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Sample records for randomized trials comparing

  1. A Randomized Trial Comparing Lichtenstein Repair and No Mesh ...

    African Journals Online (AJOL)

    Background: The objective of this study is to compare the outcomes of Lichtenstein repair and no mesh Desarda repair for inguinal hernia. Methods: This is a prospective randomized trial of 1382 patients having 1461 hernias operated from January 2002 to December 2011.704 patients were operated using ...

  2. A randomized controlled trial comparing haemodynamic stability in ...

    African Journals Online (AJOL)

    A randomized controlled trial comparing haemodynamic stability in elderly patients undergoing spinal anaesthesia at L5, S1 versus spinal anaesthesia at L3, 4 at a ... Conventionally, spinal anaesthesia is performed at the level of L3,4 interspace; with a reported incidence of hypotension in the elderly ranging between 65% ...

  3. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two ...

  4. Randomized Controlled Trial Comparing Daycare and Overnight Stay Laparoscopic Cholecystectomy.

    Science.gov (United States)

    Salleh, A A M; Affirul, C A; Hairol, O; Zamri, Z; Azlanudin, A; Hilmi, M A; Razman, J

    2015-01-01

    This present study sought to review the feasibility and patients' satisfaction of laparoscopic cholecystectomy to be perform as daycare procedure. Sixty-two patients with symptomatic gallstones were recruited within a year. They were randomized into overnight stay and daycare groups. The outcomes and post-operative complications were analyzed. Fifty-eight patients were eligible for analysis and four patients were excluded because of conversion to open cholecystectomy. All patients in daycare group reported no fever but two patients in the overnight stay group complaint of post-operative fever (p=0.150). The mean pain score using Visual Analogue Score (VAS) in daycare group was 2.93 but in the overnight stay was recorded as 3.59 (p=0.98). Five patients had post-operative nausea and vomiting (PONV) in daycare group compared to 2 patients in the overnight stay group (p=0.227). Patient's satisfaction were higher in the daycare group (p=0.160). All patients in daycare group were back at work within a week but in overnight stay, 11 patients had to stay off work for more than one week (p=0.01). Daycare laparoscopic cholecystectomy is safe and feasible. The satisfaction of daycare surgery is higher than overnight stay group. Patients' selection is an important aspect of its success.

  5. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections.

    Science.gov (United States)

    Platt, Richard; Takvorian, Samuel U; Septimus, Edward; Hickok, Jason; Moody, Julia; Perlin, Jonathan; Jernigan, John A; Kleinman, Ken; Huang, Susan S

    2010-06-01

    The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. All admissions to adult ICUs. The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. Recruitment of hospitals is complete. Data collection will end in Summer 2011. This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.

  6. A randomized trial comparing levo-alpha acetylmethadol with methadone maintenance for patients in primary care settings in Australia

    NARCIS (Netherlands)

    Ritter, AJ; Lintzeris, N; Clark, N; Kutin, JJ; Bammer, G; Panjari, M

    2003-01-01

    Aims The present study aimed to compare the efficacy of levo-alpha-acetylmethadol (LAAM) and methadone, as measured by retention in treatment and heroin use, in a randomized trial conducted under naturalistic conditions. Setting This study is the first randomized trial comparing LAAM with methadone

  7. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  8. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    Directory of Open Access Journals (Sweden)

    Oliveira Fabíola A

    2008-09-01

    Full Text Available Abstract Background Infestation with the human head louse (Pediculus humanus capitis occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92% concentration of the silicone oil dimeticone (identical in composition to NYDA®, as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5% and permethrin 66.7% (95% CI: 54.6% – 77.3%; p Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system, development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709.

  9. Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial.

    Science.gov (United States)

    Abas, Mohamed Norazam; Tan, Peng Chiong; Azmi, Noor; Omar, Siti Zawiah

    2014-06-01

    To compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum. We enrolled 160 women with hyperemesis gravidarum in a double-blind randomized trial. Participants were randomized to intravenous 4 mg ondansetron or 10 mg metoclopramide every 8 hours for 24 hours. Participants kept an emesis diary for 24 hours; at 24 hours, they expressed their well-being using a 10-point visual numeric rating scale and answered an adverse effects questionnaire. Nausea intensity was evaluated using a 10-point visual numeric rating scale at enrollment and at 8, 16, and 24 hours. Primary analysis was on an intention-to-treat basis. Eighty women each were randomized to ondansetron or metoclopramide. Median well-being visual numeric rating scale scores were 9 (range, 5-10) compared with 9 (range, 4-10) (P=.33) and vomiting episodes in the first 24 hours were 1 (range, 0-9) compared with 2 (range, 0-23) (P=.38) for ondansetron compared with metoclopramide, respectively. Repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs (P=.22). Reported rates of drowsiness (12.5% compared with 30%; P=.01; number needed to treat to benefit, 6), xerostomia (10.0% compared with 23.8%; Phyperemesis gravidarum. However, the overall profile, particularly regarding adverse effects, was better with ondansetron. In our setting, metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice. ISRCN Register, www.isrctn.org, ISRCTN00592566. I.

  10. Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

    Directory of Open Access Journals (Sweden)

    Lazo-Langner Alejandro

    2012-01-01

    Full Text Available Abstract Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding and benefit (thrombosis averted were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.

  11. Comparing a stratified treatment strategy with the standard treatment in randomized clinical trials

    DEFF Research Database (Denmark)

    Sun, Hong; Bretz, Frank; Gerke, Oke

    2016-01-01

    The increasing emergence of predictive markers for different treatments in the same patient population allows us to define stratified treatment strategies. We consider randomized clinical trials that compare a standard treatment with a new stratified treatment strategy that divides the study...... population into subgroups receiving different treatments. Because the new strategy may not be beneficial in all subgroups, we consider in this paper an intermediate approach that establishes a treatment effect in a subset of patients built by joining several subgroups. The approach is based on the simple...

  12. Comparative efficacy of aloe vera mouthwash and chlorhexidine on periodontal health: A randomized controlled trial.

    Science.gov (United States)

    Vangipuram, Swathi; Jha, Abhishek; Bhashyam, Mamtha

    2016-10-01

    With introduction of many herbal medicines, dentistry has recently evidenced shift of approach for treating many inflammatory oral diseases by using such modalities. Aloe vera is one such product exhibiting multiple benefits and has gained considerable importance in clinical research recently. To compare the efficacy of Aloevera and Chlorhexidine mouthwash on Periodontal Health. Thirty days randomized controlled trial was conducted among 390 dental students. The students were randomized into two intervention groups namely Aloe Vera (AV) chlorhexidine group (CHX) and one control (placebo) group. Plaque index and gingival index was recorded for each participant at baseline, 15 days and 30 days. The findings were than statistically analyzed, ANOVA and Post Hoc test were used. There was significant reduction (pAloe Vera (AV) and chlorhexidine group. Post hoc test showed significant difference (paloe Vera and placebo and chlorhexidine and placebo group. No significant difference (pAloe vera, chlorhexidine, dental plaque, gingivitis.

  13. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  14. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Geladé, Katleen; Janssen, Tieme W. P.; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-01-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally

  15. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  16. Resting heart rate variability after yogic training and swimming: A prospective randomized comparative trial.

    Science.gov (United States)

    Sawane, Manish Vinayak; Gupta, Shilpa Sharad

    2015-01-01

    Resting heart rate variability (HRV) is a measure of the modulation of autonomic nervous system (ANS) at rest. Increased HRV achieved by the exercise is good for the cardiovascular health. However, prospective studies with comparison of the effects of yogic exercises and those of other endurance exercises like walking, running, and swimming on resting HRV are conspicuous by their absence. Study was designed to assess and compare the effects of yogic training and swimming on resting HRV in normal healthy young volunteers. Study was conducted in Department of Physiology in a medical college. Study design was prospective randomized comparative trial. One hundred sedentary volunteers were randomly ascribed to either yoga or swimming group. Baseline recordings of digital electrocardiogram were done for all the subjects in cohorts of 10. After yoga training and swimming for 12 weeks, evaluation for resting HRV was done again. Percentage change for each parameter with yoga and swimming was compared using unpaired t-test for data with normal distribution and using Mann-Whitney U test for data without normal distribution. Most of the HRV parameters improved statistically significantly by both modalities of exercise. However, some of the HRV parameters showed statistically better improvement with yoga as compared to swimming. Practicing yoga seems to be the mode of exercise with better improvement in autonomic functions as suggested by resting HRV.

  17. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

    Science.gov (United States)

    Mackeen, A Dhanya; Durie, Danielle E; Lin, Monique; Huls, Christopher K; Qureshey, Emma; Paglia, Michael J; Sun, Haiyan; Sciscione, Anthony

    2018-01-01

    To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes. This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat. We enrolled 201 women: 93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groups: in the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, Poxytocin group. There were no differences for other infectious morbidities or any other variable studied. In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection. ClinicalTrials.gov, NCT01973036.

  18. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups.

    Science.gov (United States)

    Howard, Courtney; Rose, Caren Lee; Trouton, Konia; Stamm, Holly; Marentette, Danielle; Kirkpatrick, Nicole; Karalic, Sanja; Fernandez, Renee; Paget, Julie

    2011-06-01

    To determine whether menstrual cups are a viable alternative to tampons. Randomized controlled trial. Prince George, Victoria, and Vancouver, BC. A total of 110 women aged 19 to 40 years who had previously used tampons as their main method of menstrual management. Participants were randomized into 2 groups, a tampon group and a menstrual cup group. Using online diaries, participants tracked 1 menstrual cycle using their regular method and 3 menstrual cycles using the method of their allocated group. Overall satisfaction; secondary outcomes included discomfort, urovaginal infection, cost, and waste. Forty-seven women in each group completed the final survey, 5 of whom were subsequently excluded from analysis (3 from the tampon group and 2 from the menstrual cup group). Overall satisfaction on a 7-point Likert scale was higher for the menstrual cup group than for the tampon group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; P=.04). Approximately 91% of women in the menstrual cup group said they would continue to use the cup and recommend it to others. Women used a median of 13 menstrual products per cycle, or 169 products per year, which corresponds to approximately 771,248,400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially higher in the menstrual cup group, but the discomfort decreased with continued use. There was no significant difference in physician-diagnosed urovaginal symptoms between the 2 groups. Both of the menstrual management methods evaluated were well tolerated by subjects. Menstrual cups are a satisfactory alternative to tampons and have the potential to be a sustainable solution to menstrual management, with moderate cost savings and much-reduced environmental effects compared with tampons. Trial registration number C06-0478 (ClinicalTrials.gov).

  19. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Nickolai Titov

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for depression is effective when guided by a clinician, less so if unguided. QUESTION: Would guidance from a technician be as effective as guidance from a clinician? METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II and the Patient Health QUESTIONnaire-9 Item (PHQ-9. Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001 and PHQ-9 (p<0.001 compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large

  20. Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Emma Robinson

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for generalized anxiety disorder (GAD has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ and the Generalized Anxiety Disorder-7 Item (GAD-7. Completion rates were high, and both treatment groups reduced scores on the PSWQ (p<0.001 and GAD-7 (p<0.001 compared to the delayed treatment group, but did not differ from each other. Within group effect sizes on the PSWQ were 1.16 and 1.07 for the clinician- and technician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment

  1. A randomized comparative effectiveness trial of using cable television to deliver diabetes prevention programming

    Science.gov (United States)

    Ackermann, Ronald T; Sandy, Lewis G; Beauregard, Tom; Coblitz, Mark; Norton, Kristi L; Vojta, Deneen

    2014-01-01

    Objective To evaluate the use and effectiveness of two “in-home” strategies for delivering diabetes prevention programming using cable television. Methods An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via “video-on-demand” cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight. Results A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes. Conclusions In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content. PMID:24740868

  2. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    ). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

  3. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial.

    Science.gov (United States)

    Wang, Chenchen; Schmid, Christopher H; Iversen, Maura D; Harvey, William F; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Wong, John B; Reid, Kieran F; Rones, Ramel; McAlindon, Timothy

    2016-07-19

    Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. To compare Tai Chi with standard physical therapy for patients with knee osteoarthritis. Randomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985). An urban tertiary care academic hospital. 204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). Tai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise). The primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life. At 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred. Patients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined. Tai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis. National Center for Complementary and Integrative Health of the National Institutes of Health.

  4. Comparing cost effects of two quality strategies to improve test ordering in primary care: a randomized trial.

    NARCIS (Netherlands)

    Verstappen, W.H.; Merode, F. van; Grimshaw, J.; Dubois, W.; Grol, R.P.T.M.; Weijden, T. van der

    2004-01-01

    OBJECTIVE: To determine the costs and cost reductions of an innovative strategy aimed at improving test ordering routines of primary care physicians, compared with a traditional strategy. DESIGN: Multicenter randomized controlled trial with randomization at the local primary care physicians group

  5. Cytologic detection of cervical abnormalities using liquid-based compared with conventional cytology: a randomized controlled trial.

    NARCIS (Netherlands)

    Siebers, A.G.; Klinkhamer, P.J.; Arbyn, M.; Raifu, A.O.; Massuger, L.F.A.G.; Bulten, J.

    2008-01-01

    OBJECTIVE: To compare test positivity rates of liquid-based and conventional cytology. METHODS: This study was a cluster randomized controlled trial with family practice as the unit of randomization, performed within the Dutch national cervical screening program. Women aged 30-60 years (n=89,784)

  6. Exercise and Therapeutic Ultrasound Compared with Corticosteroid Injection for Chronic Lateral Epicondylitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Murtezani, Ardiana; Ibraimi, Zana; Vllasolli, Teuta Osmani; Sllamniku, Sabit; Krasniqi, Shaip; Vokrri, Lulzim

    2015-01-01

    Lateral epicondylitis, or tennis elbow, is a common overuse syndrome of the extensor tendons of the forearm. When the condition is chronic or not responding to initial treatment, physical therapy is initiated. The objective of this study is to compare the effectiveness of corticosteroid injections with physiotherapeutic interventions (ultrasound and exercise) for the treatment of chronic lateral epicondylitis. We performed a randomized controlled trial of 12 weeks' duration in patients with chronic lateral epicondylitis. We randomly assigned 49 subjects to an exercise group (n=25), who received ultrasound and exercise, and a control group (n=24), who were treated with local infiltration of 1mL triamcinolone acetonide (10mg/mL) and 1mL lidocaine 2%. To evaluate the subjects, three instruments were used: pain intensity, measured with a Visual Analogue Scale (VAS), functional disability, measured with the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire, and painfree grip strength. All subjects were evaluated before treatment and at the 6th and 12th week. There were no significant differences between the two groups with regard to any variable at baseline (p>0.05). In the exercise group, significant improvements were demonstrated for VAS, PRTEE pain score, PRTEE function score and pain free grip strength, compared to the control group. The exercise group reported a significantly greater increase in all variables at 12 weeks than did the control group (pexercise are beneficial in the treatment of tennis elbow.

  7. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial.

    Science.gov (United States)

    Figueroa, Dana; Jauk, Victoria Chapman; Szychowski, Jeff M; Garner, Rachel; Biggio, Joseph R; Andrews, William W; Hauth, John; Tita, Alan T N

    2013-01-01

    To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture. Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3-4) and 4-6 weeks postoperatively. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score, and patient scar satisfaction score. Analyses were by intent to treat. Of 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean delivery, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture (Psuture (P=.008, relative risk 2.5, 95% CI 1.2-5.0). Operative time was longer with suture closure (median time of 58 versus 48 minutes; Psuture is associated with significantly increased composite wound morbidity after cesarean delivery. : ClinicalTrials.gov, www.clinicaltrials.gov, NCT01008449. : I.

  8. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    Science.gov (United States)

    Heukelbach, Jorg; Pilger, Daniel; Oliveira, Fabíola A; Khakban, Adak; Ariza, Liana; Feldmeier, Hermann

    2008-01-01

    Background Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group. Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709. PMID:18783606

  9. Immediate compared with delayed oxytocin after amniotomy labor induction in parous women: a randomized controlled trial.

    Science.gov (United States)

    Tan, Peng Chiong; Soe, May Zaw; Sulaiman, Sofiah; Omar, Siti Zawiah

    2013-02-01

    To compare immediate with delayed (4 hours) oxytocin infusion after amniotomy on vaginal delivery within 12 hours and patient satisfaction with the birth process. Parous women with favorable cervixes after amniotomy for labor induction were randomized to immediate titrated oxytocin or placebo intravenous infusion in a double-blind noninferiority trial. After 4 hours, study infusions were stopped, the women were assessed, and open-label oxytocin was started if required. Maternal satisfaction with the birth process was assessed with a 10-point visual numerical rating scale (lower score, greater satisfaction). Vaginal delivery rates at 12 hours were 91 of 96 (94.8%) compared with 91 of 94 (96.8%) (relative risk 0.98, 95% confidence interval [CI] 0.92-1.04, P=.72), and maternal satisfaction on a visual numerical rating scale (median [interquartile range]) was 3 [3-4] compared with 3 [3-5], P=.36 for immediate compared with delayed arm, respectively). Cesarean delivery, maternal fever, postpartum hemorrhage, uterine hyperactivity, and adverse neonatal outcome rates were similar between arms. The immediate oxytocin arm had a shorter amniotomy-to-delivery interval of 5.3±3.1 compared with 6.9±2.9 hours (Poxytocin infusion was avoided by 35.6%. Immediate or delayed oxytocin infusions are reasonable options after amniotomy for labor induction in parous women with favorable cervixes. The choice should take into account local resources and the woman's wish. ISRCTN Register, http://isrctn.org, ISRCTN51476259. I.

  10. Comparing two web-based smoking cessation programs: randomized controlled trial.

    Science.gov (United States)

    McKay, H Garth; Danaher, Brian G; Seeley, John R; Lichtenstein, Edward; Gau, Jeff M

    2008-11-18

    Smoking cessation remains a significant public health problem. Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change. To date, the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals. We describe the 6-month follow-up results of a randomized controlled trial in which participants recruited online were randomly assigned to either a Web-based smoking cessation program (Quit Smoking Network; QSN) or a Web-based exercise enhancement program (Active Lives) adapted somewhat to encourage smoking cessation. The study was a two-arm randomized controlled trial that compared two Web-based smoking cessation programs: (1) the QSN intervention condition presented cognitive-behavioral strategies, and (2) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting. The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting. The QSN condition was designed to be more engaging (eg, it included multimedia components) and to present much greater content than is typically found in smoking cessation programs. Contrary to our hypotheses, no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessments. While participants in the QSN intervention condition spent more time than controls visiting the online program, the median number of 1.0 visit in each condition and the substantial attrition (60.8% at the 6-month follow-up) indicate that participants were not as engaged as we had expected. Contrary to our hypothesis, our test of two Web-based smoking cessation conditions, an intervention and an attention placebo control, failed to show

  11. The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone

    Directory of Open Access Journals (Sweden)

    Berger Ann

    2009-12-01

    Full Text Available Abstract Background The standard of care for metastatic gastric cancer (MGC is systemic chemotherapy which leads to a median survival of 6-15 months. Survival beyond 3 years is rare. For selected groups of patients with limited MGC, retrospective studies have shown improved overall survival following gastrectomy and metastasectomies including peritoneal stripping with continuous hyperthermic peritoneal perfusion (CHPP, liver resection, and pulmonary resection. Median survival after liver resection for MGC is up to 34 months, with a five year survival rate of 24.5%. Similarly, reported median survival after pulmonary resection of MGC is 21 months with long term survival of greater than 5 years a possibility. Several case reports and small studies have documented evidence of long-term survival in select individuals who undergo CHPP for MGC. Design The GYMSSA trial is a prospective randomized trial for patients with MGC. It is designed to compare two therapeutic approaches: gastrectomy with metastasectomy plus systemic chemotherapy (GYMS versus systemic chemotherapy alone (SA. Systemic therapy will be composed of the FOLFOXIRI regimen. The aim of the study is to evaluate overall survival and potential selection criteria to determine those patients who may benefit from surgery plus systemic therapy. The study will be conducted by the Surgery Branch at the National Cancer Institute (NCI, National Institutes of Health (NIH in Bethesda, Maryland. Surgeries and followup will be done at the NCI, and chemotherapy will be given by either the local oncologist or the medical oncology branch at NCI. Trial Registration ClinicalTrials.gov ID. NCT00941655

  12. A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14).

    Science.gov (United States)

    Boshuizen, R C; Vd Noort, V; Burgers, J A; Herder, G J M; Hashemi, S M S; Hiltermann, T J N; Kunst, P W; Stigt, J A; van den Heuvel, M M

    2017-06-01

    Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful. We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events. Dyspnea improved significantly (pIPC respectively in rest, p=0.16, (TP 13:IPC 16) and 3 and 1 during exercise, p=0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n=13) reported less dyspnea than IPC patients (n=18) (median 0 vs 1, p=0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, pIPC patients underwent more than one re-intervention (7/45 vs 15/43, p=0.09). The mean number of re-interventions was lower following IPC (0.21 vs 0.53, p=0.05). Equal number of adverse events occurred. IPC was not superior in the primary endpoint, improvement of the modified Borg scale (MBS). However, IPC patients had lower hospital stay, fewer admissions and fewer re-interventions. The IPC is an effective treatment modality in patients with symptomatic malignant pleural effusion. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

  14. Bandit solutions provide unified ethical models for randomized clinical trials and comparative effectiveness research.

    Science.gov (United States)

    Press, William H

    2009-12-29

    As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). An idealized adaptive case--the two-armed Bernoulli bandit problem--can be exactly optimized for a variety of ethically motivated cost functions that embody principles of duty-to-patient, but the solutions have been thought computationally infeasible when the numbers of patients in the study (the "horizon") is large. We report numerical experiments that yield a heuristic approximation that applies even to very large horizons, and we propose a near-optimal strategy that remains valid even when the horizon is unknown or unbounded, thus applicable to comparative effectiveness studies on large populations or to standard-of-care recommendations. For the case in which the economic cost of treatment is a parameter, we give a heuristic, near-optimal strategy for determining the superior treatment (whether more or less costly) while minimizing resources wasted on any inferior, more expensive, treatment. Key features of our heuristics can be generalized to more complicated protocols.

  15. Bandit solutions provide unified ethical models for randomized clinical trials and comparative effectiveness research

    OpenAIRE

    Press, William H.

    2009-01-01

    As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). An idealized adaptive case—the two-armed Bernoulli bandit problem—can be exactl...

  16. Pancreaticojejunostomy is comparable to pancreaticogastrostomy after pancreaticoduodenectomy: an updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Crippa, Stefano; Cirocchi, Roberto; Randolph, Justus; Partelli, Stefano; Belfiori, Giulio; Piccioli, Alessandra; Parisi, Amilcare; Falconi, Massimo

    2016-06-01

    To perform an up-to-date meta-analysis of randomized controlled trials (RCTs) comparing pancreaticojejunostomy (PJ) and pancreaticogastrostomy (PG) in order to determine the safer anastomotic technique. Compared to existing meta-analysis, new RCTs were evaluated and subgroup analyses of different anastomotic techniques were carried out. We conducted a bibliographic research using the National Library of Medicine's PubMed database from January 1990 to July 2015 of RCTs. Only RCTs, in English, that compared PG versus all types of PJ were selected. Data were independently extracted by two authors. We performed a quantitative systematic review following the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. A random-effect model was applied. Statistical heterogeneity was assessed using the I (2) and χ (2) tests. Primary outcomes were rate of overall and clinically significant pancreatic fistula (POPF). Ten RCTs were identified including 1629 patients, 826 undergoing PG and 803 undergoing PJ. RCTs showed significant heterogeneity regarding definitions of POPF, perioperative management, and characteristics of pancreatic gland. No significant differences were found in the rate of overall and clinically significant POPF, morbidity, mortality, reoperation, and intra-abdominal sepsis when PG was compared with all types PJ or when subgroup analysis (double-layer PG with or without anterior gastrotomy versus duct to mucosa PJ and single-layer PG versus single-layer end-to-end/end-to-side PJ) were analyzed. PG is not superior to PJ in the prevention of POPF. Current RCTs have major methodological limitations with significant heterogeneity in regard to surgical techniques, definition of POPF/complications, and perioperative management.

  17. Exercise augmentation compared with usual care for post-traumatic stress disorder: a randomized controlled trial.

    Science.gov (United States)

    Rosenbaum, S; Sherrington, C; Tiedemann, A

    2015-05-01

    To investigate the impact of a 12-week exercise programme in addition to usual care for post-traumatic stress disorder (PTSD). An assessor-blinded randomized controlled trial was conducted among 81 participants with a DSM-IV-TR diagnosis of primary PTSD. Participants were recruited after admission to an in-patient programme at a private hospital. Participants were randomized to receive either usual care (n=42), or exercise in addition to usual care (n=39). The exercise intervention involved three, 30-min resistance-training sessions/week and a pedometer-based walking programme. Usual care involved psychotherapy, pharmaceutical interventions, and group therapy. Primary outcome was PTSD symptoms assessed via the PTSD checklist-civilian version (PCL-C). Secondary outcomes included symptoms of depression, anthropometry, physical activity, mobility, strength, and sleep quality. Participants had a mean (SD) age of 47.8 years (12.1), 84% male. PTSD symptoms in the intervention group significantly reduced compared with the usual care group (mean difference=-5.4, 95% CI -10.5 to -0.3, P=0.04, n=58). There were significant between-group differences at follow-up for depressive symptoms, waist circumference, sleep quality, and sedentary time. This study provides the first evidence that an exercise intervention is associated with reduced PTSD and depressive symptoms, reduced waist circumference, and improved sleep quality. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. A randomized, comparative trial: does pillow type alter cervico-thoracic spinal posture when side lying?

    Science.gov (United States)

    Gordon, Susan J; Grimmer-Somers, Karen A; Trott, Patricia H

    2011-01-01

    Many patients ask for advice about choosing a pillow. This research was undertaken to determine if pillow type alters cervico-thoracic spine position when resting in the side-lying position. To investigate the effect of different pillow shape and content on the slope of cervico-thoracic spine segments when side lying. The study was a randomized blinded comparative trial set in a laboratory that replicated a bedroom. The subjects were side sleepers aged over 18 years. Exclusion criteria were history of surgery to the cervico-thoracic spine, an injury or accident to the cervico-thoracic spine in the preceding year, or currently receiving treatment for neck symptoms. Each participant rested in a standardized side-lying position for 10 minutes on each of the trial pillows: regular shaped polyester, foam, feather, and latex pillows, and a contour shaped foam pillow. Reflective markers were placed on external occipital protuberance (EOP), C2, C4, C7, and T3, and digital images were recorded of subjects at 0 and 10 minutes on each pillow. Images were digitized using each reflective marker and the slope of each spinal segment calculated. Univariate analysis of variance models were used to investigate slope differences between pillows at 0 and 10 minutes. Significance was established at P pillows. Significant differences were identified when comparing the feather pillow with the latex, regular and contour foam pillows, and when comparing the polyester and foam contour pillows. The regular and contour foam pillows produced similar slopes at all spinal segments. Cervico-thoracic spinal segment slope alters significantly when people change from a foam, latex, or polyester pillow to a feather pillow and vice versa. The shape of a foam pillow (contour versus regular shape) does not significantly alter cervico-thoracic spinal segment slope.

  19. Continuous Compared With Cyclic Oral Contraceptives for the Treatment of Primary Dysmenorrhea: A Randomized Controlled Trial

    Science.gov (United States)

    Dmitrovic, Romana; Kunselman, Allen R.; Legro, Richard S.

    2013-01-01

    Objective To estimate whether continuous OCP (oral contraceptive pills) will result in more pain relief in primary dysmenorrhea patients than cyclic OCP, which induces withdrawal bleeding with associated pain and symptoms. Material and Methods We conducted a double-blind, randomized controlled trial comparing continuous to a cyclic 21/7 OCP regimen (gestodene 0.075 mg and ethinyl estradiol 20 mcg) for 6 months in 38 primary dysmenorrhea patients. The primary outcome was the difference in subjective perception of pain as measured by the Visual Analog Scale (VAS) over the period of 6 months. Results Twenty-nine patients completed the study. In both groups, pain reduction measured by VAS declined over time and was significant at 6 months compared to baseline with no difference between groups. Continuous regimen was superior to cyclic regimen after one month (mean difference: -27.3; 95% CI: (-40.5,-14.2); p<0.001) and 3 months (mean difference: -17.8; 95% CI: (-33.4,-2.1); p=0.03) of treatment. Secondary outcomes noted no difference between groups in terms of menstrual distress as measured by the Moos Menstrual Distress Questionnaire. After 6 months, there was an increase in weight and decrease in systolic blood pressure in continuous compared with the cyclic group. Conclusions Both regimens of OCP are effective in the treatment of primary dysmenorrhea. Continuous OCP outperforms cyclic OCP in the short term, but this difference is lost after 6 months. PMID:22617578

  20. A randomized trial comparing didactics, demonstration, and simulation for teaching teamwork to medical residents.

    Science.gov (United States)

    Semler, Matthew W; Keriwala, Raj D; Clune, Jennifer K; Rice, Todd W; Pugh, Meredith E; Wheeler, Arthur P; Miller, Alison N; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A

    2015-04-01

    Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel "Recognize, Respond, Reassess" score. Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs(2)] = 0.267, P teamwork training by expert demonstration resulted in similar teamwork behavior to participation in high-fidelity simulation and was more effective than traditional didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities.

  1. CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department.

    Science.gov (United States)

    Peacock, W Frank; Varon, Joseph; Baumann, Brigitte M; Borczuk, Pierre; Cannon, Chad M; Chandra, Abhinav; Cline, David M; Diercks, Deborah; Hiestand, Brian; Hsu, A; Jois-Bilowich, Preeti; Kaminski, Brian; Levy, Philip; Nowak, Richard M; Schrock, Jon W

    2011-01-01

    Our purpose was to compare the safety and efficacy of food and drug administration (FDA) recommended dosing of IV nicardipine versus IV labetalol for the management of acute hypertension. Multicenter randomized clinical trial. Eligible patients had 2 systolic blood pressure (SBP) measures ≥180 mmHg and no contraindications to nicardipine or labetalol. Before randomization, the physician specified a target SBP ± 20 mmHg (the target range: TR). The primary endpoint was the percent of subjects meeting TR during the initial 30 minutes of treatment. Of 226 randomized patients, 110 received nicardipine and 116 labetalol. End organ damage preceded treatment in 143 (63.3%); 71 nicardipine and 72 labetalol patients. Median initial SBP was 212.5 (IQR 197, 230) and 212 mmHg (IQR 200,225) for nicardipine and labetalol patients (P = 0.68), respectively. Within 30 minutes, nicardipine patients more often reached TR than labetalol (91.7 vs. 82.5%, P = 0.039). Of 6 BP measures (taken every 5 minutes) during the study period, nicardipine patients had higher rates of five and six instances within TR than labetalol (47.3% vs. 32.8%, P = 0.026). Rescue medication need did not differ between nicardipine and labetalol (15.5 vs. 22.4%, P = 0.183). Labetalol patients had slower heart rates at all time points (P labetalol patients at 30 minutes (OR 2.73, P = 0.028; C stat for model = 0.72) Patients treated with nicardipine are more likely to reach the physician-specified SBP target range within 30 minutes than those treated with labetalol.

  2. Nurse Family Partnership: Comparing Costs per Family in Randomized Trials Versus Scale-Up.

    Science.gov (United States)

    Miller, Ted R; Hendrie, Delia

    2015-12-01

    The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale.

  3. "Right from the Start": Randomized Trial Comparing an Attachment Group Intervention to Supportive Home Visiting

    Science.gov (United States)

    Niccols, Alison

    2008-01-01

    Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…

  4. Explaining Feast or Famine in Randomized Field Trials: Medical Science and Criminology Compared.

    Science.gov (United States)

    Shepherd, Jonathan P.

    2003-01-01

    Discusses the contrast between the frequency of randomized clinical trials in the health sciences and the relative famine of such studies in criminology. Attributes this difference to the contexts in which research is done and the difference in the status of situational research in the two disciplines. (SLD)

  5. Randomized and prospective trial comparing tract creation using plasma vaporization with balloon dilatation in percutaneous nephrolithotomy.

    Science.gov (United States)

    Chiang, Po Hui; Su, Hsin Hao

    2013-07-01

    WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Use of balloon dilatation leads to less blood transfusion rates than metallic dilators. Plasma vaporization leads to less blood loss than balloon dilatation in this study. The study evaluates a novel technique for the creation of a nephrostomy tract for PCNL. Compared with other techniques, plasma vaporization is a safer procedure that causes lesser blood loss, requires a shorter hospital stay, causes less radiation exposure, and enables easier nephrostomy tract creation for PCNL. To evaluate the efficacy and safety of plasma vaporization for tract creation in percutaneous nephrolithotomy (PCNL). In this randomized prospective trial we enrolled 65 patients and assigned each to one of two groups: 33 patients were randomly scheduled to undergo plasma vaporization and 32 were scheduled to undergo balloon dilatation for tract creation. A bipolar resectoscope mounted with a plasma vaporization button electrode or a traditional balloon dilator were used to create the nephrostomy tract. The mean blood loss, mean length of hospital stay and mean operating time, stone-free rates and postoperative complications in the two groups were compared using the t-test or chi-squared test (Fisher's exact test). The plasma vaporization group had a significantly lower mean (SD) decrease in haematocrit level (3.5 [2.8]% vs 6.6 [3.3]%; P = 0.02) and a shorter mean (SD) hospital stay (2.6 [1.2] days vs 5.3 [3.4] days; P = 0.0). There were no significant differences in the operating time, stone-free rate or cases of postoperative fever between the two groups. The plasma vaporization technique is safe, leads to less blood loss than the other techniques, and is a simple solution for creating the nephrostomy tract for PCNL. © 2012 BJU International.

  6. A randomized comparative trial in the management of Alcohol Dependence: Individualized Homoeopathy versus standard Allopathic Treatment

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2016-01-01

    Full Text Available Objectives: This study was undertaken to compare the effects of IH with standard allopathic (SA treatment. Methods: A randomized controlled, open-label, comparative trial, was conducted, in which alcohol dependents were screened verbally using the CAGE scale. The participants 80 patients fulfilling the inclusion criteria were randomized either IH (n=40 or SA (n=40 and treated cum followed up for 12 months. The primary outcome was more than 50% reduction in the Severity of Alcohol Dependence Questionnaire [SADQ] rating scale at 12 th month. Data analysis was done for both intention-to-treat (ITT and per-protocol (PP populations. Results: ITT analysis reflected 80% (n = 32 of the patients in IH and 37.5% (n = 15 of the patients in the SA responding to CI before 2.4 treatment with absolute difference was 42.5% (42.5 [95% confidence interval [CI]: 23.0, 61.6] and estimated effect: 6.6 (95% C.I: 2.4, 18.2, P = 0.0002. A significant difference favoring IH was also observed in three out of four domains of WHO QOL-BREF. Statistically significant difference was found in the number of drinking days (median difference: −24.00; CI: −39.0-−8.0; P = 0.001 and number of drinks per drinking day (median difference: −6.3 [95% CI: −11.3-−1.9]; P = 0.004, favoring IH. The results showed a similar trend in PP analysis. Medicines found useful were Sulphur, Lycopodium clavatum, Arsenicum album, Nux vomica, Phosphorus, and Lachesis. Conclusion: The results conclude that IH is not inferior to SA in the management of AD patients. More rigorous studies with large sample size are however desirable.

  7. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Anderson, James W; Weiter, Kathy M; Christian, Amber L; Ritchey, Michelle B; Bays, Harold E

    2014-01-01

    To compare effects of raisin snacks with conventional snacks on glycemia and cardiovascular risk factors. A 12-week, randomized, controlled trial compared 3-times-a-day consumption of raisins with intake of processed snacks on glycemia and cardiovascular risk factors. Men and women were randomized to snacks (n = 15) or raisins (n = 31). Outcome measures were performed at baseline, 4, 8, and 12 weeks. Fasting plasma glucose levels were not significantly affected by intake of raisins or snacks. Mean subject post prandial glucose levels were significantly reduced by raisin intake at 12 weeks; changes with raisin intake were -13.1 mg/dL (P = 0.003 vs baseline; P = 0.03 vs snacks). Eating raisins significantly decreased glycated hemoglobin (HbA1c) level (-0.12%; P = 0.004), a significantly greater level decrease than seen with snack intake (P = 0.036). Snack intake did not significantly affect subject systolic or diastolic blood pressure (BP). Raisin intake was associated with reductions in systolic blood pressure (SBP) at 4, 8, and 12 weeks with mean changes of -6.0 to 10.2 mmHg; all these changes were statistically significant (P = 0.015 to 0.001). Raisins were associated with significantly greater changes in diastolic blood pressure (DBP) at 4, 8, and 12 weeks than snacks (P < 0.05). Body weight did not significantly change within or between groups. Regular consumption of raisins may reduce glycemia and cardiovascular risk factors, including BP rate.

  8. Stroke rehabilitation after hospital discharge: a randomized trial comparing domiciliary and day-hospital care.

    Science.gov (United States)

    Roderick, P; Low, J; Day, R; Peasgood, T; Mullee, M A; Turnbull, J C; Villar, T; Raftery, J

    2001-07-01

    To compare the effectiveness and costs of a new domiciliary rehabilitation service for elderly stroke patients with geriatric day-hospital care. Randomized controlled trial. Stroke patients aged 55+ who required further rehabilitation after hospital discharge or after referral to geriatricians from the community. Poole area, East Dorset, a mixed urban/rural area on the south coast of England. Primary-changes between hospital discharge and 6-month follow-up in physical function as measured by Barthel index. Secondary-changes over this period in Rivermead Mobility Index and mental state (Philadelphia Geriatric Centre Morale Scale) and differences in social activity (Frenchay Activities Index) and generic health status (SF-36). Health service and social service cost per patient were compared for the two groups. 180 patients were eligible and 140 (78%) were randomized. The groups were well balanced for age, sex, social class and initial Barthel index. We achieved follow-up in 88% of subjects who were alive at 6 months. We detected no significant differences in patient outcomes, although there was a non-significant improvement in measures of physical function and social activity in the domiciliary group. Domiciliary patients had more physiotherapy time per session and more district nurse time, and made greater use of social service day centres and home helps. Total cost per patient did not differ significantly between the two groups, with reduced health service costs in the domiciliary arm offset by higher social service costs. No significant differences were detected in the effectiveness of the two services. Neither service influenced patients' mental state, and their social activity remained low. Total costs were similar. A mixed model of day-hospital and domiciliary care may be most cost-effective for community stroke rehabilitation, but this requires further evaluation.

  9. Randomized controlled trial comparing aerosolized swallowed fluticasone to esomeprazole for esophageal eosinophilia.

    Science.gov (United States)

    Moawad, Fouad J; Veerappan, Ganesh R; Dias, Johnny A; Baker, Thomas P; Maydonovitch, Corinne L; Wong, Roy K H

    2013-03-01

    Patients with clinical symptoms of esophageal dysfunction and dense eosinophilic infiltration of the esophageal mucosa are suspected to have eosinophilic esophagitis (EoE). Topical steroids are often used as first-line therapy for EoE, although some patients respond clinically to proton pump inhibitors (PPIs). The purpose of this study was to compare the histological and clinical response of patients with esophageal eosinophilia treated with aerosolized swallowed fluticasone propionate vs. esomeprazole. This prospective single-blinded randomized controlled trial enrolled newly diagnosed patients with suspected EoE, defined as having clinical symptoms related to esophageal dysfunction with at least 15 eosinophils/high power field (hpf). Patients underwent 24-h pH/impedance monitoring to establish gastroesophageal reflux disease (GERD). Patients were stratified by the presence of GERD and randomized to receive fluticasone 440 mcg twice daily or esomeprazole 40 mg once daily for 8 weeks followed by repeat endoscopy with biopsies. The primary outcome was histological response of esophageal eosinophilia, defined as esomeprazole (n = 21) treatment arms. In all, 19% (8/42) of patients had coexisting GERD and were equally stratified into each arm (n = 4). Overall, there was no significant difference in resolution of esophageal eosinophilia between fluticasone and esomeprazole (19 vs. 33%, P = 0.484). In patients with established GERD, resolution of esophageal eosinophilia was noted in 0% (0/4) of the fluticasone group compared with 100% (4/4) of the esomeprazole group (P = 0.029). In GERD-negative patients, there was no significant difference in resolution of esophageal eosinophilia between treatment arms with fluticasone and esomeprazole (24 vs.18%, P = 1.00). The MDQ score significantly decreased after treatment with esomeprazole (19 ± 21 vs. 1.4 ± 4.5, Pesomeprazole provide a similar histological response for esophageal eosinophilia. With regard to clinical response

  10. Clothes-on PUVA in psoriasis: Single blind randomized comparative trial on 21 patients

    Directory of Open Access Journals (Sweden)

    Varma Sachin

    2004-05-01

    Full Text Available BACKGROUND: PUVASOL therapy has an inherent drawback of patient compliance in that Indian female patients with psoriasis lesions on covered parts of the body are reluctant to expose themselves. In this study we tried to evaluate a new method of administering PUVA therapy wearing a fabric. AIM: To compare the efficacy and safety of PUVA administration with and without wearing clothes in psoriasis. METHOD: We first found the UV transmissibility of plain woven, lightweight cream colored cotton fabric with 30 x 30 threads per square cm. area and calculated its sun protection factor (SPF. A single blind, randomized, comparative, clinical trial was then conducted on 21 patients with psoriasis vulgaris who were treated with bath PUVA. The study group received ultraviolet light while wearing a gown made up of the above cotton fabric and the control group received ultraviolet light without wearing the gown. The study group was given an UV dose higher in proportion to the SPF of the worn fabric so that blockage caused by cloth could be neutralized. The cloth-uncovered areas were covered with a sunscreen. UVA from artificial light source was used for better patient monitoring. RESULTS: After 12 PUVA treatments both the treatments were found to be equally effective, and there were no differences in the side effects. Conclusion: Thus we conclude that PUVA can be given wearing a fabric provided the UV dosage is increased proportional to the SPF of the fabric. The same fabric may be used for PUVASOL therapy.

  11. Comparing the effects of Calendula officinalis and clotrimazole on vaginal Candidiasis: A randomized controlled trial.

    Science.gov (United States)

    Saffari, Elnaz; Mohammad-Alizadeh-Charandabi, Sakineh; Adibpour, Mohammad; Mirghafourvand, Mojgan; Javadzadeh, Yousef

    2017-01-01

    This triple-blind trial examined the effects of Calendula officinalis vaginal cream on the treatment of vaginal Candidiasis (primary outcome) and sexual function (secondary outcome). Married women aged 18-45 years with vaginal Candidiasis (n = 150) were recruited from April to October 2014 and randomized into Calendula and clotrimazole groups, using 5-g vaginal cream every night for seven nights. Clinical and laboratory assessments were conducted at 10-15 and 30-35 days after intervention and the female sexual function index was assessed at 30-35 days. Six women were lost to follow-up. The frequency of testing negative for Candidiasis in the Calendula group was significantly lower at the first (49% vs. 74%; odds ratio (OR) 0.32; 95% confidence interval (CI) 0.16-0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5-6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up, but were significantly lower in the Calendula group at the second follow-up. Sexual function had almost equal significant improvement in both groups. Calendula vaginal cream appears to have been effective in the treatment of vaginal Candidiasis and to have a delayed but greater long-term effect compared to clotrimazole.

  12. Psychotherapy for depression: a randomized clinical trial comparing schema therapy and cognitive behavior therapy.

    Science.gov (United States)

    Carter, Janet D; McIntosh, Virginia V; Jordan, Jennifer; Porter, Richard J; Frampton, Christopher M; Joyce, Peter R

    2013-11-01

    The efficacy of Cognitive Behavior Therapy (CBT) for depression has been robustly supported, however, up to fifty percent of individuals do not respond fully. A growing body of research indicates Schema Therapy (ST) is an effective treatment for difficult and entrenched problems, and as such, may be an effective therapy for depression. In this randomized clinical trial the comparative efficacy of CBT and ST for depression was examined. 100 participants with major depression received weekly cognitive behavioral therapy or schema therapy sessions for 6 months, followed by monthly therapy sessions for 6 months. Key outcomes were comparisons over the weekly and monthly sessions of therapy along with remission and recovery rates. Additional analyses examined outcome for those with chronic depression and comorbid personality disorders. ST was not significantly better (nor worse) than CBT for the treatment of depression. The therapies were of comparable efficacy on all key outcomes. There were no differential treatment effects for those with chronic depression or comorbid personality disorders. This study needs replication. This preliminary research indicates that ST may provide an effective alternative therapy for depression. © 2013 Elsevier B.V. All rights reserved.

  13. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures.

    Science.gov (United States)

    Lantto, Iikka; Heikkinen, Juuso; Flinkkila, Tapio; Ohtonen, Pasi; Siira, Pertti; Laine, Vesa; Leppilahti, Juhana

    2016-09-01

    The optimal treatment of acute Achilles tendon ruptures for active patients is under debate. To compare clinical outcomes and calf muscle strength recovery after the nonsurgical treatment and open surgical repair of acute Achilles tendon ruptures with identical accelerated rehabilitation programs. Randomized controlled trial; Level of evidence, 1. From 2009 to 2013, a total of 60 patients with an acute Achilles tendon rupture were randomized to surgery or nonsurgical treatment. Nonsurgical treatment included first a week of cast immobilization, followed by a functional orthosis for 6 weeks, allowing full weightbearing after week 1 and active plantar flexion after week 5. Surgery was simple end-to-end open repair, and postoperative treatment was identical to nonsurgical treatment. Outcome measures included the Leppilahti Achilles tendon performance score, isokinetic calf muscle strength, and RAND 36-Item Health Survey at 18-month follow-up. At 18-month follow-up, the mean Leppilahti score was 79.5 and 75.7 for the surgically and nonsurgically treated groups, respectively (mean difference, 3.8; 95% CI, -1.9 to 9.5; P = .19). Angle-specific peak torque results of affected legs showed that surgery resulted in faster and better recovery of calf muscle strength over the entire range of motion of the ankle joint: at 6 months, the difference varied from 16% to 24% (P = .016), favoring the surgically treated group, whereas at 18 months, surgically treated patients had 10% to 18% greater strength results (P = .037). At 18 months, a 14% difference in the peak torque of the affected leg favored the surgical group versus the nonsurgical group (mean peak torque, 110.3 vs 96.5 N·m, respectively; mean difference, 13.6 N·m; 95% CI, 2.0-25.1 N·m; P = .022). The RAND 36-Item Health Survey indicated better results in the domains of physical functioning (P = .006) and bodily pain (P = .037) for surgically treated patients. Surgical and nonsurgical treatments of acute Achilles tendon

  14. Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial.

    Science.gov (United States)

    Sharma, Kathryn J; Greene, Naomi; Kilpatrick, Sarah J

    2017-02-01

    To determine whether oral labetalol is associated with a shorter time to blood pressure control compared to oral extended release nifedipine for management of persistent postpartum hypertension. This randomized controlled trial conducted between June 2014 and June 2015 included women who delivered at ≥32 weeks' gestation with persistent postpartum hypertension (sustained blood pressure ≥150/100 mmHg) requiring an oral antihypertensive agent. We included women with gestational hypertension, preeclampsia, or chronic hypertension not previously on medication. Women were randomized to labetalol or nifedipine, and the allocated study drug was incrementally increased to achieve blood pressure control. The primary outcome was time to sustained blood pressure control defined as the absence of severe hypertension for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient reported side effects. Twenty women were needed in each group as determined by the sample size calculation. We randomized 25 women to oral labetalol and 25 women to oral extended release nifedipine. The time to achieve BP control was similar between labetalol and nifedipine groups (37.6 hours versus 38.2 hours, p = 0.51). Secondary outcomes including postpartum length of stay, need for increased dosing, and need for additional oral antihypertensive agents were similar between groups. For women discharged on a single agent, significantly more subjects in the labetalol group (16/21) compared to the nifedipine group (10/22) achieved BP control with the initial starting dose (76% versus 46%, p = 0.04). No major side effects were observed. Minor side effects were significantly more common in women taking nifedipine compared to labetalol (48% versus 20%, p = 0.04). Both labetalol and nifedipine were effective for control of persistent postpartum hypertension. However, labetalol achieved control

  15. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder.

    Science.gov (United States)

    Soorya, Latha V; Siper, Paige M; Beck, Todd; Soffes, Sarah; Halpern, Danielle; Gorenstein, Michelle; Kolevzon, Alexander; Buxbaum, Joseph; Wang, A Ting

    2015-03-01

    This study evaluated the efficacy of a targeted social skills training group in school-aged children with autism spectrum disorder (ASD). The intervention, Seaver-NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training), is a 12-session cognitive-behavioral intervention (CBI) for verbal, school-aged children targeting ASD-specific social behavioral impairments. Sixty-nine children with ASD, 8 to 11 years of age, with verbal IQs greater than 70, participated in a randomized comparative trial to examine the efficacy of NETT relative to a facilitated play group. Treatment outcomes included caregiver reports of social behavior and neuropsychological assessments of social cognition conducted by blinded raters. Outcomes were collected at baseline, endpoint, and 3 months posttreatment. Significant improvements were found on social behavior outcomes such as nonverbal communication, empathic responding, and social relations in the NETT condition relative to the active control at endpoint. Verbal IQ moderated the interaction effect on social behavior, with higher verbal IQ associated with improvements in the CBI condition. No significant improvements were found on social cognitive outcomes. No significant group differences were found at 3-month follow-up conducted with approximately half the sample (n = 34). These data indicate that targeted CBI social skills groups such as NETT improve social communication deficits in verbal, school-aged children with ASD. The moderating effects of high verbal IQ suggest a need to consider participant and treatment characteristics associated with outcomes in future studies. Clinical trial registration information-Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder; https://clinicaltrials.gov; NCT01190917. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  16. Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety.

    Science.gov (United States)

    Palos, Claudia Cristina; Maturana, Ana P; Ghersel, Frederico R; Fernandes, Cesar E; Oliveira, Emerson

    2018-01-01

    The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications. This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings. Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement. The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

  17. A prospective randomized trial comparing endarterectomy to stenting in severe asymptomatic carotid stenosis.

    Science.gov (United States)

    Mannheim, Dallit; Karmeli, Ron

    2017-12-01

    For an asymptomatic patient with severe carotid stenosis the most important question is how to prevent an ischemic stroke. Carotid artery stenosis is the estimated cause of stroke in 8-20% of the cases. Today more than 50% of procedures for carotid stenosis are done on asymptomatic patients, but few of the randomized controlled trials comparing carotid endarterectomy and stenting examined specifically these patients. All patients with severe (>70%) asymptomatic carotid artery stenosis seen in the Carmel medical center vascular clinic were prospectively screened and randomized 1:1 for carotid endarterectomy (CEA) or carotid stenting (CAS). Patients eligible for both procedures were enrolled. The primary objectives of the study were: 1) periprocedural complications - stroke (CVA), transient ischemic attack (TIA), myocardial infarction (MI), and death; 2) long-term results: mortality, prevention of ipsilateral stroke or TIA, and freedom from restenosis. One-hundred and thirty-six patients were treated with mean follow-up of 26 months. There was no difference in short and long term results between the two groups. Thirty day morbidity included: 1 CVA in each group with no MI. Long-term results included 4 deaths in each group; none from CVA. One TIA was noted after CAS, and 3 cases of restenosis were found in CEA and one in CAS. CAS is a maturing procedure and has improved significantly over the past several years. Future developments of stents and protection devices will achieve better perioperative results. This along with our excellent long term results will promote the use of stenting for suitable patients.

  18. A Randomized Controlled Trial Comparing Intranasal Midazolam and Chloral Hydrate for Procedural Sedation in Children.

    Science.gov (United States)

    Stephen, Marie Christy Sharafine; Mathew, John; Varghese, Ajoy Mathew; Kurien, Mary; Mathew, George Ani

    2015-12-01

    To evaluate the efficacy and safety of intranasal midazolam and chloral hydrate syrup for procedural sedation in children. Prospective randomized placebo-controlled trial (double blind, double dummy). Tertiary care hospital over 18 months. Eighty-two children, 1 to 6 years old, undergoing auditory brainstem response testing were randomized to receive either intranasal midazolam with oral placebo or chloral hydrate syrup with placebo nasal spray. Intranasal midazolam was delivered at 0.5 mg/kg (100 mcg per spray) and oral syrup at 50 mg/kg. Children not sedated at 30 minutes had a second dose at half the initial dose. The primary outcomes measured were safety and efficacy. Secondary outcomes were time to onset of sedation, parental separation, nature of parental separation, parental satisfaction, audiologist's satisfaction, time to recovery, and number of attempts. Forty-one children were in each group, and no major adverse events were noted. The chloral hydrate group showed earlier onset of sedation (66%) compared with the intranasal midazolam group (33%). Significant difference in time to recovery was noted in the chloral hydrate group (78 minutes) versus the intranasal midazolam group (108 minutes). The parents' and audiologist's satisfaction was higher for chloral hydrate (95% and 75%) than for intranasal midazolam (49% and 29%, respectively). Overall, sedation was 95% with chloral hydrate versus 51% with intranasal midazolam. Both drugs maintained sedation. Intranasal midazolam and chloral hydrate are both safe and efficacious for pediatric procedural sedation. Chloral hydrate was superior to intranasal midazolam, with an earlier time to onset of sedation, a faster recovery, better satisfaction among parents and the audiologist, and successful sedation. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

  19. A randomized trial comparing TVT with TVT-O: 12-month results.

    Science.gov (United States)

    Rinne, Kirsi; Laurikainen, Eija; Kivelä, Arre; Aukee, Pauliina; Takala, Teuvo; Valpas, Antti; Nilsson, Carl Gustaf

    2008-08-01

    The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

  20. Cluster randomized trial to compare spectacle delivery systems at outreach eye camps in South India.

    Science.gov (United States)

    Ramasamy, Dhivya; Joseph, Sanil; Valaguru, Vijayakumar; Mitta, Vinod P; Ravilla, Thulasiraj D; Cotch, Mary Frances

    2013-10-01

    To study the optimal method for delivery of spectacles at eye camps to maximize procurement and use. A cluster randomized controlled trial, undertaken in the catchment districts of Aravind Eye Hospital - Theni, in the state of Tamil Nadu, India. Community eye camps (n = 21) were allocated to offer one of three types of service for purchase of spectacles to correct refractive error: (1) Issuance of a prescription only; (2) booking orders for spectacles with subsequent delivery; (3) on-the-spot fitting and dispensing of spectacles. Follow-up questionnaires were administered 6 weeks after interventions to assess patient outcomes. The primary outcome measured was spectacle procurement at follow-up 6 weeks post-screening. Secondary outcomes included use of and satisfaction with spectacles. Reasons for purchase/non-purchase were also assessed. Compared to those who were issued only a prescription and adjusting for distance from base hospital, spectacle procurement was significantly higher for those allowed to book spectacles for subsequent delivery (odds ratio, OR, 8.79, 95% confidence interval, CI, 4.61-16.78) and for those receiving spectacles on the spot (OR 13.97, 95% CI 8.12-24.05). Among those with spectacles at 6 weeks, spectacle use was nearly universal and satisfaction with spectacles varied between 92 and 94% among the three different dispensing modalities. Making spectacles available on the spot is important to ensure procurement in a context where availability and access to dispensing opticians is poor.

  1. Knee joint distraction compared with high tibial osteotomy: a randomized controlled trial.

    Science.gov (United States)

    van der Woude, J A D; Wiegant, K; van Heerwaarden, R J; Spruijt, S; van Roermund, P M; Custers, R J H; Mastbergen, S C; Lafeber, F P J G

    2017-03-01

    Both, knee joint distraction as a relatively new approach and valgus-producing opening-wedge high tibial osteotomy (HTO), are knee-preserving treatments for knee osteoarthritis (OA). The efficacy of knee joint distraction compared to HTO has not been reported. Sixty-nine patients with medial knee joint OA with a varus axis deviation of knee joint distraction (n = 23) or HTO (n = 46). Questionnaires were assessed at baseline and 3, 6, and 12 months. Joint space width (JSW) as a surrogate measure for cartilage thickness was determined on standardized semi-flexed radiographs at baseline and 1-year follow-up. All patient-reported outcome measures (PROMS) improved significantly over 1 year (at 1 year p knee joint distraction group (p = 0.001) and 0.4 ± 0.5 mm in the HTO group (p knee joint distraction (p = 0.05). The lateral compartment showed a small increase in the knee joint distraction group and a small decrease in the HTO group, leading to a significant increase in mean JSW for knee joint distraction only (p knee joint distraction and HTO. These findings suggest that knee joint distraction may be an alternative therapy for medial compartmental OA with a limited mechanical leg malalignment. Randomized controlled trial, Level I.

  2. Troxipide in the Management of Gastritis: A Randomized Comparative Trial in General Practice

    Directory of Open Access Journals (Sweden)

    Bhupesh Dewan

    2010-01-01

    Full Text Available Background. A trial of empirical acid-suppressive therapy is the usual practice for most patients with symptoms of gastritis in primary care. Aim. To assess the relative efficacy of Troxipide and Ranitidine in patients with endoscopic gastritis over a four-week period. Methods. In all, 142 patients were randomized to Troxipide (100 mg tid or Ranitidine (150 mg bid for a period of four weeks. The severity of the signs of endoscopic gastritis at baseline and week 4 using a four-point scale and the subjective symptom severity at baseline and week 2 & week 4 using a Visual analog scale (VAS were documented. Results. Troxipide was found to be superior to Ranitidine for both, the complete resolution and improvement of endoscopic gastritis. Higher proportion of patients showed complete healing of erosions (88.14%, oozing (96.77%, and edema (93.88% with Troxipide as compared to Ranitidine (<.01. Patients receiving Troxipide also showed a greater improvement in the VAS scores for abdominal pain, bloating, and heartburn (<.01. Both the drugs were found to be well tolerated. Conclusion. In patients with endoscopic gastritis, Troxipide, with its superior rate of improvement, resolution of signs, and subjective clinical symptoms, can be considered as an alternative to the commonly used antisecretory agents.

  3. Explaining feast or famine in randomized field trials. Medical science and criminology compared.

    Science.gov (United States)

    Shepherd, Jonathan P

    2003-06-01

    A feast of randomized controlled trials (RCTs) in medical science and comparative famine in criminology can be explained in terms of cultural and structural factors. Of central importance is the context in which the evaluation of interventions is done and the difference in status of situational research in the two disciplines. Evaluation of medical interventions has traditionally been led by practitioner (clinical) academics. This is not the case in criminal justice, where theory has had higher status than intervention research. Medical science has advanced in, or closely associated with, university teaching hospitals, but links between criminology and criminal justice services are far more tenuous. The late development of situational crime prevention seems extraordinary from a medical perspective, as does the absence of university police schools in the United Kingdom and elsewhere. These structural and cultural factors explain concentration of expectation, resource, and RCT productivity in medical science. The Campbell Collaboration and the Academy of Experimental Criminology are forces which are reducing this polarization of feast and famine in RCTs. But unless scientific criminology is embedded in university schools which are responsible for the education and training of law, probation, and police practitioners, convergence in terms of RCTs and implementation of findings in practice seems unlikely.

  4. Systematic review of randomized controlled trials comparing laparoscopic with open appendicectomy.

    Science.gov (United States)

    McCall, J L; Sharples, K; Jadallah, F

    1997-08-01

    The role of laparoscopic surgery in the management of patients with suspected appendicitis is still debated despite a number of recent randomized controlled trials (RCTs). A systematic review has been undertaken of all published RCTs comparing laparoscopic appendicectomy with open appendicectomy. Studies were identified through Medline and supplemented with a manual search of relevant journals and meeting abstracts. Data were extracted and analysed according to predefined criteria. Ten studies were identified, seven of which reported results on an intention-to-treat basis. Laparoscopic appendicectomy was associated with a longer operating time (8-29 min), a minimal reduction in hospital stay and, probably, an earlier return to normal activity. It was also associated with a reduced risk of wound infection (odds ratio 2.6) with no increase in other complications. However, bias, particularly resulting from lack of blinding, makes some of these results difficult to interpret. Laparoscopic appendicectomy was associated with some advantages and no obvious disadvantages, apart from prolonged operating time. Future RCTs should be blinded to minimize bias, document adequate follow-up and analyse results on an intention-to-treat basis.

  5. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  6. A randomized, comparative trial: does pillow type alter cervico-thoracic spinal posture when side lying?

    Directory of Open Access Journals (Sweden)

    Gordon SJ

    2011-08-01

    Full Text Available Susan J Gordon1, Karen A Grimmer-Somers2, Patricia H Trott31School of Public Health, Tropical Medicine and Rehabilitation Science, James Cook University, Townsville, QLD; 2Centre for Allied Health Sciences, 3School of Health Sciences, University of South Australia, Adelaide, SA, AustraliaBackground: Many patients ask for advice about choosing a pillow. This research was undertaken to determine if pillow type alters cervico-thoracic spine position when resting in the side-lying position.Aim: To investigate the effect of different pillow shape and content on the slope of cervico-thoracic spine segments when side lying.Materials and methods: The study was a randomized blinded comparative trial set in a laboratory that replicated a bedroom. The subjects were side sleepers aged over 18 years. Exclusion criteria were history of surgery to the cervico-thoracic spine, an injury or accident to the cervico-thoracic spine in the preceding year, or currently receiving treatment for neck symptoms. Each participant rested in a standardized side-lying position for 10 minutes on each of the trial pillows: regular shaped polyester, foam, feather, and latex pillows, and a contour shaped foam pillow. Reflective markers were placed on external occipital protuberance (EOP, C2, C4, C7, and T3, and digital images were recorded of subjects at 0 and 10 minutes on each pillow. Images were digitized using each reflective marker and the slope of each spinal segment calculated. Univariate analysis of variance models were used to investigate slope differences between pillows at 0 and 10 minutes. Significance was established at P < 0.01 to take account of chance effects from repeated measures and multiple comparisons.Results: At 0 and 10 minutes, the EOP-C2, C2-C4, and C4-C7 segmental slopes were significantly different across all pillows. Significant differences were identified when comparing the feather pillow with the latex, regular and contour foam pillows, and when

  7. Benson's Relaxation Effect in Comparing to Systematic Desensitization on Anxiety of Female Nurses: A Randomized Clinical Trial

    OpenAIRE

    Sajadi, Mahbobeh; Goudarzi, Khatereh; Khosravi, Sharareh; Farmahini-Farahani, Molod; Mohammadbeig, Abolfazl

    2017-01-01

    Introduction: Nursing staffs expose to a high level of anxiety. This study aimed to compare the effect of Benson's relaxation and systematic desensitization methods for decreasing the anxiety score of nurses. Materials and Methods: In a randomized clinical trial, 72 female nurses were assigned randomly to three different groups. Benson's relaxation and systematic desensitization were used as intervention beside control group. After intervention, the Spielberger state-trait anxiety inventory w...

  8. Therapist-rated outcomes in a randomized clinical trial comparing cognitive behavioral therapy and psychodynamic therapy for major depression

    NARCIS (Netherlands)

    Driessen, E.; Van, H.L.; Peen, J.; Don, F.J.; Kool, S.; Westra, D.; Hendriksen, M.; Cuijpers, P.; Twisk, J.W.R.; Dekker, J.J.M.

    2015-01-01

    Background The efficacy of psychodynamic therapy (PDT) for depression is debated due to a paucity of high-quality studies. We compared short psychodynamic supportive psychotherapy (SPSP) to cognitive behavioral therapy (CBT) in a randomized clinical trial. We used therapist-rated outcomes to examine

  9. Differences in Blood Pressure in Infants after General Anesthesia Compared to Awake Regional Anesthesia (GAS Study - A Prospective Randomized Trial)

    NARCIS (Netherlands)

    McCANN, M.E.; Withington, Davinia E.; Arnup, Sarah J.; Davidson, Andrew J.; DISMA, N.; FRAWLEY, G.; Morton, Neil S.; BELL, G.; Hunt, Rodney W.; Bellinger, David C; Polaner, D. M.; Leo-Macias, Alejandra; Absalom, Anthony R.; Von Ungern-Sternberg, Britta S.; Izzo, Francesca; Szmuk, Peter; Young, Vanessa; Soriano, S. G.; De Graaff, J. C.|info:eu-repo/dai/nl/249966271

    2017-01-01

    BACKGROUND: The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS

  10. Randomized clinical trial comparing the effect of computed tomography in the trauma room versus the radiology department on injury outcomes

    NARCIS (Netherlands)

    Saltzherr, T. P.; Bakker, F. C.; Beenen, L. F. M.; Dijkgraaf, M. G. W.; Reitsma, J. B.; Goslings, J. C.; Bossuyt, P. M.; Jin, P. H. P. Fung Kon; Luitse, J. S. K.; Ponsen, K. J.; Henny, C. P.; Giannakopoulos, G. F.

    2012-01-01

    Background: Computed tomography (CT) of injured patients in the radiology department requires potentially dangerous and time-consuming patient transports and transfers. It was hypothesized that CT in the trauma room would improve patient outcome and workflow. Methods: A randomized trial compared the

  11. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial.

    Science.gov (United States)

    Menéndez-Jándula, Bárbara; Souto, Juan Carlos; Oliver, Arturo; Montserrat, Isabel; Quintana, Mireia; Gich, Ignasi; Bonfill, Xavier; Fontcuberta, Jordi

    2005-01-04

    Control of oral anticoagulant treatment has been reported to be suboptimal, but previous studies suggest that patient self-management improves control. To compare the quality of control and the clinical outcomes of oral anticoagulant treatment in self-managed patients versus patients following conventional management. Randomized, controlled trial. University-affiliated hospital in Spain. 737 patients with indications for anticoagulant treatment. The self-management group (n = 368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n = 369) received usual care in an anticoagulation clinic (monthly measurement and control of international normalized ratio [INR], managed by hematologists). Percentage of INR values within the target range and major related complications. The median follow-up period was 11.8 months (range, 0.3 to 16.9 months). The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (difference, 3.0 percentage points [95% CI, 0.4 to 5.4 percentage points]). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the self-management group had major complications related to anticoagulant treatment. The unadjusted risk difference for major complications between groups was 5.1 percentage points (exact 95% CI, 1.7 to 8.5 percentage points). Fewer patients had minor hemorrhages in the self-management group (14.9%) than in the conventional management group (36.4%). Fifteen patients (4.1%) in the conventional management group and 6 (1.6%) in the self-management group died (unadjusted risk difference, 2.5 percentage points [exact 95% CI, 0.0 to 5.1 percentage points]). The trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%. Compared with conventional management by an anticoagulation clinic, self-management of oral

  12. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis.

    Science.gov (United States)

    Dohm, M; Black, C M; Dacre, A; Tillman, J B; Fueredi, G

    2014-12-01

    Several trials have compared vertebral augmentation with nonsurgical treatment for vertebral compression fractures. This trial compares the efficacy and safety of balloon kyphoplasty and vertebroplasty. Patients with osteoporosis with 1-3 acute fractures (T5-L5) were randomized and treated with kyphoplasty (n = 191) or vertebroplasty (n = 190) and were not blinded to the treatment assignment. Twelve- and 24-month subsequent radiographic fracture incidence was the primary end point. Due to low enrollment and early withdrawals, the study was terminated with 404/1234 (32.7%) patients enrolled. The average age of patients was 75.6 years (77.4% female). Mean procedure duration was longer for kyphoplasty (40.0 versus 31.8 minutes, P kyphoplasty (50/140 versus 57/131) had subsequent radiographic fracture, and there were 8.6% fewer at 24 months (54/110 versus 64/111). The results were not statistically significant (P > .21). When we used time to event for new clinical fractures, kyphoplasty approached statistical significance in longer fracture-free survival (Wilcoxon, P = .0596). Similar pain and function improvements were observed. CT demonstrated lower cement extravasation for kyphoplasty (157/214 versus 164/201 levels treated, P = .047). For kyphoplasty versus vertebroplasty, common adverse events within 30 postoperative days were procedural pain (12/191, 9/190), back pain (14/191, 28/190), and new vertebral fractures (9/191, 17/190); similar 2-year occurrence of device-related cement embolism (1/191, 1/190), procedural pain (3/191, 3/190), back pain (2/191, 3/190), and new vertebral fracture (2/191, 2/190) was observed. Kyphoplasty and vertebroplasty had similar long-term improvement in pain and disability with similar safety profiles and few device-related complications. Procedure duration was shorter with vertebroplasty. Kyphoplasty had fewer cement leakages and a trend toward longer fracture-free survival. © 2014 by American Journal of Neuroradiology.

  13. Comparing Adrenaline with Tranexamic Acid to Control Acute Endobronchial Bleeding: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mitra Samareh Fekri

    2017-03-01

    Full Text Available Background: Hemoptysis occurs due to either pulmonary diseases or bronchoscopy interventions. The aim of the present study was to compare the efficacy of the endobronchial instillation of adrenaline with that of tranexamic acid. Methods: Fifty patients were randomly selected as 2 double-blinded sample groups (n=25. In these patients, bleeding could not be controlled with cold saline lavage during bronchoscopy and they, therefore, required prescription of another medicine. Adrenaline (1 mg in one group and tranexamic acid (500 mg in the other group were diluted in 20 mL of normal saline and instilled through the bronchoscope. This technique was repeated 3 times at 90-second intervals, if necessary. In the case of persistent bleeding, 90 seconds after the last dose, a second medicine was given for bleeding control. Observation of clot through the bronchoscope meant that the bleeding had stopped. The efficacy of tranexamic acid and adrenaline was evaluated and then compared using the Mann–Whitney test. Results: The time of bleeding control had no significant difference between tranexamic acid and adrenaline (P=0.908. Another analysis was done to evaluate bleeding control with a second medicine; the results showed that 1 (4% patient in the tranexamic acid and 8 (32% in the adrenaline group needed the second medicine and there was no significant difference between the 2 groups (P=0.609. Conclusion: Our results suggested that tranexamic acid by endobronchial instillation was as efficient as adrenaline in controlling hemoptysis and required less frequent use of a second medicine. Trial Registration Number: IRCT2014120220188

  14. Randomized controlled trial comparing dynamic simulation with static simulation in trauma.

    Science.gov (United States)

    Carden, Anthony J; Salcedo, Edgardo S; Leshikar, David E; Utter, Garth H; Wilson, Machelle D; Galante, Joseph M

    2016-05-01

    Current general surgery residents have limited exposure to open trauma operative cases. Simulation supplements variable rotation volume and provides experience with critical but rarely performed procedures. Open simulation classically focuses on static models with anatomic accuracy but lacks practicality when hemorrhage control is the lifesaving maneuver. We sought to evaluate whether training on a dynamic simulator, while much less expensive than training on a static cadaver, might be at least as effective in training surgery residents to expeditiously place temporary vascular shunts (TVSs). Our research team developed an inexpensive, reusable dynamic simulator with ongoing hemorrhage to instruct trainees in the steps of TVS placement. We enrolled 54 general surgery residents in a noninferiority randomized controlled trial comparing training of TVS placement on the dynamic simulator (n = 28) versus a cadaver arm (n = 26). After standardized video didactics, trainees practiced on either the simulator or cadaver arm. After the trainees achieved competency, they were tested on placing a TVS for a live swine femoral artery injury. Two blinded trauma surgeons evaluated the recorded performances. Residents did not differ in baseline characteristics between groups, and all residents in both groups successfully completed the TVS placement test. Subjects trained on the simulator placed the TVS faster than those trained on a cadaver (584 seconds vs. 751 seconds; difference, +167 seconds faster; 90% confidence interval [CI], +52 to +282 seconds), with a trend toward faster time to hemorrhage control (110 seconds vs. 148 seconds; difference, +38 seconds faster; 90% CI, -8 to +84). There was no significant difference in Objective Structured Assessment of Technical Skills scores (3.72 vs. 3.44; difference, +0.27 units better; 90% CI, -0.04 to +0.59). Training on a dynamic simulator resulted in noninferior time to completion of vascular shunt placement compared with training on

  15. Danish randomized trial comparing breast-preserving therapy with mastectomy in mammary carcinoma. Preliminary results

    Energy Technology Data Exchange (ETDEWEB)

    Blichert-Toft, M.; Brincker, H.; Andersen, J.A.; Andersen, K.W.; Axelsson, C.K.; Mouridsen, H.T.; Dombernowsky, P.; Overgaard, M.; Gadeberg, C.; Knudsen, G.

    1988-01-01

    The present study comprises 847 women operated upon for invasive breast carcinoma at 19 surgical departments and enrolled in protocol DBCG-82TM from January 1983 to November 1987. Among them 662 (78%) were allocated for breast-preserving therapy or mastectomy by randomization, while 185 patients (22%) did not accept randomization. Within the randomized group 6% could not be entered into adjuvant protocols, i.e. subsequent programmes of postoperative therapy and follow-up. This left 619 evaluable patients. In the non-randomized series 26% did not fulfil the demands for entrance into the adjuvant protocols, leaving 136 evaluable patients, 60 of whom had chosen a breast-preserving operation and 76 mastectomy. In the randomized series the patients in the two treatment arms were comparable in age, menopausal status, site of tumour, pathoanatomical diameter of the tumour, number of removed axillary lymph nodes, number of metastatic axillary lymph nodes, and distribution on adjuvant regimens. Ninety per cent of the patients in the randomized group accepted the method offered, whereas 10% declined and wanted the alternate form of operation. The median follow-up period was approximately 1.75 years. The cumulative recurrence rate in the randomized group was 13% and in the non-randomized group 7%. These results are preliminary. Life-table analyses have not so far demonstrated differences in recurrence-free survival either in the randomized or the non-randomized series.

  16. Comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: a randomized trial

    Science.gov (United States)

    Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy f...

  17. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  18. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial

    National Research Council Canada - National Science Library

    Carrera, Fernando; Lok, Charmaine E; de Francisco, Angel; Locatelli, Francesco; Mann, Johannes F E; Canaud, Bernard; Kerr, Peter G; Macdougall, Iain C; Besarab, Anatole; Villa, Giuseppe; Kazes, Isabelle; Van Vlem, Bruno; Jolly, Shivinder; Beyer, Ulrich; Dougherty, Frank C

    2010-01-01

    .... We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly...

  19. Cluster Randomized Trial to Compare Spectacle Delivery Systems at Outreach Eye Camps in South India

    Science.gov (United States)

    Ramasamy, Dhivya; Joseph, Sanil; Valaguru, Vijayakumar; Mitta, Vinod P.; Ravilla, Thulasiraj D; Cotch, Mary Frances

    2014-01-01

    Purpose To study the optimal method for delivery of spectacles at eye camps to maximize procurement and use. Methods A cluster randomized controlled trial, undertaken in the catchment districts of Aravind Eye Hospital – Theni, in the state of Tamil Nadu, India. Community eye camps (n = 21) were allocated to offer one of three types of service for purchase of spectacles to correct refractive error: (1) Issuance of a prescription only; (2) booking orders for spectacles with subsequent delivery; (3) on-the-spot fitting and dispensing of spectacles. Follow-up questionnaires were administered 6 weeks after interventions to assess patient outcomes. The primary outcome measured was spectacle procurement at follow-up 6 weeks post-screening. Secondary outcomes included use of and satisfaction with spectacles. Reasons for purchase/non-purchase were also assessed. Results Compared to those who were issued only a prescription and adjusting for distance from base hospital, spectacle procurement was significantly higher for those allowed to book spectacles for subsequent delivery (odds ratio, OR, 8.79, 95% confidence interval, CI, 4.61–16.78) and for those receiving spectacles on the spot (OR 13.97, 95% CI 8.12–24.05). Among those with spectacles at 6 weeks, spectacle use was nearly universal and satisfaction with spectacles varied between 92 and 94% among the three different dispensing modalities. Conclusion Making spectacles available on the spot is important to ensure procurement in a context where availability and access to dispensing opticians is poor. PMID:24070102

  20. Comparing treatments for children with ADHD and word reading difficulties: A randomized clinical trial.

    Science.gov (United States)

    Tamm, Leanne; Denton, Carolyn A; Epstein, Jeffery N; Schatschneider, Christopher; Taylor, Heather; Arnold, L Eugene; Bukstein, Oscar; Anixt, Julia; Koshy, Anson; Newman, Nicholas C; Maltinsky, Jan; Brinson, Patricia; Loren, Richard E A; Prasad, Mary R; Ewing-Cobbs, Linda; Vaughn, Aaron

    2017-05-01

    This trial compared attention-deficit/hyperactivity disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). Children (n = 216; predominantly African American males) in Grades 2-5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (medication + parent training), reading treatment (reading instruction), or combined ADHD + reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with posttest regressed onto pretest. Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges's g = .87/.75; teacher g = .67/.50) and combined (parent g = 1.06/.95; teacher g = .36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g = .19/.20; teacher g = .31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g = .23; decoding g = .39) and combined (word reading g = .32; decoding g = .39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g = .09; decoding g = .00). Significant group differences were maintained at the 3- to 5-month follow-up on all outcomes except word reading. Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  1. Randomized trial of a smartphone mobile application compared to text messaging to support smoking cessation.

    Science.gov (United States)

    Buller, David B; Borland, Ron; Bettinghaus, Erwin P; Shane, James H; Zimmerman, Donald E

    2014-03-01

    Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Young adult smokers 18-30 years old (n = 102) participated in a randomized pretest-posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (pMobile. Use of both services predicted increased 30-day abstinence at 12 weeks (used, 47%; not used, 20%; p = 0.03). REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging.

  2. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

  3. A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy

    LENUS (Irish Health Repository)

    Mullaney, L.

    2014-01-10

    Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy (RT). A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume (BV) and thus reduce the bladder-related organ motion. The secondary endpoints were to assess the incidence of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity for patients and patients’ satisfaction with the bladder-filling instructions.

  4. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

    Science.gov (United States)

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-12-01

    Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  5. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    OpenAIRE

    Falgun Indravadan Vyas; Devang Ashwinkumar Rana; Patel, Piyush M.; Varsha Jitendra Patel; Bhavsar, Rekha H.

    2014-01-01

    Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, al...

  6. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia

    NARCIS (Netherlands)

    van Santen, Marijke; Bolwijn, Paulien; Verstappen, Frans; Bakker, Carla; Hidding, Alita; Houben, Harry; van der Heijde, Desiree; Landewé, Robert; van der Linden, Sjef

    2002-01-01

    To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n =

  7. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities.

    Science.gov (United States)

    Valdés, Bulmaro Adolfo; Schneider, Andrea Nicole; Van der Loos, H F Machiel

    2017-10-01

    To investigate whether the compensatory trunk movements of stroke survivors observed during reaching tasks can be decreased by force and visual feedback, and to examine whether one of these feedback modalities is more efficacious than the other in reducing this compensatory tendency. Randomized crossover trial. University research laboratory. Community-dwelling older adults (N=15; 5 women; mean age, 64±11y) with hemiplegia from nontraumatic hemorrhagic or ischemic stroke (>3mo poststroke), recruited from stroke recovery groups, the research group's website, and the community. In a single session, participants received augmented feedback about their trunk compensation during a bimanual reaching task. Visual feedback (60 trials) was delivered through a computer monitor, and force feedback (60 trials) was delivered through 2 robotic devices. Primary outcome measure included change in anterior trunk displacement measured by motion tracking camera. Secondary outcomes included trunk rotation, index of curvature (measure of straightness of hands' path toward target), root mean square error of hands' movement (differences between hand position on every iteration of the program), completion time for each trial, and posttest questionnaire to evaluate users' experience and system's usability. Both visual (-45.6% [45.8 SD] change from baseline, P=.004) and force (-41.1% [46.1 SD], P=.004) feedback were effective in reducing trunk compensation. Scores on secondary outcome measures did not improve with either feedback modality. Neither feedback condition was superior. Visual and force feedback show promise as 2 modalities that could be used to decrease trunk compensation in stroke survivors during reaching tasks. It remains to be established which one of these 2 feedback modalities is more efficacious than the other as a cue to reduce compensatory trunk movement. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. 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

    NARCIS (Netherlands)

    Davidson, Andrew J.; Morton, Neil S.; Arnup, Sarah J.; De Graaff, Jurgen C.|info:eu-repo/dai/nl/249966271; 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; Lee, Katherine; Sheppard, Suzette; Hartmann, Penelope; Ragg, Philip; Backstrom, Marie; Costi, David; Von Ungern-Sternberg, Britta S.; Knottenbelt, Graham; Montobbio, Giovanni; Mameli, Leila; Giribaldi, Gaia; Prato, Alessio Pini; Mattioli, Girolamo; Wolfler, Andrea; Izzo, Francesca; Sonzogni, Valter; Van Gool, Jose T D G; Numan, Sandra C.; Kalkman, Cor J.; Hagenaars, J. H M; Absalom, Anthony R.; Hoekstra, Frouckje M.; Volkers, Martin J.; Furue, Koto; Gaudreault, Josee; Berde, Charles; Soriano, Sulpicio; Young, Vanessa; Sethna, Navil; Kovatsis, Pete; Cravero, Joseph P.; Bellinger, David; Marmor, Jacki; Lynn, Anne; Ivanova, Iskra; Hunyady, Agnes; Verma, Shilpa; Polaner, David; Thomas, Joss; Meuller, Martin; Haret, Denisa; Szmuk, Peter; Steiner, Jeffery; Kravitz, Brian; Suresh, Santhanam; Hays, Stephen R.; Taenzer, Andreas H.; Maxwell, Lynne G.; Williams, Robert K.; Bell, Graham T.; Dorris, Liam; Adey, Claire; Bagshaw, Oliver; Chisakuta, Anthony; Eissa, Ayman; Stoddart, Peter; Davis, Annette; Myles, Paul; Wolf, Andy; McIntosh, Neil; Carlin, John; Leslie, Kate; De Lima, Jonathan; Hammer, Greg; Field, David; Gebski, Val; Tibboel, Dick

    2015-01-01

    Background: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) 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

  9. A Meta-analysis of Randomized Trials Comparing Surgery versus Endovascular Therapy for Thrombosed Arteriovenous Fistulas and Grafts in Hemodialysis

    Energy Technology Data Exchange (ETDEWEB)

    Kuhan, G., E-mail: gkuhan@nhs.net; Antoniou, G. A. [Central Manchester University Hospital Foundation Trust, Regional Vascular and Endovascular Unit (United Kingdom); Nikam, M.; Mitra, S. [Central Manchester University Hospital Foundation Trust, Department of Renal Medicine (United Kingdom); Farquharson, F. [Central Manchester University Hospital Foundation Trust, Department of Radiology (United Kingdom); Brittenden, J. [University of Aberdeen (United Kingdom); Chalmers, N. [Central Manchester University Hospital Foundation Trust, Department of Radiology (United Kingdom)

    2013-06-15

    Purpose. To carry out a systematic review of randomized trials comparing surgery vs. endovascular therapy for occluded fistulas and grafts. Methods. All randomized trials which compared surgery and endovascular therapy for occluded fistulas and grafts were retrieved from 1990 onwards. The following search terms were used: 'haemodialysis,' 'thrombosis,' 'arteriovenous fistula,' 'arteriovenous shunt,' 'end stage renal failure' on Medline and PubMed. The results of the pooled data were analysed by a fixed-effect model. Results. There were no randomized trials comparing surgery vs. endovascular therapy for native fistulas and vein grafts. Six randomized studies reporting on 573 occluded grafts were identified. Technical success, need for access line and primary patency at 30 days were similar between the two groups (odds ratio [OR] 1.40, 95 % confidence interval [CI] 0.91-2.14; OR 0.77, 95 % CI 0.44-1.34; and OR 1.15, 95 % CI 0.79-1.68, respectively). There was no significant difference in morbidity at 30 days between groups (OR 1.12, 95 % CI 0.67-1.86). There were no statistical difference between the two groups for 1 year primary patency (OR 2.08, 95 % CI 0.97-4.45). Primary assisted patency at 1 year was better with surgery (OR 3.03, 95 % CI 1.12-8.18) in a single study. Conclusion. Comparable results to surgery have been achieved with endovascular techniques for occluded prosthetic grafts for dialysis access. Long-term data comparing the two groups were lacking. Further trials designed to encompass variation in methods are warranted in order to obtain the best available evidence particularly for native fistulas.

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

    Directory of Open Access Journals (Sweden)

    Wollermann C

    2006-09-01

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

  11. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  12. A Randomized Controlled Trial Comparing Botulinum Toxin A Dosage in the Upper Extremity of Children with Spasticity

    Science.gov (United States)

    Kawamura, Anne; Campbell, Kent; Lam-Damji, Sophie; Fehlings, Darcy

    2007-01-01

    This study compared the effects of low and high doses of botulinum toxin A (BTX-A) to improve upper extremity function. Thirty-nine children (22 males, 17 females) with a mean age of 6 years 2 months (SD 2y 9mo) diagnosed with spastic hemiplegia or triplegia were enrolled into this double-blind, randomized controlled trial. The high-dose group…

  13. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    OpenAIRE

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-01-01

    Abstract Background To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the ...

  14. A randomized controlled trial comparing split and subunit influenza vaccines in adults in Colombia

    Directory of Open Access Journals (Sweden)

    A. Morales

    2003-06-01

    Full Text Available In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripeâ or sub-unit (Agrippal S1â influenza vaccine (1999-2000 formulations. For analysis, study groups were subdivided into adult (18-60 years old and elderly (over 60 years subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well tolerated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripeâ induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% of elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1â. In conclusion, the split-virion and sub-unit influenza vaccines had similar safety and reactogenicity profiles, and elicited satisfactory immunity in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT values in response to the B strain were seen with the split vaccine Imovax Gripeâ, giving it a better overall immunogenicity.En un ensayo comparativo realizado en dos centros, se asignaron de manera aleatoria 344 adultos para recibir una dosis de vacuna contra la gripe de virus fraccionado inactivado (Imovax Gripeâ o de vacuna de subunidades (Agrippal S1â (formulaciones 1999-2000. Para el análisis, los grupos estudiados fueron subdivididos en adultos (18-60 años y ancianos (más de 60 años. La sangre fue extraída justo antes y un mes después de la vacunación. La inocuidad fue evaluada utilizando un informe sobre reacciones adversas, usando un diseño de observador a ciegas. Ambas vacunas fueron muy bien toleradas, con perfiles de reactogenicidad similares y desarrollaron escasas reacciones adversas en los individuos ancianos. La vacunación con

  15. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

    Directory of Open Access Journals (Sweden)

    Mohammad Dehghani Firoozabadi

    2014-01-01

    Full Text Available Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients and conventional treatment group (30 patients. An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months. Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6 and 32.6 (±12.7 years, respectively (P = 0.45. After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80, frequency of migraine attacks (P = 0.63 and duration of attacks per hours (P = 0.48 were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001. Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  16. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

    Science.gov (United States)

    Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H

    2014-09-08

    Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind

  17. A randomized trial comparing digital and live lecture formats [ISRCTN40455708

    Directory of Open Access Journals (Sweden)

    Laird-Fick Heather S

    2004-11-01

    Full Text Available Abstract Background Medical education is increasingly being conducted in community-based teaching sites at diverse locations, making it difficult to provide a consistent curriculum. We conducted a randomized trial to assess whether students who viewed digital lectures would perform as well on a measure of cognitive knowledge as students who viewed live lectures. Students' perceptions of the digital lecture format and their opinion as whether a digital lecture format could serve as an adequate replacement for live lectures was also assessed. Methods Students were randomized to either attend a lecture series at our main campus or view digital versions of the same lectures at community-based teaching sites. Both groups completed the same examination based on the lectures, and the group viewing the digital lectures completed a feedback form on the digital format. Results There were no differences in performance as measured by means or average rank. Despite technical problems, the students who viewed the digital lectures overwhelmingly felt the digital lectures could replace live lectures. Conclusions This study provides preliminary evidence digital lectures can be a viable alternative to live lectures as a means of delivering didactic presentations in a community-based setting.

  18. Randomized clinical trial comparing a polypropylene with a poliglecaprone and polypropylene composite mesh for inguinal hernioplasty.

    Science.gov (United States)

    śmietański, M

    2008-12-01

    : The aim was to assess whether a partially absorbable monofilament mesh could influence postoperative pain and time to return to normal activity after Lichtenstein hernioplasty. : The study randomized patients undergoing inguinal hernia repair in 15 centres into two groups according to mesh type: lightweight (poliglecaprone-polypropylene composite) and heavyweight (polypropylene). A modified suture technique was used in the lightweight group. Follow-up on day 7 and at 3, 6 and 12 months evaluated the incidence of early and late complications, recurrence rate, quality of life, postoperative pain and return to physical activity. : A total of 600 patients were randomized and, after monitoring visits (leading to the exclusion of seven hospitals), 392 qualified for assessment. At 12 months, the recurrence rate did not differ (1.9 versus 0.6 per cent; P = 0.493). The lightweight group reported less pain on day 7 (55.2 versus 36.2 per cent; P health and physical activity according to Short Form 36 scores increased in both groups. : Use of partially absorbable mesh reduced postoperative pain in the short term. No difference in pain or recurrence rates were observed at 12 months. CCT-NAPN-17412 (http://www.controlled-trials.com) Published by John Wiley & Sons, Ltd. Copyright (c) 2008 British Journal of Surgery Society Ltd.

  19. Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care.

    Science.gov (United States)

    Shanahan, Joanne; Morris, Meg E; Bhriain, Orfhlaith Ni; Volpe, Daniele; Lynch, Tim; Clifford, Amanda M

    2017-09-01

    To examine the feasibility of a randomized controlled study design and to explore the benefits of a set dancing intervention compared with usual care. Randomized controlled design, with participants randomized to Irish set dance classes or a usual care group. Community based. Individuals with idiopathic Parkinson disease (PD) (N=90). The dance group attended a 1.5-hour dancing class each week for 10 weeks and undertook a home dance program for 20 minutes, 3 times per week. The usual care group continued with their usual care and daily activities. The primary outcome was feasibility, determined by recruitment rates, success of randomization and allocation procedures, attrition, adherence, safety, willingness of participants to be randomized, resource availability, and cost. Secondary outcomes were motor function (motor section of the Unified Parkinson's Disease Rating Scale), quality of life (Parkinson's Disease Questionnaire-39), functional endurance (6-min walk test), and balance (mini-BESTest). Ninety participants were randomized (45 per group). There were no adverse effects or resource constraints. Although adherence to the dancing program was 93.5%, there was >40% attrition in each group. Postintervention, the dance group had greater nonsignificant gains in quality of life than the usual care group. There was a meaningful deterioration in endurance in the usual care group. There were no meaningful changes in other outcomes. The exit questionnaire showed participants enjoyed the classes and would like to continue participation. For people with mild to moderately severe PD, set dancing is feasible and enjoyable and may improve quality of life. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Comparable three months' outcome of total arterial revascularization versus conventional coronary surgery: Copenhagen Arterial Revascularization Randomized Patency and Outcome trial

    DEFF Research Database (Denmark)

    Damgaard, S.; Lund, J.T.; Lilleor, N.B.

    2008-01-01

    OBJECTIVE: The in-hospital safety of total arterial revascularization for coronary artery bypass surgery seems to be comparable to conventional revascularization, but randomized trials evaluating this are few and data on complications in the postoperative months are sparse. METHODS: In a randomized...... single-center trial, 331 patients underwent total arterial revascularization using single or bilateral internal thoracic and radial arteries versus conventional revascularization using the left internal thoracic artery and saphenous vein grafts. We report the results from 3 months' follow-up. RESULTS...... complications requiring hospitalization: 3 (1.9%) versus 6 (3.5%) (P = .50), respectively. CONCLUSION: These results confirm previous reports that total arterial revascularization can be performed with low in-hospital morbidity and mortality. Further, in the 3 postoperative months, total arterial...

  1. Randomized trial comparing weekly versus 3-week chemotherapy in small-cell lung cancer: a Cancer Research Campaign trial.

    Science.gov (United States)

    Souhami, R L; Rudd, R; Ruiz de Elvira, M C; James, L; Gower, N; Harper, P G; Tobias, J S; Partridge, M R; Davison, A G; Trask, C

    1994-09-01

    A randomized trial of chemotherapy, given on either a 1-week or a 3-week schedule, was performed in small-cell lung cancer (SCLC) patients. The aim was to determine if weekly scheduling produced survival superior to conventional treatment. Four hundred thirty-eight patients with SCLC with either limited disease (LD; 276 patients) or good-prognosis extensive disease (ED; 162 patients) were randomized. Weekly chemotherapy was 12 alternating cycles of ifosfamide/doxorubicin and cis-platin/etoposide (PE), while 3-week treatment was six alternating cycles of cyclophosphamide/doxorubicin/vincristine (CAV) and PE. Thoracic irradiation was administered 3 weeks after completion of chemotherapy to LD patients who attained a complete response (CR) or partial response (PR). Patients were well matched for clinical characteristics and prognostic factors. Overall response was the same in both arms: 82.3% (39.4% CR) with weekly and 81.1% (36.9% CR) with 3-week treatment. The median survival (MS) durations were 10.8 and 10.6 months for weekly and 3-week chemotherapy, respectively. The 2-year survival rates were 11.8% and 11.7% in the weekly and 3-week arms, respectively. Received dose-intensity (DI) was 73.9% of projected for weekly treatment and 92.7% for 3-week treatment. Hematologic toxicity was the major dose-limiting toxicity for the weekly treatment. This trial excludes at 90% power a benefit of greater than 10% for 2-year survival for weekly treatment. The received DI was reduced to a greater extent with weekly treatment, mainly due to hematologic toxicity.

  2. A comparative analysis of recruitment methods used in a randomized trial of diabetes education interventions.

    Science.gov (United States)

    Beaton, Sarah J; Sperl-Hillen, JoAnn M; Worley, Ann Von; Fernandes, Omar D; Baumer, Dorothy; Hanson, Ann M; Parker, Emily D; Busch, Maureen E; Davis, Herbert T; Spain, C Victor

    2010-11-01

    Recruitment methods heavily impact budget and outcomes in clinical trials. We conducted a post-hoc examination of the efficiency and cost of three different recruitment methods used in Journey for Control of Diabetes: the IDEA Study, a randomized controlled trial evaluating outcomes of group and individual diabetes education in New Mexico and Minnesota. Electronic databases were used to identify health plan members with diabetes and then one of the following three methods was used to recruit study participants: 1. Minnesota Method 1--Mail only (first half of recruitment period). Mailed invitations with return-response forms. 2. Minnesota Method 2--Mail and selective phone calls (second half of recruitment period). Mailed invitations with return-response forms and subsequent phone calls to nonresponders. 3. New Mexico Method 3--Mail and non-selective phone calls (full recruitment period): Mailed invitations with subsequent phone calls to all. The combined methods succeeded in meeting the recruitment goal of 623 subjects. There were 147 subjects recruited using Minnesota's Method 1, 190 using Minnesota's Method 2, and 286 using New Mexico's Method 3. Efficiency rates (percentage of invited patients who enrolled) were 4.2% for Method 1, 8.4% for Method 2, and 7.9% for Method 3. Calculated costs per enrolled subject were $71.58 (Method 1), $85.47 (Method 2), and $92.09 (Method 3). A mail-only method to assess study interest was relatively inexpensive but not efficient enough to sustain recruitment targets. Phone call follow-up after mailed invitations added to recruitment efficiency. Use of return-response forms with selective phone follow-up to non-responders was cost effective. Copyright © 2010 Elsevier Inc. All rights reserved.

  3. A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Chenchen; McAlindon, Timothy; Fielding, Roger A; Harvey, William F; Driban, Jeffrey B; Price, Lori Lyn; Kalish, Robert; Schmid, Anna; Scott, Tammy M; Schmid, Christopher H

    2015-01-30

    Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short

  4. Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Koleini

    2010-01-01

    Full Text Available Background: Letrozole is an aromatase inhibitor which can decrease estrogen production inperipheral tissues and endometriosis. Danazol, as an androgen, inhibits estrogen production inovaries and recently has been introduced as an aromatase inhibitor. This study was designed tocompare the effects of Danazol with Letrozole on endometriosis symptom relief.Materials and Methods: This study was a randomized clinical trial in which 105 patients withconfirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozoletablets (2.5 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 2 received Danazoltablets (600 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 3 (placebo groupwere assigned to take two calcium tablets daily (500 mg/tablet and vitamin D (800 IU/day. Pelvicpain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly duringthe study for a total of six months. Data were analyzed via SPSS version 15 software with Freidmanand Wilcoxon tests.Results: Mean age in three groups has no significant difference. Of the 105 participants who wereenrolled in this study, 38 patients were assigned to group 1 (Letrozole group, 37 patients in group 2(Danazol group and 31 patients were placed in group 3 (placebo group. This study showed that themean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group wereless than the Danazol and placebo groups.Conclusion: This study showed that Letrozole can be more effective than Danazol for reducingchronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis(Registeration Number: IRCT138812043414N1.

  5. Palacos compared to Palamed bone cement in total hip replacement: a randomized controlled trial

    Science.gov (United States)

    Meinardi, Joris E; Valstar, Edward R; Van Der Voort, Paul; Kaptein, Bart L; Fiocco, Marta; Nelissen, Rob G H H

    2016-01-01

    Background and purpose Stability and survival of cemented total hip prostheses is dependent on a multitude of factors, including the type of cement that is used. Bone cements vary in viscosity, from low to medium and high. There have been few clinical RSA studies comparing the performance of low- and high-viscosity bone cements. We compared the migration behavior of the Stanmore hip stem cemented using novel low-viscosity Palamed bone cement with that of the same stem cemented with conventional high-viscosity Palacos bone cement. Patients and methods We performed a randomized controlled study involving 39 patients (40 hips) undergoing primary total hip replacement for primary or secondary osteoarthritis. 22 patients (22 hips) were randomized to Palacos and 17 patients (18 hips) were randomized to Palamed. Migration was determined by RSA. Results None of these 40 hips had been revised at the 10-year follow-up mark. To our knowledge, the patients who died before they reached the 10-year endpoint still had the implant in situ. No statistically significant or clinically significant differences were found between the 2 groups for mean translations, rotations, and maximum total-point motion (MTPM). Interpretation We found similar migration of the Stanmore stem in the high-viscosity Palacos cement group and the low-viscosity Palamed cement group. We therefore expect that the risk of aseptic loosening with the new Palamed cement would be comparable to that with the conventional Palacos cement. The choice of which type of bone cement to use is therefore up to the surgeon’s preference. PMID:27329869

  6. Treating adolescent drug abuse: a randomized trial comparing multidimensional family therapy and cognitive behavior therapy.

    Science.gov (United States)

    Liddle, Howard A; Dakof, Gayle A; Turner, Ralph M; Henderson, Craig E; Greenbaum, Paul E

    2008-10-01

    To examine the efficacy of two adolescent drug abuse treatments: individual cognitive behavioral therapy (CBT) and multidimensional family therapy (MDFT). A 2 (treatment condition) x 4 (time) repeated-measures intent-to-treat randomized design. Data were gathered at baseline, termination, 6 and 12 months post-termination. Analyses used latent growth curve modeling. Community-based drug abuse clinic in the northeastern United States. A total of 224 youth, primarily male (81%), African American (72%), from low-income single-parent homes (58%) with an average age of 15 years were recruited into the study. All youth were drug users, with 75% meeting DSM-IV criteria for cannabis dependence and 13% meeting criteria for abuse. Five outcomes were measured: (i) substance use problem severity; (ii) 30-day frequency of cannabis use; (iii) 30-day frequency of alcohol use; (iv) 30-day frequency of other drug use; and (v) 30-day abstinence. Both treatments produced significant decreases in cannabis consumption and slightly significant reductions in alcohol use, but there were no treatment differences in reducing frequency of cannabis and alcohol use. Significant treatment effects were found favoring MDFT on substance use problem severity, other drug use and minimal use (zero or one occasion of use) of all substances, and these effects continued to 12 months following treatment termination. Both interventions are promising treatments. Consistent with previous controlled trials, MDFT is distinguished by the sustainability of treatment effects.

  7. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Sharifi, Mona; Avalon, Earlene; Fiechtner, Lauren; Horan, Christine; Gerber, Monica W; Orav, E John; Price, Sarah N; Sequist, Thomas; Slater, Daniel

    2017-08-07

    Novel approaches to care delivery that leverage clinical and community resources could improve body mass index (BMI) and family-centered outcomes. To examine the extent to which 2 clinical-community interventions improved child BMI z score and health-related quality of life, as well as parental resource empowerment in the Connect for Health Trial. This 2-arm, blinded, randomized clinical trial was conducted from June 2014 through March 2016, with measures at baseline and 1 year after randomization. This intent-to-treat analysis included 721 children ages 2 to 12 years with BMI in the 85th or greater percentile from 6 primary care practices in Massachusetts. Children were randomized to 1 of 2 arms: (1) enhanced primary care (eg, flagging of children with BMI ≥ 85th percentile, clinical decision support tools for pediatric weight management, parent educational materials, a Neighborhood Resource Guide, and monthly text messages) or (2) enhanced primary care plus contextually tailored, individual health coaching (twice-weekly text messages and telephone or video contacts every other month) to support behavior change and linkage of families to neighborhood resources. One-year changes in age- and sex-specific BMI z score, child health-related quality of life measured by the Pediatric Quality of Life 4.0, and parental resource empowerment. At 1 year, we obtained BMI z scores from 664 children (92%) and family-centered outcomes from 657 parents (91%). The baseline mean (SD) age was 8.0 (3.0) years; 35% were white (n = 252), 33.3% were black (n = 240), 21.8% were Hispanic (n = 157), and 9.9% were of another race/ethnicity (n = 71). In the enhanced primary care group, adjusted mean (SD) BMI z score was 1.91 (0.56) at baseline and 1.85 (0.58) at 1 year, an improvement of -0.06 BMI z score units (95% CI, -0.10 to -0.02) from baseline to 1 year. In the enhanced primary care plus coaching group, the adjusted mean (SD) BMI z score was 1.87 (0.56) at baseline

  8. A randomized double blind control trial comparing filgrastim and pegfilgrastim in cyclophosphamide peripheral blood hematopoietic stem cell mobilization.

    Science.gov (United States)

    Kuan, Jew-Win; Su, Anselm-Ting; Wong, Shu-Ping; Sim, Xavier Yoon-Han; Toh, See-Guan; Ong, Tee-Chuan; Rajasuriarr, Jay-Suria; Lim, Su-Hong; Guan, Yong-Khee; Liew, Hong-Keng; Liew, Pek-Kuen; Tan, Jerome Tsen-Chuen; Kori, Ahlam-Naila; Cheng, Yuin-Yin; Tan, Sen-Mui; Chang, Kian-Meng

    2015-10-01

    There are few randomized trials comparing filgrastim and pegfilgrastim in peripheral blood stem cell mobilization (PBSCM). None of the trials studied the effects of the timing of pegfilgrastim administration on the outcomes of mobilization. We conducted a randomized triple blind control trial comparing the outcomes of filgrastim 5 µg/kg daily from day 3 onwards, 'early' pegfilgrastim 6 mg on day 3 and 'delayed' pegfilgrastim 6 mg on day 7 in cyclophosphamide PBSCM in patients with no previous history of mobilization. Peripheral blood (PB) CD34+ cell count was checked on day 8 and day 11 onward. Apheresis was started when PB CD34+ ≥ 10/µl from day 11 onward. The primary outcome was the successful mobilization rate, defined as cumulative collection of ≥ 2 × 10(6)/kg CD34+ cells in three or less apheresis. The secondary outcomes were the day of neutrophil and platelet engraftment post transplantation. There were 156 patients randomized and 134 patients' data analyzed. Pegfilgrastim 6 mg day 7 produced highest percentage of successful mobilization, 34 out of 48 (70.8%) analyzed patients, followed by daily filgrastim, 28 out of 44 (63.6%) and day 3 pegfilgrastim, 20 out of 42 (47.6%) (p = 0.075). Pegfilgrastim day 7 and daily filgrastim reported 1.48 (p = 0.014) and 1.49 (p = 0.013) times higher successful mobilization rate respectively as compared to pegfilgrastim day 3 after adjusting for disease, gender and exposure to myelotoxic agent. Multiple myeloma patients were three times more likely to achieve successful mobilization as compared to acute leukemia or lymphoma patients. Pegfilgrastim avoided the overshoot of white cells compared to filgrastim. There was no difference in the duration of both white cells and platelet recovery post transplantation between the three interventional arms. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Vaginoscopy compared to traditional hysteroscopy for hysteroscopic sterilization. A randomized trial.

    Science.gov (United States)

    Chapa, Hector O; Venegas, Gonzalo

    2015-01-01

    To compare vaginoscopic hysteroscopic sterilization with traditional hysteroscopic approach for differences in pain, bilateral microinsert placement rates, and procedure time. We performed a prospective, randomized, single-blinded study of hysteroscopic sterilization using the Essure System. The study setting was an inner city ObGyn clinic. Ninety patients were randomized to either vaginoscopy or traditional approach. The traditional approach was speculum insertion, paracervical analgesia, and tenaculum. All procedures were done with a 5 mm, 30 degree rigid hysteroscope. Main outcome measures were pain scores (10-point visual analog scale), bilateral placement rates, and procedure times. Vaginoscopy was successful in 42/45 patients (93%). There was no statistically significant difference in pain-scores for microinsert placement between the groups (p = 0.71). First attempt, bilateral microinsert placement rate was 95% (40/42) with vaginoscopy and 95% (43/45) with traditional (p = 0.89). Time for treatment completion was 16 minutes (mean) (range, 13-21) in the traditional group versus vaginoscopy time of 9 minutes (mean) (range, 7-11) (p = 0.03). Hysteroscopic sterilization via vaginoscopy is feasible with bilateral microinsert rates comparable to those of traditional hysteroscopy. Vaginoscopy is associated with less overall discomfort and is faster to perform.

  10. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

    Science.gov (United States)

    2011-01-01

    Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

  11. Intrahepatic cholestasis of pregnancy: a randomized controlled trial comparing dexamethasone and ursodeoxycholic acid.

    Science.gov (United States)

    Glantz, Anna; Marschall, Hanns-Ulrich; Lammert, Frank; Mattsson, Lars-Ake

    2005-12-01

    Intrahepatic cholestasis of pregnancy (ICP) is characterized by troublesome maternal pruritus, elevated serum bile acids (> or =10 micromol/L) and increased fetal risk. Recently we determined a cutoff level of serum bile acids, > or =40 micromol/L, to be associated with impaired fetal outcome. We have now studied the effects of ursodeoxycholic acid (UDCA) and dexamethasone on pruritus, biochemical markers of cholestasis, and fetal complication rates in a double-blind, placebo-controlled trial. For this purpose, 130 women with ICP were randomly allocated to UDCA (1 g/day for three weeks), or dexamethasone (12 mg/day for 1 week and placebo during weeks 2 and 3), or placebo for 3 weeks. Pruritus and biochemical markers of cholestasis were analyzed at inclusion and after 3 weeks of treatment. Fetal complications (spontaneous preterm delivery; asphyxial events; and meconium staining of amniotic fluid, placenta, and membranes) were registered at delivery. An intention-to-treat analysis showed significant reduction of alanine aminotransferase (ALT) (P = .01) and bilirubin (P = .002) in the UDCA group only. In a subgroup analysis of ICP women with serum bile acids > or =40 micromol/L at inclusion (n = 34), UDCA had significant effects on pruritus (-75%), bile acids (-79%), ALT (-80%), and bilirubin (-50%) as well, but not on fetal complication rates. Dexamethasone yielded no alleviation of pruritus or reduction of ALT and was less effective than UDCA at reducing bile acids and bilirubin. In conclusion, 3 weeks of UDCA treatment improved some biochemical markers of ICP irrespective of disease severity, whereas significant relief from pruritus and marked reduction of serum bile acids were only found in patients with severe ICP.

  12. Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

    2008-01-01

    cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain...... the first 24 h. Side-effects and 30-day follow-up for morbidity were registered. Results Data from 184 patients were available for statistical analysis. There were no significant differences in side-effects or complications between the surgical groups (P > 0.05). No significant intergroup differences in 24......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

  13. Prospective randomized controlled trial comparing 1- versus 7-day manipulation following collagenase injection for dupuytren contracture.

    Science.gov (United States)

    Mickelson, Dayne T; Noland, Shelley S; Watt, Andrew J; Kollitz, Kathleen M; Vedder, Nicholas B; Huang, Jerry I

    2014-10-01

    To compare the efficacy, tolerance, and safety of manual manipulation at day 7 to day 1 following collagenase Clostridium histolyticum (CCH) injection for Dupuytren contracture. Eligible patients were randomized to manipulation at day 1 versus day 7 following CCH injection. Preinjection, premanipulation, postmanipulation, and 30-day follow-up metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joint contractures were measured. Pain scores were recorded at each time point. Data were stratified per cohort based on primary joint treated (MCP vs PIP). Means were compared using paired and unpaired t-tests. Forty-three patients with 46 digits were eligible and were randomized to 1-day (22 digits) and 7-day (24 digits) manipulation. For MCP joints, there were no significant differences in flexion contractures between 1- and 7-day cohorts for initial (47° vs 46°), postmanipulation (0° vs 2°), or 30-day follow-up (1° vs 2°) measurements. Premanipulation, the residual contracture was significantly lower in the 7-day group (23° vs 40°). For PIP joints, there were no significant differences between 1- and 7-day cohorts for initial (63° vs 62°), premanipulation (56° vs 52°), postmanipulation (13° vs 15°), or 30-day (14° vs 16°) measurements. There were no significant differences in pain or skin tears between the 2 groups. No flexor tendon ruptures were observed. The effectiveness of CCH in achieving correction of Dupuytren contractures was preserved when manipulation was performed on day 7, with no differences in correction, pain, or skin tears. These data suggest that manipulation can be scheduled at the convenience of the patient and surgeon within the first 7 days after injection. Therapeutic I. Copyright © 2014 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  14. Randomized controlled trial comparing pudendal nerve block under ultrasound and fluoroscopic guidance.

    Science.gov (United States)

    Bellingham, Geoff A; Bhatia, Anuj; Chan, Chin-Wern; Peng, Philip W

    2012-01-01

    Although fluoroscopy is an established imaging modality for pudendal nerve block, ultrasound (US) technique allows physicians better visualization of anatomic structures. This study aimed to compare the effectiveness and safety between the US- and fluoroscopy-guided techniques. A randomized, single-blind, split-plot design was used to conduct the study. Twenty-three patients undergoing bilateral pudendal nerve blocks received US-guided injections to either the left or right side, whereas the contralateral side received a fluoroscopic-guided injection in randomized sequence. Injections consisted of 4 mL of 0.5% bupivacaine and 40 mg methylprednisone. The primary outcome was the success of the block in the distribution of the pudendal nerve along the perineum, rated as either absent, moderate, or strong. Secondary outcomes were the time to administer the blocks, quality of visualization of anatomic structures using US and fluoroscopy, distance of the final US-guided needle position from the ischial spine, and incidence of adverse effects. No differences in the degree of neural blockade were noted between US- or fluoroscopic-guided techniques for either temperature or pinprick blockade. Time to complete the procedure was significantly longer using US compared with fluoroscopy (219 [SD, 65] and 428 [SD, 151] secs, P < 0.0001). No significant differences were noted regarding the occurrence of adverse effects between the 2 techniques. Ultrasound-guided pudendal nerve blockade is as accurate as fluoroscopically guided injections when performed by an experienced clinician. However, the former took a longer time to perform.

  15. Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2009-08-01

    Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

  16. Comparing the Effects of Multisensory Stimulation and Individualized Music Sessions on Elderly People with Severe Dementia: A Randomized Controlled Trial.

    Science.gov (United States)

    Sánchez, Alba; Maseda, Ana; Marante-Moar, M Pilar; de Labra, Carmen; Lorenzo-López, Laura; Millán-Calenti, José Carlos

    2016-03-08

    The objective of this study was to compare the effects of a multisensory stimulation environment (MSSE) and individualized music sessions on agitation, emotional and cognitive status, and dementia severity in a sample of institutionalized patients with severe dementia. Twenty-two participants with a diagnosis of severe or very severe dementia were randomly assigned to two groups: MSSE and individualized music sessions. Both groups participated in two 30-min weekly sessions over 16 weeks. Outcomes were agitation (Cohen-Mansfield Agitation Inventory, CMAI), mood (Cornell Scale for Depression in Dementia, CSDD), anxiety (Rating Anxiety in Dementia, RAID), cognitive function (Severe Mini-Mental State Examination, SMMSE), and the overall severity of dementia (Bedford Alzheimer Nursing Severity Scale, BANS-S). They were assessed at baseline (pre-trial), in the middle (mid-trial), at the end of the intervention (post-trial), and 8 weeks after the intervention (follow-up). Patients in the MSSE group showed significant improvement in their RAID and BANS-S scores compared with the individualized music group post- versus pre-trial. With regard to agitation, there was improvement during the intervention in both the MSSE and individualized music groups in the CMAI total score after 16 weeks of intervention, with no significant differences between the groups. The results suggest that MSSE could have better effects on anxiety symptoms and dementia severity in comparison with individualized music sessions in elderly patients with severe dementia.

  17. Standard compared with mnemonic counseling for fecal incontinence: a randomized controlled trial.

    Science.gov (United States)

    Cichowski, Sara B; Dunivan, Gena C; Rogers, Rebecca G; Murrietta, Ambroshia M; Komesu, Yuko M

    2015-05-01

    To estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at 2 months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared with a group who underwent standard counseling. Counseling-naive women with fecal incontinence were recruited from an academic urogynecology clinic. Women underwent physical examinations, completed the Quality of the Physician-Patient Interaction, recorded fecal incontinence treatment options they recalled, and completed the Fecal Incontinence Severity Index and Manchester Health Questionnaire immediately after counseling and again at 2 months. Ninety women consented to participate, were randomized, and completed baseline questionnaires. At baseline, women did not differ in age, ethnicity, education, Fecal Incontinence Severity Index, or Manchester Health Questionnaire scores. After counseling, the mnemonic group reported higher satisfaction on Quality of the Physician-Patient Interaction (66.4±6.5 compared with 62.2±10.7, P=.03). Ninety percent (81/90) of women followed up at 2 months. Our primary endpoint, 2-month recall of fecal incontinence treatments, was not different between groups (2.3±1.6 mnemonic counseling compared with 1.8±1.0 standard counseling; P=.08). Secondary endpoints for the mnemonic group reported greater improvement on total Manchester Health Questionnaire (P=.02), emotional (P=.03), sleep (0.045), role limitations (Pmnemonic aid did not improve recall at 2 months but improved patient satisfaction and quality of life at 2 months.

  18. Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism.

    Science.gov (United States)

    Avgerinos, Efthymios D; Mohapatra, Abhisekh; Rivera-Lebron, Belinda; Toma, Catalin; Kabrhel, Christopher; Fish, Larry; Lacomis, Joan; Ocak, Iclal; Chaer, Rabih A

    2018-01-01

    Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question. Adults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic, functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm. SUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results of our study to inform future guidelines on choice of thrombolysis modality in this population of challenging

  19. Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial.

    Science.gov (United States)

    Reid, Zachary Z; Regan, Susan; Kelley, Jennifer H K; Streck, Joanna M; Ylioja, Thomas; Tindle, Hilary A; Chang, Yuchiao; Levy, Douglas E; Park, Elyse R; Singer, Daniel E; Carpenter, Kelly M; Reyen, Michele; Rigotti, Nancy A

    2015-02-07

    Smoking cessation interventions for hospitalized smokers are effective in promoting smoking cessation, but only if the tobacco dependence treatment continues after the patient leaves the hospital. Sustaining tobacco dependence treatment after hospital discharge is a challenge for health care systems. Our previous single-site randomized controlled trial demonstrated the effectiveness of an intervention that facilitated the delivery of comprehensive tobacco cessation treatment, including both medication and counseling, after hospital discharge. We subsequently streamlined the intervention model to increase its potential for dissemination. This new model is being tested in a larger multi-site trial with broader eligibility criteria in order to enroll a more representative sample of hospitalized smokers. This paper describes the trial design and contrasts it with the earlier study. A 2-arm, 3-site randomized controlled trial is testing the hypothesis that a multi-component Sustained Care intervention is more effective than Standard Care in helping hospitalized cigarette smokers stop smoking after hospital discharge. The trial enrolls adult daily cigarette smokers who are admitted to 1 of 3 participating hospitals in Massachusetts or Pennsylvania. Participants receive the same smoking cessation intervention in the hospital. They are randomly assigned to receive either Standard Care or Sustained Care after hospital discharge. Participants in the Sustained Care arm receive a free 3-month supply of FDA-approved smoking cessation medication and 5 interactive voice response calls that provide tailored motivational messages, medication refills, and access to a live tobacco treatment counselor. Participants in the Standard Care arm receive a smoking cessation medication recommendation and information about community resources. Outcomes are assessed at 1, 3, and 6 months after discharge. The primary outcome is biochemically-validated tobacco abstinence for the past 7 days at 6

  20. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Science.gov (United States)

    Howard, Andrew W; Macarthur, Colin; Rothman, Linda; Willan, Andrew; Macpherson, Alison K

    2009-12-01

    The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing. The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar), and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent) of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed Fibar and seven

  1. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  2. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

    Science.gov (United States)

    Eswaran, Shanti L; Chey, William D; Han-Markey, Theresa; Ball, Sarah; Jackson, Kenya

    2016-12-01

    There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating

  3. [Meta-analysis of clinical randomized controlled trials comparing refractive with diffractive multifocal intraocular lenses in cataract surgery].

    Science.gov (United States)

    Shao, Dewang; He, Shouzhi

    2014-02-01

    To systematic review the effectiveness of refractive multifocal intraocular lens (MIOL) versus diffractive MIOL in the treatment of cataract. Randomized controlled trials comparing refractive MIOL with diffractive MIOL were identified by searching PubMed (1966 to May, 2013), EMbase (1980 to May, 2013), Medline (1966 to May, 2013), and The Cochrane Library (Issue 1, 2013). We also hand-searched related journals. All the searches were restricted in English or Chinese. Methodological quality of randomized controlled trials (RCT) was evaluated by simple evaluate method that recommended by the Cochrane Collaboration. Data extracted by two reviewers with designed extraction form. RevMan software (release 5.2) was used for data management and analysis. A total of 11 trials (1460 eyes) were included for systematic review. Subgroup analyses were used according to different model comparison of MIOL. The results showed a significant difference in the mean of the uncorrected distance visual acuity (UCDVA) and the uncorrected intermediate visual acuity (UCIVA) in the refractive MIOL group with WMD -0.04, 95%CI -0.06 to -0.03 (P refractive MIOL show better uncorrected distance and intermediate visual acuity; patients implanted with diffractive MIOL show better uncorrected near visual acuity with less likely to appear light halo, glare and other visual adverse reactions. As for spectacles correction cases, patients implanted with diffractive or refractive MIOL have considerable performances in the far, middle, near visual acuity.

  4. Randomized Trial Comparing Amniotic Membrane Transplantation with Lamellar Corneal Graft for the Treatment of Corneal Thinning.

    Science.gov (United States)

    de Farias, Charles C; Allemann, Norma; Gomes, José Á P

    2016-04-01

    There are few studies comparing different surgical procedures for the treatment of corneal thinning. Lamellar corneal transplantation (LCT) has been reported to be efficient, but its results can be jeopardized by allograft rejection, opacification, or high astigmatism. Amniotic membrane transplantation (AMT) has been considered a good alternative, but it is not as resistant as LCT and the tissue can be reabsorbed after surgery. A prospective, randomized, interventional, and comparative study of consecutive patients with corneal thinning over 6 months was performed. Ophthalmological examination was performed before transplant surgery and then repeated 1, 7, 15, 30, 90, and 180 days after surgery and ultrasound biomicroscopy was performed before and then 30, 90, and 180 days after surgery to assess corneal thinning. Herpes simplex infection was the main cause of corneal thinning (9 eyes), followed by surgery (cataract, glaucoma, 5 cases), rheumatoid arthritis (1), chemical burn (1), perforating trauma (1), previous band keratopathy treatment (1), and Stevens-Johnson syndrome (1). Although all patients showed significant increase in final thickness in the area of thinning, it was higher in those submitted to LCT at 180 days postoperatively. Regardless of the surgical technique, all patients showed epithelialization. Patients undergoing AMT showed an 89% decrease in neovascularization. Final corrected distance visual acuity was better in patients submitted to AMT. LCT proved to be the best option for treating corneal thinning. AMT represents an alternative that allows good visual recovery but does not restore corneal thickness as efficiently as LCT.

  5. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula.

    Science.gov (United States)

    Bondi, J; Avdagic, J; Karlbom, U; Hallböök, O; Kalman, D; Šaltytė Benth, J; Naimy, N; Øresland, T

    2017-08-01

    The role of a collagen plug for treating anal fistula is not well established. A randomized prospective multicentre non-inferiority study of surgical treatment of trans-sphincteric cryptogenic fistulas was undertaken, comparing the anal fistula plug with the mucosal advancement flap with regard to fistula recurrence rate and functional outcome. Patients with an anal fistula were evaluated for eligibility in three centres, and randomized to either mucosal advancement flap surgery or collagen plug, with clinical follow-up at 3 and 12 months. The primary outcome was the fistula recurrence rate. Anal pain (visual analogue scale), anal incontinence (St Mark's score) and quality of life (Short Form 36 questionnaire) were also reported. Ninety-four patients were included; 48 were allocated to the plug procedure and 46 to advancement flap surgery. The median follow-up was 12 (range 9-24) months. The recurrence rate at 12 months was 66 per cent (27 of 41 patients) in the plug group and 38 per cent (15 of 40) in the flap group (P = 0·006). Anal pain was reduced after operation in both groups. Anal incontinence did not change in the follow-up period. Patients reported an increased quality of life after 3 months. There were no differences between the groups with regard to pain, incontinence or quality of life. There was a considerably higher recurrence rate after the anal fistula plug procedure than following advancement flap repair. Registration number: NCT01021774 (http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  6. Data extraction from machine-translated versus original language randomized trial reports: a comparative study

    Science.gov (United States)

    2013-01-01

    Background Google Translate offers free Web-based translation, but it is unknown whether its translation accuracy is sufficient to use in systematic reviews to mitigate concerns about language bias. Methods We compared data extraction from non-English language studies with extraction from translations by Google Translate of 10 studies in each of five languages (Chinese, French, German, Japanese and Spanish). Fluent speakers double-extracted original-language articles. Researchers who did not speak the given language double-extracted translated articles along with 10 additional English language trials. Using the original language extractions as a gold standard, we estimated the probability and odds ratio of correctly extracting items from translated articles compared with English, adjusting for reviewer and language. Results Translation required about 30 minutes per article and extraction of translated articles required additional extraction time. The likelihood of correct extractions was greater for study design and intervention domain items than for outcome descriptions and, particularly, study results. Translated Spanish articles yielded the highest percentage of items (93%) that were correctly extracted more than half the time (followed by German and Japanese 89%, French 85%, and Chinese 78%) but Chinese articles yielded the highest percentage of items (41%) that were correctly extracted >98% of the time (followed by Spanish 30%, French 26%, German 22%, and Japanese 19%). In general, extractors’ confidence in translations was not associated with their accuracy. Conclusions Translation by Google Translate generally required few resources. Based on our analysis of translations from five languages, using machine translation has the potential to reduce language bias in systematic reviews; however, pending additional empirical data, reviewers should be cautious about using translated data. There remains a trade-off between completeness of systematic reviews

  7. Data extraction from machine-translated versus original language randomized trial reports: a comparative study.

    Science.gov (United States)

    Balk, Ethan M; Chung, Mei; Chen, Minghua L; Chang, Lina Kong Win; Trikalinos, Thomas A

    2013-11-07

    Google Translate offers free Web-based translation, but it is unknown whether its translation accuracy is sufficient to use in systematic reviews to mitigate concerns about language bias. We compared data extraction from non-English language studies with extraction from translations by Google Translate of 10 studies in each of five languages (Chinese, French, German, Japanese and Spanish). Fluent speakers double-extracted original-language articles. Researchers who did not speak the given language double-extracted translated articles along with 10 additional English language trials. Using the original language extractions as a gold standard, we estimated the probability and odds ratio of correctly extracting items from translated articles compared with English, adjusting for reviewer and language. Translation required about 30 minutes per article and extraction of translated articles required additional extraction time. The likelihood of correct extractions was greater for study design and intervention domain items than for outcome descriptions and, particularly, study results. Translated Spanish articles yielded the highest percentage of items (93%) that were correctly extracted more than half the time (followed by German and Japanese 89%, French 85%, and Chinese 78%) but Chinese articles yielded the highest percentage of items (41%) that were correctly extracted >98% of the time (followed by Spanish 30%, French 26%, German 22%, and Japanese 19%). In general, extractors' confidence in translations was not associated with their accuracy. Translation by Google Translate generally required few resources. Based on our analysis of translations from five languages, using machine translation has the potential to reduce language bias in systematic reviews; however, pending additional empirical data, reviewers should be cautious about using translated data. There remains a trade-off between completeness of systematic reviews (including all available studies) and risk of

  8. A randomized clinical trial comparing oral, aerosolized intranasal, and aerosolized buccal midazolam.

    Science.gov (United States)

    Klein, Eileen J; Brown, Julie C; Kobayashi, Ana; Osincup, Daniel; Seidel, Kristy

    2011-10-01

    We determine whether aerosolized intranasal or buccal midazolam reduces the distress of pediatric laceration repair compared with oral midazolam. Children aged 0.5 to 7 years and needing nonparenteral sedation for laceration repair were randomized to receive oral, aerosolized intranasal, or aerosolized buccal midazolam. Patient distress was rated by blinded review of videotapes, using the Children's Hospital of Eastern Ontario Pain Score. Secondary outcomes included activity scores, sedation adequacy, sedation onset, satisfaction, and adverse events. For the 169 subjects (median age 3.1 years) evaluated for the primary outcome, we found significantly less distress in the buccal midazolam group compared with the oral route group (P=.04; difference -2; 95% confidence interval -4 to 0) and a corresponding nonsignificant trend for the intranasal route (P=.08; difference -1; 95% confidence interval -3 to 1). Secondary outcomes (177 subjects) favored the intranasal group, including a greater proportion of patients with an optimal activity score (74%), a greater proportion of parents wanting this sedation in the future, and faster sedation onset. Intranasal was the route least tolerated at administration. Adverse events were similar between groups. When comparing the administration of midazolam by 3 routes to facilitate pediatric laceration repair, we observed slightly less distress in the aerosolized buccal group. The intranasal route demonstrated a greater proportion of patients with optimal activity scores, greater proportions of parents wanting similar sedation in the future, and faster onset but was also the most poorly tolerated at administration. Aerosolized buccal or intranasal midazolam represents an effective and useful alternative to oral midazolam for sedation for laceration repair. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  9. Randomized Trial Comparing Two Algorithms for Levothyroxine Dose Adjustment in Pregnant Women With Primary Hypothyroidism.

    Science.gov (United States)

    Sullivan, Shannon D; Downs, Erin; Popoveniuc, Geanina; Zeymo, Alexander; Jonklaas, Jacqueline; Burman, Kenneth D

    2017-09-01

    Regulation of maternal thyroid hormones during pregnancy is crucial for optimal maternal and fetal outcomes. There are no specific guidelines addressing maternal levothyroxine (LT4) dose adjustments throughout pregnancy. To compare two LT4 dose-adjustment algorithms in hypothyroid pregnant women. Thirty-three women on stable LT4 doses were recruited at pregnancies and randomized to one of two dose-adjustment groups. Group 1 (G1) used an empiric two-pill/week dose increase followed by subsequent pill-per-week dose adjustments. In group 2 (G2), LT4 dose was adjusted in an ongoing approach in micrograms per day based on current thyroid stimulating hormone (TSH) level and LT4 dose. TSH was monitored every 2 weeks in trimesters 1 and 2 and every 4 weeks in trimester 3. Academic endocrinology clinics in Washington, DC. Proportion of TSH values within trimester-specific goal ranges. Mean gestational age at study entry was 6.4 ± 2.1 weeks. Seventy-five percent of TSH values were within trimester-specific goal ranges in G1 compared with 81% in G2 (P = 0.09). Similar numbers of LT4 dose adjustments per pregnancy were required in both groups (G1, 3.1 ± 2.0 vs G2, 4.1 ± 3.2; P = 0.27). Women in G1 were more likely to have suppressed TSH hypothyroidism, but not thyroid antibody status, was associated with proportion of goal TSH values. We compared two options for LT4 dose adjustment and showed that an ongoing adjustment approach is as effective as empiric dose increase for maintaining goal TSH in hypothyroid women during pregnancy.

  10. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks. RESULTS: For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children......OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects...... tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified....

  11. Randomized controlled trial comparing the effectiveness of the ultrasound-guided galvanic electrolysis technique (USGET) versus conventional electro-physiotherapeutic treatment on patellar tendinopathy

    National Research Council Canada - National Science Library

    Abat, F; Sánchez-Sánchez, J L; Martín-Nogueras, A M; Calvo-Arenillas, J I; Yajeya, J; Méndez-Sánchez, R; Monllau, J C; Gelber, P E

    2016-01-01

    .... The purpose of this study is to compare, in a randomized controlled trial, the clinical efficacy of eccentric exercise combined with either an ultrasound-guided galvanic electrolysis technique (USGET...

  12. More complications in uncemented compared to cemented hemiarthroplasty for displaced femoral neck fractures: a randomized controlled trial of 201 patients, with one year follow-up

    NARCIS (Netherlands)

    S. Moerman (Sophie); N.M.C. Mathijssen (Nina M.C.); D.D. Niesten (Dieu-Donné); R. Riedijk (Roeland); W.J. Rijnberg (Willard); S. Koëter (Sander); K. Kremers van de Hei (Keetie); Tuinebreier, W.E. (Wim E.); T.L. Molenaar (Tim L.); R.G.H.H. Nelissen (Rob); A.J.H. Vochteloo (Anne)

    2017-01-01

    textabstractBackground: It is unclear whether cemented or uncemented hemiarthroplasty is the best treatment option in elderly patients with displaced femoral neck fractures. Previous randomized trials comparing cemented and uncemented hemiarthroplasty have conflicting results. We conducted a

  13. More complications in uncemented compared to cemented hemiarthroplasty for displaced femoral neck fractures : A randomized controlled trial of 201 patients, with one year follow-up

    NARCIS (Netherlands)

    S. Moerman (Sophie); N.M.C. Mathijssen (Nina M.C.); D.D. Niesten (Dieu-Donné); R. Riedijk (Roeland); W.J. Rijnberg (Willard); S. Koëter (Sander); K. Kremers van de Hei (Keetie); W.E. Tuinebreier (Wim E.); T.L. Molenaar (Tim L.); R.G.H.H. Nelissen (Rob); A.J.H. Vochteloo (Anne)

    2017-01-01

    markdownabstractBackground: It is unclear whether cemented or uncemented hemiarthroplasty is the best treatment option in elderly patients with displaced femoral neck fractures. Previous randomized trials comparing cemented and uncemented hemiarthroplasty have conflicting results. We conducted a

  14. A randomized controlled trial comparing instructions regarding unsafe response options in a MCQ examination.

    Science.gov (United States)

    Tweed, Mike; Wilkinson, Tim

    2009-01-01

    Marking of multiple choice type examinations often just takes account of the correct responses. This may encourage guessing of incorrect and potentially unsafe responses. Ideally responses should contain a high proportion of correct, unsafe and the use of 'don't know' response rather than incorrect. This study explored the effect of instructions on responses. Fourth- and fifth-year students sitting for an optional multiple choice examination were randomized to receive one of four instruction options: number-correct marking (the control group); alert to unsafe; mark deduction for unsafe; or correction for guessing. A total of 210 students sat the test. For the fourth-year cohort, compared with the control group, being alerted to unsafe and mark deduction for unsafe or incorrect responses were associated with graduated increases in the use of 'don't know' and reductions in incorrect responses. For the fifth-year cohort, there were no differences in responses between options. The fifth-year cohort, gave more correct, and fewer incorrect, unsafe and 'don't know' responses. Both the year group and instructions had an effect. Being alerted to potentially unsafe responses, even when there is no mark deduction penalty, had an effect, although mark deduction still had the greatest effect. Assessment instructions may give subliminal messages that have important consequences.

  15. Randomized Prospective Trial Comparing the Use of Intravenous versus Oral Acetaminophen in Total Joint Arthroplasty.

    Science.gov (United States)

    Politi, Joel R; Davis, Richard L; Matrka, Alexis K

    2017-04-01

    Multimodal pain management has had a significant effect on improving total joint arthroplasty recovery and patient satisfaction. There is literature supporting that intravenous (IV) acetaminophen reduces postoperative pain and narcotic use in the total joint population. However, there are no studies comparing the effectiveness of IV vs oral (PO) acetaminophen as part of a standard multimodal perioperative pain regimen. One hundred twenty patients undergoing hip and knee arthroplasty surgeries performed by one joint arthroplasty surgeon were prospectively randomized into 2 groups. Group 1 (63 patients) received IV and group 2 (57 patients) received PO acetaminophen in addition to a standard multimodal perioperative pain regimen. Each group received 1 gram of acetaminophen preoperatively and then every 6 hours for 24 hours. Total narcotic use and visual analog scale (VAS) scores were collected every 4 hours postoperatively. The 24-hour average hydromorphone equivalents given were not different between groups (3.71 vs 3.48) at 24 hours (P = .76), or at any of the individual 4-hour intervals. The 24-hour average visual analog scale scores in group 1 (IV) was 3.00 and in group 2 (PO) was 3.40 (P = .06). None of the 4-hour intervals were significantly different except the first interval (0-4 hour postoperatively), which favored the IV group (P = .03). The use of IV acetaminophen may have a role when given intraoperatively to reduce the immediate pain after surgery. Following that, it does not provide a significant benefit in reducing pain or narcotic use when compared with the much less expensive PO form. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy

    Directory of Open Access Journals (Sweden)

    Anju Ghai

    2011-01-01

    Full Text Available Background: Pregabalin is a potent ligand for alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, which exhibits potent anticonvulsant, analgesic and anxiolytic activity. The pharmacological activity of pregabalin is similar to that of gabapentin and shows possible advantages. Although it shows analgesic efficacy against neuropathic pain, very limited evidence supports its postoperative analgesic efficacy. We investigated its analgesic efficacy in patients experiencing acute pain after abdominal hysterectomy and compared it with gabapentin and placebo. Methods: A randomized, double-blind, placebo-controlled study was conducted in 90 women undergoing abdominal hysterectomy who were anaesthetized in a standardized fashion. Patients received 300 mg pregabalin, 900 mg gabapentin or placebo, 1-2 hours prior to surgery. Postoperative analgesia was administered at visual analogue scale (VAS ≥3. The primary outcome was analgesic consumption over 24 hours and patients were followed for pain scores, time to rescue analgesia and side effects as secondary outcomes. Results: The diclofenac consumption was statistically significant between pregabalin and control groups, and gabapentin and control groups; however, pregabalin and gabapentin groups were comparable. Moreover, the consumption of tramadol was statistically significant among all the groups. Patients in pregabalin and gabapentin groups had lower pain scores in the initial hour of recovery. However, pain scores were subsequently similar in all the groups. Time to first request for analgesia was longer in pregabalin group followed by gabapentin and control groups. Conclusion: A single dose of 300 mg pregabalin given 1-2 hours prior to surgery is superior to 900 mg gabapentin and placebo after abdominal hysterectomy. Both the drugs are better than placebo.

  17. Randomized pilot trial comparing tolvaptan with furosemide on renal and neurohumoral effects in acute heart failure.

    Science.gov (United States)

    Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Furuki, Yuho; Kim, Ahsung; Suzuki, Yuki; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

    2016-09-01

    Loop diuretics are first-line medications for congestive heart failure (CHF); however, they are associated with serious adverse effects, including decreased renal function, and sympathetic nervous and renin-angiotensin system activation. We tested whether tolvaptan, a vasopressin V2-receptor antagonist, could reduce unfavourable furosemide-induced effects during CHF treatment. Sixty patients emergently hospitalized owing to CHF-induced dyspnea were randomly assigned to receive either 40 mg intravenous furosemide daily or 7.5 mg oral tolvaptan for 5 days after admission. Both groups also received intravenous carperitide and canrenoate potassium. As results, baseline patient characteristics were similar between the furosemide (n = 30) and the tolvaptan (n = 30) groups, with no significant difference in 5 day urine volume or fluid balance. Brain natriuretic peptide and body weight improvements were similar between groups. However, serum creatinine (Cr) level did not increase, and the incidence of worsening renal function was significantly lower in the tolvaptan group. Consequently, the Cr increase to gain 1000 mL urine was 2.5-fold lower in the tolvaptan group. Furthermore, the blood urea nitrogen (BUN)/Cr ratio significantly decreased in the tolvaptan group, suggesting that renal perfusion was preserved, and urea reuptake and passive water reabsorption were suppressed following tolvaptan treatment. Although catecholamine improvements after treatment were not significantly different, plasma renin activity was enhanced in the furosemide group. As compared with furosemide, tolvaptan in patients with acute heart failure is associated with comparable decongestion, better preservation of renal function and less activation of renin-angiotensin system. (UMIN 000014134).

  18. Randomized trial comparing episiotomies with Braun-Stadler episiotomy scissors and EPISCISSORS-60®

    Directory of Open Access Journals (Sweden)

    Sawant G

    2015-06-01

    Full Text Available Ganpat Sawant, Divya Kumar Dr DY Patil Medical College and Hospital, Nerul, Navi Mumbai, India Introduction: Episiotomy angle is a crucial factor in causation of obstetric anal sphincter injuries (OASIS, which are the major cause of female bowel incontinence. Sutured episiotomies angled too close to the midline (<30 degree or too far away from the midline (.60 degree fail to unload the perineum sufficiently and predispose to OASIS. A 25-degree post-delivery episiotomy suture angle has a 10% risk of OASIS while 45-degree episiotomy is associated with 0.5% risk. To account for perineal distension at crowning, a 60-degree episiotomy incision is required to achieve 43–50 degree suture angles. We compared episiotomy suture angles with commonly used Braun-Stadler episiotomy scissors with the new fixed angle EPISCISSORS-60®. Methods: Ethical approval was obtained. A prospective cluster randomization design was chosen. Thirty-one patients were required in each group for a 12-degree difference with power at 90% and 5% significance. Sutured episiotomy angles and post-delivery linear distance from caudal end of the sutured episiotomy to the anus were measured with protractors and rulers. Two-tailed t-tests were used to compare the two groups. Results: Thirty-one nulliparae had episiotomies with EPISCISSORS-60®, 32 with Braun-Stadler. Mean age (25 versus 24.8 years was similar. EPISCISSORS-60® episiotomies were angled 12 degrees more laterally away from the anus compared to Braun-Stadler (40.6 degrees, 95% confidence interval [CI] ±2, interquartile range [IQR] 35–45 versus 28.3 degrees, 95% CI ±2, IQR 25–30, P<0.0001. The post-delivery linear distance from caudal end of the sutured episiotomy to the anus was 15 mm more with the EPISCISSORS-60® compared to Braun-Stadler (35 mm, 95% CI ±2.2, IQR =30–39 versus 19.5; 95% CI ±1.3, IQR =14.75–22.25 P<0.0001. EPISCISSORS-60® episiotomies measured longer (47 mm versus 40 mm, P<0.0001. There were

  19. A randomized trial comparing reflux symptoms in sleeve gastrectomy patients with or without hiatal hernia repair.

    Science.gov (United States)

    Snyder, Brad; Wilson, Erik; Wilson, Todd; Mehta, Sheilendra; Bajwa, Kulvinder; Klein, Conniw

    2016-11-01

    The effect of laparoscopic sleeve gastrectomy (SG) on reflux symptoms is unclear. Many surgeons offer SG only to patients with minor or no reflux symptoms, fearing that patients with severe reflux symptoms will experience worsening of their condition after SG. Many also advocate crural repair at the time of SG to prevent de novo or worsening reflux symptoms. These decisions are made without suitable data to form such conclusions. To determine the effect of SG with or without hiatal hernia repair on reflux symptoms. University of Texas Health Sciences Center in Houston. The Gastrointestinal Symptom Rating Scale (GSRS) was administered to 100 consecutive, preoperative SG patients who were then randomly assigned into a crural repair group or nonrepair group in a parallel design. The patients were subsequently followed-up every 3 months for 1 year. We compared reflux symptoms of the 2 groups on the basis of demographic characteristics, body mass index, weight loss, presence and size of hiatal hernia, and GSRS for 12 months. At 1 year, with 78% follow-up, the data demonstrated a significant decrease in the GSRS for both groups (Phiatal hernia size did not correlate with change in the GSRS score. The only variable that affected outcome was the preoperative GSRS. At 12 months, 38% of patients with a preoperative GSRS score less than the median score of the study population experienced worsening of their symptoms compared with only 2% of patients who had a preoperative GSRS score greater than the median. Overall, 19% experienced worsening reflux (5% de novo), 14% had no change, and 66% reported an improvement in symptoms. These data suggest that a crural repair at the time of SG does not significantly reduce reflux symptoms compared with SG alone. Preoperative patients with significant reflux symptoms experienced a more significant improvement in symptoms after surgery compared with those who did not report significant reflux symptoms before surgery. The high incidence of

  20. Meta-analysis of randomized trials comparing fusion surgery to non-surgical treatment for discogenic chronic low back pain.

    Science.gov (United States)

    Wang, Xin; Wanyan, Pingping; Tian, Jin Hui; Hu, Long

    2015-01-01

    Chronic low back pain causes socioeconomic burdens. Whether lumbar fusion is more effective than nonsurgical treatment of discogenic low back pain (DLBP) is controversial. Several randomized controlled trials that compared conservative treatment and fusion surgery had conflicting conclusions. To compare between the effectiveness of lumbar fusion and nonsurgical intervention in patients with chronic low back pain caused by disc degeneration. PubMed, the Cochrane Library, EMBASE, the Science Citation Index, Chinese Biomedical Literature Database, and references of relevant papers published from 1990 to 2013 were searched. Related data matching standards established for this research were extracted and statistically analyzed by using the RevMan (5.2) software. Meta-analysis of 6 randomized controlled trials with a total of 889 patients revealed no difference in Oswestry Disability Index (ODI) score for DLBP between the fusion surgery and nonsurgical groups (mean difference, 1.94; 95% confidence interval [CI], -6.02 to 2.14). Postsurgical complication rate significantly differed between the 2 groups (risk ratio, 22.11; 95% CI, 55.99-81.60). Fusion surgery was not superior to nonsurgical treatment in terms of changes in ODI scores for DLBP. Fusion surgery resulted in surgical complications. Longer follow-up observation is necessary regarding condition-specific disability, pain, and life satisfaction.

  1. Comparing the analgesic effect of heat patch containing iron chip and ibuprofen for primary dysmenorrhea: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Navvabi Rigi Shahindokht

    2012-08-01

    Full Text Available Abstract Background Primary dysmenorrhea is a common and sometimes disabling condition. In recent years, some studies aimed to improve the treatment of dysmenorrhea, and therefore, introduced several therapeutic measures. This study was designed to compare the analgesic effect of iron chip containing heat wrap with ibuprofen for the treatment of primary dysmenorrhea. Methods In this randomized (IRCT201107187038N2 controlled trial, 147 students (18–30 years old with the diagnosis of primary dysmenorrhea were enrolled considering the CONSORT guideline. Screening for primary dysmenorrhea was done by a two-question screening tool. The participants were randomly assigned into one of the intervention groups (heat Patch and ibuprofen. Data regarding the severity and emotional impact of the pain were recorded by a shortened version of McGill Pain Questionnaire (SF-MPQ. Student's t test was used for statistical analysis. Results The maximum and minimum pain severities were observed at 2 and 24 hours in both groups. The severity of sensual pain at 8, 12, and 24 hours was non-significantly less in the heat Patch group. There was also no significant difference between the groups regarding the emotional impact of pain at the first 2, 4, 8, 12 and 12 hours of menstruation. Conclusions Heat patch containing Iron chip has comparable analgesic effects to ibuprofen and can possibly be used for primary dysmenorrhea. Trial registration IRCT201107187038N2

  2. The Comparative Safety of TNF Inhibitors in Ankylosing Spondylitis-a Meta-Analysis Update of 14 Randomized Controlled Trials.

    Science.gov (United States)

    Hou, Li-Qiong; Jiang, Ga-Xue; Chen, Yan-Fei; Yang, Xi-Mei; Meng, Lei; Xue, Miao; Liu, Xiao-Guang; Chen, Xi-Chao; Li, Xiao

    2017-07-17

    TNF inhibitors have been used in ankylosing spondylitis (AS). The efficacy of TNF inhibitors was already evaluated by meta-analysis of randomized controlled trials (RCTs). However, the safety of TNF inhibitors is still unclear. Therefore, we aimed to evaluate and update the safety data from RCTs of TNF inhibitors in patients treated for AS. A systematic literature search was conducted from 1990 through May 31, 2016. All studies included were randomized, double-blind, controlled trials of patients with ankylosing spondylitis that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab treatment. The overall serious adverse events, the risk of serious infection events, and the risk of malignancy and discontinuation rates were abstracted, and risk estimates were calculated by Peto odds ratios (ORs). Fourteen randomized controlled trials involving 2032 subjects receiving TNF inhibitors and 1030 subjects receiving placebo and/or traditional disease-modifying anti-rheumatic drugs (DMARDs) were included. The overall serious adverse events (OR, 1.34; 95% CI, 0.87-2.05), the risk of serious infection events (OR, 1.59; 95% CI, 0.63-4.01), the risk of malignancy (OR, 0.98; 95% CI, 0.25-3.85), and discontinuation due to adverse events (OR, 1.55; 95% CI, 0.95-2.54) in patients treated with TNF inhibitors as a group were not significantly different from those treated with placebo in the control group. TNF inhibitors were generally safe for treatment of ankylosing spondylitis. These data may help guide clinical comparative decision making in the management of AS.

  3. Oral isotretinoin in different dose regimens for acne vulgaris: A randomized comparative trial

    Directory of Open Access Journals (Sweden)

    Uma Shankar Agarwal

    2011-01-01

    Full Text Available Background: Oral isotretinoin is recommended for severe nodulocystic acne in the doses of 1-2 mg/kg/day which is usually associated with higher incidence of adverse effects. To reduce the incidence of side-effects and to make it more cost-effective, the lower dose regimen of isotretinoin has been used. Aim: To compare the efficacy and tolerability of oral isotretinoin in daily, alternate, pulse and low-dose regimens in acne of all types and also to assess whether it can be used for mild and moderate acne also. Methods: One hundred and twenty patients with acne were randomized into four different treatment regimens each consisting of 30 patients. Group A was prescribed isotretinoin 1 mg/kg/day, Group B 1 mg/kg alternate day, Group C 1 mg/kg/day for one week/four weeks and Group D 20 mg every alternate day for 16 weeks. Patients were further followed for eight weeks to see any relapse. Side-effects were also recorded. Results: Though the daily high dose treatment Group A performed better initially at eight weeks, at the end of therapy at 16 weeks results were comparable in Group A , B and D. Patients with severe acne did better in Group A than in Group B, C and D. Patients with mild acne had almost similar results in all the groups while patients with moderate acne did better in Group A, B and D. Frequency and severity of treatment-related side-effects were significantly higher in treatment Group A as compared to Group B, C and D. Conclusion: We conclude that for severe acne either conventional high doses of isotretinoin may be used or we can give conventional high dose for initial eight weeks and later maintain on low doses. Use of isotretinoin should be considered in mild to moderate acne also, in low doses; 20 mg, alternate day seems to be an effective and safe treatment option in such cases.

  4. The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Aziz, Zoriah; Abdul Rasool Hassan, Bassam

    2017-02-01

    Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  5. A randomized comparative trial on the therapeutic efficacy of topical aloe vera and Calendula officinalis on diaper dermatitis in children.

    Science.gov (United States)

    Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2012-01-01

    Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Sixty-six infants with DD (aged Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Although improvement in the severity of DD was observed in both treatment groups (P Calendula ointment had significantly fewer rash sites compared to aloe group (P = 0.001). No adverse effect was reported from either of the medications. The evidence from this study suggests that topical aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants.

  6. Randomized trial comparing the velocities of the antihypertensive effects on home blood pressure of candesartan and candesartan with hydrochlorothiazide.

    Science.gov (United States)

    Hosaka, Miki; Metoki, Hirohito; Satoh, Michihiro; Ohkubo, Takayoshi; Asayama, Kei; Kikuya, Masahiro; Inoue, Ryusuke; Obara, Taku; Hirose, Takuo; Imai, Yutaka

    2015-10-01

    We aimed to evaluate the hypotensive effect and the time to attain the maximal antihypertensive effect (stabilization time) of 8 mg candesartan/6.25 mg hydrochlorothiazide (HCTZ) combination therapy (combination regimen) and therapy with an increased candesartan dose (12 mg; maximum dose regimen) using home blood pressure (BP) measurements. A prospective, multicenter, open-label, randomized, comparative trial was conducted. Essential hypertensive patients who failed to achieve adequate BP control (systolic BP (SBP) ⩽ 135 mm Hg) on 8 mg candesartan alone were randomized to two groups: the combination regimen (n=103) and the maximum dose regimen (n=103). Home morning SBP reduction at 8 weeks after randomization was 11.4 ± 1.3 mm Hg in the combination regimen and 7.8 ± 1 .2 mm Hg in the maximum dose regimen. The combination regimen provided additional reduction of 4.0 mm Hg (95% confidence interval (CI): 0.8-7.2 mm Hg, P=0.01) in home morning SBP over the maximum dose regimen at 8 weeks after randomization. The maximal antihypertensive effect and stabilization time for home SBP were 9.4 mm Hg and 37.1 days (P0.2). The rate of achieving target BP (home morning SBP candesartan to combination therapy was more effective in reducing home SBP and achieving goal BP more rapidly than increasing the candesartan dose.

  7. HALF-DOSE DEPOT TRIPTORELIN COMPARABLE TO REDUCED DAILY BUSERELIN: A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. Safdarian

    2007-09-01

    Full Text Available Pituitary suppression by depot GnRH agonist may be excessive for ovarian stimulation. This study compares the efficacy of a single half-dose depot triptorelin and reduced-dose daily buserelin in a long protocol ICSI/ET. METHODS: A total of 182 patients were randomized into two groups using sealed envelopes. Pituitary desensitization was obtained in group 1 (91 patients with half-dose (1.87 mg depot triptorelin in the mid-luteal phase of their menstrual cycle, and in group 2 (91 patients with standard daily dose (0.5 mg buserelin, which was then reduced to 0.25 mg at the start of human menopausal gonadotropin (HMG stimulation. RESULTS: No significant differences were found among those who received HCG in terms of clinical pregnancy rate (34.4% in both groups, implantation rate (14.8% in group 1 versus 11.1% in group 2, fertilization rate (93.3 versus 95.6%, poor response rate (11.1 versus 6.7%, and miscarriage rate (11.1 versus 7.8%. No significant differences were seen in number of HMG ampoules used, follicles at HCG administration, and oocytes retrieved. The number of days of stimulation was significantly reduced in group 2 (11.2 +/- 1.8 in group 1 versus 10.6 +/- 1.9, p = 0.030. CONCLUSION: A half-dose of depot triptorelin can be successfully used in ovarian stimulation instead of reduced-dose daily buserelin, with more patient comfort and reduced stress and cost of injections.

  8. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children.

    Science.gov (United States)

    Jagannathan, Narasimhan; Sommers, Katherine; Sohn, Lisa E; Sawardekar, Amod; Shah, Ravi D; Mukherji, Isabella I; Miller, Steven; Voronov, Polina; Seraphin, Sally

    2013-02-01

    The laryngeal mask airway Supreme (Supreme) is a new single-use supraglottic device with gastric access capability now available in all sizes for children. To compare the i-gel with the Supreme in children for routine airway maintenance. One hundred and seventy children, aged 3 months to 11 years, 5-50 kg in weight, were randomly assigned to receive either the i-gel or the Supreme. The primary outcome measured was airway leak pressure. Secondary outcomes included the following: ease and time for insertion, insertion success rate, fiberoptic grade of view, ease of gastric tube placement, number of airway manipulations, quality of airway during anesthetic maintenance, and complications. A total of 168 patients were assessed for the outcomes. The median (IQR [range]) airway leak pressure for the i-gel was higher than with the Supreme, 20 (18-25 [9-40]) cm H(2)O vs 17 (14-22 [10-40]) cm H(2)O, respectively (P = 0.001). There were no differences in the time for device insertion, fiberoptic grade of view, quality of airway, and complications. Median (IQR[range]) time of successful insertion of a gastric tube was faster with the Supreme, 12 (9.2-14.3 [5.2-44.2]) s than with the i-gel, 14 (11.9-19 [6.9-75]) s; P = 0.01. The number of airway manipulations during placement was higher with the i-gel than with the laryngeal mask airway Supreme (12 vs 13 patients), P = 0.02. In infants and children, when a single-use supraglottic device with gastric access capabilities is required, the i-gel demonstrated higher airway leak pressures and can be a useful alternative to the Supreme. © 2012 Blackwell Publishing Ltd.

  9. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Science.gov (United States)

    Witt, Claudia M; Manheimer, Eric; Hammerschlag, Richard; Lüdtke, Rainer; Lao, Lixing; Tunis, Sean R; Berman, Brian M

    2012-01-01

    For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters. From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60), which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  10. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Directory of Open Access Journals (Sweden)

    Claudia M Witt

    Full Text Available For Comparative Effectiveness Research (CER there is a need to develop scales for appraisal of available clinical research. Aims were to 1 test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2 evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60, which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  11. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

    Science.gov (United States)

    Edwards, Meghan K; Loprinzi, Paul D

    2017-11-27

    No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

  12. Study comparing "Kangaroo Ward Care" with "Intermediate Intensive Care" for improving the growth outcome and cost effectiveness: randomized control trial.

    Science.gov (United States)

    Sharma, Deepak; Murki, Srinivas; Oleti, Tejo Pratap

    2017-08-02

    The aim of this study was to compare growth outcome and cost effectiveness of "Kangaroo ward care" (KWC) with "Intermediate intensive care" (IIC) in stable infants with birth weight 1000 g to Kangaroo ward immediately after randomization and in the IIC group received IIC care till they attained a weight of 1250 g before shifting to Kangaroo Ward. After shifting to Kangaroo ward, infants in the IIC group received equivalent care to KWC group infants. There was significant better weight gain post-randomization during hospital stay and better length gain till 40 weeks of gestational age in intervention arm. There was reduction of post-randomization hospital stay by 2 d in the KWC group. The infants in the KWC group were shifted 6 d earlier to Kangaroo ward from IIC when compared with the IIC group. The cost-effective analysis that used "top-down" and "bottom-up" accounting method showed significant reduction of hospital and parents expenditure in the KWC group (p Kangaroo ward with birth weight 1000 g to <1100 g leads to better growth and is cost effective (CTRI/2014/05/004625). Clinical trial registry of India CTRI/2014/05/004625.

  13. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  14. On the covariate-adjusted estimation for an overall treatment difference with data from a randomized comparative clinical trial.

    Science.gov (United States)

    Tian, Lu; Cai, Tianxi; Zhao, Lihui; Wei, Lee-Jen

    2012-04-01

    To estimate an overall treatment difference with data from a randomized comparative clinical study, baseline covariates are often utilized to increase the estimation precision. Using the standard analysis of covariance technique for making inferences about such an average treatment difference may not be appropriate, especially when the fitted model is nonlinear. On the other hand, the novel augmentation procedure recently studied, for example, by Zhang and others (2008. Improving efficiency of inferences in randomized clinical trials using auxiliary covariates. Biometrics 64, 707-715) is quite flexible. However, in general, it is not clear how to select covariates for augmentation effectively. An overly adjusted estimator may inflate the variance and in some cases be biased. Furthermore, the results from the standard inference procedure by ignoring the sampling variation from the variable selection process may not be valid. In this paper, we first propose an estimation procedure, which augments the simple treatment contrast estimator directly with covariates. The new proposal is asymptotically equivalent to the aforementioned augmentation method. To select covariates, we utilize the standard lasso procedure. Furthermore, to make valid inference from the resulting lasso-type estimator, a cross validation method is used. The validity of the new proposal is justified theoretically and empirically. We illustrate the procedure extensively with a well-known primary biliary cirrhosis clinical trial data set.

  15. Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods.

    Science.gov (United States)

    Morin, Mélanie; Dumoulin, Chantale; Bergeron, Sophie; Mayrand, Marie-Hélène; Khalifé, Samir; Waddell, Guy; Dubois, Marie-France

    2016-01-01

    Provoked vestibulodynia (PVD) is a highly prevalent and debilitating condition yet its management relies mainly on non-empirically validated interventions. Among the many causes of PVD, there is growing evidence that pelvic floor muscle (PFM) dysfunctions play an important role in its pathophysiology. Multimodal physiotherapy, which addresses these dysfunctions, is judged by experts to be highly effective and is recommended as a first-line treatment. However, the effectiveness of this promising intervention has been evaluated through only two small uncontrolled trials. The proposed bi-center, single-blind, parallel group, randomized controlled trial (RCT) aims to evaluate the efficacy of multimodal physiotherapy and compare it to a frequently used first-line treatment, topical overnight application of lidocaine, in women with PVD. A total of 212 women diagnosed with PVD according to a standardized protocol were eligible for the study and were randomly assigned to either multimodal physiotherapy or lidocaine treatment for 10weeks. The primary outcome measure is pain during intercourse (assessed with a numerical rating scale). Secondary measures include sexual function, pain quality, psychological factors (including pain catastrophizing, anxiety, depression and fear of pain), PFM morphology and function, and patients' global impression of change. Assessments are made at baseline, post-treatment and at the 6-month follow-up. This manuscript presents and discusses the rationale, design and methodology of the first RCT investigating physiotherapy in comparison to a commonly prescribed first-line treatment, overnight topical lidocaine, for women with PVD. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults

    Directory of Open Access Journals (Sweden)

    Quinn Stephen

    2009-10-01

    Full Text Available Abstract Background To compare the effectiveness of a custom-made leather wrist splint (LS with a commercially available fabric splint (FS in adults with chronic wrist pain. Methods Participants (N = 25, mean age = 54 were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN, the Canadian Occupational Performance Measure (COPM and Jamar dynamometer by an observer blinded to treatment allocation. Results Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43, improved hand function and increased grip strength compared to baseline (all p Conclusion Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction.

  17. Intraoperative monitoring of stroke volume variation versus central venous pressure in laparoscopic liver surgery: a randomized prospective comparative trial.

    Science.gov (United States)

    Ratti, Francesca; Cipriani, Federica; Reineke, Raffaella; Catena, Marco; Paganelli, Michele; Comotti, Laura; Beretta, Luigi; Aldrighetti, Luca

    2016-02-01

    Central venous pressure (CVP) is used as a marker of cardiac preload to control intraoperative blood loss in open hepatectomies, while its reliability in laparoscopy is less certain. The aim of this randomized prospective trial was to evaluate the outcome of laparoscopic resections performed with stroke volume variation (SVV) or CVP monitoring. All candidates for laparoscopic liver resection were assigned randomly to SVV or to CVP groups. Outcome was evaluated included conversion rate, cause of conversion, intraoperative blood loss, need for transfusions, length of surgery and postoperative results. Ninety consecutive patients were enrolled: both SVV and CVP groups included 45 patients each and were comparable in terms of patient and disease characteristics. A reduced rate of conversion was recorded in the SVV compared to the CVP group (6.7% and 17.8% respectively, p = 0.02). Blood loss was lower in the SVV group (150 mL), compared to the CVP group (300 mL, p = 0.04). Morbidity, mortality, length of stay and functional recovery were comparable. On multivariate analysis, lesion location, extent of hepatectomy and type of cardiac preload monitoring were associated significantly to risk of conversion. SVV monitoring in laparoscopic liver surgery improves intraoperative outcome, thus enhancing the benefits of the minimally-invasive approach and fast-track protocols. Copyright © 2015 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

  18. Marital Status and Satisfaction Five Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    Science.gov (United States)

    Christensen, Andrew; Atkins, David C.; Baucom, Brian; Yi, Jean

    2010-01-01

    Objective: To follow distressed married couples for 5 years after their participation in a randomized clinical trial. Method: A total of 134 chronically and seriously distressed married couples were randomly assigned to approximately 8 months of either traditional behavioral couple therapy (TBCT; Jacobson & Margolin, 1979) or integrative…

  19. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Directory of Open Access Journals (Sweden)

    Andrew W Howard

    2009-12-01

    Full Text Available The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed

  20. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

    Science.gov (United States)

    Geladé, Katleen; Janssen, Tieme W P; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-10-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally titrated methylphenidate and (2) a semi-active control intervention, physical activity, to account for nonspecific effects. A multicenter 3-way parallel-group study with balanced randomization was conducted. Children with a DSM-IV-TR diagnosis of ADHD, aged 7-13 years, were randomly allocated to receive neurofeedback (n = 39), methylphenidate (n = 36), or physical activity (n = 37) over a period of 10-12 weeks. Neurofeedback comprised theta/beta training on the vertex (Cz). Physical activity consisted of moderate to vigorous intensity exercises. Neurofeedback and physical activity were balanced in terms of number (~30) and duration of sessions. A double-blind pseudorandomized placebo-controlled crossover titration procedure was used to determine an optimal dose in the methylphenidate intervention. Parent and teacher ratings on the Strengths and Difficulties Questionnaire (SDQ) and Strengths and Weaknesses of ADHD Symptoms and Normal Behavior (SWAN) were used to assess intervention outcomes. Data collection took place between September 2010 and March 2014. Intention-to-treat analyses revealed an improvement in parent-reported behavior on the SDQ and the SWAN Hyperactivity/Impulsivity scale, irrespective of received intervention (ηp² = 0.21-0.22, P ≤ .001), whereas the SWAN Inattention scale revealed more improvement in children who received methylphenidate than neurofeedback and physical activity (ηp² = 0.13, P ≤ .001). Teachers reported a decrease of ADHD symptoms on all measures for methylphenidate, but not for neurofeedback or physical activity (range of ηp² = 0.14-0.29, P neurofeedback and physical activity in decreasing ADHD symptoms in children with ADHD

  1. Meta-analysis of randomized, controlled trials comparing particular doses of griseofulvin and terbinafine for the treatment of tinea capitis.

    Science.gov (United States)

    Gupta, Aditya K; Drummond-Main, Chris

    2013-01-01

    Two oral antifungal agents, griseofulvin and terbinafine, have regulatory approval in the United States, but it is unknown whether one has superior overall efficacy. Genus-specific differences in efficacy are believed to exist for the two agents. It is not clear at what doses and durations of treatment these differences apply. The goals of this meta-analysis were to determine whether a statistically significant difference in efficacy exists between these agents at a given dose and duration of each in tinea capitis infections overall and to determine whether a genus-specific difference in efficacy exists for these two treatments at a given dose and duration of each. We performed a literature search for clinically and methodologically similar randomized controlled trials comparing 8 weeks of griseofulvin (6.25-12.5 mg/kg/day) to 4 weeks of terbinafine (3.125-6.25 mg/kg/day) in the treatment of tinea capitis. A meta-analysis was performed using the Mantel-Haenszel method and random effects model; results were expressed as odds ratios with 95% confidence intervals. Meta-analysis of randomized controlled trials did not show a significant difference in the overall efficacy of the two drugs at the doses specified, but specific efficacy differences were observed based on the infectious species. For tinea capitis caused by Microsporum spp., griseofulvin is superior (p = 0.04), whereas terbinafine is superior for Trichophyton spp. infection (p = 0.04). Our results support species-specific differences in treatment efficacy between griseofulvin and terbinafine and provide a clinical context in which this knowledge may be applied. © 2012 Wiley Periodicals, Inc.

  2. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  3. Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

    DEFF Research Database (Denmark)

    Mathiesen, Elisabeth R; Hod, Moshe; Ivanisevic, Marina

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized an...

  4. Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis.

    Science.gov (United States)

    Barnard, Emily P; AbdElmagied, Ahmed M; Vaughan, Lisa E; Weaver, Amy L; Laughlin-Tommaso, Shannon K; Hesley, Gina K; Woodrum, David A; Jacoby, Vanessa L; Kohi, Maureen P; Price, Thomas M; Nieves, Angel; Miller, Michael J; Borah, Bijan J; Gorny, Krzysztof R; Leppert, Phyllis C; Peterson, Lisa G; Stewart, Elizabeth A

    2017-05-01

    Uterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery are minimally invasive therapies approved by the US Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments. The objective of the study was to summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment. Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected. Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P focused ultrasound (n = 43), 23

  5. A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix.

    Science.gov (United States)

    El Khouly, Nabih I

    2017-04-01

    The purpose of this study was to evaluate the effectiveness and safety of transcervical Foley catheter with and without oxytocin versus oxytocin alone for labour induction with unfavourable cervix. This trial enrolled 108 women with singleton pregnancies presented for labour induction with unfavourable cervix. Patients were randomly assigned to receive Foley catheter alone (I), Foley catheter plus oxytocin (II) or oxytocin alone (III). Outcomes were analysed in terms of success of induction, induction delivery interval, route of delivery, dose and duration of oxytocin, and complications. Successful normal vaginal delivery was more common in group I (p = .02) compared to group III. Induction delivery time was statistically shorter in group II and group III (p oxytocin dose and duration (p oxytocin increases success rate of normal vaginal delivery; however, it has a longer induction delivery interval with similar complications.

  6. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control.

    Directory of Open Access Journals (Sweden)

    Donal G MacCoon

    Full Text Available Mindfulness Based Stress Reduction (MBSR is a secular form of meditation training. The vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. Previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention.We used a visual continuous performance task (CPT to test the effects of eight weeks of mindfulness training on sustained attention by comparing MBSR to the Health Enhancement Program (HEP, a structurally equivalent, active control condition in a randomized, longitudinal design (ClinicalTrials.gov, NCT01301105 focusing on a non-clinical population typical of MBSR participants. Researchers were blind to group assignment. 63 community participants were randomized to either MBSR (n = 31 or HEP (n = 32. CPT analyses were conducted on 29 MBSR participants and 25 HEP participants. We predicted that MBSR would improve visual discrimination ability and sustained attention over time on the CPT compared to HEP, with more home practice associated with greater improvements. Our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research. Our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance. One of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable.Attentional sensitivity is not affected by mindfulness practice as taught in MBSR, but it is unclear whether mindfulness might positively affect another aspect of attention, vigilance. These results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in similar samples.ClinicalTrials.gov, NCT

  7. Video feedback compared to treatment as usual in families with parent-child interactions problems: a randomized controlled trial.

    Science.gov (United States)

    Høivik, Magnhild Singstad; Lydersen, Stian; Drugli, May Britt; Onsøien, Ragnhild; Hansen, Marit Bergum; Nielsen, Turid Suzanne Berg-

    2015-01-01

    For the first time to our knowledge, short- and long-term effects of a multi-site randomized-controlled trial (RCT) of video feedback of infant-parent interaction (VIPI) intervention in naturalistic settings are published. The intervention targets families with children younger than 2 years old and parent-child interactions problems. Outcome variables were 1) observed parent-child interactions and 2) parent-reported child social and emotional development. Between-group differences of the moderating effects of parental symptoms of depression, personality disorders traits, and demographic variables were investigated. The study had a parallel-group, consecutively randomized, single-blinded design; participants were recruited by health- and social workers. Seventy-five families received VIPI, and 57 families received treatment as usual (TAU). Videotapes of each parent-child interactions were obtained before treatment, right after treatment, and at a 6-month follow-up and coded according to Biringen's Emotional Availability Scales. Parental symptoms of depression and personality disorder traits were included as possible moderators. Evidence of a short-term effect of VIPI treatment on parent-child interactions was established, especially among depressed parents and parents with problematic interactions-and, to some extent, among parents with dependent and paranoid personality disorder traits. A long-term positive effect of VIPI compared with TAU on child social/emotional development was also evident. In a secondary analysis, VIPI had a direct positive effect on the depressive symptoms of parents compared with TAU. The findings of the study support the use of VIPI as an intervention in families with interaction difficulties. Current Controlled Trials ISRCTN99793905.

  8. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain.

    Science.gov (United States)

    Kjellman, Görel; Oberg, Birgitta

    2002-07-01

    Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.

  9. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial.

    Science.gov (United States)

    Irwin, Michael R; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Breen, Elizabeth C; Witarama, Tuff; Yokomizo, Megumi; Lavretsky, Helen; Carroll, Judith E; Motivala, Sarosh J; Bootzin, Richard; Nicassio, Perry

    2014-09-01

    To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Randomized controlled, comparative efficacy trial. Los Angeles community. 123 older adults with chronic and primary insomnia. Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07-0.97] P Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. © 2014 Associated Professional Sleep Societies, LLC.

  10. Comparative effects of metformin and pioglitazone on YKL-40 in type 2 diabetes: a randomized clinical trial.

    Science.gov (United States)

    Esteghamati, A; Rezvani, S; Khajeh, E; Ebadi, M; Nakhjavani, M; Noshad, S

    2014-12-01

    Metformin and pioglitazone are believed to exert their long-term benefits by means of amelioration of chronic low-grade inflammation, a key event in development of diabetes and its long-term complications. The present trial was designed to investigate the comparative efficacy of the two anti-diabetes medications on serum concentrations of YKL-40, a novel marker of inflammation. In a parallel-group, open-label, randomized trial setting (ClinicalTrials.gov Identifier No. NCT01521624), 84 newly diagnosed, medication-naïve type 2 diabetes patients were assigned to metformin 1,000 mg daily (n = 42) or pioglitazone 30 mg daily (n = 42). Serum concentrations of YKL-40, along with highly sensitive C-reactive protein, indices of glycemic control and lipid profile were measured at baseline and after 3 months. In the analyzed sample (metformin = 40, pioglitazone = 42), both medications were equally effective with regard to control of hyperglycemia, and hsCRP reduction (p > 0.05). However, metformin caused a significant decline in weight (p = 0.005), BMI (p = 0.004), and total cholesterol levels (p = 0.028) of the patients. Metformin also significantly reduced YKL-40 concentrations after 3 months (1.90 ± 17 vs. 1.66 ± 0.15 µg/L, p = 0.019). The amount of change in the pioglitazone arm did not reach statistical significance (2.18 ± 0.14 vs. 2.25 ± 0.16 µg/L, p = 0.687). When compared, metformin was significantly more effective than pioglitazone with respect to YKL-40 reduction in both univariate (p = 0.020, effect size = 6.7%) and multivariate models (p = 0.047, effect size = 5.7%). Metformin is more effective in reduction of YKL-40 concentration in short term and the effect seems to be independent of degree of glycemic control, or hsCRP reduction.

  11. Randomized controlled trial comparing direct intraoral digitization and extraoral digitization after impression taking.

    Science.gov (United States)

    Quaas, Sebastian; Loos, René; Rudolph, Heike; Luthardt, Ralph G

    2015-01-01

    This study aimed to evaluate the correspondence of intraoral digitization (ID) with extraoral digitization (ED) after impression taking. One-stage putty-and wash impressions and ID were carried out in a randomized order for 10 subjects. The impressions were used to make casts, which were then subjected to ED. ID datasets were aligned to create computer-aided design reference models. Deviations between ID and ED were calculated. The mean positive and negative deviations were 37.7 and -48.4 µm, respectively, for one quadrant. The results showed that the ID system is well suited for the acquisition of single-tooth restorations and is of limited suitability for the acquisition of small multiple unit restorations.

  12. Meta-analysis of randomized controlled trials comparing EX-PRESS implantation with trabeculectomy for open-angle glaucoma.

    Directory of Open Access Journals (Sweden)

    Wei Wang

    Full Text Available PURPOSE: To evaluate the efficacy and safety of EX-PRESS implantation compared with trabeculectomy for uncontrolled open-angle glaucoma. METHODS: Pertinent randomized controlled trials were identified through systematic searches of the PubMed, EMBASE, and Cochrane Library. The efficacy measures utilized were the weighted mean differences (WMDs for the intraocular pressure reduction (IOPR, the reduction in glaucoma medications, the change of visual acuity, and the relative risks (RRs for operative success rates. The safety measures utilized were RRs for postoperative complications. The pooled effects were calculated using the random-effects model. RESULTS: Four randomized controlled trials of 292 eyes were included in this meta-analysis. The WMDs of the IOPR comparing the EX-PRESS with trabeculectomy were -0.25 (95% Cl: -3.61 to 3.11 at 6 month, 0.053 (-4.31 to 4.42 at 12 months, 0.81 (-4.06 to 5.67 at 24 months, and 0.20 (-2.11 to 2.51 at final follow-up. There was no statistically significance for IOPR at any point after surgery. There were also no significant differences in the reduction in glaucoma medications or visual acuity between the groups. The pooled relative risks comparing EX-PRESS with Trabeculectomy were 1.36 (1.11 to 1.66 for the complete operative success rate and 1.05 (0.94 to 1.17 for the qualified operative success rate. EX-PRESS and Trabeculectomy were associated with similar incidences in most complications with the exception of hyphema, with pooled RR being 0.18 (0.046 to 0.66. CONCLUSIONS: EX-PRESS implantation and trabeculectomy have similar efficacy in IOP-lowering, medication reduction, vision recovery, and qualified operative success rates. EX-PRESS associated with higher rates of complete operative success and fewer hyphema than with Trabeculectomy. However, these should be interpreted with caution because of the inherent limitations of the included studies.

  13. Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial.

    Science.gov (United States)

    Kaldo, Viktor; Jernelöv, Susanna; Blom, Kerstin; Ljótsson, Brjánn; Brodin, Maria; Jörgensen, Mia; Kraepelien, Martin; Rück, Christian; Lindefors, Nils

    2015-08-01

    To evaluate if internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-i) with brief therapist support outperforms an active control treatment. Adults diagnosed with insomnia were recruited via media (n = 148) and randomized to either eight weeks of ICBT-i or an active internet-based control treatment. Primary outcome was the insomnia severity index (ISI) assessed before and after treatment, with follow-ups after 6 and 12 months. Secondary outcomes were use of sleep medication, sleep parameters (sleep diary), perceived stress, and a screening of negative treatment effects. Hierarchical Linear Mixed Models were used for intent-to-treat analyses and handling of missing data. ICBT-i was significantly more effective than the control treatment in reducing ISI (Cohen's d = 0.85), sleep medication, sleep efficiency, sleep latency, and sleep quality at post-treatment. The positive effects were sustained. However, after 12 months the difference was no longer significant due to a continuous decrease in ISI among controls, possibly due to their significantly higher utilization of insomnia relevant care after treatment. Forty-six negative effects were reported but did not differ between interventions. Supported ICBT-i is more effective than an active control treatment in reducing insomnia severity and treatment gains remain stable one year after treatment. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. A prospective randomized controlled trial to compare single-port endo-laparoscopic surgery versus conventional TEP inguinal hernia repair.

    Science.gov (United States)

    Wijerathne, Sujith; Agarwal, Narendra; Ramzy, Ahmad; Lomanto, Davide

    2014-11-01

    The success of laparoscopic surgery is due to the less surgical trauma, including less operative pain, complications and better cosmetics. Objective of our study was to compare in two blind randomized groups of patients, the surgical outcome of total extra-peritoneal (TEP) inguinal hernia repair using either single-port or conventional surgical technique. We will report our interim results in the first group of 50 patients. Our study is a prospective, randomized, controlled clinical trial conducted from August 2011 to June 2013. Fifty patients aged between 21 and 80 years undergoing surgery for unilateral inguinal hernia were randomised into two groups: conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair. Clinical data on patient demographics, surgical technique and findings, postoperative complications and pain scores were collected. Primary endpoint is the postoperative pain while secondary endpoints are recurrence, chronic pain, postoperative hospital stay and complications. Out of the 50 patients, 26 underwent single-port hernia TEP repair and 24 had conventional 3-port TEP hernia repair after randomization. Mean operative time was 51.7 (±13.4) min in the multiport group and 59.3 (±14.9) min in the single-port group, respectively (P = 0.064). Mean hospital stay was 19.7 (±4.8) h in the conventional group and 22.1 (±4.5) h in the single-port group (P = 0.079). No statistically significant differences were observed between the two groups for postoperative complications, and no recurrence reported at 11 months follow-up. There was no significant difference in the pain scores (visual analog scale) between the two groups at regular intervals post surgery. The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique.

  15. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery.

    Science.gov (United States)

    Hudson, B F; Ogden, J; Whiteley, M S

    2015-11-01

    High levels of anxiety during surgery are associated with poorer post-surgical outcomes. This prospective, non-blinded randomized controlled trial aimed to compare the effectiveness of four intraoperative distraction interventions for anxiety and pain management during minimally invasive venous surgery under local anaesthetic. 407 patients presenting with varicose veins at a private clinic, were randomized to one of four intraoperative distraction interventions or treatment as usual. All participants received endovenous thermoablation and/or phlebectomies of varicose veins. After losses to follow-up, 398 participants were entered into the analysis. Participants were randomly allocated to one of the following intraoperative distraction techniques: patient selected music (n = 85), patient selected DVD (n = 85), interaction with nurses (n = 81), touch (stress balls) (n = 80) or treatment as usual (TAU, n = 76). The state scale of the STAI, the Short-form McGill pain questionnaire and numeric rating scales were used to assess intraoperative pain and anxiety. Intraoperative anxiety ratings were significantly lower when participants interacted with nurses, used stress balls or watched a DVD during surgery compared to treatment as usual. Intraoperative pain ratings were significantly lower than treatment as usual when participants interacted with nurses or used stress balls during surgery. Patients' satisfaction was not significantly impacted by intraoperative distractions. The use of simple intraoperative distraction techniques, particularly interacting with nurses, using stress balls or watching a DVD during surgery conducted under local anaesthetic can significantly improve patients' experiences. © 2015 European Pain Federation - EFIC®

  16. Bacterial endogenous endophthalmitis in Vietnam: a randomized controlled trial comparing vitrectomy with silicone oil versus vitrectomy alone

    Directory of Open Access Journals (Sweden)

    Do T

    2014-08-01

    Full Text Available Tan Do,1 Do N Hon,1 Tin Aung,2 Nguyen DTN Hien,1 Claude L Cowan Jr3 1Vietnam National Institute of Ophthalmology, Hanoi, Vietnam; 2Singapore National Eye Center, Singapore; 3Georgetown University Medical Center, Washington, DC, USA Background/aims: To compare treatment outcomes with and without silicone oil tamponade in patients undergoing pars plana vitrectomy (PPV for severe endogenous bacterial endophthalmitis (BEE. Methods: One hundred and eight consecutive patients with severe BEE (defined by the absence of pupil red reflex at presentation and/or dense vitreous opacity on ultrasound and no improvement after 24–36 hours of medical treatment were randomly assigned to two treatment groups: Group 1, standard PPV with intravitreal antibiotics; and Group 2, PPV with intravitreal antibiotics and silicone tamponade. Overall success was defined as: a visual acuity ≥ count fingers at 1 meter, with an attached retina, and no intraocular oil. Results: Fifty three patients were randomized to Group 1 and 55 patients to Group 2. The mean age of study subjects was 32 years and baseline clinical characteristics were similar in both groups. At the final follow-up visit at 9 months, the overall success rate of Group 2 (67.3% was significantly better than Group 1 (43.4%; P=0.01. There were also fewer devastating complications (such as inoperable retinal detachment, phthisis bulbi in Group 2 compared with Group 1 (21.8% versus 43.4%; P=0.01. Conclusion: The outcome at 9 months of patients with BEE treated by vitrectomy with silicone oil was better than those treated by vitrectomy alone. Keywords: bacterial endogenous endophthalmitis, vitrectomy, silicone oil endotamponade, randomized controlled trial

  17. Comparative effects of two different forms of selenium on oxidative stress biomarkers in healthy men: a randomized clinical trial

    Science.gov (United States)

    Richie, John P.; Das, Arun; Calcagnotto, Ana M.; Sinha, Raghu; Neidig, Wanda; Liao, Jiangang; Lengerich, Eugene J.; Berg, Arthur; Hartman, Terryl J.; Ciccarella, Amy; Baker, Aaron; Kaag, Matthew G.; Goodin, Susan; DiPaola, Robert S.; El-Bayoumy, Karam

    2014-01-01

    Epidemiological and laboratory studies indicate that dietary selenium protects against prostate cancer. Results from clinical trials suggest that selenium-enriched yeast (SY) but not selenomethionine (SeMet) may be effective at reducing prostate cancer risk. Our objectives were to directly compare for the first time the effects of SeMet and SY on prostate cancer relevant biomarkers in men. We performed a randomized double blind, placebo-controlled trial of SY (200 or 285 µg/day) and SeMet (200 µg/day) administered for 9 months in 69 healthy men. Primary endpoints included blood levels of selenium-containing compounds and oxidative stress biomarkers (urine 8-hydroxy-2’-deoxyguanosine [8-OHdG] and 8-iso-prostaglandin-F2α [8-iso-PGF2α] and blood glutathione [GSH]). Secondary endpoints included plasma glucose and PSA levels. Compliance was high in all groups (>95%). Plasma selenium levels were increased 93%, 54%, and 86% after 9 months in SeMet and low and high dose SY groups, respectively, and returned to baseline levels after a 3 month washout (Pselenium (supplementation with SY but not SeMet in healthy men. These findings suggest that selenium-containing compounds other than SeMet may account for the decrease in oxidative stress. PMID:24938534

  18. Comparative effectiveness of antibiotics for uncomplicated urinary tract infections: Network meta-analysis of randomized trials

    NARCIS (Netherlands)

    Knottnerus, Bart J.; Grigoryan, Larissa; Geerlings, Suzanne E.; Moll van Charante, Eric P.; Verheij, Theo J. M.; Kessels, Alphons G. H.; ter Riet, Gerben

    2012-01-01

    The efficacies and adverse effects of different antibiotics for uncomplicated urinary tract infections (UTIs) have been studied by standard meta-analytic methods using pairwise direct comparisons of antimicrobial treatments: the effects of one treatment are compared to those of either another

  19. Treatment of adenotonsillar hypertrophy: A prospective randomized trial comparing azithromycin vs. fluticasone

    Directory of Open Access Journals (Sweden)

    Seyed Mostafa Hashemi Jazi

    2011-01-01

    Conclusions: It could explain that though both of the improved and mentioned symptoms comparing within initial status, Azithromycin seems to be more effective than fluticasone in improving AH-related symptoms. Short term efficacy of the antibiotic is much significant than its long term effect.

  20. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

    Science.gov (United States)

    Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

    2013-01-01

    To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  1. A Randomized Trial Using 3Mixtatin Compared to MTA in Primary Molars with Inflammatory Root Resorption: A Novel Endodontic Biomaterial.

    Science.gov (United States)

    Aminabadi, N A; Huang, B; Samiei, M; Agheli, S; Jamali, Z; Shirazi, S

    2016-01-01

    Novel methods for preserving primary teeth can help to maintain their developmental, esthetic, and functional capabilities. The aim of this study was to assess the success of the repair of bony defects, caused by pre-treatment perforations, with a mixture of three antibiotics combined with simvastatin (3Mixtatin) compared to MTA in hopeless primary molars. In this randomized clinical trial, 80 teeth from 65 healthy children aged 3-6 years with interradicular or periapical root resorption and/or perforation in primary molars were treated either with 3Mixtatin or MTA before conventional pulpectomy and restoration. The subjects were followed up clinically and radiographically for 4, 6, 12 and 24 months after pulp treatment to evaluate and compare the healing process. The data were compared using chi-square test at a significance level of 0.05. By the end of 24 months in 3Mixtatin group, 31 (96.8%) teeth revealed no clinical signs or symptoms with arrested resorption progress in radiographs. In MTA group, clinical signs and symptoms including pain, mobility and sinus tract were observed in 18 (48.6%) teeth with cessation of root/interradicular radiolucency in 7 (18.9%) teeth without bone repair. Radiographic and clinical healing occurred more successfully following 3Mixtatin treatment compared to treatment with MTA, it may lead to a paradigm shift in the pulpal treatment of primary teeth in the future.

  2. A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain.

    Science.gov (United States)

    Tan, G; Rintala, D H; Jensen, M P; Fukui, T; Smith, D; Williams, W

    2015-02-01

    Chronic low back pain (CLBP) is common and results in significant costs to individuals, families and society. Although some research supports the efficacy of hypnosis for CLBP, we know little about the minimum dose needed to produce meaningful benefits, the roles of home practice and hypnotizability on outcome, or the maintenance of treatment benefits beyond 3 months. One hundred veterans with CLBP participated in a randomized, four-group design study. The groups were (1) an eight-session self-hypnosis training intervention without audio recordings for home practice; (2) an eight-session self-hypnosis training intervention with recordings; (3) a two-session self-hypnosis training intervention with recordings and brief weekly reminder telephone calls; and (4) an eight-session active (biofeedback) control intervention. Participants in all four groups reported significant pre- to post-treatment improvements in pain intensity, pain interference and sleep quality. The hypnosis groups combined reported significantly more pain intensity reduction than the control group. There was no significant difference among the three hypnosis conditions. Over half of the participants who received hypnosis reported clinically meaningful (≥ 30%) reductions in pain intensity, and they maintained these benefits for at least 6 months after treatment. Neither hypnotizability nor amount of home practice was associated significantly with treatment outcome. The findings indicate that two sessions of self-hypnosis training with audio recordings for home practice may be as effective as eight sessions of hypnosis treatment. If replicated in other patient samples, the findings have important implications for the application of hypnosis treatment for chronic pain management. © 2014 European Pain Federation - EFIC®

  3. Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis.

    Science.gov (United States)

    Tey, Hong Liang; Tan, Andy Soon Leong; Chan, Yuin Chew

    2011-04-01

    Griseofulvin has been the standard treatment for tinea capitis but newer antifungal agents, particularly terbinafine, are increasingly being used because of their shorter duration of treatment and more consistent absorption rates. We sought to compare the efficacy of oral griseofulvin and oral terbinafine in the treatment of tinea capitis. A search of MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials, and the Cochrane Skin Group Ongoing Skin Trials Register was performed up to January 2010 for randomized controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis in immunocompetent patients. The primary outcome measure was the complete cure rate. The mycological and clinical cure rates and adverse effects were secondary outcome measures. Pooling of treatment effect was accomplished using a random effects model and the I(2) test was used to check for heterogeneity among the studies. Seven studies involving 2163 subjects were included. There was no significant difference in efficacy between griseofulvin (mean duration of treatment 8 weeks, range 6-12 weeks) and terbinafine (mean duration of treatment 4 weeks, range 2-6 weeks); odds ratio = 1.22 favoring terbinafine (95% confidence interval [CI] = 0.785-1.919; P = .37). In the pooled analysis of 5 studies in which Trichophyton species were the predominant (≥65%) pathogenic dermatophyte, terbinafine showed a trend toward greater efficacy (odds ratio 1.49; 95% CI = 0.975-2.277; P = .065). Subgroup analysis revealed that terbinafine was more efficacious than griseofulvin in treating Trichophyton species (1.616; 95% CI = 1.274-2.051; P griseofulvin was more efficacious than terbinafine in treating Microsporum species (0.408; 95% CI = 0.254-0.656; P griseofulvin and terbinafine demonstrated good safety profiles in the studies. Data on efficacy of griseofulvin and terbinafine for separate groups of Trichophyton and Microsporum species were not available from every study. In the

  4. Treatment duration of febrile urinary tract infection (FUTIRST trial: a randomized placebo-controlled multicenter trial comparing short (7 days antibiotic treatment with conventional treatment (14 days

    Directory of Open Access Journals (Sweden)

    Kuijper Ed J

    2009-08-01

    Full Text Available Abstract Background Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. Methods/Design A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febrile urinary tract infection will be randomly allocated to a short treatment arm (7 days of ciprofloxacin or 7 days of empirical β-lactams ± gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded placebo or standard treatment arm (7 days of ciprofloxacin or 7 days of empirical β-lactams ± gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded ciprofloxacin. The study is performed in the Leiden region in which one university hospital, 6 general hospitals and 32 primary health care centers are clustered. Patients eligible for randomization are competent patients aged 18 years or above with a presumptive diagnosis of acute pyelonephritis as defined by the combination of fever, one or more symptoms of urinary tract infection and a positive urine nitrate test and/or the presence of leucocyturia. Exclusion criteria are known allergy to fluoroquinolones, female patients who are pregnant or lactating, polycystic kidney disease, permanent renal replacement therapy, kidney transplantation, isolation of ciprofloxacin-resistant causal uropathogen, renal abscess, underlying chronic bacterial prostatitis, metastatic infectious foci and inability to obtain follow-up. The primary endpoint is the clinical cure rate through the 10- to 18-day post-treatment visit. Secondary endpoints are the microbiological cure rate 10- to 18-day post-treatment, the 30- and 90-day overall mortality rate, the

  5. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days)

    OpenAIRE

    Kuijper Ed J; Ablij Hans C; Delfos Nathalie M; Wattel-Louis G Hanke; Koster Ted; Leyten Eliane MS; Elzevier Henk W; Assendelft Willem JJ; van't Wout Jan W; van Nieuwkoop Cees; Pander Jan; Blom Jeanet W; Spelt Ida C; van Dissel Jaap T

    2009-01-01

    Abstract Background Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. Methods/Design A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febri...

  6. Low-dose oral isotretinoin for moderate to severe seborrhea and seborrheic dermatitis: a randomized comparative trial.

    Science.gov (United States)

    de Souza Leão Kamamoto, Cristhine; Sanudo, Adriana; Hassun, Karime M; Bagatin, Ediléia

    2017-01-01

    The efficacy of low-dose oral isotretinoin in the treatment of seborrhea and seborrheic dermatitis has been poorly investigated in randomized studies. This study was designed to determine the efficacy and safety of low-dose oral isotretinoin in the treatment of moderate to severe seborrhea and seborrheic dermatitis on the scalp and/or face. A randomized, comparative clinical trial, using two groups, was conducted over 6 months. Patients in Group ISO were treated with isotretinoin 10 mg every other day. In Group X, patients received antiseborrheic topical treatment. Patient opinion, investigator assessment, scalp pruritus, sebum production, and quality of life (QoL) comprised the efficacy outcomes. The intention-to-treat population comprised a total of 45 patients with mean ± standard deviation ages of 28.7 ± 5.8 years in Group ISO and 29.8 ± 6.5 years in Group X. The rate of sebum production significantly decreased in Group ISO. Patient opinion, investigator, and QoL assessments improved in both groups. Low-dose oral isotretinoin can be a therapeutic modality for moderate to severe seborrhea and seborrheic dermatitis. © 2016 The International Society of Dermatology.

  7. Randomized Controlled Trial Comparing Orthosis Augmented by Either Stretching or Stretching and Strengthening for Stage II Tibialis Posterior Tendon Dysfunction.

    Science.gov (United States)

    Houck, Jeff; Neville, Christopher; Tome, Josh; Flemister, Adolph

    2015-09-01

    The value of strengthening and stretching exercises combined with orthosis treatment in a home-based program has not been evaluated. The purpose of this study was to compare the effects of augmenting orthosis treatment with either stretching or a combination of stretching and strengthening in participants with stage II tibialis posterior tendon dysfunction (TPTD). Participants included 39 patients with stage II TPTD who were recruited from a medical center and then randomly assigned to a strengthening or stretching treatment group. Excluding 3 dropouts, there were 19 participants in the strengthening group and 17 in the stretching group. The stretching treatment consisted of a prefabricated orthosis used in conjunction with stretching exercises. The strengthening treatment consisted of a prefabricated orthosis used in conjunction with the stretching and strengthening exercises. The main outcome measures were self-report (ie, Foot Function Index and Short Musculoskeletal Function Assessment) and isometric deep posterior compartment strength. Two-way analysis of variance was used to test for differences between groups at 6 and 12 weeks after starting the exercise programs. Both groups significantly improved in pain and function over the 12-week trial period. The self-report measures showed minimal differences between the treatment groups. There were no differences in isometric deep posterior compartment strength. A moderate-intensity, home-based exercise program was minimally effective in augmenting orthosis wear alone in participants with stage II TPTD. Level I, prospective randomized study. © The Author(s) 2015.

  8. A randomized clinical trial comparing the efficacy of ibuprofen and paracetamol in the control of orthodontic pain.

    Science.gov (United States)

    Bradley, Rebecca L; Ellis, Pamela E; Thomas, Peter; Bellis, Hugh; Ireland, Anthony J; Sandy, Jonathan R

    2007-10-01

    Previous research has shown that ibuprofen provides effective relief from orthodontic pain. The aim of this study was to ascertain whether paracetamol (also known as acetaminophen) provided pain relief of equivalent or greater magnitude. A multicenter, noninferiority, randomized clinical trial was conducted in 3 orthodontic clinics; 159 patients aged 12 to 16 years attending for routine orthodontic treatment were randomly allocated to receive either 400 mg of oral ibuprofen or 1 g of oral paracetamol an hour before and again 6 hours after separator placement. Pain scores were recorded on 7 visual analog scales (10 cm) over a week. The margin of equivalence was defined as 10 mm. Mean orthodontic pain from 2 hours after separation to bedtime was 8.5 mm (90% CI: lower, 3.7; upper,13.2) higher in the paracetamol group. This confidence interval lies partly outside the margin of equivalence, suggesting that paracetamol is not equivalent, and excludes the value 0, suggesting that ibuprofen is superior. From day 1 onward, there was a trend for patients who had taken ibuprofen to experience less pain at most time intervals compared with the paracetamol group. Two doses of ibuprofen, taken on the day of separator placement, were insufficient to control orthodontic pain on day 1 after placement. A combination of preoperative and postoperative ibuprofen is more effective than paracetamol in the control of orthodontic pain.

  9. Preventing weight-related problems among adolescent girls: A cluster randomized trial comparing the Brazilian 'New Moves' program versus observation.

    Science.gov (United States)

    Dunker, Karin Louise Lenz; Claudino, Angélica Medeiros

    2017-08-07

    To conduct a cluster randomized controlled trial comparing the Brazilian version of the New Moves program (NMP) versus observation among Brazilian adolescent girls. Ten schools were randomly allocated to the Brazilian NMP or the observation arm. Study participants included 12-14-year-old girls. Recruitment occurred between February 2014 and March 2015. The NMP included sports, nutritional support, motivational interviews, collective lunch, and parental information materials. Our main outcome was the Body Shape Questionnaire (BSQ). Secondary outcomes included the Rosenberg Self-Esteem Scale and the Unhealthy Weight-Control Behaviors Index, as well as body mass index. Study results were evaluated through generalized estimating equations. A total of 270 adolescents participated in the study. At baseline, mean age was 13.4 years, and average BMI was 21.4. The intervention did not result in any statistically significant differences between the NMP and the observation arm, including BSQ (predicted means of 64.33 - IC 95% 59.2-69.47 vs. 62.02 - IC 95% 56.63-67.4), respectively) and our secondary outcomes. Adherence was low during the intervention (32.9%) and maintenance (19.1%) phases of the program. The New Moves program did not lead to significant changes in our measured outcomes. Future studies should investigate whether changes might occur when comprehensive behavioral programs are sustained over longer periods while also being customized to local population characteristics. Copyright © 2017 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  10. Randomized controlled trial comparing four strategies for delivering e-curriculum to health care professionals [ISRCTN88148532

    Directory of Open Access Journals (Sweden)

    Mitra Ananda

    2006-01-01

    Full Text Available Abstract Background Internet education is increasingly provided to health professionals, but little is known about the most effective strategies for delivering the content. The purpose of this study is to compare four strategies for delivering an Internet-based (e- curriculum on clinicians' knowledge (K, confidence (CONF, and communication (COMM about herbs and other dietary supplements (HDS. Methods This national randomized 2 × 2 factorial trial included physicians, pharmacists, nurses, nutritionists and trainees in these fields. Participants were randomly assigned to one of four curriculum delivery strategies for 40 brief modules about HDS: a delivering four (4 modules weekly over ten (10 weeks by email (drip-push; b modules accessible on web site with 4 reminders weekly for 10 weeks (drip-pull; c 40 modules delivered within 4 days by email (bolus-push; and d 40 modules available on the Internet with one email informing participants of availability (bolus-pull. Results Of the 1,267 enrollees, 25% were male; the average age was 40 years. The completion rate was 62%, without significant differences between delivery groups. There were statistically significant improvements in K, CONF and COMM scores after the course (P Conclusion All delivery strategies tested similarly improved K, CONF, COMM scores about HDS. Educators can use the strategy that is most convenient without diminishing effectiveness. Additional curricula may be necessary to make substantial changes in clinicians' communication practices.

  11. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lev-Tov Hadar

    2013-01-01

    Full Text Available Abstract Background Diabetic foot ulcers (DFUs represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively. The extracellular matrix (ECM in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair. To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC. Methods/Design To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts and SOC plus Oasis® (ECM devoid of living cells in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12. Discussion If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test

  12. A Randomized Trial Comparing Cisplatin Plus 5-fluorouracil With or Without Levamisole in Operable Gastric Cancer

    Science.gov (United States)

    Choi, Jong Soo; Lee, Kyoo Hyung; Ahn, Myung Ju; Lee, Jung Shin; Lee, Je Han; Zang, Dae Young; Suh, Chel Won; Kim, Sang We; Kim, Woo Gun; Kim, Jin Cheon; Kim, SukKoo; Park, Kun Choon; Lee, Moo Song; Kim, Sang-Hee

    1997-01-01

    Objectives To determine the effectiveness and toxicity when levamisole was added to the adjuvant combination chemotherapy in patients with operable gastric cancer. Methods After en bloc resection of gastric cancer without gross or microscopic evidence of residual disease from April 1991 to December 1992, 100 patients were randomized to 6 months of 5-fluorouracil 1,000mg/m2/day administered as continous infusion for 5 days, cisplatin 60mg/m2/day as intravenous infusion for 1 day with or without levamisole (50mg every eight hours P.O for a period of three days every 2 weeks for 6 months). This chemotherapy treatment was begun within 2 to 4 weeks after the surgery. The chemotherapy consisted of discrete 5-day courses administered at 4-weeks intervals. All 100 patients are assessable. Results The fifty patients were assigned to each treatment group. There was no statistical difference and no bias in the distribution of characteristics of the 100 evaluable patients between the two groups. A total of 274 courses of treatment were given in the levamisole group and 260 courses of treatment in non-levamisole group. Eleven patients in each group did not finish planned 6 courses of treatment mainly due to non-compliance. At median follow up of 39 months, 32 patients relapsed 19 in the levamisole group and 13 in the non-levamisole group (p=0.284). Twenty five patients died of relapsed diseases, 15 in the levamisole group and 10 in the non-levamisole group. The levamisole group tended to show more risk of overall death rate and recurrence than the non-levamisole group. Howerer. this result was not statistically significant at 3 years. The treatment was well tolerated in both treatment groups. The grade 2–3 toxicites were nausea/vomiting (levamisole, non-levamisole group;31.7%, 29.3% of treatment courses respectively), diarrhea (7.6%, 8.4%), mucositis (11.6%, 12.3%), and leukopenia (9.8%, 9.6%). Conclusion Levamisole had negative effects on disease-free survival and overall

  13. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted in ...... with focal dystonia (torticollis) by examining the video recordings. Results On average for all patients, DBS improved the BFMDRS movement scores (p...... ratings were assessed by using the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and video recordings. Quality of life was evaluated by using questionnaires (36-item Short Form Health Survey). Supplemental Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores were assessed for patients...

  14. Rehabilitation following arthroscopic rotator cuff repair: a prospective randomized trial of immobilization compared with early motion.

    Science.gov (United States)

    Keener, Jay D; Galatz, Leesa M; Stobbs-Cucchi, Georgia; Patton, Rebecca; Yamaguchi, Ken

    2014-01-01

    The influence of rehabilitation on the outcomes after arthroscopic rotator cuff repair remains unknown. The purpose of this study was to compare clinical results and tendon healing rates following arthroscopic rotator cuff repair utilizing two distinct rehabilitation protocols. Over a thirty-month period, 124 patients under the age of sixty-five years underwent arthroscopic repair of a full-thickness rotator cuff tear measuring rehabilitation program with early range of motion or to an immobilization group with delayed range of motion for six weeks. Clinical outcomes assessment included visual analog pain scale score, American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), relative Constant score, and strength measurements at six, twelve, and twenty-four months. Tendon integrity was assessed with ultrasonography at a minimum of twelve months postoperatively. There were no significant differences in patient age, tear size, or measures of preoperative function between groups at baseline. Final clinical follow-up was available for 114 subjects (92%). Active elevation and external rotation were better in the traditional rehabilitation group at three months. No significant differences were seen in functional scores, active motion, and shoulder strength between rehabilitation groups at later time points. Functional outcomes plateaued at six or twelve months except for the relative Constant score, which improved up to twenty-four months following surgery. Ninety-two percent of the tears were healed, with no difference between rehabilitation protocols (p = 0.46). Arthroscopic repair of small and medium full-thickness rotator cuff tears results in reliable improvements in clinical outcomes and a high rate of tendon integrity using a double-row repair technique in patients under the age of sixty-five years. There is no apparent advantage or disadvantage of early passive range of motion compared with immobilization with regard to healing or functional

  15. A randomized single blind crossover trial comparing leather and commercial wrist splints for treating chronic wrist pain in adults.

    Science.gov (United States)

    Thiele, Jill; Nimmo, Rachel; Rowell, Wendy; Quinn, Stephen; Jones, Graeme

    2009-10-21

    To compare the effectiveness of a custom-made leather wrist splint (LS) with a commercially available fabric splint (FS) in adults with chronic wrist pain. Participants (N = 25, mean age = 54) were randomly assigned to treatment order in a 2-phase crossover trial. Splints were worn for 2 weeks, separated by a one-week washout period. Outcomes were assessed at baseline and after each splint phase using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), the Canadian Occupational Performance Measure (COPM) and Jamar dynamometer by an observer blinded to treatment allocation. Both styles of wrist splint significantly reduced pain (effect size LS 0.79, FS 0.43), improved hand function and increased grip strength compared to baseline (all p wrist stiffness. There was a consistent trend for the LS to be superior to the FS but this was statistically significant only for patient perceived occupational performance (p = 0.008) and satisfaction (p = 0.015). Lastly, 72% of patients preferred the custom-made leather splint compared to the commercially available splint. Leather wrist splints were superior to a commercially available fabric splint for the short-term relief of pain and dysfunction.

  16. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children.

    Science.gov (United States)

    Vyas, Falgun Indravadan; Rana, Devang Ashwinkumar; Patel, Piyush M; Patel, Varsha Jitendra; Bhavsar, Rekha H

    2014-01-01

    Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1(st) h (P = 0.04). Highest fall of temperature was noted in the 1(st) h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.

  17. Comparative effect of cinnamon and Ibuprofen for treatment of primary dysmenorrhea: a randomized double-blind clinical trial.

    Science.gov (United States)

    Jaafarpour, Molouk; Hatefi, Masoud; Khani, Ali; Khajavikhan, Javaher

    2015-04-01

    Primary dysmenorrheal has a negative impact on women's quality of life. The purpose of this study was to compare the effect of Cinnamon and Ibuprofen for treatment of primary dysmenorrheal in a sample of Iranian female college students from Ilam University of Medical Sciences (western Iran). In a randomized, double-blind trial, out of 114, control group received placebo (empty capsules contain starch, TDS, n= 38) a test group received Ibuprofen (capsule containing 400mg Ibuprofen, TDS, n=38), or another test group received Cinnamon (capsule containing 420 mg Cinnamon, TDS, n= 38) in 24 h. To determine severity of pain, we used the VAS scale. Pain intensity and duration of pain were monitored in the group during first 72 h of cycle. The mean pain severity score and mean duration of pain in Ibuprofen and Cinnamon were less than placebo group respectively (pCinnamon and placebo group (p> 0.05). Of eight hours after the intervention, the mean pain severity in the cinnamon group was significantly lower than placebo group (pCinnamon and placebo groups (pCinnamon compared with placebo significantly reduced the severity and duration of pain during menstruation, but this effect was lower compared with Ibuprofen. Cinnamon can be regarded as a safe and effective treatment for primary dysmenorrhea. More researches are recommended to study the efficacy of Cinnamon on reducing menstrual bleeding.

  18. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial.

    Science.gov (United States)

    Chen, Kai; Wu, Yi-Ning; Ren, Yupeng; Liu, Lin; Gaebler-Spira, Deborah; Tankard, Kelly; Lee, Julia; Song, Weiqun; Wang, Maobin; Zhang, Li-Qun

    2016-08-01

    To examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for the treatment of impaired ankles in children with cerebral palsy. A randomized comparative trial design comparing a home-based training group and a laboratory-based training group. Home versus laboratory within a research hospital. Children (N=41) with cerebral palsy who were at Gross Motor Function Classification System level I, II, or III were randomly assigned to 2 groups. Children in home-based and laboratory-based groups were 8.7±2.8 (n=23) and 10.7±6.0 (n=18) years old, respectively. Six-week combined passive stretching and active movement intervention of impaired ankle in a laboratory or home environment using a portable rehabilitation robot. Active dorsiflexion range of motion (as the primary outcome), mobility (6-minute walk test and timed Up and Go test), balance (Pediatric Balance Scale), Selective Motor Control Assessment of the Lower Extremity, Modified Ashworth Scale (MAS) for spasticity, passive range of motion (PROM), strength, and joint stiffness. Significant improvements were found for the home-based group in all biomechanical outcome measures except for PROM and all clinical outcome measures except the MAS. The laboratory-based group also showed significant improvements in all the biomechanical outcome measures and all clinical outcome measures except the MAS. There were no significant differences in the outcome measures between the 2 groups. These findings suggest that the translation of repetitive, goal-directed, biofeedback training through motivating games from the laboratory to the home environment is feasible. The benefits of home-based robot-guided therapy were similar to those of laboratory-based robot-guided therapy. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p dental implants can be immediately used successfully for retaining lower complete dentures, as shown after a 1-year follow up. © 2016 Wiley Periodicals, Inc.

  20. Randomized Controlled Feasibility Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children with Suspected Extremity Fractures.

    Science.gov (United States)

    Reynolds, Stacy L; Bryant, Kathleen K; Studnek, Jonathan R; Hogg, Melanie; Dunn, Connell; Templin, Megan A; Moore, Charity G; Young, James R; Walker, Katherine Rivera; Runyon, Michael S

    2017-12-01

    We compared the tolerability and efficacy of intranasal subdissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger noninferiority trial that could investigate the potential opioid-sparing effects of intranasal ketamine. This randomized controlled trial compared 1 mg/kg intranasal ketamine to 1.5 μg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures presenting to an urban Level II pediatric trauma center from December 2015 to November 2016. Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the emergency department (ED) stay, and the feasibility of enrolling children presenting to the ED in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room. Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6-11) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73 ± 26) and fentanyl (69 ± 26; mean difference [95% CI] = 4 [-7 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most

  1. Voice Quality After Treatment of Early Vocal Cord Cancer: A Randomized Trial Comparing Laser Surgery With Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Aaltonen, Leena-Maija, E-mail: leena-maija.aaltonen@hus.fi [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Rautiainen, Noora; Sellman, Jaana [Institute of Behavioural Sciences, University of Helsinki, Helsinki (Finland); Saarilahti, Kauko [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Mäkitie, Antti; Rihkanen, Heikki [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Laranne, Jussi; Kleemola, Leenamaija [Department of Otorhinolaryngology–Head and Neck Surgery, Tampere University Hospital, and University of Tampere, Tampere (Finland); Wigren, Tuija [Department of Oncology, Tampere University Hospital, and University of Tampere, Tampere (Finland); Sala, Eeva [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Lindholm, Paula [Department of Oncology, Turku University Hospital, and University of Turku, Turku (Finland); Grenman, Reidar [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Joensuu, Heikki [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland)

    2014-10-01

    Objective: Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy. The quality of voice achieved with these treatments has not been compared in a randomized trial. Methods and Materials: Male patients with carcinoma limited to 1 mobile vocal cord (T1aN0M0) were randomly assigned to receive either laser surgery (n=32) or external beam radiation therapy (n=28). Surgery consisted of tumor excision with a CO{sub 2} laser with the patient under general anaesthesia. External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks. Voice quality was assessed at baseline and 6 and 24 months after treatment. The main outcome measures were expert-rated voice quality on a grade, roughness, breathiness, asthenia, and strain (GRBAS) scale, videolaryngostroboscopic findings, and the patients' self-rated voice quality and its impact on activities of daily living. Results: Overall voice quality between the groups was rated similar, but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy. Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment. Three patients in each group had local cancer recurrence within 2 years from randomization. Conclusions: Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding. Overall voice quality was similar in both treatment groups, however, indicating a need for careful consideration of patient-related factors in the choice of a treatment option.

  2. Internet-based self-management plus education compared with usual care in asthma: a randomized trial

    NARCIS (Netherlands)

    van der Meer, Victor; Bakker, Moira J.; van den Hout, Wilbert B.; Rabe, Klaus F.; Sterk, Peter J.; Kievit, Job; Assendelft, Willem J. J.; Sont, Jacob K.; Assendelft, W. J. J.; Thiadens, H. A.; Bakker, M. J.; van den Hout, W. B.; Kievit, J.; van der Meer, V.; Sont, J. K.; Kaptein, A. A.; Rikkers-Mutsaerts, E. R. V. M.; Rabe, K. F.; Bel, E. H. D.; Detmar, S. B.; Otten, W.; van Stel, H. F.; Roldaan, A. C.; de Jongste, J. C.; Toussaint, P. J.

    2009-01-01

    BACKGROUND: The Internet may support patient self-management of chronic conditions, such as asthma. OBJECTIVE: To evaluate the effectiveness of Internet-based asthma self-management. DESIGN: Randomized, controlled trial. SETTING: 37 general practices and 1 academic outpatient department in the

  3. Value for Money: Economic Evaluation of Two Different Caries Prevention Programmes Compared with standard Care in a Randomized Controlled Trial

    NARCIS (Netherlands)

    Vermaire, J.H.; Loveren, C. van; Brouwer, W.B.F.; Krol, M.

    2014-01-01

    A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme

  4. Value for money: economic evaluation of two different caries prevention programmes compared with standard care in a randomized controlled trial

    NARCIS (Netherlands)

    Vermaire, J.H.; van Loveren, C.; Brouwer, W.B.F.; Krol, M.

    2014-01-01

    A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme

  5. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial

    NARCIS (Netherlands)

    Hoogendam, A.; Vries Robbé, P.F. de; Overbeke, A.J.P.M.

    2012-01-01

    BACKGROUND: Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick

  6. A randomized controlled trial comparing the effectiveness of functional knee brace and neoprene sleeve use after anterior cruciate ligament reconstruction.

    Science.gov (United States)

    Birmingham, Trevor B; Bryant, Dianne M; Giffin, J Robert; Litchfield, Robert B; Kramer, John F; Donner, Allan; Fowler, Peter J

    2008-04-01

    Despite a lack of evidence for their effectiveness, functional knee braces are commonly prescribed to patients after anterior cruciate ligament (ACL) reconstruction. This trial was conducted to compare postoperative outcomes in patients using an ACL functional knee brace and patients using a neoprene knee sleeve. Patients using a brace will have superior outcomes than those using a sleeve. Randomized controlled clinical trial; Level of evidence, 1. One hundred fifty patients were randomized to receive a brace (n = 76) or neoprene sleeve (n = 74) at their 6-week postoperative visit after primary ACL reconstruction with hamstring autograft. Patients were assessed preoperatively, then 6 weeks and 6, 12, and 24 months postoperatively. Outcome measures included disease-specific quality of life (Anterior Cruciate Ligament-Quality of Life [ACL-QOL] Questionnaire), anterior tibial translation (KT-1000 arthrometer side-to-side difference), the single-limb forward hop test (limb symmetry index), and Tegner Activity Scale. Outcomes at 1 and 2 years were compared after adjusting for baseline scores. Subjective ratings of how patients felt while using the brace/sleeve were also collected for descriptive purposes using a questionnaire. Four a priori directional subgroup hypotheses were evaluated using tests for interactions. There were no significant differences between brace (n = 62) and sleeve (n = 65) groups for any of the outcomes at 1- and 2-year follow-ups. Adjusted mean differences at 2 years were as follows: -0.94 (95% confidence interval [CI], -7.52 to 5.64) for the ACL-QOL Questionnaire, -0.10 mm (95% CI, -0.99 to 0.81) for KT-1000 arthrometer side-to-side difference, -0.87% (95% CI, -8.89 to 7.12) for hop limb symmetry index, and -0.05 (95% CI, -0.72 to 0.62) for the Tegner Activity Scale. Subjective ratings of confidence in the knee provided by the brace/sleeve were higher for the brace group than the sleeve group. Subgroup findings were minimal. Adverse events were

  7. A pilot randomized trial comparing long-term effects of red and white wines on biomarkers of atherosclerosis (in vino veritas: IVV trial).

    Science.gov (United States)

    Taborsky, M; Ostadal, P; Petrek, M

    2012-01-01

    Since early 90', growing body of evidence indicates that the Mediterranean diet with mild to moderate consumption of wine, mostly red wine, has a protective effect on cardiovascular diseases. Several mechanisms have been discussed to participate in the beneficial effect of red wine, such as antioxidant or vasodilating activity. However, later it has been shown that also other alcoholic beverages have a protective effect on atherosclerosis. Up to now, data from the prospective, long-term, head-to-head comparisons of the effects of different drinks on markers of atherosclerosis are insufficient. The IVV (in vino veritas) study is a long-term, prospective, multicenter, randomized trial comparing the effect of red and white wines on the markers of atherosclerosis. One hundred and twenty healthy subjects with mild to moderate risk of atherosclerosis will be randomized to regular consumption of red wine (Pinot Noir) or white wine (Chardonnay-Pinot) for one year. The primary endpoint is the level of HDL-cholesterol at one year, while secondary endpoints are levels of other markers of atherosclerosis (LDL-cholesterol, C-reactive protein, myeloperoxidase, advanced oxidation protein product, interleukins 6 and 18, matrix metalloproteinases, glutathione s-transferase, monocyte chemoattractant protein 1, soluble CD40L). The IVV trial is the first study focusing on the long-term prospective comparison of the effects of red and white wines consumption on HDL-cholesterol and other markers of atherosclerosis. Results of the IVV trial may extend our understanding of the widely discussed "French paradox" (Tab. 1, Ref. 21)

  8. 1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass.

    Science.gov (United States)

    Reijnen, Michel M P J; van Walraven, Laurens A; Fritschy, Wilbert M; Lensvelt, Mare M A; Zeebregts, Clark J; Lemson, M Suzanna; Wikkeling, Otmar R M; Smeets, Luuk; Holewijn, Suzanne

    2017-11-27

    This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates. Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion. A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner. A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed

  9. Randomized controlled trial: a randomized controlled clinical trial comparing a remineralizing paste with an antibacterial gel to prevent early childhood caries.

    Science.gov (United States)

    Plonka, K A; Pukallus, M L; Holcombe, T F; Barnett, A G; Walsh, L J; Seow, W K

    2013-01-01

    The purpose of this study was to compare twice daily tooth-brushing using 0.304 percent fluoride toothpaste alone with: (1) twice daily tooth-brushing plus once daily 10% casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) paste; and (2) twice daily tooth-brushing plus once daily 0.12% chlorhexidine gel (CHX) for reducing early childhood caries (ECC) and mutans streptococci (MS) colonization. Subjects (n=622) recruited at birth were randomized to receive either CPP-ACP or CHX or no product (study control [SC]). All children were examined at 6, 12, and 18 months old in their homes, and at 24 months old in a community dental clinic. At 24 months old, the caries incidence was 1% (2/163) in CPP-ACP, 2% (4/180) in CHX, and 2% (3/188) in SC groups. In children who were previously MS colonized at 12 and 18 months old, 0% (0/11) and 5% (3/63), respectively, of the CPP-ACP group remained MS-positive versus 22% (2/9) and 72% (18/25) in CHX and 16% (4/25) and 50% (7/14) in SC groups (P<.001). There is insufficient evidence to justify the daily use of casein phosphopeptide-amorphous calcium phosphate or chlorhexidine gel to control early childhood caries.

  10. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  11. A Randomized Controlled Trial Comparing Outcomes of Cataract Surgery in Nanophthalmos With and Without Prophylactic Sclerostomy.

    Science.gov (United States)

    Rajendrababu, Sharmila; Babu, Naresh; Sinha, Sapna; Balakrishnan, Vijayakumar; Vardhan, Ashok; Puthuran, George Varghese; Ramulu, Pradeep Y

    2017-11-01

    To prospectively evaluate visual outcomes and complications during and after cataract surgery with or without prophylactic sclerostomy in nanophthalmic eyes with visually significant cataract. Randomized controlled trial. Sixty nanophthalmic eyes of 60 patients with visually significant cataract were randomly assigned to cataract surgery alone (control group, n = 31) or cataract surgery with concomitant prophylactic sclerostomy (sclerostomy group, n = 29). Surgery was performed using phacoemulsification or manual small-incision cataract surgery (SICS) based on the LOCS III grading score. Group differences in intraoperative and postoperative complications were analyzed and risk factors assessed. Fewer complications were noted in eyes receiving sclerostomy (5/29, 17.2%) as compared to control group eyes (12/31, 38.7%), though differences were marginally significant (P = .065). Four control group, but no sclerostomy group, eyes developed postoperative uveal effusions (P = .04). In multivariable models, sclerostomy decreased the odds of an intraoperative or postoperative complication by 80% (odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.04-0.92, P = .039); SICS was associated with a significantly higher risk of complications as compared to phacoemulsification (OR = 5.95, 95% CI = 1.49-23.73, P = .012), while high preoperative intraocular pressure (OR = 4.54, 95% CI = 0.99-20.9, P = .052) and greater lens thickness (OR = 3.38, 95% CI = 0.88-12.91, P = .075) demonstrated a marginally significant association. Cataract surgery in eyes with nanophthalmos is associated with a high risk for vision-threatening complications. Performing a simultaneous prophylactic sclerostomy with cataract surgery reduces complication rates, particularly uveal effusions. Cataract surgery at earlier stages by phacoemulsification may be more beneficial than undergoing manual SICS. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Focal cartilage defects in the knee - a randomized controlled trial comparing autologous chondrocyte implantation with arthroscopic debridement.

    Science.gov (United States)

    Randsborg, Per-Henrik; Brinchmann, Jan; Løken, Sverre; Hanvold, Heidi Andreassen; Aae, Tommy Frøseth; Årøen, Asbjørn

    2016-03-08

    Focal cartilage injuries in the knee might have devastating effect due to the predisposition of early onset osteoarthritis. Various surgical treatment options are available, however no statistically significant differences have been found between the different surgical treatments. This supports the suggestion that the improvement might be a result of the post-operative rehabilitation rather than the surgery itself. Autologous chondrocyte implantation (ACI) has become a recognized treatment option for larger cartilage lesions in the knee. Although ACI has been compared to other surgical treatment such as microfracture and mosaicplasty, it has never been directly compared to simple arthroscopic debridement and rehabilitation alone. In this study we want to increase clinical and economic knowledge about autologous chondrocyte implantation compared to arthroscopic debridement and physical rehabilitation in the short and long run. We will conduct a randomized controlled trial to compare ACI with simple arthroscopic debridement (AD) and physiotherapy for the treatment of cartilage lesions in the knee. The study will include a total of 82 patients, both men and non-pregnant women, with a full thickness cartilage defect in the weight bearing area of the femoral condyles or trochlea larger than 2 cm2. The lesion must be symptomatic, with a Lysholm score less than 75. The two treatment groups will receive identical rehabilitation protocol according to a modification of Wondrasch et al., which is an active rehabilitation and education program divided into 3 phases: accommodation, rehabilitation and return to activity. The patients will be followed for 24 months, with additional late follow-ups at 5 and 10 years to monitor the potential onset of osteoarthtitis. The primary outcome measure will be the difference in the KOOS knee-related quality of life (QoL) subscore in the ACI group compared to the AD group at 2 years. A combination of self-explanatory questionnaires

  13. Randomized, controlled trial comparing the effects of anesthesia with propofol, isoflurane, desflurane and sevoflurane on pain after laparoscopic cholecystectomy

    Directory of Open Access Journals (Sweden)

    Jaime Ortiz

    2014-06-01

    Full Text Available Background: Pain is the primary complaint and the main reason for prolonged recovery after laparoscopic cholecystectomy. The authors hypothesized that patients undergoing laparoscopic cholecystectomy will have less pain four hours after surgery when receiving maintenance of anesthesia with propofol when compared to isoflurane, desflurane, or sevoflurane. Methods: In this prospective, randomized trial, 80 patients scheduled for laparoscopic cholecystectomy were assigned to propofol, isoflurane, desflurane, or sevoflurane for the maintenance of anesthesia. Our primary outcome was pain measured on the numeric analog scale four hours after surgery. We also recorded intraoperative use of opioids as well as analgesic consumption during the first 24 h after surgery. Results: There was no statistically significant difference in pain scores four hours after surgery (p = 0.72. There were also no statistically significant differences in pain scores between treatment groups during the 24 h after surgery (p = 0.45. Intraoperative use of fentanyl and morphine did not vary significantly among the groups (p = 0.21 and 0.24, respectively. There were no differences in total morphine and hydrocodone/APAP use during the first 24 h (p = 0.61 and 0.53, respectively. Conclusion: Patients receiving maintenance of general anesthesia with propofol do not have less pain after laparoscopic cholecystectomy when compared to isoflurane, desflurane, or sevoflurane.

  14. A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain

    Directory of Open Access Journals (Sweden)

    Tamara J. Somers

    2016-01-01

    Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.

  15. A multicenter randomized trial comparing rabeprazole and itopride in patients with functional dyspepsia in Japan: the NAGOYA study.

    Science.gov (United States)

    Kamiya, Takeshi; Shikano, Michiko; Kubota, Eiji; Mizoshita, Tsutomu; Wada, Tsuneya; Tanida, Satoshi; Kataoka, Hiromi; Adachi, Hiroshi; Hirako, Makoto; Okuda, Noriaki; Joh, Takashi

    2017-03-01

    The aims of this study were to compare the therapeutic effects of a proton pump inhibitor (PPI), rabeprazole (RPZ), and a prokinetic agent, itopride (ITO), and to investigate the role of PPI in the treatment strategy for Japanese functional dyspepsia (FD) patients. We randomly assigned 134 patients diagnosed by Rome III criteria to 4 weeks treatment with RPZ 10 mg/day (n = 69) or ITO 150 mg/day (n = 65). Dyspeptic symptoms were evaluated using FD scores at baseline and after 1, 2 and 4 weeks of treatment. We also divided subjects into predominantly epigastric pain syndrome (EPS) or postprandial distress syndrome (PDS), and evaluated the efficacy of RPZ and ITO respectively. RPZ showed a significant decrease in the Rate of Change (RC) in FD score within 1 week, which was maintained until after 4 weeks, with RPZ a significant effect compared with ITO at all evaluation points. In addition, RPZ showed a significant decrease in FD score in subjects with both EPS and PDS, whereas a significant decrease in the RC with ITO was only shown in those with predominant PDS. Acid-suppressive therapy with RPZ is useful for PDS as well EPS in Japanese FD patients (UMIN Clinical Trials Registry number: UMIN 000013962).

  16. Anaesthetic efficacy of 4% articaine compared with 2% mepivacaine: a randomized, double-blind, crossover clinical trial.

    Science.gov (United States)

    Bortoluzzi, M C; de Camargo Smolarek, P; Cecato, R; Pochapski, M T; Chibinski, A C R

    2017-11-30

    The aim of this study was to evaluate the clinical efficacy of 4% articaine (Ar4) compared to 2% mepivacaine (Me2), both in combination with 1:100,000 epinephrine, in a unique soft tissue model. This was a randomized, double-blind, crossover clinical trial. The anaesthetic was applied to the lower lip using a computerized local delivery system. The following were evaluated: blood flow, thermal sensation, pressure and proprioception, extent of anaesthesia, gradual elimination, and the final duration of the effect of the anaesthesia. Seventy-two volunteers completed all parts of the study. Significant differences, which indicated better effectiveness of Me2 compared to Ar4, were observed in the following tests: reduction in blood flow (larger in the Me2 group); anaesthetized area at 30min (larger in the Me2 group); pressure tests; temperature tests after 20min; fine and discriminatory proprioception tests after 20min. The volunteers' perception of anaesthesia at 30, 40, 50, and 60min was superior for Me2 at all recorded time points. The duration of anaesthesia was also superior for Me2. The overall performance of Me2 was superior to Ar4, implying that Me2 provides a more effective anaesthesia in terms of depth, extent, and duration. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  17. Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis.

    Science.gov (United States)

    Urquhart, Jennifer C; Alrehaili, Osama A; Fisher, Charles G; Fleming, Alyssa; Rasoulinejad, Parham; Gurr, Kevin; Bailey, Stewart I; Siddiqi, Fawaz; Bailey, Christopher S

    2017-07-01

    OBJECTIVE A multicenter, prospective, randomized equivalence trial comparing a thoracolumbosacral orthosis (TLSO) to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures was recently conducted and demonstrated that the two treatments following an otherwise similar management protocol are equivalent at 3 months postinjury. The purpose of the present study was to determine whether there was a difference in long-term clinical and radiographic outcomes between the patients treated with and those treated without a TLSO. Here, the authors present the 5- to 10-year outcomes (mean follow-up 7.9 ± 1.1 years) of the patients at a single site from the original multicenter trial. METHODS Between July 2002 and January 2009, a total of 96 subjects were enrolled in the primary trial and randomized to two groups: TLSO or NO. Subjects were enrolled if they had an AO Type A3 burst fracture between T-10 and L-3 within the previous 72 hours, kyphotic deformity TLSO group and 20 in the NO group. The primary outcome measure was the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up. Secondary outcome measures included kyphosis, satisfaction, the Numeric Rating Scale for back pain, and the 12-Item Short-Form Health Survey (SF-12) Mental and Physical Component Summary (MCS and PCS) scores. In the original study, outcome measures were administered at admission and 2 and 6 weeks, 3 and 6 months, and 1 and 2 years after injury; in the present extended follow-up study, the outcome measures were administered 5-10 years postinjury. Treatment comparison between patients in the TLSO group and those in the NO group was performed at the latest available follow-up, and the time-weighted average treatment effect was determined using a mixed-effects model of longitudinal regression for repeated measures averaged over all time periods. Missing data were assumed to be missing at random and were replaced with a set of plausible values

  18. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Yakoot Mostafa

    2012-04-01

    Full Text Available Abstract Background Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Methods Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment. The two groups were followed up and blindly compared for early (after 3 months and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT, Chronic Liver Disease Questionnaire scores (CLDQ, Arizona Sexual Experience Scale scores (ASEX and the occurrence of any attributable adverse events were also compared. Results Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3% had a complete end of treatment virological response and 2 patients (6.7% had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12 and 3 months treatment (p = 0.22 by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group

  19. Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Bush, David A., E-mail: dbush@llu.edu [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Smith, Jason C. [Department of Diagnostic Radiology, Loma Linda University Medical Center, Loma Linda, California (United States); Slater, Jerry D. [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Volk, Michael L. [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Reeves, Mark E. [VA Loma Linda Health Care System, Loma Linda, California (United States); Cheng, Jason [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Grove, Roger [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Vera, Michael E. de [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States)

    2016-05-01

    Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are

  20. Treating Anxiety Disorders in Inner City Schools: Results from a Pilot Randomized Controlled Trial Comparing CBT and Usual Care

    Science.gov (United States)

    Becker, Kimberly D.; Drazdowski, Tess K.; Tein, Jenn-Yun

    2012-01-01

    Background The effectiveness of cognitive-behavioral treatment (CBT) in inner city schools, when delivered by novice CBT clinicians, and compared to usual care (UC), is unknown. Objective This pilot study addressed this issue by comparing a modular CBT for anxiety disorders to UC in a sample of 32 volunteer youth (mean age 10.28 years, 63% female, 84% African American) seen in school-based mental health programs. Methods Youth were randomly assigned to CBT (n = 17) or UC (n = 15); independent evaluators conducted diagnostic interviews with children and parents at pre- and post-intervention, and at a one-month follow-up. Results Based on intent-to-treat analyses, no differences were found in response rates between groups with 50 and 42% of the children in CBT, compared to 46 and 57% in UC no longer meeting criteria for an anxiety disorder at post-treatment and follow-up respectively. Similar improvements in global functioning were also found in both treatment groups. Baseline predictors of a positive treatment response included lower anxiety, fewer maladaptive thoughts, less exposure to urban hassles, and lower levels of parenting stress. Therapist use of more CBT session structure elements and greater competence in implementing these elements was also related to a positive treatment response. Conclusions Findings from this small pilot failed to show that CBT was superior to UC when delivered by school-based clinicians. Large scale comparative effectiveness trials are needed to determine whether CBT leads to superior clinical outcomes prior to dissemination. PMID:22701295

  1. Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction.

    Science.gov (United States)

    Jeuken, Ralph M; Schotanus, Martijn G M; Kort, Nanne P; Deenik, Axel; Jong, Bob; Hendrickx, Roel P M

    2016-07-01

    Hallux valgus is one of the most common foot deformities. This long-term follow-up study compared the results of 2 widely used operative treatments for hallux valgus: the scarf and chevron osteotomy. Conventional weight bearing anteroposterior (AP) radiographs of the foot were made for evaluating the intermetatarsal angle and hallux valgus angle. For clinical evaluation, the American Orthopaedic Foot & Ankle Society (AOFAS) rating system for the hallux metatarsophalangeal-interphalangeal scale was used together with physical examination of the foot. These data were compared with the results from the original study. The Short Form 36 questionnaire, the Manchester-Oxford Foot Questionnaire (MOXFQ), and a general questionnaire including a visual analog scale (VAS) pain score were used for subjective evaluation. The primary outcome measures were the radiologic recurrence of hallux valgus and reoperation rate of the same toe. Secondary outcome measures were the results from the radiographs and subjective and clinical evaluation. The response rate was 76% at the follow-up of 14 years; in the chevron group, 37 feet were included compared with 36 feet in the scarf group. Twenty-eight feet in the chevron group and 27 in the scarf group developed recurrence of hallux valgus (P = .483). One patient in the scarf group had a reoperation of the same toe compared with none in the chevron group (P = .314). Current VAS pain scores and results from the SF-36, MOXFQ, and AOFAS did not significantly differ between groups. Both techniques showed similar results after 2 years of follow-up. At 14 years of follow-up, neither technique was superior in preventing recurrence. Level II, randomized controlled trial. © The Author(s) 2016.

  2. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Gelade, K.; Janssen, T.W.P.; Bink, M.; van Mourik, R.; Maras, A.; Oosterlaan, J.

    2016-01-01

    Objective: The efficacy of neurofeedback as treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, are still intensely debated subjects. The current randomised controlled trial compared neurofeedback to (1) optimally

  3. Comparing Acceptance and Commitment Group Therapy and 12-Steps Narcotics Anonymous in Addict's Rehabilitation Process: A Randomized Controlled Trial.

    Science.gov (United States)

    Azkhosh, Manoochehr; Farhoudianm, Ali; Saadati, Hemn; Shoaee, Fateme; Lashani, Leila

    2016-10-01

    Objective: Substance abuse is a socio-psychological disorder. The aim of this study was to compare the effectiveness of acceptance and commitment therapy with 12-steps Narcotics Anonymous on psychological well-being of opiate dependent individuals in addiction treatment centers in Shiraz, Iran. Method: This was a randomized controlled trial. Data were collected at entry into the study and at post-test and follow-up visits. The participants were selected from opiate addicted individuals who referred to addiction treatment centers in Shiraz. Sixty individuals were evaluated according to inclusion/ exclusion criteria and were divided into three equal groups randomly (20 participants per group). One group received acceptance and commitment group therapy (Twelve 90-minute sessions) and the other group was provided with the 12-steps Narcotics Anonymous program and the control group received the usual methadone maintenance treatment. During the treatment process, seven participants dropped out. Data were collected using the psychological well-being questionnaire and AAQ questionnaire in the three groups at pre-test, post-test and follow-up visits. Data were analyzed using repeated measure analysis of variance. Results: Repeated measure analysis of variance revealed that the mean difference between the three groups was significant (Pacceptance and commitment therapy group showed improvement relative to the NA and control groups on psychological well-being and psychological flexibility. Conclusion: The results of this study revealed that acceptance and commitment therapy can be helpful in enhancing positive emotions and increasing psychological well-being of addicts who seek treatment.

  4. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial.

    Science.gov (United States)

    Piette, John D; Striplin, Dana; Marinec, Nicolle; Chen, Jenny; Trivedi, Ranak B; Aron, David C; Fisher, Lawrence; Aikens, James E

    2015-06-10

    Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help. We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach. We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a "CarePartner" outside their household. Patients randomized to "standard mHealth" (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients' responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to "mHealth+CP" (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient's status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments. Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, Phealth during weekly IVR calls. Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal

  5. Comparative study of hemodynamic changes caused by diazepam and midazolam during third molar surgery: a randomized controlled trial.

    Science.gov (United States)

    de Morais, Hécio Henrique Araújo; Barbalho, Jimmy Charles Melo; de Holanda Vasconcellos, Ricardo José; Landim, Fabricio Souza; da Costa Araújo, Fábio Andrey; de Souza Dias, Tasiana Guedes

    2015-09-01

    The aim of the present study was to compare hemodynamic changes using midazolam 7.5 mg and diazepam 10.0 mg during the surgical removal of symmetrically positioned third molars. A prospective, randomized, double-blind, clinical trial was carried out involving 120 patients divided into three groups: Group 1 (diazepam and placebo), Group 2 (midazolam and placebo), and Group 3 (diazepam and midazolam). Each subject underwent two surgeries on separate occasions under local anesthesia. The following parameters were assessed at five different times (T0, T1, T2, T3, and T4): systolic, diastolic, and mean blood pressure (SBP, DBP, and MBP, respectively); heart rate (HR); oxygen saturation (SpO(2)); rate pressure product (RPP); and pressure rate quotient (PRQ). Statistically significant differences were found regarding heart rate at T2 and T3 (p diazepam administration, whereas a higher heart rate occurred at T3 with midazolam. Midazolam 7.5 mg and diazepam 10.0 mg exert an influence on some hemodynamic parameters without perceptible clinical changes in healthy patients undergoing lower third molar surgery.

  6. A double blind randomized control trial, comparing effect of drospirenone and gestodene to sexual desire and libido.

    Science.gov (United States)

    Oranratanaphan, Shina; Taneepanichskul, Surasak

    2006-10-01

    Oral contraceptive is the most commonly used method of fertility control. Yasmin is a combination of a novel progestogen with anti-androgenic and anti-mineralcorticoid activities (3 mg Drospirenone (DRSP) and 30 microg ethinylestradiol (EE)). It has been shown in many clinical trials that Yasmin is an efficacious oral contraceptive, lacking undesired effects as with other oral contraceptives such as weight gain. However the effects of Yasmin on sexual desire and libido have not been intensively investigated so far Investigate the effects of Yasmin on sexual desire, libido and changes in the free androgen index (FAI) compare to Meliane (75 microg gestodene + 20 microg ethinylestradiol). The authors' report the results of a double blind randomized controlled study using a translated version of the Female Sexual Function Index questionnaire (FSFI) for the assessment of the sexual function. The free androgen index was calculated from measurements of testosterone and sexual hormone binding globulin. The result shows statistically significant improvements regarding sexual desire, arousal and overall satisfaction in the Yasmin group. Additionally, an increased frequency of orgasms in the Meliane group was reported. Statistically significant differences between the two treatments regarding changes in the FSFI score and changes in the free androgen index have not been observed. The novel oral contraceptive containing drospirenone (Yasmin) and the non-anti-androgenic progestin containing oral contraceptive (Meliane) do not show unfavorable effects on sexual response and libido.

  7. Value for money: economic evaluation of two different caries prevention programmes compared with standard care in a randomized controlled trial.

    Science.gov (United States)

    Vermaire, J H; van Loveren, C; Brouwer, W B F; Krol, M

    2014-01-01

    A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme or a non-operative caries treatment and prevention (NOCTP) programme. Information on resource use during the 3-year period was documented by the dental nurse at every patient visit, such as treatment time, travel time and travel distance. Caries increment scores (at D3MFS level) were used to assess effectiveness. Cost calculations were performed using bottom-up micro-costing. Incremental cost-effectiveness ratios (ICERs) were expressed as additional average costs per prevented DMFS. The ICERs compared with regular dental care from a health care system perspective and societal perspective were, respectively, EUR 269 and EUR 1,369 per prevented DMFS in the IPFA programme, and EUR 30 and EUR 100 in the NOCTP programme. The largest investments for the NOCTP group were made in the first year of the study; they decreased in the second and equalled the costs of control group in third year of the study. From both medical and economic points of view, the NOCTP strategy may be considered the preferred strategy for caries prevention.

  8. Prospective randomized trial comparing laparoscopic transabdominal preperitoneal (TAPP) and laparoscopic totally extra peritoneal (TEP) approach for bilateral inguinal hernias.

    Science.gov (United States)

    Sharma, Deborshi; Yadav, Kamal; Hazrah, Priya; Borgharia, Saurabh; Lal, Romesh; Thomas, Shaji

    2015-10-01

    Bilateral inguinal hernias form a part of the complex spectrum of weakness in the region of the myopectineal orifice. Laparoscopic surgery is one of the standard approaches for bilateral hernias. We describe the results of a randomized trial that was undertaken to compare and evaluate TAPP and TEP repair for bilateral inguinal hernias. Sixty patients were randomized into two groups. Group I (TAPP) and Group II (TEP) were compared in terms of procedure related variables, conversion, post-operative recovery and complications. Analysis was done using SPSS software version 17. Seventy-seven patients were assessed for fitness to include in the study. Seventeen patients had to be excluded due to either not meeting the inclusion criteria's or for not giving consent. The median age (52 yrs) was comparable in both groups. In Group II (TEP) mean operating time was 120.89 ± 29.28 min compared to 108.16 ± 16.10 min in Group I (TAPP). Post-operative pain scores were less in Group I(TAPP) at all levels of recording (8 h-48 h), though most patients required injectable analgesic for 32 h in both groups (p-value 0.029). Subcutaneous emphysema was more commonly noted in the Group II (TEP) (p-value 0.038). In Group I (TAPP) mean hospital stay was 52.0 ± 14.21 h while in Group II (TEP) it was 52.29 ± 9.36 h (p-value 0.427). Mean time for return to work was 11.8 ± 2.35 days in Group I (TAPP) and 12.41 ± 2.22 days in Group II (TEP) (p-value 0.339). The procedures though different in approach were quite similar in outcome. Mean operating time was increased in the TEP repairs along with immediate post-operative pain scores. The pattern of some complications like subcutaneous emphysema was significantly more in the TEP group while minor vascular injury though not significant was different in both groups. The indirect cost incurred from consumables did not vary other than need for more tacks in the TAPP group. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd

  9. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    Science.gov (United States)

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P post hoc analyses should be viewed with caution given the potential for bias, in eyes with a VA of 20/50 or worse, aflibercept has the greatest improvement in VA over 2 years. Focal/grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years. clinicaltrials.gov Identifier NCT01627249.

  10. Comparative Effects of Different Balance-Training-Progression Styles on Postural Control and Ankle Force Production: A Randomized Controlled Trial.

    Science.gov (United States)

    Cuğ, Mutlu; Duncan, Ashley; Wikstrom, Erik

    2016-02-01

    Despite the effectiveness of balance training, the exact parameters needed to maximize the benefits of such programs remain unknown. One such factor is how individuals should progress to higher levels of task difficulty within a balance-training program. Yet no investigators have directly compared different balance-training-progression styles. To compare an error-based progression (ie, advance when proficient at a task) with a repetition-based progression (ie, advance after a set amount of repetitions) style during a balance-training program in healthy individuals. Randomized controlled trial. Research laboratory. A total of 28 (16 women, 12 men) physically healthy young adults (age = 21.57 ± 3.95 years, height = 171.60 ± 11.03 cm, weight = 72.96 ± 16.18 kg, body mass index = 24.53 ± 3.7). All participants completed 12 supervised balance-training sessions over 4 weeks. Each session consisted of a combination of dynamic unstable-surface tasks that incorporated a BOSU ball and lasted about 30 minutes. Static balance from an instrumented force plate, dynamic balance as measured via the Star Excursion Balance Test, and ankle force production in all 4 cardinal planes of motion as measured with a handheld dynamometer before and after the intervention. Selected static postural-control outcomes, dynamic postural control, and ankle force production in all planes of motion improved (P .05) for any of the outcome measures. A 4-week balance-training program consisting of dynamic unstable-surface exercises on a BOSU ball improved dynamic postural control and ankle force production in healthy young adults. These results suggest that an error-based balance-training program is comparable with but not superior to a repetition-based balance-training program in improving postural control and ankle force production in healthy young adults.

  11. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    Directory of Open Access Journals (Sweden)

    Falgun Indravadan Vyas

    2014-01-01

    Full Text Available Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Results: Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P < 0.05; however, the difference was not clinically significant (<1΀C. The rate of fall of temperature was highest in the combination group. Number of afebrile children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1 st h (P = 0.04. Highest fall of temperature was noted in the 1 st h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Conclusion: Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.

  12. Comparing energy sources for surgical ablation of atrial fibrillation: a Bayesian network meta-analysis of randomized, controlled trials.

    Science.gov (United States)

    Phan, Kevin; Xie, Ashleigh; Kumar, Narendra; Wong, Sophia; Medi, Caroline; La Meir, Mark; Yan, Tristan D

    2015-08-01

    Simplified maze procedures involving radiofrequency, cryoenergy and microwave energy sources have been increasingly utilized for surgical treatment of atrial fibrillation as an alternative to the traditional cut-and-sew approach. In the absence of direct comparisons, a Bayesian network meta-analysis is another alternative to assess the relative effect of different treatments, using indirect evidence. A Bayesian meta-analysis of indirect evidence was performed using 16 published randomized trials identified from 6 databases. Rank probability analysis was used to rank each intervention in terms of their probability of having the best outcome. Sinus rhythm prevalence beyond the 12-month follow-up was similar between the cut-and-sew, microwave and radiofrequency approaches, which were all ranked better than cryoablation (respectively, 39, 36, and 25 vs 1%). The cut-and-sew maze was ranked worst in terms of mortality outcomes compared with microwave, radiofrequency and cryoenergy (2 vs 19, 34, and 24%, respectively). The cut-and-sew maze procedure was associated with significantly lower stroke rates compared with microwave ablation [odds ratio <0.01; 95% confidence interval 0.00, 0.82], and ranked the best in terms of pacemaker requirements compared with microwave, radiofrequency and cryoenergy (81 vs 14, and 1, <0.01% respectively). Bayesian rank probability analysis shows that the cut-and-sew approach is associated with the best outcomes in terms of sinus rhythm prevalence and stroke outcomes, and remains the gold standard approach for AF treatment. Given the limitations of indirect comparison analysis, these results should be viewed with caution and not over-interpreted. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  13. A prospective randomized trial comparing the efficacy of Letrozole and Clomiphene citrate in induction of ovulation in polycystic ovarian syndrome

    Directory of Open Access Journals (Sweden)

    Kallol Kumar Roy

    2012-01-01

    Full Text Available Objectives: To compare the efficacy of letrozole and clomiphene citrate (CC in patients of anovulatory polycystic ovarian syndrome (PCOS with infertility. Materials and Methods: This prospective randomized clinical trial included 204 patients of PCOS. 98 patients (294 cycles received 2.5-5 mg of letrozole; 106 patients (318 cycles received 50-100 mg of CC (both orally from Days 3-7 of menstrual cycle. The treatment continued for three cycles in both the groups. Main outcome measures: ovulation rate, endometrial thickness, and pregnancy rate. Statistical analysis was done using SPSS 13 software. P value less than 0.05 was considered significant. Results: The mean number of dominant follicles in letrozole groups and CC groups was 1.86±0.26 and 1.92±0.17, respectively (P=0.126. Number of ovulatory cycle in letrozole group was 196 (66.6% versus 216 (67.9% in CC group (P=0.712. The mean mid-cycle endometrial thickness was 9.1±0.3 mm in letrozole group and 6.3±1.1 in CC group, which was statistically significant (P=0.014. The mean Estradiol [E2] level in clomiphene citrate group was significantly higher in CC group (364.2±71.4 pg/mL than letrozole group (248.2± 42.2 pg/mL. 43 patients from the letrozole group (43.8% and 28 patients from the CC group (26.4% became pregnant. Conclusion: Letrozole and CC have comparable ovulation rate. The effect of letrozole showed a better endometrial response and pregnancy rate compared with CC.

  14. Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

    Science.gov (United States)

    Ragni, Margaret V

    2011-01-01

    A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

  15. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial

    OpenAIRE

    Carrera, Fernando; Charmaine E. Lok; de Francisco, Angel; Locatelli, Francesco; Mann, Johannes F.E.; Canaud, Bernard; Kerr, Peter G.; Macdougall, Iain C.; Besarab, Anatole; Villa, Giuseppe; Kazes, Isabelle; Van Vlem, Bruno; Jolly, Shivinder; Beyer, Ulrich; Dougherty, Frank C.

    2010-01-01

    Background. Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Methods. Haemodialysis patients (n = 490)...

  16. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days).

    Science.gov (United States)

    van Nieuwkoop, Cees; van't Wout, Jan W; Assendelft, Willem J J; Elzevier, Henk W; Leyten, Eliane M S; Koster, Ted; Wattel-Louis, G Hanke; Delfos, Nathalie M; Ablij, Hans C; Kuijper, Ed J; Pander, Jan; Blom, Jeanet W; Spelt, Ida C; van Dissel, Jaap T

    2009-08-19

    Current guidelines on the management of urinary tract infection recommend treating febrile urinary tract infection or acute pyelonephritis with antimicrobials for at least 14 days. Few randomized trials showed the effectiveness of treatment durations of 5 to 7 days but this has only been studied in young previously healthy women. A randomized placebo-controlled double-blind multicenter non-inferiority trial in which 400 patients with community acquired febrile urinary tract infection will be randomly allocated to a short treatment arm (7 days of ciprofloxacin or 7 days of empirical beta-lactams +/- gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded placebo) or standard treatment arm (7 days of ciprofloxacin or 7 days of empirical beta-lactams +/- gentamicin intravenously with early switch to oral ciprofloxacin followed by 7 days of blinded ciprofloxacin). The study is performed in the Leiden region in which one university hospital, 6 general hospitals and 32 primary health care centers are clustered. Patients eligible for randomization are competent patients aged 18 years or above with a presumptive diagnosis of acute pyelonephritis as defined by the combination of fever, one or more symptoms of urinary tract infection and a positive urine nitrate test and/or the presence of leucocyturia. Exclusion criteria are known allergy to fluoroquinolones, female patients who are pregnant or lactating, polycystic kidney disease, permanent renal replacement therapy, kidney transplantation, isolation of ciprofloxacin-resistant causal uropathogen, renal abscess, underlying chronic bacterial prostatitis, metastatic infectious foci and inability to obtain follow-up. The primary endpoint is the clinical cure rate through the 10- to 18-day post-treatment visit. Secondary endpoints are the microbiological cure rate 10- to 18-day post-treatment, the 30- and 90-day overall mortality rate, the clinical cure rate 70- to 84-day post

  17. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial.

    Science.gov (United States)

    Lønne, Greger; Johnsen, Lars Gunnar; Aas, Eline; Lydersen, Stian; Andresen, Hege; Rønning, Roar; Nygaard, Øystein P

    2015-04-15

    Randomized clinical trial with 2-year follow-up. To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis. Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment. We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio. The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886-3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: -0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700. The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to

  18. Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence

    Directory of Open Access Journals (Sweden)

    Reed George

    2011-06-01

    Full Text Available Abstract Background Despite the demonstrated need to increase screening mammography utilization and strong evidence that mail and telephone outreach to women can increase screening, most managed care organizations have not adopted comprehensive outreach programs. The uncertainty about optimum strategies and cost effectiveness have retarded widespread acceptance. While 70% of women report getting a mammogram within the prior 2 years, repeat mammography rates are less than 50%. This 5-year study is conducted though a Central Massachusetts healthcare plan and affiliated clinic. All womenhave adequate health insurance to cover the test. Methods/Design This randomized study compares 3 arms: reminder letter alone; reminder letter plus reminder call; reminder letter plus a second reminder and booklet plus a counselor call. All calls provide women with the opportunity to schedule a mammogram in a reasonable time. The invention period will span 4 years and include repeat attempts. The counselor arm is designed to educate, motivate and counsel women in an effort to alleviate PCP burden. All women who have been in the healthcare plan for 24 months and who have a current primary care provider (PCP and who are aged 51-84 are randomized to 1 of 3 arms. Interventions are limited to women who become ≥18 months from a prior mammogram. Women and their physicians may opt out of the intervention study. Measurement of completed mammograms will use plan billing records and clinic electronic records. The primary outcome is the proportion of women continuously enrolled for ≥24 months who have had ≥1 mammogram in the last 24 months. Secondary outcomes include the number of women who need repeat interventions. The cost effectiveness analysis will measure all costs from the provider perspective. Discussion So far, 18,509 women aged 51-84 have been enrolled into our tracking database and were randomized into one of three arms. At baseline, 5,223 women were eligible

  19. Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy

    NARCIS (Netherlands)

    Lacro, R.V.; Guey, L.T.; Dietz, H.C.; Pearson, G.D.; Yetman, A.T.; Gelb, B.D.; Loeys, B.L.; Benson, D.W.; Bradley, T.J.; Backer, J. de; Forbus, G.A.; Klein, G.L.; Lai, W.W.; Levine, J.C.; Lewin, M.B.; Markham, L.W.; Paridon, S.M.; Pierpont, M.E.; Radojewski, E.; Selamet Tierney, E.S.; Sharkey, A.M.; Wechsler, S.B.; Mahony, L.

    2013-01-01

    BACKGROUND: The Pediatric Heart Network designed a clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in children and young adults with Marfan syndrome randomized to receive atenolol or losartan. We report here the characteristics of the screened population and

  20. Cancer-Related Fatigue and Rehabilitation : A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    NARCIS (Netherlands)

    van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    Background. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancer-related fatigue of physical training combined with

  1. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder

    NARCIS (Netherlands)

    Landsheer, J.A.; Smit, J.H.; van Oppen, P.C.; van Balkom, A.J.L.M.

    2015-01-01

    The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply

  2. Quality of life after self-management cancer rehabilitation : A Randomized controlled trial comparing physical and cognitive-behavioral training versus physical training

    NARCIS (Netherlands)

    Korstjens, Irene; May, Anne M.; van Weert, Ellen; Mesters, Ilse; Tan, Frans; Ros, Wynand J. G.; Hoekstra-Weebers, Josette E. H. M.; van der Schans, Cees P.; van den Borne, Bart

    Objective: To conduct a randomized controlled trial and compare the effects on cancer survivors' quality of life in a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitive-behavioral training (once weekly) with those of

  3. Quality of life after self-management cancer rehabilitation: A randomized controlled trial comparing physical and cognitive-behavioral training versus physical training

    NARCIS (Netherlands)

    I. Korstjens (Irene); A.M. May (Anne); E. van Weert (Ellen); I. Mesters (Ilse); F. Tan (Frans); W.J.G. Ros (Wynand); J.E.H.M. Hoekstra-Weebers (Josette); C.P. van der Schans (Cees); B. van den Borne (Bart)

    2008-01-01

    textabstractObjective: To conduct a randomized controlled trial and compare the effects on cancer survivors' quality of life in a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitivebehavioral training (once weekly)

  4. Differences in Blood Pressure in Infants After General Anesthesia Compared to Awake Regional Anesthesia (GAS Study-A Prospective Randomized Trial)

    NARCIS (Netherlands)

    McCann, Mary Ellen; Withington, D E; Arnup, S J; Davidson, A J; Disma, N; Frawley, G; Morton, N S; Bell, G; Hunt, R W; Bellinger, D C; Polaner, D M; Leo, A; Absalom, A R; von Ungern-Sternberg, B S; Izzo, F; Szmuk, P; Young, V; Soriano, S G; de Graaff, J C

    BACKGROUND: The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS

  5. Comparably improved health-related quality of life after total arterial revascularization versus conventional coronary surgery--Copenhagen arterial revascularization randomized patency and outcome trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Lund, Jens T; Lilleør, Nikolaj B

    2011-01-01

    OBJECTIVE: We compared health-related quality of life up to 11 months after coronary artery bypass grafting using total arterial revascularization versus conventional coronary surgery. METHODS: In this randomized single-center trial, 161 patients underwent total arterial revascularization using s...

  6. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial.

    Science.gov (United States)

    Yakoot, Mostafa; Salem, Amel

    2012-04-12

    Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ) and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment.The two groups were followed up and blindly compared for early (after 3 months) and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT), Chronic Liver Disease Questionnaire scores (CLDQ), Arizona Sexual Experience Scale scores (ASEX) and the occurrence of any attributable adverse events were also compared. Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3%) had a complete end of treatment virological response and 2 patients (6.7%) had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12) and 3 months treatment (p = 0.22) by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group. Our results could suggest a therapeutically

  7. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Li-Ang Lee

    Full Text Available BACKGROUND: Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. OBJECTIVE: To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. PATIENTS AND METHOD: Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30 were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map, were also investigated at the same time. RESULTS: Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60 rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021. The maximal loudness of low-frequency (40-300 Hz snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. CONCLUSIONS: Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect

  8. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Science.gov (United States)

    Prabhakar, A. R.; Karuna, Y. M.; Yavagal, C.; Deepak, B. M.

    2015-01-01

    Context: The survival of atraumatic restorative treatment (ART) restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control), Group II (A. vera) and Group III (propolis). Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA) with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry. PMID:25821369

  9. Postoperative Ocular Inflammation: A Single Subconjunctival Injection of XG-102 Compared to Dexamethasone Drops in a Randomized Trial.

    Science.gov (United States)

    Chiquet, Christophe; Aptel, Florent; Creuzot-Garcher, Catherine; Berrod, Jean-Paul; Kodjikian, Laurent; Massin, Pascale; Deloche, Catherine; Perino, Julien; Kirwan, Bridget-Anne; de Brouwer, Sophie; Combette, Jean-Marc; Behar-Cohen, Francine

    2017-02-01

    To evaluate the efficacy and safety of XG-102 (brimapitide) compared to dexamethasone eye drops in the treatment of postoperative ocular inflammation. Multicenter, randomized, parallel group, double-masked, noninferiority clinical trial. Patients who underwent anterior and posterior segments combined surgery or glaucoma surgery or complex posterior segment surgery were eligible to participate. Patients were administered a single subconjunctival injection of 250 μL XG-102 90 μg (n = 47) or 900 μg (n = 48) or placebo (n = 50) at the end of ocular surgery. Subconjunctival injection for each group (XG-102 90 μg, XG-102 900 μg, or placebo) was followed by eye drops instilled 4 times per day for 21 days with placebo, placebo, or dexamethasone solution, respectively. The primary outcome measure was anterior chamber cell grades at day 28 comparing XG-102 900 μg with dexamethasone. The anterior cell grades for both XG-102 groups were noninferior to dexamethasone (-0.054 anterior cell grade [95% confidence interval -0.350-0.242]; P dexamethasone groups, respectively. The difference between XG-102 90 μg and dexamethasone was statistically significant (P = .013). The number of patients for whom adverse events were reported and the nature of the events reported was similar between the 3 treatment groups. A single subconjunctival injection of XG-102 at the end of ocular surgery is noninferior to dexamethasone eye drops in the treatment of postoperative ocular inflammation. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  10. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    A R Prabhakar

    2015-01-01

    Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  11. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial.

    Science.gov (United States)

    Prabhakar, A R; Karuna, Y M; Yavagal, C; Deepak, B M

    2015-03-01

    The survival of atraumatic restorative treatment (ART) restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Experimental, in vivo intergroup split mouth, randomized clinical trial. The study included Group I (Control), Group II (A. vera) and Group III (propolis). Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Repeated measures of analysis of variance (ANOVA) with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  12. Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial

    Science.gov (United States)

    Duval, Xavier; van der Werf, Sylvie; Blanchon, Thierry; Mosnier, Anne; Bouscambert-Duchamp, Maude; Tibi, Annick; Enouf, Vincent; Charlois-Ou, Cécile; Vincent, Corine; Andreoletti, Laurent; Tubach, Florence; Lina, Bruno; Mentré, France; Leport, Catherine

    2010-01-01

    Background Neuraminidase inhibitors are thought to be efficacious in reducing the time to alleviation of symptoms in outpatients with seasonal influenza. The objective of this study was to compare the short-term virological efficacy of oseltamivir-zanamivir combination versus each monotherapy plus placebo. Methods and Findings We conducted a randomized placebo-controlled trial with 145 general practitioners throughout France during the 2008–2009 seasonal influenza epidemic. Patients, general practitioners, and outcome assessors were all blinded to treatment assignment. Adult outpatients presenting influenza-like illness for less than 36 hours and a positive influenza A rapid test diagnosis were randomized to oseltamivir 75 mg orally twice daily plus zanamivir 10 mg by inhalation twice daily (OZ), oseltamivir plus inhaled placebo (O), or zanamivir plus oral placebo (Z). Treatment efficacy was assessed virologically according to the proportion of patients with nasal influenza reverse transcription (RT)-PCR below 200 copies genome equivalent (cgeq)/µl at day 2 (primary outcome), and clinically to the time to alleviation of symptoms until day 14. Overall 541 patients (of the 900 planned) were included (OZ, n = 192; O, n = 176; Z, n = 173), 49% male, mean age 39 years. In the intention-to-treat analysis conducted in the 447 patients with RT-PCR-confirmed influenza A, 46%, 59%, and 34% in OZ (n = 157), O (n = 141), and Z (n = 149) arms had RT-PCR<200 cgeq/µl (−13.0%, 95% confidence interval [CI] −23.1 to −2.9, p = 0.025; +12.3%, 95% CI 2.39–22.2, p = 0.028 for OZ/O and OZ/Z comparisons). Mean day 0 to day 2 viral load decrease was 2.14, 2.49, and 1.68 log10 cgeq/µl (p = 0.060, p = 0.016 for OZ/O and OZ/Z). Median time to alleviation of symptoms was 4.0, 3.0, and 4.0 days (+1.0, 95% CI 0.0–4.0, p = 0.018; +0.0, 95% CI −3.0 to 3.0, p = 0.960 for OZ/O and OZ/Z). Four severe adverse events were observed. Nausea

  13. Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

    Directory of Open Access Journals (Sweden)

    Ting Joseph

    2009-01-01

    Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

  14. A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial.

    Science.gov (United States)

    Sheridan, Stacey L; Sutkowi-Hemstreet, Anne; Barclay, Colleen; Brewer, Noel T; Dolor, Rowena J; Gizlice, Ziya; Lewis, Carmen L; Reuland, Daniel S; Golin, Carol E; Kistler, Christine E; Vu, Maihan; Harris, Russell

    2016-01-01

    Healthcare overuse, the delivery of low-value services, is increasingly recognized as a critical problem. However, little is known about the comparative effectiveness of alternate formats for presenting benefits and harms information to patients as a strategy to reduce overuse. To examine the effect of different benefits and harms presentations on patients' intentions to accept low-value or potentially low-value screening services (prostate cancer screening in men ages 50-69 years; osteoporosis screening in low-risk women ages 50-64 years; or colorectal cancer screening in men and women ages 76-85 years). Randomized clinical trial of 775 individuals eligible to receive information about any 1 of the 3 screening services and scheduled for a visit with their clinician. Participants were randomized to 1 of 4 intervention arms that differed in terms of presentation format: words, numbers, numbers plus narrative, and numbers plus framed presentation. The trial was conducted from September 2012 to June 2014 at 2 family medicine and 2 internal medicine practices affiliated with the Duke Primary Care Research Consortium. The data were analyzed between May and September of 2015. One-page evidence-based decision support sheets on each of the 3 screening services, with benefits and harms information presented in 1 of 4 formats: words, numbers, numbers plus narratives, or numbers plus a framed presentation. The primary outcome was change in intention to accept screening (on a response scale from 1 to 5). Our secondary outcomes included general and disease-specific knowledge, perceived risk and consequences of disease, screening attitudes, perceived net benefit of screening, values clarity, and self-efficacy for screening. We enrolled and randomly allocated 775 individuals, aged 50 to 85 years, to 1 of 4 intervention arms: 195 to words, 192 to numbers, 196 to narrative, and 192 to framed formats. Intentions to accept screening were high before the intervention and

  15. A randomized, pilot trial comparing full versus escalating dose regimens for the desensitization of AIDS patients allergic to sulfonamides

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    Straatmann Andrea

    2002-01-01

    Full Text Available Sulfonamides are drugs extensively used in the management of AIDS patients. However, the use of sulfonamides is often associated with the development of allergic reactions, provoking the substitution of the drug (by another that may be less effective; alternatively attempts are made to desensitize the patient. OBJECTIVE: Compare two drug regimens (full vs. escalating doses for the oral desensitization of AIDS patients allergic to sulfonamides. MATERIAL AND METHODS: AIDS patients with previous allergic reactions to sulfonamides and requiring prophylaxis against Pneumocistis carinii, central nervous system toxoplasmosis and diarrhea caused by Isospora belli were randomly assigned to a group receiving a routine dose of cothrimoxazole, or another that received escalating doses of an oral suspension of the same drug, initiating with 75mg/day of sulfamethoxazole that was doubled every 48 hours till the full dose was reached, if no allergic reaction occurred. Patients were monitored for at least 6 months after enrollment in the trial. The major end-point was the ability to maintain prophylactic treatment after that period of time. Plasma viral load (PVL and CD4/CD8 counts were measured at baseline. Liver enzymes and hematological parameters were measured at baseline and after 1, 3 and 6 months. RESULTS: Eighteen patients were enrolled in the study (15 men and 3 women, with ages ranging from 30 to 57 years (mean 39.9. The mean CD4 counts were slightly higher for patients receiving a full dose; there was also a trend towards higher baseline CD8 counts among patients developing new reactions. The mean PVL was similar among the patients in both desensitization groups. The incidence of new allergic reactions was identical (40% in the two groups. All adverse reactions were mild and no significant increase in liver enzymes were observed. CONCLUSON: Dose regimen is not a predictor of the development of new allergic reactions amongst patients challenged with

  16. A randomized, pilot trial comparing full versus escalating dose regimens for the desensitization of AIDS patients allergic to sulfonamides

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    Andrea Straatmann

    Full Text Available Sulfonamides are drugs extensively used in the management of AIDS patients. However, the use of sulfonamides is often associated with the development of allergic reactions, provoking the substitution of the drug (by another that may be less effective; alternatively attempts are made to desensitize the patient. OBJECTIVE: Compare two drug regimens (full vs. escalating doses for the oral desensitization of AIDS patients allergic to sulfonamides. MATERIAL AND METHODS: AIDS patients with previous allergic reactions to sulfonamides and requiring prophylaxis against Pneumocistis carinii, central nervous system toxoplasmosis and diarrhea caused by Isospora belli were randomly assigned to a group receiving a routine dose of cothrimoxazole, or another that received escalating doses of an oral suspension of the same drug, initiating with 75mg/day of sulfamethoxazole that was doubled every 48 hours till the full dose was reached, if no allergic reaction occurred. Patients were monitored for at least 6 months after enrollment in the trial. The major end-point was the ability to maintain prophylactic treatment after that period of time. Plasma viral load (PVL and CD4/CD8 counts were measured at baseline. Liver enzymes and hematological parameters were measured at baseline and after 1, 3 and 6 months. RESULTS: Eighteen patients were enrolled in the study (15 men and 3 women, with ages ranging from 30 to 57 years (mean 39.9. The mean CD4 counts were slightly higher for patients receiving a full dose; there was also a trend towards higher baseline CD8 counts among patients developing new reactions. The mean PVL was similar among the patients in both desensitization groups. The incidence of new allergic reactions was identical (40% in the two groups. All adverse reactions were mild and no significant increase in liver enzymes were observed. CONCLUSON: Dose regimen is not a predictor of the development of new allergic reactions amongst patients challenged with

  17. A randomized controlled trial comparing foster care and institutional care for children with signs of reactive attachment disorder.

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    Smyke, Anna T; Zeanah, Charles H; Gleason, Mary Margaret; Drury, Stacy S; Fox, Nathan A; Nelson, Charles A; Guthrie, Donald

    2012-05-01

    The authors examined signs of emotionally withdrawn (inhibited type) and indiscriminately social (disinhibited type) reactive attachment disorder in Romanian children enrolled in a randomized trial of foster care compared with institutional care and in a comparison group of never-institutionalized children. At baseline and when children were ages 30, 42, and 54 months and 8 years, caregivers were interviewed with the Disturbances of Attachment Interview to assess changes in signs of reactive attachment disorder in three groups of children: those receiving care as usual (including continued institutional care) (N=68); those placed in foster care after institutional care (N=68); and those who were never institutionalized (N=72). The impact of gender, ethnicity, and baseline cognitive ability was also examined. On the Disturbances of Attachment Interview, signs of the inhibited type of reactive attachment disorder decreased after placement in foster care, and scores were indistinguishable from those of never-institutionalized children after 30 months. Signs of the disinhibited type were highest in the usual care group, lower in the foster care group, and lowest in the never-institutionalized group. Early placement in foster care (before age 24 months) was associated with fewer signs of the disinhibited type. Lower baseline cognitive ability was associated with more signs of the inhibited type in the usual care group and more signs of the disinhibited type in both groups. Signs of the inhibited type of reactive attachment disorder responded quickly to placement in foster care; signs of the disinhibited type showed less robust resolution with foster placement. Lower baseline cognitive ability was linked to signs of reactive attachment disorder.

  18. Randomized clinical trial comparing lumbar percutaneous hydrodiscectomy with lumbar open microdiscectomy for the treatment of lumbar disc protrusions and herniations

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    Alexandre Fogaça Cristante

    2016-05-01

    Full Text Available OBJECTIVES: Hydrodiscectomy is a new technique used for percutaneous spinal discectomy that employs a high-intensity stream of water for herniated disc ablation and tissue aspiration. No previous clinical study has examined the effects of percutaneous hydrodiscectomy. The aim of this study is to evaluate the outcomes of hydrodiscectomy compared to open microdiscectomy regarding pain, function, satisfaction, complications and recurrence rates. METHODS: In this randomized clinical trial, patients referred to our tertiary hospital for lumbar back pain were recruited and included in the study if they had disc protrusion or small herniation in only one level, without neurological deficits and with no resolution after six weeks of conservative treatment. One group underwent open microdiscectomy, and the other group underwent percutaneous microdiscectomy via hydrosurgery. Function was evaluated using the Oswestry Disability Index and pain was assessed using a visual analog scale. Evaluations were performed preoperatively, and then during the first week and at one, three, six and twelve months postoperatively. Personal satisfaction was verified. Clinicaltrials.gov: NCT01367860. RESULTS: During the study period, 20 patients were included in each arm and 39 completed one-year of follow-up (one patient died of unrelated causes. Both groups exhibited equal improvement on the visual analog scale and Oswestry evaluations after treatment, without any significant differences. The improvement in the lumbar visual analog scale score was not significant in the hydrodiscectomy group (p=0.138. The rates of infection, pain, recurrence and satisfaction were similar between the two groups. CONCLUSION: Percutaneous hydrodiscectomy was demonstrated to be as effective as open microdiscectomy for reducing pain. The rates of complications and recurrence of herniation were similar between groups. Patient satisfaction with the treatment was also similar between groups.

  19. A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693

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    Khedmat Hossein

    2004-12-01

    Full Text Available Abstract Background Pressure sores are important and common complications of spinal cord injury. Many preventive and therapeutic approaches have been tried and new trials are evolving. One relatively recent method is application of a hydrocolloid dressing (HD. In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications, phenytoin cream (PC and simple dressing (SD. Methods Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were randomly allocated to three treatment groups. Mean age and weight of the participants were 36.64 ± 6.04 years and 61.12 ± 5.08 kg, respectively. All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses, and the ulcer status was recorded as "Complete healing", "Partial healing", "Without improvement" and "Worsening". Results Complete healing of ulcers, regardless of location and stage, was better in the HD group than the PC [23/31(74.19% vs 12/30(40%; difference: 34.19%, 95% CI = 10.85–57.52, (P 0.05]. We performed a second analysis considering only one ulcer per patient (i.e. 83 ulcers in 83 patients. This "per patient" analysis showed that complete ulcer healing in the HD group was better than in the PC [20/28(71.4% vs 11/28 (39.3%; difference: 32.1%, 95% CI = 7.4–56.7, (P Conclusion We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men.

  20. COMPARATIVE STUDY OF 4 WEEKS OF DYNAMIC B ALANCE TRAINING PROGRAM IN COLLEGIATE FOOTBALL PLAYERS: RANDOMIZED CLINICAL TRIAL

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    Nisha

    2015-03-01

    Full Text Available BACKGROUND: Balance is highly integrative dynamic process involving coordination of multiple neurological pathways that allows for the maintenance of the COG over BOS . Football players often perform lower extremity passing , shooting , twisting , cutting and dribbling skills while wearing shoes , these actions require body to be in the equilibrium position to perform the task . This leads to t he conclusion of the great importance of the ability of balance in football . AIMS: 1 . To study the effect of 4 week multidirectional balance board training on dynamic balance in football players . 2 . To study the effect of 4 week Both Sides Up ball training on dynamic balance in football players . 3 . To compare the effect of multidirectional balance board training program and BOSU ball training program on dynamic balance in football players . STUDY DESIGN: Randomized Clinical trial . METHODS: Total of 60 competitive badminton players with age group between18 - 25 were recruited in this study . The participants were allocated into 2 groups viz ., Group A (multidirectional balance board training and Group B (BOSU ball Training for a period of 4 we eks . Participants were test for SEBT and vertical jump test on first day and after 4 weeks of balance training . STATISTICAL ANALYSIS: Student t test , Chi - Square Test . RESULTS: The data analysis and statistical inference showed that , after 4 weeks of balanc e training there was improvement in dynamic balance in both the groups but there was no significant difference in dynamic balance between two groups . As seen by difference in the SEBT and VJT scores pre and post training with p<0 . 001 . CONCLUSION: 4 weeks balance training using BOSU and multidirectional balance board is effective in improving dynamic balance and vertical jump performance in football players and also can be used as a component of multifaceted training to improve dynamic balance and game skills

  1. Comparing Transcervical Intrauterine Lidocaine Instillation with Rectal Diclofenac for Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial

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    Sussan S. Mohammadi

    2015-05-01

    Full Text Available Objectives: There are a number of potential advantages to performing hysteroscopy in an outpatient setting. However, the ideal approach, using local uterine anesthesia or rectal non-steroidal anti-inflammatory drugs, has not been determined. Our objective was to compare the efficacy of intrauterine lidocaine instillation with rectal diclofenac for pain relief during diagnostic hysteroscopy. Methods: We conducted a double-blind randomized controlled trial on 70 nulliparous women with primary infertility undergoing diagnostic hysteroscopy. Subjects were assigned into one of two groups to receive either 100mg of rectal diclofenac or 5mL of 2% intrauterine lidocaine. The intensity of pain was measured by a numeric rating scale 0–10. Pain scoring was performed during insertion of the hysteroscope, during visualization of the intrauterine cavity, and during extrusion of the hysteroscope. Results: There were no statistically significant differences between the groups with regard to the mean pain score during intrauterine visualization (p=0.500. The mean pain score was significantly lower during insertion and extrusion of the hysteroscope in the diclofenac group (p=0.001 and p=0.030, respectively. Nine patients in the lidocaine group and five patients in diclofenac group needed supplementary intravenous propofol injection for sedation (p=0.060. Conclusions: Rectal diclofenac appears to be more effective than intrauterine lidocaine in reducing pain during insertion and extrusion of hysteroscope, but there are no significant statistical and clinical differences between the two methods with regard to the mean pain score during intrauterine inspection.

  2. A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica

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    Xue Zhang

    2017-01-01

    Full Text Available Objective. To investigate the short- and long-term effects of electroacupuncture (EA compared with medium-frequency electrotherapy (MFE on chronic discogenic sciatica. Methods. One hundred participants were randomized into two groups to receive EA (n=50 or MFE (n=50 for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI, patient global impression (PGI, drug use frequency, and EA acceptance. Results. The mean changes in the average leg pain numerical rating scale (NRS scores were 2.30 (1.86–2.57 and 1.06 (0.62–1.51 in the EA and MFE groups at week 4, respectively. The difference was significant (P<0.001. The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70–2.53 and 0.36 (−0.05–0.78 from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred. Conclusions. EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifier ChiCTR-IPR-15006370.

  3. Apnea after awake-regional and general anesthesia in infants: The General Anesthesia compared to Spinal anesthesia (GAS) study: comparing apnea and neurodevelopmental outcomes, a randomized controlled trial

    Science.gov (United States)

    Davidson, Andrew 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

    2015-01-01

    Background Post-operative apnea is a complication in young infants. Awake-regional anesthesia (RA) may reduce the risk; however the evidence is weak. The General Anesthesia compared to Spinal anesthesia (GAS) study is a randomized, controlled, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Methods Infants ≤ 60 weeks postmenstrual age scheduled for inguinal herniorraphy were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born < 26 weeks’ gestation. The primary outcome of this analysis was any observed apnea up to 12 hours post-operatively. Apnea assessment was unblinded. Results 363 patients were assigned to RA and 359 to GA. Overall the incidence of apnea (0 to 12 hours) was similar between arms (3% in RA and 4% in GA arms, Odds Ratio (OR) 0.63, 95% Confidence Intervals (CI): 0.31 to 1.30, P=0.2133), however the incidence of early apnea (0 to 30 minutes) was lower in the RA arm (1% versus 3%, OR 0.20, 95%CI: 0.05 to 0.91, P=0.0367). The incidence of late apnea (30 minutes to 12 hours) was 2% in both RA and GA arms (OR 1.17, 95%CI: 0.41 to 3.33, P=0.7688). The strongest predictor of apnea was prematurity (OR 21.87, 95% CI 4.38 to 109.24) and 96% of infants with apnea were premature. Conclusions RA in infants undergoing inguinal herniorraphy reduces apnea in the early post-operative period. Cardio-respiratory monitoring should be used for all ex-premature infants. PMID:26001033

  4. Randomized controlled trial of parent-enhanced CBT compared with individual CBT for obsessive-compulsive disorder in young people.

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    Reynolds, Shirley A; Clark, Sarah; Smith, Holly; Langdon, Peter E; Payne, Ruth; Bowers, Gemma; Norton, Elisabeth; McIlwham, Harriet

    2013-12-01

    Obsessive-compulsive disorder (OCD) in young people can be effectively treated with Cognitive Behavior Therapy (CBT). Practice guidelines in the United Kingdom recommend that CBT be delivered with parental or family involvement; however, there is no evidence from randomized trials that this enhances effectiveness. The aim of this trial was to assess if CBT with high parental involvement was more effective than CBT with low parental involvement (individual CBT) in reducing symptoms of OCD. Fifty young people ages 12-17 years with OCD were randomly allocated to individual CBT or parent-enhanced CBT. In parent-enhanced CBT parents attended all treatment sessions; in individual CBT, parents attended only Sessions 1, 7, and the final session. Participants received up to 14 sessions of CBT. Data were analyzed using intent-to-treat and per-protocol methods. The primary outcome measure was the Children's Yale-Brown Obsessive Compulsion Scale (Scahill et al., 1997). Both forms of CBT significantly reduced symptoms of OCD and anxiety. Change in OCD symptoms was maintained at 6 months. Per-protocol analysis suggested that parent-enhanced CBT may be associated with significantly larger reductions in anxiety symptoms. High and low parental involvement in CBT for OCD in young people were both effective, and there was no evidence that 1 method of delivery was superior on the primary outcome measure. However, this study was small. Future trials should be adequately powered and examine interactions with the age of the young person and comorbid anxiety disorders.

  5. Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide.

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    Riddle, Mark S; Connor, Patrick; Fraser, Jamie; Porter, Chad K; Swierczewski, Brett; Hutley, Emma J; Danboise, Brook; Simons, Mark P; Hulseberg, Christine; Lalani, Tahaniyat; Gutierrez, Ramiro L; Tribble, David R

    2017-11-29

    Recommended treatment for travelers' diarrhea includes the combination of an antibiotic, usually a fluoroquinolone or azithromycin, and loperamide for rapid resolution of symptoms. However, adverse events, postdose nausea with high-dose azithromycin, effectiveness of single-dose rifaximin, and emerging resistance to front-line agents are evidence gaps underlying current recommendations. A randomized, double-blind trial was conducted in 4 countries (Afghanistan, Djibouti, Kenya, and Honduras) between September 2012 and July 2015. US and UK service members with acute watery diarrhea were randomized and received single-dose azithromycin (500 mg; 106 persons), levofloxacin (500 mg; 111 persons), or rifaximin (1650 mg; 107 persons), in combination with loperamide (labeled dosing). The efficacy outcomes included clinical cure at 24 hours and time to last unformed stool. Clinical cure at 24 hours occurred in 81.4%, 78.3%, and 74.8% of the levofloxacin, azithromycin, and rifaximin arms, respectively. Compared with levofloxacin, azithromycin was not inferior (P = .01). Noninferiority could not be shown with rifaximin (P = .07). At 48 and 72 hours, efficacy among regimens was equivalent (approximately 91% at 48 and 96% at 72 hours). The median time to last unformed stool did not differ between treatment arms (azithromycin, 3.8 hours; levofloxacin, 6.4 hours; rifaximin, 5.6 hours). Treatment failures were uncommon (3.8%, 4.4%, and 1.9% in azithromycin, levofloxacin, and rifaximin arms, respectively) (P = .55). There were no differences between treatment arms with postdose nausea, vomiting, or other adverse events. Single-dose azithromycin, levofloxacin, and rifaximin with loperamide were comparable for treatment of acute watery diarrhea. NCT01618591.

  6. Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception.

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    Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien; Hart, Catherine

    2015-03-01

    Most published contraceptive continuation rates have scientific limitations and cannot be compared; this is particularly true for dissimilar contraceptives. This study uses a new approach to determine if high continuation rates of long-acting reversible contraception (LARC) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC. We are conducting a partially randomized patient preference trial (PRPPT) to compare continuation rates of short-acting reversible contraception (SARC) and LARC. Only women seeking SARC were invited to participate. Participants chose to be in the preference cohort (self-selected method use) or opted to be randomized to SARC or LARC; only those in the randomized cohort received free product. We compared participant characteristics, reasons for not trying LARC previously and the contraceptive choices that were made. We enrolled 917 eligible women; 57% chose to be in the preference cohort and 43% opted for the randomized trial. The preference and randomized cohorts were similar on most factors. However, the randomized cohort was more likely than the preference cohort to be uninsured (48% versus 36%, respectively) and to cite cost as a reason for not trying LARC previously (50% versus 10%) (pcontraceptive continuation rates and unintended pregnancy in this ongoing trial. The choices participants made were associated with numerous factors; lack of insurance was associated with participation in the randomized trial. This PRPPT will provide new estimates of contraceptive continuation rates, such that any benefits of LARC will be more easily attributable to the technology and not the user. Combined with measuring level of satisfaction with LARC, the results will help project the potential role and benefits of expanding voluntary use of LARC. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Comparative effectiveness of 30 % trisodium citrate and heparin lock solution in preventing infection and dysfunction of hemodialysis catheters: a randomized controlled trial (CITRIM trial).

    Science.gov (United States)

    Correa Barcellos, Franklin; Pereira Nunes, Bruno; Jorge Valle, Luciana; Lopes, Thiago; Orlando, Bianca; Scherer, Cintia; Nunes, Marcia; Araújo Duarte, Gabriela; Böhlke, Maristela

    2017-04-01

    Central venous catheters (CVC) are the only option when hemodialysis is needed for patients without definitive vascular access. However, CVC is associated with complications, such as infection, thrombosis, and dysfunction, leading to higher mortality and expenditures. The aim of this study was to compare the effectiveness of 30 % trisodium citrate (TSC30 %) with heparin as CVC lock solutions in preventing catheter-related bloodstream infections (CRBSI) and dysfunction in hemodialysis patients. Randomized, double-blind controlled trial comparing the event-free survival of non-tunneled CVC locked with heparin or TSC30 % in adult hemodialysis patients. The study included 464 catheters, 233 in heparin group, and 231 in TSC30 % group. The CRBSI-free survival of TSC30 % group was significantly shorter than that of heparin group. When stratified by insertion site, heparin was better than TSC30 % only in subclavian CVC. The dysfunction-free survival was not different between groups in the main analysis, but there is also a shorter survival among subclavian CVC locked with TSC30 % in stratified analysis. There was no difference on CRBSI-free or dysfunction-free survival between jugular vein CVC locked with heparin or 30 % citrate. However, subclavian CVC locked with 30 % citrate presented shorter event-free survival. This difference may be related to anatomical and positional effects, CVC design, and hydraulic aspects of the lock solution. CLINICALTRIALS. NCT02563041.

  8. Intravaginal stimulation randomized trial.

    Science.gov (United States)

    Smith, J J

    1996-01-01

    The effectiveness of intravaginal electrical stimulation was compared to standard therapy in the treatment of genuine stress urinary incontinence and detrusor instability. A total of 57 women with urinary incontinence was evaluated with video urodynamics and voiding diaries before and after treatment. Of the women 18 with stress urinary incontinence were randomized to electrical stimulation or Kegel exercise and 38 with detrusor instability were randomized to anticholinergic therapy or electrical stimulation. Of patients using electrical stimulation in the stress urinary incontinence group 66% improved and 72% of the patients with detrusor instability treated with electrical stimulation improved. These rates were not statistically significant when compared to traditional therapy. Electrical stimulation is safe and at least as effective as properly performed Kegel and anticholinergic therapy in the treatment of stress urinary incontinence and detrusor instability.

  9. Comparative Effects of Different Balance-Training–Progression Styles on Postural Control and Ankle Force Production: A Randomized Controlled Trial

    Science.gov (United States)

    Cuğ, Mutlu; Duncan, Ashley; Wikstrom, Erik

    2016-01-01

    Context:  Despite the effectiveness of balance training, the exact parameters needed to maximize the benefits of such programs remain unknown. One such factor is how individuals should progress to higher levels of task difficulty within a balance-training program. Yet no investigators have directly compared different balance-training–progression styles. Objective:  To compare an error-based progression (ie, advance when proficient at a task) with a repetition-based progression (ie, advance after a set amount of repetitions) style during a balance-training program in healthy individuals. Design:  Randomized controlled trial. Setting:  Research laboratory. Patients or Other Participants:  A total of 28 (16 women, 12 men) physically healthy young adults (age = 21.57 ± 3.95 years, height = 171.60 ± 11.03 cm, weight = 72.96 ± 16.18 kg, body mass index = 24.53 ± 3.7). Intervention(s):  All participants completed 12 supervised balance-training sessions over 4 weeks. Each session consisted of a combination of dynamic unstable-surface tasks that incorporated a BOSU ball and lasted about 30 minutes. Main Outcome Measure(s):  Static balance from an instrumented force plate, dynamic balance as measured via the Star Excursion Balance Test, and ankle force production in all 4 cardinal planes of motion as measured with a handheld dynamometer before and after the intervention. Results:  Selected static postural-control outcomes, dynamic postural control, and ankle force production in all planes of motion improved (P .05) for any of the outcome measures. Conclusions:  A 4-week balance-training program consisting of dynamic unstable-surface exercises on a BOSU ball improved dynamic postural control and ankle force production in healthy young adults. These results suggest that an error-based balance-training program is comparable with but not superior to a repetition-based balance-training program in improving postural control and ankle force production in

  10. Efficacy of oseltamivir-zanamivir combination compared to each monotherapy for seasonal influenza: a randomized placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Xavier Duval

    2010-11-01

    Full Text Available Neuraminidase inhibitors are thought to be efficacious in reducing the time to alleviation of symptoms in outpatients with seasonal influenza. The objective of this study was to compare the short-term virological efficacy of oseltamivir-zanamivir combination versus each monotherapy plus placebo.We conducted a randomized placebo-controlled trial with 145 general practitioners throughout France during the 2008-2009 seasonal influenza epidemic. Patients, general practitioners, and outcome assessors were all blinded to treatment assignment. Adult outpatients presenting influenza-like illness for less than 36 hours and a positive influenza A rapid test diagnosis were randomized to oseltamivir 75 mg orally twice daily plus zanamivir 10 mg by inhalation twice daily (OZ, oseltamivir plus inhaled placebo (O, or zanamivir plus oral placebo (Z. Treatment efficacy was assessed virologically according to the proportion of patients with nasal influenza reverse transcription (RT-PCR below 200 copies genome equivalent (cgeq/µl at day 2 (primary outcome, and clinically to the time to alleviation of symptoms until day 14. Overall 541 patients (of the 900 planned were included (OZ,  =192; O, n=176; Z, n=173, 49% male, mean age 39 years. In the intention-to-treat analysis conducted in the 447 patients with RT-PCR-confirmed influenza A, 46%, 59%, and 34% in OZ (n=157, O (n=141, and Z (n=149 arms had RT-PCR<200 cgeq/µl (-13.0%, 95% confidence interval [CI] -23.1 to -2.9, p=0.025; +12.3%, 95% CI 2.39-22.2, p=0.028 for OZ/O and OZ/Z comparisons. Mean day 0 to day 2 viral load decrease was 2.14, 2.49, and 1.68 log(10 cgeq/µl (p=0.060, p=0.016 for OZ/O and OZ/Z. Median time to alleviation of symptoms was 4.0, 3.0, and 4.0 days (+1.0, 95% CI 0.0-4.0, p=0.018; +0.0, 95% CI -3.0 to 3.0, p=0.960 for OZ/O and OZ/Z. Four severe adverse events were observed. Nausea and/or vomiting tended to be more frequent in the combination arm (OZ, n=13; O, n=4; and Z, n=5 patients

  11. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver

    Directory of Open Access Journals (Sweden)

    Biffi Roberto

    2012-05-01

    Full Text Available Abstract Background An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Methods Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel® Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel® Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. Results A total of 112 patients (58 in the experimental arm and 54 in the control group qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5% than in controls (14.3% center 1, 24.2% center 2, overall 20.4%, but the observed difference was not statistically significant (P = 0.451, even with respect to surgical-site infection grade 1 (superficial versus grades 2 and 3, or grade 1 and 2 versus grade 3. Conclusions This randomized trial did not confirm a statistically significant superiority of Aquacel® Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Trial registration Clinicaltrials.gov: NCT00981110

  12. [Pilot results of using tamsulone-FS in patients with prostatic adenoma according to the results of a randomized multicenter comparative trial].

    Science.gov (United States)

    Lopatkin, N A; Petrov, S B; Sivkov, A V; Markov, A V; Oshchepkov, N N; Bolokhanov, Iu N

    2006-01-01

    Tamsulone-FS--a novel Russian alpha1A/D-adrenoblocker (Farm-Syntez)--was studied in a randomized multicenter comparative trial in patients with prostatic adenoma. Pilot results agreed with other trials published in the literature and demonstrated tamsulone-FS efficacy and safety for management of lower urinary tract symptoms caused by prostatic adenoma. The efficacy and safety of tamsulone-FS was comparable to those of omnik. This drug can be recommended for wide clinical practice in prostatic adenoma. It is registered by Roszdravnadzor (certificate N LC-000859 of 03.11.2005) and allowed for production and sale.

  13. A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain

    DEFF Research Database (Denmark)

    Kress, Hans G; Von der Laage, Dorothea; Hoerauf, Klaus H

    2008-01-01

    to be pharmacokinetically bioequivalent to the marketed fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter...... trial, in which 220 patients were randomized to receive either the fentanyl patch or standard opioid treatment for 30 days. The primary efficacy variable, pain intensity (PI) on a 0-10-point numerical rating scale, was recorded once daily. The primary endpoint was the relative area under the curve of PI...

  14. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department.

    Science.gov (United States)

    Borland, Meredith; Jacobs, Ian; King, Barbara; O'Brien, Debra

    2007-03-01

    We compare the efficacy of intranasal fentanyl versus intravenous morphine in a pediatric population presenting to an emergency department (ED) with acute long-bone fractures. We conducted a prospective, randomized, double-blind, placebo-controlled, clinical trial in a tertiary pediatric ED between September 2001 and January 2005. A convenience sample of children aged 7 to 15 years with clinically deformed closed long-bone fractures was included to receive either active intravenous morphine (10 mg/mL) and intranasal placebo or active intranasal concentrated fentanyl (150 microg/mL) and intravenous placebo. Exclusion criteria were narcotic analgesia within 4 hours of arrival, significant head injury, allergy to opiates, nasal blockage, or inability to perform pain scoring. Pain scores were rated by using a 100-mm visual analog scale at 0, 5, 10, 20, and 30 minutes. Routine clinical observations and adverse events were recorded. Sixty-seven children were enrolled (mean age 10.9 years [SD 2.4]). Fractures were radius or ulna 53 (79.1%), humerus 9 (13.4%), tibia or fibula 4 (6.0%), and femur 1 (1.5%). Thirty-four children received intravenous (i.v.) morphine and 33 received intranasal fentanyl. Statistically significant differences in visual analog scale scores were not observed between the 2 treatment arms either preanalgesia or at 5, 10, 20, or 30 minutes postanalgesia (P=.333). At 10 minutes, the difference in mean visual analog scale between the morphine and fentanyl groups was -5 mm (95% confidence interval -16 to 7 mm). Reductions in combined pain scores occurred at 5 minutes (20 mm; P=.000), 10 minutes (4 mm; P=.012), and 20 minutes (8 mm; P=.000) postanalgesia. The mean total INF dose was 1.7 microg/kg, and the mean total i.v. morphine dose was 0.11 mg/kg. There were no serious adverse events. Intranasal fentanyl delivered as 150 microg/mL at a dose of 1.7 microg/kg was shown to be an effective analgesic in children aged 7 to 15 years presenting to an ED with

  15. Virtual Reality Compared with Bench-Top Simulation in the Acquisition of Arthroscopic Skill: A Randomized Controlled Trial.

    Science.gov (United States)

    Banaszek, Daniel; You, Daniel; Chang, Justues; Pickell, Michael; Hesse, Daniel; Hopman, Wilma M; Borschneck, Daniel; Bardana, Davide

    2017-04-05

    Work-hour restrictions as set forth by the Accreditation Council for Graduate Medical Education (ACGME) and other governing bodies have forced training programs to seek out new learning tools to accelerate acquisition of both medical skills and knowledge. As a result, competency-based training has become an important part of residency training. The purpose of this study was to directly compare arthroscopic skill acquisition in both high-fidelity and low-fidelity simulator models and to assess skill transfer from either modality to a cadaveric specimen, simulating intraoperative conditions. Forty surgical novices (pre-clerkship-level medical students) voluntarily participated in this trial. Baseline demographic data, as well as data on arthroscopic knowledge and skill, were collected prior to training. Subjects were randomized to 5-week independent training sessions on a high-fidelity virtual reality arthroscopic simulator or on a bench-top arthroscopic setup, or to an untrained control group. Post-training, subjects were asked to perform a diagnostic arthroscopy on both simulators and in a simulated intraoperative environment on a cadaveric knee. A more difficult surprise task was also incorporated to evaluate skill transfer. Subjects were evaluated using the Global Rating Scale (GRS), the 14-point arthroscopic checklist, and a timer to determine procedural efficiency (time per task). Secondary outcomes focused on objective measures of virtual reality simulator motion analysis. Trainees on both simulators demonstrated a significant improvement (p arthroscopic skills compared with baseline scores and untrained controls, both in and ex vivo. The virtual reality simulation group consistently outperformed the bench-top model group in the diagnostic arthroscopy crossover tests and in the simulated cadaveric setup. Furthermore, the virtual reality group demonstrated superior skill transfer in the surprise skill transfer task. Both high-fidelity and low

  16. Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site.

    Science.gov (United States)

    Mauri, Laura; Normand, Sharon-Lise T; Pencina, Michael; Cutlip, Donald E; Jeon, Cathy; Dreyer, Paul; Kuntz, Richard E; Baim, Donald S; Jacobs, Alice K

    2011-11-01

    Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI. The MASS COMM trial (ClinicalTrials.gov no. NCT01116882) is a randomized trial comparing the safety and effectiveness of nonemergency PCI at hospitals without surgery on-site (SOS) (non-SOS hospitals) and hospitals with SOS (SOS hospitals). A total of 3,690 subjects will be randomized in a 3:1 fashion to undergo PCI at non-SOS and SOS hospitals, with follow-up at hospital discharge, 30 days, and 12 months after PCI. The rate of major adverse cardiac events (all-cause mortality, myocardial infarction, repeat revascularization, and stroke) will serve as the primary safety end point at 30 days and the primary effectiveness end point at 12 months. The design is a 1-way randomized trial with a statistical hypothesis of noninferiority of nonemergency PCI at non-SOS hospitals for both safety and effectiveness end points. This multicenter, randomized trial will compare the relative safety and effectiveness of nonemergency PCI at sites with and without cardiac SOS. Copyright © 2011 Mosby, Inc. All rights reserved.

  17. Randomized controlled trial of motivational interviewing compared with drug information and advice for early intervention among young cannabis users.

    Science.gov (United States)

    McCambridge, Jim; Slym, Renee L; Strang, John

    2008-11-01

    To test the effectiveness of motivational interviewing (MI) in comparison with drug information and advice in opportunistically securing reductions in drug-related risk among young cannabis users not seeking help. Randomized controlled trial. Eleven London Further Education colleges. A total of 326 students aged 16-19 years who smoked cannabis weekly or more frequently. Participants were randomized to a single-session intervention of MI or drug information and advice-giving. Cannabis use, cigarette smoking and alcohol consumption and harm outcomes were assessed after both 3 and 6 months. No differences were found between MI and drug information and advice, although MI fidelity was not high. There were wide-ranging individual practitioner effects on observed outcomes and a practitioner-intervention interaction was detected in relation to cannabis cessation after 3 months. Change over time was more pronounced for cannabis use than for other drug use. Further study of the nature and consequences of MI fidelity, and individual practitioner effects more generally, is needed. Advice may be an effective brief intervention with young cannabis users in its own right and should be evaluated further in trials.

  18. Rationale and Design of a Randomized Clinical Trial Comparing Stress Reduction Treatment to Usual Cardiac Care: The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial

    Science.gov (United States)

    Donahue, Rebecca G.; Lampert, Rachel; Dornelas, Ellen; Clemow, Lynn; Burg, Matthew M.

    2010-01-01

    Objective Present the design of a multicenter randomized trial testing the effects of Stress Reduction Treatment (SRT) on the prevalence of shock treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials. Methods New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the past 6 months (n=304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6-, 12-, and 24-months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), ATP events, medication changes, hospitalizations, deaths, and quality of life. Results Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on lab stress induced and 24-hour arrhythmogenic electrophysiological indices from pre- to post-treatment, and both quality of life and measures of anger across the 2-years of the study. Conclusions The RISTA Trial is the first large scale randomized clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia provoked shock and improve quality of life. PMID:20028832

  19. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  20. The first clinical experience on efficacy of topical flutamide on melasma compared with topical hydroquinone: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2015-08-01

    Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the

  1. Multicenter randomized controlled trial comparing the performance of 22 gauge versus 25 gauge EUS-FNA needles in solid masses

    DEFF Research Database (Denmark)

    Vilmann, Peter; S?ftoiu, Adrian; Hollerbach, Stephan

    2013-01-01

    Few randomized studies have assessed the clinical performance of 25-gauge (25G) needles compared with 22-gauge (22G) needles during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) biopsy of intra-abdominal lesions. We aimed to compare the diagnostic yield, as well as performance cha...... characteristics of 22G versus 25G EUS biopsy needles by determining their diagnostic capabilities, the number of needle passes as well as cellularity of aspirated tissue specimen....

  2. Randomized clinical trial comparing manual suture and different models of mechanical suture in the mimicking of bariatric surgery in swine

    Directory of Open Access Journals (Sweden)

    Fernandes MA

    2014-02-01

    Full Text Available Marcos AP Fernandes,1 Bruno MT Pereira,2 Sandra M Guimarães,1 Aline Paganelli,3 Carlos Manoel CT Pereira,1 Claudio Sergio Batista4 1Institute of Obesity and Advanced Video Laparoscopic Surgery of Petropolis, Rio de Janeiro, Brazil; 2Division of Trauma, University of Campinas, São Paulo, Brazil; 3Laboratório de Patologia Micron Cell Diagnóstico, Rio de Janeiro, Brazil; 4Department of Gynecology and Obstetrics, Faculty of Medicine of Petropolis, Rio de Janeiro, Brazil Context and objective: Variations in the ability of surgeons served as motivation for the development of devices that, overcoming individual differences, allow the techniques to be properly performed, and of which the end result was the best possible. Every technique must be reproduced reliably by the majority of surgeons for their results to be adopted and recognized as effective. The aim of this study was to compare the results, from the point of view of anatomic pathology, of manual sutures versus mechanical sutures using different models of linear mechanical staplers, in the procedure of gastroenteroanastomosis and enteroanastomosis in swine. Methods: Thirty-six healthy, adult, male Sus scrofa domesticus pigs, weighing between 20.7 and 25.5 kg, were used. The swine were randomly divided into four groups of nine pigs, according to the type of suture employed: group A, manual suture with Polysorb® 3-0 wire; group B, 80-shear linear stapler (Covidien® Gia 8038-S; group C, 75-shear linear stapler (Ethicon® Tlc 75; and group D, 75-shear linear stapler (Resource® Yq 75-3. A temporal study was established on the seventh postoperative day for histopathological analysis, and the degree of inflammation, fibrosis, and newly formed vessels, as well as the presence or absence of granulation tissue, foreign body granuloma, and necrosis were all evaluated qualitatively and semiquantitatively. The results were analyzed statistically. Results: Observations during the histopathological

  3. Design of a randomized controlled trial to compare debridement to observation of chondral lesions encountered during partial meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial.

    Science.gov (United States)

    Bisson, Leslie J; Kluczynski, Melissa A; Wind, William M; Fineberg, Marc S; Bernas, Geoffrey A; Rauh, Michael A; Marzo, John M; Smolinski, Robert J

    2015-11-01

    Few studies have examined whether chondral lesions encountered in patients undergoing meniscectomy should be surgically treated. The primary aim of the ChAMP (Chondral Lesions And Meniscus Procedures) Trial is to determine whether there is a difference in knee pain between patients undergoing debridement versus observation of chondral lesions encountered during arthroscopic meniscectomy. This paper describes the rationale and study design for the ChAMP Trial. The ChAMP Trial is a randomized controlled trial of patients aged 30 and older undergoing partial meniscectomy and randomly allocated to debridement (CL-Deb, N=98) or observation (CL-Obs, N=92) of chondral lesions identified during surgery and deemed to be significant (Outerbridge Grade II-IV). Patients and data collectors were unaware of treatment allocation until completion of the study. Patients with surgically insignificant (Outerbridge Grade I) chondral lesions or no chondral lesions were included as a third non-randomized comparison group (NoCL, N=76). The primary outcome is the difference in knee pain assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) between the CL-Deb and CL-Obs groups at 1-year after surgery. Secondary outcomes include 1-year differences in additional measures of knee pain, function, symptoms, activity, and quality of life assessed by the WOMAC, KOOS (Knee Injury and Osteoarthritis Outcome Score), visual analog pain scale, and physical exam; as well as general health assessed with the SF-36 (Short-form Health Survey). Increased intraoperative costs associated with the addition of chondral debridement will also be assessed. This study will add to the scant literature regarding management of chondral lesions in patients undergoing meniscectomy and might provide treatment guidance for clinicians and their patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Randomized controlled trial comparing the effectiveness of the ultrasound-guided galvanic electrolysis technique (USGET) versus conventional electro-physiotherapeutic treatment on patellar tendinopathy

    OpenAIRE

    Abat, F.; S?nchez-S?nchez, J. L.; Mart?n-Nogueras, A. M.; Calvo-Arenillas, J. I.; Yajeya, J.; M?ndez-S?nchez, R.; Monllau, J. C.; Gelber, P. E.

    2016-01-01

    Background Patellar tendinopathy has a high prevalence rate among athletes. Different therapeutic options can be found in the current literature, but none of them has been clearly established as the gold standard. The purpose of this study is to compare, in a randomized controlled trial, the clinical efficacy of eccentric exercise combined with either an ultrasound-guided galvanic electrolysis technique (USGET) or conventional electrophysiotherapy to treat patellar tendinopathy. Methods Sixty...

  5. Trial participants' experiences of early enhanced speech and language therapy after stroke compared with employed visitor support: a qualitative study nested within a randomized controlled trial.

    Science.gov (United States)

    Young, Alys; Gomersall, Timothy; Bowen, Audrey

    2013-02-01

    To explore trial participants' experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Qualitative study nested within a randomized controlled trial. Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Eight English NHS usual care settings. Individual interviews. Thematic content analysis assisted by a bespoke data transformation protocol for incorporating non-verbal and semantically ambiguous data. Participants highly regarded regular and sustained contact with someone outside of immediate family/friends who engaged them in deliberate activities/communication in the early months after stroke. Participants identified differences in the process of intervention between speech and language therapists and employed visitors. But no major discriminations were made between the impact or value of this contact according to whether provided by a speech and language therapist or employed visitor. Participant-defined criteria for effectiveness of contact included: impact on mood and confidence, self-recognition of progress and the meeting of individual needs. As in the randomized controlled trial, participants reported no evidence of added benefit of early communication therapy beyond that from attention control. The findings do not imply that regular contact with any non-professional can have beneficial effects for someone with aphasia or dysarthria in the early weeks following a stroke. The study points to specific conditions that would have to be met for contact to have a positive effect.

  6. Comparing patient characteristics, type of intervention, control, and outcome (PICO) queries with unguided searching: a randomized controlled crossover trial.

    Science.gov (United States)

    Hoogendam, Arjen; de Vries Robbé, Pieter F; Overbeke, A John P M

    2012-04-01

    Translating a question into a query using patient characteristics, type of intervention, control, and outcome (PICO) should help answer therapeutic questions in PubMed searches. The authors performed a randomized crossover trial to determine whether the PICO format was useful for quick searches of PubMed. Twenty-two residents and specialists working at the Radboud University Nijmegen Medical Centre were trained in formulating PICO queries and then presented with a randomized set of questions derived from Cochrane reviews. They were asked to use the best query possible in a five-minute search, using standard and PICO queries. Recall and precision were calculated for both standard and PICO queries. Twenty-two physicians created 434 queries using both techniques. Average precision was 4.02% for standard queries and 3.44% for PICO queries (difference nonsignificant, t(21) = -0.56, P = 0.58). Average recall was 12.27% for standard queries and 13.62% for PICO queries (difference nonsignificant, t(21) = -0.76, P = 0.46). PICO queries do not result in better recall or precision in time-limited searches. Standard queries containing enough detail are sufficient for quick searches.

  7. A Prospective, Randomized, Double-blind, Split-face Clinical Trial Comparing the Efficacy of Two Topical Human Growth Factors for the Rejuvenation of the Aging Face.

    Science.gov (United States)

    Wu, Douglas C; Goldman, Mitchel P

    2017-05-01

    Background: Cosmeceutical products represent an increasingly important therapeutic option for anti-aging and rejuvenation, either used alone or in combination with dermatologic surgical procedures. Among this group of products, topical growth factors have demonstrated efficacy in randomized, controlled clinical trials. However, comparisons between different products remain uncommon. Objective: The objective of this randomized, double-blind, split-face clinical trial was to compare two different topical growth factor formulations derived from either human fibroblasts or human adipose tissue derived mesenchymal stem cells. Methods: This was an institutional review board-approved, randomized, double-blind, split-face clinical trial involving 20 healthy subjects with moderate-to-severe facial wrinkling secondary to photodamage. One half of the face was randomized to receive topical human fibroblast growth factors and the other topical human mesenchymal stem cell growth factors. Treatment was continued for three months, and evaluations were performed in a double-blind fashion. Results: Both growth factor formulations achieved significant improvement in facial wrinkling. Blinded investigator and subject evaluations did not detect any significant differences between the two formulations in terms of efficacy, safety, or tolerability. Conclusion: Both human fibroblast growth factors and human mesenchymal stem cell growth factors are effective at facial rejuvenation. Topical growth factors represent a useful therapeutic modality.

  8. The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

    DEFF Research Database (Denmark)

    Krarup, L.H.; Gluud, C.; Truelsen, T.

    2008-01-01

    of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS....... Physical activity is assessed in both groups seven times during follow-up using the Physical Activity Scale for the Elderly (PASE) questionnaire, which quantifies the amount of physical activity done in the last seven days prior to interview. The PASE score constitutes the primary outcome measure....... The secondary outcome is the time from randomization to recurrent stroke, myocardial infarction, or all-cause mortality. Further outcome measures include: time from randomization to recurrent stroke, myocardial infarction, and vascular death; recurrent stroke; modified Rankin Scale; quality of life; occurrence...

  9. Clinical efficacy of herbal coded formulation ocucure for the improvement of presbyopia: a randomized comparative clinical trial.

    Science.gov (United States)

    Khan, Muhammad Muslim; Usmanghani, Khan; Nazar, Halima; Asif, Hafiz Muhammad

    2014-03-01

    A progressively diminishing capacity of eye to visualize for close proximity increasing by age is known as presbyopia which is usually resulted due to loss of elasticity of crystalline lens. A clinical trial was conducted to evaluate the efficacy of coded herbal formulation "ocucure" (Test drug) for the treatment of presbyopia comparing with leutivit (Placebo). One hundred and eleven patients suffering from presbyopia from both groups (Males: 63, mean age: 34±14 and females: 48, mean age: 33±13 year, range: 20-60) were enrolled in the trial and divided in to two groups according to treatment regimens. Ocucure (Test drug) 500mg two tablets and leutivit (Placebo) 250mg tablets twice daily were prescribed for 6-8 weeks. Presbyopia was improved in 17 patients (28.81%) out of 59 patients by the use of ocucure (Test drug), and in 6 patients (11.53%) out of 52 by the use of leutivit (Control drug). Furthermore, there was a significant improvement in presbyopic associated clinical features as compared to leutivit. It is concluded that ocucure possesses a therapeutic value for the improvement of presbyopia and its associated symptoms as compared to leutivit.

  10. Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial.

    Science.gov (United States)

    García-Sanz, Ramón; Oriol, Albert; Moreno, María J; de la Rubia, Javier; Payer, Angel R; Hernández, Miguel T; Palomera, Luis; Teruel, Ana I; Blanchard, María J; Gironella, Mercedes; Ribas, Paz; Bargay, Joan; Abellá, Eugenia; Granell, Miquel; Ocio, Enrique M; Ribera, Josep M; San Miguel, Jesús F; Mateos, María V

    2015-09-01

    This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse. One hundred patients were randomized to receive either zoledronic acid (4 mg iv/4 weeks, 12 doses) (n=51) or not (n=49). Experimental and control groups were well balanced for disease and prognostic features. Zoledronic acid did not show an antitumor effect according to changes in M-component. However, there were fewer symptomatic progressions in the experimental group than in the control group (34 versus 41, respectively; P=0.05) resulting in a median time to symptoms of 16 versus 10 months (P=0.161). The median time to next therapy was also slightly longer for the treated group than the untreated, control group (13.4 versus 10.1 months), although the difference was not statistically significant (P=0.360). The pattern of relapses was different for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunction (1 versus 2), and plasmacytomas (1 versus 1, respectively). This concurred with fewer skeletal-related events in the treated group than in the control group (2 versus 14), with a projected 4-year event proportion of 6% versus 40% (P<0.001). In summary, zoledronic acid monotherapy does not show an antitumor effect on biochemical relapses in multiple myeloma, but does reduce the risk of progression with symptomatic bone disease and skeletal complications. This trial was registered in the ClinicalTrials.gov database with code NCT01087008. Copyright© Ferrata Storti Foundation.

  11. Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

    Science.gov (United States)

    2013-01-01

    Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p  0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test

  12. Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation.

    Science.gov (United States)

    Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Kim, Ahsung; Suzuki, Yuki; Furuki, Yuho; Ouchi, Taisuke; Ishii, Yasuhiro; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

    2016-10-15

    Stent expansion remains one of the most important predictors of restenosis and subacute thrombosis, even with the use of drug-eluting stents. This study was designed to clarify the impact of lesion preparation on final stent expansion. Sixty-six consecutive patients were included in this trial, and ultimately 52 enrolled non-calcified de novo lesions were randomly assigned to undergo single predilation with either a semi-compliant scoring balloon or a semi-compliant conventional balloon. Lesions were treated with a single 2.5- to 3.0-mm cobalt-chromium everolimus-eluting stent under optical coherence tomography (OCT) guidance without post-stenting dilation. Stent expansion was defined as the ratio of OCT-measured minimum stent area to the predicted stent area. Stent expansion was significantly higher after predilation by a scoring balloon (68.0% vs. 62.1%, p=0.017) with similar stent lumen eccentricity (0.84 vs. 0.80, p=0.18). Intimal disruption was induced significantly more frequently (68.0% vs. 38.4%, p=0.035) and was more extensive in the scoring group (122° vs. 65°, p=0.038). Lesions with intimal disruption after predilation achieved significantly higher stent expansion than that without it (67.7% vs. 61.6%, p=0.023). One case in the conventional group required target lesion revascularization; however, any other adverse clinical events including death, myocardial infarction, and stent thrombosis were not observed up to 9months after PCI in both groups. In this randomized study, pretreatment with a scoring balloon enhanced stent expansion partly through induction of intimal disruption. URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000014176. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  13. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    Science.gov (United States)

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  14. a randomized controlled trial.

    African Journals Online (AJOL)

    milk, only an estimated one -fourth of neonates in India were breastfed within ... standard of care in India and mothers are informed about. 6 months of ... weeks postpartum. A random number sequence was generated using a com- puter program. Block randomization was used with a fixed block size of four. Concealment of ...

  15. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial.

    Science.gov (United States)

    Salim, Raed; Zafran, Noah; Nachum, Zohar; Garmi, Gali; Kraiem, Nazik; Shalev, Eliezer

    2011-07-01

    To estimate the efficacy of a single-balloon catheter compared with a double-balloon catheter among women with unfavorable cervices undergoing induction of labor. This prospective randomized study was conducted at a university teaching medical center between June 2008 and December 2010. Pregnant women admitted for induction of labor with a live singleton gestation in cephalic presentation with intact membranes and a Bishop score of 6 or less were randomly assigned for cervical ripening by a single-balloon catheter or a double-balloon catheter. The primary outcome was the length of time from catheter insertion until delivery. The secondary outcome was mode of delivery. Of 368 eligible women screened during the study period, 293 were included in the final analysis; 145 were randomly assigned to receive a single-balloon catheter and 148 received a double-balloon catheter. Demographic and obstetric parameters were comparable between the two groups. Length of time from catheter insertion until delivery was 19.4 (±6.0) and 19.1 (±6.8) hours among the single-balloon and the double-balloon catheter groups, respectively (P=.80). Length of time did not differ when primiparous women were analyzed separately. Incidence of cesarean delivery was 10.3% and 17.6% among the single-balloon and double-balloon catheter groups, respectively (P=.09). The incidence of either vacuum deliveries or cesarean deliveries was significantly lower among the single-balloon group (14.4%) compared with the double-balloon catheter group (25.7%; odds ratio 0.49, 95% confidence interval 0.26-0.92; P=.02). Both the single-balloon and double-balloon catheters are equally efficacious for inducing labor. The double-balloon catheter may be associated with more operative deliveries.

  16. Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

    Science.gov (United States)

    Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

    2017-04-01

    Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

  17. Prospective, randomized, controlled trial comparing lightweight versus heavyweight mesh in chronic pain incidence after TEP repair of bilateral inguinal hernia.

    Science.gov (United States)

    Chui, L B; Ng, W T; Sze, Y S; Yuen, K S; Wong, Y T; Kong, C K

    2010-11-01

    This prospective, clinical, randomized, controlled study was performed to define the incidence of chronic pain after total extraperitoneal (TEP) repair with a light-weighted mesh compared with heavyweight mesh in patients with bilateral inguinal hernias. Consecutive patients with bilateral inguinal hernias were recruited for TEP inguinal hernia repair under general anesthesia. Heavyweight mesh was randomly assigned to one side of the groin and lightweight mesh to the other. Patients were followed up regularly for up to 1 year by an independent surgeon who was unaware of the mesh assignment. The postoperative pain score by means of a visual analogue scale (VAS) and other data were recorded. Fifty bilateral TEP hernia repairs were performed between September 2007 and February 2009. Six patients (12%) complained of chronic pain 3 months after the operation. A higher average pain score was observed for the side of hernia repaired by heavyweight mesh compared with lightweight mesh, but the difference was not statistically significant. More patients complained about foreign body sensation on the side repaired with heavyweight mesh (24%) compared with the side with lightweight mesh (8%; P TEP inguinal hernia repair because it provides less postoperative foreign body sensation; however, there was no significant difference in the incidence of chronic pain.

  18. Trial participants’ experiences of early enhanced speech and language therapy after stroke compared with employed visitor support: a qualitative study nested within a randomized controlled trial

    Science.gov (United States)

    Gomersall, Timothy; Bowen, Audrey

    2013-01-01

    Objectives: To explore trial participants’ experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Design: Qualitative study nested within a randomized controlled trial. Participants: Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Setting: Eight English NHS usual care settings. Method: Individual interviews. Thematic content analysis assisted by a bespoke data transformation protocol for incorporating non-verbal and semantically ambiguous data. Results: Participants highly regarded regular and sustained contact with someone outside of immediate family/friends who engaged them in deliberate activities/communication in the early months after stroke. Participants identified differences in the process of intervention between speech and language therapists and employed visitors. But no major discriminations were made between the impact or value of this contact according to whether provided by a speech and language therapist or employed visitor. Participant-defined criteria for effectiveness of contact included: impact on mood and confidence, self-recognition of progress and the meeting of individual needs. Conclusions: As in the randomized controlled trial, participants reported no evidence of added benefit of early communication therapy beyond that from attention control. The findings do not imply that regular contact with any non-professional can have beneficial effects for someone with aphasia or dysarthria in the early weeks following a stroke. The study points to specific conditions that would have to be met for contact to have a positive effect. PMID:22837542

  19. Oral Chloral Hydrate Compare with Rectal Thiopental in Pediatric Procedural Sedation and Analgesia; a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Reza Azizkhani

    2014-03-01

    Full Text Available Introduction: The increasing use of diagnostic imaging in pediatric medicine has resulted in growing need for procedural sedation and analgesia (PSA to minimize motion artifacts during procedures. The drug of choice in pediatric PSA was not introduced till now. The aim of the present study was comparison of oral chloral hydrate (OCH and rectal sodium thiopental (RST in pediatric PSA.Methods: In the present randomized clinical trial, 2-6 years old pediatrics who referred for performing brain computed tomography scan was enrolled and were randomly divided in to two groups. OCH (50mg/kg and RST (25mg/kg were prescribed and a trained nurse recorded the time from drug prescription to receiving the conscious sedation (onset of action, the total time period which the patient has the Ramsay score≥4 (duration of action, and adverse effect of agents. Mann-Whitney U test and chi-squared test, and Non-parametric analysis of covariance (ANCOVA were used for comparisons. Results: One hundred and forty children were entered to two groups of OCH and RST, randomly. The patients of two groups had similar age, sex, weight, and baseline vital signs except for diastolic blood pressure (p<0.001. The onset of action in OCH and RST groups were 24.5±6.1and 28.7±5.2 minutes, respectively (p<0.001. Duration of action in OCH and RST groups were 12.9±2.8 minutes and 13.7±2.6 minutes, respectively (p=0.085. Non parametric ANCOVA revealed that only diastolic blood pressure was affected by drug prescription (p=0.001. In 11(15.7% patients in RST group, diarrhea was observed during 24 hours (p=0.001. Oxygen desaturation was observed only in two patients, both in OCH group. Conclusion: Each of the sedative has advantages and disadvantages that should be considered when selecting one for inducing short-term sedation. It seems that rectal sodium thiopental and oral chloral hydrate are equally effective in pediatric PSA and based on patient’s condition we can administrate

  20. Serologic response to inactivated poliovirus vaccine: a randomized clinical trial comparing 2 vaccination schedules in Puerto Rico.

    Science.gov (United States)

    Dayan, Gustavo H; Thorley, Margaret; Yamamura, Yasuhiro; Rodríguez, Nayra; McLaughlin, Steve; Torres, Lourdes M; Seda, Antonio; Carbia, Marcia; Alexander, Lorraine N; Caceres, Victor; Pallansch, Mark A

    2007-01-01

    The World Health Organization (WHO) recommends the discontinuation of oral poliovirus vaccine after eradication of wild poliovirus. Studies assessing inactivated poliovirus vaccine (IPV) immunogenicity in tropical countries, using the WHO Expanded Programme on Immunization (EPI) schedule, have been limited. We conducted a randomized clinical trial in Ponce, Puerto Rico. Infants were assigned to 1 of 2 study arms: those in the EPI arm received IPV at 6, 10, and 14 weeks of age, and those in the US arm received IPV at 2, 4, and 6 months of age. Neutralizing antibody titers against poliovirus types 1, 2, and 3 were tested on serum specimens obtained before administration of the first dose of IPV and 28-45 days after administration of the last dose of IPV. Seroconversion rates for the EPI (n=225) and US (n=230) arms, respectively, were 85.8% and 99.6% for poliovirus type 1 (P<.001), 86.2% and 100% for poliovirus type 2 (P<.001), and 96.9% and 99.1% for poliovirus type 3 (P=.08). Seroconversion rates were lower among infants in the EPI arm who had high maternal antibody levels for all 3 poliovirus types (P<.001). The EPI schedule resulted in lower seroconversion rates for poliovirus types 1 and 2. These results are relevant for tropical countries planning to use IPV in a posteradication environment.

  1. Comparative effectiveness of cognitive and dynamic therapies for major depressive disorder in a community mental health setting: study protocol for a randomized non-inferiority trial.

    Science.gov (United States)

    Connolly Gibbons, Mary Beth; Mack, Rachel; Lee, Jacqueline; Gallop, Robert; Thompson, Donald; Burock, Debra; Crits-Christoph, Paul

    2014-01-01

    There is substantial evidence that cognitive therapy is an effective intervention for the treatment of major depressive disorder. Although dynamic psychotherapies have been widely studied and are commonly practiced worldwide, there are few randomized comparisons of cognitive therapy and dynamic therapy for major depressive disorder. We are completing data collection on a randomized non-inferiority trial comparing the effectiveness of cognitive therapy and short-term dynamic psychotherapy in the treatment of major depressive disorder in the community mental health setting. Therapists employed in the community setting have been recruited for training in either short-term dynamic psychotherapy or cognitive therapy. Patients seeking services at the community site who meet criteria for major depressive disorder based on a blind independent diagnostic interview are randomized to 16 sessions of treatment. All patients are assessed at baseline and months 1, 2, 4, and 5 utilizing a comprehensive battery. This study adds to the growing literature evaluating the effectiveness of short-term dynamic psychotherapy for specific diagnostic groups. These results will have implications for the dissemination of effective interventions for major depressive disorder in community mental health settings. This trial is registered at ClinicalTrials.gov, a service of the United States National Institute of Health. NIH Identifier: NCT01207271. Registered 21 September 2010.

  2. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study.

    Science.gov (United States)

    Montaner, J S; Reiss, P; Cooper, D; Vella, S; Harris, M; Conway, B; Wainberg, M A; Smith, D; Robinson, P; Hall, D; Myers, M; Lange, J M

    1998-03-25

    Current guidelines recommend that individuals infected with the human immunodeficiency virus type 1 (HIV-1) be treated using combinations of antiretroviral agents to achieve sustained suppression of viral replication as measured by the plasma HIV-1 RNA assay, in the hopes of achieving prolonged remission of the disease. However, until recently, many drug combinations have not led to sustained suppression of HIV-1 RNA. To compare the virologic effects of various combinations of nevirapine, didanosine, and zidovudine. Double-blind, controlled, randomized trial. University-affiliated ambulatory research clinics in Italy, the Netherlands, Canada and Australia (INCAS). Antiretroviral therapy-naive adults free of the acquired immunodeficiency syndrome with CD4 cell counts between 0.20 and 0.60x10(9)/L (200-600/microL). Patients received zidovudine plus nevirapine (plus didanosine placebo), zidovudine plus didanosine (plus nevirapine placebo), or zidovudine plus didanosine plus nevirapine. Plasma HIV-1 RNA. Of the 153 enrolled patients, 151 were evaluable. At week 8, plasma HIV-1 RNA levels had decreased by log 2.18, 1.55, and 0.90 in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.05). The proportions of patients with plasma HIV-1 RNA levels below 20 copies per milliliter at week 52 were 51%, 12%, and 0% in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively (P<.001). Viral amplification was attempted in 59 patients at 6 months. Viral isolation was unsuccessful in 19 (79%) of 24, 10 (53%) of 19, and 5 (31%) of 16 patients in the triple drug therapy, zidovudine plus didanosine, and zidovudine plus nevirapine groups, respectively. Among patients from whom virus could be amplified, resistance to nevirapine was found in all 11 patients receiving zidovudine plus nevirapine and in all 5 patients receiving triple drug therapy. Rates of disease progression or death

  3. Long-term results of a randomized clinical trial comparing Roux-en-Y gastric bypass with vertical banded gastroplasty.

    Science.gov (United States)

    Werling, M; Fändriks, L; Björklund, P; Maleckas, A; Brandberg, J; Lönroth, H; le Roux, C W; Olbers, T

    2013-01-01

    The long-term results of Roux-en-$\\hbox{Y}$ gastric bypass (gastric bypass) and vertical banded gastroplasty (VBG) from randomized studies have not been described in detail. Patients were randomized to gastric bypass or VBG. Body mass index (BMI), body composition, eating habits and gastrointestinal hormones were reviewed after 6 years. The frequency of reoperation was assessed up to 10 years after surgery. Sixty-six (80 per cent) of the 82 subjects randomized were assessed for weight and BMI 6 years after surgery, 30 (81 per cent) in the gastric bypass group and 36 (80 per cent) in the VBG group. Intention-to-treat analysis demonstrated greater weight loss after gastric bypass compared with VBG, 6 years after surgery: BMI reduced from 41·8 (95 per cent confidence interval 41·3 to 42·3) to 30·3 (28·6 to 32·0) kg/m(2) for gastric bypass and from 42·3 (42·8 to 44·8) to 32·9 (31·3 to 34·5) kg/m(2) for VBG (P = 0·036). Gastric bypass caused a larger loss of fat mass (P = 0·026) and better preservation of lean tissue (P = 0·009). Patients having a gastric bypass had greater postprandial responses to the satiety hormones glucagon-like peptide 1 and peptide YY (P = 0·003 and P = 0·004 respectively). Ghrelin levels did not differ between the groups. Patients with a gastric bypass maintained a lower intake of fat compared with those having VBG (P = 0·013). Some 89 per cent of patients who initially had VBG had undergone, or were scheduled for, conversion to gastric bypass at latest follow-up. Gastric bypass was superior to VBG regarding weight loss, body composition, dietary composition and postprandial satiety hormone responses. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  4. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

    Science.gov (United States)

    Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

    2017-12-01

    Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

  5. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence.

    Science.gov (United States)

    Maslow, Ken; Gupta, Chander; Klippenstein, Peter; Girouard, Lise

    2014-07-01

    This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence. We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n = 56) or TVT-O (n = 50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal-Wallis, Wilcoxon, and Fisher's exact tests as appropriate. P values of TVT-O compared with TVT-S at 1 year (86 % and 63 % respectively, p = 0.01). Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S. Quality of life scores through questionnaires improved in both groups and were not statistically different. Initial post-operative groin pain was more prevalent in the TVT-O group; however, this resolved quickly with time. TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up.

  6. Comparative study of amrutbhallataka and glucosamine sulphate in osteoarthritis: Six months open label randomized controlled clinical trial.

    Science.gov (United States)

    Raut, Ashwinikumar; Bichile, Lata; Chopra, Arvind; Patwardhan, Bhushan; Vaidya, Ashok

    2013-10-01

    AmrutBhallatak (ABFN02), a 'rasayana' drug from Ayurveda is indicated in degenerative diseases and arthritis. To evaluate safety and efficacy of ABFN02 in osteoarthritis (OA) and compare it with Glucosamine sulphate (GS). This was a randomized open comparative study. Ambulant OPD patients of OA knees (n = 112) were enrolled for 24 weeks. Tablets (750mg each) of GS and ABFN02 were matched. Three groups of patients: (A) GS, one tablet × twice/day × 24 weeks. (B) ABFN02, incremental pulse dosage (one tablet x twice/day × two weeks, two tablets × twice/day × two weeks, three tablets × twice/day × two weeks), two such cycles of drug and non-drug phases alternately for six weeks each (C) ABFN02 continuous dosage akin to GS. Pain visual analogue score (Pain-VAS) and Western Ontario and Mc-Master University Osteoarthritis Index (WOMAC) were the primary outcome measures. Secondary outcome measures were Health assessment questionnaire (HAQ), paracetamol consumption, 50 feet walking, physician and patient global assessment, knee stiffness, knee status, urinary CTX II, serum TNFa-SRI, SRII and MRI knee in randomly selected patients. ABFNO2 and GS demonstrated, adherence to treatment 87.75% and 74.3%, reduction in Pain-VAS at rest 61.05% and 57.1%, reduction in pain-VAS on activity 57.4% and 59.8%, WOMAC score drop 62.8% and 59.1% respectively. Secondary outcome measures were comparable in all groups. Safety measures were also comparable. No serious adverse events reported. However, asymptomatic reversible rise in liver enzymes was noted in the ABFNO2 group. ABFN02 has significant activity in OA; the formulation needs further investigation.

  7. Changing Resident Physician Studying Behaviors: A Randomized, Comparative Effectiveness Trial of Goal Setting Versus Use of WOOP.

    Science.gov (United States)

    Saddawi-Konefka, Daniel; Baker, Keith; Guarino, Anthony; Burns, Sara M; Oettingen, Gabriele; Gollwitzer, Peter M; Charnin, Jonathan E

    2017-08-01

    Following through on one's goals to study is essential for effective, self-regulated learning. This can be difficult for residents because of clinical demands and limited personal time. WOOP (Wish, Outcome, Obstacle, Plan) is a self-regulation strategy, also known as mental contrasting with implementation intentions. WOOP increases follow-through on goals in many domains, although it has not, to our knowledge, been evaluated in medical education. We compared the effect of WOOP versus goal setting on time residents spent studying. Through a prospective, randomized, comparative effectiveness study, during a 1-month, intensive care unit rotation, we clustered anesthesiology residents in single-blind fashion to WOOP versus goal setting. Both groups received organized study materials. The intervention group performed WOOP to study more; the comparison group set goals to study more. Residents tracked studying with daily diaries. The primary outcome was total time spent studying toward stated goals. Time spent studying "non-goal" medical material was a secondary outcome. Of 34 eligible residents, 100% participated. Sixteen residents were randomized to the WOOP group and 18 to the goal-setting group. The WOOP group spent significantly more time studying toward their goals compared with the goal-setting group (median = 4.3 hours versus 1.5 hours; P = .021; g = 0.66). There was no significant difference in time spent studying non-goal medical material between groups (median = 5.5 hours versus 5.0 hours, P = .99). WOOP increased the time residents spent studying toward their goals as compared with setting goals alone.

  8. Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: a protocol for a clustered, randomized clinical trial.

    Science.gov (United States)

    Vicens, Caterina; Socias, Isabel; Mateu, Catalina; Leiva, Alfonso; Bejarano, Ferran; Sempere, Ermengol; Basora, Josep; Palop, Vicente; Mengual, Marta; Beltran, Jose Luis; Aragonès, Enric; Lera, Guillem; Folch, Silvia; Piñol, Josep Lluís; Esteva, Magdalena; Roca, Miguel; Arenas, Arturo; Del Mar Sureda, María; Campoamor, Francisco; Fiol, Francisca

    2011-04-20

    Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice. In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a) a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b) a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c) routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia). The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption. Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two complex stepped care interventions with that of routine care in a

  9. Randomized Trials Comparing Inactivated Vaccine after Medium- or High-titer Measles Vaccine with Standard Titer Measles Vaccine after Inactivated Vaccine

    DEFF Research Database (Denmark)

    Aaby, Peter; Ravn, Henrik; Benn, Christine S.

    2016-01-01

    Background: Observational studies have suggested that girls have higher mortality if their most recent immunization is an inactivated vaccine rather than a live vaccine. We therefore reanalyzed 5 randomized trials of early measles vaccine (MV) in which it was possible to compare an inactivated...... vaccines [after medium-titer MV (MTMV) or high-titer MV (HTMV)] and a live standard titer MV (after an initial inactivated vaccine). Methods: The trials were conducted in Sudan, Senegal, The Gambia and Guinea-Bissau. The intervention group received live MTMV or HTMV from 4 to 5 months...... and then an inactivated vaccine from 9 to 10 months of age; the control children received inactivated vaccine/placebo from 4 to 5 months and standard titer MV from 9 to 10 months of age. We compared mortality from 9 months until end of study at 3 to 5 years of age for children who received inactivated vaccine (after MTMV...

  10. BIOKID: Randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991

    Directory of Open Access Journals (Sweden)

    Misselwitz Joachim

    2004-10-01

    Full Text Available Abstract Background Peritoneal dialysis (PD is the preferred dialysis modality in children. Its major drawback is the limited technique survival due to infections and progressive ultrafiltration failure. Conventional PD solutions exert marked acute and chronic toxicity to local tissues. Prolonged exposure is associated with severe histopathological alterations including vasculopathy, neoangiogenesis, submesothelial fibrosis and a gradual loss of the mesothelial cell layer. Recently, more biocompatible PD solutions containing reduced amounts of toxic glucose degradation products (GDPs and buffered at neutral pH have been introduced into clinical practice. These solutions contain lactate, bicarbonate or a combination of both as buffer substance. Increasing evidence from clinical trials in adults and children suggests that the new PD fluids may allow for better long-term preservation of peritoneal morphology and function. However, the relative importance of the buffer in neutral-pH, low-GDP fluids is still unclear. In vitro, lactate is cytotoxic and vasoactive at the concentrations used in PD fluids. The BIOKID trial is designed to clarify the clinical significance of the buffer choice in biocompatible PD fluids. Methods/design The objective of the study is to test the hypothesis that bicarbonate based PD solutions may allow for a better preservation of peritoneal transport characteristics in children than solutions containing lactate buffer. Secondary objectives are to assess any impact of the buffer system on acid-base status, peritoneal tissue integrity and the incidence and severity of peritonitis. After a run-in period of 2 months during which a targeted cohort of 60 patients is treated with a conventional, lactate buffered, acidic, GDP containing PD fluid, patients will be stratified according to residual renal function and type of phosphate binding medication and randomized to receive either the lactate-containing Balance solution or the

  11. Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial

    DEFF Research Database (Denmark)

    Riecke, Birgit Falk; Christensen, R; Christensen, Pia

    2010-01-01

    To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible, intensive weight-loss program for 16 weeks.......To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible, intensive weight-loss program for 16 weeks....

  12. Systematic review with meta-analysis of prospective randomized trials comparing minimally invasive video-assisted thyroidectomy (MIVAT) and conventional thyroidectomy (CT).

    Science.gov (United States)

    Pisanu, Adolfo; Podda, Mauro; Reccia, Isabella; Porceddu, Giulia; Uccheddu, Alessandro

    2013-12-01

    Minimally invasive video-assisted thyroidectomy (MIVAT) has gained acceptance among surgeons as its feasibility has been well documented. The aim of this systematic review with meta-analysis has been to assess and validate the safety and feasibility of MIVAT when compared to conventional thyroidectomy (CT) and to verify other potential benefits and drawbacks. A literature search for prospective randomized trials comparing MIVAT and CT was performed. Trials were reviewed for the primary outcome measures: overall morbidity, recurrent laryngeal nerve palsy, postoperative hypocalcemia, and postoperative hematoma; and for the secondary outcome measures: operative time, conversion to standard procedure, intraoperative blood loss, intraoperative drain insertion, nodule size and thyroid weight, postoperative pain evaluation, length of hospital stay, patient satisfactory score, and cosmetics results. Standardized mean difference (SMD) was calculated for continuous variables and odds ratio for qualitative variables. Nine prospective randomized studies comparing MIVAT and CT were analyzed. Overall, 581 patients were randomized to either MIVAT (289, 49.7 %) or CT (292, 50.3 %). The primary outcome measures of MIVAT were comparable with those of CT without statistically significant difference. Patients who underwent MIVAT experienced significantly less pain than those operated on conventionally during the whole postoperative period. Patient satisfactory score significantly favored MIVAT (9.0 vs. 6.8, SMD = -3.388, 95 % CI = -5.720 to -1.057). Operative time was significantly longer in MIVAT (75.2 vs. 59.2 min, SMD = 1.246, 95 % CI = 0.227-2.266). MIVAT is a safe and feasible alternative for the removal of small-volume benign thyroid disease and low-risk papillary thyroid carcinomas showing better cosmetics results and less postoperative pain but significantly longer operative time when compared to CT. New multicenter randomized studies are needed to evaluate the

  13. Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments.

    Science.gov (United States)

    Henry, James A; McMillan, Garnett; Dann, Serena; Bennett, Keri; Griest, Susan; Theodoroff, Sarah; Silverman, Shien Pei; Whichard, Susan; Saunders, Gabrielle

    2017-06-01

    Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4-5 months, participants returned to complete final outcome measures, which concluded their study participation. Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A "clinically significant" improvement in reaction to tinnitus (at least 13-point

  14. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    Science.gov (United States)

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.

  15. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial.

    Science.gov (United States)

    Bhadauria, Esha A; Gurudut, Peeyoosha

    2017-08-01

    The aim of the present study was to compare three different forms of exercises namely lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain (LBP) in terms of pain, range of motion, core strength and function. In this study, 44 subjects suffering from non-specific LBP for more than 3 months were randomly allocated into the lumbar stabilization group, the dynamic strengthening group, and the Pilates group. Ten sessions of exercises for 3 weeks were prescribed along with interferential current and hot moist pack. Pain was assessed by visual analog scale, functional affection by modified Oswestry Disability Questionnaire, range of motion by assessing lumbar flexion and extension by modified Schober test and core strength was assessed by pressure biofeedback on day 1 and day 10 of the treatment. There was reduction of pain, improvement in range of motion, functional ability and core strength in all the 3 exercise groups. The improvement was significantly greater in the lumbar stabilization group for all the outcome measures, when compared the posttreatment after 10th session. Pairwise comparison showed that there was greater reduction of disability in the Pilates group than the dynamic strengthening group. It was concluded that the lumbar stabilization is more superior compared to the dynamic strengthening and Pilates in chronic nonspecific LBP. However, long-term benefits need to be assessed and compared with prospective follow-up studies.

  16. A multicenter randomized controlled trial comparing absorbable barbed sutures versus conventional absorbable sutures for dermal closure in open surgical procedures.

    Science.gov (United States)

    Rubin, J Peter; Hunstad, Joseph P; Polynice, Alain; Gusenoff, Jeffrey A; Schoeller, Thomas; Dunn, Raymond; Walgenbach, Klaus J; Hansen, Juliana E

    2014-02-01

    Barbed sutures were developed to reduce operative time and improve security of wound closure. The authors compare absorbable barbed sutures (V-Loc, Covidien, Mansfield, Massachusetts) with conventional (smooth) absorbable sutures for soft tissue approximation. A prospective multicenter randomized study comparing barbed sutures with smooth sutures was undertaken between August 13, 2009, and January 31, 2010, in 241 patients undergoing abdominoplasty, mastopexy, and reduction mammaplasty. Each patient received barbed sutures on 1 side of the body, with deep dermal sutures eliminated or reduced. Smooth sutures with deep dermal and subcuticular closure were used on the other side as a control. The primary endpoint was dermal closure time. Safety was assessed through adverse event reporting through a 12-week follow-up. A total of 229 patients were ultimately treated (115 with slow-absorbing polymer and 114 with rapid-absorbing polymer). Mean dermal closure time was significantly quicker with the barbed suture compared with the smooth suture (12.0 vs 19.2 minutes; Psutures. The rapid-absorbing barbed suture showed a complication profile equivalent to the smooth suture, while the slow-absorbing barbed suture had a higher incidence of minor suture extrusion. Barbed sutures enabled faster dermal closure quicker than smooth sutures, with a comparable complication profile. 1.

  17. Randomized clinical trial comparing the effects on renal function of hydroxyethyl starch or gelatine during aortic aneurysm surgery.

    Science.gov (United States)

    Mahmood, A; Gosling, P; Vohra, R K

    2007-04-01

    The optimal colloid for renal protection during abdominal aortic aneurysm (AAA) surgery is not known. This study compared the effects of two hydroxyethyl starch (HES) solutions and gelatine on perioperative renal function. Sixty-two patients undergoing AAA surgery were randomized to 6 per cent HES of molecular weight 200/0.62 kDa or 130/0.4 kDa, or 4 per cent gelatine for plasma expansion. Measurements were taken of serum urea and creatinine to mark glomerular filtration, urinary immunoglobulin G : creatinine ratio to mark glomerular membrane function and alpha(1)-microglobulin : creatinine ratio to mark tubular dysfunction before, and for 5 days after, surgery. Serum urea was lower in both HES groups than the gelatine group. Serum creatinine was lower with HES 130/0.4 compared with gelatine at days 1, 2 and 5 after surgery (P = 0.020, P = 0.045 and P = 0.045 respectively). Urinary alpha(1)-microglobulin : creatinine ratio was lower with HES 200/0.62 compared with gelatine at 4 and 8 h (P gelatine at 4 to 24 h, and on days 4 and 5 (P gelatine. There was no difference between the two starch groups. Compared with gelatine, volume expansion with both types of HES during AAA surgery improved renal function and reduced renal injury.

  18. Randomized clinical trial comparing inguinal hernia repair with Lichtenstein technique using non-absorbable or partially absorbable mesh. Preliminary report

    Directory of Open Access Journals (Sweden)

    Konrad Pielaciński

    2011-12-01

    Full Text Available Introduction: The Lichtenstein technique is currently considered the “gold standard” of open, anterior inguinal herniarepair. It is not free, however, of adverse effects, which may be caused by the implemented synthetic material. Aim: Determination the influence of the mesh employed on treatment results including immediate complications,return to everyday activities, chronic pain occurrence and hernia recurrence. Material and methods: Tension-free hernia repair using the Lichtenstein technique was performed in all the 59patients randomized to trial groups. Group P with heavyweight polypropylene mesh contained 34 patients; group Vwith lightweight, partially absorbable mesh (polypropylene/polyglactin 910 consisted of 25 people. Controlled, scheduledfollow-up appointments took place after the 7th day and the 3rd and 6th month. Patients were clinically assessedand pain intensity was determined on an analogue-visual scale.Results: No statistically significant influence of the type of mesh on the risk of early complications, severe pain intensity,the length of hospital stay, time of recovery, or patients’ satisfaction with treatment was observed. After 6 monthsalso no statistically significant differences were observed between groups with regard to recurrence rate (P 3.4% vs.V 4.0%, chronic pain (P 5.9% vs. V 4.0% and ailments such as “foreign body presence” (V vs. P, OR = 0.30, 95% CI0.077-1.219, p = 0.093 incidence, although their probability was 70% lower for V mesh. Conclusions: The preliminary results confirm the effectiveness of the Lichtenstein technique for hernia repair withboth types of meshes. It appears that use of a partially absorbable mesh is connected with

  19. Initiation of oral contraceptives using a quick start compared with a conventional start: a randomized controlled trial.

    Science.gov (United States)

    Westhoff, Carolyn; Heartwell, Stephen; Edwards, Sharon; Zieman, Mimi; Cushman, Linda; Robilotto, Christina; Stuart, Gretchen; Morroni, Chelsea; Kalmuss, Debra

    2007-06-01

    To estimate whether young women taking the first pill on the day of prescription had higher continuation rates and lower pregnancy rates than women who waited until menses to start the oral contraceptive pill (OCP). We recruited 1,716 women aged younger than 25 years seeking to initiate the oral contraceptive at three publicly funded family planning clinics, and randomly assigned them to conventional initiation of the pill (conventional start) or immediate, directly observed ingestion of the first pill (quick start) during the clinic visit. Women underwent follow-up interviews at 3 and 6 months. Sixty percent of participants discontinued the pill, and 8% became pregnant during follow-up. Women who took the first pill in the clinic were more likely to continue to the second OCP pack (odds ratio 1.5, 95% confidence interval 1.0-2.1.); however, the Quick Start approach did not improve OCP continuation rates at 3 and 6 months. Those assigned to Quick Start were slightly less likely to become pregnant within 6 months from the time they started the pill (hazard ratio 0.90, 95% confidence interval 0.64-1.25). Eighty-one percent of women rated the Quick Start approach as acceptable or preferable to waiting. Rates of serious adverse events were low and similar in the two groups. Protocols that require a woman to wait until the next menses to start hormonal contraceptives are an obstacle to contraceptive initiation. Directly observed, immediate initiation of the pill improves short-term continuation. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00068848

  20. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...

  1. Prospective randomized double-blind trial of racecadotril compared with loperamide in elderly people with gastroenteritis living in nursing homes.

    Science.gov (United States)

    Gallelli, Luca; Colosimo, Manuela; Tolotta, Grazia A; Falcone, Daniella; Luberto, Laura; Curto, Lucia S; Rende, Pierandrea; Mazzei, Francesca; Marigliano, Norma M; De Sarro, Giovambattista; Cucchiara, Salvatore

    2010-02-01

    Our aim was to compare the efficacy and tolerability of loperamide and racecadotril in elderly patients with acute diarrhea. We performed a randomized, prospective, double-blind, and parallel group design implemented in geriatric nursing homes in Catanzaro, Italy, from February 2008 to March 2009. Patients of both sexes were randomly allocated to receive either one tablet of racecadotril 100 mg every 8 h or two tablets of loperamide 2.0 mg followed by one tablet after each unformed stool, up to four tablets in any 24-h period. Patients were treated until recovery, defined as the production of two consecutive normal stools or no stool production for a period of 12 h. Normal stools were collected 36 +/- 4 h after the beginning of racecadotril and in 63 +/- 6 h from the beginning of loperamide administration (P racecadotril and 28 h for loperamide. In the per-protocol (PP) population, the median time of abdominal pain was 14 h for racecadotril and 32 h for loperamide (P racecadotril group and 60% in the loperamide group. The most frequently occurring adverse events were nausea and constipation. Genetic analysis did not report the presence of rapid or poor metabolizers. Pharmacoeconomic analysis performed at the end of our study documented an increase in costs in the loperamide group with respect to the racecadotril group (P Racecadotril is more effective than loperamide-probably due to drug interaction with loperamide-and it is not related to pharmacogenetic susceptibility. Racecadotril is also more cost effective than loperamide.

  2. Comparing the Relative Efficacy of Narrative vs Nonnarrative Health Messages in Reducing Health Disparities Using a Randomized Trial.

    Science.gov (United States)

    Murphy, Sheila T; Frank, Lauren B; Chatterjee, Joyee S; Moran, Meghan B; Zhao, Nan; Amezola de Herrera, Paula; Baezconde-Garbanati, Lourdes A

    2015-10-01

    We compared the relative efficacy of a fictional narrative film to a more traditional nonnarrative film in conveying the same health information. We used a random digit dial procedure to survey the cervical cancer-related knowledge, attitudes, and behavior of non-Hispanic White, Mexican American, and African American women, aged 25 to 45 years, living in Los Angeles, California, from 2011 to 2012. Participants (n = 704) were randomly assigned to view either a narrative or nonnarrative film containing the same information about how cervical cancer could be prevented or detected, and they were re-contacted 2 weeks and 6 months later. At 2 weeks, both films produced a significant increase in cervical cancer-related knowledge and attitudes, but these effects were significantly higher for the narrative film. At 6 months, viewers of both films retained greater than baseline knowledge and more positive attitudes toward Papanicolaou (Pap) tests, but women who saw the narrative were significantly more likely to have had or scheduled a Pap test. The narrative was particularly effective for Mexican American women, eliminating cervical cancer screening disparities found at baseline. Narratives might prove to be a useful tool for reducing health disparities.

  3. Comparing the Relative Efficacy of Narrative vs Nonnarrative Health Messages in Reducing Health Disparities Using a Randomized Trial

    Science.gov (United States)

    Frank, Lauren B.; Chatterjee, Joyee S.; Moran, Meghan B.; Zhao, Nan; Amezola de Herrera, Paula; Baezconde-Garbanati, Lourdes A.

    2015-01-01

    Objectives. We compared the relative efficacy of a fictional narrative film to a more traditional nonnarrative film in conveying the same health information. Methods. We used a random digit dial procedure to survey the cervical cancer-related knowledge, attitudes, and behavior of non-Hispanic White, Mexican American, and African American women, aged 25 to 45 years, living in Los Angeles, California, from 2011 to 2012. Participants (n = 704) were randomly assigned to view either a narrative or nonnarrative film containing the same information about how cervical cancer could be prevented or detected, and they were re-contacted 2 weeks and 6 months later. Results. At 2 weeks, both films produced a significant increase in cervical cancer-related knowledge and attitudes, but these effects were significantly higher for the narrative film. At 6 months, viewers of both films retained greater than baseline knowledge and more positive attitudes toward Papanicolaou (Pap) tests, but women who saw the narrative were significantly more likely to have had or scheduled a Pap test. The narrative was particularly effective for Mexican American women, eliminating cervical cancer screening disparities found at baseline. Conclusions. Narratives might prove to be a useful tool for reducing health disparities. PMID:25905845

  4. An interesterified palm olein test meal decreases early-phase postprandial lipemia compared to palm olein: a randomized controlled trial.

    Science.gov (United States)

    Hall, Wendy L; Brito, Marcela Fiuza; Huang, Junlan; Wood, Lucy V; Filippou, Androulla; Sanders, Thomas A B; Berry, Sarah E E

    2014-09-01

    Palm oil that has been interesterified to produce a higher proportion of palmitic acid (16:0) in the sn-2 position reduces postprandial lipemia in young, normolipidemic men and women, but effects in older subjects with higher fasting triacylglycerol (TAG) concentrations are unknown. We tested the hypothesis that high-fat meals rich in interesterified palm olein (IPO) decrease lipemia and alter plasma lipoprotein fraction composition compared to native palm olein (NPO) in men aged 40-70 years with fasting TAG concentrations ≥1.2 mmol/L. Postprandial changes in plasma lipids following meals containing 75 g fat (NPO and IPO) were compared using a randomized, double-blind crossover design (n = 11). Although there were no significant differences in plasma TAG concentrations between meals over the total 6-h postprandial measurement period, IPO resulted in a decreased plasma TAG response during the first 4 h of the postprandial period (iAUC 1.65 mmol/L h, 95% CI 1.01-2.29) compared to NPO (iAUC 2.33 mmol/L h, 95% CI 1.58-3.07); meal effect P = 0.024. Chylomicron fraction TAG concentrations at 4-6 h were slightly reduced following IPO compared to NPO [NPO-IPO mean difference 0.29 mmol/L (95% CI -0.01-0.59), P = 0.055]. There were no differences in IDL fraction TAG, cholesterol or apolipoprotein B48 concentrations following IPO compared with NPO. In conclusion, consuming a meal containing palm olein with a higher proportion of 16:0 in the sn-2 position decreases postprandial lipemia compared to native palm olein during the early phase of the postprandial period in men with higher than optimal fasting triacylglycerol concentrations.

  5. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)

    2001-06-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9{+-} 11.2 in group M, 46.5{+-}9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of

  6. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial.

    Science.gov (United States)

    Barnard, Neal D; Scialli, Anthony R; Turner-McGrievy, Gabrielle; Lanou, Amy J

    2004-01-01

    This study aimed to assess the acceptability of a low-fat vegan diet, as compared with a more typical fat-modified diet, among overweight and obese adults. Through newspaper advertisements, 64 overweight, postmenopausal women were recruited, 59 of whom completed the study. The participants were assigned randomly to a low-fat vegan diet or, for comparison, to a National Cholesterol Education Program Step II (NCEP) diet. At baseline and 14 weeks later, dietary intake, dietary restraint, disinhibition, and hunger, as well as the acceptability and perceived benefits and adverse effects of each diet were assessed. Dietary restraint increased in the NCEP group (P vegan group. Disinhibition and hunger scores fell in each group (P vegan group participants rated their diet as less easy to prepare than their usual diets (P vegan diet is high and not demonstrably different from that of a more moderate low-fat diet among well-educated, postmenopausal women in a research environment.

  7. Personality and Differential Treatment Response in Major Depression: A Randomized Controlled Trial Comparing Cognitive-Behavioural Therapy and Pharmacotherapy

    Science.gov (United States)

    Bagby, R Michael; Quilty, Lena C; Segal, Zindel V; McBride, Carolina C; Kennedy, Sidney H; Costa, Paul T

    2008-01-01

    Objective Effective treatments for major depressive disorder exist, yet some patients fail to respond, or achieve only partial response. One approach to optimizing treatment success is to identify which patients are more likely to respond best to which treatments. The objective of this investigation was to determine if patient personality characteristics are predictive of response to either cognitive-behavioural therapy (CBT) or pharmacotherapy (PHT). Method Depressed patients completed the Revised NEO Personality Inventory, which measures the higher-order domain and lower-order facet traits of the Five-Factor Model of Personality, and were randomized to receive either CBT or PHT. Result Four personality traits—the higher-order domain neuroticism and 3 lower-order facet traits: trust, straightforwardness, and tendermindedness—were able to distinguish a differential response rate to CBT, compared with PHT. Conclusion The assessment of patient dimensional personality traits can assist in the selection and optimization of treatment response for depressed patients. PMID:18616856

  8. Balloon dilation of benign esophageal rings or strictures: a randomized clinical trial comparing two different inflation times.

    Science.gov (United States)

    Wallner, O; Wallner, B

    2014-01-01

    Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time with 2 minutes inflation time, regarding the efficacy. Twenty patients with symptomatic strictures were prospectively studied in a randomized fashion. The 10-second group required an average of 1.4 dilations per patient; the 2-minute group required an average of 1.5 dilations per patient. This pilot study indicates that 10 seconds inflation time is as effective as 2 minutes. Because the treatment is both painful and unpleasant, this is an important finding. © 2013 Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

  9. Efficacy and tolerability of Blonanserin in the patients with schizophrenia: a randomized, double-blind, risperidone-compared trial.

    Science.gov (United States)

    Yang, Jaewon; Bahk, Won-Myong; Cho, Hyun-Sang; Jeon, Yang-Whan; Jon, Duk-In; Jung, Hee-Yeon; Kim, Chan-Hyung; Kim, Hee-Cheol; Kim, Yong-Ku; Kim, Young-Hoon; Kwon, Jun-Soo; Lee, Sang-Yeol; Lee, Seung-Hwan; Yi, Jung-Seo; Yoon, Bo-Hyun; Kim, Seung-Hyun

    2010-07-01

    The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design. Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events. Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was -23.48 +/- 19.73 for the blonanserin group and -25.40 +/- 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006). Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.

  10. The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol

    Directory of Open Access Journals (Sweden)

    Ford Daniel E

    2010-11-01

    Full Text Available Abstract Background Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group. Methods The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates and patient participation (proportion referred who go to the website. We will then compare the effectiveness of the standard and augmented patient websites. Discussion Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login and patient outcomes (six-month smoking cessation. Trial Registration Web-delivered Provider Intervention for

  11. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma.

    Science.gov (United States)

    Ishikawa, Makoto; Kitayama, Joji; Kaizaki, Shoichi; Nakayama, Hiroshi; Ishigami, Hironori; Fujii, Shin; Suzuki, Hiroyuki; Inoue, Tomomi; Sako, Akihiro; Asakage, Masahiro; Yamashita, Hiroharu; Hatono, Kenji; Nagawa, Hirokazu

    2005-11-01

    To determine the clinical efficacy of Roux-en-Y reconstruction (RY) after distal gastrectomy, we compared postoperative outcomes of patients who underwent RY or conventional Billroth I reconstruction (B-I). A total of 50 patients were prospectively randomized to either B-I or RY reconstruction, and complications, postoperative course, and nutritional status were compared. Bile reflux and inflammation in the remnant stomach and lower esophagus were evaluated by postoperative follow-up endoscopy at 6 months. Operative time and blood loss as well as postoperative nutrition did not show significant differences between the two groups. As anticipated, 5 of 24 patients with RY reconstruction developed gastrojejunal stasis in the early postoperative period, which led to a longer postoperative hospital stay as compared with the B-I group (mean +/- S.D; B-I; 19.0 +/- 6.2, RY; 31.8 +/- 21.7 days) (P gastritis, but it did not prevent esophagitis. Because RY reconstruction induces the frequent complication of Roux-en-Y stasis, causing longer postoperative hospital stay, this method has limited advantages over B-I anastomosis after distal gastrectomy.

  12. Indirect vs direct bonding of mandibular fixed retainers in orthodontic patients: a single-center randomized controlled trial comparing placement time and failure over a 6-month period.

    Science.gov (United States)

    Bovali, Efstathia; Kiliaridis, Stavros; Cornelis, Marie A

    2014-12-01

    The objective of this 2-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure. Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure. Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines, and no active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4; the randomization sequence was generated using an online randomization service (www.randomization.com). Allocation concealment was secured by contacting the sequence generator for treatment assignment; blinding was possible for outcome assessment only. Bonding time was measured for each procedure. Unpaired t tests were used to assess differences in time. Patients were recalled at 1, 2, 4, and 6 months after bonding. Mandibular fixed retainers having at least 1 composite pad debonded were considered as failures. The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures. A test of proportion was applied to compare the failures at 6 months between the treatment groups. Sixty-four patients were randomized in a 1:1 ratio. One patient dropped out at baseline after the bonding procedure, and 3 patients did not attend the recalls at 4 and 6 months. Bonding time was significantly shorter for the indirect procedure (321 ± 31 seconds, mean ± SD) than for the direct procedure (401 ± 40 seconds) (per protocol analysis of 63 patients: mean difference = 80 seconds; 95% CI = 62.4-98.1; P technique and 7 of 29 (24%) with the direct technique (log rank: P = 0.35; test of proportions: risk difference = 0.08; 95% CI = -0.15 to

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

    Science.gov (United States)

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

    2017-02-09

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

  14. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Astrid V Fahlenkamp

    Full Text Available Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV. We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis.220 subjects with elevated PONV risk (Apfel score ≥2 undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up.Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044. Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138. After xenon, nausea occurred significantly earlier (p = 0.014, was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups.In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea.EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

  15. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

    Science.gov (United States)

    Fahlenkamp, Astrid V; Stoppe, Christian; Cremer, Jan; Biener, Ingeborg A; Peters, Dirk; Leuchter, Ricarda; Eisert, Albrecht; Apfel, Christian C; Rossaint, Rolf; Coburn, Mark

    2016-01-01

    Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV). We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis. 220 subjects with elevated PONV risk (Apfel score ≥2) undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up. Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044). Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138). After xenon, nausea occurred significantly earlier (p = 0.014), was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups. In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea. EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

  16. Comparative study of amrutbhallataka and glucosamine sulphate in osteoarthritis: Six months open label randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ashwinikumar Raut

    2013-01-01

    Full Text Available Background: AmrutBhallatak (ABFN02, a ′rasayana′ drug from Ayurveda is indicated in degenerative diseases and arthritis. Objective: To evaluate safety and efficacy of ABFN02 in osteoarthritis (OA and compare it with Glucosamine sulphate (GS Materials and Methods: This was a r andomized open comparative study. Ambulant OPD patients of OA knees (n = 112 were enrolled for 24 weeks. Tablets (750mg each of GS and ABFN02 were matched. Three groups of patients: (A GS, one tablet × twice/day × 24 weeks. (B ABFN02, incremental pulse dosage (one tablet x twice/day × two weeks, two tablets × twice/day × two weeks, three tablets × twice/day × two weeks, two such cycles of drug and non-drug phases alternately for six weeks each (C ABFN02 continuous dosage akin to GS. Pain visual analogue score (Pain-VAS and Western Ontario and Mc-Master University Osteoarthritis Index (WOMAC were the primary outcome measures. Secondary outcome measures were Health assessment questionnaire (HAQ, paracetamol consumption, 50 feet walking, physician and patient global assessment, knee stiffness, knee status, urinary CTX II, serum TNFa-SRI, SRII and MRI knee in randomly selected patients. Results: ABFNO2 and GS demonstrated, adherence to treatment 87.75% and 74.3%, reduction in Pain-VAS at rest 61.05% and 57.1%, reduction in pain-VAS on activity 57.4% and 59.8%, WOMAC score drop 62.8% and 59.1% respectively. Secondary outcome measures were comparable in all groups. Safety measures were also comparable. No serious adverse events reported. However, asymptomatic reversible rise in liver enzymes was noted in the ABFNO2 group. Conclusions: ABFN02 has significant activity in OA; the formulation needs further investigation.

  17. A Double-Blind Randomized Trial Comparing Implants with Laser-Microtextured and Machined Collar Surfaces: Microbiologic and Clinical Results.

    Science.gov (United States)

    Guarnieri, Renzo; Rappelli, Giorgio; Piemontese, Matteo; Procaccini, Maurizio; Quaranta, Alessandro

    2016-01-01

    The purpose of this study was to compare the clinical outcome of and determine the differences in periodonto-pathogenic microbiota around two types of implant collar surfaces: laser-microtextured (test) vs machined (control). Seventeen patients (11 periodontally healthy, and 6 periodontally compromised) were selected to receive the two different implants, placed randomly, in two edentulous sites. Six months following the surgical placement of the dental implants, subgingival plaque samples were collected using paper points from the peri-implant sulcus and from the sulcus of an adjacent tooth. The presence of five putative periodontal pathogens, namely, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola, and Tannerella forsythensis, was assessed using real-time polymerized chain reaction (RT-PCR). Peri-implant parameters and intraoral radiographs were recorded up to 1 year after abutment connection. In the main population, and in the periodontally compromised subgroup, the total number of periodontal pathogens around test implant sites was lower than control implant sites and adjacent tooth sites, with a statistically significant difference (P < .05). In periodontally healthy patients, the mean probing pocket depth for the test implant was 1.31 ± 0.51 mm, compared with 2.66 ± 0.83 mm for the control implant, while in periodontally compromised patients, it was 1.61 ± 0.58 mm for the test implant, compared with a mean value of 2.84 ± 1.0 mm for the control implant. Implants with a laser-microtextured collar surface are not more vulnerable to pathogenic microflora colonization than implants with a machined collar surface. In both of the subgroups of patients (periodontally healthy and periodontally compromised), implants with a laser-microtextured collar surface have a better clinical outcome at 1 year of loading, compared with implants with a machined collar surface.

  18. Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

    Science.gov (United States)

    Beksinska, Mags E; Smit, Jenni; Greener, Ross; Todd, Catherine S; Lee, Mei-ling Ting; Maphumulo, Virginia; Hoffmann, Vivian

    2015-02-01

    In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting. We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273. Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time. MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.

  19. Meta-analysis of Randomized Controlled Trials Comparing Clinical Outcomes Between Short Implants and Long Implants with Bone Augmentation Procedure.

    Science.gov (United States)

    Tong, Qingchun; Zhang, Xingwen; Yu, Liming

    The purpose of this meta-analysis was to assess and compare clinical outcomes of short implants versus long implants placed in conjunction with a bone augmentation procedure. The eligible studies were searched from PubMed, Embase, Springer link, and the Cochrane library databases up to 23 January 2015. Prosthesis failures, implant failures, complications, and marginal bone loss were the clinical outcomes measured. The pooled weighted mean difference (WMD) or risk ratios (RRs) and their 95% confidence intervals (CIs) were used to measure the effect size of continuous variables and dichotomous variables, respectively. A random-effects model was performed to assess the effect size. Nine eligible studies including 480 short implants (≤ 8 mm) and 503 long implants (≥ 9.3 mm) were selected for this meta-analysis. Compared with the long-implant group, a notable decrease in the short-implant group was found for complications at the 5-year follow-up (RR = 0.34, 95% CI: 0.15 to 0.79, P .05). Moreover, the results were not obviously changed when stratified by implants placed in the mandible and maxilla. Implants ≤ 8 mm in length are considered to be a suitable alternative treatment when bone height is not adequate for standard implants.

  20. Comparing primary and secondary wound healing discomfort after mandibular third molar surgery: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Refo'a, Youshiaho; Ouatik, Nabil; Golchin, Foroogh; Mahboobi, Nima

    2011-01-01

    Extraction of impacted mandibular third molars is one of the most common procedures in the oral cavity and often is followed by pain, swelling, and postextraction alveolitis and trismus. It has been suggested that postoperative discomfort is in relation to the type of surgical wound healing. The aim of this study was to compare pain, swelling, and maximum mouth opening in two groups of patients with primary and secondary wound healing after impacted mandibular third molar surgery. Thirty-two patients were enrolled in this study and randomly divided into two equal groups, quantitatively and by gender. After the surgical procedures, 16 patients received primary wound closure, while the other 16 participants received secondary wound closure. A visual analog scale was used to collect pain data three days after the surgeries. A checklist was used to record data regarding swelling size and maximum mouth opening before, immediately following, three days after, and one week after surgery. Frequency tests and a t-test were used for statistical analysis and a P value of healing group showed statistically significant lower discomfort regarding pain, swelling size, and maximal mouth opening compared to the primary wound healing group. The authors suggest the use of secondary wound healing closure to reduce postoperative complications such as pain, maximal mouth opening, and swelling size after impacted mandibular third molar extractions.

  1. Clinical effect of bovine amniotic membrane and hydrocolloid on wound by laser treatment: prospective comparative randomized clinical trial.

    Science.gov (United States)

    Min, Seonguk; Yoon, Ji Young; Park, Seon Yong; Kwon, Hyuck Hoon; Suh, Dae Hun

    2014-01-01

    Bovine amniotic membrane (BAM) has been regarded as an ideal dressing material because it accelerates epithelization and has anti-inflammatory, anti-angiogenic, and strong analgesic effects. To evaluate the clinical effects of BAM and compare them to that of hydrocolloid dressings on wounds created by ablative laser treatments, 49 subjects with nevi or scars requiring ablative laser treatment were evaluated. To compare efficacy, we divided the body into six areas and included patients with two or more similar skin lesions in the same body area. After ablative laser treatments, BAM and hydrocolloid dressing were applied to the wounds with random allocation. Clinical assessments were performed at baseline, 1, 4, 6, 8, 11, and 13 days after treatment. Histologic changes were assessed by skin biopsy. BAM treatment induced faster epithelization than hydrocolloid treatment (6.7 vs. 9.2 days). Erythema and oozing faded more quickly, and the satisfaction score was higher in BAM-treated sites than it was in hydrocolloid-treated sites, without severe adverse effects. Histologic analysis confirmed epithelization and immunohistochemistry revealed different growth factor profiles between the two treatment modalities. BAM benefits wound healing following ablative laser treatment. © 2014 by the Wound Healing Society.

  2. Double-Blind Randomized Clinical Trial Comparing Dopamine and Epinephrine in Pediatric Fluid-Refractory Hypotensive Septic Shock.

    Science.gov (United States)

    Ramaswamy, Karthik Narayanan; Singhi, Sunit; Jayashree, Muralidharan; Bansal, Arun; Nallasamy, Karthi

    2016-11-01

    We compared efficacy of dopamine and epinephrine as first-line vasoactive therapy in achieving resolution of shock in fluid-refractory hypotensive cold septic shock. Double-blind, pilot, randomized controlled study. Pediatric emergency and ICU of a tertiary care teaching hospital. Consecutive children 3 months to 12 years old, with fluid-refractory hypotensive septic shock, were enrolled between July 2013 and December 2014. Enrolled children were randomized to receive either dopamine (in incremental doses, 10 to 15 to 20 μg/kg/min) or epinephrine (0.1 to 0.2 to 0.3 μg/kg/min) till end points of resolution of shock were achieved. After reaching maximum doses of test drugs, open-label vasoactive was started as per discretion of treating team. Primary outcome was resolution of shock within first hour of resuscitation. The study was registered (CTRI/2014/02/004393) and was approved by institute ethics committee. We enrolled 29 children in epinephrine group and 31 in dopamine group. Resolution of shock within first hour was achieved in greater proportion of children receiving epinephrine (n = 12; 41%) than dopamine (n = 4; 13%) (odds ratio, 4.8; 95% CI, 1.3-17.2; p = 0.019); the trend persisted even at 6 hours (48.3% vs 29%; p = 0.184). Children in epinephrine group had lower Sequential Organ Function Assessment score on day 3 (8 vs 12; p = 0.05) and more organ failure-free days (24 vs 20 d; p = 0.022). No significant difference in adverse events (16.1% vs 13.8%; p = 0.80) and mortality (58.1% vs 48.3%; p = 0.605) was observed between the two groups. Epinephrine is more effective than dopamine in achieving resolution of fluid-refractory hypotensive cold shock within the first hour of resuscitation and improving organ functions.

  3. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

  4. Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation.

    Science.gov (United States)

    Mace, Sharon E

    2017-10-01

    Painful diagnostic and therapeutic procedures are common in the health care setting. Eliminating, or at least, minimizing the pain associated with various procedures should be a priority. Although there are many benefits of providing local/topical anesthesia prior to performing painful procedures, ranging from greater patient/family satisfaction to increased procedural success rates; local/topical anesthetics are frequently not used. Reasons include the need for a needlestick to administer local anesthetics such as lidocaine and the long onset for topical anesthetics. Vapocoolants eliminate the risks associated with needlesticks, avoids the tissue distortion with intradermal local anesthetics, eliminates needlestick pain, have a quick almost instantaneous onset, are easy to apply, require no skills or devices to apply, are convenient, and inexpensive. The aims of this study were to ascertain if peripheral intravenous (PIV) cannulation pain would be significantly decreased by using a vapocoolant (V) versus sterile water placebo (S) spray, as determined by a reduction of at least ≥1.8 points on numerical rating scale (NRS) after vapocoolant versus placebo spray, the side effects and incidence of side effects from a vapocoolant spray; and whether there were any long term visible skin abnormalities associated with the use of a vapocoolant spray. Prospective, randomized, double-blind controlled trial of 300 adults (ages 18-80) requiring PIV placement in a hospital ED, randomized to S (N=150) or V (N=150) prior to PIV. Efficacy outcome was the difference in PIV pain: NRS from 0 (none) to worst (10). Safety outcomes included a skin checklist for local adverse effects (i.e., redness, blanching, edema, ecchymosis, itching, changes in skin pigmentation), vital sign (VS) changes, and before/after photographs of the PIV site. Patient demographics (age, gender, race), comorbidity, medications, and vital signs; and PIV procedure variables (e.g., IV needle size, location

  5. Comparing Gabapentin with Clonazepam for Residual Sleeping Problems following Antidepressant Therapy in Patients with Major Depressive Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Mowla, Arash; Ahmadzadeh, Laaya; Razeghian Jahromi, Leila; Dastgheib, Seyed Ali

    2015-08-01

    Residual sleeping disturbances after improvement of depression in major depressed patients are associated with more functional problems, increased relapses and more risk of becoming resistant to treatment. The aim of this study was to compare the efficacy of gabapentin with clonazepam for treating residual sleeping disturbances. This comparative trial was designed as a randomized, controlled, double-blind study. Sixty-three patients with a DSM-IV diagnosis of major depressive disorder (MDD) who had been treated with one of the selective serotonin reuptake inhibitors (SSRIs; fluoxetine, citalopram or sertraline) were included in the study. The patients' depression had improved [Hamilton Depression Rating Scale (HDRS) sleeping problems [Pittsburgh Sleep Quality Index (PSQI) >5; Insomnia Severity Index (ISI) >8]. Patients were randomized to receive a flexible dose of gabapentin (100-600 mg/day) or clonazepam (0.5-2 mg/day) beside their current antidepressant medication for a period of 4 weeks. Outcome measures were PSQI, ISI and Clinical Global Impression (CGI). Our results demonstrated that similar to the clonazepam group, sleeping problems improved significantly in the gabapentin group at the end of the trial (PSQI: P = 0.001, Z = 3.549; ISI: P = 0.001, Z = 3.347). The two groups did not show a significant difference in treating residual sleep disturbances (PSQI: P = 0.234, Z = 1.432; ISI: P = 0.456, Z = 1.347). This study revealed that gabapentin is comparable to clonazepam for treating sleeping problems associated with major depression.

  6. Randomized trial comparing interferential therapy with motorized lumbar traction and massage in the management of low back pain in a primary care setting.

    Science.gov (United States)

    Werners, R; Pynsent, P B; Bulstrode, C J

    1999-08-01

    A randomized trial designed to compare interferential therapy with motorized lumbar traction and massage management for low back pain in a primary care setting. To measure and compare the outcome of interferential therapy and management by motorized lumbar traction and massage. Management of low back pain by interferential therapy and motorized lumbar traction and massage is common in Germany. No reports of previous randomized trials for the outcome from interferential therapy were found. Consenting patients were randomly assigned into one of two groups. A pretreatment interview was performed by the patient using a computer-based questionnaire. It also incorporated the Oswestry Disability Index and a pain visual analog scale. Management consisted of six sessions over a 2- to 3-week period. Oswestry Disability Indexes and pain visual analog scale scores also were obtained immediately after and at 3 months after treatment. A total of 152 patients were recruited. The two treatment groups had similar demographic and clinical baseline characteristics. The mean Oswestry Disability Index before treatment was 30 for both groups (n = 147). After treatment, this had dropped to 25, and, at 3 months, were 21 (interferential therapy) and 22 (motorized lumbar traction and massage). The mean pain visual analog scale score before treatment was 50 (interferential therapy) and 51 (motorized lumbar traction and massage). This had dropped, respectively, to 46 and 44 after treatment and to 42 and 39 at 3 months. This study shows a progressive fall in Oswestry Disability Index and pain visual analog scale scores in patients with low back pain treated with either-interferential therapy or motorized lumbar traction and massage. There was no difference in the improvement between the two groups at the end of treatment. Although there is evidence from several trials that traction alone is ineffective in the management of low back pain, this study could not exclude some effect from the

  7. Comparative effectiveness of electro-acupuncture versus gabapentin for sleep disturbances in breast cancer survivors with hot flashes: a randomized trial.

    Science.gov (United States)

    Garland, Sheila N; Xie, Sharon X; Li, Qing; Seluzicki, Christina; Basal, Coby; Mao, Jun J

    2017-05-01

    Sleep disturbance is a major consequence of hot flashes among breast cancer survivors. This study evaluated the effects of electro-acupuncture (EA) versus gabapentin (GP) for sleep disturbances among breast cancer survivors experiencing daily hot flashes. We analyzed data from a randomized controlled trial involving 58 breast cancer survivors experiencing bothersome hot flashes at least two times per day. Participants were randomly assigned to receive 8 weeks of EA or daily GP (total dose of 900 mg/d). The primary outcome was change in the total Pittsburgh Sleep Quality Index (PSQI) score between groups at week 8. Secondary outcomes include specific PSQI domains. By the end of treatment at week 8, the mean reduction in PSQI total score was significantly greater in the EA group than the GP group (-2.6 vs -0.8, P = 0.044). The EA also had improved sleep latency (-0.5 vs 0.1, P = 0.041) and sleep efficiency (-0.6 vs 0.0, P = 0.05) compared with the GP group. By week 8, the EA group had improved sleep duration, less sleep disturbance, shorter sleep latency, decreased daytime dysfunction, improved sleep efficiency, and better sleep quality (P efficiency. Larger randomized controlled trials with longer follow-ups are needed to confirm this preliminary finding.

  8. Effectiveness of sublingual nitroglycerin before puncture compared with conventional intra-arterial nitroglycerin in transradial procedures: a randomized trial

    Energy Technology Data Exchange (ETDEWEB)

    Turan, Burak, E-mail: drburakturan@gmail.com; Daşlı, Tolga; Erkol, Ayhan; Erden, İsmail

    2015-10-15

    Aim: Sublingual (SL) nitroglycerin administered before radial artery puncture can improve cannulation success and decrease the incidence of radial artery spasm (RAS) compared with intra-arterial (IA) nitroglycerin in transradial procedures. Methods: Patients undergoing diagnostic transradial angiography were randomized to IA (200 mcg) or SL (400 mcg) nitroglycerin. Primary endpoints were puncture time and puncture attempts. Secondary endpoint was the incidence of RAS. Results: Total of 101 participants (mean age 60 ± 11 years, 53% male) were randomized (51 in IA and 50 in SL groups). Puncture time (50 [36–75] vs 50 [35–90] sec), puncture attempts (1.18 ± 0.48 vs 1.20 ± 0.49), multiple punctures (13.7 vs 16.0%) and RAS (19.6 vs 24.0%) were not statistically different between IA vs SL groups respectively. A composite endpoint of all adverse events related to transradial angiography (multiple punctures, RAS, access site crossover, hypotension/bradycardia associated with nitroglycerin and radial artery occlusion) was very similar in IA vs SL groups (39 vs 40%, respectively). However puncture time was significantly longer with SL nitroglycerin in patients < 1.65 m height (47 [36–66] vs 63 [41–110] sec, p = 0.042). Multiple punctures seemed higher with SL nitroglycerin in patients with diabetes (0 vs 30%, p = 0.028) or in patients < 1.65 m height (7.4 vs 25%, p = 0.085). Likewise, RAS with SL nitroglycerin seemed more frequent in smokers compared to IA nitroglycerin (0 vs 27%, p = 0.089). Conclusions: SL nitroglycerin was not different from IA nitroglycerin in terms of efficiency and safety in overall study population. However it may be inferior to IA nitroglycerin in certain subgroups (shorter individuals, diabetics and smokers). - Highlights: • Improvement in radial artery puncture time and success with subcutaneous nitrate was reported. • Giving nitrate sublingually may have vasodilation along entire length of radial artery and may prevent RAS

  9. Comparative evaluation of Green Tea- Aloe Vera mouthwash and chlorhexidine 0.2% on gingival indices (A randomized clinical trial

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    Naser Sargolzaie

    2015-12-01

    Full Text Available Introduction: Nowadays in the field of dentistry, there is a trend to encourage the use of herbal and natural products. The high level of clinical research in terms of considering green tea and aloe vera, with various functionality for individual use is a typical example. The purpose of this randomized, controlled, and double-blind study was to evaluate comparative evaluation of green tea-aloe vera mouthwash and chlorhexidine 0.2% on gingival indices. Methods: A total of 60 patients (26 women and 34 men with periodontal disease were randomly allocated into one of the three double blind groups, 20 in each, to receive the following treatments :(1 0.2% chlorhexidine, (2 green tea-aloe vera and  (3 distilled water. Plaque and gingival indices were evaluated on the day of the beginning of the experiment and 14 days postoperative. Subjects were asked to rinse their mouth with the mouth rinse, twice a day, during a 14-day period. Paired t-test was used to test the mean difference on 0 and 14 days, respectively. One way analysis of variance (ANOVA was used to compare the mean difference between the groups while Tukey test was used for multiple comparisons. Results: Chlorhexidine 0.2%, green tea - aloe vera and placebo reduced the plaque index by 0.17±0.14, 0.10±0/08 and 0.02±0.18, respectively, with a statistical significance of p=0.008. This difference was related to Chlorhexidine 0.2% and green tea - aloe vera with Placebo. There exist a significant difference of p=0.001 in the bleeding index  between the three groups, and this difference was related to Chlorhexidine 0.2% and green tea - aloe vera with placebo. Conclusion: Green tea –aloe vera   mouthwash improves periodontal health status. Therefore, it can be used to improve oral and dental health status.

  10. Comparative evaluation of Green Tea- Aloe Vera mouthwash and chlorhexidine 0.2% on gingival indices (A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Naser Sargolzaie

    2016-03-01

    Full Text Available Introduction: Nowadays in the field of dentistry, there is a trend to encourage the use of herbal and natural products. The high level of clinical research in terms of considering green tea and aloe vera, with various functionality for individual use is a typical example. The purpose of this randomized, controlled, and double-blind study was to evaluate comparative evaluation of green tea-aloe vera mouthwash and chlorhexidine 0.2% on gingival indices. Methods: A total of 60 patients (26 women and 34 men with periodontal disease were randomly allocated into one of the three double blind groups, 20 in each, to receive the following treatments :(1 0.2% chlorhexidine, (2 green tea-aloe vera and  (3 distilled water. Plaque and gingival indices were evaluated on the day of the beginning of the experiment and 14 days postoperative. Subjects were asked to rinse their mouth with the mouth rinse, twice a day, during a 14-day period. Paired t-test was used to test the mean difference on 0 and 14 days, respectively. One way analysis of variance (ANOVA was used to compare the mean difference between the groups while Tukey test was used for multiple comparisons. Results: Chlorhexidine 0.2%, green tea - aloe vera and placebo reduced the plaque index by 0.17±0.14, 0.10±0/08 and 0.02±0.18, respectively, with a statistical significance of p=0.008. This difference was related to Chlorhexidine 0.2% and green tea - aloe vera with Placebo. There exist a significant difference of p=0.001 in the bleeding index  between the three groups, and this difference was related to Chlorhexidine 0.2% and green tea - aloe vera with placebo. Conclusion: Green tea –aloe vera   mouthwash improves periodontal health status. Therefore, it can be used to improve oral and dental health status.

  11. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

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    de Bie Rob A

    2010-06-01

    Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

  12. Design of the PROCON trial: a prospective, randomized multi – center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

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    Grotenhuis J André

    2006-11-01

    Full Text Available Abstract Background PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and discussion of its strengths and limitations. Methods/Design Since proof justifying the use of implants or arthroplasty after cervical anterior discectomy is lacking, PROCON was designed. PROCON is a multicenter, randomized controlled trial comparing cervical anterior discectomy without fusion, with fusion with a stand alone cage or with implantation of a disc. The study population will be enrolled from patients with a single level cervical disc disease without myelopathic signs. Each treatment arm will need 90 patients. The patients will be followed for a minimum of five years, with visits scheduled at 6 weeks, 3 months, 12 months, and then yearly. At one year postoperatively, clinical outcome and self reported outcomes will be evaluated. At five years, the development of adjacent disc disease will be investigated. Discussion The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective. Trial registration Current Controlled Trials ISRCTN41681847

  13. Does an online psychological intervention improve self-efficacy and disability in people also receiving Multimodal Manual Therapy for chronic low back pain compared to Multimodal Manual Therapy alone? Design of a randomized controlled trial

    National Research Council Canada - National Science Library

    Mackey, Martin G; Ferreira, Paulo H; Petrozzi, M. John; Jones, Mairwen K; Rubinstein, Sidney M; Leaver, Andrew

    2015-01-01

    .... Methods/Design A randomized controlled trial comparing a combined intervention, consisting of internet-based CBT utilising MoodGYM plus multimodal manual therapy, to multimodal manual therapy alone...

  14. A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer

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    Charafeddine Maya

    2010-09-01

    Full Text Available Abstract Purpose/Objective This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma. Materials/Methods Between May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m2 Cisplatin (group I; 16 patients or 50 mg/m2 paclitaxel (group II; 15 patients concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy for group I and 66 Gy (range: 40-98 Gy for group II. Median follow-up time was 46 months. Results Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44% of group I and 8 patients (53% of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively. Conclusions This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix.

  15. Randomized comparative clinical trial of artemisia sieberi 5% lotion and clotrimazole 1% lotion for the treatment of pityriasis versicolor

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    Rad Farrokh

    2008-01-01

    Full Text Available Aims: To compare the therapeutic effects of topical Artremisia sieberi 5% lotion with topical clotrimazole 1% lotion in the treatment of pityriasis versicolor. Materials and Methods: 100 patients with pityriasis versicolor and microscopic identification of Malassezia furfur were randomly assigned to treatment with either topical Artemisia sieberi 5% lotion (group 1 or topical clotrimazole 1% lotion (group 2 for 2 weeks. Group 1 and group 2 consisted of 51 and 49 patients respectively. The patients were evaluated both clinically and mycologically at baseline and every 2 weeks for a period of 4 weeks. Results: At the end of the second week, clinical cure rates were 86.3% and 65.3% for group 1 and group 2 respectively ( P < 0.01, but at the same time mycological cure rate was 92.2% for group 1 and 73.5% for group 2 ( P < 0.05. At the end of the fourth week, clinical cure rates were 86.3% and 59.2% for group 1 and group 2 respectively ( P < 0.01, and at the same time mycologic cure rate was 96.1% for group 1 and 65.3% for group 2 ( P < 0.01. Conclusions: The results of this study demonstrated that Artemisia sieberi 5% lotion was more effective than clotrimazole 1% lotion in the treatment of pityriasis versicolor.

  16. A Prospective Randomized Controlled Trial Comparing Quality of Life Following Endoscopic Totally Extraperitoneal (TEP) Versus Open Stoppa Inguinal Hernioplasty.

    Science.gov (United States)

    Kushwaha, Jitendra K; Enny, Loreno E; Anand, Akshay; Sonkar, Abhinav A; Kumar, Awanish; Pahwa, Harvinder S

    2017-08-01

    In inguinal hernia surgery, quality of life (QOL) has emerged as a striking issue. Evidence suggests better QOL of patients operated with laparoscopic procedure as compared with open anterior hernia repairs. However data are scarce with relation to open posterior repair in terms of QOL issues. A prospective randomized single-blind study from November 2014 to October 2015 including all patients who underwent elective primary endoscopic [totally extraperitoneal (TEP)] or open Stoppa inguinal hernia repair was undertaken. Mean operating time, intraoperative and postoperative complications, and QOL using short form-36 and Carolinas equation of QOL were analyzed. Physical functioning, mental health, bodily pain, and general health showed advantages of TEP over Stoppa repair in first month of postoperative period. Postoperative prediction of hernia discomfort after 1 year was found to be significantly more in Stoppa repair. Complications were slightly higher with open repair. To conclude TEP is associated with significant increased operative time, better QOL in early postoperative period, and less predicted discomfort after 1 year of surgery.

  17. A two-year randomized weight loss trial comparing a vegan diet to a more moderate low-fat diet.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Barnard, Neal D; Scialli, Anthony R

    2007-09-01

    The objective was to assess the effect of a low-fat, vegan diet compared with the National Cholesterol Education Program (NCEP) diet on weight loss maintenance at 1 and 2 years. Sixty-four overweight, postmenopausal women were randomly assigned to a vegan or NCEP diet for 14 weeks, and 62 women began the study. The study was done in two replications. Participants in the first replication (N = 28) received no follow-up support after the 14 weeks, and those in the second replication (N = 34) were offered group support meetings for 1 year. Weight and diet adherence were measured at 1 and 2 years for all participants. Weight loss is reported as median (interquartile range) and is the difference from baseline weight at years 1 and 2. Individuals in the vegan group lost more weight than those in the NCEP group at 1 year [-4.9 (-0.5, -8.0) kg vs. -1.8 (0.8, -4.3); p vegan diet was associated with significantly greater weight loss than the NCEP diet at 1 and 2 years. Both group support and meeting attendance were associated with significant weight loss at follow-up.

  18. Exercise intervention in childhood obesity: a randomized controlled trial comparing hospital-versus home-based groups.

    Science.gov (United States)

    Lisón, Juan Francisco; Real-Montes, José María; Torró, Isabel; Arguisuelas, María Dolores; Alvarez-Pitti, Julio; Martínez-Gramage, J; Aguilar, Francisco; Lurbe, Empar

    2012-01-01

    The aim of this study was to compare the effect of a hospital clinic group- versus home-based combined exercise-diet program for the treatment of childhood obesity. One hundred ten overweight/obese Spanish children and adolescents (6-16 years) in 2 intervention groups (hospital clinic group-based [n = 45] and home-based [n = 41]) and a sex-age-matched control group (n = 24) were randomly assigned to participate in a 6-month combined exercise (aerobic and resistance training) and Mediterranean diet program. Anthropometric values (including body weight, height, body mass index, BMI-Z score, and waist circumference) were measured pre- and postintervention for all the participants. Percentage body fat was also determined with a body fat analyzer (TANITA TBF-410 M). Our study showed a significant reduction in percentage body fat and body mass index Z-score among both intervention-group participants (4%, 0.16, hospital clinic group-based; 4.4%, 0.23, home-based; P exercise and Mediterranean diet program may be effective among overweight and obese children and adolescents, because it improves body composition, is feasible and can be adopted on a large scale without substantial expenses. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

  19. A randomized trial comparing in person and electronic interventions for improving adherence to oral medications in schizophrenia.

    Science.gov (United States)

    Velligan, Dawn; Mintz, Jim; Maples, Natalie; Xueying, Li; Gajewski, Stephanie; Carr, Heather; Sierra, Cynthia

    2013-09-01

    Poor adherence to medication leads to symptom exacerbation and interferes with the recovery process for patients with schizophrenia. Following baseline assessment, 142 patients in medication maintenance at a community mental health center were randomized to one of 3 treatments for 9 months: (1) PharmCAT, supports including pill containers, signs, alarms, checklists and the organization of belongings established in weekly home visits from a PharmCAT therapist; (2) Med-eMonitor (MM), an electronic medication monitor that prompts use of medication, cues the taking of medication, warns patients when they are taking the wrong medication or taking it at the wrong time, record complaints, and, through modem hookup, alerts treatment staff of failures to take medication as prescribed; (3) Treatment as Usual (TAU). All patients received the Med-eMonitor device to record medication adherence. The device was programmed for intervention only in the MM group. Data on symptoms, global functioning, and contact with emergency services and police were obtained every 3 months. Repeated measures analyses of variance for mixed models indicated that adherence to medication was significantly better in both active conditions than in TAU (both p<0.0001). Adherence in active treatments ranged from 90-92% compared to 73% in TAU based on electronic monitoring. In-person and electronic interventions significantly improved adherence to medication, but that did not translate to improved clinical outcomes. Implications for treatment and health care costs are discussed.

  20. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Earhart, Gammon M; Duncan, Ryan P; Huang, John L; Perlmutter, Joel S; Pickett, Kristen A

    2015-02-05

    important insights regarding the effects of different modes of exercise on locomotor function in PD. The protocol is innovative because it: 1) uses group exercise approaches for all conditions including treadmill training, 2) directly compares tango to treadmill training and stretching, 3) tests participants OFF medication, and 4) utilizes two distinct neuroimaging approaches to explore mechanisms of the effects of exercise on the brain. ClinicalTrials.gov NCT01768832 .

  1. Efficacy and Safety of Sparsentan Compared With Irbesartan in Patients With Primary Focal Segmental Glomerulosclerosis: Randomized, Controlled Trial Design (DUET

    Directory of Open Access Journals (Sweden)

    Radko Komers

    2017-07-01

    Discussion: This study will provide important evidence on whether dual ARB and endothelin blockade may be an effective therapeutic strategy for FSGS and may provide the rationale for next-phase trials.

  2. Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: A protocol for a clustered, randomized clinical trial

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    Roca Miguel

    2011-04-01

    Full Text Available Abstract Background Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice. Methods/Design In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia. The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption. Discussion Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two

  3. Comparing administration of questionnaires via the internet to pen-and-paper in patients with heart failure: randomized controlled trial.

    Science.gov (United States)

    Wu, Robert C; Thorpe, Kevin; Ross, Heather; Micevski, Vaska; Marquez, Christine; Straus, Sharon E

    2009-02-06

    The use of the Internet to administer questionnaires has many potential advantages over the use of pen-and-paper administration. Yet it is important to validate Internet administration, as most questionnaires were initially developed and validated for pen-and-paper delivery. While some have been validated for use over the Internet, these questionnaires have predominately been used amongst the healthy general population. To date, information is lacking on the validity of questionnaires administered over the Internet in patients with chronic diseases such as heart failure. To determine the validity of three heart failure questionnaires administered over the Internet compared to pen-and-paper administration in patients with heart failure. We conducted a prospective randomized study using test-retest design comparing administration via the Internet to pen-and-paper administration for three heart failure questionnaires provided to patients recruited from a heart failure clinic in Toronto, Ontario, Canada: the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Self-Care Heart Failure Index (SCHFI). Of the 58 subjects enrolled, 34 completed all three questionnaires. The mean difference and confidence intervals for the summary scores of the KCCQ, MLHFQ, and SCHFI were 1.2 (CI -1.5 to 4.0, scale from 0 to 100), 4.0 (CI -1.98 to 10.04, scale from 0 to 105), and 10.1 (CI 1.18 to 19.07, scale from 66.7 to 300), respectively. Internet administration of the KCCQ appears to be equivalent to pen-and-paper administration. For the MLHFQ and SCHFI, we were unable to demonstrate equivalence. Further research is necessary to determine if the administration methods are equivalent for these instruments.

  4. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain.

    Science.gov (United States)

    Cherkin, D C; Eisenberg, D; Sherman, K J; Barlow, W; Kaptchuk, T J; Street, J; Deyo, R A

    2001-04-23

    Because the value of popular forms of alternative care for chronic back pain remains uncertain, we compared the effectiveness of acupuncture, therapeutic massage, and self-care education for persistent back pain. We randomized 262 patients aged 20 to 70 years who had persistent back pain to receive Traditional Chinese Medical acupuncture (n = 94), therapeutic massage (n = 78), or self-care educational materials (n = 90). Up to 10 massage or acupuncture visits were permitted over 10 weeks. Symptoms (0-10 scale) and dysfunction (0-23 scale) were assessed by telephone interviewers masked to treatment group. Follow-up was available for 95% of patients after 4, 10, and 52 weeks, and none withdrew for adverse effects. Treatment groups were compared after adjustment for prerandomization covariates using an intent-to-treat analysis. At 10 weeks, massage was superior to self-care on the symptom scale (3.41 vs 4.71, respectively; P =.01) and the disability scale (5.88 vs 8.92, respectively; PMassage was also superior to acupuncture on the disability scale (5.89 vs 8.25, respectively; P =.01). After 1 year, massage was not better than self-care but was better than acupuncture (symptom scale: 3.08 vs 4.74, respectively; P =.002; dysfunction scale: 6.29 vs 8.21, respectively; P =.05). The massage group used the least medications (Pmassage was effective for persistent low back pain, apparently providing long-lasting benefits. Traditional Chinese Medical acupuncture was relatively ineffective. Massage might be an effective alternative to conventional medical care for persistent back pain.

  5. A randomized controlled trial comparing home-based isometric handgrip exercise versus endurance training for blood pressure management.

    Science.gov (United States)

    Goessler, Karla Fabiana; Buys, Roselien; VanderTrappen, Dieter; Vanhumbeeck, Lise; Cornelissen, Veronique Ann

    2018-02-02

    Aerobic endurance exercise (AEX) is an effective treatment in the prevention and management of high blood pressure (BP). Growing evidence suggests potential benefits from isometric handgrip (IHG) exercise, which may promote similar or even larger reductions in BP than AEX. We compared the effects of home-based AEX and home-based IHG on BP. Sixty healthy individuals (31 men; mean age, 33.1 years; mean BP, 126.9 ± 1.6/84.7 ± 1.1 mm Hg) were randomized to IHG, AEX, or a control group. Both exercise interventions were performed in the home environment. The IHG group performed daily 4 × 2 minutes sustained grips at 30% of maximal volitional contraction. Participants in the AEX group were advised to perform at least 150 min/wk of aerobic exercise at moderate intensity. Outcome measurements were assessed at baseline and 8 weeks of follow-up. Compared with the control group, AEX resulted in a larger reduction in ambulatory BP; both AEX and IHG exercise tended to induce larger reductions in office systolic BP, and office diastolic BP was significantly more reduced after AEX but not IHG exercise. Responses to training were not significantly different between both the exercise interventions. Eight weeks of home-based AEX results in significant reductions in both ambulatory BP and office BP in healthy adults, whereas IHG reduces only office BP. Copyright © 2018 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

  6. Specific strength training compared with interdisciplinary counseling for girls with tension-type headache: a randomized controlled trial

    Science.gov (United States)

    Tornøe, Birte; Andersen, Lars L; Skotte, Jørgen H; Jensen, Rigmor; Jensen, Claus; Madsen, Bjarne K; Gard, Gunvor; Skov, Liselotte; Hallström, Inger

    2016-01-01

    Background Childhood tension-type headache (TTH) is a prevalent and debilitating condition for the child and family. Low-cost nonpharmacological treatments are usually the first choice of professionals and parents. This study examined the outcomes of specific strength training for girls with TTH. Methods Forty-nine girls aged 9–18 years with TTH were randomized to patient education programs with 10 weeks of strength training and compared with those who were counseled by a nurse and physical therapist. Primary outcomes were headache frequency, intensity, and duration; secondary outcomes were neck–shoulder muscle strength, aerobic power, and pericranial tenderness, measured at baseline, after 10 weeks intervention, and at 12 weeks follow-up. Health-related quality of life (HRQOL) questionnaires were assessed at baseline and after 24 months. Results For both groups, headache frequency decreased significantly, P=0.001, as did duration, P=0.022, with no significant between-group differences. The odds of having headache on a random day decreased over the 22 weeks by 0.65 (0.50–0.84) (odds ratio [95% confidence interval]). For both groups, neck extension strength decreased significantly with a decrease in cervicothoracic extension/flexion ratio to 1.7, indicating a positive change in muscle balance. In the training group, shoulder strength increased $10% in 5/20 girls and predicted VO2max increased $15% for 4/20 girls. In the training group, 50% of girls with a headache reduction of $30% had an increase in VO2max >5%. For the counseling group, this was the case for 29%. A 24-month follow-up on HRQOL for the pooled sample revealed statistically significant improvements. Fifty-five percent of the girls reported little to none disability. Conclusion The results indicate that both physical health and HRQOL can be influenced significantly by physical exercise and nurse counseling. More research is needed to examine the relationship between physical exercise, VO2max, and

  7. Specific strength training compared with interdisciplinary counseling for girls with tension-type headache: a randomized controlled trial.

    Science.gov (United States)

    Tornøe, Birte; Andersen, Lars L; Skotte, Jørgen H; Jensen, Rigmor; Jensen, Claus; Madsen, Bjarne K; Gard, Gunvor; Skov, Liselotte; Hallström, Inger

    2016-01-01

    Childhood tension-type headache (TTH) is a prevalent and debilitating condition for the child and family. Low-cost nonpharmacological treatments are usually the first choice of professionals and parents. This study examined the outcomes of specific strength training for girls with TTH. Forty-nine girls aged 9-18 years with TTH were randomized to patient education programs with 10 weeks of strength training and compared with those who were counseled by a nurse and physical therapist. Primary outcomes were headache frequency, intensity, and duration; secondary outcomes were neck-shoulder muscle strength, aerobic power, and pericranial tenderness, measured at baseline, after 10 weeks intervention, and at 12 weeks follow-up. Health-related quality of life (HRQOL) questionnaires were assessed at baseline and after 24 months. For both groups, headache frequency decreased significantly, P=0.001, as did duration, P=0.022, with no significant between-group differences. The odds of having headache on a random day decreased over the 22 weeks by 0.65 (0.50-0.84) (odds ratio [95% confidence interval]). For both groups, neck extension strength decreased significantly with a decrease in cervicothoracic extension/flexion ratio to 1.7, indicating a positive change in muscle balance. In the training group, shoulder strength increased $10% in 5/20 girls and predicted [Formula: see text] increased $15% for 4/20 girls. In the training group, 50% of girls with a headache reduction of $30% had an increase in [Formula: see text] >5%. For the counseling group, this was the case for 29%. A 24-month follow-up on HRQOL for the pooled sample revealed statistically significant improvements. Fifty-five percent of the girls reported little to none disability. The results indicate that both physical health and HRQOL can be influenced significantly by physical exercise and nurse counseling. More research is needed to examine the relationship between physical exercise, [Formula: see text], and TTH

  8. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial.

    Science.gov (United States)

    Buerkle, Bernd; Pueth, Julia; Hefler, Lukas A; Tempfer-Bentz, Eva-Katrin; Tempfer, Clemens B

    2012-10-01

    To compare the skills of performing a shoulder dystocia management algorithm after hands-on training compared with demonstration. We randomized medical students to a 30-minute hands-on (group 1) and a 30-minute demonstration (group 2) training session teaching a standardized shoulder dystocia management scheme on a pelvic training model. Participants were tested with a 22-item Objective Structured Assessment of Technical Skills scoring system after training and 72 hours thereafter. Objective Structured Assessment of Technical Skills scores were the primary outcome. Performance time, self-assessment, confidence, and global rating scale were the secondary outcomes. Statistics were performed using Mann-Whitney U test, χ test, and multiple linear regression analysis. Two hundred three participants were randomized. Objective Structured Assessment of Technical Skills scores were significantly higher in group 1 (n=103) compared with group 2 (n=100) (17.95±3.14 compared with 15.67±3.18, respectively; PTechnical Skills scores were still significantly higher in group 1 (n=67) compared with group 2 (n=60) (18.17±2.76 compared with 14.98±3.03, respectively; PTechnical Skills scores. Hands-on training helps to achieve a significant improvement of shoulder dystocia management on a pelvic training model. www.ClinicalTrials.gov, NCT01618565. I.

  9. Comparative Effectiveness of Acupuncture and Antiarrhythmic Drugs for the Prevention of Cardiac Arrhythmias: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Yanda Li

    2017-06-01

    Full Text Available Introduction and Objectives: This study was designed to systematically evaluate the effectiveness of acupuncture treatment for arrhythmia compared to existing drug therapy.Methods: Randomized controlled trials (RCTs were identified through searches of the MEDLINE, CNKI, Embase, and Cochrane databases (1970 through 2016 and hand searches of cross-references from original articles and reviews. Clinical trials that randomized arrhythmia patients to acupuncture therapy vs. conventional drugs, sham acupuncture, or bed rest were included for analysis.Results: A total of 13 trials with 797 patients met the criteria for analysis. The results of the meta-analysis showed no statistically significant difference between acupuncture and conventional treatment for paroxysmal supraventricular tachycardia (PSVT (n = 203; RR, 1.18; 95% CI 0.78–1.79; I2 = 80%; P = 0.44. However, in the ventricular premature beat (VPB group, it showed a significant benefit of acupuncture plus oral administration of anti-arrhythmic drug (AAD on response rates compared with the oral administration of AAD (n = 286; RR, 1.15; 95% CI 1.05–1.27; I2 = 0%; P = 0.002. Finally, when compared with the sinus tachycardia (ST cases without any treatment, acupuncture has benefited these patients (n = 120; MD, 18.80, 95% CI 12.68–24.92; I2 = 81%; P < 0.00001.Conclusions: In summary, our meta-analysis demonstrates that clinical efficacy of acupuncture is not less than AAD for PSVT. Furthermore, in sub-group analysis, acupuncture with or without AAD, shows a clear benefit in treating VPB and ST. However, more definitive RCTs are warranted to guide clinical practice.

  10. Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial.

    Science.gov (United States)

    Carroll, Judith E; Seeman, Teresa E; Olmstead, Richard; Melendez, Gerson; Sadakane, Ryan; Bootzin, Richard; Nicassio, Perry; Irwin, Michael R

    2015-05-01

    Sleep disturbances have been linked to increased morbidity and mortality, yet it is unknown whether improving sleep quality in older adult patients with insomnia alters biomarkers of diabetes and cardiovascular disease risk. Determine the comparative efficacy of cognitive behavioral therapy (CBT), tai chi chih (TCC), and a sleep seminar control (SS) to reduce multisystem biomarkers of disease risk in older adults with insomnia. Randomized controlled comparative efficacy trial. Los Angeles community. A population-based sample of 109 older adults with chronic and primary insomnia. Random assignment to CBT, TCC, or SS for 2-h group sessions weekly over 4 months with a 16-month evaluation (1 year after follow-up). Multisystem biological risk comprised of 8 biomarkers: high-density lipoprotein, low-density lipoprotein, triglycerides, hemoglobinA1c, glucose, insulin, C-reactive protein, and fibrinogen. Using clinical laboratory cutoffs defined as abnormal, a multisystem risk score was computed representing a sum of the deviation around the cutoffs across the 8 biomarkers. In addition, high risk grouping was classified if subjects exhibited 4 or more biomarkers in the abnormal laboratory range. An interaction of time-by-treatment-by-high risk group was found (F(4, 197.2)=3.14, p=.02) in which both TCC (p=.04) and CBT (p=.001) showed significantly lower risk scores as compared to SS at 16-months. CBT reduced risk of being in the high risk group at 4-months (odds ratio [OR]=.21 [95% CI, .03-1.47], pchronic disease in older adults with insomnia. Clinical Trial Registration # and name—ClinicalTrials.gov: NCT00280020, Behavioral Treatment of Insomnia in Aging Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol.

    Science.gov (United States)

    Ramsauer, Brigitte; Lotzin, Annett; Mühlhan, Christine; Romer, Georg; Nolte, Tobias; Fonagy, Peter; Powell, Bert

    2014-01-30

    Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention

  12. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial.

    Science.gov (United States)

    Carrera, Fernando; Lok, Charmaine E; de Francisco, Angel; Locatelli, Francesco; Mann, Johannes F E; Canaud, Bernard; Kerr, Peter G; Macdougall, Iain C; Besarab, Anatole; Villa, Giuseppe; Kazes, Isabelle; Van Vlem, Bruno; Jolly, Shivinder; Beyer, Ulrich; Dougherty, Frank C

    2010-12-01

    Several studies with erythropoiesis-stimulating agents claim that maintenance therapy of renal anaemia may be possible at extended dosing intervals; however, few studies were randomized, results varied, and comparisons between agents were absent. We report results of a multi-national, randomized, prospective trial comparing haemoglobin maintenance with methoxy polyethylene glycol-epoetin beta and darbepoetin alfa administered once monthly. Haemodialysis patients (n = 490) on stable once-weekly intravenous darbepoetin alfa were randomized to methoxy polyethylene glycol-epoetin beta once monthly or darbepoetin alfa every 2 weeks for 26 weeks, with dose adjustment for individual haemoglobin target (11-13 g/dL; maximum decrease from baseline 1 g/dL). Subsequently, patients entered a second 26-week period of once-monthly methoxy polyethylene glycol-epoetin beta and darbepoetin alfa. The primary endpoint was the proportion of patients who maintained average haemoglobin ≥10.5 g/dL, with a decrease from baseline ≤1 g/dL, in Weeks 50-53; the secondary endpoint was dose change over time. The trial is registered at www.ClinicalTrials.gov, number NCT00394953. Baseline characteristics were similar between groups. One hundred and fifty-seven of 245 patients treated with methoxy polyethylene glycol-epoetin beta and 99 of 245 patients with darbepoetin alfa met the response definition (64.1% and 40.4%; P polyethylene glycol-epoetin beta and 58.8% with darbepoetin alfa during once-monthly treatment. Death rates were equal between treatments (5.7%). Most common adverse events included hypertension, procedural hypotension, nasopharyngitis and muscle spasms, with no differences between groups. Methoxy polyethylene glycol-epoetin beta maintained target haemoglobin more successfully than darbepoetin alfa at once-monthly dosing intervals despite dose increases with darbepoetin alfa.

  13. Comparative Effectiveness of Nonoperative Treatments for Chronic Calcific Tendinitis of the Shoulder: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Wu, Yi-Cheng; Tsai, Wen-Chung; Tu, Yu-Kung; Yu, Tung-Yang

    2017-08-01

    To investigate the effectiveness of various nonoperative treatments for chronic calcific tendinitis of the shoulder, a systematic review and network meta-analysis of randomized trials was performed to evaluate changes in pain reduction, functional improvements in patients with calcific tendinitis, and the ratio of complete resolution of calcific deposition. Studies were comprehensively searched, without language restrictions, on PubMed, Embase, Cochrane Controlled Trials Register, the Cochrane, and other databases. The reference lists of articles and reviews were cross-checked for possible studies. Randomized controlled trials from before August 2016 were included. Study selection was conducted by 2 reviewers independently. The quality of studies was assessed and data extracted by 2 independent reviewers. Disagreements were settled by consulting a third reviewer to reach a consensus. Fourteen studies with 1105 participants were included in the network meta-analysis that used a random-effect model to investigate the mean difference of pooled effect sizes of the visual analog scale, Constant-Murley score, and the ratio of complete resolution of calcific deposition on native radiographs. The present network meta-analysis demonstrates that ultrasound-guided needling (UGN), radial extracorporeal shockwave therapy (RSW), and high-energy focused extracorporeal shockwave therapy (H-FSW) alleviate pain and achieve complete resolution of calcium deposition. Compared with low-energy focused extracorporeal shockwave therapy, transcutaneous electrical nerve stimulation, and ultrasound therapy, H-FSW is the best therapy for providing functional recovery. Physicians should consider UGN, RSW, and H-FSW as alternative effective therapies for chronic calcific tendinitis of the shoulder when initial conservative treatment fails. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  14. PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer.

    Science.gov (United States)

    Naumann, R Wendel; Coleman, Robert L; Burger, Robert A; Sausville, Edward A; Kutarska, Elzbieta; Ghamande, Sharad A; Gabrail, Nashat Y; Depasquale, Stephen E; Nowara, Elzbieta; Gilbert, Lucy; Gersh, Robert H; Teneriello, Michael G; Harb, Wael A; Konstantinopoulos, Panagiotis A; Penson, Richard T; Symanowski, James T; Lovejoy, Chandra D; Leamon, Christopher P; Morgenstern, David E; Messmann, Richard A

    2013-12-10

    Vintafolide (EC145) is a folic acid-desacetylvinblastine conjugate that binds to the folate receptor (FR), which is expressed on the majority of epithelial ovarian cancers. This randomized phase II trial evaluated vintafolide combined with pegylated liposomal doxorubicin (PLD) compared with PLD alone. The utility of an FR-targeted imaging agent, (99m)Tc-etarfolatide (EC20), in selecting patients likely to benefit from vintafolide was also examined. Women with recurrent platinum-resistant ovarian cancer who had undergone ≤ two prior cytotoxic regimens were randomly assigned at a 2:1 ratio to PLD (50 mg/m(2) intravenously [IV] once every 28 days) with or without vintafolide (2.5 mg IV three times per week during weeks 1 and 3). Etarfolatide scanning was optional. The primary objective was to compare progression-free survival (PFS) between the groups. The intent-to-treat population comprised 149 patients. Median PFS was 5.0 and 2.7 months for the vintafolide plus PLD and PLD-alone arms, respectively (hazard ratio [HR], 0.63; 95% CI, 0.41 to 0.96; P = .031). The greatest benefit was observed in patients with 100% of lesions positive for FR, with median PFS of 5.5 compared with 1.5 months for PLD alone (HR, 0.38; 95% CI, 0.17 to 0.85; P = .013). The group of patients with FR-positive disease (10% to 90%) experienced some PFS improvement (HR, 0.873), whereas patients with disease that did not express FR experienced no PFS benefit (HR, 1.806). Vintafolide plus PLD is the first combination to demonstrate an improvement over standard therapy in a randomized trial of patients with platinum-resistant ovarian cancer. Etarfolatide can identify patients likely to benefit from vintafolide.

  15. Two-year outcomes after arthroscopic surgery compared to physical therapy for femoracetabular impingement: A protocol for a randomized clinical trial.

    Science.gov (United States)

    Mansell, Nancy S; Rhon, Daniel I; Marchant, Bryant G; Slevin, John M; Meyer, John L

    2016-02-04

    As the prevalence of hip pathology in the younger athletic population rises, the medical community continues to investigate effective intervention options. Femoracetabular impingement is the morphologically abnormal articulation of the femoral head against the acetabulum, and often implicated in pre-arthritic hip conditions of musculoskeletal nature. Arthroscopic surgical decompression and non-surgical rehabilitation programs focused on strengthening and stability are common interventions. However, they have never been directly compared in clinical trials. The primary purpose of this study will be to assess the difference in outcomes between these 2 commonly utilized interventions for femoracetabular impingement. The study will be a single site, non-inferiority, randomized controlled trial comparing two different treatment approaches (surgical and nonsurgical) for FAI. The enrollment goal is for a total of 80 subjects with a diagnosis of Femoracetabular impingement that are surgical candidates and have failed 6 weeks of conservative treatment. This will be a convenience sample of consecutive patients that are Tricare beneficiaries and seeking care at Madigan Army Medical Center. Patients that meet the criteria will be screened, provide written consent before enrollment, and then randomized into one of two arms (Group I = hip arthroscopy, Group II = physical therapy). Group I will undergo hip arthroscopy with or without labral repair. Group II will follow an impairment based physical therapy program consisting of 2 sessions per week for 6 weeks. The primary outcome will be the Hip Outcome Score and secondary measures will include the International Hip Outcome Tool and the Global Rating of Change. Measures will be taken at baseline, 6 months, 1 and 2 years. Hip-related healthcare utilization between both groups will also be assessed at the end of 2 years. The current evidence to support both surgical and conservative interventions for femoroacetabular impingement is

  16. Randomized clinical trial

    DEFF Research Database (Denmark)

    Kiszka-Kanowitz, Marianne; Theede, Klaus; Mertz-Nielsen, Anette

    2016-01-01

    remission rates and lower incidence of adverse events. AIM: To compare the rates of clinical remission and the rates of adverse events in IBD patients treated with either standard treatment with azathioprine or low-dose azathioprine in combination with allopurinol. METHODS: A prospective, open-label study...... to treat analysis and found a significant (69.6%) proportion of the patients treated with low-dose azathioprine in combination with allopurinol was in clinical remission without the need for steroid or biologic treatment at week 24 compared to 34.7% of the patients treated with azathioprine monotherapy (RR...

  17. E-learning interventions are comparable to user's manual in a randomized trial of training strategies for the AGREE II

    Directory of Open Access Journals (Sweden)

    Durocher Lisa D

    2011-07-01

    Full Text Available Abstract Background Practice guidelines (PGs are systematically developed statements intended to assist in patient and practitioner decisions. The AGREE II is the revised tool for PG development, reporting, and evaluation, comprised of 23 items, two global rating scores, and a new User's Manual. In this study, we sought to develop, execute, and evaluate the impact of two internet interventions designed to accelerate the capacity of stakeholders to use the AGREE II. Methods Participants were randomized to one of three training conditions. 'Tutorial'--participants proceeded through the online tutorial with a virtual coach and reviewed a PDF copy of the AGREE II. 'Tutorial + Practice Exercise'--in addition to the Tutorial, participants also appraised a 'practice' PG. For the practice PG appraisal, participants received feedback on how their scores compared to expert norms and formative feedback if scores fell outside the predefined range. 'AGREE II User's Manual PDF (control condition'--participants reviewed a PDF copy of the AGREE II only. All participants evaluated a test PG using the AGREE II. Outcomes of interest were learners' performance, satisfaction, self-efficacy, mental effort, time-on-task, and perceptions of AGREE II. Results No differences emerged between training conditions on any of the outcome measures. Conclusions We believe these results can be explained by better than anticipated performance of the AGREE II PDF materials (control condition or the participants' level of health methodology and PG experience rather than the failure of the online training interventions. Some data suggest the online tools may be useful for trainees new to this field; however, this requires further study.

  18. A randomized prospective trial comparing single dose prostaglandin E2 vaginal gel with forewater amniotomy for induction of labour.

    Science.gov (United States)

    Mahmood, T A; Rayner, A; Smith, N C; Beat, I

    1995-02-01

    A prospective randomized parallel-group study was carried out to compare the efficacy of a single dose vaginal prostaglandin E2 gel with forewater amniotomy for induction of labour at term in 260 parturients (110 primigravid and 150 parous women) with low risk pregnancy and favourable cervix. In the prostaglandin E2 (PGE2) managed group, the primigravidae were treated with 2 mg PGE2 gel and parous patients with 1 mg PGE2 gel. Forewater amniotomy was performed 4 h later, or sooner if women requested analgesia. In the amniotomy group, artificial forewater amniotomy was carried out and a repeat cervical assessment done 4 h later, or sooner if women requested analgesia. In both groups, intravenous oxytocin was established if there was evidence of disordered uterine activity, 6 h after the start of initial intervention. An assessment of consumers' views was carried out by using a standardized questionnaire completed 48 h after delivery. There was a significant reduction in the requirement for oxytocin augmentation in women treated with PGE2: primigravidae, odds ratio (OR), 0.27 and 95% confidence interval (CI), 0.12-0.61; multiparae, OR, 0.19 and 95% CI, 0.08-0.45. Fewer primigravidae managed with PGE2 gel required epidural analgesia (OR, 0.16; 95% CI, 0.06-1.00). Fewer parous women managed with PGE2 gel required parenteral opiates (OR, 0.44; 95% CI, 0.23-0.85) and more women required inhalation analgesia or no analgesia (OR, 2.22; 95% CI, 1.76-2.79). The intervention to delivery intervals were shortened in PGE2 groups independent of parity but the differences were not significant.(ABSTRACT TRUNCATED AT 250 WORDS)

  19. Children with autism spectrum disorder and social skills groups at school: a randomized trial comparing intervention approach and peer composition.

    Science.gov (United States)

    Kasari, Connie; Dean, Michelle; Kretzmann, Mark; Shih, Wendy; Orlich, Felice; Whitney, Rondalyn; Landa, Rebecca; Lord, Catherine; King, Bryan

    2016-02-01

    Peer relationships improve for children with autism spectrum disorder (ASD) in clinic-based social skills groups but rarely generalize to real world contexts. This study compares child outcomes of two social skills interventions conducted in schools with children in Kindergarten through fifth grade. Children with ASD were randomized to one of two interventions that varied on group composition (mixed typical and ASD vs. all ASD or social difficulties) and intervention approach (didactic SKILLS based vs. activity-based ENGAGE groups). Interventions were implemented at school for 8 weeks (16 sessions) with an 8-week follow-up. Innovative measures of peer nomination and playground peer engagement, as well as teacher reports of child behavior problems and teacher-child relationship were analyzed for 137 children with ASD across four sites. On the primary outcome of social network connections from the peer nomination measure, there was no main effect of treatment, but there were moderator effects. Children with low teacher-child closeness or high conflict improved more in their social connections if they received the SKILLS intervention, whereas children with higher teacher-child closeness improved more if they received the ENGAGE intervention. Only two secondary outcome measures yielded significant effects of treatment. Children in the SKILLS groups increased peer engagement and decreased isolation during recess. Child behavior problems and teacher-child closeness moderated peer engagement such that children with higher behavior problems and lower closeness benefitted more from SKILLS groups. These findings suggest that social skills groups conducted at school can affect both peer engagement during recess as well as peer acceptability. Child characteristics and teacher-child relationship prior to intervention yield important information on who might benefit from a specific social skills intervention. © 2015 Association for Child and Adolescent Mental Health.

  20. A double blind randomized clinical trial comparing lingualized and fully bilateral balanced posterior occlusion for conventional complete dentures.

    Science.gov (United States)

    Kawai, Yasuhiko; Ikeguchi, Nobuyuki; Suzuki, Asako; Kuwashima, Azusa; Sakamoto, Ryuji; Matsumaru, Yuichi; Kimoto, Suguru; Iijima, Morio; Feine, Jocelyne Sylvia

    2017-04-01

    A lingualized occlusion (LO) for complete dentures reduces lateral inferences and occlusal force contacts and direction; thus, LO is theorized to be more suitable for patients with compromised ridges than fully bilateral balanced articulation (FBBA). However, no studies have yet provided evidence to support LO in edentate patients with compromised alveolar ridges. The purpose of this study was to compare LO and FBBA in edentulous individuals with compromised ridges. Sixty edentulous individuals were randomly allocated into groups and received dentures with either LO or FBBA. Following delivery, several denture-related satisfaction variables were measured using 100mm visual analogue scales; oral health-related quality of life (OHRQoL) was also assessed using the Oral Health Impact Profile (OHIP). Sub-group analyses of the effect of moderate and severe mandibular bone loss were also carried out. No significant differences were detected between LO and FBBA with the primary outcome. At 6 months, participants with severely atrophied mandibles and FBBA rated their satisfaction with retention of mandibular dentures significantly lower than those with LO (median LO: 86, FBBA: 58.5, p=0.03). They also had significantly lower OHRQoL for the domain of Pain (median LO: 4, FBBA: 5, p=0.02). General satisfaction and total OHIP scores significantly improved between baseline and 6 months only for the LO subjects with severely atrophied mandibles (satisfaction: p=0.003, OHIP total score: p=0.0007). The results indicate that the LO occlusal scheme with hard resin artificial teeth is more efficient for patients with severely resorbed mandibular ridges. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment. Methods/Design The present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied. Discussion The study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients. Trial

  2. Immediate intensive mobilization compared with immediate conventional mobilization for the impacted osteoporotic conservatively treated proximal humeral fracture: a randomized controlled trial.

    Science.gov (United States)

    Carbone, S; Razzano, C; Albino, P; Mezzoprete, R

    2017-12-01

    To select in a 2-year survey of proximal humerus fractures accessing the emergency department, a population of osteoporotic stable impacted fractures and to randomize them into two groups, one with an immediate intensive mobilization program and the other with an immediate conventional mobilization program. In emergency department, patients with clinical signs of shoulder girdle fracture were submitted to standard X-ray examination and CT scan. Patients with stable (absence of metaphyseal comminution or fifth fragment) osteoporotic (cortical bone thickness lower than 6 mm) impacted (Is any part of metaphysis or head impacted into the shaft? YES/NO) proximal humerus fractures were selected for randomization in one of the two groups. Group 1: early intensive mobilization; Group 2: early conventional mobilization. Functional and radiographic assessment was recorded at 3, 6 and 12 months of follow-up. In the considered period, 120 patients were affected by a stable impacted osteoporotic proximal humerus fracture. At the final follow-up, 36 patients in group 1 and 39 patients in group 2 were available for statistical analysis. Functional and radiographic scores were comparable, with a trend of significance in favor of group 2. No fracture in any of the group showed significant loss of reduction respect to 6 months of follow-up. 4 (10%) and 1 (2.5%) patients in groups 1 and 2 were not compliant with the rehabilitation program (p = 0.037). This randomized controlled trial showed that impacted osteoporotic proximal humerus fractures can be managed non-operatively with an early conventional rehabilitation program composed by 10 sessions of passive motion twice a week, followed by recovery of active range of motion for further 10 sessions thrice a week, while no advantage is given by a more aggressive rehabilitation regimen. Self-assisted exercises should be explained to patients to maximize the effects of the assisted program. Level 1, randomized controlled double

  3. Randomized Trial Comparing the Effects of Ticagrelor Versus Clopidogrel on Myocardial Perfusion in Patients With Coronary Artery Disease.

    Science.gov (United States)

    Pelletier-Galarneau, Matthieu; Hunter, Chad R R N; Ascah, Kathryn J; Beanlands, Rob S B; Dwivedi, Girish; deKemp, Robert A; Chow, Benjamin J W; Ruddy, Terrence D

    2017-05-02

    Ticagrelor is a P2Y12 receptor inhibitor used in acute coronary syndromes to reduce platelet activity and to decrease thrombus formation. Ticagrelor is associated with a reduction in mortality incremental to that observed with clopidogrel, potentially related to its non-antiplatelet effects. Evidence from animal models indicates that ticagrelor potentiates adenosine-induced myocardial blood flow (MBF) increases. We investigated MBF at rest and during adenosine-induced hyperemia in patients with stable coronary artery disease treated with ticagrelor versus clopidogrel. This randomized double-blinded crossover study included 22 patients who received therapeutic interventions of ticagrelor 90 mg orally twice a day for 10 days and clopidogrel 75 mg orally once a day for 10 days, with a washout period of at least 10 days between the treatments. Global and regional MBF and myocardial flow reserve were measured using rubidium 82 positron emission tomography/computed tomography at baseline and during intermediate- and high-dose adenosine. Global MBF was significantly greater with ticagrelor versus clopidogrel (1.28±0.55 versus 1.13±0.47 mL/min per gram, P=0.002) at intermediate-dose adenosine and not different at baseline (0.65±0.19 versus 0.60±0.15 mL/min per gram, P=0.084) and at high-dose adenosine (1.64±0.40 versus 1.61±0.19 mL/min per gram, P=0.53). In regions with impaired myocardial flow reserve (ticagrelor compared with clopidogrel during intermediate and high doses of adenosine (PTicagrelor potentiates global and regional adenosine-induced MBF increases in patients with stable coronary artery disease. This effect may contribute to the incremental mortality benefit compared with clopidogrel. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01894789. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  4. Comparative Assessment of Three Approaches of Teaching Nonmedically Trained Persons in the Handling of Supraglottic Airways: A Randomized Controlled Trial.

    Science.gov (United States)

    Hensel, Mario; Schmidbauer, Willi; Benker, Michael; Schmieder, Paula; Kerner, Thoralf

    2017-03-01

    The use of supraglottic airways has been recommended in combat trauma airway management. To ensure an adequate airway management on the battlefield, suitable training concepts are sought to efficiently teach as many soldiers as possible. Our aim was to compare three approaches of teaching laypersons in the handling of supraglottic airways in a mannequin model. In this prospective randomized blinded study, 285 military service men without any medical background were divided into three groups and trained in the use of the Laryngeal Mask Airway Supreme (LMA) and the Laryngeal Tube Disposable (LT-D). The first group received a theoretical lecture, the second group was shown an instruction video, and the third group underwent a practical training. Immediately after instruction participants were asked to place the supraglottic airway and ventilate the mannequin within 60 seconds. The entire test was repeated 3 months later. Test results were evaluated with regard to success rate, insertion time, ability to judge the correct placement, and degree of difficulty. Practical training showed the highest success rate when placing supraglottic airways immediately after the instruction (lecture: 68%, video: 74%, training: 94%); (training vs. lecture and training vs. video, p instruction practical training was also superior in terms of insertion time, ability to judge the correct placement, and the self-rated degree of difficulty (p instruction. In comparison between supraglottic airways LT-D was superior to LMA regarding all the outcome parameters mentioned above (p following minimal instruction and after 3 months as well. Study participants achieved the best results after practical training followed by video presentation and finally lecture regardless of the airway device used. There are two possible reasons why practical training is the superior method. Firstly, the success is tied to more time spent with the learners. Secondly, practical training seems to be the best teaching

  5. Patient directed self management of pain (PaDSMaP compared to treatment as usual following total knee replacement: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Donell Simon

    2012-11-01

    Full Text Available Abstract Background In 2009, 665 patients underwent total knee replacements (TKRs at the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH, representing nearly 1% of the national total. Pain control following the operation can be poor, and this can cause poor mobilization and potential long-term adverse events. Although high levels of pain are not associated with patient dissatisfaction, brief periods of pain may lead to neuronal remodeling and sensitization. Patient controlled oral analgesia (PCOA may improve pain relief; however, the evidence to date has been inconclusive. Patient directed self management of pain (PaDSMaP is a single center randomized controlled trial, which aims to establish if patient self-medication improves, or is equivalent to, treatment as usual and to create an educational package to allow implementation elsewhere. Methods/design Patients eligible for a TKR will be recruited and randomized in the outpatient clinic. All patients will undergo their operations according to normal clinical practice but will be randomized into two groups. Once oral medication has commenced, one group will have pain relief administered by nursing staff in the usual way (treatment as usual; TAU, whilst the second group will self manage their pain medication (patient directed self management of pain; PaDSMaP. Those recruited for self-medication will undergo a training program to teach the use of oral analgesics according to the World Health Organization (WHO pain cascade and how to complete the study documentation. The primary endpoint of the trial is the visual analogue scale (VAS pain score at 3 days or discharge, whichever is sooner. The follow-up time is 6 weeks with a planned trial period of 3 years. The secondary objectives are satisfaction with the management of patient pain post-operatively whilst an inpatient after primary TKR; overall pain levels and pain on mobilization; satisfaction with pain management information

  6. A Randomized controlled trial of intramuscular pentazocine ...

    African Journals Online (AJOL)

    pain perception was assessed using visual analog scale (VAS) scores at presentation and after delivery while maternal ... Randomized controlled trial of intramuscular pentazocine compared to intravenous paracetamol for pain relief in labour. 117. Tropical Journal of Obstetrics .... An envelope was opened by a nurse and.

  7. Comparative Safety and Neuropsychiatric Adverse Events Associated With Efavirenz Use in First-Line Antiretroviral Therapy: A Systematic Review and Meta-Analysis of Randomized Trials.

    Science.gov (United States)

    Ford, Nathan; Shubber, Zara; Pozniak, Anton; Vitoria, Marco; Doherty, Meg; Kirby, Catherine; Calmy, Alexandra

    2015-08-01

    Efavirenz (EFV) is widely used for the treatment of antiretroviral-naive HIV-positive individuals, but there are concerns about the risk of adverse neuropsychiatric events. We systematically reviewed the safety of EFV in first-line therapy. Four databases were searched until October 2014 for randomized trials comparing EFV against non-EFV-based regimens for the treatment of antiretroviral-naive HIV-positive adults and children. The primary outcome was drug discontinuation as a result of any adverse event. Relative risks and proportions were pooled using random-effects meta-analysis. Forty-two trials were included for review. A lower relative and absolute risk of discontinuations due to adverse drug reactions was seen with EFV compared to nevirapine. The relative and absolute risk of discontinuation was greater for EFV compared with low-dose EFV, rilpivirine, tenofovir, atazanavir, and maraviroc. The relative risk of discontinuation was greater for EFV compared with dolutegravir and raltegravir, but absolute risks were not significantly different. There was no difference in the risk of any severe clinical adverse events for any comparison. With the exception of dizziness, fewer than 10% of patients exposed to EFV experienced any other specific type of neuropsychiatric event. No suicides were reported. This review found that over 90% of patients remained on an EFV-based first-line regimen after an average follow-up time of 78 weeks. The relative risk of discontinuations due to adverse events was higher for EFV compared with most other first-line options, but absolute differences were less than 5% for all comparisons.

  8. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

    Science.gov (United States)

    Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-04-25

    The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

  9. Specific strength training compared with interdisciplinary counseling for girls with tension-type headache: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tornøe B

    2016-05-01

    Full Text Available Birte Tornøe,1–4 Lars L Andersen,5,6 Jørgen H Skotte,5 Rigmor Jensen,7 Claus Jensen,8 Bjarne K Madsen,7 Gunvor Gard,1 Liselotte Skov,2 Inger Hallström,11Department of Health Sciences, Lund University, Lund, Sweden; 2Department of Pediatrics E, Children’s Headache Clinic, University of Copenhagen, Herlev and Gentofte Hospitals, Copenhagen, Denmark; 3Department of Physiotherapy and Occupational Therapy, University of Copenhagen, Glostrup Hospital, Copenhagen, Denmark; 4Department of Physiotherapy, University of Copenhagen, Herlev and Gentofte Hospitals, Copenhagen, Denmark; 5National Research Centre for the Working Environment, Copenhagen, Denmark; 6Physical Activity and Human Performance group, SMI, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark; 7Department of Neurology, Danish Headache Centre, University of Copenhagen, Glostrup Hospital, Copenhagen, Denmark; 8Huge Consulting, ApS, Haslev, Denmark Background: Childhood tension-type headache (TTH is a prevalent and debilitating condition for the child and family. Low-cost nonpharmacological treatments are usually the first choice of professionals and parents. This study examined the outcomes of specific strength training for girls with TTH. Methods: Forty-nine girls aged 9–18 years with TTH were randomized to patient education programs with 10 weeks of strength training and compared with those who were counseled by a nurse and physical therapist. Primary outcomes were headache frequency, intensity, and duration; secondary outcomes were neck–shoulder muscle strength, aerobic power, and pericranial tenderness, measured at baseline, after 10 weeks intervention, and at 12 weeks follow-up. Health-related quality of life (HRQOL questionnaires were assessed at baseline and after 24 months. Results: For both groups, headache frequency decreased significantly, P=0.001, as did duration, P=0.022, with no significant between-group differences. The odds of having

  10. Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: an open, randomized, prospective, multicenter, parallel-group trial

    DEFF Research Database (Denmark)

    Fischer, Lars; Seiler, Christoph M; Broelsch, Christoph E

    2011-01-01

    BACKGROUND: The aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation (ABC) treatment in liver resection. METHODS: This trial was designed as an international, multicenter, randomized, controlled...

  11. A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain

    Directory of Open Access Journals (Sweden)

    Peterson Caroline D

    2012-06-01

    Full Text Available Abstract Background This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results Fifty-seven participants were randomized into the exercise (n = 22, spinal manipulation (n = 15, and Neuro Emotional Technique (n = 20 treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically

  12. The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial.

    Science.gov (United States)

    Holsgaard-Larsen, A; Clausen, B; Søndergaard, J; Christensen, R; Andriacchi, T P; Roos, E M

    2017-04-01

    To investigate the effect of a neuro-muscular exercise (NEMEX) therapy program compared with instructions in optimized analgesics and anti-inflammatory drug use (PHARMA), on measures of knee-joint load in people with mild to moderate knee osteoarthritis (OA). We hypothesized that knee joint loading during walking would be reduced by NEMEX and potentially increased by PHARMA. Single-blind, randomized controlled trial (RCT) comparing NEMEX therapy twice a week with PHARMA. Participants with mild-to-moderate medial tibiofemoral knee OA were randomly allocated (1:1) to one of two 8-week treatments. Primary outcome was change in knee load during walking (Knee Index, a composite score from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes were frontal plane peak knee adduction moment (KAM), Knee Injury and Osteoarthritis Outcome Scores (KOOS) and functional performance tests. Ninety three participants (57% women, 58 ± 8 years with a body mass index [BMI] of 27 ± 4 kg/m2 (mean ± standard deviation [SD])) were randomized to NEMEX group (n = 47) or PHARMA (n = 46); data from 44 (94%) and 41 (89%) participants respectively, were available at follow-up. 49% of the participants in NEMEX and only 7% in PHARMA demonstrated good compliance. We found no difference in the primary outcome as evaluated by the Knee Index -0.07 [-0.17; 0.04] Nm/%BW HT. Secondary outcomes largely supported this finding. We found no difference in the primary outcome; knee joint load change during walking from a NEMEX program vs information on the recommended use of analgesics and anti-inflammatory drugs. ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012). Ethical Committee: S-20110153. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  13. A randomized controlled trial on office spirometry in asthma and COPD in standard general practice: data from spirometry in Asthma and COPD: a comparative evaluation Italian study.

    Science.gov (United States)

    Lusuardi, Mirco; De Benedetto, Fernando; Paggiaro, Pierluigi; Sanguinetti, Claudio M; Brazzola, Giancarlo; Ferri, Paolo; Donner, Claudio F

    2006-04-01

    To evaluate whether office spirometry by general practitioners (GPs) is feasible and may improve the diagnosis of asthma and COPD. A prospective, randomized, comparative trial was planned involving 57 Italian pulmonology centers and 570 GPs who had to enroll consecutive subjects aged 18 to 65 years with symptoms of asthma or COPD without a previous diagnosis. Patients were randomized 1:1 into two groups with an interactive voice responding system: conventional evaluation alone vs conventional evaluation and spirometry. Office spirometry was performed by GPs who were trained by reference specialists using a portable electronic spirometer (Spirobank Office; MIR; Rome, Italy). Diagnosis was confirmed by the reference specialist center in blind fashion. Seventy-four GPs complied to the trial. Of 333 patients enrolled, 136 nonrandom violators completed the protocol. Per-protocol analysis showed a concordant diagnosis between GPs and specialists in 78.6% of cases in the conventional evaluation-plus-spirometry group vs 69.2% in the conventional evaluation group (p = 0.35). In the intention-to-treat analysis, the respective percentages of concordant diagnosis were 57.9 and 56.7 (p = 0.87). Office spirometry by GPs is feasible, but frequent protocol violation and inadequate sample size did not allow us to prove a significant advantage of office spirometry in improving the diagnosis of asthma and COPD in standard general practice as organized at present in Italy, thus reinforcing the need for close cooperation between GPs and specialists in respiratory medicine.

  14. A comparative evaluation of intranasal midazolam, ketamine and their combination for sedation of young uncooperative pediatric dental patients: a triple blind randomized crossover trial.

    Science.gov (United States)

    Bahetwar, S K; Pandey, R K; Saksena, A K; Chandra, Girish

    2011-01-01

    The purpose of this study was to evaluate and compare the efficacy and safety of intranasal (IN) administration of midazolam (M), ketamine (K) and their combination (MK) to produce moderate sedation in young, uncooperative pediatric dental patients. In this three stage crossover trial forty five uncooperative ASA type-1 children, who required dental treatment, were randomly assigned to receive one of the three drugs/combination by IN route during three subsequent visits. The efficacy and safety of the agents were assessed by overall success rate and by monitoring of vital signs, respectively. The onset of sedation was rapid with K as compared to M and MK. The difference was statistically significant (P pediatric dental patients who have been otherwise indicated for treatment under general anesthesia.

  15. A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness

    Science.gov (United States)

    Jong, Miek C.; Ilyenko, Lydia; Kholodova, Irina; Verwer, Cynthia; Burkart, Julia; Weber, Stephan; Keller, Thomas; Klement, Petra

    2016-01-01

    A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 (N = 89) or comparator glycine (N = 90). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77–7.14), p sleep disorders in children. PMID:27242915

  16. Effectiveness of resistive heating compared with passive warming in treating hypothermia associated with minor trauma: a randomized trial.

    Science.gov (United States)

    Kober, A; Scheck, T; Fülesdi, B; Lieba, F; Vlach, W; Friedman, A; Sessler, D I

    2001-04-01

    To determine the occurrence of hypothermia in patients with minor trauma, to test the hypotheses that resistive heating during transport is effective treatment for hypothermia and that this treatment reduces patients' thermal discomfort, pain, and fear, and to evaluate the accuracy of oral temperatures obtained at the scene of injury. In December 1999 and January 2000, 100 patients with minor trauma were randomly assigned to passive warming or resistive heating. All patients were covered with a carbon-fiber resistive warming blanket and a wool blanket, but the warming blanket was activated only in those assigned to resistive heating. Core (tympanic membrane) and oral temperatures, heart rate, pain, fear, and overall satisfaction of patients were compared between the 2 groups on arrival at a hospital. Hypothermia was noted in 80 patients at the time of rescue. Mean initial core temperatures were 35.4 degrees C (95% confidence interval [CI], 35.2 degrees C - 35.6 degrees C) in the patients who received passive warming and 35.3 degrees C (95% CI, 35.1 degrees C - 35.5 degrees C) in those who received resistive heating. From the time of rescue until arrival at the hospital, mean core temperature decreased 0.4 degrees C/h (95% CI, 0.3 degrees C/h - 0.5 degrees C/h) with passive warming, whereas it increased 0.8 degrees C/h (95% CI, 0.7 degrees C/h - 0.9 degrees C/h) with resistive heating. Oral and tympanic membrane temperatures were similar. Mean heart rate decreased 23 beats/min in those assigned to resistive heating but remained unchanged in those assigned to passive warming. Patients in the resistive heating group felt warmer, had less pain and anxiety, and overall were more satisfied with their care. Oral temperatures are sufficiently accurate for field use. Hypothermia is common even in persons with minor trauma. Resistive heating during transport augments thermal comfort, increases core temperature, reduces pain and anxiety, and improves overall patient

  17. A randomized trial of protein supplementation compared with extra fast food on the effects of resistance training to increase metabolism.

    Science.gov (United States)

    Hambre, David; Vergara, Marta; Lood, Yvonne; Bachrach-Lindström, Margareta; Lindström, Torbjörn; Nystrom, Fredrik H

    2012-10-01

    To prospectively evaluate the effects of resistance training combined with increased energy intake or protein-supplementation on lean body-mass, resting metabolic-rate (RMR) and cardiovascular risk factors. Twenty-four healthy males (aged 19-32 years) performed resistance exercise for 12 weeks aiming for at least 1 hour training-sessions 3 times a week. The participants were randomized to consume extra protein (33 g whey protein/day) or a meal of fast-food/day (1350 kcal, 41 g protein). Body-composition was measured with Dual-Energy X-ray Absorptiometry (DEXA) and RMR by indirect calorimetry. Fasting blood samples were drawn before and after the 3-month training period and after 12 months. The body weight increased from 75.1 ± 6.9 kg to 78.7 ± 7.2 kg (p < 0.0001), without differences between the groups. RMR increased from 1787 ± 143 kcal/24 h to 1954 ± 187 kcal/24 h (p < 0.0001, N = 24), which was more than expected from the increase in lean body-mass (increase from 59.7 ± 4.3 kg to 61.8 ± 4.1 kg p = 0.004). Fasting serum-insulin levels increased in the fast-food group compared with the extra-protein group (p = 0.03). ApoB increased from 0.691 ± 0.14 g/L to 0.768 ± 0.17 g/L, p = 0.004, in the fast-food group only. Long-term follow up after 12 months showed that RMR, body weight, total fat and lean body-masses did not differ from baseline (n = 19). Resistance training for 12 weeks increased RMR and lean body-mass similarly when based on either an increased energy-intake or protein supplement. However, the increase in RMR was higher than expected from the increase in lean body-mass. Thus resistance training could potentially decrease the risk of obesity by induction of increased RMR.

  18. A 12-Week Commercial Web-Based Weight-Loss Program for Overweight and Obese Adults: Randomized Controlled Trial Comparing Basic Versus Enhanced Features

    Science.gov (United States)

    Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-01-01

    Background The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. Objective To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. Methods This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. Results We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: –0.72, SD 1.1 kg/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P 3.0, SD 4.1, control: 0.4, SD 2.3; P 2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033; http://www.anzctr.org.au/trial

  19. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial.

    Science.gov (United States)

    Esteghamati, A; Azizi, R; Ebadi, M; Noshad, S; Mousavizadeh, M; Afarideh, M; Nakhjavani, M

    2015-05-01

    The etiologic role of inflammatory pathways in the development of diabetic complications, especially cardiovascular events, has been established. The anti-inflammatory role of metformin and pioglitazone has been described; however, no study to date has compared the efficacy of these common oral agents in this regard. In this study, the authors aimed to compare the anti-inflammatory properties of pioglitazone and metformin, with respect to their effect on serum concentrations of highly sensitive C-reactive protein (hsCRP), osteoprotegerin (OPG), intercellular adhesion molecule-1 (ICAM-1) and adiponectin. In an open-label randomized clinical trial, 117 patients with newly diagnosed type 2 diabetes mellitus were visited; 84 fulfilled the inclusion criteria, and were randomly allocated to 2 arms receiving either 1,000 mg/d metformin or 30 mg/d pioglitazone, respectively. Biochemical assessments were made at baseline and the end of the 3 months trial. Significant reduction in FPG, insulin and HbA1c in women and men of both arms were observed. Log-hsCRP values significantly decreased in both arms. A decreasing, but non-significant trend in log-OPG levels was observed in women of the metformin arm (p=0.063). A greater reduction in log-ICAM levels was identifiable in men receiving pioglitazone compared to the other arm (p=0.008); in addition, the same trend was observed in log-OPG values (p=0.029). Nonetheless, reduction in log-ICAM and log-OPG levels was comparable between the 2 arms. A significant increase in adiponectin was observed in both men and women in the pioglitazone arm (pmetformin arm. Remarkably, patients receiving pioglitazone revealed more significant reduction in inflammatory markers. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Comparable benefit of β-blocker therapy in heart failure across regions of the world: meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Chatterjee, Saurav; Udell, Jacob A; Sardar, Partha; Lichstein, Edgar; Ryan, John J

    2014-08-01

    There is a concern about geographical region heterogeneity regarding clinical benefit of β-blocker (BB) therapy in heart failure with reduced ejection fraction (HFrEF). This study sought to compare benefits of BB use within randomized controlled trials (RCTs) that enrolled patients with HFrEF from North America (NA) compared with other regions of the world (ROW). We conducted a meta-analysis using MEDLINE, EMBASE, Cochrane Library, Web of Science, and Scopus (inceptions-December 2012) of BB RCTs stratified according to NA vs ROW. The primary end point was all-cause mortality and secondary end points were cardiovascular death, sudden death, death due to pump failure, and premature drug discontinuation. Summary odds ratios (ORs) and 95% confidence intervals (CIs) for each outcome were calculated with interaction terms for region. Two-sided P values were calculated with P analysis included 16 RCTs with 14,452 patients; 7 trials were conducted in NA and 9 trials in ROW with follow-up durations of 3-58 months. All-cause mortality was consistently reduced in NA (OR, 0.82; 95% CI, 0.71-0.96; P = 0.01) and ROW (OR, 0.76; 95% CI, 0.69-0.84; P < 0.001; P-interaction = 0.40). Overall and according to region, all secondary end points including premature drug discontinuation were also less with BB therapy (P-interactions all ≥ 0.10). For the regions represented in the included trials, there is no evidence to suggest that geographic region is a significant moderator of clinical outcomes with BB therapy in HFrEF patients. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  1. Comparing the effects of treatment with sildenafil and cognitive-behavioral therapy on treatment of sexual dysfunction in women: a randomized controlled clinical trial

    Science.gov (United States)

    Omidi, Abdollah; Ahmadvand, Afshin; Najarzadegan, Mohammad Reza; Mehrzad, Fateme

    2016-01-01

    Background Sexual dysfunction in women is prevalent and common in women after menopause. Many attempts to treat patients with sexual dysfunction by cognitive-behavioral therapy (CBT) methods. But to the best of our knowledge, there has been no study that compared these two methods. Objective The aim of this study was to assess and compare the effects of sildenafil and cognitive-behavioral therapy on treatment of sexual dysfunction in women. Methods In this randomized, controlled, clinical trial, 86 women with arousal and orgasm dysfunction were surveyed. The patients were divided into two groups, i.e., sildenafil and CBT groups. The patients in the sildenafil group were treated by 50 mg of oral sildenafil one hour before intercourse, and the other group had weekly sessions of CBT for eight weeks. Sexual dysfunctions were evaluated by the Female Sexual Function Index (FSFI), a sexual satisfaction questionnaire, and the Enrich marital satisfaction scale. Results The mean age of the participants was 33.14 ± 7.34 years. The mean scores for female sexual function index, sexual satisfaction, and the Enrich marital satisfaction scale were increased in both groups during treatment (p orgasm, and lubrication. Conclusion Cognitive-behavioral therapy is more effective than treatment with sildenafil for improving female sexual function. Clinical trial registration The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT2014070318338N1. Funding The authors received no financial support for the research, authorship, and/or publication of this article. PMID:27382439

  2. A Randomized Controlled Trial to Compare the Efficacy of Three Different Methods of Maternal Hydration for Oligohydramnios

    Directory of Open Access Journals (Sweden)

    Neelamma Patil

    2018-01-01

    Full Text Available Background: Oligohydramnios is defined as an Amniotic Fluid Index (AFI of less than normal for that gestational age. It is mainly associated with increased perinatal morbidity and mortality due to cord compression, fetal distress, pulmonary hypoplasia. So, an effective medical therapy is very important to prevent the complications. Aim and Objectives: To compare efficacy of maternal hydration with oral water, 1Lof Ringer Lactate (RL + 1Lof 5% Dextrose (5% D and 2L of 0.45% Normal saline (0.45% NS in increasing AFI in patients with oligohydramnios. Material and Methods: Patients who had been diagnosed as oligohydramnios (with AFI<8cm by Ultrasonography (USG were included in the study. Both Fetal Growth Restriction (FGR with oligohydramnios and idiopathic oligohydramnios were studied. Totally 108 cases were allocated into 3 groups depending on the computer generated randomized table. Group A was given oral hydration i.e., 2L of water in 2 hours. Group B received 1L RL+ 1L 5% D in 2 hours intravenously and Group C was given 2L0.45% NS in 2 hours intravenously. AFI and Symphysiofundal Height (SFH was assessed after 2 hours and 24 hours after the hydration therapy. Results: All the types of hydration therapy had significant increase in AFI and SFH at 2 hours and 24 hours. In group A, mean increased from 4.91 ± 1.58 to 5.88 ± 1.86 and 6.49 ± 2.22 at 2 hours and 24 hours respectively. Similarly in group B, mean increased from 4.98 ± 1.86 to 5.79 ± 1.89, 6.18 ± 2.23 at 2 and 24 hours respectively. In group C, mean value increased from 5.58 ± 1.31 to 7.32 ± 1.40, 8.32 ± 1.77 at 2 hours and 24 hours. There was significant increase in group C when compared to other two groups and there was no statistically significant difference between group A and group B. There was significant rise in SFH in all the three groups at 2 hours and 24 hours. Both FGR with oligohydramnios and idiopathic oligohydramnios responded well to any type of hydration, but 0

  3. Video feedback compared to treatment as usual in families with parent-infant interaction problems: a randomized controlled trial.

    OpenAIRE

    Høivik, Magnhild Singstad; Lydersen, Stian; Drugli, May Britt; Onsøien, Ragnhild; Bergum Hansen, Marit; Berg-Nielsen, Turid Suzanne

    2015-01-01

    Background: For the first time to our knowledge, short- and long-term effects of a multi-site randomizedcontrolled trial (RCT) of video feedback of infant–parent interaction (VIPI) intervention in naturalistic settings are published. The intervention targets families with children younger than 2 years old and parent–child interactions problems. Outcome variables were 1) observed parent–child interactions and 2) parent-reported child social and emotional development. Between-group dif...

  4. Yoga Improves Academic Performance in Urban High School Students Compared to Physical Education: A Randomized Controlled Trial

    Science.gov (United States)

    Hagins, Marshall; Rundle, Andrew

    2016-01-01

    Yoga programs within schools have become more widespread but research regarding the potential effect on academic achievement remains limited. This study cluster-randomized 112 students within a single New York City public high school to participate in either school-based yoga or physical education (PE) for an entire academic year. The primary…

  5. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    were randomized to IDet (n = 152) or NPH (n = 158) ≤12 months before pregnancy or at 8-12 gestational weeks. RESULTS: For IDet and NPH, there were 128 and 136 live births, 11 and 9 early fetal losses, and two and one perinatal deaths, respectively. Gestational age at delivery was greater for children...

  6. A phase III randomized trial comparing glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune haemolytic anaemia

    DEFF Research Database (Denmark)

    Birgens, Henrik; Frederiksen, Henrik; Hasselbalch, Hans Carl

    2013-01-01

    The impact of first-line treatment with the anti-CD 20 chimeric monoclonal antibody rituximab in patients with warm-antibody reactive autoimmune haemolytic anaemia (WAIHA) is unknown. We report the first randomized study of 64 patients with newly diagnosed WAIHA who received prednisolone and ritu...

  7. Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

    Science.gov (United States)

    Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

    2017-08-08

    Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

  8. Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

    Directory of Open Access Journals (Sweden)

    Carlo Bonanno

    2017-11-01

    Full Text Available Introduction: There is an ongoing debate regarding the need to conduct intraoperative defibrillation testing (DFT at the time of implantable cardioverter-defibrillator (ICD implantation. To provide sufficiently strong evidence for the feasibility of omitting intraoperative DFT in clinical practice, we conducted a meta-analysis of randomized controlled trials (RCT comparing patients with DFT and no-DFT.Methods: We systematically searched Medline (via PubMed, ClinicalTrial.gov, the Cochrane Central Register of Controlled Trials, and Embase for studies evaluating DFT vs. no-DFT on ICD implantation with regard to total mortality and arrhythmic death, efficacy of first and any appropriate shock in interrupting ventricular tachycardia (VT/ventricular fibrillation (VF, and procedural adverse events. Effect estimates [risk ratio (RR with 95% confidence intervals (CI] were pooled using the random-effects model.Results: Our meta-analysis included 4 RCTs comprising 3770 patients (1896 with DFT and 1874 without DFT. Total mortality (RR = 1.00, 95% CI 0.86–1.17; P = 0.98 and arrhythmic death (RR = 1.60, 95% CI 0.46-5.59: P = 0.46 were not statistically different. Both first (RR = 0.94, 95% CI 0.89–0.98; P = 0.004 and any appropriate ICD shock (RR = 0.97, 95% CI 0.95–1.00; P = 0.02 significantly increased the rate of VT/VF interruption in the group with no-DFT in comparison with DFT. Finally, the incidence of adverse events was lower in no-DFT patients (RR = 1.23; 95% CI 1.00–1.51; P = 0.05.Conclusions: The practice of DFT (as opposed to no-DFT did not yield benefits in mortality or the overall rate of conversion of VT/VT. Moreover, a slightly higher incidence of perioperative adverse events was observed in the DFT group.

  9. Higher compared with lower dietary protein during an energy deficit combined with intense exercise promotes greater lean mass gain and fat mass loss: a randomized trial.

    Science.gov (United States)

    Longland, Thomas M; Oikawa, Sara Y; Mitchell, Cameron J; Devries, Michaela C; Phillips, Stuart M

    2016-03-01

    A dietary protein intake higher than the Recommended Dietary Allowance during an energy deficit helps to preserve lean body mass (LBM), particularly when combined with exercise. The purpose of this study was to conduct a proof-of-principle trial to test whether manipulation of dietary protein intake during a marked energy deficit in addition to intense exercise training would affect changes in body composition. We used a single-blind, randomized, parallel-group prospective trial. During a 4-wk period, we provided hypoenergetic (~40% reduction compared with requirements) diets providing 33 ± 1 kcal/kg LBM to young men who were randomly assigned (n = 20/group) to consume either a lower-protein (1.2 g · kg(-1) · d(-1)) control diet (CON) or a higher-protein (2.4 g · kg(-1) · d(-1)) diet (PRO). All subjects performed resistance exercise training combined with high-intensity interval training for 6 d/wk. A 4-compartment model assessment of body composition was made pre- and postintervention. As a result of the intervention, LBM increased (P mass than did the CON group (PRO: -4.8 ± 1.6 kg; CON: -3.5 ± 1.4kg; P mass when combined with a high volume of resistance and anaerobic exercise. Changes in serum cortisol were associated with changes in body fat and LBM, but did not explain much variance in either measure. This trial was registered at clinicaltrials.gov as NCT01776359. © 2016 American Society for Nutrition.

  10. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial.

    Science.gov (United States)

    Kromer, Thilo O; de Bie, Rob A; Bastiaenen, Caroline H G

    2010-06-09

    Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants' adherence to the protocol, use of additional treatments

  11. Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial).

    Science.gov (United States)

    Fieten, Karin B; Zijlstra, Wieneke T; van Os-Medendorp, Harmieke; Meijer, Yolanda; Venema, Monica Uniken; Rijssenbeek-Nouwens, Lous; l'Hoir, Monique P; Bruijnzeel-Koomen, Carla A; Pasmans, Suzanne G M A

    2014-03-26

    About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. The results of this trial will provide

  12. Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol).

    Science.gov (United States)

    van IJsselmuiden, Mèlanie N; Coolen, Anne-Lotte W M; Detollenaere, Renée J; den Boon, Jan; Bongers, Marlies; van de Pol, Geerte; Vollebregt, Astrid; Radder, Celine M; Deprest, Jan; van Eijndhoven, Hugo W F

    2014-09-17

    Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman's quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial. The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher. Netherlands Trial Register (NTR): NTR4029.

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

    Science.gov (United States)

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

    2016-01-01

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

  14. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial.

    Science.gov (United States)

    Rhon, Daniel I; Boyles, Robert B; Cleland, Joshua A

    2014-08-05

    Corticosteroid injections (CSIs) and physical therapy are used to treat patients with the shoulder impingement syndrome (SIS) but have never been directly compared. To compare the effectiveness of 2 common nonsurgical treatments for SIS. Randomized, single-blind, comparative-effectiveness, parallel-group trial. (ClinicalTrials.gov: NCT01190891). Military hospital-based outpatient clinic in the United States. 104 patients aged 18 to 65 years with unilateral SIS between June 2010 and March 2012. Random assignment into 2 groups: 40-mg triamcinolone acetonide subacromial CSI versus 6 sessions of manual physical therapy. The primary outcome was change in Shoulder Pain and Disability Index scores at 1 year. Secondary outcomes included the Global Rating of Change scores, the Numeric Pain Rating Scale scores, and 1-year health care use. Both groups demonstrated approximately 50% improvement in Shoulder Pain and Disability Index scores maintained through 1 year; however, the mean difference between groups was not significant (1.5% [95% CI, -6.3% to 9.4%]). Both groups showed improvements in Global Rating of Change scale and pain rating scores, but between-group differences in scores for the Global Rating of Change scale (0 [CI, -2 to 1]) and pain rating (0.4 [CI, -0.5 to 1.2]) were not significant. During the 1-year follow-up, patients receiving CSI had more SIS-related visits to their primary care provider (60% vs. 37%) and required additional steroid injections (38% vs. 20%), and 19% needed physical therapy. Transient pain from the CSI was the only adverse event reported. The study occurred at 1 center with patients referred to physical therapy. Both groups experienced significant improvement. The manual physical therapy group used less 1-year SIS-related health care resources than the CSI group. Cardon Rehabilitation Products through the American Academy of Orthopaedic Manual Physical Therapists.

  15. Time for individualized colonoscopy bowel-prep regimens? A randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol.

    Science.gov (United States)

    Voiosu, Theodor; Ratiu, Iulia; Voiosu, Andrei; Iordache, Tiberiu; Schipor, Adrian; Baicus, Cristian; Sporea, Ioan; Voiosu, Radu

    2013-06-01

    Good bowel cleansing is essential to achieving optimal endoscopic evaluation of the colon. There are many different regimens available, but none have shown consistently superior results in achieving a clean colon. We compared the efficiency of two regimens with regard to bowel cleansing and patient satisfaction. The study also aimed to identify patient-related factors that influenced the quality of the bowel cleansing. We conducted a single-blind, multicenter, randomized controlled trial comparing sodium picosulphate and magnesium citrate versus 4-liter split-dose polyethylene glycol (PEG). Consecutive patients presenting for colonoscopy at two tertiary referral centers were invited to participate. The main outcomes were colon cleanliness and patient satisfaction with the preparation regimen. The quality of bowel cleansing was assessed by the endoscopist with the use of a 4-grade scale. Patients completed questionnaires evaluating their experience during the preparation process. Multivariate analysis was conducted in order to compare the two regimens and identify patient-related factors that influenced the main outcomes. One hundred eighty-one patients were randomized and 165 completed the trial (91.1%). PEG was slightly superior to sodium picosulphate with regard to bowel cleansing (p=0.01), while patient satisfaction was higher with sodium picosulphate (p=0.008). Patients with higher education and patients reporting high adherence to instructions achieved better colon cleansing using PEG. There seems to be no clear advantage for one bowel preparation solution over the other. However, by taking into account individual patient characteristics, opting for a particular regimen could increase the likelihood of achieving a cleaner colon.

  16. Randomized clinical trial comparing ambulatory and inpatient care after inguinal hernia repair in patients aged 65 years or older.

    Science.gov (United States)

    Mattila, Kristiina; Vironen, Jaana; Eklund, Anne; Kontinen, Vesa K; Hynynen, Markku

    2011-02-01

    There is a lack of evidence from randomized studies of the feasibility of ambulatory surgery in patients aged 65 years and older. Medically stable patients scheduled for open inguinal hernia repair, with postoperative care available at home, were randomized to receive treatment either as outpatients or inpatients. Younger patients undergoing the same procedure served as a reference group. Outcome measures during the 2 weeks after surgery were complications, unplanned admissions, visits to the hospital, unplanned visits to primary health care, and patients' acceptance of the type of provided care. Of 151 patients, 89 were included. Main reasons for exclusion were lack of postoperative company (16%), unwillingness to participate (13%), and medical conditions (10%). All outpatients were discharged home as planned, and none of the study patients were readmitted to the hospital. Patient satisfaction was high with no differences between the groups. Ambulatory surgery was safe and well accepted by older, medically stable patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  17. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations

    OpenAIRE

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2016-01-01

    Cluster-level dynamic treatment regimens can be used to guide sequential, intervention or treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level DTR, the intervention or treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including based on aggregate measures of the individuals or patients that comprise it. Cluster-randomized sequentia...

  18. A randomized factorial trial comparing 4 treatment regimens in treatment-naive HIV-infected persons with AIDS and/or a CD4 cell count Africa.

    Science.gov (United States)

    Ratsela, Andrew; Polis, Michael; Dhlomo, Sibongiseni; Emery, Sean; Grandits, Greg; Khabo, Paul; Khanyile, Thandeka; Komati, Stephanus; Neaton, Jame