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  1. Effect of Ketofol on Pain and Complication after Caesarean Delivery under Spinal Anaesthesia: A Randomized Double-blind Clinical Trial.

    Science.gov (United States)

    Jaafarpour, Molouk; Vasigh, Aminolah; Khajavikhan, Javaher; Khani, Ali

    2017-03-01

    Pain is the key concern of women after caesarean delivery that may interfere with breastfeeding. The aim of this study was to assess effect of ketofol (ketamine/propofol combination) on pain and complication after caesarean delivery under spinal anaesthesia. In this randomized double-blind clinical trial, 92 parturient scheduled for elective caesarean delivery under spinal anaesthesia were included. The simple random sampling method was used to place subjects in four groups of ketamine (0.25 mg/kg), propofol (0.25 mg/kg), ketofol (25 mg ketamine plus 25 mg propofol) and placebo (saline). The drugs were administered intravenously immediately after clamping the umbilical cord. Visual Analog Scale (VAS) was used to determine the intensity of pain. Complications after surgery including shivering, nausea and vomiting as well as onset of breastfeeding were recorded. The mean score of pain, morphine consumption and time of breastfeeding in the ketofol group were significantly lower than other groups at various intervals (ppain and complication after caesarean delivery indicated that it can be considered as a safe and alternative drug in these patients.

  2. The effects of probiotic supplement on hemoglobin in chronic renal failure patients under hemodialysis: A randomized clinical trial

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    Zahra Shariaty

    2017-01-01

    Full Text Available Background: Chronic inflammation is one of the causes of anemia in chronic renal failure patients under hemodialysis. Probiotics probably establish a balance between pro- and anti-inflammatory cytokines. The study was conducted to determine the effects of probiotic supplementation on hemoglobin (Hb in hemodialysis patients. Materials and Methods: A parallel clinical trial was conducted in which patients were randomly allocated into two groups. The intervention group (n = 18 was given a 500 mg probiotic supplement (a capsule every day whereas the control group (n = 18 received placebo (a capsule, both for 3 months. Hb levels and C-reactive protein (CRP levels were measured for three periods. The data were analyzed in SPSS-16 using statistical tests including the t-test and repeated-measures ANOVA. Results: In the probiotic supplementation group, the mean Hb was 9.22 ± 1.04 mg/dl before the intervention and reached 10.85 ± 1.177 mg/dl afterward, while in the placebo group, the mean Hb level was 9.38 ± 0.97 mg/dl before the intervention and reached 10.03 ± 1.97 mg/dl afterward (P > 0.05. During the study, the placebo caused to increase of Hb temporary, but in longer term, the effect of probiotic was more manifested. Hb levels increased in both groups although the change was not statistically significant (P > 0.05. The findings showed no significant differences between the two groups in either the pre- or post-intervention CRP levels (P = 0.239. Conclusion: Probiotic supplementation decreased Hb fluctuations in hemodialysis patients but did not result in a significant increase in Hb levels. Similar studies are therefore recommended to be conducted with a prolonged duration of the study or an increased probiotic dose with larger sample size to complete the results of the present study.

  3. Comparison of maternal and fetal outcomes among patients undergoing cesarean section under general and spinal anesthesia: a randomized clinical trial

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    Anıl İçel Saygı

    Full Text Available CONTEXT AND OBJECTIVE: As the rates of cesarean births have increased, the type of cesarean anesthesia has gained importance. Here, we aimed to compare the effects of general and spinal anesthesia on maternal and fetal outcomes in term singleton cases undergoing elective cesarean section.DESIGN AND SETTING: Prospective randomized controlled clinical trial in a tertiary-level public hospital.METHODS: Our study was conducted on 100 patients who underwent cesarean section due to elective indications. The patients were randomly divided into general anesthesia (n = 50 and spinal anesthesia (n = 50 groups. The maternal pre and postoperative hematological results, intra and postoperative hemodynamic parameters and perinatal results were compared between the groups.RESULTS: Mean bowel sounds (P = 0.036 and gas discharge time (P = 0.049 were significantly greater and 24th hour hemoglobin difference values (P = 0.001 were higher in the general anesthesia group. The mean hematocrit and hemoglobin values at the 24th hour (P = 0.004 and P < 0.001, respectively, urine volume at the first postoperative hour (P < 0.001 and median Apgar score at the first minute (P < 0.0005 were significantly higher, and the time that elapsed until the first requirement for analgesia was significantly longer (P = 0.042, in the spinal anesthesia group.CONCLUSION: In elective cases, spinal anesthesia is superior to general anesthesia in terms of postoperative comfort. In pregnancies with a risk of fetal distress, it would be appropriate to prefer spinal anesthesia by taking the first minute Apgar score into account.

  4. Randomized clinical trial

    DEFF Research Database (Denmark)

    Jensen, Berit E.S.; Hansen, Jane M.; Larsen, Kasper S.

    2017-01-01

    percutaneous coronary intervention and randomized to either screening or control. Screened high-risk patients were prescribed pantoprazole 40 mg during the 1-year after percutaneous coronary intervention. Results The incidence of UGIB was 0.8 versus 1.3% in screened patients and controls, respectively (P=0...

  5. Preventive Effect of Glycyrrhiza Glabra Extract on Oral Mucositis in Patients under Head and Neck Radiotherapy: A Randomized Clinical Trial

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    Shamsolmolok Najafi

    2017-12-01

    Full Text Available Objectives: About two-thirds of cancer patients undergo radiotherapy. Oral mucositis represents a major complication of radiotherapy, causing morbidity and mortality and decreasing the quality of life of patients. This study aimed to assess the preventive effect of Glycyrrhiza aqueous extract on oral mucositis in cancer patients under head and neck radiotherapy.Materials and Methods: In this double-blind clinical trial, 37 head and neck cancer patients were divided into intervention (n=19 group receiving Glycyrrhiza aqueous extract and control (n=18 group receiving placebo. Patients in the test group used Glycyrrhiza aqueous extract topically twice a day from the first day of starting radiotherapy until the end of the second week. Patients were examined in the first day of radiotherapy for any type of wound before treatment and those with oral ulcers before radiotherapy were excluded from the study. The grade of mucositis was determined using the classification by the World Health Organization. ANCOVA was performed to assess any difference between the two groups with regard to oral mucosal irritation and wound size after the intervention while controlling for the covariates such as sex and age.Results: Significant differences were found in the maximum grade of mucositis and oral mucosal irritation between the intervention and control groups (P<0.001.Conclusions: This study showed that aqueous extract of Glycyrrhiza can be effective for decreasing the severity of oral mucositis in head and neck cancer patients undergoing radiotherapy.

  6. Randomized clinical trials in HEPATOLOGY

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    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  7. Registration of randomized clinical trials

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

    2015-01-01

    the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  8. Sporozoite immunization of human volunteers under mefloquine prophylaxis is safe, immunogenic and protective: a double-blind randomized controlled clinical trial.

    Science.gov (United States)

    Bijker, Else M; Schats, Remko; Obiero, Joshua M; Behet, Marije C; van Gemert, Geert-Jan; van de Vegte-Bolmer, Marga; Graumans, Wouter; van Lieshout, Lisette; Bastiaens, Guido J H; Teelen, Karina; Hermsen, Cornelus C; Scholzen, Anja; Visser, Leo G; Sauerwein, Robert W

    2014-01-01

    Immunization of healthy volunteers with chloroquine ChemoProphylaxis and Sporozoites (CPS-CQ) efficiently and reproducibly induces dose-dependent and long-lasting protection against homologous Plasmodium falciparum challenge. Here, we studied whether chloroquine can be replaced by mefloquine, which is the only other licensed anti-malarial chemoprophylactic drug that does not affect pre-erythrocytic stages, exposure to which is considered essential for induction of protection by CPS immunization. In a double blind randomized controlled clinical trial, volunteers under either chloroquine prophylaxis (CPS-CQ, n = 5) or mefloquine prophylaxis (CPS-MQ, n = 10) received three sub-optimal CPS immunizations by bites from eight P. falciparum infected mosquitoes each, at monthly intervals. Four control volunteers received mefloquine prophylaxis and bites from uninfected mosquitoes. CPS-MQ immunization is safe and equally potent compared to CPS-CQ inducing protection in 7/10 (70%) versus 3/5 (60%) volunteers, respectively. Furthermore, specific antibody levels and cellular immune memory responses were comparable between both groups. We therefore conclude that mefloquine and chloroquine are equally effective in CPS-induced immune responses and protection. Trial registration: ClinicalTrials.gov NCT01422954.

  9. A randomized clinical trial comparing the efficacy and safety of ramosetron versus ondansetron in patients undergoing abdominal surgery under general anesthesia

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    Sriramamurthy Kaja

    2014-01-01

    Full Text Available Background: Post-operative nausea and vomiting is one of the most common and distressing complications after anesthesia and surgery. It may lead to serious post-operative complications. Ramosetron is a newer 5-HT3 receptor antagonist and has more potent and longer duration of antiemetic effects compared to first generation 5HT3 receptor antagonists. The purpose of this study was to compare the efficacy of Ramosetron for the prevention of post-operative nausea and vomiting with that of Ondansetron in patients undergoing abdominal surgeries under general anesthesia. Methods: In this randomized, double-blind study, 60 patients, 18-60 years of both genders falling under ASA I-II category scheduled for abdominal surgery were included. Group I received I.V ramosetron 0.3 mg while group II received I.V Ondansetron 4 mg at the time of extubation. The standard general anesthetic technique was used throughout. Postoperatively the incidences of nausea, vomiting, and safety assessments were performed at 1, 2, 6, and 24 h during the first 24 h after surgery. Results: There were no differences between groups with respect to patient demographics. The percentage of patients who had complete response (no PONV, and no need for another rescue antiemetic from 0 to 24 h after anesthesia was 56% with ramosetron and 33% with ondansetron. The corresponding rates at 1, 2, 6, and 24 h after anesthesia were 76% and 63%, 76% and 50%, 100 and 83%, 100 and 93%, respectively. Safety profiles of the two drugs were comparable, as no clinically serious adverse effects caused by study drugs were observed in either of the groups. Conclusion: Our study concludes that prophylactic therapy with ramosetron is highly efficacious than ondansetron in preventing PONV in patients undergoing abdominal surgery under general anesthesia.

  10. Fatigue Reliability under Random Loads

    DEFF Research Database (Denmark)

    Talreja, R.

    1979-01-01

    We consider the problem of estimating the probability of survival (non-failure) and the probability of safe operation (strength greater than a limiting value) of structures subjected to random loads. These probabilities are formulated in terms of the probability distributions of the loads and the...... propagation stage. The consequences of this behaviour on the fatigue reliability are discussed....

  11. Randomization in substance abuse clinical trials.

    Science.gov (United States)

    Hedden, Sarra L; Woolson, Robert F; Malcolm, Robert J

    2006-02-06

    A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA)-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn randomization schemes and other highly adaptive designs. In many

  12. Crestal Bone Loss under Delayed Loading of Full Thickness Versus Flapless Surgically Placed Dental Implants in Controlled Type 2 Diabetic Patients: A Parallel Group Randomized Clinical Trial.

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    Yadav, Rohit; Agrawal, Kaushal Kishor; Rao, Jitendra; Anwar, Mohd; Alvi, Habib Ahmed; Singh, Kalpana; Himanshu, D

    2016-10-12

    To compare crestal bone loss around dental implants using a delayed loading protocol. Bone loss was compared in patients following conventional full thickness flap and flapless surgery in controlled type 2 diabetic patients. Eighty-eight type 2 diabetic patients satisfying predetermined inclusion and exclusion criteria were selected for this single center, parallel group study after obtaining institutional review board approval and informed consent. These patients were randomly divided into two groups. Group I consisted of patients undergoing full thickness flap surgery for implant placement, and group II consisted of patients undergoing flapless surgery for implant placement. The mean age, duration of diabetes, glycosylated hemoglobin levels, and male-to-female ratio in both groups were matched and compared statistically. Dental implants were placed followed by delayed loading (4 months) in both groups. Crestal bone loss was assessed with intraoral periapical radiographs with the help of computer software (DBSWIN viewer). Actual implant length acted as the radiographic index, and implant-abutment junctions were used as a reference point for all measurements. Mesial and distal bone levels at baseline, 6, and 12 months post implant placement of the two groups were determined. Mesial and distal crestal bone loss from baseline to 6 and 12 months were calculated and compared with Tukey test using SPSS v15.0 statistical analysis software. Tukey test revealed similar (not statistically different) mean mesial crestal bone loss between the two groups after 6 months (0.47 ± 0.08 mm vs. 0.36 ± 0.13 mm, p = 0.576) and after 12 months (1.56 ± 0.25 mm vs. 1.50 ± 0.22 mm, p = 0.891). The mean distal bone loss resulting between the two groups was not statistically different at 6 months (0.44 ± 0.08 mm vs. 0.35 ± 0.12 mm, p = 0.687) and at 12 months (1.57 ± 0.23 mm vs. 1.61 ± 0.22 mm, p = 0.947). The results of this clinical randomized control trial indicated that in

  13. [Tracheal intubation quality under remifentanil-propofol with sevoflurane compared with remifentanil-propofol with rocuronium: a randomized double-blind clinical trial].

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    González Obregón, M P; Rivera Díaz, R C; Ordóñez Molina, J E; Rivera Díaz, J S; Velásquez Ossa, L F; Pineda Ibarra, C; Serna Gutiérrez, J; Franco Botero, V

    2010-01-01

    To determine whether intubation conditions under remifentanil-propofol plus sevoflurane rather than a nondepolarizing neuromuscular blocker are similar to those obtained when a neuromuscular blocker is used. In this double-blind controlled trial, 100 patients undergoing outpatient surgery were randomized to 2 groups. Intubation in one group was performed under remifentanil, propofol and sevoflurane. In the other, intubation was performed under remifentanil, propofol, and the nondepolarizing neuromuscular blocker rocuronium. We recorded dysphonia at 24 hours, Cormack-Lehane classification at laryngoscopy, mandibular relaxation, vocal cord position and mobility, and cough or movement during laryngoscopy, on intubation and on cuff inflation. Blood pressure and heart rate before and after tracheal intubation were also recorded. No significant between-group differences were observed in dysphonia 24 hours after surgery, Cormack-Lehane classification at laryngoscopy, mandibular relaxation, the position or mobility of vocal cords, or cough or movement during laryngoscopy, intubation or cuff inflation. After intubation the mean (SD) systolic blood pressure was 119.7 (75.4) mm Hg in the rocuronium group and 97.5 (54.5) mm Hg in the sevoflurane group. Mean heart rate was 80.7 beats/min in the rocuronium group and 66.7 beats/min in the sevoflurane group. The differences were significant (P < .05). Adequate doses of remifentanil, propofol, and sevoflurane provide intubation conditions that are similar to those achieved by using a nondepolarizing neuromuscular blocker, without exposing patients to additional risk. Avoiding use of a neuromuscular blocker would circumvent the development of complications associated with use of these agents or their antagonists and costs would be lower.

  14. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial.

    Science.gov (United States)

    Moslemi, Farnaz; Rasooli, Sousan

    2015-01-01

    Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in the prevention of hypotension during spinal anesthesia in elective cesarean section. Eighty-three patients were enrolled in this study and randomly divided into three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo. Vital signs (blood pressure, heart rate, and arterial oxygen saturation) were recorded throughout the surgery. Maternal and neonatal perioperative complications were also controlled and recorded. There was an insignificant difference in demographic data between the groups. Systolic and diastolic blood pressures were higher in the phenylephrine group than control, but not higher than the ephedrine group. Maternal dysrhythmias were more common in ephedrine and phenylephrine groups than the control group. Vomiting was more common in ephedrine group (Pcomplication for mother or her fetus. IRCT2012120911700N1.

  15. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial

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    Farnaz Moslemi

    2015-01-01

    Full Text Available Background: Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in the prevention of hypotension during spinal anesthesia in elective cesarean section. Methods: Eighty-three patients were enrolled in this study and randomly divided into three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo. Vital signs (blood pressure, heart rate, and arterial oxygen saturation were recorded throughout the surgery. Maternal and neonatal perioperative complications were also controlled and recorded. Results: There was an insignificant difference in demographic data between the groups. Systolic and diastolic blood pressures were higher in the phenylephrine group than control, but not higher than the ephedrine group. Maternal dysrhythmias were more common in ephedrine and phenylephrine groups than the control group. Vomiting was more common in ephedrine group (P<0.05. In addition, the fifth-minute Apgar score of neonates was higher in phenylephrine and ephedrine groups than the control group (P<0.05. Neonates of phenylephrine group had less acidosis than the other groups. Conclusion: Prophylactic infusion of phenylephrine can effectively decrease spinal anesthesia related hypotension without any significant complication for mother or her fetus. Trial Registration Number: IRCT2012120911700N1

  16. Randomization in substance abuse clinical trials

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    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  17. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  18. Fatigue in Steel Structures under Random Loading

    DEFF Research Database (Denmark)

    Agerskov, Henning

    1999-01-01

    test results. Both the fracture mechanics analysis and the fatigue test results indicate that Miner's rule, which is normally used in the design against fatigue in steel structures, may give results, which are unconservative, and that the validity of the results obtained from Miner's rule will depend......Fatigue damage accumulation in steel structures under random loading is studied. The fatigue life of welded joints has been determined both experimentally and from a fracture mechanics analysis. In the experimental part of the investigation, fatigue test series have been carried through on various...... types of welded plate test specimens and full-scale offshore tubular joints. The materials that have been used are either conventional structural steel with a yield stress of ~ 360-410 MPa or high-strength steel with a yield stress of ~ 810-1010 MPa. The fatigue tests and the fracture mechanics analyses...

  19. Fatigue durability under random cyclic loading

    Science.gov (United States)

    Volkov, S. S.; Struzhanov, V. V.

    2017-12-01

    Methods for predicting the durability of metals have been developed while taking into account the effect of random loads acting during the service life of structures. Methods of the theory of functions of random variables are applied. Normal distribution and the Rayleigh distribution are used to estimate the random loads from the experimental histogram. A numerical example illustrates the influence of the statistical parameters of the load distribution on the predicted number of cycles before failure.

  20. A randomized, rater-blinded, crossover study comparing the clinical efficacy of Ritalin(®) LA (methylphenidate) treatment in children with attention-deficit hyperactivity disorder under different breakfast conditions over 2 weeks.

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    Schulz, Eberhard; Fleischhaker, Christian; Hennighausen, Klaus; Heiser, Philip; Haessler, Frank; Linder, Martin; Stollhoff, Kirsten; Warnke, Andreas; Baier, Monika; Klatt, Jan

    2010-11-01

    Several extended-release methylphenidate medications are available for treatment of children with ADHD. Pharmacokinetic investigations suggest that the serum levels of methylphenidate are partially altered when the medication is taken without breakfast. Clinical data comparing different breakfast situations are missing. In this study, different breakfast compositions and their influence on treatment with Ritalin LA are investigated. A total of 150 patients were enrolled in a rater-blinded, randomized crossover trial that compared a minimal breakfast with a standard breakfast in patients under stable treatment with Ritalin LA. Ratings for clinical efficacy were carried out after 1 week by teachers and parents (FBB-ADHS), as well as physicians (CGI). Additionally, a math test was administered to the patients. Of the total patients, 144 finished the trial with a breakfast compliance of 93%. All of the clinical rating scales showed consistently no difference between the two breakfast conditions. Non-inferiority of minimal breakfast versus standard breakfast was shown to be statistically significant (FBB-AHDS(Teacher): 0.97 with minimal breakfast, 1.01 with standard breakfast, P Ritalin LA is not influenced by breakfast and works independently of food intake.

  1. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed...

  2. Randomized Clinical Trials on Deep Carious Lesions

    DEFF Research Database (Denmark)

    Bjørndal, Lars; Fransson, Helena; Bruun, Gitte

    2017-01-01

    Deep caries presents a dilemma in terms of which treatment that will render an optimal prognosis by maintaining pulp vitality with absence of apical pathology. Previously, 2 randomized clinical trials were performed testing the short-term effects of stepwise carious tissue removal versus nonselec......Deep caries presents a dilemma in terms of which treatment that will render an optimal prognosis by maintaining pulp vitality with absence of apical pathology. Previously, 2 randomized clinical trials were performed testing the short-term effects of stepwise carious tissue removal versus...... nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when...

  3. Quantum Entanglement Growth under Random Unitary Dynamics

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    Adam Nahum

    2017-07-01

    Full Text Available Characterizing how entanglement grows with time in a many-body system, for example, after a quantum quench, is a key problem in nonequilibrium quantum physics. We study this problem for the case of random unitary dynamics, representing either Hamiltonian evolution with time-dependent noise or evolution by a random quantum circuit. Our results reveal a universal structure behind noisy entanglement growth, and also provide simple new heuristics for the “entanglement tsunami” in Hamiltonian systems without noise. In 1D, we show that noise causes the entanglement entropy across a cut to grow according to the celebrated Kardar-Parisi-Zhang (KPZ equation. The mean entanglement grows linearly in time, while fluctuations grow like (time^{1/3} and are spatially correlated over a distance ∝(time^{2/3}. We derive KPZ universal behavior in three complementary ways, by mapping random entanglement growth to (i a stochastic model of a growing surface, (ii a “minimal cut” picture, reminiscent of the Ryu-Takayanagi formula in holography, and (iii a hydrodynamic problem involving the dynamical spreading of operators. We demonstrate KPZ universality in 1D numerically using simulations of random unitary circuits. Importantly, the leading-order time dependence of the entropy is deterministic even in the presence of noise, allowing us to propose a simple coarse grained minimal cut picture for the entanglement growth of generic Hamiltonians, even without noise, in arbitrary dimensionality. We clarify the meaning of the “velocity” of entanglement growth in the 1D entanglement tsunami. We show that in higher dimensions, noisy entanglement evolution maps to the well-studied problem of pinning of a membrane or domain wall by disorder.

  4. Celiac Patients: A Randomized, Controlled Clinical Study

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    Giuseppe Mazzarella

    2012-01-01

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

  5. Geomagnetic storm under laboratory conditions: randomized experiment

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    Gurfinkel, Yu I.; Vasin, A. L.; Pishchalnikov, R. Yu; Sarimov, R. M.; Sasonko, M. L.; Matveeva, T. A.

    2017-10-01

    The influence of the previously recorded geomagnetic storm (GS) on human cardiovascular system and microcirculation has been studied under laboratory conditions. Healthy volunteers in lying position were exposed under two artificially created conditions: quiet (Q) and storm (S). The Q regime playbacks a noise-free magnetic field (MF) which is closed to the natural geomagnetic conditions on Moscow's latitude. The S regime playbacks the initially recorded 6-h geomagnetic storm which is repeated four times sequentially. The cardiovascular response to the GS impact was assessed by measuring capillary blood velocity (CBV) and blood pressure (BP) and by the analysis of the 24-h ECG recording. A storm-to-quiet ratio for the cardio intervals (CI) and the heart rate variability (HRV) was introduced in order to reveal the average over group significant differences of HRV. An individual sensitivity to the GS was estimated using the autocorrelation function analysis of the high-frequency (HF) part of the CI spectrum. The autocorrelation analysis allowed for detection a group of subjects of study which autocorrelation functions (ACF) react differently in the Q and S regimes of exposure.

  6. Non-stationary random vibration analysis of structures under multiple correlated normal random excitations

    Science.gov (United States)

    Li, Yanbin; Mulani, Sameer B.; Kapania, Rakesh K.; Fei, Qingguo; Wu, Shaoqing

    2017-07-01

    An algorithm that integrates Karhunen-Loeve expansion (KLE) and the finite element method (FEM) is proposed to perform non-stationary random vibration analysis of structures under excitations, represented by multiple random processes that are correlated in both time and spatial domains. In KLE, the auto-covariance functions of random excitations are discretized using orthogonal basis functions. The KLE for multiple correlated random excitations relies on expansions in terms of correlated sets of random variables reflecting the cross-covariance of the random processes. During the response calculations, the eigenfunctions of KLE used to represent excitations are applied as forcing functions to the structure. The proposed algorithm is applied to a 2DOF system, a 2D cantilever beam and a 3D aircraft wing under both stationary and non-stationary correlated random excitations. Two methods are adopted to obtain the structural responses: a) the modal method and b) the direct method. Both the methods provide the statistics of the dynamic response with sufficient accuracy. The structural responses under the same type of correlated random excitations are bounded by the response obtained by perfectly correlated and uncorrelated random excitations. The structural response increases with a decrease in the correlation length and with an increase in the correlation magnitude. The proposed methodology can be applied for the analysis of any complex structure under any type of random excitation.

  7. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious

  8. Comparison of clinical hematological changes under ...

    African Journals Online (AJOL)

    The objectives of this study were to compare the clinical hematological changes under anesthetization in Crucian carp (Carassius auratus auratus) due to treatment with local anesthetics. Our data indicate that the values declined significantly (P < 0.05) with dissolved oxygen amount after anesthetization, furthermore, the ...

  9. Performance of Power Systems under Sustained Random Perturbations

    Directory of Open Access Journals (Sweden)

    Humberto Verdejo

    2014-01-01

    Full Text Available This paper studies linear systems under sustained additive random perturbations. The stable operating point of an electric power system is replaced by an attracting stationary solution if the system is subjected to (small random additive perturbations. The invariant distribution of this stationary solution gives rise to several performance indices that measure how well the system copes with the randomness. These indices are introduced, showing how they can be used for the optimal tuning of system parameters in the presence of noise. Results on a four-generator two-area system are presented and discussed.

  10. The Damage Effects in Steel Bridges under Highway Random Loading

    DEFF Research Database (Denmark)

    Agerskov, Henning; Nielsen, Jette Andkjær

    1996-01-01

    In the present investigation, fatigue damage accumulation in steel bridges under highway random loading is studied. In the experimental part of the investigation, fatigue test series on welded plate test specimens have been carried through. The fatigue tests have been carried out using load histo...

  11. The Fatigue Behavior of Steel Structures under Random Loading

    DEFF Research Database (Denmark)

    Agerskov, Henning

    2009-01-01

    Fatigue damage accumulation in steel structures under random loading has been studied in a number of investigations at the Technical University of Denmark. The fatigue life of welded joints has been determined both experimentally and from a fracture mechanics analysis. In the experimental part...

  12. The Fatigue Behavior of Steel Structures under Random Loading

    DEFF Research Database (Denmark)

    Agerskov, Henning

    2008-01-01

    Fatigue damage accumulation in steel structures under random loading has been studied in a number of investigations at the Technical University of Denmark. The fatigue life of welded joints has been determined both experimentally and from a fracture mechanics analysis. In the experimental part...

  13. Effect of low dose of intrathecal pethidine on the incidence and intensity of shivering during cesarean section under spinal anesthesia: a randomized, placebo-controlled, double-blind clinical trial.

    Science.gov (United States)

    Shami, Shoaleh; Nasseri, Karim; Shirmohammadi, Mousa; Sarshivi, Farzad; Ghadami, Negin; Ghaderi, Ebrahim; Pouladi, Mokhtar; Barzanji, Arvin

    2016-01-01

    Shivering is among the unpleasant and potentially harmful side effects of spinal anesthesia. The aim of this randomized double-blind clinical trial was to compare the antishivering effect of two different doses of intrathecal pethidine on the incidence and intensity of shivering and other side effects in patients who underwent cesarean section. In this study, 150 parturient females scheduled for nonemergent cesarean section were randomly allocated to three groups. Spinal anesthesia was performed with 0.5% hyperbaric bupivacaine (12.5 mg), plus 0.5 mL of 0.9% saline in the standard group (S group), and the same dose of bupivacaine with 5 mg (P5 group) or 10 mg of pethidine (P10 group). Demographic and surgical data, incidence and intensity of shivering (primary outcome), hemodynamic indices, forehead and core temperatures, maximum sensory level, Apgar scores, and adverse events were evaluated by a blinded observer. There were no significant differences between the three study groups regarding the demographic and surgical data, hemodynamic indices, core temperatures, and maximum sensory level ( P >0.05). The incidence and intensity of shivering were significantly less in the P5 and P10 groups ( P shivering during cesarean section, without having major side effects.

  14. Validity of tests under covariate-adaptive biased coin randomization and generalized linear models.

    Science.gov (United States)

    Shao, Jun; Yu, Xinxin

    2013-12-01

    Some covariate-adaptive randomization methods have been used in clinical trials for a long time, but little theoretical work has been done about testing hypotheses under covariate-adaptive randomization until Shao et al. (2010) who provided a theory with detailed discussion for responses under linear models. In this article, we establish some asymptotic results for covariate-adaptive biased coin randomization under generalized linear models with possibly unknown link functions. We show that the simple t-test without using any covariate is conservative under covariate-adaptive biased coin randomization in terms of its Type I error rate, and that a valid test using the bootstrap can be constructed. This bootstrap test, utilizing covariates in the randomization scheme, is shown to be asymptotically as efficient as Wald's test correctly using covariates in the analysis. Thus, the efficiency loss due to not using covariates in the analysis can be recovered by utilizing covariates in covariate-adaptive biased coin randomization. Our theory is illustrated with two most popular types of discrete outcomes, binary responses and event counts under the Poisson model, and exponentially distributed continuous responses. We also show that an alternative simple test without using any covariate under the Poisson model has an inflated Type I error rate under simple randomization, but is valid under covariate-adaptive biased coin randomization. Effects on the validity of tests due to model misspecification is also discussed. Simulation studies about the Type I errors and powers of several tests are presented for both discrete and continuous responses. © 2013, The International Biometric Society.

  15. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, Allan Gorm; Petersen, O B; Wara, P

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  16. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

    2012-01-01

    randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

  17. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  18. Quality assessment of randomized clinical trial in intensive care.

    Science.gov (United States)

    Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira

    2009-03-01

    A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

  19. Circular random motion in diatom gliding under isotropic conditions

    International Nuclear Information System (INIS)

    Gutiérrez-Medina, Braulio; Maldonado, Ana Iris Peña; Guerra, Andrés Jiménez; Rubio, Yadiralia Covarrubias; Meza, Jessica Viridiana García

    2014-01-01

    How cells migrate has been investigated primarily for the case of trajectories composed by joined straight segments. In contrast, little is known when cellular motion follows intrinsically curved paths. Here, we use time-lapse optical microscopy and automated trajectory tracking to investigate how individual cells of the diatom Nitzschia communis glide across surfaces under isotropic environmental conditions. We find a distinct kind of random motion, where trajectories are formed by circular arcs traveled at constant speed, alternated with random stoppages, direction reversals and changes in the orientation of the arcs. Analysis of experimental and computer-simulated trajectories show that the circular random motion of diatom gliding is not optimized for long-distance travel but rather for recurrent coverage of limited surface area. These results suggest that one main biological role for this type of diatom motility is to efficiently build the foundation of algal biofilms. (paper)

  20. FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial.

    Science.gov (United States)

    Baumgaertner, Annette; Grewe, Tanja; Ziegler, Wolfram; Floel, Agnes; Springer, Luise; Martus, Peter; Breitenstein, Caterina

    2013-09-23

    Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia. Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative

  1. Fatigue failure of materials under broad band random vibrations

    Science.gov (United States)

    Huang, T. C.; Lanz, R. W.

    1971-01-01

    The fatigue life of material under multifactor influence of broad band random excitations has been investigated. Parameters which affect the fatigue life are postulated to be peak stress, variance of stress and the natural frequency of the system. Experimental data were processed by the hybrid computer. Based on the experimental results and regression analysis a best predicting model has been found. All values of the experimental fatigue lives are within the 95% confidence intervals of the predicting equation.

  2. Robustness of Dengue Complex Network under Targeted versus Random Attack

    Directory of Open Access Journals (Sweden)

    Hafiz Abid Mahmood Malik

    2017-01-01

    Full Text Available Dengue virus infection is one of those epidemic diseases that require much consideration in order to save the humankind from its unsafe impacts. According to the World Health Organization (WHO, 3.6 billion individuals are at risk because of the dengue virus sickness. Researchers are striving to comprehend the dengue threat. This study is a little commitment to those endeavors. To observe the robustness of the dengue network, we uprooted the links between nodes randomly and targeted by utilizing different centrality measures. The outcomes demonstrated that 5% targeted attack is equivalent to the result of 65% random assault, which showed the topology of this complex network validated a scale-free network instead of random network. Four centrality measures (Degree, Closeness, Betweenness, and Eigenvector have been ascertained to look for focal hubs. It has been observed through the results in this study that robustness of a node and links depends on topology of the network. The dengue epidemic network presented robust behaviour under random attack, and this network turned out to be more vulnerable when the hubs of higher degree have higher probability to fail. Moreover, representation of this network has been projected, and hub removal impact has been shown on the real map of Gombak (Malaysia.

  3. Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial.

    Science.gov (United States)

    Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E; Ruan, Yue; Thabit, Hood; Acerini, Carlo L; Dunger, David B; Hovorka, Roman

    2017-05-01

    Closed-loop (CL) systems direct insulin delivery based on continuous glucose monitor (CGM) sensor values. CGM accuracy varies with sensor life, being least accurate on day 1 of sensor insertion. We evaluated the effect of sensor life (enhanced Enlite, Medtronic MiniMed, Northridge, CA) on overnight CL. In an open-label, randomized, 2-period, inpatient crossover pilot study, 12 adolescents on insulin pump (age 16.7 ± 1.9 years; HbA1c 66 ± 10 mmol/mol) attended a clinical research facility on 2 overnight occasions. In random order, participants received CL on day 1 or on day 3-4 after sensor insertion. During both periods, glucose was automatically controlled by a model predictive control algorithm informed by sensor glucose. Plasma glucose was measured every 30 to 60 min. During overnight CL (22:30 to 07:30), the proportion of time with plasma glucose readings in the target range (3.9-8.0 mmol/l, primary endpoint) when initiated on day 1 of sensor insertion vs day 3-4 were comparable (58 ± 32% day 1 vs 56 ± 36% day 3-4; P = .34), and there were no significant differences between interventions in terms of mean plasma glucose ( P = .26), percentage time above 8.0 mmol/l ( P = .49), and time spent below 3.9 mmol/l ( P = .93). Sensor accuracy varied with sensor life (mean absolute relative difference 19.8 ± 15.0% on day 1 and 13.7 ± 10.2% on day 3 to 4). Sensor glucose tended to under-read plasma glucose inflating benefits of CL on glucose control. In spite of differences in sensor accuracy, overnight CL glucose control informed by sensor glucose on day 1 or day 3-4 after sensor insertion was comparable. The model predictive controller appears to mitigate against sensor inaccuracies.

  4. Fatigue failure of materials under narrow band random vibrations. I.

    Science.gov (United States)

    Huang, T. C.; Hubbard, R. B.; Lanz, R. W.

    1971-01-01

    A novel approach for the study of fatigue failure of materials under the multifactor influence of narrow band random vibrations is developed. The approach involves the conduction of an experiment in conjunction with various statistical techniques. Three factors including two statistical properties of the excitation or response are considered and varied simultaneously. A minimum of 6 tests for 3 variables is possible for a fractional f actorial design. The four coefficients of the predicting equation can be independently estimated. A look at 3 predicting equations shows the predominant effect of the root mean square stress of the first order equation.

  5. Fatigue in Aluminum Highway Bridges under Random Loading

    DEFF Research Database (Denmark)

    Rom, Søren; Agerskov, Henning

    2014-01-01

    Fatigue damage accumulation in aluminum highway bridges under random loading is studied. The fatigue life of welded joints has been determined both experimentally and from a fracture mechanics analysis. In the experimental part of the investigation, fatigue test series on welded plate test...... is normally used in the design against fatigue in aluminum bridges, may give results which are unconservative. The validity of the results obtained from Miner’s rule will depend on the distribution of the load history in tension and compression....

  6. A Prospective Randomized Clinical Study of the Influence of Primary ...

    African Journals Online (AJOL)

    Objective: The aim of the following study is to determine the effect of primary closure or dressing on post‑operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects ...

  7. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

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

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

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

    Science.gov (United States)

    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

  10. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  11. Analysis of axial compressive loaded beam under random support excitations

    Science.gov (United States)

    Xiao, Wensheng; Wang, Fengde; Liu, Jian

    2017-12-01

    An analytical procedure to investigate the response spectrum of a uniform Bernoulli-Euler beam with axial compressive load subjected to random support excitations is implemented based on the Mindlin-Goodman method and the mode superposition method in the frequency domain. The random response spectrum of the simply supported beam subjected to white noise excitation and to Pierson-Moskowitz spectrum excitation is investigated, and the characteristics of the response spectrum are further explored. Moreover, the effect of axial compressive load is studied and a method to determine the axial load is proposed. The research results show that the response spectrum mainly consists of the beam's additional displacement response spectrum when the excitation is white noise; however, the quasi-static displacement response spectrum is the main component when the excitation is the Pierson-Moskowitz spectrum. Under white noise excitation, the amplitude of the power spectral density function decreased as the axial compressive load increased, while the frequency band of the vibration response spectrum increased with the increase of axial compressive load.

  12. Industry sponsorship and selection of comparators in randomized clinical trials.

    Science.gov (United States)

    Lathyris, D N; Patsopoulos, N A; Salanti, G; Ioannidis, J P A

    2010-02-01

    Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products. Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period. Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors. Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition.

  13. Event detection using population-based health care databases in randomized clinical trials

    DEFF Research Database (Denmark)

    Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik

    2013-01-01

    To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....

  14. Reducing bias in survival under non-random temporary emigration

    Science.gov (United States)

    Peñaloza, Claudia L.; Kendall, William L.; Langtimm, Catherine Ann

    2014-01-01

    Despite intensive monitoring, temporary emigration from the sampling area can induce bias severe enough for managers to discard life-history parameter estimates toward the terminus of the times series (terminal bias). Under random temporary emigration unbiased parameters can be estimated with CJS models. However, unmodeled Markovian temporary emigration causes bias in parameter estimates and an unobservable state is required to model this type of emigration. The robust design is most flexible when modeling temporary emigration, and partial solutions to mitigate bias have been identified, nonetheless there are conditions were terminal bias prevails. Long-lived species with high adult survival and highly variable non-random temporary emigration present terminal bias in survival estimates, despite being modeled with the robust design and suggested constraints. Because this bias is due to uncertainty about the fate of individuals that are undetected toward the end of the time series, solutions should involve using additional information on survival status or location of these individuals at that time. Using simulation, we evaluated the performance of models that jointly analyze robust design data and an additional source of ancillary data (predictive covariate on temporary emigration, telemetry, dead recovery, or auxiliary resightings) in reducing terminal bias in survival estimates. The auxiliary resighting and predictive covariate models reduced terminal bias the most. Additional telemetry data was effective at reducing terminal bias only when individuals were tracked for a minimum of two years. High adult survival of long-lived species made the joint model with recovery data ineffective at reducing terminal bias because of small-sample bias. The naïve constraint model (last and penultimate temporary emigration parameters made equal), was the least efficient, though still able to reduce terminal bias when compared to an unconstrained model. Joint analysis of several

  15. Ultrasonic properties of random media under uniaxial loading

    Science.gov (United States)

    Insana, M. F.; Hall, T. J.; Chaturvedi, P.; Kargel, Ch.

    2001-12-01

    Acoustic properties of two types of soft tissue-like media were measured as a function of compressive strain. Samples were subjected to uniaxial strains up to 40% along the axis of the transducer beam. Measurements were analyzed to test a common assumption made when using pulse-echo waveforms to track motion in soft tissues-that local properties of wave propagation and scattering are invariant under deformation. Violations of this assumption have implications for elasticity imaging procedures and could provide new opportunities for identifying the sources of backscatter in biological media such as breast parenchyma. We measured speeds of sound, attenuation coefficients, and echo spectra in compressed phantoms containing randomly positioned scatterers either stiffer or softer than the surrounding gelatin. Only the echo spectra of gel media with soft scatterers varied significantly during compression. Centroids of the echo spectra were found to be shifted to higher frequencies in proportion to the applied strain up to 10%, and increased monotonically up to 40% at a rate depending on the scatterer size. Centroid measurements were accurately modeled by assuming incoherent scattering from oblate spheroids with an eccentricity that increases with strain. While spectral shifts can be accurately modeled, recovery of lost echo coherence does not seem possible. Consequently, spectral variance during compression may ultimately limit the amount of strain that can be applied between two data fields in heterogeneous media such as lipid-filled tissues. It also appears to partially explain why strain images often produce greater echo decorrelation in tissues than in commonly used graphite-gelatin test phantoms.

  16. Determination of the underlying cause of death in three multicenter international HIV clinical trials

    DEFF Research Database (Denmark)

    Lifson, Alan R; Lundgren, Jens; Belloso, Waldo H

    2008-01-01

    PURPOSE: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. METHOD: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 co...

  17. The effect of impregnated autogenous epidural adipose tissue with bupivacaine, methylprednisolone acetate or normal saline on postoperative radicular and low back pain in lumbar disc surgery under spinal anesthesia; A randomized clinical trial study FNx01

    Directory of Open Access Journals (Sweden)

    Saeid Abrishamkar

    2011-01-01

    Full Text Available Background: Low Back Pain (LBP and radicular leg pain (RLP after lumbar disc surgery are great challenges that prevent patients and neurosurgeons in making a surgical decision. By spinal anesthesia, LBP and RLP diminish up to 2 to 3 hours postoperatively. The aim of this study was to determine the effect of impregnated epidural adipose tissue (EAT with bupivacaine or methylprednisolone acetate on reduction of late postoperative pain after spinal anesthesia. Methods: This study was performed on lumbar disc herniation surgery under spinal anesthesia. Sixty six patients entered our study who were divided into three groups, EAT impregnated with bupivacaine (group 1, methylprednisolone acetate (group2 and normal saline (control group. The LBP and RLP were evaluated during the first 24 hours postoperatively and 14 days later by visual analogue scale (VAS. Results: Of 66 patients, 53% were female and 47% male. The average (SE LBP in the first 6 hours after surgery based on VAS were 1.59 ± 0.90 in group one, 2.36 ± 2.38 in group 2 and 3.09 ± 1.41 in control group but the VAS for RLP in this period were 1.95 ± 1.13, 1.31 ± 1.39 and 2.40 ± 1.09, respectively. The average LBP and RLP did not show any differences after 14 days postoperatively. Conclusions: According to our data bupivacaine was effective on LBP relief and steroid was effective on RLP relief during the first 12 hours after surgery.

  18. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  19. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. High cycle fatigue of austenitic stainless steels under random loading

    International Nuclear Information System (INIS)

    Gauthier, J.P.; Petrequin, P.

    1987-08-01

    To investigate reactor components, load control random fatigue tests were performed at 300 0 C and 550 0 C, on specimens from austenitic stainless steels plates in the transverse orientation. Random solicitations are produced on closed loop servo-hydraulic machines by a mini computer which generates random load sequence by the use of reduced Markovian matrix. The method has the advantage of taking into account the mean load for each cycle. The solicitations generated are those of a stationary gaussian process. Fatigue tests have been mainly performed in the endurance region of fatigue curve, with scattering determination using stair case method. Experimental results have been analysed aiming at determining design curves for components calculations, depending on irregularity factor and temperature. Analysis in term of mean square root fatigue limit calculation, shows that random loading gives more damage than constant amplitude loading. Damage calculations following Miner rule have been made using the probability density function for the case where the irregularity factor is nearest to 100 %. The Miner rule is too conservative for our results. A method using design curves including random loading effects with irregularity factor as an indexing parameter is proposed

  1. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  2. On robust tail index estimation under random censorship | Sayah ...

    African Journals Online (AJOL)

    type distributions in the framework of randomly censored samples, based on the ideas of Kaplan-Meier integration using the huberized M-estimator of the tail index. We derive their asymptotic results. We illustrate the performance and the ...

  3. Optical image encryption based on interference under convergent random illumination

    International Nuclear Information System (INIS)

    Kumar, Pramod; Joseph, Joby; Singh, Kehar

    2010-01-01

    In an optical image encryption system based on the interference principle, two pure phase masks are designed analytically to hide an image. These two masks are illuminated with a plane wavefront to retrieve the original image in the form of an interference pattern at the decryption plane. Replacement of the plane wavefront with convergent random illumination in the proposed scheme leads to an improvement in the security of interference based encryption. The proposed encryption scheme retains the simplicity of an interference based method, as the two pure masks are generated with an analytical method without any iterative algorithm. In addition to the free-space propagation distance and the two pure phase masks, the convergence distance and the randomized lens phase function are two new encryption parameters to enhance the system security. The robustness of this scheme against occlusion of the random phase mask of the randomized lens phase function is investigated. The feasibility of the proposed scheme is demonstrated with numerical simulation results

  4. Optical image encryption based on interference under convergent random illumination

    Science.gov (United States)

    Kumar, Pramod; Joseph, Joby; Singh, Kehar

    2010-09-01

    In an optical image encryption system based on the interference principle, two pure phase masks are designed analytically to hide an image. These two masks are illuminated with a plane wavefront to retrieve the original image in the form of an interference pattern at the decryption plane. Replacement of the plane wavefront with convergent random illumination in the proposed scheme leads to an improvement in the security of interference based encryption. The proposed encryption scheme retains the simplicity of an interference based method, as the two pure masks are generated with an analytical method without any iterative algorithm. In addition to the free-space propagation distance and the two pure phase masks, the convergence distance and the randomized lens phase function are two new encryption parameters to enhance the system security. The robustness of this scheme against occlusion of the random phase mask of the randomized lens phase function is investigated. The feasibility of the proposed scheme is demonstrated with numerical simulation results.

  5. Philosophers assess randomized clinical trials: the need for dialogue.

    Science.gov (United States)

    Miké, V

    1989-09-01

    In recent years a growing number of professional philosophers have joined in the controversy over ethical aspects of randomized clinical trials (RCTs). Morally questionable in their utilitarian approach, RCTs are claimed by some to be in direct violation of the second form of Kant's Categorical Imperative. But the arguments used in these critiques at times derive from a lack of insight into basic statistical procedures and the realities of the biomedical research process. Presented to physicians and other nonspecialists, including the lay public, such distortions can be harmful. Given the great complexity of statistical methodology and the anomalous nature of concepts of evidence, more sustained input into the interdisciplinary dialogue is needed from the statistical profession.

  6. Fluoride concentration from dental sealants: a randomized clinical trial.

    Science.gov (United States)

    Campus, G; Carta, G; Cagetti, M G; Bossù, M; Sale, S; Cocco, F; Conti, G; Nardone, M; Sanna, G; Strohmenger, L; Lingström, P

    2013-07-01

    A randomized clinical trial was performed in schoolchildren (6-7 yrs) to evaluate fluoride concentration in interproximal fluid after the placement of 3 different sealants. The sample consisted of 2,776 children randomly divided: 926 in the high-viscosity Glass-ionomer Cement group (GIC group), 923 in the fluoride Resin-based group (fluoride-RB group), and 927 in the no-fluoride Resin-based group (RB group). In total, 2,640 children completed the trial. Sealants were applied following manufacturer's instructions. Interproximal fluid samples were collected at baseline and 2, 7, and 21 days after application of sealants, by insertion of a standardized paperpoint into the interproximal mesial space of the sealed tooth for 15 seconds. Fluoride concentration was evaluated by means of a fluoride ion-selective electrode. At 2 days after sealant application, fluoride concentration was significantly higher in GIC and fluoride-RB groups compared with that in the RB group (p sealants increased the fluoride concentrations in interproximal fluid more than did a Resin-based sealant containing fluoride.

  7. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Daniela Francescato Veiga

    Full Text Available The evidence to support dressing standards for breast surgery wounds is empiric and scarce.This two-arm randomized clinical trial was designed to assess the effect of dressing wear time on surgical site infection (SSI rates, skin colonization and patient perceptions.A total of 200 breast cancer patients undergoing breast reconstruction were prospectively enrolled. Patients were randomly allocated to group I (dressing removed on the first postoperative day, n = 100 or group II (dressing removed on the sixth postoperative day, n = 100. SSIs were defined and classified according to criteria from the Centers for Disease Control and Prevention. Samples collected before placing the dressing and after 1 day (group I and 6 days (both groups were cultured for skin colonization assessments. Patients preferences and perceptions with regard to safety, comfort and convenience were recorded and analyzed.A total of 186 patients completed the follow-up. The global SSI rate was 4.5%. Six patients in group I and three in group II had SSI (p = 0.497. Before dressing, the groups were similar with regard to skin colonization. At the sixth day, there was a higher colonization by coagulase-negative staphylococci in group I (p<0.0001. Patients preferred to keep dressing for six days (p<0.0001, and considered this a safer choice (p<0.05.Despite group I had a higher skin colonization by coagulase-negative staphylococci on the sixth postoperative day, there was no difference in SSI rates. Patients preferred keeping dressing for six days and considered it a safer choice.ClinicalTrials.gov NCT01148823.

  8. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  9. Community-equipoise and the ethics of randomized clinical trials.

    Science.gov (United States)

    Gifford, Fred

    1995-04-01

    This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clincial trials (RCTs) -- the "community equipoise" strategy (CE). The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipose strategy involves the suggestion that our judgment that neither treatment is to be preferred (that there obtains a state of "equipoise") is to be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: (i) medical knowledge is best understood as residing in the community, (ii) the judgments of others count as evidence, and so should change one's own opinion, (iii) subjects would not be better off outside the trial, and (iv) the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs.

  10. Some products from CLRI under clinical use and evaluation

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Some products from CLRI under clinical use and evaluation. As burn dressing materials. As wound healing support system. In dentistry: in treatment of gingivial recession. In ophthalmology: as lens support system.

  11. Transperitoneal versus retroperitoneal laparoscopic pyeloplasty in children: Randomized clinical trial.

    Science.gov (United States)

    Badawy, Haytham; Zoaier, Amr; Ghoneim, Tamer; Hanno, Ahmed

    2015-06-01

    Laparoscopic pyeloplasty achieves good cosmetic and functional outcomes. Both transperitoneal and retroperitoneal approaches are used. No single study to date has compared the two approaches in a prospective randomized design. We present a prospective randomized comparison between both approaches in children in a trial to define which technique is better with regard to multiple factors including operative time, hospital stay, recovery of bowel movement, analgesic requirement and complication rate. In the period from June 2010 to September 2012, 38 children (25 boys and 13 girls) were operated laparoscopically. Children were randomized into Group I (19 children) operated by the transperitoneal approach, and Group II (19 children) operated by the retroperitoneal approach. Both groups were compared as regards to the operative time, anesthetic changes, and postoperative recovery. A minimum sample size required was calculated to be 19 for each arm based on previous studies of laparoscopic pyeloplasty, using a mean difference in operative time = 40 min, effect size = 0.95, an alpha of 0.05 and power 80% and an online sample size calculator. Statistical analysis was performed using SPSS software using the Fischer exact test, chi square test and Mann-Whitney U test. The operative time was the primary endpoint for comparison between both approaches. Our series is the first in the literature that compares in a prospective randomized design the transperitoneal and retroperitoneal laparoscopic pyeloplasty in children. Shouma et al. is the only prospective randomized study to compare both techniques in adult pyeloplasty. They had a significantly shorter operative time in the transperitoneal group however, the author in the discussion mentioned that he was at the start of the learning curve for retroperitonoscopic pyeloplasty when he conducted his study, which affected the result of the operative time. Hence, as mentioned above, we stressed the importance of a single surgeon

  12. A Random Walk Phenomenon under an Interesting Stopping Rule

    Science.gov (United States)

    Chakraborty, S.

    2007-01-01

    In the simple one-dimensional random walk setup, a path is described as follows. Toss a coin. If the result is head, score +1 and move one step forward; otherwise score -1 and move one step backward. One is interested to know the position after a given number of steps. In this paper, once again a coin-tossing experiment is carried out. But this…

  13. Clinical and radiographic comparison of primary molars after formocresol and electrosurgical pulpotomy: a randomized clinical trial.

    Science.gov (United States)

    Bahrololoomi, Zahra; Moeintaghavi, Amir; Emtiazi, Maryam; Hosseini, Ghofran

    2008-01-01

    Vital pulpotomy is a single-stage procedure defined as the surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. The aim of this study was to compare the clinical and radiographic success rates for electrosurgical vs formocresol pulpotomy in human primary molar teeth. This was a prospective, randomized clinical trial. In this randomized clinical trial, pulpotomies were performed on 70 primary molars in children aged 5-10 years. The teeth were treated using either a conventional formocresol (35 teeth) or electrosurgical technique (35 teeth). Following the pulpotomy procedure, the teeth were evaluated for clinical and radiographic success for three, six and nine months. The teeth were evaluated for the presence of pain, abscess, fistula, mobility, internal and external resorption, and radiolucency. The data were assessed with Fishers' Exact test. After nine months of follow-up, the clinical and radiographic success rates were 96 and 84% respectively in the electrosurgical group and 100 and 96.8% respectively in the formocresol group. There was no statistically significant difference between the success rates in the two groups ( P > 0.05). Our results showed the failure rates for electrosurgical pulpotomy to be equal to those for formocresol pulpotomy. Although electrosurgical pulpotomy is a nonpharmacological technique giving favorable results, it is still a preservative technique. Further studies using larger samples and longer evaluation periods are recommended.

  14. Identifying randomized clinical trials in Spanish-language dermatology journals.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  15. Acupuncture for chronic nonpulsatile tinnitus: A randomized clinical trial.

    Science.gov (United States)

    Naderinabi, Bahram; Soltanipour, Soheil; Nemati, Shadman; Saberi, Alia; Parastesh, Sepideh

    2018-01-01

    There is challenge to find an effective treatment for tinnitus. Few studies were done on the effects of acupuncture on tinnitus. This study evaluated the effect of acupuncture on chronic non-pulsatile tinnitus. This randomized double-blind clinical trial was conducted from December 2014 to September 2015 . Patients suffering from chronic non-pulsatile tinnitus were randomly allocated into two groups: acupuncture vs. placebo. They were treated in 15 sessions and at the end of the fifteenth sessions and 3 weeks after completion of the treatment, visual analog scale (VAS) for tinnitus loudness and tinnitus severity index (TSI) questionnaires were completed. The case group included 26 males and 18 females, and in the control group there were 27 males and 17 females: with mean age of 49.11±1.07 and 55.20±8.33 years, respectively (p=0.005). TSI and VAS before treatment were 43.84±2.81 and 9.56±0.43 in cases and 43.52±2.94 and 9.54±0.45 in controls, respectively. Both measures improved after 15 sessions in cases to 24.82±1.04 and 2.88±0.33, and to 33.16±1.24 and 7.86±0.23 in controls. The changes of TSI and VAS were significant in all groups (pTSI and VAS in acupuncture group were lower than placebo group in each session (pTSI in the tenth session (p=0.392). Acupuncture is effective in reducing the loudness and severity of tinnitus and can be a useful treatment for nonpulsatile chronic tinnitus.

  16. A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

    Science.gov (United States)

    Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

    2011-01-01

    A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

  17. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  18. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  19. Smooth conditional distribution function and quantiles under random censorship.

    Science.gov (United States)

    Leconte, Eve; Poiraud-Casanova, Sandrine; Thomas-Agnan, Christine

    2002-09-01

    We consider a nonparametric random design regression model in which the response variable is possibly right censored. The aim of this paper is to estimate the conditional distribution function and the conditional alpha-quantile of the response variable. We restrict attention to the case where the response variable as well as the explanatory variable are unidimensional and continuous. We propose and discuss two classes of estimators which are smooth with respect to the response variable as well as to the covariate. Some simulations demonstrate that the new methods have better mean square error performances than the generalized Kaplan-Meier estimator introduced by Beran (1981) and considered in the literature by Dabrowska (1989, 1992) and Gonzalez-Manteiga and Cadarso-Suarez (1994).

  20. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial.

    Science.gov (United States)

    Edinger, Jack D; Wohlgemuth, William K; Krystal, Andrew D; Rice, John R

    2005-11-28

    Insomnia is common and debilitating to fibromyalgia (FM) patients. Cognitive-behavioral therapy (CBT) is effective for many types of patients with insomnia, but has yet to be tested with FM patients. This study compared CBT with an alternate behavioral therapy and usual care for improving sleep and other FM symptoms. This randomized clinical trial enrolled 47 FM patients with chronic insomnia complaints. The study compared CBT, sleep hygiene (SH) instructions, and usual FM care alone. Outcome measures were subjective (sleep logs) and objective (actigraphy) total sleep time, sleep efficiency, total wake time, sleep latency, wake time after sleep onset, and questionnaire measures of global insomnia symptoms, pain, mood, and quality of life. Forty-two patients completed baseline and continued into treatment. Sleep logs showed CBT-treated patients achieved nearly a 50% reduction in their nocturnal wake time by study completion, whereas SH therapy- and usual care-treated patients achieved only 20% and 3.5% reductions on this measure, respectively. In addition, 8 (57%) of 14 CBT recipients met strict subjective sleep improvement criteria by the end of treatment compared with 2 (17%) of 12 SH therapy recipients and 0% of the usual care group. Comparable findings were noted for similar actigraphic improvement criteria. The SH therapy patients showed favorable outcomes on measures of pain and mental well-being. This finding was most notable in an SH therapy subgroup that self-elected to implement selected CBT strategies. Cognitive-behavioral therapy represents a promising intervention for sleep disturbance in FM patients. Larger clinical trials of this intervention with FM patients seem warranted.

  1. Moving a randomized clinical trial into an observational cohort.

    Science.gov (United States)

    Goodman, Phyllis J; Hartline, Jo Ann; Tangen, Catherine M; Crowley, John J; Minasian, Lori M; Klein, Eric A; Cook, Elise D; Darke, Amy K; Arnold, Kathryn B; Anderson, Karen; Yee, Monica; Meyskens, Frank L; Baker, Laurence H

    2013-02-01

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute (NCI) and conducted by the Southwest Oncology Group (SWOG). A total of 35,533 men were assigned randomly to one of the four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, and placebo + placebo). The independent Data and Safety Monitoring Committee (DSMC) recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-Up (CFU) study. The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada, and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures

  2. Randomization for clinical research: an easy-to-use spreadsheet method.

    Science.gov (United States)

    Padhye, Nikhil S; Cron, Stanley G; Gusick, Gary M; Hamlin, Shannan K; Hanneman, Sandra K

    2009-10-01

    In this article, we illustrate a new method for random selection and random assignment that we developed in a pilot study for a randomized clinical trial. The randomization database is supported by a commonly available spreadsheet. Formulas were written for randomizing participants and for creating a "shadow" system to verify integrity of the randomization. Advantages of this method are that it is easy to use, effective, and portable, allowing it to be shared among multiple investigators at multiple study sites. Clinical researchers may find the method useful for research projects that are pilot studies or conducted with limited funding.

  3. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial.

    Science.gov (United States)

    Thelen, Mark D; Dauber, James A; Stoneman, Paul D

    2008-07-01

    Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. Therapy, level 1b-.

  4. Clinical and radiographic comparison of primary molars after formocresol and electrosurgical pulpotomy: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Bahrololoomi Zahra

    2008-01-01

    Full Text Available Background: Vital pulpotomy is a single-stage procedure defined as the surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. Objectives : The aim of this study was to compare the clinical and radiographic success rates for electrosurgical vs formocresol pulpotomy in human primary molar teeth. Settings and Design: This was a prospective, randomized clinical trial. Materials and Methods: In this randomized clinical trial, pulpotomies were performed on 70 primary molars in children aged 5-10 years. The teeth were treated using either a conventional formocresol (35 teeth or electrosurgical technique (35 teeth. Following the pulpotomy procedure, the teeth were evaluated for clinical and radiographic success for three, six and nine months. The teeth were evaluated for the presence of pain, abscess, fistula, mobility, internal and external resorption, and radiolucency. Statistical Analysis : The data were assessed with Fishers′ Exact test. Results: After nine months of follow-up, the clinical and radiographic success rates were 96 and 84% respectively in the electrosurgical group and 100 and 96.8% respectively in the formocresol group. There was no statistically significant difference between the success rates in the two groups ( P > 0.05. Conclusions: Our results showed the failure rates for electrosurgical pulpotomy to be equal to those for formocresol pulpotomy. Although electrosurgical pulpotomy is a nonpharmacological technique giving favorable results, it is still a preservative technique. Further studies using larger samples and longer evaluation periods are recommended.

  5. Effects of auriculotherapy on labour pain: a randomized clinical trial.

    Science.gov (United States)

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

  6. Acupuncture for Vascular Dementia: A Pragmatic Randomized Clinical Trial

    OpenAIRE

    Shi, Guang-Xia; Li, Qian-Qian; Yang, Bo-Feng; Liu, Yan; Guan, Li-Ping; Wu, Meng-Meng; Wang, Lin-Peng; Liu, Cun-Zhi

    2015-01-01

    In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily livin...

  7. Synthesis for robust synchronization of chaotic systems under output feedback control with multiple random delays

    International Nuclear Information System (INIS)

    Wen Guilin; Wang Qingguo; Lin Chong; Han Xu; Li Guangyao

    2006-01-01

    Synchronization under output feedback control with multiple random time delays is studied, using the paradigm in nonlinear physics-Chua's circuit. Compared with other synchronization control methods, output feedback control with multiple random delay is superior for a realistic synchronization application to secure communications. Sufficient condition for global stability of delay-dependent synchronization is established based on the LMI technique. Numerical simulations fully support the analytical approach, in spite of the random delays

  8. Chronological bias in randomized clinical trials arising from different types of unobserved time trends.

    Science.gov (United States)

    Tamm, M; Hilgers, R-D

    2014-01-01

    In clinical trials patients are commonly recruited sequentially over time incurring the risk of chronological bias due to (unobserved) time trends. To minimize the risk of chronological bias, a suitable randomization procedure should be chosen. Considering different time trend scenarios, we aim at a detailed evaluation of the extent of chronological bias under permuted block randomization in order to provide recommendations regarding the choice of randomization at the design stage of a clinical trial and to assess the maximum extent of bias for a realized sequence in the analysis stage. For the assessment of chronological bias we consider linear, logarithmic and stepwise trends illustrating typical changes during recruitment in clinical practice. Bias and variance of the treatment effect estimator as well as the empirical type I error rate when applying the t-test are investigated. Different sample sizes, block sizes and strengths of time trends are considered. Using large block sizes, a notable bias exists in the estimate of the treatment effect for specific sequences. This results in a heavily inflated type I error for realized worst-case sequences and an enlarged mean squared error of the treatment effect estimator. Decreasing the block size restricts these effects of time trends. Already applying permuted block randomization with two blocks instead of the random allocation rule achieves a good reduction of the mean squared error and of the inflated type I error. Averaged over all sequences, the type I error of the t-test is far below the nominal significance level due to an overestimated variance. Unobserved time trends can induce a strong bias in the treatment effect estimate and in the test decision. Therefore, already in the design stage of a clinical trial a suitable randomization procedure should be chosen. According to our results, small block sizes should be preferred, but also medium block sizes are sufficient to restrict chronological bias to an

  9. Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial

    NARCIS (Netherlands)

    Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.

    2009-01-01

    OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10

  10. DYNAMIC STRAIN MAPPING AND REAL-TIME DAMAGE STATE ESTIMATION UNDER BIAXIAL RANDOM FATIGUE LOADING

    Data.gov (United States)

    National Aeronautics and Space Administration — DYNAMIC STRAIN MAPPING AND REAL-TIME DAMAGE STATE ESTIMATION UNDER BIAXIAL RANDOM FATIGUE LOADING SUBHASISH MOHANTY*, ADITI CHATTOPADHYAY, JOHN N. RAJADAS, AND CLYDE...

  11. Mitigating randomness of consumer preferences under certain conditional choices

    Science.gov (United States)

    Bothos, John M. A.; Thanos, Konstantinos-Georgios; Papadopoulou, Eirini; Daveas, Stelios; Thomopoulos, Stelios C. A.

    2017-05-01

    Agent-based crowd behaviour consists a significant field of research that has drawn a lot of attention in recent years. Agent-based crowd simulation techniques have been used excessively to forecast the behaviour of larger or smaller crowds in terms of certain given conditions influenced by specific cognition models and behavioural rules and norms, imposed from the beginning. Our research employs conditional event algebra, statistical methodology and agent-based crowd simulation techniques in developing a behavioural econometric model about the selection of certain economic behaviour by a consumer that faces a spectre of potential choices when moving and acting in a multiplex mall. More specifically we try to analyse the influence of demographic, economic, social and cultural factors on the economic behaviour of a certain individual and then we try to link its behaviour with the general behaviour of the crowds of consumers in multiplex malls using agent-based crowd simulation techniques. We then run our model using Generalized Least Squares and Maximum Likelihood methods to come up with the most probable forecast estimations, regarding the agent's behaviour. Our model is indicative about the formation of consumers' spectre of choices in multiplex malls under the condition of predefined preferences and can be used as a guide for further research in this area.

  12. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  13. Dietary fiber supplementation for fecal incontinence: a randomized clinical trial.

    Science.gov (United States)

    Bliss, Donna Z; Savik, Kay; Jung, Hans-Joachim G; Whitebird, Robin; Lowry, Ann; Sheng, Xiaoyan

    2014-10-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appears related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16 g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. © 2014 Wiley Periodicals, Inc.

  14. Control of anxiety through music in a head and neckoutpatient clinic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mariana Alves Firmeza

    Full Text Available Abstract OBJECTIVE Evaluating the effectiveness of a musical intervention in reducing anxiety and vital parameters in people suffering from head and neck cancer. METHOD A randomized controlled clinical trial, performed in a head and neck outpatient clinic with 40 participants, subdivided into two groups (intervention and control.The classicalmusic“Spring” from The Four Seasons by Vivaldi was used as an intervention.The State-Trait Anxiety Inventory (STAI was used as the data collectioninstrument,along with an inventory of socio-demographic and clinical data. Student'st-test was used to verify intragroup and intergroup statistical significance. RESULTS Participants presented a statistically significant reduction in levels of perceived anxiety (t= 12.68; p<0.001,as well as blood pressure levels (t = 4.56; p<0.001; pulse (t = 6.15; p<0.001 and respiratory rate (t = 5.10; p<0.001. CONCLUSION Music has proven to be an effective non-pharmacological therapeutic resource in managinganxiety in an outpatient setting for people with cancer, as well as in reducing blood pressure, pulse and respiratory rate. Brazilian Registry of Clinical Trials: RBR-7W4YJJ

  15. Time-varying output performances of piezoelectric vibration energy harvesting under nonstationary random vibrations

    Science.gov (United States)

    Yoon, Heonjun; Kim, Miso; Park, Choon-Su; Youn, Byeng D.

    2018-01-01

    Piezoelectric vibration energy harvesting (PVEH) has received much attention as a potential solution that could ultimately realize self-powered wireless sensor networks. Since most ambient vibrations in nature are inherently random and nonstationary, the output performances of PVEH devices also randomly change with time. However, little attention has been paid to investigating the randomly time-varying electroelastic behaviors of PVEH systems both analytically and experimentally. The objective of this study is thus to make a step forward towards a deep understanding of the time-varying performances of PVEH devices under nonstationary random vibrations. Two typical cases of nonstationary random vibration signals are considered: (1) randomly-varying amplitude (amplitude modulation; AM) and (2) randomly-varying amplitude with randomly-varying instantaneous frequency (amplitude and frequency modulation; AM-FM). In both cases, this study pursues well-balanced correlations of analytical predictions and experimental observations to deduce the relationships between the time-varying output performances of the PVEH device and two primary input parameters, such as a central frequency and an external electrical resistance. We introduce three correlation metrics to quantitatively compare analytical prediction and experimental observation, including the normalized root mean square error, the correlation coefficient, and the weighted integrated factor. Analytical predictions are in an excellent agreement with experimental observations both mechanically and electrically. This study provides insightful guidelines for designing PVEH devices to reliably generate electric power under nonstationary random vibrations.

  16. Green banana reduces clinical severity of childhood shigellosis: a double-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Rabbani, Golam H; Ahmed, Shamsir; Hossain, Iqbal; Islam, Rafiqul; Marni, Farzana; Akhtar, Mastura; Majid, Nashiha

    2009-05-01

    Mature green banana (GB) fruit is rich in amylase-resistant starch that stimulates colonic production of short-chain fatty acids (referred to as fatty acid) and is useful in treating diarrheal diseases. We studied therapeutic effects of GB in childhood shigellosis by determining colonic fatty acid production in a double-blind, randomized, controlled, clinical trial. Seventy-three children aged 6 to 60 months with severe bloody dysentery caused by Shigella infection were either given a rice-based diet (54 kcal/dL), with cooked GB (250 g/L) (n = 34) or without GB (n = 39) for 5 days; all given ciprofloxacin (15 mg/kg, q12 hours). Stool volume, frequency, excretion of blood/mucus, and relevant clinical and laboratory indices were determined. On day 5 (post-treatment), 59% children in GB group had no mucus compared with 36% in controls, fecal blood was completely cleared from 96% in GB group compared with 60% without GB (P < 0.05). GB treatment significantly reduced (P < 0.01) numbers of stools/day compared with controls (70% vs. 50%, P < 0.05). GB-specific reductions of mean fecal volumes (mL/kg) ranged from 25% to 40%; (P < 0.05) during the 5-day observations. Clinical success rates were 85% in GB group compared with 67% in controls (P < 0.05). GB significantly (P < 0.01) reduced fecal myeloperoxidase activity and increased fecal fatty acid concentrations (P < 0.01). GB diet improves clinical severity in childhood shigellosis and could be a simple and useful adjunct for dietary management of this illness.

  17. Research on the reliability of friction system under combined additive and multiplicative random excitations

    Science.gov (United States)

    Sun, Jiaojiao; Xu, Wei; Lin, Zifei

    2018-01-01

    In this paper, the reliability of a non-linearly damped friction oscillator under combined additive and multiplicative Gaussian white noise excitations is investigated. The stochastic averaging method, which is usually applied to the research of smooth system, has been extended to the study of the reliability of non-smooth friction system. The results indicate that the reliability of friction system can be improved by Coulomb friction and reduced by random excitations. In particular, the effect of the external random excitation on the reliability is larger than the effect of the parametric random excitation. The validity of the analytical results is verified by the numerical results.

  18. Clinical and radiographic characteristics of single-tooth replacements preceded by local ridge augmentation : a prospective randomized clinical trial

    NARCIS (Netherlands)

    Meijndert, L.; Raghoebar, G. M.; Meijer, H. J. A.; Vissink, A.

    2008-01-01

    To assess in a randomized-clinical trial the influence of three augmentation techniques (chinbone with or without a Bio-Gide((R)) membrane and Bio-Oss((R)) with a Bio-Gide((R)) membrane) on the clinical and radiographic characteristics of hard and soft tissues around implants and adjacent teeth in

  19. Acupuncture for Vascular Dementia: A Pragmatic Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Guang-Xia Shi

    2015-01-01

    Full Text Available In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group. Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE, Activities of Daily Living Scale (ADL, and dementia quality of life questionnaire (DEMQOL, respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.

  20. Acupuncture for Vascular Dementia: A Pragmatic Randomized Clinical Trial.

    Science.gov (United States)

    Shi, Guang-Xia; Li, Qian-Qian; Yang, Bo-Feng; Liu, Yan; Guan, Li-Ping; Wu, Meng-Meng; Wang, Lin-Peng; Liu, Cun-Zhi

    2015-01-01

    In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE), Activities of Daily Living Scale (ADL), and dementia quality of life questionnaire (DEMQOL), respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.

  1. Erythromycin for Gastric Emptying in Patients Undergoing General Anesthesia for Emergency Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Czarnetzki, Christoph; Elia, Nadia; Frossard, Jean-Louis; Giostra, Emiliano; Spahr, Laurent; Waeber, Jean-Luc; Pavlovic, Gordana; Lysakowski, Christopher; Tramèr, Martin R

    2015-08-01

    Patients undergoing emergency procedures under general anesthesia have impaired gastric emptying and are at high risk for aspiration of gastric contents. Erythromycin has strong gastric prokinetic properties. To evaluate the efficacy of erythromycin lactobionate in gastric emptying in patients undergoing emergency surgery. The Erythro-Emerge trial was a single-center, randomized, double-blinded, placebo-controlled clinical trial in patients undergoing emergency surgery under general anesthesia at Geneva University Hospitals. We included 132 patients from March 25, 2009, through April 10, 2013, and all patients completed the study. Randomization was stratified for trauma and nontrauma procedures. The randomization code was opened on April 23, 2013, and analyses were performed through July 26, 2013. We performed an intention-to-treat analysis. Patients were randomized to intravenous erythromycin lactobionate, 3 mg/kg, or placebo 15 minutes before tracheal intubation. Patients were followed up for 24 hours. The primary outcome was a clear stomach, defined as less than 40 mL of liquids and no solids and identified through endoscopy immediately after intubation. The secondary outcome was the pH level of residual gastric content. A clear stomach was diagnosed in 42 of 66 patients (64%) receiving placebo compared with 53 of 66 patients (80%) receiving erythromycin (risk ratio, 1.26 [95% CI, 1.01-1.57]). In the population undergoing surgery for nontrauma, the association between receipt of erythromycin and having a clear stomach (adjusted odds ratio [95% CI]) was statistically significant (13.4 [1.49-120]; P = .02); in the population undergoing surgery for trauma, it was not (1.81 [0.64-5.16]; P = .26). Median (interquartile range) pH of the residual gastric liquid was 2 (1-4) in 36 patients receiving placebo and 6 (3-7) in 16 receiving erythromycin (P = .002). Patients receiving erythromycin had nausea (20 [30%] vs 4 [6%]) and stomach cramps (15 [23%] vs 2 [3

  2. Ebola Virus Disease Candidate Vaccines Under Evaluation in Clinical Trials

    Science.gov (United States)

    Martins, Karen A.; Jahrling, Peter B.; Bavari, Sina; Kuhn, Jens H.

    2016-01-01

    Summary Filoviruses are the etiological agents of two human illnesses: Ebola virus disease and Marburg virus disease. Until 2013, medical countermeasure development against these afflictions was limited to only a few research institutes worldwide as both infections were considered exotic due to very low case numbers. Together with the high case-fatality rate of both diseases, evaluation of any candidate countermeasure in properly controlled clinical trials seemed impossible. However, in 2013, Ebola virus was identified as the etiological agent of a large disease outbreak in Western Africa including almost 30,000 infections and more than 11,000 deaths, including case exportations to Europe and North America. These large case numbers resulted in medical countermeasure development against Ebola virus disease becoming a global public-health priority. This review summarizes the status quo of candidate vaccines against Ebola virus disease, with a focus on those that are currently under evaluation in clinical trials. PMID:27160784

  3. ERDO - a framework to select an appropriate randomization procedure for clinical trials

    Directory of Open Access Journals (Sweden)

    Ralf-Dieter Hilgers

    2017-12-01

    Full Text Available Abstract Background Randomization is considered to be a key feature to protect against bias in randomized clinical trials. Randomization induces comparability with respect to known and unknown covariates, mitigates selection bias, and provides a basis for inference. Although various randomization procedures have been proposed, no single procedure performs uniformly best. In the design phase of a clinical trial, the scientist has to decide which randomization procedure to use, taking into account the practical setting of the trial with respect to the potential of bias. Less emphasis has been placed on this important design decision than on analysis, and less support has been available to guide the scientist in making this decision. Methods We propose a framework that weights the properties of the randomization procedure with respect to practical needs of the research question to be answered by the clinical trial. In particular, the framework assesses the impact of chronological and selection bias on the probability of a type I error. The framework is applied to a case study with a 2-arm parallel group, single center randomized clinical trial with continuous endpoint, with no-interim analysis, 1:1 allocation and no adaptation in the randomization process. Results In so doing, we derive scientific arguments for the selection of an appropriate randomization procedure and develop a template which is illustrated in parallel by a case study. Possible extensions are discussed. Conclusion The proposed ERDO framework guides the investigator through a template for the choice of a randomization procedure, and provides easy to use tools for the assessment. The barriers for the thorough reporting and assessment of randomization procedures could be further reduced in the future when regulators and pharmaceutical companies employ similar, standardized frameworks for the choice of a randomization procedure.

  4. Noninvasive mechanical ventilation may be useful in treating patients who fail weaning from invasive mechanical ventilation: a randomized clinical trial

    OpenAIRE

    Trevisan, Cristiane E; Vieira, Silvia R

    2008-01-01

    Introduction The use of noninvasive positive-pressure mechanical ventilation (NPPV) has been investigated in several acute respiratory failure situations. Questions remain about its benefits when used in weaning patients from invasive mechanical ventilation (IMV). The objective of this study was to evaluate the use of bi-level NPPV for patients who fail weaning from IMV. Methods This experimental randomized clinical trial followed up patients undergoing IMV weaning, under ventilation for more...

  5. Randomized clinical trial of antibiotic therapy for uncomplicated appendicitis.

    Science.gov (United States)

    Park, H C; Kim, M J; Lee, B H

    2017-12-01

    Uncomplicated appendicitis may resolve spontaneously or require treatment with antibiotics or appendicectomy. The aim of this randomized trial was to compare the outcome of a non-antibiotic management strategy with that of antibiotic therapy in uncomplicated appendicitis. Patients presenting to a university teaching hospital with CT-verified uncomplicated simple appendicitis (appendiceal diameter no larger than 11 mm and without any signs of perforation) were randomized to management with a no-antibiotic regimen with supportive care (intravenous fluids, analgesia and antipyretics as necessary) or a 4-day course of antibiotics with supportive care. The primary endpoint was rate of total treatment failure, defined as initial treatment failure within 1 month and recurrence of appendicitis during the follow-up period. Some 245 patients were randomized within the trial, and followed up for a median of 19 months. The duration of hospital stay was shorter (mean 3·1 versus 3·7 days; P therapy without antibiotics. There was no difference in total treatment failure rate between the groups: 29 of 124 (23·4 per cent) in the no-antibiotic group and 25 of 121 (20·7 per cent) in the antibiotic group (P = 0·609). Eighteen patients (9 in each group) had initial treatment failure, 15 of whom underwent appendicectomy and three received additional antibiotics. Thirty-six patients (20 in the no-antibiotic group, 16 in the antibiotic group) experienced recurrence, of whom 30 underwent appendicectomy and six received further antibiotics. Treatment failure rates in patients presenting with CT-confirmed uncomplicated appendicitis appeared similar among those receiving supportive care with either a no-antibiotic regimen or a 4-day course of antibiotics. Registration number: KCT0000124 ( http://cris.nih.go.kr). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  6. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    -1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index....... There was a significant positive association between a statistically significant study outcome and the citation frequency (beta, 0.55, 95% confidence interval, 0.39-0.72). The disease area and adequate generation of the allocation sequence were also significant predictors of the citation frequency. We concluded...

  7. Cardioprotective effects of cocoa: clinical evidence from randomized clinical intervention trials in humans.

    Science.gov (United States)

    Arranz, Sara; Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Urpi-Sarda, Mireia; Lamuela-Raventos, Rosa M; Estruch, Ramon

    2013-06-01

    Cocoa is an important source of polyphenols, which comprise 12-18% of its total dry weight. The major phenolic compounds in cocoa and cocoa products are mainly flavonoids such as epicatechin, catechin, and proanthocyanidins. These products contain higher amounts of flavonoids than other polyphenol-rich foods. However, the bioavailability of these compounds depends on other food constituents and their interactions with the food matrix. Many epidemiological and clinical intervention trials have concluded that the ingestion of flavonoids reduces the risk factors of developing cardiovascular disease. This review summarizes the new findings regarding the effects of cocoa and chocolate consumption on cardiovascular risk factors. The mechanisms involved in the cardioprotective effects of cocoa flavonoids include reduction of oxidative stress, inhibition of low-density lipoproteins oxidation and platelet aggregation, vasodilatation of blood vessels, inhibition of the adherence of monocytes to vascular endothelium, promotion of fibrinolysis, and immunomodulatory and anti-inflammatory activity. Scientific evidence supports a cause and effect relationship between consumption of cocoa flavonoids and the maintenance of normal endothelium-dependent vasodilation, which contributes to normal blood flow. However, larger randomized trials are required to definitively establish the impact of cocoa and cocoa products consumption on hard cardiovascular outcomes. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  8. A commentary on randomized clinical trials: How to produce them with a good level of evidence

    OpenAIRE

    Flecha, Olga Dumont; Douglas de Oliveira, Dhelfeson Willya; Marques, Leandro Silva; Gon?alves, Patricia Furtado

    2016-01-01

    Randomized clinical trial (RCT) is the gold standard study for the evaluation of health interventions and is considered the second level of evidence for clinical decision making. However, the quality of the evidence produced by these studies is dependent on the methodological rigor employed at every stage of their execution. The purpose of randomization is to create groups that are comparable independent of any known or unknown potential confounding factor. A critical evaluation of the litera...

  9. Exogenous melatonin for sleep disorders in neurodegenerative diseases: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Zhang, Wei; Chen, Xue-yan; Su, Su-wen; Jia, Qing-zhong; Ding, Tao; Zhu, Zhong-ning; Zhang, Tong

    2016-01-01

    The purpose of this work is to investigate the efficacy of exogenous melatonin in the treatment of sleep disorders in patients with neurodegenerative disease. We searched Pubmed, the Cochrane Library, and ClinicalTrials.gov, from inception to July 2015. We included randomized clinical trials (RCTs) that compared melatonin with placebo and that had the primary aim of improving sleep in people with neurodegenerative diseases, particularly Alzheimer's disease (AD) and Parkinson's disease (PD). We pooled data with the weighted mean difference in sleep outcomes. To assess heterogeneity in results of individual studies, we used Cochran's Q statistic and the I (2) statistic. 9 RCTs were included in this research. We found that the treatment with exogenous melatonin has positive effects on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in PD patients (MD: 4.20, 95 % CI: 0.92-7.48; P = 0.01), and by changes in PSQI component 4 in AD patients (MD: 0.67, 95 % CI: 0.04-1.30; P = 0.04), but not on objective sleep outcomes in both AD and PD patients. Treatment with melatonin effectively improved the clinical and neurophysiological aspects of rapid eye movement (REM) sleep behavior disorder (RBD), especially elderly individuals with underlying neurodegenerative disorders. This meta-analysis provided some evidence that melatonin improves sleep quality in patients with AD and PD, and melatonin can be considered as a possible sole or add-on therapy in neurodegenerative disorders patients with RBD.

  10. Temporomandibular disorders and painful comorbidities: clinical association and underlying mechanisms.

    Science.gov (United States)

    Costa, Yuri Martins; Conti, Paulo César Rodrigues; de Faria, Flavio Augusto Cardoso; Bonjardim, Leonardo Rigoldi

    2017-03-01

    The association between temporomandibular disorders (TMDs) and headaches, cervical spine dysfunction, and fibromyalgia is not artefactual. The aim of this review is to describe the comorbid relationship between TMD and these three major painful conditions and to discuss the clinical implications and the underlying pain mechanisms involved in these relationships. Common neuronal pathways and central sensitization processes are acknowledged as the main factors for the association between TMD and primary headaches, although the establishment of cause-effect mechanisms requires further clarification and characterization. The biomechanical aspects are not the main factors involved in the comorbid relationship between TMD and cervical spine dysfunction, which can be better explained by the neuronal convergence of the trigeminal and cervical spine sensory pathways as well as by central sensitization processes. The association between TMD and fibromyalgia also has supporting evidence in the literature, and the proposed main mechanism underlying this relationship is the impairment of the descending pain inhibitory system. In this particular scenario, a cause-effect relationship is more likely to occur in one direction, that is, fibromyalgia as a risk factor for TMD. Therefore, clinical awareness of the association between TMD and painful comorbidities and the support of multidisciplinary approaches are required to recognize these related conditions. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Modeling Random Telegraph Noise Under Switched Bias Conditions Using Cyclostationary RTS Noise

    NARCIS (Netherlands)

    van der Wel, A.P.; Klumperink, Eric A.M.; Vandamme, L.K.J.; Nauta, Bram

    In this paper, we present measurements and simulation of random telegraph signal (RTS) noise in n-channel MOSFETs under periodic large signal gate-source excitation (switched bias conditions). This is particularly relevant to analog CMOS circuit design where large signal swings occur and where LF

  12. Therapeutic alliance in a randomized clinical trial for bulimia nervosa.

    Science.gov (United States)

    Accurso, Erin C; Fitzsimmons-Craft, Ellen E; Ciao, Anna; Cao, Li; Crosby, Ross D; Smith, Tracey L; Klein, Marjorie H; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

    2015-06-01

    This study examined the temporal relation between therapeutic alliance and outcome in two treatments for bulimia nervosa (BN). Eighty adults with BN symptoms were randomized to 21 sessions of integrative cognitive-affective therapy (ICAT) or enhanced cognitive-behavioral therapy (CBT-E). Bulimic symptoms (i.e., frequency of binge eating and purging) were assessed at each session and posttreatment. Therapeutic alliance (Working Alliance Inventory) was assessed at Sessions 2, 8, 14, and posttreatment. Repeated-measures analyses using linear mixed models with random intercepts were conducted to determine differences in alliance growth by treatment and patient characteristics. Mixed-effects models examined the relation between alliance and symptom improvement. Overall, patients in both treatments reported strong therapeutic alliances. Regardless of treatment, greater therapeutic alliance between (but not within) subjects predicted greater reductions in bulimic behavior; reductions in bulimic behavior also predicted improved alliance. Patients with higher depression, anxiety, or emotion dysregulation had a stronger therapeutic alliance in CBT-E than ICAT, while those with more intimacy problems had greater improvement in therapeutic alliance in ICAT compared to CBT-E. Therapeutic alliance has a unique impact on outcome, independent of the impact of symptom improvement on alliance. Within- and between-subjects effects revealed that changes in alliance over time did not predict symptom improvement, but rather that individuals who had a stronger alliance overall had better bulimic symptom outcomes. These findings indicate that therapeutic alliance is an important predictor of outcome in the treatment of BN. (c) 2015 APA, all rights reserved).

  13. Factors Contributing to De Qi in Acupuncture Randomized Clinical Trials

    Directory of Open Access Journals (Sweden)

    Yi Yang

    2013-01-01

    Full Text Available De qi is a core concept of acupuncture and is necessary to produce therapeutic effect. In 2010, de qi has been received as a term in the official extension of the CONSORT Statement. However, there are few articles that discuss which factors have influences on obtaining de qi in clinical trials. This paper aims to explore these factors and give advice on trial design in order to optimize de qi in acupuncture RCTs.

  14. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

    Directory of Open Access Journals (Sweden)

    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  15. Morphine, Pethidine and Fentanyl in post-operative shivering control: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hoseinkhan Z

    2007-05-01

    Full Text Available Background: Postoperative shivering is a common postoperative complication. The aim of this study was to compare the effects of morphine, pethidine and fentanyl in postoperative shivering control. Methods: In this prospective, randomized, placebo-controlled, double-blinded, clinical trial, we enrolled 72 adults scheduled for elective surgery under general anesthesia at Imam Khomeini Hospital in 2003. All the patients were anesthetized in the same manner. After transferring the patients to the post-anesthesia care unit, shivering was noted and, in patients with a shivering score of one or more, morphine (2.5 mg, pethidine (25 mg, fentanyl (25 µg or normal saline (all with a volume of 10 ml was randomly administered intravenously by a two-minute injection. A second shivering score was recorded 10 minutes later. Results: Pethidine and fentanyl were significantly more effective than normal saline, but there was no significant difference between normal saline and morphine groups. Pethidine was more effective than two other drugs in shivering control. Conclusions: Pethidine was significantly more effective than two other drugs. Fentanyl decreases postoperative shivering less effectively than pethidine, but morphine had no effect on postoperative shivering with an effect comparable to normal saline.

  16. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Allegretti, Carlos E; Sampaio, Roberta M; Horliana, Anna C R T; Armonia, Paschoal L; Rocha, Rodney G; Tortamano, Isabel Peixoto

    2016-01-01

    Inferior alveolar nerve block has a high failure rate in the treatment of mandibular posterior teeth with irreversible pulpitis. The aim of this study was to compare the anesthetic efficacy of 4% articaine, 2% lidocaine and 2% mepivacaine, all in combination with 1:100,000 epinephrine, in patients with irreversible pulpitis of permanent mandibular molars during a pulpectomy procedure. Sixty-six volunteers from the Emergency Center of the School of Dentistry, University of São Paulo, randomly received 3.6 mL of local anesthetic as a conventional inferior alveolar nerve block (IANB). The subjective signal of lip numbness, pulpal anesthesia and absence of pain during the pulpectomy procedure were evaluated respectively, by questioning the patient, stimulation using an electric pulp tester and a verbal analogue scale. All patients reported the subjective signal of lip numbness. Regarding pulpal anesthesia success as measured with the pulp tester, the success rate was respectively 68.2% for mepivacaine, 63.6% for articaine and 63.6% for lidocaine. Regarding patients who reported no pain or mild pain during the pulpectomy, the success rate was, respectively 72.7% for mepivacaine, 63.6% for articaine and 54.5% for lidocaine. These differences were not statistically significant. Neither of the solutions resulted in 100% anesthetic success in patients with irreversible pulpitis of mandibular molars.

  17. Injection frequency of botulinum toxin A for spastic equinus: a randomized clinical trial.

    Science.gov (United States)

    Hastings-Ison, Tandy; Blackburn, Christine; Rawicki, Barry; Fahey, Michael; Simpson, Pam; Baker, Richard; Graham, Kerr

    2016-07-01

    We compared two botulinum toxin A (BoNT-A) injection frequency regimens, 12-monthly versus 4-monthly, for spastic equinus in a randomized clinical trial. The primary outcome measure was passive ankle dorsiflexion. Forty-two ambulant children with spastic equinus, secondary to cerebral palsy (23 males and 19 females; mean age 3y 6mo, SD 13mo; GMFCS levels I [n=20], II [n=19], III [n=3]) were randomized to receive either 12-monthly or 4-monthly BoNT-A injections to the calf, over a 26-month period. Twenty-one children had spastic hemiplegia, 21 children had spastic diplegia. A fixed 6U/kg dose of Botox was injected into the gastrocnemius muscle of both limbs in children with diplegia and the gastrocsoleus of the affected limb in children with hemiplegia, under mask anaesthesia. Forty-two children entered the trial with 21 participants randomized to each group. There were three withdrawals and two children received serial casting midway through the trial. There was no significant difference in passive dorsiflexion between 12-monthly and 4-monthly regimens (p=0.41). There were also no significant between group differences on secondary outcome measures. There were no serious adverse events - the rate was 1.2 adverse events per child per year in the 12-monthly group and 2.2 adverse events per child per year in the 4-monthly group. Subgroup analysis revealed a significant difference in passive dorsiflexion between children with hemiplegia and diplegia (p=0.01). There was no significant difference between 12-monthly and 4-monthly injection regimens on passive dorsiflexion or secondary outcome measures. BoNT-A injections for spastic equinus may be recommended on a 12-monthly basis. © 2015 Mac Keith Press.

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

    Science.gov (United States)

    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. Acupuncture for Children with Autism Spectrum Disorders: A Systematic Review of Randomized Clinical Trials

    Science.gov (United States)

    Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard

    2012-01-01

    This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…

  20. Topical corticosteroids in the treatment of acute sunburn - A randomized, double-blind clinical trial

    DEFF Research Database (Denmark)

    Faurschou, A.; Wulf, Hans Chr.

    2008-01-01

    Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... in the acute sunburn reaction when applied 6 or 23 hours after UV exposure. Clinical Trial Registry: clinicaltrials. gov Identifier: NCT00206882 Udgivelsesdato: 2008/5...

  1. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

    NARCIS (Netherlands)

    Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

    2004-01-01

    OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

  2. Experimental determination of configurational entropy in a two-dimensional liquid under random pinning

    Science.gov (United States)

    Williams, Ian; Turci, Francesco; Hallett, James E.; Crowther, Peter; Cammarota, Chiara; Biroli, Giulio; Royall, C. Patrick

    2018-03-01

    A quasi two-dimensional colloidal suspension is studied under the influence of immobilisation (pinning) of a random fraction of its particles. We introduce a novel experimental method to perform random pinning and, with the support of numerical simulation, we find that increasing the pinning concentration smoothly arrests the system, with a cross-over from a regime of high mobility and high entropy to a regime of low mobility and low entropy. At the local level, we study fluctuations in area fraction and concentration of pins and map them to entropic structural signatures and local mobility, obtaining a measure for the local entropic fluctuations of the experimental system.

  3. Integrating dynamic acquisition pricing and remanufacturing decisions under random price-sensitive returns

    DEFF Research Database (Denmark)

    Sun, X.; Li, Y.; Govindan, Kannan

    2013-01-01

    . Used products are often collected from a large number of end users, and acquisition pricing is adopted to control the return quantity of the used product. In this paper, we study a multiperiod acquisition pricing and remanufacturing decision problem under random price-sensitive returns. First...... is a basic inventory policy not influenced by random returns. Next, we analyze characteristics of the optimal acquisition price and derive a monotonic pricing policy depending on the starting level of the whole inventory in each period. Further, an algorithm is designed to calculate the optimal inventory...

  4. Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

    Science.gov (United States)

    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D

    2016-01-01

    Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    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.

  6. Experimental gingivitis, bacteremia and systemic biomarkers: a randomized clinical trial.

    Science.gov (United States)

    Kinane, D F; Zhang, P; Benakanakere, M; Singleton, J; Biesbrock, A; Nonnenmacher, C; He, T

    2015-12-01

    Bacteremia and systemic inflammatory markers are associated with periodontal and systemic diseases and may be linking mechanisms between these conditions. We hypothesized that in the development of gingival inflammation, systemic markers of inflammation and bacteremia would increase. To study the effect of bacteremia on systemic inflammatory markers, we recruited 80 subjects to participate in an experimental gingivitis study. Subjects were stratified based on gender, smoking and the number of bleeding sites and then randomized to one of two groups: control group (n = 40) or experimental gingivitis group (n = 40). Subjects in the control group conducted an oral hygiene regimen: brushing twice daily with a regular sodium fluoride cavity protection dentifrice and a standard manual toothbrush, flossing twice daily, and mouth rinsing with an anti-cavity fluoride rinse once daily. The experimental group stopped brushing and flossing, and used only the fluoride anti-cavity mouth rinse for 21 d. Seventy-nine of 80 subjects were evaluable. One subject in the control group was excluded from the results due to antibiotic use during the study. Our data showed the experimental gingivitis group exhibited a significant (p gingival inflammatory indices relative to baseline and the control group but a decrease in bacteremia and soluble intercellular adhesion molecule-1 levels vs. baseline. Bacteremia was negatively correlated with gingival inflammatory indices and soluble intercellular adhesion molecule-1 levels in the experimental gingivitis group, thus negating our hypothesis. We conclude that there are marked differences in systemic cytokine levels over the course of short-term experimentally induced gingivitis and further conclude that a long-term periodontitis study must be considered to address mechanisms whereby oral diseases may affect systemic diseases. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Preoperative Lifestyle Intervention in Bariatric Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    Kalarchian, Melissa A.; Marcus, Marsha D.; Courcoulas, Anita P.; Cheng, Yu; Levine, Michele D.

    2015-01-01

    Background Studies of the impact of pre-surgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. Objective To evaluate whether a pre-surgery behavioral lifestyle intervention improves weight loss through 24-months post-surgery. Setting Bariatric Center of Excellence at a large, urban medical center. Methods Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual pre-surgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions followed by 16 weeks of face-to-face and telephone sessions prior to surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted at 6-, 12- and 24-months post-surgery. Results Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average BMI was 47.5 kg/m2 at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12- and 24 month assessments, respectively. Percent weight loss from study enrollment to 6- and 12-months post-surgery was comparable for both groups, but at 24-months post-surgery, the lifestyle group had significantly smaller percent weight loss than the usual care group (26.5% vs. 29.5%, respectively, p = 0.02). Conclusions Pre-surgery lifestyle intervention did not improve weight loss at 24 months post-surgery. Findings raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. PMID:26410538

  8. Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome.

    Science.gov (United States)

    Trachtman, Howard; Gipson, Debbie S; Somers, Michael; Spino, Cathie; Adler, Sharon; Holzman, Lawrence; Kopp, Jeffrey B; Sedor, John; Overfield, Sandra; Elegbe, Ayanbola; Maldonado, Michael; Greka, Anna

    2018-01-01

    Treatment-resistant nephrotic syndrome is a rare form of glomerular disease that occurs in children and adults. No Food and Drug Administration-approved treatments consistently achieve remission of proteinuria and preservation of kidney function. CD80 (B7-1) can be expressed on injured podocytes, and administration of abatacept (modified CTLA4-Ig based on a natural ligand to CD80) has been associated with sustained normalization of urinary protein excretion and maintenance of glomerular filtration rate in experimental and clinical settings. In this report, we describe the rationale for and design of a randomized, placebo-controlled, clinical trial of abatacept in patients with treatment-resistant nephrotic syndrome caused by focal segmental glomerulosclerosis or minimal change disease. The design is a hybrid of a parallel-group and crossover design (switchover) with the primary objectives assessed in the first period of the study and the secondary objectives assessed using data from both periods. All participants will receive the active agent in 1 of the periods. The duration of treatment will be 4 months per period. The primary outcome will be improvement in nephrotic-range proteinuria to subnephrotic range, that is, reduction from baseline to 4 months in urine protein:creatinine ratio ≥ 50% and to a level precision medicine-based approach to this serious kidney condition in which the selection of a therapeutic agent is guided by the underlying disease mechanism operating in individual patients.

  9. Time and frequency domain models for multiaxial fatigue life estimation under random loading

    Directory of Open Access Journals (Sweden)

    Andrea Carpinteri

    2015-07-01

    Full Text Available Engineering structures and components are often subjected to random fatigue loading produced, for example, by wind turbulences, marine waves and vibrations. The methods available in the literature for fatigue assessment under random loading are formulated in time domain or, alternatively, in frequency domain. The former methods require the knowledge of the loading time history, and a large number of experimental tests/numerical simulations is needed to obtain statistically reliable results. The latter methods are generally more advantageous with respect to the time domain ones, allowing a rapid fatigue damage evaluation. In the present paper, a multiaxial criterion formulated in the frequency-domain is presented to estimate the fatigue lives of smooth metallic structures subjected to combined bending and torsion random loading. A comparison in terms of fatigue life prediction by employing a time domain methods, previously proposed by the authors, is also performed.

  10. Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

    International Nuclear Information System (INIS)

    Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

    1996-01-01

    Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

  11. Increasing Rural Health Clinic Utilization with SMS Updates: Evidence from a Randomized Evaluation in Uganda

    OpenAIRE

    Chicoine, Luke E.; Guzman, Juan Carlos

    2016-01-01

    This paper examines an alternative to monitoring staff at a public health clinic in rural Uganda. The program sent SMS updates regarding confirmed attendance of clinic staff and activities to randomly selected cell phone-owning households in the local community. A difference-in-difference approach is used to evaluate the impact of the SMS program, and finds the messages led to an increase in clinic attendance, the receipt of medicine, and reduced duration of illness for young children aged si...

  12. A novel design for randomized immuno-oncology clinical trials with potentially delayed treatment effects

    Directory of Open Access Journals (Sweden)

    Pei He

    2015-10-01

    Full Text Available The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect. Immuno-oncology therapies pose unique challenges to the design of a trial as the treatment effect may be delayed, which violates the proportional hazards assumption, and the log-rank test has been shown to markedly lose power under the non-proportional hazards setting. A novel design and analysis approach for immuno-oncology trials is proposed through a piecewise treatment effect function, which is capable of detecting a potentially delayed treatment effect. The number of events required for the trial will be determined to ensure sufficient power for both the overall log-rank test without a delayed effect and the test beyond the delayed period when such a delay exists. The existence of a treatment delay is determined by a likelihood ratio test with resampling. Numerical results show that the proposed design adequately controls the Type I error rate, has a minimal loss in power under the proportional hazards setting and is markedly more powerful than the log-rank test with a delayed treatment effect.

  13. When to base clinical policies on observational versus randomized trial data.

    Science.gov (United States)

    Hornberger, J; Wrone, E

    1997-10-15

    Physicians must decide when the evidence is sufficient to adopt a new clinical policy. Analysis of large clinical and administrative databases is becoming an important source of evidence for changing clinical policies. Because such analysis cannot control for the effects of all potential confounding variables, physicians risk drawing the wrong conclusion about the cause-and-effect relation between a change in clinical policy and outcomes. Randomized studies offer protection against drawing a conclusion that would lead to adoption of an inferior policy. However, a randomized study may be difficult to justify because of the extra costs of collecting data for a randomized study and concerns that a study will not directly benefit the patients enrolled in the study. This article reviews the advantages and disadvantages of basing clinical policy on analysis of large databases compared with conducting a randomized study. A technique is described and illustrated for accessing the potential costs and benefits of conducting such a study. This type of analysis formed the basis for a physician-managed health care organization deciding to sponsor a randomized study among patients with end-stage renal disease as part of a quality-improvement initiative.

  14. Responses of discretized systems under narrow band nonstationary random excitations. Part 1: linear problems

    Science.gov (United States)

    Chen, Z.; To, C. W. S.

    2005-10-01

    The extended stochastic central difference (ESCD) method is proposed as a viable alternative for computing linear responses of discretized multi-degrees-of-freedom (mdof) systems under narrow band stationary and nonstationary random disturbances. The method provides a means of controlling the center frequencies and bandwidths of narrow band stationary and nonstationary random excitation processes. It is suitable for larger-scale random response analysis of complicated structures idealized by the finite element method. Its additional important feature is that application of normal mode or complex normal mode analysis or direct numerical integration algorithms such as the fourth-order Runge-Kutta scheme is not required. Examples, including one of flow-induced vibration of a pipe containing a moving fluid are included to demonstrate: (1) the capability of the proposed method and difference between responses of discretized systems under narrow band and wide band random excitations, and (2) its accuracy and efficiency by way of comparison to the Monte Carlo simulation data. Generalization of the ESCD method for computation of responses of nonlinear mdof systems is presented in a companion paper.

  15. Seismic Response of Long-Span Triple-Tower Suspension Bridge under Random Ground Motion

    Directory of Open Access Journals (Sweden)

    Chang-ke Jiao

    2017-01-01

    Full Text Available Multitower suspension bridge is of different style compared to the traditional suspension bridge with two towers, and consequently the dissimilarity of static and dynamic behaviors is distinct. As a special case of multitower suspension bridge, two long-span triple-tower suspension bridges have been constructed in China and the seismic random response of triple-tower suspension bridges is studied in this paper. A nonlinear dynamic analysis finite element model is established in ABAQUS and the Python language is utilized to facilitate the preprocess and postprocess during the finite element analysis. The procedure for random response calculation of structures based on the pseudoexcitation method is presented, with the initial equilibrium state of structure considered, which may be ignored for long-span bridges during calculating of stochastic response. The stationary seismic random responses of triple-tower suspension bridge under uniform excitation in firm, medium, and soft soil conditions and under spatially varying excitation in soft soil are investigated. The distribution of RMS of random responses of displacements and internal forces of the stiffening girder and towers is presented and discussed in detail. Results show that spatially variable ground motions should be considered in the stochastic analysis of triple-tower suspension bridge.

  16. Performance Analysis of an Island Power System Including Wind Turbines Operating under Random Wind Speed

    OpenAIRE

    Meng-Jen Chen; Yu-Chi Wu; Guo-Tsai Liu; Sen-Feng Lin

    2013-01-01

    With continuous rise of oil price, how to develop alternative energy source has become a hot topic around the world. This study discussed the dynamic characteristics of an island power system operating under random wind speed lower than nominal wind speeds of wind turbines. The system primarily consists of three diesel engine power generation systems, three constant-speed variable-pitch wind turbines, a small hydraulic induction generation system, and lumped static loads. Detailed models b...

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

    Science.gov (United States)

    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

  18. De-identification of clinical notes via recurrent neural network and conditional random field.

    Science.gov (United States)

    Liu, Zengjian; Tang, Buzhou; Wang, Xiaolong; Chen, Qingcai

    2017-11-01

    De-identification, identifying information from data, such as protected health information (PHI) present in clinical data, is a critical step to enable data to be shared or published. The 2016 Centers of Excellence in Genomic Science (CEGS) Neuropsychiatric Genome-scale and RDOC Individualized Domains (N-GRID) clinical natural language processing (NLP) challenge contains a de-identification track in de-identifying electronic medical records (EMRs) (i.e., track 1). The challenge organizers provide 1000 annotated mental health records for this track, 600 out of which are used as a training set and 400 as a test set. We develop a hybrid system for the de-identification task on the training set. Firstly, four individual subsystems, that is, a subsystem based on bidirectional LSTM (long-short term memory, a variant of recurrent neural network), a subsystem-based on bidirectional LSTM with features, a subsystem based on conditional random field (CRF) and a rule-based subsystem, are used to identify PHI instances. Then, an ensemble learning-based classifiers is deployed to combine all PHI instances predicted by above three machine learning-based subsystems. Finally, the results of the ensemble learning-based classifier and the rule-based subsystem are merged together. Experiments conducted on the official test set show that our system achieves the highest micro F1-scores of 93.07%, 91.43% and 95.23% under the "token", "strict" and "binary token" criteria respectively, ranking first in the 2016 CEGS N-GRID NLP challenge. In addition, on the dataset of 2014 i2b2 NLP challenge, our system achieves the highest micro F1-scores of 96.98%, 95.11% and 98.28% under the "token", "strict" and "binary token" criteria respectively, outperforming other state-of-the-art systems. All these experiments prove the effectiveness of our proposed method. Copyright © 2017. Published by Elsevier Inc.

  19. A better alternative to stratified permuted block design for subject randomization in clinical trials.

    Science.gov (United States)

    Zhao, Wenle

    2014-12-30

    Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization. Copyright © 2014 John Wiley & Sons, Ltd.

  20. The impact of covariate misclassification using generalized linear regression under covariate-adaptive randomization.

    Science.gov (United States)

    Fan, Liqiong; Yeatts, Sharon D; Wolf, Bethany J; McClure, Leslie A; Selim, Magdy; Palesch, Yuko Y

    2018-01-01

    Under covariate adaptive randomization, the covariate is tied to both randomization and analysis. Misclassification of such covariate will impact the intended treatment assignment; further, it is unclear what the appropriate analysis strategy should be. We explore the impact of such misclassification on the trial's statistical operating characteristics. Simulation scenarios were created based on the misclassification rate and the covariate effect on the outcome. Models including unadjusted, adjusted for the misclassified, or adjusted for the corrected covariate were compared using logistic regression for a binary outcome and Poisson regression for a count outcome. For the binary outcome using logistic regression, type I error can be maintained in the adjusted model, but the test is conservative using an unadjusted model. Power decreased with both increasing covariate effect on the outcome as well as the misclassification rate. Treatment effect estimates were biased towards the null for both the misclassified and unadjusted models. For the count outcome using a Poisson model, covariate misclassification led to inflated type I error probabilities and reduced power in the misclassified and the unadjusted model. The impact of covariate misclassification under covariate-adaptive randomization differs depending on the underlying distribution of the outcome.

  1. Non-destructive Testing by Infrared Thermography Under Random Excitation and ARMA Analysis

    Science.gov (United States)

    Bodnar, J. L.; Nicolas, J. L.; Candoré, J. C.; Detalle, V.

    2012-11-01

    Photothermal thermography is a non-destructive testing (NDT) method, which has many applications in the field of control and characterization of thin materials. This technique is usually implemented under CW or flash excitation. Such excitations are not adapted for control of fragile materials or for multi-frequency analysis. To allow these analyses, in this article, the use of a new control mode is proposed: infrared thermography under random excitation and auto regressive moving average analysis. First, the principle of this NDT method is presented. Then, the method is shown to permit detection, with low energy constraints, of detachments situated in mural paintings.

  2. Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

    Science.gov (United States)

    Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

    2013-04-01

    To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

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

    DEFF Research Database (Denmark)

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

    2004-01-01

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

  4. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.

    Science.gov (United States)

    Al-Khatib, Sana M; Piccini, Jonathan P; Knight, David; Stewart, Margaret; Clapp-Channing, Nancy; Sanders, Gillian D

    2010-05-01

    Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic. In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months. We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial.

  5. Modeling random telegraph signal noise in CMOS image sensor under low light based on binomial distribution

    International Nuclear Information System (INIS)

    Zhang Yu; Wang Guangyi; Lu Xinmiao; Hu Yongcai; Xu Jiangtao

    2016-01-01

    The random telegraph signal noise in the pixel source follower MOSFET is the principle component of the noise in the CMOS image sensor under low light. In this paper, the physical and statistical model of the random telegraph signal noise in the pixel source follower based on the binomial distribution is set up. The number of electrons captured or released by the oxide traps in the unit time is described as the random variables which obey the binomial distribution. As a result, the output states and the corresponding probabilities of the first and the second samples of the correlated double sampling circuit are acquired. The standard deviation of the output states after the correlated double sampling circuit can be obtained accordingly. In the simulation section, one hundred thousand samples of the source follower MOSFET have been simulated, and the simulation results show that the proposed model has the similar statistical characteristics with the existing models under the effect of the channel length and the density of the oxide trap. Moreover, the noise histogram of the proposed model has been evaluated at different environmental temperatures. (paper)

  6. [Tuberculosis and HIV co-infection: clinical trial under the coordination of the Institut Pasteur in Cambodia].

    Science.gov (United States)

    Borand, Laurence; Pheng, Phearavin; Saman, Manil; Leng, Chanthy; Chea, Phalla; Sarady Ay, Sao; Suom, Sophea; Roat Men, Nimul; Nerrienet, Eric; Marcy, Olivier

    2013-10-01

    Tuberculosis is a major cause of death among adults infected by HIV. The CAMELIA (ANRS 1295/CIPRA KH001) randomized clinical trial aimed to determine the optimal timing of ARV initiation after tuberculosis treatment onset to reduce mortality. Here, we describe the trial implementation in five hospitals in Cambodia under the coordination of the Institut Pasteur in Cambodia, its conduct, the challenges and public health benefits in Cambodia and beyond. © 2013 médecine/sciences – Inserm.

  7. Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial

    OpenAIRE

    Carbonell, Josep Lluis; Garcia, Ramon; Gonzalez, Adriana; Breto, Andres; Sanchez, Carlos

    2015-01-01

    Josep Lluis Carbonell,1 Ramon Garcia,2 Adriana Gonzalez,2 Andres Breto,2 Carlos Sanchez2 1Mediterranea Medica Clinic, Valencia, Spain; 2Eusebio Hernandez Gynecology and Obstetrics Teaching Hospital, Havana, Cuba Purpose: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. Methods: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women ...

  8. Stochastic thermoelastic problem of a functionally graded plate under random temperature load

    Energy Technology Data Exchange (ETDEWEB)

    Chiba, R. [Miyagi National College of Technology, Department of Mechanical Engineering, Natori (Japan); Sugano, Y. [Iwate University, Department of Mechanical Engineering, Morioka (Japan)

    2007-04-15

    This study attempts to derive the statistics of temperature and thermal stress in functionally graded material (FGM) plates exposed to random external temperatures. The thermomechanical properties of the FGM plates are assumed to vary arbitrarily only in the plate thickness direction. The external temperatures are expressed as random functions with respect to time. The transient temperature field in the FGM plate is determined by solving a nonhomogeneous heat conduction problem for a multilayered plate with linear nonhomogeneous thermal conductivity and different homogeneous heat capacity in each layer. The autocorrelations and power spectrum densities (PSDs) of temperature and thermal stress are derived analytically. These statistics for FGM plates composed of partially stabilised zirconia (PSZ) and austenitic stainless steel (SUS304) are computed under the condition that the fluctuation in the external temperature can be considered as white noise or a stationary Markov process. (orig.)

  9. Soliton broadening under random dispersion fluctuations: Importance sampling based on low-dimensional reductions

    Science.gov (United States)

    Moore, Richard O.; Schäfer, Tobias; Jones, Christopher K. R. T.

    2005-12-01

    We demonstrate that dispersion-managed solitons are less likely to experience critical broadening under the influence of random dispersion fluctuations than are solitons of the integrable nonlinear Schrödinger equation, and that this robustness increases with map strength from the constant-dispersion (integrable) limit to the large-map-strength limit. To achieve this, we exploit a separation of scales in dispersion-managed soliton dynamics to implement an importance-sampled Monte Carlo approach that determines the probability of rare broadening events. This approach reconstructs the tails (i.e., the regions of practical importance) of probability distribution functions with an efficiency that is several orders of magnitude greater than conventional Monte Carlo simulations. We further show that the variational approach with an appropriately scaled ansatz is surprisingly good at capturing the effect of random dispersion on pulse broadening; where it fails, it can still be used to guide very efficient simulation of the original equation.

  10. A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials.

    Science.gov (United States)

    Odani, Motoi; Fukimbara, Satoru; Sato, Tosiya

    2017-04-01

    Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials. To develop our meta-analysis model, we extended an existing three-stage Bayesian hierarchical model by including an additional stage of the clinical trial level in the hierarchical model; this generated a four-stage Bayesian hierarchical model. We applied the proposed Bayesian meta-analysis models to published adverse event data from three premarketing randomized clinical trials of tadalafil and to a simulation study motivated by the case example to evaluate the characteristics of three alternative models. Comparison of the results from the Bayesian meta-analysis model with those from Fisher's exact test after simple pooling showed that 6 out of 10 adverse events were the same within a top 10 ranking of individual adverse events with regard to association with treatment. However, more individual adverse events were detected in the Bayesian meta-analysis model than in Fisher's exact test under the body system "Musculoskeletal and connective tissue disorders." Moreover, comparison of the overall trend of estimates between the Bayesian model and the standard approach (odds ratios after simple pooling methods) revealed that the posterior median odds ratios for the Bayesian model for most adverse events shrank toward values for no association. Based on the simulation results, the Bayesian meta-analysis model could balance the false detection rate and power to a better extent than Fisher's exact test. For example, when the threshold value of the posterior probability for

  11. Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials.

    Science.gov (United States)

    Herman, Amir; Botser, Itamar Busheri; Tenenbaum, Shay; Chechick, Ahron

    2009-09-01

    The intention-to-treat principle implies that all patients who are randomized in a clinical trial should be analyzed according to their original allocation. This means that patients crossing over to another treatment group and patients lost to follow-up should be included in the analysis as a part of their original group. This principle is important for preserving the randomization scheme, which is the basis for correct inference in any randomized trial. In this study, we examined the use of the intention-to-treat principle in recently published orthopaedic clinical trials. We surveyed eight leading orthopaedic journals for randomized clinical trials published between January 2005 and August 2008. We determined whether the intention-to-treat principle was implemented and, if so, how it was used in each trial. Specifically, we ascertained which methods were used to account for missing data. Our search yielded 274 randomized clinical trials, and the intention-to-treat principle was used in ninety-six (35%) of them. There were significant differences among the journals with regard to the use of the intention-to-treat principle. The relative number of trials in which the principle was used increased each year. The authors adhered to the strict definition of the intention-to-treat principle in forty-five of the ninety-six studies in which it was claimed that this principle had been used. In forty-four randomized trials, patients who had been lost to follow-up were excluded from the final analysis; this practice was most notable in studies of surgical interventions. The most popular method of adjusting for missing data was the "last observation carried forward" technique. In most of the randomized clinical trials published in the orthopaedic literature, the investigators did not adhere to the stringent use of the intention-to-treat principle, with the most conspicuous problem being a lack of accounting for patients lost to follow-up. This omission might introduce bias to

  12. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... of the nervous elements have been performed. To date, no randomized studies have compared simple discectomy with discectomy followed by an interbody fusion with a titanium cage. METHODS: Eighty-six patients with symptoms of nerve root compression at 1 level were randomly allocated to either discectomy followed...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...

  13. Diagnostic efficacy of impedance plethysmography for clinically suspected deep-vein thrombosis. A randomized trial

    NARCIS (Netherlands)

    Hull, R. D.; Hirsh, J.; Carter, C. J.; Jay, R. M.; Ockelford, P. A.; Buller, H. R.; Turpie, A. G.; Powers, P.; Kinch, D.; Dodd, P. E.

    1985-01-01

    Impedance plethysmography is an accurate noninvasive method to test for proximal vein thrombosis, but it is insensitive to calf-vein thrombi. We randomly assigned patients on referral with clinically suspected deep-vein thrombosis and normal impedance plethysmographic findings to either serial

  14. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

  15. Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.

    LENUS (Irish Health Repository)

    Ridgway, P F

    2009-11-01

    Despite the high prevalence of hospitalization for left iliac fossa tenderness, there is a striking lack of randomized data available to guide therapy. The authors hypothesize that an oral antibiotic and fluids are not inferior to intravenous (IV) antibiotics and \\'bowel rest\\' in clinically diagnosed acute uncomplicated diverticulitis.

  16. The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

    NARCIS (Netherlands)

    Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

    1992-01-01

    Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

  17. Setting up a randomized clinical trial in the UK: approvals and process.

    Science.gov (United States)

    Greene, Louise Eleanor; Bearn, David R

    2013-06-01

    Randomized clinical trials are considered the 'gold standard' in primary research for healthcare interventions. However, they can be expensive and time-consuming to set up and require many approvals to be in place before they can begin. This paper outlines how to determine what approvals are required for a trial, the background of each approval and the process for obtaining them.

  18. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    Science.gov (United States)

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  19. Randomized Clinical Trial: The Use of SpeechEasy® in Stuttering Treatment

    Science.gov (United States)

    Ritto, Ana Paula; Juste, Fabiola Staróbole; Stuart, Andrew; Kalinowski, Joseph; de Andrade, Claudia Regina Furquim

    2016-01-01

    Background: Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims: The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods &…

  20. Randomized controlled clinical trials on agents used for chemical plaque control.

    Science.gov (United States)

    Paraskevas, S

    2005-11-01

    Taking into account the limitations of the daily self-performed oral hygiene the use of chemical agents that can be incorporated in dentifrice or mouth rinse formulations has been advocated. The present review deals with randomized controlled clinical trials of >or=6 months in duration, on the use of those agents and their effects on plaque and gingival inflammation.

  1. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    A prospective, randomized, double-blind clinical trial of one nano-hybrid and one high-viscosity bulk-fill composite restorative systems in class II cavities: 12 ... composites (RCs) perform just as well as nano‑hybrid RCs with the 2 mm RC layering technique, therefore could be alternative to conventional nano‑hybrid RCs.

  2. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  3. Effect of Curcumin on Anthropometric Measures: A Systematic Review on Randomized Clinical Trials.

    Science.gov (United States)

    Hariri, Mitra; Haghighatdoost, Fahimeh

    2018-01-09

    Curcumin is an active constituent of turmeric. Recently, scientists have suggested that curcumin can be used in weight reduction. We performed a systematic review based on randomized controlled trials to assess the effects of curcumin supplementation on anthropometric variables. We searched databases including PubMed, Embase, Web of Science, Scopus, and Google Scholar up to August 2017. Randomized clinical trials assessing the effects of curcumin on anthropometric parameters in human adults were included. Eight randomized clinical trials were allowed to be included in the systematic review. Five articles used the regular form of curcumin with short follow-up duration and did not indicate any significant effect on anthropometric measures, while three articles with significant results used either the more bioavailable form of curcumin or a longer intervention duration. Randomized clinical trials related to curcumin effect on weight are limited but their result indicated useful effect of curcumin on weight. It seems that the bioavailable form of curcumin can reduce obesity and overweight. Further articles with longer duration of intervention and different forms of curcumin supplementation are necessary before any recommendation is made for clinical use of these interventions.

  4. Rosiglitazone Decreases Plasma Levels of Osteoprotegerin in a Randomized Clinical Trial with Type 2 Diabetes Patients

    DEFF Research Database (Denmark)

    Nybo, Mads; Preil, Simone Rørdam; Juhl, Henning Friis

    2011-01-01

    regarding cardiovascular disease. The South Danish Diabetes Study, an investigator-driven, randomized, controlled clinical trial lasting 2 years, was used to test this hypothesis in patient groups with different medication strategies (insulin aspart or NPH insulin, added either metformin...

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    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...

  6. Cognitive-behavioral versus psychodynamic therapy for major depression: secondary outcomes of a randomized clinical trial

    NARCIS (Netherlands)

    Driessen, E.; Van, H.L.; Peen, J.; Don, F.J.; Twisk, J.W.R.; Cuijpers, Pim; Dekker, J.J.M.

    2017-01-01

    Objective: In a randomized clinical trial, we compared the efficacy of cognitive–behavioral therapy (CBT) and psychodynamic therapy for adult outpatient depression on measures of psychopathology, interpersonal functioning, pain, and quality of life. Method: There were 341 Dutch adults (70.1% female,

  7. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    Science.gov (United States)

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  8. Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    2017-03-21

    FINAL REPORT Project Title: Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial...relieving acute extremity pain , reducing medication use, decreasing time to full ambulation and improving quality of life than placebo acupuncture or...designated intervention. Acupuncture was performed by physician acupuncturists. Subjects reported pain level immediately after acupuncture , 24, 28 168

  9. Single implants with different neck designs in the aesthetic zone : a randomized clinical trial

    NARCIS (Netherlands)

    den Hartog, Laurens; Meijer, Henny J. A.; Stegenga, Boudewijn; Tymstra, Nynke; Vissink, Arjan; Raghoebar, Gerry M.

    2011-01-01

    Objectives: To compare single implants in the aesthetic zone with different neck designs for marginal bone-level changes and clinical outcome measures. Materials and methods: Ninety-three patients with a missing anterior tooth in the maxilla were randomly assigned to be treated with an implant with

  10. Crown vs. composite for post-retained restorations: A randomized clinical trial

    NARCIS (Netherlands)

    Skupien, J.A.; Cenci, M.S.; Opdam, N.J.; Kreulen, C.M.; Huysmans, M.C.; Pereira-Cenci, T.

    2016-01-01

    OBJECTIVES: This randomized clinical trial compared the survival of composite resin restorations and metal-ceramic crowns on endodontically treated teeth that received a glass fiber post using 2 different cementation methods. METHODS: Forty-seven patients (age 42.5+/-11.5) with fifty-seven

  11. A Parent-Mediated Intervention to Increase Responsive Parental Behaviors and Child Communication in Children with ASD: A Randomized Clinical Trial

    Science.gov (United States)

    Siller, Michael; Hutman, Ted; Sigman, Marian

    2013-01-01

    Longitudinal research has demonstrated that responsive parental behaviors reliably predict subsequent language gains in children with autism spectrum disorder. To investigate the underlying causal mechanisms, we conducted a randomized clinical trial of an experimental intervention (Focused Playtime Intervention, FPI) that aims to enhance…

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

    Science.gov (United States)

    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).

  13. Experiments on individual strategy updating in iterated snowdrift game under random rematching.

    Science.gov (United States)

    Qi, Hang; Ma, Shoufeng; Jia, Ning; Wang, Guangchao

    2015-03-07

    How do people actually play the iterated snowdrift games, particularly under random rematching protocol is far from well explored. Two sets of laboratory experiments on snowdrift game were conducted to investigate human strategy updating rules. Four groups of subjects were modeled by experience-weighted attraction learning theory at individual-level. Three out of the four groups (75%) passed model validation. Substantial heterogeneity is observed among the players who update their strategies in four typical types, whereas rare people behave like belief-based learners even under fixed pairing. Most subjects (63.9%) adopt the reinforcement learning (or alike) rules; but, interestingly, the performance of averaged reinforcement learners suffered. It is observed that two factors seem to benefit players in competition, i.e., the sensitivity to their recent experiences and the overall consideration of forgone payoffs. Moreover, subjects with changing opponents tend to learn faster based on their own recent experience, and display more diverse strategy updating rules than they do with fixed opponent. These findings suggest that most of subjects do apply reinforcement learning alike updating rules even under random rematching, although these rules may not improve their performance. The findings help evolutionary biology researchers to understand sophisticated human behavioral strategies in social dilemmas. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Grace under fire: aesthetic leadership in clinical nursing.

    Science.gov (United States)

    Mannix, Judy; Wilkes, Lesley; Daly, John

    2015-09-01

    This paper reports the results of an online descriptive survey that sought to determine nurses' perceptions of aesthetic leadership among clinical leaders in nursing. Clinical leadership has been identified as an essential component to ensuring the delivery of safe, high-quality health care. Leadership has been increasingly linked in the literature to aesthetics. However, little consideration has been given to aesthetics in relation to clinical leadership in nursing. A mixed-method, online descriptive survey. Participants were recruited via e-learning platforms and social media. A total of 66 surveys were completed, including 31 written accounts of aesthetic leadership in practice. Aesthetic leadership characteristics in clinical leaders most valued are support, communication and the approach taken to colleagues. Taking risks and challenging processes were least likely to be evident among effective clinical leaders. Aesthetic leadership is multi-dimensional and a style of leadership to positively influence the clinical workplace. Support, effective communication and taking into consideration the feelings of colleagues are important dimensions of aesthetic leadership. Aesthetic leadership represents a way for clinical leaders to create and sustain a calm and positive clinical workplace. © 2015 John Wiley & Sons Ltd.

  15. Modelling and simulation of randomly oriented carbon fibre-reinforced composites under thermal load

    Science.gov (United States)

    Treffler, R.; Fröschl, J.; Drechsler, K.; Ladstätter, E.

    2016-03-01

    Carbon fibre-reinforced sheet moulding compounds (CF-SMC) already exhibit a complex material behaviour under uniaxial loads due to the random orientation of the fibres in the matrix resin. Mature material models for metallic materials are generally not transferable. This paper proposes an approach for modelling the fatigue behaviour of CF-SMC based on extensive static and cyclic tests using low cost secondary carbon fibres (SCF). The main focus is on describing the stiffness degradation considering the dynamic modulus of the material. Influence factors such as temperature, orientation, rate dependence and specimen thickness were additionally considered.

  16. Random vibrations of Rayleigh vibroimpact oscillator under Parametric Poisson white noise

    Science.gov (United States)

    Yang, Guidong; Xu, Wei; Jia, Wantao; He, Meijuan

    2016-04-01

    Random vibration problems for a single-degree-of-freedom (SDOF) Rayleigh vibroimpact system with a rigid barrier under parametric Poisson white noise are considered. The averaged generalized Fokker-Planck-Kolmogorov (FPK) equations with parametric Poisson white noise are derived after using the nonsmooth variable transformation and the approximate stationary solutions for the system's response are obtained by perturbation method. The results are validated numerically by using Monte Carlo simulations from original vibroimpact system. Effects on the response for different damping coefficients, restitution coefficients and noise intensities are discussed. Furthermore, stochastic bifurcations are also explored.

  17. A group randomized trial using an appointment system to improve adherence to ART at reproductive and child health clinics implementing Option B+ in Tanzania.

    OpenAIRE

    Ross-Degnan, Dennis; Chalker, John; Liana, Jafary; Kajoka, Mwikemo Deborah; Valimba, Richard; Kimatta, Suleiman; Dillip, Angel; Vialle-Valentin, Catherine; Embrey, Martha; Lieber, Rachel; Johnson, Keith

    2017-01-01

    Introduction: In October 2013, Tanzania adopted Option B+ under which HIV-positive pregnant women are initiated on antiretroviral therapy in reproductive and child health clinics at diagnosis. Studies have shown that adherence and retention to antiretroviral treatment can be problematic. Methods: We implemented a group randomized controlled trial in 24 reproductive and child health clinics in eight districts in Mbeya region. The trial tested the impact of implementing paper-based appointment ...

  18. Short-term clinical effects of commercially available gel containing Acacia arabica: a randomized controlled clinical trial.

    Science.gov (United States)

    Pradeep, A R; Happy, D; Garg, G

    2010-03-01

    Certain plants used in folk medicine serve as a source of therapeutic agent by having antimicrobial and other multi-potential effects. This prospective, randomized, placebo and positively controlled clinical trial was designed to evaluate the short-term clinical effects of a commercially available gel containing Acacia arabica in the reduction of plaque and gingival inflammation in subjects with gingivitis. Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: Group I - placebo gel, Group II - gumtone gel and Group III - 1% chlorhexidine gel. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index at baseline, 2 weeks, 4 weeks and 6 weeks. A subjective evaluation was undertaken by questionnaire. Gumtone gel showed significant clinical improvement in gingival and plaque index scores as compared to a placebo gel. This improvement was comparable to 1% chlorhexidine gel. Unlike chlorhexidine gel, gumtone gel was not associated with any discolouration of teeth or unpleasant taste. Gumtone gel may be a useful herbal formulation for chemical plaque control agent and improvement in plaque and gingival status.

  19. Multimedia learning tools for teaching undergraduate ophthalmology: results of a randomized clinical study.

    Science.gov (United States)

    Steedman, Michael; Abouammoh, Marwan; Sharma, Sanjay

    2012-02-01

    To evaluate the effectiveness of a novel multimedia learning tool (MMLT) for teaching a method of approaching common ophthalmologic presentations. Randomized clinical study. 25 second-year medical students at Queen's University. We evaluated 2 MMLTs pertaining to common ophthalmologic presentations--acute visual loss and cataract--through the use of a randomized clinical study. Subjects were randomized either to watch a short-form video or to read a textbook excerpt for both cataract and acute visual loss. If randomized to one MMLT for the first module, the subject was allocated to the other modality for the second module. The main outcomes of interest were knowledge retention as measured by a short multiple-choice questionnaire, efficiency, and user preference. A trend was noted whereby subjects randomized to an MMLT had higher composite scores on multiple-choice questionnaires (mean score MMLT = 75.2% vs text = 67.5%; t test = 1.535; df = 22; p value = 0.139). Additionally, those who watched an MMLT spent 72% less time reviewing the education content (29 min vs 8 min; t test = 3.955, p value = 0.0003). Of the sample, 87% preferred the MMLT over the text. MMLTs can significantly reduce learning time without sacrificing knowledge retention in undergraduate students of ophthalmology. Copyright © 2012 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  20. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design.

    Science.gov (United States)

    Ports, William C; Feldman, Steven R; Gupta, Pankaj; Tan, Huaming; Johnson, Theodore R; Bissonnette, Robert

    2015-08-01

    Intra-subject, left-right, randomized, controlled study designs are often used for proof-of-concept studies in dermatology. This design was used to evaluate the safety and efficacy of a topical solution of tofacitinib (NCT00678561), a small-molecule Janus kinase inhibitor under investigation for the topical and oral treatment of patients with chronic plaque psoriasis. Eighty-one patients, each with matched left and right target plaques, were randomized to 2%, 0.2%, or 0.02% tofacitinib or vehicle solution once or twice daily. Patients treated one plaque as per their randomization group (2%, 0.2%, 0.02% tofacitinib, or vehicle solution), and used vehicle to treat the contralateral plaque for 4 weeks. Except during clinic visits, study drug applications were performed unsupervised outside the clinical trial site. Intra-subject, vehicle-adjusted mean percent change from baseline in Target Plaque Severity Score at week 4 (primary efficacy endpoint) was not significantly different from baseline for any treatment group (P values of 0.28-0.68). However, skin biopsy analyses detected tofacitinib in both tofacitinib- and vehicle-treated plaques of some patients, suggesting cross-contamination or solution misapplication. Lack of efficacy with tofacitinib relative to vehicle may be due to the intra-subject study design with unsupervised applications. These findings have potential implications for future intra-subject studies of topical treatments.

  1. Emergent dynamics of Cucker-Smale particles under the effects of random communication and incompressible fluids

    Science.gov (United States)

    Ha, Seung-Yeal; Xiao, Qinghua; Zhang, Xiongtao

    2018-04-01

    We study the dynamics of infinitely many Cucker-Smale (C-S) flocking particles under the interplay of random communication and incompressible fluids. For the dynamics of an ensemble of flocking particles, we use the kinetic Cucker-Smale-Fokker-Planck (CS-FP) equation with a degenerate diffusion, whereas for the fluid component, we use the incompressible Navier-Stokes (N-S) equations. These two subsystems are coupled via the drag force. For this coupled model, we present the global existence of weak and strong solutions in Rd (d = 2 , 3). Under the extra regularity assumptions of the initial data, the unique solvability of strong solutions is also established in R2. In a large coupling regime and periodic spatial domain T2 : =R2 /Z2, we show that the velocities of C-S particles and fluids are asymptotically aligned to two constant velocities which may be different.

  2. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder.

    Science.gov (United States)

    Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

    2008-09-15

    Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. NCT00572520.

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

    Directory of Open Access Journals (Sweden)

    Astha Palan

    2017-01-01

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

  4. Effectiveness of the Healthy Skin Clinic – a randomized clinical trial of nurse-led patient counselling in hand eczema

    DEFF Research Database (Denmark)

    Mollerup, Annette; Veien, Niels K; Johansen, Jeanne D

    2014-01-01

    BACKGROUND: Hand eczema is a common disease, and continuous preventive skin protection and skin care must be adopted to prevent a chronic course. Hand eczema is not a uniform disease, and counselling must therefore be individually tailored. OBJECTIVES: To evaluate the effectiveness of a nurse......-led counselling programme, the Healthy Skin Clinic, emphasizing the patient's self-management, resources, and risks. PATIENTS AND METHODS: Patients (n = 306) referred for diagnostic work-up and treatment of hand eczema were randomized and allocated either to the programme or to usual care. The primary outcome...... was clinical disease severity at follow-up. Secondary outcomes were quality of life, burden of disease, skin protective behaviours, and self-reported medication adherence. RESULTS: Patients in the intervention group had greater reductions in clinical severity and reported more beneficial behavioural changes...

  5. The effect of hypnotic drug type on anesthetic depth and amnesia: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Amiri HR

    2009-06-01

    Full Text Available "n Normal 0 false false false EN-GB X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Bispectral index (BIS index shows the depth of anesthesia. The effects of drugs on BIS and amnesia are different. This study was performed to evaluate the association between two different sedative regimens on BIS and amnesia."n"nMethods: In this clinical trial, 60 patients who needed elective orthopedic surgery under regional anesthesia with intravenous sedation were elected. Patients divided in two equal groups based on sedation protocol by block randomization method: midazolam plus fentanyl group (MF group or propofol group (P group. Dose of sedative drugs were adjusted according to clinical findings of sedation. Depth of sedation in all patients, preserved in four based on modified Ramsey Sedation Score. Patients questioned about spontaneous recall after full awakening in recovery room. Recall of any event during operation considered as failed amnesia. Correlation of BIS index with recall was measured in two different groups separately."n"nResults: The frequency of recall was 2 (6.7% in P group and 10 (33.3% in MF group (p=0.01. The mean± SD of BIS in P group was 76±5 (68-91 and in MF group was 93.4±5 (77-98 (p<0.001. The difference of BIS in patients without amnesia (p=0.019 and with amnesia (p<0

  6. Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

    Science.gov (United States)

    Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

    2016-08-01

    Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

  7. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial.

    Science.gov (United States)

    Abdel-Ghaffar, Hala Saad; Mohamed, Sahar Abd-Elbaky; Fares, Khaled M; Osman, Mohamed Abdel-Kadr

    2016-05-01

    The optimum dose of dexmedetomidine for shivering control with the least hemodynamic derangements is still under research. To compare the efficacy, hemodynamic and side effects of dexmedetomidine in 3 different doses with those of meperidine for the treatment of shivering in patients undergoing spinal anesthesia for minor elective lower abdominal surgery. Prospective double-blind randomized clinically controlled study. University hospital. One hundred twenty patients who developed shivering under spinal anesthesia.On shivering, patients were randomly allocated to receive an intravenous 2 mL bolus dose of meperidine 0.4 mg/kg (meperidine group, n = 30), dexmedetomidine 0.5 µg/kg (DEX I group, n = 30), 0.3 µg/kg (DEX II group, n = 30), or 0.2µg/kg (DEX III group, n = 30). Control of shivering, time taken for cessation of shivering, response rate, recurrence, hemodynamic changes, sedation score, tympanic temperature, and side effects were noted and compared between groups. The groups were comparable regarding demographic profile, tympanic temperature decline, and shivering onset time (P > 0.05). Lower shivering cessation time (P shivering activity was higher in DEX III group (36.7%, P shivering associated with spinal anesthesia with modest hemodynamic and sedation effects. ClinicalTrials.gov Identifier: NCT02382432. Dexmedetomidine, hypothermia, shivering, spinal anesthesia.

  8. Incidence of shivering after cesarean section under spinal anesthesia with or without intrathecal sufentanil: a randomized study.

    Science.gov (United States)

    de Figueiredo Locks, Giovani

    2012-01-01

    Shivering is a cause of discomfort and dissatisfaction in patients undergoing cesarean section. The objective of this study paper was to assess the impact of intrathecal administration of sufentanil on the incidence of shivering after cesarean section. In a prospective blinded, randomized clinical trial, pregnant women undergoing cesarean section under spinal anesthesia were enrolled. Pregnant women in labor, febrile, obese, with pregnancy-induced hypertension, anesthetic block failure or surgical complications were excluded. Patients were randomly assigned to two groups. In Group I, 10mg of 0.5% hyperbaric bupivacaine combined with 80 mcg of morphine and 2.5 mcg of sufentanil were administered. In Group II, 10mg of 0.5% hyperbaric bupivacaine combined with 80 mcg of morphine were administered. In the post-anesthesia care unit, patients were evaluated for signs of shivering by an investigator blinded to the patient's group allocation. The sample consisted of 80 patients. In both groups there was a decrease in axillary temperature of patients after cesarean section (pshivering in the immediate postoperative period. Copyright © 2012 Elsevier Editora Ltda. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Thomas L. Sevier

    2015-05-01

    Full Text Available 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

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

    Science.gov (United States)

    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)…

  11. Intrathecal Fentanyl Lidocaine combination for cesarean section: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Raji B

    2007-09-01

    Full Text Available Background: Spinal anesthesia can be associated with hemodynamic changes and some other complications. The aim of this study was to evaluate the effect of adding fentanyl to lidocaine on the spinal anesthesia time and its complications for cesarean section.Methods: Sixty pregnant women with gestational age of 37- 42 weeks and ASA physical status I and II undergoing elective cesarean section under spinal anesthesia were enrolled in a randomized double blinded clinical trial. They were randomly allocated to receive spinal anesthesia with lidocaine-normal saline (LS: 75 mg lidocaine 5% with 0.3 ml normal saline lidocaine-fentanyl (LF group (75 mg lidocaine 5% with 50 μg fentanyl. The duration of initiation of sensory block to achieve T4 level, time to return of sensory level to T12, time to first analgesic request, ephedrine requirement, nausea and vomiting during and after the surgery, pruritus, respirator depression, headache and apgar score of the new born  at 1st and 5th minutes were assessed. Results: There was no significant difference between time to achieve T4 level, ephedrine dose, post operative nausea and vomiting (PONV, pruritus and headache in study groups. Time to return of sensory level to T12 was significantly longer in LF group (152.6±14.7 vs. 66.2±11.2 min, P=0.0009. Time to first analgesic request was also longer in LF group (164.2±20.8 vs. 68.1±11.3 min, P=0.0009. The incidence of nausea and vomiting during surgery was significantly more in LF group (20% vs. 0%, P=0.023. No case of respiratory depression was observed in groups. The 1st and 5th minute's apgar score were comparable between groups and were between 7 and 10.Conclusions: Addition of fentanyl to intrathecal lidocaine in patients undergoing elective cesarean section results in increasing of the block duration and time to first analgesic request without significant maternal or neonatal side-effects, without effect on 1st and 5th minutes apgar score

  12. Millon Clinical Multiaxial Inventory (MCMI-III): the inability of the validity conditions to detect random responders.

    Science.gov (United States)

    Charter, Richard A; Lopez, Michael N

    2002-12-01

    The effectiveness of the MCMI-III Validity scale, Scale X, and the Clinical Personality Pattern scales to detect random responding is put to the test. The binomial expansion and Monte Carlo techniques were used. If the examiner is willing to interpret tests of questionable validity, then 50% of the random responders will not be detected. Scale X and the Clinical Personality Pattern scales were useless in detecting random responders. Copyright 2002 Wiley Periodicals, Inc.

  13. Randomized clinical study on the analgesic effect of local infiltration versus spinal block for hemorrhoidectomy

    Directory of Open Access Journals (Sweden)

    Luis Antônio Borges

    2017-05-01

    Full Text Available ABSTRACT BACKGROUND AND OBJECTIVES: Postoperative analgesia and early recovery are important for hospital discharge. The primary objective of this study was to compare the analgesic effectiveness of perianal infiltration and subarachnoid anesthesia for hemorrhoidectomy. The secondary objective was to compare time to discharge, adverse effects and complications. DESIGN AND SETTING: Randomized, prospective and comparative study at Dr. Mário Gatti Hospital. METHODS: Forty patients aged 18-60, in American Society of Anesthesiologists physical status category 1 or 2, were included. The local group (LG received local infiltration (0.75% ropivacaine under general anesthesia; the spinal group (SG received subarachnoid block (2 ml of 0.5% bupivacaine. Analgesic supplementation consisted of fentanyl for LG and lidocaine for SG. Postoperative pain intensity, sphincter relaxation, lower-limb strength, time to discharge, analgesic dose over one week and adverse effects were assessed. RESULTS: Eleven LG patients (52.4% required supplementation, but no SG patients. Pain intensity was higher for LG up to 120 min, but there were no differences at 150 or 180 min. There were no differences in the need for paracetamol or tramadol. Times to first analgesic supplementation and hospital discharge were longer for SG. The adverse effects were nausea, dizziness and urinary retention. CONCLUSIONS: Pain intensity was higher in LG than in SG over the first 2 h, but without differences after 150 and 180 min. Time to first supplementation was shorter in LG. There were no differences in doses of paracetamol and tramadol, or in adverse effects. REGISTRATION: ClinicalTrials.gov NCT02839538.

  14. Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial.

    Science.gov (United States)

    Grover, Samir C; Scaffidi, Michael A; Khan, Rishad; Garg, Ankit; Al-Mazroui, Ahmed; Alomani, Tareq; Yu, Jeffrey J; Plener, Ian S; Al-Awamy, Mohamed; Yong, Elaine L; Cino, Maria; Ravindran, Nikila C; Zasowski, Mark; Grantcharov, Teodor P; Walsh, Catharine M

    2017-11-01

    A structured comprehensive curriculum (SCC) that uses simulation-based training (SBT) can improve clinical colonoscopy performance. This curriculum may be enhanced through the application of progressive learning, a training strategy centered on incrementally challenging learners. We aimed to determine whether a progressive learning-based curriculum (PLC) would lead to superior clinical performance compared with an SCC. This was a single-blinded randomized controlled trial conducted at a single academic center. Thirty-seven novice endoscopists were recruited and randomized to either a PLC (n = 18) or to an SCC (n = 19). The PLC comprised 6 hours of SBT, which progressed in complexity and difficulty. The SCC included 6 hours of SBT, with cases of random order of difficulty. Both groups received expert feedback and 4 hours of didactic teaching. Participants were assessed at baseline, immediately after training, and 4 to 6 weeks after training. The primary outcome was participants' performance during their first 2 clinical colonoscopies, as assessed by using the Joint Advisory Group Direct Observation of Procedural Skills assessment tool (JAG DOPS). Secondary outcomes were differences in endoscopic knowledge, technical and communication skills, and global performance in the simulated setting. The PLC group outperformed the SCC group during first and second clinical colonoscopies, measured by JAG DOPS (P technical and communication skills and global performance in the simulated setting (P  .05). Our findings demonstrate the superiority of a PLC for endoscopic simulation, compared with an SCC. Challenging trainees progressively is a simple, theory-based approach to simulation whereby the performance of clinical colonoscopies can be improved. (Clinical trial registration number: NCT02000180.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  15. The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.

    Science.gov (United States)

    Han, Changsu; Kwak, Kyung-phil; Marks, David M; Pae, Chi-Un; Wu, Li-Tzy; Bhatia, Kamal S; Masand, Prakash S; Patkar, Ashwin A

    2009-03-01

    To determine whether the CONSORT recommendations influenced the quality of reporting of randomized controlled trials (RCTs) in the field of psychiatry, we evaluated the quality of clinical trial reports before and after the introduction of CONSORT statement. We selected seven high impact journals and retrieved the randomized, clinical trials in the field of psychiatry during the period of 1992-1996 (pre-CONSORT) and 2002-2007 (post-CONSORT). Among the total 5201 articles screened, 736 were identified and entered in our database. After critical review of the publications, 442 articles met the inclusion and exclusion criteria. The CONSORT Index (sum of 22 items of the checklist) during the post-CONSORT period was significantly higher than that during the pre-CONSORT period. However, over 40% of post-CONSORT studies did not adhere to CONSORT statement for reporting the process of randomization, and details of the process for obtaining informed consent were still insufficient. Furthermore, adherence to the CONSORT guidelines of reporting how blinding was accomplished and evaluated actually decreased after publication of the CONSORT statement. Although the overall quality of reporting on psychiatric RCTs generally improved after publication of the CONSORT statement, reporting the details of randomization, blinding, and obtaining informed consent remain insufficient.

  16. Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial.

    Science.gov (United States)

    Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

    2017-01-01

    The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs.

  17. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... by 0.5 for the control, 1.0 for the leaflet, 1.6 for the brochure, and 1.4 for the booklet. The brochure and the booklet improved the knowledge score significantly compared with the control. The general attitude was positive at entry (mean 71.5 points). Only the booklet significantly increased...

  18. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

    OpenAIRE

    Seyyedrasooli, Allehe; Valizadeh, Leila; Zamanzadeh, Vahid; Nasiri, Khadijeh; Kalantri, Hossein

    2013-01-01

    Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method). The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research wer...

  19. Teaching Emotional Intelligence to Intensive Care Unit Nurses and their General Health: A Randomized Clinical Trial

    OpenAIRE

    F Sharif; S Rezaie; S Keshavarzi; P Mansoori; S Ghadakpoor

    2013-01-01

    Background: Emotion and how people manage it is an important part of personality that would immensely affect their health. Investigations showed that emotional intelligence is significantly related to and can predict psychological health. Objective: To determine the effect of teaching emotional intelligence to intensive care unit nurses on their general health. Methods: This randomized clinical trial (registered as IRCT201208022812N9) was conducted on 52 of 200 in intensive care unit ...

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

    Science.gov (United States)

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

    2016-01-01

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

  1. Non-random biodiversity loss underlies predictable increases in viral disease prevalence.

    Science.gov (United States)

    Lacroix, Christelle; Jolles, Anna; Seabloom, Eric W; Power, Alison G; Mitchell, Charles E; Borer, Elizabeth T

    2014-03-06

    Disease dilution (reduced disease prevalence with increasing biodiversity) has been described for many different pathogens. Although the mechanisms causing this phenomenon remain unclear, the disassembly of communities to predictable subsets of species, which can be caused by changing climate, land use or invasive species, underlies one important hypothesis. In this case, infection prevalence could reflect the competence of the remaining hosts. To test this hypothesis, we measured local host species abundance and prevalence of four generalist aphid-vectored pathogens (barley and cereal yellow dwarf viruses) in a ubiquitous annual grass host at 10 sites spanning 2000 km along the North American West Coast. In laboratory and field trials, we measured viral infection as well as aphid fecundity and feeding preference on several host species. Virus prevalence increased as local host richness declined. Community disassembly was non-random: ubiquitous hosts dominating species-poor assemblages were among the most competent for vector production and virus transmission. This suggests that non-random biodiversity loss led to increased virus prevalence. Because diversity loss is occurring globally in response to anthropogenic changes, such work can inform medical, agricultural and veterinary disease research by providing insights into the dynamics of pathogens nested within a complex web of environmental forces.

  2. Dynamical analysis and performance evaluation of a biped robot under multi-source random disturbances

    Science.gov (United States)

    Gan, Chun-Biao; Ding, Chang-Tao; Yang, Shi-Xi

    2014-12-01

    During bipedal walking, it is critical to detect and adjust the robot postures by feedback control to maintain its normal state amidst multi-source random disturbances arising from some unavoidable uncertain factors. The radical basis function (RBF) neural network model of a five-link biped robot is established, and two certain disturbances and a randomly uncertain disturbance are then mixed with the optimal torques in the network model to study the performance of the biped robot by several evaluation indices and a specific Poincaré map. In contrast with the simulations, the response varies as desired under optimal inputting while the output is fluctuating in the situation of disturbance driving. Simulation results from noise inputting also show that the dynamics of the robot is less sensitive to the disturbance of knee joint input of the swing leg than those of the other three joints, the response errors of the biped will be increasing with higher disturbance levels, and especially there are larger output fluctuations in the knee and hip joints of the swing leg.

  3. The Parity of Set Systems under Random Restrictions with Applications to Exponential Time Problems

    DEFF Research Database (Denmark)

    Björklund, Andreas; Dell, Holger; Husfeldt, Thore

    2015-01-01

    We reduce the problem of detecting the existence of an object to the problem of computing the parity of the number of objects in question. In particular, when given any non-empty set system, we prove that randomly restricting elements of its ground set makes the size of the restricted set system...... an odd number with significant probability. When compared to previously known reductions of this type, ours excel in their simplicity: For graph problems, restricting elements of the ground set usually corresponds to simple deletion and contraction operations, which can be encoded efficiently in most...... and Husfeldt (FOCS 2013) that computes the parity of the number of Hamiltonian cycles in time 1.619^n. 2. A new result in the framework of Cygan et al. (CCC 2012) for analyzing the complexity of NP-hard problems under the Strong Exponential Time Hypothesis: If the parity of the number of Set Covers can...

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

    Science.gov (United States)

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

    2017-04-01

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

  5. Clinical and radiographic outcome following immediate loading and delayed loading of single-tooth implants: Randomized clinical trial.

    Science.gov (United States)

    Gjelvold, Björn; Kisch, Jenö; Chrcanovic, Bruno Ramos; Albrektsson, Tomas; Wennerberg, Ann

    2017-06-01

    Immediate loading of single implants is generally considered a reliable procedure. The objective of the present prospective randomized clinical study was to compare the overall treatment outcome following immediate loading (IL) and delayed loading (DL) of single implants after 1 year of follow-up. Patients with a missing maxillary tooth (15-25) were randomly assigned to IL or DL. The protocol included implant installation in healed sites, immediate loading, delayed loading, temporary screw-retained restoration, and replacement with a permanent single implant crown. Outcome measures were implant survival, marginal bone level, soft tissue changes, papillae index, pink, and white esthetic score (PES and WES), patient judged aesthetics, and oral health impact profile (OHiP-14). Implant survival rate was 100% and 96% for IL and DL, respectively. Implant success rate was 96% and 88% for IL and DL, respectively. Statistically significant lower papilla index scores were found in the IL group at temporary crown and definitive crown placement. An overall statistically significant improvement after 12 months for PES, WES and OHIP-14 was found. This prospective randomized study showed that single implants in the maxilla can present satisfactory results with respect to either immediate loading or delayed loading after 12 months. © 2017 Wiley Periodicals, Inc.

  6. Nordic Walking and chronic low back pain: design of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hartvigsen Jan

    2006-10-01

    Full Text Available Abstract Background Low Back Pain is a major public health problem all over the western world. Active approaches including exercise in the treatment of low back pain results in better outcomes for patients, but it is not known exactly which types of back exercises are most beneficial or whether general physical activity provide similar benefits. Nordic Walking is a popular and fast growing type of exercise in Northern Europe. Initial studies have demonstrated that persons performing Nordic Walking are able to exercise longer and harder compared to normal walking thereby increasing their cardiovascular metabolism. Until now no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to low back pain. The primary aim of this study is to investigate whether supervised Nordic Walking can reduce pain and improve function in a population of chronic low back pain patients when compared to unsupervised Nordic Walking and advice to stay active. In addition we investigate whether there is an increase in the cardiovascular metabolism in persons performing supervised Nordic Walking compared to persons who are advised to stay active. Finally, we investigate whether there is a difference in compliance between persons receiving supervised Nordic Walking and persons doing unsupervised Nordic Walking. Methods One hundred and fifty patients with low back pain for at least eight weeks and referred to a specialized secondary sector outpatient back pain clinic are included in the study. After completion of the standard back centre treatment patients are randomized into one of three groups: A Nordic Walking twice a week for eight weeks under supervision of a specially trained instructor; B Unsupervised Nordic Walking for eight weeks after one training session with an instructor; C A one hour motivational talk including advice to stay active. Outcome measures are pain, function, overall health, cardiovascular ability and

  7. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

    Science.gov (United States)

    Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

    2018-01-26

    Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

  8. [Clinical benefits after soluble dietary fiber supplementation: a randomized clinical trial in adults with slow-transit constipation].

    Science.gov (United States)

    Xu, Lin; Yu, Wenkui; Jiang, Jun; Li, Ning

    2014-12-30

    To explore the effect of pectin, a kind of soluble dietary fiber, on colonic transit time (CTT), clinical symptoms and gut microbiota in adults with slow-transit constipation. A total of 80 patients with slow-transit constipation were selected between June 2011 and December 2013. For this randomized controlled trial, we evaluated the efficacy of pectin on intestinal transit time and other indices of constipation in adults with slow-transit constipation. They were randomized to receive either pectin or placebo. Treatment consisted of 4-week supplementation with 24 g/d pectin (fiber group) or maltodextrin (placebo group). Before and after 4-week treatment, CTT, constipation symptoms and fecal bacterial population were compared between groups. CTT of the fiber group after treatment was lower than those of fiber group before treatment and those in the placebo group ((60.2 ± 11.2) h vs (80.3 ± 9.5), (79.4 ± 11.7) h, P fiber group after treatment also decreased than those of fiber group before treatment and those in the placebo group (both P fiber group after treatment versus the placebo group. No significant adverse effects were reported. Four-week soluble dietary fiber use accelerates colon transit time and alleviates clinical symptoms in patients with slow-transit constipation. Additionally, supplementary fiber offers protective effects on gut microbiota by increasing the population of healthy microflora.

  9. Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields.

    Science.gov (United States)

    Dai, Hong-Jie; Syed-Abdul, Shabbir; Chen, Chih-Wei; Wu, Chieh-Chen

    2015-01-01

    Electronic health record (EHR) is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF) model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents.

  10. Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields

    Directory of Open Access Journals (Sweden)

    Hong-Jie Dai

    2015-01-01

    Full Text Available Electronic health record (EHR is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents.

  11. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study

    Directory of Open Access Journals (Sweden)

    Donmez T

    2016-10-01

    Full Text Available Turgut Donmez,1 Vuslat Muslu Erdem,2 Oguzhan Sunamak,3 Duygu Ayfer Erdem,2 Huseyin Imam Avaroglu1 1Department of General Surgery, 2Department of Anesthesiology and Reanimation, Lutfiye Nuri Burat State Hospital, 3Department of General Surgery, Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey Background: Laparoscopic total extraperitoneal (TEP inguinal hernia repair is a well-known approach to inguinal hernia repair that is usually performed under general anesthesia (GA. To date, no reports compare the efficacy of spinal anesthesia (SA with that of GA for laparoscopic hernia repairs. The purpose of this study was to compare the surgical outcome of TEP inguinal hernia repair performed when the patient was treated under SA with that performed under GA. Materials and methods: Between July 2015 and July 2016, 50 patients were prospectively randomized to either the GA TEP group (Group I or the SA TEP group (Group II. Propofol, fentanyl, rocuronium, sevoflurane, and tracheal intubation were used for GA. Hyperbaric bupivacaine (15 mg and fentanyl (10 µg were used for SA to achieve a sensorial level of T3. Intraoperative events related to SA, operative and anesthesia times, postoperative complications, and pain scores were recorded. Each patient was asked to evaluate the anesthetic technique by using a direct questionnaire filled in 3 months after the operation. Results: All the procedures were completed by the allocated method of anesthesia as there were no conversions from SA to GA. Pain was significantly less for 1 h (P<0.0001 and 4 h (P=0.002 after the procedure for the SA and GA groups, respectively. There was no difference between the two groups regarding complications, hospital stay, recovery, or surgery time. Generally, patients were more satisfied with SA than GA (P<0.020. Conclusion: TEP inguinal hernia repair can be safely performed under SA, and SA was associated with less postoperative pain, better recovery, and better

  12. Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chuan Zhang

    Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

  13. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

    Directory of Open Access Journals (Sweden)

    Crawford Sybil

    2008-09-01

    Full Text Available Abstract Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174 will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520

  14. Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

    Science.gov (United States)

    Andersson, M; Kolodziej, B; Andersson, R E

    2017-10-01

    The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  15. Instructional authenticity and clinical reasoning in undergraduate medical education: a 2-year, prospective, randomized trial.

    Science.gov (United States)

    Durning, Steven J; Dong, Ting; Artino, Anthony R; LaRochelle, Jeffery; Pangaro, Louis N; van der Vleuten, Cees; Schuwirth, Lambert

    2012-09-01

    The purpose of the study was to investigate the relationship between authenticity (how close to actual practice) of preclerkship instructional formats and preclerkship and clerkship outcome measures. A secondary purpose was to investigate the effect of student's small-group assignment during preclerkship period on instructional formats and preclerkship and clerkship outcome measurements. A prospective, randomized, crossover study was carried out with preclerkship students taking a clinical reasoning course. Students were randomized to small groups and exposed to three formats of differing instructional authenticity across three subject areas. Three student cohorts were taught using one instructional format per subject area with each cohort receiving a different instructional format for each of the three areas. Outcome measures at the end of the preclerkship year and the clerkship year were selected to determine the effect of each instructional format. Hierarchical linear modeling was performed to assess impact of format on outcomes and to assess potential group effect on outcomes. Increasingly authentic instructional formats did not significantly improve clinical reasoning performance. Small-group assignment did not significantly contribute to the outcomes providing evidence that teacher training was successful. Increasing authenticity of instructional formats does not appear to significantly improve clinical reasoning performance. Faculty can be successfully trained to teach consistently in a clinical reasoning course. Medical educators should balance increasing authenticity with factors such as cognitive load and learner experience as well as engaging in frame-of-reference training to minimize group effects with designing new instructional formats.

  16. A randomized clinical trial on the sealing of occlusal carious lesions: 3–4-year results

    Directory of Open Access Journals (Sweden)

    Luana Severo ALVES

    2017-06-01

    Full Text Available Abstract This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8–43 years (median: 19 years. The inclusion criteria comprised the presence of a cavity with no access allowing biofilm control. The maximum depth of the lesion was the middle third of the dentin thickness, as assessed by bitewing radiography. The teeth were randomly assigned to sealant treatment (n = 28 or restorative treatment (n = 26. Clinical and radiographic examinations were performed after 1 year and after 3–4 years. The outcomes depended on the clinical performance of the sealant/restoration and the control of caries progression observed radiographically. Survival analysis was performed to assess success rates. Over the 3-4 years of monitoring, 2 sealants were totally lost, 1 needed repair, and 1 showed caries progression, totaling 4 failures in the sealant group. In the restoration group, 1 failure was observed (in need of repair. The success rates were 76% and 94% in the sealant and the restoration groups, respectively (p > 0.05. The sealing of occlusal carious lesions in permanent teeth succeeded in controlling caries over a 3–4-year period. However, sealed carious lesions require patient compliance in attending regular follow-ups to control the occurrence of clinical failures of the sealants.

  17. Comparison between biodentine and formocresol for pulpotomy of primary teeth: A randomized clinical trial.

    Science.gov (United States)

    El Meligy, Omar Abd El Sadek; Allazzam, Sulaiman; Alamoudi, Najlaa Mohd

    2016-01-01

    To assess and compare the clinical and radiographic success rates of biodentine and formocresol for pulpotomy in human primary teeth. A randomized, split-mouth, double-blind, controlled clinical trial was carried out in 37 healthy 4- to 8-year-old children with 56 pairs (112 teeth) of contralateral primary molars indicated for pulpotomy. Matched teeth in each pair were randomized to undergo either biodentine (n = 56 teeth) or formocresol (n = 56 teeth) pulpotomy. In both groups, the teeth were restored with stainless steel crowns. The teeth were evaluated clinically and radiographically at 3 and 6 months by two blinded, standardized, and calibrated examiners. The data were analyzed using chi-square and McNemar tests with a P value of biodentine (100%) and formocresol (100%), without any statistically significant difference (P = 1). Pulp canal obliteration was radiographically observed in 10/56 (17.9%) and 7/56 (12.5%) cases in the biodentine and formocresol groups, respectively. Both pulpotomy techniques showed favorable clinical and radiographic outcomes at 3 and 6 months posttreatment without any significant difference. Hence, biodentine has the potential to become a substitute for formocresol in primary molar pulpotomies.

  18. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

    Science.gov (United States)

    Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

    2017-12-01

    Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

  19. Sustained effect of simulation-based ultrasound training on clinical performance: a randomized trial

    Science.gov (United States)

    Tolsgaard, M G; Ringsted, C; Dreisler, E; Nørgaard, L N; Petersen, J H; Madsen, M E; Freiesleben, N L C; Sørensen, J L; Tabor, A

    2015-01-01

    Objective To study the effect of initial simulation-based transvaginal sonography (TVS) training compared with clinical training only, on the clinical performance of residents in obstetrics and gynecology (Ob-Gyn), assessed 2 months into their residency. Methods In a randomized study, new Ob-Gyn residents (n = 33) with no prior ultrasound experience were recruited from three teaching hospitals. Participants were allocated to either simulation-based training followed by clinical training (intervention group; n = 18) or clinical training only (control group; n = 15). The simulation-based training was performed using a virtual-reality TVS simulator until an expert performance level was attained, and was followed by training on a pelvic mannequin. After 2 months of clinical training, one TVS examination was recorded for assessment of each resident's clinical performance (n = 26). Two ultrasound experts blinded to group allocation rated the scans using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. Results During the 2 months of clinical training, participants in the intervention and control groups completed an average ± SD of 58 ± 41 and 63 ± 47 scans, respectively (P = 0.67). In the subsequent clinical performance test, the intervention group achieved higher OSAUS scores than did the control group (mean score, 59.1% vs 37.6%, respectively; P Simulation-based ultrasound training leads to substantial improvement in clinical performance that is sustained after 2 months of clinical training. © 2015 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology. PMID:25580809

  20. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial.

    Directory of Open Access Journals (Sweden)

    Chun-Shin Chang

    Full Text Available 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.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.58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group.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.ClinicalTrials.gov NCT01429402.

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

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

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

  2. Concurrent training protocol for men with androgen deficiency in the aging male: a randomized clinical trial.

    Science.gov (United States)

    Vieira, Melissa de Carvalho Souza; Leitão, Alice Erwig; Vieira, Guilherme; Moratelli, Jéssica; Boing, Leonessa; Seemann, Taysi; Guimarães, Adriana Coutinho de Azevedo

    2018-03-25

    The androgen deficiency in the aging male (ADAM) affects physical, sexual, and psychological aspects with characteristics symptoms of middle-aged men. The practice of regular physical activity and physical exercise can attenuate these symptoms. The aim of this randomized clinical trial is to propose a physical exercise protocol based on concurrent training for middle-aged men with ADAM. Randomized clinical trial with a 6-month intervention will randomly divided into two groups: experimental group (EG) and control group (CG). Four evaluations will be carried out, (1) pre-intervention; (2) in the first month of intervention; (3) in the third month of intervention; (4) post-intervention, evaluating: physical, psychological, sexual, and hormonal aspects. The intervention protocol with concurrent training will have duration of 6 months; frequency of 3 times weekly, with 60 min per session. The two-way ANOVA test will be used for the inter-group and intra-group comparisons with repeated measurements, and also Sydak's comparison test. This protocol was developed with the intent of easing the symptoms of ADAM. In addition, it is believed that the concurrent training protocol could be capable to recover hormonal, physical, psychological, and sexual aspect of middle-aged men with ADAM.

  3. Assessing quality of reports on randomized clinical trials in nursing journals.

    Science.gov (United States)

    Parent, Nicole; Hanley, James A

    2009-01-01

    Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

  4. Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

    Science.gov (United States)

    Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

    2014-01-01

    Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

  5. Mannitol as adjunct therapy for childhood cerebral malaria in Uganda: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Byarugaba Justus S

    2007-10-01

    Full Text Available Abstract Background Several reports have suggested that raised intracranial pressure (ICP is a major contributor to death among children with cerebral malaria. Mannitol, an osmotic diuretic, effectively lowers ICP and is used to treat post-traumatic raised ICP. It is not clear whether intravenous mannitol given to children with cerebral malaria improves clinical outcome. The objective of this study was to determine the effect of mannitol as adjunct therapy on the clinical outcome of children with cerebral malaria. Methods This randomized double-blind placebo controlled clinical trial was carried out at the Emergency Paediatric ward of Mulago Hospital, Uganda's national referral and teaching hospital. One hundred and fifty six children aged 6 to 60 months with cerebral malaria were randomized to either one dose of mannitol 1 g/kg or placebo, in addition to intravenous quinine. Main outcome measures included coma recovery time; time to sit unsupported, begin oral intake; duration of hospitalization; death and adverse effects. Results Time to regain consciousness (p = 0.11, sit unsupported (p = 0.81, time to start oral intake (p = 0.13 and total coma duration (p = 0.07 were similar in both groups. There was no significant difference in the mortality between the placebo (13/80 or 16.3% and mannitol (10/76 or 13.2% groups: RR = 1.2 (CI 0.5–2.7. No adverse effects were observed after administration of mannitol. Conclusion Mannitol had no significant impact on clinical outcome of cerebral malaria. It is difficult to recommend intravenous mannitol as adjunct therapy for childhood cerebral malaria. Clinical registration number ClinicalTrials.gov ID: NCT00113854

  6. Network analysis reveals distinct clinical syndromes underlying acute mountain sickness.

    Directory of Open Access Journals (Sweden)

    David P Hall

    Full Text Available Acute mountain sickness (AMS is a common problem among visitors at high altitude, and may progress to life-threatening pulmonary and cerebral oedema in a minority of cases. International consensus defines AMS as a constellation of subjective, non-specific symptoms. Specifically, headache, sleep disturbance, fatigue and dizziness are given equal diagnostic weighting. Different pathophysiological mechanisms are now thought to underlie headache and sleep disturbance during acute exposure to high altitude. Hence, these symptoms may not belong together as a single syndrome. Using a novel visual analogue scale (VAS, we sought to undertake a systematic exploration of the symptomatology of AMS using an unbiased, data-driven approach originally designed for analysis of gene expression. Symptom scores were collected from 292 subjects during 1110 subject-days at altitudes between 3650 m and 5200 m on Apex expeditions to Bolivia and Kilimanjaro. Three distinct patterns of symptoms were consistently identified. Although fatigue is a ubiquitous finding, sleep disturbance and headache are each commonly reported without the other. The commonest pattern of symptoms was sleep disturbance and fatigue, with little or no headache. In subjects reporting severe headache, 40% did not report sleep disturbance. Sleep disturbance correlates poorly with other symptoms of AMS (Mean Spearman correlation 0.25. These results challenge the accepted paradigm that AMS is a single disease process and describe at least two distinct syndromes following acute ascent to high altitude. This approach to analysing symptom patterns has potential utility in other clinical syndromes.

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

    Science.gov (United States)

    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.

  8. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.

    2008-01-01

    BACKGROUND: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health......-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients. HYPOTHESIS: The primary hypothesis is that daily recombinant......, and HRQoL, and has a favorable safety profile. DESIGN/MEASUREMENTS: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20...

  9. Sutures coated with antiseptic pomade to prevent bacterial colonization: a randomized clinical trial.

    Science.gov (United States)

    Cruz, Fernando; Leite, Fabiola; Cruz, Gustavo; Cruz, Silvia; Reis, Juarez; Pierce, Matthew; Cruz, Mauro

    2013-08-01

    The aim of this study was to assess if an antiseptic pomade could reduce the bacterial colonization on multifilament sutures. A randomized clinical trial was conducted with 40 volunteer patients of both sexes aged 18-70, randomly separated into experimental (n = 20) and control (n = 20) groups. The experimental group received pomade-coated sutures (iodoform + calendula) and the control group uncoated sutures. Two millimeters of the suture was harvested from each patient from the 1st to the 15th postoperative day. The bacteria that had adhered to them were cultured. The number of colony-forming units per milliliter (CFU/mL) was determined and the groups were compared using the Mann-Whitney statistical test (P antiseptic pomade was effective in reducing bacterial colonization on silk braided sutures. Copyright © 2013 Elsevier Inc. All rights reserved.

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

    DEFF Research Database (Denmark)

    van Dijken, Jan WV; Pallesen, Ulla

    2016-01-01

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

  11. Depressive Symptoms and Relationship Between Genders: Differences in Young Adults in a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mariane Ricardo Acosta Lopez Molina

    Full Text Available Abstract: Depression has a high prevalence in the general population, especially among women. There is no consensus in the scientific literature about differences between men and women in the manifestations of depressive symptoms, nor about psychotherapy indications according to gender. This research aimed to verify differences in depressive symptoms and symptoms improvement between young adult men and women with current Major Depressive Disorder and to identify differences between two brief Cognitive Psychotherapy models. Randomized clinical trial in which participants were randomized between: Cognitive Behavioral Therapy and Narrative Cognitive Therapy. Depressive symptoms pre and post-intervention were evaluated using the Hamilton Depression Rating Scale. The sample was composed of 25 men and 95 women. Genital symptoms and insight were significantly different between genders. Concerning improvement in symptoms according to the psychotherapy model, CBT presented a trend toward being more effective in men. Therefore, the symptoms and improvement in depressive symptoms are manifested differently between genders.

  12. Spouse READI (Resilience Education and Deployment Information): Randomized Clinical Trial. Formerly Reintegration: The Role of Spouse Telephone BATTLEMIND Randomized Clinical Trial

    Science.gov (United States)

    2014-04-01

    21 • Table 4. Project Benefit Themes by Randomization Arm ...................................................23 • Figure 1. Consort ...Percentages are calculated from number of responses for each randomization group. 23 Appendix – Tables and Figures Figure 1. Consort Diagram of

  13. Underlying Mechanisms of Tinnitus: Review and Clinical Implications

    Science.gov (United States)

    Henry, James A.; Roberts, Larry E.; Caspary, Donald M.; Theodoroff, Sarah M.; Salvi, Richard J.

    2016-01-01

    Background The study of tinnitus mechanisms has increased tenfold in the last decade. The common denominator for all of these studies is the goal of elucidating the underlying neural mechanisms of tinnitus with the ultimate purpose of finding a cure. While these basic science findings may not be immediately applicable to the clinician who works directly with patients to assist them in managing their reactions to tinnitus, a clear understanding of these findings is needed to develop the most effective procedures for alleviating tinnitus. Purpose The goal of this review is to provide audiologists and other health-care professionals with a basic understanding of the neurophysiological changes in the auditory system likely to be responsible for tinnitus. Results It is increasingly clear that tinnitus is a pathology involving neuroplastic changes in central auditory structures that take place when the brain is deprived of its normal input by pathology in the cochlea. Cochlear pathology is not always expressed in the audiogram but may be detected by more sensitive measures. Neural changes can occur at the level of synapses between inner hair cells and the auditory nerve and within multiple levels of the central auditory pathway. Long-term maintenance of tinnitus is likely a function of a complex network of structures involving central auditory and nonauditory systems. Conclusions Patients often have expectations that a treatment exists to cure their tinnitus. They should be made aware that research is increasing to discover such a cure and that their reactions to tinnitus can be mitigated through the use of evidence-based behavioral interventions. PMID:24622858

  14. Pregnancy rate after endometrial injury in couples with unexplained infertility: A randomized clinical trial.

    Science.gov (United States)

    Parsanezhad, Mohammad Ebrahim; Dadras, Nasrin; Maharlouei, Najmeh; Neghahban, Leila; Keramati, Peghah; Amini, Madihe

    2013-11-01

    Unexplained infertility is still a challenging issue as to its causes, appropriate management and treatment. Evidence implicates early embryopathy or implantation failure as likely causes. This study aims to investigate the effect of local endometrial injury on pregnancy rate in selected unexplained infertile patients. This was a randomized clinical trial conducted in Shiraz University Infertility Clinic of Ghadir Hospital. A total of 217 women with unexplained infertility aged 23-35 years old were randomly divided into two study groups through block randomization. After superovulation by clomiphene-citrate and gonadotropins and when the dominant follicles reached 18-20 mm, patients were randomly assigned to undergo endometrial local injury at posterior uterine wall by piplle endometrial sampling (n=114) or mock pipette biopsy (n=103) during pre-ovulatory days (when spontaneous urinary LH surge was detected). Then all the patients were instructed to follow a regularly timed intercourse. The pregnancy rate was significantly higher in the endometrial injury group compared to the control group [17/114 (14.9%) vs. 6/103 (5.8%) (OR: 2.83 95% CI: 1.07-7.49, p=0.03]. The abortion rate was comparable between two groups (17.64% vs. 14.28%; p=0.701). Local mechanical injury of the endometrium can enhance the uterine receptivity and facilitates the embryo implantation. This simple, easy, and cost effective procedure is worth considering in selective unexplained infertility patients who implantation failure is the likely causes of infertility before complex treatments. This procedure may help reduce psychological tensions and high expenses imposed through such interventions. Registration ID in IRCT: IRCT2012082510657N1.

  15. Randomized controlled trials in the journal of sexual medicine: a quality assessment and relevant clinical impact.

    Science.gov (United States)

    Jo, Jung Ki; Chung, Jae Hoon; Kim, Kyu Shik; Lee, Jeong Woo; Lee, Seung Wook

    2014-04-01

    Quality assessment of randomized clinical trials (RCTs) is important to prevent the adoption of findings of low-quality trials into clinical practice. The aim if this study was to analyze the quality of studies reporting RCTs in the Journal of Sexual Medicine (JSM) and to find relevant clinical impact. A quality assessment was conducted in all studies identified as RCTs published in the JSM from 2004 to 2012. The review period was divided into three periods: early (2004-2006), mid (2007-2009), and late (2010-2012). The Jadad scale, van Tulder scale, and the Cochrane Collaboration Risk of Bias Tool (CCRBT) quality scoring instruments were used. The RCTs were also categorized by country of origin, topic, the inclusion of institutional review board (IRB) approval, funding, citation rate, and impact factor. A total of 2,418 original articles were published in the JSM during the review period, and 188 were reports of RCTs. There were 39 (14.89%), 70 (7.77%), and 76 (6.29%) RCTs published during the early, mid, and late terms, respectively (P Citation rates and impact factor were not correlated with RCT quality using any of the tools. The number of original articles and RCTs published in the JSM increased over time. However, the ratio of RCTs to original articles did not increase significantly. Adequate randomization and blinding methods, IRB review, and financial support are required for the conduct of high-quality RCTs. © 2014 International Society for Sexual Medicine.

  16. A 3-year randomized clinical trial evaluating two different bonded posterior restorations: Amalgam versus resin composite.

    Science.gov (United States)

    Kemaloglu, Hande; Pamir, Tijen; Tezel, Huseyin

    2016-01-01

    To compare the performance and postoperative sensitivity of a posterior resin composite with that of bonded amalgam in 40 (n = 20) large sized cavities and to evaluate whether resin composite could be an alternative for bonded amalgam. This was a randomized clinical trial. Twenty patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded amalgam and the other half to composite restorations. Forty bonded amalgams (n = 20) and composites (n = 20) were evaluated for their performance on modified-US Public Health Service criteria and postoperative sensitivity using visual analogue scale (VAS) for 36-months. Success rate of this study was 100%. First clinical alterations were rated as Bravo after 1 year in marginal discoloration, marginal adaptation, anatomical form, and surface roughness for both amalgam and composite. At the 3(rd) year, overall "Bravo" rated restorations were 12 for bonded amalgam and 13 for resin composites. There were no significant differences among the VAS scores of composites and bonded amalgams for all periods (P > 0.05) except for the comparisons at the 3(rd) year evaluation (P composite and bonded amalgam were clinically acceptable. Postoperative sensitivity results tend to decrease more in composite restorations rather than amalgams. Therefore, it was concluded that posterior resin composite can be used even in large sized cavities.

  17. A commentary on randomized clinical trials: How to produce them with a good level of evidence

    Science.gov (United States)

    Flecha, Olga Dumont; Douglas de Oliveira, Dhelfeson Willya; Marques, Leandro Silva; Gonçalves, Patricia Furtado

    2016-01-01

    Randomized clinical trial (RCT) is the gold standard study for the evaluation of health interventions and is considered the second level of evidence for clinical decision making. However, the quality of the evidence produced by these studies is dependent on the methodological rigor employed at every stage of their execution. The purpose of randomization is to create groups that are comparable independent of any known or unknown potential confounding factor. A critical evaluation of the literature reveals that, for many years, RCTs have been developed based on inaccurate methodological criteria, and empirical evidence began to accumulate. Thus, guidelines were developed to assist authors, reviewers, and editors in the task of developing and assessing the methodological consistency of this type of study. The objective of this article is to review key aspects to design a good-quality RCT, supporting the scientific community in the production of reliable evidence and favoring clinical decision making to allow the patient to receive the best health care. PMID:27141473

  18. A commentary on randomized clinical trials: How to produce them with a good level of evidence

    Directory of Open Access Journals (Sweden)

    Olga Dumont Flecha

    2016-01-01

    Full Text Available Randomized clinical trial (RCT is the gold standard study for the evaluation of health interventions and is considered the second level of evidence for clinical decision making. However, the quality of the evidence produced by these studies is dependent on the methodological rigor employed at every stage of their execution. The purpose of randomization is to create groups that are comparable independent of any known or unknown potential confounding factor. A critical evaluation of the literature reveals that, for many years, RCTs have been developed based on inaccurate methodological criteria, and empirical evidence began to accumulate. Thus, guidelines were developed to assist authors, reviewers, and editors in the task of developing and assessing the methodological consistency of this type of study. The objective of this article is to review key aspects to design a good-quality RCT, supporting the scientific community in the production of reliable evidence and favoring clinical decision making to allow the patient to receive the best health care.

  19. A 3-year randomized clinical trial evaluating two different bonded posterior restorations: Amalgam versus resin composite

    Science.gov (United States)

    Kemaloglu, Hande; Pamir, Tijen; Tezel, Huseyin

    2016-01-01

    Objective: To compare the performance and postoperative sensitivity of a posterior resin composite with that of bonded amalgam in 40 (n = 20) large sized cavities and to evaluate whether resin composite could be an alternative for bonded amalgam. Materials and Methods: This was a randomized clinical trial. Twenty patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded amalgam and the other half to composite restorations. Forty bonded amalgams (n = 20) and composites (n = 20) were evaluated for their performance on modified-US Public Health Service criteria and postoperative sensitivity using visual analogue scale (VAS) for 36-months. Results: Success rate of this study was 100%. First clinical alterations were rated as Bravo after 1 year in marginal discoloration, marginal adaptation, anatomical form, and surface roughness for both amalgam and composite. At the 3rd year, overall “Bravo” rated restorations were 12 for bonded amalgam and 13 for resin composites. There were no significant differences among the VAS scores of composites and bonded amalgams for all periods (P > 0.05) except for the comparisons at the 3rd year evaluation (P amalgam were clinically acceptable. Postoperative sensitivity results tend to decrease more in composite restorations rather than amalgams. Therefore, it was concluded that posterior resin composite can be used even in large sized cavities. PMID:27011734

  20. Random Vibration Analysis of Train Moving over Slab Track on Bridge under Track Irregularities and Earthquakes by Pseudoexcitation Method

    OpenAIRE

    Zeng, Zhiping; Zhu, Kunteng; He, Xianfeng; Xu, Wentao; Chen, Lingkun; Lou, Ping

    2015-01-01

    This paper investigates the random vibration and the dynamic reliability of operation stability of train moving over slab track on bridge under track irregularities and earthquakes by the pseudoexcitation method (PEM). Each vehicle is modeled by multibody dynamics. The track and bridge is simulated by a rail-slab-girder-pier interaction finite element model. The coupling equations of motion are established based on the wheel-rail interaction relationship. The random excitations of the track i...

  1. Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial.

    Science.gov (United States)

    Johnston, Sebastian L; Szigeti, Matyas; Cross, Mary; Brightling, Christopher; Chaudhuri, Rekha; Harrison, Timothy; Mansur, Adel; Robison, Laura; Sattar, Zahid; Jackson, David; Mallia, Patrick; Wong, Ernie; Corrigan, Christopher; Higgins, Bernard; Ind, Philip; Singh, Dave; Thomson, Neil C; Ashby, Deborah; Chauhan, Anoop

    2016-11-01

    Guidelines recommend against antibiotic use to treat asthma attacks. A study with telithromycin reported benefit, but adverse reactions limit its use. To determine whether azithromycin added to standard care for asthma attacks in adults results in clinical benefit. The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom-based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. Adults with a history of asthma for more than 6 months were recruited within 48 hours of presentation to medical care with an acute deterioration in asthma control requiring a course of oral and/or systemic corticosteroids. Azithromycin 500 mg daily or matched placebo for 3 days. The primary outcome was diary card symptom score 10 days after randomization, with a hypothesized treatment effect size of -0.3. Secondary outcomes were diary card symptom score, quality-of-life questionnaires, and lung function changes, all between exacerbation and day 10, and time to a 50% reduction in symptom score. Of 4582 patients screened at 31 centers, 199 of a planned 380 were randomized within 48 hours of presentation. The major reason for nonrecruitment was receipt of antibiotics (2044 [44.6%] screened patients). Median time from presentation to drug administration was 22 hours (interquartile range, 14-28 hours). Exacerbation characteristics were well balanced across treatment arms and centers. The primary outcome asthma symptom scores were mean (SD), 4.14 (1.38) at exacerbation and 2.09 (1.71) at 10 days for the azithromycin group and 4.18 (1.48) and 2.20 (1.51) for the placebo group, respectively. Using multilevel modeling, there was no significant difference in symptom scores between azithromycin and placebo at day 10 (difference, -0.166; 95% CI, -0.670 to 0.337), nor on any day between exacerbation and day 10. No significant between

  2. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial.

    Science.gov (United States)

    Goudakos, John K; Markou, Konstantinos D; Psillas, George; Vital, Victor; Tsaligopoulos, Miltiadis

    2014-05-01

    IMPORTANCE The management of patients with unilateral acute vestibular neuritis (VN) has not been established to date. OBJECTIVE To compare the use of vestibular exercises vs corticosteroid therapy in the recovery of patients with acute VN. DESIGN, SETTING, AND PARTICIPANTS Prospective, single-blind, randomized clinical trial at a primary referral center. Among all patients with acute vertigo, those having VN were eligible for inclusion in the study. INTERVENTIONS Forty patients with acute VN were randomly assigned to perform vestibular exercises or to receive corticosteroid therapy. After a baseline examination, follow-up evaluations were performed at 1, 6, and 12 months. MAIN OUTCOMES AND MEASURES Efficacy outcomes included clinical, canal, and otolith recovery. Scores on the European Evaluation of Vertigo Scale and the Dizziness Handicap Inventory were used for the evaluation of clinical recovery. Findings of caloric irrigation and vestibular evoked myogenic potentials indicated canal and otolith improvement, respectively. RESULTS Comparing the 2 treatment groups, no statistically significant differences were found in clinical, canal, or otolith recovery. At the 6-month examination, the number of patients with complete disease resolution in the corticosteroids group was significantly higher than that in the vestibular exercises group. However, at the end of the follow-up period, 45%(9 of 20) of patients in the vestibular exercises group and 50% (10 of 20) of patients in the corticosteroids group had complete disease resolution (P > .05). CONCLUSIONS AND RELEVANCE Treating patients who have acute VN with vestibular exercises seems equivalently effective as treating them with corticosteroid therapy in clinical, caloric, and otolith recovery. Corticosteroid therapy seems to enhance earlier complete acute VN resolution, with no added benefit in the long-term prognosis.

  3. An Integrated Clinic-Community Partnership for Child Obesity Treatment: A Randomized Pilot Trial.

    Science.gov (United States)

    Hoffman, Jessica; Frerichs, Leah; Story, Mary; Jones, Jason; Gaskin, Kiah; Apple, Annie; Skinner, Asheley; Armstrong, Sarah

    2018-01-01

    Effective treatment of childhood obesity remains elusive. Integration of clinical and community systems may achieve effective and sustainable treatment. However, the feasibility and effectiveness of this integrated model are unknown. We conducted a randomized clinical trial among children aged 5 to 11 presenting for obesity treatment. We randomized participants to clinical care or clinical care plus community-based programming at a local parks and recreation facility. Primary outcomes were the change in child BMI at 6 months and the intensity of the program in treatment hours. Secondary outcomes included health behaviors, fitness, attrition, and quality of life. We enrolled 97 children with obesity, and retention at 6 months was 70%. Participants had a mean age of 9.1 years and a mean baseline BMI z score of 2.28, and 70% were living in poverty. Intervention participants achieved more treatment hours than controls (11.4 vs 4.4, SD: 15.3 and 1.6, respectively). We did not observe differences in child BMI z score or percent of the 95th percentile at 6 months. Intervention participants had significantly greater improvements in physical activity ( P = .010) and quality of life ( P = .008). An integrated clinic-community model of child obesity treatment is feasible to deliver in a low-income and racially diverse population. As compared with multidisciplinary treatment, the integrated model provides more treatment hours, improves physical activity, and increases quality of life. Parks and recreation departments hold significant promise as a partner agency to deliver child obesity treatment. Copyright © 2018 by the American Academy of Pediatrics.

  4. Using simulation pedagogy to teach clinical education skills: A randomized trial.

    Science.gov (United States)

    Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

    2016-05-01

    Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

  5. Effect of Postrhinoplasty Taping on Postoperative Edema and Nasal Draping: A Randomized Clinical Trial.

    Science.gov (United States)

    Ozucer, Berke; Yildirim, Yavuz Selim; Veyseller, Bayram; Tugrul, Selahattin; Eren, Sabri Baki; Aksoy, Fadullah; Uysal, Omer; Ozturan, Orhan

    2016-05-01

    Edema persists for months after rhinoplasty. Numerous modalities have been described to counteract postoperative edema. To evaluate the effect of postrhinoplasty taping (PRT) on nasal edema and nasal draping. In this randomized clinical trial, 57 patients undergoing rhinoplasty at a tertiary reference center from August 1, 2014, to January 31, 2015, were assigned to a control group or to 2- or 4-week PRT groups. Baseline nasal thickness was measured with ultrasonography at the nasion, rhinion, supratip, and tip, and mean nasal skin thickness (MNST) was calculated. Participants in each group were categorized by the baseline MNST measurement from the lowest to greatest MNST; those in the upper half were categorized as having thick skin; those in the lower half, thin skin. The control group underwent no PRT after the removal of external packing. Patients in the 2- and 4-week PRT groups received additional taping during the allocated time. Data were collected from August 1, 2014, to June 31, 2015. Follow-up was completed on June 31, 2015, and data were analyzed from July 1 to August 1, 2015. Postoperative measurements of MNST were performed at the end of weeks 1, 3, and 5 and month 6. Of the 57 total patients (33 male and 24 female patients; mean [SD] age, 30.0 [11.7] years), 17 were in the 2-week PRT group; 20, the 4-week PRT group; and 20, the control group. Compared with the control group, 4-week PRT had a significant effect on the supratip (P = .001). Comparisons of MNST with the control group revealed significant effects of 2-week (P = .02) and 4-week (P = .007) PRT. The effect on the tip was not significant (P = .052). Postrhinoplasty taping had no effect in thin-skinned patients. Comparison among thick-skinned patients revealed a significant effect on the MNST (P = .01) and the rhinion (P = .02) but not the tip (P = .06) and supratip (P = .07). Postrhinoplasty taping helps the skin envelope to compress to the underlying framework

  6. Immune Function Effects of Dental Amalgam in Children: A Randomized Clinical Trial

    Science.gov (United States)

    Shenker, Bruce J.; Maserejian, Nancy N.; Zhang, Annie; McKinlay, Sonja

    2010-01-01

    Background Dental amalgam is a widely used restorative material containing 50% elemental mercury that emits mercury vapor. No randomized clinical trials have determined whether there are adverse immunologic effects associated with this low-level mercury exposure in children. The objective of this study was to evaluate a sub-population of the New England Children’s Amalgam Trial (NECAT) for in vitro manifestations of immunotoxic effects of dental amalgam. Methods A randomized clinical trial in which children requiring dental restorative treatment were randomized to either amalgam for posterior restorations or resin composite. A total of 66 children, aged 6–10 years, were assessed for total white cell numbers, T-cell, B-cell, neutrophil and monocyte responsiveness over a five-year period. Owing to the small number of participants, the study is exploratory in nature with limited statistical power. Results The mean number of tooth surfaces restored during the five-year period was 7.8 for the amalgam group and 10.1 for composite group. In the amalgam group there was a slight, but not statistically significant, decline in responsiveness of T-cells and monocytes at 5–7 days post treatment; no differences were consistently observed at 6, 12 or 60 months. Conclusions This study confirms that treatment of children with dental amalgams leads to increased, albeit low level, exposure to mercury. In this exploratory analysis of immune function, amalgam exposure did not cause overt immune deficits, although small transient effects were observed 5–7 days post restoration. Clinical implications These findings suggest that immunotoxic effects of amalgam restorations in children need not be a concern when choosing this restorative dental material. PMID:18978388

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

    Science.gov (United States)

    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.

  8. Treatment of periodontal intrabony defects using autologous periodontal ligament stem cells: a randomized clinical trial.

    Science.gov (United States)

    Chen, Fa-Ming; Gao, Li-Na; Tian, Bei-Min; Zhang, Xi-Yu; Zhang, Yong-Jie; Dong, Guang-Ying; Lu, Hong; Chu, Qing; Xu, Jie; Yu, Yang; Wu, Rui-Xin; Yin, Yuan; Shi, Songtao; Jin, Yan

    2016-02-19

    Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry. We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure. A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p 0.05). This study

  9. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

    DEFF Research Database (Denmark)

    Maiers, Michele; Evans, Roni; Hartvigsen, Jan

    2015-01-01

    Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE...... was high among the 241 randomized participants. Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were...

  10. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned.

    Science.gov (United States)

    Ojo-Fati, Olamide; Joseph, Anne M; Ig-Izevbekhai, Jed; Thomas, Janet L; Everson-Rose, Susan A; Pratt, Rebekah; Raymond, Nancy; Cooney, Ned L; Luo, Xianghua; Okuyemi, Kolawole S

    2017-07-05

    There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers. ClinicalTrials.gov, ID: NCT00786149 . Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996 . Registered on 20 November 2014.

  11. Predictors of clinical outcomes after periodontal treatment of aggressive periodontitis: 12-month randomized trial.

    Science.gov (United States)

    Haas, Alex Nogueira; Silva-Boghossian, Carina Maciel; Colombo, Ana Paula; Albandar, Jasim; Oppermann, Rui Vicente; Rösing, Cassiano Kuchenbecker; Susin, Cristiano

    2016-05-20

    Little is known about the factors that may be used in clinical practice to predict the therapeutic response of aggressive periodontitis patients. The aim of this study was to determine predictors of clinical outcomes after non-surgical treatment of aggressive periodontitis. A total of 24 patients (aged 13-26 years) received oral hygiene instructions, as well as subgingival scaling and root planing. Twelve subjects received systemic azithromycin at random. Clinical variables were assessed at baseline, 3, 6, 9, and 12 months. Baseline microbiological assessment was performed by checkerboard DNA-DNA hybridization. Multivariable models used generalized estimating equations. There were significant improvements in the entire sample in regard to pocket depth, clinical attachment level and bleeding on probing. Significant predictors of a reduction in mean pocket depth were: use of azithromycin, non-molar teeth, generalized disease and baseline pocket depth. Absence of plaque predicted a 0.22 mm higher attachment gain, whereas a baseline pocket depth ≥7 mm predicted a 1.36 mm higher attachment loss. Azithromycin, plaque, and baseline pocket depth were significant predictors of bleeding on probing. The concomitant presence of all three red complex species predicted a 0.78 mm higher attachment loss. It may be concluded that dental plaque, tooth type, disease extent, baseline pocket depth, and use of azithromycin were significant predictors of the clinical response to treatment for aggressive periodontitis in young individuals. Moreover, the presence of multiple periodontal pathogens may predict challenges in achieving a favorable outcome for aggressive periodontitis.

  12. Scapular-focused treatment in patients with shoulder impingement syndrome: a randomized clinical trial.

    Science.gov (United States)

    Struyf, F; Nijs, J; Mollekens, S; Jeurissen, I; Truijen, S; Mottram, S; Meeusen, R

    2013-01-01

    The purpose of this clinical trial is to compare the effectiveness of a scapular-focused treatment with a control therapy in patients with shoulder impingement syndrome. Therefore, a randomized clinical trial with a blinded assessor was used in 22 patients with shoulder impingement syndrome. The primary outcome measures included self-reported shoulder disability and pain. Next, patients were evaluated regarding scapular positioning and shoulder muscle strength. The scapular-focused treatment included stretching and scapular motor control training. The control therapy included stretching, muscle friction, and eccentric rotator cuff training. Main outcome measures were the shoulder disability questionnaire, diagnostic tests for shoulder impingement syndrome, clinical tests for scapular positioning, shoulder pain (visual analog scale; VAS), and muscle strength. A large clinically important treatment effect in favor of scapular motor control training was found in self-reported disability (Cohen's d = 0.93, p = 0.025), and a moderate to large clinically important improvement in pain during the Neer test, Hawkins test, and empty can test (Cohen's d 0.76, 1.04, and 0.92, respectively). In addition, the experimental group demonstrated a moderate (Cohen's d = 0.67) improvement in self-experienced pain at rest (VAS), whereas the control group did not change. The effects were maintained at three months follow-up.

  13. No benefit of intraoperative whole blood sequestration and autotransfusion during coronary artery bypass grafting : results of a randomized clinical trial

    NARCIS (Netherlands)

    Ramnath, A N; Naber, H R; de Boer, A; Leusink, J A

    OBJECTIVES: In a randomized clinical trial of patients undergoing elective coronary artery bypass grafting, we evaluated the effect of intraoperative whole blood sequestration and autotransfusion on postoperative blood loss and the use of allogeneic blood products. METHODS: Male patients were

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

    Science.gov (United States)

    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. Parent Stress in a Randomized Clinical Trial of Atomoxetine and Parent Training for Children with Autism Spectrum Disorder

    Science.gov (United States)

    Lecavalier, Luc; Pan, Xueliang; Smith, Tristram; Handen, Benjamin L.; Arnold, L. Eugene; Silverman, Laura; Tumuluru, Rameshwari V.; Hollway, Jill; Aman, Michael G.

    2018-01-01

    We previously reported a 2 × 2 randomized clinical trial of atomoxetine (ATX) and parent training (PT) for attention deficit hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 children with autism spectrum disorder, ages 5-14 years. Children were randomized to one of four conditions: ATX alone, placebo alone, ATX + PT, or…

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

    Science.gov (United States)

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

    2010-01-01

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

  17. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Science.gov (United States)

    2013-10-24

    ... and assessment of meta-analyses of randomized controlled clinical trials (RCTs) to evaluate safety risks associated with the use of human drugs or biological products within the framework of regulatory...-analyses of randomized trials as a tool for safety assessment in the regulation of pharmaceutical products...

  18. Estimation of a monotone percentile residual life function under random censorship.

    Science.gov (United States)

    Franco-Pereira, Alba M; de Uña-Álvarez, Jacobo

    2013-01-01

    In this paper, we introduce a new estimator of a percentile residual life function with censored data under a monotonicity constraint. Specifically, it is assumed that the percentile residual life is a decreasing function. This assumption is useful when estimating the percentile residual life of units, which degenerate with age. We establish a law of the iterated logarithm for the proposed estimator, and its n-equivalence to the unrestricted estimator. The asymptotic normal distribution of the estimator and its strong approximation to a Gaussian process are also established. We investigate the finite sample performance of the monotone estimator in an extensive simulation study. Finally, data from a clinical trial in primary biliary cirrhosis of the liver are analyzed with the proposed methods. One of the conclusions of our work is that the restricted estimator may be much more efficient than the unrestricted one. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  19. Articaine versus lidocaine for third molar surgery: A randomized clinical study

    Science.gov (United States)

    Santos, Thiago-de-S; Santos, Jadson-A.; Maia, Marcelo-C; Mendonça, Carla-G

    2012-01-01

    Objective: Pain reduction has been the subject of continuous research in the field of oral and maxillofacial surgery since postoperative pain with ranging of intensity and duration may affects the patient submitted in an oral surgical procedure. The aim of present study was to compare the analgesic effectiveness between two different anesthetic solutions (articaine and lidocaine) in third molar surgery. Study Design: A prospective, randomized and clinical study with patients submitted to third molar surgery at two distinct times. The visual analogue scale, the McGill Pain Questionnaire and the analgesic consumption record were used to measure the pain after each surgical time. Results: Duration of surgery, latency, the amount of anesthetic used and analgesic consumption showed clinical differences with highlights of articaine, though statistical significance was not observed (Pthird molar. PMID:22157664

  20. Acupuncture for fibromyalgia--a systematic review of randomized clinical trials.

    Science.gov (United States)

    Mayhew, E; Ernst, E

    2007-05-01

    Acupuncture is often used and frequently advocated for the symptomatic treatment of fibromyalgia. A systematic review has previously demonstrated encouraging findings. As it is now outdated, we wanted to update it. We searched seven electronic databases for relevant randomized clinical trials (RCTs). The data were extracted and validated independently by both authors. As no meta-analysis seemed possible, the results were evaluated in narrative form. Five RCTs met our inclusion criteria, all of which used acupuncture as an adjunct to conventional treatments. Their methodological quality was mixed and frequently low. Three RCTs suggested positive but mostly short-lived effects and two yielded negative results. There was no significant difference between the quality of the negative and the positive RCTs. All positive RCTs used electro-acupunture. The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia.

  1. A randomized clinical trial on the sealing of occlusal carious lesions

    DEFF Research Database (Denmark)

    Alves, Luana Severo; Giongo, Fernanda Cristina Mendes de Santa; Mua, Bruna

    2017-01-01

    of a cavity with no access allowing biofilm control. The maximum depth of the lesion was the middle third of the dentin thickness, as assessed by bitewing radiography. The teeth were randomly assigned to sealant treatment (n = 28) or restorative treatment (n = 26). Clinical and radiographic examinations were...... performed after 1 year and after 3-4 years. The outcomes depended on the clinical performance of the sealant/restoration and the control of caries progression observed radiographically. Survival analysis was performed to assess success rates. Over the 3-4 years of monitoring, 2 sealants were totally lost, 1...... needed repair, and 1 showed caries progression, totaling 4 failures in the sealant group. In the restoration group, 1 failure was observed (in need of repair). The success rates were 76% and 94% in the sealant and the restoration groups, respectively (p > 0.05). The sealing of occlusal carious lesions...

  2. The placebo is powerful: estimating placebo effects in medicine and psychotherapy from randomized clinical trials.

    Science.gov (United States)

    Wampold, Bruce E; Minami, Takuya; Tierney, Sandra Callen; Baskin, Thomas W; Bhati, Kuldhir S

    2005-07-01

    The logic of the randomized double-blind placebo control group design is presented, and problems with using the design in psychotherapy are discussed. Placebo effects are estimated by examining clinical trials in medicine and psychotherapy. In medicine, a recent meta-analysis of clinical trials with treatment, placebo, and no treatment arms was conducted (Hróbjartsson & Gøtzsche, 2001), and it was concluded that placebos have small or no effects. A re-analysis of those studies, presented here, shows that when disorders are amenable to placebos and the design is adequate to detect the effects, the placebo effect is robust and approaches the treatment effect. For psychological disorders, particularly depression, it has been shown that pill placebos are nearly as effective as active medications whereas psychotherapies are more effective than psychological placebos. However, it is shown that when properly designed, psychological placebos are as effective as accepted psychotherapies.

  3. Cluster-Randomized Trial of Clinical Pharmacist Tobacco Cessation Counseling Among Patients with Cardiovascular Disease.

    Science.gov (United States)

    Adams, Jody; Cymbala, Alicia A; Delate, Thomas; Kurz, Deanna; Olson, Kari L; Youngblood, Morgan; Zadvorny, Emily

    2015-08-01

    Optimal management of patients with cardiovascular disease (CVD) includes evaluation of risk factors using a team-based approach. Tobacco use often receives less attention than other CVD risk factors; therefore, utilization of nonphysician health care providers may be valuable in addressing tobacco use. The purpose of this trial was to assess the impact of brief, structured, telephone tobacco cessation counseling (BST) delivered by clinical pharmacists on tobacco cessation attempts compared to usual care. The BST consisted of 1 to 5 minutes discussing 3 key counseling points, including a recommendation to quit and education about cessation aids. This was a cluster-randomized trial of tobacco-using patients with CVD who were enrolled in a clinical pharmacist-managed, physician-directed, CVD disease state management service. Clinical pharmacists were randomized to provide usual care (control) or BST (intervention) to their tobacco-using patients during a 4-month period. Patients were surveyed 3 months later to assess their tobacco cessation attempts, use of tobacco cessation aids, and self-reported cessation. One hundred twenty patients were enrolled. Subjects were predominately white males, aged ≥65 years, with a history of myocardial infarction. One hundred and four subjects completed the follow-up survey. No differences were detected between the 36.2% and 38.6% of control and intervention subjects, respectively, reporting a tobacco cessation attempt (P=0.804) or in the other outcomes (all P>0.05). A BST delivered by clinical pharmacists may not adequately affect patient motivation enough to increase tobacco cessation attempts in tobacco-dependent patients with CVD. Future research is needed to evaluate other team-based strategies that can decrease tobacco use in patients with CVD.

  4. The Effects of Inhalation Aromatherapy on Anxiety in Patients With Myocardial Infarction: A Randomized Clinical Trial

    Science.gov (United States)

    Najafi, Zahra; Taghadosi, Mohsen; Sharifi, Khadijeh; Farrokhian, Alireza; Tagharrobi, Zahra

    2014-01-01

    Background: Anxiety is an important mental health problem in patients with cardiac disease. Anxiety reduces patients’ quality of life and increases the risk of different cardiac complications. Objectives: The aim of this study was to investigate the effects of inhalation aromatherapy on anxiety in patients with myocardial infarction. Patients and Methods: This was a randomized clinical trial conduced on 68 patients with myocardial infarction hospitalized in coronary care units of a large-scale teaching hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in 2013. By using the block randomization technique, patients were randomly assigned to experimental (33 patients receiving inhalation aromatherapy with lavender aroma twice a day for two subsequent days) and control (35 patients receiving routine care of study setting including no aromatherapy) groups. At the beginning of study and twenty minutes after each aromatherapy session, anxiety state of patients was assessed using the Spielberger’s State Anxiety Inventory. Data was analyzed using SPSS v. 16.0. We used Chi-square, Fisher’s exact, independent-samples T-test and repeated measures analysis of variance to analyze the study data. Results: The study groups did not differ significantly regarding baseline anxiety mean and demographic characteristics. However, after the administration of aromatherapy, anxiety mean in the experimental group was significantly lower than the control group. Conclusions: Inhalation aromatherapy with lavender aroma can reduce anxiety in patients with myocardial infarction. Consequently, healthcare providers, particularly nurses, can use this strategy to improve postmyocardial infarction anxiety management. PMID:25389481

  5. Preoperative Use of Dexamethasone in Rhinoplasty: A Randomized, Double-blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Valente, Denis S; Steffen, Niveo; Carvalho, Lauro A; Borille, Giuliano B; Zanella, Rafaela K; Padoin, Alexandre V

    2015-01-01

    Postoperative edema and ecchymosis following rhinoplasty are a cause of anxiety for both patients and physicians and can affect the cosmetic results. Corticosteroids have been used to reduce these events. To determine whether preoperative use of dexamethasone sodium phosphate alters the occurrence of edema and ecchymosis following rhinoplasty. Randomized, double-blind, placebo-controlled clinical trial at an institutional referral center among a sample of individuals with rhinomegaly. Patients were randomized into 2 groups. In group 1, dexamethasone was intravenously injected before surgery. In group 2, normal saline solution was intravenously injected before surgery. When patients returned at 1 week after surgery, standardized photographs were obtained. The photographs were analyzed by 5 plastic surgeons who were blinded as to whether dexamethasone or normal saline solution had been injected. The plastic surgeons rated the degree of edema and ecchymosis. Forty-two patients participated in the study. Randomization by lottery resulted in 20 patients in group 1 and 22 patients in group 2. Group 1 showed lower rates of postoperative ecchymosis than group 2; the difference of 0.62 (P = .02) reflects less perceived ecchymosis when dexamethasone was administered. Group 1 also showed lower rates of postoperative edema than group 2; the difference of 0.68 (P = .01) reflects less perceived edema when dexamethasone was administered. Preoperative use of dexamethasone reduced edema and ecchymosis at 7 days after rhinoplasty. Rigorous methods in this trial demonstrate the beneficial effect of preoperative corticosteroid administration in this surgical procedure. 1.

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

    Directory of Open Access Journals (Sweden)

    Amir Bazrafshan

    2013-06-01

    Full Text Available 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.

  7. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial.

    Science.gov (United States)

    Abdel-Aleem, H; Alhusaini, T K; Abdel-Aleem, M A; Menoufy, M; Gülmezoglu, A M

    2013-11-01

    Cesarean section is associated with more blood loss than vaginal delivery. This could increase the risk of morbidity and mortality especially among anemic women. The objective of the trial is to assess the possible effect of tranexamic acid on blood loss during and after elective cesarean section. We conducted a randomized controlled trial at Women's Health Hospital, Assiut University, Assiut, Egypt. All pregnant women with singleton fetus planned to have elective cesarean section at ≥37 wks gestation were randomized to receive 1 g tranexamic acid slowly intravenously over 10 min before elective cesarean section group or not. Blood loss was measured during and for two hours after operation. Any side effects, complications, medications, changes in vital signs and duration of hospital stay were recorded. This study is registered, number ACTRN12612000313831. Seven hundred and forty women were randomized (373 in study group and 367 in control group). Mean total blood loss was 241.6 (SE 6.77) ml in the tranexamic acid group versus 510 (SE 7.72) ml in the control group. The mean drop in hematocrit and hemoglobin levels were statistically significantly lower in the tranexamic acid group than in the control group. There were no statistically or clinically significant differences in other outcomes. Pre-operative use of tranexamic acid is associated with reduced blood loss during and after elective cesarean section. This could be of benefit for anemic women or those who refuse blood transfusion.

  8. Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial.

    Science.gov (United States)

    Rink, Cameron; Wernke, Matthew M; Powell, Heather M; Gynawali, Surya; Schroeder, Ryan M; Kim, Jayne Y; Denune, Jeffrey A; Gordillo, Gayle M; Colvin, James M; Sen, Chandan K

    2016-01-01

    A growing number of clinical trials and case reports support qualitative claims that use of an elevated vacuum suspension (EVS) prosthesis improves residual-limb health on the basis of self-reported questionnaires, clinical outcomes scales, and wound closure studies. Here, we report first efforts to quantitatively assess residual-limb circulation in response to EVS. Residual-limb skin health and perfusion of people with lower-limb amputation (N = 10) were assessed during a randomized crossover study comparing EVS with nonelevated vacuum suspension (control) over a 32 wk period using noninvasive probes (transepidermal water loss, laser speckle imaging, transcutaneous oxygen measurement) and functional hyperspectral imaging approaches. Regardless of the suspension system, prosthesis donning decreased perfusion in the residual limb under resting conditions. After 16 wk of use, EVS improved residual-limb oxygenation during treadmill walking. Likewise, prosthesis-induced reactive hyperemia was attenuated with EVS following 16 wk of use. Skin barrier function was preserved with EVS but disrupted after control socket use. Taken together, outcomes suggest chronic EVS use improves perfusion and preserves skin barrier function in people with lower-limb amputation. ClinicalTrials.gov; "Evaluation of limb health associated with a prosthetic vacuum socket system": NCT01839123; https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1.

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

    Science.gov (United States)

    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 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.

  10. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  11. Efficacy of Tramadol Extended-Release for Opioid Withdrawal: A Randomized Clinical Trial.

    Science.gov (United States)

    Dunn, Kelly E; Tompkins, D Andrew; Bigelow, George E; Strain, Eric C

    2017-09-01

    Opioid use disorder (OUD) is a significant public health problem. Supervised withdrawal (ie, detoxification) from opioids using clonidine or buprenorphine hydrochloride is a widely used treatment. To evaluate whether tramadol hydrochloride extended-release (ER), an approved analgesic with opioid and nonopioid mechanisms of action and low abuse potential, is effective for use in supervised withdrawal settings. A randomized clinical trial was conducted in a residential research setting with 103 participants with OUD. Participants' treatment was stabilized with morphine, 30 mg, administered subcutaneously 4 times daily. A 7-day taper using clonidine (n = 36), tramadol ER (n = 36), or buprenorphine (n = 31) was then instituted, and patients were crossed-over to double-blind placebo during a post-taper period. The study was conducted from October 25, 2010, to June 23, 2015. Retention, withdrawal symptom management, concomitant medication utilization, and naltrexone induction. Results were analyzed over time and using area under the curve for the intention-to-treat and completer groups. Of the 103 participants, 88 (85.4%) were men and 43 (41.7%) were white; mean (SD) age was 28.9 (10.4) years. Buprenorphine participants (28 [90.3%]) were significantly more likely to be retained at the end of the taper compared with clonidine participants (22 [61.1%]); tramadol ER retention was intermediate and did not differ significantly from that of the other groups (26 [72.2%]; χ2 = 8.5, P = .01). Time-course analyses of withdrawal revealed significant effects of phase (taper, post taper) for the Clinical Opiate Withdrawal Scale (COWS) score (taper mean, 5.19 [SE, .26]; post-taper mean, 3.97 [SE, .23]; F2,170 = 3.6, P = .03) and Subjective Opiate Withdrawal Scale (SOWS) score (taper mean,8.81 [SE, .40]; post-taper mean, 4.14 [SE, .30]; F2,170 = 15.7, P withdrawal severity between the taper and post-taper periods for clonidine (taper mean, 13.1; post

  12. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available 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.

  13. Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane.

    Science.gov (United States)

    Ivanic, Gerd M; Pink, Peter T; Schneider, Frank; Stuecker, Markus; Homann, Nicolaus C; Preidler, Klaus W

    2006-09-01

    A randomized clinical trial compared two materials used to prevent epidural scarring after microdiscectomy. To determine whether ADCON-L Gel (ALG) or Preclude Spinal Membrane (PSM) was more effective in preventing scarring, reducing pain, and improving quality of life postoperatively. Postdiscectomy syndrome may result from epidural scarring. Various materials have been used in attempts to prevent this problem, but none have provided optimal results. Previous laboratory and clinical studies have found ALG and PSM to be effective, but none compared the two materials. Thirty-one patients undergoing primary microdiscectomy were randomly assigned to receive either ALG or PSM. Postoperatively, patients were evaluated by magnetic resonance imaging (MRI), with contrast, for volume and rostral-caudal extent of scar tissue and nerve root involvement. Back and leg pain and quality of life were assessed by neurologic examinations and standardized patient surveys. Findings at any reoperations were recorded. Results in the PSM (n = 18) and ALG (n = 13) groups were compared statistically. No operative or postoperative complications occurred. Two patients in each group required reoperation. MRI at 6 months showed no, mild or mild-moderate scarring in most patients, with no significant differences between the ALG and PSM groups in scar volume and extent or nerve root involvement. Neurologic examinations and patient surveys showed substantial reductions in pain over time in both groups but no significant differences between groups. PSM was easy to see and remove at reoperation. PSM and ALG are equally effective in preventing epidural scarring associated with postdiscectomy syndrome.

  14. Randomized Clinical Trial of Intraosseous Methylprednisolone Injection for Acute Pulpitis Pain.

    Science.gov (United States)

    Bane, Khaly; Charpentier, Emmanuel; Bronnec, François; Descroix, Vianney; Gaye-N'diaye, Fatou; Kane, Abdoul Wahabe; Toledo, Rafael; Machtou, Pierre; Azérad, Jean

    2016-01-01

    The present study reports the results of a randomized clinical trial comparing local intraosseous methylprednisolone injection and emergency pulpotomy in the management of acute pulpitis on efficacy, safety, and efficiency end points. After providing prior informed written consent, 94 patients consulting for acute irreversible pulpitis pain at university-affiliated teaching hospital dental clinics in Dakar, Senegal were randomly assigned to either the methylprednisolone treatment group (n = 47) or the pulpotomy treatment group (n = 47). Patients were followed up at 1 week and assessed 6 months later to evaluate the therapeutic outcome of their treatment. At day 7 the patients in the methylprednisolone group reported less intense spontaneous and percussion pain in the day 0-day 7 period than the patients in the pulpotomy group. Methylprednisolone treatment took approximately 7 minutes (4.6-9.3) less to accomplish than pulpotomy (or about half the time). No difference in the therapeutic outcome was found between the 2 treatment groups at 6 months (all credible intervals span 0). This study establishes that methylprednisolone injection for acute pulpitis is relieved by a minimally invasive pharmacologic approach more effectively than by the reference pulpotomy and conserves scarce dental resources (ie, endodontic equipment and supplies, dental surgeon's time). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  15. Repetitive transcranial magnetic stimulation for rehabilitation of poststroke dysphagia: A randomized, double-blind clinical trial.

    Science.gov (United States)

    Du, Juan; Yang, Fang; Liu, Ling; Hu, Jingze; Cai, Biyang; Liu, Wenhua; Xu, Gelin; Liu, Xinfeng

    2016-03-01

    This randomized, sham-controlled, double-blind study was conducted to investigate the effects of high-frequency versus low-frequency repetitive transcranial magnetic stimulation (rTMS) on patients with poststroke dysphagia during early rehabilitation. Forty patients with poststroke dysphagia were randomized to receive five daily sessions of sham, 3-Hz ipsilesional, or 1-Hz contralesional rTMS. Swallowing function, the severity of stroke and functional disability, and cortical excitability were examined before, immediately after five daily sessions, as well as the first, second, and third month after the last session. At baseline, no significant differences between groups were observed in terms of demographic and clinical rating scales. However, a significantly greater improvement in swallowing function as well as functional disability was observed after real rTMS when compared with sham rTMS, which remained 3 months after the end of the treatment sessions. In addition, 1-Hz rTMS increased cortical excitability of the affected hemisphere and decreased that of the non-affected hemisphere; however, 3-Hz rTMS only increased cortical excitability of the affected hemisphere. rTMS (both high and low frequency) improved swallowing recovery in patients with poststroke dysphagia, and the effects lasted for at least 3 months. rTMS appears to be a beneficial therapeutic modality for patients with dysphagia during the early phase of stroke. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available 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.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.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.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, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

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

    Science.gov (United States)

    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

    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. 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. 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 exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. 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, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  18. Clinical effects of probiotics containing Bacillus species on gingivitis: a pilot randomized controlled trial.

    Science.gov (United States)

    Alkaya, B; Laleman, I; Keceli, S; Ozcelik, O; Cenk Haytac, M; Teughels, W

    2017-06-01

    Lactobacillus spp. and bifidobacteria are the most frequently used probiotics in oral health research. However, although probiotic effects have been suggested for other genera, such as bacilli, no trials are available to describe the effect of bacilli probiotics on gingivitis in humans. The aim of the present study was to evaluate the clinical effects of a bacilli-containing toothpaste, a mouthrinse and a toothbrush cleaner versus a placebo in patients with generalized gingivitis. In this double-blind placebo-controlled randomized clinical trial, nonsmoking, systemically healthy patients with generalized gingivitis were included. They used a placebo or an experimental probiotic Bacillus subtilis-, Bacillus megaterium- and Bacillus pumulus-containing toothpaste, mouthrinse and toothbrush cleaner for 8 wk. Primary outcome measures of interest were plaque and gingivitis index, and the secondary outcome measures were pocket probing depth and bleeding on probing. Twenty male and 20 female patients were randomized over the two groups. All participants could be included in the final analysis. Although plaque and gingivitis indices were significantly reduced after 8 wk, no intergroup differences could be found at any time point. Also, for the secondary outcome measure, intragroup but no intergroup differences could be detected. No harm or unintended effects were reported by the patients after using the study products. This study did not show any statistically significant differences between a placebo and a bacilli-containing toothpaste, mouthrinse and toothbrush cleaner on gingivitis parameters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Is Ceftizoxime an Appropriate Surrogate for Amikacin in Neonatal Sepsis Treatment? A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Peyman Salamati

    2011-08-01

    Full Text Available Neonatal sepsis, a life-threatening condition, presents with non-specific clinical manifestations and needs immediate empirical antimicrobial therapy. Choosing an appropriate antibiotic regimen covering the most probable pathogens is an important issue. In this study we compared the effectiveness of ceftizoxime and amikacin in the treatment of neonatal sepsis both in combination with ampicillin. In a randomized clinical trial, all term neonates with suspected sepsis referred to Bahrami hospital during March 2008 to March 2010 were evaluated. Patients were randomly recruited into two groups; one group receiving ampicillin and amikacin and the other ampicillin and ceftizoxime. Blood, urine and cerebrospinal fluid cultures, leukocyte count and C-reactive protein level were measured in all neonates. A total of 135 neonates were evaluated, 65 in amikacin group and 70 in ceftizoxime group. 60 neonates (85.7% in ceftizoxime group and 54 neonates (83.1% in amikacin group responded to the treatment (P= 0.673 and χ2 = 0.178. Only 24 (18% blood samples had a report of positive blood culture. The most frequent pathogen was coagulase negative staphylococcus with the frequency of 58.32% of all positive blood samples. Ceftizoxime in combination with ampicillin is an appropriate antimicrobial regimen for surrogating the combination of ampicillin and amikacin to prevent bacterial resistance against them.

  20. Immediate Occlusal versus Non-Occlusal Loading of Implants: A Randomized Clinical Pilot Study.

    Science.gov (United States)

    Vogl, Susanne; Stopper, Marlene; Hof, Markus; Wegscheider, Walther A; Lorenzoni, Martin

    2015-06-01

    Immediate occlusal and non-occlusal loading protocols have been discussed and, despite varying success rates, are considered viable in selected cases. Preoperative implant planning and intraoperative transfer are essential to the success of implant-supported reconstructions in partially or completely edentulous jaws. This study was performed to compare clinical outcomes of immediate occlusal versus non-occlusal loading of posterior implants. Of 19 patients with 52 screw-type implants replacing mandibular molars or premolars, nine patients with 21 implants were randomized to a study group that received immediate restorations with occlusal loading, whereas 10 patients with 31 implants were randomized to a control group that received provisional restorations without occlusal loading. Occlusal loading was defined as full loading in maximum intercuspidation. Single-tooth or splinted multiunit restorations were incorporated by screw retention or cementation. Marginal bone defects (MBD), implant survival, and implant success were evaluated 12 months after insertion. Both groups revealed similar MBD levels consistent with previous reports. No implants were lost (overall survival: 100%) or found to fail (overall success: 100%). No significant intergroup differences were noted for any of the evaluated parameters. Immediate restorations in partially edentulous mandibles demonstrated successful clinical and radiographic 12-month results. Larger long-term prospective studies are needed to confirm the final evidence and predictability of immediate functional loading as a standard treatment concept for partially edentulous jaws. © 2013 Wiley Periodicals, Inc.

  1. Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481

    Directory of Open Access Journals (Sweden)

    Turner Judith A

    2005-01-01

    Full Text Available Abstract Background Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments. Method and design Two hundred patients with mild to moderate symptoms will be recruited over 3 1/2 years from neurological surgery, primary care, electrodiagnostic clinics. We will exclude patients with clinical or electrodiagnostic evidence of denervation or thenar muscle atrophy. We will randomly assign patients to either a well-defined conservative care protocol or surgery. The conservative care treatment will include visits with a hand therapist, exercises, a self-care booklet, work modification/ activity restriction, B6 therapy, ultrasound and possible steroid injections. The surgical care would be left up to the surgeon (endoscopic vs. open with usual and customary follow-up. All patients will receive a wrist MRI at baseline. Patients will be contacted at 3, 6, 9 and 12 months after randomization to complete the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ. In addition, we will compare disability (activity and work days lost and general well being as measured by the SF-36 version II. We will control for demographics and use psychological measures (SCL-90 somatization and depression scales as well as EDS and MRI predictors of outcomes. Discussion We have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.

  2. Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Pérez-Palomares, Sara; Oliván-Blázquez, Bárbara; Pérez-Palomares, Ana; Gaspar-Calvo, Elena; Pérez-Benito, Marina; López-Lapeña, Elena; de la Torre-Beldarraín, Maria Luisa; Magallón-Botaya, Rosa

    2017-01-01

    Study Design Multicenter, parallel randomized clinical trial. Background Myofascial trigger points (MTrPs) are implicated in shoulder pain and functional limitations. An intervention intended to treat MTrPs is dry needling. Objectives To investigate the effectiveness of dry needling in addition to evidence-based personalized physical therapy treatment in the treatment of shoulder pain. Methods One hundred twenty patients with nonspecific shoulder pain were randomly allocated into 2 parallel groups: (1) personalized, evidencebased physical therapy treatment; and (2) trigger point dry needling in addition to personalized, evidence-based physical therapy treatment. Patients were assessed at baseline, posttreatment, and 3-month follow-up. The primary outcome measure was pain assessed by a visual analog scale at 3 months, and secondary variables were joint range-of-motion limitations, Constant-Murley score for pain and function, and number of active MTrPs. Clinical efficacy was assessed using intention-to-treat analysis. Results Of the 120 enrolled patients, 63 were randomly assigned to the control group and 57 to the intervention group. There were no significant differences in outcome between the 2 treatment groups. Both groups showed improvement over time. Conclusion Dry needling did not offer benefits in addition to personalized, evidencebased physical therapy treatment for patients with nonspecific shoulder pain. Level of Evidence Therapy, level 1b. Registered February 11, 2009 at www.isrctn.com (ISRCTN30907460). J Orthop Sports Phys Ther 2017;47(1):11-20. Epub 9 Dec 2016. doi:10.2519/jospt.2017.6698.

  3. Efficacy of oral cholecalciferol on rhododendrol-induced vitiligo: A blinded randomized clinical trial.

    Science.gov (United States)

    Watabe, Akiko; Yamasaki, Kenshi; Asano, Masayuki; Kanbayashi, Yumi; Nasu-Tamabuchi, Mei; Terui, Hitoshi; Furudate, Sadanori; Kakizaki, Aya; Tsuchiyama, Kenichiro; Kimura, Yutaka; Ito, Yumiko; Kikuchi, Katsuko; Aiba, Setsuya

    2018-02-05

    Rhododendrol (RD), 4-(4-hydroxyphenyl)-2-butanol, inhibits melanin synthesis and has been used for skin-whitening cosmetic products. RD has been very effective in lightening skin pigmentation, but some persons have developed so-called RD vitiligo, in which vitiligo starts on the face, neck and hands where topical RD has been applied and even extended over skin areas where RD has not been applied. RD vitiligo lesions in some patients have lasted for years and have been resistant to conventional vitiligo treatments. We examined the effects of cholecalciferol on RD vitiligo in a blinded randomized clinical trial. Forty-eight female RD vitiligo patients were recruited for the trial and were randomized into two groups: the vitamin D (VD)-intervention group that received daily 5000 IU cholecalciferol for 5 months and the control group. Three blinded investigators scored vitiligo improvement by comparing photographic images of baseline and at 5-month observation. Serum 25(OH)D3 of RD vitiligo patients was not significantly different from age-matched healthy volunteers. Twenty-two in the VD-intervention group and 23 in the control group completed the 5-month observation. Serum 25(OH)D3 levels were significantly increased after the 5-month VD intervention, while the control group did not change. The improvement scores were significantly higher in the VD-intervention group than the control group. The improvement scores were positively correlated with the serum 25(OH)D3 levels after the 5-month intervention period but not before the treatment. This blinded randomized clinical trial showed favor in administrating 5000 IU cholecalciferol daily to RD vitiligo patients. © 2018 Japanese Dermatological Association.

  4. Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

    Science.gov (United States)

    Bueno, Letícia Rossi; Binda, Marcia; Monego, Heleusa; Scherer, Roberta Luísa; Rolim, Karen Machado; Bottini, Alessandra Leal; Fregnani, José H T G; dos Reis, Ricardo

    2015-06-01

    Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries. Randomized clinical trial. Hospital de Clínicas de Porto Alegre (HCPA). 102 patients that underwent cold knife conization. Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures. blood loss measured in grams. operative time and postoperative intervention. Only the participants were blinded to group assignment. From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082). Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  5. Clinic and Home-Based Behavioral Intervention for Obesity in Preschoolers: A Randomized Trial.

    Science.gov (United States)

    Stark, Lori J; Spear Filigno, Stephanie; Bolling, Christopher; Ratcliff, Megan B; Kichler, Jessica C; Robson, Shannon M; Simon, Stacey L; McCullough, Mary Beth; Clifford, Lisa M; Odar Stough, Cathleen; Zion, Cynthia; Ittenbach, Richard F

    2018-01-01

    To test the hypotheses that an innovative skills-based behavioral family clinic and home-based intervention (LAUNCH) would reduce body mass index z score (BMIz) compared with motivational interviewing and to standard care in preschool-aged children with obesity. Randomized controlled trial with children between the ages of 2 and 5 years above the 95 th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012 and June 8, 2015. Children were randomized to LAUNCH (an 18-session clinic and home-based behavioral intervention), motivational interviewing (delivered at the same frequency as LAUNCH), or standard care (no formal intervention). Weight and height were measured by assessors blinded to participant assignment. The primary outcome, BMIz at month 6 after adjusting for baseline BMIz, was tested separately comparing LAUNCH with motivational interviewing and LAUNCH with standard care using regression-based analysis of covariance models. A total of 151 of the 167 children randomized met intent-to-treat criteria and 92% completed the study. Children were 76% White and 57% female, with an average age of 55 months and BMI percentile of 98.57, with no demographic differences between the groups. LAUNCH participants demonstrated a significantly greater decrease in BMIz (mean = -0.32, SD = ±0.33) compared with motivational interviewing (mean = -0.05, SD = ±0.27), P age children, an intensive 6-month behavioral skills-based intervention is necessary to reduce obesity. Clinicaltrials.gov NCT01546727. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Taha, Nessrin A; Khazali, Mohammad A

    2017-09-01

    This study aimed to assess the outcome of partial pulpotomy using mineral trioxide aggregate (MTA) compared with calcium hydroxide (CH) in mature cariously exposed permanent molars. Fifty permanent molar teeth with carious exposures in 50 patients >20 years old were included. Preoperative pulpal and periapical diagnosis was established based on a history of presenting pain, results of cold testing, and radiographic findings. After informed consent, the tooth was anesthetized, isolated via a dental dam, and disinfected with 5% sodium hypochlorite before caries excavation. Partial pulpotomy was performed by amputating 2 mm of the exposed pulp, hemostasis was achieved, and the tooth was randomly assigned for the placement of either white MTA (White ProRoot; Dentsply, Tulsa, OK) or CH (Dycal; Dentsply Caulk, Milford, DE) as the pulpotomy agent. Postoperative periapical radiographs were taken after placement of the permanent restoration. Clinical and radiographic evaluation was completed after 6 months and 1 and 2 years postoperatively. Statistical analysis was performed using the Fisher exact test. Clinical signs and symptoms suggestive of irreversible pulpitis were established in all teeth. Immediate failure occurred in 4 teeth. At 1 year, MTA showed a higher tendency toward success compared with the CH group, and the difference was statistically significant after 2 years (83% vs 55%, P = .052 at 1 year; 85% vs 43%, P = .006 at 2 years). Sex did not have a statistically significant effect on the outcome. MTA partial pulpotomy sustained a good success rate over the 2-year follow-up in mature permanent teeth clinically diagnosed with irreversible pulpitis. More than half of the CH cases failed within 2 years. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation

    Directory of Open Access Journals (Sweden)

    Alexa A. Lopez

    2016-03-01

    Full Text Available Abstract Background This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. Methods Participants (N = 520 will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. Discussion Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. Trial registration TRN: NCT02342795 , registered December 16, 2014.

  8. Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Arruda Viani, Gustavo, E-mail: gusviani@gmail.com [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Carrara Fonseca, Ellen [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); De Fendi, Ligia Issa [Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Melani Rocha, Eduardo [Department of Ophthalmology, School of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto (Brazil)

    2012-03-01

    Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.

  9. Subsidence after anterior cervical inter-body fusion. A randomized prospective clinical trial.

    Science.gov (United States)

    Kast, Erich; Derakhshani, Sharam; Bothmann, Matthias; Oberle, Joachim

    2009-04-01

    In ventral fusion after anterior cervical discectomy there is still a remarkable number of cage subsidence and segmental kyphosis seen. The aim of the present study is to assess whether the cage design influences the extent of correction loss during follow-up. Sixty patients with single-level cervical disc herniation were randomly treated with two different cervical inter-body cages (group 1: Solis cage, Stryker Company and group 2: Shell cage, AMT Company). Clinical and radiological follow-up was done before and after surgery, 3 and 6 months post-surgery. Clinical follow-up was done with the help of Odom's criteria. Both groups were similar in the baseline parameters (age, sex, treated level). Statistically, the subsidence was significantly higher at 3 and 6-month follow-ups in group 1 than in group 2, however, clinical results showed no significant differences. In 67%, subsidence was seen in the anterior lower aspect of the treated segment. Segmental kyphosis was seen in seven patients of group 1 and two patients of group 2. A significant correlation is found between Odom's criteria and subsidence. Although there was no significant difference in a short-term clinical result between the two treatment groups, we recommend the use of cages which preserve the determined segmental height and lordosis.

  10. Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial.

    Science.gov (United States)

    Botkin, Jeffrey R; Rothwell, Erin; Anderson, Rebecca A; Rose, Nancy C; Dolan, Siobhan M; Kuppermann, Miriam; Stark, Louisa A; Goldenberg, Aaron; Wong, Bob

    2016-06-01

    Research clearly indicates that current approaches to newborn blood spot screening (NBS) education are ineffective. Incorporating NBS education into prenatal care is broadly supported by lay and professional opinion. To determine the efficacy and effect of prenatal education about newborn screening and use of residual dried blood spots (DBS) in research on parental knowledge, attitudes, and behaviors. A randomized clinical trial of prenatal educational interventions, with outcomes measured by survey at 2 to 4 weeks postpartum. Participants were recruited from obstetric clinics in Salt Lake City, Utah; San Francisco, California; and the Bronx, New York. Eligible women were English- or Spanish-speaking adults and did not have a high-risk pregnancy. A total of 901 women were enrolled. Participants who completed the follow-up survey included 212 women in the usual care group (70% retention), 231 in the NBS group (77% retention), and 221 women in the NBS + DBS group (75% retention). Those who completed the survey were similar across the 3 groups with respect to age, ethnicity, race, education, marital status, income, obstetric history, and language. Participants were randomized into 1 of 3 groups: usual care (n = 305), those viewing an NBS movie and brochure (n = 300), and those viewing both the NBS and DBS movies and brochures (n = 296). Two to four weeks postpartum, women completed a 91-item survey by telephone, addressing knowledge, attitudes, and behavior with respect to opting out of NBS or DBS for their child. A total of 901 women (mean age, 31 years) were randomized and 664 completed the follow-up survey. The total correct responses on the knowledge instrument in regard to NBS were 69% in the usual care group, 79% in the NBS group, and 75% in the NBS + DBS group, a significant between-group difference (P women who were "very supportive" was highest in the NBS group (94%), followed by the NBS + DBS group (86%) and was lowest in the usual care

  11. Evaluation the Effect of Intrathecally Fentanyl Added to Lidocaine on Interception of Shivering in Abdominal Hysterectomy: Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Maziar Mahjoubifard

    2017-01-01

    Full Text Available Background Shivering is a frequent phenomenon in postoperative period. Post spinal shivering causes a major distress for patients and may induce some complications. Investigations to control shivering could not mange it completely. Objectives The aim of this randomized single-blind study was to investigate how much the high dose (50 μg of intrathecally administered fentanyl would influence the incidence and severity of shivering in patients undergoing abdominal hysterectomy. Methods In this prospective clinical trial, seventy healthy patients scheduled for abdominal hysterectomy under spinal anesthesia using 75 mg of hyperbaric 5% lidocaine were randomly allocated to receive an additional 50 μg (1 mL of fentanyl intrathecally (group F or normal saline 1 mL (groups.Then the level of shivering was measured with crossly and mahajon scale and analyzed with chi-square test using SPSS version 17 software. Results The incidence of shivering up to two hours after spinal anesthesia was 13 from 35 patients (37.2 % in group F, and 27 from 35 patients (77.2% in group S. The difference was statistically significant (P < 0.01. The shivering score was significantly lower in group F. There was no difference in the incidence of pharmacologic side effects. Conclusions Addition of 50 μg fentanyl to 75 mg of hyperbaric 5% lidocaine intrathecally can reduce the incidence and severity of shivering in patients who receive abdominal hysterectomy without increasing other side effects.

  12. Amitriptyline Versus Pregabalin in Post Herpetic Neuralgia: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arun Achar

    2013-09-01

    Full Text Available Objective: Post herpetic neuralgia is a most common complication of herpes zoster which is difficult to treat. Significant beneficial effects found when treated with antiviral, tricyclic antidepressant, anticonvulsive like gabapentine and pregabalin, opioid and non opioid analgesic etc. Primary prevention can also be done with vaccine. The aim of this randomized comparative study was to establish clinical efficacy with amitriptyline and pregabalin. Methods: An open ended randomized clinical trial was conducted to compared clinical efficacy of amitriptyline (n=25 and pregabalin (n=25. Amitriptyline was given 25 mg once daily and pregabalin 75 mg twice daily. Total period of treatment were 6 month and patients were reviewed at the end of 2months, 4months and 6months to evaluate the degree of improvement in pain perception and any adverse reaction. Results: Four types of patients were included in this study and among them thoracic type was the commonest (54%. It was followed by cervical (24%, trigeminal (16% and lumbosacral types (6%. According to VAS score, satisfactory significant improvements in pain perception was observed at the end of 2 months (36%vs 8%, p<0.05 and 4 months (61.9%vs 27.8%, p<0.05 in pregabalin group than amitriptyline group. The chances of improvement more than 6 times and 4 times higher in patients with pregabalin group than those in amitriptyline group. There is no significant improvement difference was noticed at the end of 6months between groups. However, improvement was 89%(OR=1.89, 95%CI: 0.53-6.68 higher in pregabalin group than amitriptyline group. More importantly dizziness was the commonest side effect in pregabalin group while dryness of mouth was the commonest side affect in amitriptyline group. Conclusion: In conclusion, therapy with pregabalin is better compare to amitriptyline in post herpetic neuralgia. However a similar study with larger augmentation is required to establish the findings.

  13. Methotrexate Dosage Reduction Upon Adalimumab Initiation: Clinical and Ultrasonographic Outcomes from the Randomized Noninferiority MUSICA Trial.

    Science.gov (United States)

    Kaeley, Gurjit S; Evangelisto, Amy M; Nishio, Midori J; Goss, Sandra L; Liu, Shufang; Kalabic, Jasmina; Kupper, Hartmut

    2016-08-01

    To examine the clinical and ultrasonographic (US) outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA). MUSICA (NCT01185288) was a double-blind, randomized, parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening. Patients were randomized to high dosage (20 mg/week) or low dosage (7.5 mg/week) MTX; all patients received 40 mg open-label ADA every other week for 24 weeks. The primary endpoint was Week 24 mean 28-joint Disease Activity Score based on C-reactive protein (DAS28-CRP) to test for noninferiority of low-dosage MTX using a 15% margin. US images were scored using a 10-joint semiquantitative system incorporating OMERACT definitions for pathology, assessing synovial hypertrophy, vascularity, and bony erosions. Rapid improvement in clinical indices was observed in both groups after addition of ADA. The difference in mean DAS28-CRP (0.37, 95% CI 0.07-0.66) comparing low-dosage (4.12, 95% CI 3.88-4.34) versus high-dosage MTX (3.75, 95% CI 3.52-3.97) was statistically significant and non-inferiority was not met. Statistically significant differences were not detected for most clinical, functional, and US outcomes. Pharmacokinetic and safety profiles were similar. In MUSICA, Week 24 mean DAS28-CRP, the primary endpoint, did not meet non-inferiority for the low-dosage MTX group. Although the differences between the 2 MTX dosage groups were small, our study findings did not support routine MTX reduction in MTX inadequate responders initiating ADA.

  14. Perioperative intravenous acetaminophen attenuates lipid peroxidation in adults undergoing cardiopulmonary bypass: a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Frederic T Billings

    Full Text Available Cardiopulmonary bypass (CPB lyses erythrocytes and induces lipid peroxidation, indicated by increasing plasma concentrations of free hemoglobin, F2-isoprostanes, and isofurans. Acetaminophen attenuates hemeprotein-mediated lipid peroxidation, reduces plasma and urine concentrations of F2-isoprostanes, and preserves kidney function in an animal model of rhabdomyolysis. Acetaminophen also attenuates plasma concentrations of isofurans in children undergoing CPB. The effect of acetaminophen on lipid peroxidation in adults has not been studied. This was a pilot study designed to test the hypothesis that acetaminophen attenuates lipid peroxidation in adults undergoing CPB and to generate data for a clinical trial aimed to reduce acute kidney injury following cardiac surgery.In a prospective double-blind placebo-controlled clinical trial, sixty adult patients were randomized to receive intravenous acetaminophen or placebo starting prior to initiation of CPB and for every 6 hours for 4 doses. Acetaminophen concentrations measured 30 min into CPB and post-CPB were 11.9 ± 0.6 μg/mL (78.9 ± 3.9 μM and 8.7 ± 0.3 μg/mL (57.6 ± 2.0 μM, respectively. Plasma free hemoglobin increased more than 15-fold during CPB, and haptoglobin decreased 73%, indicating hemolysis. Plasma and urinary markers of lipid peroxidation also increased during CPB but returned to baseline by the first postoperative day. Acetaminophen reduced plasma isofuran concentrations over the duration of the study (P = 0.05, and the intraoperative plasma isofuran concentrations that corresponded to peak hemolysis were attenuated in those subjects randomized to acetaminophen (P = 0.03. Perioperative acetaminophen did not affect plasma concentrations of F2-isoprostanes or urinary markers of lipid peroxidation.Intravenous acetaminophen attenuates the increase in intraoperative plasma isofuran concentrations that occurs during CPB, while urinary markers were unaffected.ClinicalTrials.gov NCT

  15. Application of a new method to determine the modal parameters of tall buildings under random wind loading

    NARCIS (Netherlands)

    Steenbergen, R.D.J.M.; Lentzen, S.S.K.

    2011-01-01

    Modal properties of high rise buildings are mostly derived from measurements on existing buildings under dynamic random wind loading. Measured accelerometer signals are translated into values for the natural frequency and damping. In order to obtain reliable values for the modal properties, the

  16. Effectiveness of Earplugs in Preventing Recreational Noise-Induced Hearing Loss: A Randomized Clinical Trial.

    Science.gov (United States)

    Ramakers, Geerte G J; Kraaijenga, Véronique J C; Cattani, Guido; van Zanten, Gijsbert A; Grolman, Wilko

    2016-06-01

    The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem. To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure. A randomized, single-blind clinical trial was conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Normal-hearing adult volunteers were recruited via social media. An exclusion criterion was the participants' intention to wear earplugs. Of the 86 volunteers assessed, 51 were included in the study. All analyses were performed on an intention-to-treat basis. Participants were randomly assigned to a group using earplugs or an unprotected group during a 4½-hour festival visit. The primary study outcome was a temporary threshold shift (TTS) on the audiogram, primarily for frequencies at 3 and 4 kHz. Secondary study outcomes included distortion product otoacoustic emission (DPOAE) measurements and claims of tinnitus using a questionnaire and tinnitus matching experiments. Of 51 participants included, 25 were randomized to the earplug group and 26 to the unprotected group. Nine in each group (36% and 35%, respectively) were men, and the mean (SD) ages were 27.3 (5.6) years in the earplug group and 27.0 (6.2) years in the unprotected group. Baseline demographics were similar in both groups. The time-averaged, equivalent A-weighted sound pressure level experienced was 100 dBA during the festival. A TTS over frequencies at 3 and 4 kHz after exposure was seen in 4 of 50 ears (8%) in the earplug group compared with 22 of 52 ears (42%) in the unprotected group (P preventing 1 TTS was 2.9. The DPOAE amplitudes decreased significantly more over the frequencies 2 to 8 kHz in the unprotected group: the mean (SD) decrease in magnitude was 0.6 (2.8) dB in the earplug group vs 2.2 (1.9) dB in the unprotected group (P = .04). Newly induced tinnitus following sound exposure occurred in 3 of

  17. Implants in free fibula flap supporting dental rehabilitation - Implant and peri-implant related outcomes of a randomized clinical trial.

    Science.gov (United States)

    Kumar, Vinay V; Ebenezer, Supriya; Kämmerer, Peer W; Jacob, P C; Kuriakose, Moni A; Hedne, Naveen; Wagner, Wilfried; Al-Nawas, Bilal

    2016-11-01

    The objective of this study was to assess the difference in success rates of implants when using two or four implant-supported-overdentures following segmental mandibular reconstruction with fibula free flap. This prospective, parallel designed, randomized clinical study was conducted with 1:1 ratio. At baseline, all participants already had segmental reconstruction of mandible with free fibula flap. The participants were randomized into two groups: Group-I received implant-supported-overdentures on two tissue-level implants and Group-II received implant-supported-overdentures on four tissue-level implants. Success rates of the implants were evaluated at 3 months, 6 months and 12 months following implant loading using marginal bone level changes as well as peri-implant indices (Buser et al., 1990). 52 patients were randomized into two treatment groups (26 each), out of which 18 patients (36 implants) of Group-I and 17 patients (68 implants) of Group-II were evaluated. One implant in Group-I was lost due to infective complications and one patient in the same group had superior barrel necrosis. There was a statistically significant increase at both time points (p = 0.03, p = 0.04 at 6 months, 12 months) in the amount of marginal bone loss in Group-I (0.4 mm, 0.5 mm at 6 months, 12 months) as compared to Group-II (0.1 mm, 0.2 mm at 6 months, 12 months). There were no clinically significant changes peri-implant parameters between both groups. Peri-implant soft tissue hyperplasia was seen in both groups, 32% of implants at 3-months, 26% at 6-months and 3% at 12-months follow-up. The results of this study show that patients with 2-implant-supported-overdentures had higher marginal bone loss as compared to patients with 4-implant-supported-overdentures. There were no clinically significant differences in peri-implant soft tissue factors in patients with 2- or 4-implant-supported-overdentures. Hyperplastic peri-implant tissues are common in the early implant

  18. Managing bone health with zoledronic acid: a review of randomized clinical study results.

    Science.gov (United States)

    Hadji, P

    2011-06-01

    To systematically review randomized, controlled clinical trials for managing osteoporosis, cancer treatment-induced bone loss, and bone metastases from breast cancer using zoledronic acid (ZOL). A systematic review of published literature and meeting abstracts was conducted to examine the efficacy of ZOL dosing strategies in clinical trials of osteoporosis, adjuvant therapy for breast cancer, and bone metastases from breast cancer. Bone resorption rates, tumor burden, skeletal health goals, and clinical data were considered when assessing ZOL in each setting. Dosing schedules vary between approved indications for osteoporosis and bone metastases and the investigational use in women receiving endocrine therapy for BC, taking into consideration the different levels of bone loss and tumor burden in each setting. Gradual bone loss in healthy postmenopausal women with osteopenia or osteoporosis can be prevented or treated with the approved biennial or annual ZOL (5 mg), respectively. Rapid bone loss in patients receiving adjuvant chemotherapy and/or endocrine therapy for early-stage BC and low tumor burden is managed in the clinical setting with ZOL 4 mg every 6 months. In patients with bone metastases, very high tumor burden, high bone resorption levels, and decreases in bone integrity are managed by the approved ZOL schedule (4 mg every 3-4 weeks) to prevent skeleton-related events. Dosing schedules are based on clinical evidence and vary depending on goals of therapy, rate of bone loss, and tumor burden. ZOL 5 mg every 12 months and every 24 months are approved for osteoporosis and osteopenia, respectively, whereas ZOL 4 mg every 6 months has been used during adjuvant endocrine therapy and ZOL 4 mg every 3-4 weeks is approved for managing bone metastases.

  19. Eugenia uniflora Dentifrice for Treating Gingivitis in Children: Antibacterial Assay and Randomized Clinical Trial.

    Science.gov (United States)

    Jovito, Vanessa de Carvalho; Freires, Irlan Almeida; Ferreira, Danilo Augusto de Holanda; Paulo, Marçal de Queiroz; Castro, Ricardo Dias de

    2016-01-01

    School-age children are frequently at high risk for the onset of biofilm-dependent conditions, including dental caries and periodontal diseases. The objective of this study was to evaluate the clinical efficacy of a dentifrice containing Eugenia uniflora Linn. (Surinam cherry) extract versus a triclosan-based comparator in treating gingivitis in children aged 10-12 years. The in vitro antibacterial potential of the dentifrice was tested against oral pathogens (Streptococcus mutans, Streptococcus oralis and Lactobacillus casei). Then a phase-II clinical trial was conducted with 50 subjects aged 10-12 years, with clinical signs of gingivitis. The subjects were randomly assigned to the experimental group (n=25) and control group (n=25), in which participants used the experimental dentifrice and a triclosan-based fluoridated dentifrice (Colgate Total 12(r)), respectively. Clinical examinations assessed the presence of gingivitis (primary outcome) and biofilm accumulation (secondary outcome) using the Gingival-Bleeding Index (GBI) and Simplified Oral Hygiene Index (OHI-S), respectively, at baseline and after seven days of tooth brushing 3x/day. The data were analyzed using paired and unpaired t-test (GBI) and Wilcoxon and Mann-Whitney (OHI-S), with p≤0.05. The experimental dentifrice showed efficient antibacterial activity in vitro. In the clinical trial, a significant reduction in gingival bleeding was observed in both experimental and control groups (pgingivitis properties in children aged 10-12 years. Thus, it may be a potentially efficient and safe product to be used alternatively in preventive dental practice.

  20. Clinical Inertia in a Randomized Trial of Telemedicine-Based Chronic Disease Management: Lessons Learned.

    Science.gov (United States)

    Barton, Anna Beth; Okorodudu, Daniel E; Bosworth, Hayden B; Crowley, Matthew J

    2018-01-17

    Treatment nonadherence and clinical inertia perpetuate poor cardiovascular disease (CVD) risk factor control. Telemedicine interventions may counter both treatment nonadherence and clinical inertia. We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. In this analysis of a randomized trial, we studied recipients of the 12-month telemedicine intervention. This intervention comprised two nurse-administered components: (1) monthly self-management education targeting improved treatment adherence; and (2) quarterly medication management facilitation designed to support treatment intensification by primary care (thereby reducing clinical inertia). For each medication management facilitation encounter, we ascertained whether patients met treatment goals, and if not, whether primary care recommended treatment intensification following the encounter. We assessed disease control associated with encounters, where intensification was/was not recommended. We examined 455 encounters across 182 intervention recipients (100% African Americans with type 2 diabetes). Even after accounting for valid reasons for deferring intensification (e.g., treatment nonadherence), intensification was not recommended in 67.5% of encounters in which hemoglobin A1c was above goal, 72.5% in which systolic blood pressure was above goal, and 73.9% in which low-density lipoprotein cholesterol was above goal. In each disease state, treatment intensification was more likely with poorer control. Despite enhancing treatment adherence, this intervention was unsuccessful in countering clinical inertia, likely explaining its lack of effect on CVD risk factors. We identify several lessons learned that may benefit investigators and healthcare systems.

  1. Structured postoperative physiotherapy in patients with cervical radiculopathy: 6-month outcomes of a randomized clinical trial.

    Science.gov (United States)

    Wibault, Johanna; Öberg, Birgitta; Dedering, Åsa; Löfgren, Håkan; Zsigmond, Peter; Peolsson, Anneli

    2018-01-01

    OBJECTIVE Structured physiotherapy has been suggested as treatment before as well as after surgery to improve clinical outcomes in patients with cervical radiculopathy (CR), but randomized clinical trials to inform evidence-based clinical guidelines for the treatment of patients with CR after surgery are lacking. The aim of this study was to compare the results of structured postoperative physiotherapy combining neck-specific exercises with a behavioral approach to a standard postoperative approach in patients who had undergone surgery for cervical disc disease with CR at 6 months after surgery. METHODS Patients with cervical disc disease and persistent CR who were scheduled for surgery were randomized preoperatively to structured postoperative physiotherapy (n = 101) or a standard postoperative approach (n = 100). The latter included pragmatic physiotherapy in accordance with the usual Swedish postoperative care. Outcome measures included patient-reported neck disability as measured with the Neck Disability Index (NDI), intensity and frequency of neck and arm pain, global outcome of treatment, and expectation fulfillment, as well as enablement. RESULTS Patients who received structured postoperative physiotherapy reported greater expectation fulfillment (p = 0.01), and those who attended at least 50% of the treatment sessions reported less neck pain frequency (p = 0.05), greater expectation fulfillment (p = 0.001), and greater enablement (p = 0.04) compared with patients who received the standard postoperative approach. No other difference between treatment groups was found (p > 0.15). The NDI and neck and arm pain intensity were improved in both groups at 6 months after surgery (p cervical disc disease with CR. Patients who received structured postoperative physiotherapy reported higher expectation fulfillment, and many patients in the standard postoperative approach group perceived a need for additional treatments after surgery, suggesting that patients with CR

  2. Evaluation of Evidence of Statistical Support and Corroboration of Subgroup Claims in Randomized Clinical Trials.

    Science.gov (United States)

    Wallach, Joshua D; Sullivan, Patrick G; Trepanowski, John F; Sainani, Kristin L; Steyerberg, Ewout W; Ioannidis, John P A

    2017-04-01

    Many published randomized clinical trials (RCTs) make claims for subgroup differences. To evaluate how often subgroup claims reported in the abstracts of RCTs are actually supported by statistical evidence (P SATIRE) articles and Discontinuation of Randomized Trials (DISCO) articles. We used Scopus (updated July 2016) to search for English-language articles citing each of the eligible index articles with at least 1 subgroup finding in the abstract. Articles with a subgroup claim in the abstract with or without evidence of statistical heterogeneity (P < .05 from an interaction test) in the text and articles attempting to corroborate the subgroup findings. Study characteristics of trials with at least 1 subgroup claim in the abstract were recorded. Two reviewers extracted the data necessary to calculate subgroup-level effect sizes, standard errors, and the P values for interaction. For individual RCTs and meta-analyses that attempted to corroborate the subgroup findings from the index articles, trial characteristics were extracted. Cochran Q test was used to reevaluate heterogeneity with the data from all available trials. The number of subgroup claims in the abstracts of RCTs, the number of subgroup claims in the abstracts of RCTs with statistical support (subgroup findings), and the number of subgroup findings corroborated by subsequent RCTs and meta-analyses. Sixty-four eligible RCTs made a total of 117 subgroup claims in their abstracts. Of these 117 claims, only 46 (39.3%) in 33 articles had evidence of statistically significant heterogeneity from a test for interaction. In addition, out of these 46 subgroup findings, only 16 (34.8%) ensured balance between randomization groups within the subgroups (eg, through stratified randomization), 13 (28.3%) entailed a prespecified subgroup analysis, and 1 (2.2%) was adjusted for multiple testing. Only 5 (10.9%) of the 46 subgroup findings had at least 1 subsequent pure corroboration attempt by a meta-analysis or an

  3. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Lindsay S Elliott

    Full Text Available In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110 were randomized to pharmacogenetic profiling (n = 57. The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53 received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR, 0.65; 95% confidence interval (CI, 0.32-1.28; P = 0.21 and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007. The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16 and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045. Differences in composite outcomes at 60 days (exploratory endpoints

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

    Science.gov (United States)

    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. Modeling Clinic for Industrial Mathematics: A Collaborative Project Under Erasmus+ Program

    DEFF Research Database (Denmark)

    Jurlewicz, Agnieszka; Nunes, Claudia; Russo, Giovanni

    2018-01-01

    Modeling Clinic for Industrial Mathematics (MODCLIM) is a Strategic Partnership for the Development of Training Workshops and Modeling Clinic for Industrial Mathematics, funded through the European Commission under the Erasmus Plus Program, Key Action 2: Cooperation for innovation and the exchange...

  6. Comparison of Time-to-First Event and Recurrent Event Methods in Randomized Clinical Trials.

    Science.gov (United States)

    Claggett, Brian; Pocock, Stuart; Wei, L J; Pfeffer, Marc A; McMurray, John J V; Solomon, Scott D

    2018-03-27

    Background -Most Phase-3 trials feature time-to-first event endpoints for their primary and/or secondary analyses. In chronic diseases where a clinical event can occur more than once, recurrent-event methods have been proposed to more fully capture disease burden and have been assumed to improve statistical precision and power compared to conventional "time-to-first" methods. Methods -To better characterize factors that influence statistical properties of recurrent-events and time-to-first methods in the evaluation of randomized therapy, we repeatedly simulated trials with 1:1 randomization of 4000 patients to active vs control therapy, with true patient-level risk reduction of 20% (i.e. RR=0.80). For patients who discontinued active therapy after a first event, we assumed their risk reverted subsequently to their original placebo-level risk. Through simulation, we varied a) the degree of between-patient heterogeneity of risk and b) the extent of treatment discontinuation. Findings were compared with those from actual randomized clinical trials. Results -As the degree of between-patient heterogeneity of risk was increased, both time-to-first and recurrent-events methods lost statistical power to detect a true risk reduction and confidence intervals widened. The recurrent-events analyses continued to estimate the true RR=0.80 as heterogeneity increased, while the Cox model produced estimates that were attenuated. The power of recurrent-events methods declined as the rate of study drug discontinuation post-event increased. Recurrent-events methods provided greater power than time-to-first methods in scenarios where drug discontinuation was ≤30% following a first event, lesser power with drug discontinuation rates of ≥60%, and comparable power otherwise. We confirmed in several actual trials in chronic heart failure that treatment effect estimates were attenuated when estimated via the Cox model and that increased statistical power from recurrent-events methods

  7. Adjunctive use of essential oils following scaling and root planing -a randomized clinical trial.

    Science.gov (United States)

    Azad, Mohammad Fallah; Schwiertz, Andreas; Jentsch, Holger F R

    2016-06-07

    Hitherto no study has been published on the effect of the adjunctive administration of essential oils following scaling and root planing (SRP). This study describes the effect of a mouthrinse consisting of essential oils (Cymbopogon flexuosus, Thymus zygis and Rosmarinus officinalis) following SRP by clinical and microbiological variables in patients with generalized moderate chronic periodontitis. Forty-six patients (aged 40-65 years) with moderate chronic periodontitis were randomized in a double-blind study and rinsed their oral cavity following SRP with an essential oil mouthrinse (n  =  23) or placebo (n  =  23) for 14 days. Probing depth (PD), attachment level (AL), bleeding on probing (BOP) and modified sulcus bleeding index (SBI) were recorded at baseline and after 3 and 6 months. Subgingival plaque was taken for assessment of major bacteria associated with periodontitis. AL, PD, BOP and SBI were significantly improved in both groups after three (p   essential oils following SRP has a positive effect on clinical variables and on bacterial levels in the subgingival biofilm. 332-12-24092012, DRKS 00009387, German Clinical Trials Register, Freiburg i. Br., 16.09.2015.

  8. Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

    Directory of Open Access Journals (Sweden)

    Lona Roll

    2013-01-01

    Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    Background Intravenous administration of dexamethasone 90 min before laparoscopic cholecystectomy improves surgical outcome but may be impractical. The objective of this study was to assess the clinical efficacy of oral self-administration of prednisone 2 h before ambulatory laparoscopic cholecys......Background Intravenous administration of dexamethasone 90 min before laparoscopic cholecystectomy improves surgical outcome but may be impractical. The objective of this study was to assess the clinical efficacy of oral self-administration of prednisone 2 h before ambulatory laparoscopic...... cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

  10. Efficacy of Hippotherapy Versus Pharmacotherapy in Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Oh, Yunhye; Joung, Yoo-Sook; Jang, Byongsu; Yoo, Jae Hyun; Song, Jihye; Kim, Jiwon; Kim, Kiho; Kim, Seonwoo; Lee, Jiyoung; Shin, Hye-Yeon; Kwon, Jeong-Yi; Kim, Yun-Hee; Jeong, Bumseok

    2018-04-11

    Pharmacotherapy among children with attention-deficit/hyperactivity disorder (ADHD) is effective, but many patients suffer from secondary psychiatric problems even after improvement of ADHD core symptoms. Hippotherapy have been used as adjunct treatment options for physical and psychosocial rehabilitation as well as to ameliorate core symptoms. The aim of this study was to investigate the effects of Hippotherapy versus pharmacotherapy for children with ADHD. Thirty-four participants with ADHD were randomly assigned at a 1:1 ratio to either 24 sessions of a twice-weekly hippotherapy or pharmacotherapy. To assess therapeutic effects, the ADHD Rating Scale (ARS) was used pretreatment and posttreatment as the primary outcome measure. Secondary outcomes included the Child Behavior Checklist (CBCL), Self-Esteem Scale (SES), Pediatric Quality of Life Inventory (PedsQL) child and parent report version, Developmental Coordination Disorder Questionnaire (DCDQ), Clinical Global Impressions-Severity (CGI-S), and quantitative electroencephalography. Both groups showed marked improvements in ADHD symptoms, CGI-S. No significant differences between groups were detected regarding treatment outcome except thought problem subscales of CBCL. Twelve weeks of hippotherapy improved attention, impulsivity/hyperactivity, and quality of life. This trial is promising, but further studies are required to evaluate the long-term clinical effectiveness of hippotherapy. The study is registered with ClinicalTrials.gov, number NCT 02482649.

  11. Effect of tamsulosin versus prazosin on clinical and urodynamic parameters in women with voiding difficulty: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Sakineh Hajebrahimi

    2011-01-01

    Full Text Available Sakineh Hajebrahimi1, Yadollah Ahmadi Asrbadr1, Arash Azaripour1, Homayoun Sadeghi-Bazargani2,31Urology Department, Imam Reza University Hospital, Tabriz, Iran; 2Neuroscience Research Center and RDCC, Tabriz University of Medical Sciences, Tabriz, Iran; 3Karolinska Institute, Stockholm, SwedenObjective: To compare the effects of tamsulosin and prazosin on clinical and urodynamic parameters in women with voiding dysfunction.Methods: Forty women aged 20–65 years with a clinical diagnosis of voiding dysfunction were blindly randomized to two equal groups for treatment with tamsulosin 0.4 mg or 1–2 mg of prazosin daily. Symptom assessment with the American Urological Association Symptom Score (AUASS and urodynamic evaluation was performed initially and after three months of treatment. Patient satisfaction was evaluated and severe adverse drug effects recorded. Statistical analysis was carried out using the Student’s t-test and Mann–Whitney U test.Results: Although AUASS improved in both groups, the rate of improvement was larger in the tamsulosin group. Urodynamic parameters improved but did not normalize in both groups. Adverse side effects from medication in the prazosin group were more common than in the tamsulosin group. Most of the patients in the tamsulosin group (80% were satisfied with their treatment compared with those in the prazosin group (45%.Conclusion: Tamsulosin and prazosin are both effective in palliating symptoms of women with voiding dysfunction and improving their urodynamic parameters. Tamsulosin may be the preferred drug to prescribe because of its more amenable side effect profile and greater patient satisfaction.Keywords: tamsulosin, prazosin, voiding dysfunction 

  12. Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial.

    Science.gov (United States)

    Jensen, Rikke K; Leboeuf-Yde, Charlotte; Wedderkopp, Niels; Sorensen, Joan S; Manniche, Claus

    2012-02-29

    Clinical experience suggests that many patients with Modic changes have relatively severe and persistent low back pain (LBP), which typically appears to be resistant to treatment. Exercise therapy is the recommended treatment for chronic LBP, however, due to their underlying pathology, Modic changes might be a diagnostic subgroup that does not benefit from exercise. The objective of this study was to compare the current state-of-the art treatment approach (exercise and staying active) with a new approach (load reduction and daily rest) for people with Modic changes using a randomized controlled trial design. Participants were patients from an outpatient clinic with persistent LBP and Modic changes. They were allocated using minimization to either rest therapy for 10 weeks with a recommendation to rest for two hours daily and the option of using a flexible lumbar belt or exercise therapy once a week for 10 weeks. Follow-up was at 10 weeks after recruitment and 52 weeks after intervention and the clinical outcome measures were pain, disability, general health and global assessment, supplemented by weekly information on low back problems and sick leave measured by short text message (SMS) tracking. In total, 100 patients were included in the study. Data on 87 patients at 10 weeks and 96 patients at one-year follow-up were available and were used in the intention-to-treat analysis. No statistically significant differences were found between the two intervention groups on any outcome. No differences were found between the two treatment approaches, 'rest and reduced load' and 'exercise and staying active', in patients with persistent LBP and Modic changes. ClinicalTrials.gov: NCT00454792.

  13. Rest versus exercise as treatment for patients with low back pain and Modic changes. a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Jensen Rikke K

    2012-02-01

    Full Text Available Abstract Background Clinical experience suggests that many patients with Modic changes have relatively severe and persistent low back pain (LBP, which typically appears to be resistant to treatment. Exercise therapy is the recommended treatment for chronic LBP, however, due to their underlying pathology, Modic changes might be a diagnostic subgroup that does not benefit from exercise. The objective of this study was to compare the current state-of-the art treatment approach (exercise and staying active with a new approach (load reduction and daily rest for people with Modic changes using a randomized controlled trial design. Methods Participants were patients from an outpatient clinic with persistent LBP and Modic changes. They were allocated using minimization to either rest therapy for 10 weeks with a recommendation to rest for two hours daily and the option of using a flexible lumbar belt or exercise therapy once a week for 10 weeks. Follow-up was at 10 weeks after recruitment and 52 weeks after intervention and the clinical outcome measures were pain, disability, general health and global assessment, supplemented by weekly information on low back problems and sick leave measured by short text message (SMS tracking. Results In total, 100 patients were included in the study. Data on 87 patients at 10 weeks and 96 patients at one-year follow-up were available and were used in the intention-to-treat analysis. No statistically significant differences were found between the two intervention groups on any outcome. Conclusions No differences were found between the two treatment approaches, 'rest and reduced load' and 'exercise and staying active', in patients with persistent LBP and Modic changes. Trial Registration ClinicalTrials.gov: NCT00454792

  14. Intracorporeal pneumatic shock application for the treatment of chronic plantar fasciitis: a randomized, double blind prospective clinical trial.

    Science.gov (United States)

    Dogramaci, Yunus; Kalaci, Aydiner; Emir, Anil; Yanat, Ahmet Nedim; Gökçe, Ahmet

    2010-04-01

    Plantar fasciitis (PF) is a common clinical condition that usually resolves with non-operative treatments. Extracorporeal shock wave therapy (ESWT) has been used in the treatment of chronic PF not responding to other conservative measures; however, ESWT devices are expensive and available for daily practice in only few centers (In developing countries). A pneumatic lithotripter is a cheap and readily available device which uses pneumatic shock application for the intracorporeal lithotripsy. The aim of this study was to investigate the clinical efficacy of intracorporeal pneumatic shock therapy (IPST) application for the treatment of chronic PF using a cheap and readily available pneumatic lithotripter. A randomized, double-blind, placebo-controlled study was conducted. A total of 50 patients with clinically and radiologically confirmed PF were randomly allocated to either an active- (treatment) (n = 25) or inactive (placebo) (n = 25) group. Under local anesthesia and posterior tibial nerve block, a rigid probe was directly introduced into the calcaneal spur under fluoroscopic control; a standard protocol of 1,000 shock was applied during a single session into the calcaneal spur. The main outcome measure was the patients' subjective assessment of pain by means of a Visual Analog Scale (VAS) and the Roles and Maudsley Score before the treatment and 6 months later. At the 6 months, the rate of successful outcomes (excellent + good results) in the treatment group (92%) were significantly higher comparing to the control group (24%) (P < 0.001). Heel pain measured 6 months after using the VAS were 2.04 +/- 1.67 in treatment group and 7.16 +/- 1.57 in control group as compared to 8.92 +/- 1.22 and 9.12 +/- 1.23 before the commencement of the treatment. No complications attributable to the procedure such as rupture of the planter fascia, hematoma, or infection were observed during the study. This pilot study showed that IPST is an effective and safe method of treatment of

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

    Science.gov (United States)

    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.

  16. Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jing-Yi Li

    2011-01-01

    Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

  17. The effectiveness of xylitol in a school-based cluster-randomized clinical trial.

    Science.gov (United States)

    Lee, Wonik; Spiekerman, Charles; Heima, Masahiro; Eggertsson, Hafsteinn; Ferretti, Gerald; Milgrom, Peter; Nelson, Suchitra

    2015-01-01

    The purpose of this double-blind, cluster-randomized clinical trial was to examine the effects of xylitol gummy bear snacks on dental caries progression in primary and permanent teeth of inner-city school children. A total of 562 children aged 5-6 years were recruited from five elementary schools in East Cleveland, Ohio. Children were randomized by classroom to receive xylitol (7.8 g/day) or placebo (inulin fiber 20 g/day) gummy bears. Gummy bears were given three times per day for the 9-month kindergarten year within a supervised school environment. Children in both groups also received oral health education, toothbrush and fluoridated toothpaste, topical fluoride varnish treatment and dental sealants. The numbers of new decayed, missing, and filled surfaces for primary teeth (dmfs) and permanent teeth (DMFS) from baseline to the middle of 2nd grade (exit exam) were compared between the treatment (xylitol/placebo) groups using an optimally-weighted permutation test for cluster-randomized data. The mean new d(3-6)mfs at the exit exam was 5.0 ± 7.6 and 4.0 ± 6.5 for the xylitol and placebo group, respectively. Similarly, the mean new D(3-6)MFS was 0.38 ± 0.88 and 0.48 ± 1.39 for the xylitol and placebo group, respectively. The adjusted mean difference between the two groups was not statistically significant: new d(3-6)mfs: mean 0.4, 95% CI -0.25, 0.8), and new D(3-6)MFS: mean 0.16, 95% CI -0.16, 0.43. Xylitol consumption did not have additional benefit beyond other preventive measures. Caries progression in the permanent teeth of both groups was minimal, suggesting that other simultaneous prevention modalities may have masked the possible beneficial effects of xylitol in this trial. © 2014 S. Karger AG, Basel.

  18. A Randomized Clinical Trial of Primary Care Brief Mindfulness Training for Veterans with PTSD.

    Science.gov (United States)

    Possemato, Kyle; Bergen-Cico, Dessa; Treatman, Scott; Allen, Christy; Wade, Michael; Pigeon, Wilfred

    2016-03-01

    Primary care (PC) patients typically do not receive adequate posttraumatic stress disorder (PTSD) treatment. This study tested if a brief mindfulness training (BMT) offered in PC can decrease PTSD severity. VA PC patients with PTSD (N = 62) were recruited for a randomized clinical trial comparing PCBMT with PC treatment as usual. PCBMT is a 4-session program adapted from mindfulness-based stress reduction. PTSD severity decreased in both conditions, although PCBMT completers reported significantly larger decreases in PTSD and depression from pre- to posttreatment and maintained gains at the 8-week follow-up compared with the control group. Exploratory analyses revealed that the describing, nonjudging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of BMT for Veterans with PTSD. Whether PCBMT facilitates engagement into, or improves outcomes of, full-length empirically supported treatment for PTSD remains to be evaluated. © 2015 Wiley Periodicals, Inc.

  19. Efficacy of dioctahedral smectite in acute watery diarrhea in Indian children: a randomized clinical trial.

    Science.gov (United States)

    Mujawar, Quais Mohammad; Naganoor, Ravi; Ali, Mir Dilshad; Malagi, Naushad; Thobbi, Achyut Narayan

    2012-02-01

    To determine the effects and safety of dioctahedral smectite (DS) on the duration of acute watery diarrhea in children. A Randomized, open labeled, clinical controlled trial in a tertiary care hospital outpatient department (OPD) and emergency department. Participants were one hundred and seventeen children without any chronic illness between 2 and 5 years presenting to OPD, having acute watery diarrhea for diarrhea in children aged 2-5 years. There were no adverse effects on the use of DS. DS was acceptable to the children, and its administration was not accompanied with any side effects. DS reduces the duration of diarrhea in Indian children and prevents a prolonged course, and therefore, may consistently reduce the costs in treatment of acute watery diarrhea.

  20. Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Leonice Fumiko Sato Kurebayashi

    2014-06-01

    Full Text Available OBJECTIVE: this randomized single blind clinical study aimed to evaluate the efficacy of auriculotherapy with and without a protocol for reducing stress levels among nursing staff.METHOD: a total of 175 nursing professionals with medium and high scores according to Vasconcelos' Stress Symptoms List were divided into 3 groups: Control (58, Group with protocol (58, Group with no protocol (59. They were assessed at the baseline, after 12 sessions, and at the follow-up (30 days.RESULTS: in the analysis of variance, statistically significant differences between the Control and Intervention groups were found in the two evaluations (p<0.05 with greater size of effect indices (Cohen for the No protocol group. The Yang Liver 1 and 2, Kidney, Brain Stem and Shen Men were the points most used.CONCLUSION: individualized auriculotherapy, with no protocol, could expand the scope of the technique for stress reduction compared with auriculotherapy with a protocol. NCT: 01420835

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

  2. [Met-analysis on randomized controlled clinical trials of acupuncture and moxibustion on constipation].

    Science.gov (United States)

    Du, Wen-Fei; Yu, Lu; Yan, Xing-Ke; Wang, Fu-Chun

    2012-01-01

    To assess the efficacy of acupuncture and moxibustion on constipation. A retrieval on literatures concerning treatment of constipation with acupuncture was carried out in databases of VIP, CNKI, WANFANG and PubMed. And meta-analyses were conducted on randomized controlled trial (RCT) and controlled clinical trial (CCT) which met the enrolling requirements. A total number of 15 papers involving 1 052 patients were concluded. The result indicated that the curative rate of acupuncture and moxibustion on constipation is better than ordinary medication (RR = 1.92, 95% CI 1.61-2.30, Z = 7.18, P singleness still exists in the index of assessment on therapeutic effect of constipation, and the number of RCT and CCT literatures, especially high-quality, large samples and multi-center reports were still not enough, further studies are still necessary for approving the above conclusions.

  3. Therapeutic Effect of Virtual Reality on Post-Stroke Patients: Randomized Clinical Trial.

    Science.gov (United States)

    Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz

    2017-01-01

    The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P < .05. We selected 30 patients, but there were three segment losses, resulting in a total of 13 patients in the control group and 14 in the treatment group. There was an improvement in gait balance and reduced occurrence of falls in both groups. After intervention, the differences in gait balance in the control group (P = .047) and the reduction in the occurrence of falls in the treatment group (P = .049) were significant. However, in intergroup analysis, there was no difference in the two outcomes. Therapy with games was a useful tool for gait balance rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  4. Comparative Effectiveness of Chewing Stick and Toothbrush: A Randomized Clinical Trial

    Science.gov (United States)

    Malik, Aeeza S; Shaukat, Malik S; Qureshi, Ambrina A; Abdur, Rasheed

    2014-01-01

    Background: With the increasing rate of oral diseases, the global necessity of effective and economical products for its prevention and treatment has intensified. Aim: This study was to compare the effectiveness of two oral hygiene aids: Chewing stick and manual toothbrush, for plaque removal and gingival health after one month of a randomized clinical trial. Materials and Methods: Dental students (age 18-22 years) of a public sector dental hospital were recruited. Sample size was determined using the American Dental Association guidelines. Participants were randomized into two interventional groups and provided with either chewing sticks or toothbrushes. Pre- and post-intervention examinations were executed by two blind and calibrated examiners using plaque and gingival dental indices. Statistical analysis included descriptive statistics, paired t-test, and two sample independent t-tests. Results: Fifty subjects were recruited with mean age 20 ± 0.66 years (80% were females and 20% were males). Except for the mean plaque scores of toothbrush users (which increased at post-intervention examination), all other scores showed reduction. In contrast to the final mean gingival scores, a significant difference (P = toothbrush. PMID:25077082

  5. Oral magnesium supplementation reduces the incidence of gastrointestinal complications following cardiac surgery: a randomized clinical trial.

    Science.gov (United States)

    Moradian, Seyed Tayeb; Ghiasi, Mohammad Saeid; Mohamadpour, Alireza; Siavash, Yadollah

    2017-02-01

    Gastrointestinal complications are common after coronary artery bypass graft surgery. These complications are ranged from nausea and vomiting to mesenteric ischemia and liver failure. It seems that nausea, vomiting, and constipation are related to magnesium deficiency. This study was designed to examine the effect of oral magnesium supplementation on the incidence of gastrointestinal complications in patients undergoing cardiac surgery. In a single blinded randomized clinical trial, 102 patients who were undergoing coronary artery bypass graft surgery were randomly allocated into two groups, 52 patients in the intervention and 50 patients in control group. Patients in the experimental group received 800 milligram magnesium oxide (2 tablets each of them containing 240 mg elemental magnesium) daily from the admission to discharge from hospital. The incidence of post-operative nausea and vomiting, constipation, and atrial fibrillation was compared between the groups. Our results showed that postoperative hypomagnesemia is present in 41.20 and 70.80 percent of the patients in the intervention and control group patients, respectively. The overall incidence of constipation was 62%. Patients who received magnesium supplementation experienced less atrial fibrillation, nausea, vomiting, and constipation. Our data showed that oral magnesium supplementation could reduce the postoperative complications. Despite the better status in the intervention group, the hypomagnesemia was present in many of intervention group patients. It seems that supplementation with higher doses is needed.

  6. TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial.

    Science.gov (United States)

    Valpas, A; Ala-Nissilä, S; Tomas, E; Nilsson, C G

    2015-01-01

    Before the introduction of the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence, the colposuspension operation was regarded as the "gold standard" procedure. The laparoscopic variant of the colposuspension was introduced as a less invasive operation. The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension (LCM). A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence. Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence. Patient satisfaction was assessed by Patients Global Impression of Improvement, a visual analog scale, and the Urinary Incontinence Severity Score. Of 128 randomized patients, 121 underwent the allocated operation. At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol. The objective cure rate was significantly higher in the TVT group (94 %) than in the LCM group (78 %). Subjective treatment satisfaction (completely satisfied with the procedure) was significantly higher in the TVT group (64 %) than in the LCM group (51 %). By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group. If cases that were lost to follow-up were regarded as failures, the intension-to-treat analysis found no difference between the groups.

  7. Bird's nest versus the Kimray-Greenfield inferior vena cava filter: Randomized clinical study

    International Nuclear Information System (INIS)

    Athanasoulis, C.A.; Roberts, A.C.; Brown, K.; Geller, S.C.; Waltman, A.C.; Eckstein, M.R.

    1987-01-01

    A randomized clinical study was conducted comparing the percutaneously introduced bird's nest inferior vena cava (IVC) filter and the Kimray-Greenfield IVC filter. Study end points included recurrent pulmonary embolism, new or worse leg venous stasis symptoms, IVC thrombosis, and ease of filter introduction. Of the 109 patients in the study, 58 were randomly assigned to the BN and 51 to the KG filter. Demographic factors were comparable between the two groups. Follow-up entailed cavography, noninvasive assessment of the femoral veins, and standardized telephone interviews. The follow-up period was extended to 1 year after filter insertion. Results for the bird's nest versus the Kimray-Greenfield filter respectively were as follows: death due to massive pulmonary embolism, 3% versus 5%; recurrent pulmonary embolism, 1.5% versus 7.5%; filter migration, 1.1% versus 0.0%; IVC thrombosis, 6% versus 2.5%; new or worse leg edema, 28.5% versus 22%; ease of introduction (qualitative), maximal versus minimal; patient discomfort (qualitative), minimal versus maximal. The authors conclude the bird's nest filter is better than the Kimray-Greenfield filter in terms of prevention of recurrent pulmonary embolism and ease of introduction. In terms of venous stasis, the bird's nest filter is not better and may be worse than the Kimray-Greenfield filter. Filter migration is a problem with the bird's nest filter

  8. Home Visiting and Use of Infant Health Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Kilburn, M Rebecca; Cannon, Jill S

    2017-01-01

    Evaluations of home visiting models have shown that they can reduce children's health care use in the first year of life. Models that exclusively use nurses as home visitors may cost more and be infeasible given nursing shortages in some locations. The goal of this study was to test whether a universal home visiting model employing a nurse-parent educator team as home visitors reduces health care use in the first year of life. This study was a randomized controlled clinical trial of an intensive home visiting program delivered in homes of primary caregivers and their first-born children in Santa Fe, New Mexico. Intention-to-treat and contamination-adjusted intention-to-treat models were estimated, and 244 primary caregivers participated in the survey. In their first year of life, treatment group children were one-third less likely to visit the emergency department (control group mean, M C = 0.42, treatment group mean, M T = 0.28, P = .02) and were also 41% less likely to have visited a primary care provider ≥9 times (M C = 0.49, M T = 0.29, P health care use for high-risk and lower-risk families. Children in families randomly assigned to the program had less health care use in their first year, demonstrating that a universal prevention home visiting model delivered by a nurse-parent educator team can reduce infant health care use. Copyright © 2017 by the American Academy of Pediatrics.

  9. Periodontal Therapy Effects on Nitrite Related to Oral Bacteria: A 6-Month Randomized Clinical Trial.

    Science.gov (United States)

    Cortelli, Sheila C; Costa, Fernando O; Rodrigues, Edson; Cota, Luis O M; Cortelli, Jose R

    2015-08-01

    Nitrite is a biologic factor relevant to oral and systemic homeostasis. Through an oral bacteria reduction process, it was suggested that periodontal therapy and chlorhexidine (CHX) rinse could affect nitrite levels, leading to negative effects, such as an increase in blood pressure. This 6-month randomized clinical trial evaluated the effects of periodontal therapeutic protocols on salivary nitrite and its relation to subgingival bacteria. One hundred patients with periodontitis were allocated randomly to debridement procedures in four weekly sections (quadrant scaling [QS]) or within 24 hours (full-mouth scaling [FMS]) in conjunction with a 60-day CHX (QS + CHX and FMS + CHX), placebo (QS + placebo and FMS + placebo), or no mouthrinse (QS + none and FMS + none) use. Real-time polymerase chain reaction determined total bacterial, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Streptococcus oralis, and Actinomyces naeslundii levels. Salivary nitrite concentration was determined with Griess reagent. Data were analyzed statistically at baseline and 3 and 6 months by analysis of variance, Kruskal-Wallis, Mann-Whitney U, and Spearman correlation tests (P periodontal pockets. The relationship between nitrite and bacterial levels appears weak. Short-term scaling exhibited a greater influence on nitrite concentrations then long-term CHX use.

  10. Evaluation of the effects of a diabetes educational program: a randomized clinical trial

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    Heloísa de Carvalho Torres

    2018-02-01

    Full Text Available ABSTRACT OBJECTIVE Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. METHODS This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231 and control (n = 239. The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0, three (T3, six (T6 and nine (T9 months after the beginning of the intervention. RESULTS After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05. However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05. CONCLUSIONS The educational program model developed was effective to improve the glycemic control of the intervention group participants.

  11. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial.

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    Gutiérrez Espinoza, Héctor Joaquín; Pavez, Francisco; Guajardo, Cristopher; Acosta, Manuel

    2015-09-22

    To compare the short-term efficacy of a glenohumeral posterior mobilization technique versus conventional physiotherapy for the improvement of the range of external rotation in patients with primary adhesive capsulitis of the shoulder. This is a randomized clinical trial conducted at Hospital Clinico San Borja Arriaran in Chile. Fifty-seven patients with an age range of 50 to 58 years old were enrolled in two groups. Both groups were randomized to receive a treatment of 10 sessions: the experimental group (n=29) received a glenohumeral posterior mobilization technique after training with a cycle ergometer, and the control group (n=28) received conventional physiotherapy. The primary outcome measure was range of passive movement in external rotation; secondary outcomes were forward flexion and shoulder abduction, pain perception using the visual analogue scale and functionality test using the Constant-Murley Score. The study had the statistical power to detect a difference of four degrees between the groups in the improvement of the range of external rotation at the end of the treatment period. The experimental group showed a significant improvement with a mean difference of 46.3 degrees (SD=8.7) compared to 18.1 (SD=7.2) in the control group (padhesive capsulitis decreasing the severity of pain and improving joint function compared with conventional physiotherapy treatment. The degree of increase in shoulder external rotation is more than 20 degrees beyond the increase achieved with conventional treatment.

  12. Teaching Emotional Intelligence to Intensive Care Unit Nurses and their General Health: A Randomized Clinical Trial

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    F Sharif

    2013-07-01

    Full Text Available Background: Emotion and how people manage it is an important part of personality that would immensely affect their health. Investigations showed that emotional intelligence is significantly related to and can predict psychological health. Objective: To determine the effect of teaching emotional intelligence to intensive care unit nurses on their general health. Methods: This randomized clinical trial (registered as IRCT201208022812N9 was conducted on 52 of 200 in intensive care unit nurses affiliated to Shiraz University of Medical Sciences. They were recruited through purposeful convenience sampling and then randomly categorized into two groups. The intervention group members were trained in emotional intelligence. Bar-on emotional intelligence and Goldberg's general health questionnaires were administered to each participant before, immediately after, and one month after the intervention. Results: While the mean score of general health for the intervention group decreased from 25.4 before the intervention, to 18.1 immediately after the intervention and to 14.6 one month later, for the control group, it increased from 22.0, to 24.2 and to 26.5, respectively (p<0.001. Conclusion: Teaching emotional intelligence improved the general health of intensive care unit nurses.

  13. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model.

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    Charles, Christine Ann; McGuire, James Anthony; Sharma, Naresh Chandra; Qaqish, James

    2011-01-01

    Two antimicrobial agents, a fixed combination of essential oils (EOs) and 0.07% cetylpyridinium chloride (CPC) are found in commercially available mouthrinses, Listerine® Antiseptic and Crest® Pro HealthTM, respectively. Both mouthrinses have been shown to control dental plaque and gingivitis in short and longer term studies. The aim of this study was to determine the comparative effectiveness of these two mouthrinses using a 2-week experimental gingivitis model. Qualified subjects were randomly assigned to one of three mouthrinse groups: a fixed combination of EOs, 0.07% CPC, or negative control (C) rinse. Following baseline clinical assessments and a dental prophylaxis, subjects began a two-week period in which they rinsed twice daily with their assigned rinse and abstained from any mechanical oral hygiene procedures or other oral care products. Subjects were reassessed at the end of the two-week period. One hundred and forty-seven subjects were randomized and 142 completed this study. After two weeks use, the EOs rinse was superior (p plaque, and bleeding, with 9.4% and 6.6% reductions compared to CPC for gingivitis and plaque, respectively. Both rinses were superior to the negative control rinse (p mechanical oral hygiene influence.

  14. Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

    Science.gov (United States)

    Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

    2013-01-01

    Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

  15. Family Presence during Resuscitation: A Qualitative Analysis from a National Multicenter Randomized Clinical Trial.

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    De Stefano, Carla; Normand, Domitille; Jabre, Patricia; Azoulay, Elie; Kentish-Barnes, Nancy; Lapostolle, Frederic; Baubet, Thierry; Reuter, Paul-Georges; Javaud, Nicolas; Borron, Stephen W; Vicaut, Eric; Adnet, Frederic

    2016-01-01

    The themes of qualitative assessments that characterize the experience of family members offered the choice of observing cardiopulmonary resuscitation (CPR) of a loved one have not been formally identified. In the context of a multicenter randomized clinical trial offering family members the choice of observing CPR of a patient with sudden cardiac arrest, a qualitative analysis, with a sequential explanatory design, was conducted. The aim of the study was to understand family members' experience during CPR. All participants were interviewed by phone at home three months after cardiac arrest. Saturation was reached after analysis of 30 interviews of a randomly selected sample of 75 family members included in the trial. Four themes were identified: 1- choosing to be actively involved in the resuscitation; 2- communication between the relative and the emergency care team; 3- perception of the reality of the death, promoting acceptance of the loss; 4- experience and reactions of the relatives who did or did not witness the CPR, describing their feelings. Twelve sub-themes further defining these four themes were identified. Transferability of our findings should take into account the country-specific medical system. Family presence can help to ameliorate the pain of the death, through the feeling of having helped to support the patient during the passage from life to death and of having participated in this important moment. Our results showed the central role of communication between the family and the emergency care team in facilitating the acceptance of the reality of death.

  16. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

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    Mariana André Honorato Franzoi

    Full Text Available ABSTRACT Objective: to investigate the effects of music listening, for 15 minutes, on the preoperative anxiety levels in children undergoing elective surgery in comparison with conventional pediatric surgical care. Method: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26 and control group (n = 26. Anxiety was assessed in both groups by the application of the modified Yale Preoperative Anxiety Scale and measurement of the physiological variables, upon arrival and 15 minutes after the first measurement. Results: there was a statistically significant difference in preoperative anxiety between the two groups only in relation to the physiological variable, since the respiratory rate of preschool children in the experimental group reduced in the second measurement compared to the control group (p = 0.0453. The experimental group showed a statistically significant reduction in anxiety levels after 15 minutes of music listening (p = 0.0441, specifically with regard to the behavioral domains of activity, vocalization, emotional expression and apparent awakening state. Conclusion: music listening emerges as a potential nursing intervention for relief of preoperative anxiety in children undergoing surgical procedures. RBR-7mcr59.

  17. Remifentanil versus Fentanyl/Midazolam in Painless Reduction of Anterior Shoulder Dislocation; a Randomized Clinical Trial

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    Mohammad Gharavifard

    2016-04-01

    Full Text Available Introduction: Performance of painful diagnostic and therapeutic procedures is common in emergency department(ED, and procedural sedation and analgesia (PSA is a fundamental skill for every emergency physician.This studywas aim to compare the efficacy of remifentanil with fentanyl/midazolam in painless reduction of anteriorshoulder dislocation. Methods: In this randomized, double blind, clinical trial the procedural characteristics,patients satisfaction as well as adverse events were compared between fentanyl/midazolamand remifentanilfor PSA of 18–64 years old patients, which were presented to ED following anterior shoulder dislocation.Results: 96 cases were randomly allocated to two groups (86.5% male. There were no significant difference betweengroups regarding baseline characteristics. Remifentanil group had lower duration of procedure (2.5§1.6versus 4.6§1.8 minutes, p Ç 0.001, higher pain reduction (53.7§13.3 versus 33.5§19.6, p Ç 0.001, lower failurerate (1 (2.1% versus 15 (31.3%, p Ç 0.001, higher satisfaction (p Æ 0.005. Adverse events were seen in 12 (25%patients in midazolam/fentanyl and 8 (16.7% cases in remifentanil group (p Æ 0.122. Conclusion: It seemsthat use of remifentanil resulted in lower procedural time, lower failure rate, and lower pain during procedureas well as higher patient satisfaction in comparison with midazolam/fentanyl combination in anterior shoulderdislocation.

  18. A Randomized Clinical Trial of Schinus terebinthifolius Mouthwash to Treat Biofilm-Induced Gingivitis.

    Science.gov (United States)

    Freires, Irlan de Almeida; Alves, Livia Araújo; Ferreira, Gabriela Lacet Silva; Jovito, Vanessa de Carvalho; de Castro, Ricardo Dias; Cavalcanti, Alessandro Leite

    2013-01-01

    Objectives. This study aimed to investigate the efficacy of a Schinus terebinthifolius (ST) mouthwash in reducing gingival inflammation levels (GI) and biofilm accumulation (BA) in children with gingivitis. Methods. This was a randomized, controlled, triple blind, and phase II clinical trial, with children aged 9-13 years (n = 27) presenting with biofilm-induced gingivitis. The sample was randomized into experimental (0.3125% ST, n = 14) and control (0.12% chlorhexidine/CHX, n = 13) groups. Products were masked as regards color, flavor and aroma. Intervention protocol consisted in supervised rinsing of 10 mL/day for 01 minute for 10 days. Gingival bleeding and simplified oral hygiene indexes were used to assess the efficacy variables, measured at baseline and after intervention by calibrated examiners. Data were statistically treated with paired t-test, unpaired t-test, and Wilcoxon and Mann-Whitney tests ( α = .05). Results. It was found that both ST and CHX were able to significantly reduce GI levels after 10 days (P 0.05). CHX was the only product able to significantly reduce BA after 10 days when compared to baseline (P < 0.05). Conclusion. ST mouthwash showed significant anti-inflammatory activity (equivalent to CHX), but it was not able to reduce biofilm accumulation.

  19. The effects of acupressure on labor pains during child birth: randomized clinical trial

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    Reginaldo Roque Mafetoni

    Full Text Available ABSTRACT Objective: to analyze the effects of acupressure on the sanyinjiao point for pregnant women in labor at public maternity wards. Method: single-blind controlled clinical trial, randomly done employing a pragmatic profile. We selected 156 pregnant women in their ≥ 37 week/s, who had cervical dilations of ≥ 4 cm and with two or more contractions in 10 minutes. The pregnant women were randomly divided into three groups at a university hospital in the suburbs of Sao Paulo, Brazil, in order to receive either acupressure treatment, a placebo or participate as part of a control group. The acupressure was applied on the sanyinjiao point during the contractions for 20 minutes. Then the intensity of the pain was evaluated using the Visual Analogue Scale (VAS. Results: The averages for the pain measured using the VAS were not different for the three groups that were a part of the study (p-value=0.0929, however they were less in the acupressure groups immediately after receiving the treatment (p-value=<0.0001. This was also the case where the treatment lasted for 1 hour (p-value=0.0001. This was the case in comparison with placebo and control groups. Conclusion: the use of acupressure on the sanyinjiao point is a useful way to alleviate pain in a non-invasive manner. It can improve the quality of care given to pregnant women in labor. Register: RBR-9mhs8r.

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

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    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, PDASH diet had significantly lower weight (3222.7 vs 3818.8 g, Pdiet. In conclusion, consumption of DASH diet for 4 weeks among pregnant women with GDM resulted in improved pregnancy outcomes.

  1. Medialization vs. Reinnervation for Unilateral Vocal Fold Paralysis: A Multicenter Randomized Clinical Trial

    Science.gov (United States)

    Paniello, Randal C.; Edgar, Julia D.; Kallogjeri, Dorina; Piccirillo, Jay F.

    2011-01-01

    Purpose Vocal fold medialization laryngoplasty (ML) and laryngeal reinnervation (LR) as treatments for unilateral vocal fold paralysis (UVFP) were compared in a multicenter, prospective, randomized clinical trial. Methods Previously untreated patients with UVFP were randomized to undergo either ML or LR. Voice results were compared pre-treatment and at 6 and 12 months post-treatment using perceptual ratings by untrained listeners (RUL), blinded speech pathologist GRBAS scores, and voice-related quality of life (VRQOL) scores. Other secondary data included maximum phonation time (MPT), cepstral analysis, and EMG findings. Results 24 patients from 9 sites completed the study, 12 in each group. There were no significant intergroup differences in pre-treatment variables. At 12 months, both study groups showed significant improvement in RUL, GRBAS and VRQOL scores, but no significant differences were found between the two groups. However, patient age significantly affected the LR, but not the ML, group results. The age52 LR subgroup, and had better RUL and GRBAS scores than the age52 ML subgroup results were significantly better than the age>52 LR subgroup. The secondary data generally followed the primary data, except that the MPTs for the ML patients were significantly longer than for the LR patients. Conclusion ML and LR are both effective surgical options for patients with UVFP. Laryngeal reinnervation should be considered in younger patients, while medialization laryngoplasty should be favored in older patients. PMID:21898419

  2. VITAMINE E IN THE MANAGEMENT OF DRUG INDUCED TARDIVE DYSKINESIA: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

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    M KAR AHMADI

    2002-12-01

    Full Text Available Introduction. Expresssion of tardive dyskinesia as one of the side effects of antipsychotic drugs causes various problems in psychotic patients. It is the main cause of patient"s drug incompliance.Vitamine E with it"s antioxidants properties might be an effective treatment for tardive dyskinesia. Methods. In a randomized double blind clinical trial, thirty inpatients of the psychiatric hospital in Isfahan were studied. Patients were stratified according to their age, psychiatric disorder and duration, intensity of tardive dyskinesia and antipsychotic dosage. Then they were asssigned randomly into two groups. Vitamine E (600 mg/day was administered to interventional group (15 patients. Another group received placebo (15 patients. Treatment durated for 6 weeks. Abnormal Involuntary Movment Scale (AIMS was used to measure tardive dyskinesia intensity. Results. Average of disorder intensity in those who received vit. E, dropped down from 8.33/10 (befor treatment to 6.13/10 (after treatment. It means 26.3 percent reduction of tardive dyskinesia intensity. This difference was only 7.3 percent in control group. There were no statistical diffrence between two groups after treatment (P>0.05. Discussion. There is no statistical efficacy for vitamine E in the management of tardive dyskinesia. But it is recommended to make another study with more samples.

  3. The Effect of Tub Bathing on Body Temperature in Preterm Infants: Randomized Clinical Trial

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    Mahnaz Jabraeili

    2015-06-01

    Full Text Available Background: Bathing of a premature newborn is important in care giving, but due to inadequate evidences, infant caregivers are not sure about bathing being safe in terms of not causing hypothermia and are not systematically considered in the infants’ care giving programs. Aim: To determine the effect of tub bathing on body temperature of preterm infants”. Methods: This study is a randomized controlled clinical trial which was conducted in 1392 in neonatal unit of Al-zahra hospital. 118 preterm infants were randomly divided into intervention and control groups. The infants in the control group received routine skin care only. The intervention group was bathed three times every other day inside the bathtub. In both group, the infants’ body temperature was measured at the same times by the researcher. Data were analyzed with SPSS software version 14 using independent T-test, Chi-square and repeated measurements tests. Results: In both groups, boys outnumbered girls. At the time of inclusion, the infants' age was 5.8 ± 8.6 days and their weight was 320.6 ± 1660.0 grams. In both groups, the mean temperature of premature infants after bath was dropped in all three times. Which was statistically significant in the first and second baths (P

  4. Transversus abdominis plane blockade in laparoscopic colorectal surgery: a double-blind randomized clinical trial.

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    Smith, Stephen Ridley; Draganic, Brian; Pockney, Peter; Holz, Phillip; Holmes, Ryan; Mcmanus, Brendan; Carroll, Rosemary

    2015-09-01

    Adequate postoperative analgesia is essential for recovery following colorectal surgery. Transversus abdominis plane (TAP) blocks have been found to be beneficial in improving pain following a variety of abdominal operations. The objective of this study was to determine if TAP blocks are useful in improving postoperative recovery following laparoscopic colorectal surgery. A prospective double-blind randomized clinical trial, involving 226 consecutive patients having laparoscopic colorectal surgery, was performed by a university colorectal surgical department. Patients were randomized to either TAP blockade using ultrasound guidance, or control, with the primary outcome being postoperative pain, as measured by analgesic consumption. Secondary outcomes assessed were pain visual analogue score (VAS), respiratory function, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. A total of 142 patients were followed up to trial completion (74 controls, 68 interventions). Patients were well matched with regard to demographics. No complications occurred as a result of the intervention of TAP blockade. There was no difference between groups with regards to analgesic consumption (161 mEq morphine control vs 175 mEq morphine TAP; p = 0.596). There was no difference between the two groups with regards to the secondary outcomes of daily VAS, respiratory outcome, time to return of gut function, length of hospital stay, postoperative complications, and patient satisfaction. We conclude that TAP blockade appears to be a safe intervention but confers no specific advantage following laparoscopic colorectal surgery.

  5. Increased Risk for Falling Associated with Subtle Cognitive Impairment: Secondary Analysis of a Randomized Clinical Trial

    Science.gov (United States)

    Gleason, Carey E.; Gangnon, Ronald E.; Fischer, Barbara L.; Mahoney, Jane E.

    2009-01-01

    Background/Aims Having dementia increases patients’ risk for accidental falls. However, it is unknown if having mild cognitive deficits also elevates a person's risk for falls. This study sought to clarify the relationship between subtle cognitive impairment, measured with a widely-used, clinic-based assessment, the Mini Mental State Exam (MMSE), and risk for falls. Methods In a secondary analysis of the Kenosha County Falls Prevention Study, a randomized controlled trial targeting older adults at risk for falls, we examined the association between baseline MMSE and prospective rate of falls over 12 months in 172 subjects randomized to control group. Results Using univariate analysis, the rate of falls increased with each unit decrease in MMSE score down to at least 22 (rate ratio 1.25, 95% confidence interval (CI) 1.09–1.45, p = 0.0026). Using stepwise multivariate regression, controlling for ability to perform activities of daily living, use of assistive device, current exercise, and arthritis, the association between MMSE score and falls rate persisted (rate ratio 1.20, 95% CI 1.03–1.40, p = 0.021). Conclusion Minimal decrements on the MMSE were associated with elevations in rate of falls, suggesting that subtle cognitive deficits reflected in MMSE scores above a cut-off consistent with a diagnosis of dementia, can influence risk for falls. PMID:19602883

  6. Dance Improves Functionality and Psychosocial Adjustment in Cerebral Palsy: A Randomized Controlled Clinical Trial.

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    Teixeira-Machado, Lavinia; Azevedo-Santos, Isabela; DeSantana, Josimari Melo

    2017-06-01

    This randomized controlled clinical trial aimed to investigate the effect of dance in the functionality and psychosocial adjustment of young subjects with cerebral palsy (CP). Twenty-six young subjects with CP, GMFCS (Gross Motor Function Classification System) levels from II to V, were randomized into two intervention groups: kinesiotherapy and dance (n = 13 each). Twenty-four sessions (1 hour, twice a week) were performed in both groups. Functional Independence Measure (FIM) and World Health Organization Disability Assessment Schedule (WHODAS) by International Classification of Functioning, Disability and Health (ICF) were used before and after each intervention. Dance increased the classification of functioning (P = 0.001), independence function (P = 0.004), self-care (P = 0.01), mobility (P = 0.008), locomotion (P = 0.01), communication (P = 0.02), psychosocial adjustments (P = 0.04), and cognitive function (P = 0.03). Intergroup analysis evidenced significantly greater improvements in classification of functioning (P = 0.0002), independence function (P = 0.0006), self-care (P = 0.01), mobility (P = 0.001), locomotion (P = 0.002), communication (P = 0.0001), psychosocial adjustments (P = 0.002), and cognitive function (P = 0.0001) in dance group. It was shown that this approach could have an influence on basic common points in the body and motion, including emotional and social aspects, supporting the concept of complex multimodal psychomotor adjustments. Dance promoted enhancement on functionality and social activities regarding psychosocial adjustments in cerebral palsy young subjects.

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

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    Leila Valizadeh

    2016-09-01

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

  8. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

    Science.gov (United States)

    Fatheree, Nicole Y; Liu, Yuying; Taylor, Christopher M; Hoang, Thomas K; Cai, Chunyan; Rahbar, Mohammad H; Hessabi, Manouchehr; Ferris, Michael; McMurtry, Valarie; Wong, Christine; Vu, Ta; Dancsak, Theresa; Wang, Ting; Gleason, Wallace; Bandla, Vinay; Navarro, Fernando; Tran, Dat Q; Rhoads, J Marc

    2017-12-01

    To assess the safety of probiotic Lactobacillus reuteri strain Deutsche Sammlung von Mikroorganismen (DSM) 17938 with daily administration to healthy infants with colic and to determine the effect of L reuteri strain DSM 17938 on crying, fussing, inflammatory, immune, and microbiome variables. We performed a controlled, double-blinded, phase 1 safety and tolerability trial in healthy breast-fed infants with colic, aged 3 weeks to 3 months, randomly assigned to L reuteri strain DSM 17938 (5 × 10 8 colony-forming units daily) or placebo for 42 days and followed for 134 days. Of 117 screened infants, 20 were randomized to L reuteri strain DSM 17938 or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (L reuteri strain DSM 17938 produced no severe adverse events and did not significantly change crying time, plasma bicarbonate, or inflammatory biomarkers. Fecal calprotectin decreased rapidly in both groups. In the infants with dominant fecal gram negatives (Klebsiella, Proteus, and Veillonella), resolution of colic was associated with marked decreases in these organisms. Daily administration of L reuteri strain DSM 17938 appears to be safe in newborn infants with colic, including those with neutropenia, which frequently coexists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks. ClinicalTrials.gov: NCT01849991. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial.

    Science.gov (United States)

    Kangovi, Shreya; Mitra, Nandita; Grande, David; Huo, Hairong; Smith, Robyn A; Long, Judith A

    2017-10-01

    To determine whether a community health worker (CHW) intervention improved outcomes in a low-income population with multiple chronic conditions. We conducted a single-blind, randomized clinical trial in Philadelphia, Pennsylvania (2013-2014). Participants (n = 302) were high-poverty neighborhood residents, uninsured or publicly insured, and diagnosed with 2 or more chronic diseases (diabetes, obesity, tobacco dependence, hypertension). All patients set a disease-management goal. Patients randomly assigned to CHWs also received 6 months of support tailored to their goals and preferences. Support from CHWs (vs goal-setting alone) led to improvements in several chronic diseases (changes in glycosylated hemoglobin: -0.4 vs 0.0; body mass index: -0.3 vs -0.1; cigarettes per day: -5.5 vs -1.3; systolic blood pressure: -1.8 vs -11.2; overall P = .08), self-rated mental health (12-item Short Form survey; 2.3 vs -0.2; P = .008), and quality of care (Consumer Assessment of Healthcare Providers and Systems; 62.9% vs 38%; P health. A standardized CHW intervention improved chronic disease control, mental health, quality of care, and hospitalizations and could be a useful population health management tool for health care systems. clinicaltrials.gov identifier: NCT01900470.

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

    Science.gov (United States)

    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 exercises produced better improvement in disability and quality of life of the patients with CLBP than land-based exercise.

  11. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model

    Directory of Open Access Journals (Sweden)

    Christine Ann Charles

    2011-08-01

    Full Text Available Two antimicrobial agents, a fixed combination of essential oils (EOs and 0.07% cetylpyridinium chloride (CPC are found in commercially available mouthrinses, Listerine® Antiseptic and Crest® Pro HealthTM, respectively. Both mouthrinses have been shown to control dental plaque and gingivitis in short and longer term studies. The aim of this study was to determine the comparative effectiveness of these two mouthrinses using a 2-week experimental gingivitis model. Qualified subjects were randomly assigned to one of three mouthrinse groups: a fixed combination of EOs, 0.07% CPC, or negative control (C rinse. Following baseline clinical assessments and a dental prophylaxis, subjects began a two-week period in which they rinsed twice daily with their assigned rinse and abstained from any mechanical oral hygiene procedures or other oral care products. Subjects were reassessed at the end of the two-week period. One hundred and forty-seven subjects were randomized and 142 completed this study. After two weeks use, the EOs rinse was superior (p < 0.011 to the CPC rinse in inhibiting the development of gingivitis, plaque, and bleeding, with 9.4% and 6.6% reductions compared to CPC for gingivitis and plaque, respectively. Both rinses were superior to the negative control rinse (p < 0.001. This study demonstrates that the essential oil-containing mouthrinse has superior antiplaque/antigingivitis effectiveness compared to the 0.07% CPC-containing mouthrinse without mechanical oral hygiene influence.

  12. Randomized Clinical Trial Comparing Low DensityversusHigh Density Meshes in Patients with Bilateral Inguinal Hernia.

    Science.gov (United States)

    Carro, Jose Luis Porrero; Riu, Sol Villar; Lojo, Beatriz Ramos; Latorre, Lucia; Garcia, Maria Teresa Alonso; Pardo, Benito Alcaide; Naranjo, Oscar Bonachia; Herrero, Alberto Marcos; Cabezudo, Carlos Sanchez; Herreras, Esther Quiros

    2017-12-01

    We present a randomized clinical trial to compare postoperative pain, complications, feeling of a foreign body, and recurrence between heavyweight and lightweight meshes in patients with bilateral groin hernia. Sixty-seven patients with bilateral hernia were included in our study. In each patient, the side of the lightweight mesh was decided by random numbers table. Pain score was measured by visual analogue scale, on 1st, 3rd, 5th, and 7th postoperative day, and one year after the surgery. There were no statistically significative differences between both meshes in postoperative complications. About differences of pain average, there were statistically significant differences only on the 1st postoperative day (P <0.01) and the 7th postoperative day (P <0.05). In the review after a year, there were no statistically significative differences in any parameter. In our study, we did not find statistically significative differences between lightweight and heavyweight meshes in postoperative pain, complications, feeling of a foreign body, and recurrence, except pain on 1st and 7th postoperative day.

  13. Chlorhexidine and gauze and tape dressings for central venous catheters: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Edivane Pedrolo

    2014-10-01

    Full Text Available OBJECTIVE: to assess the effectiveness of the chlorhexidine antimicrobial dressing in comparison to the gauze and tape dressing in the use of central venous catheters.METHOD: a randomized clinical trial was conducted in the intensive care and adult semi intensive care units of a university hospital in the south of Brazil. The subjects were patients using short-term central venous catheters, randomly assigned to the intervention (chlorhexidine antimicrobial dressing or control (gauze and micro porous tape groups.RESULTS: a total of 85 patients were included: 43 in the intervention group and 42 in the control group. No statistically significant differences were found between dressings in regard to the occurrence of: primary bloodstream infections (p-value = 0.5170; local reactions to the dressing (p-value = 0.3774; and dressing fixation (p-value = 0.2739.CONCLUSION: both technologies are effective in covering central venous catheters in regard to the investigated variables and can be used for this purpose. Registry ECR: RBR-7b5ycz.

  14. Does Islamic spiritual program lead to successful aging? A randomized clinical trial.

    Science.gov (United States)

    Moeini, Mahin; Sharifi, Somaye; Zandiyeh, Zahra

    2016-01-01

    Successful aging is a pattern of aging that has gained much attention during recent years. One factor that has a negative impact on successful aging variables is hypertension. The phenomenon of aging when accompanied with hypertension promotes spiritual needs. The aim of this study was to examine the effect of the Islamic spiritual program on successful aging in elderly patients with hypertension who were referred to health centers of Isfahan, Iran, in 2014. This study was a randomized clinical trial. The participants (52 elderly patients with hypertension) were randomly divided into experimental and control groups. While the control group received training related to health promotion, the Islamic spiritual program was implemented in the experimental group for eight sessions in two health centers of Isfahan. The data collection tools consisted of the 12-item General Health Questionnaire developed by Goldberg and the satisfaction with life scale developed by Diener. The questionnaires were completed in three steps; pretest, posttest, and follow-up (1-month). Data were analyzed using SPSS statistical software version 20 and Chi-square, independent t-test, and repeated measures ANOVA. Statistical tests showed that the mean score of general health and life satisfaction of the experiment group had a meaningful difference from that of the control group in the posttest stage (P < 0.001). This difference was also meaningful in the follow-up stage (P < 0.001). The results of the study indicated the effectiveness of an Islamic spiritual program on successful aging variables.

  15. Family Presence during Resuscitation: A Qualitative Analysis from a National Multicenter Randomized Clinical Trial.

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    Carla De Stefano

    Full Text Available The themes of qualitative assessments that characterize the experience of family members offered the choice of observing cardiopulmonary resuscitation (CPR of a loved one have not been formally identified.In the context of a multicenter randomized clinical trial offering family members the choice of observing CPR of a patient with sudden cardiac arrest, a qualitative analysis, with a sequential explanatory design, was conducted. The aim of the study was to understand family members' experience during CPR. All participants were interviewed by phone at home three months after cardiac arrest. Saturation was reached after analysis of 30 interviews of a randomly selected sample of 75 family members included in the trial. Four themes were identified: 1- choosing to be actively involved in the resuscitation; 2- communication between the relative and the emergency care team; 3- perception of the reality of the death, promoting acceptance of the loss; 4- experience and reactions of the relatives who did or did not witness the CPR, describing their feelings. Twelve sub-themes further defining these four themes were identified. Transferability of our findings should take into account the country-specific medical system.Family presence can help to ameliorate the pain of the death, through the feeling of having helped to support the patient during the passage from life to death and of having participated in this important moment. Our results showed the central role of communication between the family and the emergency care team in facilitating the acceptance of the reality of death.

  16. Effect of Black Cohosh (Cimicifuga Racemosa) on Vasomotor Symptoms in Postmenopausal Women: A Randomized Clinical Trial

    Science.gov (United States)

    Shahnazi, Mahnaz; Nahaee, Jila; Mohammad-Alizadeh-Charandabi, Sakineh; Bayatipayan, Somaye

    2013-01-01

    Introduction:Hot flash is considered to be an early and common symptom of menopause. The present study aimed to determine the impact of black cohosh (Cimicifuga racemosa) on vasomotor symptoms in postmenopausal women. Methods:This was a randomized, double-blind, placebo-controlled clinical trial. This study was performed on 84 postmenopausal women. The participants were randomly divided into control and intervention groups. The participants of the intervention group received one black cohosh tablet per day and the control group received one placebo tablet per day for eight weeks. The severity of vasomotor symptoms and number of hot flashes were recorded during the pre-intervention phase, and 4 and 8 weeks after the intervention. The data were analyzed using repeated measures ANOVA and ANCOVA tests. The level of significance was considered lower than 0.05. Results:There was a significant difference between the two groups in terms of severity and number of hot flashes in weeks 4 and 8 by controlling the intensity of vasomotor symptoms and number of hot flashes before the intervention. Moreover, using repeated measures ANOVA, the intergroup comparison indicated a significant difference in bothgroups (the test and control groups) in terms of severity of vasomotor symptoms and number of hot flashes. Conclusion:According to the findings of the study, it seems that black cohosh can be used as an effective alternative medicine in relieving menopausal vasomotor symptoms. PMID:25276716

  17. A randomized clinical trial of preoperative versus postoperative misoprostol in elective cesarean delivery.

    Science.gov (United States)

    Ragab, Ahmed; Barakat, Rafik; Alsammani, Mohamed A

    2016-01-01

    To determine the optimum time for misoprostol administration to minimize blood loss during and after elective cesarean delivery. A randomized clinical trial was conducted at Mansoura University Hospital, Egypt, between January 1, 2013, and December 31, 2014. Eligible participants had full-term pregnancies, were scheduled to have a cesarean, and had normal fetal heart tracing. Patients were randomly allocated into two equal groups using computer-generated tables and sealed opaque envelopes. Misoprostol (400μg, given rectally) was given either before (group 1) or after (group 2) surgery. Patients, investigators, and data analysts were not masked to group assignment. The primary outcome was blood loss. A total of 348 women were included (174 in each group). Blood loss was significantly lower in group 1 than in group 2 (570±240 vs 844±270mL; Pcesarean delivery. The frequency of complications was not affected by time of administration. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  18. A randomized clinical trial on the use of medical Portland cement, MTA and calcium hydroxide in indirect pulp treatment.

    Science.gov (United States)

    Petrou, Marina Agathi; Alhamoui, Fadi Alhaddad; Welk, Alexander; Altarabulsi, Mohammed Basel; Alkilzy, Mohammed; H Splieth, Christian

    2014-01-01

    Studies on indirect pulp treatment (IPT) show varying success rates of 73 to 97 %. The necessity of re-opening the cavity and the question of the optimal capping material is still under debate. The aim of this prospective in vivo study was to compare the clinical and microbiological outcomes of mineral trioxide aggregate (MTA), medical Portland cement, and calcium hydroxide on the dentin-pulp complex of permanent and primary teeth treated with two-step IPT. In 86 regular patients (51 % men; 49 % women; age 17.2 years ±13.8), one deep carious lesion each was treated with incomplete caries removal, randomly selected capping with either calcium hydroxide (n = 31), medical Portland cement (29) or white MTA (26), and re-entry (6.3 months ±1.0). Clinical (color, humidity, and consistency of dentin) and microbiological (Lactobacilli/Mutans Strep. counts) parameters were recorded at the first and second treatment. The IPT had a high success rate of 90.3 % regardless of the material used (p = 0.72). The arrested lesions showed consistently darker, dry, and therefore, sclerotic dentine (p Portland cement. The findings of this study could promote the improvement of the IPT as a one-step treatment of deep carious lesions when the remaining demineralized dentin would be sealed with durable restorations.

  19. Exploring a New Simulation Approach to Improve Clinical Reasoning Teaching and Assessment: Randomized Trial Protocol.

    Science.gov (United States)

    Pennaforte, Thomas; Moussa, Ahmed; Loye, Nathalie; Charlin, Bernard; Audétat, Marie-Claude

    2016-02-17

    Helping trainees develop appropriate clinical reasoning abilities is a challenging goal in an environment where clinical situations are marked by high levels of complexity and unpredictability. The benefit of simulation-based education to assess clinical reasoning skills has rarely been reported. More specifically, it is unclear if clinical reasoning is better acquired if the instructor's input occurs entirely after or is integrated during the scenario. Based on educational principles of the dual-process theory of clinical reasoning, a new simulation approach called simulation with iterative discussions (SID) is introduced. The instructor interrupts the flow of the scenario at three key moments of the reasoning process (data gathering, integration, and confirmation). After each stop, the scenario is continued where it was interrupted. Finally, a brief general debriefing ends the session. System-1 process of clinical reasoning is assessed by verbalization during management of the case, and System-2 during the iterative discussions without providing feedback. The aim of this study is to evaluate the effectiveness of Simulation with Iterative Discussions versus the classical approach of simulation in developing reasoning skills of General Pediatrics and Neonatal-Perinatal Medicine residents. This will be a prospective exploratory, randomized study conducted at Sainte-Justine hospital in Montreal, Qc, between January and March 2016. All post-graduate year (PGY) 1 to 6 residents will be invited to complete one SID or classical simulation 30 minutes audio video-recorded complex high-fidelity simulations covering a similar neonatology topic. Pre- and post-simulation questionnaires will be completed and a semistructured interview will be conducted after each simulation. Data analyses will use SPSS and NVivo softwares. This study is in its preliminary stages and the results are expected to be made available by April, 2016. This will be the first study to explore a new

  20. Single-blind randomized clinical trial to evaluate clinical and radiological outcomes after one year of immediate versus delayed implant placement supporting full-arch prostheses

    OpenAIRE

    Pellicer-Chover, Hilario; Peñarrocha-Oltra, David; Bagán, Leticia; Fichy-Fernandez, Antonio J.; Canullo, Luigi; Peñarrocha-Diago, Miguel

    2013-01-01

    Purpose: To evaluate and compare peri-implant health, marginal bone loss and success of immediate and delayed implant placement for rehabilitation with full-arch fixed prostheses. Material and Methods: The present study was a prospective, randomized, single-blind, clinical preliminary trial. Patients were randomized into two treatment groups. In Group A implants were placed immediately post-extraction and in Group B six months after extraction. The following control time-points were establish...

  1. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

    2013-05-22

    The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process

  2. Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Cornelissen Jessica

    2010-07-01

    Full Text Available Abstract Background Non-pharmacological treatment (NPT is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA. The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse. The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137

  3. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial

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    S Ashraffodin Ghoshegir

    2015-01-01

    Full Text Available Background: We aimed to evaluate the effects of Pimpinella anisum (anise from Apiaceae family on relieving the symptoms of postprandial distress syndrome (PDS in this double-blind randomized clinical trial. Materials and Methods: Totally, 107 patients attending the gastroenterology clinic, aged 18-65 years, diagnosed with PDS according to ROME III criteria and signed a written consent form were enrolled. They were randomized to receive either anise or placebo, blindly, for 4 weeks. Anise group included 47 patients and received anise powders, 3 g after each meal (3 times/day. Control group involved 60 patients and received placebo powders (corn starch, 3 gafter each meal (3 times/day. The severity of Functional dyspepsia (FD symptoms was assessed by FD severity scale. Assessments were done at baseline and by the end of weeks 2, 4 and 12. Mean scores of severity of FD symptoms and the frequency distribution of patients across the study period were compared. Results: The age, sex, body mass index, smoking history, and coffee drinking pattern of the intervention and control groups were not significantly different. Mean (standard deviation total scores of FD severity scale before intervention in the anise and control groups were 10.6 (4.1 and 10.96 (4.1, respectively (P = 0.6. They were 7.04 (4.1 and 12.30 (4.3 by week 2, respectively (P = 0.0001, 2.44 (4.2 and 13.05 (5.2 by week 4, respectively (P = 0.0001, and 1.08 (3.8 and 13.30 (6.2 by week 12, respectively (P = 0.0001. Conclusion: This study showed the effectiveness of anise in relieving the symptoms of postpartum depression. The findings were consistent across the study period at weeks 2, 4 and 12.

  4. Cognitive-behavioral versus psychodynamic therapy for major depression: Secondary outcomes of a randomized clinical trial.

    Science.gov (United States)

    Driessen, Ellen; Van, Henricus L; Peen, Jaap; Don, Frank J; Twisk, Jos W R; Cuijpers, Pim; Dekker, Jack J M

    2017-07-01

    In a randomized clinical trial, we compared the efficacy of cognitive-behavioral therapy (CBT) and psychodynamic therapy for adult outpatient depression on measures of psychopathology, interpersonal functioning, pain, and quality of life. There were 341 Dutch adults (70.1% female, mean age = 38.9, SD = 10.3) meeting Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition ( DSM-IV ) criteria for a major depressive episode and with a Hamilton Depression Rating Scale (HAM-D) score ≥14, who were randomized to 16 sessions of individual manualized CBT or short-term psychodynamic supportive psychotherapy. Severely depressed patients (HAM-D >24) received additional antidepressant medication according to a protocol. Outcome measures included the Brief Symptom Inventory, Beck Anxiety Inventory, Outcome Questionnaire, a visual analogue scale for pain, and EuroQol. Data were analyzed with mixed model analyses using intention-to-treat samples. Noninferiority margins were prespecified as Cohen's d = -0.30. Across treatment conditions, 45-60% of the patients who completed posttreatment assessment showed clinically meaningful change for most outcome measures. We found no significant differences between the treatment conditions on any of the outcome measures at both posttreatment and follow-up. Noninferiority of psychodynamic therapy to CBT was shown for posttreatment and follow-up anxiety measures as well as for posttreatment pain and quality of life measures, but could not be consistently demonstrated for the other outcomes. This is the first study that shows that psychodynamic therapy can be at least as efficacious as CBT for depression on important aspects of patient functioning other than depressive symptom reduction. These findings extend the evidence-base of psychodynamic therapy for depression, but replication is needed by means of rigorously designed noninferiority trials. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  5. Radiographic methods used before removal of mandibular third molars among randomly selected general dental clinics.

    Science.gov (United States)

    Matzen, Louise H; Petersen, Lars B; Wenzel, Ann

    2016-01-01

    To assess radiographic methods and diagnostically sufficient images used before removal of mandibular third molars among randomly selected general dental clinics. Furthermore, to assess factors predisposing for an additional radiographic examination. 2 observers visited 18 randomly selected clinics in Denmark and studied patient files, including radiographs of patients who had their mandibular third molar(s) removed. The radiographic unit and type of receptor were registered. A diagnostically sufficient image was defined as the whole tooth and mandibular canal were displayed in the radiograph (yes/no). Overprojection between the tooth and mandibular canal (yes/no) and patient-reported inferior alveolar nerve sensory disturbances (yes/no) were recorded. Regression analyses tested if overprojection between the third molar and the mandibular canal and an insufficient intraoral image predisposed for additional radiographic examination(s). 1500 mandibular third molars had been removed; 1090 had intraoral, 468 had panoramic and 67 had CBCT examination. 1000 teeth were removed after an intraoral examination alone, 433 after panoramic examination and 67 after CBCT examination. 90 teeth had an additional examination after intraoral. Overprojection between the tooth and mandibular canal was a significant factor (p < 0.001, odds ratio = 3.56) for an additional examination. 63.7% of the intraoral images were sufficient and 36.3% were insufficient, with no significant difference between images performed with phosphor plates and solid-state sensors (p = 0.6). An insufficient image predisposed for an additional examination (p = 0.008, odds ratio = 1.8) but was only performed in 11% of the cases. Most mandibular third molars were removed based on an intraoral examination although 36.3% were insufficient.

  6. Angioplasty Guided by Intravascular Ultrasound: Meta-Analysis of Randomized Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Figueiredo, José Albuquerque Neto de, E-mail: jafneto@cardiol.br; Nogueira, Iara Antonia Lustosa [Universidade Federal do Maranhão, São Luiz, MA (Brazil); Figueiro, Mabel Fernandes; Buehler, Anna Maria; Berwanger, Otavio [Instituto de Ensino e Pesquisa do Hospital do Coração, São Paulo, SP (Brazil)

    2013-08-15

    The impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results. Systematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution. A search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases. It included randomized clinical trials (RCTs) that evaluated the implantation of stents guided by IVUS, compared with those using angiography alone (ANGIO). The minimum follow-up duration was six months and the following outcomes were assessed: thrombosis, mortality, myocardial infarction, percutaneous and surgical revascularization, major adverse cardiovascular events (MACE) and restenosis. The binary outcomes were presented considering the number of events in each group; the estimates were generated by a random effects model, considering Mantel-Haenszel statistics as weighting agent and magnitude of effect for the relative risk (RR) with its respective 95% confidence interval (95%CI). Higgins I{sup 2} test was used to quantify the consistency between the results of each study. A total of 2,689 articles were evaluated, including 8 RCTs. There was a 27% reduction in angiographic restenosis (RR: 0.73, 95% CI: 0.54-0.97, I{sup 2} = 51%) and statistically significant reduction in the rates of percutaneous revascularization and overall (RR: 0.88; 95% CI: 0.51 to 1.53, I{sup 2} = 61%, RR: 0.73, 95% CI: 0.54 to 0.99, I{sup 2} = 55%), with no statistical difference in surgical revascularization (RR: 0.95, 95% CI: 0.52-1.74, I{sup 2} = 0%) in favor of IVUS vs. ANGIO. There were no differences regarding the other outcomes in the comparison between the two strategies. Angioplasty with stenting guided by IVUS decreases the rates of restenosis and revascularization, with no impact on MACE, acute myocardial infarction, mortality or thrombosis outcomes.

  7. Omalizumab for the treatment of chronic spontaneous urticaria: A meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Zhao, Zuo-Tao; Ji, Chun-Mei; Yu, Wen-Jun; Meng, Ling; Hawro, Tomasz; Wei, Ji-Fu; Maurer, Marcus

    2016-06-01

    Chronic spontaneous urticaria (CSU) is defined by itchy hives, angioedema, or both for at least 6 weeks. Omalizumab, an anti-IgE antibody that affects mast cell and basophil function, is a promising new treatment option. As of now, however, the efficacy and safety of different doses of omalizumab used in clinical trials for CSU have not been systematically analyzed and summarized. We sought to assess the efficacy and safety of different doses of omalizumab for the treatment of CSU in a meta-analysis of clinical trial results. Suitable trials were identified by searching PubMed, Medline, Embase, and Web of Science databases and with the help of omalizumab's manufacturers. Only double-blind, randomized, placebo-controlled studies with omalizumab-treated versus placebo-treated patients with CSU were included in this analysis. We identified 7 randomized, placebo-controlled studies with 1312 patients with CSU. Patients treated with omalizumab (75-600 mg every 4 weeks) had significantly reduced weekly itch and weekly wheal scores compared with the placebo group. Omalizumab's effects were dose dependent, with the strongest reduction in weekly itch and weekly wheal scores observed with 300 mg. Rates of complete response were significantly higher in the omalizumab group (relative risk, 4.55; P omalizumab and placebo groups. This meta-analysis provides high-quality evidence for the efficacy and safety of omalizumab in patients with CSU and for treating these patients with 300 mg of omalizumab every 4 weeks. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  8. Randomized Clinical Trial of Lansoprazole for Poorly Controlled Asthma in Children

    Science.gov (United States)

    Holbrook, Janet T.; Wise, Robert A.; Gold, Benjamin D.; Blake, Kathryn; Brown, Ellen D.; Castro, Mario; Dozor, Allen J.; Lima, John; Mastronarde, John G.; Sockrider, Marianna; Teague, W. Gerald

    2013-01-01

    Context Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. It is not known whether treatment of GER with a proton-pump inhibitor (PPI) improves asthma control. Objective To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. Design, Setting, and Patients A multicenter, randomized, masked, placebo controlled, parallel clinical trial comparing lansoprazole to placebo in children with poor asthma control on inhaled corticosteroid treatment conducted at 18 academic clinical centers. Participants were followed for 24 weeks. A subgroup had an esophageal pH study before randomization. Intervention Children received either lansoprazole (15 mg daily lansoprazole and placebo groups, respectively (P=0.12). There were no detectable treatment differences in secondary outcomes (mean (95% CI) for FEV1(0.00 (−0.08, 0.08)), asthma quality of life (−0.1 (−0.4, 0.1) or episodes of poor asthma control, hazard ratio of 1.18 (95% CI 0.91, 1.53). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole versus placebo was observed for any asthma outcome. Children treated with lansoprazole reported more upper respiratory infections (63% vs 49%, P=0.02), sore throats (52% vs 39%, P=0.02), and bronchitis (7% vs 2%, P=0.05). Conclusion Among children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, as compared to placebo, did not improve symptoms nor lung function but was associated with increased adverse events. PMID:22274684

  9. Assessment of chemomechanical removal of carious lesions using Papacarie Duo ™: Randomized longitudinal clinical trial

    Directory of Open Access Journals (Sweden)

    Simone Ferreira Borges Matsumoto

    2013-01-01

    Full Text Available Background: Chemomechanical removal of carious lesions consists of the dissolution of carious tissue by the application of a natural or synthetic agent, followed by atraumatic mechanical removal. Aim: The aim of the present study was to assess the effectiveness of Papacarie Duo ® gel in the chemomechanical removal of carious lesions in primary teeth in comparison to the traditional method (low-speed bur. Settings and Design: A randomized clinical trial was conducted with 20 children between 5 and 8 years of age. Materials and Methods: Two teeth were treated in each child (split-mouth design, with the randomization of two methods: Group 1 - chemomechanical caries removal with Papacarie Duo™; and Group 2 - removal of carious dentin tissue using a low-speed bur. Both methods involved restoration with glass ionomer cement and follow up. The following aspects were evaluated: time required for the procedure; pain (face evaluation scale; rtention of the restorative material in the cavity; and the presence of secondary caries after 30 days. Statistical Analysis Used: Chi-squared test, Student′s t-test, and Wilcoxon test. Results: No statistically significant differences between methods were found regarding time required for the procedure (P = 0.13, the occurrence of pain (P = 0.585, or restoration status at the 30-day clinical evaluation (P = 0.713. Conclusion: The findings of the present study demonstrate that the two methods achieve similar results. The advantages of minimally invasive treatment, such as chemomechanical caries removal with Papacarie Duo™, are its ease of use, patient comfort, and the fact that it causes less damage to dental tissue.

  10. Randomized clinical trial on the use of antispasmodic drugs in barium enema: impact on radiological practice

    International Nuclear Information System (INIS)

    Goei, Reginald; Kessels, Alphons H.; Nix, Maarten; Knipschild, Paul G.

    2000-01-01

    Purpose: To assess the willingness of radiologists to change their practice when the results of a randomized clinical trial (RCT) on the use of antispasmodic drugs in barium enema are presented. Materials and Methods: During the years 1994 and 1995 two postal questionnaires were sent to 481 practicing radiologists who were all members of the Netherlands Society of Radiology. In the first questionnaire the respondents were asked to give the characteristics of their practices in performing daily barium enema. The data from this questionnaire was used as a reference. The second questionnaire was sent to the respondents together with an abstract on the randomized clinical trial supporting the use of antispasmodic drugs in barium enema. We also indicated a preference for Buscopan over Glucagon as the antispasmodic drug. The willingness to change prescription habits was measured by comparing the data of the two questionnaires. Results: Of 481 practicing radiologists, 312 responded to the first questionnaire and gave information of their prescription habits (response rate 64%). These 312 responders were sent an abstract of the RCT and were asked to fill out a second questionnaire to determine their willingness to change their practice. Two hundred and sixty-seven radiologists responded (response rate 86%). A significant number of 119 (51%) were willing to increase the use of antispasmodic drugs. A significant number of 128 (55%) chose to increase the use of Buscopan, while a significant number of 81 (32%) were willing to decrease the use of Glucagon. Conclusion: Direct exposure to the results of an RCT recommending the use of antispasmodic drugs in barium enema, especially Buscopan, is likely to increase its use by practicing radiologists

  11. Dressing the split-thickness skin graft donor site: a randomized clinical trial.

    Science.gov (United States)

    Karlsson, Matilda; Lindgren, Margareta; Jarnhed-Andersson, Ingmarie; Tarpila, Erkki

    2014-01-01

    The primary objective of this study was to compare Aquacel (ConvaTec, Skillman, New Jersey), Allevyn (Smith & Nephew, St Petersburg, Florida), and Mediskin I (Mölnlycke, Health Care AB, Gothenburg, Sweden) in the treatment of split-thickness skin graft donor sites. This study was performed as a prospective randomized, 3-arm, clinical study. A clinical study performed at a hand and plastic surgery department with burn unit. The study included 67 adults with a total of 73 donor sites, which were on the thigh, not reharvested, and ranged between 30- and 400-cm area. Subjects were randomly assigned to treatment with Aquacel, Allevyn, or Mediskin I. The donor site was assessed on postoperative days 3, 14, and 21 for healing, infection, pain, impact on everyday life, ease of use, and cost. The obtained results demonstrate significantly faster re-epithelialization for patients treated with Aquacel or Mediskin I compared with Allevyn. Regarding infections, there were no significant differences between the groups. Patients wearing Aquacel experienced significantly less pain changing the dressing and less impact on everyday life than the patients wearing Allevyn. Aquacel was shown to be significantly easier for the caregiver to use than Allevyn and Mediskin I. There is a significant difference in cost of treatment between the dressings, whereas Mediskin I is the most expensive. The authors' results support the use of Aquacel in the treatment of split-thickness skin graft donor sites. Aquacel has a low cost per unit, is user friendly, gives short healing time, and minimizes patient discomfort.

  12. Three treatments for teachers with voice disorders: a randomized clinical trial.

    Science.gov (United States)

    Roy, Nelson; Weinrich, Barbara; Gray, Steven D; Tanner, Kristine; Stemple, Joseph C; Sapienza, Christine M

    2003-06-01

    Voice problems are a common occupational hazard of teaching school, yet few studies exist that have objectively evaluated treatment approaches aimed at rehabilitating these occupation-related voice disorders. This randomized clinical trial used patient-based treatment outcome measures to evaluate the effectiveness of three treatment programs. Sixty-four teachers with voice disorders were randomly assigned to 1 of 3 treatment groups: voice amplification using the ChatterVox portable amplifier (VA; n = 25), resonance therapy (RT; n = 19), and respiratory muscle training (RMT; n = 20). Before and after a 6-week treatment phase, all teachers completed (a) the Voice Handicap Index (VHI; B. H. Jacobson et al., 1997), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders, and (b) a voice severity self-rating scale. Both intention-to-treat and as-treated analyses revealed that only the VA and RT groups reported significant reductions in mean VHI scores and in voice severity self-ratings following treatment. Furthermore, results from a posttreatment questionnaire regarding the perceived benefits of treatment showed that compared to RT and RMT, teachers in the VA group reported significantly more overall voice improvement, greater vocal clarity, and greater ease of speaking and singing voice following treatment. These findings replicate previous results from an earlier clinical trial confirming the efficacy of VA and provide new evidence to support RT as an effective treatment alternative for voice problems in teachers. The results are discussed in the context of uneven levels of self-reported compliance and disparate dropout rates among the treatment groups.

  13. Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial

    Directory of Open Access Journals (Sweden)

    W.A. Goncalves-Ferri

    2014-03-01

    Full Text Available This study evaluated whether the use of continuous positive airway pressure (CPAP in the delivery room alters the need for mechanical ventilation and surfactant during the first 5 days of life and modifies the incidence of respiratory morbidity and mortality during the hospital stay. The study was a multicenter randomized clinical trial conducted in five public university hospitals in Brazil, from June 2008 to December 2009. Participants were 197 infants with birth weight of 1000-1500 g and without major birth defects. They were treated according to the guidelines of the American Academy of Pediatrics (APP. Infants not intubated or extubated less than 15 min after birth were randomized for two treatments, routine or CPAP, and were followed until hospital discharge. The routine (n=99 and CPAP (n=98 infants studied presented no statistically significant differences regarding birth characteristics, complications during the prenatal period, the need for mechanical ventilation during the first 5 days of life (19.2 vs 23.4%, P=0.50, use of surfactant (18.2 vs 17.3% P=0.92, or respiratory morbidity and mortality until discharge. The CPAP group required a greater number of doses of surfactant (1.5 vs 1.0, P=0.02. When CPAP was applied to the routine group, it was installed within a median time of 30 min. We found that CPAP applied less than 15 min after birth was not able to reduce the need for ventilator support and was associated with a higher number of doses of surfactant when compared to CPAP applied as clinically indicated within a median time of 30 min.

  14. A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Edinger, Jack D; Grubber, Janet; Ulmer, Christi; Zervakis, Jennifer; Olsen, Maren

    2016-01-01

    To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management. This study used a randomized, parallel group, clinical intervention trial design. A total of 137 adult (29 women) VA outpatients with sleep complaints were enrolled and randomly assigned to (1) an intervention (INT) consisting of a one-time consultation with a sleep specialist who provided diagnostic feedback and treatment recommendations to the patient and the patient's primary care provider; or (2) a control condition consisting of their usual primary care (UPC). Provider-focused outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient-focused outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood, quality of life, and satisfaction with health care. The proportions of provider-initiated sleep-focused interventions were significantly higher in the INT group than in the UPC group for polysomnography referrals (49% versus 6%; P sleep efficiency (+3.7%; 95% CI: 0.8, 6.5; P = 0.01) than did UPC participants. A greater proportion of the INT group showed ≥ 1 standard deviation decline on the PSQI from baseline to the 10-mo follow-up (41% versus 21%; P = 0.02). Moreover, 69% of the INT group had normal (≤ 10) Epworth Sleepiness Scale scores at the 10-mo follow-up, whereas only 50% of the UPC group fell below this clinical cutoff (P = 0.03). A one-time sleep consultation significantly increased healthcare providers' attention to sleep problems and resulted in benefits to patients' sleep/wake symptoms. This study is registered with clinicaltrials.gov with identifier # NCT00390572. © 2016 Associated Professional Sleep Societies, LLC.

  15. Angioplasty Guided by Intravascular Ultrasound: Meta-Analysis of Randomized Clinical Trials

    International Nuclear Information System (INIS)

    Figueiredo, José Albuquerque Neto de; Nogueira, Iara Antonia Lustosa; Figueiro, Mabel Fernandes; Buehler, Anna Maria; Berwanger, Otavio

    2013-01-01

    The impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results. Systematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution. A search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases. It included randomized clinical trials (RCTs) that evaluated the implantation of stents guided by IVUS, compared with those using angiography alone (ANGIO). The minimum follow-up duration was six months and the following outcomes were assessed: thrombosis, mortality, myocardial infarction, percutaneous and surgical revascularization, major adverse cardiovascular events (MACE) and restenosis. The binary outcomes were presented considering the number of events in each group; the estimates were generated by a random effects model, considering Mantel-Haenszel statistics as weighting agent and magnitude of effect for the relative risk (RR) with its respective 95% confidence interval (95%CI). Higgins I 2 test was used to quantify the consistency between the results of each study. A total of 2,689 articles were evaluated, including 8 RCTs. There was a 27% reduction in angiographic restenosis (RR: 0.73, 95% CI: 0.54-0.97, I 2 = 51%) and statistically significant reduction in the rates of percutaneous revascularization and overall (RR: 0.88; 95% CI: 0.51 to 1.53, I 2 = 61%, RR: 0.73, 95% CI: 0.54 to 0.99, I 2 = 55%), with no statistical difference in surgical revascularization (RR: 0.95, 95% CI: 0.52-1.74, I 2 = 0%) in favor of IVUS vs. ANGIO. There were no differences regarding the other outcomes in the comparison between the two strategies. Angioplasty with stenting guided by IVUS decreases the rates of restenosis and revascularization, with no impact on MACE, acute myocardial infarction, mortality or thrombosis outcomes

  16. Mindfulness Based Relapse Prevention for Stimulant Dependent Adults: A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Glasner-Edwards, Suzette; Mooney, Larissa J; Ang, Alfonso; Garneau, Hélène Chokron; Hartwell, Emily; Brecht, Mary-Lynn; Rawson, Richard A

    2017-02-01

    In light of the known associations between stress, negative affect, and relapse, mindfulness strategies hold promise as a means of reducing relapse susceptibility. In a pilot randomized clinical trial, we evaluated the effects of Mindfulness Based Relapse Prevention (MBRP), relative to a health education control condition (HE) among stimulant dependent adults receiving contingency management. All participants received a 12-week contingency management (CM) intervention. Following a 4-week CM-only lead in phase, participants were randomly assigned to concurrently receive MBRP (n=31) or HE (n=32). Stimulant dependent adults age 18 and over. A university based clinical research center. The primary outcomes were stimulant use, measured by urine drug screens weekly during the intervention and at 1-month post-treatment, negative affect, measured by the Beck Depression Inventory and Beck Anxiety Inventory, and psychiatric severity, measured by the Addiction Severity Index. Medium effect sizes favoring MBRP were observed for negative affect and overall psychiatric severity outcomes. Depression severity changed differentially over time as a function of group, with MBRP participants reporting greater reductions through follow-up (p=0.03; Effect Size=0.58). Likewise, the MBRP group evidenced greater declines in psychiatric severity, (p=0.01; Effect Size=0.61 at follow-up). Among those with depressive and anxiety disorders, MBRP was associated with lower odds of stimulant use relative to the control condition (Odds Ratio= 0.78, p=0.03 and OR=0.68, p=0.04). MBRP effectively reduces negative affect and psychiatric impairment, and is particularly effective in reducing stimulant use among stimulant dependent adults with mood and anxiety disorders.

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

    Science.gov (United States)

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

    2016-04-01

    This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. 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. 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. 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. ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  18. CHLOROQUINE VS STEROID INJECTION IN MANAGEMENT OF PRIMARY KNEE OSTEOARTHRITIS: A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    H KARIMZADEH

    2002-03-01

    Full Text Available Introduction. Osteoarthritis (OA is one of the most common forms of articular disease and one of the major causes of pain and disability especially in old age. The purpose of this study is to assay therapeutic effect of oral chloroquine in comparison with intraarticular injection of corticosteroid in management of osteoarthritis. Methods. A controlled randomized clinical trial study was done in Isfahan Alzahra hospital from October 2000 to September 2001 (11 months. The eligible patients were randomized in one of the therapeutic modalities (oral chloroquine: 15 patients; Intraarticular steroid injection: 15 patient. The patient initially were classified as their intensity of jont pain on the base of (visual analog scale 0-100, their (global status 0-100 and Lequesne"s functional index (0 - 25. Data was obtioned in 4th, 8th, 12th weeks follow up. Results. In the first group the intensity of pain in 4th, 8th, 12th weeks became significantly attenutated in Comparison to initiation of study (P < 0.05. In contrast second group the intensity of pain in 4th week became attenuated in comparison to the bigining of the study but this effect was not significant in 8th and 12th weeks (P > 0.05. Discussion. The most clinical responsiveness including attenuation of pain improvment of global status and lequesne"s functional index in first group was observed in 12th week but this responsiveness in second group (corticosteroid decreased significantly after 4th week. Oral chloroquine in comparison with intra articular corticosteroid injection in patients with knee OA cause therapeutic benefit effect for longer time. It can be as a useful, treatment method without a serious side effects on these patients.

  19. Oral domperidone has no additional effect on chronic functional constipation in children: a randomized clinical trial.

    Science.gov (United States)

    Dehghani, Seyed Mohsen; Askarian, Mehrdad; Kaffashan, Heidar Ali

    2014-03-01

    Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children. A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment. A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (p = 1), 3 (p = 0.799), and 6 (p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment. There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation.

  20. A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience.

    Science.gov (United States)

    Arun, Banu; Austin, Taylor; Babiera, Gildy V; Basen-Engquist, Karen; Carmack, Cindy L; Chaoul, Alejandro; Cohen, Lorenzo; Connelly, Lisa; Haddad, Robin; Harrison, Carol; Li, Yisheng; Mallaiah, Smitha; Nagarathna, Raghuram; Parker, Patricia A; Perkins, George H; Reuben, James M; Shih, Ya-Chen Tina; Spelman, Amy; Sood, Anil; Yang, Peiying; Yeung, Sai-Ching J

    2017-03-01

    Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions

  1. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.

    Science.gov (United States)

    McEvoy, Joseph P; Byerly, Matthew; Hamer, Robert M; Dominik, Rosalie; Swartz, Marvin S; Rosenheck, Robert A; Ray, Neepa; Lamberti, J Steven; Buckley, Peter F; Wilkins, Tania M; Stroup, T Scott

    2014-05-21

    Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders. The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed. To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate. Multisite, double-blind, randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites. Randomized patients (n = 311) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic. Intramuscular injections of haloperidol decanoate 25 to 200 mg or paliperidone palmitate 39 to 234 mg every month for as long as 24 months. Efficacy failure, defined as a psychiatric hospitalization, a need for crisis stabilization, a substantial increase in frequency of outpatient visits, a clinician's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics, or a clinician's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit. Key secondary outcomes were common adverse effects of antipsychotic medications. There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate (adjusted hazard ratio, 0.98; 95% CI, 0.65-1.47). The number of participants who experienced efficacy failure was 49 (33.8%) in the paliperidone palmitate group and 47 (32.4%) in the haloperidol decanoate group. On average, participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight; after 6 months, the least-squares mean weight change for those taking

  2. Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Smith, Stephen R; Murray, David; Pockney, Peter G; Bendinelli, Cino; Draganic, Brian D; Carroll, Rosemary

    2018-01-01

    Lower GI hemorrhage is a common source of morbidity and mortality. Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss in a variety of clinical conditions. Information regarding the use of tranexamic acid in treating lower GI hemorrhage is lacking. The aim of this trial was to determine the clinical efficacy of tranexamic acid when used for lower GI hemorrhage. This was a prospective, double-blind, placebo-controlled, randomized clinical trial. The study was conducted at a tertiary referral university hospital in Australia. Consecutive patients aged >18 years with lower GI hemorrhage requiring hospital admission from November 2011 to January 2014 were screened for trial eligibility (N = 265). A total of 100 patients were recruited after exclusions and were randomly assigned 1:1 to either tranexamic acid or placebo. The primary outcome was blood loss as determined by reduction in hemoglobin levels. The secondary outcomes were transfusion rates, transfusion volume, intervention rates for bleeding, length of hospital stay, readmission, and complication rates. There was no difference between groups with respect to hemoglobin drop (11 g/L of tranexamic acid vs 13 g/L of placebo; p = 0.9445). There was no difference with respect to transfusion rates (14/49 tranexamic acid vs 16/47 placebo; p = 0.661), mean transfusion volume (1.27 vs 1.93 units; p = 0.355), intervention rates (7/49 vs 13/47; p = 0.134), length of hospital stay (4.67 vs 4.74 d; p = 0.934), readmission, or complication rates. No complications occurred as a direct result of tranexamic acid use. A larger multicenter trial may be required to determine whether there are more subtle advantages with tranexamic acid use in some of the secondary outcomes. Tranexamic acid does not appear to decrease blood loss or improve clinical outcomes in patients presenting with lower GI hemorrhage in the context of this trial. see Video Abstract at http://links.lww.com/DCR/A453.

  3. Standard donor lung procurement with normothermic ex vivo lung perfusion: A prospective randomized clinical trial.

    Science.gov (United States)

    Slama, Alexis; Schillab, Lukas; Barta, Maximilian; Benedek, Aris; Mitterbauer, Andreas; Hoetzenecker, Konrad; Taghavi, Shahrokh; Lang, Gyoergy; Matilla, Jose; Ankersmit, Hendrik; Hager, Helmut; Roth, Georg; Klepetko, Walter; Aigner, Clemens

    2017-07-01

    Ex vivo lung perfusion (EVLP) was primarily developed for evaluation of impaired donor lungs. The good clinical results raise the question for its possible impact on lungs meeting standard criteria. Before application of EVLP on such lungs enters routine clinical practice, it must be demonstrated whether EVLP would affect or improve outcome when used in standard donor lungs. We performed a prospective randomized trial to investigate the role of EVLP in standard lung transplantation (Tx). This prospective randomized clinical trial compared patients who underwent Tx with ex vivo evaluated donor lungs with an equivalent patient population without previous EVLP. From October 2013 to May 2015, 193 lung Tx were performed at the Medical University of Vienna. During this period, 80 recipient/donor pairs that met the inclusion criteria were included in this trial, 41 pairs in the control group, and 39 in the EVLP group. In the EVLP group, 4 lungs (10.2%) ultimately did not qualify for Tx and were rejected for lung Tx owing to technical reasons (n = 2) and quality criteria (n = 2). Donor and recipient characteristics were comparable in both groups. Total cold ischemic time in the EVLP group was significantly longer for both implanted lungs (first side, 372 minutes vs 291 minutes, p 1 was lower in the EVLP group at all time points compared with the control group (24 hours, 5.7% vs 19.5%, p = 0.10), and need for post-operative prolonged extracorporeal membrane oxygenation was lower in the EVLP group (5.7% vs 12.2%, p = 0.44). Short-term clinical outcomes did not differ between recipients in the 2 groups. Patients remained intubated (1.6 days vs 1.6 days, p = 0.67), in the intensive care unit (6 days vs 6 days, p = 0.76), and in the hospital (23 days vs 19 days, p = 0.42) for a comparable period of time. The 30-day survival was 97.1% vs 100% (p = 0.46). This study provides evidence that EVLP can safely be used in standard donor lungs. Functional results and perioperative

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

    Science.gov (United States)

    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

  5. Huperzine A for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Guoyan Yang

    Full Text Available Huperzine A is a Chinese herb extract used for Alzheimer's disease. We conducted this review to evaluate the beneficial and harmful effect of Huperzine A for treatment of Alzheimer's disease.We searched for randomized clinical trials (RCTs of Huperzine A for Alzheimer's disease in PubMed, Cochrane Library, and four major Chinese electronic databases from their inception to June 2013. We performed meta-analyses using RevMan 5.1 software. (Protocol ID: CRD42012003249.20 RCTs including 1823 participants were included. The methodological quality of most included trials had a high risk of bias. Compared with placebo, Huperzine A showed a significant beneficial effect on the improvement of cognitive function as measured by Mini-Mental State Examination (MMSE at 8 weeks, 12 weeks and 16 weeks, and by Hastgawa Dementia Scale (HDS and Wechsler Memory Scale (WMS at 8 weeks and 12 weeks. Activities of daily living favored Huperzine A as measured by Activities of Daily Living Scale (ADL at 6 weeks, 12 weeks and 16 weeks. One trial found Huperzine A improved global clinical assessment as measured by Clinical Dementia Rating Scale (CDR. One trial demonstrated no significant change in cognitive function as measured by Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog and activity of daily living as measured by Alzheimer's disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL in Huperzine A group. Trials comparing Huperzine A with no treatment, psychotherapy and conventional medicine demonstrated similar findings. No trial evaluated quality of life. No trial reported severe adverse events of Huperzine A.Huperzine A appears to have beneficial effects on improvement of cognitive function, daily living activity, and global clinical assessment in participants with Alzheimer's disease. However, the findings should be interpreted with caution due to the poor methodological quality of the included trials.

  6. Effects of Normobaric Hyperoxia in Severe Acute Stroke: a Randomized Controlled Clinical Trial Study.

    Science.gov (United States)

    Mazdeh, Mehrdokht; Taher, Abbas; Torabian, Saadat; Seifirad, Soroush

    2015-11-01

    Oxygen therapy might increase damaged tissue oxygenation, turn on the aerobic pathway, and save neurons from death and could improve clinical outcome of the patients with stroke and head trauma. Hyperbaric oxygen therapy is accompanied by some unfavorable effects. Results of normobaric oxygen therapy on clinical outcomes of patients with stroke were controversial up till now.  This study was therefore designed to evaluate effects of normobaric hyperoxia on clinical outcomes of patients with severe acute stroke. A total of 52 consecutive patients with stroke who meet the inclusion criteria of the study were entered into this randomized controlled clinical trial. The patients in the case group underwent oxygen therapy with Venturi mask for first 12 hours of admission. The patients were examined for neurologic defects at the time of discharge and after six months using both Barthel and modified Rankin Scale (mRS) neurologic disability scoring systems. There was no significant sex difference between the two groups (P=0.5). There was no statistically significant difference between ischemic-hemorrhagic stroke constitutions of two groups (P=0.2). There were no significant difference in Barthel index scores of both groups at the time of discharge as well as the follow-up examination (P=0.7) According to the mRS scoring system, there was no difference between the patients of both groups at the time of admission (P= 0.8), however after treatment there was a significant difference between mRS scores of the treated group compared to the controls (P=0.04). According to the results of this study, normobaric oxygen therapy in the first 12 hours of accident could improve long time outcome of the patients with either ischemic or hemorrhagic stroke.

  7. Randomized controlled clinical trial on the efficacy of fosfomycin trometamol for uncomplicated gonococcal urethritis in men.

    Science.gov (United States)

    Yuan, Z; He, C; Yan, S; Ke, Y; Tang, W

    2016-06-01

    We assessed the efficacy of fosfomycin trometamol in treating uncomplicated gonococcal urethritis in men. We conducted an open randomized controlled trial in 152 consecutive men with any main complaints suggestive of uncomplicated gonococcal urethritis in Dujiangyan Medical Center between 1 September 2013 and 31 August 2015. In total, 126 patients completed all aspects of this study. Sixty were provided therapy with fosfomycin trometamol 3 g orally on days 1, 3 and 5 in the intervention group; the other 61 were provided ceftriaxone 250 mg intramuscularly plus azithromycin 1 g orally simultaneously as a single dose in the control group. The primary outcomes involved clinical and microbiologic cure on days 7 and 14 after receipt of all the study medications. At the day 7 follow-up visit, all the 121 participants had complete resolution of clinical symptoms and signs. In addition, five patients (two in the intervention group and three in the control group) discontinued intervention because of unsuccessful treatment. After receipt of all the study medications, these five patients still had urethral purulent discharge and were switched to other unknown treatment regimens by other doctors. The bacterial smears and cultures of urethral or urine specimens in the 121 patients who completed all aspects of the study were negative on a test-of-cure visit. In the per-protocol analysis, both clinical and microbiologic cure were experienced by 96.8% (60/62 patients) in the intervention group and 95.3% (61/64 patients) in the control group. There were no recurrences at the day 14 test-of-cure visit. This trial indicates that fosfomycin trometamol exhibits excellent efficacy for treatment of uncomplicated gonococcal urethritis in men. Serious adverse effects are rare. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  8. Adequacy of published oncology randomized controlled trials to provide therapeutic details needed for clinical application.

    Science.gov (United States)

    Duff, Jennifer M; Leather, Helen; Walden, Edmund O; LaPlant, Kourtney D; George, Thomas J

    2010-05-19

    Randomized controlled trials (RCTs) improve clinical care through evidence-based results. Guidelines exist for RCT result reporting, but specific details of therapeutic administration promote clinical application and reproduction of the trial design. We assess the reporting methodology in RCTs published in major oncology journals. Ten essential elements of RCT reporting were identified and included drug name, dose, route, cycle length, maximum number of cycles, premedication, growth factor support, patient monitoring parameters, and dosing adjustments for hematologic and organ-specific toxicity. All therapy-based oncology RCTs published between 2005 and 2008 in the New England Journal of Medicine (NEJM), Journal of Clinical Oncology (JCO), Journal of the National Cancer Institute (JNCI), Blood, and Cancer were analyzed for inclusion of these 10 elements. Of 339 identified articles, 262 were included in the final analysis (165 from JCO, 31 from NEJM, 27 from Cancer, 20 from JNCI, and 19 from Blood). Premedication, growth factor support, and dose adjustments for toxicities were each reported less than half of the time. Only 30 articles (11%) met the main objective of complete data reporting (ie, all 10 essential elements) and was highest in JNCI (5/20; 25%), followed by Cancer (5/27; 18%), JCO (18/165; 11%), Blood (1/19; 5%), and NEJM (1/31; 3%). The presence of an online appendix did not substantially improve complete reporting. RCTs published in major oncology journals do not consistently report essential therapeutic details necessary for translation of the trial findings to clinical practice. Potential solutions to improve reporting include modification of submission guidelines, use of online appendices, and providing open access to trial protocols.

  9. Bioresorbable vascular scaffolds for the treatment of coronary artery disease: Clinical outcomes from randomized controlled trials.

    Science.gov (United States)

    Rizik, David G; Hermiller, James B; Kereiakes, Dean J

    2016-11-01

    The permanent metal prosthesis common to bare metal stents (BMS) as well as both first- and second-generation drug-eluting stents (DES) following treatment of coronary artery disease represents a long-lasting substrate for late adverse coronary events including restenosis, thrombosis, and neoatherosclerosis. Following resorbtion, bioresorbable scaffolds (BRS) may eliminate this nidus and improve late outcomes through restoration of the vessel to more normal vascular structure and function. BRS represents a single platform which incorporates the mechanical features of metallic stents to provide safe and effective revascularization, suppression of restenosis and prevention of constrictive remodeling with long-term restoration of the treated vessel to a more natural state. The landscape of BRS is rapidly evolving with new materials which target various performance goals for the duration of vascular support and polymer resorption time. The Absorb bioresorbable vascular scaffold (Absorb BVS), recently approved by United States Food and Drug Administration, has extensive clinical evidence to date in support of its clinical efficacy and safety. Recently published data from well-executed randomized clinical trials (RCTs) as part of the ABSORB Clinical development program along with other investigator-initiated trials provide insights into the safety and performance of this device in patients with de novo coronary lesions as well in the setting of ST-segment elevation myocardial infarction (STEMI). This review provides a comprehensive, outcomes based understanding of the available evidence from RCTs that offer head-to-head comparisons of Absorb BVS with metallic everolimus-eluting stents (EES). © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice

    Directory of Open Access Journals (Sweden)

    Ueberall MA

    2016-02-01

    Full Text Available Michael A Ueberall,1 Alice Eberhardt,2 Gerhard HH Mueller-Schwefe3 1Institute for Neurological Sciences, Nuernberg, Germany; 2Mundipharma GmbH, Limburg, Germany; 3Interdisciplinary Center for Pain and Palliative Care Medicine, Goeppingen, Germany Objective: To compare the quality of life of patients with moderate-to-severe chronic low back pain under treatment with the WHO-step III opioids oxycodone/naloxone, oxycodone, or morphine in routine clinical practice. Study design: Prospective, 12-week, randomized, open-label, blinded end-point study in 88 medical centers in Germany. Patients and methods: A total of 901 patients requiring around-the-clock pain treatment with a WHO-step III opioid were randomized to either morphine, oxycodone, or oxycodone/naloxone (1:1:1. Changes from baseline to week 12 in quality of life were assessed using different validated tools (EuroQoL-5 Dimensions [EQ-5D], Short Form 12 [SF-12], quality of life impairment by pain inventory [QLIP]. Results: EQ-5D weighted index scores significantly improved over the 12-week treatment period under all three opioids (P<0.001 with significantly greater improvements under oxycodone/naloxone (65.2% vs 49.6% for oxycodone and 48.2% for morphine, P<0.001. The proportion of patients without EQ-5D complaints was also significantly higher under oxycodone/naloxone (P<0.001. Although quality of life ratings with the QLIP inventory showed significant improvements in all the three treatment arms, improvements were significantly higher under oxycodone/naloxone than under oxycodone and morphine (P<0.001: 90.7% of all oxycodone/naloxone patients achieved ≥30% improvements in quality of life, 72.8% had ≥50%, and 33.2% ≥70% improvements. Similarly, both physical and mental SF-12 component scores showed significantly greater improvements under oxycodone/naloxone with both scores close to the German population norm after 12 weeks. Conclusion: Treatment with morphine, oxycodone, or oxycodone

  11. Beneficial effects of dark chocolate on exercise capacity in sedentary subjects: underlying mechanisms. A double blind, randomized, placebo controlled trial.

    Science.gov (United States)

    Taub, Pam R; Ramirez-Sanchez, Israel; Patel, Minal; Higginbotham, Erin; Moreno-Ulloa, Aldo; Román-Pintos, Luis Miguel; Phillips, Paul; Perkins, Guy; Ceballos, Guillermo; Villarreal, Francisco

    2016-09-14

    In heart failure patients the consumption of (-)-epicatechin ((-)-Epi)-rich cocoa can restore skeletal muscle (SkM) mitochondrial structure and decrease biomarkers of oxidative stress. However, nothing is known about its effects on exercise capacity and underlying mechanisms in normal, sedentary subjects. Twenty normal, sedentary subjects (∼50 years old) were randomized to placebo or dark chocolate (DC) groups and consumed 20 g of the products for 3 months. Subjects underwent before and after treatment, bicycle ergometry to assess VO2 max and work, SkM biopsy to assess changes in mitochondrial density, function and oxidative stress and blood sampling to assess metabolic endpoints. Seventeen subjects completed the trial. In the DC group (n = 9), VO2 max increased (17% increase, p = 0.056) as well as maximum work (watts) achieved (p = 0.026) with no changes with placebo (n = 8). The DC group evidenced increases in HDL levels (p = 0.005) and decreased triglycerides (p = 0.07). With DC, SkM evidenced significant increases in protein levels for LKB1, AMPK and PGC1α and in their active forms (phosphorylated AMPK and LKB1) as well as in citrate synthase activity while no changes were observed in mitochondrial density. With DC, significant increases in SkM reduced glutathione levels and decreases in protein carbonylation were observed. Improvements in maximum work achieved and VO2 max may be due to DC activation of upstream control systems and enhancement of SkM mitochondria efficiency. Larger clinical studies are warranted to confirm these observations.

  12. Neurobehavioral effects of dental amalgam in children: a randomized clinical trial.

    Science.gov (United States)

    DeRouen, Timothy A; Martin, Michael D; Leroux, Brian G; Townes, Brenda D; Woods, James S; Leitão, Jorge; Castro-Caldas, Alexandre; Luis, Henrique; Bernardo, Mario; Rosenbaum, Gail; Martins, Isabel P

    2006-04-19

    Dental (silver) amalgam is a widely used restorative material containing 50% elemental mercury that emits small amounts of mercury vapor. No randomized clinical trials have determined whether there are significant health risks associated with this low-level mercury exposure. To assess the safety of dental amalgam restorations in children. A randomized clinical trial in which children requiring dental restorative treatment were randomized to either amalgam for posterior restorations or resin composite instead of amalgam. Enrollment commenced February 1997, with annual follow-up for 7 years concluding in July 2005. A total of 507 children in Lisbon, Portugal, aged 8 to 10 years with at least 1 carious lesion on a permanent tooth, no previous exposure to amalgam, urinary mercury level or =67, and with no interfering health conditions. Routine, standard-of-care dental treatment, with one group receiving amalgam restorations for posterior lesions (n = 253) and the other group receiving resin composite restorations instead of amalgam (n = 254). Neurobehavioral assessments of memory, attention/concentration, and motor/visuomotor domains, as well as nerve conduction velocities. During the 7-year trial period, children had a mean of 18.7 tooth surfaces (median, 16) restored in the amalgam group and 21.3 (median, 18) restored in the composite group. Baseline mean creatinine-adjusted urinary mercury levels were 1.8 microg/g in the amalgam group and 1.9 microg/g in the composite group, but during follow-up were 1.0 to 1.5 microg/g higher in the amalgam group than in the composite group (Pamalgam and composite groups over all 7 years of follow-up, with no statistically significant differences observed at any time point (P values from .29 to .91). Starting at 5 years after initial treatment, the need for additional restorative treatment was approximately 50% higher in the composite group. In this study, children who received dental restorative treatment with amalgam did not, on

  13. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial.

    Science.gov (United States)

    Zhao, Ling; Chen, Jiao; Li, Ying; Sun, Xin; Chang, Xiaorong; Zheng, Hui; Gong, Biao; Huang, Yinlan; Yang, Mingxiao; Wu, Xi; Li, Xuezhi; Liang, Fanrong

    2017-04-01

    The long-term prophylactic effects of acupuncture for migraine are uncertain. To investigate the long-term effects of true acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. This was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to true acupuncture, sham acupuncture, or a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at 3 clinical sites in China. A total of 249 participants 18 to 65 years old with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month. Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks. A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. One hundred eighty-nine (77.1%) were women. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (P acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true

  14. Security under Uncertainty: Adaptive Attackers Are More Challenging to Human Defenders than Random Attackers

    Directory of Open Access Journals (Sweden)

    Frédéric Moisan

    2017-06-01

    Full Text Available Game Theory is a common approach used to understand attacker and defender motives, strategies, and allocation of limited security resources. For example, many defense algorithms are based on game-theoretic solutions that conclude that randomization of defense actions assures unpredictability, creating difficulties for a human attacker. However, many game-theoretic solutions often rely on idealized assumptions of decision making that underplay the role of human cognition and information uncertainty. The consequence is that we know little about how effective these algorithms are against human players. Using a simplified security game, we study the type of attack strategy and the uncertainty about an attacker's strategy in a laboratory experiment where participants play the role of defenders against a simulated attacker. Our goal is to compare a human defender's behavior in three levels of uncertainty (Information Level: Certain, Risky, Uncertain and three types of attacker's strategy (Attacker's strategy: Minimax, Random, Adaptive in a between-subjects experimental design. Best defense performance is achieved when defenders play against a minimax and a random attack strategy compared to an adaptive strategy. Furthermore, when payoffs are certain, defenders are as efficient against random attack strategy as they are against an adaptive strategy, but when payoffs are uncertain, defenders have most difficulties defending against an adaptive attacker compared to a random attacker. We conclude that given conditions of uncertainty in many security problems, defense algorithms would be more efficient if they are adaptive to the attacker actions, taking advantage of the attacker's human inefficiencies.

  15. Comparison of Bilateral and Unilateral Cochlear Implantation in Adults: A Randomized Clinical Trial.

    Science.gov (United States)

    Smulders, Yvette E; van Zon, Alice; Stegeman, Inge; Rinia, Albert B; Van Zanten, Gijsbert A; Stokroos, Robert J; Hendrice, Nadia; Free, Rolien H; Maat, Bert; Frijns, Johan H M; Briaire, Jeroen J; Mylanus, Emmanuel A M; Huinck, Wendy J; Smit, Adriana L; Topsakal, Vedat; Tange, Rinze A; Grolman, Wilko

    2016-03-01

    The cost of bilateral cochlear implantation (BCI) is usually not reimbursed by insurance companies because of a lack of well-designed studies reporting the benefits of a second cochlear implant. To determine the benefits of simultaneous BCI compared with unilateral cochlear implantation (UCI) in adults with postlingual deafness. A multicenter randomized clinical trial was performed. The study took place in 5 Dutch tertiary referral centers: the University Medical Centers of Utrecht, Maastricht, Groningen, Leiden, and Nijmegen. Forty patients eligible for cochlear implantation met the study criteria and were included from January 12, 2010, through November 2, 2012. The main inclusion criteria were postlingual onset of hearing loss, age of 18 to 70 years, duration of hearing loss of less than 20 years, and a marginal hearing aid benefit. Two participants withdrew from the study before implantation. Nineteen participants were randomized to undergo UCI and 19 to undergo BCI. The BCI group received 2 cochlear implants during 1 surgery. The UCI group received 1 cochlear implant. The primary outcome was the Utrecht Sentence Test with Adaptive Randomized Roving levels (speech in noise, both presented from straight ahead). Secondary outcomes were consonant-vowel-consonant words in silence, speech-intelligibility test with spatially separated sources (speech in noise from different directions), sound localization, and quality of hearing questionnaires. Before any data were collected, the hypothesis was that the BCI group would perform better on the objective and subjective tests that concerned speech intelligibility in noise and spatial hearing. Thirty-eight patients were included in the study. Fifteen patients in the BCI group used hearing aids before implantation compared with 19 in the UCI group. Otherwise, there were no significant differences between the groups' baseline characteristics. At 1-year follow-up, there were no significant differences between groups on the

  16. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.

    Science.gov (United States)

    Shanahan, William R; Rose, Jed E; Glicklich, Alan; Stubbe, Scott; Sanchez-Kam, Matilde

    2017-08-01

    Lorcaserin is a selective serotonin 2C receptor agonist approved by the Food and Drug Administration for chronic weight management. Preclinical data suggest that it may also be effective in smoking cessation through modulation of the dopaminergic reward system. This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. Six hundred three adult smokers with a Body Mass Index of 18.5-35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo; all received standardized smoking cessation counseling weekly. The target quit date was day 15. The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for weeks 9-12 (month 3). Continuous Abstinence Rates for month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p = .0027. Change in weight at week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p = .0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue. Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted. Trial Registration: ClinicalTrials.gov. Identifier: NCT02044874. This randomized, controlled trial demonstrated that lorcaserin used in conjunction with standard cessation counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain. To our knowledge, this is the first demonstration in humans of a potential role of 5-HT2C agonism in the modulation of central neurological

  17. Clonidine versus tramadol for post spinal shivering during caesarean section: A randomized double blind clinical study

    Directory of Open Access Journals (Sweden)

    Velayudha S Reddy

    2011-01-01

    Full Text Available Background : Control of post spinal shivering is essential for optimal perioperative care, which can be achieved either by oral or parental medications. The present study is designed to evaluate the efficacy and safety of intravenous low-dose clonidine and tramadol in the treatment of post spinal shivering. Materials and Methods : In this prospective, a double blind, randomized study, 90 ASA grade I or II, parturients aged 18 - 35 years, undergoing caesarean section under spinal anaesthesia, who subsequently developed shivering grade 3 or 4, were randomized into two groups, to receive either clonidine or tramadol. The efficacy and response rate of the study drugs were evaluated and recorded. Side effects like, nausea, vomiting, hypotension, bradycardia, dry mouth, sedation, skin rash and headache, if present, were recorded. All data were analyzed by using the Chi square test and the Z-test. Results : There were significant differences in the response rate between the drugs (P < 0.05. Time taken from the starting of treatment to cessation of shivering was significantly less with the tramadol group (P < 0.05, however, the frequency of nausea, vomiting, sedation and headache were also significantly more in the tramadol group Conclusion : In our study we concluded that both clonidine and tramadol control shivering. However, the response rate was higher and time taken to control shivering was lesser with tramadol, but the response rate and the side effects were lesser with clonidine.

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

    Science.gov (United States)

    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

  19. Which orthodontic appliance is best for oral hygiene? A randomized clinical trial.

    Science.gov (United States)

    Chhibber, Aditya; Agarwal, Sachin; Yadav, Sumit; Kuo, Chia-Ling; Upadhyay, Madhur

    2018-02-01

    Clear aligners and to a lesser extent self-ligated brackets are considered to facilitate better oral hygiene than traditional fixed orthodontic appliances. This 3-arm parallel-group prospective randomized clinical trial compared the long-term and short-term effects of clear aligners, self-ligated brackets, and conventional (elastomeric-ligated) brackets on patients' oral hygiene during active orthodontic treatment. Seventy-one participants (41 boys, 30 girls; mean age, 15.6 years) undergoing orthodontic treatment were randomly allocated through a computer-generated randomization schedule to one of the groups based on the choice of intervention: Clear Aligners (CLA) (Align Technology, San Jose, Calif) (n = 27), preadjusted edgewise fixed appliance with self-ligated brackets (SLB) (Carriere, Carlsbad, Calif (n = 22), or preadjusted edgewise fixed appliance with elastomeric ligated brackets (ELB) (Ortho Organizers Inc., Carlsbad, CA) (n = 22). For each participant, the primary outcome, plaque index (PI), and secondary outcomes, gingival Index (GI) and periodontal bleeding index (PBI), were measured at baseline (T0), after 9 months of treatment (T1), and after 18 months of treatment (T2). Blinding of the clinicians and the patients to the intervention was impossible. It was only done for outcome assessment and for the statistician. Ten participants did not receive the allocated intervention for various reasons. The means and standard deviations of PI at T0 (CLA, 0.50 ± 0.51; SLB, 0.65 ± 0.49; ELB, 0.70 ± 0.73), T1 (CLA, 0.83 ± 0.48; SLB, 1.38 ± 0.72; ELB, 1.32 ± 0.67), and T2 (CLA, 0.92 ± 0.58; SLB, 1.07 ± 0.59; ELB, 1.32 ± 0.67) were similar. The odds ratio (OR) for plaque index (0 or ≥1) comparing SLB or CLA to ELB was not significant. OR for SLB vs ELB = 1.54 at T0 (95% CI, 0.39-6.27), 0.88 at T1 (95% CI, 0.03-24.69), and 0.83 at T2 (95% CI, 0.02-27.70); OR for CLA vs ELB = 1.07 at T0 (95% CI, 0.30-3.88), 0.24 at T1 (95% CI

  20. Diphenhydramine as adjuvant therapy for acute migraine. An ED-based randomized clinical trial

    Science.gov (United States)

    Friedman, Benjamin W; Cabral, Lisa; Adewunmi, Victoria; Solorzano, Clemencia; Esses, David; Bijur, Polly E; Gallagher, E John

    2015-01-01

    Background More than one million patients present to US emergency departments (ED) annually seeking care for acute migraine. Parenteral anti-histamines have long been used in combination with anti-dopaminergics such as metoclopramide to treat acute migraine in the ED. High quality data supporting this practice do not exist. We determined whether administration of diphenhydramine 50mg IV + metoclopramide 10mg IV resulted in greater rates of sustained headache relief than placebo+ metoclopramide 10mg IV. Methods This was a randomized, double-blind clinical trial comparing two active treatments for acute migraine in an ED. Eligible patients were adults younger than 65 years presenting with an acute moderate or severe headache meeting International Classification of Headache Disorders-2 migraine criteria. Patients were stratified based on presence or absence of allergic symptoms. The primary outcome was sustained headache relief, defined as achieving a headache level of mild or none within two hours of medication administration, and maintaining this level of relief without use of any additional headache medication for 48 hours. Secondary efficacy outcomes include mean improvement on a 0 to 10 verbal scale between baseline and one hour, the frequency with which subjects indicated they would want the same medication the next time they present to the ED with migraine, and the ED throughput time. Sample size calculation using a 2-sided alpha of 0.05, a beta of 0.20 and a 15% difference between study arms determined the need for 374 patients. An interim analysis was conducted when data were available for 200 subjects. Results 420 patients were approached for participation. 208 eligible patients consented to participate and were randomized. At the planned interim analysis, the data safety monitoring committee recommended that the study be halted for futility. Baseline characteristics were comparable between the groups. 14% (29/208) of the sample reported allergic symptoms

  1. Study on the Business Cycle Model with Fractional-Order Time Delay under Random Excitation

    Directory of Open Access Journals (Sweden)

    Zifei Lin

    2017-07-01

    Full Text Available Time delay of economic policy and memory property in a real economy system is omnipresent and inevitable. In this paper, a business cycle model with fractional-order time delay which describes the delay and memory property of economic control is investigated. Stochastic averaging method is applied to obtain the approximate analytical solution. Numerical simulations are done to verify the method. The effects of the fractional order, time delay, economic control and random excitation on the amplitude of the economy system are investigated. The results show that time delay, fractional order and intensity of random excitation can all magnify the amplitude and increase the volatility of the economy system.

  2. Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial.

    Science.gov (United States)

    Kao, Dina; Roach, Brandi; Silva, Marisela; Beck, Paul; Rioux, Kevin; Kaplan, Gilaad G; Chang, Hsiu-Ju; Coward, Stephanie; Goodman, Karen J; Xu, Huiping; Madsen, Karen; Mason, Andrew; Wong, Gane Ka-Shu; Jovel, Juan; Patterson, Jordan; Louie, Thomas

    2017-11-28

    Fecal microbiota transplantation (FMT) is effective in preventing recurrent Clostridium difficile infection (RCDI). However, it is not known whether clinical efficacy differs by route of delivery. To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy. Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada. A total of 116 adult patients with RCDI were enrolled between October 2014 and September 2016, with follow-up to December 2016. The noninferiority margin was 15%. Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio. The primary outcome was the proportion of patients without RCDI 12 weeks after FMT. Secondary outcomes included (1) serious and minor adverse events, (2) changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst possible quality of life) to 100 (best quality of life), and (3) patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst). Among 116 patients randomized (mean [SD] age, 58 [19] years; 79 women [68%]), 105 (91%) completed the trial, with 57 patients randomized to the capsule group and 59 to the colonoscopy group. In per-protocol analysis, prevention of RCDI after a single treatment was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52) (difference, 0%; 1-sided 95% CI, -6.1% to infinity; P < .001), meeting the criterion for noninferiority. One patient in each group died of underlying cardiopulmonary illness unrelated to FMT. Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group. There was no significant between-group difference in improvement in quality of life. A significantly greater proportion of participants receiving capsules rated their experience as "not at all unpleasant" (66% vs 44%; difference, 22% [95% CI, 3%-40%]; P = .01). Among

  3. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial

    Science.gov (United States)

    Arias-Buría, José L.; Truyols-Domínguez, Sebastián; Valero-Alcaide, Raquel; Salom-Moreno, Jaime; Atín-Arratibel, María A.; Fernández-de-las-Peñas, César

    2015-01-01

    Objective. To compare effects of ultrasound- (US-) guided percutaneous electrolysis combined with an eccentric exercise program of the rotator cuff muscles in subacromial pain syndrome. Methods. Thirty-six patients were randomized and assigned into US-guided percutaneous electrolysis (n = 17) group or exercise (n = 19) group. Patients were asked to perform an eccentric exercise program of the rotator cuff muscles twice every day for 4 weeks. Participants assigned to US-guided percutaneous electrolysis group also received the application of galvanic current through acupuncture needle on each session once a week (total 4 sessions). Shoulder pain (NPRS) and disability (DASH) were assessed at baseline, after 2 sessions, and 1 week after the last session. Results. The ANOVA revealed significant Group∗Time interactions for shoulder pain and disability (all, P electrolysis combined with the eccentric exercises experienced greater improvement than those receiving eccentric exercise alone. Conclusions. US-guided percutaneous electrolysis combined with eccentric exercises resulted in small better outcomes at short term compared to when only eccentric exercises were applied in subacromial pain syndrome. The effect was statistically and clinically significant for shoulder pain but below minimal clinical difference for function. Future studies should investigate the long-term effects and potential placebo effect of this intervention. PMID:26649058

  4. Ultrasound-Guided Percutaneous Electrolysis and Eccentric Exercises for Subacromial Pain Syndrome: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    José L. Arias-Buría

    2015-01-01

    Full Text Available Objective. To compare effects of ultrasound- (US- guided percutaneous electrolysis combined with an eccentric exercise program of the rotator cuff muscles in subacromial pain syndrome. Methods. Thirty-six patients were randomized and assigned into US-guided percutaneous electrolysis (n=17 group or exercise (n=19 group. Patients were asked to perform an eccentric exercise program of the rotator cuff muscles twice every day for 4 weeks. Participants assigned to US-guided percutaneous electrolysis group also received the application of galvanic current through acupuncture needle on each session once a week (total 4 sessions. Shoulder pain (NPRS and disability (DASH were assessed at baseline, after 2 sessions, and 1 week after the last session. Results. The ANOVA revealed significant Group∗Time interactions for shoulder pain and disability (all, P<0.01: individuals receiving US-guided percutaneous electrolysis combined with the eccentric exercises experienced greater improvement than those receiving eccentric exercise alone. Conclusions. US-guided percutaneous electrolysis combined with eccentric exercises resulted in small better outcomes at short term compared to when only eccentric exercises were applied in subacromial pain syndrome. The effect was statistically and clinically significant for shoulder pain but below minimal clinical difference for function. Future studies should investigate the long-term effects and potential placebo effect of this intervention.

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

    Science.gov (United States)

    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 aromatherapy massage group and the placebo massage group had a lower menopausal score than the control group (P aromatherapy massage and the placebo massage groups were compared, the menopausal score for the aromatherapy massage group was found to be significantly lower (P aromatherapy massage were effective in reducing menopausal symptoms. However, aromatherapy massage was more effective than only massage.

  6. Randomized Clinical Trials on Acupuncture in Korean Literature: A Systematic Review

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    Jae Cheol Kong

    2009-01-01

    Full Text Available The aim of this systematic review was to summarize randomized clinical trials (RCTs assessing the effectiveness of acupuncture as published in Korean literature. Systematic searches were conducted on eight Korean medical databases. Manual searches were also conducted through eight major Korean medical journals. The methodological quality was assessed using a Jadad score. Studies evaluating needle acupuncture or auricular acupuncture (AA with or without electrical stimulation were considered if they were sham or placebo-controlled or controlled against a comparative intervention. We also excluded acupuncture as an adjuvant to other treatments and other forms of acupuncture were excluded. Seven hundred and nine possibly relevant studies were identified and 10 RCTs were included. The methodological quality of the trials was generally poor. Manual acupuncture was compared to placebo acupuncture in four studies of patients with chronic low back pain, shoulder pain, premenstrual syndrome and allergic rhinitis. Three studies tested AA (two trials and electroacupuncture (one trial against no treatment, while three trials compared acupuncture with other active therapeutic controls. The methodological limitations of the included trials make their contribution to the current clinical evidence of acupuncture somewhat limited. The trial for premenstrual syndrome, shoulder pain and chronic low back pain added a limited contribution among those included RCTs. However, well-designed RCTs of acupuncture with a rigorous methodology are in progress or have been completed in Korea and will contribute to establish or contribute to the current progress of research in this field.

  7. DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL.

    Science.gov (United States)

    Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

    2016-01-01

    As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.

  8. How Does Cognitive Behavior Therapy for IBS Work?: A Mediational Analysis of a Randomized Clinical Trial

    Science.gov (United States)

    Lackner, Jeffrey M.; Jaccard, James; Krasner, Susan S.; Katz, Leonard A.; Gudleski, Gregory D.; Blanchard, Edward B.

    2009-01-01

    Background & Aims: While multiple clinical trials support the efficacy of psychological treatments for reducing IBS symptoms, the mechanisms responsible for symptomatic improvement are unknown. One hypothesis is that psychological treatments work by alleviating comorbid psychological distress implicated in the worsening of bowel symptoms and quality of life. An alternative hypothesis assumes that changes in distress are not strictly a cause but a consequence of IBS that will decrease with symptomatic improvement. Methods: We evaluated these two hypothesis by applying structural equation modeling (SEM) to the data set of a large number (N = 147) of Rome II diagnosed participants randomized to cognitive behavior therapy (CBT), psychoeducation, or wait list. Per Rome guidelines, the primary endpoint was global improvement of GI symptoms measured two weeks after a 10-week regimen. Secondary endpoints were distress and quality of life (QOL). Results: SEM analyses lend support to a model in which CBT is associated with improvements in IBS symptoms, but that therapeutic gains are not dependent on changes in patients' overall level of psychological distress. Symptom severity, but not clinical status (pain catastrophizing, predominant bowel habits, symptom duration, abuse, diagnosable psychiatric disorder) or relevant sociodemographic variables (e.g., gender, age) moderated treatment outcome. Conclusion: CBT has a direct effect on global IBS symptom improvement independent of its effects on distress. Improvement in IBS symptoms is associated with improvements in the QOL, which may lower distress. Symptom improvements are not moderated by variables reflecting the mental well being of IBS patients. PMID:17681164

  9. Benefits of whole body vibration training in patients hospitalised for COPD exacerbations - a randomized clinical trial.

    Science.gov (United States)

    Greulich, Timm; Nell, Christoph; Koepke, Janine; Fechtel, Juliane; Franke, Maja; Schmeck, Bernd; Haid, Daniel; Apelt, Sandra; Filipovic, Silke; Kenn, Klaus; Janciauskiene, Sabina; Vogelmeier, Claus; Koczulla, Andreas Rembert

    2014-04-11

    Patients with stable COPD show improvements in exercise capacity and muscular function after the application of whole body vibration. We aimed to evaluate whether this modality added to conventional physiotherapy in exacerbated hospitalised COPD patients would be safe and would improve exercise capacity and quality of life. 49 hospitalised exacerbated COPD patients were randomized (1:1) to undergo physiotherapy alone or physiotherapy with the addition of whole body vibration. The primary endpoint was the between-group difference of the 6-minute walking test (day of discharge - day of admission). Secondary assessments included chair rising test, quality of life, and serum marker analysis. Whole body vibration did not cause procedure-related adverse events. Compared to physiotherapy alone, it led to significantly stronger improvements in 6-minute walking test (95.55 ± 76.29 m vs. 6.13 ± 81.65 m; p = 0.007) and St. Georges Respiratory Questionnaire (-6.43 ± 14.25 vs. 5.59 ± 19.15, p = 0.049). Whole body vibration increased the expression of the transcription factor peroxisome proliferator receptor gamma coactivator-1-α and serum levels of irisin, while it decreased serum interleukin-8. Whole body vibration during hospitalised exacerbations did not cause procedure-related adverse events and induced clinically significant benefits regarding exercise capacity and health-related quality of life that were associated with increased serum levels of irisin, a marker of muscle activity. German Clinical Trials Register DRKS00005979. Registered 17 March 2014.

  10. Improving function in age-related macular degeneration: design and methods of a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Tasman, William S

    2011-03-01

    Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in older adults and impairs the ability to read, drive, and live independently and increases the risk for depression, falls, and earlier mortality. Although new medical treatments have improved AMD's prognosis, vision-related disability remains a major public health problem. Improving Function in AMD (IF-AMD) is a two-group randomized, parallel design, controlled clinical trial that compares the efficacy of Problem-Solving Therapy (PST) with Supportive Therapy (ST) (an attention control treatment) to improve vision function in 240 patients with AMD. PST and ST therapists deliver 6 one-hour respective treatment sessions to subjects in their homes over 2 months. Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects). The primary outcome is targeted vision function (TVF), which refers to specific vision-dependent functional goals that subjects highly value but find difficult to achieve. TVF is an innovative outcome measure in that it is targeted and tailored to individual subjects yet is measured in a standardized way. This paper describes the research methods, theoretical and clinical aspects of the study treatments, and the measures used to evaluate functional and psychiatric outcomes in this population. Copyright © 2010 Elsevier Inc. All rights reserved.

  11. Steroid/Antiviral for the treatment of Bell's palsy: Double blind randomized clinical trial.

    Science.gov (United States)

    Khedr, Eman Mohamed; Badry, Reda; Ali, Anwer Mohamed; Abo El-Fetoh, Noha; El-Hammady, Dina Hatem; Ghandour, Abeer Mohamed; Abdel-Haleem, Ahmed

    2016-11-22

    A large number of patients with Bell's palsy fail to recover facial function completely after steroid therapy. Only a few small trials have been conducted to test whether outcomes can be improved by the addition of antiviral therapy. To evaluate the efficacy of treatment with steroid alone versus steroid + antiviral in a group of patients with moderately severe to severe acute Bell's palsy. Fifty eligible patients out of a total of 65 with acute onset Bell's palsy were randomized to receive the two treatments. Evaluation was performed before starting treatment, after 2 weeks of treatment and 3 months after onset, using the House and Brackmann facial nerve grading system (HB) and the Sunnybrook grading system.This study was registered with ClinicalTrials.gov, number NCT02328079. Both treatments had comparable demographics and clinical scores at baseline. There was greater improvement in the mean HB and Sunnybrook scores of the steroid + antiviral group in comparison to steroid group at 3 months. At the end of the 3rd month, 17 patients (68%) had good recovery and 8 patients (32%) had poor recovery in the steroid group compared with 23 patients (92%) and 2 (8%) respectively in the steroid and antiviral group (p = 0.034). The combination of steroid and antiviral treatment increases the possibility of recovery in moderately severe to complete acute Bell's palsy.

  12. A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation.

    Science.gov (United States)

    Dai, Ruoxi; Lam, Otto L T; Lo, Edward C M; Li, Leonard S W; McGrath, Colman

    2017-06-01

    The objectives of this study were to evaluate and compare the effectiveness of an advanced oral hygiene care programme (AOHCP) and a conventional oral hygiene care programme (COHCP) in improving oral hygiene, and reducing gingival bleeding among patients with stroke during outpatient rehabilitation. Subjects were randomized to receive (i) the COHCP comprising a manual toothbrush, toothpaste, and oral hygiene instruction, or (ii) the AOHCP comprising a powered toothbrush, 0.2% chlorhexidine mouthrinse, toothpaste, and oral hygiene instruction. Dental plaque, gingival bleeding, and other clinical oral health outcomes were assessed at baseline, the end of the clinical trial, and the end of observation period. Development of infectious complications was also monitored. Participants of both programmes had a significant reduction in the percentages of sites with moderate to abundant dental plaque (poral hygiene care programmes were effective in terms of plaque and gingival bleeding control, the AOHCP was more effective than the COHCP in reducing dental plaque and gingival bleeding. This study highlighted the value of oral hygiene programmes within stroke outpatient rehabilitation and provides evidence to advocate for the inclusion of oral hygiene care programmes within stroke outpatient rehabilitation for patients with normal cognitive abilities. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial

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    Kumkum Gupta

    2012-01-01

    Full Text Available Background : Fiberoptic intubation is the gold standard technique for difficult airway management in patients of temporomandibular joint. This study was aimed to evaluate the clinical efficacy and safety of dexmedetomidine as premedication with propofol infusion for fiberoptic intubation. Methods: Consent was obtained from 46 adult patients of temporomandibular joint ankylosis, scheduled for gap arthroplasty. They were enrolled for thisdouble-blind, randomized, prospective clinical trial with two treatment groups - Group D and Group P, of 23 patients each. Group D patients had received premedication of dexmedetomidine 1 μg/kg infused over 10 min followed by sedative propofol infusion and the control Group P patients were given only propofol infusion to achieve sedation. Condition achieved at endoscopy, intubating conditions, hemodynamic changes and postoperative events were evaluated as primary outcome. Results : The fiberoptic intubation was successful with satisfactory endoscopic and intubating condition in all patients. Dexmedetomidine premedication has provided satisfactory conditions for fiberoptic intubation and attenuated the hemodynamic response of fiberoptic intubation than the propofol group. Conclusion : Fiberoptic intubation was found to be easier with dexmedetomidine premedication along with sedative infusion of propofol with complete amnesia of the procedure, hemodynamic stability and preservation of patent airway.

  14. Therapist facilitative interpersonal skills and training status: A randomized clinical trial on alliance and outcome.

    Science.gov (United States)

    Anderson, Timothy; Crowley, Mary Ellen J; Himawan, Lina; Holmberg, Jennifer K; Uhlin, Brian D

    2016-09-01

    Therapist effects, independent of the treatment provided, have emerged as a contributor to psychotherapy outcomes. However, past research largely has not identified which therapist factors might be contributing to these effects, though research on psychotherapy implicates relational characteristics. The present Randomized Clinical Trial tested the efficacy of therapists who were selected by their facilitative interpersonal skills (FIS) and training status. Sixty-five clients were selected from 2713 undergraduates using a screening and clinical interview procedure. Twenty-three therapists met with 2 clients for 7 sessions and 20 participants served in a no-treatment control group. Outcome and alliance differences for Training Status were negligible. High FIS therapists had greater pre-post client outcome, and higher rates of change across sessions, than low FIS therapists. All clients treated by therapists improved more than the silent control, but effects were greater with high FIS than low FIS therapists. From the first session, high FIS therapists also had higher alliances than low FIS therapists as well as significant improvements on client-rated alliance. Results were consistent with the hypothesis that therapists' common relational skills are independent contributors to therapeutic alliance and outcome.

  15. Re-Evaluating the Treatment of Nongonococcal Urethritis: Emphasizing Emerging Pathogens–A Randomized Clinical Trial

    Science.gov (United States)

    Rompalo, A.; Taylor, S.; Seña, A. C.; Martin, D. H.; Lopez, L. M.; Lensing, S.; Lee, J. Y.

    2011-01-01

    Background. Nongonococcal urethritis (NGU) is a common chlamydia-associated syndrome in men; however, Trichomonas vaginalis and Mycoplasma genitalium are associated with its etiology and should be considered in approaches to therapy. We sought to determine whether the addition of tinidazole, an anti-trichomonal agent, to the treatment regimen would result in higher cure rates than those achieved with treatment with doxycycline or azithromycin alone. A secondary aim was to compare the efficacy of doxycycline therapy and with that of azithromycin therapy. Methods. Randomized, controlled, double-blinded phase IIB trial of men with NGU. Participants were randomized to receive doxycycline plus or minus tinidazole or azithromycin plus or minus tinidazole and were observed for up to 45 days. Results. The prevalences of Chlamydia trachomatis, M. genitalium, and T. vaginalis were 43%, 31%, and 13%, respectively. No pathogens were identified in 29% of participants. Clinical cure rates at the first follow-up visit were 74.5% (111 of 149 patients) for doxycycline-containing regimens and 68.6% (107 of 156 patients) for azithromycin-containing regimens. By the final visit, cure rates were 49% (73 of 149 patients) for doxycycline-containing regimens and 43.6% (68 of 156 patients) for azithromycin-containing regimens. There were no significant differences in clinical response rates among the treatment arms. However, the chlamydia clearance rate was 94.8% (55 of 58 patients) for the doxycycline arm and 77.4% (41 of 53 patients) for the azithromycin arm (P = .011), and the M. genitalium clearance rate was 30.8% (12 of 39 patients) for the doxycycline arm and 66.7% (30 of 45 patients) for the azithromycin arm (P = .002). Conclusions. Addition of tinidazole to the treatment regimen did not result in higher cure rates but effectively eradicated trichomonas. Clinical cure rates were not significantly different between patients treated with doxycycline and those treated

  16. Impact of clinical decision support on radiography for acute ankle injuries: a randomized trial

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    Shahein Tajmir

    2017-04-01

    Full Text Available Introduction: While only 15-20% of patients with foot and ankle injuries presenting to urgent care centers have clinically significant fractures, most undergo radiography. We examined the impact of electronic point-of-care clinical decision support (CDS on adherence to the Ottawa Ankle Rules (OAR, as well as use and yield of foot and ankle radiographs in patients with acute ankle injury. Methods: We obtained institutional review board approval for this randomized controlled study performed April 18, 2012—December 15, 2013. All ordering providers credentialed at an urgent care affiliated with a quaternary care academic hospital were randomized to either receive or not receive CDS, based on the OAR and integrated into the physician order-entry system, with feedback at the time of imaging order. If the patient met OAR low-risk criteria, providers were advised against imaging and could either cancel the order or ignore the alert. We identified patients with foot and ankle complaints via ICD-9 billing codes and electronic health records and radiology reports reviewed for those who were eligible. Chi-square was used to compare adherence to the OAR (primary outcome, radiography utilization rate and radiography yield of foot and ankle imaging (secondary outcomes between the intervention and control groups. Results: Of 14,642 patients seen at urgent care during the study period, 613 (4.2%, representing 632 visits presented with acute ankle injury and were eligible for application of the OAR; 374 (59.2% of these were seen by control-group providers. In the intervention group, CDS adherence was higher for both ankle (239/258=92.6% vs. 231/374=61.8%, p=0.02 and foot radiography (209/258=81.0% vs. 238/374=63.6%; p<0.01. However, ankle radiography use was higher in the intervention group (166/258=64.3% vs. 183/374=48.9%; p<0.01, while foot radiography use (141/258=54.6% vs. 202/374=54.0%; p=0.95 was not. Radiography yield was also higher in the intervention

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

    Science.gov (United States)

    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

  18. A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects.

    Science.gov (United States)

    Cochran, D L; Oh, T-J; Mills, M P; Clem, D S; McClain, P K; Schallhorn, R A; McGuire, M K; Scheyer, E T; Giannobile, W V; Reddy, M S; Abou-Arraj, R V; Vassilopoulos, P J; Genco, R J; Geurs, N C; Takemura, A

    2016-05-01

    Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP (ClinicalTrials.gov NCT01728844). © International & American Associations for Dental Research 2016.

  19. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial.

    Science.gov (United States)

    Kroenke, Kurt; Krebs, Erin E; Wu, Jingwei; Yu, Zhangsheng; Chumbler, Neale R; Bair, Matthew J

    2014-07-16

    Chronic musculoskeletal pain is among the most prevalent, costly, and disabling medical disorders. However, few clinical trials have examined interventions to improve chronic pain in primary care. To determine the effectiveness of a telecare intervention for chronic pain. The Stepped Care to Optimize Pain Care Effectiveness (SCOPE) study was a randomized trial comparing a telephone-delivered collaborative care management intervention vs usual care in 250 patients with chronic (≥3 months) musculoskeletal pain of at least moderate intensity (Brief Pain Inventory [BPI] score ≥5). Patients were enrolled from 5 primary care clinics in a single Veterans Affairs medical center from June 2010 through May 2012, with 12-month follow-up completed by June 2013. Patients were randomized either to an intervention group (n = 124) or to a usual care group whose members received all pain care as usual from their primary care physicians (n = 126). The intervention group received 12 months of telecare management that coupled automated symptom monitoring with an algorithm-guided stepped care approach to optimizing analgesics. Primary outcome was the BPI total score, which ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine") and for which a 1-point change is considered clinically important. Secondary pain outcomes included BPI interference and severity, global pain improvement, treatment satisfaction, and use of opioids and other analgesics. Overall, mean (SD) baseline BPI scores in the intervention and control groups were 5.31 (1.81) and 5.12 (1.80), respectively. Compared with usual care, the intervention group had a 1.02-point lower (95% CI, -1.58 to -0.47) BPI score at 12 months (3.57 vs 4.59). Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (51.7% vs 27.1%; relative risk, 1.9 [95% CI, 1.4 to 2.7]), with a number needed to treat of 4.1 (95% CI, 3.0 to 6.4) for a 30

  20. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

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    Wong Samuel YS

    2011-11-01

    Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

  1. Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial.

    Science.gov (United States)

    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.

  2. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial.

    Science.gov (United States)

    Gattie, Eric Robert; Cleland, Joshua A; Snodgrass, Suzanne J

    2017-11-22

    Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck pain. Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues, and muscle with the intent to mechanically disrupt tissue without the use of an anesthetic. Dry needling is emerging as a treatment modality that is widely used clinically to address a variety of musculoskeletal conditions. Recent studies of dry needling in mechanical neck pain suggest potential benefits, but do not utilize methods typical to clinical practice and lack long-term follow-up. Therefore, a clinical trial with realistic treatment time frames and methods consistent with clinical practice is needed to examine the effectiveness of dry needling on reducing pain and enhancing function in patients presenting to physical therapy with mechanical neck pain. The aim of this trial will be to examine the short- and long-term effectiveness of dry needling delivered by a physical therapist on pain, disability, and patient-perceived improvements in patients with mechanical neck pain. We will conduct a randomized, double-blind, placebo-controlled trial in accordance with the CONSORT guidelines. A total of 76 patients over the age of 18 with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy will be enrolled after meeting the eligibility criteria. Subjects will be excluded if they have previous history of surgery, whiplash in the last 6 weeks, nerve root compression, red flags, or contraindications to dry needling or manual therapy. Participants will be randomized to receive (1) dry needling, manual therapy, and exercise or (2) sham dry needling, manual therapy, and exercise

  3. Omega-3 supplementation on inflammatory markers in patients with chronic Chagas cardiomyopathy: a randomized clinical study.

    Science.gov (United States)

    Silva, Paula Simplício da; Mediano, Mauro Felippe Felix; Silva, Gilberto Marcelo Sperandio da; Brito, Patricia Dias de; Cardoso, Claudia Santos de Aguiar; Almeida, Cristiane Fonseca de; Sangenis, Luiz Henrique Conde; Pinheiro, Roberta Olmo; Hasslocher-Moreno, Alejandro Marcel; Brasil, Pedro Emmanuel Alvarenga Americano do; Sousa, Andrea Silvestre de

    2017-06-09

    Several studies have been focusing on the effect of omega-3 polyunsaturated fatty acids on modulation of inflammatory markers in several cardiopathies. Although immunoregulatory dysfunction has been associated to the chronic cardiac involvement in Chagas disease, there is no study examining the effects of omega-3 supplementation in these patients. We investigated the effects of omega-3 PUFAs on markers of inflammation and lipid profile in chronic Chagas cardiomyopathy patients. The present study was a single-center double-blind clinical trial including patients with chronic Chagas cardiomyopathy. Patients were randomly assigned to receive omega-3 PUFAs capsules (1.8g EPA and 1.2g DHA) or placebo (corn oil) during an 8-week period. Cytokines, fasting glucose, lipid, and anthropometric profiles were evaluated. Forty-two patients (23 women and 19 men) were included in the study and there were only two losses to follow-up during the 8-week period. Most of sociodemographic and clinical characteristics were similar between the groups at baseline, except for the cytokines IL-1β, IL-6, IL-8, IL-10, IL-17α, and IFNγ. The omega-3 PUFAs group demonstrated greater improvements in serum triglycerides (-21.1 vs. -4.1; p = 0.05) and IL-10 levels (-10.6 vs. -35.7; p = 0.01) in comparison to controls after 8 weeks of intervention. No further differences were observed between groups. Omega-3 PUFAs supplementation may favorably affect lipid and inflammatory profile in chronic Chagas cardiomyopathy patients, demonstrated by a decrease in triglycerides and improvements on IL-10 concentration. Further studies examining the clinical effects of omega-3 fatty acids supplementation in chronic Chagas cardiomyopathy are necessary. NCT01863576.

  4. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Zakeri, Kaveh; Rose, Brent S.; D’Amico, Anthony V.; Jeong, Jong-Hyeon; Mell, Loren K.

    2015-01-01

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  5. Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.

    Science.gov (United States)

    Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M

    2016-10-01

    Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.

  6. A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Elizabeth; Tancredi, Daniel J; Decker, Michele R; McCauley, Heather L; Jones, Kelley A; Anderson, Heather; James, Lisa; Silverman, Jay G

    2016-07-01

    We assessed the effectiveness of a provider-delivered intervention targeting reproductive coercion, an important factor in unintended pregnancy. We randomized 25 family planning clinics (17 clusters) to deliver an education/counseling intervention or usual care. Reproductive coercion and partner violence victimization at 1 year follow-up were primary outcomes. Unintended pregnancy, recognition of sexual and reproductive coercion, self-efficacy to use and use of harm reduction behaviors to reduce victimization and contraception nonuse, and knowledge and use of partner violence resources were secondary outcomes. Analyses included all available data using an intention-to-treat approach. Among 4009 females ages 16 to 29 years seeking care, 3687 completed a baseline survey prior to clinic visit from October 2011 to November 2012; 3017 provided data at 12-20weeks post-baseline (T2) and 2926 at 12months post-baseline (T3) (79% retention). Intervention effects were not significant for reproductive coercion [adjusted risk ratio (ARR) 1.50 (95% confidence interval 0.95-2.35)] or partner violence [ARR 1.07 (0.84-1.38)]. Intervention participants reported improved knowledge of partner violence resources [ARR 4.25 (3.29-5.50)] and self-efficacy to enact harm reduction behaviors [adjusted mean difference 0.06 (0.02-0.10)]. In time point-specific models which included moderating effects of exposure to reproductive coercion at baseline, a higher reproductive coercion score at baseline was associated with a decrease in reproductive coercion 1 year later (T3). Use and sharing of the domestic violence hotline number also increased. This brief clinic intervention did not reduce partner violence victimization. The intervention enhanced two outcomes that may increase safety for women, specifically awareness of partner violence resources and self-efficacy to enact harm reduction behaviors. It also appeared to reduce reproductive coercion among women experiencing multiple forms of such

  7. TOPICAL MITOMYCIN C IN DACRIOCYSTORHINOSTOMY: ITS EFFECT ON FAILURE RATE OF PROCEDURE - A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    A ZANDI

    2002-03-01

    Full Text Available Introduction. Epiphoria is one of the most common symptom among patients in ophtalmologic clinics. The most important cause of it, is tear drainage obstrution through the nasolacrimal duct. Dacryocystorhinostomy (DCR is the only critical treatment. The failure is important complication of DCR and in spite of varios methods, failure rate has remained 10 percent. Ingrowgh of fibrous tissue in osteotomy site and flaps has been known as cause of surgical failue. In this study we investigated the efficacy of mitomycin C as antiproliferative agent on DCR failure rate. Methods. In this clinical trial study, 110 patients with primary acquired nasolacrimal duct obstruction have been chosen between who that refer to the Farabi clinic, and were assigned randomly to either mitomycin or control group. Both group were operated with standard method and one surgen. In control group a cotton aid band and in interventional group a cottonoid band soaked with 0.2 mg/cc mitomycin C was applied to the osteotomy site. After 30 minutes was removed transnasaly. Groups have been examined at 1, 3 and 6 months intervals after surgery. Results. All patients in mitomycin group remained symptom free in all examination, and there was five pateints in control group who had recurrent epiphora. In the control group, 3 patients in 1 st month, 1 patient in 3rd months and 1 patient in 6th month were failed. In 3 patients of mitomycin group, severe post operative bleeding was seen. Discussion. The difference between these groups is (P < 0.01. Intraoperative mitomycin C may possibly improve success rates of DCR procedure with no serious complication.

  8. Continuous positive airway pressure (CPAP after lung resection: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ligia dos Santos Roceto

    Full Text Available CONTEXT AND OBJECTIVE: Noninvasive mechanical ventilation during the postoperative period (PO following lung resection can restore residual functional capacity, improve oxygenation and spare the inspiratory muscles. The objective of this study was to assess the efficacy of continuous positive airway pressure (CPAP associated with physiotherapy, compared with physiotherapy alone after lung resection. DESIGN AND SETTING: Open randomized clinical trial conducted in the clinical hospital of Universidade Estadual de Campinas. METHOD: Sessions were held in the immediate postoperative period (POi and on the first and second postoperative days (PO1 and PO2, and the patients were reassessed on the discharge day. CPAP was applied for two hours and the pressure adjustment was set between 7 and 8.5 cmH2O. The oxygenation index (OI, Borg scale, pain scale and presence of thoracic drains and air losses were evaluated. RESULTS : There was a significant increase in the OI in the CPAP group in the POi compared to the Chest Physiotherapy (CP group, P = 0.024. In the CP group the OI was significantly lower on PO1 (P = 0,042, than CPAP group. The air losses were significantly greater in the CPAP group in the POi and on PO1 (P = 0.001, P = 0.028, but there was no significant difference between the groups on PO2 and PO3. There was a statistically significant difference between the groups regarding the Borg scale in the POi (P < 0.001, but there were no statistically significant differences between the groups regarding the pain score. CONCLUSION: CPAP after lung resection is safe and improves oxygenation, without increasing the air losses through the drains. CLINICAL TRIAL REGISTRATION: NCT01285648

  9. Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial.

    Science.gov (United States)

    Bonouvrié, Laura A; Becher, Jules G; Vles, Johannes S H; Boeschoten, Karin; Soudant, Dan; de Groot, Vincent; van Ouwerkerk, Willem J R; Strijers, Rob L M; Foncke, Elisabeth; Geytenbeek, Joke; van de Ven, Peter M; Teernstra, Onno; Vermeulen, R Jeroen

    2013-10-28

    Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a potential treatment option for dystonia and has become common practice. Despite this widespread adoption, high quality evidence on the effects of intrathecal baclofen treatment on daily activities is lacking and prospective data are needed to judge the usefulness and indications for dystonic cerebral palsy. The primary aim of this study is to provide level one clinical evidence for the effects of intrathecal baclofen treatment on the level of activities and participation in dystonic cerebral palsy patients. Furthermore, we hope to identify clinical characteristics that will predict a beneficial effect of intrathecal baclofen in an individual patient. A double blind placebo-controlled multi-center randomized clinical trial will be performed in 30 children with dystonic cerebral palsy. Patients aged between 4 and 25 years old with a confirmed diagnosis of dystonic cerebral palsy, Gross Motor Functioning Classification System level IV or V, with lesions in the cerebral white matter, basal ganglia or central cortex and who are eligible for intrathecal baclofen treatment will be included. Group A will receive three months of continuous intrathecal baclofen treatment and group B will receive three months of placebo treatment, both via an implanted pump. After this three month period, all patients will receive intrathecal baclofen treatment, with a follow-up after nine months. The primary outcome measurement will be the effect on activities of and participation in daily life measured by Goal Attainment Scaling. Secondary outcome measurements on the level of body functions include dystonia, spasticity, pain, comfort and sleep-related breathing disorders. Side effects will be monitored and we will study whether patient characteristics influence outcome. The results of

  10. Random Vibration Analysis of Train Moving over Slab Track on Bridge under Track Irregularities and Earthquakes by Pseudoexcitation Method

    Directory of Open Access Journals (Sweden)

    Zhiping Zeng

    2015-01-01

    Full Text Available This paper investigates the random vibration and the dynamic reliability of operation stability of train moving over slab track on bridge under track irregularities and earthquakes by the pseudoexcitation method (PEM. Each vehicle is modeled by multibody dynamics. The track and bridge is simulated by a rail-slab-girder-pier interaction finite element model. The coupling equations of motion are established based on the wheel-rail interaction relationship. The random excitations of the track irregularities and seismic accelerations are transformed into a series of deterministic pseudoexcitations by PEM. The time-dependent power spectral densities (PSDs of the random vibration of the system are obtained by step-by-step integration method, and the corresponding dynamic reliability is estimated based on the first-passage failure criterion. A case study is then presented in which a high-speed train moves over a slab track resting on a simply supported girder bridge. The PSD characteristics of the random vibration of the bridge and train are analyzed, the influence of the wheel-rail-bridge interaction models on the random vibration of the bridge and train is discussed, and furthermore the influence of train speed, earthquake intensity, and pier height on the dynamic reliability of train operation stability is studied.

  11. A multidisciplinary audit of clinical coding accuracy in otolaryngology: financial, managerial and clinical governance considerations under payment-by-results.

    Science.gov (United States)

    Nouraei, S A R; O'Hanlon, S; Butler, C R; Hadovsky, A; Donald, E; Benjamin, E; Sandhu, G S

    2009-02-01

    To audit the accuracy of otolaryngology clinical coding and identify ways of improving it. Prospective multidisciplinary audit, using the 'national standard clinical coding audit' methodology supplemented by 'double-reading and arbitration'. Teaching-hospital otolaryngology and clinical coding departments. Otolaryngology inpatient and day-surgery cases. Concordance between initial coding performed by a coder (first cycle) and final coding by a clinician-coder multidisciplinary team (MDT; second cycle) for primary and secondary diagnoses and procedures, and Health Resource Groupings (HRG) assignment. 1250 randomly-selected cases were studied. Coding errors occurred in 24.1% of cases (301/1250). The clinician-coder MDT reassigned 48 primary diagnoses and 186 primary procedures and identified a further 209 initially-missed secondary diagnoses and procedures. In 203 cases, patient's initial HRG changed. Incorrect coding caused an average revenue loss of 174.90 pounds per patient (14.7%) of which 60% of the total income variance was due to miscoding of a eight highly-complex head and neck cancer cases. The 'HRG drift' created the appearance of disproportionate resource utilisation when treating 'simple' cases. At our institution the total cost of maintaining a clinician-coder MDT was 4.8 times lower than the income regained through the double-reading process. This large audit of otolaryngology practice identifies a large degree of error in coding on discharge. This leads to significant loss of departmental revenue, and given that the same data is used for benchmarking and for making decisions about resource allocation, it distorts the picture of clinical practice. These can be rectified through implementing a cost-effective clinician-coder double-reading multidisciplinary team as part of a data-assurance clinical governance framework which we recommend should be established in hospitals.

  12. Spouse READI (Resilience Education and Deployment Information): Randomized Clinical Trial Formerly Reintegration: The Role of Spouse Telephone BATTLEMIND Randomized Clinical Trial

    Science.gov (United States)

    2015-05-01

    Gender differences in Veterans Health Administration mental health service use: Effects of age and psychiatric diagnosis. Women’s Health Issues, 19(3...psychological health (Green, Nurius & Lester, 2013). Deployment effects on the military spouse include increased loneliness , anxiety, depression...ongoing education webinars. At baseline there were no statistically significant differences among the three randomization arms. On average, participants

  13. Evaluation of the clinical application of a leaflet for clinical practice guidelines in patients with herniated intervertebral discs: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ju Ah Lee

    2016-06-01

    Methods and analysis: We will evaluate efficacy through a comparison of satisfaction and clinical outcomes in randomly allocated groups of HIVD lumbar patients visiting the Jaseng Hospital of Korean Medicine who do or do not receive CPG-based treatment. Following the evaluation, we will make recommendations on whether to implement CPG interventions for patients selecting TKM treatment after HIVD diagnosis and the method of clinical treatment. Finally, we will evaluate the perception of and satisfaction with CPGs among TKM doctors and patients.

  14. Nerve Stimulator Guided Axillary Block in Painless Reduction of Distal Radius Fractures; a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hossein Alimohammadi

    2013-12-01

    Full Text Available Introduction: Given the high prevalence of upper extremity fractures and increasing need to perform painless reduction in the emergency departments, the use of analgesic methods with fewer complications and more satisfaction appears to be essential. The aim of this study is comparison the nerve stimulator guided axillary block (NSAB with intravenous sedation in induction of analgesia for painless reduction of distal radius fractures. Methods: In the present randomized clinical trial, 60 patients (18-70 years of age suffered from distal radius fractures, were divided into two equal groups. One group received axillary nerve block by nerve stimulator guidance and the other procedural sedation and analgesia (PSA using midazolam/fentanyl. Onset of analgesia, duration of analgesic effect, total procedure time and pain scores were recorded using visual analogue scale (VAS and the outcomes were compared. Chi-squared and student t test were performed to evaluate differences between two groups. Results: Sixty patients were randomly divided into two groups (83.3% male. The mean age of patients was 31 ±0.7 years. While the onset of analgesia was significantly longer in the NSAB group, the mean total time of procedure was shorter than PSA (p<0.001. The NSAB group needed a shorter post-operative observation time (P<0.001. Both groups experienced equal pain relief before, during and after procedure (p>0.05. Conclusion: It seems that shorter post-operative monitoring time and consequently lesser total time of procedure, make nerve stimulator guided axillary block as an appropriate alternative for procedural sedation and analgesia in painless reduction of distal radius fractures in emergency department. 

  15. Donepezil for Irradiated Brain Tumor Survivors: A Phase III Randomized Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    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

    2015-05-20

    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. 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. 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. 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. © 2015 by American Society of Clinical Oncology.

  16. Are postoperative intravenous fluids in patients undergoing elective laparoscopic cholecystectomy a necessity? A randomized clinical trial.

    Science.gov (United States)

    Henriques, Jessimara Ribeiro; Correia, Maria Isabel Toulson Davisson

    2018-04-01

    Intravenous (IV) fluid therapy should be individualized according to each patient's weight, disease, and comorbidities, as well as the type and duration of the operative procedure. Laparoscopic cholecystectomy represents one of the most common, short-duration operations; thus, the aim of this study was to assess the necessity of postoperative administration of IV fluids. A randomized clinical trial with patients undergoing elective laparoscopic cholecystectomy was performed. Patients were randomly assigned to control group (IV fluids at the surgeon's discretion) and study group (no IV fluids after the operation). Body weight and composition, total intravenous fluids, urinary output, creatinine levels, and the presence of thirst and hunger were assessed. Costs related to the administration of postoperative IV fluids were measured. The study and control groups were similar with regard to sex distribution, age, and general characteristics. There was a significant difference in the amount of infused IV fluids (1,600 mL vs 3,000 mL), directly related to the amount offered postoperatively to the control group. Weight, extracellular water, and urinary output (1,257 ± 736 mL vs 888 ± 392 mL; P fluids (r = 0.333). There were no differences in creatinine levels, thirst, hunger, and well-being features. An average of 10.7 minutes per patient of nursing time was required for IV administration. Cost related to IV fluids was increased in the control group. Postoperative intravenous fluids are not necessary in patients undergoing laparoscopic cholecystectomy, and their use is associated with increased nursing time and costs. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. How to deal with morning bad breath: A randomized, crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Jeronimo M Oliveira-Neto

    2013-01-01

    Full Text Available Context: The absence of a protocol for the treatment of halitosis has led us to compare mouthrinses with mechanical oral hygiene procedures for treating morning breath by employing a hand-held sulfide monitor. Aims: To compare the efficacy of five modalities of treatment for controlling morning halitosis in subjects with no dental or periodontal disease. Settings and Design: This is a five-period, randomized, crossover clinical trial. Materials and Methods: Twenty volunteers were randomly assigned to the trial. Testing involved the use of a conventional tongue scraper, a tongue scraper joined to the back of a toothbrush′s head, two mouthrinses (0.05% cetylpyridinium chloride and 0.12% chlorhexidine digluconate and a soft-bristled toothbrush and fluoride toothpaste for practicing oral hygiene. Statistical Analysis Used: Data analysis was performed using SPSS version 17 for Windows and NCSS 2007 software (P < 0.05. The products and the periods were compared with each other using the Friedman′s test. When significant differences (P < 0.05 were determined, the products and periods were compared in pairs by using the Wilcoxon′s test and by adjusting the original significance level (0.05 for multiple comparisons by using the Bonferroni′s method. Results: The toothbrush′s tongue scraper was able to significantly reduce bad breath for up to 2 h. Chlorhexidine reduced bad breath only at the end of the second hour, an effect that lasted for 3 h. Conclusions: Mechanical tongue cleaning was able to immediately reduce bad breath for a short period, whereas chlorhexidine and mechanical oral hygiene reduced bad breath for longer periods, achieving the best results against morning breath.

  18. Is Exposure Necessary? A Randomized Clinical Trial of Interpersonal Psychotherapy for PTSD

    Science.gov (United States)

    Markowitz, John C.; Petkova, Eva; Neria, Yuval; Van Meter, Page E.; Zhao, Yihong; Hembree, Elizabeth; Lovell, Karina; Biyanova, Tatyana; Marshall, Randall D.

    2015-01-01

    Background Exposure to trauma reminders has been considered imperative in psychotherapy for posttraumatic stress disorder (PTSD). No treatment benefits all patients, however. We tested Interpersonal Psychotherapy, which has demonstrated antidepressant efficacy and showed promise in pilot PTSD research, as a non-exposure-based, non-cognitive behavioral PTSD treatment. Methods A randomized, fourteen-week trial compared Interpersonal Psychotherapy; Prolonged Exposure, an exposure-based exemplar; and Relaxation Therapy, an active control psychotherapy. Subjects were 110 unmedicated patients having DSM-IV chronic PTSD and Clinician-Administered PTSD Scale (CAPS) score >50. Randomization stratified for comorbid major depression. We hypothesized Interpersonal Psychotherapy would be no more than minimally inferior (CAPS difference therapies had large within-group pre/post effect sizes (d=1.32–1.88). Response rates (>30% CAPS improvement) were: Interpersonal Psychotherapy 63%, Prolonged Exposure 47%, Relaxation Therapy 38% (n.s.). Interpersonal psychotherapy and Prolonged Exposure CAPS outcome differed by 5.5 points (n.s.); the null hypothesis of more than minimal Interpersonal Psychotherapy inferiority was rejected (p=0.035). Patients with comorbid major depression dropped out from Prolonged Exposure nine times more than non-depressed Prolonged Exposure patients. Interpersonal Psychotherapy and Prolonged Exposure improved quality of life and social functioning more than Relaxation Therapy. Conclusions This first controlled study of individual Interpersonal Psychotherapy for PTSD demonstrated non-inferiority to the “gold standard” PTSD treatment. Interpersonal Psychotherapy had (non-significantly) lower attrition and higher response rates than Prolonged Exposure. Contradicting a widespread clinical belief, PTSD treatment may not require cognitive behavioral exposure to trauma reminders. Moreover, as differential therapeutics, patients with comorbid major depression

  19. Dry needling of the trapezius muscle in office workers with neck pain: a randomized clinical trial.

    Science.gov (United States)

    Cerezo-Téllez, Ester; Lacomba, María Torres; Fuentes-Gallardo, Isabel; Mayoral Del Moral, Orlando; Rodrigo-Medina, Beatriz; Gutiérrez Ortega, Carlos

    2016-09-01

    Neck pain is a frequent complaint in office workers. This pain can be caused by myofascial trigger points (MTrPs) in the trapezius muscle. This study aimed to determine the effectiveness of deep dry needling (DDN) of active MTrPs in the trapezius muscle. A randomized, single blinded clinical trial was carried out at the Physical Therapy Department at Physiotherapy in Women's Health Research Group at Physical Therapy Department of University of Alcalá, in Alcalá de Henares, Madrid, Spain. Forty-four office workers with neck pain and active MTrPs in the trapezius muscle were randomly allocated to either the DDN or the control group (CG). The participants in the DDN group were treated with DDN of all MTrPs found in the trapezius muscle. They also received passive stretch of the trapezius muscle. The CG received the same passive stretch of the trapezius muscle only. The primary outcome measure was subjective pain intensity, measured using a visual analogue scale (VAS). Secondary outcomes were pressure pain threshold (PPT), cervical range of motion (CROM) and muscle strength. Data were collected at baseline, after interventions and 15 days after the last treatment. Differences were found between the DDN group and the CG for the VAS (P dry needling and passive stretch seems to be more effective than passive stretch only. The effects are maintained in the short term. The results support the use of DDN in the management of trapezius muscle myofascial pain syndrome in neck pain.

  20. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions.

    Science.gov (United States)

    Brienza, David; Kelsey, Sheryl; Karg, Patricia; Allegretti, Ana; Olson, Marian; Schmeler, Mark; Zanca, Jeanne; Geyer, Mary Jo; Kusturiss, Marybeth; Holm, Margo

    2010-12-01

    To determine the efficacy of skin protection wheelchair seat cushions in preventing pressure ulcers in the elderly nursing home population. Clinical trial with participants assigned at random to a skin protection or segmented foam cushion. Two hundred thirty-two participants were recruited between June 2004 and May 2008 and followed for 6 months or until pressure ulcer incidence. Twelve nursing homes. Nursing home residents aged 65 and older who were using wheelchairs for 6 or more hours per day and had a Braden score of 18 or less and a combined Braden activity and mobility score of 5 or less. Participants were recruited from a referred sample. All participants were provided with a fitted wheelchair and randomized into skin protection (SPC, n=113) or segmented foam (SFC, n=119) cushion groups. The SPC group received an air, viscous fluid and foam, or gel and foam cushion. The SFC group received a 7.6-cm crosscut foam cushion. Pressure ulcer incidence over 6 months for wounds near the ischial tuberosities (IT ulcers) were measured. Secondary analysis was performed on combined IT ulcers and ulcers over the sacrum and coccyx (sacral ulcers). One hundred eighty participants reached a study end point, and 42 were lost to follow-up. Ten did not receive the intervention. There were eight (6.7%) IT ulcers in the SFC group and one (0.9%) in the SPC group (P=.04). There were 21 (17.6%) combined IT and sacral ulcers in the SFC group and 12 (10.6%) in the SPC group (P=.14). Skin protection cushions used with fitted wheelchairs lower pressure ulcer incidence for elderly nursing home residents and should be used to help prevent pressure ulcers. © 2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society.

  1. Physical activity and cardiovascular risk factors in children: meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Cesa, Claudia Ciceri; Sbruzzi, Graciele; Ribeiro, Rodrigo Antonini; Barbiero, Sandra Mari; de Oliveira Petkowicz, Rosemary; Eibel, Bruna; Machado, Natássia Bigolin; Marques, Renata das Virgens; Tortato, Gabriela; dos Santos, Tiago Jerônimo; Leiria, Carina; Schaan, Beatriz D'Agord; Pellanda, Lucia Campos

    2014-12-01

    To assess the effects of physical activity interventions in preventing cardiovascular risk factors in childhood through a systematic review and meta-analysis of randomized clinical trials (RCTs). A search of online databases (PubMed, EMBASE and Cochrane CENTRAL) was conducted from inception until June 2013. RCTs enrolling children 6-12years old conducted physical activity interventions longer than 6months, assessing their effect on body mass index (BMI), systolic (SBP) and diastolic blood pressure (DBP), total cholesterol (TC) and triglycerides (TG) were included. Data analysis was performed using a random-effects model. Of 23.091 articles retrieved, 11 RCTs (10.748 subjects) were included. Physical activity interventions were not associated with reductions of BMI [-0.03kg/m(2) (95%CI -0.16, 0.13) I(2) 0%]. However, there was an association between the interventions and reduction of SBP [-1.25mmHg (95%CI -2.47, -0.02) I(2) 0%], DBP [-1.34mmHg (95%CI -2.57, -0.11) I(2) 43%] and TG [-0.09mmol/L (95%CI -0.14, -0.04) I(2) 0%], and increase of TC [0.14mmol/L (95%CI 0.01, 0.27) I(2) 0%]. As physical activity intervention programs lasting longer than 6months are associated with reductions in blood pressure levels and triglycerides, they should be considered to be included in prevention programs for cardiovascular diseases in schoolchildren. Copyright © 2014 Elsevier Inc. All rights reserved.

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

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

    2018-01-01

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

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

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    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.

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

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    Knol Dirk L

    2011-08-01

    Full Text Available Abstract 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

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

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    Navid Koleini

    2010-01-01

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

  6. Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial.

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    Tiro, Jasmin A; Sanders, Joanne M; Pruitt, Sandi L; Stevens, Clare Frey; Skinner, Celette Sugg; Bishop, Wendy P; Fuller, Sobha; Persaud, Donna

    2015-11-01

    Evaluate effects of a multicomponent intervention (human papillomavirus [HPV] vaccine-specific brochure and recalls) on HPV vaccination and secondarily examine if race/ethnicity moderates effects. Unvaccinated girls aged 11 to 18 years attending 4 safety-net pediatric clinics and their parent/guardian (n = 814 dyads) were randomized to (1) active comparison (general adolescent vaccine brochure), or (2) intervention consisting of a HPV vaccine-specific brochure, telephone recalls to parents who declined, and recalls to patients overdue for doses 2 and 3. HPV 1-dose and 3-dose coverages were assessed via electronic health records 12 months after randomization. Multivariate logistic regressions estimated adjusted odds and marginal predicted vaccine coverage by study arm and race/ethnicity. Intent-to-treat analyses found no main effect of the HPV vaccine-specific brochure on 1-dose coverage (42.0% vs 40.6%); however, secondary analyses found race/ethnicity was a significant moderator such that the intervention was effective only for Hispanic individuals (adjusted odds ratio [AOR] 1.43; 95% confidence interval [CI] 1.02-2.02), and not effective for black individuals (AOR 0.64; 95% CI 0.41-1.13). Recalls to parents who declined the vaccine during the index visit were not effective, but recalls to patients overdue for doses 2 and 3 were effective at increasing 3-dose coverage regardless of race/ethnicity (AOR 1.99; 95% CI 1.16-3.45). Educational materials describing only the HPV vaccine were effective for Hispanic but not black individuals. Future research should test mechanisms that may mediate intervention effects for different racial/ethnic groups, such as different informational needs or vaccine schemas (experiences, beliefs, norms). Copyright © 2015 by the American Academy of Pediatrics.

  7. Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

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    Yadollah Zahed Pasha

    2017-10-01

    Full Text Available Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for phototherapy in Amirkola Children’s Hospital, Babol- Iran, during October 5, 2016 till May 19, 2017. Eligible neonates were randomly divided into two; intervention (n=75, and control (n=75 groups. Both groups received standard conventional phototherapy, but the intervention group received 10 drop/day of probiotics (Pedilact Zisttakhmir. Co. Iran, until hospital discharge. The outcome variables were SBL and the duration of phototherapy. The data was analyzed by SPSS 22.0 and   the P 0.05.After 24, 48 and 72hours it decreased to 13.73±1.72, 10.92±1.87 and 10.25±1.32 in the intervention and 13.66±1.91, 11.01±1.69 and10.09 ±1.38 in the control groups, respectively but comparison of the amount of SBL reduction  between the two groups was not significant (P>0.05. The duration of phototherapy in the intervention group and the control group was 3.61±1.17 days and 3.72±1.18 days respectively (P>0.05. Conclusion Oral probiotics in neonates with jaundice has no significant effect on SBL and the duration of phototherapy. Further studies are needed to with longer time follow-up.

  8. Feedback in group psychotherapy for eating disorders: A randomized clinical trial.

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    Davidsen, Annika Helgadóttir; Poulsen, Stig; Lindschou, Jane; Winkel, Per; Tróndarson, Marjun Frígerð; Waaddegaard, Mette; Lau, Marianne

    2017-05-01

    To investigate the effect of client feedback in group psychotherapy on attendance and treatment outcome for patients with eating disorders. We conducted a randomized clinical trial with central randomization stratified for diagnosis and treatment type according to a computer-generated allocation sequence concealed to the investigators. One-hundred and 59 adult participants, diagnosed with bulimia nervosa, binge eating disorder, or eating disorder not otherwise specified according to DSM-IV, were included. Eighty participants were allocated to the experimental group, and 79 participants to the control group. Both groups received 20-25 weekly group psychotherapy sessions. In the experimental group, participants gave and received feedback about therapy progress and alliance, measured before and after each session using the Outcome Rating Scale and the Group Session Rating Scale. The primary outcome was rate of attendance to treatment sessions; the secondary outcome was severity of eating disorder symptoms measured with the Eating Disorder Examination interview. Exploratory outcomes were psychological distress measured with the Symptom Checklist-90-R and the Outcome Rating Scale, social functioning measured with the Sheehan Disability Scale, and episodes of self-harm and suicide measured with a modified version of the Self-Harm Inventory. Feedback compared with control did not affect the rate of attendance (0.59 vs. 0.58; p = .96), the severity of symptoms (2.03 vs. 2.02; p = .46), or any of the exploratory outcomes (p values from 0.06 to 0.67). Feedback neither increased attendance nor improved outcomes for outpatients in group psychotherapy for eating disorders. The results are discussed from different perspectives. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  9. The Use of Wet Cupping for Persistent Nonspecific Low Back Pain: Randomized Controlled Clinical Trial.

    Science.gov (United States)

    AlBedah, Abdullah; Khalil, Mohamed; Elolemy, Ahmed; Hussein, Asim A; AlQaed, Meshari; Al Mudaiheem, Abdullah; Abutalib, Raid A; Bazaid, Faisal Mohamed; Bafail, Ahmad Saeed; Essa, AboBakr; Bakrain, Mohammed Yahia

    2015-08-01

    To evaluate the effectiveness and safety of wet cupping therapy as a single treatment for persistent nonspecific low back pain (PNSLBP). Randomized controlled trial comparing wet cupping versus no treatment in PNSLBP. Outpatient clinic in three secondary care hospitals in Saudi Arabia. Eighty eligible participants with PNSLBP for at least 3 months were randomly allocated to an intervention group (n=40) or to a control group (n=40). Six wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points among BL23, BL24, and BL25. Only acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded. At the end of the intervention, statistically significant differences in the three outcome measures favoring the wet cupping group compared with the control group were seen: NRS score, 29.2 (95% confidence interval [CI], 24.6-33.8) versus 57.9 (95% CI, 53.3-62.6), respectively; PPI score, 1.17 (95% CI, 0.96-1.4) versus 2.3 (95% CI, 2.1- 2.7); and ODQ score, 19.6 (95% CI, 16.5-22.7) versus 35.4 (95% CI, 32.3-38.5) (p=0.0001). This improvement continued for another 2 weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported. Wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.

  10. Is there a value for probiotic supplements in gestational diabetes mellitus? A randomized clinical trial.

    Science.gov (United States)

    Dolatkhah, Neda; Hajifaraji, Majid; Abbasalizadeh, Fatemeh; Aghamohammadzadeh, Naser; Mehrabi, Yadollah; Abbasi, Mehran Mesgari

    2015-11-25

    Although several studies have found probiotics encouraging in prevention of gestational diabetes mellitus (GDM), the evidence for the use of probiotics in diagnosed GDM is largely limited. The aim of this study was to assess the effect of a probiotic supplement capsule containing four bacterial strains on glucose metabolism indices and weight changes in women with newly diagnosed GDM. Sixty-four pregnant women with GDM were enrolled into a double-blind placebo-controlled randomized clinical trial. They were randomly assigned to receive either a probiotic or placebo capsule along with dietary advice for eight consecutive weeks. The trend of weight gain along with glucose metabolism indices was assayed. During the first 6 weeks of the study, the weight gain trend was similar between the groups. However, in the last 2 weeks of the study, the weight gain in the probiotic group was significantly lower than in the placebo group (p Fasting blood sugar (FBS) decreased in both intervention (from 103.7 to 88.4 mg/dl) and control (from 100.9 to 93.6 mg/dl) groups significantly, and the decrease in the probiotic group was significantly higher than in the placebo group (p probiotic group had 6.74% reduction over the study period (p probiotic group was not significantly different from placebo when adjusted for the baseline levels. The probiotic supplement appeared to affect glucose metabolism and weight gain among pregnant women with GDM. This needs to be confirmed in other settings before a therapeutic value could be approved.

  11. Effects of piroxicam administration on pregnancy outcome in intrauterine insemination (IUI) cycles: a randomized clinical trial.

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    Zarei, A; Mahboubi, M; Parsanezhad, M E; Alborzi, S; Younesi, M; Madadi, G

    2016-01-01

    Uterus contractibility is considered a powerful prognostic factor in predicting the embryo transfer outcome. Moreover, uterine contractions are known to be stimulated by prostaglandins which are produced by cyclooxygenase from arachidonic acid. As such, suppressing the inflammatory response and contractions using anti-inflammatory and relaxant agents is expected to result in increased success rate of embryo transfer and artificial insemination. To investigate the effect of piroxicam administration on the success rate in intrauterine insemination (IU) cycles in patients presenting with unexplained infertility. This randomized, placebo-controlled clinical trial included 260 women with unexplained infertility undergoing IUI cycles. Patients were randomly assigned to receive either piroxicam ten mg/day on days 4-6 after IUI or placebo (control group). The main outcome measures were number of IUI cycles, pregnancy, abortion, and multiple pregnancy rates. The pregnancy rate was found to be 25 (19.2%) and 16 (12.3%) in piroxicam and control groups, respectively (p = 0.039). Five patients (3.8%) in piroxicam group experienced twin pregnancy whereas only three patients (2.3%) in control group had twin pregnancy (p = 0.361). The pregnancy rate per cycle was also significantly higher in those who received piroxicam as compared to controls (11.16 vs. 6.66; p = 0.021). Administration of piroxicam after IUI is associated with decreased number of cycles, as well as increased pregnancy rate and pregnancy rate per cycle in IUI cycles. However, piroxicam did not have any effect on abortion, multiple pregnancy, and ongoing pregnancy rates.

  12. The Effect of Chamomile Cream on Episiotomy Pain in Primiparous Women: A Randomized Clinical Trial.

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    Aradmehr, Maryam; Azhari, Sedigheh; Ahmadi, Sedigheh; Azmoude, Elham

    2017-03-01

    Introduction: Episiotomy is a surgical incision made in the perineum to enlarge it. Perineal pain is the most common complaint of mothers after episiotomy. Chamomile extract has been proposed as a sedative in traditional medicine. This study was conducted to assess the effect of chamomile cream on the pain after episiotomy. Methods: This triple blind clinical trial was performed on 114 eligible women at Ommolbanin Hospital in Mashhad, Iran in 2014.They were randomly assigned to two groups using random blocks. After delivery, mothers in the intervention group used 0.5 g of prescribed chamomile while the control group used placebo cream on the stitch twice a day lasting ten days. Episiotomy pain was evaluated before intervention and 12 hours after episiotomy repair and also on the first, seventh, tenth and fourteenth day after delivery by McGill pain questionnaire. Data was analyzed by SPSS ver.13. Results: There was no significant difference between the two groups before the intervention, 12 hours and the first day after delivery. However, a significant difference was found on the seventh, tenth and fourteenth day after delivery. McGill mean (SD) score on the seventh, tenth and fourteenth in experimental group was 11.36 (5.04), 4.44 (3.43) and 7.16 (4.10) respectively. It was reported 14.88 (7.34), 7.41(4.92) and 9.96 (4.81) in placebo group, respectively. Conclusion: Chamomile cream can be used to reduce episiotomy pain in Primiparous us women.

  13. Patient navigation improves cancer diagnostic resolution: an individually randomized clinical trial in an underserved population.

    Science.gov (United States)

    Raich, Peter C; Whitley, Elizabeth M; Thorland, William; Valverde, Patricia; Fairclough, Diane

    2012-10-01

    Barriers to timely resolution of abnormal cancer screening tests add to cancer health disparities among low-income, uninsured, and minority populations. We conducted a randomized trial to evaluate the impact of lay patient navigators on time to resolution and completion of follow-up testing among patients with abnormal screening tests in a medically underserved patient population. Denver Health, the safety-net health care system serving Denver, is one of 10 performance sites participating in the Patient Navigation Research Program. Of 993 eligible subjects with abnormal screening tests randomized to navigation and no-navigation (control) arms and analyzed, 628 had abnormal breast screens (66 abnormal clinical breast examinations, 304 BIRADS 0, 200 BIRADS 3, 58 BIRADS 4 or 5) whereas 235 had abnormal colorectal and 130 had abnormal prostate screens. Time to resolution was significantly shorter in the navigated group (stratified log rank test, P BIRADS 3 (P = 0.0003) and BIRADS 0 (P = 0.09), but not BIRADS 4/5 or abnormal breast examinations. Navigation shortened the time for both colorectal (P = 0.0017) and prostate screening resolution (P = 0.06). Participant demographics included 72% minority, 49% with annual household income less than $10,000, and 36% uninsured. Patient navigation positively impacts time to resolution of abnormal screening tests for breast, colorectal, and prostate cancers in a medically underserved population. By shortening the time to and increasing the proportion of patients with diagnostic resolution patient navigation could reduce disparities in stage at diagnosis and improve cancer outcomes. 2012 AACR

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

    Science.gov (United States)

    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 (Pwound 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.

  15. Postoperative Pain after Endodontic Retreatment Using Rotary or Reciprocating Instruments: A Randomized Clinical Trial.

    Science.gov (United States)

    Comparin, Daniel; Moreira, Edson Jorge Lima; Souza, Erick M; De-Deus, Gustavo; Arias, Ana; Silva, Emmanuel João Nogueira Leal

    2017-07-01

    The aim of this randomized clinical trial was to evaluate the influence of rotary or reciprocating retreatment techniques on the incidence, intensity, duration of postoperative pain, and medication intake. After power analysis calculations, 65 patients who needed endodontic retreatment were randomly assigned to 1 of 2 groups according to the instrumentation system used: Mtwo (VDW, Munich, Germany) or Reciproc (VDW). Retreatments were performed in a single visit by an endodontic specialist. Participants were asked to rate the incidence and intensity of the postoperative pain on a verbal rating scale 24, 48, and 72 hours after treatment. Patients were also asked to record the number of prescribed analgesic medication tablets (ibuprofen 400 mg) taken. A logistic regression analysis was used to assess both the incidence and duration of pain. Differences in the intensity of pain were analyzed using the ordinal (linear) chi-square test, and the Mann-Whitney U test was used to assess differences in the intake of analgesic medication between groups. No statistically significant difference was found among the 2 groups in relation to postoperative pain or analgesic medication intake at the 3 time points assessed (P > .05). Multivariate analysis showed a significantly higher incidence of pain after 24 hours when preoperative pain was present and a significantly longer duration of pain for men than women independently of the retreatment technique used. The reciprocating system and the continuous rotary system were found to be equivalent regarding the incidence, intensity, duration of postoperative pain, and intake of analgesic medication. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  16. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial.

    Science.gov (United States)

    Steingrimsson, S; Thimour-Bergström, L; Roman-Emanuel, C; Scherstén, H; Friberg, Ö; Gudbjartsson, T; Jeppsson, A

    2015-12-01

    Surgical site infection is a common complication following cardiac surgery. Triclosan-coated sutures have been shown to reduce the rate of infections in various surgical wounds, including wounds after vein harvesting in coronary artery bypass grafting patients. Our purpose was to compare the rate of infections in sternotomy wounds closed with triclosan-coated or conventional sutures. A total of 357 patients that underwent coronary artery bypass grafting were included in a prospective randomized double-blind single-center study. The patients were randomized to closure of the sternal wound with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Inc., Somerville, NJ, USA) (n = 179) or identical sutures without triclosan (n = 178). Patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). The primary endpoint was the prevalence of sternal wound infection according to the Centers for Disease Control and Prevention (CDC) criteria. The demographics in both groups were comparable, including age, gender, body mass index, and rate of diabetes and smoking. Sternal wound infection was diagnosed in 43 patients; 23 (12.8%) sutured with triclosan-coated sutures compared to 20 (11.2%) sutured without triclosan (p = 0.640). Most infections were superficial (n = 36, 10.1%), while 7 (2.0%) were deep sternal wound infections. There were 16 positive cultures in the triclosan group and 17 in the non-coated suture group (p = 0.842). The most commonly identified main pathogens were Staphylococcus aureus (45.4%) and coagulase-negative staphylococci (36.4%). Skin closure with triclosan-coated sutures did not reduce the rate of sternal wound infection after coronary artery bypass grafting. (clinicaltrials.gov: NCT01212315).

  17. The effects of vitamin D supplementation on maternal and neonatal outcome: A randomized clinical trial

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    Mahdieh Mojibian

    2015-11-01

    Full Text Available Background: Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes. Objective: This randomized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes (GDM, gestational hypertension, preeclampsia and preterm labor, vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily. Materials and Methods: 500 women with gestational age 12-16 weeks and serum 25 hydroxy vitamin D (25 (OH D less than 30 ng/ml randomly categorized in two groups. Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery. Maternal and Neonatal outcomes were assessed in two groups. Results: The incidence of GDM in group B was significantly lower than group A (6.7% versus 13.4% and odds ratio (95% Confidence interval was 0.46 (0.24-0.87 (P=0.01. The mean ± SD level of 25 (OH D at the time of delivery in mothers in group B was significantly higher than A (37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml, respectively (P=0.001. There were no differences in the incidence of preeclampsia, gestational hypertension, preterm labor, and low birth weight between two groups. The mean level of 25 (OH D in cord blood of group B was significantly higher than group A (37.9 ± 18 versus 29.7 ± 19ng/ml, respectively. Anthropometric measures between neonates were not significantly different. Conclusion: Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM.

  18. Skin closure methods after single port laparoscopic surgery: a randomized clinical trial.

    Science.gov (United States)

    Park, Sue Yeon; Kim, Kye Hyun; Yuk, Jin-Sung; Ji, Hyun Young; Lee, Jung Hun

    2015-06-01

    To compare postoperative cosmetic outcomes according to different umbilical closure methods after single port laparoscopic surgery (SP-LS). A total of 138 women who were scheduled to receive elective SP-LS were randomized to undergo closure of the umbilical incision with either a subcutaneous suture only without subcuticular skin suture (case group, n=68) or both a subcutaneous suture and subcuticular skin suture (control group, n=70) after fascial closure. At postoperative months 1 and 3, the umbilical scar was evaluated using the Vancouver scar scale (VSS), the patient and observer scar assessment scale, and a visual analog scale (VAS). Overall satisfaction with scar cosmesis and surgery was assessed with the VAS. There was no significant difference in the clinical characteristics and operative data between the groups. The objective and subjective scar assessments and the overall satisfaction with scar cosmesis were not different between the groups. In the control group, four (5.7%) women experienced wound discharge and were treated with conservative treatments and delayed closure. In women who completed the first and second assessments, the changes in the scar assessment and overall satisfaction with the scar according to time after surgery were not different in either group, but the patient scar assessment scale in both groups and the VSS in the case group improved. After SP-LS, the approximation of the fascia and subcutaneous layer seems to be enough for the closure of an umbilical incision. Skin closure with subcuticular sutures did not improve the postoperative cosmetic outcomes and might lead to impaired wound healing. However, large randomized trials with various closure techniques and materials are needed to confirm this finding. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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

    Science.gov (United States)

    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 pat