but also severe nausea. In contrast, epidural neostigmine enhances opioid and local anesthetic analgesia without causing nausea. Previous studies examined only single epidural neostigmine bolus administration and did not assess the efficacy of continuous epidural infusion or several aspects of maternal and fetal safety. We therefore tested the hypothesis that epidural neostigmine in combination with bupivacaine by continuous infusion during labor would reduce the amount of bupivacaine required. Methods Twelve healthy women scheduled for elective cesarean delivery were assigned to receive epidural neostigmine, 40 μg (first 6 subjects) or 80 μg (second 6 subjects) as a single bolus, with fetal heart rate and uterine contractions monitored for 20 minutes. In a subsequent experiment, 40 healthy laboring women were randomized to receive bupivacaine 1.25 mg/mL alone or with neostigmine 4 μg/mL by patient-controlled epidural analgesia. The primary outcome measure was hourly bupivacaine use. Results Epidural neostigmine bolus did not alter baseline fetal heart rate, induce contractions or produce nausea. Epidural neostigmine infusion reduced bupivacaine requirement by 19% in all patients and 25% in those with > 4 hours of treatment (P<0.05 for both), but might have contributed to the incidence of mild sedation. Mode of delivery, incidence of maternal nausea and fetal heart rate abnormality were similar between groups. Conclusions These data show that adding epidural neostigmine 4 μg/mL reduces the hourly bupivacaine requirement by 19% to 25% with patient-controlled epidural analgesia during labor. Administered as a bolus and by continuous infusion at the studied doses, epidural neostigmine does not cause nausea and does not induce uterine contractions or fetal heart rate abnormalities, but mild sedation can occur. PMID:19377050

  8. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Chmiel C

    2014-10-01

    Full Text Available Corinne Chmiel, Oliver Senn, Thomas Rosemann, Valerio Del Prete, Claudia Steurer-Stey Institute of General Practice and Health Services Research, University of Zurich, Zurich, Switzerland Background: Inadequate blood pressure (BP control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP improves BP control and adherence with home BP measurement.Methods: In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg, and adherence with home BP measurement after 6 months.Results: One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7. BP control (treatment target <140/90 mmHg was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5. Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1Conclusion: Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months, but no significant between-group difference was

  9. Melatonin for chronic sleep onset insomnia in children: A Randomized placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.G.; Nagtegaal, J.E.; Heijden, J.A.M. van der; Coenen, A.M.L.; Kerkhof, G.A.

    2001-01-01

    To establish the efficacy of melatonin treatment in childhood sleep onset insomnia, 40 elementary school children, 6 to 12 years of age, who suffered more than 1 year from chronic sleep onset insomnia, were studied in a double-blind, placebo-controlled study. The children were randomly assigned to

  10. Melatonin for chronic sleep onset insomnia in children: A Randomized placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.G.; Nagtegaal, J.E.; Heijden, J.A.M. van der; Coenen, A.M.L.; Kerkhof, G.A.

    2001-01-01

    To establish the efficacy of melatonin treatment in childhood sleep onset insomnia, 40 elementary school children, 6 to 12 years of age, who suffered more than 1 year from chronic sleep onset insomnia, were studied in a double-blind, placebo-controlled study. The children were randomly assigned to r

  11. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    2008-01-01

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and Stat

  12. Double-blind randomized controlled study of coblation tonsillotomy versus coblation tonsillectomy on postoperative pain.

    Science.gov (United States)

    Arya, A; Donne, A J; Nigam, A

    2003-12-01

    This double-blind randomized controlled trial of coblation tonsillotomy versus coblation tonsillectomy uses visual analogue scoring to compare the pain experienced in the 24h postoperative period. No statistically significant difference in pain is demonstrated in the group of 14 patients studied. Tonsillectomy is recommended over tonsillotomy.

  13. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    Science.gov (United States)

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

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

    Science.gov (United States)

    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.

  15. Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies

    Directory of Open Access Journals (Sweden)

    Shobana Balasingam

    2016-08-01

    Conclusions: Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events.

  16. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study

    OpenAIRE

    2014-01-01

    Background Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments. This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years. Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract (7.5 mg/day) or placebo for 4 weeks. De...

  17. Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies.

    Science.gov (United States)

    Omboni, Stefano; Guarda, Alessia

    2011-09-01

    Home blood pressure telemonitoring figures among the possible solutions that could help improve blood pressure control of hypertensive patients. To summarize the effectiveness of home blood pressure telemonitoring on blood pressure control from randomized, controlled studies. Electronic databases were searched for publications in English, reporting on randomized trials of home blood pressure telemonitoring vs. usual care. Outcome measures were office or ambulatory blood pressure changes, rate of blood pressure control, and number of antihypertensive drugs used by patients. A random effects model was applied. Twelve studies met inclusion criteria. A high level of heterogeneity was found among studies for all the variables explored. Office blood pressure was reduced significantly more in patients randomized to home telemonitoring (systolic: 5.64 (95% confidence interval: 7.92, 3.36) mm Hg; diastolic: 2.78 (3.93, 1.62) mm Hg; 11 comparisons, n = 4,389). The effect on ambulatory blood pressure was smaller than on office blood pressure (systolic: 2.28 (4.32, 0.24); diastolic: 1.38 (3.55, +0.79) mm Hg; 3 comparisons, n = 655). The relative risk of blood pressure normalization (telemonitoring vs. the usual care group was 1.31 (1.06, 1.62) (5 comparisons, n = 2,432 subjects). Use of telemonitoring was associated with a significantly increased use of antihypertensive medications (+0.22 (+0.02, +0.43), 5 comparisons, n = 1,991). Home blood pressure telemonitoring may represent a useful tool to improve blood pressure control. However, heterogeneity of published studies suggests that well designed, large-scale, randomized, controlled studies are still needed to demonstrate the clinical usefulness of this technique.

  18. A Virtual Reality Game for Chronic Pain Management: A Randomized, Controlled Clinical Study.

    Science.gov (United States)

    Jin, Weina; Choo, Amber; Gromala, Diane; Shaw, Chris; Squire, Pamela

    2016-01-01

    Although Virtual Reality (VR) applications have been shown to reduce many forms of acute pain, such research of VR applications and their effects on chronic pain is still at its infancy. In this study, we designed a VR game Cryoslide, and examined its analgesic effect on chronic pain patients, its end users, in a clinical setting. In this randomized, controlled crossover clinical study of 20 chronic pain patients, Cryoslide significantly reduced perceived pain compared to the baseline and the control group. The results demonstrate that Cryoslide can be effectively used as an analgesic intervention for chronic pain management to lessen pain intensity during short-term symptom spikes.

  19. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    OpenAIRE

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the...

  20. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    OpenAIRE

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep; Kempf, Mirjam-Colette

    2015-01-01

    Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of P...

  1. Impacts of Comprehensive Teacher Induction: Results from the First Year of a Randomized Controlled Study

    OpenAIRE

    Steven Glazerman Sarah Dolfin Martha Bleeker Amy Johnson Eric Isenberg Julieta Lugo-Gil Mary Grider Edward Britton

    2008-01-01

    Comprehensive teacher induction provides novice teachers with carefully selected and trained full-time mentors, as well as a curriculum of intensive and structured support. This report presents the first round of results from a large-scale randomized controlled study of the effects of two comprehensive teacher induction programs. Intensive mentoring and professional development for teachers just entering the profession did not increase teacher retention or generate any significant improvement...

  2. Impacts of Comprehensive Teacher Induction: Results from the First Year of a Randomized Controlled Study.

    OpenAIRE

    Steven Glazerman; Sarah Dolfin; Martha Bleeker; Amy Johnson; Eric Isenberg; Julieta Lugo-Gil; Mary Grider; Edward Britton

    2008-01-01

    Comprehensive teacher induction provides novice teachers with carefully selected and trained full-time mentors, as well as a curriculum of intensive and structured support. This report presents the first round of results from a large-scale randomized controlled study of the effects of two comprehensive teacher induction programs. Intensive mentoring and professional development for teachers just entering the profession did not increase teacher retention or generate any significant improvement...

  3. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study.

    Science.gov (United States)

    Optale, Gabriele; Urgesi, Cosimo; Busato, Valentina; Marin, Silvia; Piron, Lamberto; Priftis, Konstantinos; Gamberini, Luciano; Capodieci, Salvatore; Bordin, Adalberto

    2010-05-01

    Memory decline is a prevalent aspect of aging but may also be the first sign of cognitive pathology. Virtual reality (VR) using immersion and interaction may provide new approaches to the treatment of memory deficits in elderly individuals. The authors implemented a VR training intervention to try to lessen cognitive decline and improve memory functions. The authors randomly assigned 36 elderly residents of a rest care facility (median age 80 years) who were impaired on the Verbal Story Recall Test either to the experimental group (EG) or the control group (CG). The EG underwent 6 months of VR memory training (VRMT) that involved auditory stimulation and VR experiences in path finding. The initial training phase lasted 3 months (3 auditory and 3 VR sessions every 2 weeks), and there was a booster training phase during the following 3 months (1 auditory and 1 VR session per week). The CG underwent equivalent face-to-face training sessions using music therapy. Both groups participated in social and creative and assisted-mobility activities. Neuropsychological and functional evaluations were performed at baseline, after the initial training phase, and after the booster training phase. The EG showed significant improvements in memory tests, especially in long-term recall with an effect size of 0.7 and in several other aspects of cognition. In contrast, the CG showed progressive decline. The authors suggest that VRMT may improve memory function in elderly adults by enhancing focused attention.

  4. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Bindu John

    2016-01-01

    Full Text Available Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n=34; control group, n=24. Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

  5. Study on semi-active control of mega-sub controlled structure by MR damper subject to random wind loads

    Institute of Scientific and Technical Information of China (English)

    Qin Xiangjun; Zhang Xun'an; Sheldon Cherry

    2008-01-01

    The recently proposed mega-sub controlled structure (MSCS), a new type of structure associated with the design and construction of super-tall buildings, has attracted the attention of designers for use in enhancing the control effectiveness in mega-fi'ame buildings. In this paper, a dynamic equation and method to assemble parameter matrixes for a mega-sub controlled structure under random wind loads is presented. Semi-active control using magnetorheological dampers for the MSCS under random wind loads is investigated, and is compared with a corresponding system without dampers. A parametric study of the relative stiffness ratio and relative mass ratio between the mega-frame and the substructures, as well as the additional column stiffness ratio that influences the response control effectiveness of the MSCS, is discussed. The studies reveal, for the first time, that different control mechanisms exist. The results indicate that the proposed structure employing semi-active control can offer an effective control mechanism. Guidelines for selecting parameters are provided based on the analytical study.

  6. Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Timmerby, Nina; Austin, Stephen F; Ussing, Kristian;

    2016-01-01

    BACKGROUND: Major depressive disorder has been shown to affect many domains of family life including family functioning. Conversely, the influence of the family on the course of the depression, including the risk of relapse, is one reason for targeting the family in interventions. The few studies...... will investigate the effect of family psychoeducation compared to social support on the course of the illness in patients with major depressive disorder. METHOD/DESIGN: The study is designed as a dual center, two-armed, observer-blinded, randomized controlled trial. Relatives are randomized to participate in one...... conducted within this area indicate that family psychoeducation as a supplement to traditional treatment can effectively reduce the risk of relapse in patients with major depression as well as being beneficial for the relatives involved. However, the evidence is currently limited. This study...

  7. The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study

    NARCIS (Netherlands)

    Sturkenboom, I.H.W.M.; Graff, M.J.L.; Borm, G.F.; Veenhuizen, Y.; Bloem, B.R.; Munneke, M.; Nijhuis-Van der Sanden, M.W.G.

    2013-01-01

    AIM: To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. DESIGN: Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at

  8. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  9. Comparison of the effectiveness of two different interventions to reduce preoperative anxiety: A randomized controlled study.

    Science.gov (United States)

    Ertuğ, Nurcan; Ulusoylu, Özge; Bal, Ayça; Özgür, Hazal

    2017-06-01

    This study was conducted to determine and compare the effectiveness of nature sounds and relaxation exercises for reducing preoperative anxiety. A repeated measures randomized controlled trial design was used. We divided 159 preoperative patients into three groups: nature sounds (n = 53), relaxation exercises (n = 53), and control groups (n = 53). We evaluated anxiety using the visual analog scale and state anxiety inventory scores immediately before, immediately after, and 30 min after interventions in nature sounds and relaxation exercises groups, and silent rest in the control. We found no differences between the measurement values in the intervention groups, but we did observe a difference between the intervention and control groups. The two interventions were similarly effective in reducing preoperative anxiety. These simple and low-cost interventions can be used to reduce preoperative anxiety in surgical clinics. © 2017 John Wiley & Sons Australia, Ltd.

  10. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Shawn D Aaron

    Full Text Available BACKGROUND: Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF. METHODS: We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18 or placebo (N = 17 for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1 and quality of life. RESULTS: Over the 24 week treatment period, 4 of 18 (22% patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31% placebo treated patients, P = 0.70. FEV(1 declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34. Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. CONCLUSION: We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00528190.

  11. Preventive home visits to older people in Denmark: methodology of a randomized controlled study

    DEFF Research Database (Denmark)

    Vass, Mikkel; Avlund, Kirsten; Hendriksen, Carsten

    2002-01-01

    BACKGROUND AND AIMS: Preventive home visits were introduced by legislation in Denmark in 1998. This ongoing randomized controlled intervention study introduces a model where preventive home visits to elderly people are carried out in a standardized way, focusing on early signs of disability...... and on physical activity. The study includes general practitioners (GPs) in relevant parts of the assessment and endeavors coordinated interdisciplinary follow-up. Our main aim was to investigate whether this model gives enhanced active life expectancy, but the focus of the present paper is the design...

  12. [Periprostatic anaesthesic infiltration for prostatic biopsy: a prospective, randomized, double blind and placebo-controlled study].

    Science.gov (United States)

    Valero, Gonzalo; González, E U Roxana

    2005-06-01

    A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (panesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.

  13. Posterior bulk-filled resin composite restorations. A 5-year randomized controlled clinical study

    DEFF Research Database (Denmark)

    van Dijken, Jan WV; Pallesen, Ulla

    2016-01-01

    mm as needed to fill the cavity 2 mm short of the occlusal cavosurface. The occlusal part was completed with the nano-hybrid resin composite (Ceram X mono+). In the other cavity, the resin composite-only (Ceram X mono+) was placed in 2 mm increments. The restorations were evaluated using slightly......Objective: To evaluate in a randomized controlled study the 5-year clinical durability of a flowable resin composite bulk-fill technique in Class I and Class II restorations. Material and methods: 38 pairs Class I and 62 pairs Class II restorations were placed in 44 male and 42 female (mean age 52.......4 years). Each patient received at least two, as similar as possible, extended Class I or Class II restorations. In all cavities, a 1-step self-etch adhesive (Xeno V+) was applied. Randomized, one of the cavities of each pair received the flowable bulk-filled resin composite (SDR), in increments up to 4...

  14. Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shi Guang-Xia

    2012-11-01

    Full Text Available Abstract Background Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the theory of traditional Chinese medicine, acupoints located on both the adjacent and distal area of the disease can be needled to treat disease. Furthermore, the way of combining acupoints is for strengthening the curative effect. We aim to evaluate the efficacy of acupuncture at local points in combination with distal points in subjective tinnitus patients. Method This trial is a randomized, single-blind, controlled study. A total of 112 participants will be randomly assigned to one of four treatment groups receiving acupuncture treatment for 4 weeks. The primary outcome measure is subjective tinnitus loudness and annoyance perception, which is graded using the Visual Analogue Scale (VAS. The assessment is at baseline (before treatment initiation, 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion Completion of this trial will help to identify whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN29230777

  15. Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol

    Directory of Open Access Journals (Sweden)

    Leatherdale Scott T

    2011-09-01

    Full Text Available Abstract Background Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered - do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required. Methods/Design A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months. Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000. Eligible subjects interested in free NRT will be determined at baseline (N = 1,000 and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco at 6-month follow-up as compared to subjects who do not

  16. Study protocol: optimization of complex palliative care at home via telemedicine. A cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hasselaar Jeroen

    2011-08-01

    Full Text Available Abstract Background Due to the growing number of elderly with advanced chronic conditions, healthcare services will come under increasing pressure. Teleconsultation is an innovative approach to deliver quality of care for palliative patients at home. Quantitative studies assessing the effect of teleconsultation on clinical outcomes are scarce. The aim of this present study is to investigate the effectiveness of teleconsultation in complex palliative homecare. Methods/Design During a 2-year recruitment period, GPs are invited to participate in this cluster randomized controlled trial. When a GP refers an eligible patient for the study, the GP is randomized to the intervention group or the control group. Patients in the intervention group have a weekly teleconsultation with a nurse practitioner and/or a physician of the palliative consultation team. The nurse practitioner, in cooperation with the palliative care specialist of the palliative consultation team, advises the GP on treatment policy of the patient. The primary outcome of patient symptom burden is assessed at baseline and weekly using the Edmonton Symptom Assessment Scale (ESAS and at baseline and every four weeks using the Hospital Anxiety and Depression Scale (HADS. Secondary outcomes are self-perceived burden from informal care (EDIZ, patient experienced continuity of medical care (NCQ, patient and caregiver satisfaction with the teleconsultation (PSQ, the experienced problems and needs in palliative care (PNPC-sv and the number of hospital admissions. Discussion This is one of the first randomized controlled trials in palliative telecare. Our data will verify whether telemedicine positively affects palliative homecare. Trial registration The Netherlands National Trial Register NTR2817

  17. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    Zhang-Jin Zhang

    Full Text Available BACKGROUND: Previous studies suggest that electroacupuncture possesses therapeutic benefits for depressive disorders. The purpose of this study was to determine whether dense cranial electroacupuncture stimulation (DCEAS could enhance the antidepressant efficacy in the early phase of selective serotonin reuptake inhibitor (SSRI treatment of major depressive disorder (MDD. METHODS: In this single-blind, randomized, controlled study, patients with MDD were randomly assigned to 9-session DCEAS or noninvasive electroacupuncture (n-EA control procedure in combination with fluoxetine (FLX for 3 weeks. Clinical outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17, Clinical Global Impression-severity (CGI-S, and Self-rating Depression Scale (SDS as well as the response and remission rates. RESULTS: Seventy-three patients were randomly assigned to n-EA (n = 35 and DCEAS (n = 38, of whom 34 in n-EA and 36 in DCEAS group were analyzed. DCEAS-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores at Day 3 through Day 21 and in SDS scores at Day 3 and Day 21 compared to patients receiving n-EA. DCEAS intervention also produced a higher rate of clinically significant response compared to n-EA procedure (19.4% (7/36 vs. 8.8% (3/34. The incidence of adverse events was similar in the two groups. CONCLUSIONS: DCEAS is a safe and effective intervention that augments the antidepressant efficacy. It can be considered as an additional therapy in the early phase of SSRI treatment of depressed patients. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88008690.

  18. Randomized pilot study to disseminate caries-control services in dentist offices

    Directory of Open Access Journals (Sweden)

    Reynolds Debra

    2006-05-01

    Full Text Available Abstract Background To determine whether education and financial incentives increased dentists' delivery of fluoride varnish and sealants to at risk children covered by capitation dental insurance in Washington state (U.S.. Methods In 1999, 53 dental offices in Washington Dental Service's capitation dental plan were invited to participate in the study, and consenting offices were randomized to intervention (n = 9 and control (n = 10 groups. Offices recruited 689 capitation children aged 6–14 and at risk for caries, who were followed for 2 years. Intervention offices received provider education and fee-for-service reimbursement for delivering fluoride varnish and sealants. Insurance records were used to calculate office service rates for fluoride, sealants, and restorations. Parents completed mail surveys after follow-up to measure their children's dental utilization, dental satisfaction, dental fear and oral health status. Regression models estimated differences in service rates between intervention and control offices, and compared survey measures between groups. Results Nineteen offices (34% consented to participate in the study. Fluoride and sealant rates were greater in the intervention offices than the control offices, but the differences were not statistically significant. Restoration rates were lower in the intervention offices than the control offices. Parents in the intervention group reported their children had less dental fear than control group parents. Conclusion Due to low dentist participation the study lacked power to detect an intervention effect on dentists' delivery of caries-control services. The intervention may have reduced children's dental fear.

  19. Comparing three knowledge communication strategies - Diffusion, Dissemination and Translation - through randomized controlled studies.

    Science.gov (United States)

    Lane, Joseph P; Stone, Vathsala I

    2015-01-01

    This paper describes a series of three randomized controlled case studies comparing the effectiveness of three strategies for communicating new research-based knowledge (Diffusion, Dissemination, Translation), to different Assistive Technology (AT) stakeholder groups. Pre and post intervention measures for level of knowledge use (unaware, aware, interested, using) via the LOKUS instrument, assessed the relative effectiveness of the three strategies. The latter two approaches were both more effective than diffusion but also equally effective. The results question the value added by tailoring research findings to specific audiences, and instead supports the critical yet neglected role for relevance in determining knowledge use by stakeholders.

  20. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study

    DEFF Research Database (Denmark)

    Werner, Louise B.; Hellgren, Lars; Raff, Marianne;

    2011-01-01

    . DESIGN: In a double-blind, randomized, 4 wk, parallel intervention study 14 healthy young subjects were given 45 g milk fat/d from test butter and cheese with 0.24 wt% phytanic acid or a control diet with 0.13 wt% phytanic acid. Difference in phytanic acid was obtained by feeding roughage with low......BACKGROUND: Phytanic acid produced in ruminants from chlorophyll may have preventive effects on the metabolic syndrome, partly due to its reported RXR and PPAR- α agonist activity. Milk from cows fed increased levels of green plant material, contains increased phytanic acid concentrations...

  1. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study)

    Science.gov (United States)

    von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. Clinical Trial Registration— URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN

  2. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

    Science.gov (United States)

    Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

    2015-03-01

    Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe

  3. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  4. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

    National Research Council Canada - National Science Library

    Steinan, Mette Kvisten; Krane-Gartiser, Karoline; Langsrud, Knut; Sand, Trond; Kallestad, Håvard; Morken, Gunnar

    2014-01-01

    .... In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep, stabilizing minor mood...

  5. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    National Research Council Canada - National Science Library

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C; Thurston, Wilfreda E; Newby-Clark, Ian R; Radtke, H Lorraine; Hobden, Karen L

    2013-01-01

    .... The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university...

  6. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  7. Mirror therapy for distal radial fractures: A pilot randomized controlled study.

    Science.gov (United States)

    Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

    2016-10-12

    To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

  8. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Science.gov (United States)

    Ivanov, Iliya V; Mackeben, Manfred; Vollmer, Annika; Martus, Peter; Nguyen, Nhung X; Trauzettel-Klosinski, Susanne

    2016-01-01

    Degenerative retinal diseases, especially retinitis pigmentosa (RP), lead to severe peripheral visual field loss (tunnel vision), which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST). Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses) that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental) and reading (control) training. All subjects who first performed reading training underwent experimental training later (waiting list control group). To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT) during exploratory saccade training, Percent Preferred Walking Speed (PPWS), the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field. In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training condition

  9. The chronic care for wet age related macular degeneration (CHARMED) study: a randomized controlled trial

    OpenAIRE

    Markun, Stefan; Dishy, Avraham; Neuner-Jehle, Stefan; Rosemann, Thomas; Frei, Anja

    2015-01-01

    BACKGROUND: In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). METHODS: Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, ...

  10. The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial

    OpenAIRE

    Stefan Markun; Avraham Dishy; Stefan Neuner-Jehle; Thomas Rosemann; Anja Frei

    2015-01-01

    Background In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). Methods Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using...

  11. Determinants of glycemic control in youth with type 2 diabetes at randomization in the TODAY study.

    Science.gov (United States)

    Bacha, Fida; Pyle, Laura; Nadeau, Kristen; Cuttler, Leona; Goland, Robin; Haymond, Morey; Levitsky, Lynne; Lynch, Jane; Weinstock, Ruth S; White, Neil H; Caprio, Sonia; Arslanian, Silva

    2012-08-01

    To investigate insulin sensitivity and secretion indices and determinants of glycemic control in youth with recent-onset type 2 diabetes (T2DM) at randomization in the TODAY study, the largest study of youth with T2DM to date. We examined estimates of insulin sensitivity [1/fasting insulin (1/I(F)), fasting glucose/insulin (G(F) /I(F)), 1/fasting C-peptide (1/C(F)), G(F) /C(F)], β-cell function [insulinogenic index (ΔI30/ΔG30), and ΔC30/ΔG30], and disposition index (DI) in the TODAY cohort of 704 youth (14.0 ± 2.0 yr; diabetes duration 7.8 ± 5.8 months; 64.9% female; 41.1% Hispanic, 31.5% Black, 19.6% White, 6.1% American Indian, and 1.7% Asian) according to hemoglobin A1c (HbA1c) quartiles at study randomization. The randomization visit followed a run-in period (median 71 d) during which glycemic control (HbA1c ≤ 8% for at least 2 months) was achieved with metformin alone. These measures were also examined in relation to screening HbA1c levels before run-in. Insulin secretion indices declined with increasing HbA1c quartiles, at randomization (ΔC30/ΔG30: 0.11 ± 0.09, 0.10 ± 0.19, 0.07 ± 0.06, and 0.03 ± 0.03 ng/mL per mg/dL, p DI: 0.03 ± 0.03, 0.03 ± 0.05, 0.02 ± 0.02, and 0.01 ± 0.01 mg/dL(-1) , p DI (r = -0.3, p < 0.001), with ΔC30/ΔG30, but not with insulin sensitivity estimates. In youth with recent-onset T2DM treated with metformin, glycemic control, as measured by HbA1c, appears to be associated with residual β-cell function and not insulin sensitivity. © 2012 John Wiley & Sons A/S.

  12. Pioneering Strategies for Relieving Dental Anxiety in Hearing Impaired Children: a Randomized Controlled Clinical Study.

    Science.gov (United States)

    Chandrasekhar, Shalini; Madu, Ghanashyam Prasad; Ambati, Naga Radhakrishna; Suravarapu, Pavani Reddy; Uppu, Kalyani; Bolla, Deepthi

    2017-06-01

    Hearing impaired children have a problem in understanding and comprehending with dental treatments. Visual language is the sensible answer of how to improve communication with them. To evaluate the applicability of dental sign language in Hearing impaired children in relieving anxiety during stressful dental treatment by improving their means of communication. This randomized clinical trial was carried out in the Department of Pedodontics and Preventive Dentistry which included 40 Hearing Impaired children meeting inclusion criteria. The selected children were randomly divided into the study and control group comprising of 20 each. In the control group, initial oral examination and dental treatment (oral prophylaxis and class I restoration) were performed without the use of dental sign language. In the study group, the dental sign language specific to dental treatment was educated and during their subsequent visit to the dental clinic after dental sign language reinforcement, oral prophylaxis and class I restoration were done. Subjective and objective measurements of anxiety were recorded for both groups using facial image scale (FIS), pulse oximeter and electronic blood pressure apparatus to compare for correlation. The obtained data were subjected to statistical analysis using unpaired t-test. There was a statistically significant reduction in the anxiety levels (pcontrol group. Dental sign language was effective in reducing the level of anxiety in children who are hard of hearing. Dental sign language was able to improve behavior positively during dental treatment and may also aid in developing a positive dental attitude among children who are hard of hearing.

  13. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

    Science.gov (United States)

    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p stretching groups were observed (p > 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests.

  14. The prevalence of ibuprofen-sensitive asthma in children: a randomized controlled bronchoprovocation challenge study.

    Science.gov (United States)

    Debley, Jason S; Carter, Edward R; Gibson, Ronald L; Rosenfeld, Margaret; Redding, Gregory J

    2005-08-01

    To determine the prevalence of ibuprofen-sensitive asthma in school-aged children with mild or moderate persistent asthma. A randomized, double-blind, placebo-controlled, crossover bronchoprovocation challenge study in children 6 to 18 years of age with mild or moderate persistent asthma. Patients received a single dose of ibuprofen or placebo, per randomization, and then returned 2 to 7 days later to repeat the procedures after taking that study drug not received at the first visit. At each visit, patients performed spirometry before and (1/2), 1, 2, and 4 hours after administration of study drug. We defined bronchospasm as a > or =20% decrease from baseline in the forced expired volume in the first second (FEV1) and ibuprofen sensitivity as bronchospasm following administration of ibuprofen but not placebo. Of the 127 patients screened, 100 (mean age, 11 years) completed the study. Two patients met criteria for ibuprofen-sensitive asthma, resulting in a prevalence of 2% (95% CI: 0.2%-7%). Neither patient was known to have had any exposure to ibuprofen before the study. The prevalence of ibuprofen-sensitive asthma was low but non-zero in this group of children with mild or moderate asthma. The possibility of ibuprofen-induced bronchospasm should be considered before administering ibuprofen to children with asthma.

  15. Manual and Electroacupuncture for Labour Pain: Study Design of a Longitudinal Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Linda Vixner

    2012-01-01

    Full Text Available Introduction. Results from previous studies on acupuncture for labour pain are contradictory and lack important information on methodology. However, studies indicate that acupuncture has a positive effect on women’s experiences of labour pain. The aim of the present study was to evaluate the efficacy of two different acupuncture stimulations, manual or electrical stimulation, compared with standard care in the relief of labour pain as the primary outcome. This paper will present in-depth information on the design of the study, following the CONSORT and STRICTA recommendations. Methods. The study was designed as a randomized controlled trial based on western medical theories. Nulliparous women with normal pregnancies admitted to the delivery ward after a spontaneous onset of labour were randomly allocated into one of three groups: manual acupuncture, electroacupuncture, or standard care. Sample size calculation gave 101 women in each group, including a total of 303 women. A Visual Analogue Scale was used for assessing pain every 30 minutes for five hours and thereafter every hour until birth. Questionnaires were distributed before treatment, directly after the birth, and at one day and two months postpartum. Blood samples were collected before and after the first treatment. This trial is registered at ClinicalTrials.gov: NCT01197950.

  16. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

    Directory of Open Access Journals (Sweden)

    Lavinia Fiorentino

    2009-12-01

    Full Text Available Lavinia Fiorentino1, John R McQuaid2, Lianqi Liu3, Loki Natarajan4, Feng He4, Monique Cornejo3, Susan Lawton3, Barbara A Parker6, Georgia R Sadler5, Sonia Ancoli-Israel31Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA, USA; 2Department of Psychiatry, University of California, San Francisco, CA, USA; 3Department of Psychiatry, 4Department of Family and Preventive Medicine, 5Department of Surgery, University of California, San Diego School of Medicine, La Jolla, CA, USA; 6Moores UCSD Cancer Center, La Jolla, CA, USAPurpose: Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I on sleep in breast cancer survivors.Patients and methods: Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions. Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group.Results: Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre–post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep.Conclusions: These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting.Keywords: insomnia, breast cancer, cognitive behavioral therapy

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

    Science.gov (United States)

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

    2013-11-01

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

  18. Loss to follow-up in a randomized controlled trial study for pediatric weight management (EPOC).

    Science.gov (United States)

    Warschburger, Petra; Kröller, Katja

    2016-11-14

    Attrition is a serious problem in intervention studies. The current study analyzed the attrition rate during follow-up in a randomized controlled pediatric weight management program (EPOC study) within a tertiary care setting. Five hundred twenty-three parents and their 7-13-year-old children with obesity participated in the randomized controlled intervention trial. Follow-up data were assessed 6 and 12 months after the end of treatment. Attrition was defined as providing no objective weight data. Demographic and psychological baseline characteristics were used to predict attrition at 6- and 12-month follow-up using multivariate logistic regression analyses. Objective weight data were available for 49.6 (67.0) % of the children 6 (12) months after the end of treatment. Completers and non-completers at the 6- and 12-month follow-up differed in the amount of weight loss during their inpatient stay, their initial BMI-SDS, educational level of the parents, and child's quality of life and well-being. Additionally, completers supported their child more than non-completers, and at the 12-month follow-up, families with a more structured eating environment were less likely to drop out. On a multivariate level, only educational background and structure of the eating environment remained significant. The minor differences between the completers and the non-completers suggest that our retention strategies were successful. Further research should focus on prevention of attrition in families with a lower educational background. Current Controlled Trials ISRCTN24655766 . Registered 06 September 2008, updated 16 May 2012.

  19. Control of Intraoperative Shivering Under Spinal Anaesthesia- A Prospective Randomized Comparative Study of Butorphanol with Tramadol

    Directory of Open Access Journals (Sweden)

    Astha Palan

    2017-01-01

    Full Text Available Background: Shivering is very uncomfortable and distressing for the patient, anaesthesiologist and the surgeon, especially when the patient is under regional anaesthesia. Aim and Objectives: The present study was designed to evaluate the efficacy of butorphanol and tramadol in the control of shivering under spinal anaesthesia and to compare their side effects. To compare the efficacy, potency, response time, hemodynamic alterations, and adverse effects of intravenously administered tramadol and butorphanol for relief of shivering occurring during spinal anaesthesia. Material and Methods: This randomized prospective study was conducted in 100 patients who developed shivering under spinal anaesthesia during various abdominal, orthopaedic, urological and gynaecological procedures. Patients with fever, acute infections, drug allergy and compromised cardiorespiratory functions were not included in the study. On shivering, patients were randomly allocated in two groups of 50 patients each who received intravenously 1mg of butorphanol or 50 mg of tramadol in a double blinded manner. Control of shivering, time taken for cessation, recurrence, hemodynamic changes, axillary temperatures and side effects were noted and compared for both the groups. Collected data were analysed using Chi square test and Student's unpaired t test. Results: All patients were relieved of shivering after butorphanol, 58% within 1 min, 82% within 3min and 100% within 5 min. Tramadol relieved shivering in 98% of patients, 32% within 1 min, 60% within 3 min, 98% within 5 mins (p<0.05. There was higher incidence of side effects like nausea and vomiting with tramadol (16% and 12% respectively as compared to butorphanol. Conclusion: Both the drugs, tramadol and butorphanol are effective to control shivering after spinal anaesthesia. Butorphanol is better as compared to tramadol in treating shivering under spinal anaesthesia because of its quicker onset of action, higher success rate

  20. Impacts of dietary fat changes on pregnant women with gestational diabetes mellitus: a randomized controlled study.

    Science.gov (United States)

    Wang, Huiyan; Jiang, Hongyi; Yang, Liping; Zhang, Ming

    2015-01-01

    This study aims to determine the impact of increasing polyunsaturated fatty acid intake on blood glucose, lipid metabolism, and pregnancy outcomes of pregnant women with gestational diabetes mellitus. Under constant total energy and protein intake, 84 pregnant women with gestational diabetes mellitus were randomly divided into the experimental and control groups, which were given oil-rich and conventional low-oil meals, respectively. After the dietary intervention, the intake and energy supply of fat and the three fatty acids were significantly higher in the experimental group than the control group (pchange in the control group. In both the intervention and the control group, fasting blood glucose, 2 h postprandial plasma glucose, and the insulin resistance index decreased significantly post-intervention (pchanges were consistent between groups. Pregnancy outcomes did not differ significantly between the two groups (p>0.05). An appropriate increase in polyunsaturated fatty acid intake benefits pregnant women with gestational diabetes mellitus as well as fetuses, as long as the diet therapy follows basic recommendations and total energy intake is strictly controlled.

  1. Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: A randomized controlled pilot study

    NARCIS (Netherlands)

    Dronkers, J.J.; Lamberts, H.; Reutelingsperger, I.M.M.D.; Naber, R.H.; Dronkers-Landman, C.M.; Veldman, A.; Meeteren, N.L.U. van

    2010-01-01

    Objective: Investigation of the feasibility and preliminary effect of a short-term intensive preoperative exercise programme for elderly patients scheduled for elective abdominal oncological surgery. Design: Single-blind randomized controlled pilot study. Setting: Ordinary hospital in the Netherland

  2. Impact of yoga on biochemical profile of asthmatics: A randomized controlled study.

    Science.gov (United States)

    Agnihotri, Shruti; Kant, Surya; Kumar, Santosh; Mishra, Ranjeet K; Mishra, Satyendra K

    2014-01-01

    Asthma is a chronic inflammatory disorder of the airways. The chronic inflammation causes an associated increase in airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing at night or in the early morning. Most of the studies have reported, as the effects of yoga on bronchial asthma, significant improvements in pulmonary functions, quality of life, and decrease in medication use, but none of the studies has attempted to show the effect of yoga on biochemical changes. To evaluate the effect of yoga on biochemical profile of asthmatics. In the present study, 276 patients of mild to moderate asthma (FEV 1> 60%) aged between 12 to 60 years were recruited from the Department of Pulmonary Medicine, King George's Medical University, U.P., Lucknow, India. They were randomly divided into two groups: Yoga group (with standard medical treatment and yogic intervention) and control group as standard medical treatment (without yogic intervention). At completion of 6 months of the study period, 35 subjects were dropped out, so out of 276 subjects, only 241 subjects completed the whole study (121 subjects from yoga group and 120 subjects from control group). Biochemical assessment was carried out at baseline and after 6 months of the study period. In yoga group, there was significant improvement found in the proportion of hemoglobin and antioxidant superoxide dismutase in comparison to control group and significant decrease was found in total leukocyte count (TLC) and differential leukocytes count in comparison to control group. There was no significant change found in TLC, polymorphs, and monocytes in between group comparison. Yoga group got significantly better improvement in biochemical variables than control group. Result shows that yoga can be practiced as adjuvant therapy with standard inhalation therapy for better outcome of asthma.

  3. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Overgaard Hans J

    2012-10-01

    Full Text Available Abstract Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA; dengue interventions (DEN; combined diarrhea and dengue interventions (DIADEN; and control (C. Schools were allocated publicly in each municipality (strata at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de

  4. Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation

  5. High incidence of bacteriuria in early post-kidney transplantation; results from a randomized controlled study.

    Science.gov (United States)

    Parapiboon, W; Ingsathit, A; Jirasiritham, S; Sumethkul, V

    2012-04-01

    Since the incidence of bacteriuria in kidney transplant recipients varyes according to the study, we examined it among our cases. Our post hoc analysis of data from a single-center, parallel, randomized, controlled, open label study included 90 patients who underwent kidney transplantation at our hospital from April 2010 to January 2011. Patients were randomized to early ureteric stent removal at 8 days versus routine ureteric stent removal at 15 days after kidney transplantation. We identified the incidence of and causative organism for bacteriuria in the early posttransplant period. Seventy-Four patients (58% living donors) participated in this study. The overall incidence of bacteriuria was 56.7% during the first month after kidney transplantation. In patients who had bacteriuria, 48% showed symptomatic urinary tract infection, 40% asymptomatic bacteriuria and 12% urosepsis. The most common organism was Escherichia coli (40%) follow by Klebsiella pneumoniae (19%). The incidence of an ESBL producing organism was 34%. The incidence of bacteriuria was high during the early post-kidney transplant period, requiring increased awareness and surveillance. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. The Chronic CARe for diAbeTes study (CARAT: a cluster randomized controlled trial

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    Birnbaum Beatrice

    2010-06-01

    Full Text Available Abstract Background Diabetes is a major challenge for the health care system and especially for the primary care provider. The Chronic Care Model represents an evidence-based framework for the care for chronically ill. An increasing number of studies showed that implementing elements of the Chronic Care Model improves patient relevant outcomes and process parameters. However, most of these findings have been performed in settings different from the Swiss health care system which is dominated by single handed practices. Methods/Design CARAT is a cluster randomized controlled trial with general practitioners as the unit of randomization (trial registration: ISRCTN05947538. The study challenges the hypothesis that implementing several elements of the Chronic Care Model via a specially trained practice nurse improves the HbA1c level of diabetes type II patients significantly after one year (primary outcome. Furthermore, we assume that the intervention increases the proportion of patients who achieve the recommended targets regarding blood pressure ( Discussion This study challenges the hypothesis that the Chronic Care Model can be easily implemented by a practice nurse focused approach. If our results will confirm this hypothesis the suggestion arises whether this approach should be implemented in other chronic diseases and multimorbid patients and how to redesign care in Switzerland.

  7. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

    Directory of Open Access Journals (Sweden)

    Moretti Biagio

    2012-06-01

    Full Text Available Abstract Background Total knee arthroplasty (TKA is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value  Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I-ONE group, NSAID use was

  8. Improving psychology students' attitudes toward people with schizophrenia: A quasi-randomized controlled study.

    Science.gov (United States)

    Magliano, Lorenza; Rinaldi, Angela; Costanzo, Regina; De Leo, Renata; Schioppa, Giustina; Petrillo, Miriam; Read, John

    2016-01-01

    Despite scientific evidence that the majority of people with schizophrenia (PWS) have personal histories of traumatic life events and adversities, their needs for psychological support often remain unmet. Poor availability of nonpharmacological therapies in schizophrenia may be partly because of professionals' attitudes toward people diagnosed with this disorder. As future health professionals, psychology students represent a target population for efforts to increase the probability that PWS will be offered effective psychological therapies. This quasi-randomized controlled study investigated the effect of an educational intervention, addressing common prejudices via scientific evidence and prerecorded audio-testimony from PWS, on the attitudes of psychology students toward PWS. Students in their fifth year of a master's degree in Psychology at the Second University of Naples, Italy were randomly assigned to an experimental group-which attended two 3-hr sessions a week apart-or to a control group. Compared with their baseline assessment, at 1-month reassessment the 76 educated students endorsed more psychosocial causes and more of them recommended psychologists in the treatment of schizophrenia. They were also more optimistic about recovery, less convinced that PWS are recognizable and unpredictable, and more convinced that treatments, pharmacological and psychological, are useful. No significant changes were found, from baseline to 1-month reassessment, in the 112 controls. At 1-month reassessment, educated students were more optimistic about recovery and less convinced that PWS are unpredictable than controls. These findings suggest that psychology students' attitudes toward PWS can be improved by training initiatives including education and indirect contact with users. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  9. A Randomized Controlled Study of Art Observation Training to Improve Medical Student Ophthalmology Skills.

    Science.gov (United States)

    Gurwin, Jaclyn; Revere, Karen E; Niepold, Suzannah; Bassett, Barbara; Mitchell, Rebecca; Davidson, Stephanie; DeLisser, Horace; Binenbaum, Gil

    2017-08-03

    Observation and description are critical to the practice of medicine, and to ophthalmology in particular. However, medical education does not provide explicit training in these areas, and medical students are often criticized for deficiencies in these skills. We sought to evaluate the effects of formal observation training in the visual arts on the general and ophthalmologic observational skills of medical students. Randomized, single-masked, controlled trial. Thirty-six first-year medical students, randomized 1:1 into art-training and control groups. Students in the art-training group were taught by professional art educators at the Philadelphia Museum of Art, during 6 custom-designed, 1.5-hour art observation sessions over a 3-month period. All subjects completed pre- and posttesting, in which they described works of art, retinal pathology images, and external photographs of eye diseases. Grading of written descriptions for observational and descriptive abilities by reviewers using an a priori rubric and masked to group assignment and pretesting/posttesting status. Observational skills, as measured by description testing, improved significantly in the training group (mean change +19.1 points) compared with the control group (mean change -13.5 points), P = 0.001. There were significant improvements in the training vs. control group for each of the test subscores. In a poststudy questionnaire, students reported applying the skills they learned in the museum in clinically meaningful ways at medical school. Art observation training for first-year medical students can improve clinical ophthalmology observational skills. Principles from the field of visual arts, which is reputed to excel in teaching observation and descriptive abilities, can be successfully applied to medical training. Further studies can examine the impact of such training on clinical care. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  10. Robotic resistance/assistance training improves locomotor function in individuals poststroke: a randomized controlled study.

    Science.gov (United States)

    Wu, Ming; Landry, Jill M; Kim, Janis; Schmit, Brian D; Yen, Sheng-Che; Macdonald, Jillian

    2014-05-01

    To determine whether providing a controlled resistance versus assistance to the paretic leg at the ankle during treadmill training will improve walking function in individuals poststroke. Repeated assessment of the same patients with parallel design and randomized controlled study between 2 groups. Research units of rehabilitation hospitals. Patients (N=30) with chronic stroke. Subjects were stratified based on self-selected walking speed and were randomly assigned to the resistance or assistance training group. For the resistance group, a controlled resistance load was applied to the paretic leg at the ankle to resist leg swing during treadmill walking. For the assistance group, a load that assists swing was applied. Primary outcome measures were walking speed and 6-minute walking distance. Secondary measures included clinical assessments of balance, muscle tone, and quality of life. Outcome measures were evaluated before and after 6 weeks of training and at 8 weeks' follow-up, and compared within group and between the 2 groups. After 6 weeks of robotic training, walking speed significantly increased for both groups, with no significant differences in walking speed gains observed between the 2 groups. In addition, 6-minute walking distance and balance significantly improved for the assistance group but not for the resistance group. Applying a controlled resistance or an assistance load to the paretic leg during treadmill training may induce improvements in walking speed in individuals poststroke. Resistance training was not superior to assistance training in improving locomotor function in individuals poststroke. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. Safety and effectiveness of autoinoculation therapy in cutaneous warts: A double - blind, randomized, placebo - controlled study

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    Niharika Ranjan Lal

    2014-01-01

    Full Text Available Background: In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. Aims: To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. Methods: A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Results: Forty-eight patients with cutaneous warts (male: female = 32:16 were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P = 0.293. Reduction in the number of warts was significantly more in the autoinoculation group (8.50 ± 13.88 than in the control group (10.04 ± 5.80 from 8 weeks onwards (P = 0.010. Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases, keloid formation (3 and hypopigmentation (3. Conclusion: Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

  12. Does a mineral wristband affect balance? A randomized, controlled, double-blind study.

    Science.gov (United States)

    Hansson, Eva Ekvall; Beckman, Anders; Persson, Liselott

    2015-06-26

    Having good balance is a facilitating factor in the performance of everyday activities. Good balance is also essential in various sport activities in order to both get results and prevent injury. A common measure of balance is postural sway, which can be measured both antero-posteriorly and medio-laterally. There are several companies marketing wristbands whose intended function is to improve balance, strength and flexibility. Randomized controlled trials have shown that wristbands with holograms have no effect on balance but studies on wristbands with minerals seem to be lacking. The aim of this study was to investigate if the mineral wristband had any effect on postural sway in a group of healthy individuals. Randomized, controlled, double-blind study. The study group consisted of 40 healthy persons. Postural sway was measured antero-posteriorly and medio-laterally on a force plate, to compare: the mineral wristband, a placebo wristband, and without any wristband. The measurements were performed for 30 s, in four situations: with open eyes and closed eyes, standing on a firm surface and on foam. Analyses were made with multilevel technique. The use of wristband with or without minerals did not alter postural sway. Closed eyes and standing on foam both prolonged the dependent measurement, irrespective if it was medio-lateral or antero-posterior. Wearing any wristband (mineral or placebo) gave a small (0.22-0.36 mm/s) but not statistically significant reduction of postural sway compared to not wearing wristband. This study showed no effect on postural sway by using the mineral wristband, compared with a placebo wristband or no wristband. Wearing any wristband at all (mineral or placebo) gave a small but not statistically significant reduction in postural sway, probably caused by sensory input.

  13. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial

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    Holz Jonathan D

    2011-08-01

    Full Text Available Abstract Background Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD only moderately lower than young normal individuals. Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved. Methods/design We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5 and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety. Discussion If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated. Trial registration This study is registered at ClinicalTrials.gov, NCT01271647.

  14. The value of including spirometry in health checks - a randomized controlled study in primary health care

    DEFF Research Database (Denmark)

    Ørts, Lene Maria; Ottesen, Anders Løkke; Bjerregaard, Anne-Louise

    studies in the Ph.D. project will evaluate whether early spirometry measurements can be used to predict future lung disease and describe the follow up of patients with abnormal spirometry measurements at the general practitioner. Disclosure of interest: None to declare. Key words: early spirometry......Background Lung diseases are among the most frequent and most serious ailments in Denmark. Preventive health checks including spirometry can be used to detect lung diseases earlier. Over time the attendance at preventive health checks has decreased and at present the response rate is approximately...... 50%. Little is known about initiatives that can influence the attendance rate. Objectives To examine whether focused information on spirometry in the invitation material will influence the attendance in preventive health checks. Materiel/Methods Design: A randomized controlled study on information...

  15. Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

    2015-07-15

    Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

  16. Impact of multiplex PCR on antimicrobial treatment in febrile neutropenia: a randomized controlled study.

    Science.gov (United States)

    Idelevich, Evgeny A; Silling, Gerda; Niederbracht, Yvonne; Penner, Hanna; Sauerland, Maria Cristina; Tafelski, Sascha; Nachtigall, Irit; Berdel, Wolfgang E; Peters, Georg; Becker, Karsten

    2015-10-01

    Multiplex PCR (mPCR) directly from blood has been suggested as a promising method for rapid identification of pathogens causing sepsis. This study aimed to investigate whether mPCR has any impact on antimicrobial treatment. Hematological patients with febrile neutropenia were randomized into two groups. In the study group, mPCR was performed as an addition to standard diagnostics, and PCR finding was immediately communicated to the clinicians, thus being available for decision making. In the control group, clinicians were not aware of PCR result. PCR samples were collected simultaneously with clinically indicated blood culture specimens from peripheral vein and/or central venous catheter at fever onset and once again if fever persisted up to 72 h. Overall, 74 patients of the study group and 76 patients of the control group were enrolled and 253 samples collected. Therapy was changed to targeted antimicrobial therapy (AMT) in 12 patients (16.2%) in the study group and in 12 patients (15.8%) in the control group. For patients with changes, the median time to change to the targeted AMT was 21.4 h in the study group and 47.5 h in the control group (p = 0.018). In the study group, 57.1% (8/14) of changes to targeted AMT was due to PCR finding. PCR led to AMT change in 9.5% (7/74) of study group patients, i.e., in 33.3% (7/21) of patients who had positive PCR finding. There were no significant differences in patient outcomes (secondary endpoints). In conclusion, PCR method accelerates change to the targeted AMT in febrile neutropenic patients.

  17. Written Educational Material Relieves Anxiety after Endoscopic Biopsy: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kim, Hae Won; Jung, Da Hyun; Youn, Young Hoon; Kim, Jie-Hyun; Kim, Jae Jin; Park, Hyo Jin

    2016-02-01

    Patients who undergo endoscopic biopsy suffer anxiety until results are confirmed. This study assesses the effects of written educational material on the anxiety level of patients following endoscopic biopsy. This study was a randomized controlled study trial with 83 patients divided into the following three groups: a biopsy group given written educational material prepared by our institution following the biopsy (intervention group, n=28), a biopsy group without written material (biopsy only group, n=25), and a control group without biopsy (control group, n=30). The anxiety level of each patient was evaluated three times using Spielberger's State-Trait Anxiety Inventory (STAI): for baseline at the first visit to our institution, at the day of endoscopy, one day later, and one week after the procedure. We compared baseline characteristics, STAI scores at each visit, and differences in STAI scores among the three groups. No difference was found in STAI score among groups at baseline and before and after the endoscopic procedure. However, the STAI-state score of the intervention group was slightly lower than biopsy only group one day post-procedure (40.3 ± 7.7 vs. 43.9 ± 7.1, p=0.135). The STAI-state score significantly decreased from pre- to post-procedure only in the intervention group (-2.75 ± 6.1 vs. 0.92 ± 4.0, pmaterial for patients having biopsy might lessen their anxiety level.

  18. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  19. Cognitive behavioural therapy in multiple sclerosis: a randomized controlled pilot study of acceptance and commitment therapy.

    Science.gov (United States)

    Nordin, Linda; Rorsman, Ia

    2012-01-01

    The aim of this study was to design a trial that could evaluate the effect of acceptance and commitment therapy as a group-intervention for multiple sclerosis patients with psychological distress. Randomized controlled trial with assessment at pretreatment, end of treatment, and at 3-month follow-up. Multiple sclerosis outpatients with elevated symptoms of anxiety and/or depression (n = 21). Patients were randomly assigned to acceptance and commitment therapy or relaxation training. Both treatments consisted of 5 sessions over 15 weeks containing didactic sessions, group discussions, and exercises. Outcome was assessed by self-rated symptoms of anxiety, depression, and a measure of acceptance. At 3-month follow-up, the relaxation training group had a significant decline in anxiety symptoms whereas the acceptance and commitment therapy group showed a maintained improvement in rated acceptance at follow-up. The results reflect the different emphases of the therapies. Acceptance and commitment therapy is aimed at living an active, valued life and increasing acceptance, while relaxation training focuses directly on coping strategies to handle emotional symptoms. The results are preliminary, but supportive of further study of brief group interventions for reducing psychological distress in patients with multiple sclerosis.

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

    Science.gov (United States)

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

    2013-03-01

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

  1. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  2. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study A Randomized Controlled Trial

    Science.gov (United States)

    HENSEL, Kendi L.; BUCHANAN, Steve; BROWN, Sarah K.; RODRIGUEZ, Mayra; CRUSER, des Anges

    2014-01-01

    Objective To evaluate the efficacy of Osteopathic Manipulative Treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and improve selected outcomes of labor and delivery. Study Design PROMOTE was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were randomized to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included seven treatments over nine weeks. The OMT protocol included specific techniques administered by board-certified OMT specialists. Outcomes were assessed using self-report measures for pain and back-related functioning, and medical records for delivery outcomes. Results There were 136 women in the OMT group, 131 in PUT, and 133 in UCO. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back related functioning (POMT group similar to that of the PUT, but both groups were significantly improved compared to UCO. For secondary outcome of meconium- stained amniotic fluid there were no differences between the groups. Conclusion OMT was effective for mitigating pain and functional deterioration compared to the UCO group; however OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during their third trimester. PMID:25068560

  3. Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shireman Theresa I

    2011-05-01

    Full Text Available Abstract Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8% persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456

  4. Comparison of Levetiracetam and sodium Valproate in migraine prophylaxis: A randomized placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Homa Sadeghian

    2015-01-01

    Full Text Available Background: Migraine is a chronic and disabling disorder. Treatment of migraine often comprises of symptomatic (abortive and preventive (prophylactic treatment. The current drugs used in migraine prophylaxis include antidepressant drugs (Serotonin Reuptake Inhibitors, Tricyclic antidepressants, and anti-epileptic drugs (valproate, gabapentin, etc. Objective: The objective of our study was to assess the efficacy and tolerability of levetiracetam in adult migraine prophylaxis, compared to valproate and placebo. Materials and Methods: We conducted a prospective, randomized, placebo-controlled study. A total of 85 patients were randomized to receive levetiracetam 500 mg/d (n = 27, valproate 500 mg/d (n = 32 or placebo (n = 26. The patients were evaluated for treatment efficacy after 6 months. Efficacy was assessed as a more than 50% decrease in headache frequency. Results: In levetiracetam group, 17 (63.0% patients experienced a more than 50% decrease in headache frequency, while this efficacy number was 21 (65.6% for valproate group and 4 (15.4% for placebo group. The difference was not statistically significant between levetiracetam and valproate, while it was significant when comparing either levetiracetam or valproate to placebo. Conclusion: Compared to placebo, levetiracetam offers improvement in headache frequency in patients with migraine. The efficacy of levetiracetam in migraine prophylaxis is comparable to currently used drugs such as valproate.

  5. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

    Science.gov (United States)

    Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

    2017-01-17

     To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1

  6. Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

    2015-11-01

    Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

  7. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  8. Effect of yoga on quality of life of CLBP patients: A randomized control study

    Directory of Open Access Journals (Sweden)

    Tekur Padmini

    2010-01-01

    Full Text Available Context: In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP, 12 to 16 weeks of intervention were found effective in reducing pain and disability. Aim: To study the efficacy of a residential short term intensive yoga program on quality of life in CLBP. Materials and Methods: About 80 patients with CLBP (females 37 registered for a week long treatment at SVYASA Holistic Health Centre in Bengaluru, India. They were randomized into two groups (40 each. The yoga group practiced a specific module for CLBP comprising of asanas (physical postures, pranayama (breathing practices, meditation and lectures on yoga philosophy. The control group practiced physical therapy exercises for back pain. Perceived stress scale (PSS was used to measure baseline stress levels. Outcome measures were WHOQOL Bref for quality of life and straight leg raising test (SLR using a Goniometer. Results: There were significant negative correlations (Pearson′s, P<0.005, r>0.30 between baseline PSS with all four domains and the total score of WHOQOLBref. All the four domains′ WHOQOLBref improved in the yoga group (repeated measures ANOVA P=0.001 with significant groupFNx01time interaction (P<0.05 and differences between groups (P<0.01. SLR increased in both groups (P=0.001 with higher increase in yoga (31.1 % right, 28.4 % left than control (18.7% right, 21.5 % left group with significant groupFNx01time interaction (SLR right leg P=0.044. Conclusion: In CLBP, a negative correlation exists between stress and quality of life. Yoga increases quality of life and spinal flexibility better than physical therapy exercises.

  9. Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Levenson, Jessica C; Rollman, Bruce L; Ritterband, Lee M; Strollo, Patrick J; Smith, Kenneth J; Yabes, Jonathan G; Moore, Charity G; Harvey, Allison G; Buysse, Daniel J

    2017-06-06

    Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

  10. Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

    Science.gov (United States)

    Kucera, Miroslav; Barna, Milos; Horàcek, Ondrej; Kàlal, Jan; Kucera, Alexander; Hladìkova, Marie

    2005-01-01

    The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (Pback pain can be concluded.

  11. Study protocol: effect of playful training on functional abilities of older adults - a randomized controlled trial

    DEFF Research Database (Denmark)

    Jessen, Jari Due; Lund, Henrik Hautop

    2017-01-01

    paired t-test, otherwise using Wilcoxon signed-rank test. "Intention to treat" analysis will be done.Discussion: The trial tests for increased mobility, agility, balancing and general fitness of community-dwelling elderly as a result of playing, in this case on modular interactive tiles. A positive...... of community dwelling elderly as a result of short-term playing with an exergame system in the form of interactive modular tiles. Such playful training may be motivational to perform and viewed by the subjects to offer life-fulfilling quality, while providing improvement in physical abilities, e.g. related...... to prevent fall accidents. The RCT will test for a variety of health parameters of community-dwelling elderly playing on interactive modular tiles.Methods: The study will be a single blinded, randomized controlled trial with 60 community-dwelling adults 70+ years. The trial will consist an intervention group...

  12. A Radical Sodium Reduction Policy is not Supported by Randomized Controlled Trials or Observational Studies

    DEFF Research Database (Denmark)

    Graudal, Niels

    2016-01-01

    Several health institutions recommend sodium intake be reduced to below 2,300 mg, which means that 6-7 billion individuals should alter their diet to accommodate. Such a radical recommendation should be based on solid evidence. However, this review reveals that (i) there are no randomized...... controlled trials (RCTs) allocating individuals to below 2,300 mg and measuring health outcomes; (ii) RCTs allocating risk groups such as obese prehypertensive individuals and hypertensive individuals down to (but not below) 2,300 mg show no effect of sodium reduction on all-cause mortality; (iii) RCTs...... allocating individuals to below 2,300 mg show a minimal effect on blood pressure in the healthy population (less than 1mm Hg) and significant increases in renin, aldosterone, noradrenalin cholesterol, and triglyceride; and (iv) observational studies show that sodium intakes below 2,645 and above 4,945 mg...

  13. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    Science.gov (United States)

    Fuller, Daniel; Potvin, Louise

    2012-06-01

    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  14. Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly: A Randomized Controlled Study

    Science.gov (United States)

    Drumond Marra, Hellen Livia; Myczkowski, Martin Luiz; Maia Memória, Cláudia; Arnaut, Débora; Leite Ribeiro, Philip; Sardinha Mansur, Carlos Gustavo; Lancelote Alberto, Rodrigo; Boura Bellini, Bianca; Alves Fernandes da Silva, Adriano; Tortella, Gabriel; Ciampi de Andrade, Daniel; Teixeira, Manoel Jacobsen; Forlenza, Orestes Vicente; Marcolin, Marco Antonio

    2015-01-01

    Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique with potential to improve memory. Mild cognitive impairment (MCI), which still lacks a specific therapy, is a clinical syndrome associated with increased risk of dementia. This study aims to assess the effects of high-frequency repetitive TMS (HF rTMS) on everyday memory of the elderly with MCI. We conducted a double-blinded randomized sham-controlled trial using rTMS over the left dorsolateral prefrontal cortex (DLPFC). Thirty-four elderly outpatients meeting Petersen's MCI criteria were randomly assigned to receive 10 sessions of either active TMS or sham, 10 Hz rTMS at 110% of motor threshold, 2,000 pulses per session. Neuropsychological assessment at baseline, after the last session (10th) and at one-month follow-up, was applied. ANOVA on the primary efficacy measure, the Rivermead Behavioural Memory Test, revealed a significant group-by-time interaction (p = 0.05), favoring the active group. The improvement was kept after one month. Other neuropsychological tests were heterogeneous. rTMS at 10 Hz enhanced everyday memory in elderly with MCI after 10 sessions. These findings suggest that rTMS might be effective as a therapy for MCI and probably a tool to delay deterioration. PMID:26160997

  15. Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Hellen Livia Drumond Marra

    2015-01-01

    Full Text Available Transcranial magnetic stimulation (TMS is a noninvasive brain stimulation technique with potential to improve memory. Mild cognitive impairment (MCI, which still lacks a specific therapy, is a clinical syndrome associated with increased risk of dementia. This study aims to assess the effects of high-frequency repetitive TMS (HF rTMS on everyday memory of the elderly with MCI. We conducted a double-blinded randomized sham-controlled trial using rTMS over the left dorsolateral prefrontal cortex (DLPFC. Thirty-four elderly outpatients meeting Petersen’s MCI criteria were randomly assigned to receive 10 sessions of either active TMS or sham, 10 Hz rTMS at 110% of motor threshold, 2,000 pulses per session. Neuropsychological assessment at baseline, after the last session (10th and at one-month follow-up, was applied. ANOVA on the primary efficacy measure, the Rivermead Behavioural Memory Test, revealed a significant group-by-time interaction p=0.05, favoring the active group. The improvement was kept after one month. Other neuropsychological tests were heterogeneous. rTMS at 10 Hz enhanced everyday memory in elderly with MCI after 10 sessions. These findings suggest that rTMS might be effective as a therapy for MCI and probably a tool to delay deterioration.

  16. Posterior bulk-filled resin composite restorations. A 5-year randomized controlled clinical study

    DEFF Research Database (Denmark)

    van Dijken, Jan WV; Pallesen, Ulla

    2016-01-01

    .4 years). Each patient received at least two, as similar as possible, extended Class I or Class II restorations. In all cavities, a 1-step self-etch adhesive (Xeno V+) was applied. Randomized, one of the cavities of each pair received the flowable bulk-filled resin composite (SDR), in increments up to 4mm......Objective: To evaluate in a randomized controlled study the 5-year clinical durability of a flowable resin composite bulk-fill technique in Class I and Class II restorations. Material and methods: 38 pairs Class I and 62 pairs Class II restorations were placed in 44 male and 42 female (mean age 52...... as needed to fill the cavity 2mm short of the occlusal cavosurface. The occlusal part was completed with the ormocer-based nano-hybrid resin composite (Ceram X mono+). In the other cavity, the resin composite-only (Ceram X mono+) was placed in 2mm increments. The restorations were evaluated using slightly...

  17. Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.

    Science.gov (United States)

    McLennon, Susan M; Hancock, Rebecca D; Redelman, Kathleen; Scarton, Lisa J; Riley, Elizabeth; Sweeney, Bobbie; Habermann, Barbara; Jessup, Nenette M; Bakas, Tamilyn

    2016-05-01

    To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage and 3) nurse intervener perspectives. A randomized controlled clinical trial design. Urban, community, midwestern United States. A total of 254 stroke caregivers (mean ±SD age, 54.4 ±11.8 years), 55 (22.0%) males and 199 (78.4%) females) randomized to the TASK II intervention (n=123) or an Information, Support, and Referral comparison group (n=131). TASK II participants received the TASK II Resource Guide; Information, Support, and Referral participants received a standard caregiver brochure. At approximately 8 weeks after discharge, both groups received 8 weekly calls from a nurse, with a booster call 4 weeks later. Protocol adherence was evaluated with the TASK II Checklist for Monitoring Adherence. Intervention dosage was measured by the number of minutes caregivers spent reading materials and talking with the nurse. Nurse intervener perspectives were obtained through focus groups. Protocol adherence was 80% for the TASK II and 92% for the Information, Support, and Referral. As expected, intervention dosage differed between TASK II and Information, Support, and Referral with respect to caregiver time spent reading materials (t=-6.49; Pstroke caregiver intervention trial (NIH R01NR010388; ClinicalTrials.govNCT01275495). © The Author(s) 2015.

  18. A double-blind, randomized, placebo-controlled study of nifedipine on early renal allograft function.

    Science.gov (United States)

    Wilkie, M E; Beer, J C; Evans, S J; Raftery, M J; Lord, R H; Moore, R; Marsh, F P

    1994-01-01

    A double-blind, randomized, placebo-controlled study was conducted to determine the effect of nifedipine on early renal allograft function when added to a triple therapy immunosuppression regime comprising low-dose cyclosporin (CsA), prednisolone and azathioprine. Fifty adult cadaveric renal allograft recipients were randomized to placebo (group P n = 17), nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 48 h, followed by matching placebo for 3 months (group NS n = 16) or nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 3 months (group NL n = 17). Donor and recipient exclusion criteria included recent calcium antagonist treatment. At 3 months after transplantation mean GFR adjusted for graft loss was significantly higher in group NL than in NS (mean +/- SD 61 +/- 28 versus 34 +/- 25 ml/min/1.73 m2; P nifedipine commenced preoperatively and continued for 3 months following transplantation has beneficial effects on early renal allograft function when incorporated as part of an immunotherapy regimen based on cyclosporin.

  19. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

    OpenAIRE

    Ramesh R Rai; Manisha Dwivedi; Nirmal Kumar

    2014-01-01

    Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo tre...

  20. A randomized controlled pilot study of the therapeutic effects of yoga in people with Parkinson's disease.

    Science.gov (United States)

    Sharma, Neena K; Robbins, Kristin; Wagner, Kathleen; Colgrove, Yvonne M

    2015-01-01

    Exercise can be beneficial for cardiopulmonary, musculoskeletal or neurological systems, and other factors including mood, and may be beneficial in reducing fall risks, dementia and variables associated with quality of life (QOL). Parkinson's disease (PD) produces progressive motor and cognitive deterioration that may leave those inflicted unable to participate in standard exercise programs. Alternative forms of exercise such as yoga may be successful in improving physical function, QOL and physiological variables for overall well-being. This randomized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD. Thirteen people with stage 1-2 PD were randomized to either a yoga (n = 8) or a control group (n = 5). The yoga group participated in twice-weekly yoga sessions for 12 weeks. Participants were tested at baseline, and at 6 and 12 weeks using the Unified Parkinson's Disease Rating Scale (UPDRS), clinical measures of health-related QOL and physiological measures. Significant improvement in UPDRS scores (P = .006), diastolic blood pressure (P = 0.036) and average forced vital capacity (P = 0.03) was noted in the yoga group over time. Changes between groups were also noted in two SF-36 subscales. Positive trends of improvement were noted in depression scores (P = 0.056), body weight (P = 0.056) and forced expiratory volume (P = 0.059). Yoga participants reported more positive symptom changes including immediate tremor reduction. The results suggest that yoga may improve aspects of QOL and physiological functions in stages 1-2 PD. Future larger studies are needed to confirm and extend our findings of the effects of yoga in PD.

  1. Perioperative celecoxib administration for pain management after total knee arthroplasty – A randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Lin Wei-Peng

    2008-06-01

    Full Text Available Abstract Background Non-steroidal anti-inflammatory drugs (NSAIDs are recommended for multimodal postoperative pain management. We evaluated opioid-sparing effects and rehabilitative results after perioperative celecoxib administration for total knee arthroplasty. Methods This was a prospective, randomized, observer-blind control study. Eighty patients that underwent total knee arthroplasty were randomized into two groups of 40 each. The study group received a single 400 mg dose of celecoxib, one hour before surgery, and 200 mg of celecoxib every 12 hours for five days, along with patient-controlled analgesic (PCA morphine. The control group received only PCA morphine for postoperative pain management. Visual analog scale (VAS pain scores, active range of motion (ROM, total opioid use and postoperative nausea/vomiting were analyzed. Results Groups were comparable for age, pre-operative ROM, operation duration and intraoperative blood loss. Resting VAS pain scores improved significantly in the celecoxib group, compared with controls, at 48 hrs (2.13 ± 1.68 vs. 3.43 ± 1.50, p = 0.03 and 72 hrs (1.78 ± 1.66 vs. 3.17 ± 2.01, p = 0.02 after surgery. Active ROM also increased significantly in the patients that received celecoxib, especially in the first 72 hrs [40.8° ± 17.3° vs. 25.8° ± 11.5°, p = 0.01 (day 1; 60.7° ± 18.1° vs. 45.0° ± 17.3°, p = 0.004 (day 2; 77.7° ± 15.1° vs. 64.3° ± 16.9°, p = 0.004 (day 3]. Opioid requirements decreased about 40% (p = 0.03 in the celecoxib group. Although patients suffering from post-operative nausea/vomiting decreased from 43% in control group to 28% in celecoxib group, this was not significant (p = 0.57. There were no differences in blood loss (intra- and postoperative between the groups. Celecoxib resulted in no significant increase in the need for blood transfusions. Conclusion Perioperative celecoxib significantly improved postoperative resting pain scores at 48 and 72 hrs, opioid

  2. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Directory of Open Access Journals (Sweden)

    Iliya V Ivanov

    Full Text Available Degenerative retinal diseases, especially retinitis pigmentosa (RP, lead to severe peripheral visual field loss (tunnel vision, which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST.Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental and reading (control training. All subjects who first performed reading training underwent experimental training later (waiting list control group. To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT during exploratory saccade training, Percent Preferred Walking Speed (PPWS, the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field.In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training

  3. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Kangjun

    2011-06-01

    Full Text Available Abstract Background There are a variety of treatment options for Bell's palsy. Evidence from randomized controlled trials indicates corticosteroids can be used as a proven therapy for Bell's palsy. Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease. The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify whether prednisolone in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients. Methods/Design In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with prednisolone and/or acupuncture. In total, 1200 patients aged 18 to 75 years within 72 h of onset of acute, unilateral, peripheral facial palsy will be assessed. There are six treatment groups, with four treated according to different path-stages and two not. These patients are randomly assigned to be in one of the following six treatment groups, i.e. 1 placebo prednisolone group, 2 prednisolone group, 3 placebo prednisolone plus acute stage acupuncture group, 4 prednisolone plus acute stage acupuncture group, 5 placebo prednisolone plus resting stage acupuncture group, 6 prednisolone plus resting stage acupuncture group. The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain, the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period. Discussion The result of this trial will assess the

  4. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study

    OpenAIRE

    Teughels, Wim; Durukan, Andaç; Ozcelik, Onur; Pauwels, Martine; Quirynen, Marc; Haytac, Mehmet Cenk

    2013-01-01

    Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol 2013; 40: 1025–1035. doi: 10.1111/jcpe.12155. AimThe aim of this randomized placebo-controlled clinical trial was to evaluate the effects of Lactobacillus reuteri-containing probiotic lozenges as an adjunct to scaling and root planing (SRP). Material and ...

  5. "The educating nursing staff effectively (TENSE) study": design of a cluster randomized controlled trial.

    Science.gov (United States)

    Hazelhof, Theo J G M; Gerritsen, Debby L; Schoonhoven, Lisette; Koopmans, Raymond T C M

    2014-01-01

    Challenging behavior exhibited by people with dementia can have adverse outcomes, like stress, low morale, low work satisfaction and absenteeism for nursing staff in long-term care settings. Training nursing staff to manage challenging behavior may reduce its impact. Although much of the research into training nursing staff shows methodological limitations, several studies find some effect of training programs on knowledge about and on management of challenging behavior. Effects on stress or burnout are almost not found. The TENSE-study is a randomized controlled study on 18 nursing home units (9 control, 9 intervention) investigating the effects of a continuous educational program for nursing staff about managing challenging behavior. Nursing staff of intervention units receive the program, nursing staff of control units do not and continue usual care. The primary outcome is stress experienced by nursing staff (N = 135). Secondary outcomes are: emotional workload, work satisfaction, stress reactions at work and knowledge about challenging behaviour of nursing staff; and frequency of challenging behavior, quality of life and social engagement of residents (N = 135). Because there are many unknown factors influencing the effect of the training, a process evaluation to evaluate sampling-, implementation- and intervention quality as well as barriers and facilitators to implementation will also be included in the analysis. Nursing staff could not be blinded to the intervention, but were blinded for the outcomes. Strengths of this study are the (good) description of the intervention complemented by a process evaluation and the tailoring of the intervention to the wishes and needs of the nursing homes at any moment during the study. Sustaining the effects of the intervention by using follow up sessions is another strength. Possible drawbacks may be dropout because of the frailty of the elderly population and because nursing staff might move to another job during

  6. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

    Directory of Open Access Journals (Sweden)

    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  7. BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY

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    Pavel Skok

    2002-06-01

    Full Text Available Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98.Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80 in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80 with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks, and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week. The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05. In 6 patients (7.5%, 6/ 80 from the study group and in 7 (8.8%, 7/80 from the control group we introduced a replacement treatment

  8. Dresden PTSD treatment study: randomized controlled trial of motor vehicle accident survivors

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    Menning Hans

    2006-07-01

    Full Text Available Abstract Background We translated, modified, and extended a cognitive behavioral treatment (CBT protocol by Blanchard and Hickling (2003 for the purpose of treating survivors of MVA with full or subsyndromal posttraumatic stress disorder (PTSD whose native language is German. The treatment manual included some additional elements, e. g. cognitive procedures, imaginal reliving, and facilitating of posttraumatic growth. The current study was conducted in order to test the efficacy of the modified manual by administering randomized controlled trial in which a CBT was compared to a wait-list control condition. Methods Forty-two motor vehicle accident survivors with chronic or severe subsyndromal posttraumatic stress disorder (PTSD completed the treatment trial with two or three detailed assessments (pre, post, and 3-month follow-up. Results CAPS-scores showed significantly greater improvement in the CBT condition as compared to the wait list condition (group × time interaction effect size d = 1.61. Intent-to-treat analysis supported the outcome (d = 1.34. Categorical diagnostic data indicated clinical recovery of 67% (post-treatment and 76% (3 months FU in the treatment group. Additionally, patients of the CBT condition showed significantly greater reductions in co-morbid major depression than the control condition. At follow-up the improvements were stable in the active treatment condition. Conclusion The degree of improvement in our treatment group was comparable to that in previously reported treatment trials of PTSD with cognitive behavioral therapy. Trial registration ISRCTN66456536

  9. Google Glass for Residents Dealing With Pediatric Cardiopulmonary Arrest: A Randomized, Controlled, Simulation-Based Study.

    Science.gov (United States)

    Drummond, David; Arnaud, Cécile; Guedj, Romain; Duguet, Alexandre; de Suremain, Nathalie; Petit, Arnaud

    2017-02-01

    To determine whether real-time video communication between the first responder and a remote intensivist via Google Glass improves the management of a simulated in-hospital pediatric cardiopulmonary arrest before the arrival of the ICU team. Randomized controlled study. Children's hospital at a tertiary care academic medical center. Forty-two first-year pediatric residents. Pediatric residents were evaluated during two consecutive simulated pediatric cardiopulmonary arrests with a high-fidelity manikin. During the second evaluation, the residents in the Google Glass group were allowed to seek help from a remote intensivist at any time by activating real-time video communication. The residents in the control group were asked to provide usual care. The main outcome measures were the proportion of time for which the manikin received no ventilation (no-blow fraction) or no compression (no-flow fraction). In the first evaluation, overall no-blow and no-flow fractions were 74% and 95%, respectively. During the second evaluation, no-blow and no-flow fractions were similar between the two groups. Insufflations were more effective (p = 0.04), and the technique (p = 0.02) and rate (p Google Glass group than in the control group. Real-time video communication between the first responder and a remote intensivist through Google Glass did not decrease no-blow and no-flow fractions during the first 5 minutes of a simulated pediatric cardiopulmonary arrest but improved the quality of the insufflations and chest compressions provided.

  10. A RANDOMIZED CONTROLLED PLACEBO STUDY OF DEXTROSE IONTOPHORESIS VERSUS DEXTROSE PROLOTHERAPY IN CASE OF KNEE OSTEOARTHRITIS

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    Mahmoud Mohamed Ahmed Ewidea

    2015-12-01

    Full Text Available Background: Osteoarthritis is the most common cause of musculoskeletal pain and disability in the knee joint. This study investigated the efficacy of Dextrose iontophoresis versus Dextrose prolotherapy in case of knee osteoarthritis in a randomized, placebo-controlled, double-blinded study. Methods: sixty patients diagnosed mild to moderate osteoarthritis were included in the study. Their age's were45:65 years with mean age 51 ± 3.5 years. Patients were divided randomly into three equal groups, group (Areceived 50 % dextrose iontophoresis, group (B Each patient received three intra-articular injections of dextrose at 1-month intervals in weeks 0, 4, and 8 and group (C received sham iontophoresis. The outcome measurements were Western Ontario and McMaster Universities arthritis index (WOMAC values, knee ROM, and pain severity at rest (seated and in activity (after walking 6 m using the visual analogue scale (VAS were recorded. The patients were evaluated for these parameters before allocated in their groups then after 4, 8, and 24 weeks later. Results: compared to sham group (placebo there were significant improvement of VAS and ROM of iontophoresis group than sham (placebo group (p<0.000. Also there were significant improvement of prolotherapy group than placebo (p<0.006, and 0.02 respectively. Furthermore there was significant improve of iontophoresis group than prolotherapy where p was <0.000 for VAS, ROM and (WOMAC. Conclusion: The results of this study suggested that both dextrose iontophoresis and dextrose prolotherapy may be as useful modalities in treatment of osteoarthritis with better effects of dextrose iontophoresis than prolotherapy.

  11. Online gambling's moderators: how effective? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Caillon, Julie; Grall-Bronnec, Marie; Hardouin, Jean-Benoit; Venisse, Jean-Luc; Challet-Bouju, Gaelle

    2015-05-30

    Online gambling has been legalized in France in 2010. Licenses are issued to gambling operators who demonstrate their ability to respect the legal framework (security, taxation, consumer protection, etc.). The preventive measures to protect vulnerable gamblers include an obligation to provide online gambling moderators. These moderators should allow gamblers to limit their bets, exclude themselves from the website for 7 days, and consult the balance of the gambler's account at any time. However, there are only a few published reports of empirical research investigating the effectiveness of Internet-based protective measures implemented by French law. Moreover, no empirical research has yet studied the impact of bonuses on gambling behaviors. This research is an experimental randomized controlled trial, risk prevention targeted. The research is divided into four sub-studies depending on the studied moderator: limiting bonuses, self-exclusion, self-limitation and information. The study sample consists of 485 volunteers. For each experimental condition and the control groups, the sample is composed of gamblers equally recruited from gamblers having preferences in each of the three major forms of games (lottery and scratch tickets, sports and horserace betting, and poker). For each form of gambling, the gamblers are recruited in order to obtain as many problem gamblers as non-problem gamblers. According to the randomization, the experimental session begins. The experimental session is a gambling situation on a computer in our research center. The gambler is invited to play on his favorite gambling site as usual, with his own gambler account and his own money. Data collected comprise sociodemographic characteristics, gambling habits, an interview about enjoyment and feeling out of control during the gambling session, moderator impact on gambling practice, statement of gambling parameters and questionnaires (BMIS, GRCS, CPGI, GACS). Moderator efficiency is assessed based

  12. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

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    Wilson Graeme B

    2012-09-01

    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  13. Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    McCambridge Jim

    2012-07-01

    Full Text Available Abstract Background Alcohol causes huge problems for population health and for society, which require interventions with individuals as well as populations to prevent and reduce harms. Brief interventions can be effective and increasingly take advantage of the internet to reach high-risk groups such as students. The research literature on the effectiveness of online interventions is developing rapidly and is confronted by methodological challenges common to other areas of e-health including attrition and assessment reactivity and in the design of control conditions. Methods/design The study aim is to evaluate the effectiveness of a brief online intervention, employing a randomized controlled trial (RCT design that takes account of baseline assessment reactivity, and other possible effects of the research process. Outcomes will be evaluated after 3 months both among student populations as a whole including for a randomized no contact control group and among those who are risky drinkers randomized to brief assessment and feedback (routine practice or to brief assessment only. A three-arm parallel groups trial will also allow exploration of the magnitude of the feedback and assessment component effects. The trial will be undertaken simultaneously in 2 universities randomizing approximately 15,300 students who will all be blinded to trial participation. All participants will be offered routine practice intervention at the end of the study. Discussion This trial informs the development of routine service delivery in Swedish universities and more broadly contributes a new approach to the study of the effectiveness of online interventions in student populations, with relevance to behaviors other than alcohol consumption. The use of blinding and deception in this study raise ethical issues that warrant further attention. Trial registration ISRCTN28328154

  14. Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

    2014-11-27

    Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a

  15. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

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    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  16. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study.

    Science.gov (United States)

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-07-15

    The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200 mg) before flying to Lhasa, China (altitude of 4300 meters). Acute mountain sickness (AMS) severity was assessed with the Lake Louise scoring (LLS) system within 5 days after landing on the plateau (at high altitude). Routine check-ups, clinical biochemistry, and blood tests were performed before departure and 24 h after arrival. A total of 38 participants completed the study (ISS group: n=19; CON group: n=19). The rate of subjects with AMS (LLS>3) was lower in the ISS group compared with the CON group, but no significant differences were obtained (P>0.05). There were no differences in patients' baseline characteristics. The physiological indices were similar in both groups except for serum iron concentrations (19.44±10.02 vs. 85.10±26.78 μmol/L) and transferrin saturation rates (28.20±12.14 vs. 68.34±33.12%), which were significantly higher in the ISS group (Piron supplementation has no significant protective effect on AMS in healthy Chinese low-altitude inhabitants.

  17. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

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    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  18. Cost effectiveness of preventive home visits to the elderly: economic evaluation alongside randomized controlled study

    DEFF Research Database (Denmark)

    Kronborg, Christian; Vass, Mikkel; Lauridsen, Jørgen

    2006-01-01

    We evaluated the cost effectiveness of preventive home visits to elderly persons in Denmark alongside a 3-year randomized controlled study. The main outcome measure was incremental costs per active life-year gained. The number of active life-years was defined as those during which the person......, and interdisciplinary follow-up. The remaining 17 municipalities offered preventive home visits as usual. Outcomes were measured in 4,034 persons aged 75 or 80 years old and dwelling at home. The difference in mean total costs between the intervention and the control group discounted at 3% was -856 euro (95% CI -2......,455 to 744) in 75-year-olds and 694 euro (-2,684 to 4,071) in 80-year-olds. The discounted difference in mean active life-years was 0.034 (-0.058 to 0.125) and 0.197 (0.013 to 0.380), respectively. The study did not provide conclusive evidence on the cost effectiveness of the programs under consideration....

  19. The Effectiveness of School-Based Nutritional Education Program among Obese Adolescents: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Supinya In-Iw

    2012-01-01

    Full Text Available The purpose of the study was to determine the change in body weight and body mass index (BMI, as well as diet behaviors at 4 months after intervention between obese adolescent girls who participated in the school-based nutritional education program, addressed by pediatrician, compared to those who attended regular nutritional class. Methods. 49 obese girls were recruited from a secondary school. Those, were randomized into 2 groups of intervention and control. The intensive interactive nutritional program was provided to the intervention group. Weight and height, dietary record and % fat consumption, as well as self-administered questionnaires on healthy diet attitudes were collected at baseline and 4-month follow-up, and then compared between two groups. Results. There was a statistically significant change of BMI in the intervention group by  kg/m2 ( compared to the control group ( kg/m2, but no significant change in calorie and % fat consumption between groups. The attitudes on healthy eating behaviors in the intervention group were shown improving significantly (. Conclusions. Interactive and intensive nutritional education program as shown in the study was one of the most successful school-based interventions for obese adolescents.

  20. Using Virtual Patients to Teach Empathy: A Randomized Controlled Study to Enhance Medical Students' Empathic Communication.

    Science.gov (United States)

    Foster, Adriana; Chaudhary, Neelam; Kim, Thomas; Waller, Jennifer L; Wong, Joyce; Borish, Michael; Cordar, Andrew; Lok, Benjamin; Buckley, Peter F

    2016-06-01

    Physician empathy is a complex phenomenon known to improve illness outcomes; however, few tools are available for deliberate practice of empathy. We used a virtual patient (VP) to teach empathic communication to first-year medical students. We then evaluated students' verbal empathy in a standardized patient (SP) interaction. Seventy medical students, randomly assigned to 3 separate study groups, interacted with (1) a control VP portraying depression, (2) a VP with a backstory simulating patient shadowing, or (3) a VP able to give immediate feedback about empathic communication (empathy-feedback VP). Subsequently, the students interviewed an SP portraying a scenario that included opportunities to express empathy. All SP interviews were recorded and transcribed. The study outcomes were (1) the students' verbal response to the empathic opportunities presented by the SP, as coded by reliable assessors using the Empathic Communication Coding System, and (2) the students' responses as coded by the SPs, using a communication checklist. There were no significant differences in student demographics between groups. The students who interacted with the empathy-feedback VP showed higher empathy in the SP interview than did the students in the backstory VP and the control VP groups [mean (SD) empathy scores coded on a 0-6 scale were 2.91 (0.16) vs. 2.20 (0.22) and 2.27 (0.21), respectively). The difference in scores was significant only for the empathy-feedback VP versus the backstory VP group (P = 0.027). The SPs rated the empathy-feedback and the backstory VP groups significantly higher than the control VP group on offering empathic statements (P empathy in a VP interaction increased students' empathy in encounters with SPs, as rated by trained assessors, whereas a simulation of patient shadowing did not. Both VP interventions increased students' empathy as rated by SPs, compared with the control VP group.

  1. A Randomized Controlled Study of Brief Interventions To Teach Residents about Domestic Violence.

    Science.gov (United States)

    Coonrod, Dean V.; Bay, R. Curtis; Rowley, Beverley D.; Del Mar, Nancy B.; Gabriele, Laura; Tessman, Terrie D.; Chambliss, Linda R.

    2000-01-01

    Medical residents were randomly assigned to either a 20-minute session on the importance of screening for domestic violence or to an unrelated topic. Subsequently, 71 percent of the trained residents diagnosed at least one case of domestic violence compared to 52 percent of residents in the control group. Rates of diagnosis also differed by…

  2. Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial.

    Science.gov (United States)

    Giosan, Cezar; Cobeanu, Oana; Mogoaşe, Cristina; Szentagotai, Aurora; Mureşan, Vlad; Boian, Rareș

    2017-05-12

    weeks. A short therapist check-in via phone will take place every week. Participants in the delayed-intervention condition will be given access to the app after 6 weeks from randomization. The primary outcome is the level of depressive symptomatology. The intervention delivered through the app to the active condition includes psychoeducational materials and exercises based on CBT for depression, while the placebo intervention uses a sham version of the app (i.e., similar structure of courses and exercises). To our knowledge, this study protocol is the first to test the efficacy of a smartphone app for depressive symptomatology in the form of a randomized controlled trial (RCT) that includes an active placebo condition. As such, this can substantially add to the body of evidence supporting the use of apps designed to decrease depression. ClinicalTrials.gov, identifier: NCT03060200 . Registered on 1 February 2017. The first participant was enrolled on 17 February 2017.

  3. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Phuttharak Warinthorn

    2008-03-01

    Full Text Available Abstract Background An acute complication of thyroidectomy is fatal hematoma, which can produce an upper airway obstruction needing immediate intubation or tracheostomy. After neck surgery, we usually apply a pressure dressing with a non-woven, adhesive fabric to reduce bleeding and fluid collection at the operative bed. We conducted a prospective, randomized, controlled study to evaluate a pressure vs. a non-pressure dressing after thyroid surgery by monitoring blood and serum in the operative bed. Methods We studied 108 patients who underwent 116 thyroid surgeries at Srinagarind Hospital, Khon Kaen University, between December 2006 and September 2007. The patients were randomized to either the pressure dressing or non-pressure dressing group. Ultrasound of the neck was performed 24 ± 3 hours after surgery. The volume of fluid collection in the operative bed was calculated. All patients were observed for any post-operative respiratory distress, wound complications, tingling sensation or tetany. Results The distributions of age, sex, surgical indications and approaches were similar between the two groups. There was no statistically significant difference in the volume of fluid collection in the operative bed (p = 0.150 and the collected drained content (p = 0.798. The average time a drain was retained was 3 days. One patient in the pressure dressing group suffered cutaneous bruising while one patient in the non-pressure dressing group developed immediate hemorrhage after the skin sutures. Conclusion Pressure dressing after thyroidectomy does not have any significant impact on decreasing fluid collection at the operative bed. The use of pressure dressing after thyroidectomy may not therefore be justified. Trial Registration NCT00400465, ISRCTN52660978

  4. Deep Neuromuscular Blockade Improves Laparoscopic Surgical Conditions: A Randomized, Controlled Study.

    Science.gov (United States)

    Rosenberg, Jacob; Herring, W Joseph; Blobner, Manfred; Mulier, Jan P; Rahe-Meyer, Niels; Woo, Tiffany; Li, Michael K; Grobara, Peter; Assaid, Christopher A; Fennema, Hein; Szegedi, Armin

    2017-04-01

    Sustained deep neuromuscular blockade (NMB) during laparoscopic surgery may facilitate optimal surgical conditions. This exploratory study assessed whether deep NMB improves surgical conditions and, in doing so, allows use of lower insufflation pressures during laparoscopic cholecystectomy. We further assessed whether use of low insufflation pressure improves patient pain scores after surgery. This randomized, controlled, blinded study (NCT01728584) compared use of deep (1-2 post-tetanic-counts) or moderate (train-of-four ratio 10%) NMB, and lower (8 mmHg) or higher (12 mmHg; 'standard') insufflation pressure in a 2 × 2 factorial design. Primary endpoint was surgeon's overall satisfaction with surgical conditions, rated at end of surgery using an 11-point numerical scale. Post-operative pain scores were also evaluated. Data were analyzed using analysis of covariance. Of 127 randomized patients, 120 had evaluable data for the primary endpoint. Surgeon's score of overall satisfaction with surgical conditions was significantly higher with deep versus moderate NMB indicated by a least-square mean difference of 1.1 points (95% confidence interval 0.1-2.0; P = 0.026). Furthermore, strong evidence of an effect was observed for standard versus low pressure: least-square mean difference of 3.0 points (95% confidence interval 2.1-4.0; P < 0.001). No significant difference was observed in average pain scores within 24 h post-surgery for low versus standard pressure [0.17 (95% confidence interval -0.67 to +0.33); P = 0.494]. Although associated with significantly improved surgical conditions, deep NMB alone was insufficient to promote use of low insufflation pressure during laparoscopic cholecystectomy. Furthermore, low insufflation pressure did not result in reduced pain, compared with standard pressure. ClinicalTrials.gov identifier, NCT01728584. Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

  5. Diabetes telemonitoring reduces the risk of hypoglycaemia during Ramadan: a pilot randomized controlled study.

    Science.gov (United States)

    Lee, J Y; Lee, S W H; Nasir, N H; How, S; Tan, C S S; Wong, C P

    2015-12-01

    This pilot study evaluated the short-term benefits of a telemonitoring-supplemented focused diabetic education compared with education alone in participants with Type 2 diabetes who were fasting during Ramadan. In this pilot mixed-method study, we identified 37 participants and randomly allocated them to either a telemonitoring group (n = 18) or a group receiving Ramadan-focused pre-education only (usual care; n = 19). The telemonitoring group received goal-setting and personalized feedback. The telemonitoring group was less likely to experience hypoglycaemia than the usual care group (odds ratio: 0.1273; 95% confidence interval: 0.0267-0.6059). No significant differences were noted in glycaemic control at the end of study. Participants viewed telemedicine as a more convenient alternative although technological barriers remain a concern. The results of this study reinforce the need for monitoring as well as educational initiatives for Muslims with diabetes who fast during Ramadan. Telemonitoring offers an attractive option requiring further research. (Clinical Trial Registry No. NCT02189135). © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  6. Modular Ankle Robotics Training in Early Sub-Acute Stroke: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Forrester, Larry W.; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F.

    2014-01-01

    Background Modular lower extremity (LE) robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually-guided and visually-evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. Objective Assess the feasibility and efficacy of daily anklebot training during early sub-acute hospitalization post-stroke. Methods Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (N=18) or passive manual stretching (N=16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an “assist-as-needed” approach during > 200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Results Both groups walked faster at discharge, however the robot group improved more in percent change of temporal symmetry (p=0.032) and also of step length symmetry (p=0.038), with longer nonparetic step lengths in the robot (133%) vs. stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (p≤ 0.001) and mean (p≤ 0.01) angular speeds, and increased movement smoothness (p≤ 0.01). There were no adverse events. Conclusion Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early sub-acute hospitalization is well tolerated and improves ankle motor control and gait patterning. PMID:24515923

  7. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Forrester, Larry W; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F

    2014-09-01

    BACKGROUND. Modular lower extremity robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually guided and visually evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. To assess the feasibility and efficacy of daily anklebot training during early subacute hospitalization poststroke. Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (n = 18) or passive manual stretching (n = 16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an "assist-as-needed" approach during >200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Both groups walked faster at discharge; however, the robot group improved more in percentage change of temporal symmetry (P = .032) and also of step length symmetry (P = .038), with longer nonparetic step lengths in the robot (133%) versus stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (P ≤ .001) and mean (P ≤ .01) angular speeds, and increased movement smoothness (P ≤ .01). There were no adverse events. Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early subacute hospitalization is well tolerated and improves ankle motor control and gait patterning. © The Author(s) 2014.

  8. Working Memory Training in Post-Secondary Students with ADHD: A Randomized Controlled Study.

    Directory of Open Access Journals (Sweden)

    Karizma Mawjee

    Full Text Available To determine whether standard-length computerized training enhances working memory (WM, transfers to other cognitive domains and shows sustained effects, when controlling for motivation, engagement, and expectancy.97 post-secondary students (59.8% female aged 18-35 years with Attention-Deficit/Hyperactivity Disorder, were randomized into standard-length adaptive Cogmed WM training (CWMT; 45-min/session, a shortened-length adaptive version of CWMT (15 min/session that controlled for motivation, engagement and expectancy of change, or into a no training group (waitlist-control group. All three groups received weekly telephone calls from trained coaches, who supervised the CWMT and were independent from the research team. All were evaluated before and 3 weeks post-training; those in the two CWMT groups were also assessed 3 months post-training. Untrained outcome measures of WM included the WAIS-IV Digit Span (auditory-verbal WM, CANTAB Spatial Span (visual-spatial WM and WRAML Finger Windows (visual-spatial WM. Transfer-of-training effects included measures of short-term memory, cognitive speed, math and reading fluency, complex reasoning, and ADHD symptoms.Performance on 5/7 criterion measures indicated that shortened-length CWMT conferred as much benefit on WM performance as did standard-length training, with both CWMT groups improving more than the waitlist-control group. Only 2 of these findings remained robust after correcting for multiple comparisons. Follow-up analyses revealed that post-training improvements on WM performance were maintained for at least three months. There was no evidence of any transfer effects but the standard-length group showed improvement in task-specific strategy use.This study failed to find robust evidence of benefits of standard-length CWMT for improving WM in college students with ADHD and the overall pattern of findings raise questions about the specificity of training effects.ClinicalTrials.gov NCT01657721.

  9. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  10. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study.

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients' engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed.

  11. [Acupuncture in fibromyalgia: a randomized, controlled study addressing the immediate pain response].

    Science.gov (United States)

    Stival, Rebecca Saray Marchesini; Cavalheiro, Patrícia Rechetello; Stasiak, Camila Edith Stachera; Galdino, Dayana Talita; Hoekstra, Bianca Eliza; Schafranski, Marcelo Derbli

    2014-01-01

    To evaluate the efficacy of acupuncture in the treatment of fibromyalgia, considering the immediate response of the visual analogue pain scale (VAS) as its primary outcome. Randomized, controlled, double-blind study including 36 patients with fibromyalgia (ACR 1990) selected from the outpatient rheumatology clinic, Santa Casa de Misericórdia, Ponta Grossa, PR. Twenty-one patients underwent an acupuncture session, under the principles of the traditional Chinese medicine, and 15 patients underwent a placebo procedure (sham acupuncture). For pain assessment, the subjects completed a Visual Analogue Scale (VAS) before and immediately after the proposed procedure. The mean change in VAS was compared among groups. The variation between the final and initial VAS values was -4.36±3.23 (P=0.0001) in the treatment group and -1.70±1.55 in the control group (P=0.06). The difference in terms of amplitude of variation of VAS (initial - final VAS) among groups favored the actual procedure (P=0.005). The effect size (ES) for the treatment group was d=1.7, which is considered a large effect. Although small, the statistical power of the sample for these results was very relevant (94.8%). Acupuncture has proven effective in the immediate pain reduction in patients with fibromyalgia, with a quite significant effect size. Copyright © 2014 Elsevier Editora Ltda. All rights reserved.

  12. Flaxseed supplementation in non-alcoholic fatty liver disease: a pilot randomized, open labeled, controlled study.

    Science.gov (United States)

    Yari, Zahra; Rahimlou, Mehran; Eslamparast, Tannaz; Ebrahimi-Daryani, Naser; Poustchi, Hossein; Hekmatdoost, Azita

    2016-06-01

    A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Participants were assigned to take either a lifestyle modification (LM), or LM +30 g/day brown milled flaxseed for 12 weeks. At the end of the study, body weight, liver enzymes, insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups (p< 0.05); however, this reduction was significantly greater in those who took flaxseed supplementation (p < 0.05). The significant mean differences were reached in hepatic markers between flaxseed and control group, respectively: ALT [-11.12 compared with -3.7 U/L; P< 0.001], AST [-8.29 compared with -4 U/L; p < 0.001], GGT [-15.7 compared with -2.62 U/L; p < 0.001], fibrosis score [-1.26 compared with -0.77 kPa; p = 0.013] and steatosis score [-47 compared with -15.45 dB/m; p = 0.022]. In conclusion, flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management.

  13. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

  14. [Chronic prostatitis/chronic pelvic pain syndrome. Influence of osteopathic treatment - a randomized controlled study].

    Science.gov (United States)

    Marx, S; Cimniak, U; Beckert, R; Schwerla, F; Resch, K L

    2009-11-01

    Prostatitis is the most common urological disease in males under [corrected] the age of 50 years old. As bacteria are detected in only prostatitis. The symptoms of this problem complex, often described as chronic prostatitis and chronic pelvic pain syndrome (CP-CPPS), seem to be multifactorial so that an improvement can only rarely be achieved with conventional forms of therapy. The aim of this study was to investigate whether osteopathic treatment can influence the symptoms of CP-CPPS (randomized controlled study, 5 sessions, follow-up after 6 weeks and 1.5 years without treatment). The study was carried out in a practice for osteopathy. Patients were recruited by referral from urologists, newspaper articles and lectures on the topic. A total of 35 males with medically diagnosed CP-CPPS aged 29-70 years old took part in the study. Of the patients 20 were allocated to the treatment group and 15 to the placebo group whereby 2 patients had to retire from the study prematurely. Patients in the treatment group received 5 osteopathic treatment sessions separated by 1 week at the beginning and by up to 3 weeks at the end (total period 8 weeks). The osteopathic dysfunctions of the patients were treated according to the principles of osteopathy. The placebo treatment in the control group consisted of a training program with simple gymnastic and physiotherapeutic exercises. Improvements of the complaints by urination (LUTS), chronic pelvic pain (CPPS) and quality of life (QOL) were measured using the questionnaires for international prostate symptom score (IPSS), the National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) and the quality of life index (QOL). Comparison of the results from the osteopathy and placebo groups revealed statistically significant differences in favor of the osteopathy group (ppatients should be carried out to substantiate these results.

  15. Assessment of Neonatal Pain During Heel Prick: Lancet vs Needle-A Randomized Controlled Study.

    Science.gov (United States)

    Britto, Carl; P N Rao, Suman

    2017-01-21

    Heel prick is a frequent painful procedure in newborns. A lancet or a 26-gauge needle is used for a heel prick in India. To compare the pain caused by heel prick with a lancet or a 26-gauge needle in newborns admitted in the neonatal intensive care unit (NICU) using the preterm infant pain profile (PIPP). This randomized controlled trial was conducted over 2 months in a Level III NICU with a sample size of 40 subjects (20 in each group), which was required for the study to have a power of 80% with an alpha error of 0.05. Hemodynamically stable newborns on at least those on partial oral feeds undergoing heel prick for routine glucose monitoring were randomized into two groups within 48 h of NICU admission after informed parental consent: heel prick with a lancet or with a 26-gauge needle using computer-generated random numbers. Two milliliters of expressed breast milk was given 2 min before the heel prick. Pain before, during and after (1 and 5 min) was assessed using the PIPP score. The primary outcome measure was the PIPP score. The secondary outcome measures were the duration of audible cry and the number of pricks needed for an adequate sample. Statistical analysis was done using the Mann Whitney U test and Friedman's test on SPSS v.21. A p value of < 0.05 was significant. There were 40 neonates, 24 males and 16 females included in the study with a median age of 7 days. The mean birth weight was 2441 g (SD: 699) at a mean gestation of 34.4 weeks (SD: 3.2). The median PIPP scores at 0-30 s after heel prick were 7.05 ± 3.57 with a lancet vs. 9.35 ± 3.68 a needle (p = 0.052). There was a significantly lower duration of audible cry with use of lancet (10.5 ± 18.5 s vs. 75.2 ± 12.0 s with needle; p = 0.03). All heel pricks resulted in adequate sampling. Heel prick with a lancet causes less crying than a 26-gauge needle, though the PIPP scores are not significantly different. © The Author [2017]. Published by Oxford

  16. Randomized controlled trial to study plaque inhibition in calcium sodium phosphosilicate dentifrices.

    Science.gov (United States)

    Claydon, Nicholas C A; Hall, Claire; Hughes, Alison J; Shaw, David; Seong, Joon; Davies, Maria; West, Nicola X

    2016-03-01

    To evaluate the effect of three calcium sodium phosphosilicate (CSPS)/sodium monofluorophosphate containing dentifrices, compared to positive and negative controls on plaque re-growth in a non-brushing model, after 4 days of twice daily use, as determined by plaque area and Turesky plaque index (TPI). This was an exploratory, single-centre, examiner-blind, randomised, controlled, five treatment period, crossover, plaque re-growth study, with supervised use of study products. Twenty-three healthy adult volunteers were randomized to receive experimental 5% CSPS dentifrice; two marketed 5% CSPS dentifrices; active comparator mouthrinse and negative control dentifrice. At the start of each treatment period, zero plaque was established by dental prophylaxis and study products were dispensed as either dentifrice slurries or mouthrinse, twice daily for the next 4 days. No other forms of oral hygiene were permitted. After 96h, supra-gingival plaque was determined by plaque area (direct entry, planimetric method) and TPI. Changes from zero plaque were analysed. For both measures, plaque re-growth at 96h was significantly lower following treatment with active comparator mouthrinse and significantly higher following treatment with the experimental 5% CSPS dentifrice, compared to all other treatments. There were no statistically significant differences between the three other treatments, except between the marketed 5% CSPS dentifrices, for overall plaque area. The comparator mouthwash was significantly more effective at preventing plaque accumulation than the dentifrice slurries. The three marketed dentifrices contained sodium lauryl sulphate and were more effective at reducing plaque re-growth than the experimental dentifrice formulated with a tegobetaine/adinol surfactant system. The CSPS containing dentifrices tested in this study showed no significant chemical-therapeutic anti-plaque benefits compared to a negative control dentifrice. However, sodium lauryl sulphate

  17. Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study

    Directory of Open Access Journals (Sweden)

    Marcy McCall

    2015-01-01

    Full Text Available An increase in patient-led uptake of complementary therapies in adult cancer has led to a need for more rigorous study of such interventions and their outcomes. This study therefore aimed to evaluate the feasibility and acceptability of a yoga intervention in men and women receiving conventional treatment for a cancer diagnosis. Prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys. Fifteen participants were included (11 female undergoing treatment for breast, prostate, colorectal, brain, and blood and lung cancer. Two participants dropped out and complete qualitative and quantitative data sets were collected from 12 participants and four yoga instructors. Other outcome measures included implementation costs patient-reported preferences for yoga intervention and changes in QOL-CA/CS. Three types of yoga intervention were safely administered in adult cancer. Mixed methods, cost-efficiency, QOL-CA/CS, and evidence-based design of yoga intervention have been used to establish feasibility and patient-preferences for yoga delivery in adult caner. Results suggest that, with some methodological improvements, a large-scale randomized controlled trial is warranted to test the efficacy of yoga for male and female cancer patients. This trial is registered with Clinicaltrials.gov NCT02309112.

  18. Coffee, caffeine, and sleep: A systematic review of epidemiological studies and randomized controlled trials.

    Science.gov (United States)

    Clark, Ian; Landolt, Hans Peter

    2017-02-01

    Caffeine is the most widely consumed psychoactive substance in the world. It is readily available in coffee and other foods and beverages, and is used to mitigate sleepiness, enhance performance, and treat apnea in premature infants. This review systematically explores evidence from epidemiological studies and randomized controlled trials as to whether coffee and caffeine have deleterious effects on sleep. Caffeine typically prolonged sleep latency, reduced total sleep time and sleep efficiency, and worsened perceived sleep quality. Slow-wave sleep and electroencephalographic (EEG) slow-wave activity were typically reduced, whereas stage-1, wakefulness, and arousals were increased. Dose- and timing-response relationships were established. The sleep of older adults may be more sensitive to caffeine compared to younger adults. Pronounced individual differences are also present in young people, and genetic studies isolated functional polymorphisms of genes implicated in adenosine neurotransmission and metabolism contributing to individual sensitivity to sleep disruption by caffeine. Most studies were conducted in male adults of Western countries, which limits the generalizability of the findings. Given the importance of good sleep for general health and functioning, longitudinal investigations aimed at establishing possible causal relationships among coffee- and caffeine-induced changes in sleep quality and health development are warranted.

  19. Effect of patient-controlled sedation with propofol on patient satisfaction: a randomized study.

    Science.gov (United States)

    Maurice-Szamburski, A; Loundou, A; Auquier, P; Girard, N; Bruder, N

    2013-12-01

    In this trial we sought to determine whether propofol-based patient-controlled sedation (PCS) during diagnostic cerebral angiography would result in improved patient satisfaction compared to placebo-based PCS. We randomly assigned 61 patients to receive propofol-based PCS (n=33, 15mg bolus in 9 s) or placebo-based PCS (n=28, bolus of 1.5mL of a 20% lipid emulsion in 9 s). We recorded the number of PCS bolus requirements, the need for rescue sedative drugs, and physiological variables. Prior to the procedure, the anxiety level of each patient was evaluated using the Anxiety State Traits Assessment (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The quality of patient conditioning was quoted by both the anesthetist and neuroradiologist using Visual Analog Scale (VAS). The day following the procedure, patients were given the EVAN questionnaire, a validated tool for assessing patient satisfaction. Both groups were similar in term of demographics, American Society of Anesthesiologist (ASA) physical status scores, STAI and APAIS scores, and procedure lengths. There were no differences between groups in EVAN scores 76.9±16.1 vs. 75.7±12.8; P=0.78. The number of PCS bolus requirements was significantly higher in the placebo group 3.96±9.5 vs. 3.13±3.1 (P=0.02). No adverse event was recorded. This prospective, double-blind, randomized study showed that sedation using propofol PCS did not improve patients' satisfaction during diagnostic cerebral angiography. Therefore, an anesthetist should be rapidly available on request but not necessarily present during the whole procedure. Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

  20. Acceptance and commitment therapy for anxious children and adolescents: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Swain, Jessica; Hancock, Karen; Dixon, Angela; Koo, Siew; Bowman, Jenny

    2013-05-15

    Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based acceptance and commitment therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (acceptance and commitment therapy, cognitive behavior therapy or waitlist control). Those in the acceptance and commitment therapy and cognitive behavior therapy groups will receive 10 × 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the cognitive behavior therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation. To the best of our knowledge, this study will be the largest trial of acceptance and commitment therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of acceptance and commitment therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of cognitive behavior therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently implemented widely in contemporary

  1. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

    Science.gov (United States)

    Hochstenbach, Laura M J; Courtens, Annemie M; Zwakhalen, Sandra M G; van Kleef, Maarten; de Witte, Luc P

    2015-05-19

    Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting. This study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS≥4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be

  2. Pain management using Han's acupoint nerve stimulator combined with patient-controlled analgesia following neurosurgery A randomized case control study

    Institute of Scientific and Technical Information of China (English)

    Junming Ye; Zuyu Zhu; Cheng Huang; Jun Wei

    2008-01-01

    BACKGROUND:Han's acupoint ncwve stimulator(HANS)has been frequently used to relieve pain by promoting the central ncrvve system's release of endogenous opioid peptides through electric stimulation to the body surface.OBJECTIVE:To investigate the pain-relieving effects of HANS,combined with patient-controlled analgesia,following neurosurgery,and to observe adverse reactions and effects.DESIGN,TIME AND SETTING:A randomized centrel observation was performed at the Department of Neurology in the First Affiliated Hospital of Gannan MeScal College(Ganzhou,Jiangxi Province,China)from January 2005 to February 2006.PARTICIPANTS:Forty patients,who were selected for craniotomy and required pain relief following surgery at the Department of Neurology in the First Affiliated Hospital of Garman Medical College(China),were included in this study.METHODS:Forty patients underwent neurosurgery and were randomly divided into two groups:patient-controlled analgesia plus HANS(+HANS,n=20)and patient-controlled analgesia(-HANS,n=20).Both groups were well matched in baseline data.Automatic syringe infusion pump ZZB-150 was the product of Nantong Aipeng Medical Instruments Co.,Ltd.(China).Patient-controlled analgesia consisted of 100 mL 0.02% lappaconitine/0.02% metoclopramide.LH-402 HANS instrument was produced in Beijing(China),with a serial number of 402183.The HANS instrumentation was used to stimulate the Hegu-Laogong acupoint on one side and Jiaogan,Shenmen penetrating Shen,Waifei,Naogan penetrating Pizhixia ear acupoints on the affected side for one hour,with 2-hour intervals.The disperse-dense wave was alternating,with a 2/100 Hz frequency of dectrical stimulation.MAIN OUTCOME MEASURE:The scores of visual analogue scale and incidence of adverse reaction were observed in two groups following surgery.RESULTS:Compared with the-HANS group,the visual analogue scale scores were remarkably lower in the+HANS group six hours after surgery(P<0.01),and the incidence rate of adverse reactions

  3. Population-based tobacco treatment: study design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Steven S

    2012-03-01

    Full Text Available Abstract Background Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1 Assess the effect of a proactive care intervention (PRO on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment and on utilization of tobacco treatment compared to reactive/usual care (UC among a diverse population of smokers, (2 Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3 Determine the cost-effectiveness of the proactive care intervention. Methods/Design This prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA electronic medical record health factor dataset. The proactive care intervention combines: (1 proactive outreach and (2 offer of choice of smoking cessation services (telephone or face-to-face. Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA

  4. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

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    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  5. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study.

    Science.gov (United States)

    Gajecki, Mikael; Berman, Anne H; Sinadinovic, Kristina; Rosendahl, Ingvar; Andersson, Claes

    2014-07-02

    Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students. Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks. Among 28574 students offered participation, 4823 agreed to join; 415 were excluded due to incomplete data, and 1932 fulfilled eligibility criteria for randomization. Attrition was 22.7-39.3 percent, higher among heavier drinkers and highest in Group 2. Self-reported app use was higher in Group 1 (74%) compared to Group 2 (41%). Per-protocol analyses revealed only one significant time-by-group interaction, where Group 1 participants increased the frequency of their drinking occasions compared to controls (p = 0.001). Secondary analyses by gender showed a significant difference among men in Group 1 for frequency of drinking occasions per week (p = 0.001), but not among women. Among all participants, 29 percent showed high-risk drinking, over the recommended weekly drinking levels of 9 (women) and 14 (men) standard glasses. Smartphone apps can make brief interventions available to large numbers of university students. The apps studied using eBAC calculation did not, however, seem to affect alcohol consumption among

  6. Cerebral Hemodynamics With rTMS in Alcohol Dependence: A Randomized, Sham-Controlled Study.

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    Mishra, Biswa Ranjan; Maiti, Rituparna; Nizamie, S Haque

    2016-04-08

    The authors studied cerebral hemodynamics in alcohol dependence and evaluated their changes with application of high-frequency rTMS. A prospective, single-blind, randomized, parallel-group, sham-controlled clinical study was conducted with patients with alcohol dependence (DSM-IV-TR). The study population comprised 25 subjects each in active rTMS, sham rTMS, and healthy control groups. At baseline, cerebral hemodynamic indices were measured with transcranial Doppler sonography. Subjects in the active rTMS group received 10 sessions of rTMS daily; the sham group was administered sham rTMS with the same parameters. Cerebral hemodynamic parameters were repeated 5 minutes after the last rTMS session. At baseline, mean velocity (MV) of both middle cerebral artery (MCA; R-MCA: p=0.003; L-MCA: p=0.002) and anterior cerebral artery (ACA; R-ACA: p=0.003; L-ACA: p=.001) was significantly reduced. Pulsatility index (PI) of MCA (prTMS group, except L-MCA PI, significant differences were observed in values of MV, PI, and RI of both MCA and ACA following rTMS intervention; such changes were not evident in the sham rTMS group. The changes in mean difference in MV of L-MCA (p=0.006) and L-ACA (p=0.015) were statistically significant in the active rTMS group, in comparison with the sham group. Significant differences were also observed between the two groups postintervention, in RI of L-MCA (p=0.001) and ACA (R-ACA: p=0.010; L-ACA: p=0.015). Alcohol dependence may result in altered cerebral hemodynamic parameters, which can be improved with high-frequency rTMS application.

  7. Lifestyle intervention for gestational diabetes mellitus prevention: A cluster-randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    Shuang Wang; Jing-Mei Ma; Hui-Xia Yang

    2015-01-01

    Objective: The study was to examine whether gestational diabetes mellitus (GDM) can be prevented by early trimester lifestyle counseling in a high-risk population.Methods: From September 2012 to January 2013, 1664 pregnancies in the Department of Obstetrics and Gynecology of First Hospital of Peking University were enrolled in the study during their first prenatal care visit before the 8 gestational weeks visit and asked to fill out a questionnaire on GDM risk evaluation.According to the questionnaire and medical records, those with at least one risk factor of GDM were included in the intervention study and randomly allocated to two groups, intervention group and control group.Routine prenatal care was offered, while standardized two-step lifestyle intervention was provided to the intervention group during 6-8 gestational weeks, and at 12-13 gestational weeks, enforcement intervention based on maternal anthropometrics were offered.Both groups were followed until 75 g oral glucose tolerance test (OGTT) testing at 24-28 gestational weeks.The weight gain after intervention and the prevalence of GDM were used to evaluate the effect.Results: (1) According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, the positive rate of GDM for the intervention group was 17.16% (23/134), lower than the control group which was 23.91% (33/138), P =0.168.(2) The weight gain during the first and second trimester for the intervention group was (1.38 ± 2.34) kg and (5.51 ± 2.18) kg, lower than in the control group which was (1.41 ± 2.58) kg and (5.66 ± 2.25) kg, (P =0.905, P =0.567).(3) Positive rate of GDM for those fasting plasma glucose (FPG) ≥5.1 mmol/L during early pregnancy was 11/36 (30.55%) for the intervention group that was lower than 17/37 (45.95%) for the control group, but the statistical difference was not significant (P =0.076).Conclusion: The positive rate of GDM could be reduced by a certain amount lifestyle

  8. A neurocognitive approach for recovering upper extremity movement following subacute stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Sallés, Laia; Martín-Casas, Patricia; Gironès, Xavier; Durà, María José; Lafuente, José Vicente; Perfetti, Carlo

    2017-04-01

    [Purpose] This study aims to describe a protocol based on neurocognitive therapeutic exercises and determine its feasibility and usefulness for upper extremity functionality when compared with a conventional protocol. [Subjects and Methods] Eight subacute stroke patients were randomly assigned to a conventional (control group) or neurocognitive (experimental group) treatment protocol. Both lasted 30 minutes, 3 times a week for 10 weeks and assessments were blinded. Outcome measures included: Motor Evaluation Scale for Upper Extremity in Stroke Patients, Motricity Index, Revised Nottingham Sensory Assessment and Kinesthetic and Visual Imagery Questionnaire. Descriptive measures and nonparametric statistical tests were used for analysis. [Results] The results indicate a more favorable clinical progression in the neurocognitive group regarding upper extremity functional capacity with achievement of the minimal detectable change. The functionality results are related with improvements on muscle strength and sensory discrimination (tactile and kinesthetic). [Conclusion] Despite not showing significant group differences between pre and post-treatment, the neurocognitive approach could be a safe and useful strategy for recovering upper extremity movement following stroke, especially regarding affected hands, with better and longer lasting results. Although this work shows this protocol's feasibility with the panel of scales proposed, larger studies are required to demonstrate its effectiveness.

  9. Luteal Phase Support in the Intrauterine Insemination (IUI Cycles: A Randomized Double Blind, Placebo Controlled Study.

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    Batool Hossein Rashidi

    2014-12-01

    Full Text Available To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG, in sub fertile couples.This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They underwent ovarian stimulation with clomiphene citrate (100 mg and hMG (75 IU in preparation for the IUI cycle. Study group (n = 127 received luteal phase support in the form of vaginal progesterone (400 mg twice a day, and control group (n = 126 received placebo. Clinical pregnancy and abortion rates were assessed and compared between the two groups.The clinical pregnancy rate was not significantly higher for supported cycles than that for the unsupported ones (15.75% vs. 12.69%, p = 0.3. The abortion rate in the patients with progesterone luteal support compared to placebo group was not statistically different (10% vs. 18.75%, p = 0.45.It seems that luteal phase support with vaginal progesterone was not enhanced the success of IUI cycles outcomes, when clomiphene citrate and hMG were used for ovulation stimulation.

  10. Combining emotion regulation and mindfulness skills for preventing depression relapse: a randomized-controlled study.

    Science.gov (United States)

    Elices, Matilde; Soler, Joaquim; Feliu-Soler, Albert; Carmona, Cristina; Tiana, Thais; Pascual, Juan C; García-Palacios, Azucena; Álvarez, Enric

    2017-01-01

    Dialectical behavioral therapy (DBT) skills have become increasingly used to treat several psychiatric conditions, including major depressive disorder (MDD). The aim of the study was to investigate the efficacy of an intervention that combines emotion regulation and mindfulness skills of DBT to prevent depression relapse/recurrence. A total of 75 individuals (79% females; mean age, 52 years) with a diagnosis of MDD in complete or partial remission were recruited. Participants were randomly allocated either to an intervention combining emotion regulation and mindfulness skills (ER + M group, n = 37) or to a psychoeducative program (n = 38). After the 10-week treatment period, participants were followed for 1 year. Analyses were run in per-protocol (PP) and intention-to-treat (ITT) samples. The primary outcome measure was time to depression relapse/recurrence. ER + M training was not more effective than the control intervention in preventing depression relapse. However, PP and ITT analyses showed that participants trained in ER + M presented a significant reduction in depressive symptoms and overall psychopathology. Based on the PP and ITT analyses, neither of the interventions were related with an increase in dispositional mindfulness. More studies are needed to confirm the efficacy of ER + M to decrease depressive symptoms and overall psychopathology. NCT02747134. Registered on 20 April 2016.

  11. A randomized controlled clinical study evaluating the efficacy of two desensitizing dentifrices.

    Science.gov (United States)

    Salian, Sowmya; Thakur, Srinath; Kulkarni, Sudhindra; LaTorre, Guy

    2010-01-01

    The primary aim of this study was to compare the in vivo efficacy and safety of dentifrices containing either 5% NovaMin or 5% potassium nitrate, and a non-desensitizing dentifrice, on dentin hypersensitivity in a four-week, double-blind clinical study among a population in south India. In addition, a companion scanning electron microscopy evaluation was performed to demonstrate whether or not the test products occlude open dentin tubules in vitro. Thirty volunteers with tooth sensitivity were recruited, and a double-blind, randomized, parallel, controlled clinical trial was conducted in a hospital setting. Clinical evaluation for dentin hypersensitivity was done using tactile, air blast, and cold water methods. Following baseline measures, subjects were randomly divided into three groups and treated as follows: Group A--dentifrice containing 5% potassium nitrate; Group B--dentifrice containing 5% NovaMin; and Group C--dentifrice containing no desensitizing ingredients. Clinical evaluations were repeated after two and four weeks of product use. Compared to baseline, there was a significant decrease in dentin hypersensitivity in Groups A and B following four weeks' use of the dentifrice containing 5% potassium nitrate and the dentifrice containing 5% calcium sodium phosphosilicate (NovaMin), respectively. There was a statistically greater reduction in hypersensitivity at both two and four weeks following use of the dentifrice containing NovaMin compared with the use of a non-desensitizing dentifrice, as well as the dentifrice containing potassium nitrate. Air and cold water scores were significantly lower following four weeks' use of the potassium nitrate dentifrice compared to the non-desensitizing dentifrice. Tubule occlusion was observed in the companion in vitro study following treatment with 5% NovaMin, but not after treatment with the 5% potassium nitrate or non-desensitizing dentifrices. The results suggest that the dentifrice containing 5% NovaMin occludes

  12. CONTROLLED HYPOTENSIVE ANAESTHESIA WITH DEXMEDETOMIDINE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY: A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY

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    Sunil

    2014-08-01

    Full Text Available : OBJECTIVE: Controlled hypotension is commonly used to achieve a bloodless operative field which is needed for successful FESS. This study was carried out to assess the hypotensive effect of dexmedetomidine (DEX during FESS. METHODS: Fifty ASA grades I and II patients of either sex aged 20–50 years undergoing FESS were randomly divided into two groups of 25 each. Group D received 10–15 min prior to induction of anesthesia 1 μg/kg IV bolus DEX diluted in 10 ml of normal saline over 10 min. Immediately thereafter an infusion of 0.4 μg/kg/hr of DEX commenced. Group C received placebo bolus and infusion of saline at a rate similar to DEX in Group D. Standard anesthetic technique was used. The surgical field was assessed using Average Category Scale and average blood loss was calculated. Hemodynamic variables (MAP and HR; emergence time and total recovery from anesthesia (Aldrete score ≥9 were recorded. RESULT: Group D reached the desired MAP (55-65 mmHg. In group D patients the average MAP was 55.9±5.3 mm of Hg, where as in group C it was 86.2±11.4 mm of Hg. Patients in group D had a better surgical field, and the duration of surgery was significantly reduced(78.34±16.7mins in group D vs 103.2±113.1 mins in group C The mean awakening time was significantly reduced in patients of Group D (9.1±2.7 mins in group D vs12.8±2.2 mins in group C when compared to patients of Group C. CONCLUSION: This study demonstrated that dexmedetomidine is a safe agent for controlled hypotension and is effective in providing ideal surgical field during FESS.

  13. Low Intensity laser therapy in patients with burning mouth syndrome: a randomized, placebo-controlled study

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    Norberto Nobuo SUGAYA

    Full Text Available Abstract The aim of this study was to assess the effectiveness of low intensity laser therapy in patients with Burning Mouth Syndrome (BMS. Thirty BMS subjects were randomized into two groups – Laser (LG and Placebo (CG. Seven patients dropped out, leaving 13 patients in LG and 10 patients in CG. Each patient received 4 irradiations (laser or placebo twice a week, for two consecutive weeks (blinded to the type of irradiation received. Infrared laser (AsGaAI irradiations were applied to the affected mucosa in scanning mode, wavelength of 790 nm, output power of 20 mW and fluence of 6 J/cm2. A visual analogue scale (VAS was used to assess the therapeutic effect before and after each irradiation, and at all the control time periods: 7, 14, 30, 60 and 90 days after the last irradiation. One researcher delivered irradiation and another recorded the results. Both researchers were blinded, the first to the results, and the second to the type of radiation applied. The results were categorized according to the percentage of symptom level variation, and showed a statistically better response in LG in only two categories of the control checkpoints (p=0.02; Fisher’s Exact Test. According to the protocol used in this study, low intensity laser therapy is as beneficial to patients with BMS as placebo treatment, indicating a great emotional component of involvement in BMS symptomatology. Nevertheless, there were positive results in some statistical analyses, thus encouraging further research in BMS laser therapy with other irradiation parameters.

  14. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

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    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823

  15. A 15-year randomized controlled study of a reduced shrinkage stress resin composite.

    Science.gov (United States)

    van Dijken, Jan W V; Lindberg, Anders

    2015-09-01

    The aim of this randomized controlled study was to evaluate the long term effectiveness of a reduced shrinkage stress resin composite in Class II restorations. The material was compared intra-individually with a microhybrid resin composite. Each of 50 patients with at least one pair of two similar sized Class II cavities participated (22 female, 28 male, mean age 43 years, range 18-64). Each participant received in each pair, in a randomized way, one Class II restoration performed with a reduced shrinkage stress resin composite (InTen-S) and the other restoration with a microhybrid resin composite restoration (Point 4). Both restorations were placed with an etch-and-rinse bonding system and an oblique layering technique. A total of 106 restorations, 33 premolar and 73 molars, were placed. The restorations were evaluated blindly each year using modified USPHS criteria. The overall performance of the experimental restorations was tested after intra-individual comparison using the Friedmańs two-way analysis of variance test. The hypothesis was rejected at the 5% level. At 15 years, 91 restorations were evaluated. The drop out frequency was 15 restorations (5 male, 3 female participants; 2 premolar and 13 molar restorations). Except for 2 participants, who reported slight symptoms during a few weeks after placement, no post-operative sensitivity was observed at the recalls. The overall success rate at 15 years was 77%. Twenty-one non acceptable restorations were observed during the 15 years follow up, 10 InTen-S (21.7%) and 11 Point 4 (24.4%) restorations (p>0.05). Annual failure rates for the resin composites were 1.5% and 1.6%, respectively. The main reasons for failure were secondary caries (8) and resin composite fracture (7). The differences between premolar vs. molar restorations and between restorations in male vs. female participants were not significant. Significant differences were observed between 2-surface vs. 3-surface restorations. During the 15-year

  16. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

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    Bou Christophe

    2009-08-01

    Full Text Available Abstract Background Periodontitis is a common, chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth. Epidemiological studies have consistently shown increased frequency, extent and severity of periodontitis among diabetic adults. More recently, some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients. However current evidence does not provide sufficient information on which to confidently base any clinical recommendations. The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis. Methods The DIAPERIO trial is an open-label, 13-week follow-up, randomized, controlled trial. The total target sample size is planned at 150 participants, with a balanced (1:1 treatment allocation (immediate treatment vs delayed treatment. Periodontal treatment will include full mouth non-surgical scaling and root planing, systemic antibiotherapy, local antiseptics (chlorhexidine 0.12% and oral health instructions. The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks' follow-up. Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups. Discussion The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis. The results of this trial will help to provide evidence-based recommendations for clinicians and a draft framework for designing national health policies. Trial registration Current Controlled Trials ISRCTN15334496

  17. Working Memory Training in Post-Secondary Students with ADHD: A Randomized Controlled Study

    OpenAIRE

    Karizma Mawjee; Steven Woltering; Rosemary Tannock

    2015-01-01

    Objectives To determine whether standard-length computerized training enhances working memory (WM), transfers to other cognitive domains and shows sustained effects, when controlling for motivation, engagement, and expectancy. Methods 97 post-secondary students (59.8% female) aged 18–35 years with Attention-Deficit/Hyperactivity Disorder, were randomized into standard-length adaptive Cogmed WM training (CWMT; 45-min/session), a shortened-length adaptive version of CWMT (15 min/session) that c...

  18. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers

    Science.gov (United States)

    Pickering, Gisèle; Macian, Nicolas; Dubray, Claude; Pereira, Bruno

    2016-01-01

    Background Acetaminophen (APAP, paracetamol) mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467) was carried out from May 30, 2011 to July 12, 2011. Methods Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature), and a battery of cognitive tests were recorded before and after oral APAP (2 g) or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05). Spatial planning and working memory initial thinking time were decreased (P=0.04). All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01) and body temperature did not change. Conclusion This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance and antinociception are independent of APAP effect on thermogenesis. We suggest that cognitive performance mirrors the analgesic rather than thermic cascade of events, with possibly a central role for serotonergic and cannabinoid systems that need to be explored further in the context of pain and cognition. PMID:27980393

  19. SPINAL ANAESTHESIA VERSUS GENERAL ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY - A PROSPECTIVE RANDOMIZED CONTROLLED STUDY

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    Prasad

    2014-02-01

    Full Text Available INTRODUCTION: Combining minimal invasive surgical and lesser invasive anesthesia technique reduces morbidity and mortality. The aim of the study is to compare spinal anesthesia with the gold standard general anesthesia for elective laparoscopic cholecystectomy. MATERIALS & METHODS: 60 healthy patients were randomized under spinal anesthesia (n=30 & General Anesthesia (n=30 . Hyperbaric 3ml bupivacaine plus 25mcg fenta nyl was administered for spinal group and conventional general anesthesia for GA group. Intraoperative parameters and post - operative pain and recovery were noted. Under spinal group any intraoperative discomfort were taken care by reassurance , drugs or con verted to GA. Questionnaire forms were provided for patients and surgeons to comment about the operation. RESULTS: None of the patients had significant hemodynamic and respiratory disturbance except for transient hypotension and bradycardia. Operative time was comparable. 6patients under spinal anesthesia had right shoulder pain , 2 patients were converted to GA and 4 patients were managed by injection midazolam and infiltration of lignocaine over the diaphragm. There was significant post - operative pain reli ef in spinal group. All the patients were comfortable and surgeons satisfied. CONCLUSION: Spinal anesthesia is adequate and safe for laparoscopic cholecystectomy in otherwise healthy patients and offers better postoperative pain control than general anesth esia without limiting recovery , but require cooperative patient , skilled surgeon , a gentle surgical technique and an enthusiastic anesthesiologist

  20. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

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    Andrew J. Butler

    2015-01-01

    Full Text Available Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP, would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14 were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control. SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control. This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.

  1. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Science.gov (United States)

    Butler, Andrew J.; Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.

    2015-01-01

    Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287

  2. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study

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    Drachmann Tue

    2011-06-01

    Full Text Available Abstract Background Phytanic acid produced in ruminants from chlorophyll may have preventive effects on the metabolic syndrome, partly due to its reported RXR and PPAR- α agonist activity. Milk from cows fed increased levels of green plant material, contains increased phytanic acid concentrations, but it is unknown to what extent minor increases in phytanic acid content in dairy fat leads to higher circulating levels of phytanic acid in plasma of the consumers. Objective To investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human. Design In a double-blind, randomized, 4 wk, parallel intervention study 14 healthy young subjects were given 45 g milk fat/d from test butter and cheese with 0.24 wt% phytanic acid or a control diet with 0.13 wt% phytanic acid. Difference in phytanic acid was obtained by feeding roughage with low or high content of chlorophyll. Results There tended to be a difference in plasma phytanic acid (P = 0.0730 concentration after the dietary intervention. Plasma phytanic acid increased significantly within both groups with the highest increase in control group (24% compared to phytanic acid group (15%. There were no significant effects of phytanic acid on risk markers for the metabolic syndrome. Conclusions The results indicate that increased intake of dairy fat modify the plasma phytanic acid concentration, regardless of cows feeding regime and the minor difference in dietary phytanic acid. Whether the phytanic acid has potential to affects the risk markers of the metabolic syndrome in human still remain to be elucidated. Trial Registration ClinicalTrials.gov: NCT01343576

  3. Intervention effects on adolescent physical activity in the multicomponent SPACE study: a cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mette Toftager

    Full Text Available BACKGROUND: Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents' physical activity (PA, yet there is not consistent evidence to guide non-curricular and school environment interventions. The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention, designed to reduce the age-related decline in PA among adolescents. METHODS: A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools. Baseline measurements were carried out in spring 2010 with 2 years of follow-up. A total of 1,348 students (11-13 years, in grade 5 and 6 enrolled in the study at baseline. The 14 schools included in the study were located in the Region of Southern Denmark. The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components. The primary outcome measure was overall PA (cpm, counts per minute and was supported by analyses of time spent in MVPA, and time spent sedentary. Furthermore, a secondary outcome measure was PA in school time and during recess. PA was measured using accelerometer (Actigraph GT3X. RESULTS: A total of 797 students completed the trial and had valid accelerometer data. No significant difference was found for overall PA with an adjusted difference of -19.1 cpm (95% CI: -93, 53 or for school time activity with an adjusted difference of 6 cpm (95% CI: -73, 85. A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm. CONCLUSIONS: No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents. The intervention was positively associated with PA during school time and recess, however, with small estimates. Lack of effect on overall PA could be due to both program theory and different degrees of

  4. COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Ferguson GT

    2013-03-01

    Full Text Available Gary T Ferguson,1 Mo Ghafouri,2 Luyan Dai,2 Leonard J Dunn31Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Clinical Research of West Florida, Inc, Clearwater, FL, USABackground: Ipratropium bromide/albuterol Respimat inhaler (CVT-R was developed as an environmentally friendly alternative to ipratropium bromide/albuterol metered-dose inhaler (CVT-MDI, which uses a chlorofluorocarbon propellant.Objective: The objective of this study was to evaluate patient satisfaction, device usage, and long-term safety of CVT-R compared to CVT-MDI, and to the simultaneous administration of ipratropium bromide hydrofluoroalkane (HFA; I and albuterol HFA (A metered-dose inhalers as dual monotherapies (I + A.Design: This is a 48-week, open-label, randomized, active-controlled, parallel-group study (n = 470 comparing CVT-R to CVT-MDI and to I + A.Participants: Patients were at least 40 years of age, diagnosed with chronic obstructive pulmonary disease (COPD, and current or exsmokers.Interventions: Patients were randomized to receive: (1 CVT-R, one inhalation four times daily (QID; or (2 CVT-MDI, two inhalations QID; or (3 I + A two inhalations of each inhaler QID.Main measures: Patient Satisfaction and Preference Questionnaire (PASAPQ performance score (primary endpoint and adverse events.Key results: PASAPQ performance score was significantly higher (CVT-R versus CVT-MDI, 9.6; and CVT-R versus I + A, 6.2; both P < 0.001 when using CVT-R compared to CVT-MDI or I + A at all visits starting from week 3, while CVT-MDI and I + A treatment groups were similar. Time to first COPD exacerbation was slightly longer in the CVT-R group compared to the other treatment groups, although it did not reach statistical significance (CVT-R versus CVT-MDI, P = 0.57; CVT-R versus I + A, P = 0.22. Rates of withdrawal and patient refusal to continue treatment were lower in CVT-R compared with CVT

  5. Oxygen persufflation as adjunct in liver preservation (OPAL: Study protocol for a randomized controlled trial

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    Scherag Andre

    2011-10-01

    Full Text Available Abstract Background Early graft dysfunction due to preservation/reperfusion injury represents a dramatic event after liver transplantation. Enhancement of donor organ criteria, in order to cope with the ever increasing donor shortage, further increases graft susceptibility to ischemic alterations. Major parts of post-preservation injury, however, occur at the time of warm reperfusion but not during ischemic storage; successful reperfusion of ischemic tissue in turn depends on an adequate redox and intracellular signal homeostasis. The latter has been shown experimentally to be favorably influenced by oxygen persufflation within short time spans. Thus viability of marginally preserved liver grafts could still be augmented by transient hypothermic reconditioning even after normal procurement and static cold storage. The present study is aimed to confirm the conceptual expectations, that hypothermic reconditioning by gaseous oxygen persufflation is a useful method to suppress injurious cellular activation cascades and to improve post-ischemic recovery of marginally preserved liver grafts. Methods/Design OPAL is a prospective single center randomized proof of concept study, including two parallel groups in a total of 116 liver transplant patients. The effect of an in hospital treatment of the isolated liver graft by 2 hours of oxygen persufflation immediately prior to transplantation will be assesses as compared to standard procedure (cold storage without further intervention. The primary endpoint is the peak transaminase serum level (AST during the first three days after transplantation as a surrogate readout for parenchymal liver injury. Other outcomes comprise patient and graft survival, time of intensive care requirement, hepatic tissue perfusion 1h after revascularisation, early onset of graft dysfunction based on coagulation parameters, as well as the use of a refined scoring-system for initial graft function based on a multi-parameter (AST

  6. [Efficacy of glycopyrronium bromide and scopolamine hydrobromide in patients with death rattle: a randomized controlled study].

    Science.gov (United States)

    Likar, Rudolf; Rupacher, Ernst; Kager, Hans; Molnar, Mario; Pipam, Wofgang; Sittl, Reinhard

    2008-01-01

    Death rattle is an extremely distressing symptom for the dying patient and for his environment. The aim of this study was to assess the efficacy of glycopyrronium bromide as compared with scopolamine hydrobromide in alleviating death rattle in terminal cancer patients with cognitive impairment. In a randomized, controlled study design patients were allocated in two groups. Group A received scopolamine hydrobromide in a dose of 0.5 mg intravenously every 6 hours for a period of 12 hours, group B received glycopyrronium bromide 0.4 mg every 6 hours for a period of 12 hours. In addition, standardized sedatives were administered as required and the analgesic therapy continued either orally or, if necessary, subcutaneously or intravenously in equipotent doses. Every 2 hours death rattle was assessed and rated on a scale of 1 to 5 (1 = audible breathing noises, 5 = very severe rattling noises). In addition, restlessness and expressions of pain were assessed and rated on a scale of 1 to 3 (1 = mild, 2 = moderate, 3 = severe). 13 patients were included in the study, 7 patients were allocated to group A and 6 patients to group B. There were no significant differences in demographic data, age, weight and diagnosis distribution between the two groups. Group B demonstrated a significant reduction of death rattle in the first 12 hours (p = 0.029) in comparison to group A. There were no significant differences concerning the side effects (restlessness, expressions of pain) in both groups. Glycopyrronium bromide given in a dose of 0,4 mg every six hours demonstrated a significant reduction of death rattle compared to scopolamine hydrobromide. Concerning side effects (restlessness, expressions of pain) there was no difference between both substances.

  7. A Randomized Control Study of Instructional Approaches for Struggling Adult Readers

    Science.gov (United States)

    Greenberg, Daphne; Wise, Justin C.; Morris, Robin; Fredrick, Laura D.; Rodrigo, Victoria; Nanda, Alice O.; Pae, Hye K.

    2011-01-01

    This study measured the effectiveness of various instructional approaches on the reading outcomes of 198 adults who read single words at the 3.0 through 5.9 grade equivalency levels. The students were randomly assigned to one of the following interventions: Decoding and Fluency; Decoding, Comprehension, and Fluency; Decoding, Comprehension,…

  8. Lesson Study to Scale up Research-Based Knowledge: A Randomized, Controlled Trial of Fractions Learning

    Science.gov (United States)

    Lewis, Catherine; Perry, Rebecca

    2017-01-01

    An understanding of fractions eludes many U.S. students, and research-based knowledge about fraction, such as the utility of linear representations, has not broadly influenced instruction. This randomized trial of lesson study supported by mathematical resources assigned 39 educator teams across the United States to locally managed lesson study…

  9. Moderate alcohol consumption reduces plasma C-reactive protein and fibrinogen levels : a randomized, diet-controlled intervention study

    NARCIS (Netherlands)

    Sierksma, A.; Gaag, M.S. van der; Kluft, C.; Hendriks, H.F.J.

    2002-01-01

    Objective: To evaluate the effect of moderate alcohol consumption on the acute phase proteins C-reactive protein and fibrinogen. Design: Randomized, diet-controlled, cross-over study. Setting: The study was performed at TNO Nutrition and Food Research, Zeist, The Netherlands. Subjects: Ten middle-ag

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

    Science.gov (United States)

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

    2007-01-01

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

  11. The effect of infliximab, a monoclonal antibody against TNF-alpha, on disc herniation resorption - A randomized controlled study

    NARCIS (Netherlands)

    Autio, Reijo A.; Karppinen, Jaro; Niinimaki, Jaakko; Ojala, Risto; Veeger, Nic; Korhonen, Timo; Hurri, Heikki; Tervonen, Osmo

    2006-01-01

    Study Design. Randomized, controlled study. Objective. To evaluate the effect of infliximab on herniated nucleus pulposus (HNP) resorption. Summary of Background Data. Although the effects of tumor necrosis factor alpha (TNF-alpha) on HNP resorption are not fully understood, TNF-alpha appears to be

  12. The Effects of Improvisational Music Therapy on Joint Attention Behaviors in Autistic Children: A Randomized Controlled Study

    Science.gov (United States)

    Kim, Jinah; Wigram, Tony; Gold, Christian

    2008-01-01

    The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy and play sessions with toys, and using standardized…

  13. The Effects of Improvisational Music Therapy on Joint Attention Behaviors in Autistic Children: A Randomized Controlled Study

    Science.gov (United States)

    Kim, Jinah; Wigram, Tony; Gold, Christian

    2008-01-01

    The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy and play sessions with toys, and using standardized…

  14. Heart rate variability biofeedback in patients with alcohol dependence: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Penzlin AI

    2015-10-01

    Full Text Available Ana Isabel Penzlin,1 Timo Siepmann,2 Ben Min-Woo Illigens,3 Kerstin Weidner,4 Martin Siepmann4 1Institute of Clinical Pharmacology, 2Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 3Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; 4Department of Psychotherapy and Psychosomatic Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany Background and objective: In patients with alcohol dependence, ethyl-toxic damage of vasomotor and cardiac autonomic nerve fibers leads to autonomic imbalance with neurovascular and cardiac dysfunction, the latter resulting in reduced heart rate variability (HRV. Autonomic imbalance is linked to increased craving and cardiovascular mortality. In this study, we sought to assess the effects of HRV biofeedback training on HRV, vasomotor function, craving, and anxiety. Methods: We conducted a randomized controlled study in 48 patients (14 females, ages 25–59 years undergoing inpatient rehabilitation treatment. In the treatment group, patients (n=24 attended six sessions of HRV biofeedback over 2 weeks in addition to standard rehabilitative care, whereas, in the control group, subjects received standard care only. Psychometric testing for craving (Obsessive Compulsive Drinking Scale, anxiety (Symptom Checklist-90-Revised, HRV assessment using coefficient of variation of R-R intervals (CVNN analysis, and vasomotor function assessment using laser Doppler flowmetry were performed at baseline, immediately after completion of treatment or control period, and 3 and 6 weeks afterward (follow-ups 1 and 2. Results: Psychometric testing showed decreased craving in the biofeedback group immediately postintervention (OCDS scores: 8.6±7.9 post-biofeedback versus 13.7±11.0 baseline [mean ± standard deviation], P<0.05, whereas craving was unchanged at

  15. Virtual reality in the rehabilitation of the arm after hemiplegic stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Crosbie, J H; Lennon, S; McGoldrick, M C; McNeill, M D J; McDonough, S M

    2012-09-01

    To assess the feasibility of a trial to investigate the effectiveness of virtual reality-mediated therapy compared to conventional physiotherapy in the motor rehabilitation of the arm following stroke, and to provide data for a power analysis to determine numbers for a future main trial. Pilot randomized controlled trial. Clinical research facility. Eighteen people with a first stroke, 10 males and 8 females, 7 right and 2 left side most affected. Mean time since stroke 10.8 months. Participants were randomized to a virtual reality group or a conventional arm therapy group for nine sessions over three weeks. The upper limb Motricity Index and the Action Research Arm Test were completed at baseline, post intervention and six weeks follow-up. Outcome data were obtained from 95% of participants at the end of treatment and at follow-up: one participant withdrew. Compliance was high; only two people reported side-effects from virtual reality exposure. Both groups demonstrated small (7-8 points on upper limb Motricity Index and 4 points on the Action Research Arm Test), but non-significant, changes to their arm impairment and activity levels. A randomized controlled trial of virtual reality-mediated therapy comparable to conventional therapy would be feasible, with some suggested improvements in recruitment and outcome measures. Seventy-eight participants (39 per group) would be required for a main trial.

  16. Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sturkenboom, Ingrid H W M; Graff, Maud J; Borm, George F; Adang, Eddy M M; Nijhuis-van der Sanden, Maria W G; Bloem, Bastiaan R; Munneke, Marten

    2013-02-02

    Occupational therapists may have an added value in the care of patients with Parkinson's disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson's disease. A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson's disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as

  17. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: a Multi-Center, Randomized, Controlled Study

    Science.gov (United States)

    Talley, Nicholas J.; Locke, G. Richard; Saito, Yuri A.; Almazar, Ann E.; Bouras, Ernest P.; Howden, Colin W.; Lacy, Brian E.; DiBaise, John K.; Prather, Charlene M.; Abraham, Bincy P.; El-Serag, Hashem B.; Moayyedi, Paul; Herrick, Linda M.; Szarka, Lawrence A.; Camilleri, Michael; Hamilton, Frank A.; Schleck, Cathy D.; Tilkes, Katherine E.; Zinsmeister, Alan R.

    2015-01-01

    Background & Aims Anti-depressants are frequently prescribed to treat functional dyspepsia (FD), a common disorder characterized by upper abdominal symptoms, including discomfort or post-prandial fullness. However, there is little evidence for the efficacy of these drugs in patients with FD. We performed a randomized, double-blind, placebo-controlled trial to evaluate the effects of anti-depressant therapy effects on symptoms, gastric emptying (GE), and mealinduced satiety in patients with FD. Methods We performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use anti-depressants. Subjects (n=292; 44±15 y old, 75% female, 70% with dysmotility-like FD, and 30% with ulcer-like FD) were randomly assigned to groups given placebo, 50 mg amitriptyline, or 10 mg escitalopram for 10 weeks. The primary endpoint was adequate relief of FD symptoms for ≥5 weeks of the last 10 weeks (out of 12). Secondary endpoints included GE time, maximum tolerated volume in a nutrient drink test, and FD-related quality of life. Results An adequate relief response was reported by 39 subjects given placebo (40%), 51 given amitriptyline (53%), and 37 given escitalopram (38%) (P=.05, following treatment, adjusted for baseline balancing factors including all subjects). Subjects with ulcer-like FD given amitriptyline were more than 3-fold more likely to report adequate relief than those given placebo (odds ratio=3.1; 95% confidence interval, 1.1–9.0). Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10 week period in any group. Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE (odds ratio=0.4; 95% confidence interval, 0.2–0.8). Both anti-depressants improved overall quality-of-life. Conclusions Amitriptyline, but not escitalopram, appears to benefit some patients with FD— particularly those with ulcer-like (painful) FD. Patients

  18. Posterior bulk-filled resin composite restorations: A 5-year randomized controlled clinical study.

    Science.gov (United States)

    van Dijken, Jan W V; Pallesen, Ulla

    2016-08-01

    To evaluate in a randomized controlled study the 5-year clinical durability of a flowable resin composite bulk-fill technique in Class I and Class II restorations. 38 pairs Class I and 62 pairs Class II restorations were placed in 44 male and 42 female (mean age 52.4 years). Each patient received at least two, as similar as possible, extended Class I or Class II restorations. In all cavities, a 1-step self-etch adhesive (Xeno V+) was applied. Randomized, one of the cavities of each pair received the flowable bulk-filled resin composite (SDR), in increments up to 4mm as needed to fill the cavity 2mm short of the occlusal cavosurface. The occlusal part was completed with the nano-hybrid resin composite (Ceram X mono+). In the other cavity, the resin composite-only (Ceram X mono+) was placed in 2mm increments. The restorations were evaluated using slightly modified USPHS criteria at baseline and then yearly during 5 years. Caries risk and bruxing habits of the participants were estimated. No post-operative sensitivity was reported. At 5-year 183, 68 Class I and 115 Class II, restorations were evaluated. Ten restorations failed (5.5%), all Class II, 4 SDR-CeramX mono+ and 6 CeramX mono+-only restorations. The main reasons for failure were tooth fracture (6) and secondary caries (4). The annual failure rate (AFR) for all restorations (Class I and II) was for the bulk-filled-1.1% and for the resin composite-only restorations 1.3% (p=0.12). For the Class II restorations, the AFR was 1.4% and 2.1%, respectively. The stress decreasing flowable bulk-fill resin composite technique showed good durability during the 5-year follow-up. The use of a 4mm incremental technique with the flowable bulk-fill resin composite showed during the 5-year follow up slightly better, but not statistical significant, durability compared to the conventional 2mm layering technique in posterior resin composite restorations. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Improving ambulatory saliva-sampling compliance in pregnant women: a randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Julian Moeller

    Full Text Available OBJECTIVE: Noncompliance with scheduled ambulatory saliva sampling is common and has been associated with biased cortisol estimates in nonpregnant subjects. This study is the first to investigate in pregnant women strategies to improve ambulatory saliva-sampling compliance, and the association between sampling noncompliance and saliva cortisol estimates. METHODS: We instructed 64 pregnant women to collect eight scheduled saliva samples on two consecutive days each. Objective compliance with scheduled sampling times was assessed with a Medication Event Monitoring System and self-reported compliance with a paper-and-pencil diary. In a randomized controlled study, we estimated whether a disclosure intervention (informing women about objective compliance monitoring and a reminder intervention (use of acoustical reminders improved compliance. A mixed model analysis was used to estimate associations between women's objective compliance and their diurnal cortisol profiles, and between deviation from scheduled sampling and the cortisol concentration measured in the related sample. RESULTS: Self-reported compliance with a saliva-sampling protocol was 91%, and objective compliance was 70%. The disclosure intervention was associated with improved objective compliance (informed: 81%, noninformed: 60%, F(1,60  = 17.64, p<0.001, but not the reminder intervention (reminders: 68%, without reminders: 72%, F(1,60 = 0.78, p = 0.379. Furthermore, a woman's increased objective compliance was associated with a higher diurnal cortisol profile, F(2,64  = 8.22, p<0.001. Altered cortisol levels were observed in less objective compliant samples, F(1,705  = 7.38, p = 0.007, with delayed sampling associated with lower cortisol levels. CONCLUSIONS: The results suggest that in pregnant women, objective noncompliance with scheduled ambulatory saliva sampling is common and is associated with biased cortisol estimates. To improve sampling compliance, results suggest

  20. Confronting Fear Using Exposure and Response Prevention for Anorexia Nervosa: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Steinglass, Joanna E; Albano, Anne Marie; Simpson, H Blair; Wang, Yuanjia; Zou, Jingjing; Attia, Evelyn; Walsh, B. Timothy

    2014-01-01

    Objective Anorexia nervosa (AN) is a severe illness with high rates of relapse. Exposure and Response Prevention for AN (AN-EXRP) is a new approach that specifically addresses maladaptive eating behavior by targeting eating-related fear and anxiety. The aim of this study was to evaluate AN-EXRP as an adjunctive strategy to improve eating behavior during weight restoration, at a pivotal moment when treatment goals shift toward relapse prevention. Method A randomized controlled trial was conducted to compare AN-EXRP with a comparison condition, Cognitive Remediation Therapy (CRT). Hospitalized patients with AN (n=32) who had achieved weight restoration to a BMI > 18.5 kg/m2 received 12 sessions of either AN-EXRP or CRT. Outcome was assessed by change in caloric intake in an objective assessment of eating behavior. Results The average test meal caloric intake of participants who received AN-EXRP increased from 352±263 kcal at baseline to 401±215 kcal post-treatment, while that of participants who received CRT decreased from 501±232 kcal at baseline to 424±221 kcal post-treatment (t(28)=2.5, p=0.02). Improvement in intake was significantly associated with improvement in eating-related anxiety (Spearman’s ρ=0.40, p=0.03). Conclusions These data demonstrate that AN-EXRP, compared to a credible comparison intervention, is associated with better caloric intake in a laboratory meal over time in AN. Additional studies are required to determine whether incorporation of these techniques into a longer treatment program leads to enduring and clinically significant change. PMID:24488838

  1. Steroid injection and needle aponeurotomy for Dupuytren contracture: a randomized, controlled study.

    Science.gov (United States)

    McMillan, Catherine; Binhammer, Paul

    2012-07-01

    To compare flexion deformity at 6 months in patients with Dupuytren contracture who had percutaneous needle aponeurotomy (PNA) combined with a series of triamcinolone acetonide (TA) injections to that of patients who had PNA alone. Forty-seven patients with Dupuytren disease who were candidates for PNA (at least 1 contracture of at least 20°) participated in the study. Patients were randomized either to receive TA injections immediately following and 6 weeks and 3 months after the procedure or to receive no injections. Injections were administered into cords. The number of injections and the amount of TA per injection was determined based on the number of digits involved and the cord size. All subjects returned for 3 follow-up visits after the procedure, and contractures were measured using a goniometer. Change in total active extension deficit (TAED) was analyzed using a repeated measures analysis of variance to assess for differences between groups, time points, and interaction between group and time point. Descriptive statistics were calculated for all variables of interest. Continuous measures were summarized using means and standard deviations. There was no significant difference in TAED between groups before cord aponeurotomy. Correction at 6 months was 87% of preoperative TAED for the TA group versus 64% for the control group. This difference was statistically significant. The amount of TA administered did not correlate with TAED improvement. The study group who received TA in combination with PNA experienced a significantly greater degree of correction of flexion deformity at 6 months than those who had PNA alone. Copyright © 2012 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  2. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Rajni Gupta

    2013-01-01

    Full Text Available Background: Hyperbaric ropivacaine produce more reliable sensory and motor block, with faster onset, better quality of muscles relaxation than isobaric ropivacaine. So, this study was designed to compare the efficacy of hyperbaric ropivacaine with isobaric ropivacaine in patients undergoing lower abdominal surgery. Methods: A randomized controlled double blind study in two groups of patients. group A (n=35 received 3 ml of isobaric ropivacaine 6 mg/ml (18 mg. Group B (n=35 received 3 ml of hyperbaric ropivacaine 6 mg/ml (18 mg. The onset and duration of sensory block at dermatome level T10, maximum upper and lower spread of sensory block, intensity, and duration of motor block were recorded. Statistical Analysis: Block characteristics were compared using the two-tailed Mann - Whitney U-test. The proportion of side effects was compared using the Chi-square test. Results: The median time of onset of sensory block at the T10 dermatome was 4.4±1.3 min in group B and 6.0±1.03 min in group A. The median time to maximum block height was 16.7±3.7 min in group A and 12.03±1.96 min in group B. The median duration of complete motor recovery (B0 was significantly shorter in the heavy ropivacaine group (166.5±11.7 min compared with the isobaric ropivacaine group (192.9±9.6 min. Conclusions: Intrathecal hyperbaric ropivacaine provides more rapid, adequate, and good quality of sensory and motor block with rapid post-operative recovery as compare to isobaric ropivacaine.

  3. Change in Pulmonary Function after Incentive Spirometer Exercise in Children with Spastic Cerebral Palsy: A Randomized Controlled Study.

    Science.gov (United States)

    Choi, Ja Young; Rha, Dong-wook; Park, Eun Sook

    2016-05-01

    The aim of this study was to investigate the effect of incentive spirometer exercise (ISE) on pulmonary function and maximal phonation time (MPT) in children with spastic cerebral palsy (CP). Fifty children with CP were randomly assigned to two groups: the experimental group and the control group. Both groups underwent comprehensive rehabilitation therapy. The experimental group underwent additional ISE. The forced vital capacity (FVC), forced expiratory volume at one second (FEV₁), FEV₁/FVC ratio, peak expiratory flow (PEF), and MPT were assessed as outcome measures before and after 4 weeks of training. There were significant improvements in FVC, FEV₁, PEF, and MPT in the experimental group, but not in the control group. In addition, the improvements in FVC, FEV₁, and MPT were significantly greater in the experimental group than in the control group. The results of this randomized controlled study support the use of ISE for enhancing pulmonary function and breath control for speech production in children with CP.

  4. Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment

    OpenAIRE

    Allen, Jerilyn K.; Janna Stephens; Dennison Himmelfarb, Cheryl R.; Stewart, Kerry J.; Sara Hauck

    2013-01-01

    Background. The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology. Methods. The study randomized 68 obese adults to receive one of four interventions for six months: (1) intensive counseling intervention, (2) intensi...

  5. Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial.

    Science.gov (United States)

    Bryant, Amy G; Kamanga, Gift; Stuart, Gretchen S; Haddad, Lisa B; Meguid, Tarek; Mhango, Chisale

    2013-06-01

    This study aimed to evaluate the feasibility of conducting a randomized controlled trial of postpartum intrauterine device insertion and to demonstrate that the postpartum intrauterine device is acceptable to women. Women attending prenatal care at a maternity hospital in Lilongwe, Malawi were recruited into a trial comparing immediate (10 minutes to 48 hours) to 6 week postpartum insertion. Feasibility of recruiting and consenting 140 women and randomizing 70% of them was evaluated. Satisfaction with the intrauterine device was also assessed. One hundred fifteen women consented and 49 (61%) were randomized. Twenty-six women were assigned to immediate insertion, and 23 to insertion at 6 weeks postpartum. Thirty (24%) women received the device as part of the study protocol, and 28 (93%) had the device in place at 12 weeks postpartum. The intrauterine device is acceptable to some postpartum women in Malawi, but conducting a randomized clinical trial may not be feasible.

  6. The Anticoagulation of Calf Thrombosis (ACT project: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Horner Daniel

    2012-04-01

    Full Text Available Abstract Background Half of all lower limb deep vein thrombi (DVT in symptomatic ambulatory patients are located in the distal (calf veins. While proximal disease warrants therapeutic anticoagulation to reduce the associated risks, distal DVT often goes untreated. However, a proportion of untreated distal disease will undoubtedly propagate or embolize. Concern also exists that untreated disease could lead to long-term post thrombotic changes. Currently, it is not possible to predict which distal thrombi will develop such complications. Whether these potential risks outweigh those associated with unrestricted anticoagulation remains unclear. The Anticoagulation of Calf Thrombosis (ACT trial aims to compare therapeutic anticoagulation against conservative management for patients with acute symptomatic distal deep vein thrombosis. Methods ACT is a pragmatic, open-label, randomized controlled trial. Adult patients diagnosed with acute distal DVT will be allocated to either therapeutic anticoagulation or conservative management. All patients will undergo 3 months of clinical and assessor blinded sonographic follow-up, followed by 2-year final review. The project will commence initially as an external pilot study, recruiting over a 16-month period at a single center to assess feasibility measures and clinical event rates. Primary outcome measures will assess feasibility endpoints. Secondary clinical outcomes will be collected to gather accurate data for the design of a definitive clinical trial and will include: (1 a composite endpoint combining thrombus propagation to the popliteal vein or above, development of symptomatic pulmonary embolism or sudden death attributable to venous thromboembolic disease; (2 the incidence of major and minor bleeding episodes; (3 the incidence of post-thrombotic leg syndrome at 2 years using a validated screening tool; and (4 the incidence of venous thromboembolism (VTE recurrence at 2 years. Discussion The ACT trial

  7. Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome

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    Sternlieb Beth

    2011-01-01

    Full Text Available Abstract Introduction Irritable bowel syndrome affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms that can significantly impact quality of life and daily functioning. Emotional stress appears to exacerbate irritable bowel syndrome symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. For many sufferers, symptoms can be traced to childhood and adolescence, making the early manifestation of irritable bowel syndrome important to understand. The current study will focus on young people aged 14-26 years with irritable bowel syndrome. The study will test the potential benefits of Iyengar yoga on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, Iyengar yoga is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. An extensive and standardized teacher-training program support Iyengar yoga's reliability and safety. It is hypothesized that yoga will be feasible with less than 20% attrition; and the yoga group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements. Methods/Design Sixty irritable bowel syndrome patients aged 14-26 will be randomly assigned to a standardized 6-week twice weekly Iyengar yoga group-based program or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of irritable bowel syndrome symptoms, quality of life and global improvement at post-treatment and 2-month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized

  8. Exercise rehabilitation on home-dwelling patients with Alzheimer's disease - a randomized, controlled trial. Study protocol

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    Tilvis Reijo S

    2010-10-01

    Full Text Available Abstract Background Besides cognitive decline, Alzheimer's disease (AD leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. Methods During years 2008-2010, patients with AD (n = 210 living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1 tailored home-based exercise twice weekly 2 group-based exercise twice weekly in rehabilitation center 3 control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36. Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. Discussion To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. Trial registration ACTRN12608000037303

  9. Radon balneotherapy and physical activity for osteoporosis prevention: a randomized, placebo-controlled intervention study.

    Science.gov (United States)

    Winklmayr, Martina; Kluge, Christian; Winklmayr, Wolfgang; Küchenhoff, Helmut; Steiner, Martina; Ritter, Markus; Hartl, Arnulf

    2015-03-01

    Low-dose radon hyperthermia balneo treatment (LDRnHBT) is applied as a traditional measure in the non-pharmacological treatment of rheumatic diseases in Europe. During the last decades, the main approach of LDRnHBT was focused on the treatment of musculoskeletal disorders, but scientific evidence for the biological background of LDRnHBT is weak. Recently, evidence emerged that LDRnHBT influences bone metabolism. We investigated, whether combined LDRnHBT and exercise treatment has an impact on bone metabolism and quality of life in a study population in an age group at risk for developing osteoporosis. This randomized, double-blind, placebo-controlled trial comprised guided hiking tours and hyperthermia treatment in either radon thermal water (LDRnHBT) or radon-free thermal water (PlaceboHBT). Markers of bone metabolism, quality of life and somatic complaints were evaluated. Statistics was performed by linear regression and a linear mixed model analysis. Significant changes over time were observed for most analytes investigated as well as an improvement in self-assessed health in both groups. No significant impact from the LDRnHBT could be observed. After 6 months, the LDRnHBT group showed a slightly stronger reduction of the osteoclast stimulating protein receptor activator of nuclear kB-ligand compared to the PlaceboHBT group, indicating a possible trend. A combined hyperthermia balneo and exercise treatment has significant immediate and long-term effects on regulators of bone metabolism as well as somatic complaints. LDRnHBT and placeboHBT yielded statistically equal outcomes.

  10. Outcome of Percutaneous Release of Tennis Elbow: A Non-Randomized Controlled Trial Study

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    Khatri, Kishor; Kharel, Krishna; Byanjankar, Subin; Shrestha, Rahul; Sharma, Jay R; Vaishya, Raju; Agarwal, Amit kumar; Vijay, Vipul

    2017-01-01

    Background Tennis elbow is a common disorder of the upper extremity. It can be treated conservatively in the majority of patients, but some resistant cases eventually can be treated by percutaneous release with good functional outcome. Materials and methods This non-randomized control trial was conducted at the Department of Orthopaedics Surgery in a tertiary care hospital from July 2015 to June 2016 on 50 patients who underwent percutaneous release of the common extensor origin using an 18 gauge hypodermic needle. These patients did not respond to conservative treatment including rest, nonsteroidal anti-inflammatory drugs (NSAIDS) and local steroid injections. The outcome was graded as Excellent, Good, Fair, and Poor. Results Fifty patients (50 elbows) were included in the study. Thirty-two patients were female (64%), and 18 were male (36%). The right side was affected in 37 patients (74%) and left side in 13 (26%). The time taken to achieve a completely pain-free elbow ranged from one day to two months (average of 26.2 days). Those who did not achieve a pain-free elbow had a residual pain of 1.5 to six on the visual analogue scale (VAS) (average 2.32). Excellent outcome was noticed in 24 patients (48%); Good result in eight patients (36% ); Fair in four patients (eight percent) and Poor in four patients (eight percent). Conclusion Tennis elbow probably results from the degenerative tear of the common extensor origin, and a percutaneous tenotomy using an 18 gauge hypodermic needle is a simple, safe, patient-friendly, efficient, and easily reproducible method of treating tennis elbow in those who are resistant to conservative treatment, and it can be done as an outpatient procedure. PMID:28168130

  11. Hypnosis can reduce pain in hospitalized older patients: a randomized controlled study.

    Science.gov (United States)

    Ardigo, Sheila; Herrmann, François R; Moret, Véronique; Déramé, Laurence; Giannelli, Sandra; Gold, Gabriel; Pautex, Sophie

    2016-01-15

    Chronic pain is a common and serious health problem in older patients. Treatment often includes non pharmacological approaches despite a relatively modest evidence base in this population. Hypnosis has been used in younger adults with positive results. The main objective of this study was to measure the feasibility and efficacy of hypnosis (including self hypnosis) in the management of chronic pain in older hospitalized patients. A single center randomized controlled trial using a two arm parallel group design (hypnosis versus massage). Inclusion criteria were chronic pain for more than 3 months with impact on daily life activities, intensity of > 4; adapted analgesic treatment; no cognitive impairment. Brief pain inventory was completed. Fifty-three patients were included (mean age: 80.6 ± 8.2--14 men; 26 hypnosis; 27 massage. Pain intensity decreased significantly in both groups after each session. Average pain measured by the brief pain index sustained a greater decrease in the hypnosis group compared to the massage group during the hospitalisation. This was confirmed by the measure of intensity of the pain before each session that decreased only in the hypnosis group over time (P = 0.008). Depression scores improved significantly over the time only in the hypnosis group (P = 0.049). There was no effect in either group 3 months post hospitals discharge. Hypnosis represents a safe and valuable tool in chronic pain management of hospitalized older patients. In hospital interventions did not provide long term post discharge relief. ISRCTN15615614; registered 2/1/2015.

  12. Efficacy of the LiSN & Learn Auditory Training Software: randomized blinded controlled study

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    Sharon Cameron

    2012-01-01

    Full Text Available Background: Children with a spatial processing disorder (SPD require a more favorable signal-to-noise ratio in the classroom because they have difficulty perceiving sound source location cues. Previous research has shown that a novel training program - LiSN & Learn - employing spatialized sound, overcomes this deficit. Here we investigate whether improvements in spatial processing ability are specific to the LiSN & Learn training program. Materials and methods: Participants were ten children (aged between 6;0 [years;months] and 9;9 with normal peripheral hearing who were diagnosed as having SPD using the Listening in Spatialized Noise – Sentences Test (LISN-S. In a blinded controlled study, the participants were randomly allocated to train with either the LiSN & Learn or another auditory training program – Earobics - for approximately 15 minutes per day for twelve weeks. Results: There was a significant improvement post-training on the conditions of the LiSN-S that evaluate spatial processing ability for the LiSN & Learn group (p=0.03 to 0.0008, η2=0.75 to 0.95, n=5, but not for the Earobics group (p=0.5 to 0.7, η2=0.1 to 0.04, n=5. Results from questionnaires completed by the participants and their parents and teachers revealed improvements in real-world listening performance post-training were greater in the LiSN & Learn group than the Earobics group. Conclusions: LiSN & Learn training improved binaural processing ability in children with SPD, enhancing their ability to understand speech in noise. Exposure to non-spatialized auditory training does not produce similar outcomes, emphasizing the importance of deficit-specific remediation.

  13. Efficacy of the LiSN & Learn auditory training software: randomized blinded controlled study

    Directory of Open Access Journals (Sweden)

    Sharon Cameron

    2012-09-01

    Full Text Available Children with a spatial processing disorder (SPD require a more favorable signal-to-noise ratio in the classroom because they have difficulty perceiving sound source location cues. Previous research has shown that a novel training program - LiSN & Learn - employing spatialized sound, overcomes this deficit. Here we investigate whether improvements in spatial processing ability are specific to the LiSN & Learn training program. Participants were ten children (aged between 6;0 [years;months] and 9;9 with normal peripheral hearing who were diagnosed as having SPD using the Listening in Spatialized Noise - Sentences test (LiSN-S. In a blinded controlled study, the participants were randomly allocated to train with either the LiSN & Learn or another auditory training program - Earobics - for approximately 15 min per day for twelve weeks. There was a significant improvement post-training on the conditions of the LiSN-S that evaluate spatial processing ability for the LiSN & Learn group (P=0.03 to 0.0008, η 2=0.75 to 0.95, n=5, but not for the Earobics group (P=0.5 to 0.7, η 2=0.1 to 0.04, n=5. Results from questionnaires completed by the participants and their parents and teachers revealed improvements in real-world listening performance post-training were greater in the LiSN & Learn group than the Earobics group. LiSN & Learn training improved binaural processing ability in children with SPD, enhancing their ability to understand speech in noise. Exposure to non-spatialized auditory training does not produce similar outcomes, emphasizing the importance of deficit-specific remediation.

  14. Effect of jumping interval training on neuromuscular and physiological parameters: a randomized controlled study.

    Science.gov (United States)

    Ache-Dias, Jonathan; Dellagrana, Rodolfo A; Teixeira, Anderson S; Dal Pupo, Juliano; Moro, Antônio R P

    2016-01-01

    This study analyzed the effect of 4 weeks of jumping interval training (JIT), included in endurance training, on neuromuscular and physiological parameters. Eighteen recreational runners, randomized in control and experimental groups, performed 40 min of running at 70% of velocity at peak oxygen uptake, for 3 times per week. Additionally, the experimental group performed the JIT twice per week, which consisted of 4 to 6 bouts of continuous vertical jumps (30 s) with 5-min intervals. Three days before and after the training period, the countermovement (CMJ) and continuous jump (CJ30), isokinetic and isometric evaluation of knee extensors/flexors, progressive maximal exercise, and submaximal constant-load exercise were performed. The JIT provoked improvement in neuromuscular performance, indicated by (i) increased jump height (4.7%; effect size (ES) = 0.99) and power output (≈ 3.7%; ES ≈ 0.82) of CMJ and rate of torque development of knee extensors in isometric contraction (29.5%; ES = 1.02); (ii) anaerobic power and capacity, represented by the mean of jump height (7.4%; ES = 0.8), and peak power output (PPO) (5.6%; ES = 0.73) of the first jumps of CJ30 and the mean of jump height (10.2%, ES = 1.04) and PPO (9.5%, ES = 1.1), considering all jumps of CJ30; and (iii) aerobic power and capacity, represented by peak oxygen uptake (9.1%, ES = 1.28), velocity at peak oxygen uptake (2.7%, ES = 1.11), and velocity corresponding to the onset of blood lactate accumulation (9.7%, ES = 1.23). These results suggest that the JIT included in traditional endurance training induces moderate to large effects on neuromuscular and physiological parameters.

  15. Does electrical stimulation reduce spasticity after stroke? A randomized controlled study.

    Science.gov (United States)

    Bakhtiary, Amir H; Fatemy, Elham

    2008-05-01

    To investigate the therapeutic effect of electrical stimulation on plantarflexor spasticity in stroke patients. A randomized controlled clinical trial study. Rehabilitation clinic of Semnan University of Medical Sciences. Forty stroke patients (aged from 42 to 65 years) with ankle plantarflexor spasticity. Fifteen minutes of inhibitory Bobath techniques were applied to one experimental group and a combination of 9 minutes of electrical stimulation on the dorsiflexor muscles and inhibitory Bobath techniques was applied to another group for 20 sessions daily. Passive ankle joint dorsiflexion range of motion, dorsiflexion strength test, plantarflexor muscle tone by Modified Ashworth Scale and soleus muscle H-reflex. The mean change of passive ankle joint dorsiflexion in the combination therapy group was 11.4 (SD 4.79) degrees versus 6.1 (SD 3.09) degrees, which was significantly higher (P = 0.001). The mean change of plantarflexor muscle tonicity measured by the Modified Ashworth Scale in the combination therapy group was -1.6 (SD 0.5) versus -1.1 (SD 0.31) in the Bobath group (P = 0.001). Dorsiflexor muscle strength was also increased significantly (P = 0.04) in the combination therapy group (0.7 +/- 0.37) compared with the Bobath group (0.4 +/- 0.23). However, no significant change in the amplitude of H-reflex was found between combination therapy (-0.41 +/- 0.29) and Bobath (-0.3 +/- 0.28) groups. Therapy combining Bobath inhibitory technique and electrical stimulation may help to reduce spasticity effectively in stroke patients.

  16. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

    Science.gov (United States)

    O'Cathain, Alicia; Goode, Jackie; Drabble, Sarah J; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-06-09

    Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research

  17. Paracetamol sharpens reflection and spatial memory: a double-blind randomized controlled study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Pickering G

    2016-12-01

    Full Text Available Gisèle Pickering,1–3 Nicolas Macian,1,2 Claude Dubray,1–3 Bruno Pereira4 1University Hospital, CHU Clermont-Ferrand, Centre de Pharmacologie Clinique, 2Inserm, CIC 1405, UMR Neurodol 1107, 3Clermont Université, Laboratoire de Pharmacologie, Faculté de médecine, 4CHU de Clermont-Ferrand, Délégation Recherche Clinique Innovation, Clermont-Ferrand, France Background: Acetaminophen (APAP, paracetamol mechanism for analgesic and antipyretic outcomes has been largely addressed, but APAP action on cognitive function has not been studied in humans. Animal studies have suggested an improved cognitive performance but the link with analgesic and antipyretic modes of action is incomplete. This study aims at exploring cognitive tests in healthy volunteers in the context of antinociception and temperature regulation. A double-blind randomized controlled study (NCT01390467 was carried out from May 30, 2011 to July 12, 2011. Methods: Forty healthy volunteers were included and analyzed. Nociceptive thresholds, core temperature (body temperature, and a battery of cognitive tests were recorded before and after oral APAP (2 g or placebo: Information sampling task for predecisional processing, Stockings of Cambridge for spatial memory, reaction time, delayed matching of sample, and pattern recognition memory tests. Analysis of variance for repeated measures adapted to crossover design was performed and a two-tailed type I error was fixed at 5%. Results: APAP improved information sampling task (diminution of the number of errors, latency to open boxes, and increased number of opened boxes; all P<0.05. Spatial planning and working memory initial thinking time were decreased (P=0.04. All other tests were not modified by APAP. APAP had an antinociceptive effect (P<0.01 and body temperature did not change. Conclusion: This study shows for the first time that APAP sharpens decision making and planning strategy in healthy volunteers and that cognitive performance

  18. Randomized controlled study of icodextrin on the treatment of peritoneal dialysis patients during acute peritonitis.

    Science.gov (United States)

    Chow, Kai Ming; Szeto, Cheuk Chun; Kwan, Bonnie Ching Ha; Pang, Wing Fai; Ma, Terry; Leung, Chi Bon; Law, Man Ching; Li, Philip Kam-Tao

    2014-07-01

    The clinical benefits of using icodextrin during acute peritonitis in peritoneal dialysis are uncertain. On the premise that high glucose concentration might jeopardize the peritoneal defense during peritonitis, icodextrin administration during acute peritonitis could have the potential to improve the peritonitis outcome whilst improving ultrafiltration. We conducted a single-center, open-label, randomized controlled trial in which 53 adult continuous ambulatory peritoneal dialysis patients underwent randomization to receive either icodextrin or original glucose-based dialysis solution. The primary outcome measure was the peritoneal dialyzate white cell count on Day 3. Secondary outcome measures comprised the need of additional hypertonic exchanges, fluid control as denoted by changes in body weight, and the clinical outcome of peritonitis including 30-day and 120-day all-cause mortality. Between icodextrin and control treatment groups, there were no statistically significant differences in the peritoneal dialyzate white cell count on day (1829 versus 987/mm(3), P = 0.13). There was neither improvement in primary cure rate (31.8 versus 32.3%, P = 1.00), nor was there any change in 120-day mortality after icodextrin use (13.6 versus 12.9%, P = 1.00). However, requirement of hypertonic dialysis exchange was much more frequent in the control group than in those randomized to icodextrin (35.5 versus 0%, P = 0.001). Body weight did not change significantly in the icodextrin group, but body weight in the control group increased from 63.3 ± 14.5 kg at baseline to 64.2 ± 14.2 kg at Day 5 (P = 0.0002) and 65.2 ± 14.1 kg at Day 10 (P icodextrin achieved better ultrafiltration and fluid control during acute peritonitis complicating continuous ambulatory peritoneal dialysis, although we found no evidence of a worthwhile clinical benefit on peritonitis resolution. (ClinicalTrial.gov number, NCT0104446 [ClinicalTrial.gov].). © The Author 2014. Published by Oxford University

  19. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

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    Tuomi, Lisa, E-mail: lisa.tuomi@vgregion.se [Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden); Andréll, Paulin [Department of Molecular and Clinical Medicine/Multidisciplinary Pain Center, Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden); Finizia, Caterina [Department of Otorhinolaryngology, Head and Neck Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (Sweden)

    2014-08-01

    Background: Patients treated with radiation therapy for laryngeal cancer often experience voice problems. The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist. Methods and Materials: Sixty-nine male patients irradiated for laryngeal cancer participated. Voice recordings and self-assessments of communicative dysfunction were performed 1 and 6 months after radiation therapy. Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and 36 to a control group. Furthermore, comparisons with 23 healthy control individuals were made. Acoustic analyses were performed for all patients, including the healthy control individuals. The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function. Results: The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation. Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function, whereas the control group did not. Conclusion: Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements. The patients experienced better voice function after rehabilitation. Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes. Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy, particularly for patients with supraglottic tumors.

  20. Efficacy of the epilepsy nurse: Results of a randomized controlled study.

    Science.gov (United States)

    Pfäfflin, Margarete; Schmitz, Bettina; May, Theodor W

    2016-07-01

    We investigated the efficacy of epilepsy nurses on satisfaction with counseling about epilepsy in a randomized, controlled, prospective trial. Patients with epilepsy treated by neurologists in outpatient clinics were consecutively enrolled and randomly allocated to either the epilepsy nurse (EN) group (n = 92) or the control group (n = 95). Patients in the EN group were advised according to their needs by epilepsy nurses. The control group received routine care without additional counseling. The EN group completed the questionnaires before the first consultation (T1) and 6 months later (T2); the control group completed the questionnaires twice with an interval of 6 months. Primary outcome measure was satisfaction of patients with information and support. Secondary outcome measures were satisfaction with patient-doctor relationship, organization of treatment, epilepsy knowledge, coping, and restrictions in daily life. Anxiety and depression (Hospital Anxiety and Depression Scale) and global Quality of Life (item from QOLIE-31) were also assessed. Statistical analysis included generalized estimating equation (GEE) and nonparametric tests. Satisfaction with information and support improved significantly in the EN group compared to the control group (GEE, interaction group × time, p = 0.001). In addition, Epilepsy Knowledge (p = 0.014) and Coping (subscale Information Seeking) (p = 0.023) improved. Increase in satisfaction with counseling was dependent on patients' needs for information and on the amount of received information (Jonckheere-Terpstra test, p care has been developed. Epilepsy nurses improve the satisfaction of patients with counseling and information about epilepsy and concomitant problems. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

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

    Directory of Open Access Journals (Sweden)

    Menniti-Ippolito Francesca

    2007-01-01

    Full Text Available Abstract Background One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties. The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema, using two treatment administration routes (sub-plantar injection and oral administration. Methods In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement procedure. In a second phase, some of the remedies (in the same and in different dilutions were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170–180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30, saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. Results In the first phase

  2. Practice-Based Professional Development for Self-Regulated Strategies Development in Writing: A Randomized Controlled Study

    Science.gov (United States)

    Harris, Karen R.; Lane, Kathleen Lynne; Graham, Steve; Driscoll, Steven A.; Sandmel, Karin; Brindle, Mary; Schatschneider, Christopher

    2012-01-01

    In this randomized controlled study, 20 second- and third-grade teachers participated in practice-based professional development in strategies instruction in either story or opinion essay writing, using the Self-Regulated Strategies Development (SRSD) instructional model. These teachers worked in schools collaborating with a local university to…

  3. Renal Hemodynamic Effects of Serelaxin in Patients With Chronic Heart Failure A Randomized, Placebo-Controlled Study

    NARCIS (Netherlands)

    Voors, Adriaan A.; Dahlke, Marion; Meyer, Sven; Stepinska, Janina; Gottlieb, Stephen S.; Jones, Andrew; Zhang, Yiming; Laurent, Didier; Slart, Riemer H. J. A.; Navis, Gerjan J.

    2014-01-01

    Background-Serelaxin is a promising therapy for acute heart failure. The renal hemodynamic effects of serelaxin in patients with chronic heart failure are unknown. Methods and Results-In this double-blind, randomized, placebo-controlled, multicenter study, patients with New York Heart Association Cl

  4. Sulfasalazine in the treatment of juvenile chronic arthritis - A randomized, double-blind, placebo-controlled, multicenter study

    NARCIS (Netherlands)

    Fiselier, TJW; Franssen, MJAM; Zwinderman, AH; ten Cate, R; van Suijlekom-Smit, LWA; van Luijk, WHJ; van Soesbergen, RM; Wulffraat, NM; Oostveen, JCM; Kuis, W; Dijkstra, PF; van Ede, CFP; Dijkmans, BAC

    1998-01-01

    Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. we conducted a 24-week randomized, placebo-controlled, double-blind, multicenter study of patients with active JCA of both oligoarticular and polyarticula

  5. Social Skills Training for Young Adults with High-Functioning Autism Spectrum Disorders: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Gantman, Alexander; Kapp, Steven K.; Orenski, Kaely; Laugeson, Elizabeth A.

    2012-01-01

    Despite the psychosocial difficulties common among young adults with autism spectrum disorders (ASD), little to no evidence-based social skills interventions exist for this population. Using a randomized controlled trial (RCT) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention…

  6. Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa

    NARCIS (Netherlands)

    Olivennes, F.; Trew, G.; Borini, A.; Broekmans, F.; Arriagada, P.; Warne, D. W.; Howles, C. M.

    2015-01-01

    In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18-34 years) eligible for assisted reproductive techniques were recruited (

  7. Effects of errorless skill learning in people with mild-to-moderate or severe dementia: A randomized controlled pilot study

    NARCIS (Netherlands)

    Kessels, R.P.C.; Olde Hensken, L.M.G.

    2009-01-01

    This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with m

  8. Effects of errorless skill learning in people with mild-to-moderate or severe dementia: a randomized controlled pilot study.

    NARCIS (Netherlands)

    Kessels, R.P.C.; Hensken, L.M.

    2009-01-01

    This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with m

  9. Myocardial Infarct Size by CMR in Clinical Cardioprotection Studies: Insights From Randomized Controlled Trials.

    Science.gov (United States)

    Bulluck, Heerajnarain; Hammond-Haley, Matthew; Weinmann, Shane; Martinez-Macias, Roberto; Hausenloy, Derek J

    2017-03-01

    The aim of this study was to review randomized controlled trials (RCTs) using cardiac magnetic resonance (CMR) to assess myocardial infarct (MI) size in reperfused patients with ST-segment elevation myocardial infarction (STEMI). There is limited guidance on the use of CMR in clinical cardioprotection RCTs in patients with STEMI treated by primary percutaneous coronary intervention. All RCTs in which CMR was used to quantify MI size in patients with STEMI treated with primary percutaneous coronary intervention were identified and reviewed. Sixty-two RCTs (10,570 patients, January 2006 to November 2016) were included. One-third did not report CMR vendor or scanner strength, the contrast agent and dose used, and the MI size quantification technique. Gadopentetate dimeglumine was most commonly used, followed by gadoterate meglumine and gadobutrol at 0.20 mmol/kg each, with late gadolinium enhancement acquired at 10 min; in most RCTs, MI size was quantified manually, followed by the 5 standard deviation threshold; dropout rates were 9% for acute CMR only and 16% for paired acute and follow-up scans. Weighted mean acute and chronic MI sizes (≤12 h, initial TIMI [Thrombolysis in Myocardial Infarction] flow grade 0 to 3) from the control arms were 21 ± 14% and 15 ± 11% of the left ventricle, respectively, and could be used for future sample-size calculations. Pre-selecting patients most likely to benefit from the cardioprotective therapy (≤6 h, initial TIMI flow grade 0 or 1) reduced sample size by one-third. Other suggested recommendations for standardizing CMR in future RCTs included gadobutrol at 0.15 mmol/kg with late gadolinium enhancement at 15 min, manual or 6-SD threshold for MI quantification, performing acute CMR at 3 to 5 days and follow-up CMR at 6 months, and adequate reporting of the acquisition and analysis of CMR. There is significant heterogeneity in RCT design using CMR in patients with STEMI. The authors provide recommendations for standardizing

  10. Train High Eat Low for Osteoarthritis study (THE LO study: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yareni Guerrero

    2015-10-01

    Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee.

  11. A national study of the psychological impact of bank robbery with a randomized control group

    DEFF Research Database (Denmark)

    Hansen, Maj; Armour, Cherie; Shevlin, Mark

    but surprisingly significantly higher than the follow-up robbery group. The results are discussed in relation to existing research and the effect of other factors such as prior traumatic exposure. In conclusion bank robberies are a traumatizing event for the employees, especially when disregarding avoidance...... of bank employees exposed to robbery (response rate: 73.6 %). Several related factors were also investigated including prior traumatic exposure, anxiety, and general traumatic symptoms. The results were compared to a randomized control group of bank employees never exposed to robbery (N= 303......). The estimated ASD rate was 11.1 % (n = 41), and the estimated PTSD rate was 6.2 % (n = 23). Both prevalence rates were limited by the avoidance diagnostic criteria. Preliminary results indicated that the control group scored significantly lower than the acute robbery group on general traumatization and anxiety...

  12. Treadmill training as an augmentation treatment for Alzheimer?s disease: a pilot randomized controlled study

    Directory of Open Access Journals (Sweden)

    Cynthia Arcoverde

    2014-03-01

    Full Text Available Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD patients. Method Elderly (n=20 with mild dementia (NINCDS-ADRDA/CDR1 were randomly assigned to an exercise group (EG on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max and control group (GC 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG. Specifics instruments were also applied to evaluate executive function, memory, attention and concentration, cognitive flexibility, inhibitory control and functional capacity. Results After 16 weeks, the EG showed improvement in cognition CAMCOG whereas the CG declined. Compared to the CG, the EG presented significant improvement on the functional capacity. The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables. Conclusion Walking on treadmill may be recommended as an augmentation treatment for patients with AD.

  13. The Chronic Care for Wet Age Related Macular Degeneration (CHARMED Study: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Stefan Markun

    Full Text Available In real life, outcomes in wet age related macular degeneration (W-AMD continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM.Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support. In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT macular retinal thickness and quality of life (NEI VFQ-25 questionnaire.169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7. After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15; difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60; difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19.The intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD.Controlled-Trials.com ISRCTN32507927.

  14. Efficacy of vision restoration therapy after optic neuritis (VISION study: study protocol for a randomized controlled trial

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    Schinzel Johann

    2012-06-01

    Full Text Available Abstract Background Optic neuritis is a frequent manifestation of multiple sclerosis. Visual deficits range from a minor impairment of visual functions through to complete loss of vision. Although many patients recover almost completely, roughly 35% of patients remain visually impaired for years, and therapeutic options for those patients hardly exist. Vision restoration therapy is a software-based visual training program that has been shown to improve visual deficits after pre- and postchiasmatic injury. The aim of this pilot study is to evaluate whether residual visual deficits after past or recent optic neuritis can be reduced by means of vision restoration therapy. Methods/design A randomized, controlled, patient- and observer-blinded clinical pilot study (VISION study was designed to evaluate the efficacy of vision restoration therapy in optic neuritis patients. Eighty patients with a residual visual deficit after optic neuritis (visual acuity ≤0.7 and/or scotoma will be stratified according to the time of optic neuritis onset (manifestation more than 12 months ago (40 patients, fixed deficit versus manifestation 2 to 6 months ago (40 patients, recent optic neuritis, and randomized into vision restoration therapy arm or saccadic training arm (control intervention. Patients will be instructed to complete a computer-based visual training for approximately 30 minutes each day for a period of 6 months. Patients and evaluators remain blinded to the treatment allocation throughout the study. All endpoints will be analyzed and P-values  Discussion If vision restoration therapy is shown to improve visual function after optic neuritis, this method might be a first therapeutic option for patients with incomplete recovery from optic neuritis. Trial registration NCT01274702

  15. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    M. Pradhan; S.A. Brinkman; A. Beatty; A. Maika; E. Satriawan; J. de Ree; A. Hasan

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program w

  16. Reintroduction of gluten following flour transamidation in adult celiac patients: a randomized, controlled clinical study.

    Science.gov (United States)

    Mazzarella, Giuseppe; Salvati, Virginia M; Iaquinto, Gaetano; Stefanile, Rosita; Capobianco, Federica; Luongo, Diomira; Bergamo, Paolo; Maurano, Francesco; Giardullo, Nicola; Malamisura, Basilio; Rossi, Mauro

    2012-01-01

    A lifelong gluten-free diet (GFD) is mandatory for celiac disease (CD) but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12) or transamidated (35) flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (P = 0.04) whereas intestinal permeability was mainly altered in the control group (50% versus 20%, P = 0.06). On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (P = 0.63), Marsh-Oberhuber grading (P = 0.08), or intestinal IFN-γ mRNA (P > 0.05). Creatinine clearance did not vary after 90 days of treatment (P = 0.46). In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  17. Tramadol vs dexmedetomidine for emergence agitation control in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia: prospective randomized controlled clinical study.

    Science.gov (United States)

    Bedirli, Nurdan; Akçabay, Mehmet; Emik, Ulku

    2017-03-11

    This study was designed to compare the efficacy of an intraoperative single dose administration of tramadol and dexmedetomidine on hemodynamics and postoperative recovery profile including pain, sedation, emerge reactions in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia. Seventy-seven patient, aged 2-12, undergoing adenotonsillectomy with sevoflurane anesthesia was enrolled in this study. Patients were randomly assigned to receive either intravenous 2 mg/kg tramadol (Group T; n = 39) or 1 μg/kg dexmedetomidine (Group D; n = 38) after intubation. Heart rates (HR), mean arterial pressure (MAP) were recorded before induction, at induction and every 5 min after induction. Observational pain scores (OPS), pediatric anesthesia emergence delirium (PAED) scores, percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4, and Ramsay sedation scores (RSS) were recorded on arrival to the postoperative care unit (PACU) and at 5, 10, 15, 30, 45, 60 min. Extubation time and time to reach Alderete score > 9 were recorded. Dexmedetomidine significantly decreased the HR and MAP 10 and 15 min after induction; increased the RSS 15, 30 and 45 min after arrival to PACU. OPS and PAED scores and percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4 in both groups did not show any significant difference. Extubation time and time to have Alderete score > 9 was significantly longer in Group D. Both tramadol and dexmedetomidine were effective for controlling pain and emergence agitation. When compared with tramadol intraoperative hypotension, bradycardia and prolonged sedation were problems related with dexmedetomidine administration. Retrospectively registered, registration number: ISRCTN89326952 registration date: 14.07.2016.

  18. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Kira Geoffrey

    2011-05-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of death worldwide. Cardiac rehabilitation (CR is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial. Methods A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention. The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ, cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio, health related quality of life (SF-36, and cost-effectiveness. Discussion This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed

  19. Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort study.

    Science.gov (United States)

    Yavchitz, Amélie; Boutron, Isabelle; Bafeta, Aida; Marroun, Ibrahim; Charles, Pierre; Mantz, Jean; Ravaud, Philippe

    2012-01-01

    Previous studies indicate that in published reports, trial results can be distorted by the use of "spin" (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment). We aimed to (1) evaluate the presence of "spin" in press releases and associated media coverage; and (2) evaluate whether findings of randomized controlled trials (RCTs) based on press releases and media coverage are misinterpreted. We systematically searched for all press releases indexed in the EurekAlert! database between December 2009 and March 2010. Of the 498 press releases retrieved and screened, we included press releases for all two-arm, parallel-group RCTs (n = 70). We obtained a copy of the scientific article to which the press release related and we systematically searched for related news items using Lexis Nexis. "Spin," defined as specific reporting strategies (intentional or unintentional) emphasizing the beneficial effect of the experimental treatment, was identified in 28 (40%) scientific article abstract conclusions and in 33 (47%) press releases. From bivariate and multivariable analysis assessing the journal type, funding source, sample size, type of treatment (drug or other), results of the primary outcomes (all nonstatistically significant versus other), author of the press release, and the presence of "spin" in the abstract conclusion, the only factor associated, with "spin" in the press release was "spin" in the article abstract conclusions (relative risk [RR] 5.6, [95% CI 2.8-11.1], p < 0.001). Findings of RCTs based on press releases were overestimated for 19 (27%) reports. News items were identified for 41 RCTs; 21 (51%) were reported with "spin," mainly the same type of "spin" as those identified in the press release and article abstract conclusion. Findings of RCTs based on the news item was overestimated for ten (24%) reports. "Spin" was identified in about half of press releases and media coverage. In

  20. Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort study.

    Directory of Open Access Journals (Sweden)

    Amélie Yavchitz

    Full Text Available BACKGROUND: Previous studies indicate that in published reports, trial results can be distorted by the use of "spin" (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment. We aimed to (1 evaluate the presence of "spin" in press releases and associated media coverage; and (2 evaluate whether findings of randomized controlled trials (RCTs based on press releases and media coverage are misinterpreted. METHODS AND FINDINGS: We systematically searched for all press releases indexed in the EurekAlert! database between December 2009 and March 2010. Of the 498 press releases retrieved and screened, we included press releases for all two-arm, parallel-group RCTs (n = 70. We obtained a copy of the scientific article to which the press release related and we systematically searched for related news items using Lexis Nexis. "Spin," defined as specific reporting strategies (intentional or unintentional emphasizing the beneficial effect of the experimental treatment, was identified in 28 (40% scientific article abstract conclusions and in 33 (47% press releases. From bivariate and multivariable analysis assessing the journal type, funding source, sample size, type of treatment (drug or other, results of the primary outcomes (all nonstatistically significant versus other, author of the press release, and the presence of "spin" in the abstract conclusion, the only factor associated, with "spin" in the press release was "spin" in the article abstract conclusions (relative risk [RR] 5.6, [95% CI 2.8-11.1], p < 0.001. Findings of RCTs based on press releases were overestimated for 19 (27% reports. News items were identified for 41 RCTs; 21 (51% were reported with "spin," mainly the same type of "spin" as those identified in the press release and article abstract conclusion. Findings of RCTs based on the news item was overestimated for ten (24% reports. CONCLUSION: "Spin" was identified in

  1. Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring

    Directory of Open Access Journals (Sweden)

    Karen Day

    2016-06-01

    Full Text Available Abstract Background Action research (AR and randomized controlled trials (RCTs are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. Methods Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban, airways disease (Site B, urban, and diabetes (Site C, rural. The research ran from 2008 (project inception until 2012 (project close-off. Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing. Results We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger

  2. Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol

    DEFF Research Database (Denmark)

    Vik, Ingvild; Bollestad, Marianne; Grude, Nils

    2014-01-01

    BackgroundAlthough uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution.Methods/DesignThis is a randomized......, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three.......DiscussionIf treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale.Trial registrationEudraCTnr: 2012-002776-14. ClinicalTrials.gov: NCT01849926....

  3. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tulbure Bogdan Tudor

    2012-10-01

    Full Text Available Abstract Background Social anxiety disorder (SAD is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96 will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a an active treatment, or b a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention. Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894

  4. Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sheeran Paschal

    2011-02-01

    Full Text Available Abstract Background What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. Methods/Design A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design. Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. Discussion The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000846022

  5. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study

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    Angsuwatcharakon Phonthep

    2012-08-01

    Full Text Available Abstract Background ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP. Methods ERCP patients were randomized into 2 groups; the cocktail group (n = 103 and the controls (n = 102. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation. Results In the cocktail group, the average administration rate of propofol was 6.2 mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03 mg/kg and 0.12 mg/kg, respectively. Recovery times and patients’ satisfaction scores in the cocktail and control groups were 9.67 minutes and 12.89 minutes (P = 0.045, 93.1and 87.6 (P P Conclusions Cocktail sedation containing propofol provides faster recovery time and better patients’ satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop. Trial registration ClinicalTrials.gov, NCT01540084

  6. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gregson Barbara A

    2012-10-01

    Full Text Available Abstract Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH; subdural (SDH; and intraparenchymal (TICH. Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial, but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to

  7. Can visual aides influence rehabilitation and length of stay following knee replacement? A randomized controlled study

    Directory of Open Access Journals (Sweden)

    Simon Abson

    2015-03-01

    Full Text Available Arthroplasty is increasingly performed within Australia, with a 2.7% rate increase of total knee arthroplasty (TKR over the last year. With an increasing burden on the public health system and increasing waiting lists, all efforts are being made to decrease length of stay and improve the post operative rehabilitation process. There is currently insufficient evidence to make a conclusive statement about visual aids and improved goal attainment post TKR. The purpose of this study is to evaluate one such visual aid clinical photographs of patients knee range of motion (ROM pre- and post-operatively and their effect on length of stay. Photographs of knee range of motion were obtained pre and post-operatively while the patient was anesthetized. In this study, a randomized, single blinded design allocated patients to either be shown or not shown their photographs on day 1 post operatively. Primary outcome measures were the number of days the patient remained in hospital. Secondary measures were Western Ontario and McMaster Universities Arthritis Index scores, Oxford Knee Scores, American Society of Anesthesiologists Score and knee ROM. Thirty-two patients (3 exclusions were randomized to the photo group and 27 patients (4 exclusions were randomized to the no photo group. The median length of stay between groups was not significantly different. Currently there is not enough evidence to conclude that visual aids effect length of stay or rehabilitation pathways. Further assessment with larger cohort groups is needed. Preoperative targeting and rehabilitation for patients with lower functional status may shorten post operative length of patient stay in our institution.

  8. Randomized Controlled Study of a Remote Flipped Classroom Neuro-otology Curriculum.

    Science.gov (United States)

    Carrick, Frederick Robert; Abdulrahman, Mahera; Hankir, Ahmed; Zayaruzny, Maksim; Najem, Kinda; Lungchukiet, Palita; Edwards, Roger A

    2017-01-01

    Medical Education can be delivered in the traditional classroom or via novel technology including an online classroom. To test the hypothesis that learning in an online classroom would result in similar outcomes as learning in the traditional classroom when using a flipped classroom pedagogy. Randomized controlled trial. A total of 274 subjects enrolled in a Neuro-otology training program for non-Neuro-otologists of 25 h held over a 3-day period. Subjects were randomized into a "control" group attending a traditional classroom and a "trial" group of equal numbers participating in an online synchronous Internet streaming classroom using the Adobe Connect e-learning platform. Subjects were randomized into a "control" group attending a traditional classroom and a "treatment" group of equal numbers participating in an online synchronous Internet streaming classroom. Pre- and post-multiple choice examinations of VOR, Movement, Head Turns, Head Tremor, Neurodegeneration, Inferior Olivary Complex, Collateral Projections, Eye Movement Training, Visual Saccades, Head Saccades, Visual Impairment, Walking Speed, Neuroprotection, Autophagy, Hyperkinetic Movement, Eye and Head Stability, Oscilllatory Head Movements, Gaze Stability, Leaky Neural Integrator, Cervical Dystonia, INC and Head Tilts, Visual Pursuits, Optokinetic Stimulation, and Vestibular Rehabilitation. All candidates took a pretest examination of the subject material. The 2-9 h and 1-8 h sessions over three consecutive days were given live in the classroom and synchronously in the online classroom using the Adobe Connect e-learning platform. Subjects randomized to the online classroom attended the lectures in a location of their choice and viewed the sessions live on the Internet. A posttest examination was given to all candidates after completion of the course. Two sample unpaired t tests with equal variances were calculated for all pretests and posttests for all groups including gender differences. All 274

  9. Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.

    Science.gov (United States)

    Kennelly, Maria A; Ainscough, Kate; Lindsay, Karen; Gibney, Eileen; Mc Carthy, Mary; McAuliffe, Fionnuala M

    2016-01-01

    Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population. We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference. This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Microscope versus endoscope in root-end management: a randomized controlled study.

    Science.gov (United States)

    Taschieri, S; Del Fabbro, M; Testori, T; Weinstein, R

    2008-11-01

    The purpose of this prospective, randomized, clinical study was to monitor the outcome of periradicular surgery, in which either a surgical microscope or an endoscope was used as a magnification device. A total of 113 teeth in 70 patients were included in the study, according to specific selection criteria. The choice of endoscope or surgical microscope was made using a randomized table. One hundred cases were followed for at least 2 years. Of these, 59 root-end management procedures were performed using a microscope and 41 using an endoscope. At the 2-year follow-up they were classified into three groups (success, uncertain healing and failure) according to radiographic and clinical criteria. After a 2-year follow-up, 91 teeth (91%) healed successfully. In the group using an endoscope 90% of successful healing was achieved, while 92% of success was recorded for the group using a microscope. No statistically significant difference was found in the treatment results relating to the type of magnification device. The type of magnification device used did not seem to affect the outcome of endodontic surgery.

  11. Acupuncture and Immune Function in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Randomized, Controlled Study

    Science.gov (United States)

    Lee, Shaun Wen Huey; Liong, Men Long; Yuen, Kah Hay; Krieger, John N

    2014-01-01

    Objective The immune system has been implicated as one mechanism underlying the benefits of acupuncture therapy. Evidence suggests that acupuncture can ameliorate symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but the association between clinical response and the immune system has not been investigated. Design/Setting We investigated 12 CP/CPPS patients participating in a prospective randomized clinical trial comparing acupuncture versus sham acupuncture for effects on cellular immunity. Blood samples were taken before the first needling and after the last of 20 treatment sessions (week 10). Patients also completed questionnaires examining their CP/CPPS symptoms and mood status at the baseline and end of study visits. Results At the end of study 8 of 12 participants (67%) were classified as treatment responders, 4 participants each from the acupuncture and sham groups. The acupuncture group averaged a 5% increase in natural killer cell levels compared to corresponding sham (-13%; p=0.03). Similarly, patients randomized to acupuncture reported a reduction in other white blood cell parameters examined, supporting the possibility that immunity might be important in the pathophysiology of CP/CPPS. Conclusions The specific effect of acupuncture on CP/CPPS remains unclear. Further research is warranted to examine the mechanisms by which acupuncture therapy may improve clinical symptoms in patients with CP/CPPS. PMID:25453515

  12. Mindfulness practice reduces cortisol blunting during chemotherapy: A randomized controlled study of colorectal cancer patients.

    Science.gov (United States)

    Black, David S; Peng, Cheng; Sleight, Alix G; Nguyen, Nathalie; Lenz, Heinz-Josef; Figueiredo, Jane C

    2017-08-15

    The objective of this randomized clinical experiment was to test the influence of a mindfulness meditation practice, when delivered during 1 session of active chemotherapy administration, on the acute salivary cortisol response as a marker of neuroendocrine system activity in cancer patients. A mindfulness, attention-control, or resting exposure was assigned to 57 English- or Spanish-speaking colorectal cancer patients at 1 county oncology clinic and 1 university oncology clinic at the start of chemotherapy. Saliva samples were collected at the start of chemotherapy and at subsequent 20-minute intervals during the first 60 minutes of chemotherapy (4 samples in all). Self-reporting on biobehavioral assessments after chemotherapy included distress, fatigue, and mindfulness. An area-under-the-curve analysis (AUC) showed a relative increase in cortisol reactivity in the mindfulness group after adjustments for biological and clinical measures (β = 123.21; P = .03). More than twice as many patients in the mindfulness group versus the controls displayed a cortisol rise from the baseline to 20 minutes (69% vs 34%; P = .02). AUC values were uncorrelated with biobehavioral measure scores, although mindfulness scores were inversely correlated with fatigue (r = -0.46; P cancer patients. Implications include support for the use of mindfulness practice in integrative oncology. Cancer 2017;123:3088-96. © 2017 American Cancer Society. © 2017 American Cancer Society.

  13. Effect of Rebamipide on the Premalignant Progression of Chronic Gastritis: A Randomized Controlled Study.

    Science.gov (United States)

    Han, Xue; Jiang, Kui; Wang, Bangmao; Zhou, Lu; Chen, Xin; Li, Shu

    2015-10-01

    Chronic gastritis frequently progresses into precancerous intestinal metaplasia and intraepithelial neoplasia lesions. Rebamipide is a free radical scavenger and we assessed its efficacy on clinical symptoms, gastric mucosal lesions, pathologic grade, and immunohistochemistry in chronic gastritis patients. 178 eligible patients were randomized into treatment and control groups. Both groups followed an optimized lifestyle for 26 weeks, but the treatment group was additionally medicated with rebamipide 0.1 g three times per day. Upper gastrointestinal endoscopy was performed in all patients to evaluate the severity of gastritis by the Modified Lanza Scoring (MLS) and histological changes were evaluated by the Updated Sydney System Score (USSS). Gastric mucosa immunohistochemistry in the treatment group was performed using the intestinal metaplasia markers caudal type homeobox transcription factor 2 (CDX2) and trefoil factor 3 (TFF3) detection. There were significant outcome differences between the treatment and control groups regarding the clinical symptom scores (2.62 ± 1.86 vs. 1.55 ± 1.61, P = 0.0001), gastric mucosal lesion scores (0.57 ± 1.05 vs. 0.16 ± 0.90, P = 0.002), and inflammation (P rebamipide medication than pre-treatment values. Rebamipide improved the clinical symptoms, gastric mucosal lesions, and pathological grades of chronic gastritis patients and decreased the expression rates of CDX2 and TFF3 in gastric cells.

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

    Science.gov (United States)

    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.

  15. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  16. Randomized placebo- and active-controlled study of desvenlafaxine for menopausal vasomotor symptoms.

    Science.gov (United States)

    Bouchard, P; Panay, N; de Villiers, T J; Vincendon, P; Bao, W; Cheng, R J; Constantine, G

    2012-02-01

    To evaluate the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) vs. tibolone and placebo for menopausal vasomotor symptoms and the incidence of uterine bleeding. This 12-week, double-blind, randomized, controlled trial was conducted at 35 sites in Europe, two sites in South Africa, and one site in Mexico. Postmenopausal women with ≥50 moderate or severe hot flushes per week (n = 485) were randomized to desvenlafaxine 100 mg/day, tibolone 2.5 mg/day, or placebo. Reduction in the average daily number of moderate and severe hot flushes at weeks 4 and 12 (primary endpoint) was evaluated using analysis of covariance. Safety assessments included incidence of uterine bleeding, adverse events, laboratory values, and vital signs. At week 12, no statistically significant difference was observed in reduction of the average daily number of moderate and severe hot flushes for desvenlafaxine (-5.78) vs. placebo (-5.82; p = 0.921), although time to 50% reduction was significantly less than placebo (13 vs. 26 days, p = 0.006). Hot flush reduction with tibolone (-8.21) was significantly greater than placebo (p desvenlafaxine, was generally mild to moderate, and resolved within the first 2 weeks. Significantly more subjects experienced bleeding with tibolone (23%) vs. desvenlafaxine (12%; p Desvenlafaxine did not separate from placebo in reducing the number of moderate to severe hot flushes at week 12, although it did allow women to achieve 50% reduction sooner than placebo. Tibolone did separate from placebo, but with smaller than expected effect. The placebo effect was high (57%). Adverse drug reactions were consistent with the known safety profile of desvenlafaxine, and significantly more women who received tibolone experienced episodes of bleeding compared with women who received desvenlafaxine or placebo.

  17. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

    2014-02-01

    The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

  18. Lifestyle referral assessment in an acute cardiology setting: study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Hill, Kate M; Walwyn, Rebecca E A; Camidge, Diana C; Meads, David M; Murray, Jenni Y; Reynolds, Greg; Farrin, Amanda J; House, Allan O

    2013-07-11

    Lifestyle and behaviour change are important factors in the prevention of cardiovascular disease and reduction of premature mortality. Public health initiatives have focused on opportunities for healthcare staff to deliver lifestyle advice routinely in primary and secondary care but there is no consistent approach to onward referrals and the rate of uptake of advice remains low. We do not know if advice is more effective in supporting behaviour change when a systematic approach is taken that includes identification of barriers to change, directing patients toward services, referral to services, and feedback on outcome. This is a single-centre, randomized, unblinded feasibility trial in an acute hospital setting which aims to assess the feasibility of a definitive trial and provide proof of concept for the systematic delivery of individualized lifestyle advice in patients managed through an acute cardiology in-patient service.Patients will be recruited before discharge and randomized to two groups. A control group will receive the usual lifestyle assessment and referral, while an intervention group will receive the usual assessment plus the new individualized lifestyle assessment and referral. The new assessment will inform assignment of each patient to one of three categories based on personal barriers to change. Patients may be referred to a formal lifestyle-change programme, through the 'Leeds Let's Change' website, or they may be guided in self-management, using goal setting, or they may be assigned to a 'deferment' category, for reassessment at follow-up. These latter patients will be given a contact card for the 'Leeds Let's Change' service. Lifestyle change is an important mechanism for improving health and wellbeing across the population but there are widely acknowledged difficulties in addressing lifestyle factors with patients and supporting behaviour change. A systematic approach to assessment would facilitate audit and provide an indicator of the quality

  19. Controlled-Release Oxycodone and Naloxone in the Treatment of Chronic Low Back Pain: A Placebo-Controlled, Randomized Study

    Directory of Open Access Journals (Sweden)

    C Cloutier

    2013-01-01

    Full Text Available BACKGROUND: For Canadian regulatory purposes, an analgesic study was required to complement previously completed, pivotal studies on bowel effects and analgesia associated with controlled-release (CR oxycodone/CR naloxone.

  20. Long-term effect of physical activity counseling on mobility limitation among older people: a randomized controlled study

    DEFF Research Database (Denmark)

    Mänty, Minna Regina; Heinonen, Ari; Leinonen, Raija

    2009-01-01

    BACKGROUND: Physical activity counseling increases physical activity among older people, but its effectiveness on mobility, that is, maintaining the ability to move independently, is unknown. We studied the effect of physical activity counseling on mobility among older people and evaluated whether...... counseling-induced benefits persist after cessation of the intervention. METHODS: In a 2-year, single-blinded, randomized controlled study, 632 sedentary participants aged 75-81 years were randomly assigned into the intervention (n = 318) or control (n = 314) group. The intervention group received a single...... individualized physical activity counseling session with a supportive telephone contact every 4 months for 2 years. The outcome measures-perceived difficulty in advanced (walking 2 km) and basic (walking 0.5 km) mobility-were gathered semiannually during the intervention and the 1.5-year postintervention follow...

  1. Randomized Controlled Study of a Remote Flipped Classroom Neuro-otology Curriculum

    Directory of Open Access Journals (Sweden)

    Frederick Robert Carrick

    2017-07-01

    Full Text Available ContextMedical Education can be delivered in the traditional classroom or via novel technology including an online classroom.ObjectiveTo test the hypothesis that learning in an online classroom would result in similar outcomes as learning in the traditional classroom when using a flipped classroom pedagogy.DesignRandomized controlled trial. A total of 274 subjects enrolled in a Neuro-otology training program for non-Neuro-otologists of 25 h held over a 3-day period. Subjects were randomized into a “control” group attending a traditional classroom and a “trial” group of equal numbers participating in an online synchronous Internet streaming classroom using the Adobe Connect e-learning platform.InterventionsSubjects were randomized into a “control” group attending a traditional classroom and a “treatment” group of equal numbers participating in an online synchronous Internet streaming classroom.Main outcome measuresPre- and post-multiple choice examinations of VOR, Movement, Head Turns, Head Tremor, Neurodegeneration, Inferior Olivary Complex, Collateral Projections, Eye Movement Training, Visual Saccades, Head Saccades, Visual Impairment, Walking Speed, Neuroprotection, Autophagy, Hyperkinetic Movement, Eye and Head Stability, Oscilllatory Head Movements, Gaze Stability, Leaky Neural Integrator, Cervical Dystonia, INC and Head Tilts, Visual Pursuits, Optokinetic Stimulation, and Vestibular Rehabilitation.MethodsAll candidates took a pretest examination of the subject material. The 2–9 h and 1–8 h sessions over three consecutive days were given live in the classroom and synchronously in the online classroom using the Adobe Connect e-learning platform. Subjects randomized to the online classroom attended the lectures in a location of their choice and viewed the sessions live on the Internet. A posttest examination was given to all candidates after completion of the course. Two sample unpaired t tests with equal variances

  2. Effect of Prometheus liver assist system on systemic hemodynamics in patients with cirrhosis: A randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    Thomas Dethloff; Flemming Tofteng; Hans-Jorgen Frederiksen; Michael Hojskov; Bent Adel Hansen; Fin Stolze Larsen

    2008-01-01

    AIM: To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus? liver assist system in a randomized, controlled study.METHODS: Twenty-four patients were randomized to either the study group or to one of two control groups: Fractionated Plasma Separation Adsorption and Dialysis, Prometheus? system (Study group; n = 8); Molecular Adsorbent Recirculation System (MARS)? (Control group 1, n = 8); or hemodialysis (Control group 2; n = 8). All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins.RESULTS: Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group (P = 0.008). No adverse effects were observed in any of the groups. Creatinine levels significantly decreased in the MARS group (P = 0.03) and hemodialysis group (P = 0.04). Platelet count deceased in the Prometheus group (P = 0.04).CONCLUSION: Extra-corporal liver support with Prometheus is proven to be safe in patients with end-stage liver disease but does not exert the beneficial effects on arterial pressure as seen in the MARS group.

  3. Effect of Prometheus liver assist system on systemic hemodynamics in patients with cirrhosis: a randomized controlled study.

    Science.gov (United States)

    Dethloff, Thomas; Tofteng, Flemming; Frederiksen, Hans-Jorgen; Hojskov, Michael; Hansen, Bent-Adel; Larsen, Fin-Stolze

    2008-04-07

    To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus liver assist system in a randomized, controlled study. Twenty-four patients were randomized to either the study group or to one of two control groups: Fractionated Plasma Separation Adsorption and Dialysis, Prometheus system (Study group; n = 8); Molecular Adsorbent Recirculation System (MARS) (Control group 1, n = 8); or hemodialysis (Control group 2; n = 8). All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group (P = 0.008). No adverse effects were observed in any of the groups. Creatinine levels significantly decreased in the MARS group (P = 0.03) and hemodialysis group (P = 0.04). Platelet count deceased in the Prometheus group (P = 0.04). Extra-corporal liver support with Prometheus is proven to be safe in patients with endstage liver disease but does not exert the beneficial effects on arterial pressure as seen in the MARS group.

  4. Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study

    OpenAIRE

    Morone, Natalia E.; Greco, Carol M.; Weiner, Debra K.

    2007-01-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were ra...

  5. Interferential light therapy in the treatment of shoulder tendinopathies: a randomized controlled pilot study.

    Science.gov (United States)

    Montes-Molina, Ramón; Martínez-Rodríguez, Maria Elena; Rodríguez, Ana Belén Romojaro; Martínez-Ruiz, Fidel; Prieto-Baquero, Almudena

    2012-12-01

    To test the safety of the diode light therapy and evaluate the advantages of the interferential effect of two light probes versus a conventional light probe in the relief of shoulder pain and disability caused by shoulder tendinopathies. Randomized single-blind pilot study. Clinical electrotherapy unit. A total of 30 patients with shoulder pain from tendinopathies. The patients were randomly assigned into two groups. Group 1 (n = 15) received interferential light therapy generated by two independent and identical cluster probes composed of light emitting and superluminescent diodes. Similarly, two applicators were applied in group 2 (n = 15), but only one was active, as in conventional clinical therapy. Each multi-diode cluster probe was composed of seven light-emitting diodes at 600 nm and 12 superluminescent diodes at 950 nm. Pain was evaluated by visual analogue scale (VAS) at day, at night and during several shoulder movements. Shoulder functional status was measured by means of the University California Los Angeles scale (UCLA). Comparison between both treatments using the Mann-Whitney U-test showed better results for the interferential treatment. There were significant differences in pain reduction during abduction (P < 0.05) and external rotation (P < 0.05), with pain reductions in abduction and external rotation of 1.5 (± 1.3) and 0.5 (± 1.0) respectively. Interferential light therapy was safe and effective regarding the shoulder pain reduction during abduction and external rotation movements. The estimated size sample needed for future two-treatment parallel-design studies will require about 60 patients.

  6. Psychophysiological effects of massage-myofascial release after exercise: a randomized sham-control study.

    Science.gov (United States)

    Arroyo-Morales, Manuel; Olea, Nicolas; Martínez, Marin Manuel; Hidalgo-Lozano, Amparo; Ruiz-Rodríguez, Concepción; Díaz-Rodríguez, Lourdes

    2008-12-01

    The aim of this study was to evaluate the effect of massage on neuromuscular recruitment, mood state, and mechanical nociceptive threshold (MNT) after high-intensity exercise. This was a prospective randomized clinical trial using between-groups design. The study was conducted at a university-based sports medicine clinic. Sixty-two (62) healthy active students age 18-26 participated. Participants, randomized into two groups, performed three 30-second Wingate tests and immediately received whole-body massage-myofascial induction or placebo (sham ultrasound/magnetotherapy) treatment. The duration (40 minutes), position, and therapist were the same for both treatments. Dependent variables were surface electromyography (sEMG) of quadriceps, profile of mood states (POMS) and mechanical nociceptive threshold (MNT) of trapezius and masseter muscles. These data were assessed at baseline and after exercise and recovery periods. Generalized estimating equations models were performed on dependent variables to assess differences between groups. Significant differences were found in effects of treatment on sEMG of Vastus Medialis (VM) (p = 0.02) and vigor subscale (p = 0.04). After the recovery period, there was a significant decrease in electromyographic (EMG) activity of VM (p = 0.02) in the myofascial-release group versus a nonsignificant increase in the placebo group (p = 0.32), and a decrease in vigor (p exercise protocol. Massage may induce a transient loss of muscle strength or a change in the muscle fiber tension-length relationship, influenced by alterations of muscle function and a psychological state of relaxation.

  7. Oxytocin Effect on Collective Decision Making: A Randomized Placebo Controlled Study.

    Science.gov (United States)

    Hertz, Uri; Kelly, Maria; Rutledge, Robb B; Winston, Joel; Wright, Nicholas; Dolan, Raymond J; Bahrami, Bahador

    2016-01-01

    Collective decision making often benefits both the individuals and the group in a variety of contexts. However, for the group to be successful, individuals should be able to strike a balance between their level of competence and their influence on the collective decisions. The hormone oxytocin has been shown to promote trust, conformism and attention to social cues. We wondered if this hormone may increase participants' (unwarranted) reliance on their partners' opinion, resulting in a reduction in collective benefit by disturbing the balance between influence and competence. To test this hypothesis we employed a randomized double-blind placebo-controlled design in which male dyads self-administered intranasal oxytocin or placebo and then performed a visual search task together. Compared to placebo, collective benefit did not decrease under oxytocin. Using an exploratory time dependent analysis, we observed increase in collective benefit over time under oxytocin. Moreover, trial-by-trial analysis showed that under oxytocin the more competent member of each dyad was less likely to change his mind during disagreements, while the less competent member showed a greater willingness to change his mind and conform to the opinion of his more reliable partner. This role-dependent effect may be mediated by enhanced monitoring of own and other's performance level under oxytocin. Such enhanced social learning could improve the balance between influence and competence and lead to efficient and beneficial collaboration.

  8. A Simulation-based Randomized Controlled Study of Factors Influencing Chest Compression Depth

    Directory of Open Access Journals (Sweden)

    Kelsey P. Mayrand

    2015-12-01

    Full Text Available Introduction: Current resuscitation guidelines emphasize a systems approach with a strong emphasis on quality cardiopulmonary resuscitation (CPR. Despite the American Heart Association (AHA emphasis on quality CPR for over 10 years, resuscitation teams do not consistently meet recommended CPR standards. The objective is to assess the impact on chest compression depth of factors including bed height, step stool utilization, position of the rescuer’s arms and shoulders relative to the point of chest compression, and rescuer characteristics including height, weight, and gender. Methods: Fifty-six eligible subjects, including physician assistant students and first-year emergency medicine residents, were enrolled and randomized to intervention (bed lowered and step stool readily available and control (bed raised and step stool accessible, but concealed groups. We instructed all subjects to complete all interventions on a high-fidelity mannequin per AHA guidelines. Secondary end points included subject arm angle, height, weight group, and gender. Results: Using an intention to treat analysis, the mean compression depths for the intervention and control groups were not significantly different. Subjects positioning their arms at a 90-degree angle relative to the sagittal plane of the mannequin’s chest achieved a mean compression depth significantly greater than those compressing at an angle less than 90 degrees. There was a significant correlation between using a step stool and achieving the correct shoulder position. Subject height, weight group, and gender were all independently associated with compression depth. Conclusion: Rescuer arm position relative to the patient’s chest and step stool utilization during CPR are modifiable factors facilitating improved chest compression depth.

  9. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ubbink Dirk T

    2011-10-01

    Full Text Available Abstract Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale. Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such

  10. Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury

    Directory of Open Access Journals (Sweden)

    Roberts Ian

    2011-08-01

    Full Text Available Abstract Background In Traumatic Brain Injury (TBI, large between-centre differences in outcome exist and many clinicians believe that such differences influence estimation of the treatment effect in randomized controlled trial (RCTs. The aim of this study was to assess the influence of between-centre differences in outcome on the estimated treatment effect in a large RCT in TBI. Methods We used data from the MRC CRASH trial on the efficacy of corticosteroid infusion in patients with TBI. We analyzed the effect of the treatment on 14 day mortality with fixed effect logistic regression. Next we used random effects logistic regression with a random intercept to estimate the treatment effect taking into account between-centre differences in outcome. Between-centre differences in outcome were expressed with a 95% range of odds ratios (OR for centres compared to the average, based on the variance of the random effects (tau2. A random effects logistic regression model with random slopes was used to allow the treatment effect to vary by centre. The variation in treatment effect between the centres was expressed in a 95% range of the estimated treatment ORs. Results In 9978 patients from 237 centres, 14-day mortality was 19.5%. Mortality was higher in the treatment group (OR = 1.22, p = 0.00010. Using a random effects model showed large between-centre differences in outcome (95% range of centre effects: 0.27- 3.71, but did not substantially change the estimated treatment effect (OR = 1.24, p = 0.00003. There was limited, although statistically significant, between-centre variation in the treatment effect (OR = 1.22, 95% treatment OR range: 1.17-1.26. Conclusion Large between-centre differences in outcome do not necessarily affect the estimated treatment effect in RCTs, in contrast to current beliefs in the clinical area of TBI.

  11. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

    OpenAIRE

    Smith Lisa; Pisinger Charlotta; Lau Cathrine; Ovesen Lars; Ladelund Steen; Kristoffersen Lis; Toft Ulla; Borch-Johnsen Knut; Jørgensen Torben

    2008-01-01

    Abstract Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; grou...

  12. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

    Directory of Open Access Journals (Sweden)

    Rousseau Sally

    2010-10-01

    Full Text Available Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP is a National Cancer Institute-sponsored, patient-level randomized trial (RCT of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT

  13. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial.

    Science.gov (United States)

    Fron Chabouis, Hélène; Prot, Caroline; Fonteneau, Cyrille; Nasr, Karim; Chabreron, Olivier; Cazier, Stéphane; Moussally, Christian; Gaucher, Alexandre; Khabthani Ben Jaballah, Inès; Boyer, Renaud; Leforestier, Jean-François; Caumont-Prim, Aurore; Chemla, Florence; Maman, Louis; Nabet, Cathy; Attal, Jean-Pierre

    2013-09-03

    Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis. The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument's items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials. For clinicians, the CECOIA trial results may help with evidence-based recommendations concerning the choice of materials for

  14. Improving health-related fitness in children: the fit-4-Fun randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Eather Narelle

    2011-12-01

    Full Text Available Abstract Background Declining levels of physical fitness in children are linked to an increased risk of developing poor physical and mental health. Physical activity programs for children that involve regular high intensity physical activity, along with muscle and bone strengthening activities, have been identified by the World Health Organisation as a key strategy to reduce the escalating burden of ill health caused by non-communicable diseases. This paper reports the rationale and methods for a school-based intervention designed to improve physical fitness and physical activity levels of Grades 5 and 6 primary school children. Methods/Design Fit-4-Fun is an 8-week multi-component school-based health-related fitness education intervention and will be evaluated using a group randomized controlled trial. Primary schools from the Hunter Region in NSW, Australia, will be invited to participate in the program in 2011 with a target sample size of 128 primary schools children (age 10-13. The Fit-4-Fun program is theoretically grounded and will be implemented applying the Health Promoting Schools framework. Students will participate in weekly curriculum-based health and physical education lessons, daily break-time physical activities during recess and lunch, and will complete an 8-week (3 × per week home activity program with their parents and/or family members. A battery of six health-related fitness assessments, four days of pedometery-assessed physical activity and a questionnaire, will be administered at baseline, immediate post-intervention (2-months and at 6-months (from baseline to determine intervention effects. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention program, assessments, process evaluation and statistical analyses are described. Discussion The Fit-4-Fun program is an innovative school-based intervention targeting fitness improvements in primary school children. The program will

  15. A randomized controlled study of a healthy corner store initiative on the purchases of urban, low-income youth.

    Science.gov (United States)

    Lent, Michelle R; Vander Veur, Stephanie S; McCoy, Tara A; Wojtanowski, Alexis C; Sandoval, Brianna; Sherman, Sandy; Komaroff, Eugene; Foster, Gary D

    2014-12-01

    Although many initiatives exist to improve the availability of healthy foods in corner stores, few randomized trials have assessed their effects. This study evaluated, in a randomized controlled trial, the effects of a first-generation healthy corner store intervention on students' food and beverage purchases over a 2-year period. Participants (n = 767) were fourth-, fifth-, and sixth-grade students. Ten schools and their nearby corner stores (n = 24) were randomly assigned to the healthy corner store intervention or an assessment-only control. Intercept surveys directly assessed the nutritional characteristics of students' corner store purchases at baseline, 1 and 2 years. Students' weight and heights were measured at baseline, 1 and 2 years. There were no differences in energy content per intercept purchased from control or intervention schools at year 1 (P = 0.12) or 2 (P = 0.58). There were no differences between control and intervention students in BMI z score (year 1, P = 0.83; year 2, P = 0. 98) or obesity prevalence (year 1, P = 0.96; year 2, P = 0.58). A healthy corner store initiative did not result in significant changes in the energy content of corner store purchases or in continuous or categorical measures of obesity. These data will help to inform future interventions. © 2014 The Obesity Society.

  16. Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Vedanthan, Rajesh; Kamano, Jemima H; Naanyu, Violet; Delong, Allison K; Were, Martin C; Finkelstein, Eric A; Menya, Diana; Akwanalo, Constantine O; Bloomfield, Gerald S; Binanay, Cynthia A; Velazquez, Eric J; Hogan, Joseph W; Horowitz, Carol R; Inui, Thomas S; Kimaiyo, Sylvester; Fuster, Valentin

    2014-04-27

    Hypertension is the leading global risk factor for mortality. Hypertension treatment and control rates are low worldwide, and delays in seeking care are associated with increased mortality. Thus, a critical component of hypertension management is to optimize linkage and retention to care. This study investigates whether community health workers, equipped with a tailored behavioral communication strategy and smartphone technology, can increase linkage and retention of hypertensive individuals to a hypertension care program and significantly reduce blood pressure among them. The study will be conducted in the Kosirai and Turbo Divisions of western Kenya. An initial phase of qualitative inquiry will assess facilitators and barriers of linkage and retention to care using a modified Health Belief Model as a conceptual framework. Subsequently, we will conduct a cluster randomized controlled trial with three arms: 1) usual care (community health workers with the standard level of hypertension care training); 2) community health workers with an additional tailored behavioral communication strategy; and 3) community health workers with a tailored behavioral communication strategy who are also equipped with smartphone technology. The co-primary outcome measures are: 1) linkage to hypertension care, and 2) one-year change in systolic blood pressure among hypertensive individuals. Cost-effectiveness analysis will be conducted in terms of costs per unit decrease in blood pressure and costs per disability-adjusted life year gained. This study will provide evidence regarding the effectiveness and cost-effectiveness of strategies to optimize linkage and retention to hypertension care that can be applicable to non-communicable disease management in low- and middle-income countries. This trial is registered with (NCT01844596) on 30 April 2013.

  17. Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sackley, Catherine M; Smith, Christina H; Rick, Caroline; Brady, Marian C; Ives, Natalie; Patel, Ramilla; Roberts, Helen; Dowling, Francis; Jowett, Sue; Wheatley, Keith; Patel, Smitaa; Kelly, Debbie; Sands, Gina; Clarke, Carl

    2014-06-07

    Parkinson's disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment. This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson's disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control. The PD COMM pilot is a three arm, assessor-blinded, randomized controlled trial. Randomization will be computer-generated with participants randomized at a ratio of 1:1:1. Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist. The target population are patients with a confirmed diagnosis of idiopathic Parkinson's disease who have problems with their speech or voice. The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60 minutes in length over four weeks, with extra home practice. The standard speech and language therapy intervention group will receive a dose determined by patients' individual needs, but not exceeding eight weeks of treatment. The control group will receive standard care with no speech and language therapy input for at least six months post-randomization. Outcomes will be assessed at baseline (pre-randomization) and post- randomization at three, six, and 12 months. The outcome measures include patient-reported voice measures, quality of life, resource use, and assessor-rated speech recordings. The recruitment aim is at least 60 participants over 21 months from 11 sites, equating to at least 20 participants in each arm of the trial. This trial is ongoing and recruitment commenced in May 2012. This study will

  18. Myoelectrically driven functional electrical stimulation may increase motor recovery of upper limb in poststroke subjects: A randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Rune Thorsen, PhD, MScee

    2013-08-01

    Full Text Available The objective of this randomized controlled pilot study was to assess the feasibility and effectiveness of myoelectrically controlled functional electrical stimulation (MeCFES for rehabilitation of the upper limb in poststroke subjects. Eleven poststroke hemiparetic subjects with residual proximal control of the arm, but impaired volitional opening of the paretic hand, were enrolled and randomized into a treated and a control group. Subjects received 3 to 5 treatment sessions per week until totaling 25 sessions. In the experimental group, myoelectric activity from wrist and finger extensors was used to control stimulation of the same muscles. Patients treated with MeCFES (n = 5 had a significant (p = 0.04 and clinically important improvement in Action Research Arm Test score (median change 9 points, confirmed by an Individually Prioritized Problem Assessment self-evaluation score. This improvement was maintained at follow-up. The control group did not show a significant improvement (p = 0.13. The reduced sample size of participants, together with confounding factors such as spontaneous recovery, calls for larger studies to draw definite conclusions. However, the large and persistent treatment effect seen in our results indicate that MeCFES could play an important role as a clinical tool for stroke rehabilitation.

  19. Ella-V and technology usage technology usage in an english language and literacy acquisition validation randomized controlled trial study

    Directory of Open Access Journals (Sweden)

    Roisin P. Corcoran

    2014-12-01

    Full Text Available This paper describes the use of technology to provide virtual professional development (VPD for teachers and to conduct classroom observations in a study of English Language Learner (ELL instruction in grades K–3. The technology applications were part of a cluster randomized control trial (RCT design for a federally funded longitudinal validation study of a particular program, English Language and Literacy Acquisition-Validation, ELLA- V, to determine its degree of impact on English oral language/literacy, reading, and science across 63 randomly assigned urban, suburban, and rural schools (first year of implementation. ELLA-V also examines the impact of bimonthly VPD for treatment teachers compared to comparison group teachers on pedagogical skills, measured by sound observation instruments, and on student achievement, measured by state/national English language/literacy/reading tests and a national science test. This study features extensive technology use via virtual observations, bimonthly VPD, and randomly assigned treatment and control schools with students served in English as second language (ESL instructional time. The study design and methodology are discussed relativeto the specialized uses of technology and issues involving the evaluation of technology’s contribution to the intervention of interest and of the efficient, cost-effective execution of the study.

  20. Motor imagery training for children with developmental coordination disorder: Study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Adams, I.L.J.; Steenbergen, B.; Lust, J.M.; Smits-Engelsman, B.C.M.

    2016-01-01

    Background: Previous studies have shown that the predictive control of movements is impaired in children with Developmental Coordination Disorder (DCD), most likely due to a deficit in the internal modeling of movements. Motor imagery paradigms have been used to test this internal modeling deficit.

  1. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  2. Short cognitive behavioral therapy and cognitive training for adults with ADHD - a randomized controlled pilot study.

    Science.gov (United States)

    Virta, Maarit; Salakari, Anita; Antila, Mervi; Chydenius, Esa; Partinen, Markku; Kaski, Markus; Vataja, Risto; Kalska, Hely; Iivanainen, Matti

    2010-09-07

    In clinical practice, a growing need exists for effective non-pharmacological treatments of adult attention-deficit/hyperactivity disorder (ADHD). Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual cognitive- behavioral therapy (CBT), 9 adults participating in cognitive training (CT), and 10 controls. Self-report questionnaires, independent evaluations, and computerized neurocognitive testing were collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the self- report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing.

  3. Effect Of Iron Supplementation In Breastfed Infants: A Randomized Controlled Study

    OpenAIRE

    seyma Kayali; Nilgun Caylan; Gonca Yilmaz; Selim Gokce; Candemir Karacan

    2016-01-01

    Aim The purpose of this study was to investigate the efficacy of daily iron supplementation for prevention of iron-deficiency and iron-deficiency anemia in healthy exclusively breast-fed infants and the factors affecting development of iron-deficiency anemia. Methods This study was conducted with 65 infants (35 in the iron supplemented group and 30 in the non-supplemented controls) between January 2009-March 2010. Detailed physical examination of all infants was carried out at ages...

  4. Motor imagery training for children with developmental coordination disorder: Study protocol for a randomized controlled trial

    OpenAIRE

    2016-01-01

    Background Previous studies have shown that the predictive control of movements is impaired in children with Developmental Coordination Disorder (DCD), most likely due to a deficit in the internal modeling of movements. Motor imagery paradigms have been used to test this internal modeling deficit. The aim of the present study is to examine whether a training focused on the mental imagery of motor skills, can help to improve the motor abilities of children with DCD. Methods/Design A pre-post d...

  5. Aerobic endurance training versus relaxation training in patients with migraine (ARMIG: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Totzeck Andreas

    2012-04-01

    Full Text Available Abstract Background Migraine is one of the most frequent headache diseases and impairs patients’ quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized controlled trial to evaluate the efficacy of aerobic endurance training versus relaxation training in patients with migraine (ARMIG. Methods This is a single-center, open-label, prospective, randomized trial. Sixty participants with migraine are randomly allocated to either endurance training or a relaxation group. After baseline headache diary documentation over at least 4 weeks, participants in the exercise group will start moderate aerobic endurance training under a sport therapist’s supervision at least 3 times a week over a 12-week period. The second group will perform Jacobson’s progressive muscle relaxation training guided by a trained relaxation therapist, also at least 3 times a week over a 12-week period. Both study arms will train in groups of up to 10 participants. More frequent individual training is possible. The follow-up period will be 12 weeks after the training period. The general state of health, possible state of anxiety or depression, impairments due to the headache disorder, pain-related disabilities, the headache-specific locus of control, and the motor fitness status are measured with standardized questionnaires. Discussion The study design is adequate to generate meaningful results. The trial will be helpful in gaining important data on exercise training for non-medical migraine prophylaxis. Trial registration The trial is registered at ClinicalTrials.gov: NCT01407861.

  6. Needling versus liquid nitrogen cryotherapy for the treatment of pedal warts a randomized controlled pilot study.

    Science.gov (United States)

    Cunningham, Daniel J; Brimage, Jessica T; Naraghi, Reza N; Bower, Virginia M

    2014-07-01

    We hypothesized that needling of a pedal wart creates local inflammation and a subsequent cell-mediated immune response (CMIR) against human papillomavirus. The primary objective of this study was to investigate whether needling to induce a CMIR against human papillomavirus is an effective treatment for pedal warts compared with liquid nitrogen cryotherapy. A secondary objective was to investigate whether the CMIR induced by needling is effective against satellite pedal warts. Eligible patients with pedal warts were randomly allocated to receive either needling or liquid nitrogen cryotherapy. Only the primary pedal wart was treated during the study. Follow-up was 12 weeks, with outcome assessments made independently under blinded circumstances. Of 37 patients enrolled in the study, 18 were allocated to receive needling and 19 to receive liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% of the needling group (11 of 17) and in 6.2% of the liquid nitrogen cryotherapy group (1 of 16) (P =  .001). No significant relationship was found between needling of the primary pedal wart and regression of satellite pedal warts (P = .615) or complete pedal wart regression (P = .175). There was no significant difference in pain, satisfaction, or cosmesis between the two groups. The regression rate of the primary pedal wart was significantly higher in the needling group compared with the liquid nitrogen cryotherapy group.

  7. Two-year clinical evaluation of resin composite in posterior teeth: A randomized controlled study

    Science.gov (United States)

    Gianordoli-Neto, Ranulfo; Padovani, Gislaine Cristina; Mondelli, José; de Lima Navarro, Maria Fidela; Mendonça, Juliano Sartori; Santiago, Sérgio Lima

    2016-01-01

    Background: Clinical evaluations as fundamental method to prove the efficiency of restorative materials. Aim: This study evaluated the clinical performance of restorative systems during 2 years of clinical service. Materials and Methods: This study assessed the clinical performance of restorative systems (Filtek Z250 and P60), during 2 years of clinical service, using the US Public Health Service system. The randomized and double-blind study comprising thirty volunteers. The restorations were evaluated at baseline, 6, 12, and 24 months. It was used the following criteria: marginal discoloration (MD), marginal integrity (MI), superficial texture (ST), wear (W), postoperative sensitivity (PS) and recurrent caries (RC). Results: Statistic analysis was performed using Fisher's and McNemar's exact tests and Pearsons's Chi-square in a significance level of 5%. The results at baseline and 24 months for Group I were: MD – 100, 100%; MI – 100, 88.6%; ST – 100, 94.3%; W – 100, 94.3%; PS – 100, 100%; RC – 100, 100%, of alpha scores; Group II: MD – 100, 97.1%; MI – 100, 91.4%; ST – 100, 94.3%; W – 100, 91.4%; PS – 100, 100%; RC – 100, 100%, of alpha scores. It was observed no statistical difference in the evaluated criteria and period. Conclusions: After 24 months of evaluation, both restorative systems exhibited acceptable clinical performance. PMID:27563176

  8. Treadmill training improves overground walking economy in Parkinson's disease: a randomized, controlled pilot study.

    Science.gov (United States)

    Fernández-Del-Olmo, Miguel Angel; Sanchez, Jose Andres; Bello, Olalla; Lopez-Alonso, Virginia; Márquez, Gonzalo; Morenilla, Luis; Castro, Xabier; Giraldez, Manolo; Santos-García, Diego

    2014-01-01

    Gait disturbances are one of the principal and most incapacitating symptoms of Parkinson's disease (PD). In addition, walking economy is impaired in PD patients and could contribute to excess fatigue in this population. An important number of studies have shown that treadmill training can improve kinematic parameters in PD patients. However, the effects of treadmill and overground walking on the walking economy remain unknown. The goal of this study was to explore the walking economy changes in response to a treadmill and an overground training program, as well as the differences in the walking economy during treadmill and overground walking. Twenty-two mild PD patients were randomly assigned to a treadmill or overground training group. The training program consisted of 5 weeks (3 sessions/week). We evaluated the energy expenditure of overground walking, before and after each of the training programs. The energy expenditure of treadmill walking (before the program) was also evaluated. The treadmill, but not the overground training program, lead to an improvement in the walking economy (the rate of oxygen consumed per distance during overground walking at a preferred speed) in PD patients. In addition, walking on a treadmill required more energy expenditure compared with overground walking at the same speed. This study provides evidence that in mild PD patients, treadmill training is more beneficial compared with that of walking overground, leading to a greater improvement in the walking economy. This finding is of clinical importance for the therapeutic administration of exercise in PD.

  9. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liang Zhao-Hui

    2012-07-01

    Full Text Available Abstract Background Neck pain is one of the chief symptoms of cervical spondylosis (CS. Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ and The Short Form (36 Health Survey (SF-36 are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA for primary and secondary outcomes of group and time differences. Adverse events (AEs will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the

  10. The treatment of disc herniation-induced sciatica with infliximab - Results of a randomized, controlled, 3-month follow-up study

    NARCIS (Netherlands)

    Korhonen, T; Karppinen, J; Paimela, L; Malmivaara, A; Lindgren, KA; Jarvinen, S; Niinimaki, J; Veeger, N; Seitsalo, S; Hurri, H

    2005-01-01

    Study Design. A randomized controlled trial. Objectives. To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. Summary of Background Data. Recently, we obtained encouraging results in an open-label study of inflixi

  11. Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment

    Directory of Open Access Journals (Sweden)

    Jerilyn K. Allen

    2013-01-01

    Full Text Available Background. The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology. Methods. The study randomized 68 obese adults to receive one of four interventions for six months: (1 intensive counseling intervention, (2 intensive counseling plus smartphone intervention, (3 a less intensive counseling plus smartphone intervention, and (4 smartphone intervention only. The outcome measures of weight, BMI, waist circumference, and self-reported dietary intake and physical activity were assessed at baseline and six months. Results. The sample was 78% female and 49% African American, with an average age of 45 years, and average BMI of 34.3 kg/m2. There were trends for differences in weight loss among the four intervention groups. Participants in the intensive counseling plus self-monitoring smartphone group and less intensive counseling plus self-monitoring smartphone group tended to lose more weight than other groups (5.4 kg and 3.3 kg, resp.. Conclusions. The results of this pilot trial of a weight loss intervention provide preliminary support for using a smartphone application for self-monitoring as an adjunct to behavioral counseling.

  12. EFFECTIVENESS OF KATIVASTHI AND EXERCISE IN CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROL STUDY

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    Panda Ashok Kumar

    2011-02-01

    Full Text Available Chronic low back pain is very common and comprises of 2 .21% in US population and 15% in working groups over the age of 30. In this study there were two groups, one was Kativasthi therapy group and another was Exercise therapy group. Both groups were continued for 10 days. Kativasthi is process specially prepared warm medicated oil kept over low back area with Masa churna (Black gram powder paste boundary over a period of 45 minutes. An open prospective study was conducted to evaluate the effectiveness of Kativasthi (warm oil stagnation procedure in patients of chronic low back pain. Mahanarayan taila is used in Kativasthi for 10 days after Sarvanga Snehana with Mahanarayan taila (oil massage and Sarvanga Baspa Svedana (steam bath. 40 patients, aged 40±10.4 years were divided into two groups by a computer generated random number table. X ray of lumbo-sacral spine (antero-posterior & lateral view was reviewed. Differences of lumbar and ridiculer pains on an analog visual scale, Modified Oswestry Disability score and distance finger ground test were assessed at 0-day & 10th -day. There is significant improvement in all above parameters on 10th day. It was found that Kativasthi was more effective than the conventional exercise practices.

  13. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study.

    Science.gov (United States)

    Brueckmann, B; Sasaki, N; Grobara, P; Li, M K; Woo, T; de Bie, J; Maktabi, M; Lee, J; Kwo, J; Pino, R; Sabouri, A S; McGovern, F; Staehr-Rye, A K; Eikermann, M

    2015-11-01

    This study aimed to investigate whether reversal of rocuronium-induced neuromuscular blockade with sugammadex reduced the incidence of residual blockade and facilitated operating room discharge readiness. Adult patients undergoing abdominal surgery received rocuronium, followed by randomized allocation to sugammadex (2 or 4 mg kg(-1)) or usual care (neostigmine/glycopyrrolate, dosing per usual care practice) for reversal of neuromuscular blockade. Timing of reversal agent administration was based on the providers' clinical judgement. Primary endpoint was the presence of residual neuromuscular blockade at PACU admission, defined as a train-of-four (TOF) ratio sugammadex patients and 33 out of 76 (43.4%) usual care patients had TOF-Watch SX-assessed residual neuromuscular blockade at PACU admission (odds ratio 0.0, 95% CI [0-0.06], Psugammadex vs usual care (14.7 vs. 18.6 min respectively; P=0.02). After abdominal surgery, sugammadex reversal eliminated residual neuromuscular blockade in the PACU, and shortened the time from start of study medication administration to the time the patient was ready for discharge from the operating room. Clinicaltrials.gov:NCT01479764. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  14. Carboprost Versus Oxytocin for Active Management of Third Stage of Labor: A Prospective Randomized Control Study.

    Science.gov (United States)

    Sunil Kumar, K S; Shyam, Sundar; Batakurki, Pavitra

    2016-10-01

    Postpartum hemorrhage is the single largest and leading cause of maternal morbidity and mortality not only in developing countries but also in developed countries. The present study is an attempt to evaluate the scope of using prophylactic intramuscular carboprost tromethamine 125 μg in comparison with intramuscular oxytocin 10 units for the active management of third stage of labor. Two hundred pregnant women at term with spontaneous onset of labor were included in the study and were randomly divided into 2 groups of 100 women each. Group A and group B were given injection oxytocin 10 units and injection carboprost tromethamine 125 μg intramuscularly, respectively, at the time of delivery of anterior shoulder. The main outcome measures with respect to third stage of labor were: duration, blood loss by volume, difference in hemoglobin, need for additional oxytocics and side effects. Subjects who received carboprost tromethamine 125 μg showed a significant reduction in duration of third stage of labor (p oxytocin 10 units. Likelihood of occurrence of postpartum hemorrhage was reduced without significant side effects except for diarrhea. Additional need for other uterotonics after carboprost was significantly less compared to oxytocin. Intramuscular carboprost 125 μg is a better cost-effective alternative as compared to 10 units intramuscular oxytocin in active management of third stage of labor.

  15. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study.

    Science.gov (United States)

    Särkämö, Teppo; Tervaniemi, Mari; Laitinen, Sari; Numminen, Ava; Kurki, Merja; Johnson, Julene K; Rantanen, Pekka

    2014-08-01

    During aging, musical activities can help maintain physical and mental health and cognitive abilities, but their rehabilitative use has not been systematically explored in persons with dementia (PWDs). Our aim was to determine the efficacy of a novel music intervention based on coaching the caregivers of PWDs to use either singing or music listening regularly as a part of everyday care. Eighty-nine PWD-caregiver dyads were randomized to a 10-week singing coaching group (n = 30), a 10-week music listening coaching group (n = 29), or a usual care control group (n = 30). The coaching sessions consisted primarily of singing/listening familiar songs coupled occasionally with vocal exercises and rhythmic movements (singing group) and reminiscence and discussions (music listening group). In addition, the intervention included regular musical exercises at home. All PWDs underwent an extensive neuropsychological assessment, which included cognitive tests, as well as mood and quality of life (QOL) scales, before and after the intervention period and 6 months later. In addition, the psychological well-being of family members was repeatedly assessed with questionnaires. Compared with usual care, both singing and music listening improved mood, orientation, and remote episodic memory and to a lesser extent, also attention and executive function and general cognition. Singing also enhanced short-term and working memory and caregiver well-being, whereas music listening had a positive effect on QOL. Regular musical leisure activities can have long-term cognitive, emotional, and social benefits in mild/moderate dementia and could therefore be utilized in dementia care and rehabilitation. © The Author 2013. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. Effect of Brazilian green propolis in patients with type 2 diabetes: A double-blind randomized placebo-controlled study

    Science.gov (United States)

    FUKUDA, TAKUYA; FUKUI, MICHIAKI; TANAKA, MUHEI; SENMARU, TAKAFUMI; IWASE, HIROYA; YAMAZAKI, MASAHIRO; AOI, WATARU; INUI, TOSHIO; NAKAMURA, NAOTO; MARUNAKA, YOSHINORI

    2015-01-01

    Propolis contains a variety of chemical compounds, including polyphenols, flavonoids, phenolic aldehydes, amino acids and vitamins, and presents numerous biological and pharmacological properties. The aim of the present study was to evaluate the effect of propolis on blood examination data in patients with type 2 diabetes. In the double-blind, 8-week randomized controlled study, 80 patients with type 2 diabetes were enrolled. Patients were randomly assigned to receive Brazilian green propolis (226.8 mg/day for 8 weeks) (n=41) or the placebo (n=39). The primary endpoint was to detect changes in blood examination data associated with metabolic disorders in patients suffering from diabetes mellitus, including the homeostasis model assessment of insulin resistance (HOMA-IR), uric acid and estimated glomerular filtration rate (eGFR) from baseline to the end of this study. The value of HOMA-IR was not significantly changed by the 8-week administration of propolis or placebo from the baseline data. Values of blood uric acid and eGFR in patients taking the placebo became worse at 8 weeks compared to the baseline, whereas this did not occur in patients consuming Brazilian green propolis. However, HOMA-IR was not improved by propolis intake. A randomized, controlled 8-week trial suggests that Brazilian green propolis (226.8 mg/day) prevents patients with type 2 diabetes from developing worse blood uric acid and eGFR. PMID:26137235

  17. Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hongying Kuang

    2013-01-01

    Full Text Available Acupuncture is an alternative therapy to induce ovulation in women with polycystic ovary syndrome (PCOS, but there is no study reporting the live birth rate following ovulation induction by acupuncture or its potential as an adjuvant treatment to clomiphene citrate (CC. We assess the efficacy of acupuncture with or without CC in achieving live births among 1000 PCOS women in Mainland China. This paper reports the methodology of an ongoing multicenter randomized controlled trial. The randomization scheme is coordinated through the central mechanism and stratified by the participating sites. Participants will be randomized into one of the four treatment arms: (A true acupuncture and CC, (B control acupuncture and CC, (C true acupuncture and placebo CC, and (D control acupuncture and placebo CC. To ensure the quality and integrity of the trial we have developed a unique multinational team of investigators and Data and Safety Monitoring Board. Up to the end of April 2013, 326 subjects were recruited. In conclusion, the success of this trial will allow us to evaluate the additional benefit of acupuncture beyond the first line medicine for fertility treatment in PCOS women in an unbiased manner.

  18. Chest pain control with kinesiology taping after lobectomy for lung cancer: initial results of a randomized placebo-controlled study.

    Science.gov (United States)

    Imperatori, Andrea; Grande, Annamaria; Castiglioni, Massimo; Gasperini, Laura; Faini, Agnese; Spampatti, Sebastiano; Nardecchia, Elisa; Terzaghi, Lorena; Dominioni, Lorenzo; Rotolo, Nicola

    2016-08-01

    Kinesiology taping (KT) is a rehabilitative technique performed by the cutaneous application of a special elastic tape. We tested the safety and efficacy of KT in reducing postoperative chest pain after lung lobectomy. One-hundred and seventeen consecutive patients, both genders, age 18-85, undergoing lobectomy for lung cancer between January 2013 and July 2015 were initially considered. Lobectomies were performed by the same surgical team, with thoracotomy or video-assisted thoracoscopic surgery (VATS) access. Exclusion criteria (n = 25 patients) were: previous KT exposure, recent trauma, pre-existing chest pain, lack of informed consent, >24-h postoperative intensive care unit treatment. After surgery, the 92 eligible patients were randomized to KT experimental group (n = 46) or placebo control group (n = 46). Standard postoperative analgesia was administered in both groups (paracetamol/non-steroidal anti-inflammatory drugs, epidural analgesia including opioids), with supplemental analgesia boluses at patient request. On postoperative day 1 in addition, in experimental group patients a specialized physiotherapist applied KT, with standardized tape length, tension and shape, over three defined skin areas: at the chest access site pain trigger point; over the ipsilateral deltoid/trapezius; lower anterior chest. In control group, usual dressing tape mimicking KT was applied over the same areas, as placebo. Thoracic pain severity score [visual analogue scale (VAS) ranging 0-10] was self-assessed by all patients on postoperative days 1, 2, 5, 8, 9 and 30. The KT group and the control group had similar demographics, lung cancer clinico-pathological features and thoracotomy/VATS ratio. Postoperatively, the two groups also resulted similar in supplemental analgesia, complication rate, mean duration of chest drainage and length of stay. There were no adverse events with KT application. After tape application, KT patients reported overall less thoracic pain than the

  19. The effect of Breezy candy on halitosis: a double-blind, controlled, and randomized study.

    Science.gov (United States)

    Barak, Shlomo; Katz, Joseph

    2012-04-01

    Halitosis (bad breath) is a common condition that is socially crippling for vast parts of the population and results from malodorous volatile sulfur compounds, which are by-products of oral bacteria. In this doubled-blind, randomized study, 75 subjects with halitosis were evaluated. The participants were treated with or without abrasive microcapsules (candy) containing zinc gluconate 0.5%, propolis 2%, and a combination of both (zinc 0.25% and propolis 1%). The halitosis was assessed by a Halimeter, a portable instrument that measures the emission of volatile sulfur compounds at different time exposures to the treatments. Breezy candy (which is sugar-free) was found effective in the treatment of halitosis for up to 4 hours. While treatment with regular candy (group 1, traditional candy without abrasive particles) showed reduction in malodor of 10%, Breezy candy showed reduction of up to 60% in malodor (P halitosis. The combined effect of abrasion by microcapsules with zinc supplement represents a novel and successful approach for the treatment of halitosis.

  20. Acupuncture compared with placebo acupuncture in radiotherapy-induced nausea--a randomized controlled study.

    Science.gov (United States)

    Enblom, A; Johnsson, A; Hammar, M; Onelöv, E; Steineck, G; Börjeson, S

    2012-05-01

    It is not known if verum (real) acupuncture is effective for nausea and vomiting (emesis) during radiotherapy. We randomly treated 215 blinded cancer patients with verum: penetrating 'deqi' creating acupuncture (n = 109) or non-penetrating sham needles (n = 106) two to three times per week. The patients documented emesis daily during the radiotherapy period. Primary end point was the number of patients with at least one episode of nausea. In the verum and the sham acupuncture group, 70% and 62% experienced nausea at least once during the radiotherapy period (relative risk 1.1, 95% CI 0.9-1.4) for a mean number of 10.1 and 8.7 days. Twenty five percent and 28% vomited, and 42% and 37% used antiemetic drugs at least once, respectively. Ninety-five percent in the verum acupuncture group and 96% in the sham acupuncture group believed that the treatment had been effective against nausea. In both groups, 67% experienced positive effects on relaxation, mood, sleep or pain reduction and 89% wished to receive the treatment again. Acupuncture creating deqi is not more effective than sham in radiotherapy-induced nausea, but in this study, nearly all patients in both groups experienced that the treatment was effective for nausea.

  1. The chronic care for age-related macular degeneration study (CHARMED: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Held Ulrike

    2011-10-01

    Full Text Available Abstract Background Neovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world. As in other chronic diseases, several effective treatments are available, but in clinical daily practice there is an evidence performance gap. The Chronic Care Model represents an evidence-based framework for the care of chronically ill patients and aims at closing that gap. However, no data are available regarding patients with neovascular age-related macular degeneration. Methods/Design CHARMED is a multicenter randomized controlled trial. The study challenges the hypothesis that the implementation of core elements of the Chronic Care Model (patient empowerment, delivering evidence based information, clinical information system, reminder system with structured follow up and frequent monitoring via a specially trained Chronic Care Coach in Swiss centres for neovascular age-related macular degeneration results in better visual acuity (primary outcome and an increased disease specific quality of life (secondary outcome in patients with neovascular age-related macular degeneration. According to the power calculation, a total sample size of 352 patients is needed (drop out rate of 25%. 14 specialised medical doctors from leading ophtalmologic centres in Switzerland will include 25 patients. In each centre, a Chronic Care Coach will provide disease specific care according to the Chronic Care Model for intervention group. Patients from the control group will be treated as usual. Baseline measurements will be taken in month III - XII, starting in March 2011. Follow-up data will be collected after 6 months and 1 year. Discussion Multiple studies have shown that implementing Chronic Care Model elements improve clinical outcomes as well as process parameters in different chronic diseases as osteoarthritis, depression or e.g. the cardiovascular risk profile of diabetes patients. This

  2. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study.

    Science.gov (United States)

    Peungsuwan, Punnee; Parasin, Pattamavadee; Siritaratiwat, Wantana; Prasertnu, Jilada; Yamauchi, Junichiro

    2017-01-01

    The purpose of this study was to investigate the effects of combined exercise training on functional performance in participants with cerebral palsy. Fifteen participants with spastic cerebral palsy were randomly allocated into either exercise or control groups. Participants in the exercise group participated in a combined strength and endurance training program for 70 minutes per day, 3 days per week, for 8 weeks, whereas those in the control group did not participate in an exercise program. Study participants in both groups continued with their regular physical therapy during the study. After the 8-week training, a 6-minute walk, 30-second sit-to-stand, 10-m walk, and Functional Reach Tests, participants in the exercise group had significant improvement over their baseline values and were significantly higher than those in the control group. Combined exercise training improved walking ability, functional lower limb strength, and balance in participants with cerebral palsy.

  3. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  4. Effect of Acupressure on Non-stress Test (NST Results: A Randomized-Controlled Trial Study

    Directory of Open Access Journals (Sweden)

    Masoume Pirhadi

    2015-10-01

    Full Text Available BackgroundPregnancy and delivery are among the most stressful events in women’s life . Breech presentation is defined as a fetus in a longitudinal lie with the buttocks or feet closest to the cervix. This occurs in 3-4% of all deliveries.The risk for perinatal mortality was 1 in 300 for planned breech deliveries.Some conventional non-surgical therapies for breech presentation are available. acupoint (BL67 stimulations are commonly used for the correction of breech presentation. The present study aimed to evaluate the effect of acupressure on fetal wellbeing test results.MethodThis study is a clinical trialthat was conducted in one group and the two-steps.Participantswere pregnant women (primigravida who were 35 to 18 years that refer to Shahid Beheshti hospital in Isfahan in 2013 to receive routine prenatal care.The 32 pregnant women (32-36 weeks were randomly selected.They were stimulated immediately after the first Non stress test and before the second test.The researchers’ evaluated and analyzed variables using SPSS software version 20.FindingsMean (SD age of the subjects was 24/7±2/8 and 93/8% of them was housekeeper. The frequency of reactive Non Stress Test (NST was same before and after stimulation. The mean time of the tests’ result was decreased after stimulation significantly ( p-value=0.048. ConclusionsAlthough fetal non-stress test result wasn’t influenced by acupressure but this intervention led to shorter testing time to achieve results. In other words, after the intervention, the time it takes to reach a reactive fetal non-stress test is about 2/7 minutes less than the time without intervention.

  5. Ondansetron in patients with tinnitus: randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Taslimi, Shervin; Vahidi, Hamed; Pourvaziri, Ali; Modabbernia, Amirhossein; Fallah, Arezoo Yeke; Yazdani, Nasrin; Taslimi, Negin; Hosseini, Mostafa; Zarandi, Masoud Motesadi

    2013-05-01

    The aim of this study was to assess the effect of ondansetron on symptoms of patients with subjective tinnitus accompanied by sensorineural hearing loss or normal hearing. Sixty patients with a chief complaint of tinnitus (with duration of more than 3 months) were equally randomized to ondansetron or placebo for 4 weeks. The dose of ondansetron was gradually increased from 4 mg/day (one tablet) to 16 mg/day (4 tablets) during 12 days and then continued up to 4 weeks. The exact number of tablets was prescribed in the placebo group. Patients underwent audiologic examinations and filled questionnaires at baseline and after 4 weeks of treatment. Our primary outcomes were changes in Tinnitus Handicap Inventory questionnaire (THI), Tinnitus Severity Index (TSI) and visual analog scale (VAS) scores. Our secondary outcomes were the changes in depression and anxiety based on Hospital Anxiety and Depression (HADS) questionnaire, side effects, tinnitus loudness matching, tinnitus pitch matching, pure tone audiometry and speech recognition threshold (SRT). In the ondansetron and placebo groups, 27 and 26 patients completed the study, respectively. The changes in VAS (P = 0.934), THI (P = 0.776), anxiety (P = 0.313) and depression (P = 0.163) scores were not different between the groups. TSI score decreased significantly in the ondansetron compared with the placebo group (P = 0.004). Changes in tinnitus loudness matching (P = 0.75) and pitch matching (P = 0.56) did not differ between the two groups. Ondansetron, but not placebo, decreased the SRT threshold (right, P tinnitus hypothetically through cochlear amplification.

  6. Patients' communication with doctors: a randomized control study of a brief patient communication intervention.

    Science.gov (United States)

    Talen, Mary R; Muller-Held, Christine F; Eshleman, Kate Grampp; Stephens, Lorraine

    2011-09-01

    In research on doctor-patient communication, the patient role in the communication process has received little attention. The dynamic interactions of shared decision making and partnership styles which involve active patient communication are becoming a growing area of focus in doctor-patient communication. However, patients rarely know what makes "good communication" with medical providers and even fewer have received coaching in this type of communication. In this study, 180 patients were randomly assigned to either an intervention group using a written communication tool to facilitate doctor-patient communication or to standard care. The goal of this intervention was to assist patients in becoming more effective communicators with their physicians. The physicians and patients both rated the quality of the communication after the office visit based on the patients' knowledge of their health concerns, organizational skills and questions, and attitudes of ownership and partnership. The results supported that patients in the intervention group had significantly better communication with their doctors than patients in the standard care condition. Physicians also rated patients who were in the intervention group as having better overall communication and organizational skills, and a more positive attitude during the office visit. This study supports that helping patients structure their communication using a written format can facilitate doctor-patient communication. Patients can become more adept at describing their health concerns, organizing their needs and questions, and being proactive, which can have a positive effect on the quality of the doctor-patient communication during outpatient office visits. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

  7. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nascimento, L S; Santos, A C; Lucena, Jms; Silva, Lgo; Almeida, Aem; Brasileiro-Santos, M S

    2017-06-02

    Resistant hypertension is a specific condition that affects approximately 10% of subjects with hypertension, and is characterized by persistently high blood pressure levels even using therapy of three or more antihypertensive agents or with blood pressure control using therapy with four or more antihypertensive agents. Changes in lifestyle, such as physical exercise, are indicated for controlling blood pressure. However, investigating studies about this therapy in individuals with resistant hypertension are few. This is a randomized controlled clinical trial. Forty-eight patients with resistant hypertension will be submitted to perform four short-term interventions: aerobic exercise sessions (mild-, moderate- and high-intensity) and control session, in random order and on separate days. After the short-term sessions, the patients will be randomly allocated into four groups for 8 weeks of follow-up: mild-, moderate- and high-intensity aerobic exercise, and a control group. The primary outcome is the occurrence of blood pressure reduction (office and ambulatory analysis, and acute and chronic effects). Secondary outcomes are autonomic and hemodynamic mechanisms: cardiac and vasomotor autonomic modulation, spontaneous baroreflex sensitivity, forearm blood flow and vascular resistance. The importance of exercise for hypertension has been known for decades, but little is known about the effects on patients with resistant hypertension. This study will help to understand whether different aerobic exercise intensities can induce different responses, as well as by what mechanisms adjustments in blood pressure levels may occur. ClinicalTrials.gov, ID: NCT02670681 . Registered on 28 January 2016 (first version); Brazilian Registry Platform Clinical Trials: protocol RBR-5q24zh . Registered on 24 June 2015.

  8. Evaluating a selective prevention programme for binge drinking among young adolescents: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wiers Reinout

    2011-02-01

    Full Text Available Abstract Background In comparison to other Europe countries, Dutch adolescents are at the top in drinking frequency and binge drinking. A total of 75% of the Dutch 12 to 16 year olds who drink alcohol also engage in binge drinking. A prevention programme called Preventure was developed in Canada to prevent adolescents from binge drinking. This article describes a study that aims to assess the effects of this selective school-based prevention programme in the Netherlands. Methods A randomized controlled trial is being conducted among 13 to 15-year-old adolescents in secondary schools. Schools were randomly assigned to the intervention and control conditions. The intervention condition consisted of two 90 minute group sessions, carried out at the participants' schools and provided by a qualified counsellor and a co-facilitator. The intervention targeted young adolescents who demonstrated personality risk for alcohol abuse. The group sessions were adapted to four personality profiles. The control condition received no further intervention above the standard substance use education sessions provided in the Dutch national curriculum. The primary outcomes will be the percentage reduction in binge drinking, weekly drinking and drinking-related problems after three specified time periods. A screening survey collected data by means of an Internet questionnaire. Students have completed, or will complete, a post-treatment survey after 2, 6, and 12 months, also by means of an online questionnaire. Discussion This study protocol presents the design and current implementation of a randomized controlled trial to evaluate the effectiveness of a selective alcohol prevention programme. We expect that a significantly lower number of adolescents will binge drink, drink weekly, and have drinking-related problems in the intervention condition compared to the control condition, as a result of this intervention. Trial registration This trial is registered in the Dutch

  9. Surgically induced astigmatism after phacoemulsification with and without correction for posture-related ocular cyclotorsion: randomized controlled study.

    LENUS (Irish Health Repository)

    Dooley, Ian

    2012-02-01

    PURPOSE: To report the impact of posture-related ocular cyclotorsion on one surgeon\\'s surgically induced astigmatism (SIA) results and the variance in SIA. SETTING: Institute of Eye Surgery, Whitfield Clinic, Waterford, Ireland. METHODS: This prospective randomized controlled study included eyes that had phacoemulsification with intraocular lens implantation. Eyes were randomly assigned to have (intervention group) or not have (control group) correction for posture-related ocular cyclotorsion. In the intervention group, the clear corneal incision was placed precisely at the 120-degree meridian with instruments designed to correct posture-related ocular cyclotorsion. In the control group, the surgeon endeavored to place the incision at the 120-degree meridian, but without markings. RESULTS: The intervention group comprised 41 eyes and the control group, 61 eyes. The mean absolute SIA was 0.74 diopters (D) in the intervention group and 0.78 D in the control group; the difference between groups was not statistically significant (P>.5, unpaired 2-tailed Student t test). The variance in SIA was 0.29 D(2) and 0.31 D(2), respectively; the difference between groups was not statistically significant (P>.5, unpaired F test). CONCLUSIONS: Attempts to correct for posture-related ocular cyclotorsion did not influence SIA or its variance in a single-surgeon series. These results should be interpreted with full appreciation of the limitations of currently available techniques to correct for posture-related ocular cyclotorsion in the clinical setting.

  10. Motivational Interviewing delivered by existing prison staff: a randomized controlled study of effectiveness on substance use after release.

    Science.gov (United States)

    Forsberg, Lars Georg; Ernst, Denise; Sundqvist, Kristina; Farbring, Carl Åke

    2011-01-01

    A sample of 296 drug-using inmates in 14 Swedish prisons was randomized during 2004-2006 into three intervention groups; Motivational Interviewing delivered by counselors with workshop-only training, or by counselors with workshop training followed by peer group supervision, and controls. Drug and alcohol use was measured by the Addiction Severity Index (ASI) at intake and at 10 months after release. Complete data from 114 clients were analyzed by a stepwise regression analysis. All three groups reduced alcohol and drug use. Limitations in the study are discussed and future research is suggested. The study is financed by grants from the Research Committee of the National Prison and Probation Administration.

  11. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

    Directory of Open Access Journals (Sweden)

    Lutschg Meghan Z

    2011-10-01

    Full Text Available Abstract Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control. All participants at the hospital (cluster were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful

  12. The use of Animal-Assisted Therapy in adolescents with acute mental disorders: A randomized controlled study.

    Science.gov (United States)

    Stefanini, M C; Martino, A; Allori, P; Galeotti, F; Tani, F

    2015-02-01

    The aim of this study was to compare the effects of Animal-Assisted Therapy (AAT) with a standard treatment protocol in children and adolescents admitted to the psychiatry hospital for acute mental disorders. We used a methodology involving high quality standards for AAT research. A pre-post experimental design with a randomized controlled trial (RCT) in 34 hospitalized patients (17 treatment, 17 control) was carried out. The study focused on improvement in clinical status including, global functioning measured by the Children Global Assessment Scale (C GAS), format of care and ordinary school attendance measured by a rating scale. Our results indicate a statistically significant improvement in global functioning, reduction in format of care and increased ordinary school attendance in the treatment group, but not in the control group. Our results verify that AAT can have significant positive effects on therapeutic progress and the recovery process. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Is magnetotherapy applied to bilateral hips effective in ankylosing spondylitis patients? A randomized, double-blind, controlled study.

    Science.gov (United States)

    Turan, Yasemin; Bayraktar, Kevser; Kahvecioglu, Fatih; Tastaban, Engin; Aydin, Elif; Kurt Omurlu, Imran; Berkit, Isil Karatas

    2014-03-01

    This double-blind, randomized controlled study was conducted with the aim to investigate the effect of magnetic field therapy applied to the hip region on clinical and functional status in ankylosing spondylitis (AS) patients. Patients with AS (n = 66) who were diagnosed according to modified New York criteria were enrolled in this study. Patients were randomly divided in two groups. Participants were randomly assigned to receive magnetic field therapy (2 Hz) (n = 35), or placebo magnetic field therapy (n = 31) each hip region for 20 min. Patients in each group were given heat pack and short-wave treatments applied to bilateral hip regions. Both groups had articular range of motion and stretching exercises and strengthening exercises for surrounding muscles for the hip region as well as breathing and postural exercises by the same physical therapist. These treatment protocols were continued for a total of 15 sessions (1 session per day), and patients were examined by the same physician at months 1, 3 and 6. Visual analogue scale (VAS) pain, VAS fatigue, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrologic Index (BASMI), DFI, Harris hip assessment index and Ankylosing Spondylitis Quality of Life scale (ASQOL) were obtained at the beginning of therapy and at month 1, month 3 and month 6 for each patient. There were no significant differences between groups in the VAS pain, VAS fatigue, morning stiffness, BASDAI, BASFI, BASMI, DFI, Harris hip assessment index and ASQoL at baseline, month 1, month 3 or month 6 (p > 0.05). Further randomized, double-blind controlled studies are needed in order to establish the evidence level for the efficacy of modalities with known analgesic and anti-inflammatory action such as magnetotherapy, particularly in rheumatic disorders associated with chronic pain.

  14. Effect of Helicobacter pylori Eradication on Reflux Esophagitis Therapy: A Multi-center Randomized Control Study

    Institute of Scientific and Technical Information of China (English)

    Yan Xue; Li-Ya Zhou; San-Ren Lin; Xiao-Hua Hou; Zhao-Shen Li; Min-Hu Chen; Xiu-E Yan

    2015-01-01

    Background:Helicobacterpylori (H.pylori) frequently colonizes the stomach.Gastroesophageal reflux disease (GERD) is a common and costly disease.But the relationship ofH.pylori and GERD is still unclear.This study aimed to explore the effect ofH.pylori and its eradication on reflux esophagitis therapy.Methods:Patients diagnosed with reflux esophagitis by endoscopy were enrolled;based on rapid urease test and Warth-Starry stain,they were divided into H.pylori positive and negative groups.H.pylori positive patients were randomly given H.pylori eradication treatment for 1 0 days,then esomeprazole 20 mg bid for 46 days.The other patients received esomeprazole 20 mg bid therapy for 8 weeks.After treatment,three patient groups were obtained:H.pylori positive eradicated,H.pylori positive uneradicated,and H.pylori negative.Before and after therapy,reflux symptoms were scored and compared.Healing rates were compared among groups.The x2 test and t-test were used,respectively,for enumeration and measurement data.Results:There were 176 H.pylori positive (with 92 eradication cases) and 180 negative cases.Healing rates in the H.pylori positive eradicated and H.pylori positive uneradicated groups reached 80.4% and 79.8% (P =0.911),with reflux symptom scores of 0.22 and 0.14 (P =0.588).Healing rates of esophagitis in the H.pylori positive uneradicated and H.pylori negative groups were,respectively,79.8% and 82.2% (P =0.848);reflux symptom scores were 0.14 and 0.21 (P =0.546).Conclusions:Based on esomeprazole therapy,H.pylori infection and eradication have no significant effect on reflux esophagitis therapy.

  15. Regenerative Endodontics Versus Apexification in Immature Permanent Teeth with Apical Periodontitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lin, Jiacheng; Zeng, Qian; Wei, Xi; Zhao, Wei; Cui, Minyi; Gu, Jing; Lu, Jiaxuan; Yang, Maobin; Ling, Junqi

    2017-08-29

    The aim of the study was to compare the outcomes of regenerative endodontic treatment (RET) and apexification on immature permanent teeth with pulp necrosis and apical periodontitis. A total of 118 patients (118 teeth) were recruited and randomly assigned to either RET or apexification treatment. Each treatment group was divided into 2 subgroups according to the etiology: dens evaginatus or trauma. Clinical symptoms and complications were recorded, and cone-beam computed tomographic imaging with a limited field of view was used to measure the change of root length, root thickness, and apical foramen size at the 12-month follow-up. The t test/rank sum test and Fisher exact test were applied to compare the change of root morphology between RET and apexification. One hundred three of 118 cases were completed at the 12-month follow-up. The survival rate was 100% for both treatment groups. All cases were asymptomatic with apical healing. The RET group showed a significant increase in root length and root thickness compared with the apexification group (P < .05). In the RET group, the cases caused by dens evaginatus achieved increased root length and root thickness compared with those caused by trauma (P < .05). RET and apexification achieved a comparable outcome in regard to the resolution of symptoms and apical healing. RET showed a better outcome than apexification regarding increased root thickness and root length. The etiology had an impact on the outcome of RET. Dens evaginatus cases showed better prognoses than trauma cases after RET. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  16. Resistance versus Balance Training to Improve Postural Control in Parkinson's Disease: A Randomized Rater Blinded Controlled Study.

    Directory of Open Access Journals (Sweden)

    Christian Schlenstedt

    Full Text Available Reduced muscle strength is an independent risk factor for falls and related to postural instability in individuals with Parkinson's disease. The ability of resistance training to improve postural control still remains unclear.To compare resistance training with balance training to improve postural control in people with Parkinson's disease.40 patients with idiopathic Parkinson's disease (Hoehn&Yahr: 2.5-3.0 were randomly assigned into resistance or balance training (2x/week for 7 weeks. Assessments were performed at baseline, 8- and 12-weeks follow-up: primary outcome: Fullerton Advanced Balance (FAB scale; secondary outcomes: center of mass analysis during surface perturbations, Timed-up-and-go-test, Unified Parkinson's Disease Rating Scale, Clinical Global Impression, gait analysis, maximal isometric leg strength, PDQ-39, Beck Depression Inventory. Clinical tests were videotaped and analysed by a second rater, blind to group allocation and assessment time.32 participants (resistance training: n = 17, balance training: n = 15; 8 drop-outs were analyzed at 8-weeks follow-up. No significant difference was found in the FAB scale when comparing the effects of the two training types (p = 0.14; effect size (Cohen's d = -0.59. Participants from the resistance training group, but not from the balance training group significantly improved on the FAB scale (resistance training: +2.4 points, Cohen's d = -0.46; balance training: +0.3 points, Cohen's d = -0.08. Within the resistance training group, improvements of the FAB scale were significantly correlated with improvements of rate of force development and stride time variability. No significant differences were found in the secondary outcome measures when comparing the training effects of both training types.The difference between resistance and balance training to improve postural control in people with Parkinson's disease was small and not significant with this sample size. There was weak evidence that

  17. Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review

    Science.gov (United States)

    Le Fourn, Elodie; Giraudeau, Bruno; Chosidow, Olivier; Doutre, Marie-Sylvie; Lorette, Gérard

    2013-01-01

    Background The recommended first-line therapy of chronic urticaria is second-generation antihistamines, but the modalities of treatment remains unclear. Numerous recommendations with heterogeneous conclusions have been published. We wondered whether such heterogeneous conclusions were linked to the quality of published studies and their reporting. Objective To review the study design and quality of reporting of randomized control trials investigating pharmacological treatment of autoimmune or idiopathic chronic urticaria. Methodology/Principal Findings MEDLINE and EMBASE were searched for pharmacological randomized controlled trials involving patients with chronic autoimmune or idiopathic urticaria, with the main outcome being treatment efficacy. Data were collected on general characteristics of the studies, internal validity, studied treatments, design of the trial, outcome measures and “spin” strategy in interpreting results. Spin was defined as use of specific reporting strategies to highlight that the experimental treatment is beneficial, despite statistically nonsignificant results. We evaluated 52 articles that met our criteria. Patients were reported as blinded in 42 articles (81%) and the outcome assessor was blinded in 37 (71%). A placebo was the only comparator in 13 (25%) studies. The study duration was urticaria, studies should focus on choosing clinically relevant and reproducible primary outcomes, long-term follow-up, limited use of placebo and avoiding spin strategies. PMID:23940632

  18. a randomized controlled clinical trial

    OpenAIRE

    2013-01-01

    In this study we aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. 77 with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale (VAS) were randomized to a nine week Iyengar yoga program with weekly 90-minute classes or to a self-care/exercise program. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week ten. Secondary outcomes included pain at motion, functional disabilit...

  19. PERIPHERAL APPLICATION OF REPETITIVE PULSE MAGNETIC STIMULATION ON JOINT CONTRACTURE FOR MOBILITY RESTORATION: CONTROLLED RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Efthimios J. Kouloulas

    2016-10-01

    Full Text Available Background: Joint contracture is a limitation in the passive or active range of motion (ROM of a joint, where in addition to the mobility limiting factor the pain is also present. Repetitive pulsed Magnetic Stimulation (rPMS appears to be an effective, non-invasive and safety solution for treating this condition. Therefore aim of this study was to evaluate the effect of rPMS in treating joint contracture. Methods: 30 subjects with joint contracture in the knee were enrolled in this study and divided respectively into Treatment and Control group. The treatment group were delivered with rPMS therapy. The control group was delivered with conventional physiotherapy method (ultrasound. The primary outcome measurements were: 1. Mobility evaluation by goniometry (ROM in degrees while performing flexion and Patient Functional Assessment Questionnaire (PFAQ for ability to perform Activities of Daily Living (ADL and 2. Pain evaluation by 10-point Visual Analog Scale (VAS for pain perception. Absence of adverse events was set as a secondary measure. Results: The results of the study show statistical difference (p<0.05 between the levels of improvement of all studied parameters while comparing between both groups. The results suggest greater immobility restoration and pain relieving effect of the rPMS in comparison to conventional physiotherapy method. Conclusion: rPMS an effective and safe non-invasive method for mobility restoration and pain relief in case of joint contractures. This study suggests the method as beneficial and quality of life ameliorating among patients suffering from immobilized joints accompanied by pain.

  20. Pregnant womens' concerns when invited to a randomized trial : a qualitative case control study

    NARCIS (Netherlands)

    Oude Rengerink, Katrien; Logtenberg, Sabine; Hooft, Lotty; Bossuyt, Patrick M; Mol, Ben Willem; Oude Rengerink, K

    2015-01-01

    BACKGROUND: Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolm

  1. The “Healthy Habits, Healthy Girls” randomized controlled trial for girls: study design, protocol, and baseline results

    Directory of Open Access Journals (Sweden)

    Ana Carolina Barco Leme

    2015-07-01

    Full Text Available The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices. There were no significant differences between the groups for most of the variables, except age (p = 0.000 and waist circumference (p = 0.014. The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  2. Effectiveness of team-based learning in microbiology: a non-randomized control study.

    Science.gov (United States)

    Harakuni, Sheetal U; Nagamoti, Jyoti M; Mallapur, Maheshwar D

    2015-01-01

    As per the present curriculum in India, pre- and paraclinical subjects are taught away from the clinical setting. Therefore, students fail to connect the subject taught through didactic lectures to the clinical setting. Team-based learning (TBL) can be used in conjunction with lectures to teach applied microbiology. This study aims to evaluate the effectiveness of TBL sessions in conjunction with lectures to enhance learning of applied microbiology, among Indian students. All students enrolled in the study were taught systemic bacteriology through lectures. Of the 88 students, 49 students (study group) attended TBL sessions on the topics of diarrhea, fever of unknown origin, urinary tract infection and 39 students (control group) preferred self-study on the topics without attending the TBL sessions. Students' feedback on their perception on TBL sessions was collected using a questionnaire of 10 items. The performance of both the groups on the pre- and post-test were analyzed using unpaired t-test and analysis of variance (ANOVA). Gender-wise performance within the teams was analyzed by paired t-test using SPSS version 12. The TBL group outperformed the self-study group on the post-test [F 1 = 5.521, P = 0.021]. Female students as a whole performed better than males on the pre-test, scoring higher within both the TBL and self-study groups. Male students in the TBL group performed significantly better on the post-test than female students who participated in TBL sessions (P = 0.013). Students generally enjoyed and appreciated the TBL sessions. TBL sessions can be used judiciously in combination with the lectures to enhance learning of applied microbiology in India. In this study, TBL improved the performance of male students over self-study, but performance for female students following TBL was no better than when they simply studied by themselves.

  3. Effects of phytoestrogen genistein on cytogenetic biomarkers in postmenopausal women: 1 year randomized, placebo-controlled study.

    Science.gov (United States)

    Atteritano, Marco; Pernice, Francesco; Mazzaferro, Susanna; Mantuano, Stefania; Frisina, Alessia; D'Anna, Rosario; Cannata, Maria Letizia; Bitto, Alessandra; Squadrito, Francesco; Frisina, Nicola; Buemi, Michele

    2008-07-28

    To evaluate in a twelve-month, randomized placebo-controlled study whether pure administration of phytoestrogen genistein (54 mg/day) might reduce cytogenetic biomarkers in peripheral lymphocytes of postmenopausal women. A total of 57 postmenopausal women met the criteria and were randomly assigned to receive phytoestrogen genistein (n = 30) or placebo (n = 27). There was no significant difference in age, length of time since menopause or body mass index between the two groups. After one year, plasma genistein level was 0.14 +/- 0.01 micromol/L in the control group and 0.72 +/- 0.08 micromol/L in the genistein group (P < 0.0001). At baseline, sister chromatid exchange rate was 4.97 +/- 2.17 in the control group and 4.96 +/- 1.83 in the genistein group (P = 0.89). After one year, sister chromatid exchange rate was 4.96 +/- 2.16 in the control group and 3.98 +/- 1.14 in the genistein group (P < 0.05). High frequency cells count was 3% in the genistein group and 5% in the control group (P < 0.05) at the end of the study. Chromosomal aberration frequency was 5.55% in the control group at time 0 and 5.75% in the genistein group; after one year, the figures were 5.86% in the control group and 4.5% in the genistein group (P < 0.05). After one year, there was a negative relationship between sister chromatid exchange rate and plasma levels (r = - 0.43; P < 0.05) in the genistein group. Phytoestrogen genistein has been shown in postmenopausal women to be effective in the reduction of cytogenetic biomarkers. The protective effect on genomic damage appears to be a particularly promising tool in reducing the risk of cancer.

  4. An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Campos, Daniel; Bretón-López, Juana; Botella, Cristina; Mira, Adriana; Castilla, Diana; Baños, Rosa; Tortella-Feliu, Miquel; Quero, Soledad

    2016-08-20

    Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of the exposure or the number of sessions. ICTs could help to reduce these limitations. Computer-assisted treatments have remarkable advantages in treating FP. Furthermore, they can be delivered through the Internet, increasing their advantages and reaching more people in need. The Internet has been established as an effective way to treat a wide range of mental disorders. However, as far as we know, no controlled studies exist on FP treatment via the Internet. This study aims to evaluate the efficacy of an Internet-based treatment for FP (NO-FEAR Airlines) versus a waiting list control group. Secondary objectives will be to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance, and study the patients' acceptance of the program. This paper presents the study protocol. The study is a randomized controlled trial. A minimum of 57 participants will be randomly assigned to three conditions: a) NO-FEAR Airlines totally self-applied, b) NO-FEAR Airlines with therapist guidance, or c) a waiting list control group (6 weeks). Primary outcomes measures will be the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes will be included to assess other relevant clinical measures, such as the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Analyses of post-treatment flights will be conducted. Treatment acceptance and preference measures will also be included. Intention-to-treat and per protocol analyses will be

  5. Does Kinesiology Taping Improve the Early Postoperative Outcomes in Anterior Cruciate Ligament Reconstruction? A Randomized Controlled Study.

    Science.gov (United States)

    Chan, Mark Ci-En; Wee, Justin Wen-Jie; Lim, Mui-Hong

    2017-05-01

    The efficacy of kinesiology taping in arthroscopic knee surgery has not been reported. The objective of this study is to investigate the efficacy of kinesiology taping in the early postoperative phase after anterior cruciate ligament reconstruction (ACLR). We hypothesized that kinesiology taping reduces knee pain and swelling and improves knee range of movement and functional outcome. Randomized controlled study. Primary Institutional Hospital. Sixty subjects who underwent an elective ACLR with or without concurrent meniscectomy were randomized into intervention (with kinesiology taping postsurgery) and control groups. Subjects from both groups received standardized postoperative physiotherapy. Subjects from the intervention group received additional kinesiology taping on the first and second weeks postsurgery, each application lasting 5 days. Pain visual analogue score (VAS), total range of motion (ROM) of the knee, Lysholm-Tegner scale, and mid patella circumferential girth were measured before the surgery and at the first, second, and sixth week postsurgery. Within each group, statistically significant differences were found in all study parameters in both groups. Comparison of the study parameters between both groups revealed no statistical significance at various time points except the reduction of pain in the taping group in the early postoperative phase (between the first and second week) (P kinesiology taping in arthroscopic knee surgery. Our study showed that kinesiology taping reduced pain in the early postoperative period after ACLR. There was no statistical significance in the reduction of swelling or improvement of knee score and total range of motion with kinesiology taping.

  6. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease.

    Science.gov (United States)

    2013-01-01

    BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect of latrepirdine on cognition and global function in patients with mild to moderate Huntington disease. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Sixty-four research centers in Australia, Europe, and North America. PATIENTS Four hundred three patients with mild to moderate Huntington disease and baseline cognitive impairment (Mini-Mental State Examination score, 10-26). INTERVENTION Latrepirdine (20 mg) vs matching placebo administered orally 3 times daily for 26 weeks. MAIN OUTCOME MEASURES The co-primary outcome measures were cognition as measured by the change in Mini-Mental State Examination score from baseline to week 26 and global function at week 26 as measured by the Clinician Interview-Based Impression of Change, plus carer interview, which ranges from 1 (marked improvement) to 7 (marked worsening). Secondary efficacy outcome measures included behavior, daily function, motor function, and safety. RESULTS The mean change in Mini-Mental State Examination score among participants randomized to latrepirdine (1.5-point improvement) did not differ significantly from that among participants randomized to placebo (1.3-point improvement) (P=.39). Similarly, the distribution of the Clinician Interview-Based Impression of Change, plus carer interview did not differ significantly among those randomized to latrepirdine compared with placebo (P=.84). No significant treatment effects were detected on the secondary efficacy outcome measures. The incidence of adverse events was similar between those randomized to latrepirdine (68.5%) and placebo (68.0%). CONCLUSION In patients with mild to moderate Huntington disease and cognitive impairment, treatment with

  7. Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study

    DEFF Research Database (Denmark)

    Vogt, Katja C; Uhlyarik, M; Schroeder, Torben V

    2007-01-01

    This study was a randomized-controlled trial comparing the standard type of dry dressing, Mepore, with moist wound healing, using a hydrofiber dressing, Aquacel, in primary closed wounds after vascular surgery. The endpoints were patient comfort, cost-effectiveness, infections, wound complications....... No difference in the infection rate (13% vs. 11%, p=0.73), length of hospital stay, or wound complications was noted between the two groups. We conclude that although the Aquacel dressing needed significantly fewer changes than the conventional dressing, this did not influence the patient comfort. Moreover...

  8. Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mahendran, Rathi; Rawtaer, Iris; Fam, Johnson; Wong, Jonathan; Kumar, Alan Prem; Gandhi, Mihir; Jing, Kenny Xu; Feng, Lei; Kua, Ee Heok

    2017-07-12

    Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to improve the cognition of community living elderly with mild cognitive impairment. This open-label, interventional study involves a parallel randomized controlled trial design with three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based randomization system. Interventions will be provided by trained staff with a control group not receiving any intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated measurements and further analysis may be undertaken to adjust for potential confounders. This will be the first study to compare the effectiveness of

  9. Effects of interactive visual feedback training on post-stroke pusher syndrome: a pilot randomized controlled study.

    Science.gov (United States)

    Yang, Yea-Ru; Chen, Yi-Hua; Chang, Heng-Chih; Chan, Rai-Chi; Wei, Shun-Hwa; Wang, Ray-Yau

    2015-10-01

    We investigated the effects of a computer-generated interactive visual feedback training program on the recovery from pusher syndrome in stroke patients. Assessor-blinded, pilot randomized controlled study. A total of 12 stroke patients with pusher syndrome were randomly assigned to either the experimental group (N = 7, computer-generated interactive visual feedback training) or control group (N = 5, mirror visual feedback training). The scale for contraversive pushing for severity of pusher syndrome, the Berg Balance Scale for balance performance, and the Fugl-Meyer assessment scale for motor control were the outcome measures. Patients were assessed pre- and posttraining. A comparison of pre- and posttraining assessment results revealed that both training programs led to the following significant changes: decreased severity of pusher syndrome scores (decreases of 4.0 ± 1.1 and 1.4 ± 1.0 in the experimental and control groups, respectively); improved balance scores (increases of 14.7 ± 4.3 and 7.2 ± 1.6 in the experimental and control groups, respectively); and higher scores for lower extremity motor control (increases of 8.4 ± 2.2 and 5.6 ± 3.3 in the experimental and control groups, respectively). Furthermore, the computer-generated interactive visual feedback training program produced significantly better outcomes in the improvement of pusher syndrome (p visual feedback training program. Although both training programs were beneficial, the computer-generated interactive visual feedback training program more effectively aided recovery from pusher syndrome compared with mirror visual feedback training. © The Author(s) 2014.

  10. Mobile Phone Apps for University Students With Hazardous Alcohol Use: Study Protocol for Two Consecutive Randomized Controlled Trials

    Science.gov (United States)

    Gajecki, Mikael; Fredriksson, Morgan; Sinadinovic, Kristina; Andersson, Claes

    2015-01-01

    Background About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. Objective (1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Methods Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (≥6 for women; ≥8 points for men) are randomized into three groups. Group 1

  11. Mobile Phone Apps for University Students With Hazardous Alcohol Use: Study Protocol for Two Consecutive Randomized Controlled Trials.

    Science.gov (United States)

    Berman, Anne H; Gajecki, Mikael; Fredriksson, Morgan; Sinadinovic, Kristina; Andersson, Claes

    2015-12-22

    About 50% of university students overconsume alcohol, and drinking habits in later adulthood are to some extent established during higher educational studies. Several studies have demonstrated that Internet-based interventions have positive effects on drinking habits among university students. Our recent study evaluated two mobile phone apps targeting drinking choices at party occasions via personalized feedback on estimated blood alcohol concentration (eBAC) for students with hazardous drinking. No changes in drinking parameters were found over a seven-week period apart from an increase in number of drinking occasions among men for one of the apps tested. Up to 30% of the study participants drank at potentially harmful levels: higher than the national recommended number of standard drinks per week (a maximum of 9 for women and 14 for men) in Sweden. (1) To evaluate improved versions of the two mobile phone apps tested in our prior trial, in a new, 3-armed randomized controlled trial among university students with at least hazardous drinking habits according to the Alcohol Use Disorders Identifications Test (AUDIT; Study 1). (2) After 6 weeks, to target study participants showing alcohol consumption higher than the national recommended levels for standard drinks per week by offering them participation in a second, 2-armed randomized trial evaluating an additional mobile phone app with skill enhancement tasks (Study 2). (3) To follow participants at 6, 12 and 18 weeks after recruitment to Study 1 and at 6 and 12 weeks after recruitment to Study 2. Two randomized controlled trials are conducted. Study 1: Students are recruited at four Swedish universities, via direct e-mail and advertisements on Facebook and student union web sites. Those who provide informed consent, have a mobile phone, and show at least hazardous alcohol consumption according to the AUDIT (≥6 for women; ≥8 points for men) are randomized into three groups. Group 1 has access to the Swedish

  12. The effects of improvisational music therapy on joint attention behaviors in autistic children: A randomized controlled study

    DEFF Research Database (Denmark)

    Kim, Jinah; Wigram, Tony; Gold, Christian

    2008-01-01

    The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy a...... skills in children than play. Session analysis showed significantly more and lengthier events of eye contact and turn-taking in improvisational music therapy than play sessions. The implications of these findings are discussed further.......The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy...... and play sessions with toys, and using standardized tools and DVD analysis of sessions to evaluate behavioral changes in children with autism. The overall results indicated that improvisational music therapy was more effective at facilitating joint attention behaviors and non-verbal social communication...

  13. Periacetabular bone mineral density changes after resurfacing hip arthroplasty versus conventional total hip arthroplasty. A randomized controlled DEXA study

    NARCIS (Netherlands)

    Smolders, J.M.; Pakvis, D.F.M.; Hendrickx, B.W.; Verdonschot, N.J.; Susante, J.L.C. van

    2013-01-01

    A randomized controlled trial was performed to evaluate acetabular bone mineral density (BMD) changes after hip resurfacing (RHA) versus an established conventional total hip arthroplasty (THA). A total of 71 patients were allocated randomly to receive either an RHA press-fit cobalt-chromium cup (n=

  14. Periacetabular Bone Mineral Density Changes After Resurfacing Hip Arthroplasty Versus Conventional Total Hip Arthroplasty. A Randomized Controlled DEXA Study

    NARCIS (Netherlands)

    Smolders, J.M.H.; Pakvis, D.F.; Hendrickx, B.W.; Verdonschot, N.J.J.; Susante, van J.L.C.

    2013-01-01

    A randomized controlled trial was performed to evaluate acetabular bone mineral density (BMD) changes after hip resurfacing (RHA) versus an established conventional total hip arthroplasty (THA). A total of 71 patients were allocated randomly to receive either an RHA press-fit cobalt–chromium cup (n

  15. App-based serious gaming for training of chest tube insertion: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Friedrich, Mirco; Bergdolt, Christian; Haubruck, Patrick; Bruckner, Thomas; Kowalewski, Karl-Friedrich; Müller-Stich, Beat Peter; Tanner, Michael C; Nickel, Felix

    2017-02-06

    Chest tube insertion is a standard intervention for management of various injuries of the thorax. Quick and accurate execution facilitates efficient therapy without further complications. Here, we propose a new training concept comprised of e-learning elements as well as continuous rating using an objective structured assessment of technical skills (OSATS) tool. The study protocol is presented for a randomized trial to evaluate e-learning with app-based serious gaming for chest drain insertion. The proposed randomized trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University in the context of regular curricular teaching for medical students (n = 90, 3rd to 6th year). The intervention group will use e-learning with the serious gaming app Touch Surgery (TM) for chest drain insertion, whereas the control group uses serious gaming for an unrelated procedure. Primary endpoint is operative performance of chest drain insertion in a porcine cadaveric model according to OSATS. The randomized trial will help determine the value of e-learning with the serious gaming app Touch Surgery (TM) for chest drain insertion by using the OSATS score. The study will improve surgical training for trauma situations. Trial Registration Number, DRKS00009994 . Registered on 27 May 2016.

  16. Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

    Directory of Open Access Journals (Sweden)

    Willich Stefan N

    2011-02-01

    Full Text Available Abstract Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an

  17. Individual Cognitive Stimulation Therapy for dementia (iCST: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Orrell Martin

    2012-09-01

    Full Text Available Abstract Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

  18. The effect of fines on nonattendance in public hospital outpatient clinics: study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Blæhr, Emely; Kristensen, Thomas; Væggemose, Ulla

    2016-01-01

    . The aim of this study is to assess the effect of fines on hospital outpatient nonattendance. Methods/design A 1:1 randomized controlled trial of scheduled outpatient appointments was used, with follow-ups until the date of appointment. The setting is an orthopedic clinic at a regional hospital in Denmark...... prior notice. Appointments assigned to the control arm follow usual practice (same system but no letter attachment). The primary outcome is the proportion of nonattendance. Secondary outcomes are proportions of cancellations, sociodemographics, and health-problem characteristics. Furthermore......, the intervention costs and production value of nonattended appointments will be measured. An analysis of effect and cost-effectiveness will be conducted based on a 5 % significance level. Discussion The study is initiated and funded by the Danish Regions, which have the responsibility for the Danish public...

  19. Effect of individualized worksite exercise training on aerobic capacity and muscle strength among construction workers - a randomized controlled intervention study

    DEFF Research Database (Denmark)

    Gram, Bibi; Holtermann, Andreas; Søgaard, Karen;

    2012-01-01

    tailored exercise programs on their physical fitness and muscular capacity. METHOD: The study was a randomized controlled trial of male constructions workers allocated to either an exercise or control group. The intervention lasted 12 weeks, and the exercise group trained 3 x 20 minutes a week....... The participants completed health checks before and after the intervention period. Data from the first health check were used to tailor the exercise in the interventions. RESULTS: At baseline, participants had maximal oxygen consumption (VO (2max)) of 2.9 [standard deviation (SD) 0.7L/min] and body mass index (BMI......) of 28.3 (SD 4.7). Compared to representative data on employees in Denmark (N=78), this study population (N=67) had significantly lower relative aerobic capacity [difference in z-score -1.13 (SE 0.1), P...

  20. Protection of salivary function by concomitant pilocarpine during radiotherapy : A double-blind, randomized, placebo-controlled study

    NARCIS (Netherlands)

    Burlage, Fred R.; Roesink, Judith M.; Kampinga, Harm H.; Coppes, Rob P.; Terhaard, Chris; Langendijk, Johannes A.; van Luijk, Peter; Stokman, Monique A.; Vissink, Arjan

    2008-01-01

    Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with

  1. Internet-based cognitive bias modification for obsessive compulsive disorder : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Williams, Alishia D; Pajak, Rosanna; O'Moore, Kathleen; Andrews, Gavin; Grisham, Jessica R

    2014-01-01

    BACKGROUND: Cognitive bias modification (CBM) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology. The current randomized controlled trial (RCT) will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification intervention

  2. A randomized controlled study for the treatment of acne vulgaris using high-intensity 414 nm solid state diode arrays.

    Science.gov (United States)

    Ash, Caerwyn; Harrison, Anna; Drew, Samantha; Whittall, Rebecca

    2015-01-01

    The treatment of acne vulgaris poses a challenge to the dermatologist, and the disease causes emotional anxiety for the patient. The treatment of acne vulgaris may be well-suited to home-use applications, where sufferers may be too embarrassed to seek medical treatment. This randomized controlled study is designed to quantify the effectiveness of using a blue light device in a therapy combined with proprietary creams, in the investigation of a self-treatment regimen. A total of 41 adults with mild-to-moderate facial inflammatory acne were recruited. The subjects were randomly assigned to combination blue light therapy (n = 26) or control (n = 15). Photography was used for qualitative assessment of lesion counts, at weeks 1, 2, 4, 8, and 12. All subjects in the treatment cohort achieved a reduction in their inflammatory lesion counts after 12 weeks. The mean inflammatory lesion counts reduced by 50.02% in the treatment cohort, and increased by 2.45% in the control cohort. The reduction in inflammatory lesions was typically observable at week-3, and maximal between weeks 8 and 12. The treatment is free of pain and side-effects. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical treatments. Blue light phototherapy, using a narrow-band LED light source, appears to be a safe and effective additional therapy for mild to moderate acne.

  3. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

    Directory of Open Access Journals (Sweden)

    Oedegaard Ketil J

    2010-02-01

    Full Text Available Abstract Background The treatment of depressive phases of bipolar disorder is challenging. The effects of the commonly used antidepressants in bipolar depression are questionable. Electroconvulsive therapy is generally considered to be the most effective treatment even if there are no randomized controlled trials of electroconvulsive therapy in bipolar depression. The safety of electroconvulsive therapy is well documented, but there are some controversies as to the cognitive side effects. The aim of this study is to compare the effects and side effects of electroconvulsive therapy to pharmacological treatment in treatment resistant bipolar depression. Cognitive changes and quality of life during the treatment will be assessed. Methods/Design A prospective, randomised controlled, multi-centre six- week acute treatment trial with seven clinical assessments. Follow up visit at 26 weeks or until remission (max 52 weeks. A neuropsychological test battery designed to be sensitive to changes in cognitive function will be used. Setting: Nine study centres across Norway, all acute psychiatric departments. Sample: n = 132 patients, aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, Montgomery Åsberg Depression Rating Scale Score of at least 25 at baseline. Intervention: Intervention group: 3 sessions per week for up to 6 weeks, total up to 18 sessions. Control group: algorithm-based pharmacological treatment as usual. Discussion This study is the first randomized controlled trial that aims to investigate whether electroconvulsive therapy is better than pharmacological treatment as usual in treatment resistant bipolar depression. Possible long lasting cognitive side effects will be evaluated. The study is investigator initiated, without support from industry. Trial registration NCT00664976

  4. Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

    Science.gov (United States)

    Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

    2014-01-01

    We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

  5. Cerebrolysin enhances cognitive recovery of mild traumatic brain injury patients: double-blind, placebo-controlled, randomized study.

    Science.gov (United States)

    Chen, Chun-Chung; Wei, Sung-Tai; Tsaia, Shiu-Chiu; Chen, Xian-Xiu; Cho, Der-Yang

    2013-12-01

    In adults, mild traumatic brain injury (MTBI) frequently results in impairments of cognitive functions which would lead to psychological consequences in the future. Cerebrolysin is a nootropic drug, and can significantly improve cognitive function in patients with Alzheimer's disease and stroke. The purpose of this study was to investigate how Cerebrolysin therapy enhances cognitive recovery for mild traumatic brain injury patients using a double-blinded, placebo-controlled, randomized phase II pilot study. Patients having head injury within 24 h sent to our hospital were screened and recruited if patients were alert and conscious, and had intracranial contusion haemorrhage. From July 2009 to June 2010, totally, thirty-two patients were recruited in the double-blinded, placebo-controlled, and randomized study. Patients were randomized to receive Cerebrolysin (Group A, once daily intravenous infusion of 30 mL Cerebrolysin over a 60-min period for 5 days) or placebo (Group B, same dosage and administration of normal saline as Group A). The primary outcome measures were differences of cognitive function including Mini-Mental Status Examination (MMSE), and Cognitive Abilities Screening Instrument (CASI) scores between baseline and week 1, between baseline and week 4, and between baseline and week 12. Thirty-two patients completed the trial. For Group A, the CASI score difference between baseline and week 12 was 21.0 ± 20.4, a significantly greater change than that of Group B (7.6 ± 12.1) (p = 0.0461). Besides, drawing function (one of the domains of CASI; p = 0.0066) on week 4 and both drawing function (p = 0.0472) and long-term memory (one of the domains of CASI; p = 0.0256) on week 12 were also found to be significantly improved in the patients receiving Cerebrolysin treatment. Our results suggest that Cerebrolysin improves the cognitive function of the MTBI in patients at 3rd month after injury, especially for long-term memory and drawing function.

  6. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study.

    Science.gov (United States)

    Morone, Natalia E; Greco, Carol M; Weiner, Debra K

    2008-02-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P=.008, P=.004) and SF-36 Physical Function (P=.03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.

  7. Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Valery Patricia C

    2012-08-01

    Full Text Available Abstract Background The prevalence of chronic suppurative lung disease (CSLD and bronchiectasis unrelated to cystic fibrosis (CF among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis. Methods/design We are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis with no underlying disease identified (such as CF or primary immunodeficiency, and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week or placebo (once a week for 12–24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children ≥6 years, and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical

  8. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

    2013-05-07

    It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more

  9. Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study.

    Science.gov (United States)

    Hasan, Alkomiet; Wolff-Menzler, Claus; Pfeiffer, Sebastian; Falkai, Peter; Weidinger, Elif; Jobst, Andrea; Hoell, Imke; Malchow, Berend; Yeganeh-Doost, Peyman; Strube, Wolfgang; Quast, Silke; Müller, Norbert; Wobrock, Thomas

    2015-10-01

    Despite many pharmacological and psychosocial treatment options, schizophrenia remains a debilitating disorder. Thus, new treatment strategies rooted in the pathophysiology of the disorder are needed. Recently, vagus nerve stimulation (VNS) has been proposed as a potential treatment option for various neuropsychiatric disorders including schizophrenia. The objective of this study was to investigate for the first time the feasibility, safety and efficacy of transcutaneous VNS in stable schizophrenia. A bicentric randomized, sham-controlled, double-blind trial was conducted from 2010 to 2012. Twenty schizophrenia patients were randomly assigned to one of two treatment groups. The first group (active tVNS) received daily active stimulation of the left auricle for 26 weeks. The second group (sham tVNS) received daily sham stimulation for 12 weeks followed by 14 weeks of active stimulation. Primary outcome was defined as change in the Positive and Negative Symptom Scale total score between baseline and week 12. Various other secondary measures were assessed to investigate safety and efficacy. The intervention was well tolerated with no relevant adverse effects. We could not observe a statistically significant difference in the improvement of schizophrenia psychopathology during the observation period. Neither psychopathological and neurocognitive measures nor safety measures showed significant differences between study groups. Application of tVNS was well tolerated, but did not improve schizophrenia symptoms in our 26-week trial. While unsatisfactory compliance questions the feasibility of patient-controlled neurostimulation in schizophrenia, the overall pattern of symptom change might warrant further investigations in this population.

  10. A randomized placebo-controlled study on the effects of pioglitazone on cortisol metabolism in polycystic ovary syndrome

    DEFF Research Database (Denmark)

    Glintborg, Dorte; Hermann, Anne Pernille; Hagen, Claus

    2009-01-01

    OBJECTIVE: To investigate possible effects of insulin-sensitizing treatment on cortisol metabolism in insulin-resistant patients with polycystic ovary syndrome (PCOS). DESIGN: Randomized placebo-controlled study. SETTING: Academic tertiary care medical center. PATIENT(S): Thirty insulin-resistant......OBJECTIVE: To investigate possible effects of insulin-sensitizing treatment on cortisol metabolism in insulin-resistant patients with polycystic ovary syndrome (PCOS). DESIGN: Randomized placebo-controlled study. SETTING: Academic tertiary care medical center. PATIENT(S): Thirty insulin......-resistant PCOS patients. INTERVENTION(S): Sixteen weeks of pioglitazone (30 mg/day) or placebo treatment. MAIN OUTCOME MEASURE(S): Twenty-four-hour 20 min integrated blood sampling for measurement of cortisol and 24 h urinary excretion of steroid metabolites. Relative 5alpha-reductase activity was evaluated...... levels. Delta A/E ratio inversely correlated with Delta IGF-I and Delta peak GH during GH stimulation tests. No significant changes were measured in T, DHT, DHEA, DHEAS, 24 h mean cortisol, or urinary excretion of steroid metabolites. CONCLUSION(S): Pioglitazone decreased relative 5alpha...

  11. Effects of transcranial direct current stimulation (tDCS) on cognition, symptoms, and smoking in schizophrenia: A randomized controlled study.

    Science.gov (United States)

    Smith, Robert C; Boules, Sylvia; Mattiuz, Sanela; Youssef, Mary; Tobe, Russell H; Sershen, Henry; Lajtha, Abel; Nolan, Karen; Amiaz, Revital; Davis, John M

    2015-10-01

    Schizophrenia is characterized by cognitive deficits which persist after acute symptoms have been treated or resolved. Transcranial direct current stimulation (tDCS) has been reported to improve cognition and reduce smoking craving in healthy subjects but has not been as carefully evaluated in a randomized controlled study for these effects in schizophrenia. We conducted a randomized double-blind, sham-controlled study of the effects of 5 sessions of tDCS (2 milliamps for 20minutes) on cognition, psychiatric symptoms, and smoking and cigarette craving in 37 outpatients with schizophrenia or schizoaffective disorder who were current smokers. Thirty subjects provided evaluable data on the MATRICS Consensus Cognitive Battery (MCCB), with the primary outcome measure, the MCCB Composite score. Active compared to sham tDCS subjects showed significant improvements after the fifth tDCS session in MCCB Composite score (p=0.008) and on the MCCB Working Memory (p=0.002) and Attention-Vigilance (p=0.027) domain scores, with large effect sizes. MCCB Composite and Working Memory domain scores remained significant at Benjamini-Hochberg corrected significance levels (α=0.05). There were no statistically significant effects on secondary outcome measures of psychiatric symptoms (PANSS scores), hallucinations, cigarette craving, or cigarettes smoked. The positive effects of tDCS on cognitive performance suggest a potential efficacious treatment for cognitive deficits in partially recovered chronic schizophrenia outpatients that should be further investigated.

  12. The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Daniel

    2012-11-01

    Full Text Available Abstract Background Our approach to advancing the treatment of psychosis is to focus on key single symptoms and develop interventions that target the mechanisms that maintain them. In our theoretical research we have found worry to be an important factor in the development and maintenance of persecutory delusions. Worry brings implausible ideas to mind, keeps them there, and makes the experience distressing. Therefore the aim of the trial is to test the clinical efficacy of a cognitive-behavioral intervention for worry for patients with persecutory delusions and determine how the worry treatment might reduce delusions. Methods/Design An explanatory randomized controlled trial - called the Worry Intervention Trial (WIT - with 150 patients with persecutory delusions will be carried out. Patients will be randomized to the worry intervention in addition to standard care or to standard care. Randomization will be carried out independently, assessments carried out single-blind, and therapy competence and adherence monitored. The study population will be individuals with persecutory delusions and worry in the context of a schizophrenia spectrum diagnosis. They will not have responded adequately to previous treatment. The intervention is a six-session cognitive-behavioral treatment provided over eight weeks. The control condition will be treatment as usual, which is typically antipsychotic medication and regular appointments. The principal hypotheses are that a worry intervention will reduce levels of worry and that it will also reduce the persecutory delusions. Assessments will be carried out at 0 weeks (baseline, 8 weeks (post treatment and 24 weeks (follow-up. The statistical analysis strategy will follow the intention-to-treat principle and involve the use of linear mixed models to evaluate and estimate the relevant between- and within-subjects effects (allowing for the possibility of missing data. Both traditional regression and newer instrumental

  13. The Placorhen study : A double-blind, placebo-controlled, randomized radionuclide study with Re-186-etidronate in hormone-resistant prostate cancer patients with painful bone metastases

    NARCIS (Netherlands)

    Han, SH; de Klerk, JMH; Tan, S; van het Schip, AD; Derksen, BH; van Dijk, A; Kruitwagen, CLJJ; Blijham, GH; van Rijk, PP; Zonnenberg, BA

    2002-01-01

    Re-186-1,1-hydroxyethylidene diphosphonate (etidronate) can be used for the palliative treatment of metastatic bone pain. A randomized, placebo-controlled study using Re-186-etidronate was conducted on end-stage prostate cancer patients with metastatic bone pain. Methods: Pain relief was assessed us

  14. CONTEMPORARY APPROACHES TO MALE URINARY INCONTINENCE: A CONTROLLED RANDOMIZED COMPARATIVE STUDY

    Directory of Open Access Journals (Sweden)

    Hany M. I. Elgohary

    2015-12-01

    Full Text Available Background: Urinary incontinence UI is an involuntary leakage of urine due to loss of bladder control which is a common and often embarrassing problem that may cause tremendous emotional distress. Prevalence and risk factors depend on baseline physiological mechanisms, including weakness of pelvic floor muscles, hyperactive bladder that may result in urge UI, poor urethral sphincter function associated with stress UI, and impaired structural and functional integrity of pudendal nerve activity, associated with Pelvic floor muscle weakness plays an important role in UI etiology. Pelvic floor muscles work to support the bladder neck in the intra- abdominal cavity and maintain urinary continence. Weakness of these muscles leads the bladder to shift to the extra-abdominal cavity and thus a change in the urethra-vesicle angle occurs. Methods: Group (A twenty participants who received behavioral training (BT pelvic floor exercises (PFE and interferential current, group (B twenty participants who received BT, PFE and posterior tibial nerve stimulation, and group (C twenty participants who received BT, PFE and placebo interferential current. Urodynamic and cystometric measures including bladder volume at first desire to void, maximum cystometric capacity, and pressure at maximum flow rate were measured before and after intervention. Results: Results of this study revealed that there was a statistical significant difference in bladder volume at first desire to void, maximum cystometric capacity, and pressure at maximum flow rate in favor of participants who received a combination of BT, PFE and interferential current compared with those who received a combination of BH and PFE with either posterior tibial nerve stimulation or placebo interferential current. Conclusion: Interferential current is better than posterior tibial nerve stimulation in the rehabilitation of urinary incontinence.

  15. Impact of yoga on biochemical profile of asthmatics: A randomized controlled study

    Directory of Open Access Journals (Sweden)

    Shruti Agnihotri

    2014-01-01

    Conclusions: Yoga group got significantly better improvement in biochemical variables than control group. Result shows that yoga can be practiced as adjuvant therapy with standard inhalation therapy for better outcome of asthma.

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

    OpenAIRE

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

    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 In...

  17. Opuntia Extract Reduces Scar Formation in Rabbit Ear Model: A Randomized Controlled Study.

    Science.gov (United States)

    Fang, Quan; Huang, Chunlan; You, Chuangang; Ma, Shaolin

    2015-12-01

    The purpose of this article is to investigate the effect of Opuntia stricta H (Cactaceae) extract on suppression of hypertrophic scar on ventral surface wounds of rabbit ears. Full thickness skin defection was established in a rabbit ear to simulate hypertrophic scar. Opuntia extract was sprayed on the wounds in the experimental group, and normal saline was used in the control group. After the wounds healed with scar formation, the hypertrophic scar tissue was harvested on days 22, 39, and 54 for histological analysis. The expression of type I and type III collagen and matrix metalloproteinase-1 (MMP-1) were evaluated by immunohistochemistry and real-time quantitative polymerase chain reaction. The results indicated that the scar of the control group is more prominent compared with the opuntia extract group. The expression of type I collagen in the opuntia extract group was lower than the control group, while type III collagen in opuntia extract group gradually increased and exceeded control group. The expression of MMP-1 decreased in the opuntia extract group, while the control group increased over time, but the amount of MMP-1 was much higher than that in the control group on day 22. In conclusion, opuntia extract reduces hypertrophic scar formation by means of type I collagen inhibition, and increasing type III collagen and MMP-1.T he novel application of opuntia extract may lead to innovative and effective antiscarring therapies.

  18. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

    Directory of Open Access Journals (Sweden)

    Harvey Nicholas C

    2012-02-01

    Full Text Available Abstract MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11, funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Background Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods/Design Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford. Women with circulating 25(OH-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477 or placebo at 14 weeks (n = 477. Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. Discussion As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform

  19. [A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

    Science.gov (United States)

    Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

    2017-05-22

    Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg(-1), Group C getting clonidine 1mcg.kg(-1) and Group D patients receiving dexmedetomidine 0.5mcg.kg(-1). The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  20. Transdermal diclofenac patches for control of post-extraction pain. Pilot randomized controlled double-blind study.

    Science.gov (United States)

    Krishnan, Sriram; Sharma, Pankaj; Sharma, Rakesh; Kumar, Suman; Verma, Mahesh; Chaudhary, Zainab

    2015-03-01

    The scope of transdermal analgesics have been limited to pain control following local trauma, muscle spasm, minor esthetic surgeries, or sports-related injuries. Its scope of application can be extended in the field of dentistry and minor oral surgical procedures. A total of 40 healthy patients between the age of 18 and 50 years with deeply carious, nontender mandibular molar tooth deemed unsalvageable which was indicated for extraction were taken into study of which subjects were divided into cases and controls. The data were analyzed with chi-square test and Mann-Whitney U test; the chi-square test showed significant association with expected outcome in visual analog scale pain scores, the two groups at 6th and 12th hour. A Mann-Whitney U test was performed to identify strength of association between two groups where there were significant association between all parameters except for pain interference with routine activities and dental health status(0.022, 0.001); the differences between two groups in these parameters were significant (Transdermal route seems to be comparable to oral diclofenac in post-extraction pain relief; further studies are required to confirm the results and safety for its use in various other dental situations.

  1. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  2. The impact of a microsavings intervention on reducing violence against women engaged in sex work: a randomized controlled study.

    Science.gov (United States)

    Tsai, Laura Cordisco; Carlson, Catherine E; Aira, Toivgoo; Norcini Pala, Andrea; Riedel, Marion; Witte, Susan S

    2016-10-28

    Women who engage in sex work are at risk for experiencing violence from numerous perpetrators, including paying partners. Empirical evidence has shown mixed results regarding the impact of participation in microfinance interventions on women's experiences of violence, with some studies demonstrating reductions in intimate partner violence (IPV) and others showing heightened risk for IPV. The current study reports on the impact of participation in a microsavings intervention on experiences of paying partner violence among women engaged in sex work in Mongolia. Between 2011 and 2013, we conducted a two-arm, non-blinded randomized controlled trial (RCT) comparing an HIV/STI risk reduction intervention (HIVSRR) (control condition) to a combined microsavings and HIVSRR intervention (treatment condition). Eligible women (aged 18 or older, reported having engaged in unprotected sex with paying partner in past 90 days, expressed interest in microsavings intervention) were invited to participate. One hundred seven were randomized, including 50 in the control and 57 in the treatment condition. Participants completed assessments at baseline, immediate post-test following HIVSRR, and at 3-months and 6-months after completion of the treatment group intervention. Outcomes for the current study include any violence (physical and/or sexual), sexual violence, and physical violence from paying partners in the past 90 days. An intention-to-treat approach was utilized. Linear growth models revealed significant reductions over time in both conditions for any violence (β = -0.867, p impact women's risk for paying partner violence. Qualitative research is recommended to understand the cause for reductions in paying partner violence in both study conditions. Evaluating a Microfinance Intervention for High Risk Women in Mongolia; NCT01861431 ; May 20, 2013.

  3. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Tsai Midi

    2011-06-01

    Full Text Available Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33% do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention or control (no change. At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI and standardized body mass index (zBMI. Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous, Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight

  4. Healthy Learning Mind - a school-based mindfulness and relaxation program: a study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Volanen, Salla-Maarit; Lassander, Maarit; Hankonen, Nelli; Santalahti, Päivi; Hintsanen, Mirka; Simonsen, Nina; Raevuori, Anu; Mullola, Sari; Vahlberg, Tero; But, Anna; Suominen, Sakari

    2016-07-11

    Mindfulness has shown positive effects on mental health, mental capacity and well-being among adult population. Among children and adolescents, previous research on the effectiveness of mindfulness interventions on health and well-being has shown promising results, but studies with methodologically sound designs have been called for. Few intervention studies in this population have compared the effectiveness of mindfulness programs to alternative intervention programs with adequate sample sizes. Our primary aim is to explore the effectiveness of a school-based mindfulness intervention program compared to a standard relaxation program among a non-clinical children and adolescent sample, and a non-treatment control group in school context. In this study, we systematically examine the effects of mindfulness intervention on mental well-being (primary outcomes being resilience; existence/absence of depressive symptoms; experienced psychological strengths and difficulties), cognitive functions, psychophysiological responses, academic achievements, and motivational determinants of practicing mindfulness. The design is a cluster randomized controlled trial with three arms (mindfulness intervention group, active control group, non-treatment group) and the sample includes 59 Finnish schools and approx. 3 000 students aged 12-15 years. Intervention consists of nine mindfulness based lessons, 45 mins per week, for 9 weeks, the dose being identical in active control group receiving standard relaxation program called Relax. The programs are delivered by 14 educated facilitators. Students, their teachers and parents will fill-in the research questionnaires before and after the intervention, and they will all be followed up 6 months after baseline. Additionally, students will be followed 12 months after baseline. For longer follow-up, consent to linking the data to the main health registers has been asked from students and their parents. The present study examines

  5. In a randomized placebo-controlled add-on study orlistat significantly reduced clozapine-induced constipation.

    Science.gov (United States)

    Chukhin, Evgeny; Takala, Pirjo; Hakko, Helinä; Raidma, Mirjam; Putkonen, Hanna; Räsänen, Pirkko; Terevnikov, Viacheslav; Stenberg, Jan-Henry; Eronen, Markku; Joffe, Grigori

    2013-03-01

    Constipation is a common and potentially fatal side effect of clozapine treatment. Another important side effect of clozapine may also be significant weight gain. Orlistat is a weight-control medication that is known to induce loose stools as a common side effect. This study aimed to explore whether orlistat used to control clozapine-induced weight gain can simultaneously tackle clozapine-related constipation. In this 16-week randomized-controlled study, clozapine-treated patients received add-on orlistat (n=30) or add-on placebo (n=24). Colonic function was measured using the Bristol Stool Form Scale. There was a significant (P=0.039) difference in the prevalence of constipation in favor of orlistat over placebo in completers (n=40) at the endpoint. A decrease in the prevalence of constipation within the orlistat group (P=0.035) was observed (vs. no statistically significant changes in the placebo group). In clozapine-treated patients, orlistat may be beneficial not only for weight control but also as a laxative. As no established treatments for clozapine-induced constipation exist, orlistat can be considered for this population, although more studies are required.

  6. Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bricker Jonathan B

    2011-09-01

    Full Text Available Abstract Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement, and twelve months after start of the intervention (follow-up measurement. Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home. In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized

  7. Caffeine improves endurance in 75-year old citizens. A randomized, double-blind, placebo-controlled, cross-over study

    DEFF Research Database (Denmark)

    Buchard Nørager, Charlotte; Jensen, Martin Bach; Madsen, Mogens Rørbæk

    2005-01-01

    This study investigated the effect of caffeine on physical performance in healthy citizens aged ≥70 yr. The randomized, double-blind, placebo-controlled, crossover study was conducted in 15 men and 15 women recruited by their general practitioner. Participants abstained from caffeine for 48 h...... = 0.0001). Caffeine also reduced the rating of perceived exertion after 5 min of cycling by 11% (95% CI: 5–17; P = 0.002) and postural stability with eyes open by 25% (95% CI: 2–53; P = 0.03). Caffeine ingestion did not affect muscle strength, walking speed, reaction, and movement times. At the end...... consumption. Further studies are required to investigate whether caffeine can be utilized to improve the physical performance of elderly citizens....

  8. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment, cartilage, and other structures necessary to joint stability. There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (low-level laser therapy and light-emitting diode therapy) in the same apparatus for the treatment of osteoarthritis. The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee. Methods/Design A double-blind, controlled, randomized clinical trial will be conducted involving patients with osteoarthritis of the knee. Evaluations will be performed using functional questionnaires before and after the treatment protocols, in a reserved room with only the evaluator and participant present, and no time constraints placed on the answers or evaluations. The following functional tests will also be performed: stabilometry (balance assessment), dynamometry (muscle strength of gluteus medius and quadriceps), algometry (pain threshold), fleximeter (range of motion), timed up-and-go test (functional mobility), and the functional reach test. The participants will then be allocated to three groups through a randomization process using opaque envelopes: exercise program, exercise program + phototherapy, or exercise program + placebo phototherapy, all of which will last for eight weeks. Discussion The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee. The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee. Data will be published after the study is completed. Trial registration The protocol for this study has been submitted to Clinical Trials, registration number

  9. Neoadjuvant chemoradiotherapy for resectable esophageal cancer:an in-depth study of randomized controlled trials and literature review

    Institute of Scientific and Technical Information of China (English)

    Xiao-Feng Duan; Peng Tang; Zhen-Tao Yu

    2014-01-01

    Surgery following neoadjuvant chemoradiotherapy (NCRT) is a common multidisciplinary treatment for resectable esophageal cancer (EC). Atfer analyzing 12 randomized controlled trials (RCTs), we discuss the key issues of surgery in the management of resectable EC. Along with chemoradiotherapy, NCRT is recommended for patients with squamous cell carcinoma (SCC) and adenocarcinoma (AC), and most chemotherapy regimens are based on cisplatin, lfuorouracil (FU), or both (CF). However, taxane-based schedules or additional studies, together with newer chemotherapies, are warranted. In nine clinical trials, post-operative complications were similar without significant differences between two treatment groups. In-hospital mortality was signiifcantly different in only 1 out of 10 trials. Half of the randomized trials that compare NCRT with surgery in EC demonstrate an increase in overall survival or disease-free survival. NCRT offers a great opportunity for margin negative resection, decreased disease stage, and improved loco-regional control. However, NCRT does not affect the quality of life when combined with esophagectomy. Future trials should focus on the identiifcation of optimum regimens and selection of patients who are most likely to beneift from speciifc treatment options.

  10. Pulmonary infection control window in treatment of severe respiratory failure of chronic obstructive pulmonary diseases: a prospective, randomized controlled, multi-centred study

    Institute of Scientific and Technical Information of China (English)

    Collaborating Research Group for Noninvasive Mecha

    2005-01-01

    Background Early withdraw from invasive mechanical ventilation (MV) followed by noninvasive MV is a new strategy for changing modes of treatment. This study was conducted to estimate the feasibility and the efficacy of early extubation and sequential noninvasive MV commenced at beginning of pulmonary infection control window in patients with exacerbated hypercapnic respiratory failure caused by chronic obstructive pulmonary diseases (COPD). Methods A prospective, randomized controlled study was conducted in eleven teaching hospitals' respiratory or medical intensive care units in China. Ninety intubated COPD patients with severe hypercapnic respiratory failure triggered by pulmonary infection (pneumonia or purulent bronchitis) were involved in the study. When the pulmonary infection had been controlled by antibiotics and comprehensive therapy, the "pulmonary infection control window (PIC window)" has been reached. Each case was randomly assigned to study group (extubation and noninvasive MV via facial mask immediately) or control group (invasive MV was received continuously after PIC window by using conventional weaning technique).Results Study group (n=47) and control group (n=43) had similar clinical characteristics initially and at the time of PIC window. Compared with control group, study group had shorter duration of invasive MV [(6.4±4.4) days vs (11.3±6.2) days, P=0.000], lower rate of ventilator associated pneumonia (VAP) (3/47 vs 12/43, P=0.014), fewer days in ICU [(12±8) days vs (16±11) days, P=0.047] and lower hospital mortality (1/47 vs 7/43, P=0.025).Conclusions In COPD patients requiring intubation and invasive MV for hypercapnic respiratory failure, which is exacerbated by pulmonary infection, early extubation followed by noninvasive MV initiated at the start of PIC window may decrease significantly the duration of invasive MV, the risk of VAP and hospital mortality.

  11. Lifestyle intervention using an internet-based curriculum with cell phone reminders for obese Chinese teens: a randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Anisha A Abraham

    Full Text Available Obesity is an increasing public health problem affecting young people. The causes of obesity are multi-factorial among Chinese youth including lack of physical activity and poor eating habits. The use of an internet curriculum and cell phone reminders and texting may be an innovative means of increasing follow up and compliance with obese teens. The objectives of this study were to determine the feasibility of using an adapted internet curriculum and existing nutritional program along with cell phone follow up for obese Chinese teens.This was a randomized controlled study involving obese teens receiving care at a paediatric obesity clinic of a tertiary care hospital in Hong Kong. Forty-eight subjects aged 12 to 18 years were randomized into three groups. The control group received usual care visits with a physician in the obesity clinic every three months. The first intervention (IT group received usual care visits every three months plus a 12-week internet-based curriculum with cell phone calls/texts reminders. The second intervention group received usual care visits every three months plus four nutritional counselling sessions.The use of the internet-based curriculum was shown to be feasible as evidenced by the high recruitment rate, internet log-in rate, compliance with completing the curriculum and responses to phone reminders. No significant differences in weight were found between IT, sLMP and control groups.An internet-based curriculum with cell phone reminders as a supplement to usual care of obesity is feasible. Further study is required to determine whether an internet plus text intervention can be both an effective and a cost-effective adjunct to changing weight in obese youth.Chinese Clinical Trial Registry ChiCTR-TRC-12002624.

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

    Science.gov (United States)

    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.

  13. Effect and cost of perioperative use of antibiotics in coronary artery bypass grafting: a randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    ZHOU Zi-jun; ZHENG Ying-li; HU Yong-hua

    2011-01-01

    Background Bacterial infections remain a serious complication following coronary artery bypass grafting (CABG). The objective of the study was to determine the effectiveness of a guideline for the appropriate use of antibiotics in CABG during the perioperative period.Methods Six hundred and fourteen hospitalized patients who had undergone CABG from January to June 2006 were randomly allocated to an intervention group and a control group. The data on the hospital stay, days of antibiotic used,types of prophylactic antibiotics used, surgical wound infection and pulmonary infection and antibiotic costs for the patients were compared.Results The postoperative hospitalization days of the intervention group were significantly fewer than that for the control group (P<0.05). The time of antibiotic use and post-infection treatment time were also significantly less in the intervention group than in the control group (P <0.05). The average hospital daily cost and total cost of antibiotics were less in the intervention group than in the control group (P<0.05). Compared with the control group, prophylactic antibiotic use in the intervention group was more reasonable.Conclusions The guideline for the appropriate use of antibiotics in CABG during the perioperative period is effective strategies for reducing antibiotic costs, the time of antibiotic use and post-infection treatment time without compromising the patients' clinical outcome.

  14. Effect of probiotics on digestibility and immunity in infants: A study protocol for a randomized controlled trial.

    Science.gov (United States)

    Xiao, Lingli; Ding, Guodong; Ding, Yifang; Deng, Chaoming; Ze, Xiaolei; Chen, Liang; Zhang, Yao; Song, Lihua; Yan, Hongli; Liu, Fang; Ben, Xiaoming

    2017-04-01

    The gastrointestinal (GI) tract of a fetus in utero is sterile but it becomes colonized with environmental microorganisms shortly after birth. Since the gut microbiota undergoes substantial changes in early life, healthy gut microflora is essential to an infant's gut health and immune system and probably also has an effect on overall health status in later life. Probiotics, defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. Although randomized controlled trials using probiotics in infants have shown promising results in the prevention and treatment of common diseases such as diarrhea and allergy, little is known about whether probiotics could offer benefits to healthy infants. We have designed a randomized controlled trial to test the hypothesis that an oral preparation of probiotics is superior to placebo in improving digestive and immune function in healthy infants.The trial will be a randomized, double-blind, placebo-controlled, 2-parallel-group study in Shanghai, China. After a 2-week run-in period, 200 exclusively formula-fed healthy infants aged 4 to 6 months will be randomly allocated to receive either a probiotic product containing Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052 or an identical placebo once daily for 4 weeks and will be followed up for 8 weeks. The duration of the subject's participation will be 14 weeks, with a total of 5 visits: inclusion (Visit 1, Day 1), start of intervention (V2, D15), end of intervention (V3, D44), and follow-up (V4 and V5, D72 and D100). Stool and saliva samples will be collected at the first 3 visits to measure microbial populations and secretory immunoglobulin A (SIgA), respectively. Physical examination will be performed at each visit, and tolerance records will be completed 1 day prior to each visit. The primary endpoints will be the changes in the composition of fecal microbiota

  15. Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

    National Research Council Canada - National Science Library

    Davidson, Anew J; Morton, Neil S; Arnup, Sarah J; de Graaff, Jurgen C; Disma, Nicola; Withington, Davinia E; Frawley, Geoff; Hunt, Rodney W; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen; Absalom, Anthony

    2015-01-01

    ...) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA...

  16. A systematic literature review on the efficacy-effectiveness gap : comparison of randomized controlled trials and observational studies of glucose-lowering drugs

    NARCIS (Netherlands)

    Ankarfeldt, Mikkel Z; Adalsteinsson, Erpur; Groenwold, Rolf Hh|info:eu-repo/dai/nl/30481203X; Ali, M Sanni; Klungel, Olaf H

    2017-01-01

    AIM: To identify a potential efficacy-effectiveness gap and possible explanations (drivers of effectiveness) for differences between results of randomized controlled trials (RCTs) and observational studies investigating glucose-lowering drugs. METHODS: A systematic literature review was conducted in

  17. Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen Inoculum From Unrelated Donors: A Randomized, Open-Label, Controlled Pilot Study

    OpenAIRE

    Youngster, Ilan; Sauk, Jenny; Pindar, Christina; Wilson, Robin G; Kaplan, Jess L.; Smith, Mark B.; Alm, Eric J; Gevers, Dirk; Russell, George H.; Hohmann, Elizabeth L.

    2014-01-01

    Fecal microbiota transplant is increasingly used to treat recurrent or relapsing Clostridium difficile infection. In this randomized controlled study, using a frozen inoculum from unrelated donors was safe and effective, whether administered by nasogastric tube or by colonoscopy.

  18. Effectiveness of a Randomized Controlled Lifestyle Intervention to Prevent Obesity among Chinese Primary School Students: CLICK-Obesity Study.

    Directory of Open Access Journals (Sweden)

    Fei Xu

    Full Text Available Childhood obesity has been increasing rapidly worldwide. There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide, especially in developing countries like China. The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program (the CLICK-Obesity study in Mainland China.A cluster randomized controlled trial was developed among grade 4 students from 8 urban primary schools (638 students in intervention, 544 as control in Nanjing City, China. Students were randomly allocated to the control or intervention group at school-level. A one-year multi-component intervention program (classroom curriculum, school environment support, family involvement and fun programs/events together with routine health education was provided to the intervention group, while the control group received routine health education only. The main outcome variables assessed were changes in body mass index, obesity occurrence, obesity-related lifestyle behaviors and knowledge.Overall, 1108 (93.7% of the 1182 enrolled students completed the intervention study. The intervention group had a larger marginal reduction than did the control group in overall mean BMI value (-0.32±1.36 vs. -0.29±1.40, p = 0.09, although this was not significant. Compared with the control group, the intervention group was more likely to decrease their BMI (OR = 1.44, 95%CI = 1.10, 1.87 by 0.5 kg/m2 or above, increase the frequency of jogging/running (OR = 1.55, 95%CI = 1.18, 2.02, decrease the frequency of TV/computer use (OR = 1.41, 95%CI = 1.09, 1.84 and of red meat consumption (OR = 1.50, 95%CI = 1.15, 1.95, change commuting mode to/from school from sedentary to active mode (OR = 2.24, 95%CI = 1.47, 3.40, and be aware of the harm of selected obesity risk factors.The school-based lifestyle intervention program was practical and effective in improving health behaviors and obesity

  19. Effect of kinesiology taping on hemiplegic shoulder pain and functional outcomes in subacute stroke patients: a randomized controlled study.

    Science.gov (United States)

    Huang, Yu C; Leong, Chau P; Wang, Lin; Wang, Lin Y; Yang, Yu C; Chuang, Chien Y; Hsin, Yi J

    2016-12-01

    Hemiplegic shoulder pain (HSP) impedes functional motor recovery of the affected limbs and negatively affects quality of life and daily activities. Kinesiology taping (KT) may provide improvement in hemiplegic shoulder pain and upper extremity function after an acute stroke. To assess the impact of KT on HSP, upper extremity functional outcomes, and the prevention of shoulder soft tissue injury in subacute stroke patients with hemiplegic shoulders during rehabilitation. Randomized, double-blind controlled trial. Rehabilitation unit at a single medical center. Forty-four subacute stroke patients with hemiplegia. Forty-four subacute stroke patients with hemiplegia participated in this study and were randomly allocated to the control group (sham KT) or experimental group (therapeutic KT). In the experimental group, a 3-week therapeutic KT with conventional inpatient rehabilitation was applied for 5 days per week. In the control group, the patients received a 3-week sham KT with conventional inpatient rehabilitation for 5 days per week. Shoulder subluxation, spasticity, hemiplegic shoulder pain, the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), modified Barthel Index (MI), Stroke-Specific Quality of Life (SSQOL) scale, and shoulder sonography were measured before and after treatment. Pain-free flexion was significantly increased in hemiplegic shoulders after therapeutic KT. From 16 (70%) to 20 (87%) patients in the control and from 12 (57%) to 12 (57%) in the experimental groups had HSP after intervention, and a significant difference in the occurrence of HSP was found between these groups after treatment (P0.05). Therapeutic KT may limit the development of HSP and improve shoulder flexion in subacute stroke patients with flaccid shoulders during inpatient rehabilitation. For subacute stroke patients with hemiplegia, therapeutic KT may not provide improvements in the upper extremity function, daily activity, and quality of life over sham KT during conventional

  20. Investigating a training supporting shared decision making (IT'S SDM 2011: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Geiger Friedemann

    2011-10-01

    Full Text Available Background Shared Decision Making (SDM is regarded as the best practice model for the communicative challenge of decision making about treatment or diagnostic options. However, randomized controlled trials focusing the effectiveness of SDM trainings are rare and existing measures of SDM are increasingly challenged by the latest research findings. This study will 1 evaluate a new physicians' communication training regarding patient involvement in terms of SDM, 2 validate SDMMASS, a new compound measure of SDM, and 3 evaluate the effects of SDM on the perceived quality of the decision process and on the elaboration of the decision. Methods In a multi-center randomized controlled trial with a waiting control group, 40 physicians from 7 medical fields are enrolled. Each physician contributes a sequence of four medical consultations including a diagnostic or treatment decision. The intervention consists of two condensed video-based individual coaching sessions (15min. supported by a manual and a DVD. The interventions alternate with three measurement points plus follow up (6 months. Realized patient involvement is measured using the coefficient SDMMASS drawn from the Multifocal Approach to the Sharing in SDM (MAPPIN'SDM which includes objective involvement, involvement as perceived by the patient, and the doctor-patient concordance regarding their judges of the involvement. For validation purposes, all three components of SDMMASS are supplemented by similar measures, the OPTION observer scale, the Shared Decision Making Questionnaire (SDM-Q and the dyadic application of the Decisional Conflict Scale (DCS. Training effects are analyzed using t-tests. Spearman correlation coefficients are used to determine convergent validities, the influence of involvement (SDMMASS on the perceived decision quality (DCS and on the elaboration of the decision. The latter is operationalised by the ELAB coefficient from the UP24 (Uncertainty Profile, 24 items version

  1. Safety and effectiveness of autoinoculation therapy in cutaneous warts: a double--blind, randomized, placebo--controlled study.

    Science.gov (United States)

    Lal, Niharika Ranjan; Sil, Amrita; Gayen, Tirthankar; Bandyopadhyay, Debabrata; Das, Nilay Kanti

    2014-01-01

    In spite of the availability of multiple treatment options, viral warts are known for their persistence and recurrence, causing frustration to patients and treating physicians. To study the effectiveness and safety of autoinoculation as a treatment modality in cutaneous warts. A double-blind, placebo-controlled study was carried out. In the treatment group, full-thickness warty tissue was excised, minced and implanted in a small dermal pocket. In the control group, warty tissue was only excised and not implanted, though a dermal pocket was made. Patients were evaluated every four weeks with lesion counts. The procedure was repeated at 4 and 8 weeks. Response was assessed at each visit and at 12 weeks. Forty-eight patients with cutaneous warts (male: female=32:16) were randomized into autoinoculation and control groups. The number of warts at baseline was comparable in both groups (P=0.293). Reduction in the number of warts was significantly more in the autoinoculation group (8.50±13.88) than in the control group (10.04±5.80) from 8 weeks onwards (P=0.010). Complete resolution occurred only in the autoinoculation group, in 62.5% of cases. Adverse effects were seen in 11 patients, including infection of the donor site (5 cases), keloid formation (3) and hypopigmentation (3). Autoinoculation may be an effective therapeutic modality for cutaneous warts and two sessions may be required for optimum results.

  2. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery. A Randomized, Controlled Study

    DEFF Research Database (Denmark)

    Bjørn, Siska; Linde, Frank; Nielsen, Kristian Kibak;

    2016-01-01

    prolongs the duration of analgesia and postpones as well as reduces opioid-requiring pain. METHODS: Forty patients were included in this prospective, randomized, controlled study. All patients received a continuous sciatic catheter and were randomized to receive a single-injection saphenous nerve block...

  3. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Kreuzer Peter M

    2012-11-01

    Full Text Available Abstract Background Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Methods Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend and in four further two-hour sessions (week 2, 9, 18 and 22. Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ. Results ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010. Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p  Conclusions Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes. The study is registered with clinicaltrials.gov (NCT01540357.

  4. Strategies to reduce safety violations for working from heights in construction companies: study protocol for a randomized controlled trial.

    Science.gov (United States)

    van der Molen, Henk F; Frings-Dresen, Monique H W

    2014-05-31

    Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries. However, according to the labor inspectorate, more than 80% of Dutch construction sites violate safety regulations for working from heights. To increase compliance with safety regulations, employers and workers have to select, implement and monitor safety measures. To facilitate this behavioral change, stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques. For this study, two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate. These strategies consist of 1) face-to-face contacts with safety consultants and 2) direct mail with access to internet facilities. The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights, the process and the cost measures. This study is a block randomized intervention trial in 27 cities to establish the effects of the face-to-face guidance strategy (N = 9), a direct mailing strategy (N = 9) and a control condition of no guidance (N = 9) on safety violations to record by labor inspectors after three months. A process evaluation for both strategies will be performed to determine program implementation (reach, dose delivered and dose received), satisfaction, knowledge and perceived safety behavior. A cost analysis will be performed to establish the financial costs for both strategies. The present study is in accordance with the CONSORT statement. This study increases insight into performing practice-based randomized controlled trials. The outcome will help to evaluate the effect of two guidance strategies on safety violations. If these strategies are effective, implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide construction companies in complying with

  5. A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol

    OpenAIRE

    Ogedegbe, Gbenga; Plange-Rhule, Jacob; Gyamfi, Joyce; Chaplin, William; Ntim, Michael; Apusiga, Kingsley; Khurshid, Kiran; Cooper, Richard

    2014-01-01

    Background Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA....

  6. Promoting the Purchase of Low-Calorie Foods from School Vending Machines: A Cluster-Randomized Controlled Study

    Science.gov (United States)

    Kocken, Paul L.; Eeuwijk, Jennifer; van Kesteren, Nicole M.C.; Dusseldorp, Elise; Buijs, Goof; Bassa-Dafesh, Zeina; Snel, Jeltje

    2012-01-01

    Background: Vending machines account for food sales and revenue in schools. We examined 3 strategies for promoting the sale of lower-calorie food products from vending machines in high schools in the Netherlands. Methods: A school-based randomized controlled trial was conducted in 13 experimental schools and 15 control schools. Three strategies…

  7. Effect of a diet intervention during pregnancy on dietary behavior in the randomized controlled Norwegian Fit for Delivery study.

    Science.gov (United States)

    Hillesund, E R; Bere, E; Sagedal, L R; Vistad, I; Øverby, N C

    2016-10-01

    A mother's diet during pregnancy has the potential to influence both her own and her child's short- and long-term health. This paper reports the effects of a randomized controlled diet intervention during pregnancy on dietary behavior post-intervention as reported in late pregnancy. The diet intervention was part of a lifestyle intervention targeting both diet and physical activity behaviors among nulliparous women participating in the randomized controlled Norwegian Fit for Delivery study (NFFD). Eligible women were enrolled in early pregnancy from eight healthcare clinics in southern Norway between 2009 and 2013. The diet intervention was based on 10 dietary recommendations that were conveyed during two counseling sessions by phone and in a pamphlet describing the recommendations and their simplified rationale. A diet score was constructed from a 43-item food frequency questionnaire (FFQ) and used to assess intervention effect on dietary behavior (score range 0-10). Between-group dietary differences post-intervention were estimated with analysis of covariance, with adjustment for baseline diet. A total of 508 women completed the FFQ both at baseline and post-intervention. There were no between-group differences in diet score and subscales at baseline. Post-intervention, the intervention group had higher overall diet score (control: 4.61, intervention: 5.04, P=0.013) and favorable dietary behavior in seven of the 10 dietary domains: 'consumption of water relative to total beverage consumption' (P=0.002), 'having vegetables with dinner' (P=0.027), 'choosing fruits and vegetables for between-meal snacks' (P=0.023), 'buying small portion sizes of unhealthy foods' (P=0.010), 'limiting sugar intake' (P=0.005), 'avoiding eating beyond satiety' (P=0.009) and 'reading food labels' (P=0.011). The NFFD diet intervention improved dietary behavior. Potential long-term clinical influence in mother and child will be investigated in further studies.

  8. Study protocol: Münster tinnitus randomized controlled clinical trial-2013 based on tailor-made notched music training (TMNMT).

    Science.gov (United States)

    Pantev, Christo; Rudack, Claudia; Stein, Alwina; Wunderlich, Robert; Engell, Alva; Lau, Pia; Wollbrink, Andreas; Shaykevich, Alex

    2014-03-02

    Tinnitus is a result of hyper-activity/hyper-synchrony of auditory neurons coding the tinnitus frequency, which has developed to synchronous mass activity owing the lack of inhibition. We assume that removal of exactly these frequency components from an auditory stimulus will cause the brain to reorganize around tonotopic regions coding the tinnitus frequency. Based on this assumption a novel treatment for tonal tinnitus - tailor-made notched music training (TMNMT) (Proc Natl Acad Sci USA 107:1207-1210, 2010; Ann N Y Acad Sci 1252:253-258, 2012; Frontiers Syst Neurosci 6:50, 2012) has been introduced and will be tested in this clinical trial on a large number of tinnitus patients. A randomized controlled trial (RCT) in parallel group design will be performed in a double-blinded manner. The choice of the intervention we are going to apply is based on two "proof of concept" studies in humans (Proc Natl Acad Sci USA 107:1207-1210, 2010; Ann N Y Acad Sci 1252:253-258, 2012; Frontiers Syst Neurosci 6:50, 2012; PloS One 6(9):e24685, 2011) and on a recent animal study (Front Syst Neurosci 7:21, 2013).The RCT includes 100 participants with chronic, tonal tinnitus who listened to tailor-made notched music (TMNM) for two hours a day for three months. The effect of TMNMT is assessed by the tinnitus handicap questionnaire and visual analogue scales (VAS) measuring perceived tinnitus loudness, distress and handicap. This is the first randomized controlled trial applying TMNMT on a larger number of patients with tonal tinnitus. Our data will verify more securely and reliably the effectiveness of this kind of completely non-invasive and low-cost treatment approach on tonal tinnitus. Current Controlled Trials ISRCTN04840953.

  9. Immediate versus conditional treatment of uncomplicated urinary tract infection - a randomized-controlled comparative effectiveness study in general practices

    Directory of Open Access Journals (Sweden)

    Gágyor Ildikó

    2012-06-01

    Full Text Available Abstract Background Uncomplicated urinary tract infections (UTI are usually treated with antibiotics as recommended by primary care guidelines. Antibiotic treatment supports clinical cure in individual patients but also leads to emerging resistance rates in the population. We designed a comparative effectiveness study to investigate whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen, reserving antibiotic treatment to patients who return due to ongoing or recurrent symptoms. Methods/design This is a randomized-controlled, double-blind, double dummy multicentre trial assessing the comparative effectiveness of immediate vs. conditional antibiotic therapy in uncomplicated UTI. Women > 18 and  Discussion This study aims at investigating whether the use of antibiotics for uncomplicated UTI could be reduced by initial treatment with ibuprofen. The comparative effectiveness design was chosen to prove the effectiveness of two therapeutic strategies instead of the pure drug efficacy. Trial registration Clinicaltrials.Gov: NCT01488955

  10. A randomized controlled study of power posing before public speaking exposure for social anxiety disorder: No evidence for augmentative effects.

    Science.gov (United States)

    Davis, Michelle L; Papini, Santiago; Rosenfield, David; Roelofs, Karin; Kolb, Sarah; Powers, Mark B; Smits, Jasper A J

    2017-09-18

    This manuscript details a randomized controlled study designed to test the efficacy of power posing (i.e., briefly holding postures associated with dominance and power) as an augmentative strategy for exposure therapy for social anxiety disorder (SAD). Seventy-three individuals diagnosed with SAD were assigned to one of three conditions: power posing, submissive posing, or rest (no posing) prior to participating in an exposure therapy session. Participants were assessed for between-group differences in pre- and post-manipulation salivary hormone levels, within-session subjective experiences of fear, and pre- and 1-week post-treatment SAD severity outcome measures. Though the intervention resulted in decreased SAD symptom severity one week later, analyses revealed no significant between-group differences on any tested variables. Accordingly, this study provides no evidence to suggest that power posing impacts hormone levels or exposure therapy outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Stroke Rehabilitation in Frail Elderly with the Robotic Training Device ACRE: A Randomized Controlled Trial and Cost-Effectiveness Study

    Directory of Open Access Journals (Sweden)

    M. Schoone

    2011-01-01

    Full Text Available The ACRE (ACtive REhabilitation robotic device is developed to enhance therapeutic treatment of upper limbs after stroke. The aim of this study is to assess effects and costs of ACRE training for frail elderly patients and to establish if ACRE can be a valuable addition to standard therapy in nursing home rehabilitation. The study was designed as randomized controlled trial, one group receiving therapy as usual and the other receiving additional ACRE training. Changes in motor abilities, stroke impact, quality of life and emotional well-being were assessed. In total, 24 patients were included. In this small number no significant effects of the ACRE training were found. A large number of 136 patients were excluded. Main reasons for exclusion were lack of physiological or cognitive abilities. Further improvement of the ACRE can best be focused on making the system suitable for self-training and development of training software for activities of daily living.

  12. A randomized, double blind, placebo controlled study of spirulina supplementation on indices of mental and physical fatigue in men.

    Science.gov (United States)

    Johnson, Morgan; Hassinger, Lauren; Davis, Joshua; Devor, Steven T; DiSilvestro, Robert A

    2016-01-01

    Spirulina may increase people's ability to resist mental and physical fatigue. This study tested that hypothesis in a randomized, double blinded, placebo controlled study in men. After 1 week, a 3 g/day dose of spirulina produced a small, but statistically significant increase in exercise output (Kcals consumed in 30 min exercise on a cross trainer machine). A mathematical based mental fatigue test showed improved performance 4 h after the first time of supplementation as well as 8 weeks later. Similarly, a subjective survey for a sense of physical and mental fatigue showed improvement within 4 h of the first supplementation as well as 8 weeks later. These results show that spirulina intake can affect fatigue in men.

  13. Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES – a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Weinberger Morris

    2009-02-01

    Full Text Available Abstract Background Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C. The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. Methods Veteran outpatients with above-goal LDL-C (N = 250 and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support. The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. Discussion Given the social

  14. Effect of honey on 50% complement hemolytic activity in infants with protein energy malnutrition: a randomized controlled pilot study.

    Science.gov (United States)

    Abdulrhman, Mamdouh Abdulmaksoud; Nassar, May Fouad; Mostafa, Hisham Waheed; El-Khayat, Zakaria Abdulhalim; Abu El Naga, Marwa Wageh

    2011-05-01

    Protein energy malnutrition (PEM) is associated with a significant impairment of cell-mediated immunity and complement system, which may be responsible for the high incidence of infections among these patients. This study was designed to examine the effect of honey, as a natural substance, on the 50% complement hemolytic activity (CH50) in patients with PEM. Thirty patients with PEM and 20 healthy infants serving as controls participated in this study. The patients were randomized to receive either honey (group 1) or placebo (group 2), in addition to conventional nutritional rehabilitation therapy. Measurements of weight, midarm circumference, skin fold thickness, serum albumin, and CH50 were done for all patients before and after 2 weeks of rehabilitation. Before nutritional rehabilitation, the CH50 was significantly lower in the PEM groups compared with the control. However, after rehabilitation, the CH50 increased significantly in both PEM groups, compared with the pre-interventional state and with the controls. Moreover, the rise of CH50 was significantly more in the honey group compared with the placebo. On the other hand, the improvement in the anthropometric measures and serum albumin did not differ significantly between the honey and placebo groups after rehabilitation. Thus honey supplementation in patients with PEM increased the level of CH50. Whether this would have an effect on the frequency and severity of infections in patients with PEM needs further studies.

  15. A Randomized, Double-blind, Placebo-Controlled Study of Efficacy of Oral Acyclovir in the Treatment of Pityriasis Rosea.

    Science.gov (United States)

    Ganguly, Satyaki

    2014-05-01

    Pityriasis rosea is an acute self-limiting skin disorder of unknown aetiology. Recently human herpes virus 6 and 7 has been hypothesized to be the cause of pityriasis rosea. To determine the efficacy of acyclovir, an anti-viral drug, in the treatment of pityriasis rosea. A randomized, double-blind, placebo-controlled study of efficacy of oral acyclovir in the treatment of pityriasis rosea was conducted on 73 patients. Thirty eight randomly selected patients were started on oral acyclovir. Thirty-five patients were prescribed placebo. The patients as well as the chief investigator were unaware of the therapeutic group to which patients belonged (acyclovir or placebo). Patients in both the groups were evaluated clinically after 7 and 14 days following the first visit and the data were analysed. Follow up data of 60 patients was available and these were included in the statistical analysis. 53.33% and 86.66% of the patients belonging to the acyclovir group showed complete resolution on the 7(th) day and 14(th) day respectively following the first visit compared to 10% and 33.33% of patients from the placebo group. The findings were statistically significant. The study showed that high dose acyclovir is effective in the treatment of pityriasis rosea.

  16. Predictors of remission in depression to individual and combined treatments (PReDICT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dunlop Boadie W

    2012-07-01

    Full Text Available Abstract Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD. Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1 cognitive behavior therapy (CBT, 16 sessions; (2 duloxetine (30–60 mg/d; or (3 escitalopram (10–20 mg/d. Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI, immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12

  17. [Parental education to reduce blood lead levels in children with mild and moderate lead poisoning: a randomized controlled study].

    Science.gov (United States)

    Shen, Xiao-ming; Yan, Chong-huai; Wu, Sheng-hu; Shi, Rong

    2004-12-01

    To evaluate the effectiveness of parental education on reducing lead exposure of children by examining the changes in blood lead levels of children whose parents receiving or not receiving educational intervention. Two hundred children with confirmed blood lead levels beyond 100 microg/L were selected. They were randomized into two groups, 107 children in study group and 93 in control. At the beginning of the study, parents of both study and control groups were called for interview to complete KABP questionnaire and lead study questionnaire. The study group was provided with interventional measures while control group was not contacted until the end of study. Intervention of parental education was undertaken by means of a TV program, a set of slides and a brochure, and focused on the questions regarding harmful effects of lead poisoning, the sources of environmental lead and prevention of this preventable disease. Tests for blood lead level were repeated for both study and control groups 3 months after the determination of the initial blood lead level. All the relevant knowledge of health effect, lead sources and prevention of childhood lead poisoning of participating parents of study group were improved significantly (chi(2) = 14.06, 13.07, 10.08, 28.26, P parents control group also were significantly improved in the sub-catalogs of concept and prevention (chi(2) = 7.69, 8.64, P parents' behavior in study group was improved accordingly and significantly. Less children ate popcorn (chi(2) = 4.08, P parents changed their coat or took shower or washed hands before going home after work (chi(2) = 4.00, P control group only the number of kids playing on road side was decreased significantly (chi(2) = 9.60, P control (t = 3.398, P parents' occupational exposure to lead, the improvement of knowledge about prevention of childhood lead poisoning, the chang of habit of snacks intake, parents' education levels, the change of attitude of parents for the childhood lead

  18. Skin-impedance in Fabry Disease: A prospective, controlled, non-randomized clinical study

    Directory of Open Access Journals (Sweden)

    Lidicker Jeffrey R

    2008-11-01

    Full Text Available Abstract Background We previously demonstrated improved sweating after enzyme replacement therapy (ERT in Fabry disease using the thermo-regularity sweat and quantitative sudomotor axon reflex tests. Skin-impedance, a measure skin-moisture (sweating, has been used in the clinical evaluation of burns and pressure ulcers using the portable dynamic dermal impedance monitor (DDIM system. Methods We compared skin impedance measurements in hemizygous patients with Fabry disease (22 post 3-years of bi-weekly ERT and 5 ERT naive and 22 healthy controls. Force compensated skin-moisture values were used for statistical analysis. Outcome measures included 1 moisture reading of the 100th repetitive reading, 2 rate of change, 3 average of 60–110th reading and 4 overall average of all readings. Results All outcome measures showed a significant difference in skin-moisture between Fabry patients and control subjects (p Conclusion The instrument portability, ease of its use, a relatively short time required for the assessment, and the fact that DDIM system was able to detect the difference in skin-moisture renders the instrument a useful clinical tool.

  19. Effects of tai chi chuan on anxiety and sleep quality in young adults: lessons from a randomized controlled feasibility study

    Directory of Open Access Journals (Sweden)

    Caldwell KL

    2016-11-01

    in young adults. Keywords: anxiety, sleep quality, tai chi chuan, randomized controlled trial, feasibility study

  20. Positive psychology interventions: A meta-analysis of randomized controlled studies

    National Research Council Canada - National Science Library

    Bolier, L; Haverman, M; Westerhof, G.J; Riper, H; Smit, F; Bohlmeijer, E

    2013-01-01

    .... The present article constitutes a meta-analytical study of the effectiveness of positive psychology interventions for the general public and for individuals with specific psychosocial problems...

  1. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study.

    Science.gov (United States)

    Abdolahian, Somayeh; Ghavi, Fatemeh; Abdollahifard, Sareh; Sheikhan, Fatemeh

    2014-03-30

    There are a wide variety of non- pharmacologic pain relief techniques for labor which include pelvic movement, upright position, back massage and partner support during the first stage of labor. The effectiveness of dance labor- which is a combination of these techniques- has not been evaluated. This study aimed to evaluate the effectiveness of dance labor in pain reduction and woman's satisfaction during the first stage of labor. 60 primiparous women aged 18-35 years old were randomly assigned to dance labor and control groups. In the dance labor group, women were instructed to do standing upright with pelvic tilt and rock their hips back and forth or around in a circle while their partner massaged their back and sacrum for a minimum of 30 minutes. In the control group, the participants received usual care during physiologic labor. Pain and satisfaction scores were measured by Visual Analogue Scale. Data were analyzed by using the t. test and Chi-square. Mean pain score in the dance labor group was significantly lower than the control group (P dance labor group was significantly higher than in the control group (P Dance labor which is a complementary treatment with low risk can reduce the intensity of pain and increase mothers, satisfaction with care during the active phase of labor.

  2. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poh Catherine F

    2011-10-01

    Full Text Available Abstract Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160 and invasive squamous cell carcinoma (N = 240. Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm or white light-guided surgery (control arm. The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1 the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization; or 2 further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS

  3. Impact of oral melatonin on critically ill adult patients with ICU sleep deprivation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Huang, Huawei; Jiang, Li; Shen, Ling; Zhang, Guobin; Zhu, Bo; Cheng, Jiajia; Xi, Xiuming

    2014-08-18

    Sleep deprivation is common in critically ill patients in intensive care units (ICU). It can result in delirium, difficulty weaning, repeated nosocomial infections, prolonged ICU length of stay and increased ICU mortality. Melatonin, a physiological sleep regulator, is well known to benefit sleep quality in certain people, but evidence for the effectiveness in ICU sleep disturbance is limited. This study has a prospective, randomized, double-blind, controlled, parallel-group design. Eligible patients are randomly assigned to one of the two treatment study groups, labelled the 'melatonin group' or the 'placebo group'. A dose of 3 mg of oral melatonin or placebo is administered at 9:00 pm on four consecutive days. Earplugs and eye masks are made available to every participant. We plan to enrol 198 patients. The primary outcome is the objective sleep quality measured by the 24-hour polysomnography. The secondary outcomes are the subjective sleep quality assessed by the Richards Campbell Sleep Questionnaire, the anxiety level evaluated by the Visual Analogue Scale-Anxiety, the number of delirium-free days in 8 and 28 days, the number of ventilation-free days in 28 days, the number of antibiotic-free days, ICU length of stay, the overall ICU mortality in 28 days and the incidence and severity of the side effects of melatonin in ICU patients. Additionally, the body stress levels, oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin, cortisone, norepinephrine, malonaldehyde(MDA), superoxide dismutase(SOD), interleukin-6 (IL-6) and interleukin-8 (IL-8)concentrations. The proposed study will be the first randomized controlled study to use the polysomnography, which is the gold standard of assessing sleep quality, to evaluate the effect of melatonin on the sleep quality and circadian rhythms of ICU patients. The results may recommend a new treatment for ICU patients with sleep deprivation that is safe, effective and easily

  4. No Evidence of Intelligence Improvement after Working Memory Training: A Randomized, Placebo-Controlled Study

    Science.gov (United States)

    Redick, Thomas S.; Shipstead, Zach; Harrison, Tyler L.; Hicks, Kenny L.; Fried, David E.; Hambrick, David Z.; Kane, Michael J.; Engle, Randall W.

    2013-01-01

    Numerous recent studies seem to provide evidence for the general intellectual benefits of working memory training. In reviews of the training literature, Shipstead, Redick, and Engle (2010, 2012) argued that the field should treat recent results with a critical eye. Many published working memory training studies suffer from design limitations…

  5. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G;

    2012-01-01

    bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design...

  6. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  7. Control of Established Gingivitis and Dental Plaque Using a 1450 ppm Fluoride/Zinc-based Dentifrice: A Randomized Clinical Study.

    Science.gov (United States)

    Zhong, Y; Li, X; Hu, D Y; Mateo, L R; Morrison, B M; Delgado, E; Zhang, Y P

    2015-01-01

    To investigate the clinical efficacy in controlling established gingivitis and dental plaque of a 1450 ppm fluoride as sodium monofluorophosphate (SMFP)/zinc-based dentifrice, as compared to a zinc-free dentifrice with 1450 ppm fluoride as SMFP after six months product use. A six-month clinical study, with eighty-six (86) subjects, was conducted in Chengdu, China, using a double-blind, randomized, parallel-group treatment design. After a baseline evaluation, study subjects were randomly assigned to one of the two study treatments: 1) 1450 ppm fluoride as SMFP/zinc-based dentifrice (Test) or 2) 1450 ppm fluoride as SMFP/zinc-free dentifrice (Negative Control). Subjects were provided with a soft bristle toothbrush and brushed their teeth twice daily (morning and evening) for one minute with their assigned dentifrice. After three months, and again after six months of product use, subjects returned to the testing facility for their followup gingivitis and plaque examinations. Statistical analyses were performed separately for the gingivitis assessments and dental plaque assessments using the appropriate statistical methods. All statistical tests of hypotheses were two-sided, and employed a level of significance of α = 0.05. After three and six months of product use, subjects assigned to the Test treatment exhibited statistically significant (p dentifrice provides clinically meaningful and statistically significant reductions in gingivitis (23.8%) and dental plaque (22.5%) as compared to a 1450 ppm fluoride as SMFP/zinc-free dentifrice over a six-month period of twice-daily product use.

  8. Group versus Internet-based cognitive-behavioral therapy for procrastination: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Alexander Rozental

    2014-04-01

    Full Text Available Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday lives. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive-behavioral therapy is often deemed a treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the proposed study is therefore to test the efficacy of cognitive-behavioral therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into blocks of thirty will be used, comparing an eight-week Internet-based cognitive-behavioral therapy intervention, and an eight-week group cognitive-behavioral therapy based intervention. It is believed that the proposed study will result in two important findings. First, different treatment interventions in cognitive-behavioral therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both an Internet-based cognitive-behavioral therapy intervention and a group intervention are presumed suitable for administering treatment for procrastination, which is considered important as the availability of adequate care is limited, particularly among students. The proposed study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well

  9. Day care PNL using ‘Santosh-PGI hemostatic seal’ versus standard PNL: A randomized controlled study

    Science.gov (United States)

    Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

    2016-01-01

    Introduction To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. Material and methods It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. Results A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission. PMID:27551557

  10. Local Infiltration of Tramadol versus Bupivacaine for Post Cesarean Section Pain Control: A Double-Blind Randomized Study.

    Science.gov (United States)

    Sahmeddini, Mohammad Ali; Azemati, Simin; Motlagh, Ehsan Masoudi

    2017-05-01

    Postoperative pain control after cesarean section (C/S) is important because inadequate postoperative pain control can result in a prolonged hospital stay. In this study, we compared postoperative somatic wound pain control between patients receiving tramadol and bupivacaine, infiltrated at the wound site. In this randomized clinical trial, 98 patients, eligible for elective C/S under general anesthesia, were randomly allocated to 2 groups. Before wound closure, 20 cc of 0.025% bupivacaine and 2 mg/kg of tramadol, diluted to 20 cc, were infiltrated at the wound site in groups A and B, respectively. After surgery, the pain score was measured using the visual analogue scale (VAS). Additionally, 24-hour total morphine consumption, nausea and vomiting, and respiratory depression were compared after 2, 4, 8, 16, and 24 hours between the 2 groups. The data were analyzed using SPSS with the Student independent t test, χ(2) test, Fisher exact test, and repeated measure test. Postoperatively, there was no significant difference between these 2 groups in their VAS scores until 16 hours (P>0.05). However, at the 16(th) and 24(th) hours, the mean VAS scores were 3.20±2.24 and 2.51±2.55 in the bupivacaine group and 2.51±0.99 and 1.40±0.88 in the tramadol group, respectively (Ptramadol (2 mg/kg) at the incision site of C/S was effective in somatic wound pain relief without significant complications. IRCT2013070111662N2.

  11. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

    Directory of Open Access Journals (Sweden)

    Berry Diane C

    2012-03-01

    Full Text Available Abstract Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. Methods/Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy. A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I, 9 months of continued monthly contact

  12. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study.

    Science.gov (United States)

    Berry, Diane C; McMurray, Robert; Schwartz, Todd A; Skelly, Anne; Sanchez, Maria; Neal, Madeline; Hall, Gail

    2012-03-30

    Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy.A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m² have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I), 9 months of continued monthly contact (Phase II) and then 6 months (follow-up) on their own

  13. Control of odontogenic pain by diclofenac and meloxicam mucoadhesive patches: A randomized, double-blinded, placebo-controlled, preliminary study

    Directory of Open Access Journals (Sweden)

    Pratik R Pipalia

    2016-01-01

    Full Text Available Aims and Objectives: To evaluate and compare the efficacy of diclofenac and meloxicam as mucoadhesive patches in dental pain management. Materials and Method: This study was conducted among 45 adult patients of either sex, who were diagnosed with dental pain and were attending the outpatient department. Written informed consent was obtained from all the patients. A 1 × 1 cm2 mucoadhesive patch of any one (diclofenac, meloxicam or placebo was applied on the attached gingival region of the tooth with pain. Pain was recorded using a ten point visual analog scale (VAS score at every 5 min for 30 min. Pain was measured and compared before and after the application of the patch. Results: The results showed that patients with diclofenac patch gained mean pain reduction from 6 ± 1.54 mm to 2.60 ± 1.32 mm after 30 min (P 0.05. The maximum pain reduction was seen with meloxicam patch. Conclusion: Transmucosal mucoadhesive analgesic patches are a better alternative to oral analgesics to control dental pain. Hence, routine use of mucoadhesive analgesic patch for dental pain reduction is recommended in day to day practice.

  14. Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Huang, Fang; Qian, Qiujin; Wang, Yufeng

    2015-04-14

    Attention-deficit hyperactivity disorder (ADHD) is a mental disorder beginning in childhood, and about half of patients have symptoms lasting into adulthood. Adult ADHD causes various impairments of emotional, self-esteem, and executive function and life quality aspects. Furthermore, adverse outcomes include academic and occupational failures, traffic accidents and substance abuse, which would be a family and social burden. A combination of medication and psychotherapy is recommended as the treatment for adult ADHD, and cognitive behavioral therapy (CBT) has been validated mostly with evidence-based researches. However, there has been a lack of randomized controlled trials of CBT for patients in China. Moreover, booster sessions of CBT for other disorders have proven effective in reducing recurrence and improving long-term outcomes, which has not been investigated for adult ADHD. This study will testify to the effect of CBT and explore the efficacy of subsequent booster sessions on adult ADHD. It is a three-armed randomized controlled trial to evaluate the efficacy of 12 weeks of CBT based on the published and validated manual and its booster sessions. The 12 weeks of CBT will be conducted weekly and will end at the 12th week, and then the booster sessions will be conducted monthly and end at the 24th week. There are three randomized groups, including a CBT with booster sessions group, a CBT group and a waiting group. Participants are outpatients of the Peking University Sixth Hospital who are diagnosed as having adult ADHD. The Primary efficacy endpoints are the scores of ADHD core symptoms at 12 and 24 weeks. Secondary endpoints include emotion, executive function, self-esteem, life quality and functional magnetic resonance imaging (fMRI) data at different time points, and the change within every group will also be analyzed. This is the first study to explore the efficacy of booster sessions of CBT in adult ADHD as far as we know. The results might increase proof

  15. Small laser spot versus standard laser spot photodynamic therapy for idiopathic choroidal neovascularization: a randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    LI Xiao-xin; TAO Yong

    2012-01-01

    Backcround Idiopathic choroidal neovascularization (ICNV) affects young patients and thus may have a significant impact on vision and life quality over a patient's lifespan.This study was designed to compare the visual outcome and retinal pigment epithelium (RPE) damage after photodynamic therapy (PDT) with small laser spot and PDT with standard laser spot for idiopathic choroidal neovascularization (ICNV).Methods This was a randomized controlled study.Fifty-two patients with ICNV were enrolled and randomly divided into a study group (small laser spot PDT,n=27) and a control group (standard laser spot PDT,n=25).Best corrected visual acuity (BCVA),optic coherence tomography (OCT) and fluorescein angiography (FA) findings were the main measurements.The patients were followed up 1 week,1,3,6,9 months and 1 year after PDT.Results BCVA improvement was statistically significantly higher in the study group than the control group at 6-month ((25.53±15.01) letters vs.(14.71±11.66) letters,P=0.025) and 9-month follow-ups ((27.53±17.78) letters vs.(15.59±12.21) letters,P=0.039).At 3-and 6-month follow-ups,the quadrants of RPE damage between the two groups varied significantly (P <0.001 and P=0.023,respectively).In each follow-up,the number of cases with decreased or unchanged leakage of choroidal neovascularization by FA and reduced subretinal fluid by OCT did not vary significantly between the two groups.Ten cases (37.0%) in the study group and eight cases (32.0%) in the control group suffered from recurrent CNV (P=0.703).Conclusions Better visual improvements,less RPE damage,a similar recurrent rate of CNV and change of subretinal fluid were observed in the small laser spot PDT group than in the standard laser spot PDT group for ICNV.

  16. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    National Research Council Canada - National Science Library

    Xia, Feng; Han, Junliang; Liu, Xuedong; Wang, Jingcun; Jiang, Zhao; Wang, Kangjun; Wu, Songdi; Zhao, Gang

    2011-01-01

    .... Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease...

  17. Levosimendan for resuscitating the microcirculation in patients with septic shock: A randomized controlled study

    National Research Council Canada - National Science Library

    Morelli, Anea; Donati, Abele; Ertmer, Christian; Rehberg, Sebastian; Lange, Matthias; Orecchioni, Alessana; Cecchini, Valeria; Landoni, Giovanni; Pelaia, Paolo; Pietropaoli, Paolo; Aken, Hugo; Teboul, Jean Louis; Ince, Can; Westphal, Manfred

    2010-01-01

    textabstractIntroduction: The purpose of the present study was to investigate microcirculatory blood flow in patients with septic shock treated with levosimendan as compared to an active comparator drug (i.e. dobutamine...

  18. Quality of Life Enhancement Programme for Individuals with Mood Disorder: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Yun-Ling Chen

    2015-06-01

    Conclusion: The participants who received the 8-week QOLEP demonstrated significant improvement in the level of depression. Studies with a sample size of at least 104 participants are recommended in the future.

  19. Impacts of dietary fat changes on pregnant women with gestational diabetes mellitus: A randomized controlled study

    National Research Council Canada - National Science Library

    Wang, Huiyan; Jiang, Hongyi; Yang, Liping; Zhang, Ming

    2015-01-01

    Objective: This study aims to determine the impact of increasing polyunsaturated fatty acid intake on blood glucose, lipid metabolism, and pregnancy outcomes of pregnant women with gestational diabetes mellitus. Methods...

  20. Impact of the training on the compliance and persistence of weekly bisphosphonate treatment in postmenopausal osteoporosis: a randomized controlled study.

    Science.gov (United States)

    Tüzün, Şansın; Akyüz, Gülseren; Eskiyurt, Nurten; Memiş, Asuman; Kuran, Banu; İçağasıoğlu, Afitap; Sarpel, Tunay; Özdemir, Ferda; Özgirgin, Neşe; Günaydın, Rezzan; Cakçı, Aytül; Yurtkuran, Merih

    2013-01-01

    Long-term patient adherence to osteoporosis treatment is poor despite proven efficacy. In this study, we aimed to assess the impact of active patient training on treatment compliance and persistence in patients with postmenopausal osteoporosis. In the present national, multicenter, randomized controlled study, postmenopausal osteoporosis patients (45-75 years) who were on weekly bisphosphonate treatment were randomized to active training (AT) and passive training (PT) groups and followed-up by 4 visits after the initial visit at 3 months interval during 12 months of the treatment. Both groups received a bisphosphonate usage guide and osteoporosis training booklets. Additionally, AT group received four phone calls (at 2(nd), 5(th), 8(th), and 11(th) months) and participated to four interactive social/training meetings held in groups of 10 patients (at 3(rd), 6(th), 9(th), and 12(th) months). The primary evaluation criteria were self-reported persistence and compliance to the treatment and the secondary evaluation criteria was quality life of the patients assessed by 41-item Quality of Life European Foundation for Osteoporosis (QUALEFFO-41) questionnaire. Of 448 patients (mean age 62.4±7.7 years), 226 were randomized to AT group and 222 were randomized to PT group. Among the study visits, the most common reason for not receiving treatment regularly was forgetfulness (54.9% for visit 2, 44.3% for visit 3, 51.6% for visit 4, and 43.8% for visit 5), the majority of the patients always used their drugs regularly on recommended days and dosages (63.8% for visit 2, 60.9% for visit 3, 72.1% for visit 4, and 70.8% for visit 5), and most of the patients were highly satisfied with the treatment (63.4% for visit 2, 68.9% for visit 3, 72.4% for visit 4, and 65.2% for visit 5) and wanted to continue to the treatment (96.5% for visit 2, 96.5% for visit 3, 96.9% for visit 4, and 94.4% for visit 5). QUALEFFO scores of the patients in visit 1 significantly improved in visit 5 (37.7

  1. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication

    DEFF Research Database (Denmark)

    Momsen, A H; Jensen, M B; Norager, C B

    2010-01-01

    Intermittent claudication is a disabling symptom of peripheral arterial disease for which few medical treatments are available. This study investigated the effect of caffeine on physical capacity in patients with intermittent claudication.......Intermittent claudication is a disabling symptom of peripheral arterial disease for which few medical treatments are available. This study investigated the effect of caffeine on physical capacity in patients with intermittent claudication....

  2. Effects of zinc supplementation on obesity: study protocol for a randomized controlled clinical trial

    OpenAIRE

    Rathnayake, Kumari M; Silva, KDRR; Jayawardena, Ranil

    2016-01-01

    Background The prevalence of obesity is escalating alarmingly worldwide, and it is now becoming a rapidly growing epidemic in developing countries. Recent studies have reported that zinc has been implicated in altered lipid markers, insulin resistance and some obesity markers. There is a lack of evidence on zinc as a potential therapeutic agent to reduce weight and improve metabolic parameters in obese adults. The present study is designed to evaluate the effects of zinc supplementation on ob...

  3. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION: A RANDOMIZED CASE CONTROL PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Tullika

    2014-03-01

    Full Text Available : INTRODUCTION: To reduce maternal mortality and morbidity caused by bleeding, it is important to reduce the amount of bleeding during and after lower segment caesarean section (LSCS. Tranexamic acid helps to reduce bleeding during and after LSCS. OBJECTIVES: To study the efficacy and safety of Tranexamic acid in reducing blood loss during and after Lower segment Caesarean Section (LSCS. METHODS: A randomized case controlled prospective study was conducted on 200 women undergoing lower segment cesarean section. Hundreds of them that were given tranexamic acid immediately before LSCS were compared to hundred others to whom tranexamic acid was not given. Blood loss was collected and measured during the two periods, from plancental delivery to end of LSCS and second from end of LSCS to two hours postpartum. RESULTS: Tranexamic acid significantly reduced the quantity of blood loss from placental delivery to end of LSCS, 202.25ml in the study group vs392.20 ml in the control group (p<0.001; from the end of LSCS, to 2 hours postpartum 3.80ml in the study group versus 112.25ml in the control group (p<0.001; In totality, it significantly reduced the quantity of blood loss from placental delivery to two hours postpartum i.e. 27.05ml in the study group versus 510.45ml in the control group (p < 0.001. No complications or side effects were noted. CONCLUSION: Tranexamic acid significantly reduced the amount of blood loss during and after LSCS. Tranexamic acid can be used prophylactically; moreover it is safer and effective in women undergoing LSCS.

  4. The effect of a structured intervention on caregivers of patients with dementia and problem behaviors: a randomized controlled pilot study.

    Science.gov (United States)

    Nobili, Alessandro; Riva, Emma; Tettamanti, Mauro; Lucca, Ugo; Liscio, Mariarosaria; Petrucci, Bianca; Porro, Gabriella Salvini

    2004-01-01

    The objective was to assess the effect of a structured intervention on caregiver stress and the institutionalization rate of patients with dementia and problem behaviors. Caregivers contacting the Federazione Alzheimer Italia (AI) to receive help, advice, or information in relation to problem behaviors of outpatients were enrolled. Eligible caregiver-patient dyads were randomized to receive either a structured intervention or the counseling AI usually provides (control group). After basal assessment, families were reassessed at 6 and 12 months. Problem behavior (particularly agitation) was the only variable significantly correlated (P = 0.006) with the baseline caregivers' stress score. Thirty-nine families completed the 12-month follow-up; the mean problem behavior score was significantly lower in the intervention than the control group (p < 0.03); the time needed for care of the patient increased by 0.5 +/- 9.7 hours/day in the control group and decreased by 0.3 +/- 4.1 in the intervention group (p = 0.4, Wilcoxon test). The main determinant of institutionalization seemed to be the level of caregiver stress (p = 0.03). In patients of the intervention group, there was a significant reduction in the frequency of delusions. This pilot study suggests that caregiver stress is relieved by a structured intervention. The number of families lost to follow-up, the relatively short duration of the study, and the ceiling effect due to the severity of the clinical characteristics of patients probably all partly dilute the observed findings.

  5. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    Science.gov (United States)

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  6. The effects of parental presence in the postanesthetic care unit on children's postoperative behavior: a prospective, randomized, controlled study.

    Science.gov (United States)

    Lardner, David R; Dick, Bruce D; Crawford, Susan

    2010-04-01

    The effects on children of parental presence in the postanesthesia care unit (PACU) have not been extensively studied. The few published studies are retrospective, nonrandomized, or lack adequate controls. They suggest that parental presence in the PACU decreases crying and negative behavior change postoperatively. We performed this prospective, randomized, controlled study to determine whether the presence of a parent affected crying behaviors in the PACU and behavior change 2 weeks postoperatively. Randomly selected patients, aged 2.0 to 8 years 11 months, ASA physical status I or II, and scheduled for elective outpatient surgery with an anticipated PACU stay of >10 minutes were randomly assigned to the parent present group (n = 150) or parent absent group (n = 150) in the PACU. All parents underwent the same preparation program. Reunification occurred once children's eyes had opened for the parent present group. In the PACU, crying was scored each minute after eye opening using a 5-point scale. Negative behavior change 2 weeks after discharge was determined using the Post Hospitalization Behavior Questionnaire. Because the anesthesia technique to be used was not determined a priori, data on the technique used were collected to ensure that groups were similar. Multiple and logistic regression techniques were used to determine predictors of crying in the PACU and behavior change 2 weeks postoperatively. Parental presence in the PACU made no difference in crying in the PACU. Negative behavior change 2 weeks postoperatively occurred more frequently in the parent absent group than the parent present group (45.8% vs 29.3%; P = 0.007). Multiple regression identified the following significant factors as predictive of larger proportion of time spent crying in the PACU (R(2) = 0.256, F[5, 273] = 15.66, P < 0.001): age <5 years (P < 0.001) and higher Children's Hospital of Eastern Ontario Pain Scale score at 15 minutes after arrival in day surgery (P < 0.001). Parental

  7. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

    Directory of Open Access Journals (Sweden)

    Carrasquillo O

    2014-02-01

    Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added

  8. Effect of GutGard in the Management of Helicobacter pylori: A Randomized Double Blind Placebo Controlled Study

    Directory of Open Access Journals (Sweden)

    Sreenivasulu Puram

    2013-01-01

    Full Text Available A randomized, double blind placebo controlled study was conducted to evaluate the efficacy of GutGard (root extract of Glycyrrhiza glabra in the management of Helicobacter pylori (H. pylori gastric load. Participants diagnosed with H. pylori infection were randomly assigned to two groups to orally receive 150 mg of GutGard (n=55 or placebo (n=52 once daily for 60 days. H. pylori infection was assessed using 13C-urea breath test (13C-UBT at days 0, 30, and 60. Stool Antigen test (HpSA was also performed on days 0, 30, and 60. Repeated measures of analysis of variance (RMANOVA, chi-square, and Fisher's exact probability tests were used to compare the treatment outcomes. A significant interaction effect between group and time (P=0.00 and significant difference in mean Delta Over Baseline (DOB values between GutGard (n=50 and placebo (n=50 treated groups after intervention period were observed. On day 60, the results of HpSA test were negative in 28 subjects (56% in GutGard treated group whereas in placebo treated group only 2 subjects (4% showed negative response; the difference between the groups was statistically significant. On day 60, the results of 13C-UBT were negative in 24 (48% in GutGard treated group and the difference between the groups was statistically significant. The findings suggest GutGard is effective in the management of H. pylori.

  9. A pilot randomized control study to evaluate endoscopic resection using a ligation device for rectal carcinoid tumors

    Institute of Scientific and Technical Information of China (English)

    Hiroyuki Sakata; Sadahiro Amemori; Kotaro Mannen; Masanobu Mizuguchi; Kazuma Fujimoto; Ryuichi Iwakiri; Akifumi Ootani; Seiji Tsunada; Shinichi Ogata; Hibiki Ootani; Ryo Shimoda; Kanako Yamaguchi; Yasuhisa Sakata

    2006-01-01

    AIM: Rectal carcinoid tumors smaller than 10 mm can be resected with local excision using endoscopy. In order to remove rectal carcinoid tumors completely, we evaluated endoscopic mucosal resection with a ligation device in this pilot control randomized study.METHODS: Fifteen patients were diagnosed with rectal carcinoid tumor (less than 10 mm) in our hospital from 1993 to 2002. There were 9 males and 6 females,with a mean age 61.5 years (range, 34-77 years).The patientshad no complaints of carcinoid syndrome symptoms. Fifteen patients were randomly divided into 2 groups: 7 carcinoid tumors were treated by conventional endoscopic resection, an