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Sample records for clinical randomized controlled

  1. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  2. Random allocation in controlled clinical trials: a review.

    PubMed

    Egbewale, Bolaji Emmanuel

    2014-01-01

    An allocation strategy that allows for chance placement of participants to study groups is crucial to the experimental nature of randomised controlled trials. Following decades of the discovery of randomisation considerable erroneous opinion and misrepresentations of its concept both in principle and practice still exists. In some circles, opinions are also divided on the strength and weaknesses of each of the random allocation strategies. This review provides an update on various random allocation techniques so as to correct existing misconceptions on this all important procedure. This is a review of literatures published in the Pubmed database on concepts of common allocation techniques used in controlled clinical trials. Allocation methods that use; case record number, date of birth, date of presentation, haphazard or alternating assignment are non-random allocation techniques and should not be confused as random methods. Four main random allocation techniques were identified. Minimisation procedure though not fully a random technique, however, proffers solution to the limitations of stratification at balancing for multiple prognostic factors, as the procedure makes treatment groups similar in several important features even in small sample trials. Even though generation of allocation sequence by simple randomisation procedure is easily facilitated, a major drawback of the technique is that treatment groups can by chance end up being dissimilar both in size and composition of prognostic factors. More complex allocation techniques that yield more comparable treatment groups also have certain drawbacks. However, it is important that whichever allocation technique is employed, unpredictability of random assignment should not be compromised.

  3. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  4. Clinical randomized controlled trial of chemomechanical caries removal (Carisolv).

    PubMed

    Lozano-Chourio, M A; Zambrano, O; González, H; Quero, M

    2006-05-01

    The purpose of this study was to compare the chemomechanical caries-removal system (Carisolv) with high-speed excavation in cavitated occlusal caries of primary molars. Design and setting. The study was a randomized controlled, clinical trial in which the two techniques were compared in each subject. Participants were chosen from public schools, in Maracaibo County, Zulia State, Venezuela. The sample consisted of 80 primary molars selected from 40 children (mean age 7.7+/-0.7 years). Each patient had at least two contralateral primary molars with cavitated occlusal caries and approximately equal-size access to lesions. The outcome variables were: clinically complete caries removal, size of the opening of the cavity, volume of carious tissue removed, pain during caries removal, anaesthesia requested by the patient, caries-removal time, and behaviour and preference of patients. All treated molars were clinically caries free whichever caries-removal procedure was used. When Carisolv' was used the final cavity entrance sizes were smaller (P<0.001) and the estimated volume of tissue removed was less (P<0.001). The time taken for caries removal was three times longer (7.51+/-1.83 min, P<0.001). Some pain was reported by seven (17.5%) participants when Carisolv was used, compared with 16 (40%) when high-speed excavation was used (P<0.05). Using the Carisolv method there was a higher proportion of patients with positive behaviour (P<0.01), and 71.0% (P<0.05) preferred this treatment. Carisolv is an effective clinical alternative treatment for the removal of occlusal dentinal caries in cavitated primary molars; it is more conservative of dental tissue and appeared to be more comfortable for most patients, although the clinical time spent is longer than when using high-speed excavation.

  5. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    PubMed

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p < 0.001). The distance center bifocal contact lenses tested in this study achieved greater control over myopia progression and axial elongation (>70%) compared with most published results with multifocal spectacles. Further

  6. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial.

    PubMed

    Pradeep, A R; Agarwal, Esha; Bajaj, Pavan; Naik, Savitha B; Kumari, Minal; Guruprasad, C N

    2012-07-01

    The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF) as the active ingredient on gingivitis. NINETY SUBJECTS DIAGNOSED WITH CHRONIC GENERALIZED GINGIVITIS WERE SELECTED AND RANDOMLY DIVIDED IN THREE GROUPS: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  7. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial

    PubMed Central

    Pradeep, A. R.; Agarwal, Esha; Bajaj, Pavan; Naik, Savitha B.; Kumari, Minal; Guruprasad, C. N.

    2012-01-01

    Background: The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF) as the active ingredient on gingivitis. Materials and Methods: Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided in three groups: Group 1 – placebo toothpaste, Group 2 – AF containing toothpaste, and Group 3 – triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. Results: AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. Conclusions: AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health. PMID:23293479

  8. Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial.

    PubMed

    Pradeep, A R; Agarwal, Esha; Naik, Savitha B

    2012-06-01

    Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects. This prospective, randomized, placebo, and positively controlled clinical trial was designed to evaluate the clinical and microbiologic effects of a commercially available dentifrice containing aloe vera on the reduction of plaque and gingival inflammation in patients with gingivitis. Ninety patients diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: group 1, placebo toothpaste; group 2, toothpaste containing aloe vera; and group 3, toothpaste with polymer and fluoride containing triclosan. Clinical evaluation was undertaken using a gingival index, plaque was assessed using a modification of the Quigley-Hein index, and microbiologic counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by questionnaire. Toothpaste containing aloe vera showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to those achieved with toothpaste containing triclosan. Toothpaste containing aloe vera may be a useful herbal formulation for chemical plaque control agents and improvement in plaque and gingival status.

  9. Phytothermotherapy in osteoarthritis: a randomized controlled clinical trial.

    PubMed

    Fioravanti, Antonella; Bellisai, Barbara; Iacoponi, Francesca; Manica, Patrizia; Galeazzi, Mauro

    2011-05-01

    The aim of this study was to assess the efficacy of adding a cycle of phytothermotherapy (a traditional treatment with fermenting grass used in Trentino-Alto Adige, Italy) to the usual drug treatment, in patients with primary symptomatic osteoarthritis (OA) of the knee, hip, or lumbar spine. In this randomized, single-blind, controlled trial, 218 outpatients were enrolled; 109 patients were treated with a cycle of phytothermotherapy at the thermal resort of Garniga Terme (Trento, Italy) for 10 days; the other 109 patients continued regular outpatient care. Patients were assessed at baseline, after 2 weeks, and after 3 months from the beginning of the study and were evaluated using a visual analogue scale (VAS) for spontaneous pain, a Health Assessment Questionnaire, the Lequesne index for hip and knee osteoarthritis, and the Rolland Morris Questionnaire for lumbar spine OA and symptomatic drug consumption. In patients treated with phytothermotherapy, a significant improvement of VAS and a reduction of nonsteroidal anti-inflammatory drug consumption at the end of treatment and 3 months later were observed. In the control group, no significant differences were noted. The analyses performed separately for each subgroup for OA localization showed that the best results were evident in lumbar spine OA. Concerning tolerability, in the group treated with phytothermotherapy 10% of patients presented side-effects due to treatment, but these were of low intensity and did not interrupt the therapy. In conclusion, the results show beneficial effects of a cycle of phytothermotherapy in patients with OA of the hip, knee, or lumbar spine. Phytothermotherapy may therefore be a useful aid alongside the usual pharmacologic and physiokinesic therapies, or may be used as a valid alternative for patients who do not tolerate pharmacologic treatments.

  10. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  11. Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

    PubMed

    Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

    2014-01-01

    This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

  12. In utero Repair of Myelomeningocele: Rationale, Initial Clinical Experience and a Randomized Controlled Prospective Clinical Trial

    PubMed Central

    Danzer, Enrico; Flake, Alan W.

    2008-01-01

    Myelomeningocele (MMC), one of the most common congenital malformations, can result in severe lifelong disabilities, including paraplegia, hydrocephalus, Arnold-Chiari II malformation, incontinence, sexual dysfunction, skeletal deformations, and mental impairment. MMC was the first nonlethal anomaly to be treated by fetal surgery. Studies in animals provide compelling evidence that the primary cause of the neurological deficit associated with MMC is not simply incomplete neurulation but rather chronic mechanical injury and amniotic-fluid-induced chemical trauma that progressively damage the exposed neural tissue during gestation. Initial results suggest that the surgical repair of MMC before 25 weeks of gestation may preserve neurological function, reverse the hindbrain herniation of the Arnold-Chiari II malformation, and obviate the need for postnatal placement of a ventriculoperitoneal shunt. As it is currently unknown whether fetal surgery for MMC is truly beneficial compared to standard postnatal care, a randomized, controlled clinical trial has been initiated within the United States. PMID:22479081

  13. Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

    PubMed

    Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

    2013-05-01

    This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

  14. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  15. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  16. Creation and implementation of a historical controls database from randomized clinical trials

    PubMed Central

    Desai, Jigar R; Bowen, Edward A; Danielson, Mark M; Allam, Rajasekhar R; Cantor, Michael N

    2013-01-01

    Background Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation. Objective To create a historical controls database by leveraging internal clinical trial data at Pfizer, focusing on patients who received only placebo in randomized controlled trials. Methods We transformed disparate clinical data sources by indexing, developing, and integrating clinical data within internal databases and archives. We focused primarily on trials mapped into a consistent standard and trials in the pain therapeutic area as a pilot. Results Of the more than 20 000 internal Pfizer clinical trials, 2404 completed placebo controlled studies with a parallel design were identified. Due to challenges with informed consent and data standards used in older clinical trials, studies completed before 2000 were excluded, yielding 1134 studies from which placebo subjects and associated clinical data were extracted. Conclusions It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process. PMID:23449762

  17. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

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

    PubMed

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

    2016-01-01

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

  19. Clinical hypnosis in the treatment of postmenopausal hot flashes: a randomized controlled trial.

    PubMed

    Elkins, Gary R; Fisher, William I; Johnson, Aimee K; Carpenter, Janet S; Keith, Timothy Z

    2013-03-01

    The use of estrogen and progesterone to manage vasomotor symptoms (ie, hot flashes and night sweats) has declined because of concerns about their risks, and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized controlled trial of clinical hypnosis for treating vasomotor symptoms among postmenopausal women. This is a randomized, single-blind, controlled, clinical trial involving 187 postmenopausal women reporting a minimum of seven hot flashes per day (or at least 50 hot flashes a week) at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries on weeks 2 to 6 and week 12. Secondary outcomes included measures of hot flash-related daily interference, sleep quality, and treatment satisfaction. In a modified intent-to-treat analysis that included all randomized participants who provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 (74.16%) hot flashes for the clinical hypnosis intervention versus a mean reduction of 12.89 (17.13%) hot flashes for controls (P < 0.001; 95% CI, 36.15-49.67). The mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared with 3.53 (15.38%) for controls (P < 0.001; 95% CI, 12.60-17.54). At 12-week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and 0.88 (9.94%) for controls (P < 0.001; 95% CI, 2.00-5.46). Secondary outcomes were significantly improved compared with controls at 12-week follow-up: hot flash-related interference (P < 0.001; 95% CI, 2.74-4.02), sleep quality (P < 0.001; 95% CI, 3.65-5.84), and treatment satisfaction (P < 0.001; 95% CI, 7.79-8.59). Compared

  20. Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy.

    PubMed

    Larsson, Ingrid; Fridlund, Bengt; Arvidsson, Barbro; Teleman, Annika; Bergman, Stefan

    2014-01-01

    To compare and evaluate the treatment outcomes of a nurse-led rheumatology clinic and a rheumatologist-led clinic in patients with low disease activity or in remission who are undergoing biological therapy. Patients with chronic inflammatory arthritis treated with biological therapy are usually monitored by rheumatologists. Nurse-led rheumatology clinics have been proposed in patients with low disease activity or in remission. Randomized controlled trial. A 12-month follow-up trial was conducted between October 2009 and August 2011, where 107 patients were randomized into two groups with a 6-month follow-up to a nurse-led rheumatology clinic based on person-centred care (intervention group; n = 53) or to a rheumatologist-led clinic (control group; n = 54). The hypothesis was that the nurse-led clinic outcomes would not be inferior to those obtained from a rheumatologist-led clinic at the 12-month follow-up. The primary outcome was disease activity measured by Disease Activity Score 28. A total of 47 patients in the intervention group and 50 in the control group completed the 12-month trial. The trial revealed no statistically significant differences between groups in mean change of Disease Activity Score 28, Visual Analogue Scales for pain, the Health Assessment Questionnaire, satisfaction with or confidence in obtaining rheumatology care. Patients with stable chronic inflammatory arthritis undergoing biological therapy could be monitored by a nurse-led rheumatology clinic without difference in outcome as measured by the Disease Activity Score 28. © 2013 The Authors. Journal of Advanced Nursing published by John Wiley & Sons Ltd.

  1. Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

    PubMed

    Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

    2017-08-01

    This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Randomized controlled clinical trial of Blood Glucose Awareness Training (BGAT III) in Switzerland and Germany.

    PubMed

    Schachinger, Hartmut; Hegar, Karin; Hermanns, Norbert; Straumann, Madeleine; Keller, Ulrich; Fehm-Wolfsdorf, Gabriele; Berger, Willi; Cox, Daniel

    2005-12-01

    Although both diabetes and the efficacy of medical management are international issues, psycho-educational interventions might be culturally bound. Blood Glucose Awareness Training (BGAT) is a psycho-educational program for patients with type 1 diabetes mellitus. It is focused on improving recognition and management of extreme blood glucose levels, and is the best documented American psycho-educational program for this purpose. A randomized controlled clinical trial of BGAT's long-term benefits in a non-American setting has been lacking. One hundred and eleven adults with type 1 diabetes mellitus from Switzerland and Germany participated. After a 6 months baseline assessment, subjects were randomly assigned to receive either 2 months of BGAT (n = 56) or a physician-guided self-help control intervention (n = 55). BGAT improved recognition of low (p = 0.008), high (p = .03), and overall blood glucose (p = 0.001), and reduced frequency of severe hypoglycemia (p = 0.04), without compromising metabolic control. BGAT reduced both the external locus of control (p < 0.02) and fear of hypoglycemia (p < 0.02). BGAT was efficacious in reducing adverse clinical events and achieving clinically desirable goals in a European, as well as American setting.

  3. Systematic review on randomized controlled clinical trials of acupuncture therapy for neurovascular headache.

    PubMed

    Zhao, Lei; Guo, Yi; Wang, Wei; Yan, Li-juan

    2011-08-01

    To evaluate the effectiveness of acupuncture as a treatment for neurovascular headache and to analyze the current situation related to acupuncture treatment. PubMed database (1966-2010), EMBASE database (1986-2010), Cochrane Library (Issue 1, 2010), Chinese Biomedical Literature Database (1979-2010), China HowNet Knowledge Database (1979-2010), VIP Journals Database (1989-2010), and Wanfang database (1998-2010) were retrieved. Randomized or quasi-randomized controlled studies were included. The priority was given to high-quality randomized, controlled trials. Statistical outcome indicators were measured using RevMan 5.0.20 software. A total of 16 articles and 1 535 cases were included. Meta-analysis showed a significant difference between the acupuncture therapy and Western medicine therapy [combined RR (random efficacy model)=1.46, 95% CI (1.21, 1.75), Z=3.96, P<0.0001], indicating an obvious superior effect of the acupuncture therapy; significant difference also existed between the comprehensive acupuncture therapy and acupuncture therapy alone [combined RR (fixed efficacy model)=3.35, 95% CI (1.92, 5.82), Z=4.28, P<0.0001], indicating that acupuncture combined with other therapies, such as points injection, scalp acupuncture, auricular acupuncture, etc., were superior to the conventional body acupuncture therapy alone. The inclusion of limited clinical studies had verified the efficacy of acupuncture in the treatment of neurovascular headache. Although acupuncture or its combined therapies provides certain advantages, most clinical studies are of small sample sizes. Large sample size, randomized, controlled trials are needed in the future for more definitive results.

  4. Randomized controlled clinical trial of long-term chemo-mechanical caries removal using Papacarie™ gel.

    PubMed

    Motta, Lara Jansiski; Bussadori, Sandra Kalil; Campanelli, Ana Paula; Silva, André Luis da; Alfaya, Thays Almeida; Godoy, Camila Haddad Leal de; Navarro, Maria Fidela de Lima

    2014-01-01

    Compare the effectiveness of Papacarie™ gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings. A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with Papacarie™ and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations. No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment. Papacarie™ is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

  5. Text Message Reminders Increase Appointment Adherence in a Pediatric Clinic: A Randomized Controlled Trial

    PubMed Central

    Mistry, Nila; Boneh, Jordana; Li, Hong; Lazebnik, Rina

    2016-01-01

    Background. High no-show rates can burden clinic productivity and affect patient care. Although multiple studies have shown that text messages improve appointment adherence, very little research has focused on low-income and predominantly African American populations in resident clinic settings. Objectives. To determine whether incorporating a text message reminder reduces the no-show rate at an urban, pediatric resident clinic. Methods. A randomized controlled trial was conducted at a tertiary level ambulatory pediatric practice between August 2014 and February 2015. Following a demographic survey, 170 patients were enrolled. Patients were randomized into control or intervention groups. All patients received the standard voice message appointment reminder, but the intervention group additionally received a text message reminder. The primary outcome was no-show rate. Results. 95.3% of the participants were African American, and the overall no-show rate was 30.8%. No-show rate was significantly lower in the intervention group (23.5%) than the control group (38.1%) representing a difference of 14.6% (p = 0.04). No demographic factors were found to alter the association between no-show rate and text message intervention. Conclusions. Text message reminders effectively improve show rates at a resident pediatric practice with high no-show rates, representing a promising approach to improving appointment adherence. PMID:28127311

  6. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  7. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  8. Yoga for Generalized Anxiety Disorder: Design of a Randomized Controlled Clinical Trial

    PubMed Central

    Hofmann, Stefan G.; Curtiss, Joshua; Khalsa, Sat Bir S.; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-01-01

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N = 95) to both CBT for GAD (N=95) and stress education (N = 40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6 month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. PMID:26255236

  9. Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

    PubMed

    Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-08-06

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications.

  10. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    PubMed

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  11. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial.

    PubMed

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by "d" Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength.

  12. Klapp method effect on idiopathic scoliosis in adolescents: blind randomized controlled clinical trial

    PubMed Central

    Dantas, Diego De Sousa; De Assis, Sanderson José Costa; Baroni, Marina Pegoraro; Lopes, Johnnatas Mikael; Cacho, Enio Walker Azevedo; Cacho, Roberta De Oliveira; Pereira, Silvana Alves

    2017-01-01

    [Purpose] To estimate the effect of Klapp method on idiopathic scoliosis in school students. [Subjects and Methods] A single-blind randomized clinical trial with 22 students randomly divided into intervention group (n=12) and inactive control group (n=10). Exercise protocol consisted of Klapp method, 20 sessions, three times a week for intervention group, and inactivity for control group. Dorsal muscle strength was measured by dynamometer; body asymmetries and gibbosity angles were measured by biophotogrammetry. Data were obtained by Generalized Estimated Equation, with 5% significance level. Clinical impact for dependent variables was estimated by “d” Cohen. [Results] There was no change in intragroup analysis and intergroup for all postural symmetry variables. However, it was detected intergroup difference in extensor muscle strength and intergroup difference with marginal significance of gibbosity angles. Regarding extensor muscle strength, intervention group produced average improvement of 7.0 kgf compared to control group. Gibbosity angles progressed less in intervention group, with 5.71° average delay compared to control group. [Conclusion] Klapp method was effective for gibbosity stabilization and it improves spine extensor muscle strength. PMID:28210027

  13. Covariate-adjusted borrowing of historical control data in randomized clinical trials.

    PubMed

    Han, Baoguang; Zhan, Jia; John Zhong, Z; Liu, Dawei; Lindborg, Stacy

    2017-07-01

    The borrowing of historical control data can be an efficient way to improve the treatment effect estimate of the current control group in a randomized clinical trial. When the historical and current control data are consistent, the borrowing of historical data can increase power and reduce Type I error rate. However, when these 2 sources of data are inconsistent, it may result in a combination of biased estimates, reduced power, and inflation of Type I error rate. In some situations, inconsistency between historical and current control data may be caused by a systematic variation in the measured baseline prognostic factors, which can be appropriately addressed through statistical modeling. In this paper, we propose a Bayesian hierarchical model that can incorporate patient-level baseline covariates to enhance the appropriateness of the exchangeability assumption between current and historical control data. The performance of the proposed method is shown through simulation studies, and its application to a clinical trial design for amyotrophic lateral sclerosis is described. The proposed method is developed for scenarios involving multiple imbalanced prognostic factors and thus has meaningful implications for clinical trials evaluating new treatments for heterogeneous diseases such as amyotrophic lateral sclerosis. Copyright © 2017 John Wiley & Sons, Ltd.

  14. Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

    ERIC Educational Resources Information Center

    Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

    2017-01-01

    Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

  15. The case for randomized controlled trials to assess the impact of clinical information systems

    PubMed Central

    Wyatt, Jeremy C

    2011-01-01

    There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

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

    PubMed

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

    2012-01-01

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

  17. Reintroduction of Gluten Following Flour Transamidation in Adult Celiac Patients: A Randomized, Controlled Clinical Study

    PubMed Central

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

    2012-01-01

    A lifelong gluten-free diet (GFD) is mandatory for celiac disease (CD) but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12) or transamidated (35) flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (P = 0.04) whereas intestinal permeability was mainly altered in the control group (50% versus 20%, P = 0.06). On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (P = 0.63), Marsh-Oberhuber grading (P = 0.08), or intestinal IFN-γ mRNA (P > 0.05). Creatinine clearance did not vary after 90 days of treatment (P = 0.46). In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function. PMID:22899947

  18. Clinical Effects of a Pharmacist Intervention in Acute Wards - A Randomized Controlled Trial.

    PubMed

    Nielsen, Trine R H; Honoré, Per H; Rasmussen, Mette; Andersen, Stig E

    2017-10-01

    The purpose of the study was to investigate the clinical effect of a clinical pharmacist (CP) intervention upon admission to hospital on inpatient harm and to assess a potential educational bias. Over 16 months, 593 adult patients taking ≥4 medications daily were included from three Danish acute medicine wards. Patients were randomized to either the CP intervention or the usual care (prospective control). To assess a potential educational bias, a retrospective control group was formed by randomization. The CP intervention comprised medication history, medication reconciliation, medication review and entry of proposed prescriptions into the electronic prescribing system. The primary outcome of inpatient harm was identified using triggers from the Institute of Healthcare Improvement Global Trigger Tool. Harms were validated and rated for severity by two independent and blinded outcome panels. Secondary end-points were harms per patient, length of hospital stay, readmissions and 1-year mortality. Harm affected 11% of the patients in the intervention group compared to 17% in the combined control group, odds ratio (OR) 0.57 (CI 0.32-1.02, p = 0.06). The incidence of harm was similar in the intervention and prospective control groups, OR 0.80 (CI 0.40-1.59, p = 0.52) but occurred less frequently in the intervention than in the retrospective control group OR 0.46 (CI 0.25-0.85, p = 0.01). An educational bias from the intervention to the control group might have contributed to this negative outcome. In conclusion, the CP intervention at admission to hospital had no statistically significant effect on inpatient harm. © 2017 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  19. Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

    PubMed

    Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

    2017-03-22

    Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms.

  20. Clinical and neurobiological effects of aerobic exercise in dental phobia: A randomized controlled trial.

    PubMed

    Lindenberger, Brigitt L; Plag, Jens; Schumacher, Sarah; Gaudlitz, Katharina; Bischoff, Sophie; Bobbert, Thomas; Dimeo, Fernando; Petzold, Moritz B; Kirschbaum, Clemens; Dudás, Zsuzsa; Ströhle, Andreas

    2017-05-26

    Physical activity has shown to be effective in anxiety disorders. For specific phobia, no studies are available that systematically examined the effects of an aerobic exercise intervention on phobic fear within a randomized-controlled design. Therefore, we investigated the acute effect of a standardized aerobic training on clinical symptoms of dental phobia as well as on stress-related neurobiological markers. Within a crossover design, 30 patients with dental phobia (mean age: 34.1 years; mean score of the Dental Anxiety Scale: 18.8) underwent two minor dental interventions separated by 7 days. Dental treatment was performed after 30 min of physical activity at either 20% VO2 max (control) or 70% VO2 max (intervention), respectively. To control for habituation, patients were randomly assigned to one of the two conditions prior to the first intervention. Moreover, saliva samples were collected at five times in order to determine changes in salivary cortisol (sC) and alpha-amylase (sAA) due to treatment. In comparison to baseline, aerobic exercise within 70% VO2 max significantly reduced clinical anxiety and sC concentrations before, during, and after the dental treatment. In contrast, the control condition led to decreased sAA levels at different time points of measurement. Habituation occurred at the second study day, independent of the order. Our study provides evidence for an effect of moderate-intense exercise on clinical symptoms and sC in patients with dental phobia. Therefore, acute aerobic exercise might be a simple and low-cost intervention to reduce disorder-specific phobic fear. © 2017 Wiley Periodicals, Inc.

  1. The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

    PubMed Central

    2010-01-01

    Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601 PMID:20487567

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

    PubMed Central

    Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

    2013-01-01

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

  3. Effects of RYGB on energy expenditure, appetite and glycaemic control: a randomized controlled clinical trial.

    PubMed

    Schmidt, J B; Pedersen, S D; Gregersen, N T; Vestergaard, L; Nielsen, M S; Ritz, C; Madsbad, S; Worm, D; Hansen, D L; Clausen, T R; Rehfeld, J F; Astrup, A; Holst, J J; Sjödin, A

    2016-02-01

    Increased energy expenditure (EE) has been proposed as an important mechanism for weight loss following Roux-en-Y gastric bypass (RYGB). However, this has never been investigated in a controlled setting independent of changes in energy balance. Similarly, only few studies have investigated the effect of RYGB on glycaemic control per se. Here, we investigated the effect of RYGB on EE, appetite, glycaemic control and specific signalling molecules compared with a control group in comparable negative energy balance. Obese normal glucose-tolerant participants were randomized to receive RYGB after 8 (n=14) or 12 weeks (n=14). The protocol included a visit at week 0 and three visits (weeks 7, 11 and 78) where 24-h EE, appetite and blood parameters were assessed. Participants followed a low-calorie diet from weeks 0-11, with those operated at week 12 serving as a control group for those operated at week 8. Compared with controls, RYGB-operated participants had lower body composition-adjusted 24-h EE and basal EE 3 weeks postoperatively (both P<0.05) but EE parameters at week 78 were not different from preoperative values (week 7). Surgery changed the postprandial response of glucagon-like peptide-1 (GLP-1), peptide YY3-36 (PYY), ghrelin, cholecystokinin, fibroblast growth factor-19 and bile acids (all P<0.05). Particularly, increases in GLP-1, PYY and decreases in ghrelin were associated with decreased appetite. None of HOMA-IR (homeostasis model assessment-estimated insulin resistance), Matsuda index, the insulinogenic index, the disposition index and fasting hepatic insulin clearance were different between the groups, but RYGB operated had lower fasting glucose (P<0.05) and the postprandial glucose profile was shifted to the left (P<0.01). Our data do not support that EE is increased after RYGB. More likely, RYGB promotes weight loss by reducing appetite, partly mediated by changes in gastrointestinal hormone secretion. Furthermore, we found that the early changes in

  4. Modified Atkins diet in adult with refractory epilepsy: A controlled randomized clinical trial.

    PubMed

    Zare, Mohammad; Okhovat, Ali Asghar; Esmaillzadeh, Ahmad; Mehvari, Jafar; Najafi, Mohammad Reza; Saadatnia, Mohammad

    2017-04-04

    Background: The usefulness of the modified Atkins diet (mAD) in refractory epilepsy in adults has been rarely investigated. We aimed to evaluate the efficacy of mAD in adult with refractory epilepsy. Methods: In a controlled randomized clinical trial, we enrolled 66 refractory adult epileptic cases from February 2010 to December 2012. The patients were randomly divided into two groups, case groups (22 patients) used antiepileptic drugs and mAD and control group (32 patients) only use antiepileptic drugs. The primary outcome was at least 50% decrement in seizure frequency after 2 months of therapy. Results: No significant difference was shown in our data between groups regarding baseline characteristic. The differences of mean seizure attack after 2 months (P < 0.001). (17.6%) had > 50% seizure decrease at 1 and after 2 months and 12 (35.3%) had 50% decrease in seizure frequency. Furthermore, in mAD group, the mean urinary ketone positivity was 1.75 ± 0.28 and increasing liver enzyme was shown 5 cases (14.7%) in mAD group and 5 cases (15.6%) in control group (P < 0.050). Conclusion: The mAD may be effective as a cotherapy treatment for adults with refractory epilepsy and decrease 2.19 times seizure frequency in comparison with control groups. Trials with the more tolerant dietary regime, with larger sample size and longer duration, should be performed in future.

  5. A multicenter randomized placebo-controlled clinical trial of pramipexole for Tourette's syndrome.

    PubMed

    Kurlan, Roger; Crespi, Giovanna; Coffey, Barbara; Mueller-Vahl, Kirsten; Koval, Stephen; Wunderlich, Glen

    2012-05-01

    Dopamine agonists could theoretically normalize the suspected central dopamine hypersensitivity in Tourette's syndrome. There was a multicenter randomized, placebo-controlled, double-blind clinical trial of pramipexole given for 6 weeks in 63 children and adolescents with Tourette's syndrome. There were no significant differences in the adjusted mean change in the Total Tic Score of the Yale Global Tic Severity Scale for patients treated with pramipexole (-7.16) and placebo (-7.17). There were no significant treatment effects on change from baseline in the Global Severity score of the Yale Scale and parent- and investigator-scored Clinical Global Impression of Improvement. In patients with attention deficit hyperactivity disorder, there was improvement in DuPaul ADHD scale scores for patients receiving pramipexole compared with placebo. There was no evidence that pramipexole has efficacy in suppressing tics. Pramipexole may decrease symptoms of associated attention deficit hyperactivity disorder. Copyright © 2012 Movement Disorder Society.

  6. Evaluating the Clinical Efficacy of Tooth Powder on Plaque-Induced Gingivitis: A Randomized Controlled Trial.

    PubMed

    Khan, Muhammad Khalil

    2017-09-01

    Toothpastes and tooth powders are common oral care products used to control plaque and other deposits from tooth surfaces, thereby reducing gingivitis. This study was conducted to evaluate the efficacy of tooth powder in controlling dental plaque and gingivitis. A double-blind, parallel-arm, randomized controlled trial was conducted on 154 participants, aged 33 to 40 years, having at least 20 teeth with a full-mouth gingival index (GI) score ≥ 1.04 and fulfilling other inclusion/exclusion criteria. The plaque index (PI) and GI scores were used as measures of oral hygiene. Outcome variables of gingivitis and dental plaque were evaluated in test and control groups randomized with 1:1 ratio at 4, 12, and 24 weeks of follow-up. Repeated measure analysis of variance (ANOVA), t test, and paired t test were used for statistical analysis with a significance level of ≤ 0.050. One hundred and thirty-seven (N = 137) participants completed the study. Demographic and oral clinical parameters showed no statistical difference between the test group and the control group at baseline. A statistically significant difference (P ≤ .033) between the test group and the control group was observed for dental PI and GI scores at follow-up examinations. The repeated measure ANOVA also revealed a significant group interaction (P ≤ .01) for a reduction in outcome variables. From the current study, it may be concluded that tooth powder has been shown to be statistically superior to toothpastes in controlling dental plaque and gingivitis.

  7. No Effect of Aspirin on Mammographic Density in a Randomized Controlled Clinical Trial

    PubMed Central

    McTiernan, Anne; Wang, CY; Sorensen, Bess; Xiao, Liren; Buist, Diana S. M.; Bowles, Erin J. Aiello; White, Emily; Rossing, Mary Anne; Potter, John; Urban, Nicole

    2009-01-01

    Background: Epidemiologic studies suggest a reduced risk of breast cancer among women who regularly use aspirin; a plausible mechanism is through aspirin effect on mammographic breast density, a breast cancer risk factor, possibly mediated through aspirin interference with estrogen synthesis. Methods: In a 2-arm randomized placebo-controlled clinical trial, we evaluated the effects of 6-months administration of 325 mg/day aspirin on total mammographic breast dense area and percent of the mammographic breast image occupied by dense areas (% density) in 143 postmenopausal women. Eligible women, recruited 2005-7, were healthy, not taking hormone therapy, with elevated mammographic breast density (American College of Radiology Breast Imaging Reporting and Data System (BI-RADS®) density category 2, 3 or 4) within 6 months prior to enrollment. Results: Women were a mean (s.d.) 59.5 (5.5) years. Geometric mean baseline percent density was 17.6% (95% CI 14.8, 20.9) in women randomized to aspirin and 19.2% (95% CI 16.3, 22.7) in women randomized to placebo. Percent density decreased in women randomized to aspirin by an absolute 0.8% vs. an absolute decrease of 1.2% in controls (p = 0.84). Total breast area and dense area decreased to a similar degree in women assigned to aspirin and in those assigned to placebo, with no differences statistically significantly different between trial arms. Conclusions: A single daily administration of adult-dose aspirin for 6 months had no effect on mammographic density in postmenopausal women. If aspirin affects breast cancer risk in postmenopausal women, it may do so through alternative pathways than mammographic breast density. PMID:19423529

  8. Non-participation in a randomized controlled trial: the effect on clinical and non-clinical variables.

    PubMed

    Vermaire, J H; van Loveren, C; Poorterman, J H G; Hoogstraten, J

    2011-01-01

    Studies reporting clinical and non-clinical parameters of participants and non-participants of clinical trials are scarce. In the available studies non-participants were likely to show less favourable outcomes than participants on both socioeconomic parameters as well as on caries experience. However, the impact of non-participation on the total sample of the research population is not established. In the present study, as part of baseline data collection for a randomized controlled trial on caries-preventive strategies, 346 parents of children 6.0 years (± 3 months) of age were approached to let their child participate. Sixty parents refused, but 56 of them were willing to fill out the same set of questionnaires and to allow their child to be clinically examined once. Parents from participating children had higher socioeconomic status, were more often of autochthonous origin and scored better on knowledge questions than parents of non-participating children. Furthermore, parents of participating children reported a higher willingness to invest, were more likely to hold on to regular meals and their child had lower levels of plaque compared to non-participating children. Surprisingly, the participating children had higher dmfs scores than the non-participating children. Their care index (fs/ds + fs) was higher than that of non-participating children. Based on the findings of this study, the presumption that non-participating children will show less favourable clinical outcomes cannot be supported. Although participants differed from non-participants, they did not differ from the total population. It is suggested that the external validity of a randomized controlled trial on caries-preventive strategies is not necessarily affected by non-participation bias. Copyright © 2011 S. Karger AG, Basel.

  9. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

    PubMed

    Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

    2017-01-01

    The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P < 0.001]. Among the 226 RCTs for which the ESMO-MCBS could be applied, 31% (70/226) were designed to detect an effect size that could meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs.

  10. Effectiveness of Argan oil on knee osteoarthritis symptoms : a randomized controlled clinical trial.

    PubMed

    Essouiri, Jamila; Harzy, Taoufik; Benaicha, Nadia; Errasfa, Mourad; Abourazzak, Fatima Ezzahra

    2017-07-10

    Knee osteoarthritis (KOA) is a common chronic degenerative disorder. It causes joints pain, walking difficulties and a decline of general physical function. Many pain drugs and treatment modalities can be prescribed for KOA. Among traditional medicine in Morocco, Argan oil has been used in the treatment of knee osteoarthritis to reduce pain and improve physical activity, though there have been no medical-based evidence for such treatment. Argan oil is known to have anti-oxidant and lipid modulatory properties due to its content of many substances, such as tocopherols, phytosterols, saturated and unsaturated fatty acids. This study was undertaken in order to investigate the effect of daily consumption of culinary argan oil on KOA symptoms. We conducted a randomized controlled clinical trial on patients with KOA according to the American College of Rheumatology (ACR) criteria. Patients were devided into 2 groups: Argan oil group who received Argan oil to be consumed every morning (30 ml per day) for 8 weeks and control group with no treatment. Clinical assessment before and after 8 weeks study was performed by several tests such as the visual analogue scale (VAS) for pain, walking perimeter, the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), and the Lequesne index. The study included 100 patients. 51 patients were randomly assigned to Argan oilgroup while 49 patients were randomly assigned to control group with no treatment. Mean age of our patients was 58.24 ± 7.2 years, with a majority of women (93%). Following 8 weeks of Argan oil consumption, Argan oil group had a very significant decrease of VAS for pain (p< 0.0001), as well as a significant decrease of WOMAC pain index (p < 0.0001), and an improvement of WOMAC function index (p < 0.0001). Lequesne index (p < 0.0001) as well as walking distance (p =0,002) were significantly improved. When data of Argan oil groupe were compared to those of control group, we found statistically

  11. The effect of DASH diet on pregnancy outcomes in gestational diabetes: a randomized controlled clinical trial.

    PubMed

    Asemi, Z; Samimi, M; Tabassi, Z; Esmaillzadeh, A

    2014-04-01

    The current study was performed to investigate the effects of the Dietary Approaches to Stop Hypertension (DASH) eating plan on pregnancy outcomes in pregnant women with gestational diabetes mellitus (GDM). This randomized controlled clinical trial was performed among 52 women diagnosed with GDM. Participants were randomly assigned to consume either the control (n=26) or the DASH diet (n=26) for 4 weeks. The control diet was designed to contain 45-55% carbohydrates, 15-20% protein and 25-30% total fat. The DASH diet was rich in fruits, vegetables, whole grains and low-fat dairy products, and contained lower amounts of saturated fats, cholesterol and refined grains with a total of 2400 mg/day sodium. The numbers of women who commenced insulin therapy after dietary intervention, the mode of delivery and prevalence of polyhydramnios were assessed. The length, weight and head circumference of infants were measured during the first 24 h after birth. Whereas 46.2% of women in the DASH diet needed to have a cesarean section, this percentage for the control group was 80.8% (P=0.01). The percentage of those who needed to commence insulin therapy after intervention was also significantly different between the two groups (23% for DASH vs 73% for control group, P<0.0001). Infants born to mothers on the DASH diet had significantly lower weight (3222.7 vs 3818.8 g, P<0.0001), head circumference (34.2 vs 35.1 cm, P=0.01) and ponderal index (2.50 vs 2.87 kg/m(3), P<0.0001) compared with those born to mothers on the control diet. In conclusion, consumption of DASH diet for 4 weeks among pregnant women with GDM resulted in improved pregnancy outcomes.

  12. Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial

    PubMed Central

    Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; McLoughlin, Karen Sax; Ramelson, Harley; Schneider, Louise; Bates, David W

    2012-01-01

    Background Accurate clinical problem lists are critical for patient care, clinical decision support, population reporting, quality improvement, and research. However, problem lists are often incomplete or out of date. Objective To determine whether a clinical alerting system, which uses inference rules to notify providers of undocumented problems, improves problem list documentation. Study Design and Methods Inference rules for 17 conditions were constructed and an electronic health record-based intervention was evaluated to improve problem documentation. A cluster randomized trial was conducted of 11 participating clinics affiliated with a large academic medical center, totaling 28 primary care clinical areas, with 14 receiving the intervention and 14 as controls. The intervention was a clinical alert directed to the provider that suggested adding a problem to the electronic problem list based on inference rules. The primary outcome measure was acceptance of the alert. The number of study problems added in each arm as a pre-specified secondary outcome was also assessed. Data were collected during 6-month pre-intervention (11/2009–5/2010) and intervention (5/2010–11/2010) periods. Results 17 043 alerts were presented, of which 41.1% were accepted. In the intervention arm, providers documented significantly more study problems (adjusted OR=3.4, p<0.001), with an absolute difference of 6277 additional problems. In the intervention group, 70.4% of all study problems were added via the problem list alerts. Significant increases in problem notation were observed for 13 of 17 conditions. Conclusion Problem inference alerts significantly increase notation of important patient problems in primary care, which in turn has the potential to facilitate quality improvement. Trial Registration ClinicalTrials.gov: NCT01105923. PMID:22215056

  13. Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials.

    PubMed

    Dechartres, Agnes; Bond, Elizabeth G; Scheer, Jordan; Riveros, Carolina; Atal, Ignacio; Ravaud, Philippe

    2016-11-30

    Publication bias and other reporting bias have been well documented for journal articles, but no study has evaluated the nature of results posted at ClinicalTrials.gov. We aimed to assess how many randomized controlled trials (RCTs) with results posted at ClinicalTrials.gov report statistically significant results and whether the proportion of trials with significant results differs when no treatment effect estimate or p-value is posted. We searched ClinicalTrials.gov in June 2015 for all studies with results posted. We included completed RCTs with a superiority hypothesis and considered results for the first primary outcome with results posted. For each trial, we assessed whether a treatment effect estimate and/or p-value was reported at ClinicalTrials.gov and if yes, whether results were statistically significant. If no treatment effect estimate or p-value was reported, we calculated the treatment effect and corresponding p-value using results per arm posted at ClinicalTrials.gov when sufficient data were reported. From the 17,536 studies with results posted at ClinicalTrials.gov, we identified 2823 completed phase 3 or 4 randomized trials with a superiority hypothesis. Of these, 1400 (50%) reported a treatment effect estimate and/or p-value. Results were statistically significant for 844 trials (60%), with a median p-value of 0.01 (Q1-Q3: 0.001-0.26). For the 1423 trials with no treatment effect estimate or p-value posted, we could calculate the treatment effect and corresponding p-value using results reported per arm for 929 (65%). For 494 trials (35%), p-values could not be calculated mainly because of insufficient reporting, censored data, or repeated measurements over time. For the 929 trials we could calculate p-values, we found statistically significant results for 342 (37%), with a median p-value of 0.19 (Q1-Q3: 0.005-0.59). Half of the trials with results posted at ClinicalTrials.gov reported a treatment effect estimate and/or p-value, with significant

  14. Metaanalysis and review of heart failure disease management randomized controlled clinical trials.

    PubMed

    Whellan, David J; Hasselblad, Vic; Peterson, Eric; O'Connor, Christopher M; Schulman, Kevin A

    2005-04-01

    The medical community has turned to disease management (DM) to bridge the gap between proven therapies and clinical practice for patients with heart failure (HF). The aim of this study was to assess the effectiveness of DM programs in reducing hospitalization and mortality in patients with HF on the basis of the results of existing trials. We compared the published results from 19 randomized controlled clinical trials evaluating HF DM programs. A random effects model was used to combine the hazards ratio for all-cause hospitalization across the studies evaluating specific types of HF DM programs. We identified 19 relevant studies, with 5752 enrolled patients, which assessed the benefits of HF DM programs. The overall effect was a significant decrease in all-cause hospitalization for patients with HF. There was significant heterogeneity in the results (P < .0001). The results of this analysis indicate that HF DM is an intervention that could significantly decrease hospitalization for patients with HF. However, due to differences in the types of strategies and the variety of health care settings in which they were evaluated, further studies of HF DM programs with multiple participating centers are required.

  15. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial

    PubMed Central

    Motta, Lara Jansiski; Bussadori, Sandra Kalil; Campanelli, Ana Paula; da Silva, André Luis; Alfaya, Thays Almeida; de Godoy, Camila Haddad Leal; Navarro, Maria Fidela de Lima

    2013-01-01

    The aim of the present study was to assess pain and the need for anesthesia during chemomechanical caries removal with Papacarie gel and the traditional method (low-speed bur) in pediatric patients. A randomized, controlled, clinical trial with a “split-mouth” design was carried out involving 20 children (10 girls and 10 boys) aged four to seven years. Forty primary teeth (two per child) were randomly allocated to either Group 1 (G1: chemomechanical caries removal with Papacarie gel) or Group 2 (G2: removal of carious dentin with low-speed bur). A face scale was used to classify the sensation of pain during the procedure (1: absence of pain; 2: mild pain; 3: moderate pain; 4: moderately intense pain; 5: intense pain; and 6: extremely intense pain). Statistical analysis of the data was performed using the Wilcoxon-Mann-Whitney (U) test. Pain scores were higher in G2, with statistically significant differences in comparison to G1 (U = 148.0; W = 358.0; P = 0.041). Chemomechanical caries removal with Papacarie provides a lesser degree of pain in comparison to conventional caries removal and does not require the use of local anesthesia. The clinical trial registration number is NCT01811420. PMID:24363672

  16. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial.

    PubMed

    Motta, Lara Jansiski; Bussadori, Sandra Kalil; Campanelli, Ana Paula; da Silva, André Luis; Alfaya, Thays Almeida; de Godoy, Camila Haddad Leal; Navarro, Maria Fidela de Lima

    2013-01-01

    The aim of the present study was to assess pain and the need for anesthesia during chemomechanical caries removal with Papacarie gel and the traditional method (low-speed bur) in pediatric patients. A randomized, controlled, clinical trial with a "split-mouth" design was carried out involving 20 children (10 girls and 10 boys) aged four to seven years. Forty primary teeth (two per child) were randomly allocated to either Group 1 (G1: chemomechanical caries removal with Papacarie gel) or Group 2 (G2: removal of carious dentin with low-speed bur). A face scale was used to classify the sensation of pain during the procedure (1: absence of pain; 2: mild pain; 3: moderate pain; 4: moderately intense pain; 5: intense pain; and 6: extremely intense pain). Statistical analysis of the data was performed using the Wilcoxon-Mann-Whitney (U) test. Pain scores were higher in G2, with statistically significant differences in comparison to G1 (U = 148.0; W = 358.0; P = 0.041). Chemomechanical caries removal with Papacarie provides a lesser degree of pain in comparison to conventional caries removal and does not require the use of local anesthesia. The clinical trial registration number is NCT01811420.

  17. Efficacy of Acupuncture for Primary Insomnia: A Randomized Controlled Clinical Trial

    PubMed Central

    Wang, Lin-Peng; Liu, Cun-Zhi; Zhang, Jie; Wang, Gui-Ling; Yi, Jing-Hong; Cheng, Jin-Lian

    2013-01-01

    Objectives. To investigate the six-week influence of acupuncture on sleep quality and daytime functioning in primary insomnia. Methods. The study was a double-dummy, single-blinded, randomized, placebo-controlled clinical trial. A total of 180 patients with primary insomnia were randomly assigned to 3 groups: verum group underwent verum acupuncture plus placebo; estazolam group underwent estazolam plus sham acupuncture; sham group underwent sham acupuncture plus placebo. The outcome was measured by Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the 36-item short-form health survey (SF-36). Results. The three groups showed significant improvement compared with the pretreatment baseline. Compared with the other two groups, the verum group reported improved sleep quality (SQ) and vitality (VT), decreased daytime dysfunction (DD) and sleepiness (ESS score). The differences were kept from the treatment period to the end of the trial. Discussion. Verum acupuncture appeared to be more effective in increasing sleep quality and daytime functioning than sham acupuncture and estazolam. Trial Registration. The trial is registeded with ClinicalTrials.gov ISRCTN12585433. PMID:24159338

  18. Characterization of published randomized controlled trials assessing clinical pharmacy services around the world.

    PubMed

    Rotta, Inajara; Souza, Thais Teles; Salgado, Teresa M; Correr, Cassyano J; Fernandez-Llimos, Fernando

    A critical analysis of the research on clinical pharmacy services with regards to study characteristics has not been undertaken since 1998. However, several meta-analyses have been conducted to demonstrate the impact of pharmacists' interventions in specific medical conditions. These meta-analyses present high heterogeneity in part because the interventions are poorly and inconsistently described in primary studies. The aim of this article is to present the characteristics of randomized control trials (RCTs) that assess clinical pharmacy services to identify areas of improvement in future pharmacy practice research studies. Different emphasis of research across geographic regions of the world were also examined. During these 40 years, 520 articles reporting 439 RCTs assessing clinical pharmacy services were published. Of the 439 studies, 77.7% (n = 341) were published in the year 2000 or thereafter, 41.46% (n = 182) were conducted in the US, 27.56% (n = 121) in Europe, and 30.98% (n = 136) in the rest of the world. Studies in pharmacy practice have improved in terms of design, with an increase in the number of published RCTs after 2000. However, the small sample size of RCTs is still an issue. After 2000, a significantly higher proportion of studies were conducted in community pharmacy, targeting specific medical conditions, and with a higher number of patients randomized to the intervention group. Conversely, a significantly smaller proportion of studies were conducted in the hospital and targeted a single recipient after 2000. Studies conducted in the US had significantly more intervention arms, focused mostly on a specific medical condition, and were performed in primary care. Different health care systems' organization and policies may influence clinical pharmacy services research across countries.

  19. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.

    PubMed

    Fransen, Marlene; Nairn, Lillias; Winstanley, Julie; Lam, Paul; Edmonds, John

    2007-04-15

    To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits. A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb). At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi. Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA.

  20. Removal of extrinsic stain using a tartar control whitening dentifrice: a randomized clinical trial.

    PubMed

    Gerlach, R W; White, D J

    2001-01-01

    A nine-week, double blind clinical trial was conducted to evaluate the effectiveness of a novel tartar control whitening dentifrice with a silica-based abrasive system on induced dental stain. The study model involved three weeks of stain induction followed by six weeks of unsupervised brushing to assess efficacy. To induce stain, 222 healthy adult volunteers received a dental prophylaxis, and then began a limited brushing regimen supplemented by three-times daily rinsing with tea and once daily rinsing with 15 ml of 0.12% chlorhexidine. This regimen was suspended, and 187 subjects with tooth stain were entered into a six-week clinical trial where they were randomized to either a silica-based tartar control whitening dentifrice or a marketed regular dentifrice control, balancing for stain levels and smoking status. At baseline, three and six weeks, stain area and stain intensity were measured on the 8 anterior teeth using the Lobene Index. After six weeks' use, composite Lobene means were 35% lower for the whitening dentifrice compared to the regular control. In addition to the overall reductions, there were statistically significant reductions in stain area (p < 0.015) and stain intensity (p < 0.01) at both three and six weeks. The tartar control whitening dentifrice was effective in removing stain on the gingival margins and elsewhere on the body of the tooth. Safety profiles for the two test dentifrices were generally similar. After three and six weeks' use, the tartar control whitening dentifrice reduced chlorhexidine and tea stain compared to the marketed control.

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

    PubMed

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

    2017-06-01

    Hearing impaired children have a problem in understanding and comprehending with dental treatments. Visual language is the sensible answer of how to improve communication with them. To evaluate the applicability of dental sign language in Hearing impaired children in relieving anxiety during stressful dental treatment by improving their means of communication. This randomized clinical trial was carried out in the Department of Pedodontics and Preventive Dentistry which included 40 Hearing Impaired children meeting inclusion criteria. The selected children were randomly divided into the study and control group comprising of 20 each. In the control group, initial oral examination and dental treatment (oral prophylaxis and class I restoration) were performed without the use of dental sign language. In the study group, the dental sign language specific to dental treatment was educated and during their subsequent visit to the dental clinic after dental sign language reinforcement, oral prophylaxis and class I restoration were done. Subjective and objective measurements of anxiety were recorded for both groups using facial image scale (FIS), pulse oximeter and electronic blood pressure apparatus to compare for correlation. The obtained data were subjected to statistical analysis using unpaired t-test. There was a statistically significant reduction in the anxiety levels (p< 0.05) in the study group compared to the control group. Dental sign language was effective in reducing the level of anxiety in children who are hard of hearing. Dental sign language was able to improve behavior positively during dental treatment and may also aid in developing a positive dental attitude among children who are hard of hearing.

  2. Clinical and Immunological Changes of Immunotherapy in Patients with Atopic Dermatitis: Randomized Controlled Trial

    PubMed Central

    Sánchez Caraballo, Jorge Mario; Cardona Villa, Ricardo

    2012-01-01

    Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients. PMID:23724240

  3. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study.

    PubMed

    Heinz, Bernd; Kasaj, Adrian; Teich, Marie; Jepsen, Søren

    2010-10-01

    The purpose of the present randomized controlled clinical study was to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a novel nanocrystalline hydroxyapatite (nano-HA) bone graft substitute. Fourteen patients with paired intrabony periodontal defects of ≥ 4 mm participated in this split-mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels (PBL) from a customized acrylic stent and probing pocket depths (PPD) were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months (p < 0.05). At 6 months after therapy, the sites treated with nano-HA paste showed a reduction in mean PPD from 8.3 ± 1.2 to 4.0 ± 1.1 mm and a gain in PBL of 4.3 ± 1.4 mm, whereas in the control group, the mean PPD changed from 7.9 ± 1.2 mm to 5.0 ± 1.2 mm and PBL gain was 2.6 ± 1.4 mm. Results demonstrated statistically greater PPD reduction and PBL gain (p < 0.05) in the test group as compared with the control group. In conclusion, after 6 months, the treatment of intrabony periodontal defects with a nano-HA paste leads to significantly improved clinical outcomes when compared with papilla preservation flap surgery alone.

  4. Clinical effectiveness of dermal substitution in burns by topical negative pressure: a multicenter randomized controlled trial.

    PubMed

    Bloemen, Monica C T; van der Wal, Martijn B A; Verhaegen, Pauline D H M; Nieuwenhuis, Marianne K; van Baar, Margriet E; van Zuijlen, Paul P M; Middelkoop, Esther

    2012-01-01

    Previous research has shown clinical effectiveness of dermal substitution; however, in burn wounds, only limited effect has been shown. A problem in burn wounds is the reduced take of the autograft, when the substitute and graft are applied in one procedure. Recently, application of topical negative pressure (TNP) was shown to improve graft take. The aim of this study was to investigate if application of a dermal substitute in combination with TNP improves scar quality after burns. In a four-armed multicenter randomized controlled trial, a split-skin graft with or without a dermal substitute and with or without TNP was compared in patients with deep dermal or full-thickness burns requiring skin transplantation. Graft take and rate of wound epithelialization were evaluated. Three and 12 months postoperatively, scar parameters were measured. The results of 86 patients showed that graft take and epithelialization did not reveal significant differences. Significantly fewer wounds in the TNP group showed postoperative contamination, compared to other groups. Highest elasticity was measured in scars treated with the substitute and TNP, which was significantly better compared to scars treated with the substitute alone. Concluding, this randomized controlled trial shows the effectiveness of dermal substitution combined with TNP in burns, based on extensive wound and scar measurements. © 2012 by the Wound Healing Society.

  5. Effect of olive oil massage on weight gain in preterm infants: A randomized controlled clinical trial

    PubMed Central

    Jabraeile, Mahnaz; Rasooly, Alehe Seyyed; Farshi, Mahni Rahkar; Malakouti, Jamileh

    2016-01-01

    Background: Despite the fact that effect of massage with or without oil on the baby's weight gain is not clear, but recent studies have shown that massage with essential oils make lipid absorption through the skin. The aim of this study was to evaluate the effect of olive oil massage on weight gain in preterm infants. Materials and Methods: This study was a single-blind, randomized controlled clinical trial. In this study, infants who met inclusion criteria for the study were divided into two groups by using random numbers table. Newborns in intervention group were under massage for 10 days and 3 times for 15 min daily; the mother of these newborns had been trained already using olive oil. Moreover, the infants of the control group were under massaging without oil same as the above-mentioned method. Researchers weighed babies daily during 10 days and recorded it at the checklist. Data from the study were reviewed and analyzed by descriptive statistics and repeated measure test using the statistical software SPSS/13. Results: This study showed that the neonatal weight gain in the infants with the oil massage was 21 g daily in average, whereas the increase in infant massage without oil was 7 g. This difference was statistically significant (P < 0.001). Conclusion: Considering the positive effect of infant massage on weight gain in premature infants with olive oil, it is recommended that nurses use oil in infant massage in the neonatal units. PMID:27397955

  6. Effects of zinc and magnesium supplements on postpartum depression and anxiety: A randomized controlled clinical trial.

    PubMed

    Fard, Fatemeh Edalati; Mirghafourvand, Mojgan; Mohammad-Alizadeh Charandabi, Sakineh; Farshbaf-Khalili, Azizeh; Javadzadeh, Yousef; Asgharian, Hanieh

    2017-10-01

    Postpartum anxiety and depression are prevalent disorders. The authors of this study aimed to determine the effects of zinc and magnesium supplements on depressive symptoms and anxiety in postpartum women referred to three governmental, educational hospitals in Tabriz, Iran during 2014-2015. In this triple-blind, randomized, controlled clinical trial, the participants were randomly assigned to the zinc sulfate, magnesium sulfate, and placebo groups (n = 33 per group). The intervention groups received a 27-mg zinc sulfate tablet or 320-mg magnesium sulfate tablet per day for 8 weeks, whereas the control group received a placebo tablet each day during the same period. The Edinburgh Postnatal Depression Scale and the Spielberger State-Trait Anxiety Inventory were completed before and 8 weeks after the intervention. Blood samples were drawn from each participant to determine serum levels of zinc and magnesium before intervention at 48 hours after delivery. Also, a 24-hour dietary questionnaire was used during the first and last 3 days of the intervention. Adjusting for baseline scores as well as zinc and magnesium serum levels, no significant difference was observed between groups 8 weeks after delivery in mean scores of depressive symptoms (p = .553), state anxiety (p = .995), and trait anxiety (p = .234). This study concluded magnesium and zinc did not reduce postpartum anxiety and depressive symptoms.

  7. Intuitive control of a powered prosthetic leg during ambulation: a randomized clinical trial.

    PubMed

    Hargrove, Levi J; Young, Aaron J; Simon, Ann M; Fey, Nicholas P; Lipschutz, Robert D; Finucane, Suzanne B; Halsne, Elizabeth G; Ingraham, Kimberly A; Kuiken, Todd A

    2015-06-09

    Some patients with lower leg amputations may be candidates for motorized prosthetic limbs. Optimal control of such devices requires accurate classification of the patient's ambulation mode (eg, on level ground or ascending stairs) and natural transitions between different ambulation modes. To determine the effect of including electromyographic (EMG) data and historical information from prior gait strides in a real-time control system for a powered prosthetic leg capable of level-ground walking, stair ascent and descent, ramp ascent and descent, and natural transitions between these ambulation modes. Blinded, randomized crossover clinical trial conducted between August 2012 and November 2013 in a research laboratory at the Rehabilitation Institute of Chicago. Participants were 7 patients with unilateral above-knee (n = 6) or knee-disarticulation (n = 1) amputations. All patients were capable of ambulation within their home and community using a passive prosthesis (ie, one that does not provide external power). Electrodes were placed over 9 residual limb muscles and EMG signals were recorded as patients ambulated and completed 20 circuit trials involving level-ground walking, ramp ascent and descent, and stair ascent and descent. Data were acquired simultaneously from 13 mechanical sensors embedded on the prosthesis. Two real-time pattern recognition algorithms, using either (1) mechanical sensor data alone or (2) mechanical sensor data in combination with EMG data and historical information from earlier in the gait cycle, were evaluated. The order in which patients used each configuration was randomized (1:1 blocked randomization) and double-blinded so patients and experimenters did not know which control configuration was being used. The main outcome of the study was classification error for each real-time control system. Classification error is defined as the percentage of steps incorrectly predicted by the control system. Including EMG signals and

  8. Antimicrobial photodynamic therapy suppresses dental plaque formation in healthy adults: a randomized controlled clinical trial.

    PubMed

    Ichinose-Tsuno, Akiko; Aoki, Akira; Takeuchi, Yasuo; Kirikae, Teruo; Shimbo, Takuro; Lee, Masaichi-Chang-Il; Yoshino, Fumihiko; Maruoka, Yutaka; Itoh, Toshiyuki; Ishikawa, Isao; Izumi, Yuichi

    2014-12-15

    Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. A combination of 500 or 1000 μg/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 μg/ml TBO and red LED irradiation significantly suppressed dental plaque

  9. Randomized controlled trials 5: Determining the sample size and power for clinical trials and cohort studies.

    PubMed

    Greene, Tom

    2015-01-01

    Performing well-powered randomized controlled trials is of fundamental importance in clinical research. The goal of sample size calculations is to assure that statistical power is acceptable while maintaining a small probability of a type I error. This chapter overviews the fundamentals of sample size calculation for standard types of outcomes for two-group studies. It considers (1) the problems of determining the size of the treatment effect that the studies will be designed to detect, (2) the modifications to sample size calculations to account for loss to follow-up and nonadherence, (3) the options when initial calculations indicate that the feasible sample size is insufficient to provide adequate power, and (4) the implication of using multiple primary endpoints. Sample size estimates for longitudinal cohort studies must take account of confounding by baseline factors.

  10. Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial.

    PubMed

    Eftekharian, Ali; Amizadeh, Maryam

    2016-01-01

    To evaluate in patients with idiopathic sensorineural hearing loss whether pulse therapy with methylprednisolone leads to better recovery of hearing than traditional oral prednisolone therapy. Randomized controlled trial. Sixty-seven patients diagnosed with idiopathic sensorineural hearing loss were randomly divided into two groups based on therapy. The study group received 500-mg daily intravenous methylprednisolone for 3 consecutive days, followed by 1 mg/kg (maximum 60 mg) oral prednisolone for 11 days (total treatment: 14 days). The control group received 1 mg/kg (maximum 60 mg) oral prednisolone for 14 days. Hearing change was evaluated by comparing initial hearing tests and the third-month hearing tests in three ways: 1) pure tone improvement in each individual tone (0.5, 1, 2, 3, and 4 kHz); 2) word-recognition score improvement; and 3) complete, partial, and no recovery of hearing calculated (as defined by American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines). Sixty of 67 patients, 29 of 34 patients in the study group and 31 of 33 patients in the control group, completed the study. Frequency-specific hearing improvement did not differ significantly among the groups. Word-recognition score improvement was 20.34% ± 27.35% for the study group and 13.41% ± 23.48% for the control group, which had no statistically significant difference. There was also no significant difference in hearing recovery rates for the two groups. Pulse therapy with methylprednisolone and traditional oral prednisolone therapy resulted in similar hearing improvement. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  11. A randomized placebo-controlled clinical trial of five smoking cessation pharmacotherapies

    PubMed Central

    Piper, Megan E.; Smith, Stevens S.; Schlam, Tanya R.; Fiore, Michael C.; Jorenby, Douglas E.; Fraser, David; Baker, Timothy B.

    2010-01-01

    Context Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use. Objective The primary objective of this research was to assess the relative efficacies of five smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons. Design This was a randomized double-blind, placebo-controlled clinical trial. Setting Smokers were recruited from the community at two urban research sites. Patients Participants were 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported: using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications. Interventions Participants were randomized to one of six treatment conditions: nicotine lozenge, nicotine patch, bupropion SR, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge or placebo. In addition, all participants received six individual counseling sessions. Main Outcome Measures The main outcome measures were biochemically-confirmed 7-day point-prevalence abstinence assessed at 1 week post-quit, end of treatment (8 weeks post-quit) and 6 months post-quit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. Results All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (OR’s = 1.63–2.34). With such protection, only the nicotine patch + nicotine lozenge (OR = 2.34, p < .001) produced significantly higher abstinence rates at 6-months post-quit than did placebo. Conclusions While the nicotine lozenge, bupropion, and bupropion + lozenge produced effects that were comparable to those

  12. Randomized, Controlled Clinical Trial of Bilayer Ceramic and Metal-Ceramic Crown Performance

    PubMed Central

    Esquivel-Upshaw, Josephine; Rose, William; Oliveira, Erica; Yang, Mark; Clark, Arthur E.; Anusavice, Kenneth

    2013-01-01

    Purpose Analyzing the clinical performance of restorative materials is important, as there is an expectation that these materials and procedures will restore teeth and do no harm. The objective of this research study was to characterize the clinical performance of metal-ceramic crowns, core ceramic crowns, and core ceramic/veneer ceramic crowns based on 11 clinical criteria. Materials and Methods An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study. The following three types of full crowns were fabricated: (1) metal-ceramic crown (MC) made from a Pd-Au-Ag-Sn-In alloy (Argedent 62) and a glass-ceramic veneer (IPS d.SIGN veneer); (2) non-veneered (glazed) lithium disilicate glass-ceramic crown (LDC) (IPS e.max Press core and e.max Ceram Glaze); and (3) veneered lithia disilicate glass-ceramic crown (LDC/V) with glass-ceramic veneer (IPS Empress 2 core and IPS Eris). Single-unit crowns were randomly assigned. Patients were recalled for each of 3 years and were evaluated by two calibrated clinicians. Thirty-six crowns were placed in 31 patients. A total of 12 crowns of each of the three crown types were studied. Eleven criteria were evaluated: tissue health, marginal integrity, secondary caries, proximal contact, anatomic contour, occlusion, surface texture, cracks/chips (fractures), color match, tooth sensitivity, and wear (of crowns and opposing enamel). Numerical rankings ranged from 1 to 4, with 4 being excellent, and 1 indicating a need for immediate replacement. Statistical analysis of the numerical rankings was performed using a Fisher’s exact test. Results There was no statistically significant difference between performance of the core ceramic crowns and the two veneered crowns at year 1 and year 2 (p > 0.05). All crowns were rated either as excellent or good for each of the clinical criteria; however, between years 2 and 3, gradual roughening of the occlusal surface occurred in some of the ceramic-ceramic crowns

  13. Randomized, controlled clinical trial of bilayer ceramic and metal-ceramic crown performance.

    PubMed

    Esquivel-Upshaw, Josephine; Rose, William; Oliveira, Erica; Yang, Mark; Clark, Arthur E; Anusavice, Kenneth

    2013-04-01

    Analyzing the clinical performance of restorative materials is important, as there is an expectation that these materials and procedures will restore teeth and do no harm. The objective of this research study was to characterize the clinical performance of metal-ceramic crowns, core ceramic crowns, and core ceramic/veneer ceramic crowns based on 11 clinical criteria. An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study. The following three types of full crowns were fabricated: (1) metal-ceramic crown (MC) made from a Pd-Au-Ag-Sn-In alloy (Argedent 62) and a glass-ceramic veneer (IPS d.SIGN veneer); (2) non-veneered (glazed) lithium disilicate glass-ceramic crown (LDC) (IPS e.max Press core and e.max Ceram Glaze); and (3) veneered lithia disilicate glass-ceramic crown (LDC/V) with glass-ceramic veneer (IPS Empress 2 core and IPS Eris). Single-unit crowns were randomly assigned. Patients were recalled for each of 3 years and were evaluated by two calibrated clinicians. Thirty-six crowns were placed in 31 patients. A total of 12 crowns of each of the three crown types were studied. Eleven criteria were evaluated: tissue health, marginal integrity, secondary caries, proximal contact, anatomic contour, occlusion, surface texture, cracks/chips (fractures), color match, tooth sensitivity, and wear (of crowns and opposing enamel). Numerical rankings ranged from 1 to 4, with 4 being excellent, and 1 indicating a need for immediate replacement. Statistical analysis of the numerical rankings was performed using a Fisher's exact test. There was no statistically significant difference between performance of the core ceramic crowns and the two veneered crowns at year 1 and year 2 (p > 0.05). All crowns were rated either as excellent or good for each of the clinical criteria; however, between years 2 and 3, gradual roughening of the occlusal surface occurred in some of the ceramic-ceramic crowns, possibly caused by dissolution and

  14. Improving HIV Rapid Testing Rates Among STD Clinic Patients: A Randomized Controlled Trial

    PubMed Central

    Carey, Michael P.; Coury-Doniger, Patricia; Senn, Theresa E.; Vanable, Peter A.; Urban, Marguerite A.

    2008-01-01

    Objective The Centers for Disease Control and Prevention recommends that HIV testing be a standard part of medical care; however, testing is voluntary and some patients decline. We evaluated two brief interventions to promote rapid HIV testing among STD clinic patients who initially declined testing. Method Using a randomized controlled trial, patients either viewed an educational digital video disc (DVD) or participated in stage-based behavioral counseling (SBC) provided by a nurse. Sixty clients presenting for care at a STD clinic who initially declined HIV testing at registration and during risk behavior screening participated in the study. Results The primary outcome was whether patients agreed to be tested for HIV. The secondary outcomes included attitudes, knowledge, and stage-of-change regarding HIV testing. Patients receiving both interventions improved their attitudes and knowledge about testing (ps < .01). Patients receiving SBC agreed to testing more often (45%) than did patients who viewed the DVD (19%; p < .05). Conclusions Brief interventions can increase rapid HIV testing acceptance among patients who are reluctant to be tested; counseling guided by behavioral science theory is more effective than a well-designed information-based intervention. PMID:19025280

  15. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    PubMed Central

    Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

  16. Clinical decision support tools for osteoporosis disease management: a systematic review of randomized controlled trials.

    PubMed

    Kastner, Monika; Straus, Sharon E

    2008-12-01

    Studies indicate a gap between evidence and clinical practice in osteoporosis management. Tools that facilitate clinical decision making at the point of care are promising strategies for closing these practice gaps. To systematically review the literature to identify and describe the effectiveness of tools that support clinical decision making in osteoporosis disease management. Medline, EMBASE, CINAHL, and EBM Reviews (CDSR, DARE, CCTR, and ACP J Club), and contact with experts in the field. Randomized controlled trials (RCTs) in any language from 1966 to July 2006 investigating disease management interventions in patients at risk for osteoporosis. Outcomes included fractures and bone mineral density (BMD) testing. Two investigators independently assessed articles for relevance and study quality, and extracted data using standardized forms. Of 1,246 citations that were screened for relevance, 13 RCTs met the inclusion criteria. Reported study quality was generally poor. Meta-analysis was not done because of methodological and clinical heterogeneity; 77% of studies included a reminder or education as a component of their intervention. Three studies of reminders plus education targeted to physicians and patients showed increased BMD testing (RR range 1.43 to 8.67) and osteoporosis medication use (RR range 1.60 to 8.67). A physician reminder plus a patient risk assessment strategy found reduced fractures [RR 0.58, 95% confidence interval (CI) 0.37 to 0.90] and increased osteoporosis therapy (RR 2.44, CI 1.43 to 4.17). Multi-component tools that are targeted to physicians and patients may be effective for supporting clinical decision making in osteoporosis disease management.

  17. Clinical Decision Support Tools for Osteoporosis Disease Management: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Straus, Sharon E.

    2008-01-01

    BACKGROUND Studies indicate a gap between evidence and clinical practice in osteoporosis management. Tools that facilitate clinical decision making at the point of care are promising strategies for closing these practice gaps. OBJECTIVE To systematically review the literature to identify and describe the effectiveness of tools that support clinical decision making in osteoporosis disease management. DATA SOURCES Medline, EMBASE, CINAHL, and EBM Reviews (CDSR, DARE, CCTR, and ACP J Club), and contact with experts in the field. REVIEW METHODS Randomized controlled trials (RCTs) in any language from 1966 to July 2006 investigating disease management interventions in patients at risk for osteoporosis. Outcomes included fractures and bone mineral density (BMD) testing. Two investigators independently assessed articles for relevance and study quality, and extracted data using standardized forms. RESULTS Of 1,246 citations that were screened for relevance, 13 RCTs met the inclusion criteria. Reported study quality was generally poor. Meta-analysis was not done because of methodological and clinical heterogeneity; 77% of studies included a reminder or education as a component of their intervention. Three studies of reminders plus education targeted to physicians and patients showed increased BMD testing (RR range 1.43 to 8.67) and osteoporosis medication use (RR range 1.60 to 8.67). A physician reminder plus a patient risk assessment strategy found reduced fractures [RR 0.58, 95% confidence interval (CI) 0.37 to 0.90] and increased osteoporosis therapy (RR 2.44, CI 1.43 to 4.17). CONCLUSION Multi-component tools that are targeted to physicians and patients may be effective for supporting clinical decision making in osteoporosis disease management. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0812-9) contains supplementary material, which is available to authorized users. PMID:18836782

  18. A Randomized Controlled Trial of Online versus Clinic-Based CBT for Adolescent Anxiety

    ERIC Educational Resources Information Center

    Spence, Susan H.; Donovan, Caroline L.; March, Sonja; Gamble, Amanda; Anderson, Renee E.; Prosser, Samantha; Kenardy, Justin

    2011-01-01

    Objective: The study examined the relative efficacy of online (NET) versus clinic (CLIN) delivery of cognitive behavior therapy (CBT) in the treatment of anxiety disorders in adolescents. Method: Participants included 115 clinically anxious adolescents aged 12 to 18 years and their parent(s). Adolescents were randomly assigned to NET, CLIN, or…

  19. A Randomized Controlled Trial of Online versus Clinic-Based CBT for Adolescent Anxiety

    ERIC Educational Resources Information Center

    Spence, Susan H.; Donovan, Caroline L.; March, Sonja; Gamble, Amanda; Anderson, Renee E.; Prosser, Samantha; Kenardy, Justin

    2011-01-01

    Objective: The study examined the relative efficacy of online (NET) versus clinic (CLIN) delivery of cognitive behavior therapy (CBT) in the treatment of anxiety disorders in adolescents. Method: Participants included 115 clinically anxious adolescents aged 12 to 18 years and their parent(s). Adolescents were randomly assigned to NET, CLIN, or…

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

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks

  1. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial

    PubMed Central

    Imamura, Marta; Imamura, Satiko Tomikawa; Targino, Rosa Alves; Morales-Quezada, León; Onoda Tomikawa, Luis C.; Onoda Tomikawa, Luis G.; Alfieri, Fabio M.; Filippo, Thais R.; da Rocha, Ivan D.; Neto, Raul Bolliger; Fregni, Felipe; Battistella, Linamara Rizzo

    2016-01-01

    In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization. PMID:26828801

  2. Pulsed electromagnetic fields on postmenopausal osteoporosis in Southwest China: a randomized, active-controlled clinical trial.

    PubMed

    Liu, Hui-Fang; Yang, Lin; He, Hong-Chen; Zhou, Jun; Liu, Ying; Wang, Chun-Yan; Wu, Yuan-Chao; He, Cheng-Qi

    2013-05-01

    A randomized, active-controlled clinical trial was conducted to examine the effect of pulsed electromagnetic fields (PEMFs) on women with postmenopausal osteoporosis (PMO) in southwest China. Forty-four participants were randomly assigned to receive alendronate or one course of PEMFs treatment. The primary endpoint was the mean percentage change in bone mineral density of the lumbar spine (BMDL), and secondary endpoints were the mean percentage changes in left proximal femur bone mineral density (BMDF), serum 25OH vitamin D3 (25(OH)D) concentrations, total lower-extremity manual muscle test (LE MMT) score, and Berg Balance Scale (BBS) score. The BMDL, BMDF, total LE MMT score and BBS score were recorded at baseline, 5, 12, and 24 weeks. Serum concentrations of 25(OH)D were measured at baseline and 5 weeks. Using a mixed linear model, there was no significant treatment difference between the two groups in the BMDL, BMDF, total LE MMT score, and BBS score (P ≥ 0.05). For 25(OH)D concentrations, the effects were also comparable between the two groups (P ≥ 0.05) with the Mann-Whitney's U-test. These results suggested that a course of PEMFs treatment with specific parameters was as effective as alendronate in treating PMO within 24 weeks.

  3. Clinical effectiveness of aquatic exercise to treat chronic low back pain: a randomized controlled trial.

    PubMed

    Dundar, Umit; Solak, Ozlem; Yigit, Ilknur; Evcik, Deniz; Kavuncu, Vural

    2009-06-15

    This study was a prospective, randomized, controlled study. To compare the effectiveness of aquatic exercise interventions with land-based exercises in the treatment of chronic low back pain (CLBP). Land-based exercise and physiotherapy are the main treatment tools used for CLBP. Clinical experience indicates that aquatic exercise may have advantages for patients with musculoskeletal disorders. A total of 65 patients with CLBP were included in this study. Patients were randomly assigned to receive aquatic exercise or land-based exercise treatment protocol. Aquatic exercise program consisted of 20 sessions, 5 x per week for 4 weeks in a swimming pool at 33 degrees C. Land-based exercise (home-based exercise) program were demonstrated by a physiotherapist on one occasion and then they were given written advice The patients were assessed for spinal mobility, pain, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (week 4 and week 12). In both groups, statistically significant improvements were detected in all outcome measures (except modified Schober test) compared with baseline. However, improvement in modified Oswestry Low Back Pain Disability questionnaire and physical function and role limitations due to physical functioning subpart of Short-Form 36 Health Survey were better in aquatic exercise group (P < 0.05). It is concluded that a water-based exercises produced better improvement in disability and quality of life of the patients with CLBP than land-based exercise.

  4. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    ERIC Educational Resources Information Center

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  5. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    ERIC Educational Resources Information Center

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  6. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial.

    PubMed

    Cerritelli, Francesco; Ginevri, Liana; Messi, Gabriella; Caprari, Emanuele; Di Vincenzo, Marcello; Renzetti, Cinzia; Cozzolino, Vincenzo; Barlafante, Gina; Foschi, Nicoletta; Provinciali, Leandro

    2015-04-01

    To assess the effectiveness of OMT on chronic migraineurs using HIT-6 questionnaire, drug consumption, days of migraine, pain intensity and functional disability. 3-Armed randomized controlled trial setting: all patients admitted in the Department of Neurology of Ancona's United Hospitals, Italy, with a diagnosis of migraine and without chronic illness, were considered eligible for the study. Patients were randomly divided into three groups: (1) OMT+medication therapy, (2) sham+medication therapy and (3) medication therapy only. Patients received 8 treatments in a study period of 6 months. Changing from baseline HIT-6 score. 105 subjects were included. At the end of the study, ANOVA showed that OMT significantly reduced HIT-6 score (mean change scores OMT-conventional care: -8.74; 95% confidence interval (CI) -12.96 to -4.52; p<0.001 and OMT-sham: -6.62; 95% CI -10.85 to -2.41; p<0.001), drug consumption (OMT-sham: RR=0.22, 95% CI 0.11-0.40; OMT-control: RR=0.20, 95% CI 0.10-0.36), days of migraine (OMT-conventional care: M=-21.06; 95% CI -23.19 to -18.92; p<0.001 and OMT-sham: -17.43; 95% CI -19.57 to -15.29; p<0.001), pain intensity (OMT-sham: RR=0.42, 95% CI 0.24-0.69; OMT-control: RR=0.31, 95% CI 0.19-0.49) and functional disability (p<0.001). These findings suggest that OMT may be considered a valid procedure for the management of migraineurs. The present trial was registered on www.ClinicalTrials.gov (identifier: NCT01851148). Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. A randomized controlled clinical trial to assess the desensitizing effect of a stannous fluoride dentifrice.

    PubMed

    He, Tao; Barker, Matthew L; Biesbrock, Aaron; Sharma, Naresh

    2014-04-01

    To assess the dentin hypersensitivity-reducing effectiveness of a 0.454% stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after 3 days and 2 weeks of twice daily use. This was a 2-week, randomized, double-blind, parallel group, single-center clinical investigation in confirmed dentin hypersensitivity adult sufferers. At baseline, subjects were stratified by age, gender, and thermal sensitivity scores, and randomly assigned to a marketed 0.454% stannous fluoride (SnF2) dentifrice or a marketed sodium fluoride (NaF) dentifrice negative control. Following baseline assessment of tactile and thermal sensitivity via the Yeaple Probe and air-blast/Schiff Air Index evaluations, respectively, subjects brushed once on-site with their assigned test product following the same usage instructions. Post-brushing tactile and thermal sensitivity were then assessed ('Immediate' evaluation). Subjects subsequently brushed twice daily at home for a 2-week period, with the same tactile and thermal efficacy evaluations repeated at Day 3 and Week 2 post-baseline. All 116 enrolled subjects completed all evaluations. The stannous fluoride dentifrice provided significantly (P < 0.0001) superior dentin hypersensitivity reduction compared to the negative control dentifrice at each time point and by both evaluation measures: superior mean relative Yeaple Probe (tactile) benefits were 124.5% after one use, 203.8% after 3 days, and 222.5% after 2 weeks; and superior mean relative Schiff Air Index (thermal) benefits were 27.6% after a single use, 44.6% at Day 3, and 74.2% at Week 2. Both dentifrices were well-tolerated.

  8. Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

    PubMed Central

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2015-01-01

    Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

  9. Aloe vera gel and cesarean wound healing; a randomized controlled clinical trial.

    PubMed

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2014-08-31

    Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. The participants' mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel.

  10. Effect of aromatherapy massage on menopausal symptoms: a randomized placebo-controlled clinical trial.

    PubMed

    Darsareh, Fatemeh; Taavoni, Simin; Joolaee, Soodabeh; Haghani, Hamid

    2012-09-01

    Menopause is a significant event in most women's lives because it marks the end of a woman's natural reproductive life. The purpose of this study was to determine the effect of aromatherapy massage on menopausal symptoms. A randomized placebo-controlled clinical trial was conducted at a menopausal clinic at a gynecology hospital in Tehran. The study population comprised 90 women who were assigned to an aromatherapy massage group, a placebo massage group, or a control group. Each participant in the aromatherapy massage group received 30-minute aromatherapy treatment sessions twice a week for 4 weeks with aroma oil, whereas participants in the placebo massage group received the same treatment with plain oil. No treatment was provided to participants in the control group. The outcome measures in this study were menopausal symptoms, as obtained through the Menopause Rating Scale. The mean baseline level of the menopausal score did not differ among all groups. However, after eight sessions of intervention, the Menopause Rating Scale score differed significantly among the three groups (P < 0.001). Post hoc analysis revealed that women in both the aromatherapy massage group and the placebo massage group had a lower menopausal score than the control group (P < 0.001). When the aromatherapy massage and the placebo massage groups were compared, the menopausal score for the aromatherapy massage group was found to be significantly lower (P < 0.001) than for the placebo group. The results of the study demonstrate that both massage and aromatherapy massage were effective in reducing menopausal symptoms. However, aromatherapy massage was more effective than only massage.

  11. Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial

    PubMed Central

    Summers, C Gail; Connett, John E; Holleschau, Ann M; Anderson, Jennifer L; De Becker, Inge; McKay, Brian S; Brilliant, Murray H

    2014-01-01

    Background Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism. Design Prospective, randomized, placebo-controlled, double-masked randomized clinical trial conducted at the University of Minnesota Participants 45 subjects with albinism Methods Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76 mg/kg with 25% carbidopa, levodopa 0.51 mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side effects were recorded with a symptom survey. Blood was drawn for genotyping. Main Outcome Measures Side effects and best-corrected visual acuity 20 weeks after enrollment. Results All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow-up was 100% and compliance was good. Minor side effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa. Conclusions Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism. PMID:24641678

  12. [Effectiveness of IPD treatment for delirium prevention in hospitalized elderly. A controlled randomized clinical trial].

    PubMed

    Bonaventura, Marino; Zanotti, Renzo

    2007-01-01

    Delirium is a common and serious complication for hospitalized elderly people. Early detection of risk and preventive treatment may significantly reduce delirium and its consequences. In Inouye's study of elderly people with delirium (1993), an interesting predictive model was proposed ,but never applied, for hospitalized elderly. The aim of this study was to test the effectiveness of IPD, a standardized package of caring activities, in the prevention of delirium in inpatient elderly The study consisted of an experimental controlled randomized trial with standardized treatment (Prevention of Delirium Interventions - IPD) with 30 subjects in the experimental group and 30 comparable subjects in the control group. Subjects were recruited if they obtained a score of 24 or less in the Mini Mental State Examination (MMSE). All the subjects have been assessed on the first, second, fourth and seventh day of their hospital stay according to the MMSE, Barthel Index, Tinetti Balance and Gait Scale, Neecham Confusion Scale, and Delirium Rating Scale. The method of assessment was the Confusion Assessment protocol. There was a statistically and clinically significant reduction in both the risk of delirium and related events in the treatment group compared to the control. Therefore, the IPD model proved to be highly effective in comparison to traditional care for elderly inpatients.

  13. Mobile-Based Video Learning Outcomes in Clinical Nursing Skill Education: A Randomized Controlled Trial.

    PubMed

    Lee, Nam-Ju; Chae, Sun-Mi; Kim, Haejin; Lee, Ji-Hye; Min, Hyojin Jennifer; Park, Da-Eun

    2016-01-01

    Mobile devices are a regular part of daily life among the younger generations. Thus, now is the time to apply mobile device use to nursing education. The purpose of this study was to identify the effects of a mobile-based video clip on learning motivation, competence, and class satisfaction in nursing students using a randomized controlled trial with a pretest and posttest design. A total of 71 nursing students participated in this study: 36 in the intervention group and 35 in the control group. A video clip of how to perform a urinary catheterization was developed, and the intervention group was able to download it to their own mobile devices for unlimited viewing throughout 1 week. All of the students participated in a practice laboratory to learn urinary catheterization and were blindly tested for their performance skills after participation in the laboratory. The intervention group showed significantly higher levels of learning motivation and class satisfaction than did the control. Of the fundamental nursing competencies, the intervention group was more confident in practicing catheterization than their counterparts. Our findings suggest that video clips using mobile devices are useful tools that educate student nurses on relevant clinical skills and improve learning outcomes.

  14. The reduction of distress using therapeutic geothermal water procedures in a randomized controlled clinical trial.

    PubMed

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P < 0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P = 0.01). Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine.

  15. The Reduction of Distress Using Therapeutic Geothermal Water Procedures in a Randomized Controlled Clinical Trial

    PubMed Central

    Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

    2015-01-01

    Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P < 0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P = 0.01). Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine. PMID:25866680

  16. A randomized, double blinded, placebo-controlled clinical trial of silymarin in ulcerative colitis.

    PubMed

    Rastegarpanah, Mansoor; Malekzadeh, Reza; Vahedi, Homayoun; Mohammadi, Maryam; Elahi, Elham; Chaharmahali, Meghedi; Safarnavadeh, Tahereh; Abdollahi, Mohammad

    2015-12-01

    To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients. A randomized double blinded placebo-controlled clinical trial was conducted in 80 UC patients whose disease had been documented and were in remission state between September 2009 and October 2010. Patients were assigned to silymarin group (42 cases) and placebo group (38 cases) using a random number table. Either silymarin (140 mg) or placebo (lactose mono-hydrate, corn starch magnesium stearate) tablets were given once daily for 6 months along with their standard therapy. The efficacies were assessed by disease activity index (DAI), frequency difference of the disease flare-up, and paraclinical data. Ten patients (4 in the silymarin group due to nausea and 6 in the placebo group due to disease flare-up and abdominal pain) discontinued the study. An improvement in hemoglobin level (11.8±1.6 g/dL vs. 13.4±1.2 g/dL,P<0.05) and erythrocyte sedimentation rate (23.7±11.5 mm/h vs.10.8±3.2 mm/h,P<0.05) was observed in the silymarin group but not in the placebo group. DAI significantly decreased in the silymarin group and reached from 11.3±3.5 to 10.7±2.8 (P<0.05). Thirty-five out of 38 patients in the silymarin group were in complete remission with no flare-up after 6 months as compared to 21 out of 32 patients in the placebo group (P=0.5000). Silymarin as a natural supplement may be used in UC patients to maintain remission.

  17. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial

    PubMed Central

    Miceli, Giovanni; Marino, Natale; Sciortino, Davide; Bagnato, Gian Filippo

    2016-01-01

    Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 PMID:26705327

  18. Impact of icodextrin on clinical outcomes in peritoneal dialysis: a systematic review of randomized controlled trials.

    PubMed

    Cho, Yeoungjee; Johnson, David W; Badve, Sunil; Craig, Jonathan C; Strippoli, Giovanni F K; Wiggins, Kathryn J

    2013-07-01

    Although icodextrin has been shown to augment peritoneal ultrafiltration in peritoneal dialysis (PD) patients, its impact upon other clinical end points, such as technique survival, remains uncertain. This systematic review evaluated the effect of icodextrin use on patient level clinical outcomes. The Cochrane CENTRAL Registry, MEDLINE, Embase and reference lists were searched (last search 13 September 2012) for randomized controlled trials of icodextrin versus glucose in the long dwell exchange. Summary estimates of effect were obtained using a random effects model. Eleven eligible trials (1222 patients) were identified. There was a significant reduction in episodes of uncontrolled fluid overload [two trials; 100 patients; relative risk (RR) 0.30, 95% confidence interval (CI) 0.15-0.59] and improvement in peritoneal ultrafiltration [four trials; 102 patients; mean difference (MD) 448.54 mL/day, 95% CI 289.28-607.80] without compromising residual renal function [four trials; 114 patients; standardized MD (SMD) 0.12, 95% CI -0.26 to 0.49] or urine output (three trials; 69 patients; MD -88.88, 95% CI -356.88 to 179.12) with icodextrin use for up to 2 years. There was no significant effect on peritonitis incidence (five trials; 607 patients; RR 0.97, 95% CI 0.76-1.23), peritoneal creatinine clearance (three trials; 237 patients; SMD 0.36, 95% CI -0.24 to 0.96), technique failure (three trials; 290 patients; RR 0.58, 95% CI 0.28-1.20), patient survival (six trials; 816 patients; RR 0.82, 95% CI 0.32-2.13) or adverse events. Icodextrin prescription improved peritoneal ultrafiltration, mitigated uncontrolled fluid overload and was not associated with increased risk of adverse events. No effects of icodextrin on technique or patient survival were observed, although trial sample sizes and follow-up durations were limited.

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

    PubMed

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

    2016-05-01

    To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage and 3) nurse intervener perspectives. A randomized controlled clinical trial design. Urban, community, midwestern United States. A total of 254 stroke caregivers (mean ±SD age, 54.4 ±11.8 years), 55 (22.0%) males and 199 (78.4%) females) randomized to the TASK II intervention (n=123) or an Information, Support, and Referral comparison group (n=131). TASK II participants received the TASK II Resource Guide; Information, Support, and Referral participants received a standard caregiver brochure. At approximately 8 weeks after discharge, both groups received 8 weekly calls from a nurse, with a booster call 4 weeks later. Protocol adherence was evaluated with the TASK II Checklist for Monitoring Adherence. Intervention dosage was measured by the number of minutes caregivers spent reading materials and talking with the nurse. Nurse intervener perspectives were obtained through focus groups. Protocol adherence was 80% for the TASK II and 92% for the Information, Support, and Referral. As expected, intervention dosage differed between TASK II and Information, Support, and Referral with respect to caregiver time spent reading materials (t=-6.49; P<.001) and talking with the nurse (t=-7.38; P<.001). Focus groups with nurses yielded further evidence for treatment fidelity and recommendations for future trials. These findings substantiate treatment fidelity in both study arms of the TASK II stroke caregiver intervention trial (NIH R01NR010388; ClinicalTrials.govNCT01275495). © The Author(s) 2015.

  20. Impact of a Brief Educational Intervention on Glaucoma Persistence: A Randomized Controlled Clinical Trial.

    PubMed

    Djafari, Fawzia; Lesk, Mark R; Giguère, Charles-Édouard; Siam, Ghada; Freeman, Ellen E

    2015-01-01

    To determine whether two sessions of a glaucoma educational intervention resulted in better persistence to glaucoma eye drop therapy compared to normal care. A total of 165 patients newly diagnosed with glaucoma who required eye drop therapy were recruited into a randomized clinical trial from the glaucoma clinic at Maisonneuve-Rosemont Hospital in Montreal, Canada. Patients were randomized to either an immediate intervention or normal care. The intervention consisted of two 60-90 minute sessions of education on glaucoma and its management, given in a small group format by a non-practicing ophthalmologist. Persistence to glaucoma medication was examined for 1 year by the use of Hospital medical records and by pharmacy claims records from the Régie de l'assurance maladie du Québec (Quebec Health Insurance Program). A questionnaire was administered, and medication possession ratio calculated. The primary outcome was persistence, defined as having medication available at least 75% of the time. Secondary outcomes included eye drop instillation technique and perception of the importance of eye drop therapy. The intervention group achieved better persistence to eye drop therapy, as 77% of controls and 89% of people receiving the intervention were persistent (p = 0.049). The intervention also resulted in better eye drop instillation technique (p < 0.001) and greater perception of the importance of eye drop therapy (p < 0.001). Brief instructional sessions offered to newly diagnosed glaucoma patients can result in better persistence rates over 1-year follow-up. Strategies to permanently offer these types of initiatives should be considered.

  1. When Using Patient-Reported Outcomes in Clinical Practice, the Measure Matters: A Randomized Controlled Trial

    PubMed Central

    Snyder, Claire F.; Herman, Joseph M.; White, Sharon M.; Luber, Brandon S.; Blackford, Amanda L.; Carducci, Michael A.; Wu, Albert W.

    2014-01-01

    Background: Patient-reported outcome (PRO) measures are increasingly being used in clinical practice to inform individual patient management, but evidence is needed on which PROs are best suited for clinical use. Methods: This controlled trial randomly assigned patients with breast and prostate cancer undergoing treatment to complete one of three PRO measures: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30), Supportive Care Needs Survey-Short Form (SCNS-SF34), or six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS). Patients completed the PRO measures before clinic visits, and the results were provided to both the patient and clinician. At treatment completion, patients and clinicians completed brief feedback forms on the intervention's usefulness and value. Exit interviews were conducted with patients (at end of treatment) and clinicians (at end of study). The primary outcome was the proportion of patients in each arm who either strongly agreed or agreed to all feedback form items. Results: Of 294 eligible patients invited to participate, 224 (76%) enrolled (median age 66 years, 78% white, 72% prostate). Of the 181 patients (81%) who completed at least one feedback form item, participants in the QLQ-C30 study arm were most likely to strongly agree/agree to all items (74%) followed by PROMIS (61%) and SCNS-SF34 (52%; P = .03). Of the 116 participants (52%) who completed all feedback form items, the results were similar: 82% for the QLQ-C30, 62% for PROMIS, and 56% for SCNS-SF34 (P = .05). Clinicians did not prefer one questionnaire over the others. Conclusion: These results suggest that, when using PROs in clinical practice for patient management, the measure matters in terms of usefulness to patients. PMID:24986113

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

    PubMed

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

    2010-01-01

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

  3. [Study on clinical effectiveness of acupuncture and moxibustion on acute Bell's facial paralysis: randomized controlled clinical observation].

    PubMed

    Wu, Bin; Li, Ning; Liu, Yi; Huang, Chang-qiong; Zhang, Yong-ling

    2006-03-01

    To investigate the adverse effects of acupuncture on the prognosis, and effectiveness of acupuncture combined with far infrared ray in the patient of acute Bell's facial paralysis within 48 h. Clinically randomized controlled trial was used, and the patients were divided into 3 groups: group A (early acupuncture group), group B (acupuncture combined with far infrared ray) and group C (acupuncture after 7 days). The facial nerve functional classification at the attack, 7 days after the attack and after treatment, the clinically cured rate of following-up of 6 months, and the average cured time, the cured time of complete facial paralysis were observed in the 3 groups. There were no significant differences among the 3 groups in the facial nerve functional classification 7 days after the attack, the clinically cured rate of following-up of 6 months and the average cured time (P > 0.05), but the cured time of complete facial paralysis in the group A and the group B were shorter than that in the group C (P < 0.05). The patient of acute Bell's facial paralysis can be treated with acupuncture and moxibustion, and traditional moxibustion can be replaced by far infrared way.

  4. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial.

    PubMed

    Masterson Creber, Ruth; Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-03-01

    Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients' information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

  6. Clinical usefulness of therapeutic concentration monitoring for imatinib dosage individualization: results from a randomized controlled trial.

    PubMed

    Gotta, V; Widmer, N; Decosterd, L A; Chalandon, Y; Heim, D; Gregor, M; Benz, R; Leoncini-Franscini, L; Baerlocher, G M; Duchosal, M A; Csajka, C; Buclin, T

    2014-12-01

    This study assessed whether a cycle of "routine" therapeutic drug monitoring (TDM) for imatinib dosage individualization, targeting an imatinib trough plasma concentration (C min) of 1,000 ng/ml (tolerance: 750-1,500 ng/ml), could improve clinical outcomes in chronic myelogenous leukemia (CML) patients, compared with TDM use only in case of problems ("rescue" TDM). Imatinib concentration monitoring evaluation was a multicenter randomized controlled trial including adult patients in chronic or accelerated phase CML receiving imatinib since less than 5 years. Patients were allocated 1:1 to "routine TDM" or "rescue TDM." The primary endpoint was a combined outcome (failure- and toxicity-free survival with continuation on imatinib) over 1-year follow-up, analyzed in intention-to-treat (ISRCTN31181395). Among 56 patients (55 evaluable), 14/27 (52 %) receiving "routine TDM" remained event-free versus 16/28 (57 %) "rescue TDM" controls (P = 0.69). In the "routine TDM" arm, dosage recommendations were correctly adopted in 14 patients (median C min: 895 ng/ml), who had fewer unfavorable events (28 %) than the 13 not receiving the advised dosage (77 %; P = 0.03; median C min: 648 ng/ml). This first target concentration intervention trial could not formally demonstrate a benefit of "routine TDM" because of small patient number and surprisingly limited prescriber's adherence to dosage recommendations. Favorable outcomes were, however, found in patients actually elected for target dosing. This study thus shows first prospective indication for TDM being a useful tool to guide drug dosage and shift decisions. The study design and analysis provide an interesting paradigm for future randomized TDM trials on targeted anticancer agents.

  7. Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting. Methods and design An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up. Discussion This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS. Trial registration Trial registration number: NTR2575 PMID:21849055

  8. Randomized controlled clinical trial of surgery versus no surgery in patients with mild asymptomatic primary hyperparathyroidism.

    PubMed

    Rao, D Sudhaker; Phillips, Evelyn R; Divine, George W; Talpos, Gary B

    2004-11-01

    Parathyroidectomy is the definitive therapy for patients with symptomatic primary hyperparathyroidism. However, the role of surgery in mild asymptomatic primary hyperparathyroidism remains controversial. Accordingly, we conducted a prospective, randomized, controlled clinical trial of parathyroidectomy to determine the benefits of surgery vs. adverse effects of no surgery. Fifty-three patients were randomly assigned to either parathyroidectomy (n = 25) or regular follow-up (n = 28). Bone mineral density (BMD), biochemical indices of the disease, quality of life, and psychological function were measured at 6- or 12-month intervals for at least 24 months. Twenty-three of the 25 patients randomized to parathyroidectomy had surgery within the specified time of the protocol and three of the 28 patients randomized to regular follow-up had parathyroidectomy during follow-up. After parathyroidectomy, there was an increase in BMD of the spine (1.2%/yr, P < 0.001), femoral neck (0.4%/yr, P = 0.031), total hip (0.3%/yr, P = 0.07), and forearm (0.4%/yr, P < 0.001) and an expected fall in serum total and ionized calcium, serum PTH, and urine calcium (P < 0.001 for all). In contrast, patients followed up without surgery lost BMD at the femoral neck (-0.4%/yr, P = 0.117) and total hip (-0.6%/yr, P = 0.007) but gained at the spine (0.5%/yr; P = ns) and forearm (0.2%/yr, P = 0.047), with no significant changes in biochemical indices of disease. Consequently, a significant effect of parathyroidectomy on BMD was evident only at the femoral neck (a group difference of 0.8%/yr; P = 0.01) and total hip (a group difference of 1.0%/yr; P = 0.001) but not at the spine (a group difference of 0.6%/yr) or forearm (a group difference of 0.2%/yr). Quality-of-life scores as measured by a 36-item short-form health survey showed significant declines in five of the nine domains (social functioning, physical problem, emotional problem, energy, and health perception) in patients followed up without

  9. Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

    PubMed

    Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

    2017-08-01

    Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

  10. [Electromyographic changes in bruxism after auricular stimulation. A randomized controlled clinical trial].

    PubMed

    Romoli, M; Ridi, R; Giommi, A

    2003-08-01

    The aim of this study was to verify in bruxism patients the possible efficacy of auricular stimulation in reducing the hypertonicity of some masticatory muscles. Forty-three bruxism patients were randomly allocated to 3 groups: acupuncture, needle contact for 10 seconds, no treatment (control). Helkimo's clinical dysfunction index (CDI) and anamnestic dysfunction index (ADI) were used to assess the functional state of the masticatory system. The resting electrical activity of the anterior temporalis (AT), masseter (MM), digastric (DA) and sternocleidomastoid (SCM) muscles was measured, according to Jankelson, with surface electrodes at baseline, after stimulation and continually for 30 minutes (120 measurements in total). The electromyographical variations in the 3 groups were studied with t test for independent samples. Acupuncture and needle contact were superior to control in reducing the muscle hypertonicity of all muscles except SCM. In the comparison between acupuncture and needle contact the former showed better results only for the right TA and left DA (p = 0.000). In this study it was possible to measure the efficacy of the stimulation of only one point or area, which is an ideal model for research in acupuncture. The auricular area we chose for stimulation was never used before for the purpose of relaxing masticatory muscles. Acupuncture and needle contact for 10 seconds showed similar effects.

  11. Randomized Controlled Trial of Antiseptic Hand Hygiene Methods in an Outpatient Surgery Clinic.

    PubMed

    Therattil, Paul J; Yueh, Janet H; Kordahi, Anthony M; Cherla, Deepa V; Lee, Edward S; Granick, Mark S

    2015-12-01

    Outpatient wound care plays an integral part in any plastic surgery practice. However, compliance with hand hygiene measures has shown to be low, due to skin irritation and lack of time. The objective of this trial was to determine whether single-use, long-acting antiseptics can be as effective as standard multiple-use hand hygiene methods in an outpatient surgical setting. A prospective, randomized controlled trial was performed in the authors' outpatient plastic surgery clinic at Rutgers New Jersey Medical School, Newark, NJ to compare the efficacy of an ethyl alcohol-based sanitizer (Avagard D Instant Hand Aniseptic, 3M Health Care, St. Paul, MN), a benzalkonium chloride-based sanitizer (Soft & Shield, Bioderm Technologies, Inc, Trenton, NJ, distributed by NAPP Technologies, Hackensack, NJ ), and soap and- water handwashing. Subjects included clinic personnel, who were followed throughout the course of a 3-hour clinic session with hourly hand bacterial counts taken. During the course of the trial, 95 subjects completed the clinic session utilizing 1 of the hand hygiene methods (36 ethyl alcohol-based sanitizer, 38 benzalkonium chloride-based sanitizer, and 21 soap-and-water handwashing). There was no difference between hand bacterial counts using the different methods at 4 hourly time points (P greater than 0.05). Hand bacterial counts increased significantly over the 3-hour clinic session with the ethyl alcohol-based sanitizer (9.24 to 21.90 CFU, P less than 0.05), benzalkonium chloride-based sanitizer (6.69 to 21.59 CFU, P less than 0.05), and soap-and-water handwashing (8.43 to 22.75 CFU, P less than 0.05). There does not appear to be any difference in efficacy between single-use, long-acting sanitizer, and standard multiple-use hand hygiene methods. Hand bacterial counts increased significantly over the course of the 3-hour clinic session regardless of the hand hygiene measure used. Hand condition of subjects was improved with the ethyl alcohol

  12. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

    PubMed Central

    Wiljer, David; Cafazzo, Joseph A

    2016-01-01

    Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study

  13. Effectiveness of bonded and vacuum-formed retainers: A prospective randomized controlled clinical trial.

    PubMed

    O'Rourke, Niamh; Albeedh, Hussein; Sharma, Pratik; Johal, Ama

    2016-09-01

    The objective of this prospective trial was to compare the clinical effectiveness of bonded retainers with vacuum-formed retainers, in terms of maintaining the results of orthodontic treatment in the lower arch up to 18 months post debond. This was a hospital-based, prospective randomized controlled clinical trial in which a total of 82 subjects were randomly allocated using a computer-generated number sequence to 1 of 2 groups, receiving either a vacuum-formed retainer (Essix Ace plastic (120 mm; DENTSPLY Raintree Essix, Sarasota, Fla) or a bonded retainer (0.0175 coaxial archwire (Ortho-Care, UK, Shipley, United Kingdom) bonded in place with Transbond LR (3M United Kingdom, Brachnell, United Kingdom) for the mandibular arch. Each number was placed in an opaque, concealed envelope and chosen randomly by the study subject; this determined the allocation group. Eligibility criteria included patients nearing debond after treatment with 0.022 × 0.028-in slot size preadjusted edgewise fixed orthodontic appliances whose pretreatment records and study models were available to confirm pretreatment labial segment crowding or spacing and who had clinically acceptable alignment at the end of treatment. The main outcome was to investigate the clinical effectiveness of the 2 types of retainers in terms of changes in incisor irregularity at 6 months of retention. The following measurements were recorded at each time point (6, 12, and 18 months) with a digital caliper: Little's irregularity index, intercanine width, intermolar width, arch length, and extraction site opening. Blinding was applicable only at debond because of the permanence of 1 intervention. The 2 groups were well matched with respect to age, sex, clinical characteristics, and treatment plans. There was a statistically significant difference between the groups for changes in Little's irregularity index at 6 months, with the vacuum-formed retainer group showing greater changes than the bonded retainer

  14. Promising New Wart Treatment: A Randomized, Placebo-Controlled, Clinical Trial

    PubMed Central

    Zandi, Shokrollah; Ahmad Zadeh, Razyeh; Yousefi, Sayedeh Reyhaneh; Gharibi, Fardin

    2016-01-01

    Background Warts are common dermatological lesion caused by skin epithelial cells’ infection with human Papillomavirus (HPV). Objectives This study aimed to assess the efficacy of a new method for the treatment of dermal warts. Patients and Methods In this clinical trial study, 60 patients (older than 10 years) with dermal warts living in Baneh city, west of Iran, were allocated into the intervention and control groups using the block randomized method in 2012. In the intervention group, outer layers of the dermal wart carved using scalpel and HD tablet set on it and covered with adhesive. In the second and third days, it was repeated again. All stages in the intervention group were similar to the placebo group. Placebo was prepared by a pharmacologist, which was similar to the HD tablet. In both groups, patients were examined one week and one month after taking the last tablet by the physician in terms of improvement or lack of improvement. Data were analyzed by SPSS software version 18 using chi-square test, Fisher’s exact test, Mann-Whitney test and ANOVA for repeated measures. Results In the first week after the intervention, warts were changed in 93.3% of the cases; however, no changes were recorded in the control group. One month after follow-up, the mean was 0.4 ± 0.7 in the intervention group and 5.5 ± 4.9 in the control group (P = 0.0001). Based on ANOVA for repeated measures and t-test, the average number of warts, before, one week and one month after the intervention was statistically significant for both intervention (P = 0.009) and control groups (P = 0.0001). Conclusions This method is recommended for the treatment of dermal warts, owing to the effectiveness, short duration of treatment, and low cost of topical treatment for dermal warts using HD tablets. PMID:27761268

  15. Promising New Wart Treatment: A Randomized, Placebo-Controlled, Clinical Trial.

    PubMed

    Zandi, Shokrollah; Ahmad Zadeh, Razyeh; Yousefi, Sayedeh Reyhaneh; Gharibi, Fardin

    2016-08-01

    Warts are common dermatological lesion caused by skin epithelial cells' infection with human Papillomavirus (HPV). This study aimed to assess the efficacy of a new method for the treatment of dermal warts. In this clinical trial study, 60 patients (older than 10 years) with dermal warts living in Baneh city, west of Iran, were allocated into the intervention and control groups using the block randomized method in 2012. In the intervention group, outer layers of the dermal wart carved using scalpel and HD tablet set on it and covered with adhesive. In the second and third days, it was repeated again. All stages in the intervention group were similar to the placebo group. Placebo was prepared by a pharmacologist, which was similar to the HD tablet. In both groups, patients were examined one week and one month after taking the last tablet by the physician in terms of improvement or lack of improvement. Data were analyzed by SPSS software version 18 using chi-square test, Fisher's exact test, Mann-Whitney test and ANOVA for repeated measures. In the first week after the intervention, warts were changed in 93.3% of the cases; however, no changes were recorded in the control group. One month after follow-up, the mean was 0.4 ± 0.7 in the intervention group and 5.5 ± 4.9 in the control group (P = 0.0001). Based on ANOVA for repeated measures and t-test, the average number of warts, before, one week and one month after the intervention was statistically significant for both intervention (P = 0.009) and control groups (P = 0.0001). This method is recommended for the treatment of dermal warts, owing to the effectiveness, short duration of treatment, and low cost of topical treatment for dermal warts using HD tablets.

  16. Diuretics vs. placebo for postpartum blood pressure control in preeclampsia (DIUPRE): a randomized clinical trial.

    PubMed

    Cursino, Telma; Katz, Leila; Coutinho, Isabela; Amorim, Melania

    2015-08-05

    Hypertension affects about 10% of pregnancies and is responsible for both maternal and neonatal devastating complications such as eclampsia, HELLP syndrome, prematurity and maternal and neonatal death. The resolution of the disease occurs in the first twelve weeks postpartum. The behavior of blood pressure and occurrence of very high blood pressure episodes among women with severe preeclampsia is related to remodeling of the dynamics of body fluids with consequent increase in intravascular volume. The persistence of hypertension in critical levels results in increased puerperal morbidity. To evaluate the effectiveness of furosemide in accelerating blood pressure recovery among women with severe preeclampsia. A triple-masked placebo controlled clinical trial, will be conducted including 120 postpartum women with severe preeclampsia, after eclampsia prophylaxis with magnesium sulfate and with adequate diuresis. Women with chronic hypertension and users of diuretics will be deleted. Informed consent will be obtained from all participants. Patients will be randomized to receive furosemide (40 mg orally every twenty four hours) or placebo. The variables are systolic and diastolic blood pressure, frequency of hypertensive crises, need for maintenance of antihypertensive therapy, number of antihypertensive agents used to control blood pressure, urine output, length of hospital stay, adverse effects and maternal complications. This study was approved by the Research Ethics Committee in humans of our institution. All participants will be duly informed about the aims of the project and will be included only if they agree to participate voluntarily, signing the informed consent. This study was registered on Clinical Trials.gov under the number NCT02163655. ( http://clinicaltrials.gov/show/NCT02163655).

  17. Recruiting to Clinical Trials on the Telephone - a randomized controlled trial.

    PubMed

    Foss, Kim Thestrup; Kjærgaard, Jesper; Stensballe, Lone Graff; Greisen, Gorm

    2016-11-21

    Informed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done. We examined the use of the telephone for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent Form. Two to 4 weeks later we contacted the mothers to discuss potential participation in the present trial. At this initial telephone contact, and after consent from the mothers, we randomized expectant mothers to receive the verbal information about The Danish Calmette Study by telephone, or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about The Danish Calmette Study and satisfaction with the information process. The outcome was measured using a questionnaire 2 days after the information was provided, and 2.5 months after the birth of the child. The communication score obtained 2 days after information was given was significantly reduced in the telephone group, effect size -0.74 (95% confidence interval (CI), -1.11 to -0.36). The effect sizes of the subscores were -0.87 (95% CI, -1.25 to -0.49) for satisfaction and -0.22 (95% CI, -0.58 to 0.14) for comprehension. The effect sizes were slightly reduced when assessed 2.5 months after the birth. The communication score was reduced in the telephone group. This was due to a reduction in satisfaction, while no difference in the comprehension could be found in comparison to the control group. This may be ethically acceptable as both groups had high satisfaction scores. ClinicalTrials.gov, registered on 5 October 2015 with trial registration number NCT

  18. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial.

    PubMed

    Mummaneni, Praveen V; Burkus, J Kenneth; Haid, Regis W; Traynelis, Vincent C; Zdeblick, Thomas A

    2007-03-01

    The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD). Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees. In the investigational group, there were no cases of implant failure or migration. The PRESTIGE ST Cervical Disc System maintained

  19. Clinical evaluation of Nigella sativa seeds for the treatment of hyperlipidemia: a randomized, placebo controlled clinical trial.

    PubMed

    Sabzghabaee, Ali Mohammad; Dianatkhah, Mehrnoush; Sarrafzadegan, Nizal; Asgary, Sedigheh; Ghannadi, Alireza

    2012-01-01

    Natural products are proved to play a good role as an alternative to synthetic chemicals in many clinical conditions. Hypercholesterolemia is the most important risk factor for atherosclerosis. Previous studies showed that Nigella sativa L. has both antioxidant and lipid lowering potentials. To evaluate the efficacy of the seeds of Nigella sativa on the treatment of hyperlipidemia. In this randomized, placebo controlled clinical trial which was conducted in Isfahan city (Iran), 88 subjects aged > or =18 years with a total cholesterol concentration >200 mg/dl were included. According to the patients" profiles number, they were randomized to receive either N. sativa capsules or the matching placebo. Each N sativa capsule contained 500 +/- 10 mg N. sativa crushed seeds, and patients had to take 2 g N. sativa per day for 4 weeks. Fasting baseline laboratory values (fasting blood sugar, total cholesterol, low density lipoprotein, high density lipoprotein and triglyceride) were obtained for all parameters on each subject prior to the start of the study and at the end of 4 weeks. In our study a significant decrease was observed in the concentration of total cholesterol (4.78%), Low density lipoprotein (7.6%) and Triglyceride (16.65%), and this decrease was more significant for TG concentration. N. sativa had not any beneficial effects on Fasting blood sugar and High density lipoprotein. According to the results of our present study it seems that N. sativa may have some beneficial therapeutic effects in the treatment of hyperlipidemia. However, further investigations with a larger sample size are necessary.

  20. Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial.

    PubMed

    Imamura, Marta; Imamura, Satiko Tomikawa; Targino, Rosa Alves; Morales-Quezada, León; Onoda Tomikawa, Luis C; Onoda Tomikawa, Luis G; Alfieri, Fabio M; Filippo, Thais R; da Rocha, Ivan D; Neto, Raul Bolliger; Fregni, Felipe; Battistella, Linamara Rizzo

    2016-05-01

    In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization. NCT02387567. There are few data to support paraspinous lidocaine injection use in patients with nonspecific chronic low back pain. Our results show that this therapy when combined with standard therapy significantly increases the number of responders versus standard treatment alone. Its effects on hyperalgesia might correlate with a change in central sensitization. Copyright © 2016. Published by Elsevier Inc.

  1. Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial.

    PubMed

    Carney, Colleen E; Edinger, Jack D; Kuchibhatla, Maragatha; Lachowski, Angela M; Bogouslavsky, Olya; Krystal, Andrew D; Shapiro, Colin M

    2017-04-01

    To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. A blinded, randomized split-plot experimental study. Two urban academic clinical centers. 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH's sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of

  2. Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

    PubMed

    Summers, C Gail; Connett, John E; Holleschau, Ann M; Anderson, Jennifer L; De Becker, Inge; McKay, Brian S; Brilliant, Murray H

    2014-11-01

    Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism. Prospective, randomized, placebo-controlled, double-masked clinical trial conducted at the University of Minnesota. Forty-five subjects with albinism. Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76 mg/kg with 25% carbidopa, levodopa 0.51 mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side-effects were recorded with a symptom survey. Blood was drawn for genotyping. Side-effects and best-corrected visual acuity 20 weeks after enrolment. All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow up was 100% and compliance was good. Minor side-effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa. Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism. © 2014 Royal Australian and New Zealand College of Ophthalmologists.

  3. Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial.

    PubMed

    Gross, Cynthia R; Kreitzer, Mary Jo; Reilly-Spong, Maryanne; Wall, Melanie; Winbush, Nicole Y; Patterson, Robert; Mahowald, Mark; Cramer-Bornemann, Michel

    2011-01-01

    The aim of this study was to investigate the potential of mindfulness-based stress reduction (MBSR) as a treatment for chronic primary insomnia. A randomized controlled trial was conducted. The study was conducted at a university health center. Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, Text Revision, 4th Edition were randomized 2:1 to MBSR or pharmacotherapy (PCT). Mindfulness-based stress reduction, a program of mindfulness meditation training consisting of eight weekly 2.5 hour classes and a daylong retreat, was provided, with ongoing home meditation practice expectations during three-month follow-up; PCT, consisting of three milligrams of eszopiclone (LUNESTA) nightly for eight weeks, followed by three months of use as needed. A 10-minute sleep hygiene presentation was included in both interventions. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diaries, and wrist actigraphy were collected pretreatment, posttreatment (eight weeks), and at five months (self-reports only). Between baseline and eight weeks, sleep onset latency (SOL) measured by actigraphy decreased 8.9 minutes in the MBSR arm (P < .05). Large, significant improvements were found on the ISI, PSQI, and diary-measured total sleep time, SOL, and sleep efficiency (P < .01, all) from baseline to five-month follow-up in the MBSR arm. Changes of comparable magnitude were found in the PCT arm. Twenty-seven of 30 patients completed their assigned treatment. This study provides initial evidence for the efficacy of MBSR as a viable treatment for chronic insomnia as measured by sleep diary, actigraphy, well-validated sleep scales, and measures of remission and clinical recovery. Copyright © 2011 Elsevier Inc. All rights reserved.

  4. Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial

    PubMed Central

    Ang, Dennis C.; Hilligoss, Janna; Stump, Timothy

    2014-01-01

    Objectives Compared to healthy controls, patients with fibromyalgia (FM) have more mast cells in the skin. Whether mast cells are involved in the pathogenesis of FM is unclear. We sought to determine the effects of a mast cell stabilizer (ketotifen) on FM symptoms. Methods Fifty-one FM subjects were randomized to daily oral ketotifen 2 mg BID (n=24) for 8 weeks or placebo (N=27). Mean age of subjects was 51.2 years (standard deviation/SD 8.4); 88% were female and 88% were white; 22% were taking concomitant opiates; and mean pressure pain sensitivity (range 0-20) was 10.0 (0.4). At study entry, the weekly average pain intensity was 6.4 (1.1) and the mean score on the Revised Fibromyalgia Impact Questionnaire (FIQR) was 66.8 (14.0). Results We found no statistically significant treatment group differences from baseline in either group for the two primary measures: weekly average pain intensity [ketotifen −1.3 (1.9) vs. placebo −1.5 (1.9), p=0.7]; and FIQR score [−12.1 (19.5) vs. −12.2 (18.1), p=0.9]. No secondary outcome measures (BPI pain intensity, and pressure pain sensitivity) reached statistical significance; results did not differ in the intent-to-treat and completer analyses. Other than transient sedation [6 (28.6%) vs. 1 (4.0%)], ketotifen was well tolerated. Discussion The study results question whether skin mast cells play a major role in the pathogenesis of FM. However, given the role of mast cells in peripheral and central nociception, and the minimal side effects of ketotifen, a randomized clinical trial using increasing doses of ketotifen may be warranted. PMID:25370135

  5. A Strategy to Use Soft Data Effectively in Randomized Controlled Clinical Trials.

    ERIC Educational Resources Information Center

    Kraemer, Helena Chmura; Thiemann, Sue

    1989-01-01

    Sees soft data, measures having substantial intrasubject variability due to errors of measurement or response inconsistency, as important measures of response in randomized clinical trials. Shows that using intensive design and slope of response on time as outcome measure maximizes sample retention and decreases within-group variability, thus…

  6. Effects of Normobaric Hyperoxia in Traumatic Brain Injury: A Randomized Controlled Clinical Trial

    PubMed Central

    Taher, Abbas; Pilehvari, Zahra; Poorolajal, Jalal; Aghajanloo, Mashhood

    2016-01-01

    Background Traumatic brain injury (TBI) is one of the important causes of morbidity and mortality throughout the world, especially in young people. In recent years normobaric hyperoxia has become an important and useful step for recovery and improvement of outcome in TBI. Objectives The purpose of this study was to evaluate the effects of normobaric hyperoxia on clinical neurological outcomes of patients with severe traumatic brain injuries. We used the Glasgow outcome scale (GOS), barthel index, and modified rankin scale (mRS) to measure the outcomes of patients with TBI. Patients and Methods Sixty-eight consecutive patients with severe TBI (mean Glasgow coma scale [GCS] score: 7.4) who met the inclusion criteria were entered in this randomized controlled clinical trial. The patients were randomized into two groups, as follows: 1) experimental: received 80% oxygen via mechanical ventilator in the first 6 hours of admission, 2) control: received 50% oxygen by mechanical ventilator in the first 6 hours of admission and then standard medical care. We measured the GOS, Barthel Index, and mRS at the time of discharge from hospital and reassessed these measurements at the 6-month follow-up after injury. Results According to our study, there were no significant sex or age differences between the two groups (P = 0.595 and 0.074). The number of days in the intensive care unit (ICU) in the control group and experimental group were 11.4 and 9.4 days, respectively (P = 0.28), while the numbers of days of general ward admission were 13.9 and 11.4 days (P = 0.137) respectively. The status of GOS at time of discharge were severe = 13 and 10, moderate = 16 and 19, and low = 5 and 5 in the control and experimental groups, respectively (P = 0.723); 6 months after injury, the scores were as follows: moderate = 16 and 9, low = 15 and 25, and severe = 3 and 0 (P = 0.024). The Barthel index scores in the control and experimental groups were 59.7 and 63.9 at time of discharge (P = 0

  7. Does waterfall aerosol influence mucosal immunity and chronic stress? A randomized controlled clinical trial.

    PubMed

    Grafetstätter, Carina; Gaisberger, Martin; Prossegger, Johanna; Ritter, Markus; Kolarž, Predrag; Pichler, Christina; Thalhamer, Josef; Hartl, Arnulf

    2017-01-13

    The specific microclimate of alpine waterfalls with high levels of ionized water aerosols has been suggested to trigger beneficial immunological and psychological effects. In the present three-armed randomized controlled clinical study, we focused on effects on (i) immunological reagibility, on (ii) physiological stress responses, and on (iii) stress-related psychological parameters. People with moderate to high stress levels (n = 65) spent an active sojourn with daily hiking tours in the National Park Hohe Tauern (Großkirchheim, Austria). Half of the group was exposed to water aerosol of an alpine waterfall for 1 h/day (first arm, n = 33), whereas the other half spent the same time at a distant site (second arm, n = 32). A third arm (control, n = 26) had no intervention (except vaccination) and stayed at home, maintaining their usual lifestyle. The effect of the interventions on the immune system was tested by oral vaccination with an approved cholera vaccine and measuring specific salivary IgA antibody titers. Lung function was determined by peak expiratory flow measurement. Electric skin conductance, heart rate, and adaption of respiration rate were assessed as physiological stress parameters. Psychological stress-related parameters were analyzed by questionnaires and scales. Compared to the control group, both intervention groups showed improvement of the lung function and of most physiological stress test parameters. Analysis of the mucosal immune response revealed a waterfall-specific beneficial effect with elevated IgA titers in the waterfall group. In line with these results, exposure to waterfall revealed an additional benefit concerning psychological parameters such as subjective stress perception (measured via visual analog scale), the Global Severity Index (GSI), and the Positive Symptom Total (PST). Our study provides new data, which strongly support an "added value" of exposure to waterfall microclimate when combined with a

  8. Effects of Inspiratory Muscle Training in Subjects With Sarcoidosis: A Randomized Controlled Clinical Trial.

    PubMed

    Karadallı, Müşerrefe Nur; Boşnak-Güçlü, Meral; Camcıoğlu, Burcu; Kokturk, Nurdan; Türktaş, Haluk

    2016-04-01

    Respiratory muscle weakness occurs in sarcoidosis and is related to decreased exercise capacity, greater fatigue, dyspnea, and lower quality of life in sarcoidosis patients. The effects of inspiratory muscle training in this population have not been comprehensively investigated so far. This study was planned to investigate the effects of inspiratory muscle training on exercise capacity, respiratory and peripheral muscle strength, pulmonary function and diffusing capacity, fatigue, dyspnea, depression, and quality of life in subjects with sarcoidosis. This was a prospective, randomized, controlled, and double blind study. Fifteen sarcoidosis subjects (treatment group) received inspiratory muscle training at 40% of maximal inspiratory pressure (P(Imax)), and 15 subjects (control group) received sham therapy (5% of P(Imax)) for 6 weeks. Functional and maximal exercise capacity, respiratory and peripheral muscle strength, pulmonary function and diffusing capacity, fatigue, dyspnea, depression, and quality of life were evaluated. Functional (P < .001) and maximal exercise capacity (P = .038), respiratory muscle strength (P(Imax) [P < .001] and P(Emax) [P = .001]), severe fatigue (P = .002), and dyspnea perception (P = .02) were statistically significantly improved in the treatment group compared with controls; no significant improvements were observed in pulmonary function and diffusing capacity, peripheral muscle strength, fatigue, depression, and quality of life between groups after inspiratory muscle training. Inspiratory muscle training improves functional and maximal exercise capacity and respiratory muscle strength and decreases severe fatigue and dyspnea perception in subjects with early stages of sarcoidosis. Inspiratory muscle training can be safely and effectively included in rehabilitation programs. (ClinicalTrials.gov registration NCT02270333.). Copyright © 2016 by Daedalus Enterprises.

  9. Nurse-Driven Clinical Pathway for Inpatient Asthma: A Randomized Controlled Trial.

    PubMed

    Pound, Catherine M; Gelt, Victoria; Akiki, Salwa; Eady, Kaylee; Moreau, Katherine; Momoli, Franco; Murchison, Barbara; Zemek, Roger; Mulholland, Brett; Kovesi, Tom

    2017-04-01

    We examined the impact of a nurse-driven clinical pathway on length of stay (LOS) for children hospitalized with asthma. We conducted a randomized controlled trial involving children hospitalized with asthma. Nurses of children in the intervention group weaned salbutamol frequency using an asthma scoring tool, whereas physicians weaned salbutamol frequency for the control group patients as per standard care. The primary outcome was LOS in hours. Secondary outcomes included number of salbutamol treatments administered, ICU transfers, unplanned medical visits postdischarge, and stakeholders' pathway satisfaction. Research staff, investigators, and statisticians were blinded to group assignment, except for research assistants enrolling participants. Qualitative interviews were done to assess acceptability of intervention by physicians, nurses, residents, and patients. We recruited 113 participants (mean age 4.9 years, 62% boys) between May 2012 and September 2015. Median LOS was 49 hours (21-243 hours) and 47 hours (22-188 hours) (P = .11), for the control and intervention groups, respectively. A post hoc analysis designed to deal with highly skewed LOS data resulted in a relative 18% (95% confidence interval 0.68-0.99) LOS reduction for the intervention group. There was no difference in secondary outcomes. No significant adverse events resulted from the intervention. The 14 participants included in the qualitative component reported a positive experience with the pathway. This nurse-driven pathway led to increased efficiency as evidenced by a modest LOS reduction. It allowed for care standardization, improved utilization of nursing resources, and high stakeholder satisfaction. Copyright © 2017 by the American Academy of Pediatrics.

  10. All-ceramic restoration of zirconia two-piece implants--a randomized controlled clinical trial.

    PubMed

    Payer, Michael; Heschl, Alexander; Koller, Martin; Arnetzl, Gerwin; Lorenzoni, Martin; Jakse, Norbert

    2015-04-01

    Aim of this controlled prospective randomized study was to evaluate the outcome of two-piece zirconia implants compared to titanium implants over a period of up to 24 months. A total of 31 implants (16 zirconia/Ziterion vario Z(®) + 15 titanium/Ziterion vario T(®) ) were inserted primary stable (>30 Ncm) in the maxilla (7) and mandible (24) of 22 patients (13 male, nine female) requiring neither bone nor soft tissue augmentation. After a healing period of 6 months in the maxilla and 4 months in the mandible, ceramic abutments were luted adhesively to the zirconia implants and definitive all-ceramic restoration was performed with high-density ceramics. Radiographic bone levels, condition of the peri-implant mucosa, aesthetic outcome, implant survival and success were recorded for up to 24 months. Measurements of mean marginal bone levels 24 months after surgery showed a significant bone loss (P < 0.001) in both groups (Ti: 1.43 (SD ± 0.67) vs. Zir 1.48 (SD ± 1.05). One zirconia implant was lost 8 months after restoration. No further complications were recorded, giving an overall survival and success rate of 93.3% for zirconia and 100% for titanium implants after a period of up to 24 months. After 24 months, success rates of the two-piece ceramic implants showed no significant difference compared to control two-piece titanium implants. The bonded zirconia implant abutment connection appears to be capable with clinical application over the observed period. However, further control measurements need to confirm the presented data. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study

    PubMed Central

    Roshdy, Eman; Rajaratnam, Veera; Maitra, Sarbani; Sabry, Mohamed; Allah, Abdou S Ait; Al-Hendy, Ayman

    2013-01-01

    Background Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF. Objectives To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial. Methods A total of 39 reproductive-age women (age 18–50 years, day 3 serum follicle-stimulating hormone <10 \\U/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm3 or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student’s t-test was used to evaluate statistical significance of treatment effect between the two groups. Results Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss

  12. In vivo assessment of Ectoin: a randomized, vehicle-controlled clinical trial.

    PubMed

    Heinrich, U; Garbe, B; Tronnier, H

    2007-01-01

    The aim of the study was to assess an Ectoin formulation with regard to the antiageing properties. The study was designed as a monocentric, randomized, double-blind application test, in order to ensure the compatibility and the efficacy of Ectoin in comparison to a vehicle emulsion. A total of 104 voluntary healthy female test subjects were included in the study. Moisturizing properties as well as other parameters of skin ageing, like skin surface structure and skin elasticity, were determined for treatment A (vehicle) and treatment B (with 2% Ectoin) versus an untreated control. Statistical evaluations according to the Wilcoxon rank-sum test indicate a general preference for the Ectoin treatment by the test subjects in both the application and the efficacy tests. None of the participating test subjects had any side effects throughout the study. In terms of antiageing properties, previous in vitro studies could be confirmed by this clinical trial, clarifying that the natural cell protection concept of Ectoin is transferable to skin care with manifold benefits.

  13. Oral Midazolam for Voiding Dysfunction in Children Undergoing Voiding Cystourethrography: A Controlled Randomized Clinical Trial

    PubMed Central

    Azarfar, Anoush; Esmaeeili, Mohammad; Farrokh, Azadeh; Alamdaran, Ali; Keykhosravi, Aghilallah; Neamatshahi, Mahboobe; Hebrani, Alireza; Ravanshad, Yalda

    2014-01-01

    Background: Voiding Cystourethrography (VCUG) is the gold standard of detecting and grading the vesicoureteral reflux. Moreover, VCUG is a part of the standard review for infants and children with a urinary tract infection and urinary dysfunction. Objectives: The purpose of our study was to compare using oral midazolam in contrast to prescribing no sedative medication for voiding dysfunction in children undergoing VCUG. Patients and Methods: In a clinical trial, we studied 84 children referred for VCUG. Children were allocated randomly into two equal groups. The intervention group received 0.5 mg/kg midazolam orally half an hour before the VCUG procedure. Then both groups were compared using statistical methods. Results: Then both groups were compared using statistical methods. In more than half of the patients, the main cause of performing VCUG was urinary tract infection. Dysuria was evaluated immediately after VCUG and was more frequent in girls than in boys (P = 0.006). After one week, the urinary irritation and restlessness in the intervention group was significantly lower than the control group. Conclusion: The use of midazolam 0.5 mg/kg reduced children's stress and increased their cooperation during the procedure. PMID:25032141

  14. Periodontal Tissue Regeneration Using Fibroblast Growth Factor -2: Randomized Controlled Phase II Clinical Trial

    PubMed Central

    Kitamura, Masahiro; Nakashima, Keisuke; Kowashi, Yusuke; Fujii, Takeo; Shimauchi, Hidetoshi; Sasano, Takashi; Furuuchi, Toshi; Fukuda, Mitsuo; Noguchi, Toshihide; Shibutani, Toshiaki; Iwayama, Yukio; Takashiba, Shogo; Kurihara, Hidemi; Ninomiya, Masami; Kido, Jun-ichi; Nagata, Toshihiko; Hamachi, Takafumi; Maeda, Katsumasa; Hara, Yoshitaka; Izumi, Yuichi; Hirofuji, Takao; Imai, Enyu; Omae, Masatoshi; Watanuki, Mitsuru; Murakami, Shinya

    2008-01-01

    Background The options for medical use of signaling molecules as stimulators of tissue regeneration are currently limited. Preclinical evidence suggests that fibroblast growth factor (FGF)-2 can promote periodontal regeneration. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation. Methodology/Principal Findings We used recombinant human FGF-2 with 3% hydroxypropylcellulose (HPC) as vehicle and conducted a randomized double-blinded controlled trial involving 13 facilities. Subjects comprised 74 patients displaying a 2- or 3-walled vertical bone defect as measured ≥3 mm apical to the bone crest. Patients were randomly assigned to 4 groups: Group P, given HPC with no FGF-2; Group L, given HPC containing 0.03% FGF-2; Group M, given HPC containing 0.1% FGF-2; and Group H, given HPC containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 µL of the appropriate investigational drug to the bone defect. Before and for 36 weeks following administration, patients underwent periodontal tissue inspections and standardized radiography of the region under investigation. As a result, a significant difference (p = 0.021) in rate of increase in alveolar bone height was identified between Group P (23.92%) and Group H (58.62%) at 36 weeks. The linear increase in alveolar bone height at 36 weeks in Group P and H was 0.95 mm and 1.85 mm, respectively (p = 0.132). No serious adverse events attributable to the investigational drug were identified. Conclusions Although no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for FGF-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of

  15. Effectiveness of treadmill training on balance control in elderly people: a randomized controlled clinical trial.

    PubMed

    Pirouzi, Soraya; Motealleh, Ali Reza; Fallahzadeh, Fatemeh; Fallahzadeh, Mohammad Amin

    2014-11-01

    Physical exercise would improve postural stability, which is an essential factor in preventing accidental fall among the elderly population. The aim of this study is to examine the effectiveness of treadmill walking on balance improvement among the elderly people. A total of 30 community dwelling older adults with a Berg Balance Scale score of 36-48 and the ability to walk without aid were considered and divided into control (n=15) and experimental (n=15) groups. Individuals in the experimental group participated in 30 minutes of forward and backward treadmill training based on three times a week interval for a period of four weeks. Individuals in the control group were instructed to continue with their daily routine activity. Before and after training, gait speed was measured by six-minute walk test and balance ability was evaluated by Fullerton Advanced Balance Scale (FABS) and Berg Balance Scale (BBS) tests. Postural sway items such as the Center of Pressure (COP), average displacement and velocity were evaluated by using a force platform system. Data were collected in quiet standing, tandem position and standing on foam pads before and after intervention. After intervention, balance variables in the experimental group indicated a significant improvement in quiet standing on firm and foam surfaces, but no considerable improvement was shown in tandem position. A between-group comparison showed a significant reduction in COP velocity in the sagittal plane (P=0.030) during quiet standing and in the frontal plane (P=0.001) during standing on foam, whereas no significant reduction in COP parameters during tandem position was found. It is recommended that twelve sessions of forward and backward treadmill walk are effective in balance improvement in elderly people. IRCT201209199440N2.

  16. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    PubMed Central

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  17. Hyperproteic hypocaloric enteral nutrition in the critically ill patient: A randomized controlled clinical trial

    PubMed Central

    Rugeles, Saúl-Javier; Rueda, Juan-David; Díaz, Carlos-Eduardo; Rosselli, Diego

    2013-01-01

    Introduction: Our aim was to evaluate the impact of hyperproteic hypocaloric enteral feeding on clinical outcomes in critically ill patients, particularly on severity of organic failure measured with the Sequential Organ Failure Assessment (SOFA). Materials and Methods: In a double blind clinical trial, 80 critically ill adult patients were randomized to hyperproteic hypocaloric or to isocaloric enteral nutrition; all patients completed follow-up of at least 4 days. Prescribed caloric intake was: Hyperproteic hypocaloric enteral nutrition (15 kcal/kg with 1.7 g/kg of protein) or isocaloric enteral nutrition (25 kcal/kg with 20% of the calories as protein). The main outcome was the differences in delta SOFA at 48 h. Secondary outcomes were intensive care unit (ICU) length of stay, days on ventilator, hyperglycemic events, and insulin requirements. Results: There were no differences in SOFA score at baseline (7.5 (standard deviation (SD) 2.9) vs 6.7 (SD 2.5) P = 0.17). The total amount of calories delivered was similarly low in both groups (12 kcal/kg in intervention group vs 14 kcal/kg in controls), but proteic delivery was significantly different (1.4 vs 0.76 g/kg, respectively P ≤ 0.0001). The intervention group showed an improvement in SOFA score at 48 h (delta SOFA 1.7 (SD 1.9) vs 0.7 (SD 2.8) P = 0.04) and less hyperglycemic episodes per day (1.0 (SD 1.3) vs 1.7 (SD 2.5) P = 0.017). Discussion: Enteral hyperproteic hypocaloric nutrition therapy could be associated with a decrease in multiple organ failure measured with SOFA score. We also found decreased hyperglycemia and a trend towards less mechanical ventilation days and ICU length of stay. PMID:24501485

  18. Randomized controlled clinical trial of 2 types of hydroxyapatite-coated implants on moderate periodontitis patients

    PubMed Central

    2016-01-01

    Purpose The aim of this study was to compare and analyze the peri-implant tissue conditions and prospective clinical outcomes associated with 2 types of hydroxyapatite (HA)-coated implants: (1) fully HA-coated implants and (2) partially HA-coated implants with resorbable blast medium on the coronal portion of the threads. Methods Forty-four partially edentulous patients were randomly assigned to undergo the placement of 62 HA-coated implants, and were classified as the control group (partially HA-coated, n=30) and the test group (fully HA-coated, n=32). All patients had chronic periodontitis with moderate crestal bone loss around the edentulous area. The stability and clinical outcomes of the implants were evaluated using the primary and secondary implant stability quotient (ISQ), as well as radiographic, mobility, and peri-implant soft tissue assessments around the implants. The Wilcoxon signed-rank test and the Mann-Whitney test were used to evaluate differences between and within the 2 groups, with P values <0.05 considered to indicate statistical significance. Results The fully HA-coated implants displayed good retention of crestal bone, and insignificant differences were found in annual marginal bone loss between the 2 types of HA-coated implants (P>0.05). No significant differences were found in the survival rate (group I, 100%; group II, 100%) or the success rate (group I, 93.3%; group II, 93.8%). The fully HA-coated implants also did not significantly increase the risk of peri-implantitis (P>0.05). Conclusions The fully HA-coated implants did not lead to an increased risk of peri-implantitis and showed good retention of the crestal bone, as well as good survival and success rates. Our study suggests that fully HA-coated implants could become a reliable treatment alternative for edentulous posterior sites and are capable of providing good retention of the crestal bone. PMID:27800216

  19. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.

    PubMed

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients.

  20. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial.

    PubMed

    Al-Khotani, Amal; Bello, Lanre A'aziz; Christidis, Nikolaos

    2016-08-01

    Dental anxiety leads to undesirable distresses such as avoidance of dental treatment and increase stress among caregivers that consequently affect the treatment quality. The aim of this study was therefore to evaluate the effectiveness of viewing videotaped cartoons using an eyeglass system (i-theatre™) as an audiovisual (AV) distraction technique on behaviour and anxiety in children receiving dental restorative treatment. Fifty-six consecutive children patients who presented for treatment and met inclusion criteria were included and randomly divided into two groups; a control group without distraction (CTR-group) and a distraction-group (AV-group). Three dental treatment visits were provided for each patient. Anxiety and cooperative behaviour were assessed with the Facial Image Scale (FIS) and the Modified Venham's clinical ratings of anxiety and cooperative behaviour scale (MVARS). The vital signs, blood pressure and pulse were also taken. The AV-group showed significantly lower MVARS scores than the CTR-group (p = 0.029), and the scores decreased significantly during treatment in the AV-group (p = 0.04). Further, the pulse rate was significantly increased in the CTR-group during injection with local anaesthesia (p = 0.02), but not in the AV-group. AV distraction seems to be an effective method in reducing fear and anxiety in children during dental treatment. Further, children who used eyeglass goggle display as a distraction tool during dental treatment reported not only less anxiety than control groups but also showed more positive responses after injection with local anaesthesia. Hence, AV-distraction seems to be a useful tool to decrease the distress and dental anxiety during dental treatment.

  1. A Randomized Controlled Clinical Trial to Evaluate Extrinsic Stain Removal of a Whitening Dentifrice.

    PubMed

    Terézhalmy, Géza; He, Tao; Anastasia, Mary Kay; Eusebio, Rachelle

    2016-12-01

    To evaluate the extrinsic stain removal efficacy of a new whitening dentifrice containing sodium hexametaphosphate (SHMP) over a two-week period. This study used a controlled and randomized, examiner-blind, single-center, two-treatment, parallel group design. Subjects with visible extrinsic dental stain on facial surfaces of their anterior teeth, and meeting all study criteria, were entered into the trial. The test group received the whitening dentifrice with sodium fluoride and SHMP and an ADA reference soft manual toothbrush. Subjects in the control group received a dental prophylaxis after the initial examination at Baseline and were instructed to use their usual oral hygiene products at home. Subjects returned at Day 3 and Week 2 for re-evaluation of extrinsic dental stain. Extrinsic stain was measured using the Interproximal Modified Lobene (IML) Stain Index; safety was assessed based on clinical examination. Fifty subjects (mean age 32.0 years) completed the study, with 25 in each group. Statistically significant reductions in composite stain for whole tooth, as well as interproximal, gingival, and body surfaces were observed for both groups at Day 3 and Week 2 (p < 0.0001) with no significant differences between the two groups (p > 0.3). At Day 3, median percent reductions in composite IML stain from Baseline were 98% for the prophylaxis group and 100% for the test dentifrice group. At Week 2, median percent reductions in composite IML stain were 100% compared to Baseline for both groups. No adverse events were reported for either group. The whitening dentifrice demonstrated a statistically significant reduction in IML stain after three days and two weeks of use relative to baseline. Stain reduction with the toothpaste was comparable to a dental prophylaxis.

  2. Effect of nonsurgical periodontal therapy and strict plaque control on preterm/low birth weight: a randomized controlled clinical trial.

    PubMed

    Weidlich, Patricia; Moreira, Carlos Heitor C; Fiorini, Tiago; Musskopf, Marta L; da Rocha, José M; Oppermann, Maria Lucia R; Aass, Anne M; Gjermo, Per; Susin, Cristiano; Rösing, Cassiano K; Oppermann, Rui V

    2013-01-01

    This randomized controlled clinical trial was carried out to assess the effect of comprehensive nonsurgical periodontal treatment and strict plaque control performed during pregnancy on the reduction of preterm and/or low birth weight rates (PTLBW). Three hundred and three women were randomly allocated to receive periodontal treatment either during pregnancy (n = 147, test group) or after delivery (n = 156, control group). During pregnancy, the control group received only one session of supragingival scaling and oral hygiene instruction. In contrast, the test group received comprehensive periodontal treatment including multiple sessions of scaling and root planing, oral hygiene instructions, and frequent maintenance visits. At baseline, periodontal inflammation was observed in approximately 50% of sites and attachment loss affected <15% of sites. Compared to controls, women in the test group had significant reductions in the percentage of sites with plaque (48.5% vs. 10.3%, p < 0.001), gingival bleeding (23.3% vs. 2.5%, p < 0.001), calculus (21.3% vs. 4.1%, p < 0.001), bleeding on probing (38.1% vs. 2.6%, p < 0.001) and probing depth ≥3 mm (19.97% vs. −2.45%, p < 0.001). No significant differences were observed between the groups in the occurrence of PT (11.7% vs. 9.1%, p = 0.57), LBW (5.6 % vs. 4.1%, p = 0.59), and PTLBW (4.15% vs. 2.60%, p = 0.53). Comprehensive periodontal treatment and strict plaque control significantly improved periodontal health; however, no reduction of PTLBW rates was observed. Thus, remaining periodontal inflammation posttreatment cannot explain the lack of effect of periodontal treatment on PTLBW. Clinical relevance This study demonstrated that periodontal diseases may be successfully treated during pregnancy. Our results do not support a potential beneficial effect of periodontal treatment on PTLBW.

  3. Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

    ERIC Educational Resources Information Center

    Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

    2016-01-01

    Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

  4. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    PubMed Central

    Stegink-Jansen, Caroline W.

    2015-01-01

    Introduction. Patients with chronic lateral elbow (LE) tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1) to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE) for patients with chronic LE tendinopathy, and (2) to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment. Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities. Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows) were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows) or EE treatment (56 elbows). Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments. Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047) and in maximum grip strength (p = 0.008) than EE subjects. Astym therapy also resolved 20/21 (95.7%) of the EE non-responders, who showed improvements in DASH scores (p < 0.005), pain with activity (p = 0.002), and function (p = 0.004) following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported. Conclusion. This study

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

    PubMed

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

    2017-03-01

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

  6. Effects of doxycycline on clinical, microbiological and immunological parameters in well-controlled diabetes type-2 patients with periodontal disease: a randomized, controlled clinical trial.

    PubMed

    Tsalikis, Lazaros; Sakellari, Dimitra; Dagalis, Panagiotis; Boura, Panagiota; Konstantinidis, Antonios

    2014-10-01

    To evaluate the clinical, microbiological and immunological effects of systemic doxycycline as an adjunct to scaling and root planing (SRP) in chronic periodontitis patients with well-controlled type 2 diabetes. Sixty-six patients compliant to oral hygiene (Hygiene Index <20%) allocated to either a test (systemic doxycycline for 21 days) or a control (placebo) group participated in the present randomized controlled trial (RCT). Clinical assessments were recorded at baseline, 3 and 6 months after therapy and included clinical attachment level (CAL), set as the primary outcome of the study, probing pocket depth (PPD), recession (RE) and bleeding on probing (BOP). At the same time points, counts of 15 subgingival species were evaluated by "checkerboard" DNA-DNA hybridization, gingival crevicular fluid samples were analysed for matrix metalloproteinase-8 (MMP-8) by ELISA and HbA1c levels were determined. Comparisons between and within groups were performed by non-parametric tests (Mann-Whitney, Wilcoxon signed-ranks and z-test for proportions with Bonferroni corrections) at the 0.05 level. No major differences were noticed in clinical and microbiological parameters of periodontal disease or levels of MMP-8 between the two groups. Adjunctive systemic doxycycline does not seem to significantly enhance the effects of SRP in well-controlled diabetes type 2 patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    PubMed

    van Dijken, Jan W V; Pallesen, Ulla

    2016-08-01

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

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

    PubMed

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

    2005-01-01

    The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

  9. Efficacy of an outpatient treatment for prolonged grief disorder: a randomized controlled clinical trial.

    PubMed

    Rosner, Rita; Pfoh, Gabriele; Kotoučová, Michaela; Hagl, Maria

    2014-01-01

    Abnormal forms of grief, currently referred to as complicated grief or prolonged grief disorder, have been discussed extensively in recent years. While the diagnostic criteria are still debated, there is no doubt that prolonged grief is disabling and may require treatment. To date, few interventions have demonstrated efficacy. We investigated whether outpatients suffering from prolonged grief disorder (PGD) benefit from a newly developed integrative cognitive behavioural therapy for prolonged grief (PG-CBT). A total of 51 patients were randomized into two groups, stratified by the type of death and their relationship to the deceased; 24 patients composed the treatment group and 27 patients composed the wait list control group (WG). Treatment consisted of 20-25 sessions. Main outcome was change in grief severity; secondary outcomes were reductions in general psychological distress and in comorbidity. Patients on average had 2.5 comorbid diagnoses in addition to PGD. Between group effect sizes were large for the improvement of grief symptoms in treatment completers (Cohen׳s d=1.61) and in the intent-to-treat analysis (d=1.32). Comorbid depressive symptoms also improved in PG-CBT compared to WG. The completion rate was 79% in PG-CBT and 89% in WG. The major limitations of this study were a small sample size and that PG-CBT took longer than the waiting time. PG-CBT was found to be effective with an acceptable dropout rate. Given the number of bereaved people who suffer from PGD, the results are of high clinical relevance. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. Effect of systemic antibiotics on clinical and patient-reported outcomes of implant therapy - a multicenter randomized controlled clinical trial.

    PubMed

    Tan, Wah Ching; Ong, Marianne; Han, Jie; Mattheos, Nikos; Pjetursson, Bjarni E; Tsai, Alex Yi-Min; Sanz, Ignacio; Wong, May C M; Lang, Niklaus P

    2014-02-01

    To determine the effect of various systemic antibiotic prophylaxis regimes on patient-reported outcomes and postsurgical complications in patients undergoing conventional implant installation. Three hundred and twenty-nine healthy adults in need of conventional implant installation were randomly assigned to one of four groups: (i) preoperatively 2 g of amoxycillin 1 h before surgery (positive control, PC), (ii) postoperatively 2 g of amoxycillin immediately following surgery (test 1, T1), (iii) preoperatively 2 g of amoxycillin 1 h before and 500 mg thrice daily on days 2 and 3 after surgery (test 2, T2), (iv) preoperatively 2 g of placebo 1 h before surgery (negative control, NC). Subjects were examined clinically by blinded examiners over 8 weeks after implant installation. In addition, Visual Analogue Scales (VAS) for pain, swelling, bruising and bleeding were obtained over 14 days. ANOVA was performed for the VAS. Chi-square tests were applied for postsurgical complications. All VAS scores were low for all groups and decreased over time (P < 0.001). There were no significant differences for the VAS scores between the various groups at any time point (P > 0.05). There was only a significant difference in flap closure at week 4, where NC had 5% of the subjects not achieving complete wound closure compared to 0% for the three other groups (P = 0.01), with no other significant differences for any postsurgical complications (P > 0.05). For standard single implant placement, prophylactic systemic antibiotics either before or after, or before and after the surgical procedure do not improve patient-reported outcomes or prevalence of postsurgical complications. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

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

    PubMed

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

    2017-06-01

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

  12. Increasing smoking cessation care in a preoperative clinic: a randomized controlled trial.

    PubMed

    Wolfenden, Luke; Wiggers, John; Knight, Jenny; Campbell, Elizabeth; Spigelman, Allan; Kerridge, Ross; Moore, Karen

    2005-07-01

    Evidence suggests that preoperative clinics, like other hospital outpatient clinics and inpatient wards, fail to systematically provide smoking cessation care to patients having planned surgery. The aim of the study was to assess the efficacy, acceptability, and cost of a multifaceted intervention to facilitate the provision of comprehensive smoking cessation care to patients attending a preoperative clinic. Two hundred ten smoking patients attending a preoperative clinic at a major teaching hospital in Australia took part in the study. One hundred twenty-four patients were randomly assigned to an experimental group and 86 patients to a usual cessation care group. A multifaceted intervention was developed that included the use of opinion leaders, consensus processes, computer-delivered cessation care, computer-generated prompts for care provision by clinic staff, staff training, and performance feedback. Ninety-six percent of experimental group patients received behavioral counseling and tailored self-help material. Experimental group patients were significantly more likely than usual care patients to report receiving brief advice by nursing (79% vs. 47%; P < 0.01) and anaesthetic (60% vs. 39%; P < 0.01) staff. Experimental group patients who were nicotine dependent were also more likely to be offered preoperative nicotine replacement therapy (NRT) (82% vs. 8%; P < 0.01) and be prescribed postoperative NRT (86% vs. 0%; P < 0.01). The multifaceted intervention was found to be acceptable by staff. A multifaceted clinical practice change intervention may be effective in improving the delivery of smoking cessation care to preoperative surgical patients.

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

    PubMed Central

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

    2016-01-01

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

  14. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  15. Can forced-use therapy be clinically applied after stroke? An exploratory randomized controlled trial.

    PubMed

    Ploughman, Michelle; Corbett, Dale

    2004-09-01

    To determine the efficacy, safety, and compliance with forced-use therapy (FUT) applied without additional "shaping" therapy during the rehabilitation phase of stroke. Prospective, randomized controlled trial. Tertiary mixed rehabilitation center. Consecutive sample of 30 inpatients or outpatients with first stroke showing minimal movement of the arm and hand. Subjects who scored below 26 on the Mini-Mental State Examination were excluded. Seven subjects either did not provide consent or withdrew from the study. The remaining subjects were randomized into the control group (n=13) and the FUT group (n=10). FUT involved wearing a thick constraint mitten on the sound arm for as many as 6 hours a day. The Chedoke McMaster Impairment Inventory for arm, hand, postural control, and shoulder pain; Action Research Arm Test; grip strength; and FIM instrument. FUT subjects experienced 20% more recovery of the arm than did control subjects and more recovery of postural control (P=.04). Men benefited most from the program, and there was a tendency for FUT subjects to have more shoulder pain. Compliance was related to cognitive status. FUT, without shaping therapy, appears to augment arm recovery, but a larger sample is required to confirm these findings. The FUT mitten was safe and well tolerated; however, more research is needed to determine the relation between FUT and hemiplegic shoulder pain.

  16. Clinical effectiveness of basic root canal treatment after 24 months: a randomized controlled trial.

    PubMed

    Jordan, Rainer A; Holzner, Anna L; Markovic, Ljubisa; Brueckner, Inga; Zimmer, Stefan

    2014-04-01

    The purpose of this study was to investigate the effectiveness of basic root canal treatment (BRT) with tactile working length determination in terms of radiographic and clinical outcome parameters compared with endodontic treatment with standard radiographic working length control. This was a clinical, multicenter, controlled, open-label trial to evaluate BRT effectiveness after 24 months. The primary end point was the apical extension score of the radiographic quality parameter of root canal fillings. The secondary radiographic end point was the periapical index, and the secondary clinical end point was tooth tender to percussion. The safety end point was tooth loss as a consequence of endodontic failure. Statistical analyses of binary and categoric data were calculated using cross tables and the chi-square test. BRT with tactile working length determination compared with standard radiographic working length control did not significantly differ in terms of radiographic and clinical outcomes after 24 months. The apical extension of the root canal fillings and the periapical anatomic structures showed no significant differences according to radiographic analyses (P = .5). Corresponding results were found in clinical aspects of tooth tender to percussion (P = .6) and tooth loss (P = .7). Tactile working length determination in BRT resulted in comparable treatment outcomes compared with standard endodontic treatment with radiographic working length control and turned out to be an accurate method in BRT. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  17. Quantification of the External Validity of Randomized Controlled Trials Supporting Clinical Care Guidelines: The Case of Thromboprophylaxis.

    PubMed

    Morin-Ben Abdallah, Sami; Dutilleul, Aurore; Nadon, Valérie; Yang, Ji Wei; Marchand-Sénécal, Xavier; Van Nguyen, Paul; Lamarre-Cliche, Maxime; Wistaff, Robert; Kolan, Christophe; Laskine, Mikhael; Durand, Madeleine

    2016-07-01

    Clinical guidelines are based on the results of several randomized controlled trials. However, due to the stringent exclusion criteria of these trials, their external validity may be low. We aimed to evaluate the external validity of the randomized controlled trials cited in the American College of Chest Physicians guidelines for the use of pharmacological thromboprophylaxis in hospitalized medical patients. We conducted a cross-sectional, chart-review study of a random sample of patients admitted between July 1, 2013 and June 30, 2014 to the Internal Medicine ward of a large Canadian teaching university hospital. We identified the proportion of our population presenting exclusion criteria used in the randomized controlled trials cited in support of clinical care guidelines on thromboprophylaxis in the medical setting. Nine trials were identified for a total of 28,793 included patients following 23 distinct exclusion criteria. We included 429 patients. Median age was 65 years (interquartile ratio 51-77 years), and 236 (55%) were males. Of those not already anticoagulated at admission (n = 351), between 26% and 67% (weighted average, 51%) of our population presented at least one exclusion criterion, making them ineligible to be enrolled in randomized controlled trials. When restricting our population to patients with an indication for thromboprophylaxis based on a Padua risk score at admission ≥4, 21% to 76% (weighted average 55%) were ineligible to be enrolled in individual trials. Our cross-sectional study illustrates that the external validity of randomized controlled trials cited in the guidelines was low in our population, and lower when applying the risk-stratification tool recommended by guidelines. This can bias the clinicians toward treating patients that were not represented in the supporting evidence. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2013-01-01

    Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol 2013; 40: 1025–1035. doi: 10.1111/jcpe.12155. AimThe aim of this randomized placebo-controlled clinical trial was to evaluate the effects of Lactobacillus reuteri-containing probiotic lozenges as an adjunct to scaling and root planing (SRP). Material and MethodsThirty chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, 3, 6, 9 and 12 weeks after therapy. All patients received one-stage full-mouth disinfection and randomly assigned over a test (SRP + probiotic, n = 15) or control (SRP + placebo, n = 15) group. The lozenges were used two times a day for 12 weeks. ResultsAt week 12, all clinical parameters were significantly reduced in both groups, while there was significantly more pocket depth reduction (p < 0.05) and attachment gain (p < 0.05) in moderate and deep pockets; more Porphyromonas gingivalis reduction was observed in the SRP + probiotic group. ConclusionsThe results indicate that oral administration of L. reuteri lozenges could be a useful adjunct to SRP in chronic periodontitis. PMID:24164569

  19. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial.

    PubMed

    Xiong, Hong-Yan; Liu, Yang; Shu, Duan-Chao; Zhang, Sheng-Li; Qian, Xinhong; Duan, Wei-Xun; Cheng, Liang; Yu, Shi-Qiang; Jin, Zhen-Xiao

    2016-01-01

    The effects of sevoflurane inhalation during cardiopulmonary bypass (CPB) on postoperative courses and serum cardiac troponin I (cTnI) concentrations in pediatric patients undergoing cardiac surgery have not been extensively investigated. In this single-center, prospective, randomized trial, an anesthetic regimen containing 2% sevoflurane used throughout the CPB process was compared with a total intravenous anesthesia (TIVA) regimen. One hundred and three patients undergoing congenital heart defect repair with CPB were included in this prospective randomized controlled study. They were randomized into two groups: the sevoflurane group, who received 2% sevoflurane during CPB via an oxygenator, and the control group, who received only an oxygen-air mixture. The pre- and intra-operative parameters were comparable between the two groups. There was a slight but significant increase of arterial diastolic pressure in the sevoflurane group immediately after CPB compared with control patients (46.9 ± 9.3 mm Hg vs. 43.6 ± 8.9 mm Hg; p = 0.033). There was no death in either group. The postoperative ventilation time (in mean [95% confidence interval]) was shorter in the sevoflurane group than that in the control group (26.1 [19.2, 33.0] h vs. 37.7 [24.4, 50.9] h; p = 0.014). The postoperative ICU time, hospital days, and serial serum cTnI concentrations were not significantly different between the two groups. Inhalation of 2% sevoflurane during CPB is beneficial to the recovery of pediatric patients undergoing cardiac surgery but has no significant effect on postoperative cTnI release.

  20. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    PubMed Central

    Khorsan, Raheleh; Coulter, Ian D.; Crawford, Cindy; Hsiao, An-Fu

    2011-01-01

    A systematic review was conducted to assess the level of evidence for integrative health care research. We searched PubMed, Allied and Complementary Medicine (AMED), BIOSIS Previews, EMBASE, the entire Cochrane Library, MANTIS, Social SciSearch, SciSearch Cited Ref Sci, PsychInfo, CINAHL, and NCCAM grantee publications listings, from database inception to May 2009, as well as searches of the “gray literature.” Available studies published in English language were included. Three independent reviewers rated each article and assessed the methodological quality of studies using the Scottish Intercollegiate Guidelines Network (SIGN 50). Our search yielded 11,891 total citations but 6 clinical studies, including 4 randomized, met our inclusion criteria. There are no available systematic reviews/meta-analyses published that met our inclusion criteria. The methodological quality of the included studies was assessed independently using quality checklists of the SIGN 50. Only a small number of RCTs and CCTs with a limited number of patients and lack of adequate control groups assessing integrative health care research are available. These studies provide limited evidence of effective integrative health care on some modalities. However, integrative health care regimen appears to be generally safe. PMID:20953383

  1. Clinical-pharmacist intervention reduces clinically relevant drug-drug interactions in patients with heart failure: A randomized, double-blind, controlled trial.

    PubMed

    Roblek, Tina; Deticek, Andreja; Leskovar, Bostjan; Suskovic, Stanislav; Horvat, Matej; Belic, Ales; Mrhar, Ales; Lainscak, Mitja

    2016-01-15

    Incidence of drug-drug interactions (DDIs) increases with complexity of treatment and comorbidities, as in heart failure (HF). This randomized, double-blind study evaluated the intervention of the pharmacist on prevalence of clinically relevant DDIs (NCT01855165). Patients admitted with HF were screened for clinically relevant DDIs, and randomized to control or intervention. All attending physicians received standard advice about pharmacological therapy; those in the intervention group also received alerts about clinically relevant DDIs. Primary endpoint was DDI at discharge and secondary were re-hospitalization or death during follow-up. Of 213 patients, 51 (mean age, 79 ± 6 years; male, 47%) showed 66 clinically relevant DDIs and were randomized. For intervention (n=26) versus control (n=25), the number of patients with and the number of DDIs were significantly lower at discharge: 8 vs. 18 and 10 vs. 31; p=0.003 and 0.0049, respectively. Over a 6 month follow-up period, 11 control and 9 intervention patients were re-hospitalized or died (p>0.2 for all). No significant differences were seen between control and intervention for patients with eGFR <60 mL/min/1.73 m(2) (78%) for re-hospitalization or death (10 vs. 7; p=0.74). Pharmacist intervention significantly reduces the number of patients with clinically relevant DDIs, but not clinical endpoints 6 months from discharge. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  2. Acupuncture for Preventing Complications after Radical Hysterectomy: A Randomized Controlled Clinical Trial

    PubMed Central

    Yi, Wei-min; Chen, Qing; Liu, Chang-hao; Hou, Jia-yun; Chen, Liu-dan; Wu, Wei-kang

    2014-01-01

    We aimed to investigate the preventive effects of acupuncture for complications after radical hysterectomy. A single-center randomized controlled single-blinded trial was performed in a western-style hospital in China. One hundred and twenty patients after radical hysterectomy were randomly allocated to two groups and started acupuncture from sixth postoperative day for five consecutive days. Sanyinjiao (SP6), Shuidao (ST28), and Epangxian III (MS4) were selected with electrical stimulation and Zusanli (ST36) without electrical stimulation for thirty minutes in treatment group. Binao (LI14) was selected as sham acupuncture point without any stimulation in control group. The main outcome measures were bladder function and prevalence of postoperative complications. Compared with control group, treatment group reported significantly improved bladder function in terms of maximal cystometric capacity, first voiding desire, maximal flow rate, residual urine, and bladder compliance, and decreased bladder sensory loss, incontinence, and urinary retention on fifteenth and thirtieth postoperative days. Treatment group showed significant advantage in reduction of urinary tract infection on thirtieth postoperative day. But no significant difference between groups was observed for lymphocyst formation. By improving postoperative bladder function, early intervention of acupuncture may provide a valuable alternative method to prevent bladder dysfunctional disorders and urinary tract infection after radical hysterectomy. PMID:24839455

  3. HERNIOPLASTY WITH AND WITHOUT MESH: ANALYSIS OF THE IMMEDIATE COMPLICATIONS IN A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    PALERMO, Mariano; ACQUAFRESCA, Pablo A.; BRUNO, Miguel; TARSITANO, Francisco

    2015-01-01

    Background: Inguinal hernia repair is the most common procedure in general surgery and 80,000 operations are performed annually in Great Britain, 100,000 in France and 700,000 in the US. Given its high frequency has a major impact, both in the medical and economic aspects. Aim: Analyze the immediate postoperative complications comparing mesh versus non mesh hernioplasty. Method: Randomized control trial, with the enrollment of 263 patients underwent surgery for inguinal hernia randomized by randomization table. Treatment (mesh, Lichtenstein or without mesh, Bassini technique) was assigned using sequentially numbered opaque envelopes having fulfilled the inclusion criteria. The variables analyzed were: postoperative pain, seroma, hematoma, infection, return to normal activities and recurrence. Results: The mean age was 55.5 years, 88% patients were male and 12% female. The pain was higher in patients operated with mesh. Conclusions: The inguinal hernia repair mesh group had less immediate postoperative complications and significantly earlier return to work than hernioplasty without mesh, this being one of the most important conclusions. PMID:26537136

  4. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

    PubMed Central

    Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2010-01-01

    Objective To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Methods Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. Results For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control. Conclusions Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting. PMID:21113076

  5. Supportive Nursing Care and Satisfaction of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    PubMed Central

    Navidian, Ali; Ebrahimi, Hossein; Keykha, Roghaieh

    2015-01-01

    Background: Patient satisfaction is the most important criterion in evaluating the quality of care. Besides, its assessment in patients with severe mental disorder treated by electroconvulsive therapy (ECT) is highly appropriate. The ECT is accompanied by lower satisfaction and may exacerbate the patients’ condition. Objectives: The current study aimed to determine the effect of supportive nursing care on the satisfaction of patients receiving ECT. Patients and Methods: This randomized controlled trial was conducted in the education center of Baharan psychiatric hospital, Zahedan, Iran. Seventy hospitalized patients receiving ECT were randomly divided into two groups of control (n = 35) and intervention (n = 35).The socio-personal and Webster Satisfaction Questionnaire were used as data collection tools. The intervention group received supportive nursing care by nurses trained in informational, emotional, and physical aspects. The control group received only regular nursing care. The levels of satisfaction were measured and compared between groups, before and after the intervention. Data were analyzed using the SPSS software, and Chi-square, independent and paired t tests, as well as covariance analysis were performed. Results: The results showed similarities in socio-personal characteristics of both groups. However, there was a significant difference (P < 0.001) between the means of satisfaction in the groups, predominantly for the intervention group. In other words, a significant difference (P < 0.001) was observed between the means of satisfaction of the intervention (54.71 ± 5.27) and control (36.28 ± 7.00) groups after intervention by controlling the effect of socio-personal variables. Conclusions: Results of the current study confirmed the effect of supportive nursing care on increasing the level of satisfaction in ECT receiving patients, recommending the use of this therapeutic method. PMID:26473077

  6. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

    PubMed

    Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2011-01-01

    To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of 'late' DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of 'late' DSTs (p=0.57) compared with the control. Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

  7. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial.

    PubMed

    Zhao, Xian L; Zhu, Shi F; Xue, Gui J; Li, Juan; Liu, Yi L; Wan, Mei H; Huang, Wei; Xia, Qing; Tang, Wen F

    2015-01-01

    Early enteral nutrition is beneficial for acute pancreatitis (AP), but the optimal timing and criteria remain unclear. The aim of this study was to explore the feasibility and safety of early oral refeeding (EORF) based on hunger in patients with moderate or severe AP. In a prospective, single-center, controlled, randomized clinical trial (ChiCTR-TRC-12002994), eligible patients with moderate or severe AP were randomized to either EORF or conventional oral refeeding (CORF). Patients in the EORF group restarted an oral diet when they felt hungry, regardless of laboratory parameters. Those in the CORF group restarted an oral diet only when clinical and laboratory symptoms had resolved. Clinical outcomes were compared between the two groups. In all, 146 eligible patients with moderate or severe AP were included and randomized to the EORF (n = 70) or CORF (n = 76) group. There were eight dropouts after randomization (three in EORF group; five in CORF group). The groups had similar baseline characteristics. The total length of hospitalization (13.7 ± 5.4 d versus 15.7 ± 6.2 d; P = 0.0398) and duration of fasting (8.3 ± 3.9 d versus 10.5 ± 5.1 d; P = 0.0047) were shorter in the EORF group than in the CORF group. There was no difference in the number of adverse events or complications between the two groups. The mean blood glucose level after oral refeeding was higher in the EORF group than in the CORF group (P = 0.0030). This controlled, randomized clinical trial confirmed the effectiveness and feasibility of EORF based on hunger in patients with moderate or severe AP. EORF could shorten the length of hospitalization in patients with moderate or severe AP. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care

    PubMed Central

    Francis, Nick A.; Ridd, Matthew J.; Thomas-Jones, Emma; Butler, Christopher C.; Hood, Kerenza; Shepherd, Victoria; Marwick, Charis A.; Huang, Chao; Longo, Mirella; Wootton, Mandy; Sullivan, Frank

    2017-01-01

    PURPOSE Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema. METHODS We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Children with clinical, non-severely infected eczema were randomized to receive oral and topical placebos (control), oral antibiotic (flucloxacillin) and topical placebo, or topical antibiotic (fusidic acid) and oral placebo, for 1 week. We compared Patient Oriented Eczema Measure (POEM) scores at 2 weeks using analysis of covariance (ANCOVA). RESULTS We randomized 113 children (40 to control, 36 to oral antibiotic, and 37 to topical antibiotic). Mean (SD) baseline Patient Oriented Eczema Measure scores were 13.4 (5.1) for the control group, 14.6 (5.3) for the oral antibiotic group, and 16.9 (5.5) for the topical antibiotic group. At baseline, 104 children (93%) had 1 or more of the following findings: weeping, crusting, pustules, or painful skin. Mean (SD) POEM scores at 2 weeks were 6.2 (6.0) for control, 8.3 (7.3) for the oral antibiotic group, and 9.3 (6.2) for the topical antibiotic group. Controlling for baseline POEM score, neither oral nor topical antibiotics produced a significant difference in mean (95% CI) POEM scores (1.5 [−1.4 to 4.4] and 1.5 [−1.6 to 4.5] respectively). There were no significant differences in adverse effects and no serious adverse events. CONCLUSIONS We found rapid resolution in response to topical steroid and emollient treatment and ruled out a clinically meaningful benefit from the addition of either oral or topical antibiotics. Children seen in ambulatory care with mild clinically infected eczema do not need treatment with antibiotics. PMID:28289111

  9. Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial

    PubMed Central

    2014-01-01

    Background When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. Methods We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. Results The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants’ different positions along two continuities from ‘Our participation in trial is not important’ to ‘Our participation in trial is important’, and ‘Vaccine not important to us’ to ‘Vaccine important to us’. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. Conclusions This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The

  10. Effect of ozonated oil and chlorhexidine gel on plaque induced gingivitis: A randomized control clinical trial

    PubMed Central

    Indurkar, Maya Sanjeev; Verma, Renu

    2016-01-01

    Background: Several chemotherapeutic agents have been developed to prevent gingivitis and its progression into periodontitis. In this present study, the efficacy of ozonated oil and chlorhexidine gel was assessed and compared on plaque induced gingivitis. Aim: To evaluate the effect of ozonated oil on plaque induced gingivitis and to compare its efficacy with chlorhexidine gel. Materials and Methods: A total of 20 subjects, aged from 18 to 65 years, with plaque-induced gingivitis were selected from the outpatient Department of Periodontology, Government Dental College and Hospital, Aurangabad, for this study. They were divided randomly into the test or ozonated oil group (Group I) and the control or chlorhexidine gel group (Group II) with 10 subjects in each group. Subjects were randomly assigned to massage their gingiva thrice a day for 3 weeks with ozonated oil (test), and chlorhexidine gel (control). Plaque index and gingival index scores were recorded for the 20 subjects at baseline and after 3 weeks. Results: Ozonated oil (Group I) and chlorhexidine gel (Group II) groups showed statistically significant differences with respect to plaque index and gingival index, from the baseline to 3 weeks (P < 0.001 in both). But the difference between Group I and Group II, at the end of the study period, was not statistically significant with respect to the plaque index and gingival index. Conclusions: The ozonated oil and chlorhexidine gel, both can be used as an effective agent in maintaining and improving gingival health. PMID:27041835

  11. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial.

    PubMed

    dos Santos, Gisele Munhoes; Bento, Ricardo Ferreira; de Medeiros, Italo Roberto Torres; Oiticcica, Jeanne; da Silva, Eleonora Csipai; Penteado, Silvio

    2014-07-23

    Hearing aids with an integrated sound generator have been used to enhance the treatment of tinnitus. The main aim of this study was to verify whether the combined use of amplification and sound generator is more effective than conventional amplification alone in reducing tinnitus annoyance by means of the use of a new hearing aid with an integrated sound generator. A total of 49 patients underwent a blind randomized clinical trial. Tinnitus annoyance was measured by Tinnitus Handicap Inventory and numerical scales, and psychoacoustic measures of tinnitus were also performed. The sound generator was set at the lowest intensity capable of providing relief from tinnitus. Results showed that 62.5% of the patients presented a reduction in tinnitus annoyance in the combined fitting group and in the group with amplification alone, 78% showed a reduction. This difference between the groups was not statistically significant. © The Author(s) 2014.

  12. Do interventions to prevent lifestyle-related diseases reduce healthcare expenditures? A randomized controlled clinical trial.

    PubMed

    Babazono, Akira; Kuwabara, Kazuaki; Hagiihara, Akihito; Nagano, Jun; Ishihara, Reiko

    2011-01-01

    In 2008, the Japanese government implemented a program of health lifestyle interventions to reduce health care expenditure. This study evaluated whether these interventions decreased health care expenditures. The study enrolled 99 participants insured by Japanese National Health Insurance, who, in our previous study conducted in 2004, were allocated by random sampling into an intervention group (50 participants) and a control group (49 participants). In the intervention group, we used a health support method that facilitated the attainment of goals established by each participant. The control group received instruction in exercise, as well as health support using publically available media. Although 3 participants in the intervention group and 9 participants in the control group did not participate in a follow-up health examination 1 year after the intervention, the health care expenditures of all initial participants were assessed. Expenditures before and after the intervention were compared within and between groups. Data on health care expenditures were obtained from inpatient, outpatient, pharmacy, and dental health insurance claims. After the intervention, the pharmacy and dental expenditures were significantly higher in the intervention group, while the pharmacy expenditure was significantly higher in the control group. However, there was no significant difference in any medical expenditure item between the intervention and control groups before or after the intervention. No significant differences were observed in short-term medical expenses for any medical expenditure item after a lifestyle intervention.

  13. Randomized controlled clinical trial on the three-dimensional accuracy of fast-set impression materials.

    PubMed

    Rudolph, Heike; Quaas, Sebastian; Haim, Manuela; Preißler, Jörg; Walter, Michael H; Koch, Rainer; Luthardt, Ralph G

    2013-06-01

    The use of fast-setting impression materials with different viscosities for the one-stage impression technique demands precise working times when mixing. We examined the effect of varying working time on impression precision in a randomized clinical trial. Focusing on tooth 46, three impressions were made from each of 96 volunteers, using either a polyether (PE: Impregum Penta H/L DuoSoft Quick, 3 M ESPE) or an addition-curing silicone (AS: Aquasil Ultra LV, Dentsply/DeTrey), one with the manufacturer's recommended working time (used as a reference) and two with altered working times. All stages of the impression-taking were subject to randomization. The three-dimensional precision of the non-standard working time impressions was digitally analyzed compared to the reference impression. Statistical analysis was performed using multivariate models. The mean difference in the position of the lower right first molar (vs. the reference impression) ranged from ±12 μm for PE to +19 and -14 μm for AS. Significantly higher mean values (+62 to -40 μm) were found for AS compared to PE (+21 to -26 μm) in the area of the distal adjacent tooth. Fast-set impression materials offer high precision when used for single tooth restorations as part of a one-stage impression technique, even when the working time (mixing plus application of the light- and heavy-body components) diverges significantly from the manufacturer's recommended protocol. Best accuracy was achieved with machine-mixed heavy-body/light-body polyether. Both materials examined met the clinical requirements regarding precision when the teeth were completely syringed with light material.

  14. Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

    PubMed

    Xu, Tian-Min; Zhang, Xiaoyun; Oh, Hee Soo; Boyd, Robert L; Korn, Edward L; Baumrind, Sheldon

    2010-11-01

    The objective of this pilot randomized clinical trial was to investigate the relative effectiveness of anchorage conservation of en-masse and 2-step retraction techniques during maximum anchorage treatment in patients with Angle Class I and Class II malocclusions. Sixty-four growing subjects (25 boys, 39 girls; 10.2-15.9 years old) who required maximum anchorage were randomized to 2 treatment techniques: en-masse retraction (n = 32) and 2-step retraction (n = 32); the groups were stratified by sex and starting age. Each patient was treated by a full-time clinic instructor experienced in the use of both retraction techniques at the orthodontic clinic of Peking University School of Stomatology in China. All patients used headgear, and most had transpalatal appliances. Lateral cephalograms taken before treatment and at the end of treatment were used to evaluate treatment-associated changes. Differences in maxillary molar mesial displacement and maxillary incisor retraction were measured with the before and after treatment tracings superimposed on the anatomic best fit of the palatal structures. Differences in mesial displacement of the maxillary first molar were compared between the 2 treatment techniques, between sexes, and between different starting-age groups. Average mesial displacement of the maxillary first molar was slightly less in the en-masse group than in the 2-step group (mean, -0.36 mm; 95% CI, -1.42 to 0.71 mm). The average mesial displacement of the maxillary first molar for both treatment groups pooled (n = 63, because 1 patient was lost to follow-up) was 4.3 ± 2.1 mm (mean ± standard deviation). Boys had significantly more mesial displacement than girls (mean difference, 1.3 mm; P <0.03). Younger adolescents had significantly more mesial displacement than older adolescents (mean difference, 1.3 mm; P <0.02). Average mesial displacement of the maxillary first molar with 2-step retraction was slightly greater than that for en-masse retraction, but the

  15. Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial.

    PubMed

    Morin, Charles M; Koetter, Uwe; Bastien, Célyne; Ware, J Catesby; Wooten, Virgil

    2005-11-01

    Insomnia is a prevalent health complaint associated with daytime impairments, reduced quality of life, and increased health-care costs. Although it is often self-treated with herbal and dietary supplements or with over-the-counter sleep aids, there is still little evidence on the efficacy and safety of those products. To evaluate the efficacy and safety of a valerian-hops combination and diphenhydramine for the treatment of mild insomnia. Multicenter, randomized, placebo-controlled, parallel-group study conducted in 9 sleep disorders centers throughout the United States. A total of 184 adults (110 women, 74 men; mean age of 44.3 years) with mild insomnia. (1) Two nightly tablets of standardized extracts of a valerian (187-mg native extracts; 5-8:1, methanol 45% m/m) and hops (41.9-mg native extracts; 7-10:1, methanol 45% m/m) combination for 28 days (n = 59), (2) placebo for 28 days (n = 65), or (3) 2 tablets of diphenhydramine (25 mg) for 14 days followed by placebo for 14 days (n = 60). Sleep parameters measured by daily diaries and polysomnography, clinical outcome ratings from patients and physicians, and quality of life measures. Modest improvements of subjective sleep parameters were obtained with both the valerian-hops combination and diphenhydramine, but few group comparisons with placebo reached statistical significance. Valerian produced slightly greater, though nonsignificant, reductions of sleep latency relative to placebo and diphenhydramine at the end of 14 days of treatment and greater reductions than placebo at the end of 28 days of treatment. Diphenhydramine produced significantly greater increases in sleep efficiency and a trend for increased total sleep time relative to placebo during the first 14 days of treatment. There was no significant group difference on any of the sleep continuity variables measured by polysomnography. In addition, there was no alteration of sleep stages 3-4 and rapid eye movement sleep with any of the treatments. Patients

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

    PubMed

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

    2016-10-01

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

  17. 3-Year Randomized Controlled Prospective Clinical Trial on Different CAD-CAM Implant Abutments.

    PubMed

    Ferrari, Marco; Tricarico, Maria Gabriella; Cagidiaco, Maria Crysanti; Vichi, Alessandro; Gherlone, Enrico Felice; Zarone, Fernando; Sorrentino, Roberto

    2016-12-01

    Zirconia abutments were introduced to restore esthetic regions and showed sufficient stability to support implant restorations. Nonetheless, to date the observation periods are shorter than those of titanium abutments. To assess the survival of implant crowns supported by computer aided design-computer aided manufacturing (CAD-CAM) abutments after 3 years. Fifty-six patients were selected for this prospective clinical study. Each patient received at least 1 titanium implant for a total of 89 fixtures. A two-stage surgical technique and no additional soft or hard tissue graft were used. The implants were randomly divided into 3 groups receiving different CAD-CAM abutments: titanium, titanium nitride, and zirconia. Zirconia or metal-ceramic crowns were used as final restorations. Cementation was the baseline and the restorations were checked after 6 months, 1, 2, and 3 years, assessing any mechanical complication. Statistical analyses were performed to evaluate the 3-year success rates. Five failures were reported in the zirconia group; all the failed restorations showed fractures of the abutment connection. Four failures occurred in posterior regions and one more occurred while screwing the abutment. Titanium and titanium nitride abutments had significantly higher 3-year success rates than zirconia abutments (p < .05). Atlantis titanium and titanium nitride abutments showed optimal clinical performances after 3 years. Conversely, Atlantis zirconia abutments should be avoided to restore posterior regions. © 2016 Wiley Periodicals, Inc.

  18. Systematic review of randomized controlled trials of clinical prediction rules for physical therapy in low back pain.

    PubMed

    Patel, Shilpa; Friede, Tim; Froud, Robert; Evans, David W; Underwood, Martin

    2013-04-20

    Systematic review. To evaluate randomized controlled trials validating the effects of a clinical prediction rule for patients with non-specific low back pain (LBP). The outcomes of interest were any back pain or pain-related measures. LBP is a common and costly condition. Interventions for back pain seem to have, at best, small to moderate mean beneficial effects. Identifying subgroups of patients who may respond better to certain treatments may help to improve clinical outcomes in back pain. The development of clinical prediction rules is an attempt to determine who will respond best to certain treatments. We conducted electronic searches of MEDLINE (1980-2009), EMBASE (1980-2009), PsycINFO (1980-2009), Allied and Complementary Medicine (1980-2009), PubMed (1980-2009), ISI Web of Knowledge (1980-2009), and the Cochrane Library (1980-2009). The reference lists of relevant articles were searched for further references. We identified 1821 potential citations; 3 articles were included. The results from the available data do not support the use of clinical prediction rules in the management of non-specific LBP. There is a lack of good quality randomized controlled trials validating the effects of a clinical prediction rule for LBP. Furthermore, there is no agreement on appropriate methodology for the validation and impact analysis. The evidence for, and development of, the existing prediction rules is generally weak.

  19. Clinical curative effect of electric acupuncture on acute cerebral infarction: a randomized controlled multicenter trial.

    PubMed

    Wang, Chengwei; Wu, Zhongchao; Li, Ning; Zhao, Yu; Tian, Fengwei; Zhou, Xi; Wang, Zhuxing

    2014-12-01

    To examine whether electric acupuncture can improve the daily life of patients with ischemic cerebral apoplexy at acute stage. A stratified-block randomized controlled multicenter trial was designed for this study. Totally 340 patients with acute ischemic cerebral apoplexy were randomly divided into an electric acupuncture group and a control group. In the electric acupuncture group, 170 patients were treated with electric acupuncture and routine therapy, and 170 patients in the control group with routine therapy alone. Major indexes for judging curative effect were Barthel index at 3- and 6- months follow-up visits and number of re-hospitalized patients. Minor indexes for judging curative effect were change in the score for nervous dysfunction at 4 and 12 weeks follow-up visits and number of patients persisting in rehabilitation treatment with acupuncture during follow-up visit. Baseline data at the time of case selection between the two groups were similar. The odds ratio (OR) was 0.92, and the 95% confidence interval (CI) was 0.49-1.73 in disabled rate and 0.73 and 0.51-1.05 in the number of re-hospitalized patients in the electric acupuncture group at 6-month follow up visit compared with the control group. There was no difference in the score for nervous dysfunction at the end of 12-week follow-up visit between the two groups. The score for nervous dysfunction at the end of 4-week treatment in the electric acupuncture group was significantly higher than that in the control group (P < 0.05). The number of patients discharged from hospital who persisted in rehabilitation treatment with acupuncture in the acupuncture group was significantly higher than that in the control group. Using electric acupuncture to treat patients with acute ischemic cerebral apoplexy can effectively improve the nervous dysfunction scores after 4-week treatment and their ability to deal with daily life after 6-month follow-up visit. Systematic treatment with acupuncture may also reduce

  20. Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial.

    PubMed

    Bakas, Tamilyn; Austin, Joan K; Habermann, Barbara; Jessup, Nenette M; McLennon, Susan M; Mitchell, Pamela H; Morrison, Gwendolyn; Yang, Ziyi; Stump, Timothy E; Weaver, Michael T

    2015-12-01

    There are few evidence-based programs for stroke family caregivers postdischarge. The purpose of this study was to evaluate efficacy of the Telephone Assessment and Skill-Building Kit (TASK II), a nurse-led intervention enabling caregivers to build skills based on assessment of their own needs. A total of 254 stroke caregivers (primarily female TASK II/information, support, and referral 78.0%/78.6%; white 70.7%/72.1%; about half spouses 48.4%/46.6%) were randomized to the TASK II intervention (n=123) or to an information, support, and referral group (n=131). Both groups received 8 weekly telephone sessions, with a booster at 12 weeks. General linear models with repeated measures tested efficacy, controlling for patient hospital days and call minutes. Prespecified 8-week primary outcomes were depressive symptoms (with Patient Health Questionnaire Depressive Symptom Scale PHQ-9 ≥5), life changes, and unhealthy days. Among caregivers with baseline PHQ-9 ≥5, those randomized to the TASK II intervention had a greater reduction in depressive symptoms from baseline to 8, 24, and 52 weeks and greater improvement in life changes from baseline to 12 weeks compared with the information, support, and referral group (P<0.05); but not found for the total sample. Although not sustained at 12, 24, or 52 weeks, caregivers randomized to the TASK II intervention had a relatively greater reduction in unhealthy days from baseline to 8 weeks (P<0.05). The TASK II intervention reduced depressive symptoms and improved life changes for caregivers with mild to severe depressive symptoms. The TASK II intervention reduced unhealthy days for the total sample, although not sustained over the long term. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01275495. © 2015 American Heart Association, Inc.

  1. Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial

    PubMed Central

    Bakas, Tamilyn; Austin, Joan K.; Habermann, Barbara; Jessup, Nenette M.; McLennon, Susan M.; Mitchell, Pamela H.; Morrison, Gwendolyn; Yang, Ziyi; Stump, Timothy E.; Weaver, Michael T.

    2015-01-01

    Background and Purpose There are few evidence-based programs for stroke family caregivers post-discharge. The purpose of this study was to evaluate efficacy of the Telephone Assessment and Skill-Building Kit (TASKII), a nurse-led intervention enabling caregivers to build skills based on assessment of their own needs. Methods A total of 254 stroke caregivers (primarily female TASK II/ISR 78.0%/78.6%; white 70.7%/72.1%; about half spouses 48.4%/46.6%) were randomized to the TASKII intervention (n=123) or to an Information, Support, and Referral (ISR) group (n=131). Both groups received 8 weekly telephone sessions, with a booster at 12 weeks. General linear models with repeated measures tested efficacy, controlling for patient hospital days and call minutes. Pre-specified 8 week primary outcomes were depressive symptoms (with Patient Health Questionnaire Depressive Symptom Scale PHQ-9≥5), life changes, and unhealthy days. Results Among caregivers with baseline PHQ-9≥5, those randomized to the TASK II intervention had a greater reduction in depressive symptoms from baseline to 8, 24, and 52 weeks and greater improvement in life changes from baseline to 12 weeks compared to the ISR group (p<.05); but not found for the total sample. Although not sustained at 12, 24, or 52 weeks, caregivers randomized to the TASK II intervention had a relatively greater reduction in unhealthy days from baseline to 8 weeks (p<.05) Conclusions The TASK II intervention reduced depressive symptoms and improved life changes for caregivers with mild to severe depressive symptoms. The TASK II intervention reduced unhealthy days for the total sample, although not sustained over the long term. PMID:26549488

  2. The Effect of Probiotic Yogurt on Constipation in Pregnant Women: A Randomized Controlled Clinical Trial

    PubMed Central

    Mirghafourvand, Mojgan; Homayouni Rad, Aziz; Mohammad Alizadeh Charandabi, Sakineh; Fardiazar, Zahra; Shokri, Kolsoum

    2016-01-01

    Background Probiotics can alter the colonic microbiota and might improve bowel function. Objectives The aim of this study was to evaluate the effect of the consumption of yogurt, enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 (CFU) on the symptoms of constipated pregnant women. Materials and Methods This triple-blind randomized controlled trial was conducted on 60 constipated pregnant women who were diagnosed by the ROME III criteria in Tabriz, Iran from December 2014 to July 2015. Participants were randomly put into two groups including the treatment and the control group through block randomization. The treatment group received 300 g of yogurt enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 colony forming units (CFU) (n = 30) while the control group received conventional yogurt (n = 30) for 4 weeks. The defecation frequency, stool consistency, straining during defecation, sensation of anorectal obstruction, sensation of incomplete evacuation and manual manoeuvres to facilitate defecation were primary outcomes while the amount of defecation, stool colure, and quality of life were secondary outcomes. Results The frequency of defecation was increased from 2.1 (0.8) at baseline to 8.3 (4.4) in the probiotic yogurt group vs. 2.3 (0.7) at baseline to 8.1 (4.3) in the conventional yogurt group at the end of 4th week. These results were based on the repeated measure ANOVA test and there was no statistically significant difference between the two groups (mean difference: 0.1; Confidence Interval 95%: -1.4 to 1.7; P = 0.872). Constipation symptoms including straining, anorectal obstruction, manipulation to facilitate defecation, consistency of stool and color of stool were improved significantly (P < 0.05) in both groups. In addition, the amount of defecation was significantly increased in both groups (P < 0.05), while incomplete evacuation was significantly reduced in the treatment group (P = 0.01). There was no statistically significant

  3. Trimethoprim as adjuvant treatment in schizophrenia: a double-blind, randomized, placebo-controlled clinical trial.

    PubMed

    Shibre, Teshome; Alem, Atalay; Abdulahi, Abdulreshid; Araya, Mesfin; Beyero, Teferra; Medhin, Girmay; Deyassa, Negusse; Negash, Alemayehu; Nigatu, Alemayehu; Kebede, Derege; Fekadu, Abebaw

    2010-07-01

    Various infectious agents, such as Toxoplasma gondii, have been hypothesized to be potentially relevant etiological factors in the onset of some cases of schizophrenia. We conducted a randomized, double-blind, placebo-controlled treatment trial in an attempt to explore the hypothesis that the symptoms of schizophrenia may be related to infection of the central nervous system with toxoplasma gondii. Systematically selected patients with ongoing and at least moderately severe schizophrenia from Butajira, in rural Ethiopia, were randomly allocated to trimethoprim or placebo, which were added on to participants' regular antipsychotic treatments. Trial treatments were given for 6 months. The Positive and Negative Syndrome Scale (PANSS) was used to assess outcome. Ninety-one patients were included in the study, with 80 cases (87.9%) positive for T. gondii immunoglobulin G antibody. Seventy-nine subjects (87.0%) completed the trial. The mean age of subjects was 35.3 (SD = 8.0) years, with a mean duration of illness of 13.2 (SD = 6.7) years. Both treatment groups showed significant reduction in the overall PANSS score with no significant between-group difference. In this sample of patients with chronic schizophrenia, trimethoprim used as adjuvant treatment is not superior to placebo. However, it is not possible to draw firm conclusion regarding the etiological role of toxoplasmosis on schizophrenia based on this study because the timing and the postulated mechanisms through which toxoplasmosis produces schizophrenia are variable.

  4. Can a simple clinical test detect impairment of zopiclone and alcohol? - A randomized controlled trial.

    PubMed

    Hjelmeland, Knut; Gustavsen, Ingebjørg; Bernard, Jean-Paul; Mørland, Jørg

    2015-03-01

    The risk of traffic accident involvement is increased among patients prescribed the z-hypnotic drug zopiclone. Clinical test observations able to indicate drug impairment are therefore essential. This study compared the findings of a simplified clinical test of impairment (SCTI) with those of a battery of computerized psychomotor tests of impairment (CPTI). 16 healthy young male volunteers attended a research unit on four different study days, receiving in randomized order either placebo, zopiclone 5mg, zopiclone 10mg, or alcohol 50g. The SCTI was performed twice and the CPTI was performed three times on each study day, with blood samples being collected for drug analysis. The SCTI (and the CPTI) was able to demonstrate impairment at 1.5h, but no major impairment was found at 7h with the SCTI, after intake of both zopiclone and ethanol. The CPTI detected a significantly higher proportion of impaired observations than the SCTI, both for zopiclone and for ethanol, at all concentration levels. The sensitivity of the clinical tests in detecting blood drug concentrations often associated with impairment, due to zopiclone (above 23ng/ml) and alcohol (above 0.5g/l), was low, revealing 27 per cent and 18 per cent, respectively. The specificity, however, was higher, both for zopiclone (88 per cent) and for alcohol (96 per cent). The SCTI may be a useful tool, especially during roadside investigation, when the police are in doubt as to whether the apprehended driver is impaired or not. A subject, who has consumed zopiclone or alcohol, tested with the SCTI, with one or more subtests diverging from a habitual result, is likely to have a blood zopiclone concentration above 23ng/ml or a BAC above 0.5g/l. A negative result, however, is less helpful. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. Biochemical, physiological and clinical effects of l-methylfolate in schizophrenia: a randomized controlled trial.

    PubMed

    Roffman, J L; Petruzzi, L J; Tanner, A S; Brown, H E; Eryilmaz, H; Ho, N F; Giegold, M; Silverstein, N J; Bottiglieri, T; Manoach, D S; Smoller, J W; Henderson, D C; Goff, D C

    2017-03-14

    Folic acid supplementation confers modest benefit in schizophrenia, but its effectiveness is influenced by common genetic variants in the folate pathway that hinder conversion to its active form. We examined physiological and clinical effects of l-methylfolate, the fully reduced and bioactive form of folate, in schizophrenia. In this randomized, double-blind trial, outpatients with schizophrenia (n=55) received l-methylfolate 15 mg or placebo for 12 weeks. Patients were maintained on stable doses of antipsychotic medications. The pre-defined primary outcome was change in plasma methylfolate at 12 weeks. Secondary outcomes included change in symptoms (Positive and Negative Syndrome Scale (PANSS), Scale for Assessment of Negative Symptoms, Calgary Depression Scale for Schizophrenia), cognition (Measurement and Treatment Research to Improve Cognition in Schizophrenia composite) and three complementary magnetic resonance imaging measures (working memory-related activation, resting connectivity, cortical thickness). Primary, mixed model, intent-to-treat analyses covaried for six genetic variants in the folate pathway previously associated with symptom severity and/or response to folate supplementation. Analyses were repeated without covariates to evaluate dependence on genotype. Compared with placebo, l-methylfolate increased plasma methylfolate levels (d=1.00, P=0.0009) and improved PANSS Total (d=0.61, P=0.03) as well as PANSS Negative and General Psychopathology subscales. Although PANSS Total and General Psychopathology changes were influenced by genotype, significant PANSS Negative changes occurred regardless of genotype. No treatment differences were seen in other symptom rating scales or cognitive composite scores. Patients receiving l-methylfolate exhibited convergent changes in ventromedial prefrontal physiology, including increased task-induced deactivation, altered limbic connectivity and increased cortical thickness. In conclusion, l

  6. Effect of UV irradiation on cutaneous cicatrices: a randomized, controlled trial with clinical, skin reflectance, histological, immunohistochemical and biochemical evaluations.

    PubMed

    Due, Eva; Rossen, Kristian; Sorensen, Lars Tue; Kliem, Anette; Karlsmark, Tonny; Haedersdal, Merete

    2007-01-01

    The aim of this study was to examine the effect of ultraviolet (UV) irradiation on human cutaneous cicatrices. In this randomized, controlled study, dermal punch biopsy wounds served as a wound healing model. Wounds healed by primary or second intention and were randomized to postoperative solar UV irradiation or to no UV exposure. Evaluations after 5 and 12 weeks included blinded clinical assessments, skin reflectance measurements, histology, immunohistochemistry, and biochemical analyses of the N-terminal propeptide from procollagen-1, hydroxyproline, hydroxylysine, and proline. Twelve weeks postoperatively, UV-irradiated cicatrices healing by second intention: (i) were significantly pointed out as the most disfiguring; (ii) obtained significantly higher scores of colour, infiltration and cicatrix area; and (iii) showed significantly higher increase in skin-reflectance measurements of skin-pigmentation vs. non-irradiated cicatrices. No histological, immunohistochemical or biochemical differences were found. In conclusion, postoperative UV exposure aggravates the clinical appearance of cicatrices in humans.

  7. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    NASA Astrophysics Data System (ADS)

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  8. Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used With Progressive Tinnitus Management.

    PubMed

    Henry, James A; Thielman, Emily J; Zaugg, Tara L; Kaelin, Christine; Schmidt, Caroline J; Griest, Susan; McMillan, Garnett P; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

    2017-05-24

    This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention involved 5 group workshops: 2 led by an audiologist (teaching how to use sound as therapy) and 3 by a psychologist (teaching coping skills derived from cognitive behavioral therapy). It was hypothesized that PTM would be more effective than wait-list control in reducing functional effects of tinnitus and that there would be no differences in effectiveness between sites. At both sites, a statistically significant improvement in mean Tinnitus Functional Index scores was seen at 6 months for the PTM group. Combined data across sites revealed a statistically significant improvement in Tinnitus Functional Index relative to wait-list control. The effect size for PTM using the Tinnitus Functional Index was 0.36 (small). Results suggest that PTM is effective at reducing tinnitus-related functional distress in clinical settings. Although effect sizes were small, they provide evidence of clinical effectiveness of PTM in the absence of stringent research-related inclusion criteria and with a relatively small number of sessions of cognitive behavioral therapy.

  9. Effect of dexmedetomidine on postoperative pain in knee arthroscopic surgery; a randomized controlled clinical trial.

    PubMed

    Alipour, Mohammad; Tabari, Masoomeh; Faz, Reza Farhadi; Makhmalbaf, Hadi; Salehi, Maryam; Moosavitekye, Seyed Mostafa

    2014-03-01

    Various drugs are administered intra-articularly to provide postoperative analgesia after arthroscopic knee surgery. The purpose of this study was to assess the analgesic effects of intra-articular injection of a dexmedetomidine following knee arthroscopy. Forty six patients scheduled for arthroscopic knee surgery under general anaesthesia, were randomly devided into two groups. Intervention group received 1µg/kg dexmedetomidine (D) and isotonic saline. Control group received 25ml isotonic saline (P). Analgesic effects were evaluated by measuring pain intensity (VAS scores) and duration of analgesia. There was no significant difference between the two groups in terms of age, sex and weight. The mean of post-operation pain severity in 1, 3, 6,12, and 24 h was significantly lower in the intervention group (D) in comparison with the control group (P). the mean of the total dose of tramadol consumption was significantly lower in the intervention group in comparison with the control group (P<0.001). Intra-articular injection of dexmedetomidine at the end of arthroscopic knee surgery, alleviates the patients' pain, reducing the postoperative need for narcotics as analgesics, and increase the first analgesic request after operation.

  10. Effect of Dexmedetomidine on Postoperative Pain in Knee Arthroscopic Surgery; a Randomized Controlled Clinical Trial

    PubMed Central

    Alipour, Mohammad; Tabari, Masoomeh; faz, Reza Farhadi; Makhmalbaf, Hadi; Salehi, Maryam; Moosavitekye, Seyed Mostafa

    2014-01-01

    Background: Various drugs are administered intra-articularly to provide postoperative analgesia after arthroscopic knee surgery. The purpose of this study was to assess the analgesic effects of intra-articular injection of a dexmedetomidine following knee arthroscopy. Methods: Forty six patients scheduled for arthroscopic knee surgery under general anaesthesia, were randomly devided into two groups. Intervention group received 1µg/kg dexmedetomidine (D) and isotonic saline. Control group received 25ml isotonic saline (P). Analgesic effects were evaluated by measuring pain intensity (VAS scores) and duration of analgesia. Results: There was no significant difference between the two groups in terms of age, sex and weight. The mean of post-operation pain severity in 1, 3, 6,12, and 24 h was significantly lower in the intervention group (D) in comparison with the control group (P). the mean of the total dose of tramadol consumption was significantly lower in the intervention group in comparison with the control group (P<0.001). Conclusions: Intra-articular injection of dexmedetomidine at the end of arthroscopic knee surgery, alleviates the patients’ pain, reducing the postoperative need for narcotics as analgesics, and increase the first analgesic request after operation. PMID:25207314

  11. Determination of efficacy of reflexology in managing patients with diabetic neuropathy: a randomized controlled clinical trial.

    PubMed

    Dalal, Krishna; Maran, V Bharathi; Pandey, Ravindra M; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

  12. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    PubMed Central

    Dalal, Krishna; Maran, V. Bharathi; Pandey, Ravindra M.; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy. PMID:24527055

  13. Mechanism for prevention of infection in preterm neonates by topical emollients: a randomized, controlled clinical trial.

    PubMed

    Darmstadt, Gary L; Ahmed, Saifuddin; Ahmed, A S M Nawshad Uddin; Saha, Samir K

    2014-11-01

    Topical applications of emollients such as sunflower seed oil and Aquaphor have been shown to reduce the incidence of bloodstream infections and mortality of preterm infants in resource-poor settings. The causal mechanism for prevention of infection through cutaneous portals of entry is not well understood. We examined the relationship between skin condition score as a measure of skin barrier integrity and risk for bloodstream infection, and the effect of emollients on that relationship. Data for this study come from a randomized controlled trial of the impact of topical emollient therapy on nosocomial infections in 491 preterm infants <33 weeks gestational age at Dhaka Shishu Hospital, Bangladesh. Latent growth trajectory model with random-coefficient and multivariable logistic regression were utilized. Rate of deterioration of skin condition was significantly lower (P < 0.05) in both emollient arms compared with the untreated control group. Adjusted odds ratio of skin score for infection was 1.32 (95% confidence interval: 1.06-1.65). Emollients reduced the incidence of infection only when the skin had no signs of deterioration [Aquaphor incidence rate ratio: 0.43 (95% confidence interval: 0.19-0.97) and sunflower seed oil incidence rate ratio: 0.46 (95% confidence interval: 0.21-0.99)]. Skin condition deteriorated progressively after birth and compromised skin condition increased the risk of infection. Emollients preserved skin integrity and thus prevented infection in preterm neonates. To optimize benefits of emollients for the prevention of bloodstream infection, use of emollients should begin immediately after birth when the skin is still intact.

  14. Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial.

    PubMed

    Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M

    2013-02-01

    The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p < 0.05). There were no significant differences between groups for any clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.

  15. Randomized phase II clinical trials.

    PubMed

    Jung, Sin-Ho; Sargent, Daniel J

    2014-01-01

    Traditionally, Phase II trials have been conducted as single-arm trials to compare the response probabilities between an experimental therapy and a historical control. Historical control data, however, often have a small sample size, are collected from a different patient population, or use a different response assessment method, so that a direct comparison between a historical control and an experimental therapy may be severely biased. Randomized Phase II trials entering patients prospectively to both experimental and control arms have been proposed to avoid any bias in such cases. The small sample sizes for typical Phase II clinical trials imply that the use of exact statistical methods for their design and analysis is appropriate. In this article, we propose two-stage randomized Phase II trials based on Fisher's exact test, which does not require specification of the response probability of the control arm for testing. Through numerical studies, we observe that the proposed method controls the type I error accurately and maintains a high power. If we specify the response probabilities of the two arms under the alternative hypothesis, we can identify good randomized Phase II trial designs by adopting the Simon's minimax and optimal design concepts that were developed for single-arm Phase II trials.

  16. Selective medicated (saline + natural surfactant) bronchoalveolar lavage in unilateral lung contusion. A clinical randomized controlled trial.

    PubMed

    Marraro, Giuseppe A; Denaro, Carmelo; Spada, Claudio; Luchetti, Marco; Giansiracusa, Carla

    2010-02-01

    Open lung and low tidal volume ventilation appear to be a promising ventilation for chest trauma as it can reduce ARDS and improve outcome. Local therapy (e.g. BAL) can be synergic to remove from the lung the debris, mitigate inflammatory cascade and avoid damage spreading to not compromised lung areas. 44 pulmonary contused patients were randomized to receive broncho-suction and volume controlled low tidal volume ventilation-VCLTVV (Control Group) or the same ventilation plus medicated (saline + surfactant) BAL (Treatment Group). Tidal volume <10 ml/kg, PEEP of 10-12 cm H(2)O and PaO(2) 60-100 mm Hg and PaCO(2) 35-45 mm Hg were used in both groups. BAL was performed using a fiberscope. 4 boluses of 25 ml saline with 2.4 mg/ml of surfactant were introduced into each contused lobe in which, subsequently, 240 mg of surfactant was instilled. All patients survived. In the Control Group 18 patients developed pneumonia, 5 ARDS and days of intubation were 11.50 (3.83) compared to 5.05 (1.21) of Treatment Group in which OI and PaO(2)/FiO(2) significantly improved from 36 h. VCLTVV alone was not able to prevent ARDS and infection in the Control Group as the reduction of intubation. In the Treatment Group, VCLTVV and medicated BAL facilitated the removal of degradated lung material and recruited the contused lung regions, enabling the healing of the lung pathology.

  17. A randomized controlled clinical trial of auricular acupuncture in smoking cessation.

    PubMed

    Wu, Ta-Peng; Chen, Fang-Pey; Liu, Jui-Yao; Lin, Ming-Hsien; Hwang, Shinn-Jang

    2007-08-01

    Tobacco smoking is responsible for human diseases of the lung, heart, circulatory system and various kinds of cancers, and is a serious public health problem worldwide. Acupuncture has been promoted as a treatment modality for smoking cessation. However, its efficacy still remains controversial. We conducted a prospective, randomized, controlled trial using auricular acupuncture for smoking cessation in 131 adults who wanted to stop smoking. Thirteen subjects withdrew from the study and 118 subjects were included in the final analyses (mean age, 53.7 +/- 16.8 years; 100 males, 18 females). The treatment group (n = 59) received auricular acupuncture in Shen Men, Sympathetic, Mouth and Lung points for 8 weeks. The control group (n = 59) received sham acupuncture in non-smoking-cessation-related auricular acupoints (Knee, Elbow, Shoulder and Eye points). The enrolled subjects were then followed monthly for 6 months after stopping the acupuncture treatment. Between both groups before acupuncture treatment, there was no significant difference with regard to gender, mean age, education level, and mean values for the age at which smoking started, smoking duration, daily number of cigarettes smoked and nicotine dependent score. At the end of treatment, cigarette consumption had significantly decreased in both groups, but only the treatment group showed a significant decrease in the nicotine withdrawal symptom score. Smoking cessation rate showed no significant difference between the treatment group (27.1%) and the control group (20.3%) at the end of treatment. There was also no significant difference in the smoking cessation rate between the treatment group (16.6%) and the control group (12.1%) at the end of follow-up. There were no major side effects of auricular acupuncture in both groups. Our results showed that auricular acupuncture did not have a better efficacy in smoking cessation compared to sham acupuncture. Combined acupuncture with behavior counseling or with

  18. Randomized controlled clinical trial of long-term chemo-mechanical caries removal using PapacarieTM gel

    PubMed Central

    MOTTA, Lara Jansiski; BUSSADORI, Sandra Kalil; CAMPANELLI, Ana Paula; da SILVA, André Luis; ALFAYA, Thays Almeida; de GODOY, Camila Haddad Leal; NAVARRO, Maria Fidela de Lima

    2014-01-01

    Objectives Compare the effectiveness of PapacarieTM gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings. Material and Methods A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with PapacarieTM and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations. Results No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment. Conclusion PapacarieTM is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia. PMID:25141203

  19. Nursing appointment and cardiometabolic control of diabetics: a randomized clinical trial.

    PubMed

    Teston, Elen Ferraz; Arruda, Guilherme Oliveira de; Sales, Catarina Aparecida; Marcon, Sonia Silva

    2017-01-01

    to verify the effect of nursing appointment on cardiometabolic profile of people with Diabetes Mellitus type 2. randomized controlled trial, developed with 134 individuals chosen for two groups: intervention and control. The intervention consisted of three nursing appointments alternated bimonthly, with two phone calls, over five months. The control group received usual care offered by the Health Unit. Data were collected through semi-structured interviews before and after the intervention, in addition to conducting laboratory tests. after the intervention, a significant difference was shown in the amount of glycated hemoglobin (p = 0.006) and in the systolic blood pressure (p = 0.031), which were higher in the control group. besides being low-cost and easy to develop on the monitoring routine of people with diabetes, the intervention performed influenced positively the biochemical profile. verificar o efeito da consulta de enfermagem sobre o perfil cardiometabólico de pessoas com Diabetes Mellitus tipo 2. ensaio clínico controlado e randomizado, desenvolvido com 134 indivíduos sorteados para dois grupos: intervenção e controle. A intervenção consistiu em três consultas de enfermagem bimensais alternadas, com duas ligações telefônicas, ao longo de cinco meses. O grupo-controle recebeu os cuidados habituais oferecidos pela Unidade de Saúde. Os dados foram coletados mediante entrevistas semiestruturadas antes e após a intervenção, além da realização de exames laboratoriais. após a intervenção, foi evidenciada diferença significativa no valor da hemoglobina glicada (p=0,006) e da pressão arterial sistólica (p=0,031), que se mostraram mais elevadas no grupo-controle. a intervenção realizada, além de ser de baixo custo e de fácil desenvolvimento na rotina de acompanhamento da pessoa com diabetes, influenciou positivamente a melhora do perfil bioquímico.

  20. Massive Access Control Aided by Knowledge-Extraction for Co-Existing Periodic and Random Services over Wireless Clinical Networks.

    PubMed

    Du, Qinghe; Zhao, Weidong; Li, Weimin; Zhang, Xuelin; Sun, Bo; Song, Houbing; Ren, Pinyi; Sun, Li; Wang, Yichen

    2016-07-01

    The prosperity of e-health is boosted by fast development of medical devices with wireless communications capability such as wearable devices, tiny sensors, monitoring equipments, etc., which are randomly distributed in clinic environments. The drastically-increasing population of such devices imposes new challenges on the limited wireless resources. To relieve this problem, key knowledge needs to be extracted from massive connection attempts dispersed in the air towards efficient access control. In this paper, a hybrid periodic-random massive access (HPRMA) scheme for wireless clinical networks employing ultra-narrow band (UNB) techniques is proposed. In particular, the proposed scheme towards accommodating a large population of devices include the following new features. On one hand, it can dynamically adjust the resource allocated for coexisting periodic and random services based on the traffic load learned from signal collision status. On the other hand, the resource allocation within periodic services is thoroughly designed to simultaneously align with the timing requests of differentiated services. Abundant simulation results are also presented to demonstrate the superiority of the proposed HPRMA scheme over baseline schemes including time-division multiple access (TDMA) and random access approach, in terms of channel utilization efficiency, packet drop ratio, etc., for the support of massive devices' services.

  1. Effect of QRS morphology on clinical event reduction with cardiac resynchronization therapy: Meta-analysis of randomized controlled trials

    PubMed Central

    Sipahi, Ilke; Chou, Josephine C.; Hyden, Marshall; Rowland, Douglas Y.; Simon, Daniel I.; Fang, James C.

    2014-01-01

    Background Cardiac resynchronization therapy (CRT) is effective in reducing clinical events in systolic heart failure patients with a wide QRS. Previous retrospective studies suggest only patients with QRS prolongation due to a left bundle-branch block (LBBB) benefit from CRT. Our objective was to examine this by performing a meta-analysis of all randomized controlled trials of CRT. Methods Systematic searches of MEDLINE and the Food and Drug Administration official website were conducted for randomized controlled CRT trials. Trials reporting adverse clinical events (eg, all-cause mortality, heart failure hospitalizations) according to QRS morphology were included in the meta-analysis. Results Four randomized trials totaling 5,356 patients met the inclusion criteria. In patients with LBBB at baseline, there was a highly significant reduction in composite adverse clinical events with CRT (RR = 0.64 [95% CI (0.52–0.77)], P = .00001). However no such benefit was observed for patients with non-LBBB conduction abnormalities (RR = 0.97 [95% CI (0.82–1.15)], P = .75). When examined separately, there was no benefit in patients with right-bundle branch block (RR = 0.91 [95% CI (0.69–1.20)], P = .49) or non-specific intraventricular conduction delay (RR = 1.19 [95% CI (0.87–1.63)], P = .28). There was no heterogeneity among the clinical trials with regards to the lack of benefit in non-LBBB patients (I2 = 0%). When directly compared, the difference in effect of CRT between LBBB versus non-LBBB patients was highly statistically significant (P = .0001 by heterogeneity analysis). Conclusions While CRT was very effective in reducing clinical events in patients with LBBB, it did not reduce such events in patients with wide QRS due to other conduction abnormalities. PMID:22305845

  2. Control of Established Gingivitis and Dental Plaque Using a 1450 ppm Fluoride/Zinc-based Dentifrice: A Randomized Clinical Study.

    PubMed

    Zhong, Y; Li, X; Hu, D Y; Mateo, L R; Morrison, B M; Delgado, E; Zhang, Y P

    2015-01-01

    To investigate the clinical efficacy in controlling established gingivitis and dental plaque of a 1450 ppm fluoride as sodium monofluorophosphate (SMFP)/zinc-based dentifrice, as compared to a zinc-free dentifrice with 1450 ppm fluoride as SMFP after six months product use. A six-month clinical study, with eighty-six (86) subjects, was conducted in Chengdu, China, using a double-blind, randomized, parallel-group treatment design. After a baseline evaluation, study subjects were randomly assigned to one of the two study treatments: 1) 1450 ppm fluoride as SMFP/zinc-based dentifrice (Test) or 2) 1450 ppm fluoride as SMFP/zinc-free dentifrice (Negative Control). Subjects were provided with a soft bristle toothbrush and brushed their teeth twice daily (morning and evening) for one minute with their assigned dentifrice. After three months, and again after six months of product use, subjects returned to the testing facility for their followup gingivitis and plaque examinations. Statistical analyses were performed separately for the gingivitis assessments and dental plaque assessments using the appropriate statistical methods. All statistical tests of hypotheses were two-sided, and employed a level of significance of α = 0.05. After three and six months of product use, subjects assigned to the Test treatment exhibited statistically significant (p < 0.001) reductions in gingival index and plaque index scores as compared to subjects assigned to the Negative Control treatment. The results of this single-center, double-blind, parallel-group and randomized clinical study support the conclusion that a 1450 ppm fluoride as SMFP/zinc-based dentifrice provides clinically meaningful and statistically significant reductions in gingivitis (23.8%) and dental plaque (22.5%) as compared to a 1450 ppm fluoride as SMFP/zinc-free dentifrice over a six-month period of twice-daily product use.

  3. Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view.

    PubMed

    Saturni, S; Bellini, F; Braido, F; Paggiaro, P; Sanduzzi, A; Scichilone, N; Santus, P A; Morandi, L; Papi, A

    2014-04-01

    Randomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate. In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies. Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.

  4. A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia.

    PubMed

    Gomar, Jesús J; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J; Ovejero, María R; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J

    2015-11-01

    The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results.

  5. A Multisite, Randomized Controlled Clinical Trial of Computerized Cognitive Remediation Therapy for Schizophrenia

    PubMed Central

    Gomar, Jesús J.; Valls, Elia; Radua, Joaquim; Mareca, Celia; Tristany, Josep; del Olmo, Francisco; Rebolleda-Gil, Carlos; Jañez-Álvarez, María; de Álvaro, Francisco J.; Ovejero, María R.; Llorente, Ana; Teixidó, Cristina; Donaire, Ana M.; García-Laredo, Eduardo; Lazcanoiturburu, Andrea; Granell, Luis; Mozo, Cristina de Pablo; Pérez-Hernández, Mónica; Moreno-Alcázar, Ana; Pomarol-Clotet, Edith; McKenna, Peter J.

    2015-01-01

    The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results. PMID:26006264

  6. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    DTIC Science & Technology

    2010-01-01

    to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

  7. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial.

    PubMed

    Monteiro, E P; Franzoni, L T; Cubillos, D M; de Oliveira Fagundes, A; Carvalho, A R; Oliveira, H B; Pantoja, P D; Schuch, F B; Rieder, C R; Martinez, F G; Peyré-Tartaruga, L A

    2017-03-01

    We compare the effects of Nordic walking training (NW) and Free walk (FW) on functional parameters (motor symptoms, balance) and functional mobility (Timed Up and Go at Self-selected Speed - TUGSS, and at forced speed, TUGFS; Self-selected Walking Speed, SSW; locomotor rehabilitation index, LRI) of Parkinson's disease (PD) patients. The study included 33 patients with clinical diagnosis of idiopathic PD, and staging between 1 and 4 in the Hoehn and Yahr scale (H&Y) randomized into two groups: NW (N = 16) and FW (N = 17) for 6 weeks. Baseline characteristics were compared trough a one-way ANOVA. Outcomes were analyzed using the Generalized Estimation Equations (GEE) with a Bonferroni post-hoc. Data were analyzed using SPSS v.20.0. Improvements in UPDRS III (P < 0.001), balance scores (P < 0.035), TUGSS distance (P < 0.001), TUGFS distance (P < 0.001), SSW (P < 0.001), and LRI (P < 0.001) were found for both groups. However, the NW group showed significant differences (P < 0.001) when compared to the FW group for the functional mobility. We conclude the NW improves functional parameters and walking mobility demonstrating that NW is as effective as the FW, including benefits for FW on the functional mobility of people with PD. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. A Randomized Controlled Clinical Trial Comparing Belatacept With Tacrolimus After De Novo Kidney Transplantation.

    PubMed

    de Graav, Gretchen N; Baan, Carla C; Clahsen-van Groningen, Marian C; Kraaijeveld, Rens; Dieterich, Marjolein; Verschoor, Wenda; von der Thusen, Jan H; Roelen, Dave L; Cadogan, Monique; van de Wetering, Jacqueline; van Rosmalen, Joost; Weimar, Wilem; Hesselink, Dennis A

    2017-10-01

    Belatacept, an inhibitor of the CD28-CD80/86 costimulatory pathway, allows for calcineurin-inhibitor free immunosuppressive therapy in kidney transplantation but is associated with a higher acute rejection risk than ciclosporin. Thus far, no biomarker for belatacept-resistant rejection has been validated. In this randomized-controlled trial, acute rejection rate was compared between belatacept- and tacrolimus-treated patients and immunological biomarkers for acute rejection were investigated. Forty kidney transplant recipients were 1:1 randomized to belatacept or tacrolimus combined with basiliximab, mycophenolate mofetil, and prednisolone. The 1-year incidence of biopsy-proven acute rejection was monitored. Potential biomarkers, namely, CD8CD28, CD4CD57PD1, and CD8CD28 end-stage terminally differentiated memory T cells were measured pretransplantation and posttransplantation and correlated to rejection. Pharmacodynamic monitoring of belatacept was performed by measuring free CD86 on monocytes. The rejection incidence was higher in belatacept-treated than tacrolimus-treated patients: 55% versus 10% (P = 0.006). All 3 graft losses, due to rejection, occurred in the belatacept group. Although 4 of 5 belatacept-treated patients with greater than 35 cells CD8CD28 end-stage terminally differentiated memory T cells/μL rejected, median pretransplant values of the biomarkers did not differ between belatacept-treated rejectors and nonrejectors. In univariable Cox regressions, the studied cell subsets were not associated with rejection-risk. CD86 molecules on circulating monocytes in belatacept-treated patients were saturated at all timepoints. Belatacept-based immunosuppressive therapy resulted in higher and more severe acute rejection compared with tacrolimus-based therapy. This trial did not identify cellular biomarkers predictive of rejection. In addition, the CD28-CD80/86 costimulatory pathway appeared to be sufficiently blocked by belatacept and did not predict

  9. Clinical Effects of Dry Needling Among Asymptomatic Individuals With Hamstring Tightness: A Randomized Controlled Trial.

    PubMed

    Geist, Kathleen; Bradley, Claire; Hofman, Alan; Koester, Rob; Roche, Fenella; Shields, Annalise; Frierson, Elizabeth; Rossi, Ainsley; Johanson, Marie

    2016-11-11

    Randomized controlled trial. The aim of this study was to determine the effects of dry needling on hamstring extensibility and functional performance tests among asymptomatic individuals with hamstring muscle tightness. Dry needling has been shown to increase range of motion in the upper quarter and may have similar effects in the lower quarter. Twenty-seven subjects with hamstring extensibility deficits were randomly assigned to side of treatment (dominant or non-dominant) and group (blunt needling or dry needling). The first session included measurement of hamstring extensibility and performance on four unilateral hop tests, instruction in home hamstring stretching exercises and needling distal to the ischial tuberosity and mid-bellies of the medial and lateral hamstrings. A second session, 3-5 days following the first session included outcome measures and a second needling intervention, and a third session, 4-6 weeks following the first session included outcome measures only. A 2x3x2 ANOVA was used to statistically analyze the data. Hamstring extensibility showed a significant side x time interaction (p<.05). The single hop for distance, timed six meter hop, and the crossover hop test had a significant main effect of time (p<.05). The triple hop for distance showed a significant side x time x group interaction (p<.05). It does not appear dry needling results in increased extensibility beyond that of stretching alone in asymptomatic individuals. Our study findings suggest that dry needling may improve certain dimensions of functional performance, although no clear conclusion can be made. Intervention, level 2b.

  10. DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL OF BENFOTIAMINE FOR SEVERE ALCOHOL DEPENDENCE

    PubMed Central

    Manzardo, Ann M.; He, Jianghua; Poje, Albert; Penick, Elizabeth C.; Campbell, Jan; Butler, Merlin G.

    2013-01-01

    Background Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analogue, benfotiamine (BF), and BF’s effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. Methods A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Results Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, −611±380 Std Dev; PL: N=11, −159±562 Std Dev, p-value=0.02). Conclusions BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism. PMID:23992649

  11. Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study.

    PubMed

    Potter, W D; de Villemeur, Maxence

    2003-07-01

    Although latex remains the primary material for male condoms, a number of condoms made from synthetic materials have appeared in commercial markets in recent years. Published data on the safety and efficacy of these condoms is still limited, but nevertheless synthetic condoms do offer the user a wider choice and may encourage greater use of condoms for contraception and sexual transmitted infection prophylaxis. This paper reports on a study carried out in the Paris region of France on a new, commercial polyurethane condom marketed in Japan as Sagami Original and in Europe as Protex Original. A standard latex condom complying with the European standard for condoms (EN 600:1996) from the same manufacturer was used as the control in the study. The clinical breakage rate for the polyurethane condom was 0.6% (95% confidence interval 0.2-1.4%) compared to 1.3% (95% confidence interval 0.6-2.2%) for the latex condom. The difference was not statistically significant (chi(2) = 1.9, p = 0.168). Clinically significant slippage (complete slippage of the condom off the penis) was 1.1% (95% confidence interval 0.5-1.9%) for the polyurethane condom, compared to 0.5% (95% confidence interval 0.2-1.2%) for the latex; a difference that again was not statistically significant (chi(2) = 1.783, p = 0.182). The polyurethane condom was therefore equivalent to the latex condom in terms of clinical failure rate.

  12. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial.

    PubMed

    El-Gammal, Mona Y; Salem, Ahmed S; Anees, Mohamed M; Tawfik, Mohamed A

    2016-04-01

    Immediate loading of dental implants in situations where low bone density exist, such as the posterior maxillary region, became possible recently after the introduction of biomimetic agents. This 1-year preliminary clinical trial was carried out to clinically and radiographically evaluate immediate-loaded 1-piece implants with local application of melatonin in the osteotomy site as a biomimetic material. 14 patients with missing maxillary premolars were randomized to receive 14 implants of 1-piece type that were subjected to immediate loading after 2 weeks of initial placement. Group I included 7 implants with acid-etched surface while group II included 7 implants with acid-etched surface combined with local application of melatonin gel at the osteotomy site. Patients were recalled for follow up at 1, 3, 6, and 12 months after loading. All implants were considered successful after 12 months of follow-up. Significant difference (P < 0.05) was found between both groups at 1 month of implant loading when considering the implant stability. At 1 and 3 months there were significant differences in the marginal bone level between the 2 groups. These results suggest that the local application of melatonin at the osteotomy site is associated with good stability and minimal bone resorption. However, more studies for longer follow-up periods are required to confirm the effect of melatonin hormone on osseointegration of dental implants.

  13. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder.

    PubMed

    Bateman, Anthony; Fonagy, Peter

    2009-12-01

    This randomized controlled trial tested the effectiveness of an 18-month mentalization-based treatment (MBT) approach in an outpatient context against a structured clinical management (SCM) outpatient approach for treatment of borderline personality disorder. Patients (N=134) consecutively referred to a specialist personality disorder treatment center and meeting selection criteria were randomly allocated to MBT or SCM. Eleven mental health professionals equal in years of experience and training served as therapists. Independent evaluators blind to treatment allocation conducted assessments every 6 months. The primary outcome was the occurrence of crisis events, a composite of suicidal and severe self-injurious behaviors and hospitalization. Secondary outcomes included social and interpersonal functioning and self-reported symptoms. Outcome measures, assessed at 6-month intervals, were analyzed using mixed effects logistic regressions for binary data, Poisson regression models for count data, and mixed effects linear growth curve models for self-report variables. Substantial improvements were observed in both conditions across all outcome variables. Patients randomly assigned to MBT showed a steeper decline of both self-reported and clinically significant problems, including suicide attempts and hospitalization. Structured treatments improve outcomes for individuals with borderline personality disorder. A focus on specific psychological processes brings additional benefits to structured clinical support. Mentalization-based treatment is relatively undemanding in terms of training so it may be useful for implementation into general mental health services. Further evaluations by independent research groups are now required.

  14. Use of chewing gum in children undergoing an appendectomy: A randomized clinical controlled trial.

    PubMed

    López-Jaimez, Gabriela; Cuello-García, Carlos A

    2016-08-01

    Post-operative ileus is a common condition among pediatric patients undergoing appendectomy. We aim to assess the feasibility, safety, and effectiveness of chewing gum to reduce ileus, and decrease time to oral tolerance. A randomized trial was conducted in 5-18 year old patients that underwent an appendectomy. Subjects in the intervention group received sugar-free chewing gum within the first 12 h after surgery and control group received the usual therapy. We assessed the acceptability of the intervention, time to pass first flatus, present first bowel movement, and time to tolerate oral intake. A total of 41 patients were recruited, 21 in the intervention group and 20 in the control group. Mean time (SD) to first flatus in the intervention group was 17.18 h (8.18), and 24.37 h (17.53) in the control group (mean difference [MD] of -7.19 h; 95% CI, -15.7 to 1.38). Time to first bowel movement (MD, -4.6 h, 95%CI -18.5 to 9.3), time to tolerate oral intake (MD, 4.17 h; 95%CI -9.2 to 17.5), and length of hospital stay (MD, 6.9 h, 95%CI -19.1 to 33.1) appeared not to be affected by the intervention. Chewing gum was accepted, well tolerated, and without complications. The use of chewing gum in children undergoing an appendectomy was safe and well tolerated and might lead to a faster recovery of bowel function, more studies are needed to prove if length of hospital stay and other outcomes are improved. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  15. Low-level laser therapy and myofacial pain dysfunction syndrome: a randomized controlled clinical trial.

    PubMed

    Shirani, Amir Mansour; Gutknecht, Norbert; Taghizadeh, Mahshid; Mir, Maziar

    2009-09-01

    Myofacial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The effects of low-level lasers (LLLs) for controlling the discomfort of patients are investigated frequently. However, the aim of this study was to evaluate the efficacy of a particular source producing 660 nm and 890 nm wavelengths that was recommended to reduce of the pain in the masticatory muscles. This was a double-blind and placebo-controlled trial. Sixteen MPDS patients were randomly divided into two groups. For the laser group, two diode laser probes (660 nm (nanometers), 6.2 J/cm(2), 6 min, continuous wave, and 890 nm, 1 J/cm(2) (joules per square centimetre), 10 min, 1,500 Hz (Hertz)) were used on the painful muscles. For the control group, the treatment was similar, but the patients were not irradiated. Treatment was given twice a week for 3 weeks. The amount of patient pain was recorded at four time periods (before and immediately after treatment, 1 week after, and on the day of complete pain relief). A visual analog scale (VAS) was selected as the method of pain measurement. Repeated-measures analysis of variance (ANOVA), the t-test and the paired t-test were used to analyze the data. In each group the reduction of pain before and after the treatment was meaningful, but, between the two groups, low-level laser therapy (LLLT) was more effective (P = 0.031) According to this study, this type of LLLT was the effective treatment for pain reduction in MPDS patients.

  16. Modest heterologous protection after Plasmodium falciparum sporozoite immunization: a double-blind randomized controlled clinical trial.

    PubMed

    Walk, Jona; Reuling, Isaie J; Behet, Marije C; Meerstein-Kessel, Lisette; Graumans, Wouter; van Gemert, Geert-Jan; Siebelink-Stoter, Rianne; van de Vegte-Bolmer, Marga; Janssen, Thorsten; Teelen, Karina; de Wilt, Johannes H W; de Mast, Quirijn; van der Ven, André J; Diez Benavente, Ernest; Campino, Susana; Clark, Taane G; Huynen, Martijn A; Hermsen, Cornelus C; Bijker, Else M; Scholzen, Anja; Sauerwein, Robert W

    2017-09-13

    A highly efficacious vaccine is needed for malaria control and eradication. Immunization with Plasmodium falciparum NF54 parasites under chemoprophylaxis (chemoprophylaxis and sporozoite (CPS)-immunization) induces the most efficient long-lasting protection against a homologous parasite. However, parasite genetic diversity is a major hurdle for protection against heterologous strains. We conducted a double-blind, randomized controlled trial in 39 healthy participants of NF54-CPS immunization by bites of 45 NF54-infected (n = 24 volunteers) or uninfected mosquitoes (placebo; n = 15 volunteers) against a controlled human malaria infection with the homologous NF54 or the genetically distinct NF135.C10 and NF166.C8 clones. Cellular and humoral immune assays were performed as well as genetic characterization of the parasite clones. NF54-CPS immunization induced complete protection in 5/5 volunteers against NF54 challenge infection at 14 weeks post-immunization, but sterilely protected only 2/10 and 1/9 volunteers against NF135.C10 and NF166.C8 challenge infection, respectively. Post-immunization plasma showed a significantly lower capacity to block heterologous parasite development in primary human hepatocytes compared to NF54. Whole genome sequencing showed that NF135.C10 and NF166.C8 have amino acid changes in multiple antigens targeted by CPS-induced antibodies. Volunteers protected against heterologous challenge were among the stronger immune responders to in vitro parasite stimulation. Although highly protective against homologous parasites, NF54-CPS-induced immunity is less effective against heterologous parasite clones both in vivo and in vitro. Our data indicate that whole sporozoite-based vaccine approaches require more potent immune responses for heterologous protection. This trial is registered in clinicaltrials.gov, under identifier NCT02098590 .

  17. A Randomized Controlled Clinical Trial of the Strength at Home Men's Program for Partner Violence in Military Veterans.

    PubMed

    Taft, Casey T; Macdonald, Alexandra; Creech, Suzannah K; Monson, Candice M; Murphy, Christopher M

    2016-09-01

    We evaluated the efficacy of the Strength at Home Men's Program (SAH-M), a trauma-informed group intervention based on a social information processing model to end intimate partner violence (IPV) use in a sample of veterans/service members and their partners. To date, no randomized controlled trial has supported the efficacy of an IPV intervention in this population. Participants included 135 male veterans/service members and 111 female partners. Recruitment was conducted from February 2010 through August 2013, and participation occurred within 2 Department of Veterans Affairs hospitals. Male participants completed an initial assessment that included diagnostic interviews and measures of physical and psychological IPV using the Revised Conflict Tactics Scales and were randomly assigned to an enhanced treatment as usual (ETAU) condition or SAH-M. Those randomized to SAH-M were enrolled in this 12-week group immediately after baseline. Those randomized to ETAU received clinical referrals and resources for mental health treatment and IPV services. All male participants were reassessed 3 and 6 months after baseline. Female partners completed phone assessments at the same intervals that were focused both on IPV and on the provision of safety information and clinical referrals. Primary analyses using hierarchical linear modeling indicated significant time-by-condition effects such that SAH-M participants compared with ETAU participants evidenced greater reductions in physical and psychological IPV use (β = -0.135 [SE = 0.061], P = .029; β = -0.304 [SE = 0.135], P = .026; respectively). Additional analyses of a measure that disaggregated forms of psychological IPV showed that SAH-M, relative to ETAU, reduced controlling behaviors involving isolation and monitoring of the partner (β = -0.072 [SE = 0.027], P = .010). Results provide support for the efficacy of SAH-M in reducing and ending IPV in male veterans and service members. ClinicalTrials.gov Identifier: NCT

  18. One-stage full-mouth disinfection combined with a periodontal dressing: a randomized controlled clinical trial.

    PubMed

    Keestra, Johan A J; Coucke, Wim; Quirynen, Marc

    2014-02-01

    To compare the clinical benefit of a periodontal dressing applied after a one-stage full-mouth disinfection (OSFMD) in patients with chronic periodontitis up to 3 months after therapy. This randomized, controlled split-mouth study included 24 patients. After OSFMD, a test and a control side were selected by means of a computer-generated randomization list. Test sides received a periodontal dressing (Coepak(®) ) for 7 days and the control sides received no periodontal dressing. After 7 days the periodontal dressing was removed and the pain experience was recorded. After 3 months, the clinical periodontal parameters were recorded. The periodontal dressing group showed a significant (p < 0.05) additional pocket depth reduction and additional clinical attachment gain for the moderate pockets of single- and multi-rooted teeth compared with the control group. A significant (p < 0.05) lower percentage of sites with probing pocket depth ≥5 mm were shown for the periodontal dressing group compared with the control group (2.7 ± 16.3% versus 4.8 ± 21.4%). The pain intensity was significantly reduced when using a periodontal dressing (5.13 ± 0.89 versus 3.42 ± 1.27). The use of a periodontal dressing for 7 days after a OSFMD offers an additional short-term clinical improvement and lowers the pain intensity. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Efficacy of 15% azelaic acid in psoriasis vulgaris: a randomized, controlled clinical trial.

    PubMed

    Iraji, Fariba; Faghihi, Gita; Siadat, Amir Hossein; Enshaieh, Shahla; Shahmoradi, Zabihlah; Joia, Abolfazl; Soleimani, Fatemeh

    2010-08-01

    Psoriasis is a common disorder affecting 1-3 percent of the general global population. Many therapeutic modalities have been suggested for treatment of this condition, but still there is no definite treatment for this disease. The objective in this study was to evaluate the efficacy of topical azelaic acid gel versus placebo in the treatment of psoriasis vulgaris. This study was a single-blinded randomized clinical trial. Overall, 31 patients were selected and the left or right sided lesions of the patients were randomized to receive either 15% azelaic acid or gel twice daily for a one-month period. Two symmetrical lesions with almost similar severity in every patient were selected and considered as index lesions to evaluate lesion response to treatment. The severity of erythema, scaling, hyperkeratosis and pruritus of the index lesions were scored in range of 0-3 for each lesion by the investigator at the baseline and follow up visits. The percent of involvement of each side of body was also measured using rule of nines. The collected data were analyzed using statistical tests including Mann-Whitney and ANOVA tests. There was no significant difference between the two groups before treatment (P > 0.05). After treatment, however, except pruritus, there was significant difference between the two groups (P < 0.05). There was no significant difference regarding total psoriasis score between the two groups before treatment (P > 0.05). After treatment, however, there was significant difference between the two groups (P < 0.05) in favor of more efficacy for azelaic acid. There was no significant difference regarding percent of body involvement between the two groups before treatment (P > 0.05). After treatment, however, there was a significant difference between the two groups (P < 0.05) in favor of more efficacy on the part of azelaic acid gel. The results of our study showed that 15% azelaic acid gel was effective in reduction of purities, scaling and hyperkeratosis of

  20. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    PubMed

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

  1. Effects of Family-Center Empowerment Model on the Lifestyle of Heart Failure Patients: A Randomized Controlled Clinical Trial

    PubMed Central

    Rakhshan, Mahnaz; Kordshooli, Khadijeh Rahimi; Ghadakpoor, Soraya

    2015-01-01

    Background: Cardiovascular diseases are the most prevalent disorders in developed countries and heart failure is the major one among them. This disease is caused by numerous factors and one of the most considerable risk factors is unhealthy lifestyle. So the aim of this research was to study the effect of family-center empowerment model on the lifestyle of heart failure patients. Methods: This is a randomized controlled clinical trial on 70 heart failure patients referring to Hazrate Fatemeh heart clinic in Shiraz. After convenience sampling the patients were divided into two control and intervention groups using block randomization Method. The intervention based on family-center empowerment model was performed during 5 sessions. Research tools are lifestyle and demographic information questionnaires. Results: Both intervention and control groups were similar regarding their demographic information (P>0.001). Before the intervention on lifestyle, all measures of the two groups were equal (P>0.001) but after the intervention; statistically significant differences were reported in all dimensions of lifestyle, the total lifestyle score in the intervention group was 70.09±16.38 and in the control group -6.03±16.36 (P<0.001). Conclusion: Performing the family-center empowerment model for heart failure patients is practically possible, leading to improvement or refinement of their and their families’ lifestyle. Trial Registration Number: IRCT 2014072018468N3 PMID:26448952

  2. Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial

    PubMed Central

    Anyanwu, Juliana N; Williams, Olatundun; Sautter, Casey L; Kasirye, Phillip; Hume, Heather; Opoka, Robert O; Latham, Teresa; Ndugwa, Christopher; Ware, Russell E

    2016-01-01

    Background Sickle cell anemia (SCA), one of most prevalent monogenic diseases worldwide, is caused by a glutamic acid to valine substitution on the beta globin protein of hemoglobin, which leads to hemolytic anemia. Hydroxyurea, the only disease-modifying therapy approved by the Food and Drug Administration for SCA, has proven to be a viable therapeutic option for SCA patients in resource-rich settings, given clinical improvements experienced while taking the medication and its once-daily oral dosing. Significant studies have demonstrated its safety and clinical efficacy among children and adults in developed countries. In Sub-Saharan Africa, however, the risk of malaria, hematologic toxicities, and safety of hydroxyurea in children with SCA living in malaria-endemic areas are unknown. Objectives Study objectives include determining the incidence of malaria in SCA patients taking hydroxyurea versus placebo; establishing the frequency of hematologic toxicities and adverse events (AEs) in children with SCA treated with hydroxyurea versus placebo; and defining the relationships between hydroxyurea treatment and fetal hemoglobin, soluble intracellular adhesion molecule-1, and nitric oxide levels, and between levels of these factors and risk of subsequent malaria. Methods Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM, NCT01976416) is a prospective, randomized, placebo-controlled, double-blinded phase III trial to compare risk of malaria with oral hydroxyurea versus placebo. Children will be recruited from the Mulago Hospital Sickle Cell Clinic in Kampala, Uganda. Results Two hundred Ugandan children aged between 1.00 and 3.99 years with confirmed SCA will be randomized into treatment groups by order of entry in the study, based on a predetermined blinded randomization list. The primary outcome of the trial is malaria incidence in the 2 study groups, defined as episodes of clinical malaria occurring over the 1-year randomized study treatment period

  3. [Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

    PubMed

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-04-01

    To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  4. The Effectiveness and Cost of Clinical Supervision for Motivational Interviewing: A Randomized Controlled Trial

    PubMed Central

    Martino, Steve; Paris, Manuel; Añez, Luis; Nich, Charla; Canning-Ball, Monica; Hunkele, Karen; Olmstead, Todd A.; Carroll, Kathleen M.

    2016-01-01

    The effectiveness of a competency-based supervision approach called Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP) was compared to Supervision-As-Usual (SAU) for increasing clinicians’ motivational interviewing (MI) adherence and competence and client retention and primary substance abstinence in a multisite Hybrid Type 2 effectiveness-implementation randomized controlled trial. Participants were 66 clinicians and 450 clients within one of eleven outpatient substance abuse programs. An independent evaluation of audio recorded supervision sessions indicated that MIA: STEP and SAU were highly and comparably discriminable across sites. While clinicians in both supervision conditions improved their MI performance, clinician supervised with MIA: STEP, compared to those in SAU, showed significantly greater increases in the competency in which they used fundamental and advanced MI strategies when using MI across seven intakes through a 16-week follow-up. There were no retention or substance use differences among the clients seen by clinicians in MIA: STEP or SAU. MIA: STEP was substantially more expensive to deliver than SAU. Innovative alternatives to resource-intensive competency-based supervision approaches such as MIA: STEP are needed to promote the implementation of evidence-based practices. PMID:27431042

  5. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial.

    PubMed

    Banks, Phil; Wright, Jean; O'Brien, Kevin

    2004-11-01

    The aim of this study was to evaluate the effectiveness of incremental and maximum bite advancement during treatment of Class II Division 1 malocclusion with the Twin-block appliance in the permanent dentition. It was performed at 3 district general hospitals in the United Kingdom with 4 operators. Two hundred three patients, 10-14 years old, were randomized. Control patients had the initial bite taken edge-to-edge for appliance construction with a standard Twin-block. Experimental patients had 2 mm initial bite advancement and subsequent 2 mm advancements at 6 weekly intervals with a Twin-block appliance incorporating advancement screws. Data were collected at the start and the finish of Twin-block treatment. The use of incremental advancement of the Twin-block did not confer any advantages in terms of process and outcome of the treatment. However, patient compliance was influenced by operator and patient age. The duration of treatment was influenced by operator and initial overjet. Incremental bite advancement produced no advantages over maximum advancement.

  6. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    PubMed

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD.

  7. Efficacy and safety of jollab to treat functional dyspepsia: a randomized placebo-controlled clinical trial.

    PubMed

    Pasalar, Mehdi; Choopani, Rasool; Mosaddegh, Mahmoud; Kamalinejad, Mohammad; Mohagheghzadeh, Abdolali; Fattahi, Mohammad Reza; Ghanizadeh, Ahmad; Bagheri Lankarani, Kamran

    2015-01-01

    Functional dyspepsia (FD) is a common gastrointestinal disease that is highly prevalent worldwide. Because of its heterogeneous pathophysiology, treatment options for FD can be difficult to choose; in this context, complementary and alternative medicine modalities have been suggested as promising options. To evaluate the efficacy of a traditional Persian medicine, jollab, in reducing patients' FD symptoms. In a double-blind randomized clinical trial, 160 patients with a diagnosis of FD were enrolled and treated with either jollab or placebo (15ml, t.i.d., four weeks, orally). The outcomes reported were changes in symptom frequency and severity as recorded in patients' diaries and evaluated with the Short Form of the Leeds Dyspepsia Questionnaire (SF-LDQ), and physical examination. The response rate was higher in the treatment group (78%) than in the placebo group (31%) according to per-protocol sample analysis (P < .001). Symptoms of FD disappeared significantly more frequently, and the rate of concomitant synthetic drug consumption was significantly lower, in the jollab group compared to the placebo group at the end of the trial. Mean total symptom frequency and severity according to the SF-LDQ score was 1.55 ± 2.78 in the treatment group versus 5.61 ± 3.80 in the placebo group at the last follow-up time point (P < .001). A promising safety profile for jollab was observed throughout the trial. In patients with FD, jollab appeared to be more effective than the placebo. Complementary and alternative therapies such as the use of this traditional medicinal substance may be beneficial in relieving symptoms of dyspepsia [ACTRN12613000584730]. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Metformin in Amnestic Mild Cognitive Impairment: results of a pilot randomized placebo controlled clinical trial

    PubMed Central

    Luchsinger, José A.; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Devangere P.; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (AMCI) with the goal of collecting preliminary data on feasiblity, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with AMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake (rCMRgl) in the posterior cingulate-precuneus in brain Fluorodeoxyglucose Positron Emission Tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty % of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7 ± 8.5 vs. 5.3 ± 8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD. PMID:26890736

  9. Garlic powder intake and cardiovascular risk factors: a meta-analysis of randomized controlled clinical trials

    PubMed Central

    Kwak, Jin Sook; Kim, Ji Yeon; Paek, Ju Eun; Lee, You Jin; Kim, Haeng-Ran; Park, Dong-Sik

    2014-01-01

    BACKGROUND/OBJECTIVES Although preclinical studies suggest that garlic has potential preventive effects on cardiovascular disease (CVD) risk factors, clinical trials and reports from systematic reviews or meta-analyses present inconsistent results. The contradiction might be attributed to variations in the manufacturing process that can markedly influence the composition of garlic products. To investigate this issue further, we performed a meta-analysis of the effects of garlic powder on CVD risk factors. MATERIALS/METHODS We searched PubMed, Cochrane, Science Direct and EMBASE through May 2014. A random-effects meta-analysis was performed on 22 trials reporting total cholesterol (TC), 17 trials reporting LDL cholesterol (LDL-C), 18 trials reporting HDL cholesterol (HDL-C), 4 trials reporting fasting blood glucose (FBG), 9 trials reporting systolic blood pressure (SBP) and 10 trials reporting diastolic blood pressure (DBP). RESULTS The overall garlic powder intake significantly reduced blood TC and LDL-C by -0.41 mmol/L (95% confidence interval [CI], -0.69, -0.12) (-15.83 mg/dL [95% CI, -26.64, -4.63]) and -0.21 mmol/L (95% CI, -0.40, -0.03) (-8.11 mg/dL [95% CI, -15.44, -1.16]), respectively. The mean difference in the reduction of FBG levels was -0.96 mmol/L (95% CI, -1.91, -0.01) (-17.30 mg/dL [95% CI, -34.41, -0.18]). Evidence for SBP and DBP reduction in the garlic supplementation group was also demonstrated by decreases of -4.34 mmHg (95% CI, -8.38, -0.29) and -2.36 mmHg (95% CI, -4.56, -0.15), respectively. CONCLUSIONS This meta-analysis provides consistent evidence that garlic powder intake reduces the CVD risk factors of TC, LDL-C, FBG and BP. PMID:25489404

  10. Effect of Borago Officinalis Extract on Moderate Persistent Asthma: A Phase two Randomized, Double Blind, Placebo-Controlled Clinical Trial.

    PubMed

    Mirsadraee, Majid; Khashkhashi Moghaddam, Sara; Saeedi, Parisa; Ghaffari, Sakineh

    2016-01-01

    Borago officinalis and its derivatives are used in folk medicine to treat asthma because of its special effect on allergic disorders. It suppresses the tumor necrosis factor-alpha (TNF-alpha) and delivers gamma-linolenic acid. The objective of this clinical trial was to determine the effect of Borago officinalis on clinical and physiological findings in moderate persistent asthma. This prospective, randomized, double blind, placebo-controlled, clinical trial was conducted on patients aged 15-90 years with moderate asthma and forced expiratory volume in one second (FEV1) of 60-79% of predicted who presented to a sub-specialty clinic of pulmonary medicine. We randomly allocated subjects to receive either Borago extract (5 mL three times a day) or a matched placebo for one month. The primary outcome was the asthma control test (ACT) score and fractional exhaled nitric oxide (FENO) test. Secondary outcomes included clinical findings, spirometry, and sputum cytology including inflammatory cells. Thirty-eight subjects with a mean age of 46.8±15.3 years and mean duration of asthma of 71±103 months were enrolled in our study. Cough, dyspnea, wheezing, nocturnal symptoms, and airway hyper-responsiveness reduced significantly in the Borago group after the treatment and ACT scores improved significantly (10.8±5.26 before and 15.4±5.12 after the trial). Flare up of asthma and emergency department visits in the Borago group also decreased significantly (3.6±2.33 to 2±1.86 flare ups per month and 0.62±0.9 to 0.05±0.23 for emergency department visits per month). Physiological parameters including spirometry, FENO, and sputum cytology including eosinophil and neutrophil did not change significantly. Borago improved the clinical findings of asthma, but it was not able to suppress the inflammation involved in asthma.

  11. Effect of Borago Officinalis Extract on Moderate Persistent Asthma: A Phase two Randomized, Double Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Khashkhashi Moghaddam, Sara; Saeedi, Parisa; Ghaffari, Sakineh

    2016-01-01

    Background: Borago officinalis and its derivatives are used in folk medicine to treat asthma because of its special effect on allergic disorders. It suppresses the tumor necrosis factor-alpha (TNF-alpha) and delivers gamma-linolenic acid. The objective of this clinical trial was to determine the effect of Borago officinalis on clinical and physiological findings in moderate persistent asthma. Materials and Methods: This prospective, randomized, double blind, placebo-controlled, clinical trial was conducted on patients aged 15–90 years with moderate asthma and forced expiratory volume in one second (FEV1) of 60–79% of predicted who presented to a sub-specialty clinic of pulmonary medicine. We randomly allocated subjects to receive either Borago extract (5 mL three times a day) or a matched placebo for one month. The primary outcome was the asthma control test (ACT) score and fractional exhaled nitric oxide (FENO) test. Secondary outcomes included clinical findings, spirometry, and sputum cytology including inflammatory cells. Results: Thirty-eight subjects with a mean age of 46.8±15.3 years and mean duration of asthma of 71±103 months were enrolled in our study. Cough, dyspnea, wheezing, nocturnal symptoms, and airway hyper-responsiveness reduced significantly in the Borago group after the treatment and ACT scores improved significantly (10.8±5.26 before and 15.4±5.12 after the trial). Flare up of asthma and emergency department visits in the Borago group also decreased significantly (3.6±2.33 to 2±1.86 flare ups per month and 0.62±0.9 to 0.05±0.23 for emergency department visits per month). Physiological parameters including spirometry, FENO, and sputum cytology including eosinophil and neutrophil did not change significantly. Conclusion: Borago improved the clinical findings of asthma, but it was not able to suppress the inflammation involved in asthma. PMID:28210282

  12. Favorable effect of rehabilitation on balance in ankylosing spondylitis: a quasi-randomized controlled clinical trial.

    PubMed

    Demontis, Alessandra; Trainito, Sabina; Del Felice, Alessandra; Masiero, Stefano

    2016-03-01

    Balance impairment is a frequent and undertreated manifestation in ankylosing spondylitis, leading to increased risk of falls and lower quality of life. Our aim was to assess supervised training and home-based rehabilitation efficacy on balance improvement in ankylosing spondylitis subjects on biologic agents. This was a single-blinded, quasi-randomized parallel study in a single outpatient Rehabilitation Clinic of a tertiary referral center. Subjects with ankylosing spondylitis on biologic agents were assigned either to supervised training and home-based rehabilitation program (rehabilitation group) plus educational-behavioral therapy, or to educational-behavioral therapy alone (educational groups). The same therapist provided therapy. Outcome measures were assessed at baseline (T0), end of treatment (T1) and at 7-month follow-up (T2). Rheumatologic outcomes were Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index. Balance parameters (anterior-posterior oscillation, latero-lateral oscillation, sway area, sway density and sway path) were evaluated by stabilometry in a condition of open and closed eyes. Forty-six subjects (36 M, 10 F) were enrolled. Demographic data and clinical status at baseline were comparable between the two groups (22 rehabilitation group, 20 educational group). Primary outcome was sway density that improved both at T1 (SDy: open eyes p = 0.003, closed eyes p = 0.004) and at T2 (SDx: open eyes p = 0.0015, closed eyes p = 0.032). A trend toward improvement in the rehabilitation group rather than in the educational group emerged for balance parameters, especially those measured with closed eyes (0.004 < p < 0.048 at T1 and 0.004 < p < 0.036 at T2). Supervised training and home exercise lead to balance improvement in people with ankylosing spondylitis. Eyes-closed trials show a more marked trend toward improvement, and this may suggest a

  13. A double-blind randomized placebo-controlled clinical trial of squalamine ointment for tinea capitis treatment.

    PubMed

    Coulibaly, Oumar; Thera, Mahamadou A; Koné, Abdoulaye K; Siaka, Goïta; Traoré, Pierre; Djimdé, Abdoulaye A; Brunel, Jean-Michel; Gaudart, Jean; Piarroux, Renaud; Doumbo, Ogobara K; Ranque, Stéphane

    2015-04-01

    Novel treatments against for tinea capitis are needed, and the natural aminosterol squalamine is a potential topical antidermatophyte drug candidate. This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Males aged 6-15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for 3 weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily. Five patients were treated with 1% squalamine ointment and 15 with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly (p = 0.03) better hair-growth score, indicating a partial clinical improvement of the tinea capitis lesion, was observed in the patients treated with squalamine compared to those treated with placebo. This three-week squalamine ointment regimen was well tolerated and showed an encouraging partial clinical activity for the treatment of tinea capitis. Further studies are needed to evaluate the efficacy of topical squalamine alone against tinea corporis or in combination with a systemic antidermatophyte drug against tinea capitis.

  14. Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial

    PubMed Central

    Wilson, S. Jo-Anne; Wells, Philip S.; Kovacs, Michael J.; Lewis, Geoffrey M.; Martin, Janet; Burton, Erica; Anderson, David R.

    2003-01-01

    Background There is growing evidence that better outcomes are achieved when anticoagulation is managed by anticoagulation clinics rather than by family physicians. We carried out a randomized controlled trial to evaluate these 2 models of anticoagulant care. Methods We randomly allocated patients who were expected to require warfarin sodium for 3 months either to anticoagulation clinics located in 3 Canadian tertiary hospitals or to their family physician practices. We evaluated the quality of oral anticoagulant management by comparing the proportion of time that the international normalized ratio (INR) of patients receiving warfarin sodium was within the target therapeutic range ± 0.2 INR units (expanded therapeutic range) while they were managed in anticoagulation clinics as opposed to family physicians' care over 3 months. We measured the rates of thromboembolic and major hemorrhagic events and patient satisfaction in the 2 groups. Results Of the 221 patients enrolled, 112 were randomly assigned to anticoagulation clinics and 109 to family physicians. The INR values of patients who were managed by anticoagulation clinics were within the expanded therapeutic range 82% of the time versus 76% of the time for those managed by family physicians (p = 0.034). High-risk INR values (defined as being < 1.5 or > 5.0) were more commonly observed in patients managed by family physicians (40%) than in patients managed by anticoagulation clinics (30%, p = 0.005). More INR measurements were performed by family physicians than by anticoagulation clinics (13 v. 11, p = 0.001). Major bleeding events (2 [2%] v. 1 [1%]), thromboembolic events (1 [1%] v. 2 [2%]) and deaths (5 [4%] v. 6 [6%]) occurred at a similar frequency in the anticoagulation clinic and family physician groups respectively. Of the 170 (77%) patients who completed the patient satisfaction questionnaire, more were satisfied when their anticoagulant management was managed through anticoagulation clinics than by

  15. Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial.

    PubMed

    Chatterjee, S; Biswas, T; Dutta, A; Sengupta, G; Mitra, A; Kundu, S

    2011-02-01

    Acute exacerbation of chronic bronchitis (AECB) is a commonly encountered problem and those suspected to be due to bacterial infections require antibiotic therapy. This randomized, controlled trial was designed to evaluate the effectiveness and safety of gemifloxacin, a new fluoroquinolone, versus cefpodoxime, an oral third-generation cephalosporin, for the treatment of mild to moderately severe cases of AECB. Adult subjects diagnosed with chronic bronchitis with clinical symptoms suggestive of an Anthonisen type II acute exacerbation (any two of the following criteria - increased dyspnea, cough, sputum purulence) were eligible and those fulfilling the subject selection criteria were randomized to receive either gemifloxacin 320 mg once daily or cefpodoxime 200 mg twice daily orally for 7 days. The primary outcome measure was clinical success rate at day 14 visit and the secondary outcome measures were changes in Clinical Global impression (CGI) scales and incidence of adverse events (AEs). Fifty-two subjects were enrolled: 26 in gemifloxacin group and 24 in the other and 2 were lost to follow-up. The clinical success rates were comparable (84.6% in gemifloxacin group versus 83.3% in cefpodoxime group) and no statistically significant difference was observed between the groups. AEs were mild, self-limiting and few (two in gemifloxacin and three in cefpodoxime arm) and tolerability was also good. The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients.

  16. Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial

    PubMed Central

    Chatterjee, S.; Biswas, T.; Dutta, A.; Sengupta, G.; Mitra, A.; Kundu, S.

    2011-01-01

    Objective: Acute exacerbation of chronic bronchitis (AECB) is a commonly encountered problem and those suspected to be due to bacterial infections require antibiotic therapy. This randomized, controlled trial was designed to evaluate the effectiveness and safety of gemifloxacin, a new fluoroquinolone, versus cefpodoxime, an oral third-generation cephalosporin, for the treatment of mild to moderately severe cases of AECB. Materials and Methods: Adult subjects diagnosed with chronic bronchitis with clinical symptoms suggestive of an Anthonisen type II acute exacerbation (any two of the following criteria – increased dyspnea, cough, sputum purulence) were eligible and those fulfilling the subject selection criteria were randomized to receive either gemifloxacin 320 mg once daily or cefpodoxime 200 mg twice daily orally for 7 days. The primary outcome measure was clinical success rate at day 14 visit and the secondary outcome measures were changes in Clinical Global impression (CGI) scales and incidence of adverse events (AEs). Fifty-two subjects were enrolled: 26 in gemifloxacin group and 24 in the other and 2 were lost to follow-up. Results: The clinical success rates were comparable (84.6% in gemifloxacin group versus 83.3% in cefpodoxime group) and no statistically significant difference was observed between the groups. AEs were mild, self-limiting and few (two in gemifloxacin and three in cefpodoxime arm) and tolerability was also good. Conclusion: The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients. PMID:21455420

  17. Clinical application of prismatic lenses in the rehabilitation of neglect patients. A randomized controlled trial.

    PubMed

    Mancuso, M; Pacini, M; Gemignani, P; Bartalini, B; Agostini, B; Ferroni, L; Caputo, M; Capitani, D; Mondin, E; Cantagallo, A

    2012-06-01

    Many studies reveal that neglect is a major cause of disability in stroke patients, and two months from onset neglect is still present in approximately 50% of individuals with a right brain lesion. Among the various methods of neglect rehabilitation, we have turned our attention to the prism adaptation treatment, developed by Rossetti in 1998. This treatment uses prismatic lenses, which produce a deviation of the fixation point of the visual field of 10 degrees to the right, 5 degrees below the coordinates of reference resulting from neglect. To set out the possible effectiveness of less powerful lenses, we studied the response of a group of neglect patients treated with prismatic lenses that produce a deviation of the fixation point of only 5 degrees to the right, comparing them with a group of patients receiving placebo lenses. Randomized controlled trial. Outpatients. The study involved 29 patients with left visual neglect. All patients were assessed with a battery of seven visual-spatial tests. All patients were randomized by the pilot center and assigned to two different groups: "A" treated with pointing exercises and prismatic lenses of 5° to the right; "B" treated with pointing exercises and neutral lenses. Each group was treated with 5 rehabilitation sessions, lasting about 30 minutes each, from Monday to Friday for one week in the morning, by the same investigator, in each center. The results showed that the prismatic lenses of only five degrees, used for the study, did not contribute to the variation in performance. Thus, this deviation of the fixation point of the visual field to the right is not sufficient to create a therapeutic effect. The improvement observed within the two groups, seems likely to be correlated with the pointing exercises, which force the subject to perform a visuomotor task with the healthy arm also in the neglected side. We believe that in order to carry out an effective treatment with prismatic lenses they must have a grade of at

  18. Teaching evidence-based medicine literature searching skills to medical students during the clinical years: a randomized controlled trial.

    PubMed

    Ilic, Dragan; Tepper, Katrina; Misso, Marie

    2012-07-01

    Constructing an answerable question and effectively searching the medical literature are key steps in practicing evidence-based medicine (EBM). This study aimed to identify the effectiveness of delivering a single workshop in EBM literature searching skills to medical students entering their first clinical years of study. A randomized controlled trial was conducted with third-year undergraduate medical students. Participants were randomized to participate in a formal workshop in EBM literature searching skills, with EBM literature searching skills and perceived competency in EBM measured at one-week post-intervention via the Fresno tool and Clinical Effectiveness and Evidence-Based Practice Questionnaire. A total of 121 participants were enrolled in the study, with 97 followed-up post-intervention. There was no statistical mean difference in EBM literature searching skills between the 2 groups (mean difference = 0.007 (P = 0.99)). Students attending the EBM workshop were significantly more confident in their ability to construct clinical questions and had greater perceived awareness of information resources. A single EBM workshop did not result in statistically significant changes in literature searching skills. Teaching and reinforcing EBM literature searching skills during both preclinical and clinical years may result in increased student confidence, which may facilitate student use of EBM skills as future clinicians.

  19. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics

    PubMed Central

    2014-01-01

    Background Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment. Methods/Design We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models. Discussion This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment. Trial Registration clinicaltrials.gov NCT01378858 PMID:24928218

  20. Teaching evidence-based medicine literature searching skills to medical students during the clinical years: a randomized controlled trial

    PubMed Central

    Tepper, Katrina; Misso, Marie

    2012-01-01

    Objectives: Constructing an answerable question and effectively searching the medical literature are key steps in practicing evidence-based medicine (EBM). This study aimed to identify the effectiveness of delivering a single workshop in EBM literature searching skills to medical students entering their first clinical years of study. Methods: A randomized controlled trial was conducted with third-year undergraduate medical students. Participants were randomized to participate in a formal workshop in EBM literature searching skills, with EBM literature searching skills and perceived competency in EBM measured at one-week post-intervention via the Fresno tool and Clinical Effectiveness and Evidence-Based Practice Questionnaire. Results: A total of 121 participants were enrolled in the study, with 97 followed-up post-intervention. There was no statistical mean difference in EBM literature searching skills between the 2 groups (mean difference = 0.007 (P = 0.99)). Students attending the EBM workshop were significantly more confident in their ability to construct clinical questions and had greater perceived awareness of information resources. Conclusions: A single EBM workshop did not result in statistically significant changes in literature searching skills. Teaching and reinforcing EBM literature searching skills during both preclinical and clinical years may result in increased student confidence, which may facilitate student use of EBM skills as future clinicians. PMID:22879808

  1. Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

    PubMed

    Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

    2015-04-01

    Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

  2. Clinical Outcomes Comparing Capsular Repair vs. No Repair Following Hip Arthroscopy: A Prospective, Randomized, Control Study

    PubMed Central

    Sugarman, Etan P.; Birns, Michael E.; Fishman, Matthew; Patel, Deepan N.; Goldsmith, Laura; Greene, Renee Shirley; Banffy, Michael B.

    2017-01-01

    Objectives: As hip arthroscopy procedures become more common there is increasing concern of iatrogenic instability from excessive capsulotomy during surgery. As a result, greater attention is being focused preserving hip capsule integrity following surgery. To date, there are no large scale prospective blinded studies that address whether capsular closure has any detrimental effect on outcomes. Our goal is to evaluate outcomes in patients undergoing interportal capsulotomy repair compared to outcomes when not repairing the capsule. The purpose of this study is to demonstrate a clinical/functional difference at 1 & 2 year follow up between patients who undergo capsular repair vs no repair following hip arthroscopy. Our hypothesis is that restoration of normal capsular anatomy with interportal repair will achieve similar clinical outcomes as the “no repair” group without functional deficits from over-constraint. Methods: Adult patients were recruited from November 2013 to July 2015 who were scheduled to undergo hip arthroscopy for femoral acetabular. Subjects were randomized into either the capsular repair (CR) or no repair (NR) groups. Standard AP/Dunn view radiographs were evaluated and alpha angle (AA) /center-edge (CEA) angle measurements were performed for all patients preoperatively. All patients underwent standard hip arthroscopy with labral repair +/- CAM/pincer lesion resection. Primary clinical outcomes were measured via the Hip Outcome Score Activities of Daily Living (HOS-ADL) and Sport-Specific (HOS-SS) subscales at 3 months, 6 months and 1 year. Secondary outcome measures included the modified Harris Hip Score (mHHS), visual analog scale (VAS), the international hip outcome tool (iHOT-12), and the Veterans RAND 12 Item Health Survey (VR-12) scores. Results: A total of 56 patients were included in this study (30 male, 26 females) with a mean age of 33 years. Follow up was available for 49 patients at 6 months, 41 patients at 1 year and 26 patients at

  3. The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

    PubMed

    Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

    2016-06-01

    Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p < 0.001). Pain severity decreased significantly in treatment group after eight weeks of treatment. There was a significant difference in pain intensity between the two groups after eight weeks of treatment and one month after the end of treatment (p < 0.001 for both). A weekly high dose (50 000 IU) oral vit D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.

  4. Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

    PubMed

    Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

    2012-02-01

    Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (P<0.05), but not in the control groups (ns). In study 1, a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group (P<0.05), and a trend in the same direction was seen in study 2 (P=0.17). The results seen at 3 months were sustained up to 1 year. Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

  5. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching.

    PubMed

    Pintado-Palomino, Karen; Peitl Filho, Oscar; Zanotto, Edgar Dutra; Tirapelli, Camila

    2015-09-01

    To evaluate the efficacy of experimental proposals of desensitizing agents during tooth bleaching. 140 participants without tooth sensitivity (TS) received 16% carbamide peroxide (14 days-04 h each) (T1) or 35% hydrogen peroxide (single session-45 min) (T2). Participants used concomitantly (10 per group): desensitizing dentifrices (D1-experimental bioactive glass-ceramic; D2-commercial potassium nitrate; D3-commercial calcium and sodium phosphosilicate) in-home, daily and, desensitizing pastes (D4-experimental bioactive glass-ceramic; D5-experimental Bioglass type 45S5; D6-commercial calcium phosphate), in-office, immediately after the treatment and more 4 times. Participants in the control group did not use any desensitizing agent. We assessed TS with Visual Analogue Scale. Assessment point 1 was immediately after the first participant's exposure to the treatments; and points 2, 3, 4, and 5 were every 72 h along the period of the study. Two-way ANOVA (considering time and desensitizing as factors) and post-hoc Tukey test (α=0.05) analyzed the data. In the control group treated with 35% hydrogen peroxide, TS increased significantly on assessment points 1 and 2. The participants who used a 5% potassium nitrate dentifrice and in-office experimental pastes did not experience TS because of the 35% in-office bleaching treatment. TS caused by 35% hydrogen peroxide in-office tooth bleaching was controlled by experimental products prepared as pastes D4-experimental bioactive glass-ceramic and D5-experimental Bioglass type 45S5, but not by D1-experimental dentifrice containing bioactive glass-ceramic. There is no a gold standard protocol for TS caused by tooth bleaching. The study of novel desensitizing agents that can obliterate the dentinal tubules in a faster-acting and long-lasting way may help meet this clinical need. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Aspirin and serum estrogens in postmenopausal women: a randomized controlled clinical trial.

    PubMed

    Duggan, Catherine; Wang, Ching-Yun; Xiao, Liren; McTiernan, Anne

    2014-09-01

    Epidemiologic studies suggest a reduced risk of breast cancer among women who use aspirin. A plausible mechanism is through aspirin's effect on estrogens, possibly mediated through interference with estrogen synthesis via reduction in inflammation, which is increased in adipose tissues, including breast. In a randomized placebo-controlled trial, we evaluated the effects of six-month administration of 325 mg/day aspirin on serum estrogens (estradiol, estrone, free estradiol, and bioavailable estradiol) and sex hormone-binding globulin (SHBG) in 144 healthy postmenopausal women. Eligible participants, recruited 2005-2007, were not taking nonsteroidal anti-inflammatory medication, including aspirin >2 times/week or menopausal hormone therapy, and had a Breast Imaging-Reporting and Data System (BI-RADS) mammographic density classification of 2, 3, or 4. The intervention effects (intent-to-treat) were evaluated by differences in the geometric mean outcome changes at six months between aspirin and placebo groups using generalized estimating equations (GEE). Participants were a mean 59.4 (SD, 5.4) years of age, with a mean body mass index (BMI) of 26.4 (SD, 5.4) kg/m(2). Between baseline and six months, none of the serum estrogens or SHBG changed substantially and there were no differences between groups. Stratifying by BMI did not change results. In conclusion, a single daily administration of 325 mg of aspirin for six months had no effect on serum estrogens or SHBG in postmenopausal women. Larger doses or longer duration of aspirin administration may be needed to affect circulating estrogens. Alternately, if aspirin influences breast cancer risk in postmenopausal women, it may do so through direct breast tissue effects, or through pathways other than estrogens.

  7. [Intravenous lidocaine for post-mastectomy pain treatment: randomized, blind, placebo controlled clinical trial].

    PubMed

    Couceiro, Tania Cursino de Menezes; Lima, Luciana Cavalcanti; Burle, Léa Menezes Couceiro; Valença, Marcelo Moraes

    2015-01-01

    Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was conducted with intravenous lidocaine at a dose of 3 mg/kg infused over one hour in 45 women undergoing mastectomy under general anesthesia. One patient from placebo group was Groups were similar in age, body mass index, type of surgery, and postoperative need for opioids. Two of 22 patients in lidocaine group and three of 22 patients in placebo group requested opioid (p=0.50). Pain on awakening was identified in 4/22 of lidocaine group and 5/22 of placebo group (p=0.50); in the post-anesthetic recovery room in 14/22 and 12/22 (p=0.37) of lidocaine and placebo groups, respectively. Pain evaluation 24hours after surgery showed that 2/22 and 3/22 patients (p=0.50) of lidocaine and placebo groups, respectively, complained of pain. Intravenous lidocaine at a dose of 3 mg/kg administered over a period of an hour during mastectomy did not promote additional analgesia compared to placebo in the first 24hours, and has not decreased opioid consumption. However, a beneficial effect of intravenous lidocaine in selected and/or other therapeutic regimens patients can not be ruled out. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  8. Intravenous lidocaine for postmastectomy pain treatment: randomized, blind, placebo controlled clinical trial.

    PubMed

    Couceiro, Tania Cursino de Menezes; Lima, Luciana Cavalcanti; Burle, Léa Menezes Couceiro; Valença, Marcelo Moraes

    2015-01-01

    Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was conducted with intravenous lidocaine at a dose of 3mg/kg infused over 1h in 45 women undergoing mastectomy under general anesthesia. One patient from placebo group was. Groups were similar in age, body mass index, type of surgery, and postoperative need for opioids. Two of 22 patients in lidocaine group and three of 22 patients in placebo group requested opioid (p=0.50). Pain on awakening was identified in 4/22 of lidocaine group and 5/22 of placebo group (p=0.50); in the post-anesthetic recovery room in 14/22 and 12/22 (p=0.37) of lidocaine and placebo groups, respectively. Pain evaluation 24h after surgery showed that 2/22 and 3/22 patients (p=0.50) of lidocaine and placebo groups, respectively, complained of pain. Intravenous lidocaine at a dose of 3mg/kg administered over a period of an hour during mastectomy did not promote additional analgesia compared to placebo in the first 24h, and has not decreased opioid consumption. However, a beneficial effect of intravenous lidocaine in selected and/or other therapeutic regimens patients cannot be ruled out. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  9. Vapocoolant Spray Versus Lidocaine Infiltration for Radial Artery Cannulation: A Prospective, Randomized, Controlled Clinical Trial.

    PubMed

    Rüsch, Dirk; Koch, Tilo; Seel, Florian; Eberhart, Leopold

    2017-02-01

    Local infiltration with lidocaine is a frequently used measure to prevent pain during arterial cannulation. Its administration is associated with pain. Vapocoolants like ethyl chloride or alkanes also affect rapid-onset anesthesia. However, their administration causes less discomfort compared with administration of lidocaine. The effectiveness of vapocoolants in mitigating discomfort associated with arterial cannulation never has been studied. The authors therefore compared vapocoolant with lidocaine for reducing discomfort caused by arterial cannulation. Prospective, randomized, controlled study. University hospital, single center. One hundred sixty adult patients requiring arterial cannulation before induction of general anesthesia for cardiac surgery or carotid endarterectomy. Patients received either lidocaine infiltration or vapocoolant spray prior to arterial cannulation. Overall discomfort resulting from the whole procedure (applying local/topical anesthesia followed by arterial puncture) was rated on a 0 to 10 numerical rating scale. Puncture failure rate and time required for the intervention also were recorded. One hundred forty-three patients were included in the per-protocol analysis. Mean pain scores in the vapocoolant group were 3.4 (±1.58) compared with 4.5 (±2.29) in the lidocaine group (difference 1.1±0.33; p = 0.032; Mann-Whitney U-test). The higher puncture failure rate in the lidocaine group (n = 11 v 4) was not significant (p = 0.06; Fisher's exact test). The time required for the intervention was longer in the lidocaine group (138±44 s v 128±44 s; p = 0.019; Mann-Whitney U-test). Vapocoolant spray is an alternative to lidocaine infiltration to mitigate discomfort associated with arterial cannulation. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Efficacy of hydrotherapy in fibromyalgia syndrome--a meta-analysis of randomized controlled clinical trials.

    PubMed

    Langhorst, Jost; Musial, Frauke; Klose, Petra; Häuser, Winfried

    2009-09-01

    To systematically review the efficacy of hydrotherapy in FM syndrome (FMS). We screened MEDLINE, PsychInfo, EMBASE, CAMBASE and CENTRAL (through December 2008) and the reference sections of original studies and systematic reviews on hydrotherapy in FMS. Randomized controlled trials (RCTs) on the treatment of FMS with hydrotherapy (spa-, balneo- and thalassotherapy, hydrotherapy and packing and compresses) were analysed. Methodological quality was assessed by the van Tulder score. Effects were summarized using standardized mean differences (SMDs). Ten out of 13 RCTs with 446 subjects, with a median sample size of 41 (range 24-80) and a median treatment time of 240 (range 200-300) min, were included into the meta-analysis. Only three studies had a moderate quality score. There was moderate evidence for reduction of pain (SMD -0.78; 95% CI -1.42, -0.13; P < 0.0001) and improved health-related quality of life (HRQOL) (SMD -1.67; 95% CI -2.91, -0.43; P = 0.008) at the end of therapy. There was moderate evidence that the reduction of pain (SMD -1.27; 95% CI -2.15, -0.38; P = 0.005) and improvement of HRQOL (SMD -1.16; 95% CI -1.96, -0.36; P = 0.005) could be maintained at follow-up (median 14 weeks). There is moderate evidence that hydrotherapy has short-term beneficial effects on pain and HRQOL in FMS patients. There is a risk to over-estimate the effects of hydrotherapy due to methodological weaknesses of the studies and to small trials included in meta-analysis.

  11. Control of White Spot Lesions with Use of Fluoride Varnish or Chlorhexidine Gel During Orthodontic Treatment A Randomized Clinical Trial.

    PubMed

    Restrepo, M; Bussaneli, D G; Jeremias, F; Cordeiro, R C L; Raveli, D B; Magalhães, A C; Candolo, C; Santos-Pinto, L

    2016-01-01

    To compare the effectiveness of fluoride varnish and 2% chlorhexidine gel for controlling active white spot lesions (WSLs) adjacent to orthodontic brackets. Thirty-five orthodontic patients (17.2 ± 2.3 years old) presenting 60 WSLs adjacent to orthodontic brackets were enrolled in this randomized, blind, 3-armed and controlled clinical trial. The patients were randomly allocated to 1 of 3 arms: (1) two applications of 5% NaF varnish- F, with one-week interval, (2) two applications of 2% chlorhexidine gel-CHX, with one-week interval and (3) usual home care-control (CO). The WSLs were scored by using a DIAGNOdent pen. An independent examiner scored the surfaces using Nyvad criteria for caries assessment. A total of thirty patients presenting 51 lesions completed the study. All treatments reduced the fluorescence values during the experimental period; however, F induced faster remineralization than CHX. After 3 months, 70.58 % were inactive considering all groups. DIAGNOdent pen and Nyvad presented a significant correlation. After 3 months of treatment, F, CHX and CO were capable of controlling the WSLs adjacent to the orthodontic brackets. However, the treatment with F was capable of controlling the progression of the WSLs in a shorter period of time.

  12. Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial

    PubMed Central

    Hartmann, Andreas; Müllner, Julia; Meier, Niklaus; Hesekamp, Helke; van Meerbeeck, Priscilla; Habert, Marie-Odile; Kas, Aurélie; Tanguy, Marie-Laure; Mazmanian, Merry; Oya, Hervé; Abuaf, Nissen; Gaouar, Hafida; Salhi, Sabrina; Charbonnier-Beaupel, Fanny; Fievet, Marie-Hélène; Galanaud, Damien; Arguillere, Sophie; Roze, Emmanuel; Degos, Bertrand; Grabli, David; Lacomblez, Lucette; Hubsch, Cécile; Vidailhet, Marie; Bonnet, Anne-Marie

    2016-01-01

    In the present study, we examined the potential symptomatic and/or disease-modifying effects of monthly bee venom injections compared to placebo in moderatly affected Parkinson disease patients. We conducted a prospective, randomized double-blind study in 40 Parkinson disease patients at Hoehn & Yahr stages 1.5 to 3 who were either assigned to monthly bee venom injections or equivalent volumes of saline (treatment/placebo group: n = 20/20). The primary objective of this study was to assess a potential symptomatic effect of s.c. bee venom injections (100 μg) compared to placebo 11 months after initiation of therapy on United Parkinson’s Disease Rating Scale (UPDRS) III scores in the « off » condition pre-and post-injection at a 60 minute interval. Secondary objectives included the evolution of UPDRS III scores over the study period and [123I]-FP-CIT scans to evaluate disease progression. Finally, safety was assessed by monitoring specific IgE against bee venom and skin tests when necessary. After an 11 month period of monthly administration, bee venom did not significantly decrease UPDRS III scores in the « off » condition. Also, UPDRS III scores over the study course, and nuclear imaging, did not differ significantly between treatment groups. Four patients were excluded during the trial due to positive skin tests but no systemic allergic reaction was recorded. After an initial increase, specific IgE against bee venom decreased in all patients completing the trial. This study did not evidence any clear symptomatic or disease-modifying effects of monthly bee venom injections over an 11 month period compared to placebo using a standard bee venom allergy desensitization protocol in Parkinson disease patients. However, bee venom administration appeared safe in non-allergic subjects. Thus, we suggest that higher administration frequency and possibly higher individual doses of bee venom may reveal its potency in treating Parkinson disease. Trial Registration

  13. Text-messaging versus telephone reminders to reduce missed appointments in an academic primary care clinic: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Telephone or text-message reminders have been shown to significantly reduce the rate of missed appointments in different medical settings. Since text-messaging is less resource-demanding, we tested the hypothesis that text-message reminders would be as effective as telephone reminders in an academic primary care clinic. Methods A randomized controlled non-inferiority trial was conducted in the academic primary care division of the Geneva University Hospitals between November 2010 and April 2011. Patients registered for an appointment at the clinic, and for whom a cell phone number was available, were randomly selected to receive a text-message or a telephone call reminder 24 hours before the planned appointment. Patients were included each time they had an appointment. The main outcome was the rate of unexplained missed appointments. Appointments were not missed if they were cancelled or re-scheduled before or independently from the intervention. We defined non-inferiority as a difference below 2% in the rate of missed appointments and powered the study accordingly. A satisfaction survey was conducted among a random sample of 900 patients (response rate 41%). Results 6450 patients were included, 3285 in the text-message group and 3165 in the telephone group. The rate of missed appointments was similar in the text-message group (11.7%, 95% CI: 10.6-12.8) and in the telephone group (10.2%, 95% CI: 9.2-11.3 p = 0.07). However, only text message reminders were cost-effective. No patient reported any disturbance by any type of reminder in the satisfaction survey. Three quarters of surveyed patients recommended its regular implementation in the clinic. Conclusions Text-message reminders are equivalent to telephone reminders in reducing the proportion of missed appointments in an academic primary care clinic and are more cost-effective. Both types of reminders are well accepted by patients. PMID:23557331

  14. Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Yousefichaijan, Parsa; Cyrus, Ali; Dorreh, Fatemeh; Rafeie, Mohammad; Sharafkhah, Mojtaba; Frohar, Faryar; Safi, Fatemeh

    2015-01-01

    Background: Nephrolithiasis in children is associated with a high rate of complications and recurrence. Objectives: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. Patients and Methods: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. Results: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001) in a way that the decrease in the intervention group showed no difference with the control group. Conclusions: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field. PMID:26635934

  15. Suspected black cohosh hepatotoxicity: no evidence by meta-analysis of randomized controlled clinical trials for isopropanolic black cohosh extract.

    PubMed

    Naser, Belal; Schnitker, Jörg; Minkin, Mary Jane; de Arriba, Susana Garcia; Nolte, Klaus-Ulrich; Osmers, Rüdiger

    2011-04-01

    Black cohosh, a popular herbal treatment for menopausal symptoms, has been implicated in a number of hepatotoxicity case reports. The purpose of this investigation was to analyze data gained from clinical trials on the effect of black cohosh on liver function. A meta-analysis of randomized, double-blind, and controlled clinical trials was conducted. These studies primarily evaluated the efficacy and safety of the isopropanolic black cohosh extract (iCR) in perimenopausal and postmenopausal women. Raw data on liver function values of aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltranspeptidase were considered in this analysis, if these data at baseline and after 3 to 6 months of treatment were available. Standard methods of descriptive statistics were used in this analysis. Five studies involving a total of 1,117 women were included in the meta-analyses. A total of 1,020 women (test population=517 and reference population=503) completed the studies. Perimenopausal and postmenopausal women (40-60 y) were treated daily with iCR (corresponding to 40-128 mg drug) for 3 to 6 months. The meta-analyses of the standardized mean differences in the "test" versus "reference" showed no significant effects and no differences between double-blind, placebo-controlled and other trials. The overall fixed effect ± SEM was 0.055 ± 0.062 (P=0.37) for aspartate aminotransferase and 0.063 ± 0.062 (P=0.31) for alanine aminotransferase. The nonsignificant effects concerned the overall analyses of all included studies as well as the proportion of placebo-controlled studies. The results of this meta-analysis of five randomized, double-blind, and controlled clinical trials showed no evidence that iCR has any adverse effect on liver function. © 2011 by The North American Menopause Society

  16. [Treatment of vascular dementia by Chinese herbal medicine: a systematic review of randomized controlled trials of clinical studies].

    PubMed

    Jian, Wen-Jia; Shi, Jing; Tian, Jin-Zhou; Ni, Jing-Nian

    2015-01-01

    Chinese herbal medicine has been extensively used in the treatment of vascular dementia (VaD), but lacked systematic review on its efficacy and safety. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating VaD. CNKI, CBM, PubMed, and Wiley Online Library were retrieved for randomized trials (RCTs) on Chinese herbal medicine treating VaD patients. Randomized parallel control trials by taking Chinese herbal medicine as one treatment method and placebos/cholinesterase inhibitors/Memantine hydrochloride as the control were included. Quality rating and data extraction were performed. RevMan5.2.0 Software was used for meta-analysis. Standardized mean difference (SMD) at 95% confidence interval (CI) was used to indicate effect indicators of results. Seven RCTs met the inclusive criteria. Totally 677 VaD patients were randomly assigned to the treatment group and the control group. Descriptive analyses were performed in inclusive trials. The cognitive function was assessed in all trials. Results showed Mini-Mental state examination (MMSE) score was better in the Chinese herbal medicine group than in the placebo group, but with no significant difference when compared with the donepezil group (P > 0.05). Adverse reactions were mainly manifested as gastrointestinal symptoms such as abdominal pain in the Chinese herbal medicine group. But they occurred more in the donepezil group than in the Chinese herbal medicine group. The methodological quality of included trials was poor with less samples. Results of different trials were lack of consistency. Present evidence is not sufficient to prove or disapprove the role of Chinese herbal medicine in improving clinical symptoms and outcome indicators of VaD patients. Their clinical efficacy and safety need to be supported by more higher quality RCTs.

  17. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol.

    PubMed

    Fukuoka, Yoshimi; Komatsu, Judith; Suarez, Larry; Vittinghoff, Eric; Haskell, William; Noorishad, Tina; Pham, Kristin

    2011-12-14

    Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth. ClinicalTrials.gov#:NCTO1280812.

  18. Antiobesity effect of caraway extract on overweight and obese women: a randomized, triple-blind, placebo-controlled clinical trial.

    PubMed

    Kazemipoor, Mahnaz; Radzi, Che Wan Jasimah Bt Wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377.

  19. Efficacy of Acupuncture in Itch: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials

    PubMed Central

    Yu, Chi; Lv, Zheng-Tao; Li, Jing-Jing; Wu, Cai-Hua; Gao, Fang; Yuan, Xiao-Cui; Zhang, Jing; He, Wei; Jing, Xiang-Hong

    2015-01-01

    Background. Itch (pruritus) is a sensitive state that provokes the desire to scratch. It is not only a common symptom of skin diseases but it also occurs in some systemic diseases. Clinical studies on the efficacy of the acupuncture therapy in alleviating itch are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This systematic review aims to assess the effectiveness of acupuncture therapy for itch. Materials and Methods. A comprehensive literature search of eight databases was performed up to June 2014, and randomized controlled trials which compared acupuncture therapy and placebo acupuncture or no treatment group were identified. Accordingly, a meta-analysis was conducted. Results. This review included three articles of randomized controlled trials (RCTs) from a total of 2530 articles. The results of Meta-analysis showed that acupuncture therapy was effective to alleviate itch compared with placebo acupuncture and no treatment group. Conclusion. Based on the findings of this systematic review, we cautiously suggest that acupuncture therapy could improve the clinical efficacy of itch. However, this conclusion needs more studies on various ethnic samples to confirm our final conclusion. PMID:26064156

  20. Efficacy of Acupuncture in Itch: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials.

    PubMed

    Yu, Chi; Zhang, Pei; Lv, Zheng-Tao; Li, Jing-Jing; Li, Hong-Ping; Wu, Cai-Hua; Gao, Fang; Yuan, Xiao-Cui; Zhang, Jing; He, Wei; Jing, Xiang-Hong; Li, Man

    2015-01-01

    Background. Itch (pruritus) is a sensitive state that provokes the desire to scratch. It is not only a common symptom of skin diseases but it also occurs in some systemic diseases. Clinical studies on the efficacy of the acupuncture therapy in alleviating itch are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This systematic review aims to assess the effectiveness of acupuncture therapy for itch. Materials and Methods. A comprehensive literature search of eight databases was performed up to June 2014, and randomized controlled trials which compared acupuncture therapy and placebo acupuncture or no treatment group were identified. Accordingly, a meta-analysis was conducted. Results. This review included three articles of randomized controlled trials (RCTs) from a total of 2530 articles. The results of Meta-analysis showed that acupuncture therapy was effective to alleviate itch compared with placebo acupuncture and no treatment group. Conclusion. Based on the findings of this systematic review, we cautiously suggest that acupuncture therapy could improve the clinical efficacy of itch. However, this conclusion needs more studies on various ethnic samples to confirm our final conclusion.

  1. Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

    PubMed Central

    Chang, Chun-Shin; Wallace, Christopher Glenn; Hsiao, Yen-Chang; Chang, Chee-Jen; Chen, Philip Kuo-Ting

    2014-01-01

    Background Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. Methods In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths. Results 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. Conclusion Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. Trial Registration ClinicalTrials.gov NCT01429402 PMID:25541942

  2. Continuous subcutaneous hydrocortisone infusion therapy in Addison's disease: a randomized, placebo-controlled clinical trial.

    PubMed

    Gagliardi, Lucia; Nenke, Marni A; Thynne, Tilenka R J; von der Borch, Jenny; Rankin, Wayne A; Henley, David E; Sorbello, Jane; Inder, Warrick J; Torpy, David J

    2014-11-01

    Patients with Addison's disease (AD) report impaired subjective health status (SHS). Since cortisol exhibits a robust circadian cycle that entrains other biological clocks, impaired SHS may be due to the noncircadian cortisol profile achieved with conventional glucocorticoid replacement. Continuous subcutaneous hydrocortisone infusion (CSHI) reproduces a circadian cortisol profile, but its effects on SHS have not been objectively evaluated. The aim of this study was to determine the effect of CSHI on SHS in AD. This was a multicentre, double-blind, placebo-controlled trial of CSHI vs oral glucocorticoid therapy. Participants received in random order 4 weeks of: CSHI and oral placebo, and subcutaneous placebo and oral hydrocortisone, separated by a 2-week washout period. SHS was assessed using the Short-Form 36 (SF-36), General Health Questionnaire (GHQ-28), Fatigue Scale (FS), Gastrointestinal Symptom Rating Scale (GSRS); and Addison's Quality of Life Questionnaire (AddiQoL). Participants were asked their (blinded) treatment preference. Twenty-four hour urine free cortisol (UFC) and diurnal salivary cortisol collections compared cortisol exposure during each treatment. Ten participants completed the study. Baseline SHS scores (mean ± SE) were consistent with mild impairment: SF-36 physical component summary 48.4 (± 2.4), mental component summary 53.3 (± 3.0); GHQ-28 18.1 (± 3.3); GSRS 3.7 (± 1.6), and AddiQoL 94.7 (± 3.7). FS was similar to other AD cohorts 13.5 (± 1.0) (P = 0.82). UFC between treatments was not different (P = 0.87). The salivary cortisol at 0800 h was higher during CSHI (P = 0.03), but not at any other time points measured. There was no difference between the treatments in the SHS assessments. Five participants preferred CSHI, four oral hydrocortisone, and one was uncertain. Biochemical measurements indicate similar cortisol exposure during each treatment period, although a more circadian pattern was evident during CSHI. CSHI does not

  3. Early filiform needle acupuncture for poststroke depression: a meta-analysis of 17 randomized controlled clinical trials

    PubMed Central

    Zhang, Jiping; Chen, Jing; Chen, Junqi; Li, Xiaohui; Lai, Xueyan; Zhang, Shaoqun; Wang, Shengxu

    2014-01-01

    OBJECTIVE: To evaluate the effectiveness and safety of filiform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efficacy of antidepressant drugs. DATA RETRIEVAL: We retrieved data from the Chinese National Knowledge Infrastructure (1979–2012), Wanfang (1980–2012), VIP (1989–2012), Chinese Biomedical Literature (1975–2012), PubMed (1966–2012), Ovid Lww (–2012), and Cochrane Library (–2012) Database using the internet. SELECTION CRITERIA: Randomized controlled trials on filiform needle acupuncture versus antidepressant drugs for treatment of poststroke depression were included. Moreover, the included articles scored at least 4 points on the Jadad scale. Exclusion criteria: other acupuncture therapies as treatment group, not stroke-induced depression patients, score < 4 points, non-randomized controlled trials, or animal trials. MAIN OUTCOME MEASURES: These were the Hamilton Depression Scale scores, clinical effective rate, Self-Rating Depression Scale scores, Side Effect Rating Scale scores, and incidence of adverse reaction and events. RESULTS: A total of 17 randomized controlled clinical trials were included. Meta-analysis results displayed that after 4 weeks of treatment, clinical effective rate was better in patients treated with filiform needle acupuncture than those treated with simple antidepressant drugs [relative risk = 1.11, 95% confidence interval (CI): 1.03–1.21, P = 0.01]. At 6 weeks, clinical effective rate was similar between filiform needle acupuncture and antidepressant drug groups. At 2 weeks after filiform needle acupuncture, Hamilton Depression Scale (17 items) scores were lower than in the antidepressant drug group (mean difference = −2.34, 95%CI: −3.46 to −1.22, P < 0.000,1). At 4 weeks, Hamilton Depression Scale (24 items) scores were similar between filiform needle acupuncture and antidepressant drug groups. Self-Rating Depression Scale scores were lower in filiform needle

  4. Cervical Lateral Glide Neural Mobilization Is Effective in Treating Cervicobrachial Pain: A Randomized Waiting List Controlled Clinical Trial.

    PubMed

    Rodríguez-Sanz, David; Calvo-Lobo, César; Unda-Solano, Francisco; Sanz-Corbalán, Irene; Romero-Morales, Carlos; López-López, Daniel

    2017-03-13

     Cervicobrachial pain (CP) is a high-incidence and prevalent condition. Cervical lateral glide (CLG) is a firstline treatment of CP. There is a current lack of enough high-quality randomized controlled double-blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over CP.  The aim of the present study was to assess the effect of CLG neural mobilization in treating subjects who suffer from CP, compared with the complete absence of treatment.  This investigation was a single-center, blinded, parallel randomized controlled clinical trial (RCT).  One hundred forty-seven individuals were screened in a medical center from July to November 2015. Fifty-eight participants were diagnosed with CP.  Participants were recruited and randomly assigned into two groups of 29 subjects. The intervention group received CLG treatment, and the control group (CG) was assigned to a six-week waiting list to receive treatment. Randomization was carried out by concealed computer software randomized printed cards. The primary outcome was pain intensity, reported through the Numeric Rating Scale for Pain (NRSP). Secondary outcomes were physical function involving the affected upper limb using the Quick DASH scale and ipsilateral cervical rotation (ICR) using a CROM device. Assessments were made at baseline and one hour after treatment.  The CLG group NRSP mean value was significantly ( P  < 0.0001) superior to those obtained by the CG. Subjects treated with CLG reported an average NRSP decrease of 2.16 points (35%). CROM device and Quick DASH outcome values also reported significant ( P < 0.0001) improvements only in the CLG group. Cohen's d showed a very large effect of the CLG intervention at subject discharge.  Due to the lack of dipper subgroup analysis and additional reproductions of the applied protocol, the authors considered the generalization of the study results to be impossible.

  5. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial.

    PubMed

    Iorio-Siciliano, Vincenzo; Blasi, Andrea; Nicolò, Michele; Iorio-Siciliano, Alessandro; Riccitiello, Francesco; Ramaglia, Luca

    The aim of this study was to evaluate the clinical remodeling of the alveolar socket following the application of bovine-derived xenograft collagen and collagen membrane compared to natural spontaneous healing during the first 6 months following tooth extraction. A total of 20 patients with 20 fresh alveolar sockets were randomly allocated into a test or control group. After a 6-month follow-up period, surgical reentry was performed and implants were placed. Significant statistical differences were recorded in terms of vertical and horizontal bone changes between the test and control groups. Within the limitations of this study, socket preservation procedures may provide more favorable conditions for subsequent implant placement.

  6. Green tea (Camellia sinensis) for patients with knee osteoarthritis: A randomized open-label active-controlled clinical trial.

    PubMed

    Hashempur, Mohammad Hashem; Sadrneshin, Sara; Mosavat, Seyed Hamdollah; Ashraf, Alireza

    2016-12-18

    Green tea is known as a dietary supplement and a novel functional food worldwide. Since there are increasing preclinical evidence about efficacy of green tea for treating osteoarthritis, this study has aimed at assessing its efficacy and safety for patients with knee osteoarthritis. This is a randomized open-label active-controlled clinical trial. As many as fifty adults with osteoarthritis of knee were randomly allocated to receive the green tea extract (in dosage form of tablet) plus diclofenac tablet as "intervention group"; or: diclofenac tablet alone as "control group" for a period of four weeks. Patients were assessed at the beginning of intervention, and then 4 weeks later, in terms of pain score via visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire's total score in addition to its 3 sub-scores. Furthermore, they were asked about any adverse effects during intervention period. Mean differences of VAS pain, total WOMAC, and WOMAC physical function scores in green tea group showed a significant reduction, compared with the control group (P = 0.038, P = 0.006, and P = 0.004, respectively). However, No significant differences between the two groups were observed, regarding mean differences of WOMAC pain and stiffness scores of the enrolled patients (P = 0.163, and P = 0.150, respectively). Additionally, only 1 patient reported gastric upset [in control group]. It seems that green tea extract might well be considered as an adjunctive treatment both for control of pain and for the betterment of knee joint physical function in adults with osteoarthritis. However, further studies of longer duration and larger sample size are needed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  7. Effect of health information technology interventions on lipid management in clinical practice: a systematic review of randomized controlled trials.

    PubMed

    Aspry, Karen E; Furman, Roy; Karalis, Dean G; Jacobson, Terry A; Zhang, Audrey M; Liptak, Gregory S; Cohen, Jerome D

    2013-01-01

    Large gaps in lipid treatment and medication adherence persist in high-risk outpatients in the United States. Health information technology (HIT) is being applied to close quality gaps in chronic illness care, but its utility for lipid management has not been widely studied. To perform a qualitative review of the impact of HIT interventions on lipid management processes of care (screening or testing; drug initiation, titration or adherence; or referrals) or clinical outcomes (percent at low density lipoprotein cholesterol goal; absolute lipid levels; absolute risk scores; or cardiac hospitalizations) in outpatients with coronary heart disease or at increased risk. PubMed and Google Scholar databases were searched using Medical Subject Headings related to clinical informatics and cholesterol or lipid management. English language articles that described a randomized controlled design, tested at least one HIT tool in high risk outpatients, and reported at least 1 lipid management process measure or clinical outcome, were included. Thirty-four studies that enrolled 87,874 persons were identified. Study ratings, outcomes, and magnitude of effects varied widely. Twenty-three trials reported a significant positive effect from a HIT tool on lipid management, but only 14 showed evidence that HIT interventions improve clinical outcomes. There was mixed evidence that provider-level computerized decision support improves outcomes. There was more evidence in support of patient-level tools that provide connectivity to the healthcare system, as well as system-level interventions that involve database monitoring and outreach by centralized care teams. Randomized controlled trials show wide variability in the effects of HIT on lipid management outcomes. Evidence suggests that multilevel HIT approaches that target not only providers but include patients and systems approaches will be needed to improve lipid treatment, adherence and quality. Copyright © 2013 National Lipid

  8. Effect of surgical periodontal treatment associated to antimicrobial photodynamic therapy on chronic periodontitis: A randomized controlled clinical trial.

    PubMed

    Martins, Sérgio H L; Novaes, Arthur B; Taba, Mario; Palioto, Daniela B; Messora, Michel R; Reino, Danilo M; Souza, Sérgio L S

    2017-07-01

    This randomized controlled clinical trial evaluated the effects of an adjunctive single application of antimicrobial photodynamic therapy (aPDT) in Surgical Periodontal Treatment (ST) in patients with severe chronic periodontitis (SCP). In a split-mouth design, 20 patients with SCP were treated with aPDT+ST (Test Group, TG) or ST only (Control Group, CG). aPDT was applied in a single episode, using a diode laser and a phenothiazine photosensitizer. All patients were monitored until 90 days after surgical therapy. Levels of 40 subgingival species were measured by checkerboard DNA-DNA hybridization at baseline, 60 and 150 days. Clinical and microbiological parameters were evaluated. In deep periodontal pockets depth (PPD ≥5 mm), Test Group presented a significantly higher decrease in PPD than Control Group at 90 days after surgical therapy (p < .05). Test Group also demonstrated significantly less periodontal pathogens of red complex (Treponema denticola) (p < .05). A single episode of aPDT used in adjunct to open flap debridement of the root surface in the surgical treatment of SCP: i) significantly improved clinical periodontal parameters; ii) eliminates periodontal pathogens of the red complex more effectively (NCT02734784). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Comparison of the pain levels of computer controlled and conventional anesthesia techniques in supraperiosteal injections: a randomized controlled clinical trial.

    PubMed

    Singh, Smita; Garg, Aniket

    2013-01-01

    To compare the pain perception using a traditional Syringe vs Computer controlled 'Anaeject' device in supra periosteal injections. One hundred volunteers were selected on a random basis for the study and were explained about the goals of study and signed the consent form. They served as their own controls, i.e. in the same subject both the computer controlled 'Anaeject' device and traditional syringe were used on the contralateral sides for obtaining anesthesia. Pain levels were recorded during needle prick and anesthetic delivery. Post-operative pain at the site of injection 5 h after the anesthesia was also recorded. Heft Parker visual analog scale (VAS) was used to evaluate pain levels. Final analysis was done on 90 subjects. Subjects reported significantly lower pain ratings at the time of needle prick and the delivery of local anesthetic using a computer-controlled 'Anaeject' device as compared to traditional syringes. Pain at the site of injection 5 h post-operative was also low in the computerized anesthesia group but it was not statistically significant. In this in vivo study it was found that subjects perception of pain was significantly low for supraperiosteal injections while using computerized anesthesia as compared to that of conventional disposable syringes.

  10. Efficacy of sodium butyrate adjunct therapy in shigellosis: a randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    2012-01-01

    Background Treatment of shigellosis in rabbits with butyrate reduces clinical severity and counteracts the downregulation of cathelicidin (CAP-18) in the large intestinal epithelia. Here, we aimed to evaluate whether butyrate can be used as an adjunct to antibiotics in the treatment of shigellosis in patients. Methods A randomized, double-blind, placebo-controlled, parallel-group designed clinical trial was conducted. Eighty adult patients with shigellosis were randomized to either the Intervention group (butyrate, n = 40) or the Placebo group (normal saline, n = 40). The Intervention group was given an enema containing sodium butyrate (80 mM), twice daily for 3 days, while the Placebo group received the same dose of normal saline. The primary endpoint of the trial was to assess the efficacy of butyrate in improving clinical, endoscopic and histological features of shigellosis. The secondary endpoint was to study the effect of butyrate on the induction of antimicrobial peptides in the rectum. Clinical outcomes were assessed and concentrations of antimicrobial peptides (LL-37, human beta defensin1 [HBD-1] and human beta defensin 3 [HBD-3]) and pro-inflammatory cytokines (interleukin-1β [IL-1β] and interleukin-8 [IL-8]) were measured in the stool. Sigmoidoscopic and histopathological analyses, and immunostaining of LL-37 in the rectal mucosa were performed in a subgroup of patients. Results Compared with placebo, butyrate therapy led to the early reduction of macrophages, pus cells, IL-8 and IL-1β in the stool and improvement in rectal histopathology. Butyrate treatment induced LL-37 expression in the rectal epithelia. Stool concentration of LL-37 remained significantly higher in the Intervention group on days 4 and 7. Conclusion Adjunct therapy with butyrate during shigellosis led to early reduction of inflammation and enhanced LL-37 expression in the rectal epithelia with prolonged release of LL-37 in the stool. Trial Registration Clinical

  11. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial

    PubMed Central

    Khosrawi, Saeid; Emadi, Masoud; Mahmoodian, Amir Ebrahim

    2016-01-01

    Background: The Study aimed to compare the effectiveness of two commonly used conservative treatments, splinting and local steroid injection in improving clinical and nerve conduction findings of the patients with severe carpal tunnel syndrome (CTS). Materials and Methods: In this randomized control clinical trial, the patients with severe CTS selected and randomized in two interventional groups. Group A was prescribed to use full time neutral wrist splint and group B was injected with 40 mg Depo-Medrol and prescribed to use the full time neutral wrist splint for 12 weeks. Clinical and nerve conduction findings of the patients was evaluated at baseline, 4 and 12 weeks after interventions. Results: Twenty-two and 21 patients were allocated in group A and B, respectively. Mean of clinical symptoms and functional status scores, nerve conduction variables and patients’ satisfaction score were not significant between group at baseline and 4 and 12 weeks after intervention. Within the group comparison, there was significant improvement in the patients’ satisfaction, clinical and nerve conduction items between the baseline level and 4 weeks after intervention and between the baseline and 12 weeks after intervention (P < 0.01). The difference was significant for functional status score between 4 and 12 weeks after intervention in group B (P = 0.02). Conclusion: considering some findings regarding the superior effect of splinting plus local steroid injection on functional status scale and median nerve distal motor latency, it seems that using combination therapy could be more effective for long-term period specially in the field of functional improvement of CTS. PMID:26962518

  12. A randomized clinical evaluation of triclosan-containing dentifrice and mouthwash association in the control of plaque and gingivitis.

    PubMed

    Villalpando, Karina Teixeira; Casarin, Renato Correa Viana; Pimentel, Suzana Peres; Cirano, Fabiano Ribeiro; Casati, Marcio Zafallon

    2010-01-01

    The aim of this double-blind study was to evaluate the clinical efficacy of the association of triclosan-containing mouthrinse and dentifrice on biofilm and gingivitis reduction. Forty patients with a diagnosis of gingivitis were selected and randomly divided into four groups (n = 10): group TT-triclosan-containing mouthrinse and triclosan-containing dentifrice; group CT-control mouthrinse and triclosan-containing dentifrice; group TC-triclosan-containing mouthrinse and control dentifrice; group CC-control mouthrinse and control dentifrice. Patients were evaluated by a calibrated examiner using a quantitative Plaque Index and Gingivitis Index at 0, 15, and 30 days. Intragroup analysis was performed by Friedman test and intergroup analysis by Kruskal-Wallis. Intragroup evaluation revealed a statistically significant reduction in Plaque Index for groups that used triclosan, independently of the group (TT, CT, and TC) (P < .05). Intergroup analysis suggested that only the group that used the association of triclosan dentifrice and mouthrinse (group TT) demonstrated statistically reduced Plaque Index at 30 days, when compared to the control group (CC) (P < .05). With regard to gingivitis reduction, no difference was observed between groups, although the association presented a faster reduction in bleeding levels. Only the association of triclosan dentifrice and triclosan mouthrinse statistically reduced Plaque Index, when compared to the control group; however, regarding the additional benefits to gingivitis control, more studies should be done to confirm the results.

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

    PubMed Central

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

    2014-01-01

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

  14. Impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes: Randomized controlled trial.

    PubMed

    Wishah, Ruba A; Al-Khawaldeh, Omar A; Albsoul, Abla M

    2015-01-01

    The primary aim of this study was to evaluate the impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes patients in Jordan. A randomized controlled clinical trial was conducted on 106 patients with uncontrolled type 2 diabetes seeking care in the diabetes clinics at Jordan University Hospital. Patients were randomly allocated into control and intervention group. The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician while the control group patients received usual care without clinical pharmacist's input. Fasting blood glucose and HbA1c were measured at the baseline, at three months, and six months intervals for both intervention and control groups. After the six months follow-up, mean of HbA1c and FBS of the patients in the intervention group decreased significantly compared to the control group patients (P<0.05). Also, the results indicated that mean scores of patients' knowledge about medications, knowledge about diabetes and adherence to medications and diabetes self-care activities of the patients in the intervention group increased significantly compared to the control group (P<0.05). This study demonstrated an improvement in HbA1c, FBS, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The results suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare team and diabetes management in Jordan. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  15. The anti-plaque efficacy of a novel stannous-containing sodium fluoride dentifrice: a randomized and controlled clinical trial.

    PubMed

    He, Tao; Sun, Lily; Li, Sarah; Ji, Nelson

    2010-09-01

    To evaluate the anti-plaque efficacy of a novel stannous-containing sodium fluoride dentifrice compared to a negative control regular anti-caries dentifrice and a positive control marketed triclosan-containing dentifrice. This was a randomized and controlled, single-center, double-blind, three-treatment, three-period, crossover clinical trial in generally healthy adults. A prophylaxis was followed by three 4-day treatment periods of limited brushing, each separated by an approximate 7-day washout phase. Subjects used the test dentifrice on Days 0-3 of each period according to their randomly assigned sequence; either Crest Cavity Protection (negative control); an experimental stannous-containing sodium fluoride dentifrice; or a marketed triclosan positive control (Colgate Total). A dental polishing was given at Day 0 of each treatment period, and subjects brushed the lingual surfaces only and then swished the entire dentition with a dentifrice slurry twice daily under supervision through Day 3. At baseline and Day 4 of each treatment period, plaque levels were assessed via the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Twenty-eight fully evaluable subjects completed the trial. Both the experimental and positive control dentifrices provided significantly lower mean whole mouth TMQHPI plaque scores after treatment compared to the negative control: 11.4% lower for the experimental stannous-containing dentifrice and 8.4% for Colgate Total (P< 0.0001). The experimental stannous-containing dentifrice group resulted in directionally lower whole mouth plaque scores when compared to Colgate Total (P= 0.07). The experimental stannous-containing dentifrice had significantly lower mean plaque scores post-treatment at lingual sites compared with Total (P= 0.0355). All dentifrices were well-tolerated.

  16. Effects of Gentle Human Touch and Field Massage on Urine Cortisol Level in Premature Infants: A Randomized, Controlled Clinical Trial

    PubMed Central

    Asadollahi, Malihe; Jabraeili, Mahnaz; Mahallei, Majid; Asgari Jafarabadi, Mohammad; Ebrahimi, Sakine

    2016-01-01

    Introduction: Hospitalization in neonatal intensive care unit may leads to many stresses for premature infants. Since premature infants cannot properly process stressors, identifying interventions that reduce the stress level for them is seems necessary. The aim of present study was to compare the effects of Field massage and Gentle Human Touch (GHT) techniques on the urine level of cortisol, as an indicator of stress in preterm infants. Methods: This randomized, controlled clinical trial was carried out in Al-Zahra hospital, Tabriz. A total of 84 premature infants were randomly assigned into three groups. First groups were touched by their mothers three times a day (15 minutes in each session) for 5 days by GHT technique. The second group was received 15 minutes Field massage with sunflower oil three times a day by their mothers for 5 days. The third group received routine care. In all groups, 24-hours urine samples were collected in the first and sixth day after the intervention and analyzed for cortisol level. Data were analyzed by SPSS software. Results: There were significant differences between mean of changes in cortisol level between GHT and control groups and Field massage and control groups (0.026). Conclusion: Although the massage with Field technique resulted in a significant reduction in blood cortisol level, but the GHT technique have also a similar effect. So, both methods are recommended for decreasing of stress in preterm infants. PMID:27752484

  17. Integrative TCM Conservative Therapy for Low Back Pain due to Lumbar Disc Herniation: A Randomized Controlled Clinical Trial

    PubMed Central

    Yuan, Wei An; Huang, Shi Rong; Guo, Kai; Sun, Wu Quan; Xi, Xiao Bing; Zhang, Ming Cai; Kong, Ling Jun; Lu, Hua; Zhan, Hong Sheng; Cheng, Ying Wu

    2013-01-01

    Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3 : 1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, −16.62 points, P < 0.001 in VAS; −15.55 points, P < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (−7.68 points, P < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH. PMID:23864883

  18. Using Community Health Workers to Improve Clinical Outcomes Among People Living with HIV: A Randomized Controlled Trial

    PubMed Central

    Jones, Jamal; Arheart, Kristopher; Kobetz, Erin; Chida, Natasha; Baer, Shelly; Powell, Alexis; Symes, Stephen; Hunte, Tai; Monroe, Anne; Carrasquillo, Olveen

    2014-01-01

    AIDS-related mortality remains a leading cause of preventable death among African-Americans. We sought to determine if community health workers could improve clinical outcomes among vulnerable African-Americans living with HIV in Miami, Florida. We recruited 91 medically indigent persons with HIV viral loads ≥1,000 and/or a CD4 cell count ≤350. Patients were randomized to a community health worker (CHW) intervention or control group. Viral load and CD4 cell count data were abstracted from electronic medical records. At 12 months, the mean VL in the intervention group was log 0.9 copies/μL lower than the control group. The CD4 counts were not significantly different among the groups. Compared to the control group, patients randomized to CHWs experienced statistically significant improvements in HIV viral load. Larger multi-site studies of longer duration are needed to determine whether CHWs should be incorporated into standard treatment models for vulnerable populations living with HIV. PMID:23515640

  19. Integrative TCM Conservative Therapy for Low Back Pain due to Lumbar Disc Herniation: A Randomized Controlled Clinical Trial.

    PubMed

    Yuan, Wei An; Huang, Shi Rong; Guo, Kai; Sun, Wu Quan; Xi, Xiao Bing; Zhang, Ming Cai; Kong, Ling Jun; Lu, Hua; Zhan, Hong Sheng; Cheng, Ying Wu

    2013-01-01

    Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3 : 1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, -16.62 points, P < 0.001 in VAS; -15.55 points, P < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (-7.68 points, P < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH.

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

    PubMed

    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.

  1. Limited Clinical Utility of Remote Ischemic Conditioning in Renal Transplantation: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wu, Ran; Xin, Hui; Lu, Tian-Ze; Li, Ming-Hao; Song, Kai-Wei; Wang, Min; Zhu, Yun-Peng; Zhu, Meng; Geng, Li-Guo; Gao, Xiao-Fei; Zhou, Liu-Hua; Zhang, Sheng-Li; Zhu, Jia-Geng; Jia, Rui-Peng

    2017-01-01

    Objective We conducted this meta-analysis of randomized controlled trials (RCTs) to investigate whether remote ischemic conditioning (RIC) could improve graft functions in kidney transplantation. Methods PubMed, Web of Science, and Cochrane Library were comprehensively searched to identify all eligible studies by October 5, 2016. The treatment effects were examined with risk ratio (RR) and weighted mean difference with the corresponding 95% confidence intervals (CI). The statistical significance and heterogeneity were assessed with both Z-test and Q-test. Results A total of six RCTs including 651 recipients, were eventually identified. Compared to the controls, RIC could reduce the incidence of delayed graft function (DGF) after kidney transplantation (random-effects model: RR = 0.89; fixed-effect model: RR = 0.84). However, the decrease did not reveal statistical significance. The subgroup analysis by RIC type demonstrated no significant difference among the three interventions in protecting renal allografts against DGF. Furthermore, no significant difference could be observed in the incidence of acute rejection, graft loss, 50% fall in serum creatinine, as well as the estimated glomerular filtration rate and hospital stay between the RIC and Control groups. Conclusions This meta-analysis suggested that RIC might exert renoprotective functions in human kidney transplantation, and further well-designed RCTs with large sample size are warranted to assess its clinical efficacy. PMID:28129389

  2. The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial.

    PubMed

    Kelle, Bayram; Güzel, Rengin; Sakallı, Hakan

    2016-10-01

    To investigate the effect of Kinesio taping application in acute non-specific low back pain. A randomized controlled clinical trial. Physical Medicine and Rehabilitation Clinic. A total of 109 patients with acute low back pain were randomized into either Kinesio taping (n = 54) or control (n = 55) groups. The intervention group was treated with information and reassurance plus Kinesio taping, while the control group received merely information and reassurance. All participants were allowed to use as-needed doses of paracetamol. Kinesio tape was applied to the most painful area of the low back for a total of 12 days. Worst pain and disability were assessed at baseline, after the 12-day intervention, and at four weeks follow-up. During the first 12 days, participants filled in a pain diary consisting of a numeric rating scale and recorded the number of paracetamol tablets consumed daily. Disability was assessed with the Oswestry Disability Index. After 12 days of intervention, pain intensity and the Oswestry Disability Index improved significantly in both groups; the improvements were significantly superior in the Kinesio taping group (p = 0.003, p = 0.011). The Kinesio taping group reached pain control earlier (sixth day vs. 12th day) and consumed less paracetamol. At the fourth week, although pain intensity was significantly more reduced in the Kinesio taping group (p = 0.015), there were no differences with regard to disability. Kinesio taping provided significant improvements in pain and disability; thus, it can be used as a complementary method in acute non-specific low back pain. © The Author(s) 2015.

  3. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention) or control treatment (a leaflet on healthy living). Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic intervention for excessive

  4. Effect of tolvaptan on acute heart failure with hyponatremia – A randomized, double blind, controlled clinical trial

    PubMed Central

    Shanmugam, Elangovan; Doss, C.R. Madhu Prabhu; George, Melvin; Jena, Amrita; Rajaram, Muthukumar; Ramaraj, Balaji; Anjaneyan, Karthik; Kanagesh, B.

    2016-01-01

    Objectives To assess the efficacy of tolvaptan in acute heart failure with hyponatremia using a randomized double-blinded placebo-controlled study design. Background Tolvaptan is a selective vasopressin receptor 2 antagonist. There are no published clinical trials on the utility of tolvaptan in acute heart failure with hyponatremia in the Indian population. Methods After screening and informed consent, 51 HF patients with hyponatremia were randomized using computer-generated randomization sequence to receive placebo or 15 mg of tolvaptan for 5 days along with conventional medical therapy. The patient's perception of dyspnea using Likert score and the plasma sodium was measured at baseline and for the next 4 days. Results There was a mean improvement in sodium concentration by 5 mEq/L (p = 0.001) in patients receiving tolvaptan, whereas no significant improvement was seen in the placebo group (p = 0.33). Significant improvement in Likert score was observed in both the groups (p = 0.001), even though there was no difference between both the groups. Dry mouth and thirst were the most commonly occurring adverse effects observed in both the groups. There were no significant hemodynamic changes with tolvaptan therapy. Conclusion Tolvaptan at a dose of 15 mg is effective in reversing hyponatremia in acute heart failure and may be a suitable option in these patients. PMID:27056648

  5. Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

    PubMed Central

    Herring, W. Joseph; Connor, Kathleen M.; Snyder, Ellen; Snavely, Duane B.; Zhang, Ying; Hutzelmann, Jill; Matzura-Wolfe, Deborah; Benca, Ruth M.; Krystal, Andrew D.; Walsh, James K.; Lines, Christopher; Roth, Thomas; Michelson, David

    2016-01-01

    Study Objectives: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials. Methods: Prespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18–64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints. Results: Suvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use. Conclusions: Suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated. Clinical Trial Registration: ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629. Citation: Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in

  6. Maintaining Interrater Agreement of Core Assessment Instruments in a Multisite Randomized Controlled Clinical Trial: The Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Trial.

    PubMed

    Lebet, Ruth; Hayakawa, Jennifer; Chamblee, Tracy B; Tala, Joana A; Singh, Nakul; Wypij, David; Curley, Martha A Q

    RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure) was a cluster randomized clinical trial evaluating a sedation strategy in children 2 weeks to <18 years of age with acute respiratory failure supported on mechanical ventilation. A total of 31 U.S. pediatric intensive care units (PICUs) participated in the trial. Staff nurse rater agreement on measures used to assess a critical component of treatment fidelity was essential throughout the 4-year data collection period. The purpose of the study is to describe the method of establishing and maintaining interrater agreement (IRA) of two core clinical assessment instruments over the course of the clinical trial. IRA cycles were carried out at all control and intervention sites and included a minimum of five measurements of the State Behavioral Scale (SBS) and Withdrawal Assessment Tool-Version 1 (WAT-1). Glasgow Coma Scale scores were also obtained. PICUs demonstrating <80% agreement repeated their IRA cycle. Fleiss's kappa coefficient was used to assess IRA. Repeated IRA cycles were required for 8% of 226 SBS cycles and 2% of 222 WAT-1 cycles. Fleiss's kappa coefficients from more than 1,350 paired assessments were .86 for SBS and .92 for WAT-1, demonstrating strong agreement and similar to .91 for the Glasgow Coma Scale. There was no difference in Fleiss's kappa for any of the instruments based on unit size or timing of assessment (earlier or later in the study). For SBS scores, Fleiss's kappa was significantly different in larger and smaller PICUs (.82 vs. .92, p = .003); however, Fleiss's kappa for both groups indicated excellent agreement. Monitoring measurement reliability is an essential step in ensuring treatment fidelity and, thus, the validity of study results. Standardization on the use of these core assessment instruments among participating sites was achieved and maintained throughout the trial.

  7. Efficacy of fermented green tea on peripheral skin temperature: a randomized and placebo-controlled clinical study.

    PubMed

    Lee, Eunyoung; Lee, Bum-Jin; Ha, Jaehyoun; Shin, Hyun-Jung; Chung, Jin-Oh

    2016-09-01

    This study was aimed at assessing the therapeutic efficacy of green tea on peripheral skin for cold hypersensitive subjects, who had the feeling of cold hands and feet at cold temperatures, one of the most common complaints in Asian women. This randomized and placebo-controlled clinical study included 60 female Korean subjects who had the feeling of cold hands and feet at cold temperatures. The subjects were randomly assigned into two groups to receive fermented green tea or a placebo (hot water). The skin temperature of the hands and feet was measured using digital infrared thermography at the baseline and at 15, 30, 45, and 60 min after the oral administration of the tea or placebo. The skin temperature of the hands and feet of the fermented green tea-administered group was significantly higher than that of the placebo-administered group. The temperature difference between the finger and the dorsum of the hand was significantly lower in the fermented green tea-administered group than that in the placebo group. Fermented green tea is helpful for cold hypersensitivity. This is the first clinical study to evaluate the efficacy of fermented green tea on peripheral skin in subjects having the feeling of cold hands and feet at cold temperatures by infrared thermography. However, further studies are necessary to evaluate the long-term effects of the fermented green tea for cold hypersensitivity and to elucidate the underlying physiological mechanism. © 2015 Wiley Periodicals, Inc.

  8. Efficacy of Papacarie® in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial

    PubMed Central

    Motta, Lara Jansiski; Bussadori, Sandra Kalil; Campanelli, Ana Paula; da Silva, André Luis; Alfaya, Thays Almeida; de Godoy, Camila Haddad Leal; de Lima Navarro, Maria Fidela

    2014-01-01

    OBJECTIVES: The aim of the present study was to analyze the efficacy of Papacarie® gel compared with the traditional method (low-speed bur) in reducing the counts of total bacteria, Lactobacillus, total Streptococcus and Streptococcus mutans group. METHODS: A randomized, controlled clinical trial with a split-mouth design was performed. The sample comprised 40 deciduous teeth in 20 children (10 males and 10 females) aged four to seven years. The teeth were randomly allocated to two groups: G1, or chemomechanical caries removal with Papacarie Duo®, and G2, or the removal of carious dentin tissue with a low-speed bur. Infected dentin was collected prior to the procedure, and the remaining dentin was collected immediately following the removal of the carious tissue. Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units (CFUs) of each microorganism studied. ClinicalTrials.gov: NCT01811420. RESULTS: Reductions were found in the numbers of total bacteria, total Streptococcus and Streptococcus mutans group following either of the caries removal methods (p<0.05). A reduction was also noted in the number of Lactobacillus CFUs; however, this difference did not achieve statistical significance (p>0.05). CONCLUSION: Papacarie® is an excellent option for the minimally invasive removal of carious tissue, achieving significant reductions in total bacteria, total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method. PMID:24838896

  9. Efficacy of Papacarie(®) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial.

    PubMed

    Motta, Lara Jansiski; Bussadori, Sandra Kalil; Campanelli, Ana Paula; Silva, André Luis da; Alfaya, Thays Almeida; Godoy, Camila Haddad Leal de; Navarro, Maria Fidela de Lima

    2014-01-01

    The aim of the present study was to analyze the efficacy of Papacarie(®) gel compared with the traditional method (low-speed bur) in reducing the counts of total bacteria, Lactobacillus, total Streptococcus and Streptococcus mutans group. A randomized, controlled clinical trial with a split-mouth design was performed. The sample comprised 40 deciduous teeth in 20 children (10 males and 10 females) aged four to seven years. The teeth were randomly allocated to two groups: G1, or chemomechanical caries removal with Papacarie Duo(®), and G2, or the removal of carious dentin tissue with a low-speed bur. Infected dentin was collected prior to the procedure, and the remaining dentin was collected immediately following the removal of the carious tissue. Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units (CFUs) of each microorganism studied. ClinicalTrials.gov: NCT01811420. Reductions were found in the numbers of total bacteria, total Streptococcus and Streptococcus mutans group following either of the caries removal methods (p<0.05). A reduction was also noted in the number of Lactobacillus CFUs; however, this difference did not achieve statistical significance (p>0.05). Papacarie(®) is an excellent option for the minimally invasive removal of carious tissue, achieving significant reductions in total bacteria, total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method.

  10. Effect of Papacarie and Alternative Restorative Treatment on Pain Reaction during Caries Removal among Children: A Randomized Controlled Clinical Trial.

    PubMed

    Abdul Khalek, Amg; Elkateb, M A; Abdel Aziz, W E; El Tantawi, M

    To compare the effect of Papacarie and Atraumatic Restorative Treatment (ART) on pain and discomfort during caries removal among children. Fifty healthy, 4-8 year-old children were equally and randomly allocated to Papacarie and ART to remove caries from decayed primary teeth. A randomized, controlled, blinded, two parallel-arms clinical trial was conducted in the clinic of the Pediatric Dentistry and Dental Public Health Department, Alexandria University, Egypt in March 2014. Pain and discomfort were assessed blindly by two independent investigators watching videotaped treatment sessions using the Sound, Eye and Motor scale (SEM). Their reliability was assessed using Kappa statistics. The effect of caries removal methods, time spent to remove caries and other confounders on SEM score was assessed using regression analysis. Mean time to remove caries using Papacarie and ART was 5.8 and 4.8 minutes, P= 0.005. Median Paparie and ART scores for the S, E and M components were 1, 1, 1 and 3, 2, 3. Adjusted mean SEM score= 3.6 and 7.8, P <0.0001. Method of caries removal was the only factor significantly affecting pain and discomfort. Papacarie is associated with minimal pain during caries removal from primary teeth compared to ART, although it has longer working time.

  11. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial.

    PubMed

    Mahajan, Amit K; Diette, Gregory B; Hatipoğlu, Umur; Bilderback, Andrew; Ridge, Alana; Harris, Vanessa Walker; Dalapathi, Vijay; Badlani, Sameer; Lewis, Stephanie; Charbeneau, Jeff T; Naureckas, Edward T; Krishnan, Jerry A

    2011-09-10

    High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second. Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. ClinicalTrials.gov: NCT00181285.

  12. The Effect of Lemon Inhalation Aromatherapy on Nausea and Vomiting of Pregnancy: A Double-Blinded, Randomized, Controlled Clinical Trial

    PubMed Central

    Yavari kia, Parisa; Safajou, Farzaneh; Shahnazi, Mahnaz; Nazemiyeh, Hossein

    2014-01-01

    Background: Nausea and vomiting of pregnancy are amongst the most common complaints that effects on both the physical and mental conditions of the pregnant women. Due to the increasing tendency of women to use herbal medications during pregnancy, the effect of lemon inhalation aromatherapy on nausea and vomiting of pregnancy was investigated in this study. Objectives: The aim of this study was to determine the effect of lemon inhalation aromatherapy on nausea and vomiting during pregnancy. Materials and Methods: This was a randomized clinical trial in which 100 pregnant women with nausea and vomiting who had eligibility criteria were randomly divided into intervention and control groups based on four- and six-random block sampling method. Lemon essential oil and placebo were given to the intervention and control groups, respectively, to inhale it as soon as they felt nausea. The nausea, vomiting, and retch intensity were investigated 24 hours before and during the four days of treatment by means of PUQE-24 (24-hour Pregnancy Unique Quantification of Emesis). Results: There was a statistically significant difference between the two groups in the mean scores of nausea and vomiting on the second and fourth days (P = 0.017 and P = 0.039, respectively). The means of nausea and vomiting intensity in the second and fourth days in the intervention group were significantly lower than the control group. In addition, in intragroup comparison with ANOVA with repeated measures, the nausea and vomiting mean in the five intervals, showed a statistically significant difference in each group (P < 0.001 and P = 0.049, respectively). Conclusions: Lemon scent can be effective in reducing nausea and vomiting of pregnancy. PMID:24829772

  13. Effects of Median Nerve Neural Mobilization in Treating Cervicobrachial Pain: A Randomized Waiting List-controlled Clinical Trial.

    PubMed

    Rodríguez-Sanz, David; López-López, Daniel; Unda-Solano, Francisco; Romero-Morales, Carlos; Sanz-Corbalán, Irene; Beltrán-Alacreu, Hector; Calvo-Lobo, César

    2017-07-22

    There is a current lack of sufficiently high-quality randomized controlled clinical trials that measure the effectiveness of neural tissue mobilization techniques such as median nerve neural mobilization (MNNM) and their specific effects on cervicobrachial pain (CP). This study aim was to compare the effectiveness of MNNM in subjects with CP versus a waiting list control group (WLCG). A single-blinded, parallel, randomized controlled clinical trial was performed (NCT02596815). Subjects were recruited with a medical diagnosis of CP corroborated by magnetic resonance imaging. In total, 156 individuals were screened, 60 subjects were recruited, and 51 completed the trial. Pain intensity reported using the Numeric Rating Scale for Pain (NRSP; primary outcome), cervical range of motion (CROM) and functionality using the Quick-DASH scale were the outcome measurements. Assessments were conducted at baseline and 1-hour after treatment (1, 15 and 30 intervention days). Therefore, MNNM was implemented with 30-days of follow-up. The NRSP values of the MNNM group were significantly (p<0.0001; 95% CI) superior to those obtained in the WLCG. Subjects treated with MNNM reported an NRSP decrease of 3.08 points at discharge. CROM and Quick-DASH outcome values were significantly (p˂0.0001; 95%CI) improved only in the MNNM group. Hedges' g showed a very large effect of the MNNM intervention. MNNM may be superior to no treatment in reducing pain and increasing function in the affected upper limb of subjects with CP. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  14. The Effect of Melatonin on Climacteric Symptoms in Menopausal Women; A Double-Blind, Randomized Controlled, Clinical Trial

    PubMed Central

    PARANDAVAR, Nehleh; ABDALI, Khadijeh; KESHTGAR, Sara; EMAMGHOREISHI, Maasoumeh; AMOOEE, Seddegheh

    2014-01-01

    Abstract Background Menopause is one of the most critical periods of woman’s life. With reducing of ovarian estrogen; women are more prone to psychological and physical symptoms. The present study aimed to investigate the effect of melatonin on the climacteric symptoms. Methods The present double blind, placebo randomized controlled clinical trial was conducted on 240 menopausal women (40 - 60 years old) referring to the gynecology clinics of Shiraz University of Medical Sciences (January - November 2012). The participants were randomly divided into two groups through sortition. Demographic characteristics, Goldberg’s general health questionnaire (GHQ), Greene Climacteric Scale and level of Follicle Stimulating Hormone (FSH) were determined for both groups before the intervention. The intervention group received one 3mg melatonin tablet each night for 3 months and the control group received the placebo in the same period. Changes of climacteric symptoms and drug complications were measured 1, 2 and 3 months after the intervention Results We analyzed the data of 99 postmenopausal women in the intervention group and 101 postmenopausal women in the control group. In the melatonin group, the climacteric symptoms score decreased from 35.73+11.6 to 17.09+10.22 during the 3-month study period and regardless of time, a significant difference was observed between the two groups (P<0.001). In addition, a significant difference was found between the two groups regarding various dimensions of the climacteric symptoms over time (P<0.001). No significant difference was found regarding side effects between the two groups (P= 0.135). Conclusion The study findings showed that using melatonin improved the climacteric symptoms. PMID:26060703

  15. A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy.

    PubMed

    Modi, Avani C; Guilfoyle, Shanna M; Mann, Krista A; Rausch, Joseph R

    2016-03-01

    The primary aim was to examine the preliminary efficacy of a family tailored problem-solving intervention to improve antiepileptic drug (AED) adherence in families of children with new-onset epilepsy. Secondary aims were to assess changes in targeted mechanisms and treatment feasibility and acceptability. Fifty families (M(age) = 7.6 ± 3.0; 80% Caucasian; 42% idiopathic localization related) completed baseline questionnaires and were given an electronic monitor to observe daily AED adherence. If adherence was ≤ 95% in the first 7 months of the study, families were randomized (Supporting Treatment Adherence Regimens (STAR): n = 11; Treatment as Usual (TAU): n = 12). Twenty-one families were not randomized due to adherence being ≥95%. The STAR intervention included four face-to-face and two telephone problem-solving sessions over 8 weeks. Significant group differences in adherence were found during active intervention (weeks 4-6; TAU = -12.0 vs. STAR = 18.1, p < 0.01; and weeks session 6-8: TAU = -9.7 vs. STAR = 15.3, p < 0.05). Children who received the STAR intervention exhibited improved adherence compared to children in the TAU group during active treatment. Significant changes in epilepsy knowledge and management were noted for the STAR group. Families expressed benefitting from the STAR intervention. Future studies should include a larger sample size and booster intervention sessions to maintain treatment effects over time.

  16. Effects of alveolar recruitment on arterial oxygenation in patients after cardiac surgery: a prospective, randomized, controlled clinical trial.

    PubMed

    Minkovich, Leonid; Djaiani, George; Katznelson, Rita; Day, Fergal; Fedorko, Ludwik; Tan, Jens; Carroll, Jo; Cheng, Davy; Karski, Jacek

    2007-06-01

    Pulmonary atelectasis and hypoxemia remain considerable problems after cardiac surgery. The objective of this study was to determine the efficacy of consecutive vital capacity maneuvers (C-VCMs) to improve oxygenation in patients after cardiac surgery. Randomized, controlled clinical trial. Tertiary referral teaching center. Ninety-five patients requiring elective cardiac surgery with cardiopulmonary bypass (CPB). Patients were randomly allocated to either C-VCM or control groups. In the C-VCM group, lung inflation at pressure of 35 cmH(2)O was sustained for 15 seconds before separation from CPB and at 30 cmH(2)O for 5 seconds after admission to the intensive care unit (ICU). The primary outcome was the ratio of arterial oxygen tension to inspired oxygen fraction measured at the following predetermined time intervals: after induction of anesthesia, 15 minutes after separation from CPB, after admission to the ICU, after 3 hours of positive-pressure ventilation, after extubation, and before ICU discharge. C-VCM resulted in better arterial oxygenation extending from the immediate postoperative period to approximately 24 hours after surgery at the time of ICU discharge. There were no significant adverse events related to C-VCM application. C-VCM is an effective method to reduce hypoxemia associated with the formation of atelectasis after cardiac surgery with CPB.

  17. Effect of educational package on lifestyle of primiparous mothers during postpartum period: a randomized controlled clinical trial.

    PubMed

    Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

    2017-10-01

    A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received face-to-face, phone and SMS counseling and a booklet in addition to routine postpartum training; in the control group, the mothers received only routine training. The Health Behaviors Questionnaire, a Food Frequency Questionnaire and the International Physical Activity Questionnaire were used for data collection. There were no significant differences between the two groups 6 weeks after delivery in terms of physical activity level and nutritional status (P > 0.05) except for the mean consumption of milk and dairy, which was higher in the intervention group (P = 0.041). Training significantly improved certain health behaviors in the intervention group compared to the controls, such as the first time brushing the teeth after delivery, the frequency of sun exposure, the frequency of ventilating the home, keeping warm and iron supplementation. The training provided positively affected certain health behaviors in the mothers; however, it failed to improve their physical activity level and nutritional status. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  18. DASH diet, insulin resistance, and serum hs-CRP in polycystic ovary syndrome: a randomized controlled clinical trial.

    PubMed

    Asemi, Z; Esmaillzadeh, A

    2015-03-01

    This study was designed to assess the effects of Dietary Approaches to Stop Hypertension (DASH) eating plan on insulin resistance and serum hs-CRP in overweight and obese women with PCOS. This randomized controlled clinical trial was done on 48 women diagnosed with PCOS. Subjects were randomly assigned to consume either the control (n=24) or the DASH eating pattern (n=24) for 8 weeks. The DASH diet consisted of 52% carbohydrates, 18% proteins, and 30% total fats. It was designed to be rich in fruits, vegetables, whole grains, and low-fat dairy products and low in saturated fats, cholesterol, refined grains, and sweets. Sodium content of the DASH diet was designed to be less than 2 400 mg/day. The control diet was also designed to contain 52% carbohydrates, 18% protein, and 30% total fat. Fasting blood samples were taken at baseline and after 8 weeks intervention to measure -insulin resistance and serum hs-CRP levels. -Adherence to the DASH eating pattern, compared to the -control diet, resulted in a significant reduction of serum insulin levels (-1.88 vs. 2.89 μIU/ml, p=0.03), HOMA-IR score (-0.45 vs. 0.80; p=0.01), and serum hs-CRP levels (-763.29 vs. 665.95 ng/ml, p=0.009). Additionally, a significant reduction in waist (-5.2 vs. -2.1 cm; p=0.003) and hip circumference (-5.9 vs. -1 cm; p<0.0001) was also seen in the DASH group compared with the control group. In conclusion, consumption of the DASH eating pattern for 8 weeks in overweight and obese women with PCOS resulted in the improvement of insulin resistance, serum hs-CRP levels, and abdominal fat accumulation. www.irct.ir: IRCT201304235623N6. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial.

    PubMed

    Cobo, Ana; Meseguer, Marcos; Remohí, José; Pellicer, Antonio

    2010-09-01

    An efficient oocyte cryopreservation method is mandatory to establish a successful egg-banking programme. Although there are increasing reports showing good clinical outcomes after oocyte cryopreservation, there is still a lack of large controlled studies evaluating the effectiveness of oocyte cryo-banking. In this study, we aimed to compare the outcome of vitrified-banked oocytes with the gold standard procedure of employing fresh oocytes. A randomized, prospective, triple-blind, single-centre, parallel-group controlled-clinical trial (NCT00785993), including 600 recipients (alpha = 0.05 and power of 80% for sample-size calculation) selected among 1032 eligible patients from November 2008 to September 2009, was designed to compare the outcome of vitrified-banked oocytes with the gold standard procedure of employing fresh oocytes. The study was designed to establish the superiority of the ongoing pregnancy rate (OPR) of fresh oocytes over that of vitrified oocytes, by performing a likelihood ratio test in a logistic regression analysis expressed as odds ratio (OR) with 95% confidence interval (CI). A limit of 0.66 for OR of vitrified versus fresh groups was defined to set up a possible conversion from superiority to non-inferiority. Randomization was performed 1:1 based on a computer randomization list in vitrification (n = 300) or fresh groups (n = 300). The primary end-point was the OPR per randomized patient i.e. intention-to-treat population (ITT). Secondary end-points were clinical pregnancy (CPR), implantation (IR) and fertilization rates, respectively. Additionally, embryo developmental characteristics were recorded. There were no differences in donor ovarian stimulation parameters, demographic baseline characteristics for donors and recipients, ovum donation indications or male factor distribution between groups (NS). The OPR per ITT was 43.7 and 41.7% in the vitrification and fresh groups, respectively. The OR of OPR was 0.921 in favour of the

  20. Effect of Massage Therapy on Vital Signs and GCS Scores of ICU Patients: A Randomized Controlled Clinical Trial

    PubMed Central

    Vahedian-Azimi, Amir; Ebadi, Abbas; Asghari Jafarabadi, Mohammad; Saadat, Soheil; Ahmadi, Fazlollah

    2014-01-01

    Background: Unalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness. Objectives: The purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU). Patients and Methods: This randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient’s vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques. Results: Significant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05). Conclusions: Massage via family members had several positive effects on the patients’ clinical conditions, and therefore, it should

  1. Rationale and design of a randomized controlled trial of directly observed hepatitis C treatment delivered in methadone clinics.

    PubMed

    Litwin, Alain H; Berg, Karina M; Li, Xuan; Hidalgo, Jennifer; Arnsten, Julia H

    2011-11-12

    Most methadone-maintained injection drug users (IDUs) have been infected with hepatitis C virus (HCV), but few initiate HCV treatment. Physicians may be reluctant to treat HCV in IDUs because of concerns about treatment adherence, psychiatric comorbidity, or ongoing drug use. Optimal HCV management approaches for IDUs remain unknown. We are conducting a randomized controlled trial in a network of nine methadone clinics with onsite HCV care to determine whether modified directly observed therapy (mDOT), compared to treatment as usual (TAU), improves adherence and virologic outcomes among opioid users. We plan to enroll 80 HCV-infected adults initiating care with pegylated interferon alfa-2a (IFN) plus ribavirin, and randomize them to mDOT (directly observed daily ribavirin plus provider-administered weekly IFN) or TAU (self-administered ribavirin plus provider-administered weekly IFN). Our outcome measures are: 1) self-reported and pill count adherence, and 2) end of treatment response (ETR) or sustained viral response (SVR). We will use mixed effects linear models to assess differences in pill count adherence between treatment arms (mDOT v. TAU), and we will assess differences between treatment arms in the proportion of subjects with ETR or SVR with chi square tests. Of the first 40 subjects enrolled: 21 have been randomized to mDOT and 19 to TAU. To date, the sample is 77% Latino, 60% HCV genotype-1, 38% active drug users, and 27% HIV-infected. Our overall retention rate at 24 weeks is 92%, 93% in the mDOT arm and 92% in the TAU arm. This paper describes the design and rationale of a randomized clinical trial comparing modified directly observed HCV therapy delivered in a methadone program to on-site treatment as usual. Our trial will allow rigorous evaluation of the efficacy of directly observed HCV therapy (both pegylated interferon and ribavirin) for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a

  2. Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial

    PubMed Central

    Ephraim, Patti L.; Hill-Briggs, Felicia; Roter, Debra; Bone, Lee; Wolff, Jennifer; Lewis-Boyer, LaPricia; Levine, David; Aboumatar, Hanan; Cooper, Lisa A; Fitzpatrick, Stephanie; Gudzune, Kimberly; Albert, Michael; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary; Fagan, Peter; Ramamurthi, Hema; Ameling, Jessica; Charlston, Jeanne; Sam, Tanyka; Carson, Kathryn A.; Wang, Nae-Yuh; Crews, Deidra; Greer, Raquel; Sneed, Valerie; Flynn, Sarah J.; DePasquale, Nicole; Boulware, L. Ebony

    2014-01-01

    Background Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. Methods/Design We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months. Discussion Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control. PMID:24956323

  3. Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

    PubMed Central

    2013-01-01

    Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

  4. Donepezil for Irradiated Brain Tumor Survivors: A Phase III Randomized Placebo-Controlled Clinical Trial

    PubMed Central

    Rapp, Stephen R.; Case, L. Doug; Peiffer, Ann; Naughton, Michelle M.; Chan, Michael D.; Stieber, Volker W.; Moore, Dennis F.; Falchuk, Steven C.; Piephoff, James V.; Edenfield, William J.; Giguere, Jeffrey K.; Loghin, Monica E.; Shaw, Edward G.

    2015-01-01

    Purpose Neurotoxic effects of brain irradiation include cognitive impairment in 50% to 90% of patients. Prior studies have suggested that donepezil, a neurotransmitter modulator, may improve cognitive function. Patients and Methods A total of 198 adult brain tumor survivors ≥ 6 months after partial- or whole-brain irradiation were randomly assigned to receive a single daily dose (5 mg for 6 weeks, 10 mg for 18 weeks) of donepezil or placebo. A cognitive test battery assessing memory, attention, language, visuomotor, verbal fluency, and executive functions was administered before random assignment and at 12 and 24 weeks. A cognitive composite score (primary outcome) and individual cognitive domains were evaluated. Results Of this mostly middle-age, married, non-Hispanic white sample, 66% had primary brain tumors, 27% had brain metastases, and 8% underwent prophylactic cranial irradiation. After 24 weeks of treatment, the composite scores did not differ significantly between groups (P = .48); however, significant differences favoring donepezil were observed for memory (recognition, P = .027; discrimination, P = .007) and motor speed and dexterity (P = .016). Significant interactions between pretreatment cognitive function and treatment were found for cognitive composite (P = .01), immediate recall (P = .05), delayed recall (P = .004), attention (P = .01), visuomotor skills (P = .02), and motor speed and dexterity (P < .001), with the benefits of donepezil greater for those who were more cognitively impaired before study treatment. Conclusion Treatment with donepezil did not significantly improve the overall composite score, but it did result in modest improvements in several cognitive functions, especially among patients with greater pretreatment impairments. PMID:25897156

  5. Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial.

    PubMed

    Gropper, Savion; Albareda, Nuria; Chelius, Klaus; Kruger, Dawie; Mitha, Ismail; Vahed, Yacoob; Gani, Mashra; García-Alonso, Fernando

    2014-01-01

    We compared the efficacy and safety of ozenoxacin (a new nonfluorinated quinolone) 1% cream with placebo in the treatment of impetigo. In a randomized, double-blind, multicenter study, patients received ozenoxacin cream or placebo cream twice daily for 5 days (a third group received retapamulin 1% ointment as a control). Clinical, microbiological and laboratory evaluations were performed during follow-up (over 2 weeks). Ozenoxacin was superior to placebo (success rate 34.8 vs 19.2%; p = 0.003). Microbiological success was 70.8% for ozenoxacin and 38.2% for placebo after 3-4 days and 79.2% versus 56.6% after 6-7 days. Ozenoxacin produced more rapid microbiological clearance than retapamulin. All treatments were well tolerated. Ozenoxacin 1% cream was effective and safe in the treatment of impetigo.

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

    PubMed

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

    2017-01-01

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

  7. A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence -based medicine course.

    PubMed

    Kulier, Regina; Khan, Khalid S; Gulmezoglu, A Metin; Carroli, Guillermo; Cecatti, Jose G; Germar, Maria J; Lumbiganon, Pisake; Mittal, Suneeta; Pattinson, Robert; Wolomby-Molondo, Jean-Jose; Bergh, Anne-Marie; May, Win

    2010-05-14

    Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL) as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning) course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand), involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online.The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs) and a skills-assessing questionniare administered eletronically. These questions have been developed by using questions from

  8. A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence -based medicine course

    PubMed Central

    2010-01-01

    Background and objectives Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL) as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning) course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. Methods The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand), involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online. The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs) and a skills-assessing questionniare administered eletronically. These questions have been

  9. Effects of testosterone replacement in middle-aged men with dysthymia: a randomized, placebo-controlled clinical trial.

    PubMed

    Seidman, Stuart N; Orr, Guy; Raviv, Gil; Levi, Rachel; Roose, Steven P; Kravitz, Efrat; Amiaz, Revital; Weiser, Mark

    2009-06-01

    Mid-life onset male dysthymic disorder (DD) seems to be a distinct clinical condition with limited therapeutic options. Testosterone replacement is mood-enhancing and has been proposed as an antidepressant therapy, though this strategy has received limited systematic study. We therefore conducted a six-week double-blind placebo-controlled clinical trial in 23 men with DD and with low or low-normal testosterone (T) level (i.e, screening total serum testosterone <350 ng/dL). Enrolled men were randomized to receive intramuscular injections of 200 mg of testosterone cypionate or placebo every 10 days. The primary outcome measures were the Clinical Global Impression (CGI) improvement score and the 21-item Hamilton Depression Rating Scale (HDRS) score.Twenty-three patients were randomized. The mean (SD) age of the enrolled patients was 50.6 (7.0) years and that of total testosterone level was 339 (93) ng/dL. The median duration of the current dysthymic episode was 3.6 (2.3) years, and the mean (SD) HDRS was 14.0 (2.9). After the intervention, the mean HDRS score decreased significantly more in the testosterone group (7.46 [4.56]) than in the placebo group (1.8 [4.13], t21 = -3.07, P = 0.006). Remission, defined as a CGI improvement score of 1 or 2 and a final HDRS score lower than 8, was achieved by 7 (53.8%) of 13 in the testosterone group and 1 (10%) of 10 in the placebo group (P = 0.03). Testosterone replacement may be an effective antidepressant strategy for late-onset male dysthymia.

  10. Effects of Collaboration Care Model on the Quality of Life in Patients after Coronary Angioplasty: A Randomized Controlled Clinical Trial

    PubMed Central

    Rezapoor, Parastoo; Shahriari, Mohsen; Sanei, Hamid; Moeini, Mahin

    2017-01-01

    ABSRTACT Background: Coronary artery diseases and therapies such as coronary angioplasty would lead to changes in the quality of life in patients. The aim of this study was to determine the effects of collaborative care model on the quality of life in patients after coronary angioplasty. Methods: This randomized controlled clinical trial was conducted in Isfahan, Iran during 2015. In this study, 50 samples were selected by simple sampling and randomly allocated into two equal groups of intervention and control. Collaborative care model was performed in the intervention group for 3 months. Data were collected using quality of life (SF-36) questionnaire which includes 36 questions on physical and psychological dimensions and was completed before and one month after the intervention in both groups. Data were analyzed using descriptive and analytical statistics and by independent t- test, paired t test, Chi square and Mann-Whitney tests through SPSS 18. Results: After the intervention, the mean score of quality of life in the intervention group was significantly higher than the control group (P<0.05). The results of independent t-test showed a significant difference between both groups regarding the mean of changes in the score of quality of life and its dimensions in patients undergoing coronary angioplasty 3 months after the intervention (P<0.001). Conclusion: Results revealed that patients who had been cared based on collaborative care model had better scores of quality of life in all the physical, mental and social dimensions than the control group. Therefore, using this model for taking care of patients after coronary angioplasty is recommended. Trial Registration Number: IRCT2015120120912N4 PMID:28409165

  11. Effects of Collaboration Care Model on the Quality of Life in Patients after Coronary Angioplasty: A Randomized Controlled Clinical Trial.

    PubMed

    Rezapoor, Parastoo; Shahriari, Mohsen; Sanei, Hamid; Moeini, Mahin

    2017-04-01

    Coronary artery diseases and therapies such as coronary angioplasty would lead to changes in the quality of life in patients. The aim of this study was to determine the effects of collaborative care model on the quality of life in patients after coronary angioplasty. This randomized controlled clinical trial was conducted in Isfahan, Iran during 2015. In this study, 50 samples were selected by simple sampling and randomly allocated into two equal groups of intervention and control. Collaborative care model was performed in the intervention group for 3 months. Data were collected using quality of life (SF-36) questionnaire which includes 36 questions on physical and psychological dimensions and was completed before and one month after the intervention in both groups. Data were analyzed using descriptive and analytical statistics and by independent t- test, paired t test, Chi square and Mann-Whitney tests through SPSS 18. After the intervention, the mean score of quality of life in the intervention group was significantly higher than the control group (P<0.05). The results of independent t-test showed a significant difference between both groups regarding the mean of changes in the score of quality of life and its dimensions in patients undergoing coronary angioplasty 3 months after the intervention (P<0.001). Results revealed that patients who had been cared based on collaborative care model had better scores of quality of life in all the physical, mental and social dimensions than the control group. Therefore, using this model for taking care of patients after coronary angioplasty is recommended. Trial Registration Number: IRCT2015120120912N4.

  12. Continuous postoperative blood glucose monitoring and control by artificial pancreas in patients having pancreatic resection: a prospective randomized clinical trial.

    PubMed

    Okabayashi, Takehiro; Nishimori, Isao; Yamashita, Koichi; Sugimoto, Takeki; Maeda, Hiromichi; Yatabe, Tomoaki; Kohsaki, Takuhiro; Kobayashi, Michiya; Hanazaki, Kazuhiro

    2009-10-01

    To evaluate a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection. Prospective, randomized clinical trial. Thirty patients who had pancreatic resection for pancreatic neoplasm. Patients were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method (sliding scale group, n = 13) or the artificial pancreas (artificial pancreas group, n = 17). Incidence of severe hypoglycemia (<40 mg/dL) during the intensive care period following pancreatic resection in patients monitored with the artificial pancreas. The secondary outcome measure was the total amount of insulin required for glycemic control in the first 18 hours after pancreatic resection in each patient group. In the sliding scale group, postoperative blood glucose levels rose initially before reaching a plateau of approximately 200 mg/dL between 4 and 6 hours after pancreatectomy. The levels remained high for 18 hours postoperatively. In the artificial pancreas group, blood glucose levels reduced steadily, reaching the target zone (80-110 mg/dL) by 6 hours after surgery. The total insulin dose administered per patient during the first postoperative 18 hours was significantly higher in the artificial pancreas group (mean [SD], 107 [109] IU) than the sliding scale group (8 [6] IU; P < .01). Neither group showed hypoglycemia. Perioperative use of an artificial endocrine pancreas to control pancreatogenic diabetes after pancreatic resection is an easy and effective way to maintain near-normal blood glucose levels. The artificial pancreas shows promise for use as insulin treatment for patients with pancreatogenic diabetes after pancreatic resection.

  13. Assessing Sample Representativeness in Randomized Control Trials: Application to the National Institute of Drug Abuse Clinical Trials Network

    PubMed Central

    Susukida, Ryoko; Crum, Rosa M.; Stuart, Elizabeth A.; Ebnesajjad, Cyrus; Mojtabai, Ramin

    2016-01-01

    Aims To compare characteristics of individuals participating in randomized control trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nationwide usual SUD treatment settings in the United States. Participants A total of 3,592 individuals from 10 CTN samples and 1,602,226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use, and the number of prior treatments. Findings The proportion of those with ≥12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at p<.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at p<.001. Conclusions In the USA, individuals recruited into randomized control trials (RCT) of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. PMID:26825855

  14. Assessing sample representativeness in randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

    PubMed

    Susukida, Ryoko; Crum, Rosa M; Stuart, Elizabeth A; Ebnesajjad, Cyrus; Mojtabai, Ramin

    2016-07-01

    To compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States. A total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P < 0.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P < 0.001. In the United States, individuals recruited into randomized controlled trials of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. © 2016 Society for the Study of Addiction.

  15. Socket preservation using bovine bone mineral and collagen membrane: a randomized controlled clinical trial with histologic analysis.

    PubMed

    Cardaropoli, Daniele; Tamagnone, Lorenzo; Roffredo, Alessandro; Gaveglio, Lorena; Cardaropoli, Giuseppe

    2012-08-01

    After tooth extraction, varying amounts of bone resorption occur because of qualitative and quantitative changes at the edentulous site of the alveolar process. The aims of this randomized controlled clinical trial were (1) to compare the postextraction changes in residual ridge dimensions during spontaneous healing with those during socket preservation, (2) to analyze the histologic and histomorphometric aspects of the grafted sockets, and (3) to compare probing procket depth (PPD) and clinical attachment level (CAL) changes at teeth adjacent to extraction sites. Forty-eight teeth were extracted from 41 patients referred for extraction of 1 or more maxillary or mandibular premolars or molars. The edentulous sites were randomly assigned to the control (EXT, extraction alone) or experimental groups (SP, extraction and socket preservation). In the SP group, the sockets were filled with bovine bone mineral and covered with porcine collagen membrane. At baseline and after 4 months, PPD, gingival recession (REC), and CAL were measured at teeth adjacent to the edentulous sites. The changes in ridge dimensions from baseline to 4 months were assessed on dental casts. At 4 months, bone was harvested from the grafted areas in the SP group and the edentulous areas in the EXT group. PPD, REC, and CAL were comparable between groups. However, from baseline to 4 months, the SP group showed significantly less reduction in ridge width (1.04 ± 1.08 mm vs 4.48 ± 0.65 mm, P < .001) and height (0.46 ± 0.46 mm vs 1.54 ± 0.33 mm, P < .001). Histologically, the grafted sockets exhibited various stages of bone maturation and formation without inflammatory responses. No significant difference in the mineralized and nonmineralized fractions was noted between the groups. Socket preservation using bovine bone mineral and porcine collagen membrane considerably limits the amount of horizontal and vertical bone resorption when compared with extraction alone.

  16. Xinfeng capsule for the treatment of rheumatoid arthritis patients with decreased pulmonary function--a randomized controlled clinical trial.

    PubMed

    Wan, Lei; Liu, Jian; Huang, Chuan-bing; Wang, Yuan; Chen, Xi; Zhang, Wan-dong; Wang, Gui-zhen; Fan, Hai-xia; Ge, Yao; Chen, Rui-lian; Cao, Yun-xiang; Zong, Rui-kai; Liu, Tian-yang

    2016-03-01

    To determine the effectiveness and safety of Xinfeng Capsules (XFC) for the treatment of rheumatoid arthritis (RA) patients with decreased pulmonary function. This was a randomized controlled clinical trial of 80 RA patients. Participants were assigned to the trial group (40 cases) and the control group (40 cases) by block randomization. The trial group was treated with XFC, three pills each time three times daily for 2 months. The control group was treated with tripterygium glycoside (TPT), two pills each time three times daily for 2 months. Both groups were followed up after 2 months. The clinical effects, changes in joint and pulmonary function, and quality of life before and after treatment were observed; safety indices were also evaluated. Pain, swelling, tenderness, and duration of morning stiffness of joints were obviously decreased after treatment in both the trial and the control groups compared with baseline (P<0.01). Compared with before treatment, hand grip strength increased significantly after treatment in the trial group (P=0.0000); pulmonary function parameters such as forced expiratory volume in the first second of expiration/forced vital capacity (FEV1/FVC), 50% of the expiratory flow of forced vital capacity (FEF50), carbon monoxide diffusing capacity (DLco) were increased (P<0.01 or P<0.05); measures of quality of life such as role-physical, body pain, vitality and mental health were also improved after treatment in the trial group (all P<0.05). Joint swelling in the trial group decreased compared with the control group (P=0.0043), while hand grip strength was increased after treatment (P=0.0000). The increase in FEF50, DLco, and the dimensions of quality of life such as vitality and mental health were all significantly greater in the trial group than the control group (P<0.05 or P<0.01). XFC not only relieved joint pain in RA patients, but also significantly improved the ventilation and diffusion function of the lungs. Therefore, XFC could

  17. Meta-analysis of randomized controlled trials reveals an improved clinical outcome of using genotype plus clinical algorithm for warfarin dosing.

    PubMed

    Liao, Zhenqi; Feng, Shaoguang; Ling, Peng; Zhang, Guoqing

    2015-02-01

    Previous studies have raised interest in using the genotyping of CYP2C9 and VKORC1 to guide warfarin dosing. However, there is lack of solid evidence to prove that genotype plus clinical algorithm provides improved clinical outcomes than the single clinical algorithm. The results of recent reported clinical trials are paradoxical and needs to be systematically evaluated. In this study, we aim to assess whether genotype plus clinical algorithm of warfarin is superior to the single clinical algorithm through a meta-analysis of randomized controlled trials (RCTs). All relevant studies from PubMed and reference lists from Jan 1, 1995 to Jan 13, 2014 were extracted and screened. Eligible studies included randomized trials that compared clinical plus pharmacogenetic algorithms group to single clinical algorithm group using adult (≥ 18 years) patients with disease conditions that require warfarin use. We further used fix-effect models to calculate the mean difference or the risk ratios (RRs) and 95% CIs to analyze the extracted data. The statistical heterogeneity was calculated using I(2). The percentage of time within the therapeutic INR range was considered to be the primary clinical outcome. The initial search strategy identified 50 citations and 7 trials were eligible. These seven trials included 1,910 participants, including 960 patients who received genotype plus clinical algorithm of warfarin dosing and 950 patients who received clinical algorithm only. We discovered that the percentage of time within the therapeutic INR range of the genotype-guided group was improved compared with the standard group in the RCTs when the initial standard dose was fixed (95% CI 0.09-0.40; I(2) = 47.8%). However, for the studies using non-fixed initial doses, the genotype-guided group failed to exhibit statistically significant outcome compared to the standard group. No significant difference was observed in the incidences of adverse events (RR 0.94, 95% CI 0.84-1.04; I(2) = 0%, p

  18. The empirical antibiotic treatment of nosocomial spontaneous bacterial peritonitis: Results of a randomized, controlled clinical trial.

    PubMed

    Piano, Salvatore; Fasolato, Silvano; Salinas, Freddy; Romano, Antonietta; Tonon, Marta; Morando, Filippo; Cavallin, Marta; Gola, Elisabetta; Sticca, Antonietta; Loregian, Arianna; Palù, Giorgio; Zanus, Giacomo; Senzolo, Marco; Burra, Patrizia; Cillo, Umberto; Angeli, Paolo

    2016-04-01

    Spontaneous bacterial peritonitis (SBP) is a common, life-threatening complication of liver cirrhosis. Third-generation cephalosporins have been considered the first-line treatment of SBP. In 2014, a panel of experts suggested a broader spectrum antibiotic regimen for nosocomial SBP, according to the high rate of bacteria resistant to third-generation cephalosporins found in these patients. However, a broader-spectrum antibiotic regimen has never been compared to third-generation cephalosporins in the treatment of nosocomial SBP. The aim of our study was to compare meropenem plus daptomycin versus ceftazidime in the treatment of nosocomial SBP. Patients with cirrhosis and nosocomial SBP were randomized to receive meropenem (1 g/8 hours) plus daptomycin (6 mg/kg/day) or ceftazidime (2 g/8 hours). A paracentesis was performed after 48 hours of treatment. A reduction in ascitic fluid neutrophil count <25% of pretreatment value was considered a treatment failure. The primary outcome was the efficacy of treatment defined by the resolution of SBP after 7 days of treatment. Thirty-two patients were randomized and 31 were analyzed. The combination of meropenem plus daptomycin was significantly more effective than ceftazidime in the treatment of nosocomial SBP (86.7 vs. 25%; P < 0.001). Ninety-day transplant-free survival (TFS) was not significantly different between the two groups. In the multivariate analysis, ineffective response to first-line treatment (hazard ratio [HR]: 20.6; P = 0.01), development of acute kidney injury during hospitalization (HR: 23.2; P = 0.01), and baseline mean arterial pressure (HR: 0.92; P = 0.01) were found to be independent predictors of 90-day TFS. The combination of meropenem plus daptomycin is more effective than ceftazidime as empirical antibiotic treatment of nosocomial SBP. Efficacy of the empirical antibiotic treatment is a strong predictor of 90-day survival in patients with nosocomial SBP. © 2015 by the American

  19. Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study.

    PubMed

    Giordano, Rosaria; Canesi, Margherita; Isalberti, Maurizio; Isaias, Ioannis Ugo; Montemurro, Tiziana; Viganò, Mariele; Montelatici, Elisa; Boldrin, Valentina; Benti, Riccardo; Cortelezzi, Agostino; Fracchiolla, Nicola; Lazzari, Lorenza; Pezzoli, Gianni

    2014-01-17

    Progressive Supranuclear Palsy (PSP) is a sporadic and progressive neurodegenerative disease which belongs to the family of tauopathies and involves both cortical and subcortical structures. No effective therapy is to date available. Autologous bone marrow (BM) mesenchymal stem cells (MSC) from patients affected by different type of parkinsonisms have shown their ability to improve the dopaminergic function in preclinical and clinical models. It is also possible to isolate and expand MSC from the BM of PSP patients with the same proliferation rate and immuphenotypic profile as MSC from healthy donors. BM MSC can be efficiently delivered to the affected brain regions of PSP patients where they can exert their beneficial effects through different mechanisms including the secretion of neurotrophic factors.Here we propose a randomized, placebo-controlled, double-blind phase I clinical trial in patients affected by PSP with MSC delivered via intra-arterial injection. To our knowledge, this is the first clinical trial to be applied in a no-option parkinsonism that aims to test the safety and to exploit the properties of autologous mesenchymal stem cells in reducing disease progression. The study has been designed to test the safety of this "first-in-man" approach and to preliminarily explore its efficacy by excluding the placebo effect. NCT01824121.

  20. The use of a transparent cap in sigmoidoscopy-A randomized controlled clinical trial on pain, time and success rate.

    PubMed

    Ploug, Magnus; Poulsen, Jacob Kvist; Jensen, Henning Quist; Achiam, Michael

    2017-08-01

    Trials on cap-assisted colonoscopy have shown a reduction in pain, faster intubation time and a higher success rate attributed to the use of the cap. No similar studies have been published on sigmoidoscopy even though it is a common procedure associated with significant pain. Our objective was to investigate whether the use of a transparent cap for sigmoidoscopy has an impact on pain, time or success rate. To mimic the tendencies of daily clinical practice, the trainee endoscopist performed the procedures, and no analgesics or sedatives were used. We conducted a randomized, controlled clinical trial with a parallel design consisting of two groups masked for the intervention. The primary endpoint was pain, recorded on a 100-mm visual analogue scale (VAS). Our results found cap-assisted sigmoidoscopy to be significantly more painful than non-cap-assisted sigmoidoscopy (median VAS 50 vs. 38 mm; p = 0.047). We found no differences on time or success rate due to the cap. Our results suggest pain management, e.g. analgesics which is not routinely used for sigmoidoscopy, when a cap is used to gain therapeutic or diagnostic advantages. ClinicalTrials.gov Identifier: NCT02243930.

  1. Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial.

    PubMed

    Wood, Jeffrey J; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C; De Nadai, Alessandro S; Arnold, Elysse; Lewin, Adam B; Murphy, Tanya K; Storch, Eric A

    2015-01-01

    Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009) was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Thirty-three adolescents (11-15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and posttreatment/postwaitlist. In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators' ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed.

  2. Cognitive Behavioral Therapy for Early Adolescents with Autism Spectrum Disorders and Clinical Anxiety: A Randomized, Controlled Trial

    PubMed Central

    Wood, Jeffrey J.; Ehrenreich-May, Jill; Alessandri, Michael; Fujii, Cori; Renno, Patricia; Laugeson, Elizabeth; Piacentini, John C.; De Nadai, Alessandro S.; Arnold, Elysse; Lewin, Adam B.; Murphy, Tanya K.; Storch, Eric A.

    2014-01-01

    Background Clinically elevated anxiety is a common, impairing feature of autism spectrum disorders (ASD). A modular CBT program designed for preteens with ASD, Behavioral Interventions for Anxiety in Children with Autism (BIACA; Wood et al., 2009), was enhanced and modified to address the developmental needs of early adolescents with ASD and clinical anxiety. Method Thirty-three adolescents (11–15 years old) were randomly assigned to 16 sessions of CBT or an equivalent waitlist period. The CBT model emphasized exposure, challenging irrational beliefs, and behavioral supports provided by caregivers, as well as numerous ASD-specific treatment elements. Independent evaluators, parents, and adolescents rated symptom severity at baseline and post-treatment/post-waitlist. Results In intent-to-treat analyses, the CBT group outperformed the waitlist group on independent evaluators’ ratings of anxiety severity on the Pediatric Anxiety Rating Scale (PARS) and 79% of the CBT group met Clinical Global Impressions-Improvement scale criteria for positive treatment response at posttreatment, as compared to only 28.6% of the waitlist group. Group differences were not found for diagnostic remission or questionnaire measures of anxiety. However, parent-report data indicated that there was a positive treatment effect of CBT on autism symptom severity. Conclusions The CBT manual under investigation, enhanced for early adolescents with ASD, yielded meaningful treatment effects on the primary outcome measure (PARS), although additional developmental modifications to the manual are likely warranted. Future studies examining this protocol relative to an active control are needed. PMID:25526831

  3. Surgical microscope may enhance root coverage with subepithelial connective tissue graft: a randomized-controlled clinical trial.

    PubMed

    Bittencourt, Sandro; Del Peloso Ribeiro, Erica; Sallum, Enilson A; Nociti, Francisco H; Casati, Márcio Zaffalon

    2012-06-01

    Minimally invasive techniques have broadened the horizons of periodontal plastic surgery to improve treatment outcomes. Thus, the purpose of this clinical trial was to compare root coverage, postoperative morbidity, and esthetic outcomes of subepithelial connective tissue graft (SCTG) technique with or without the use of a surgical microscope in the treatment of gingival recessions. In this split-mouth study, twenty-four patients with bilateral Miller's Class I or II buccal gingival recessions ≥2.0 mm in canines or premolars were selected. Gingival recessions were randomly designated to receive treatment with SCTG with or without the assistance of the surgical microscope (test and control groups, respectively). Clinical parameters evaluated included the following: depth (RH) and width (RW) of the gingival defect, width (WKT) and thickness (TKT) of keratinized tissue, probing depth (PD), and clinical attachment level (CAL). Postoperative morbidity was evaluated by means of an analog visual scale and questionnaire. Patient satisfaction was also evaluated with a questionnaire. Descriptive statistics were expressed as mean ± SD. Repeated-measures analysis of variance was used for examination of differences regarding PD, CAL, and TKT. The Wilcoxon test was used to detect differences between groups and the Friedman test to detect differences within group regarding WKT, RH, and RW. The average percentages of root coverage for test and control treatments, after 12 months, were 98.0% and 88.3%, respectively (P <0.05). Complete root coverage was achieved in 87.5% and 58.3% of teeth treated in test and control groups, respectively. For all parameters except recession height, there was an improvement in the final examination but without difference between treatments. For the RH, a lower value was found in the test group compared to the control group (P <0.05). In the test group, all patients were satisfied with the esthetics obtained, and 19 patients (79.1%) were satisfied

  4. Randomized Clinical Trial of Portion-Controlled Prepackaged Foods to Promote Weight Loss

    PubMed Central

    Rock, Cheryl L.; Flatt, Shirley W.; Pakiz, Bilgé; Barkai, Hava-Shoshana; Heath, Dennis D.; Krumhar, Kim C.

    2017-01-01

    Objective Providing portion-controlled prepackaged foods in a behavioral counseling intervention may promote more weight and fat loss than a standard self-selected diet. Methods: The primary aim was to test whether providing portion-controlled prepackaged lunch and dinner entrées within a behavioral weight loss intervention promotes greater weight loss at 12 weeks in overweight/obese adults compared to self-selected foods. Other aims were to examine effects on biological factors, fitness, and meal satisfaction. One-half of those assigned to prepackaged entrées were provided items with a higher protein level (>25% energy) as an exploratory aim. Results Participants (N=183) had a baseline weight of 95.9 (15.6) kg (mean [SD]) and BMI of 33.2 (3.5) kg/m2. Weight data at 12 weeks were available for 180 subjects. Weight loss for regular entrée, higher protein entrée and control groups was 8.6 (3.9), 7.8 (5.1), and 6.0 (4.4)%, respectively (P<0.05, intervention vs. control). Intervention participants lost more body fat than controls (5.7 [3.4] vs. 4.4 [3.3] kg, P<0.05). Conclusions A meal plan incorporating portion-controlled prepackaged entrées promotes greater weight and fat loss than a standard self-selected diet, with comparable meal satisfaction. Initial weight loss predicts long-term weight loss so these results are relevant to likelihood of longer term success. PMID:27225596

  5. Effect of supportive nursing care on self esteem of patients receiving electroconvulsive therapy: a randomized controlled clinical trial.

    PubMed

    Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

    2014-06-01

    Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ(2), t-test and ANCOVA. RESULTS showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients.

  6. Effect of Supportive Nursing Care on Self Esteem of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    PubMed Central

    Ebrahimi, Hossein; Navidian, Ali; Keykha, Roghaieh

    2014-01-01

    Introduction: Self-esteem is an important potential indicator in etiology, diagnosis and treatment of patients with severe mental illness. ECT is a popular treatment for these patients that can effect on their self-esteem and reinforce their problems. The purpose of this study is to determine the effect of supportive nursing care in increasing self esteem of patients receiving ECT. Methods: This clinical trial was conducted in the Baharan psychiatric hospital of Zahedan. A total of 70 cases of patients who received ECT were randomly allocated to control (n=35) and intervention (n=35) groups. The data were collected by demographic characteristics questionnaire and Rosenberg Self Esteem Scale (RSES). Intervention group received the supportive nursing care. The control group received only routine treatment. Self esteem level was measured and compared before and after intervention for two groups. The data was analyzed by SPSS using the χ2, t-test and ANCOVA. Results: Results showed that both groups were homogeneous on the socio- demographic characteristics. The mean self esteem in the intervention group compared with the control group was significantly increased. While controlling the effects of individual and social variables, the result shows significant differences between two groups in the mean scores of self esteem after the intervention. Conclusion: The results suggest that supportive nursing care can have positive effect on self esteem of patients receiving ECT. It is recommended to use this method for increasing self esteem of these patients. PMID:25276758

  7. Effect of ginger (Zingiber officinale) on heavy menstrual bleeding: a placebo-controlled, randomized clinical trial.

    PubMed

    Kashefi, Farzaneh; Khajehei, Marjan; Alavinia, Mohammad; Golmakani, Ebrahim; Asili, Javad

    2015-01-01

    A wide range of herbal plants have been reported to treat various gynecological problems of women. This study was set out to investigate the effect of ginger (Zingiber officinale) on heavy menstrual bleeding (HMB) in high school girls. Ninety-two young women who experienced HMB and met the inclusion criteria were recruited in this study. Participants were evaluated for six consecutive menstrual cycles. During 3 assessment cycles, their HMB was confirmed by Pictorial Blood Assessment Chart. They were then randomly allocated to two study groups to receive either ginger or placebo capsules. The participants filled in the same chart during three intervention cycles. The level of menstrual blood loss dramatically declined during the three intervention cycles in ginger-receiving group. The decrease of blood loss in ginger-receiving group was significantly more remarkable than that of participants receiving placebo (p<0.001). Minimum number of participants reported adverse effects. HMB is highly prevalent among young women. Considering the significance of appropriate and timely treatment and also the importance of prevention of unwanted consequences, ginger may be considered as an effective therapeutic option for HMB. Copyright © 2014 John Wiley & Sons, Ltd.

  8. Comparative Efficacy of Topical Curcumin and Triamcinolone for Oral Lichen Planus: A Randomized, Controlled Clinical Trial

    PubMed Central

    Kia, Seid Javad; Shirazian, Shiva; Mansourian, Arash; Khodadadi Fard, Leila; Ashnagar, Sajjad

    2015-01-01

    Objectives: Lichen planus (LP) is a chronic inflammatory mucocutaneous disease. Its treatment is often symptomatic and includes topical and systemic corticosteroids. Although corticosteroid therapy is usually successful, it has side effects and thus, an alternative treatment is favorable. The aim of this study was to compare the efficacy of topical curcumin and triamcinolone for treatment of oral lichen planus (OLP). Materials and Methods: In this study, 50 patients (36 women and 14 men) in the age range of 38 to 73 years with OLP were randomly divided into two groups. Each group received 0.1% triamcinolone or 5% curcumin oral paste three times a day for four weeks. Assessment of the appearance score and severity of pain was done at baseline and at the end of two and four weeks and recorded in the patients’ questionnaires. The data were analyzed by SPSS 17 software, using the Mann-Whitney and Spearman's tests. Results: With respect to pain reduction, nine patients (36%) in the curcumin group and eight patients (32%) in the triamcinolone group showed complete remission. With respect to the appearance score, one patient (4%) in each group showed complete remission. No statistically significant difference was noted between the two groups. Conclusion: Application of curcumin is suggested for treatment of OLP because of its desirable anti-inflammatory effects and insignificant side effects. PMID:27507989

  9. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

    PubMed Central

    2010-01-01

    Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498. PMID:20958995

  10. A tale of two RCTs: using randomized controlled trials to benchmark routine clinical (psychological) treatments for chronic pain.

    PubMed

    Fenton, Grania; Morley, Stephen

    2013-10-01

    This article reports the development of natural history and active treatment benchmarks for psychological treatments of chronic pain. The benchmarks were derived from randomized controlled trials (RCTs) reported in a published meta-analysis. In two preliminary studies we surveyed small samples of active clinicians working in U.K. pain management programs. Study 1 assessed the fit between routine clinical treatment and the selected RCTs. In study 2 Delphi methodology was used to determine a set of outcome domains to be used in the development of benchmarks. In study 3 we extracted data from a set of RCTs where both pre- and post-treatment data were reported. Measures were allocated to 1 of 5 outcome domains (cognitive coping and appraisal, pain experience, pain behavior, emotional functioning, and physical functioning). Pre-treatment to post-treatment effect sizes (Cohen's d) were computed and, where necessary, aggregated within trial so that each trial contributed a single estimate to outcome domain. Effect size (ES) benchmarks were computed for all trials and those trials with an explicit cognitive behavior therapy protocol. In no case did the ES estimates for the untreated control deviate from 0. The average ES across outcome domains for the treatment arms was approximately 0.35. These benchmarks may be used to assess the effectiveness of routine clinical treatments for chronic pain. The application of these data and the limitations of the study are discussed.

  11. Psychological, behavioral, and clinical effects of intra-oral camera: a randomized control trial on adults with gingivitis.

    PubMed

    Araújo, Mário-Rui; Alvarez, Maria-João; Godinho, Cristina A; Pereira, Cícero

    2016-12-01

    To evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral, and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework. A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control. Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy, and planning) and IOC opinion were evaluated 1 week before or during the appointment and 4 months later. Repeated-measures anova was used to compare groups over time. Almost all the patients brushed their teeth daily, while 78% either never or hardly ever used dental floss. The IOC group showed significant improvements in BOMP index (P < 0.001), self-reported flossing (P < 0.05), and self-efficacy (P < 0.05) compared to the control group. The use of IOC significantly improves clinical, behavioral, and psychological determinants of periodontal health 4 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial.

    PubMed

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T

    2012-03-30

    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  13. Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomized, controlled clinical study.

    PubMed

    Hägi, Tobias T; Hofmänner, Petra; Salvi, Giovanni E; Ramseier, Christoph A; Sculean, Anton

    2013-01-01

    The aim of this prospective, randomized, controlled clinical study was to compare the clinical outcomes of the subgingival treatment with erythritol powder by means of an air-polishing (EPAP) device and of scaling and root planing (SRP) during supportive periodontal therapy (SPT). 40 patients enrolled in SPT were randomly assigned to two groups of equal size. Sites had to show signs of inflammation (bleeding on probing [BOP]-positive) and a probing pocket depth (PPD) of ≥ 4 mm, however, without presence of detectable subgingival calculus. During SPT, these sites were treated with EPAP or SRP, respectively. Full mouth and site-specific plaque indices, BOP, PPD, and clinical attachment level (CAL) were recorded at baseline (BL) and at 3 months, whereas the percentage of study sites positive for BOP (BOP+) was considered as primary outcome variable. Additionally, patient comfort using a visual analog scale (VAS) and the time needed to treat per site was evaluated. At 3 months, mean BOP level measured 45.1% at test sites and 50.6% at control sites, respectively, without a statistically significant difference between the groups (P > .05). PPD and CAL slightly improved for both groups with comparable mean values at 3 months. Evaluation of patient tolerance showed statistically significantly better values among patients receiving the test treatment (mean VAS [0-10], 1.51) compared to SRP (mean VAS [0-10], 3.66; P = .0012). The treatment of test sites was set to 5 seconds per site. The treatment of control sites, on the other hand, lasted 85 seconds on average. The new erythritol powder applied with an air-polishing device can be considered a promising modality for repeated instrumentation of residual pockets during SPT. With regard to clinical outcomes during SPT, similar results can be expected irrespective of the two treatment approaches of hand instrumentation or subgingival application of erythritol powder with an air-polishing device in sites where only biofilm

  14. Evaluation of clinical, antiinflammatory and antiinfective properties of amniotic membrane used for guided tissue regeneration: A randomized controlled trial

    PubMed Central

    Kumar, Aravind; Chandra, Rampalli Viswa; Reddy, Aileni Amarender; Reddy, Bavigadda Harish; Reddy, Chakravarthy; Naveen, Anumala

    2015-01-01

    Background: The objective of this study was to evaluate the antiinflammatory, antiinfective and clinical properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in contained interdental defects. Materials and Methods: A total of 30 subjects participated in this study. Two sites in each subject were randomly assigned into each of the following experimental groups; test group: AM with bone graft and control group: Bone graft only. Clinical parameters included recording site-specific measures of plaque, gingivitis, probing pocket depth (PPD), and clinical attachment loss (CAL). The levels of interleukin-1β (IL-1β) and human beta-defensin-2 (hBD-2) levels in gingival crevicular fluid (GCF) from the test and control sites were measured by using commercially available enzyme linked immunosorbent assay kits. The evaluation of bone fill was performed by using digital subtraction technique and morphometric area analysis. One-way analysis of variance followed by the post-hoc test was used for intragroup and intergroup comparison. A P < 0.05 was considered as statistically significant. Results: Combination therapy using an AM increased bone fill and reduced PPD and CAL when compared to controls. AM also resulted in a significant reduction of GCF IL-1β levels and insignificant increase in the hBD-2 levels. Conclusion: From this trial conducted over a period of 24 weeks, AM demonstrated a marked antiinflammatory effect and its use resulted in an improvement in periodontal parameters. AM has the potential to function as a barrier for GTR and the unique properties associated with this material can augment its potential as a matrix for periodontal regeneration. PMID:25878677

  15. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study.

    PubMed

    Sertel, Serkan; Bergmann, Zazie; Ratzlaff, Kerstin; Baumann, Ingo; Greten, Henry Johannes; Plinkert, Peter Karl

    2009-01-01

    Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus ("wind") disease of traditional Chinese medicine (TCM). Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

  16. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 3: Design considerations.

    PubMed

    Ball, Greg; Silverman, Michael H

    2011-09-01

    Ongoing safety monitoring of clinical trials of investigational treatments must operate at levels that range from the minute and detailed - namely, mathematical treatment of trial data - to the philosophical and societal - namely, ethical concerns for individuals and populations. Between those two poles lies a realm of environmental and pragmatic considerations that reflect the goals, biases, risk-tolerance, and constraints of study sponsors and organizers. These factors, while more difficult to quantify or, at times, to justify, also have a meaningful impact on the approach to safety monitoring and the resulting actions and outcomes. This paper considers the influence and interaction of two such factors, study design and statistical framework, on continuous safety monitoring procedures. Group sequential designs have been generally preferred for clinical trials over continuous sequential designs because of practical considerations. The group means and greater time for deliberation when using a group sequential procedure, as opposed to a continuous sequential procedure, can improve the quality of the analyses with minimal loss in sensitivity. However, undertaking any sequential analysis within a frequentist framework provokes considerable theoretical and practical difficulties. Continuous monitoring with a likelihood based method, on the other hand, has the advantages that all available information, including new data, can be used; sample sizes need not be fixed; and decisions can be made at any time without statistical penalty, irrespective of trial design. Such responsive statistical rules are needed to provide guidance to the human beings charged with trial monitoring.

  17. Effectiveness of Behavioral Parent Training for Children with ADHD in Routine Clinical Practice: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Van Den Hoofdakker, Barbara J.; Van Der Veen-Mulders, Lianne; Sytema, Sjoerd; Emmelkamp, Paul M. G.; Minderaa, Ruud B.; Nauta, Maaike H.

    2007-01-01

    Objective: To investigate the effectiveness of behavioral parent training (BPT) as adjunct to routine clinical care (RCC). Method: After a first phase of RCC, 94 children with attention-deficit/hyperactivity disorder (ADHD) ages 4-12, all referred to a Dutch outpatient mental health clinic, were randomly assigned to 5 months of BPT plus concurrent…

  18. Clinical evaluation of an improved cementation technique for implant-supported restorations: a randomized controlled trial.

    PubMed

    Canullo, Luigi; Cocchetto, Roberto; Marinotti, Fabio; Oltra, David Peñarrocha; Diago, María Peñarrocha; Loi, Ignazio

    2016-12-01

    Cement remnants were frequently associated with peri-implantitis. Recently, a shoulderless abutment was proposed, raising some concern about cement excess removal. To compare different cementation techniques for implant-supported restorations assessing the amount of cement remnants in the peri-implant sulcus. Additional aim was to compare the effect of these cementation techniques using two different abutment designs. Forty-six patients requiring double implant-supported restoration in the posterior maxilla were randomly divided in two groups according to the cementation modality: intraoral and extraoral. According to the abutment finishing line, implants in each patient were randomly assigned to shoulderless or chamfer subgroup. In the intraoral group, crowns were directly seated onto the titanium abutment. In the extraoral group, crowns were firstly seated onto a resin abutment replica and immediately removed, then cleansed of the cement excess and finally seated on the titanium abutment. After cement setting, in both groups, cement excess was carefully tried to remove. Three months later, framework/abutment complexes were disconnected and prepared for microscopic analysis: surface occupied by exposed cement remnants and marginal gaps were measured. Additionally, crown/abutment complexes were grinded, and voids of cement were measured at abutment/crown interface. Related-samples Friedman's two-way analysis of variance by ranks was used to detect differences between groups and subgroups (P ≤ 0.5). At the end of the study, a mean value of 0.45 mm(2) (±0.80), 0.38 mm(2) (±0.84), and 0.065 mm(2) (±0.13) and 0.07 mm(2) (±0.15) described surface occupied by cement remnants in shoulderless and chamfer abutment with intraoral cementation and shoulderless and chamfer abutment with extraoral cementation, respectively. A mean value of 0.40 mm(2) (±0.377), 0.41 mm(2) (±0.39) and 0.485 mm(2) (±0.47) and 0.477 mm(2) (±0.43) described cement voids at the

  19. Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial.

    PubMed

    Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang

    2014-09-17

    Virtual patient simulation has grown substantially in health care education. A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients. The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy, by comparing with a conventional mannequin-based simulation, for improving the nursing students' performances in assessing and managing patients with clinical deterioration. A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email. After a baseline evaluation of all participants' clinical performance in a simulated environment, the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training. All participants were then re-tested one day (first posttest) and 2.5 months (second posttest) after the intervention. The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation. Compared to their baseline scores, both experimental and control groups demonstrated significant improvements (P<.001) in first and second post-test scores. While the experimental group had significantly lower (P<.05) second post-test scores compared with the first post-test scores, no significant difference (P=.94) was found between these two scores for the control group. The scores between groups did not differ significantly over time (P=.17). The virtual patient simulation was rated positively. A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed. Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation, both simulations have demonstrated

  20. Remote ischemic preconditioning in percutaneous coronary revascularization: a double-blind randomized controlled clinical trial.

    PubMed

    Ghaemian, Ali; Nouraei, S Mahmoud; Abdollahian, Fatemeh; Naghshvar, Farshad; Giussani, Dino A; Nouraei, S A Reza

    2012-10-01

    To assess the impact of pre-procedural remote ischemic preconditioning on the incidence of myocardial complications following percutaneous coronary intervention. Ischemic preconditioning of a remote vascular territory improves the subsequent ischemic tolerance of distant organs. The Myocardial Event Reduction with Ischemic Preconditioning Therapy (MERIT) trial recruited 80 consecutive patients undergoing elective angioplasty with drug-eluting stents to receive two 5-min lower limb tourniquet occlusions or an un-inflated tourniquet (controls) 1 h before the procedure. The primary outcome was troponin T level at 24 h. Secondary outcomes were intra-procedural chest pain and ST-segment deviation. 6 patients in the control group and 2 in the ischemic preconditioning group had pre-procedural raised troponin T (p = 0.23). This increased to 16 (40%) in the control group and 5 (12.5%) in the study group at 24 h (p = 0.01). Fewer patients in the study group experienced intra-procedural chest pain (1 vs. 7, p = 0.056). Mean ST-segment deviation time was 13 ± 35 s in the study group and 58 ± 118 s in the control group (p = 0.02). At a mean follow-up of 11 months, the major adverse cardiac event rate did not differ significantly between the groups. These data suggest that ischemic preconditioning reduces the absolute risk of post-procedure cardiomyocyte necrosis by 27.5%, and reduces intra-procedural chest pain and ST-segment deviation in patients undergoing percutaneous coronary interventions. We suggest its routine use in percutaneous coronary intervention, although the long-term prognostic impact in this patient group warrants further investigation.

  1. Cumulative recruitment experience in two large single-center randomized, controlled clinical trials.

    PubMed

    Galbreath, Autumn Dawn; Smith, Brad; Wood, Pamela; Forkner, Emma; Peters, Jay I

    2008-05-01

    Trial recruitment is challenging for researchers, who frequently overestimate the pool of qualified, willing participants. Little has been written about recruitment and the comparative success of recruitment strategies. We describe one center's experience with recruitment in two regional single-center clinical trials with a combined total of 1971 participants. The heart failure trial was conducted between 1999 and 2003. The asthma trial was performed between 2003 and 2006. Trial databases were queried for referral source of each individual. Data were analyzed for effectiveness of referral source using three measures: percentage of enrollment due to that source, subject commitment to the trial (retention rate), and economics (cost per enrollee). 47.8% of CHF enrollees came from computer-generated lists or from healthcare provider referrals. Average marketing cost for enrollees and completers was $29.20 and $41.96 respectively. The most economical marketing strategy was self-referral in response to flyers. Most asthma participants (53.5%) were referred from healthcare providers, mailings to lists from local healthcare institutions, or self-referred in response to flyers. Average marketing cost for enrollees and completers was $20.44 and $38.10 respectively. The most economical marketing strategy was patient mailings. Retention rates were not markedly different among referral sources in either trial. In order to be considered effective, a recruitment strategy must demonstrate a balance between response to recruitment, retention rates, and economics. Despite the differences between these two clinical trials, the most effective recruitment strategies in both trials were mailings to locally-generated, targeted lists, and referrals from healthcare providers.

  2. The effect of thyme honey nasal spray on chronic rhinosinusitis: a double-blind randomized controlled clinical trial.

    PubMed

    Hashemian, Farnaz; Baghbanian, Neda; Majd, Zahra; Rouini, Mohammad-Reza; Jahanshahi, Javaneh; Hashemian, Farshad

    2015-06-01

    Chronic rhinosinusitis is a common disease which causes persisting inflammatory conditions of one or more sinuses. This study was designed to evaluate the effect of thyme honey nasal spray as an adjunctive medication on chronic rhinosinusitis after functional endoscopic sinus surgery. This was a randomized, placebo controlled, double-blind clinical study. 64 patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery were enrolled in this study. Patients were randomized and blinded to receive either placebo or thyme honey nasal spray in addition to the standard regimen postoperatively. Patients were visited on postoperative days 7, 30 and 60. The sino-nasal outcome test, endoscopic grading system and sinus CT-scan were scored before operation and on the day 60 after surgery. 54 patients completed the study. Significant improvement was observed in both treatment groups. There were no significant changes in SNOT-22, endoscopy and CT-scan scores between the two study groups. However, a greater reduction in endoscopic scores was shown in thyme honey group. The incidence of adverse effects was not significantly different between the groups, but synechiae formation and epistaxis were lower in treatment group. Thyme honey nasal spray seems to be a low-priced potential adjuvant remedy with excellent safety profile, to reduce inflammation and polyp formation and also fostering mucosal healing for patients suffering from chronic rhinosinusitis. However, further studies are recommended.

  3. Effect of Ginger Supplementation on Proinflammatory Cytokines in Older Patients with Osteoarthritis: Outcomes of a Randomized Controlled Clinical Trial.

    PubMed

    Mozaffari-Khosravi, Hassan; Naderi, Zahra; Dehghan, Ali; Nadjarzadeh, Azadeh; Fallah Huseini, Hassan

    2016-01-01

    There is limited evidence that ginger powder consumption can relieve pain and inflammation due to specific anti-inflammatory phytochemical constitutents. This study investigates the effect of ginger supplementation on proinflammatory factors in participants (n = 120) of a randomized double-blind placebo-controlled 3-month clinical trial investigating knee osteoarthritis. Patients were randomly assigned to one of two groups: the ginger group (GG) or the placebo group (PG). Administered daily for 3 months, participants in the GG intervention received capsules containing 500 mg of ginger powder, while PG participants received capsules filled with 500 mg starch. Serum samples collected at baseline and 3 months were analyzed for serum levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). At baseline, proinflammatory cytokine concentrations did not differ by group. However, at 3 months, both cytokines decreased in the GG relative to the PG. The results of this study indicate that ginger supplementation may have a promising benefits for knee osteoarthritis and may, therefore, may warrant further study.

  4. Augmentation of fluoxetine with lovastatin for treating major depressive disorder, a randomized double-blind placebo controlled-clinical trial.

    PubMed

    Ghanizadeh, Ahmad; Hedayati, Arvin

    2013-11-01

    There are contradictory evidence about the effect of statins on depression. This 6-week-randomized placebo-controlled clinical trial assessed the efficacy and safety of lovastatin as an adjuvant agent for treating major depressive disorder (MDD). The participants were 68 patients with MDD according to DSM-IV diagnostic criteria. The sample was randomly allocated into fluoxetine (up to 40 mg/day) plus lovastatin (30 mg/day) group or fluoxetine plus placebo group. Hamilton Depression Rating scale was used to measure depression score at baseline, week 2, and week 6. Both groups showed a significant decrease of depression score on the Hamilton Depression scale. However, the treatment group decreased depression score more than placebo group [12.8(6.3) vs. 8.2(4.0), t = 3.4, df = 60, P < .001]. Any serious adverse effect was not found. These results suggest that lovastatin as an adjuvant treatment may be effective for treating patients with MDD. © 2013 Wiley Periodicals, Inc.

  5. Acetaminophen Versus Liquefied Ibuprofen for Control of Pain During Separation in Orthodontic Patients: A Randomized Triple Blinded Clinical Trial.

    PubMed

    Hosseinzadeh Nik, Tahereh; Shahsavari, Negin; Ghadirian, Hannaneh; Ostad, Seyed Nasser

    2016-07-01

    The aim of this randomized clinical study was to investigate the effectiveness of acetaminophen 650 mg or liquefied ibuprofen 400 mg in pain control of orthodontic patients during separation with an elastic separator. A total of 101 patients with specific inclusion criteria were divided randomly into three groups (acetaminophen, liquefied ibuprofen, and placebo). They were instructed to take their drugs one hour before separator placement and every six hours afterward (five doses in total). They recorded their discomfort on visual analog scales immediately after separator placement, 2 hours later, 6 hours later, at bedtime, and 24 hours after separator placement. Repeated measure analysis of variance (ANOVA) was used to compare the mean pain scores between the three groups. Data were collected from 89 patients. The pain increased with time in all groups. Pain scores were statistically lower in the analgesic groups compared with the placebo group (P.value<0.001), but no statistically significant difference was found in mean pain scores between the two drug groups (acetaminophen and liquefied ibuprofen) (P.value=1). Acetaminophen and liquefied ibuprofen have similar potential in pain reduction during separation.

  6. Self-Efficacy in Foot-Care and Effect of Training: A Single-Blinded Randomized Controlled Clinical Trial

    PubMed Central

    Seyyedrasooli, Alehe; Parvan, Kobra; Valizadeh, Leila; Rahmani, Azad; Zare, Maryam; Izadi, Tayyebeh

    2015-01-01

    Background Diabetes mellitus (DM) is one of the most common metabolic and non-communicable disorders worldwide and the mortality rates caused by the complications associated with the disease, such as diabetic foot ulcer, is increasing dramatically. Patient education is considered as an essential part of controlling DM. Therefore, we aimed to compare the effects of individual and group training methods on self-efficacy in foot care among the patients with DM. Methods In this single-blinded, randomized controlled clinical trial, we enrolled 150 patients with type 1 and 2 DM. The final participants were randomly assigned into two intervention groups (collective and individual training group) and a control group. Data were collected using foot-care self-efficacy questionnaire (Corrbet, 2003). A research assistant collected the data by interviewing the participants using the questionnaire once before and once one month after the intervention. The participants of the intervention groups attended a training program consisting of three sessions per week for one week. Statistical descriptive tests such as mean and standard deviation (SD) percentage were used to describe the features of the data inferential statistics test such as Chi-square, independent t-test and repeated measures analysis of variance and analysis co-variance (ANOVA, ANCOVA) tests were also used as appropriate. The significance level was set at <0.05. Results The results indicated that there was no significant difference between the three groups regarding the mean of self-efficacy scores before foot-care training intervention (P=0.39). But, comparison of the scores before and after the intervention showed that both group and individual training interventions increased the patients’ self-efficacy (P≤0/05). Conclusion It can be concluded that both group and individual training approaches could increase foot care self-efficacy in the patients with DM. Trial Registration Number: IRCT201203086918N6. PMID

  7. Effect of Postoperative Amoxicillin on Early Bacterial Colonization of Peri-Implant Sulcus: A Randomized Controlled Clinical Trial

    PubMed Central

    Moslemi, Neda; Shahnaz, Aysan; Bahador, Abbas; Torabi, Sepehr; Jabbari, Sanaa; Oskouei, Zahra Alizadeh

    2016-01-01

    Objectives: With side effects of antibiotics taken into consideration, the necessity of antibiotic therapy after simple implant placement procedures is still a subject of debate and the existing literature on this topic is widely controversial. The aim of this study was to assess the effect of postoperative amoxicillin therapy on early colonization of peri-implant sulcus after implant placement. Materials and Methods: In this randomized controlled clinical trial, 20 patients requiring simple implant placement were randomly allocated to test or control groups and received postoperative amoxicillin or placebo, respectively. Microbiological samples were collected on day 0 and day 7. Mann Whitney and Wilcoxon signed rank tests were utilized to evaluate changes in colony count of identified bacterial species between the test and control groups, and between day 0 and day 7. Results: The decrease in the number of sensitive facultative species and the increase in the number of resistant anaerobes in amoxicillin group were statistically significant as compared to the placebo group (P=0.025 and P=0.005, respectively). The increase in the number of sensitive anaerobes in the placebo group as compared to amoxicillin group, and the decrease in the number of facultative Gram-positive cocci as compared to the placebo group were statistically significant (P=0.011 and P=0.035, respectively). Conclusions: Postoperative administration of amoxicillin resulted in an increase in the number of resistant anaerobes and a decrease in the number of sensitive facultative bacteria and facultative Gram-positive cocci, as compared to the placebo, but with no sign/symptom of infection in any group. PMID:28127324

  8. The effects of massage and music on pain, anxiety and relaxation in burn patients: Randomized controlled clinical trial.

    PubMed

    Najafi Ghezeljeh, T; Mohades Ardebili, F; Rafii, F

    2017-08-01

    The aim of this study was to evaluate the effects of massage and music on pain intensity, anxiety intensity and relaxation level in burn patients. Pain and anxiety are common among burn patients, but there are many physical and psychological consequences. This randomized controlled clinical trial with factorial design 2×2 included 240 burn patients admitted at Shahid Motahari Burns Hospital, Tehran, Iran, between September 2013 and May 2015. The patients were allocated into the following groups: (i) control (n=60) receiving the conventional primary care, (ii) music group (n=60) receiving their favorite songs, (iii) massage group (n=60) receiving Swedish massage, and (iv) music-plus-massage group (n=60) receiving a combination of their favorite songs and Swedish massage, for 20min once a day for 3 consecutive days, using random permuted blocks of sizes 4 with a 1:1 ratio. To collect the data before and after the intervention, a specific Visual Analogue Scale (VAS) was applied for pain intensity, anxiety intensity, and relaxation level. The data were analyzed using SPSS, version 21. Our findings showed a decrease in pain and anxiety intensity and an increase in relaxation level in all three intervention groups as compared to the control group, indicating there was no significant difference among the interventions applied. Furthermore, following application of each intervention, pain and anxiety intensity decreased and relaxation level increased in the intervention groups as compared to before intervention. Our results revealed that music, massage and a combination of both interventions were effective on reducing pain and anxiety intensity and increasing relaxation level. Due to easy, low-cost and availability of the interventions applied, these complementary therapies are suggested for the burn patients. Although application of a single complementary therapy is cost-effective, further studies are required to determine the most effective and cost-effective method to

  9. Comparison of oral oxycodone and naproxen in soft tissue injury pain control: a double-blind randomized clinical trial.

    PubMed

    Fathi, Marzieh; Zare, Mohammad Amin; Bahmani, Hamid Reza; Zehtabchi, Shahriar

    2015-09-01

    This randomized clinical trial compares the efficacy and safety of oral oxycodone (an oral opioid) with naproxen (a nonsteroidal anti-inflammatory drug) in acute pain control in patients with soft tissue injury. It also evaluates the need for additional doses of analgesics in the first 24 hours of discharge from emergency department (ED). Adult (>18 years old) patients with soft tissue injuries were enrolled in a teaching urban ED. Subjects were randomly allocated to receive a single dose of oral oxycodone (5 mg) or oral naproxen (250 mg). Pain scores and drugs' adverse effects were assessed before, 30 minutes, and 60 minutes after medication. efficacy in pain control (reduction in pain scale >2 points) and safety (rate of side effects). The need for additional pain medication after discharge was assessed by follow-up phone call 24 hours after discharge. A total of 150 patients were enrolled. Pain scores were similar in oxycodone vs naproxen groups before (6.21 ± 0.9 in vs 6.0 ± 1.0), 30 minutes (4.5 ± 1.4 vs 4.4 ± 1.2), and 60 minutes (2.5 ± 1.3 in vs 2.6 ± 1.3) after medication, respectively. Twelve (16.0%) patients in oral oxycodone group and 5 (6.6%) patients in naproxen group needed more analgesics in first 24 hours after ED discharge. Adverse effects were more common in oxycodone group (statistically significant difference). The most common adverse effects in oxycodone group were nausea, (13.3%); vomiting, (8.0%); dizziness, (5.3%); drowsiness, 3 (4.0%); and pruritis, (2.7%). Oral oxycodone is as effective as naproxen in soft tissue injury pain control but has a less favorable safety profile. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Study protocol: Münster tinnitus randomized controlled clinical trial-2013 based on tailor-made notched music training (TMNMT).

    PubMed

    Pantev, Christo; Rudack, Claudia; Stein, Alwina; Wunderlich, Robert; Engell, Alva; Lau, Pia; Wollbrink, Andreas; Shaykevich, Alex

    2014-03-02

    Tinnitus is a result of hyper-activity/hyper-synchrony of auditory neurons coding the tinnitus frequency, which has developed to synchronous mass activity owing the lack of inhibition. We assume that removal of exactly these frequency components from an auditory stimulus will cause the brain to reorganize around tonotopic regions coding the tinnitus frequency. Based on this assumption a novel treatment for tonal tinnitus - tailor-made notched music training (TMNMT) (Proc Natl Acad Sci USA 107:1207-1210, 2010; Ann N Y Acad Sci 1252:253-258, 2012; Frontiers Syst Neurosci 6:50, 2012) has been introduced and will be tested in this clinical trial on a large number of tinnitus patients. A randomized controlled trial (RCT) in parallel group design will be performed in a double-blinded manner. The choice of the intervention we are going to apply is based on two "proof of concept" studies in humans (Proc Natl Acad Sci USA 107:1207-1210, 2010; Ann N Y Acad Sci 1252:253-258, 2012; Frontiers Syst Neurosci 6:50, 2012; PloS One 6(9):e24685, 2011) and on a recent animal study (Front Syst Neurosci 7:21, 2013).The RCT includes 100 participants with chronic, tonal tinnitus who listened to tailor-made notched music (TMNM) for two hours a day for three months. The effect of TMNMT is assessed by the tinnitus handicap questionnaire and visual analogue scales (VAS) measuring perceived tinnitus loudness, distress and handicap. This is the first randomized controlled trial applying TMNMT on a larger number of patients with tonal tinnitus. Our data will verify more securely and reliably the effectiveness of this kind of completely non-invasive and low-cost treatment approach on tonal tinnitus. Current Controlled Trials ISRCTN04840953.

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

    PubMed

    Bedirli, Nurdan; Akçabay, Mehmet; Emik, Ulku

    2017-03-11

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

  12. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

    PubMed Central

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-01-01

    Background/Aims: Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). Methods: This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial’s sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. Results: We included 142 of 231 protocols in the final analysis (concept = 78; ad hoc = 64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval = 0.10–0.58)) than in the concept arm (0.27 (0.06–0.50)), but the difference was not significant (p = 0.67). Limitations: The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. Conclusion: A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines

  13. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

    PubMed

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-12-01

    Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. We included 142 of 231 protocols in the final analysis (concept=78; ad hoc=64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval=0.10-0.58)) than in the concept arm (0.27 (0.06-0.50)), but the difference was not significant (p=0.67). The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application. © The Author(s) 2015.

  14. Stock Versus CAD/CAM Customized Zirconia Implant Abutments – Clinical and Patient‐Based Outcomes in a Randomized Controlled Clinical Trial

    PubMed Central

    Meijer, Henny J.A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco

    2016-01-01

    Abstract Background Single‐tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. Purpose This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient‐based outcome measures. Material and Methods Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri‐implant bone level (primary outcome), Plaque‐index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. Results No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. Conclusion The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. PMID:27476829

  15. Clinical Performance and Safety of Closed-Loop Systems: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

    PubMed

    Brogi, Etrusca; Cyr, Shantale; Kazan, Roy; Giunta, Francesco; Hemmerling, Thomas M

    2017-02-01

    Automated systems can improve the stability of controlled variables and reduce the workload in clinical practice without increasing the risks to patients. We conducted this review and meta-analysis to assess the clinical performance of closed-loop systems compared with manual control. Our primary outcome was the accuracy of closed-loop systems in comparison with manual control to maintain a given variable in a desired target range. The occurrence of overshoot and undershoot episodes was the secondary outcome. We retrieved randomized controlled trials on accuracy and safety of closed-loop systems versus manual control. Our primary outcome was the percentage of time during which the system was able to maintain a given variable (eg, bispectral index or oxygen saturation) in a desired range or the proportion of the target measurements that was within the required range. Our secondary outcome was the percentage of time or the number of episodes that the controlled variable was above or below the target range. The standardized mean difference and 95% confidence interval (CI) were calculated for continuous outcomes, whereas the odds ratio and 95% CI were estimated for dichotomous outcomes. Thirty-six trials were included. Compared with manual control, automated systems allowed better maintenance of the controlled variable in the anesthesia drug delivery setting (95% CI, 11.7%-23.1%; percentage of time, P < 0.0001, number of studies: n = 15), in patients with diabetes mellitus (95% CI, 11.5%-30.9%; percentage of time, P = 0.001, n = 8), and in patients mechanically ventilated (95% CI, 1.5%-23.1%; percentage of time, P = 0.03, n = 8). Heterogeneity among the studies was high (>75%). We observed a significant reduction of episodes of overshooting and undershooting when closed-loop systems were used. The use of automated systems can result in better control of a given target within a selected range. There was a decrease of overshooting or undershooting of a given target with

  16. A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response.

    PubMed

    Varshney, Pooja; Jones, Stacie M; Scurlock, Amy M; Perry, Tamara T; Kemper, Alex; Steele, Pamela; Hiegel, Anne; Kamilaris, Janet; Carlisle, Suzanne; Yue, Xiaohong; Kulis, Mike; Pons, Laurent; Vickery, Brian; Burks, A Wesley

    2011-03-01

    Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been evaluated in double-blind, placebo-controlled trials. To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind, placebo-controlled study. In this multicenter study, children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo. Initial escalation, build-up, and maintenance phases were followed by an oral food challenge (OFC) at approximately 1 year. Titrated skin prick tests (SPTs) and laboratory studies were performed at regular intervals. Twenty-eight subjects were enrolled in the study. Three peanut OIT subjects withdrew early in the study because of allergic side effects. During the double-blind, placebo-controlled food challenge, all remaining peanut OIT subjects (n = 16) ingested the maximum cumulative dose of 5000 mg (approximately 20 peanuts), whereas placebo subjects (n = 9) ingested a median cumulative dose of 280 mg (range, 0-1900 mg; P < .001). In contrast with the placebo group, the peanut OIT group showed reductions in SPT size (P < .001), IL-5 (P = .01), and IL-13 (P = .02) and increases in peanut-specific IgG(4) (P < .001). Peanut OIT subjects had initial increases in peanut-specific IgE (P < .01) but did not show significant change from baseline by the time of OFC. The ratio of forkhead box protein 3 (FoxP3)(hi): FoxP3(intermediate) CD4+ CD25+ T cells increased at the time of OFC (P = .04) in peanut OIT subjects. These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation. The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance. Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  17. Therapeutic efficacy of bromelain in impacted third molar surgery: a randomized controlled clinical study.

    PubMed

    Ordesi, Paolo; Pisoni, Luca; Nannei, Pierluigi; Macchi, Maurizia; Borloni, Roberto; Siervo, Sandro

    2014-09-01

    Bromelain is the name given to a family of proteolytic enzymes obtained from Ananas comosus, the pineapple plant. It is considered a potent anti-inflammatory and antiedematous substance. Surgery of impacted third molars in the outpatient setting is one of the procedures most often associated with postoperative pain and swelling. The aim of this study was to evaluate the efficacy of bromelain in reducing postoperative pain and swelling. 80 patients were recruited to the study from patients attending the Maxillofacial Surgery Unit of the Istituto Stomatologico Italiano, Milan, Italy, for impacted third molar surgery. At time 0 when surgery was performed, patients started simultaneous antibiotic and analgesic therapy. On the following day, patients were divided into two groups. Patients in group 1 were prescribed bromelain. Patients in group 2 were prescribed only the analgesic if required. Three parameters were evaluated: pain, edema, and erythema. The first evaluation visit was performed 3 hours after surgery, the second 48 hours after surgery, and the final evaluation 7 days after surgery. Postoperative pain, edema, and erythema were significantly lower in the study group than in the control group. Analgesic consumption, both in terms of days of treatment and number of tablets taken, was slightly lower in the study group. Only one adverse event was recorded, which occurred in a patient in the control group. The present study demonstrates an important anti-inflammatory and anti-edematous effect of bromelain. Statistical analysis shows that in the group treated with bromelain the inflammatory response was significantly less than in the control group.

  18. Efficacy of a CO2-releasing suppository in dyschezia: a double-blind, randomized, placebo-controlled clinical trial.

    PubMed

    Tarrerias, Anne Laure; Abramowitz, Laurent; Marty, Marc M L; Coulom, Pierre; Staumont, Ghislain; Merlette, Christophe; Berger, Véronique; Savarieau, Bernard; Ducrotté, Philippe

    2014-08-01

    Constipation has a significant impact on quality of life. Aim of this study was to evaluate the safety and the efficacy for relieving dyschezia symptoms of a CO2-releasing suppository in a randomized, placebo-controlled, clinical trial. Fifty-three office-based primary care physicians and 24 gastroenterologists conducted the study in France, between November 2010 and January 2012. Patients (aged 18-75 years) with dyschezia were eligible. Patients were randomly allocated a once-a-day suppository (CO2-releasing suppository or placebo) for 21 days. Primary endpoint was the change, from Day 0 to Day 21, in the intensity of discomfort related to dyschezia based on a self-assessed 0-100 visual analogue scale. A total of 323 patients were randomized, i.e. 166 into the intervention group and 157 into the placebo group. Co-variance analysis showed a greater reduction in discomfort visual analogue scale score in the intervention group (-34.5mm; standard error of the mean: 1.8mm) than in the placebo group (-26.2mm; standard error of the mean: 1.9 mm; p<0.001). The greater efficacy of the CO2-releasing suppository was confirmed for all secondary efficacy parameters. No significant side effects for either treatment were observed. A CO2-releasing suppository is more effective than a placebo for the relief of symptoms of dyschezia. This efficacy is associated with a good safety profile. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  19. Effect of Continued Support of Midwifery Students in Labour on the Childbirth and Labour Consequences: A Randomized Controlled Clinical Trial

    PubMed Central

    Bolbol-Haghighi, Nahid; Masoumi, Seyedeh Zahra

    2016-01-01

    Introduction Childbirth experience is a process throughout women’s life and the most important consequence of labour. Support is the key factor to have a positive experience of childbirth. In order to improve and reduce the stress and anxiety levels in women during labour and cope with the childbirth pain, the emotional, physical and educational support of doulas can be used. Aim This study was aimed to evaluate the effect of continued support of midwifery students in labour on the childbirth and labour consequences. Materials and Methods The present study was conducted using a randomized controlled clinical trial design on 100 pregnant women referred to the maternity ward at Fatemieh Hospital, Shahroud, Iran. The participants were assigned to the supportive or non-supportive group based on allocation sequence using a randomized block design and table of computer-generated random numbers prior to beginning the study. Supportive care was provided by the trained midwifery students. Childbirth and labour consequences were analysed by chi-square test, Fisher-exact test, independent t-test, Mann-Whitney U-test using SPSS-21 software. Results The results showed a significantly lower duration of the first stage of labour in the supportive group, as compared to that in the non-supportive group (p <0.001). Moreover, Apgar scores in the supportive group, compared to those in the non-supportive group, significantly increased at minutes 1 and 5 (p <0.001 and p = 0.04, respectively). Conclusion The findings of this study showed that the supportive care provided by the midwifery students shortens duration of the first stage of labour and improves the Apgar scores in the first and fifth minutes. PMID:27790526

  20. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 2: Statistical considerations.

    PubMed

    Ball, Greg; Piller, Linda B

    2011-09-01

    If the primary objective of a trial is to learn about the ability of a new treatment to help future patients without sacrificing the safe and effective treatment of the current patients, then a Bayesian design with frequent assessments of the accumulating data should be considered. Unfortunately, Bayesian analyses typically do not have standard approaches, and because of the subjectivity of prior probabilities and the possibility for introducing bias, statisticians have developed other methods for statistical inference that only depend on deductive probabilities. However, these frequentist probabilities are just theories about how certain relative frequencies will develop over time. They have no real meaning in a single experiment. Designed to work well in the long run, p-values become hard to explain for individual experiments. Fortunately, the controversy surrounding Bayes' theorem comes, not from the representation of evidence, but from the use of probabilities to measure belief. A prior distribution is not necessary. The likelihood function contains all of the information in a trial relevant for making inferences about the parameters. Monitoring clinical trials is a dynamic process which requires flexibility to respond to unforeseen developments. Likelihood ratios allow the data to speak for themselves, without regard for the probability of observing weak or misleading evidence, and decisions to stop, or continue, a trial can be made at any time, with all of the available information. A likelihood based method is needed.

  1. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial

    PubMed Central

    2014-01-01

    Background Erosive degenerative disc disease, also known as Modic type 1 changes, is usually characterized by low back pain with an inflammatory pain pattern, as seen in spondyloarthropathies. Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs, and in painful bone diseases in general, such as Paget’s disease, fibrous dysplasia or vertebral fractures. We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes. Methods/Design This study, called PEPTIDE (short for the French title “Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives”), will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug-induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale (VAS) at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit (inclusion, at six weeks, three months, and six months). If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group. Discussion To date, only local treatments, for example intradiscal corticosteroid therapy, lumbar arthrodesis or back braces have been studied in randomized, controlled trials, with controversial results. This trial is

  2. Randomized clinical trial of two oral care regimens in reducing and controlling established dental plaque and gingivitis.

    PubMed

    Ayad, Farid; Mateo, Luis R; Dillon, Rensi; Miller, Jeffrey M; Pilch, Shira; Stewart, Bernal

    2015-09-01

    To evaluate the efficacy of a test regimen (TR) integrating the use of a commercially available triclosan, PVM/MA copolymer, and sodium fluoride containing toothpaste, an alcohol-free, fluoride-free cetylpyridinium chloride (CPC) mouthwash, and a manual toothbrush with cheek and tongue cleaner compared to a negative control regimen (NCR) integrating a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush and a fluoride-free and alcohol-free non-antibacterial mouthwash in the reduction and control of established plaque and gingivitis after 4 weeks of product use. A 4-week, two-cell, double-blind, parallel-group, randomized clinical study was conducted in Cedar Knolls, New Jersey, USA. Recruited subjects were randomly assigned to two regimens: (1) a commercially available toothpaste containing triclosan, PVM/MA copolymer, and 0.243% sodium fluoride, a manual toothbrush with cheek and tongue cleaner, and commercially available mouthwash containing 0.075% CPC in a fluoride-free and alcohol-free base (TR), or (2) a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush with rounded/polished bristles, and a fluoride-free and alcohol-free non-antibacterial mouthwash (NCR). Subjects were examined for dental plaque and gingivitis. Gingival, Gingival Severity, Gingival Interproximal, Plaque, Plaque Severity and Plaque Interproximal Index scores were calculated. For regimen comparison, independent t-test and ANCOVA analyses were performed. 130 subjects were screened; 120 enrolled; and 115 subjects completed the randomized clinical trial (RCT). After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 22.3%, 27.8% and 20.4% in mean Gingival, Gingival Severity and Gingival Interproximal Index scores, respectively, as compared to subjects using NCR. After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 28

  3. Design of a multicentered randomized controlled trial on the clinical and cost effectiveness of schema therapy for personality disorders

    PubMed Central

    2012-01-01

    Background Despite international guidelines describing psychotherapy as first choice for people with personality disorders (PDs), well-designed research on the effectiveness and cost-effectiveness of psychotherapy for PD is scarce. Schema therapy (ST) is a specific form of psychological treatment that proved to be effective for borderline PD. Randomized controlled studies on the effectiveness of ST for other PDs are lacking. Another not yet tested new specialized treatment is Clarification Oriented Psychotherapy (COP). The aim of this project is to perform an effectiveness study as well as an economic evaluation study (cost effectiveness as well as cost-utility) comparing ST versus COP versus treatment as usual (TAU). In this study, we focus on avoidant, dependent, obsessive-compulsive, paranoid, histrionic and narcissistic PD. Methods/Design In a multicentered randomized controlled trial, ST, and COP as an extra experimental condition, are compared to TAU. Minimal 300 patients are recruited in 12 mental health institutes throughout the Netherlands, and receive an extensive screening prior to enrolment in the study. When eligible, they are randomly assigned to one of the intervention groups. An economic evaluation and a qualitative research study on patient and therapist perspectives on ST are embedded in this trial. Outcome assessments (both for clinical effectiveness and economic evaluation) take place at 6,12,18,24 and 36 months after start of treatment. Primary outcome is recovery from PD; secondary measures include general psychopathological complaints, social functioning and quality of life. Data for the cost-effectiveness and cost-utility analyses are collected by using a retrospective cost interview. Information on patient and therapist perspectives is gathered using in-depth interviews and focus groups, and focuses on possible helpful and impeding aspects of ST. Discussion This trial is the first to compare ST and COP head-to-head with TAU for people with

  4. Comparison of Neurofeedback and Transcutaneous Electrical Nerve Stimulation Efficacy on Treatment of Primary Headaches: A Randomized Controlled Clinical Trial

    PubMed Central

    Moshkani Farahani, Davood; Tavallaie, Seyed Abbas; Ahmadi, Khodabakhsh; Fathi Ashtiani, Ali

    2014-01-01

    Background: Headache is one of the most prevalent investigated complaints in the neurology clinics and is the most common pain-related complaint worldwide. Stress is a significant factor that causes and triggers headaches. Since healthcare practitioners experience a lot of stress in their careers, they are more prone to headaches. Objectives: This study was designed to evaluate and compares the efficacy of neurofeedback behavioural therapy (NFB) and transcutaneous electrical nerve stimulation (TENS) in the treatment of primary headaches in healthcare providers. Patients and Methods: The current study was a clinical trial, performed in Teheran, IR Iran, with two experimental groups and a control group. Convenient sampling method was used to recruit patients. Independent variables were NFB and TENS and dependent variables were frequency, severity, and duration of headache. Blanchard headache diary was used for assessment. Hence, 45 healthcare providers with primary headache were selected and randomly allocated to one of the NFB, TENS, and control groups by block random assignment method. All three groups completed the headache diary during one week before and after the treatment period as pretest and posttests, respectively. The NFB group was treated in the period between pretest and posttest with fifteen 30-minute treatment sessions three times a week and the TENS group was treated with fifteen 20-minute daily sessions. The control group received none of these treatments. Results: The results from the analysis of covariance showed that treatment with NFB and TENS had caused significant decrease in the frequency, severity, and duration of headache in experimental groups. The results of the LSD post-hoc test indicated that there were significant differences in the frequency, severity, and duration of pain among experimental groups and the control group. Moreover, there were significant differences between pain frequencies in experimental groups. Conclusions: According

  5. Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways?

    PubMed

    Cui, Qi; Tian, Jinhui; Song, Xuping; Yang, Kehu

    2014-12-01

    The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides reporting guidelines to improve the reporting quality of randomized controlled trials (RCTs). This present study was aim to assess the reporting quality of abstracts of RCTs on clinical pathway. Eight databases were searched from inception to November 2012 to identify RCTs. We extracted basic information and CONSORT items from abstracts. Each abstract was assessed independently by two reviewers. Statistical analyses were performed with SPSS 13.0. Level of significance was set at P < 0.05. 328 abstracts were included. 300 (91.5%) were published in Chinese, of which 292 were published on high impact factor journals. 28 English abstracts were all published on Science Citation Index (SCI) journals. (1) Intervention, objective and outcome were almost fully reported in all abstracts, while recruitment and funding were never reported. (2) There are nine items (P < 0.05) in Chinese that were of low quality compared with in English. There was statistically difference on total score between Chinese and English abstracts (P < 0.00001). (3) There was no difference in any items between high and low impact factor journal in China. (4) In SCI journals, there were significant changes in reporting for three items trial design (P = 0.026), harms (P = 0.039) and trial registration (P = 0.019) in different periods (pre- and post-CONSORT), but only the numbers of randomized (P = 0.003) changed in Chinese abstracts. The reporting quality of abstracts of RCTs on clinical pathway still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The abstracts in Chinese journals showed non-adherence to the CONSORT for abstracts guidelines. © 2014 John Wiley & Sons, Ltd.

  6. A Randomized Controlled Trial of a Mobile Clinical Decision Aid to Improve Access to Kidney Transplantation: iChoose Kidney

    PubMed Central

    Patzer, Rachel E.; Basu, Mohua; Mohan, Sumit; Smith, Kayla D.; Wolf, Michael; Ladner, Daniela; Friedewald, John J.; Chiles, Mariana; Russell, Allison; McPherson, Laura; Gander, Jennifer; Pastan, Stephen

    2016-01-01

    Kidney transplantation is the preferred treatment for patients with end-stage renal disease, as it substantially increases a patient's survival and is cost saving compared to a lifetime of dialysis. However, transplantation is not universally chosen by patients with renal failure, and limited knowledge about the survival benefit of transplantation vs. dialysis may play a role. We created a mobile application clinical decision aid called iChoose Kidney to improve access to individualized prognosis information comparing dialysis and transplantation outcomes. We describe the iChoose Kidney study, a randomized controlled trial designed to test the clinical efficacy of a mobile health decision aid among end-stage renal disease patients referred for kidney transplantation at three large, diverse transplant centers across the U.S. Approximately 450 patients will be randomized to receive either: (1) standard of care or “usual” transplantation education, or (2) standard of care plus iChoose Kidney. The primary outcome is change in knowledge about the survival benefit of kidney transplantation vs. dialysis from baseline to immediate follow-up; secondary outcomes include change in treatment preferences, improved decisional conflict, and increased access to kidney transplantation. Analyses are also planned to examine effectiveness across subgroups of race, socioeconomic status, health literacy and health numeracy. Engaging patients in health care choices can increase patient empowerment and improve knowledge and understanding of treatment choices. If the effectiveness of iChoose Kidney has a greater impact on patients with low health literacy, lower socioeconomic status, and minority race, this decision aid could help reduce disparities in access to kidney transplantation. PMID:27610423

  7. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials.

    PubMed

    Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J Jack; Heymach, John V; Swisher, Stephen G; Welsh, James W; Zhang, Jianjun; Lin, Steven H; Gomez, Daniel R

    2017-03-15

    Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Effect of self-performed mechanical plaque control frequency on gingival inflammation revisited: a randomized clinical trial.

    PubMed

    de Freitas, Guilherme Camponogara; Pinto, Tatiana Militz Perrone; Grellmann, Alessandra Pascotini; Dutra, Danilo Antonio Milbradt; Susin, Cristiano; Kantorski, Karla Zanini; Moreira, Carlos Heitor Cunha

    2016-04-01

    To evaluate the effect of self-performed mechanical plaque control (SPC) frequency on gingival health. Thirty-nine subjects exhibiting limited gingival inflammation and minimal clinical attachment loss were enrolled in a single-blind, parallel group, randomized clinical trial. The subjects that were divided into three groups were tasked to perform SPC (using tooth brush and dental floss) at 12, 24 or 48 h intervals. Gingival index (GI), plaque index (PlI), and gingival crevicular fluid (GCF) volume were evaluated at baseline and 30 days follow-up. Groups were compared using anova and Tukey. No significant differences in mean GI change were observed between the 12 and 24 h SPC intervals from baseline to 30 days (-0.06 ± 0.13 versus 0.05 ± 0.09; p = 0.11). In contrast, the 48 h interval had significantly higher mean GI change than the 12 and 24 h intervals (0.33 ± 0.17; p = 0.001). Similarly, mean PlI change was not significantly different between the 12 and 24 h SPC intervals (0.11 versus 0.28; p = 0.15), whereas SPC at 48 h-intervals yielded a significantly increased PlI (0.39; p = 0.001). Self-performed mechanical plaque control performed at 12 h or 24 h intervals appears sufficient to maintain gingival health in subjects with no or limited clinical attachment loss. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  9. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

    PubMed

    Cohen, Craig R; Grossman, Daniel; Onono, Maricianah; Blat, Cinthia; Newmann, Sara J; Burger, Rachel L; Shade, Starley B; Bett, Norah; Bukusi, Elizabeth A

    2017-01-01

    To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. Eighteen health facilities in Kenya. Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. "One-stop shop" approach to integrating FP and HIV services. Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19-1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87). Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. ClinicalTrials.gov NCT01001507.

  10. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya

    PubMed Central

    Cohen, Craig R.; Grossman, Daniel; Onono, Maricianah; Blat, Cinthia; Newmann, Sara J.; Burger, Rachel L.; Shade, Starley B.; Bett, Norah; Bukusi, Elizabeth A.

    2017-01-01

    Objectives To determine if integration of family planning (FP) and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices) and decreased pregnancy rates. Design Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration) sites and oversaw integrated services at the original intervention (early integration) sites. Setting Eighteen health facilities in Kenya. Subjects Women aged 18–45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2. Intervention “One-stop shop” approach to integrating FP and HIV services. Main outcome measures Use of more effective contraceptive methods and incident pregnancy across two years of follow-up. Results Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR) = 1.39 (1.19–1.63). Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%). Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60–0.87). Conclusions Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model. Trial registration ClinicalTrials.gov NCT01001507 PMID:28328966

  11. Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

    PubMed

    Vernon, Howard; Triano, John T; Soave, David; Dinulos, Maricelle; Ross, Kim; Tran, Steven

    2013-10-01

    Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials. © 2013. Published by National University of Health Sciences All rights reserved.

  12. Padua prediction score or clinical judgment for decision making on antithrombotic prophylaxis: a quasi-randomized controlled trial.

    PubMed

    Germini, Federico; Agnelli, Giancarlo; Fedele, Marta; Galli, Maria Giulia; Giustozzi, Michela; Marcucci, Maura; Paganelli, Gloria; Pinotti, Emanuele; Becattini, Cecilia

    2016-10-01

    The Padua prediction score (PPS) has been suggested as the best available model for the assessment of the risk of venous thromboembolism (VTE) in hospitalized medical patients. The impact of its use in clinical practice has never been prospectively evaluated. According to a quasi-randomized study design, consecutive patients admitted to Internal Medicine Section 1 were allocated to a PPS-based decisional strategy suggesting thromboprophylaxis in patients with PPS score ≥4, and those admitted to Section 2 to a clinical judgment-based strategy. Study patients underwent complete compression ultrasonography of the lower limbs at discharge. The primary outcome was symptomatic or asymptomatic VTE during hospital stay. Secondary outcomes were VTE excluding isolated distal deep vein thrombosis, bleedings, and appropriate thromboprophylaxis. 628 patients were included in the analysis, 235 in the PPS group, and 393 in the clinical judgment group. The two groups differed for length of hospital stay, prevalence of recent trauma or surgery, and stroke. Compared with control, the PPS group had a significantly lower incidence of VTE (8.5 vs. 15.5 %, OR 0.51, 95 % CI 0.30-0.86), also after adjusting for thromboprophylaxis use and patient PPS-risk category (OR 0.54, 95 % CI 0.31-0.94). In conclusion, the use of PPS was associated with a higher rate of appropriate thromboprophylaxis prescription; no significant differences were found in the other secondary outcomes. The use of PPS for the assessment of risk for VTE is associated with a reduced incidence of VTE compared with the clinical judgment. These result needs to be confirmed in future studies.

  13. Clinical and Radiographic Assessment of the Efficacy of a Collagen Membrane in Regenerative Endodontics: A Randomized, Controlled Clinical Trial.

    PubMed

    Jiang, Xijun; Liu, He; Peng, Chufang

    2017-09-01

    Recent reviews confirm a general lack of randomized, controlled clinical studies on the efficacy of regenerative endodontics in immature teeth affected by pulp and periapical diseases. Moreover, we have no evidence of the curative efficacy of collagen membranes used as scaffolds in regenerative endodontics. Here, we evaluated whether a Bio-Gide collagen membrane (Geistlich Pharma AG, Wolhusen, Switzerland) has efficacy in promoting dentin formation in regenerative endodontics. Forty-three patients yielding a total of 46 nonvital immature teeth were divided randomly into 2 groups. Subsequent to chemomechanical preparation, regenerative endodontics with (the experimental group) and without (the control group) Bio-Gide were performed. All cases were followed up clinically and radiographically every 3 months for at least 6 months. Quantitative analyses using an imaging program yielded percentage changes in root dimensions based on a comparison between preoperative and recall radiographs. The results of 40 patients (43 teeth) were included in the final analyses. All patients from both groups showed clinical success with complete resolution of signs and symptoms. Radiographically, the thickness of the dentin wall at the middle third of the root was higher for the experimental group than the control group. However, other indicators were comparable between both groups. The use of the Bio-Gide collagen membrane promoted the development of the dentin wall in the middle third of the root in patients undergoing regenerative endodontic procedures. The convenience of operation and the assured positioning of the sealing material make the Bio-Gide collagen membrane especially suitable for handling wide root canals. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

    PubMed Central

    Rosen, Sydney; Maskew, Mhairi; Fox, Matthew P.; Nyoni, Cynthia; Mongwenyana, Constance; Sanne, Ian; Sauls, Celeste; Long, Lawrence

    2016-01-01

    Background High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit. Methods and Findings RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study (“rapid arm”) received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study (“standard arm”) followed standard clinic procedures (three to five additional clinic visits over 2–4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis

  15. Mobile Device–Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges

    PubMed Central

    Liu, Yu; Wang, Hongyi; Sun, Ningling

    2017-01-01

    Background Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device–based electronic data capture (mEDC) system has not been well evaluated. Objective The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). Methods We developed an mEDC to support an RCT called “Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)” study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. Results The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. Conclusions The innovative mEDC has many merits and is well acceptable in supporting

  16. Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.

    PubMed

    Zhang, Jing; Sun, Lei; Liu, Yu; Wang, Hongyi; Sun, Ningling; Zhang, Puhong

    2017-03-08

    Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated. The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely

  17. Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial.

    PubMed

    Shimabukuro, Yoshio; Nakayama, Yohei; Ogata, Yorimasa; Tamazawa, Kaoru; Shimauchi, Hidetoshi; Nishida, Tetsuya; Ito, Koichi; Chikazawa, Takashi; Kataoka, Shinsuke; Murakami, Shinya

    2015-01-01

    Reactive oxygen species might be associated with the onset and progression of gingival inflammation. The aim of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt (APM), a long-acting ascorbic acid derivative with antioxidant properties, on gingival inflammation. The clinical effects of APM were investigated in a multicenter, randomized, parallel-group, controlled clinical trial comprising 300 individuals with gingivitis. Half of the participants were given an APM-containing dentifrice and half were given a control dentifrice. The primary outcome was the gingival index (GI) at 3 months. Secondary outcomes included gingival redness as an indicator of the degree of local gingival inflammation, gingival bleeding as a measure of the gingivitis severity index, and total antioxidant activity of the saliva. Under the intent-to-treat analysis, GI did not significantly differ between the groups (P = 0.12). However, under the per-protocol analysis, GI was significantly lower in the APM group (P = 0.01) than in the control group. In the APM group, gingival redness was significantly lower, and the difference from the baseline gingivitis severity index was significantly greater (P = 0.04 and P = 0.02, respectively). The total antioxidant activity of the saliva was significantly higher in the APM group (P = 0.03). The incidence of adverse events did not significantly differ between the groups (P > 0.15). These findings indicate that the regular application of an APM-containing dentifrice could reduce gingival inflammation.

  18. Effect of Consultation and Educating in Preparation Classes for Delivery on Pregnancy Consequences: A Randomized Controlled Clinical Trial

    PubMed Central

    Karimi, Simin; Kazemi, Farideh; Masoumi, Seyedeh Zahra; Shobeiri, Fatemeh; Roshanaei, Ghodratollah

    2016-01-01

    Background Care during pregnancy and performing consultation for delivery preparation play an important role in improving pregnant women’s knowledge. Objective The purpose of this study was to investigate the effect of consultation and instruction in the preparation classes for delivery on pregnancy consequences, including choosing the type of delivery, the performed type of delivery, and infant’s weight. Methods This study was conducted in 2015 on 170 pregnant women who had been referred to the prenatal clinic in Hamedan. The participants were randomly divided into intervention and control groups. Eight sessions of consultation for delivery preparation were held for the women in 20 to 36 weeks of pregnancy. The control group received only the routine care. After 37 weeks of pregnancy, the participants answered a questionnaire. The infant’s weight was measured after birth. Data were analyzed Using SPSS-21 and McNemar–Bowker Test, independent t-test, chi-square test, and Fisher exact test. Results Results showed a significant statistical difference between the two groups concerning their selective and performed delivery (p<0.001). The weight of infants in the intervention group was significantly higher than that of those in the control group (p<0.001). Conclusion The findings of this study showed that the consultation for delivery preparation had a positive effect on some pregnancy consequences such as selecting the type of delivery performed and infant’s weight. Trial registration The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCTID: IRCT2015012513405N9. Funding The authors received no financial support for the research, authorship, and/or publication of this article. PMID:28070250

  19. Twice-weekly aripiprazole for treating children and adolescents with tic disorder, a randomized controlled clinical trial.

    PubMed

    Ghanizadeh, Ahmad

    2016-01-01

    Treating tic disorder is challenging. No trial has ever examined whether twice weekly aripiprazole is effective for treating tic disorders. Participants of this 8-week randomized controlled parallel-group clinical trial were a clinical sample of 36 children and adolescents with tic disorder. Yale global tic severity scale was used to assess the outcome. Both groups received daily dosage of aripiprazole for the first 14 days. Then, one group received daily dose of aripiprazole while the other group received twice weekly dosage of aripiprazole for the next 46 days. The patients were assessed at baseline, week 2, 4, and 8. Tic scores decreased in both group significantly 22.8 (18.5) versus 22.0 (11.6). Moreover, there was no between group difference. The final mean (SD) score of motor and vocal tics in the group treated with daily treatment was not significantly different from the twice weekly group (Cohen's d = 0.36). The odds ratios for sedation and increased appetite were 3.05 and 3, respectively. For the first time, current findings support that twice weekly aripiprazole efficacy was not different from that of daily treatment. The rate of drowsiness in the twice weekly treatment group was less than that of the daily treatment group. This trial was registered at http://www.irct.ir. The registration number of this trial was: IRCT201312263930N32. http://www.irct.ir/searchresult.php?id=3930&number=32.

  20. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2015-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14–65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood. PMID:26870678

  1. Efficacy of Dragon's blood cream on wound healing: A randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Namjoyan, Foroogh; Kiashi, Fatemeh; Moosavi, Zahra Beigom; Saffari, Fatemeh; Makhmalzadeh, Behzad Sharif

    2016-01-01

    The blood-red sap of Dragon's blood has been used in folk medicine for fractures, wounds, inflammation, gastrointestinal disorders, rheumatism, blood circulation dysfunctions, and cancer. Existing in vitro and in vivo bioactivity of this herb on different mechanisms of healing shows strong potential of this sap in wound healing. This clinical trial study was designated to evaluate the wound healing effect of Dragon's blood on human wounds. Sixty patients, between the ages of 14-65 years, who were referred to remove their skin tag, were assigned to this double-blind, placebo-controlled, randomized clinical trial and received either Dragon's blood or a placebo cream. They were visited on the 3rd, 5th, 7th, 10th, 14th, and 20th day of the trial to check the process of healing and to measure the wound's surface. At the end of trial, there was a significant difference in the mean duration of wound healing between the two groups (p = 0.0001). The phenolic compounds and the alkaloid taspine, which exist in Dragon's-blood resin, are probably the main reasons for the wound healing property of this plant. Being natural accessible, safe, and affordable makes Dragon's blood cream, a good choice for addition to the wound healing armamentarium. Further studies on wounds with different causes and among larger populations are suggested to ensure the effectiveness and safety of Dragon's blood.

  2. Effect of Silymarin Administration on Cisplatin Nephrotoxicity: Report from A Pilot, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

    PubMed

    Shahbazi, Foroud; Sadighi, Sanambar; Dashti-Khavidaki, Simin; Shahi, Farhad; Mirzania, Mehrzad; Abdollahi, Alireza; Ghahremani, Mohammad-Hossein

    2015-07-01

    Despite several introduced preventive modalities, cisplatin nephrotoxicity remains a clinical problem. Some in vitro and in vivo studies have addressed the protective effects of silymarin against cisplatin nephrotoxicity. This study evaluated the effects of silymarin administration on cisplatin nephrotoxicity as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting 24-48 h before the initiation of cisplatin infusion and continuing to the end of three 21-day cisplatin-containing chemotherapy courses on cisplatin-induced renal electrolytes wasting and kidney function were assessed. Cisplatin-associated acute kidney injury (AKI) occurred in 8% of the patients. Urine neutrophil gelatinase-associated lipocalin to urine creatinine ratio (NGAL/Cr) and urinary magnesium and potassium wasting increased significantly after cisplatin infusion in both groups. Significant positive correlation was found between cumulative dose of cisplatin and urine NGAL/Cr after three courses of cisplatin infusion. Incidence of AKI and the magnitude of urinary magnesium and potassium wasting did not differ between silymarin and placebo groups. No adverse reaction was reported by silymarin administration. Prophylactic administration of conventional form of silymarin tablets could not prevent cisplatin-induced urine electrolyte wasting or renal function impairment. Copyright © 2015 John Wiley & Sons, Ltd.

  3. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial.

    PubMed

    Carcuac, O; Derks, J; Charalampakis, G; Abrahamsson, I; Wennström, J; Berglundh, T

    2016-01-01

    The aim of the present randomized controlled clinical trial was to investigate the adjunctive effect of systemic antibiotics and the local use of chlorhexidine for implant surface decontamination in the surgical treatment of peri-implantitis. One hundred patients with severe peri-implantitis were recruited. Surgical therapy was performed with or without adjunctive systemic antibiotics or the local use of chlorhexidine for implant surface decontamination. Treatment outcomes were evaluated at 1 y. A binary logistic regression analysis was used to identify factors influencing the probability of treatment success, that is, probing pocket depth ≤5 mm, absence of bleeding/suppuration on probing, and no additional bone loss. Treatment success was obtained in 45% of all implants but was higher in implants with a nonmodified surface (79%) than those with a modified surface (34%). The local use of chlorhexidine had no overall effect on treatment outcomes. While adjunctive systemic antibiotics had no impact on treatment success at implants with a nonmodified surface, a positive effect on treatment success was observed at implants with a modified surface. The likelihood for treatment success using adjunctive systemic antibiotics in patients with implants with a modified surface, however, was low. As the effect of adjunctive systemic antibiotics depended on implant surface characteristics, recommendations for their use in the surgical treatment of peri-implantitis should be based on careful assessments of the targeted implant (ClinicalTrials.gov NCT01857804). © International & American Associations for Dental Research 2015.

  4. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    PubMed Central

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  5. Prophylactic phenylephrine infusion for the prevention of hypotension after spinal anesthesia in the elderly: a randomized controlled clinical trial.

    PubMed

    Ferré, Fabrice; Marty, Philippe; Bruneteau, Laura; Merlet, Virgine; Bataille, Benoît; Ferrier, Anne; Gris, Claude; Kurrek, Matt; Fourcade, Olivier; Minville, Vincent; Sommet, Agnes

    2016-12-01

    Hypotension frequently occurs during spinal anesthesia (SA), especially in the elderly. Phenylephrine is effective to prevent SA-induced hypotension during cesarean delivery. The objective of this study was to evaluate the efficacy and safety of prophylactic infusion of phenylephrine after SA for orthopedic surgery in the elderly. This prospective, randomized, double-blind, and placebo-controlled study included 54 patients older than 60 years undergoing elective lower limb surgery under SA (injection of 10 mg of isobaric bupivacaine with 5 μg of sufentanyl). Patients were randomized to group P (100-μg/mL solution of phenylephrine solution at 1 mL/min after placement of SA) or the control group C (0.9% isotonic sodium chloride solution). The flow of the infusion was stopped if the mean arterial blood pressure (MAP) was higher than the baseline MAP and maintained or restarted at 1 mL/min if MAP was equal to or lower than the baseline MAP. Heart rate and MAP were collected throughout the case. Hypotension was defined by a 20% decrease and hypertension as a 20% increase from baseline MAP. Bradycardia was defined as a heart rate lower than 50 beats per minute. Twenty-eight patients were randomized to group P and 26 patients to group C. MAP was higher in group P than in group C (92 ± 2 vs 82 ± 2 mm Hg, mean ± SD, P< .001). The number of hypotensive episodes per patient was higher in group C compared with group P (9 [0-39] vs 1 [0-10], median [extremes], P< .01), but the number of hypotensive patients was similar between groups (19 [73%] vs 20 [71%], P= 1). The time to onset of the first hypotension was shorter in group C (3 [1-13] vs 15 [1-95] minutes, P= .004). The proportion of patients without hypotension (cumulative survival) was better in group P (P= .04). The number of hypertensive episodes per patient and the number of bradycardic episodes per patient were similar between groups (P= not significant). Prophylactic phenylephrine infusion is an effective method

  6. Effects of Reiki on Post-cesarean Delivery Pain, Anxiety, and Hemodynamic Parameters: A Randomized, Controlled Clinical Trial.

    PubMed

    Midilli, Tulay Sagkal; Eser, Ismet

    2015-06-01

    The aim of this study was to investigate the effect of Reiki on pain, anxiety, and hemodynamic parameters on postoperative days 1 and 2 in patients who had undergone cesarean delivery. The design of this study was a randomized, controlled clinical trial. The study took place between February and July 2011 in the Obstetrical Unit at Odemis Public Hospital in Izmir, Turkey. Ninety patients equalized by age and number of births were randomly assigned to either a Reiki group or a control group (a rest without treatment). Treatment applied to both groups in the first 24 and 48 hours after delivery for a total of 30 minutes to 10 identified regions of the body for 3 minutes each. Reiki was applied for 2 days once a day (in the first 24 and 48 hours) within 4-8 hours of the administration of standard analgesic, which was administered intravenously by a nurse. A visual analog scale and the State Anxiety Inventory were used to measure pain and anxiety. Hemodynamic parameters, including blood pressure (systolic and diastolic), pulse and breathing rates, and analgesic requirements also were recorded. Statistically significant differences in pain intensity (p = .000), anxiety value (p = .000), and breathing rate (p = .000) measured over time were found between the two groups. There was a statistically significant difference between the two groups in the time (p = .000) and number (p = .000) of analgesics needed after Reiki application and a rest without treatment. Results showed that Reiki application reduced the intensity of pain, the value of anxiety, and the breathing rate, as well as the need for and number of analgesics. However, it did not affect blood pressure or pulse rate. Reiki application as a nursing intervention is recommended as a pain and anxiety-relieving method in women after cesarean delivery. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  7. Randomized, controlled trial of the effectiveness of simulation education: A 24-month follow-up study in a clinical setting.

    PubMed

    Jansson, Miia M; Syrjälä, Hannu P; Ohtonen, Pasi P; Meriläinen, Merja H; Kyngäs, Helvi A; Ala-Kokko, Tero I

    2016-04-01

    Critical care nurses' knowledge and skills in adhering to evidence-based guidelines for avoiding complications associated with intubation and mechanical ventilation are currently limited. We hypothesized that single simulation education session would lead to a long-lasting higher level of skills among critical care nurses. A randomized controlled trial was conducted in a 22-bed adult mixed medical-surgical intensive care unit in Finland during the period February 2012-March 2014. Thirty out of 40 initially randomized critical care nurses participated in a 24-month follow-up study. Behavior and cognitive development was evaluated through a validated Ventilator Bundle Observation Schedule and Questionnaire at the baseline measurement and repeated 3 times during simulation and real-life clinic settings. After simulation education, the average skills score increased from 46.8%-58.8% of the total score in the final postintervention measurement (Ptime < .001, Ptime × group = .040, and Pgroup = .11). The average knowledge scores within groups did not change significantly. The average between-group difference in skills scores was significant only at the measurement taken at 6 months (P = .006). Critical care nurses' skills in adhering to evidence-based guidelines improved in both groups over time, but the improvements between the study groups was significantly different only at 6 months and was no longer evident after 2 years following a single simulation education. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  8. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Hsu, Chung-Hua; Tsai, Tung-Hu; Kao, Yung-Hsi; Hwang, Kung-Chang; Tseng, Ting-Yu; Chou, Pesus

    2008-06-01

    To examine the effect of green tea extract (GTE) on obese women and to explore the relationship between GTE and obesity-related hormone peptides. A randomized, double-blind, placebo-controlled clinical trial was conducted from July 2006 to June 2007 in Taipei Hospital, Taiwan. Seventy-eight of 100 obese women aged between 16 and 60 years with BMI>27 kg/m(2) and who had not received any other weight control maneuvers within the last 3 months completed this study. The subjects were randomly divided into Groups A and B. Group A (n=41) received GTE while Group B (n=37) took cellulose as a placebo, one capsule (400mg) three times each day for 12 weeks. The body weight (BW), body mass index (BMI) and waist circumflex (WC) were measured at the beginning of the study and after 12 weeks of treatment with GTE. The data were compared and expressed as % reduction. There was only a 0.3% reduction in BW (0.15 kg) after 12 weeks of treatment with GTE. There was no statistical difference in % reduction in BW, BMI and WC between the GTE and placebo groups. Within group comparison revealed that the GTE group had significant reduction in LDL-cholesterol and triglyceride, and marked increase in the level of HDL-cholesterol, adiponectin and ghrelin. On the other hand, the placebo group showed significant reduction in triglyceride only, and a marked increase in the level of ghrelin alone. This study showed no statistical difference in % reduction in BW, BMI and WC between the GTE and placebo groups after 12 weeks of treatment. The intake of GTE (491 mg catechins containing 302 mg EGCG) for 12 weeks is considered safe as shown by the results.

  9. Randomized controlled clinical pilot study of all-ceramic single-tooth implant reconstructions: clinical and microbiological outcomes at one year of loading.

    PubMed

    Brandenberg, Francine D; Sailer, Irena; Fehmer, Vincent; Büchi, Dominik L E; Hämmerle, Christoph H F; Thoma, Daniel S

    2017-04-01

    To test whether or not pink veneering of the submucosal part of zirconia abutments influences clinical, microbiological and histological outcomes of cemented implant-supported single crowns (ISSC). A total of 20 patients with one single-tooth implant in the esthetic zone were included. Implants were randomly restored with either pink-veneered zirconia abutments (test group; n = 10) or non-veneered white zirconia abutments (control group; n = 10) and with adhesively cemented all-ceramic crowns. At the 6-month follow-up, soft tissue biopsies were prepared for histological evaluation and microbiological samples were collected around abutments and the respective contra-lateral teeth (in 10 of 20 patients). One year after the initiation of loading, clinical parameters were assessed. Robust linear mixed model and cumulative linked mixed model analyses were performed to investigate the effect of group and time-point on clinical and biological outcomes. Clinical evaluations revealed stable peri-implant soft tissues in terms of probing pocket depth, but a high BOP index (87.5% control; 80.0% test). No statistically significant differences were observed between the test and control group for any outcome measure (P > 0.05). No major biological complications occurred during the observation period. Histological samples revealed a remarkable degree of inflammation in both groups without clear differences in qualitative histological features. Microbiological evaluation demonstrated a slightly higher bacterial count at implants compared to natural teeth at one year of loading without marked differences between groups. Limited by a small sample size and a relatively short observation period, pink-veneered zirconia abutments exhibited similar clinical, histological and microbiological outcomes as non-veneered zirconia abutments supporting cemented single crowns. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Limited Amount of Formula May Facilitate Breastfeeding: Randomized, Controlled Trial to Compare Standard Clinical Practice versus Limited Supplemental Feeding.

    PubMed

    Straňák, Zbyněk; Feyereislova, Simona; Černá, Marcela; Kollárová, Jana; Feyereisl, Jaroslav

    2016-01-01

    Breastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless, breastfeeding rates remain low despite public health efforts. Our study aims to investigate the effect of controlled limited formula usage during birth hospitalisation on breastfeeding, using the primary hypothesis that early limited formula feeds in infants with early weight loss will not adversely affect the rate of exclusive or any breastfeeding as measured at discharge, 3 and 6 months of age. We randomly assigned 104 healthy term infants, 24 to 48 hours old, with ≥ 5% loss of birth weight to controlled limited formula (CLF) intervention (10 ml formula by syringe after each breastfeeding, discontinued at onset of lactation) or control group (standard approach, SA). Groups were compared for demographic data and breastfeeding rates at discharge, 3 months and 6 months of age (p-values adjusted for multiple testing). Fifty newborns were analysed in CLF and 50 in SA group. There were no differences in demographic data or clinical characteristics between groups. We found no evidence of difference between treatment groups in the rates of exclusive as well as any breastfeeding at discharge (p-value 0.2 and >0.99 respectively), 3 months (p-value 0.12 and 0.10) and 6 months of infants' age (p-value 0.45 and 0.34 respectively). The percentage weight loss during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in SA group, p = 0.002). The study shows that controlled limited formula use does not have an adverse effect on rates of breastfeeding in the short and long term. Larger studies are needed to confirm a possible potential in controlled limited formula use to support establishing breastfeeding and to help to improve the rates of breastfeeding overall. ISRCTN registry ISRCTN61915183.

  11. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized,