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Sample records for randomized comparative study

  1. A Comparative Study of Random Patterns for Digital Image Correlation

    NASA Astrophysics Data System (ADS)

    Stoilov, G.; Kavardzhikov, V.; Pashkouleva, D.

    2012-06-01

    Digital Image Correlation (DIC) is a computer based image analysis technique utilizing random patterns, which finds applications in experimental mechanics of solids and structures. In this paper a comparative study of three simulated random patterns is done. One of them is generated according to a new algorithm, introduced by the authors. A criterion for quantitative evaluation of random patterns after the calculation of their autocorrelation functions is introduced. The patterns' deformations are simulated numerically and realized experimentally. The displacements are measured by using the DIC method. Tensile tests are performed after printing the generated random patterns on surfaces of standard iron sheet specimens. It is found that the new designed random pattern keeps relatively good quality until reaching 20% deformation.

  2. Comparative study of ring and random cavities for fiber lasers.

    PubMed

    Fernandez-Vallejo, Montserrat; Rota-Rodrigo, Sergio; Lopez-Amo, Manuel

    2014-06-01

    An experimental comparison of three fiber laser structures with the same Raman gain medium is presented in order to establish the main pros and cons of each basic scheme. The first fiber laser is based on a hybrid ring-random fiber laser, the second one is a pure ring fiber laser, and the last one is a random fiber laser. Several aspects have been taken into account in the study. First, from the optical point of view, the parameters of interest compared are output power, lasing threshold, slope efficiency, power fluctuations, and the longitudinal modes have been analyzed. Second, the possible utilization of fiber lasers in digital modulated optical communication systems is also studied.

  3. Randomized study comparing inflammatory response after tonsillectomy versus tonsillotomy.

    PubMed

    Kordeluk, Sofia; Goldbart, Aviv; Novack, Lena; Kaplan, Daniel Michael; El-Saied, Sabri; Alwalidi, Musa; Shapira-Parra, Angelica; Segal, Nili; Slovik, Yuval; Max, Puterman; Joshua, Ben-Zion

    2016-11-01

    To determine if there was a difference in the inflammatory reaction after tonsil surgery with "traditional" techniques (tonsillectomy and adenoidectomy or TA) compared to partial intracapsular tonsillectomy and adenoidectomy (PITA). Randomized, double-blind study. tertiary care academic hospital. Children under the age of 16 years with a diagnosis of obstructive sleep disordered breathing were randomly allocated into three study groups: TA with electrocautery (n = 34), PITA with CO2 laser (n = 30) and PITA with debrider (n = 28). All of the children underwent adenoidectomy with a current at the same surgical procedure. c-reactive protein level (CRP) was the primary endpoint. In addition, the following were assessed: white blood cells (WBC), neutrophils (NEU), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). Pre- and post-procedure measurements were compared between the groups. Parents filled out a questionnaire daily during the first postoperative week assessing pain, swallowing and snoring. CRP levels ascended higher in the PITA groups after surgery (p = 0.023), WBC and NEU showed the same pattern, IL-6 levels were higher in PITA group and there was no difference in TNF-alpha levels between the two types of procedures. Postoperative pain and postoperative hemorrhage were significantly lower in the PITA groups as compared to the TA group (p = 0.01 and 0.048). PITA in comparison to TA is associated with lower morbidity; however, the inflammatory response does not differ significantly in the first 24 h after surgery. Additional long-term studies assessing efficacy of PITA are warranted. Level 1, prospective randomized controlled trial.

  4. An open multicenter comparative randomized clinical study on chitosan.

    PubMed

    Mo, Xiaohui; Cen, John; Gibson, Elaine; Wang, Robin; Percival, Steven L

    2015-01-01

    Chitosan, a natural polysaccharide derivate from chitin, offers a promising alternative biomaterial for use in wound dressings. In this work, the safety and efficacy of a next-generation KA01 chitosan wound dressing in facilitating the healing of nonhealing chronic wounds was studied. This open multicenter comparative prospective randomized clinical study was conducted at three medical centers in China. A total of 90 patients (45 in test group and 45 in control group) with unhealed chronic wounds including pressure ulcers, vascular ulcers, diabetic foot ulcers, and wounds with minor infections, or at risk of infection, were treated with the next generation chitosan wound dressing as the test article or traditional vaseline gauze as a control. Baseline assessments were undertaken with the primary end point being wound area reduction. The secondary end points included pain reduction (using the NRS11 pain scale) at dressing change, wound exudate levels, wound depth and duration of the treatment. After 4 weeks treatment, the wound area reduction was significantly greater in the test group (65.97 ± 4.48%) than the control group (39.95 ± 4.48%). The average pain level in the test group was 1.12 ± 0.23 and 2.30 ± 0.23 in the control group. The wound depth was also lower in the test group 0.30 ± 0.48 cm than the control group 0.54 ± 0.86 cm. The level of exudate fell and the dressing could be removed integrally in both the test and control groups. The mean duration of the test group was 27.31 ± 5.37 days and control group 27.09 ± 6.44 days. No adverse events were reported in either group. In conclusion this open multicenter comparative prospective randomized clinical study has provided compelling evidence that the next generation chitosan wound dressing can enhance wound progression towards healing by facilitating wound reepithelialization and reducing the patients pain level. Furthermore the dressing was shown to be clinically safe and effective in the management

  5. PROSPECTIVE RANDOMIZED STUDY COMPARING TWO ANESTHETIC METHODS FOR SHOULDER SURGERY

    PubMed Central

    Ikemoto, Roberto Yukio; Murachovsky, Joel; Prata Nascimento, Luis Gustavo; Bueno, Rogerio Serpone; Oliveira Almeida, Luiz Henrique; Strose, Eric; de Mello, Sérgio Cabral; Saletti, Deise

    2015-01-01

    Objective: To evaluate the efficacy of suprascapular nerve block in combination with infusion of anesthetic into the subacromial space, compared with interscalene block. Methods: Forty-five patients with small or medium-sized isolated supraspinatus tendon lesions who underwent arthroscopic repair were prospectively and comparatively evaluated through random assignation to three groups of 15, each with a different combination of anesthetic methods. The efficacy of postoperative analgesia was measured using the visual analogue scale for pain and the analgesic, anti-inflammatory and opioid drug consumption. Inhalation anesthetic consumption during surgery was also compared between the groups. Results: The statistical analysis did not find any statistically significant differences among the groups regarding anesthetic consumption during surgery or postoperative analgesic efficacy during the first 48 hours. Conclusion: Suprascapular nerve block with infusion of anesthetic into the subacromial space is an excellent alternative to interscalene block, particularly in hospitals in which an electrical nerve stimulating device is unavailable. PMID:27022569

  6. A Comparative Study of Randomized Constraint Solvers for Random-Symbolic Testing

    NASA Technical Reports Server (NTRS)

    Takaki, Mitsuo; Cavalcanti, Diego; Gheyi, Rohit; Iyoda, Juliano; dAmorim, Marcelo; Prudencio, Ricardo

    2009-01-01

    The complexity of constraints is a major obstacle for constraint-based software verification. Automatic constraint solvers are fundamentally incomplete: input constraints often build on some undecidable theory or some theory the solver does not support. This paper proposes and evaluates several randomized solvers to address this issue. We compare the effectiveness of a symbolic solver (CVC3), a random solver, three hybrid solvers (i.e., mix of random and symbolic), and two heuristic search solvers. We evaluate the solvers on two benchmarks: one consisting of manually generated constraints and another generated with a concolic execution of 8 subjects. In addition to fully decidable constraints, the benchmarks include constraints with non-linear integer arithmetic, integer modulo and division, bitwise arithmetic, and floating-point arithmetic. As expected symbolic solving (in particular, CVC3) subsumes the other solvers for the concolic execution of subjects that only generate decidable constraints. For the remaining subjects the solvers are complementary.

  7. A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

    PubMed

    Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J

    2016-08-31

    In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

  8. A Double-Blind Randomized Pilot Study Comparing Quetiapine and Divalproex for Adolescent Mania

    ERIC Educational Resources Information Center

    Delbello, Melissa P.; Kowatch, Robert A.; Adler, Caleb M.; Stanford, Kevin E.; Welge, Jeffrey A.; Barzman, Drew H.; Nelson, Erik; Strakowski, Stephen M.

    2006-01-01

    Objective: To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania. Method: Fifty adolescents (ages 12-18 years) with bipolar I disorder, manic or mixed episode, were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 [micro]g/mL) for 28 days for this double-blind study,…

  9. Power doppler ultrasonography guided and random prostate biopsy in prostate cancer diagnosis - a comparative study.

    PubMed

    Sohail, Shahzada Khalid; Sarfraz, Rahat; Imran, Muhammad; Khan, Naeem Ahmed; Yusuf, Noshin Wasim

    2015-01-01

    To compare the diagnostic accuracy of power Doppler-guided targeted prostate biopsy and random sextant biopsy in the diagnosis of prostate cancer. The prospective study was carried out at the Allama Iqbal Medical College and Jinnah Hospital, Lahore, Pakistan, from January to December, 2012, and comprised clinically suspected cases of carcinoma prostate. Power Doppler-guided biopsies using automatic biopsy gun were obtained from the suspected targeted site. One to three cores per suspected site were obtained. Subsequently random sextant biopsies were performed in the same sitting. Six cores were obtained from 6 random sites using the same gun. Biopsies from both sources were processed for routine haematoxylin and eosin stainstained sections for histopathological examination. Of the 50 patients in the study, 30(60%) were diagnosed with power Doppler-guided biopsy as malignant, whereas random sextant biopsy could pick up 22(44%) cases. For benign prostatic hyperplasia, random sextant biopsy labelled 28(56%)as benign, whereas only 20 (40%) were labelled as benign with power Doppler-guided biopsy. Discrepancy in the results between the two procedures was observed in 14(28%) cases, and of them, 1 1(22%) were labelled as malignant on power Doppler-guided biopsy while histopathology of sextant biopsies labelled these as benign.The sextant biopsies rendered a specificity, sensitivity, negative predictive value, positive predictive value and diagnostic accuracy of 60.71%, 86.36%, 85%, 63.33% and 72% respectively. Random sextant biopsy in combination with power Doppler-guided targeted biopsy increases the rate of detection of prostate cancer whereas both procedures in isolation have low sensitivity and specificity for cancer detection.

  10. A simulation study for comparing testing statistics in response-adaptive randomization

    PubMed Central

    2010-01-01

    Background Response-adaptive randomizations are able to assign more patients in a comparative clinical trial to the tentatively better treatment. However, due to the adaptation in patient allocation, the samples to be compared are no longer independent. At large sample sizes, many asymptotic properties of test statistics derived for independent sample comparison are still applicable in adaptive randomization provided that the patient allocation ratio converges to an appropriate target asymptotically. However, the small sample properties of commonly used test statistics in response-adaptive randomization are not fully studied. Methods Simulations are systematically conducted to characterize the statistical properties of eight test statistics in six response-adaptive randomization methods at six allocation targets with sample sizes ranging from 20 to 200. Since adaptive randomization is usually not recommended for sample size less than 30, the present paper focuses on the case with a sample of 30 to give general recommendations with regard to test statistics for contingency tables in response-adaptive randomization at small sample sizes. Results Among all asymptotic test statistics, the Cook's correction to chi-square test (TMC) is the best in attaining the nominal size of hypothesis test. The William's correction to log-likelihood ratio test (TML) gives slightly inflated type I error and higher power as compared with TMC, but it is more robust against the unbalance in patient allocation. TMC and TML are usually the two test statistics with the highest power in different simulation scenarios. When focusing on TMC and TML, the generalized drop-the-loser urn (GDL) and sequential estimation-adjusted urn (SEU) have the best ability to attain the correct size of hypothesis test respectively. Among all sequential methods that can target different allocation ratios, GDL has the lowest variation and the highest overall power at all allocation ratios. The performance of

  11. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes.

    PubMed

    Campoli, Paulo; Cardoso, Daniela; Turchi, Marilia; Mota, Orlando

    2011-04-01

    The use of percutaneous endoscopic gastrostomy (PEG) for nutrition support is increasing worldwide, but few studies have evaluated the durability of and complications related to the different materials used to manufacture gastrostomy tubes. Latex PEG tubes are widely used in our clinical setting, but no studies have compared their durability with silicone PEG tubes. The aim of the present study was to compare the durability of latex tubes with the durability of silicone tubes. A randomized clinical trial was conducted in patients with head and neck cancer with indications for PEG. Sixty patients were randomized to receive either latex or silicone PEG tubes and followed up for 90 days. The analyzed outcomes were duration, peristomal infection, granulated tissue formation, and leakage around the tube. The durability of silicone PEG tubes was significantly greater than the durability of latex PEG tubes. The survival curves showed that silicone PEG tubes lasted twice as long (hazard ratio = 2.0, 95% confidence interval = 1.1-3.7, P = 0.01). No differences were found with regard to rate of peristomal infection, granulated tissue formation, or leakage. Silicone PEG tubes are associated with a reduced need for replacement (attributable to higher durability) compared with latex PEG tubes. © 2010 The Authors. Digestive Endoscopy © 2010 Japan Gastroenterological Endoscopy Society.

  12. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials.

    PubMed

    Anglemyer, Andrew; Horvath, Hacsi T; Bero, Lisa

    2014-04-29

    Researchers and organizations often use evidence from randomized controlled trials (RCTs) to determine the efficacy of a treatment or intervention under ideal conditions. Studies of observational designs are often used to measure the effectiveness of an intervention in 'real world' scenarios. Numerous study designs and modifications of existing designs, including both randomized and observational, are used for comparative effectiveness research in an attempt to give an unbiased estimate of whether one treatment is more effective or safer than another for a particular population.A systematic analysis of study design features, risk of bias, parameter interpretation, and effect size for all types of randomized and non-experimental observational studies is needed to identify specific differences in design types and potential biases. This review summarizes the results of methodological reviews that compare the outcomes of observational studies with randomized trials addressing the same question, as well as methodological reviews that compare the outcomes of different types of observational studies. To assess the impact of study design (including RCTs versus observational study designs) on the effect measures estimated.To explore methodological variables that might explain any differences identified.To identify gaps in the existing research comparing study designs. We searched seven electronic databases, from January 1990 to December 2013.Along with MeSH terms and relevant keywords, we used the sensitivity-specificity balanced version of a validated strategy to identify reviews in PubMed, augmented with one term ("review" in article titles) so that it better targeted narrative reviews. No language restrictions were applied. We examined systematic reviews that were designed as methodological reviews to compare quantitative effect size estimates measuring efficacy or effectiveness of interventions tested in trials with those tested in observational studies

  13. Randomized Study of Noninferiority Comparing Prosthetic and Autologous Vein Above-Knee Femoropopliteal Bypasses.

    PubMed

    Midy, Dominique; Papon, Xavier; Patra, Philippe; Hassen Kodja, Réda; Feugier, Patrick; Plissonnier, Didier; Reix, Thierry; Chene, Geneviève; Berard, Xavier

    2016-02-01

    The main aim of this study was to compare the 5 years rates of secondary patency of above-knee femoropopliteal revascularizations with autologous veins or prosthetic grafts. The secondary objectives were to compare the rates of primary patency, limb salvage, morbidity, and mortality between the 2 groups. This was a single-blind randomized study of noninferiority (ratio 1:1), carried out in 11 centers of vascular surgery with 2 parallel groups between July 2002 and November 2005. Follow-up finished in May 2011. The monitoring protocol included a clinical examination and an ultrasound control at 1 month, 3 and 6 months, then annually. One hundred patients were included and randomized in the study, 52 in the prosthetic group and 48 in the autologous vein group. Four patients randomized in the vein group received a prosthetic graft. No patient was excluded from the analysis. In the in intent-to-treat analysis, the 5 years secondary patency was 84.6% in the prosthetic group (IC 95%, 71.9-93.1) and 70.8% in the autologous vein group (IC 95%: 55.9-83.1), and the difference in secondary patency between the prosthetic and the autologous vein groups was 13.8% (IC 95%, -4.4 to 32.0). In the under treatment analysis, the 5 years secondary patency was 96.2% among patients receiving a prosthesis (IC 95%, 80.4-99.9) and 90.5% among patients receiving an autologous vein (IC 95%, 66.9-98.9), and the difference in the rate of patency between prostheses and veins was 5.7% (IC 95%, -13.2 to 24.6). Although there was no significant difference at 5 years, the death rate and the rate of amputation were higher in the prosthetic group. Although it is impossible to conclude definitely to the noninferiority of prosthetic bypass compared with venous bypass because of the insufficient number of inclusions, this randomized study nevertheless showed at 5 years the satisfactory results obtained with prostheses compared with autologous vein for above-knee femoropopliteal bypasses. Copyright

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

    PubMed

    Lane, Joseph P; Stone, Vathsala I

    2015-01-01

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

  15. Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis.

    PubMed

    Raja, Indu M; Basavareddy, Asha; Mukherjee, Deepali; Meher, Bikash Ranjan

    2016-01-01

    To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1(st) week and 4(th) week. They were categorized as cured, partially cured, and not cured based on Amsel's criteria at the end of the study and compared between two groups using Chi-square test. A total 120 women were enrolled in the study, of which 114 completed the study. The treatment arms were comparable. The cure rate with low-dose tinidazole was significantly more compared to metronidazole at 4(th) week (P = 0.0013), but not at 1(st) week (P = 0.242). The adverse drug reactions were less with tinidazole compared to metronidazole. Tinidazole at lower dose offers a better efficacy than metronidazole in long-term cure rates and in preventing relapses with better side effect profile.

  16. Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis

    PubMed Central

    Raja, Indu M.; Basavareddy, Asha; Mukherjee, Deepali; Meher, Bikash Ranjan

    2016-01-01

    Objective: To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. Patients and Methods: This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1st week and 4th week. They were categorized as cured, partially cured, and not cured based on Amsel's criteria at the end of the study and compared between two groups using Chi-square test. Results: A total 120 women were enrolled in the study, of which 114 completed the study. The treatment arms were comparable. The cure rate with low-dose tinidazole was significantly more compared to metronidazole at 4th week (P = 0.0013), but not at 1st week (P = 0.242). The adverse drug reactions were less with tinidazole compared to metronidazole. Conclusion: Tinidazole at lower dose offers a better efficacy than metronidazole in long-term cure rates and in preventing relapses with better side effect profile. PMID:28066102

  17. Intrathecal Versus Intravenous Morphine in Minimally Invasive Posterior Lumbar Fusion: A Blinded Randomized Comparative Prospective Study.

    PubMed

    Araimo Morselli, Fabio Silvio Mario; Zuccarini, Francesco; Caporlingua, Federico; Scarpa, Ilaria; Imperiale, Carmela; Caporlingua, Alessandro; De Biase, Lorenzo; Tordiglione, Paolo

    2017-03-01

    A blinded, randomized, comparative prospective study. The aim of this study was to compare the use of intrathecal morphine to endovenous morphine on postoperative pain after posterior lumbar surgery. Intrathecal morphine can provide significant safe analgesia for at least 12 hours and up to 24 hours in patients undergoing major surgery. Its dosages have been decreasing in the last 30 years, but currently, the optimal dose remains unknown. As of today, there are no studies comparing the efficacy and the side effects of this technique with intravenous morphine administration after minimally invasive lumbar fusion surgery. We randomized and compared two groups of 25 patients, who were given either 100 μg intrathecal (ITM group) or 5 ± 2 mg intravenous morphine delivered intravenously for 24 hours at 2 mL/h (IVM group) after minimally invasive posterior lumbar fusion. VAS score at 0, 6, 12, 24 hours, mobilization out of bed at 6 hours, hospitalization duration and complications as lower limbs paresthesia, urinary retention at 6 and 12 hours, nausea, vomit, itch, and constipation were evaluated. Data showed a lower VAS score, a reduction of constipation, lower limbs paresthesia, or urinary retention at 12 hours in ITM rather than in the IVM group. None suffered of vomit, itch, or nausea in both groups. Urinary retention was observed more frequently in ITM group at 6 hours. Patients of ITM group were mobilized out bed earlier than those from IVM group. A low dosage of intrathecal morphine is safe and effective after minimally invasive lumbar fusion surgery. The reduction of pain in the study group permitted a shorter hospitalization and earlier mobilization out of bed, augmenting patients' comfort. 2.

  18. Randomized clinical study comparing piezosurgery and conventional rotatory surgery in mandibular cyst enucleation.

    PubMed

    Pappalardo, Sabrina; Guarnieri, Renzo

    2014-07-01

    The aim of the present study is to compare piezoelectric surgery to the conventional rotatory surgery in mandibular cyst enucleation, and to determine the 2 method's suitability and the postoperative outcomes. Eighty patients were included in the study. 35 male and 45 female, which showed cystic mandibular lesions, compared with the inferior alveolar nerve or the mental nerve. The patients were randomly divided into two groups. In the test group, cystectomy was performed using conventional rotatory instrumentation (rotatory-group), and in the other one piezoelectric surgery (piezo-group). The swelling was documented 24/48/72 h and 1 week post-surgery and the patients recorded their subjective postoperative pain daily for 7 days using a Visual Analog Scale (VAS). Patients treated with piezoelectric technique have presented a lower VAS, minor swelling and less recovery time compared to the rotatory-group. No lesions of the mandible nerve were detected with piezosurgery whereas surgery with rotary instruments resulted in 8% hypesthesia at least up to one week. The results of this study suggest that piezosurgery may be considered effective in cyst enucleation compared to traditional procedures with burs, since it grants the patients significantly less post-surgical pain and swelling. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  19. A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients.

    PubMed

    Spies, Claudia; Macguill, Martin; Heymann, Anja; Ganea, Christina; Krahne, Daniel; Assman, Angelika; Kosiek, Heinrich-Rudolf; Scholtz, Kathrin; Wernecke, Klaus-Dieter; Martin, Jörg

    2011-03-01

    To compare the quality of analgesia provided by a remifentanil-based analgesia regime with that provided by a fentanyl-based regime in critically ill patients. This was a registered, prospective, two-center, randomized, triple-blind study involving adult medical and surgical patients requiring mechanical ventilation (MV) for more than 24 h. Patients were randomized to either remifentanil infusion or a fentanyl infusion for a maximum of 30 days. Sedation was provided using propofol (and/or midazolam if required). Primary outcome was the proportion of patients in each group maintaining a target analgesia score at all time points. Secondary outcomes included duration of MV, discharge times, and morbidity. At planned interim analysis (n = 60), 50% of remifentanil patients (n = 28) and 63% of fentanyl patients (n = 32) had maintained target analgesia scores at all time points (p = 0.44). There were no significant differences between the groups with respect to mean duration of ventilation (135 vs. 165 h, p = 0.80), duration of hospital stay, morbidity, or weaning. Interim analysis strongly suggested futility and the trial was stopped. The use of remifentanil-based analgesia in critically ill patients was not superior regarding the achievement and maintenance of sufficient analgesia compared with fentanyl-based analgesia.

  20. Comparative study of standing wave reduction methods using random modulation for transcranial ultrasonication.

    PubMed

    Furuhata, Hiroshi; Saito, Osamu

    2013-08-01

    Various transcranial sonotherapeutic technologies have risks related to standing waves in the skull. In this study, we present a comparative study on standing waves using four different activation methods: sinusoidal (SIN), frequency modulation by noise (FMN), periodic selection of random frequency (PSRF), and random switching of both inverse carriers (RSBIC). The standing wave was produced and monitored by the schlieren method using a flat plane and a human skull. The minimum ratio RSW, which is defined by the ratio of the mean of the difference between local maximal value and local minimal value of amplitude to the average value of the amplitude, was 36% for SIN, 24% for FMN, 13% for PSRF, and 4%for RSBIC for the flat reflective plate, and it was 25% for SIN, 11% for FMN, 13% for PSRF, and 5% for RSBIC for the inner surface of the human skull. This study is expected to have a role in the development of safer therapeutic equipment. Copyright © 2013 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.

  1. A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures

    PubMed Central

    Mahajan, Kanika; Singh, Girish Kumar; Kumar, Santosh; Avasthi, Sachin

    2016-01-01

    Introduction A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George’s Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP). Aim To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union. Materials and Methods This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review. Statistical Analysis Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint. Results Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343). Conclusion EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture

  2. A randomized comparative study on modified Joel-Cohen incision versus Pfannenstiel incision for cesarean section

    PubMed Central

    Saha, Shyama Prasad; Bhattarcharjee, Nabendu; Das Mahanta, Sabysachi; Naskar, Animesh; Bhattacharyya, Sanjoy Kumar

    2013-01-01

    Objective: Pfanennstiel incision is the most commonly used incision for cesarean section, but may not be the best. This study compared the modified Joel-Cohen incision with the Pfannenstiel incision to evaluate whether techniques to open the abdomen might influence operative time, and maternal and neonatal outcomes. Material and Methods: In a randomized comparative trial, 302 women with gestational age >34 weeks, requiring cesarean section, were randomly assigned to either modified Joel-Cohen incision or Pfannenstiel incision for entry into the peritoneal cavity. The primary outcome measure was total time required for performing operation and secondary outcome measures were baby extraction time, number of haemostatic procedures used in the abdominal wall, postoperative morbidity, postoperative hospital stay and neonatal outcome. Results: Mean total operative time was significantly less in the modified Joel-Cohen group as compared to the Pfannenstiel group (29.81 vs 32.67 min, p<0.0001, 95%CI=2.253 to 3.467). Time taken to deliver the baby and haemostatic procedures required during operation were also significantly less in the modified Joel-Cohen group as compared to the Pfannenstiel group. Requirement of strong analgesics was higher in the Pfannenstiel group (53.64% vs 21.85%, p<0.0001). There was no statically significant difference in the incidence of postoperative wound complications but postoperative stay in hospital was significantly less in the modified Joel-Cohen group (p=0.002). Neonatal outcomes were similar in both groups. Conclusion: The modified Joel-Cohen incision for entry into peritoneal cavity during cesarean section is associated with reduced mean total operative and baby extraction times with less postoperative pain and shorter hospital stay, which may be beneficial and cost effective. PMID:24592067

  3. Efficacy of an eye drop mixture for pupillary dilatation: A randomized comparative study.

    PubMed

    Bhurayanontachai, Patama; Saengkaew, Suwapat; Apiromruck, Penjamaporn

    Pupillary dilatation with three types of eye drops is used regularly in the clinic; however, a mixture of these drops in a single bottle may be more beneficial in reducing workloads and resources. This study compared the efficacy in pupillary dilatation between two protocols of dilating drop instillation. This prospective, randomized, comparative study included 30 eligible Thai patients. The patients randomly received preoperative pupillary dilatations by either the conventional protocol (1% tropicamide (T), 10% phenylephrine (P) and 0.1% diclofenac (D) in three separate bottles) or the fixed combination (TPD) protocol which had the three types of eye drops mixed in a single bottle in a ratio of 4:3:3. The chi-square test and independent t-test were used to analyze the data. The conventional protocol group and TPD protocol group each had 15 patients. Sixty minutes after the initial instillation, all patients in the TPD protocol and 13 patients (86.7%) in conventional protocol achieved at least 6mm in the shortest diameter. The mydriatic rate between protocols showed no difference. In patients who received the TPD protocol, the systemic effects on the mean arterial blood pressure and pulse rate decreased over time. The mixture of tropicamide, phenylephrine and diclofenac had a comparable efficacy for a pupillary dilatation to the conventional dilating drops in separate bottles. The systemic complications on blood pressure and arterial pulse of the TPD mixture were less than the conventional protocol. TCTR20130325001. Copyright © 2016 Spanish General Council of Optometry. Published by Elsevier España, S.L.U. All rights reserved.

  4. Eurotransplant randomized multicenter kidney graft preservation study comparing HTK with UW and Euro-Collins.

    PubMed

    de Boer, J; De Meester, J; Smits, J M; Groenewoud, A F; Bok, A; van der Velde, O; Doxiadis, I I; Persijn, G G

    1999-01-01

    The aim was to evaluate the effect of HTK compared to UW and Euro-Collins (EC) on the initial graft function and long term graft survival in two prospective randomized studies. Only kidneys from heart-beating, kidney-only or kidney + heart donors were eligible for entry. Initial non-function (INF) was defined as the absence of life-sustaining renal function, requiring dialysis treatment on two or more occasions, during the first week after transplantation. To evaluate the contribution of the preservation solutions on INF in relation to other factors, a multivariate, 2-step logistic regression model was used. Randomization was performed between July 1990 and September 1992. The UW-HTK study comprised 342 donors and 611 transplants (UW: 168 donors and 297 transplants, HTK: 174 donors and 314 transplants). In the EC-HTK study 317 donors and 569 transplants were included (EC: 155 donors and 277 transplants, HTK: 162 donors and 292 transplants). INF occurred in 33% of either HTK-(n = 105) or UW-(n = 99) preserved kidneys (P = NS), and in 29% of the HTK-(n = 85) and in 43% of the EC-(n = 119) preserved kidneys (P = 0.001). Multivariate analysis showed no significant influence of the preservation solution on the incidence of INF in the UW-HTK study, but factors contributing to INF were donor age, cause of death, retransplantation, and cold ischemic period. The EC-HTK study showed a significantly higher risk of INF, using EC as preservation, in addition to cold ischemic period and donor quality. The 3-year graft survival of HTK-preserved kidneys was 73%, compared to 68% for UW-preserved kidneys in the UW-HTK study (P = NS); while the 3-year graft survival of HTK preserved kidneys was 70% compared to 67% for EC-preserved kidneys in the EC-HTK study (P = NS). We can conclude that HTK is comparable to UW in its preservative abilities, using kidneys from heart-beating kidney-only donors, whereas EC as renal preservation solution should be avoided.

  5. A Randomized Study Comparing the Shaker Exercise with Traditional Therapy: A Preliminary Study

    PubMed Central

    Rademaker, Alfred; Pauloski, Barbara Roa; Kelly, Amy; Stangl-McBreen, Carrie; Antinoja, Jodi; Grande, Barbara; Farquharson, Julie; Kern, Mark; Easterling, Caryn; Shaker, Reza

    2010-01-01

    Seven institutions participated in this small clinical trial that included 19 patients who exhibited oropharyngeal dysphagia on videofluorography (VFG) involving the upper esophageal sphincter (UES) and who had a 3-month history of aspiration. All patients were randomized to either traditional swallowing therapy or the Shaker exercise for 6 weeks. Each patient received a modified barium swallow pre- and post-therapy, including two swallows each of 3 ml and 5 ml liquid barium and 3 ml barium pudding. Each videofluorographic study was sent to a central laboratory and digitized in order to measure hyoid and larynx movement as well as UES opening. Fourteen patients received both pre-and post-therapy VFG studies. There was significantly less aspiration post-therapy in patients in the Shaker group. Residue in the various oral and pharyngeal locations did not differ between the groups. With traditional therapy, there were several significant increases from pre- to post-therapy, including superior laryngeal movement and superior hyoid movement on 3-ml pudding swallows and anterior laryngeal movement on 3-ml liquid boluses, indicating significant improvement in swallowing physiology. After both types of therapy there is a significant increase in UES opening width on 3-ml paste swallows. PMID:19472007

  6. Comparative Efficacy of Newer Antidepressants in Combination with Pregabalin for Fibromyalgia Syndrome: A Controlled, Randomized Study.

    PubMed

    Ramzy, Eiad A

    2017-01-01

    This controlled, randomized study investigated the hypothesis that the combined use of pregabalin plus paroxetine for fibromyalgia management would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and Center for Epidemiological Studies Depression Scale (CESDS) scores, but higher tolerability than the combined use of pregabalin plus either amitriptyline or venlafaxine. After institutional ethics committee approval, 75 female subjects diagnosed with fibromyalgia and in receipt of pregabalin (75 mg/day) were randomly allocated to concurrently receive amitriptyline (25 mg/day; n = 24), venlafaxine (75 mg/day; n = 25), or paroxetine (25 mg/day; n = 26). All patients were assessed bimonthly for 6 consecutive months for changes in SSS-8 and CESDS scores, life satisfaction, mood, sleep quality, fatigue, medication tolerability, and adverse events. Compared with pregabalin plus amitriptyline or venlafaxine, the combined use of pregabalin plus paroxetine in fibromyalgia patients resulted in significantly lower SSS-8 and CESDS scores from 18 (P < 0.05) and 10 weeks (P < 0.001) after the initiation of study medications, respectively; higher medication tolerability (P < 0.001); improved life satisfaction, mood, and sleep quality at most observation times (P < 0.05); and fewer instances of dry mouth and elevated blood pressure (P < 0.02). Medication termination due to poor tolerability was observed most frequently in the venlafaxine group (P < 0.05), while drowsiness, dizziness, blurred vision, abnormal taste, hunger, hallucination, urination problems, and sexual dysfunction were observed most frequently in the amitriptyline group (P < 0.02). The combined use of pregabalin plus paroxetine offers an effective method with increased tolerability to reduce the somatic and depressive symptoms of fibromyalgia and to enhance the quality of life in affected individuals. © 2016 World Institute of Pain.

  7. A Randomized Controlled Study Comparing Reverse Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Infection.

    PubMed

    Hsu, Ping-I; Kao, Sung-Shuo; Wu, Deng-Chyang; Chen, Wen-Chi; Peng, Nan-Jing; Yu, Hsien-Chung; Wang, Huay-Min; Lai, Kwok-Hung; Cheng, Jin-Shiung; Chen, Angela; Chuah, Seng-Kee; Tsay, Feng-Woei

    2015-12-01

    Reverse hybrid therapy is an 1-step 2-phase treatment for Helicobacter pylori (H. pylori) infection with less cost than standard triple therapy. We conducted a randomized, controlled study to compare the efficacies of standard triple therapy and reverse hybrid therapy in the treatment of H. pylori infection. From October 2012 to March 2015, consecutive H. pylori-infected subjects were randomly allocated to receive either a reverse hybrid therapy (pantoprazole plus amoxicillin for 12 days and clarithromycin plus metronidazole for the initial 7 days) or a standard triple therapy (pantoprazole plus amoxicillin and clarithromycin for 12 days). H. pylori status was assessed 6 weeks after treatment. Additionally, antibiotic resistances and host CYP2C19 genotypes were examined and analyzed. A total of 440 H. pylori-infected patients were randomly assigned to receive either a reverse hybrid (n = 220) or a standard triple therapy (n = 220). The reverse hybrid group had a higher eradication rate than standard triple group either by intention-to-treat (93.6% vs. 86.8%; P = 0.016) or per-protocol analysis (95.7% vs. 88.3%; P = 0.005). The 2 patient groups exhibited similar frequencies of overall adverse events (14.1% vs. 9.5%) and drug compliance (96.8% vs. 98.6%). Clarithromycin resistance was an independent risk factor predicting eradication failure in standard triple group (P < 0.001), but not in reverse hybrid group. CYP2C19 genotypes did not affect the eradication rates in both groups. Reverse hybrid therapy can be considered for first-line treatment of H. pylori infection since the new therapy achieves a higher eradication rate than standard triple therapy with similar tolerability and less pharmaceutical cost.

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

    PubMed

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

    2012-01-01

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

  9. Bispectral index under propofol anesthesia in children: a comparative randomized study between TIVA and TCI.

    PubMed

    Louvet, Nicolas; Rigouzzo, Agnès; Sabourdin, Nada; Constant, Isabelle

    2016-09-01

    In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study was to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0 ), titration of the infusion rate on the BIS (TIVABIS ), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS ) or the Schnider model (TCI SBIS ). Sixty-six children (aged from 4 to 14 years) were prospectively randomized into one of the four groups. In the TIVA0 group, the anesthesiologist was blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias, and imprecision were calculated. The propofol consumption was similar in the four groups. During the maintenance phase, the percentage of time spent in the targeted BIS range was significantly lower in the TIVA0 group compared to the three other groups (TIVA0 : 31% ± 22, TIVABIS : 59% ± 17, TCI KBIS : 53% ± 12, TCI SBIS : 56% ± 17). The bias was not statistically different between the four groups, but the imprecision was larger for the TIVA0 group. Compared to the Kataria model, the Schnider model was associated with shorter time delay to reach the desired BIS, to eyes opening, and to tracheal extubation. Propofol administration using manual infusion guided by clinical signs was associated with higher risks of over- or underdosage when compared to BIS-guided administrations. When propofol infusion was guided by the BIS, no major difference was found between TIVA and TCI (either with the Kataria or the Schnider model). This study highlights the need of a pharmacodynamic feedback during propofol anesthesia in children. © 2016 John Wiley & Sons Ltd.

  10. Comparative study of random and oriented antibody immobilization techniques on the binding capacity of immunosensor.

    PubMed

    Kausaite-Minkstimiene, A; Ramanaviciene, A; Kirlyte, J; Ramanavicius, A

    2010-08-01

    A comparative study of four different antibody immobilization techniques that are suitable for modification of surface plasmon resonance (SPR) chip (SPR-chip) is reported. Antibodies against human growth hormone (anti-HGH) were used as the model system. The evaluated SPR-chip modification techniques were (i) random immobilization of intact anti-HGH (intact-anti-HGH) via self-assembled monolayer (SAM) based on 11-mercaptoundecanoic acid (MUA); (ii) random immobilization of intact-anti-HGH within carboxymethyl dextran (CMD) hydrogel by direct covalent amine coupling technique; (iii) oriented coupling of intact-anti-HGH via Fc-fragment to protein-G layer assembled on SAM consisting of MUA (MUA/pG); (iv) oriented immobilization of fragmented anti-HGH antibodies (frag-anti-HGH) via their native thiol-groups directly coupled to the gold. To liberate these thiol groups, the intact-anti-HGH was chemically "divided" into two frag-anti-HGH fragments by chemical reduction with 2-mercaptoethylamine (2-MEA). Optimal concentration of 2-MEA for preparation of anti-HGH was 15 mM. The surface concentration of immobilized antibodies and the antigen binding capacity for all four differently modified SPR-chips was evaluated and compared. The maximum surface concentration of immobilized intact-anti-HGH was obtained by immobilizing the antibody within CMD-hydrogel. The maximal antigen binding capacity was obtained by SPR-chip based on intact-anti-HGH immobilized via MUA/pG. The immobilization based on application of frag-anti-HGH was found to be the most suitable for design of SPR-immunosensor for HGH detection, due to its sufficient antigen binding capacity, simplicity, and low cost in respect to the currently evaluated techniques.

  11. Glenoumeral dislocation: a prospective randomized study comparing spazo and kocher maneuvers

    PubMed Central

    Rezende, Bruno da Rocha Moreira; de Almeida, José Inácio; de Sousa, Uriel Jaime; Bomfim, Leônidas de Souza; Ferreira, Mário Soares

    2015-01-01

    OBJECTIVE: To evaluate and to compare the Spaso and Kocher reduction maneuvers in terms of efficiency, time of reduction, facileness, pain, discomfort to the patient, complications and risks, besides promoting the comparison between the two maneuvers, aiming to ground the emergency conduct. METHODS: A prospective study with 105 patients with acute shoulder dislocations were enrolled in the study between February 2011 and September 2012. The patients were randomized into two groups and they were submitted to the reduction of dislocation using the Spaso maneuver (group A) or the Kocher technique (group B) by first, second or third-year orthopedic surgery residents from our service. The results were evaluated and compared. RESULTS: There was no statistically significant difference between the two groups in terms of age, gender, timing of reduction, number of precedent episodes and complications after reduction. However, reduction was achieved in more cases using the Spaso method than it was among the Kocher group, as well as the mean duration of the reduction maneuver and discomfort were shorter in the group A patients. CONCLUSIONS: Both methods presented good results in terms of dislocation reduction and low complications rates. Nevertheless, the Spaso maneuver was more efficient, fast and easily applicable in comparison with Kocher's method. Level of Evidence I, Therapeutic. PMID:26327800

  12. Greater occipital nerve block in the treatment of triptan-overuse headache: A randomized comparative study.

    PubMed

    Karadaş, Ö; Özön, A Ö; Özçelik, F; Özge, A

    2017-04-01

    This study aims to investigate the efficiency of a single and repeated greater occipital nerve (GON) block using lidocaine in the treatment of triptan-overuse headache (TOH), whose importance has increased lately. In the study, 105 consecutive subjects diagnosed with TOH were evaluated. The subjects were randomized into three groups. In Group 1 (n=35), only triptan was abruptly withdrawn. In Group 2 (n=35), triptan was abruptly withdrawn and single GON block was performed. In Group 3 (n=35), triptan was abruptly withdrawn and three-stage GON block was performed. All patients were injected bilaterally with a total amount of 5 cc 1% lidocaine in each stage. During follow-up, the number of headache days per month, the severity of pain (VAS), the number of triptans used, and hsCRP and IL-6 levels were recorded three times; in the pretreatment period, in the second month post-treatment, and in the fourth month post-treatment. They were then compared. There was a statistically significant difference in the post-treatment fourth month in comparison with the pretreatment period in Group 3 (P<.05). Compared to Group 1, the number of headache days, VAS, and decrease in triptan need in Group 3 was statistically significant compared to Group 2 (P<.05). Compared to pretreatment, in the fourth month post-treatment, both hsCRP and IL-6 levels were lower only in Group 3 (P<.05). We are of the opinion that repeated GON block in addition to the discontinuation of medication has significant efficacy for TOH cases. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    PubMed

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

    2016-05-01

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

  14. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant.

    PubMed

    Apter, Dan; Briggs, Paula; Tuppurainen, Marjo; Grunert, Julia; Lukkari-Lax, Eeva; Rybowski, Sarah; Gemzell-Danielsson, Kristina

    2016-07-01

    To compare the levonorgestrel intrauterine system (LNG-IUS 8), which has an average levonorgestrel release rate of ∼8 μg/24 hours during the first year (total levonorgestrel content 13.5 mg; Jaydess/Skyla), with the etonogestrel (ENG) subdermal implant (total content, 68 mg) with regard to the 12-month discontinuation rate (primary outcome). Randomized, open-label, phase III study. Thirty-eight centers in six European countries. Study population of 766 healthy nulliparous and parous women aged 18-35 years. The LNG-IUS 8 or the ENG implant. Discontinuation rate, by treatment group, at Month 12. The 12-month discontinuation rates were 19.6% and 26.8% in the LNG-IUS 8 and ENG implant groups, respectively. The -7.2% difference was statistically significant (95% confidence interval -13.2%, -1.2%). Fewer women in the LNG-IUS 8 group than in the ENG implant group discontinued because of increased bleeding (3.2% vs. 11.3%) or adverse events (14.3% vs. 21.8%). At 12 months, more women in the LNG-IUS 8 group than in the ENG implant group were "very/somewhat satisfied" with their bleeding pattern (60.9% vs. 33.6%) and reported a preference to use their study treatment after study completion (70.1% vs. 58.5%). The LNG-IUS 8 was associated with a significantly lower 12-month discontinuation rate compared with the ENG implant; mainly because ENG implant users frequently discontinued due to increased bleeding. More LNG-IUS 8 users than ENG implant users reported being "very/somewhat satisfied" with their bleeding pattern, and reported a preference to continue using their study treatment after the study. NCT01397097. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  15. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study.

    PubMed

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution.

  16. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    PubMed Central

    Vachiramon, Vasanop; Anusaksathien, Pattarin; Kanokrungsee, Silada; Chanprapaph, Kumutnart

    2016-01-01

    Objective. Keratosis pilaris (KP) is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2) laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians' global assessment (p = 0.02). Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution. PMID:27247936

  17. The treatment of Staphyloccocus aureus infected sore nipples: a randomized comparative study.

    PubMed

    Livingstone, V; Stringer, L J

    1999-09-01

    Sore, cracked nipples are commonly experienced by breastfeeding mothers. We have previously reported a strong correlation between sore, cracked nipples and S. aureus colonization. A prospective, randomized clinical trial was performed to compare four treatment regimes for S. aureus infected sore nipples. Eighty-four breastfeeding mothers were enrolled in the study. After 5 days to 7 days of treatment, only 8% of mothers showed improvement in the "optimal breastfeeding technique alone" group, 16% improved with topical mupiricin, 29% improved with topical fusidic acid, yet 79% improved with oral antibiotics (p < .0001). Optimal breastfeeding techniques and topical antibiotics ointment failed to heal most infected, sore, cracked nipples. Mastitis developed in 12% to 35% of mothers not treated with systemic antibiotics compared to 5% of mothers treated with systemic antibiotics (p < .005). In conclusion, S. aureus infected sore, cracked nipples should be diagnosed as a potentially widespread impetigo vulgaris and treated aggressively with systemic antibiotics in order to improve healing and decrease the risk of developing mastitis due to an ascending lactiferous duct bacterial infection.

  18. Double-blind prospective randomized study comparing polyethylene glycol to lactulose for bowel preparation in colonoscopy.

    PubMed

    Menacho, Aline Moraes; Reimann, Adriano; Hirata, Lie Mara; Ganzerella, Caroline; Ivano, Flavio Heuta; Sugisawa, Ricardo

    2014-01-01

    Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation.

  19. DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY COMPARING POLYETHYLENE GLYCOL TO LACTULOSE FOR BOWEL PREPARATION IN COLONOSCOPY

    PubMed Central

    MENACHO, Aline Moraes; REIMANN, Adriano; HIRATA, Lie Mara; GANZERELLA, Caroline; IVANO, Flavio Heuta; SUGISAWA, Ricardo

    2014-01-01

    Background Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. PMID:24676290

  20. An open, randomized, comparative study of oral finasteride and 5% topical minoxidil in male androgenetic alopecia.

    PubMed

    Arca, Ercan; Açikgöz, Gürol; Taştan, Halis Bülent; Köse, Osman; Kurumlu, Zafer

    2004-01-01

    Androgenetic alopecia (AGA) is undoubtedly the most common form of hair loss in males. It is a condition which may cause cosmetic and psychosocial problems in androgen-dependent cases. In this open, randomized and comparative study we evaluated the efficacy of oral finasteride and 5% topical minoxidil treatment for 12 months in 65 male patients with mild to severe AGA. We randomly assigned 40 (61.53%) patients to receive 1 mg/day oral finasteride for 12 months, and 25 (38.47%) patients applied 5% topical minoxidil solution twice daily for 12 months. There were no significant differences between the 2 groups considering age, age of onset of hair loss, family history and type of hair loss (p > 0.05). In the clinical evaluation at the endpoint of treatment, the clinical cure rates (i.e. increased intensity of hair) were 80% (32/40) for the oral finasteride group and 52% (13/25) for the 5% topical minoxidil group. Encountered side effects were all mild, and there was no need to stop the treatment. In the group given oral finasteride, side effects were noted in 7 patients: 6 patients suffered from loss of libido, and 1 patient had an increase in other body hairs; irritation of the scalp was seen in 1 patient in the group administered 5% minoxidil. These adverse events disappeared as soon as the treatment was stopped. The laboratory data on both drug groups did not show any statistically or clinically significant intragroup changes from baseline values to the endpoint (p > 0.05), except the level of serum total testosterone which was increased, and free testosterone and serum prostate-specific antigen in the finasteride group which were statistically decreased from baseline values to the endpoint (p < 0.05). In this comparative study of systemic finasteride and topical minoxidil, it was concluded that both drugs were effective and safe in the treatment of mild to severe AGA, although oral finasteride treatment was more effective (p < 0.05). Adverse events were not

  1. Randomized comparative efficacy study of parent-mediated interventions for toddlers with autism.

    PubMed

    Kasari, Connie; Gulsrud, Amanda; Paparella, Tanya; Hellemann, Gerhard; Berry, Kathleen

    2015-06-01

    This study compared effects of two parent-mediated interventions on joint engagement outcomes as augmentations of an early intervention program for toddlers with autism spectrum disorder (ASD). Participants included 86 toddlers (range 22-36 months) with ASD and their primary caregiver. Caregiver-child dyads were randomized to receive 10 weeks of hands-on parent training in a naturalistic, developmental behavioral intervention (joint attention, symbolic play, engagement and regulation-JASPER) or a parent-only psychoeducational intervention (PEI). Dose was controlled in terms of researcher-parent contact and early intervention services received by the child. Results yielded significant effects of the JASPER intervention on the primary outcome of joint engagement. The treatment effect was large (Cohen's f² = .69) and maintained over the 6-month follow-up. JASPER effects were also found on secondary outcomes of play diversity, highest play level achieved, and generalization to the child's classroom for child-initiated joint engagement. The PEI intervention was found to be effective in reducing parenting stress associated with child characteristics. All secondary effects were generally small to moderate. These data highlight the benefit of a brief, targeted, parent-mediated intervention on child outcomes. Future studies may consider the combination of JASPER and PEI treatments for optimal parent and child outcomes. Trial registry no. NCT00999778. (c) 2015 APA, all rights reserved).

  2. A randomized cross-over study comparing cabergoline and quinagolide in the treatment of hyperprolactinemic patients.

    PubMed

    De Luis, D A; Becerra, A; Lahera, M; Botella, J I; Valero; Varela, C

    2000-01-01

    Quinagolide (QUI) and cabergoline (CAB) are dopamine agonists recently introduced for the treatment of hyperprolactinemia. In the present study, these drugs have been compared in terms of effectiveness and tolerability. Twenty patients (18 females and 2 males) with hyperprolactinemia (8 with microprolactinomas, 6 with idiopathic hyperprolactinemia and 6 with empty sella turcica syndrome) were treated with oral QUI (75 microg once daily) and CAB (0,5 mg twice weekly), in a randomized cross-over trial with placebo between both drugs. Each drug was administered for 12 weeks, separated by other 12 weeks with placebo. PRL levels decreased with both drugs at 2 or 4 weeks of starting the treatment, without differences between both drugs at weeks 4, 8 and 12. At week 12, normal PRL levels (<20 ng/ml) were attained in 90% patients with CAB and only in 75% patients with QUI (p<0.05). After discontinuation of treatment, significant increase in serum PRL was higher after QUI withdrawal than after CAB. Clinical efficacy of both treatments was similar in terms of improvement amenorrhea, oligomenorrhea, galactorrhea, and impotence. All patients completed both cycles of treatment, and the most frequent side-effects were nausea, headache and dizziness, without significant differences between CAB (30%) and QUI (55%). Our study indicates that, at the doses employed here, CAB showed a high percentage of patients with normal PRL at the end of treatment and long-lasting efficacy in the levels of PRL. Clinical response and side-effects were similar in both drugs.

  3. Randomized controlled trial comparing lecture versus self studying by an online tool.

    PubMed

    Peroz, Ingrid; Beuche, Andrea; Peroz, Nazir

    2009-06-01

    Since 2001, an e-learning tool has been developed for dentistry. To compare online self study with traditional lectures, a module about instrumental occlusal analysis was offered by oral lecture and by a unit in the virtual library of the e-learning tool. 85 pre-clinical dental students were randomly divided into two groups: the computer assisted learning (CAL) group (n = 48) and the lecture group (n = 37). A pre-test was made to assess the students' basic knowledge. The first post-test and the scoring of the teaching methods were performed immediately after the lecture or the self studying by the online tool and a second post-test six weeks later. The oral lecture got better educational and enjoyment values. The students prefer CAL in addition to traditional lectures. The results of the pre-tests were not different between the two groups (p = 0.706). The lecture group significantly improved their scores in the first post-test (p = 0.011), but the scores of the second post-test did not differ significantly (p = 0.157). In the short term, knowledge acquisition seems to be better in oral lectures but in the long term there is no difference in knowledge retention between the two learning scenarios.

  4. A prospective randomized study in 20 patients undergoing bilateral TKA comparing midline incision to anterolateral incision.

    PubMed

    Maniar, Rajesh N; Singhi, Tushar; Nanivadekar, Arun; Maniar, Parul R; Singh, Jaivardhan

    2017-02-11

    Lateral flap numbness is a known side-effect of midline skin incision in total knee arthroplasty (TKA) and a cause of patient dissatisfaction. Anterolateral incision is an alternative approach which preserves the infrapatellar branches of the saphenous nerve and avoids numbness. Studies have compared both incisions, but in different patients. However, different patients may assess the same sensory deficit dissimilarly, because of individual variations in anatomy and healing responses. We compared the two incisions in the same patient at the same time, using an anterolateral incision on one knee and a midline incision on the other knee in simultaneous bilateral TKA. Other surgical steps including medial arthrotomy were idential. We also correlated subjective and objective findings. Twenty patients were prospectively randomized. Sensory loss and skin healing were assessed at 6, 12 and 52 weeks. Subjective preference for the knee with less numbness was charted on Wald's Sequential Probability Ratio Test. Sensation scores for touch, vibration, static and moving two-point discrimination were measured. Scar healing was evaluated using the Patient and Observer Scar Assessment Scale (POSAS). Functional scores were measured. A statistically significant difference favoring knees with anterolateral incision was observed in patient preference at all assessment points and this correlated with sensation scores. A statistically significant difference was observed in POSAS score favoring knees with anterolateral incision at 6 and 12 weeks which became statistically insignificant at 1 year. Functional scores remained comparable. We recommend anterolateral incision as a safe and effective method to circumvent the problem of lateral flap numbness with midline incision. I.

  5. Comparative Evaluation of Gingival Depigmentation by Tetrafluroethane Cryosurgery and Surgical Scalpel Technique. A Randomized Clinical Study.

    PubMed

    Narayankar, Suraj D; Deshpande, Neeraj C; Dave, Deepak H; Thakkar, Dhaval J

    2017-01-01

    Importance of good smile cannot be underestimated in enhancement of beauty, self-confidence and personality of a person. Health and appearance of gingiva is an essential part of attractive smile. Gingival pigmentation gives rise to unesthetic smile line. In present world, with increasing awareness to esthetic, people have become highly concerned about black gums. Various treatment modalities like abrasion, scrapping, scalpel technique, cryosurgery, electrosurgery and laser are available for treatment of gingival pigmentation. The present study was conducted with an objective of comparing efficacy of gingival depigmentation by cryosurgery and scalpel technique. A Randomized control split mouth study was conducted for 25 patients with gingival pigmentation. Gingival pigmentation Index (GPI) for pigmentation and Visual Analoug Scale (VAS) for pain was evaluated for both test (Cryosurgery) and control sites (Scalpel technique) at baseline, 1month, 3months and 6 months. GPI score was 3 and 2 for 21/25 and 4/25 control sites and was 22/25 and 3/25 test sites respectively at baseline. Both the groups showed significant reduction in GPI score i.e., 0 at 1 and 3 months interval after treatment. GPI score increased to 1 for 5/25 sites treated with scalpel technique and 2/25 sites treated with cryosurgery at 6 months interval (P =0.0691). This indicates recurrence rate for pigmentation is higher after scalpel treatment. VAS Score was 3 for 10/25 sites treated with scalpel and was 2 for 12/25 sites treated with cryosurgery (P <0.001). It can be concluded that cryosurgery can be effectively and efficiently used for depigmentation by keeping patients acceptance and comfort in mind and also the long term results and ease of use when compared to scalpel technique.

  6. Is topical zinc effective in the treatment of melasma? A double-blind randomized comparative study.

    PubMed

    Yousefi, Alireza; Khani Khoozani, Zahra; Zakerzadeh Forooshani, Saeed; Omrani, Nooshin; Moini, Amir Mansoor; Eskandari, Yasaman

    2014-01-01

    Zinc plays a role in skin health, and preliminary data have shown its beneficial effects for melasma. We compared the effect of topical zinc with that of hydroquinone as the standard treatment on severity of melasma. Ninety-three women with melasma were randomized to receive zinc sulfate 10% or hydroquinone 4% solutions once daily for 2 months. They were followed for an additional 3 months while using sunscreen. The severity of melasma was assessed at baseline and at 2 and 5 months using the Melasma Area and Severity Index (MASI). Eighty-two patients completed the study. The MASI score fell significantly in both groups, but a greater decrease was seen in those who received hydroquinone (43.5 ± 15.5% vs 18.6 ± 20.8%, p < .001). Postinflammatory pigmentation occurred in 5.2% of the zinc group and irritation in 30.9% of the hydroquinone group. Topical zinc therapy is not highly effective in reducing the severity of melasma, but further trials are needed to determine whether adding zinc to current topical treatments could improve treatment response. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  7. A Prospective Randomized Study Comparing Disposable with Reusable Blades for a Morcellator Device.

    PubMed

    Becker, Benedikt; Orywal, Ann Katrin; Hausmann, Teresa; Gross, Andreas J; Netsch, Christopher

    2017-03-01

    Transurethral enucleation of the prostate for the management of benign prostatic obstruction (BPO) involves two steps: the enucleation and morcellation procedure. The aim of our study was to assess the efficacy of a morcellator device using disposable and reusable blades with different settings of morcellation speed. A prospective randomized study was initiated for patients with symptomatic BPO undergoing Thulium laser enucleation of the prostate. Mechanical tissue morcellation was performed using the Piranha™ morcellator (R. Wolf, Knittlingen, Germany) with disposable or reusable blades at 850 (n = 24) or 1500 revolutions per minute (rpm) (n = 24). Patient characteristics, intraoperative complications, and the morcellation rate (g/min) were recorded. Data are expressed as median and interquartile range (IQR). Forty-eight patients were randomized using disposable (n = 24) or reusable blades (n = 24). For reusable blades, the morcellation rate did not increase when changing the morcellation speed from 850 to 1500 rpm (5 vs 4.53 g/min, p = 0.843). The morcellation rate increased significantly when changing the morcellation speed from 850 to 1500 rpm using single-use blades (4.77 vs 10 g/min, p ≤ 0.014). The morcellation rate was not different at 850 rpm between reusable and single-use blades (5 vs 4.77 g/min, p = 0.671). Conversely, the morcellation rate was significantly different at 1500 rpm between reusable and single-use blades (4.53 vs 10 g/min, p ≤ 0.017). The total morcellation rate (at 850 and 1500 rpm) was significantly increased using single-use blades compared to reusable blades (7.67 vs 4.8 g/min, p ≤ 0.026). Interestingly, enucleated weight (g) and the morcellation rate (g/min) correlated inversely using single-use blades at 1500 rpm (r = -0.742, p ≤ 0.004). Only one superficial bladder injury occurred at 1500 rpm, which needed no further interventions. The Piranha morcellator

  8. Prospective, randomized comparative study between single-port laparoscopic appendectomy and conventional laparoscopic appendectomy.

    PubMed

    Villalobos Mori, Rafael; Escoll Rufino, Jordi; Herrerías González, Fernando; Mias Carballal, M Carmen; Escartin Arias, Alfredo; Olsina Kissler, Jorge Juan

    2014-01-01

    Laparoscopic appendectomy is probably the technique of choice in acute appendicitis. Single port laparoscopic surgery (SILS) has been proposed as an alternative technique. The objective of this study is to compare the safety and efficacy of SILS against conventional laparoscopic appendectomy (LA). From January 2011 to September 2012, 120 patients with acute appendicitis were prospectively randomized; 60 for SILS and 60 for LA. Patients between 15 to 65 years were selected, with onset of symptoms less than 48h. We compared BMI, surgery time, start of oral intake, hospital stay, postoperative pain, pathology and costs. The median age, BMI, sex and time of onset of symptoms to diagnosis were similar. There were no statistically significant differences in the operative time, start of oral intake or hospital stay. There was a significant difference in postoperative pain being higher in SILS (4±1.3) than in LA (3.3±0.5) with a P=.004. Flemonous appendicitis predominated in both groups in a similar percentage. A total of 3 cases with intra-abdominal abscess (SILS 2, LA 1) required readmission and resolved spontaneously with intravenous antibiotic treatment. One case of SILS required assistance by a 5mm trocar in the RLC for drainage placement. The cost was higher in SILS due the single port device. SILS appendectomy is safe, effective and has similar results to LA in selected patients, and although the cost is greater, the long term results will determine the future of this technique. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

  9. A prospective randomized study comparing centrifugation and sedimentation for fat grafting in breast reconstruction.

    PubMed

    Sarfati, I; van la Parra, R F D; Terem-Rapoport, C A; Benyahi, D; Nos, C; Clough, K B

    2017-09-01

    Fat grafting is an efficient method to correct large volumetric defects after mastectomy. There is an ongoing debate regarding the best method of processing the harvested fat before fat grafting. This study aimed to introduce a new MRI model and to compare two fat processing techniques measuring the gain in soft tissue thickness after fat grafting to the chest wall. Fifty-one mastectomy patients (one double sided), who required delayed implant reconstruction, with poor skin conditions were proposed fat grafting prior to implant reconstruction. At the time of fat grafting, patients were randomly assigned to centrifugation or sedimentation of the aspirated fat. The trial was undertaken in a single-center private practice setting. The gain in soft tissue thickness of the chest wall was measured using an MRI model, with 12 predefined points for measurement. Two MRIs were performed, one prior to fat grafting and one 8 weeks thereafter. The radiologist was blinded to the fat graft processing method used. Seven cases were excluded because they did not complete their second MRI. The analyses were thus based on 44 patients (one double sided). Centrifugation was performed in 21 cases and sedimentation in 24 cases. The mean gain in soft tissue thickness was +7.0 mm in the centrifugation group and +8.8 mm in the sedimentation group (p = .268). The mean operative time was 88 min in the centrifugation group and 78 min in the sedimentation group (p = .11). There were no adverse events for any of the patients. We developed a simple and reproducible MRI model to objectively measure and evaluate different fat processing techniques prior to fat grafting. At a median time of 8 weeks after one session of fat grafting, there was no benefit of centrifugation over sedimentation. Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  10. Transperitoneal versus extraperitoneal robot-assisted laparoscopic radical prostatectomy: A prospective single surgeon randomized comparative study.

    PubMed

    Akand, Murat; Erdogru, Tibet; Avci, Egemen; Ates, Mutlu

    2015-10-01

    To compare operative, pathological, and functional results of transperitoneal and extraperitoneal robot-assisted laparoscopic radical prostatectomy carried out by a single surgeon. After having experience with 32 transperitoneal laparoscopic radical prostatectomies, 317 extraperitoneal laparoscopic radical prostatectomies, 30 transperitoneal robot-assisted laparoscopic radical prostatectomies and 10 extraperitoneal robot-assisted laparoscopic radical prostatectomies, 120 patients with prostate cancer were enrolled in this prospective randomized study and underwent either transperitoneal or extraperitoneal robot-assisted laparoscopic radical prostatectomy. The main outcome parameters between the two study groups were compared. No significant difference was found for age, body mass index, preoperative prostate-specific antigen, clinical and pathological stage, Gleason score on biopsy and prostatectomy specimen, tumor volume, positive surgical margin, and lymph node status. Transperitoneal robot-assisted laparoscopic radical prostatectomy had shorter trocar insertion time (16.0 vs 25.9 min for transperitoneal robot-assisted laparoscopic radical prostatectomy and extraperitoneal robot-assisted laparoscopic radical prostatectomy, P < 0.001), whereas extraperitoneal robot-assisted laparoscopic radical prostatectomy had shorter console time (101.5 vs 118.3 min, respectively, P < 0.001). Total operation time and total anesthesia time were found to be shorter in extraperitoneal robot-assisted laparoscopic radical prostatectomy, without statistical significance (200.9 vs 193.2 min; 221.8 vs 213.3 min, respectively). Estimated blood loss was found to be lower for extraperitoneal robot-assisted laparoscopic radical prostatectomy (P = 0.001). Catheterization and hospitalization times were observed to be shorter in extraperitoneal robot-assisted laparoscopic radical prostatectomy (7.3 vs 5.8 days and 3.1 vs 2.3 days for transperitoneal robot-assisted laparoscopic

  11. [Preliminary results of DERMATEL: prospective randomized study comparing synchronous and asynchronous modalities of teledermatology].

    PubMed

    Romero, G; García, M; Vera, E; Martínez, C; Cortina, P; Sánchez, P; Guerra, A

    2006-12-01

    There is considerable variability in the results of studies that evaluate diagnostic reliability in teledermatology. There are only two studies that compare the synchronous and asynchronous modalities of teleconsult in the same sample. We present the results of the pilot project DERMATEL, a study of diagnostic concordance that aims to increase the evidence of these aspects. One-hundred-fifty.nine patients referred by the general practitioner in the first consult were randomized (algorithm 3:2:1) in three arms: asyncronous teledermatology (store-and-forward or SAF), synchronous teldermatology (real-time or VTC), and conventional consult (CC). We used high-quality, fixed digital images in all cases. The patients on the VTC teledermatology arm were also evaluated by videoconference. Finally all patients attended a face-to-face consult, considered the gold standard of patient care. A second dermatologist evaluated the diagnostic and management concordance between the teleconsults and the face-to-face consults. One-hundred.forty-seven patients completed the study as follows: 74 in the SAF teledermatology arm, 47 in the VTC teledermatology arm and 26 in the conventional consult (control group). The teledermatological (SAF and VTC) and face-to-face evaluations were identical in 100 of 121 patients (82.6%). The errors were mild in 14 cases (11.6%) and severe in 7 (5.8%). The diagnostic concordance was very high (kappa=0,813). The errors grouped by diseases were as follows: 6/54 (11%) for tumors, 10/30 (33.3%) for inflammatory conditions, 1/20 (5%) for infectious diseases, 3/12 (25%) for alopecia/acne and 1/5 (20%) for others. There were 15 errors in the SAF teledermatology arm (20.3%) and 6 in the VTC teledermatology arm (12.8%); these differences were not statistically significant (chi2 1.12; p=0.288). The reliability of dermatological teleconsult is very high, especially for tumoral or infectious diseases. The synchronous interaction with audio requires more resources

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

    PubMed Central

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

    2017-01-01

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

  13. A comparative study of continuous versus pulsed radiofrequency discectomy for management of low backache: Prospective randomized, double-blind study

    PubMed Central

    Jena, Bhagya Ranjan; Paswan, Anil; Singh, Yashpal; Loha, Sandeep; Singh, Anil Prasad; Rastogi, Virendra

    2016-01-01

    Background: Radiofrequency (RF) is a minimally invasive target-selective technique that has been used with success for many years in the treatment of different pathologies, such as low back pain, trigeminal neuralgia, and others. Aim: The aim of this study is to compare different mode of RF - continuous RF (CRF) versus pulsed RF (PRF) along with steroid in the management of low back pain of discogenic origin. Setting and Design: Prospective, randomized, double-blind trial. Materials and Methods: Forty patients with chronic discogenic low back pain were randomized to receive CRF plus intradiscal triamcinolone 40 mg (Group 1) or to receive PRF plus intradiscal triamcinolone 40 mg (Group 2). Outcome measured includes immediate as well as long-term pain relief using visual analog scale, the Oswestry Disability Index and straight leg raising test. Statistical Analysis: The continuous variables were compared by one-way analysis of variance test. Discrete variables were compared by Fisher's exact test/Chi-square test/Student's t-test, whichever appropriate. The value of P < 0.05 was considered statistically significant. Results: There was a significant decrease in pain score after CRF without any added side effect. Pain relief after PRF was insignificant. Conclusion: CRF with steroid seems to be better for treatment of chronic discogenic low back pain than PRF with steroid. PMID:27746559

  14. Immediate loading of mandibular dental implants in partially edentulous patients: a prospective randomized comparative study.

    PubMed

    Margossian, Patrice; Mariani, Paul; Stephan, Grégory; Margerit, Jacques; Jorgensen, Christian

    2012-04-01

    While immediate loading in the edentulous mandible is a well-documented procedure, there are limited scientific data on immediate loading in the partially edentulous mandible. Two-year success rates of immediate loading and conventional delayed loading of dental implants in partially dentate mandibles were compared. Patients were randomized into three groups: group A (n = 40), immediate provisionalization with nonocclusal loading; group B (n = 40), immediate provisionalization with occlusal loading; and group C (n = 37), delayed loading with single-stage surgery. Baseline and 2-year measurements included implant stability quotient, insertion torque, and peri-implant bone crest radiography. Two hundred nine implants were immediately loaded in 80 patients. The 2-year success rates were 93.3% for group B and 100% for groups A and C. Immediate provisionalization provided success rates similar to those for delayed loading only when not loaded in occlusion.

  15. Randomized controlled trial versus comparative cohort study in verifying the therapeutic role of lymphadenectomy in endometrial cancer.

    PubMed

    Todo, Yukiharu; Sakuragi, Noriaki

    2013-04-01

    A consensus regarding the therapeutic role of lymphadenectomy in endometrial cancer has not been reached because of conflicting negative results of randomized controlled trials and positive results of a cohort study. Since the effects of new treatments tend to be overestimated in observational studies, positive results of an observational study should be validated by a future trial. However, special difficulties are presented in randomized controlled trials in surgery. External validity is important for guaranteeing the reliability of a result of the trial. Physicians' recruitment of eligible patients into a trial depends on the confidence of those physicians for a surgical procedure, workplace environment and feelings of personal responsibility relevant to patients' risk of recurrence. When two surgical procedures are compared in a randomized controlled trial, technical quality control may be reduced in the complicated surgery group due to experienced surgeons' non-participation. It is highly possible that the recruitment issue is a threat to external validity. Therefore, a randomized controlled trial may not be the best format for demonstrating the full benefits of complicated surgery. Multiple studies have demonstrated that the results of well-designed observational studies can be reliable and are comparable with those of randomized controlled trials. Journal editors and funding sources are requested to become more generous with observational studies, especially prospective cohort studies.

  16. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study

    PubMed Central

    Hanling, Steven; Bicket, Mark C; White, Ronald L; Veizi, Elias; Kurihara, Connie; Zhao, Zirong; Hayek, Salim; Guthmiller, Kevin B; Griffith, Scott R; Gordin, Vitaly; White, Mirinda Anderson; Vorobeychik, Yakov; Pasquina, Paul F

    2015-01-01

    Objective To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. Design A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. Settings Eight military, Veterans Administration, and civilian hospitals. Participants 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. Interventions Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. Main outcome measures Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. Results There were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline −2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and −1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval −0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline −2.0 (SD 2.6) versus 3.7 (SD 2.8) and −1.6 (SD 2.7), respectively; adjusted difference 0.3, −0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (−3.0, SD 2.8) than those treated with gabapentin (−2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three

  17. A Prospective Randomized Study Comparing the Interference Screw and Suture Anchor Techniques for Biceps Tenodesis.

    PubMed

    Park, Ji Soon; Kim, Sae Hoon; Jung, Ho Jin; Lee, Ye Hyun; Oh, Joo Han

    2017-02-01

    Several methods are used to perform biceps tenodesis in patients with superior labrum-biceps complex (SLBC) lesions accompanied by a rotator cuff tear. However, limited clinical data are available regarding the best technique in terms of clinical and anatomic outcomes. To compare the clinical and anatomic outcomes of the interference screw (IS) and suture anchor (SA) fixation techniques for biceps tenodesis performed along with arthroscopic rotator cuff repair. Randomized controlled trial; Level of evidence, 2. A total of 80 patients who underwent arthroscopic rotator cuff repair with SLBC lesions were prospectively enrolled and randomly divided according to the tenodesis method: the IS and SA groups. Functional outcomes were evaluated with the visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), Constant score, Korean Shoulder Score (KSS), and long head of the biceps (LHB) score at least 2 years after surgery. The anatomic status of tenodesis was estimated using magnetic resonance imaging or ultrasonography, and the anatomic failure of tenodesis was determined when the biceps tendon was not traced in the intertubercular groove directly from the insertion site of the IS or SA. Thirty-three patients in the IS group and 34 in the SA group were monitored for more than 2 years. All postoperative functional scores improved significantly compared with the preoperative scores (all P < .001) and were not significantly different between the groups, including the LHB score (all P > .05). Nine anatomic failures of tenodesis were observed: 7 in the IS group and 2 in the SA group ( P = .083). In a multivariate analysis using logistic regression, IS fixation ( P = .003) and a higher (ie, more physically demanding) work level ( P = .022) were factors associated with the anatomic failure of tenodesis significantly. In patients with tenodesis failure, the LHB score ( P = .049) and the degree of Popeye deformity by the

  18. Comparative, prospective, and randomized study between urotherapy and the pharmacological treatment of children with urinary incontinence

    PubMed Central

    Campos, Renata Martins; Gugliotta, Antonio; Ikari, Osamu; Perissinoto, Maria Carolina; Lúcio, Adélia Correia; Miyaoka, Ricardo; D'Ancona, Carlos Arturo Levi

    2013-01-01

    ABSTRACT Objective: To verify and compare the results of behavioral modification plus pelvic floor muscle training and behavioral modifications plus oxybutynin chloride in children with nonmonosymptomatic enuresis. Methods: A total of 47 children were randomized using opaque and sealed envelopes sequentially numbered. Group I was composed of 21 children who underwent antimuscarinic treatment (oxybutynin), and Group II was composed of 26 patients who underwent pelvic floor muscle training. Both groups were instructed as to behavioral modifications. Results: The voiding diary results were compared each month between Groups I and II. In the first month of treatment, children in Group I presented 12.2 dry nights, 13.4 in the second month, and 15.9 in the last month. In Group II, the results were: 14.9 dry nights in the first month, 20.8 dry nights in the second and 24.0 dry nights in the last month. There was a significant difference between the groups in second and third months. Conclusion: Pelvic floor exercises associated with behavioral changes were more effective than pharmacological treatment in children with urinary incontinence. PMID:23843062

  19. Randomized clinical study comparing metallic and glass fiber post in restoration of endodontically treated teeth.

    PubMed

    Gbadebo, Olaide S; Ajayi, Deborah M; Oyekunle, Oyekunle O Dosumu; Shaba, Peter O

    2014-01-01

    Post-retained crowns are indicated for endodontically treated teeth (ETT) with severely damaged coronal tissue. Metallic custom and prefabricated posts have been used over the years, however, due to unacceptable color, extreme rigidity and corrosion, fiber posts, which are flexible, aesthetically pleasing and have modulus of elasticity comparable with dentin were introduced. To compare clinical performance of metallic and glass fiber posts in restoration of ETT. 40 ETT requiring post retained restorations were included. These teeth were randomly allocated into 2 groups. Twenty teeth were restored using a glass fiber-reinforced post (FRP) and 20 others received stainless steel parapost (PP), each in combination with composite core buildups. Patients were observed at 1 and 6 months after post placement and cementation of porcelain fused to metal (PFM) crown. Marginal gap consideration, post retention, post fracture, root fracture, crown fracture, crown decementation and loss of restoration were part of the data recorded. All teeth were assessed clinically and radiographically. Fisher's exact test was used for categorical values while log-rank test was used for descriptive statistical analysis. One tooth in the PP group failed, secondary to decementation of the PFM crown giving a 2.5% overall failure while none in the FRP group failed. The survival rate of FRP was thus 100% while it was 97.5% in the PP group. This however was not statistically significant (log-rank test, P = 0.32). Glass FRPs performed better than the metallic post based on short-term clinical performance.

  20. Medical versus surgical abortion efficacy, complications and leave of absence compared in a partly randomized study.

    PubMed

    Rørbye, Christina; Nørgaard, Mogens; Nilas, Lisbeth

    2004-11-01

    To provide optimal information to women choosing between early medical and surgical abortion, rigorous comparisons of the two methods are warranted. We compared the outcome of 1135 consecutive women with gestational age (GA) < or = 63 days receiving either a medical (600 mg mifepristone and 1 mg gemeprost) or a surgical abortion (vacuum aspiration in general anesthesia). One hundred eleven of these women were randomized for abortion method. Surgical interventions and complications leading to readmission within the following 15 weeks were identified through a computer system. Information about antibiotic treatment, leave of absence and number of contacts to the health care system were obtained from mailed questionnaires. The number of complications was identical after the two methods, but surgical abortion was associated with a higher success rate [97.7% (708/725) vs. 94.1% (386/410), p < .01] and also with a higher risk of antibiotic treatment than medical abortion [7.8% (37/467) vs. 3.7% (13/356), p < .05]. The median leave of absence was shorter in women choosing a medical (1 day) than a surgical termination (2 days), p < .05. On average, one third of all the women requested at least one extra unscheduled consultation apart from a routine follow-up visit. We conclude that the chance of a primary successful termination at GA < or = 63 days is higher after a surgical abortion in general anesthesia compared to a medical abortion induced with 600 mg mifepristone and 1 mg gemeprost. A surgical abortion is associated with an increased risk of antibiotic treatment compared to medical abortion. The women's need for follow-up might be higher than we expect.

  1. A Randomized Study Comparing Parathyroidectomy with Cinacalcet for Treating Hypercalcemia in Kidney Allograft Recipients with Hyperparathyroidism.

    PubMed

    Cruzado, Josep M; Moreno, Pablo; Torregrosa, José V; Taco, Omar; Mast, Richard; Gómez-Vaquero, Carmen; Polo, Carolina; Revuelta, Ignacio; Francos, José; Torras, Joan; García-Barrasa, Arantxa; Bestard, Oriol; Grinyó, Josep M

    2016-08-01

    Tertiary hyperparathyroidism is a common cause of hypercalcemia after kidney transplant. We designed this 12-month, prospective, multicenter, open-label, randomized study to evaluate whether subtotal parathyroidectomy is more effective than cinacalcet for controlling hypercalcemia caused by persistent hyperparathyroidism after kidney transplant. Kidney allograft recipients with hypercalcemia and elevated intact parathyroid hormone (iPTH) concentration were eligible if they had received a transplant ≥6 months before the study and had an eGFR>30 ml/min per 1.73 m(2) The primary end point was the proportion of patients with normocalcemia at 12 months. Secondary end points were serum iPTH concentration, serum phosphate concentration, bone mineral density, vascular calcification, renal function, patient and graft survival, and economic cost. In total, 30 patients were randomized to receive cinacalcet (n=15) or subtotal parathyroidectomy (n=15). At 12 months, ten of 15 patients in the cinacalcet group and 15 of 15 patients in the parathyroidectomy group (P=0.04) achieved normocalcemia. Normalization of serum phosphate concentration occurred in almost all patients. Subtotal parathyroidectomy induced greater reduction of iPTH and associated with a significant increase in femoral neck bone mineral density; vascular calcification remained unchanged in both groups. The most frequent adverse events were digestive intolerance in the cinacalcet group and hypocalcemia in the parathyroidectomy group. Surgery would be more cost effective than cinacalcet if cinacalcet duration reached 14 months. All patients were alive with a functioning graft at the end of follow-up. In conclusion, subtotal parathyroidectomy was superior to cinacalcet in controlling hypercalcemia in these patients with kidney transplants and persistent hyperparathyroidism.

  2. Randomized, multicenter, comparative study of NEURO versus CIMT in poststroke patients with upper limb hemiparesis: the NEURO-VERIFY Study.

    PubMed

    Abo, Masahiro; Kakuda, Wataru; Momosaki, Ryo; Harashima, Hiroaki; Kojima, Miki; Watanabe, Shigeto; Sato, Toshihiro; Yokoi, Aki; Umemori, Takuma; Sasanuma, Jinichi

    2014-07-01

    Many poststroke patients suffer functional motor limitation of the affected upper limb, which is associated with diminished health-related quality of life. The aim of this study is to conduct a randomized, multicenter, comparative study of low-frequency repetitive transcranial magnetic stimulation combined with intensive occupational therapy, NEURO (NovEl intervention Using Repetitive TMS and intensive Occupational therapy) versus constraint-induced movement therapy in poststroke patients with upper limb hemiparesis. In this randomized controlled study of NEURO and constraint-induced movement therapy, 66 poststroke patients with upper limb hemiparesis were randomly assigned at 2:1 ratio to low-frequency repetitive transcranial magnetic stimulation plus occupational therapy (NEURO group) or constraint-induced movement therapy (constraint-induced movement therapy group) for 15 days. Fugl-Meyer Assessment and Wolf Motor Function Test and Functional Ability Score of Wolf Motor Function Test were used for assessment. No differences in patients' characteristics were found between the two groups at baseline. The Fugl-Meyer Assessment score was significantly higher in both groups after the 15-day treatment compared with the baseline. Changes in Fugl-Meyer Assessment scores and Functional Ability Score of Wolf Motor Function Test were significantly higher in the NEURO group than in the constraint-induced movement therapy group, whereas the decrease in the Wolf Motor Function Test log performance time was comparable between the two groups (changes in Fugl-Meyer Assessment score, NEURO: 5·39 ± 4·28, constraint-induced movement therapy: 3·09 ± 4·50 points; mean ± standard error of the mean; P < 0·05) (changes in Functional Ability Score of Wolf Motor Function Test, NEURO: 3·98 ± 2·99, constraint-induced movement therapy: 2·09 ± 2·96 points; P < 0·05). The results of the 15-day rehabilitative protocol showed the superiority of NEURO

  3. Comparing reduced-dose sodium phosphate tablets to 2 L of polyethylene glycol: A randomized study

    PubMed Central

    Ako, Soichiro; Takemoto, Koji; Yasutomi, Eriko; Sakaguchi, Chihiro; Murakami, Mayu; Sunami, Tomoko; Oka, Shohei; Kenta, Hamada; Okazaki, Noriko; Baba, Yuki; Yamasaki, Yasushi; Asato, Toshiyuki; Kawai, Daisuke; Takenaka, Ryuta; Tsugeno, Hirohumi; Hiraoka, Sakiko; Kato, Jun; Fujiki, Shigeatsu

    2017-01-01

    AIM To compare the tolerability and quality of bowel cleansing between 2 L polyethylene glycol (PEG) and reduced-dose sodium phosphate (NaP) tablets as a preparation for colonoscopy. METHODS Two hundred patients were randomly assigned to the PEG or NaP groups at the same ratio. The NaP group patients took 30 tablets with 2 L of clear liquid, while the PEG group patients took 2L of PEG. Tolerability was assessed by a questionnaire about taste, volume, and the overall impression. The bowel cleansing quality was evaluated by colonoscopists. RESULTS Although NaP showed better tolerability in terms of taste, volume and overall impression (P < 0.01, P < 0.01 and P = 0.02, respectively), the overall cleansing quality was better in the PEG group (P < 0.01). A subgroup analysis, stratified by sex and age, indicated that NaP was associated with better tolerability and equivalent bowel cleansing quality in females of < 50 years of age. CONCLUSION Despite the better tolerability, the use of 30 NaP tablets with 2 L of clear liquid should be limited due to its lower cleansing quality; however, in certain cases the regimen may deserve consideration, particularly in cases involving young women. PMID:28706429

  4. A comparative study of energy minimization methods for Markov random fields with smoothness-based priors.

    PubMed

    Szeliski, Richard; Zabih, Ramin; Scharstein, Daniel; Veksler, Olga; Kolmogorov, Vladimir; Agarwala, Aseem; Tappen, Marshall; Rother, Carsten

    2008-06-01

    Among the most exciting advances in early vision has been the development of efficient energy minimization algorithms for pixel-labeling tasks such as depth or texture computation. It has been known for decades that such problems can be elegantly expressed as Markov random fields, yet the resulting energy minimization problems have been widely viewed as intractable. Recently, algorithms such as graph cuts and loopy belief propagation (LBP) have proven to be very powerful: for example, such methods form the basis for almost all the top-performing stereo methods. However, the tradeoffs among different energy minimization algorithms are still not well understood. In this paper we describe a set of energy minimization benchmarks and use them to compare the solution quality and running time of several common energy minimization algorithms. We investigate three promising recent methods graph cuts, LBP, and tree-reweighted message passing in addition to the well-known older iterated conditional modes (ICM) algorithm. Our benchmark problems are drawn from published energy functions used for stereo, image stitching, interactive segmentation, and denoising. We also provide a general-purpose software interface that allows vision researchers to easily switch between optimization methods. Benchmarks, code, images, and results are available at http://vision.middlebury.edu/MRF/.

  5. Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

    PubMed

    Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

    2014-07-01

    The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  6. A randomized crossover study comparing a novel needle guidance technology for simulated internal jugular vein cannulation.

    PubMed

    Auyong, David B; Yuan, Stanley C; Rymer, Alyse N; Green, Cynthia L; Hanson, Neil A

    2015-09-01

    Despite ultrasound guidance for central line placement, complications persist, as exact needle location is often difficult to confirm with standard two-dimension ultrasound. A novel real-time needle guidance technology has recently become available (eZono, Germany) that tracks the needle during insertion. This randomized, blinded, crossover study examined whether this needle guidance technology improved cannulation of a simulated internal jugular (IJ) vein in an ultrasound phantom. One hundred physicians were randomized to place a standard needle in an ultrasound neck phantom with or without the needle guidance system. Video cameras were placed externally and within the lumens of the vessels to record needle location in real time. The primary outcome measured was the rate of posterior wall puncture. Secondary outcomes included number of carotid artery punctures, number of needle passes, final needle position, time to cannulation, and comfort level with this new technology. The incidence of posterior vessel wall puncture without and with needle guidance was 49 and 13%, respectively (P < 0.001, odds ratio [OR] = 7.33 [3.44 to 15.61]). The rate of carotid artery puncture was higher without needle navigation technology than with needle navigation 21 versus 2%, respectively (P = 0.001, OR = 12.97 [2.89 to 58.18]). Final needle tip position being located within the lumen of the IJ was 97% accurate with the navigation technology and 76% accurate with standard ultrasound (P < 0.001, OR = 10.42 [2.76 to 40.0]). Average time for successful vessel cannulation was 1.37 times longer without guidance technology. This real-time needle guidance technology (eZono) shows significant improvement in needle accuracy and cannulation time during simulated IJ vein puncture.

  7. Randomized and comparative study between two intra-hospital exercise programs for heart transplant patients.

    PubMed

    Kawauchi, Tatiana Satie; Almeida, Patricia Oliva de; Lucy, Karen Rodrigues; Bocchi, Edimar Alcides; Feltrim, Maria Ines Zanetti; Nozawa, Emilia

    2013-01-01

    To compare the effects of two physical therapy exercise in-hospital programs in pulmonary function and functional capacity of patients in the postoperative period of heart transplantation. Twenty-two heart transplanted patients were randomized to the control group (CG, n=11) and training group (TG, n=11). The control group conducted the exercise program adopted as routine in the institution and the training group has had a protocol consisting of 10 stages, with incremental exercises: breathing exercises, resistance training, stretching and walking. The programs began on the first day after extubation and stretched until hospital discharge. Assessed pulmonary function, distance walked in six minutes walk test (6MWT) and peripheral muscle strength by one repetition maximum test (1RM). Similar behavior was observed between the two groups treated, with statistically significant increases between the first and second test of the following variables: FVC (59% in CG and 35.2% in TG); MIP (8.6% in CG and 53.5% in TG), MEP (28.8% in CG and 40.7% in TG) and 6MWT (44.5% in CG and 31.4% in TG). There was an increase of peripheral strength by 1RM test, over time, to the muscle groups of the elbow flexors, shoulder flexors, hip abductors and knee flexors. Heart transplant patients benefit from exercise programs in hospital, regardless of the program type applied. A new training proposal did not result in superiority compared to routine programme applied. Exercise protocols provided improves in ventilatory variables and functional capacity of this population.

  8. Neither Orthodoxy nor Randomness: Differing Logics of Conducting Comparative and International Studies in Education

    ERIC Educational Resources Information Center

    Schriewer, Jürgen

    2014-01-01

    The issue of the presumed "identity" of Comparative Education as a field of study or a discipline has been discussed for decades. Yet what remains open to question is a kind of systematic structure that provides the basic principles for a coherent exposition of the field. After conceptualising and rejecting almost a dozen possible…

  9. A blinded, randomized, palatability study comparing variations of 2 popular field water disinfection tablets.

    PubMed

    Heiner, Jason D; Simmons, Emily A; Hile, David C; Wedmore, Ian S

    2011-12-01

    Halogen-based water disinfection tablets may render an unpleasant taste to treated water. Proposed safe additives such as ascorbic acid may reduce this objectionable taste. We compared the palatability of 2 field water disinfectants: iodine-based tetraglycine hydroperiodide (TGHP) and chlorine-based chlorine dioxide (CD) both with and without the concomitant use of an ascorbic acid taste neutralizer. Blinded participants randomly sampled 5 different distilled water samples containing combinations of disinfectant tablets and ascorbic acid: 1) water; 2) water with TGHP; 3) water with CD; 4) water with TGHP plus ascorbic acid; and 5) water with CD plus ascorbic acid. Participants rated beverage taste via a 100 mm visual analogue scale (VAS) and ranked the samples from "most pleasant" to "least pleasant." Sixty participants evaluated the samples. On the VAS, water with TGHP tasted worst and water with CD tasted second worst. Water with TGHP plus ascorbic acid, water alone, and water with CD plus ascorbic acid measured similarly as significantly best tasting. Water with TGHP was ranked by 58% as "least pleasant" tasting, while water with TGHP and ascorbic acid was ranked by 40% as "most pleasant" tasting. Participants found halogen-based disinfected water significantly less palatable prior to the addition of ascorbic acid. Addition of ascorbic acid to treated water created a beverage of similar preference to distilled water. These results may increase compliance with the use of disinfecting tablets by increasing the palatability of drinking water made potable via addition of ascorbic acid to halogen-based chemical disinfection. Copyright © 2011 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  10. Efficacy of paraffin wax bath for carpal tunnel syndrome: a randomized comparative study.

    PubMed

    Ordahan, Banu; Karahan, Ali Yavuz

    2017-08-07

    Carpal tunnel syndrome (CTS) is the most frequently diagnosed neuropathy of upper extremity entrapment neuropathies. We aimed to investigate the effectiveness of paraffin therapy in patients with CTS. Seventy patients diagnosed with mild or moderate CTS were randomly divided into two groups as splint treatment (during the night and day time as much as possible for 3 weeks) alone and splint (during the night and day time as much as possible for 3 weeks) + paraffin treatment (five consecutive days a week for 3 weeks). Clinical and electrophysiological assessments were performed before and 3 weeks after treatment. The patients were assessed by using visual analog scale (VAS) for pain, electroneuromyography (ENMG), and Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ). The significant improvement was found in VAS scores in both groups when compared with pretreatment values (p < 0.05). There was no significant improvement in functional capacity score (p > 0.05), whereas a significant improvement was noted in the BCTQ symptom severity scale score in the splint group (p < 0.05). Significant improvements were demonstrated in both scorers in the combined treatment group. Similarly, significant improvements were found in the combined treatment group in terms of motor and sensory distal latency, sensory amplitude, and median sensory nerve velocity (p < 0.05). There was no significant change in electrophysiologic parameters in the splint group (p > 0.05), and the difference in these parameters between the groups was statistically significant (p < 0.05). In conclusion, using splinting alone in patients with CTS is an effective treatment for reducing symptoms in the early stages. Paraffin treatment with splint increases the recovery in functional and electrophysiological parameters.

  11. Efficacy of paraffin wax bath for carpal tunnel syndrome: a randomized comparative study

    NASA Astrophysics Data System (ADS)

    Ordahan, Banu; Karahan, Ali Yavuz

    2017-08-01

    Carpal tunnel syndrome (CTS) is the most frequently diagnosed neuropathy of upper extremity entrapment neuropathies. We aimed to investigate the effectiveness of paraffin therapy in patients with CTS. Seventy patients diagnosed with mild or moderate CTS were randomly divided into two groups as splint treatment (during the night and day time as much as possible for 3 weeks) alone and splint (during the night and day time as much as possible for 3 weeks) + paraffin treatment (five consecutive days a week for 3 weeks). Clinical and electrophysiological assessments were performed before and 3 weeks after treatment. The patients were assessed by using visual analog scale (VAS) for pain, electroneuromyography (ENMG), and Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ). The significant improvement was found in VAS scores in both groups when compared with pretreatment values (p < 0.05). There was no significant improvement in functional capacity score (p > 0.05), whereas a significant improvement was noted in the BCTQ symptom severity scale score in the splint group (p < 0.05). Significant improvements were demonstrated in both scorers in the combined treatment group. Similarly, significant improvements were found in the combined treatment group in terms of motor and sensory distal latency, sensory amplitude, and median sensory nerve velocity (p < 0.05). There was no significant change in electrophysiologic parameters in the splint group (p > 0.05), and the difference in these parameters between the groups was statistically significant (p < 0.05). In conclusion, using splinting alone in patients with CTS is an effective treatment for reducing symptoms in the early stages. Paraffin treatment with splint increases the recovery in functional and electrophysiological parameters.

  12. A Randomized Experiment Comparing Random and Cutoff-Based Assignment

    ERIC Educational Resources Information Center

    Shadish, William R.; Galindo, Rodolfo; Wong, Vivian C.; Steiner, Peter M.; Cook, Thomas D.

    2011-01-01

    In this article, we review past studies comparing randomized experiments to regression discontinuity designs, mostly finding similar results, but with significant exceptions. The latter might be due to potential confounds of study characteristics with assignment method or with failure to estimate the same parameter over methods. In this study, we…

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

    PubMed

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

    2012-05-01

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

  14. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients.

    PubMed

    Ransford, A O; Morley, T; Edgar, M A; Webb, P; Passuti, N; Chopin, D; Morin, C; Michel, F; Garin, C; Pries, D

    1998-01-01

    We have evaluated the use of a synthetic porous ceramic (Triosite) as a substitute for bone graft in posterior spinal fusion for idiopathic scoliosis. In a prospective, randomised study 341 patients at five hospitals in the UK and France were randomly allocated either to autograft from the iliac crest or rib segments (171) or to receive Triosite blocks (170). All patients were assessed after operation and at 3, 6, 12 and 18 months. The two groups were similar with regard to all demographic and baseline variables, but the 184 treated in France (54%) had Cotrel-Dubouset instrumentation and the 157 treated in the UK usually had Harrington-Luque implants. In the Triosite group the average Cobb angle of the upper curve was 56 degrees, corrected to 24 degrees (57%). At 18 months, the average was 26 degrees (3% loss). In the autograft group the average preoperative upper curve of 53 degrees was corrected to 21 degrees (60%). At 18 months the mean curve was 25 degrees (8% loss). Pain levels after operation were similar in the two groups, being mild in most cases. In the Triosite group only three patients had problems of wound healing, but in the autograft group, 14 patients had delayed healing, infection or haematoma in the spinal wound. In addition, 15 autograft patients had pain at the donor site at three months. Seven had infections, two had haematoma and four had delayed healing. The haematological and serum biochemistry results showed no abnormal trends and no significant differences between the groups. There were no adverse events related to the graft material and no evidence of allergenicity. Our results suggest that Triosite synthetic porous ceramic is a safe and effective substitute for autograft in these patients. Histological findings on biopsy indicate that Triosite provides a favourable scaffolding for the formation of new bone and is gradually incorporated into the fusion mass.

  15. Controlled randomized study comparing the cardiovascular profile of everolimus with tacrolimus in renal transplantation.

    PubMed

    Cruzado, Josep M; Pascual, Julio; Sánchez-Fructuoso, Ana; Serón, Daniel; Díaz, Joan M; Rengel, Manuel; Oppenheimer, Federico; Hernández, Domingo; Paravisini, Alexandra; Saval, Núria; Morales, José M

    2016-12-01

    Left ventricular hypertrophy (LVH) regression after kidney transplantation may be influenced by immunosuppression. In a 24-month open-label, multicenter, phase-IV study, 71 kidney allograft recipients without previous acute rejection, showing eGFR >40 ml/min and proteinuria <500 mg/day and between 6 months and 3 years post-transplantation, were randomized to receive everolimus (EVR) + mycophenolic acid (MPA) or were maintained on tacrolimus (TAC) + MPA. The aim was to assess whether the conversion to EVR could reduce left ventricular mass index (LVMi) at month-24. LVMi at month-24 decreased without differences between groups (TAC: 54.0 vs. 48.2 g/m(2.7) ; EVR: 53.4 vs. 49.4 g/m(2.7) ). The LVH prevalence at baseline and month-24 was 59.4% and 40.6% in TAC group and 57.1% and 50.0% in EVR group. EVR conversion was associated with nearly disappearance of concentric LVH and concentric remodeling pattern. The procollagen type I N-terminal propeptide at month-24 showed greater reduction in EVR group (51.6 vs. 58.2 mg/l; P = 0.004). Conversion from TAC to EVR was associated with a significant improvement of eGFR (P = 0.0315, ancova). Adverse events were similar between groups without rejection episode or graft loss. Conversion from TAC to EVR did not further reduce LVMi after 24 months, although its effect on concentric LVH deserves further investigation (NCT01169701). © 2016 Steunstichting ESOT.

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

    PubMed

    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. Improving the quality of sleep with an optimal pillow: a randomized, comparative study.

    PubMed

    Jeon, Mi Yang; Jeong, HyeonCheol; Lee, SeungWon; Choi, Wonjae; Park, Jun Hyuck; Tak, Sa Jin; Choi, Dae Ho; Yim, Jongeun

    2014-01-01

    Because sleep comprises one-third of a person's life, using an optimal pillow for appropriate neck support to maintain cervical curve may contribute to improve quality of sleep. Design of orthopedic pillow conforms to orthopedic guidelines to ensure the right support of the cervical curve. The aim of this study was to investigate effect of different pillow shape and content on cervical curve, pillow temperature, and pillow comfort. A feather pillow is regarded as a standard pillow, and a memory foam pillow is one of the most popular pillows among pillow users. We, therefore, compared these two pillows with an orthopedic pillow. Twenty healthy subjects (10 men and 10 women; age range, 21-30 years) participated in the study. Each subject was asked to assume the supine position with 3 different pillows for 30 minute in each trial and then cervical curve, pillow temperature, and pillow comfort were measured. When comparing the cervical curve of the 3 different pillows, that of the orthopedic pillow was significantly higher than that of the other 2 pillows (p < 0.001). The degree of temperature increase was significantly lower for the orthopedic pillow than for the memory foam and feather pillows (p < 0.001). The visual analog scale (VAS) score of pillow comfort was significantly higher in orthopedic pillow than the other 2 pillows. This study shows that pillow shape and content plays a crucial role in cervical curve, pillow temperature, and pillow comfort and orthopedic pillow may be an optimal pillow for sleep quality.

  18. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    PubMed Central

    Toscano, I. L.; Rezende, M.V.; Mello, L. F.; Pires, L.; Paulillo, D.; Glina, S.

    2016-01-01

    ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week). Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5) score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019) and 50.4° and 42.08° before and after verapamil, respectively (p=0.012). The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23) in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58). In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine. PMID:24893912

  19. Comparative study of enalapril vs. losartan on residual renal function preservation in automated peritoneal dialysis. A randomized controlled study.

    PubMed

    Reyes-Marín, Fernando Arturo; Calzada, Claudia; Ballesteros, Araceli; Amato, Dante

    2012-01-01

    Residual renal function (RRF) is an important determinant of mortality and morbidity in patients receiving peritoneal dialysis (PD). Recent studies have shown a positive effect of angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs) on RRF in PD patients. To compare enalapril and losartan for RRF preservation in automated peritoneal dialysis (APD) patients. An open label randomized controlled trial (RCT) with a 12 month follow-up period was conducted to compare the effect of enalapril vs. losartan on RRF preservation in 60 APD patients. Measurements were done at the start of the study (baseline), 3, 6, 9, and 12 months. A historical control group (HCG) without treatment was included to assess the natural history of RRF loss. RRF in the enalapril group dropped from 3.65 +/- 1.6 (baseline) to 2.36 +/- 0.38 mL/min/1.73 m2 (12 months). In the losartan group RRF was reduced from 4.1+/- 2.01 (baseline) to 2.54 +/- 0.47 mL/min/ 1.73 m2 (12 months). There were not significant differences between the two groups regarding RRF at 12 months. In the HCG, RRF declined from 3.68 +/- 0.48 to 1.4 +/- 0.29 mL/min/ 1.73 m2 (12 months). RRF in the HCG was significantly lower than RRF in the two treated groups at 12 months (P < 0.05). There was not significant difference on RRF preservation between enalapril and losartan groups. Comparing these results to those of the HCG suggests that the treatment with any of the drugs is useful in preserving RRF.

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

    PubMed

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

    2013-11-07

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

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

    PubMed Central

    2013-01-01

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

  2. Skin prick testing with standardized extracts from 3 different manufacturers. A comparative randomized study.

    PubMed

    Nielsen, N H; Dirksen, A; Mosbech, H; Launbjerg, J; Biering, I; Søborg, M

    1992-01-01

    The aim of this study was to compare skin reactivity to routine allergen prick test with panels of allergens, supplied by three different manufacturers. The allergens comprised ten aero-allergens commonly used for skin prick test in Northern Europe, and included pollen, dander, house dust mites, and moulds. Two hundred consecutive patients were tested. The methods for standardization of allergen extracts, declaration of allergenic potency, and recommended lancets differed. The equipment were Soluprick SQ (Allergologisk Laboratorium A/S, Denmark) (ALK), Alphatest (Dome/Hollister-Stier, U.K.) (DHS), and Phazet (Pharmacia, Sweden) (PHA). The coefficient of variation for the allergen coated PHA (same lancet was applied twice) was 0.31, and for ALK and DHS allergen extracts 0.13 and 0.18, respectively. The frequencies of patients with positive reactions to the various allergens were generally similar, although DHS appeared to elicit less positive reactions to Timothy, dog, and Dermatophagoides pteronnyssinus. For the individual physician, it may be important to know the allergenic activity of the different allergens in his routine panel compared to the activity in other similar panels.

  3. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

    PubMed

    Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

    2014-02-01

    Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

  4. Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

    PubMed

    Furst, Daniel E; Venkatraman, Manorama M; McGann, Mary; Manohar, P Ram; Booth-LaForce, Cathryn; Sarin, Reshmi; Sekar, P G; Raveendran, K G; Mahapatra, Anita; Gopinath, Jidesh; Kumar, P R Krishna

    2011-06-01

    To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

  5. A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis.

    PubMed

    Elmore, Joann G; Longton, Gary M; Pepe, Margaret S; Carney, Patricia A; Nelson, Heidi D; Allison, Kimberly H; Geller, Berta M; Onega, Tracy; Tosteson, Anna N A; Mercan, Ezgi; Shapiro, Linda G; Brunyé, Tad T; Morgan, Thomas R; Weaver, Donald L

    2017-01-01

    Digital whole slide imaging may be useful for obtaining second opinions and is used in many countries. However, the U.S. Food and Drug Administration requires verification studies. Pathologists were randomized to interpret one of four sets of breast biopsy cases during two phases, separated by ≥9 months, using glass slides or digital format (sixty cases per set, one slide per case, n = 240 cases). Accuracy was assessed by comparing interpretations to a consensus reference standard. Intraobserver reproducibility was assessed by comparing the agreement of interpretations on the same cases between two phases. Estimated probabilities of confirmation by a reference panel (i.e., predictive values) were obtained by incorporating data on the population prevalence of diagnoses. Sixty-five percent of responding pathologists were eligible, and 252 consented to randomization; 208 completed Phase I (115 glass, 93 digital); and 172 completed Phase II (86 glass, 86 digital). Accuracy was slightly higher using glass compared to digital format and varied by category: invasive carcinoma, 96% versus 93% (P = 0.04); ductal carcinoma in situ (DCIS), 84% versus 79% (P < 0.01); atypia, 48% versus 43% (P = 0.08); and benign without atypia, 87% versus 82% (P < 0.01). There was a small decrease in intraobserver agreement when the format changed compared to when glass slides were used in both phases (P = 0.08). Predictive values for confirmation by a reference panel using glass versus digital were: invasive carcinoma, 98% and 97% (not significant [NS]); DCIS, 70% and 57% (P = 0.007); atypia, 38% and 28% (P = 0.002); and benign without atypia, 97% and 96% (NS). In this large randomized study, digital format interpretations were similar to glass slide interpretations of benign and invasive cancer cases. However, cases in the middle of the spectrum, where more inherent variability exists, may be more problematic in digital format. Future studies evaluating the effect these findings exert on

  6. A Comparative Study of Group Contingencies and Randomized Reinforcers to Reduce Disruptive Classroom Behavior

    ERIC Educational Resources Information Center

    Theodore, Lea A.; Bray, Melissa A.; Kehle, Thomas J.

    2004-01-01

    The present investigation employed an alternating treatments design to (1) examine the efficacy of group contingencies in the reduction of disruptive behavior, and (2) compare the effects of independent, interdependent, and dependent group contingencies in the reduction of disruptive behavior in adolescent males identified with serious emotional…

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

    PubMed

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

    2017-08-02

    The aim of this study was to compare growth outcome and cost effectiveness of "Kangaroo ward care" (KWC) with "Intermediate intensive care" (IIC) in stable infants with birth weight 1000 g to <1100 g. In this secondary analysis, we included 79 infants, with birth weight 1000 g to <1100 g. Thirty-eight were randomized to KWC and 41 to IIC group once the infant reached a weight of 1150 g. Infants in the KWC group were shifted to Kangaroo ward immediately after randomization and in the IIC group received IIC care till they attained a weight of 1250 g before shifting to Kangaroo Ward. After shifting to Kangaroo ward, infants in the IIC group received equivalent care to KWC group infants. There was significant better weight gain post-randomization during hospital stay and better length gain till 40 weeks of gestational age in intervention arm. There was reduction of post-randomization hospital stay by 2 d in the KWC group. The infants in the KWC group were shifted 6 d earlier to Kangaroo ward from IIC when compared with the IIC group. The cost-effective analysis that used "top-down" and "bottom-up" accounting method showed significant reduction of hospital and parents expenditure in the KWC group (p < .001) with saving of 570 USD per patient in the KWC group. Early shifting of infants to Kangaroo ward with birth weight 1000 g to <1100 g leads to better growth and is cost effective (CTRI/2014/05/004625). Clinical trial registry of India CTRI/2014/05/004625.

  8. A study to compare the overall effectiveness between midazolam and dexmedetomidine during monitored anesthesia care: A randomized prospective study

    PubMed Central

    Rasheed, Mohd. Asim; Punera, Dinesh Chandra; Bano, Mehar; Palaria, Urmila; Tyagi, Abhilasha; Sharma, Shatrunjay

    2015-01-01

    Background: Monitored anesthesia care (MAC) combines intravenous sedation along with local anesthetic infiltration or nerve block. Several drugs have been used for MAC, but all are associated with complications. Dexmedetomidine is a selective α2-adrenoceptor agonist with both sedative and analgesic properties and is devoid of respiratory depressant effects. Its short elimination half-life makes it an attractive agent for sedation during MAC. Aim: Comparative evaluation of dexmedetomidine and midazolam for MAC. Methods: In this prospective, randomized, double-blind study, 50 American Society of Anesthesiologist I and II patients undergoing a surgical or diagnostic procedure of <1 h requiring MAC were enrolled. Dexmedetomidine-ketamine (Group “KD”) patients (n = 25) received intravenous (I.V.) dexmedetomidine 1 mcg/kg over 10 min followed by 0.5 mg/kg of I.V. ketamine. Midazolam-ketamine patients (n = 25) received I.V. midazolam 0.05 mg/kg over 10 min followed by 0.5 mg/kg of I.V. ketamine to get a targeted level of sedation (≤4 using Observer's Assessment of Alertness/Sedation Scale score). Inadequate sedation (e.g., 15% increase in mean arterial blood pressure or heart rate, decrease in degree of calmness, increase in respiratory rate, physical movement) was treated by a ketamine bolus of 0.5 mg/kg as a rescue analgesia. Statistical Analysis: The statistical tests used in the study are unpaired Student's t-test for continuous variables and Chi-square test for categorical variables. Mann–Whitney test was used to assess the patient and surgeon satisfaction. Data were expressed as mean ± standard deviation. Value of P < 0.05 is considered significant and P < 0.0001 as highly significant. Results: Clinically desired sedation and analgesia was achieved earlier and better with dexmedetomidine. Patients and surgeons satisfaction were significantly higher with dexmedetomidine. The requirement of additional sedation and analgesia was less in dexmedetomidine (KD

  9. Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

    PubMed

    Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

    2015-03-01

    Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

  10. Comparing Two Story-Writing Mnemonic Strategies: A Randomized Control Trial Study

    ERIC Educational Resources Information Center

    Dunn, Michael

    2013-01-01

    Educators often use mnemonic strategies as a prime method to help children who struggle with writing. This study analyzed 12 fourth-grade students' stories during their participation in one of three groups. The first group learned the Ask, Reflect, Text (ART) mnemonic strategy with art media in the pre-writing/planning phase. The second group used…

  11. Evaluation of dysprosia aerogels as drug delivery systems: a comparative study with random and ordered mesoporous silicas.

    PubMed

    Bang, Abhishek; Sadekar, Anand G; Buback, Clayton; Curtin, Brice; Acar, Selin; Kolasinac, Damir; Yin, Wei; Rubenstein, David A; Lu, Hongbing; Leventis, Nicholas; Sotiriou-Leventis, Chariklia

    2014-04-09

    Biocompatible dysprosia aerogels were synthesized from DyCl3·6H2O and were reinforced mechanically with a conformal nano-thin-polyurea coating applied over their skeletal framework. The random mesoporous space of dysprosia aerogels was filled up to about 30% v/v with paracetamol, indomethacin, or insulin, and the drug release rate was monitored spectrophotometrically in phosphate buffer (pH = 7.4) or 0.1 M aqueous HCl. The drug uptake and release study was conducted comparatively with polyurea-crosslinked random silica aerogels, as well as with as-prepared (native) and polyurea-crosslinked mesoporous silica perforated with ordered 7 nm tubes in hexagonal packing. Drug uptake from random nanostructures (silica or dysprosia) was higher (30-35% w/w) and the release rate was slower (typically >20 h) relative to ordered silica (19-21% w/w, <1.5 h, respectively). Drug release data from dysprosia aerogels were fitted with a flux equation consisting of three additive terms that correspond to drug stored successively in three hierarchical pore sites on the skeletal framework. The high drug uptake and slow release from dysprosia aerogels, in combination with their low toxicity, strong paramagnetism, and the possibility for neutron activation render those materials attractive multifunctional vehicles for site-specific drug delivery.

  12. Pilot randomized crossover study comparing the efficacy of transnasal disposable endosheath with standard endoscopy to detect Barrett's esophagus.

    PubMed

    Shariff, Mohammed K; Varghese, Sibu; O'Donovan, Maria; Abdullahi, Zarah; Liu, Xinxue; Fitzgerald, Rebecca C; di Pietro, Massimiliano

    2016-02-01

    The transnasal endosheath endoscope is a new disposable technology with potential applicability to the primary care setting. The aim of this study was to evaluate the efficacy of transnasal endosheath endoscopy (TEE) for the detection of Barrett's esophagus, by comparing the diagnostic accuracy of TEE with that of standard endoscopy. This was a prospective, randomized, crossover study performed in a single tertiary referral center. Consecutive patients undergoing surveillance for Barrett's esophagus or referred for diagnostic assessment were recruited. All patients were randomized to undergo TEE followed by standard endoscopy or the reverse. Endoscopy experiences and patient preferences were evaluated using a questionnaire. Endoscopic and histologic diagnosis of Barrett's esophagus, and optical image quality of both endoscopic procedures, were compared. A total of 21 of 25 patients completed the study. TEE had sensitivity and specificity of 100 % for an endoscopic diagnosis of Barrett's esophagus, and of 66.7 % and 100 %, respectively, for the histologic diagnosis of Barrett's esophagus. The mean optical quality of standard endoscopy was significantly better than that of TEE (7.11 ± 0.42 vs. 4.06 ± 0.27; P < 0.0001). However, following endoscopy, patients reported a significantly better experience with TEE compared with standard endoscopy (7.05 ± 0.49 vs. 4.35 ± 0.53; P = 0.0006), with 60 % preferring TEE and 25 % preferring sedated standard endoscopy. In this study, TEE had equal accuracy for an endoscopic diagnosis of Barrett's esophagus compared with standard endoscopy, at the expense of reduced image quality and a lower yield of intestinal metaplasia on biopsy. TEE was better tolerated and preferred by patients. Hence, TEE needs further evaluation in primary care as an initial diagnostic tool. © Georg Thieme Verlag KG Stuttgart · New York.

  13. Prospective randomized study to compare between intravenous dexmedetomidine and esmolol for attenuation of hemodynamic response to endotracheal intubation.

    PubMed

    Selvaraj, Venkatesh; Manoharan, Karthik Raj

    2016-01-01

    Esmolol has an established role in attenuation of hemodynamic response to laryngoscopy and endotracheal intubation. We studied the effect of dexmedetomidine compared to that of esmolol in this study. To study the role of dexmedetomidine in attenuation of hemodynamic response to laryngoscopy and oral endotracheal intubation compared to that of esmolol hydrochloride in patients posted for elective surgery under general anesthesia. Prospective randomized study double-dummy blinding method. A total of 60 American Society of Anesthesiologists I patients, aged 18-60 years randomly divided into two groups; Group A patients received dexmedetomidine 1 mcg/kg diluted in 50 ml with normal saline and infused over 10 min before induction and also 20 ml of normal saline intravenous (IV) 2 min before endotracheal intubation. Group B patients received 50 ml IV infusion of normal saline over 10 min before induction and IV bolus of esmolol 0.5 mg/kg diluted in 20 ml with normal saline given 2 min before intubation. Standard induction technique followed. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded just before induction and after intubation at 1 min, 3 min, and 5 min after intubation. Independent samples t-test and repeated measures of analysis of variance. Dexmedetomidine group showed statistically significant reduction in all the study parameters at all study time intervals following intubation. While esmolol group showed significant attenuation of HR, SBP, and MAP following intubation but failed to produce significant reduction in DBP. Dexmedetomidine is more effective in attenuating the hemodynamic response to oral endotracheal intubation compared to that of esmolol hydrochloride.

  14. Comparative effectiveness of quetiapine and haloperidol in delirium: A single blind randomized controlled study

    PubMed Central

    Grover, Sandeep; Mahajan, Sudhir; Chakrabarti, Subho; Avasthi, Ajit

    2016-01-01

    AIM To evaluate the effectiveness of quetiapine and haloperidol in patients of delirium referred to psychiatry consultation liaison services. METHODS The study followed a single blind randomised controlled trial design. Thirty-two patients in the haloperidol group and 31 patients in the quetiapine group were assessed at the baseline and 6 consecutive days. Flexible dosing regimen (haloperidol: 0.25-1.25 mg; quetiapine 12.5-75 mg/d) was used. Delirium Rating Scale-Revised-98 (DRS-R-98) and mini mental status examination (MMSE) were the primary and secondary efficacy measures respectively. RESULTS Baseline DRS-R-98 severity score and MMSE scores did not differ between the 2 study groups. From baseline to day 6, there was significant reduction in the total DRS-R-98 scores, DRS-R-98 cognitive domain scores, DRS-R-98 non-cognitive domain scores and significant increase in the MMSE scores in both the groups. Both the groups did not differ on any of the assessments in terms of DRS-R98 and MMSE scores. The effectiveness of both the medications was similar in adult and elderly (≥ 60 years) patients. At the end of the trial, 68.75% and 67.74% of subjects in the haloperidol and quetiapine group respectively had mean DRS-R-98 scores below 10. By 6th day, 12 (37.5%) patients in haloperidol group and 9 (29.03%) patients in the quetiapine group had DRS-R98 score of “0” with no significant difference between the two groups (P = 0.47). CONCLUSION Quetiapine is as effective as haloperidol in the management of delirium. PMID:27679777

  15. A prospective randomized study of a dental appliance compared with uvulopalatopharyngoplasty in the treatment of obstructive sleep apnoea.

    PubMed

    Wilhelmsson, B; Tegelberg, A; Walker-Engström, M L; Ringqvist, M; Andersson, L; Krekmanov, L; Ringqvist, I

    1999-01-01

    The enthusiasm for uvulopalatopharyngoplasty (UPPP) in the treatment of obstructive sleep apnoea (OSA) has declined in recent years, partly because of a lower success rate over time and partly because of adverse effects. Reports on the beneficial effects of dental appliances exist, but only one prospective randomized study has been published comparing dental appliances with nasal continuous positive airway pressure (CPAP) treatment. No study has been published comparing dental appliance treatment with UPPP. Ninety-five male patients with confirmed OSA, subjective daytime sleepiness and an apnoea index (AI) > 5 were randomized for subsequent treatment with either a dental appliance or UPPP. There were 49 patients in the dental appliance group and 46 in the UPPP group. Thirty-seven patients in the dental appliance group and 43 in the UPPP group completed the 12-month follow-up. The success rate (rate of patients with at least a 50% reduction in AI) for the dental appliance group was 95%, which was significantly higher (p < 0.01) than the 70% success rate for the UPPP group. According to the criteria for OSA (apnoea index > or = 5 or apnoea/hypopnoea index > or = 10), 78% of the dental appliance group and 51% of the UPPP group were normalized after 12 months. The difference between the groups was significant (p < 0.05). These findings suggest that the dental appliance technique is useful in the treatment of mild to moderate OSA.

  16. Antidepressant monotherapy compared with combinations of antidepressants in the treatment of resistant depressive patients: a randomized, open-label study.

    PubMed

    Bares, Martin; Novak, Tomas; Kopecek, Miloslav; Stopkova, Pavla; Cermak, Jan; Kozeny, Jiri; Höschl, Cyril

    2013-02-01

    This randomized, 6-week, open-label study compared efficacy of CAD and antidepressant monotherapies (ADM) that had been chosen according to clinical judgment of the attending psychiatrist. A total of 60 inpatients (intent-to-treat analysis) with depressive disorder (≥ 1 unsuccessful antidepressant treatment) were randomly assigned to the interventions. The responders who completed the acute phase of study, were evaluated for relapse within 2 months of follow-up treatment. The primary outcome measure was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) and response was defined as a ≥ 50% reduction of MADRS score. Mean changes in total MADRS score from baseline to week 6 for patients in both treatment modalities were not different (ADM = 13.2 ± 8.6 points; CAD = 14.5 ± 9.5 points; P = 0.58). The analysis of covariance performed for significantly higher value of imipramine equivalent dose in CAD group showed only a non-significant between-group difference for total MADRS change (P = 0.17). There were also no differences between groups in response rate (ADM = 48%; CAD = 58%) and number of drop-outs in acute treatment as well as proportion of responders' relapses in the follow-up. Both treatment modalities produced clinically relevant reduction of depressive symptomatology in acute treatment of patients with resistant depression and their effect was comparable.

  17. Randomization Does Not Help Much, Comparability Does

    PubMed Central

    Saint-Mont, Uwe

    2015-01-01

    According to R.A. Fisher, randomization “relieves the experimenter from the anxiety of considering innumerable causes by which the data may be disturbed.” Since, in particular, it is said to control for known and unknown nuisance factors that may considerably challenge the validity of a result, it has become very popular. This contribution challenges the received view. First, looking for quantitative support, we study a number of straightforward, mathematically simple models. They all demonstrate that the optimism surrounding randomization is questionable: In small to medium-sized samples, random allocation of units to treatments typically yields a considerable imbalance between the groups, i.e., confounding due to randomization is the rule rather than the exception. In the second part of this contribution, the reasoning is extended to a number of traditional arguments in favour of randomization. This discussion is rather non-technical, and sometimes touches on the rather fundamental Frequentist/Bayesian debate. However, the result of this analysis turns out to be quite similar: While the contribution of randomization remains doubtful, comparability contributes much to a compelling conclusion. Summing up, classical experimentation based on sound background theory and the systematic construction of exchangeable groups seems to be advisable. PMID:26193621

  18. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia.

    PubMed

    Knauf, Wolfgang U; Lissichkov, Toshko; Aldaoud, Ali; Liberati, Anna; Loscertales, Javier; Herbrecht, Raoul; Juliusson, Gunnar; Postner, Gerhard; Gercheva, Liana; Goranov, Stefan; Becker, Martin; Fricke, Hans-Joerg; Huguet, Francoise; Del Giudice, Ilaria; Klein, Peter; Tremmel, Lothar; Merkle, Karlheinz; Montillo, Marco

    2009-09-10

    This randomized, open-label, parallel-group, multicenter study was designed to compare the efficacy and safety of bendamustine and chlorambucil in previously untreated patients with advanced (Binet stage B or C) chronic lymphocytic leukemia (CLL). Patients (randomly assigned to receive bendamustine 100 mg/m(2)/d intravenously on days 1 to 2, or chlorambucil 0.8 mg/kg (Broca's normal weight) orally on days 1 and 15; treatment cycles were repeated every 4 weeks for a maximum of six cycles. The response to treatment was assessed according to National Cancer Institute Working Group criteria, and the final determination of response was made by a blinded independent review committee. A total of 319 patients were randomly assigned (162 bendamustine, 157 chlorambucil). Complete or partial responses were achieved in 110 (68%) of 162 bendamustine-treated and 48 (31%) of 157 chlorambucil-treated patients (P < .0001). More patients showed complete responses with bendamustine than with chlorambucil (31% v 2%). Median progression-free survival was 21.6 months with bendamustine and 8.3 months with chlorambucil (P < .0001). Bendamustine was also associated with an improvement in duration of remission, compared with chlorambucil (median, 21.8 v 8.0 months). Hematologic National Cancer Institute Common Toxicity Criteria grade 3 to 4 adverse events were more common with bendamustine than with chlorambucil (occurring in 40% v 19% of patients). Severe infections (grade 3 to 4) occurred in 8% of bendamustine-treated patients and 3% of chlorambucil-treated patients. Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.

  19. A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

    PubMed Central

    Elmore, Joann G.; Longton, Gary M.; Pepe, Margaret S.; Carney, Patricia A.; Nelson, Heidi D.; Allison, Kimberly H.; Geller, Berta M.; Onega, Tracy; Tosteson, Anna N. A.; Mercan, Ezgi; Shapiro, Linda G.; Brunyé, Tad T.; Morgan, Thomas R.; Weaver, Donald L.

    2017-01-01

    Background: Digital whole slide imaging may be useful for obtaining second opinions and is used in many countries. However, the U.S. Food and Drug Administration requires verification studies. Methods: Pathologists were randomized to interpret one of four sets of breast biopsy cases during two phases, separated by ≥9 months, using glass slides or digital format (sixty cases per set, one slide per case, n = 240 cases). Accuracy was assessed by comparing interpretations to a consensus reference standard. Intraobserver reproducibility was assessed by comparing the agreement of interpretations on the same cases between two phases. Estimated probabilities of confirmation by a reference panel (i.e., predictive values) were obtained by incorporating data on the population prevalence of diagnoses. Results: Sixty-five percent of responding pathologists were eligible, and 252 consented to randomization; 208 completed Phase I (115 glass, 93 digital); and 172 completed Phase II (86 glass, 86 digital). Accuracy was slightly higher using glass compared to digital format and varied by category: invasive carcinoma, 96% versus 93% (P = 0.04); ductal carcinoma in situ (DCIS), 84% versus 79% (P < 0.01); atypia, 48% versus 43% (P = 0.08); and benign without atypia, 87% versus 82% (P < 0.01). There was a small decrease in intraobserver agreement when the format changed compared to when glass slides were used in both phases (P = 0.08). Predictive values for confirmation by a reference panel using glass versus digital were: invasive carcinoma, 98% and 97% (not significant [NS]); DCIS, 70% and 57% (P = 0.007); atypia, 38% and 28% (P = 0.002); and benign without atypia, 97% and 96% (NS). Conclusions: In this large randomized study, digital format interpretations were similar to glass slide interpretations of benign and invasive cancer cases. However, cases in the middle of the spectrum, where more inherent variability exists, may be more problematic in digital format. Future studies

  20. High-Velocity Quadriceps Exercises Compared to Slow-Velocity Quadriceps Exercises Following Total Knee Arthroplasty: A Randomized Clinical Study.

    PubMed

    Doerfler, Deborah; Gurney, Burke; Mermier, Christine; Rauh, Mitchell; Black, Liza; Andrews, Ron

    2016-01-01

    Despite improvement in pain and perceived function in older adults following total knee arthroplasty (TKA), objective outcome measures of muscular impairment and ambulatory function demonstrate significant deficits. Evidence suggests that quadriceps power may play a greater role in ambulatory function than measures of strength alone following TKA. The purpose of this study was to compare the effect of high-velocity (HV) quadriceps exercises with that of slow-velocity (SV) quadriceps exercises on functional outcomes and quadriceps power following TKA. This study was a randomized clinical study conducted in an outpatient physical therapy clinic. Twenty-one participants who were 4 to 6 weeks post unilateral TKA were randomly assigned to an HV or SV group. Participants performed an evidence-based standardized progressive resistance exercise program in addition to HV quadriceps exercises or SV quadriceps exercises. Participants attended 2 sessions per week for 8 weeks. Before and after the 8-week exercise intervention, participants completed a functional questionnaire, health survey, functional testing, and underwent quadriceps strength and power testing. Both groups demonstrated improvements in ambulatory outcome measures, strength, speed, and power. The HV group demonstrated significantly greater improvements in distance walked and quadriceps strength than the SV group. These data should be considered preliminary because of a small sample size. HV quadriceps exercises may be an effective rehabilitation strategy in conjunction with a standardized progressive resistance exercise program beginning 4 to 6 weeks after TKA.

  1. Clinical performance of a light-cured denture base material compared to polymethylmethacrylate--a randomized clinical study.

    PubMed

    Gohlke-Wehrße, Hanna-Lena; Giese-Kraft, Katja; Wöstmann, Bernd

    2012-06-01

    The aim of this study was to evaluate the clinical long-term performance of a visible light-cured resin (VLCR) denture base material and to compare it to a well-established polymethylmethacrylate (PMMA)-based denture acrylic in a randomized split-mouth clinical long-term study. One hundred removable partial dentures in 90 patients, with at least two saddles each, were investigated. One saddle was made of VLCR, while the other was made of PMMA at random. Plaque adhesion, tissue reaction, and technical parameters of the dentures were assessed 6, 12, and 18 months after treatment. Statistical analysis was performed using the Wilcoxon rank-sum test. Though VLCR showed higher plaque adhesion than PMMA after 6, 12, and 18 months (p < 0.001), there were no important differences with regard to tissue reaction. Concerning plaque adhesion, surface quality with regard to the lower side, interfaces between denture acrylic and metal and the boundary between denture acrylic and denture tooth PMMA was rated higher than VLCR. The surface quality of the upper side of the denture saddles showed no significant differences (p > 0.05). Neither VLCR nor PMMA showed discoloration at any point in time (p > 0.05). It can be concluded that VLCR is a viable alternative for the production of removable dentures. Especially in patients with hypersensitivities to PMMA, VLCR is particularly suitable for clinical use.

  2. Internal fixation of the fibula in ankle fractures: a prospective, randomized and comparative study: plating versus nailing.

    PubMed

    Asloum, Y; Bedin, B; Roger, T; Charissoux, J-L; Arnaud, J-P; Mabit, C

    2014-06-01

    Open reduction and internal plate fixation of the fibula is the gold standard treatment for ankle fractures. The aim of this study was to perform a prospective randomized study to compare bone union, complications and functional results of two types of internal fixation of the fibula (plating and the Epifisa FH intramedullary nail). Inclusion criteria were: closed fractures, isolated displaced fractures of the lateral malleolus, inter- and supra-tubercular bimalleolar fractures, and trimalleolar fractures. This study included 71 patients (mean age 53 ± 19): plate fixation group (n=35) and intramedullary nail fixation group (n=36). In seven cases, intramedullary nailing was technically impossible and was converted to plate fixation (the analysis of this sub-group was performed independently). Two patients died and two patients were lost to follow-up. The final comparative series included 32 cases of plate fixation and 28 cases of intramedullary nail fixation. Union, postoperative complications and Kitaoka and Olerud-Molander functional scores were analyzed after one year of follow-up. There was no significant difference in the rate of union (P=0.5605) between the two types of fixation. There were significantly fewer complications (7% versus 56%) and better functional scores (96 versus 82 for the Kitaoka score; 97 versus 83 for the Olerud-Molander score) with intramedullary nailing than with plate fixation. Intramedullary nailing of the lateral malleolus in non-comminuted ankle fractures without syndesmotic injury is a reproducible technique with very few complications that provides better functional results than plate fixation. II (randomized prospective study). Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  3. A Comparative Study of Postoperative Pulmonary Complications Using Fast Track Regimen and Conservative Analgesic Treatment: A Randomized Clinical Trial

    PubMed Central

    Aghdam, Babak Abri; Golzari, Samad Eslam Jamal; Moghadaszadeh, Majid

    2011-01-01

    Background Postoperative pulmonary complications and pain are important causes of postoperative morbidity following thoracotomy. This study aimed to compare the effects of fast track and conservative treatment regimens on patients undergoing thoracotomy. Materials and Methods In this randomized controlled clinical trial, we recruited 60 patients admitted to the thoracic ICU of Imam Reza Hospital in two matched groups of 30 patients each. Group 1 patients received fast track regimen randomly; whereas, group 2 cases randomly received conservative analgesic regimen after thoracotomy and pulmonary resection. The outcome was determined based on the incidence of pulmonary complications and reduction of post-thoracotomy pain in all patients with forced expiratory volume in one second (FEV1) <75% predicted value which was measured while the patients were in ICU. The length of ICU stay, thoracotomy pain, morbidity, pulmonary complications and mortality were compared in two groups. Results A total of 60 patients, 45 (75%) males and 15(25%) females with ASA class I-III were recruited in this study. Postoperative pulmonary complications were observed in 5 (16.7%) patients in group 1 versus 17 (56.7%) patients in group 2. There were statistically significant differences in development of postoperative pulmonary complications such as atelectasis and prolonged air leak between both groups (P< 0.001 and P = 0.003). There was also a statistically significant difference in the rate of preoperative FEV1 (p = 0.001) and ASA scoring (p = 0.01) and value of FEV1 < 75% predicted in the two groups. The difference in length of ICU stay in two groups was statistically significant (P= 0.003 and P = 0.017 in FEV1 < 75% group). Four patients in group 1 and 9 patients in group 2 had FEV1reduced to less than 75% of predicted value (p = 0.03). Conclusion Using fast track regimen reduced postoperative pain and incidence of some pulmonary complications significantly when compared to the

  4. A Randomized Effectiveness Study Comparing Trauma-Focused Cognitive Behavioral Therapy With Therapy as Usual for Youth

    PubMed Central

    Jensen, Tine K.; Holt, Tonje; Ormhaug, Silje M.; Egeland, Karina; Granly, Lene; Hoaas, Live C.; Hukkelberg, Silje S.; Indregard, Tore; Stormyren, Shirley D.; Wentzel-Larsen, Tore

    2013-01-01

    The efficacy of trauma-focused cognitive behavioral therapy (TF-CBT) has been shown in several randomized controlled trials. However, few trials have been conducted in community clinics, few have used therapy as usual (TAU) as a comparison group, and none have been conducted outside of the United States. The objective of this study was to evaluate the effectiveness of TF-CBT in regular community settings compared with TAU. One hundred fifty-six traumatized youth (M age = 15.1 years, range = 10–18; 79.5% girls) were randomly assigned to TF-CBT or TAU. Intent-to-treat analysis using mixed effects models showed that youth receiving TF-CBT reported significantly lower levels of posttraumatic stress symptoms (est. = 5.78, d = 0.51), 95% CI [2.32, 9.23]; depression (est. = 7.00, d = 0.54), 95% CI [2.04, 11.96]; and general mental health symptoms (est. = 2.54, d = 0.45), 95% CI [0.50, 4.58], compared with youth in the TAU group. Youth assigned to TF-CBT showed significantly greater improvements in functional impairment (est. = −1.05, d = −0.55), 95% CI [−1.67, −0.42]. Although the same trend was found for anxiety reduction, this difference was not statistically significant (est. = 4.34, d = 0.30), 95% CI [−1.50, 10.19]. Significantly fewer youths in the TF-CBT condition were diagnosed with posttraumatic stress disorder compared to youths in the TAU condition, χ2(1, N = 116) = 4.61, p = .031, Phi = .20). Findings indicate that TF-CBT is effective in treating traumatized youth in community mental health clinics and that the program may also be successfully implemented in countries outside the United States. PMID:23931093

  5. Comparative study of two collagen membranes for guided tissue regeneration therapy in periodontal intrabony defects: a randomized clinical trial

    PubMed Central

    2014-01-01

    Purpose The purpose of this study was to assess and compare the clinical and radiographic outcomes of guided tissue regeneration therapy for human periodontal intrabony defects using two different collagen membranes: a porous nonchemical cross-linking collagen membrane (NC) and a bilayer collagen membrane (BC). Methods Thirty subjects were randomly assigned and divided into the following 3 groups: a test group (NC+BM), in which a NC was used with xenograft bone mineral (BM), a positive control group (BC+BM), in which a BC was used with xenograft BM, and a negative control group (BM), in which only xenograft BM was used. The following clinical measurements were taken at baseline and 3 months after surgery: plaque index, gingival index, probing pocket depth, gingival recession, and clinical attachment level. Radiographic analysis was performed at baseline, 1 week and 3 months after surgery. Results Membrane exposure was not observed in any cases. Significant probing depth reduction, attachment-level gain and bone fill were observed for both test and control groups compared to baseline at 3 months after surgery (P<0.05). However, there were no statistically significant differences in clinical improvement and radiographic bone fill between treatment protocols (P>0.05). Conclusions Within the limitations of this study, the results suggest that both NC and BC were comparable in terms of clinical and radiographic outcomes for the treatment of periodontal intrabony defects in human subjects. Graphical Abstract PMID:25177521

  6. A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients.

    PubMed

    Bloom, R D; Trofe-Clark, J; Wiland, A; Alloway, R R

    2013-01-01

    An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving their pre-study twice-daily dose. Pharmacokinetic parameters were compared in 68 patients according to gender, African American ethnicity, the presence or absence of diabetes, and use of steroids. The ratios of tacrolimus AUC0-12 h , Cmax , and C12 with generic vs. reference tacrolimus were calculated using the geometric mean (GM) of dose-normalized values at days 14 and 28. Mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/d. There were no consistent differences in dose-normalized AUC0-12 h , C12 , Cmax, or tmax between the generic and reference preparations within subpopulations. The 90% confidence intervals (CI) for the ratios of dose-normalized AUC0-12 h and C12 with generic vs. reference tacrolimus were within 80-125% for all subpopulations, as were 90% CIs for Cmax other than for females, African Americans, and non-diabetics, which is not unexpected given the wide variability of tacrolimus Cmax and the small subpopulation sizes. These exploratory results suggest that this generic tacrolimus preparation would be expected to offer comparable bioavailability to the reference drug in these patient subpopulations.

  7. Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Comparative effectiveness research (CER) documents important differences in antidepressants in terms of efficacy, safety, cost, and burden to the patient. Decision aids can adapt this evidence to help patients participate in making informed choices. In turn, antidepressant therapy will more likely reflect patients’ values and context, leading to improved adherence and mood outcomes. Methods/Design The objective of this study is to develop the Depression Medication Choice decision aid for use during primary care encounters, and to test its efficacy by conducting a clustered practical randomized trial comparing the decision aid to usual depression care in primary care practices. We will use a novel practice-based, patient-centered approach based on participatory action research that involves a multidisciplinary team of designers, investigators, clinicians, patient representatives, and other stakeholders for the development of the decision aid. We will then conduct a clustered practical randomized trial enrolling clinicians and their patients (n = 300) with moderate to severe depression from rural, suburban and inner city primary care practices (n = 10). The intervention will consist of the use of the depression medication choice decision aid during the clinical encounter. This trial will generate preliminary evidence of the relative impact of the decision aid on patient involvement in decision making, decision making quality, patient knowledge, and 6-month measures of medication adherence and mental health compared to usual depression care. Discussion Upon completion of the proposed research, we will have developed and evaluated the efficacy of the decision aid depression medication choice as a novel translational tool for CER in depression treatment, engaged patients with depression in their care, and refined the process by which we conduct practice-based trials with limited research footprint. Trial registration Clinical Trials.gov: NCT01502891 PMID

  8. Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study.

    PubMed

    Hoang, Thanh D; Olsen, Cara H; Mai, Vinh Q; Clyde, Patrick W; Shakir, Mohamed K M

    2013-05-01

    Patients previously treated with desiccated thyroid extract (DTE), when being switched to levothyroxine (L-T₄), occasionally did not feel as well despite adequate dosing based on serum TSH levels. Our objective was to investigate the effectiveness of DTE compared with L-T₄ in hypothyroid patients. We conducted a randomized, double-blind, crossover study at a tertiary care center. Patients (n = 70, age 18-65 years) diagnosed with primary hypothyroidism on a stable dose of L-T₄ for 6 months were included in the study. Patients were randomized to either DTE or L-T₄ for 16 weeks and then crossed over for the same duration. Biochemical and neurocognitive tests at baseline and at the end of each treatment period were evaluated. There were no differences in symptoms and neurocognitive measurements between the 2 therapies. Patients lost 3 lb on DTE treatment (172.9 ± 36.4 lb vs 175.7 ± 37.7 lb, P < .001). At the end of the study, 34 patients (48.6%) preferred DTE, 13 (18.6%) preferred L-T₄, and 23 (32.9%) had no preference. In the subgroup analyses, those patients who preferred DTE lost 4 lb during the DTE treatment, and their subjective symptoms were significantly better while taking DTE as measured by the general health questionnaire-12 and thyroid symptom questionnaire (P < .001 for both). Five variables were predictors of preference for DTE. DTE therapy did not result in a significant improvement in quality of life; however, DTE caused modest weight loss and nearly half (48.6%) of the study patients expressed preference for DTE over L-T₄. DTE therapy may be relevant for some hypothyroid patients.

  9. Robust estimates of divergence times and selection with a poisson random field model: a case study of comparative phylogeographic data.

    PubMed

    Amei, Amei; Smith, Brian Tilston

    2014-01-01

    Mutation frequencies can be modeled as a Poisson random field (PRF) to estimate speciation times and the degree of selection on newly arisen mutations. This approach provides a quantitative theory for comparing intraspecific polymorphism with interspecific divergence in the presence of selection and can be used to estimate population genetic parameters. Although the original PRF model has been extended to more general biological settings to make statistical inference about selection and divergence among model organisms, it has not been incorporated into phylogeographic studies that focus on estimating population genetic parameters for nonmodel organisms. Here, we modified a recently developed time-dependent PRF model to independently estimate genetic parameters from a nuclear and mitochondrial DNA data set of 22 sister pairs of birds that have diverged across a biogeographic barrier. We found that species that inhabit humid habitats had more recent divergence times and larger effective population sizes than those that inhabit drier habitats, and divergence time estimated from the PRF model were similar to estimates from a coalescent species-tree approach. Selection coefficients were higher in sister pairs that inhabited drier habitats than in those in humid habitats, but overall the mitochondrial DNA was under weak selection. Our study indicates that PRF models are useful for estimating various population genetic parameters and serve as a framework for incorporating estimates of selection into comparative phylogeographic studies.

  10. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

    PubMed Central

    Gobbi, Gabriella; Comai, Stefano; Debonnel, Guy

    2014-01-01

    Objective Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints) and psychotic symptoms (secondary endpoints) from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results Quetiapine (525±45 mg) and olanzapine (18.5±4.8 mg) were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. PMID:24855361

  11. Comparative antiplaque and antigingivitis effectiveness of tea tree oil mouthwash and a cetylpyridinium chloride mouthwash: A randomized controlled crossover study.

    PubMed

    Rahman, Betul; Alkawas, Sausan; Al Zubaidi, Elaf A; Adel, Omar I; Hawas, Nuha

    2014-10-01

    The aim of this study was to compare the antiplaque and antigingivitis effects of a mouthwash containing tea tree oil (TTO) with a cetylpyridinium chloride (CPC) mouthwash. This was a randomized 4 × 4, controlled, cross-over, involving 20 healthy volunteers in a 5-day plaque re-growth model. Test mouthwashes were TTO (Tebodont(®)) and a mouthwash containing CPC 0.05% (Aquafresh(®)). A 0.12% chlorhexidine (CHX) mouthwash (Oro-Clense(®)) was used as positive and colored water (placebo [PLB]) as negative controls. Gingival bleeding index (GBI) and plaque index (PI) scores were recorded before and after each test period. Test periods were separated with 2 weeks washout period. All four mouthwashes significantly (P < 0.001) reduced the GBI scores when compared to the baseline GBI scores. There was no significant difference between PLB and active mouthwashes in the GBI scores. CHX and CPC mouthwashes were found more effective in reducing the PI scores than TTO and PLB mouthwashes. There was no significant difference in PI scores of CHX and CPC mouthwashes. 0.05% CPC mouthwash can be an alternative to CHX mouthwash since it is alcohol free and found as efficient as CHX in dental plaque reduction with lesser side effects. More studies are needed to test antigingivitis effects of the mouthwashes used in this study, preferably without initial scaling and polishing.

  12. Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with Palonosetron

    PubMed Central

    Komatsu, Yoshito; Okita, Kenji; Yuki, Satoshi; Furuhata, Tomohisa; Fukushima, Hiraku; Masuko, Hiroyuki; Kawamoto, Yasuyuki; Isobe, Hiroshi; Miyagishima, Takuto; Sasaki, Kazuaki; Nakamura, Michio; Ohsaki, Yoshinobu; Nakajima, Junta; Tateyama, Miki; Eto, Kazunori; Minami, Shinya; Yokoyama, Ryoji; Iwanaga, Ichiro; Shibuya, Hitoshi; Kudo, Mineo; Oba, Koji; Takahashi, Yasuo

    2015-01-01

    The purpose of this study is to compare the efficacy of a single administration of dexamethasone (DEX) on day 1 against DEX administration on days 1–3 in combination with palonosetron (PALO), a second-generation 5-HT3 receptor antagonist, for chemotherapy-induced nausea and vomiting (CINV) in non-anthracycline and cyclophosphamide (AC) moderately-emetogenic chemotherapy (MEC). This phase III trial was conducted with a multi-center, randomized, open-label, non-inferiority design. Patients who received non-AC MEC as an initial chemotherapy were randomly assigned to either a group administered PALO (0.75 mg, i.v.) and DEX (9.9 mg, i.v.) prior to chemotherapy (study treatment group), or a group administered additional DEX (8 mg, i.v. or p.o.) on days 2–3 (control group). The primary endpoint was complete response (CR) rate. The CR rate difference was estimated by logistic regression with allocation factors as covariates. The non-inferiority margin was set at −15% (study treatment group − control group). From April 2011 to March 2013, 305 patients who received non-AC MEC were randomly allocated to one of two study groups. Overall, the CR rate was 66.2% in the study treatment group (N = 151) and 63.6% in the control group (N = 154). PALO plus DEX day 1 was non-inferior to PALO plus DEX days 1–3 (difference, 2.5%; 95% confidence interval [CI]: −7.8%–12.8%; P-value for non-inferiority test = 0.0004). There were no differences between the two groups in terms of complete control rate (64.9 vs 61.7%) and total control rate (49.7% vs 47.4%). Anti-emetic DEX administration on days 2–3 may be eliminated when used in combination with PALO in patients receiving non-AC MEC. PMID:25872578

  13. A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects

    PubMed Central

    Shin, Donghoon; Kim, Youngdoe; Kang, Jungwon; Gauliard, Anke; Fuhr, Rainard

    2016-01-01

    Aims SB4 has been developed as a biosimilar of etanercept. The primary objective of the present study was to demonstrate the pharmacokinetic (PK) equivalence between SB4 and European Union ‐sourced etanercept (EU‐ETN), SB4 and United States‐sourced etanercept (US‐ETN), and EU‐ETN and US‐ETN. The safety and immunogenicity were also compared between the treatments. Methods This was a single‐blind, three‐part, crossover study in 138 healthy male subjects. In each part, 46 subjects were randomized at a 1:1 ratio to receive a single 50 mg subcutaneous dose of the treatments (part A: SB4 or EU‐ETN; part B: SB4 or US‐ETN; and part C: EU‐ETN or US‐ETN) in period 1, followed by the crossover treatment in period 2 according to their assigned sequences. PK equivalence between the treatments was determined using the standard equivalence margin of 80–125%. Results The geometric least squares means ratios of AUCinf, AUClast and Cmax were 99.04%, 98.62% and 103.71% (part A: SB4 vs. EU‐ETN); 101.09%, 100.96% and 104.36% (part B: SB4 vs. US‐ETN); and 100.51%, 101.27% and 103.29% (part C: EU‐ETN vs. US‐ETN), respectively, and the corresponding 90% confidence intervals were completely contained within the limits of 80–125 %. The incidence of treatment‐emergent adverse events was comparable, and the incidence of the antidrug antibodies was lower in SB4 compared with the reference products. Conclusions The present study demonstrated PK equivalence between SB4 and EU‐ETN, SB4 and US‐ETN, and EU‐ETN and US‐ETN in healthy male subjects. SB4 was well tolerated, with a lower immunogenicity profile and similar safety profile compared with those of the reference products. PMID:26972584

  14. A New Viscous Cysteamine Eye Drops Treatment for Ophthalmic Cystinosis: An Open-Label Randomized Comparative Phase III Pivotal Study.

    PubMed

    Liang, Hong; Labbé, Antoine; Le Mouhaër, Jeannie; Plisson, Céline; Baudouin, Christophe

    2017-04-01

    The purpose of this study was to evaluate the efficacy of new viscous cysteamine hydrochloride (CH) eye drops (vCH 0.55%) compared with standard CH 0.10% drops treatment. This was an open-label, phase III, randomized, two-arm multicenter trial conducted at two centers in France. Cystinosis patients ≥2 years old were randomized 1:1 to receive eye drops, four times per day for 90 days in both eyes. We compared the superiority in reducing corneal cystine crystal density as assessed by in vivo confocal microscopy (IVCM). We also evaluated photophobia, corneal cystine crystal scores (CCCSs), and cystine crystal depth measured by optical coherence tomography. Safety objectives were to assess adverse events (AEs), local adverse drug reactions, and ocular safety parameters. We included 15 patients with vCH 0.55% and 16 patients with CH 0.10% drops for 90 days. The mean absolute change in IVCM total score at day 90 in the vCH 0.55% drops group (-4.6 ± 3.1) was significantly greater than and superior to the mean absolute change in the CH 0.10% drops group (-0.46 ± 3.38; P < 0.0001). Photophobia, CCCS, and corneal cystine crystal depth were significantly more improved in the vCH 0.55% drops group than in the CH 0.10% group. The most frequent local adverse drug reactions in both groups were stinging, burning, redness, and blurred vision. vCH 0.55% was effective in reducing corneal cystine crystal density and superior to treatment with CH 0.10% drops, which offer advantages over hospital pharmacy formulations and is a more preferable and convenient treatment option.

  15. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

    PubMed

    Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

    2016-03-31

    Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

  16. Open, randomized, comparative study of efficacy and safety between Haemopressin and Glypressin in treating acute esophageal varices hemorrhage.

    PubMed

    Hu, Rey-Heng; Lee, Po-Huang

    2008-01-01

    Hemorrhage from esophageal varices is a major consequence of liver cirrhosis. Pharmacological treatment can be started immediately by an internist to arrest acute esophageal variceal hemorrhage (EVH). Terlipressin is easy to administer and effective in treating acute EVH, with or without adjuvant endoscopic sclerotherapy, and in reducing mortality in these patients. Due to these potentials, a phase IV bioequivalence study was conducted to compare a new brand of terlipressin (Haemopressin: contains 1 mg tri-glycyl-lysin-vasopressin acetate) with one that is currently available in the market (Glypressin). All cirrhotic patients with acute EVH were randomized to receive Haemopressin (n = 19) or Glypressin (n = 22) 2mg i.v. immediately followed by 1 mg. i.v. q4h for 5 days. The demographics were similar between H-group and G-group. Successful control of acute bleeding within 24 hours was no different between the 2 groups (18/19 vs. 19/22). Failure to control bleeding within 5 days of drug administration was also no different between the 2 groups (4/19 vs. 6/22). Rebleeding events, the requirement for blood transfusions and rescued treatment were also comparative between the 2 groups. Half of the patients in either group had mild, temporary and self-limited side effects. The study confirms that administration of terlipressin, by either Haemopressin or Glypressin, is generally safe and indeed highly effective in the treatment of acute EVH.

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

    PubMed Central

    Davidson, Andrew J.; Morton, Neil S.; Arnup, Sarah J.; de Graaff, Jurgen C.; Disma, Nicola; Withington, Davinia E.; Frawley, Geoff; Hunt, Rodney W.; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S.; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen

    2015-01-01

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

  18. A prospective randomized study comparing shock wave lithotripsy and semirigid ureteroscopy for the management of proximal ureteral calculi.

    PubMed

    Salem, Hosni K

    2009-12-01

    To conduct a prospective randomized study comparing both techniques for the management of solitary radio-opaque upper ureteral stones < 2 cm in diameter. The ideal treatment for upper ureteral stones > 1 cm size remains to be determined with shock wave lithotripsy (SWL) and ureteroscopy (URS) being acceptable options. A total of 200 patients were included in the study. They were randomized into 2 equal groups. Group A underwent in situ SWL as a primary therapy. Group B underwent URS, using semirigid URS with intracorporeal lithotripsy. Efficiency quotient (EQ), cost analysis, and predictors of failure were estimated for both techniques. For stones of size > or = 1 cm, the initial stone-free rate for URS and SWL was 88% and 60%, respectively. The estimated EQ was 0.79 and 0.43 for both techniques respectively. For stones < 1 cm, the initial stone-free rate for URS and SWL was 100% and 80%, respectively. The estimated EQ was 0.88 and 0.70 for both techniques, respectively. The mean cumulative costs were significantly more in SWL group (P <.05). Predictors of URS failure included; male gender, failure to pass guidewire beyond the stone, and extravasation. Predictors of SWL failure included large stone size > 1 cm, calcium oxalate monohydrate stone, and higher degrees of hydronephrosis. URS with intracorporeal lithotripsy is an acceptable treatment modality for all proximal ureteral calculi, particularly stones > 1 cm. SWL should remain the first-line therapy for proximal ureteral calculi < or = 1 cm because of the less invasive nature and lower anesthesia (i.v. sedation).

  19. Comparative Evaluation of Volatile Anaesthetic Agents for Attenuation of Venous Cannulation Pain: A Prospective, Randomized Controlled Study

    PubMed Central

    Das, Pravin K; Gautam, Sujeet KS; Jaisawal, Parineeta; Kadiyala, Venkat N.; Rambhad, Sonal

    2016-01-01

    Introduction Topical application of volatile anaesthetic agents has been found to attenuate the response to a mechanical stimulus; however, this effect of volatile anaesthetic on perception of pain during venous cannulation is not known. Aim To compare the efficacy of topically administered volatile anaesthetic agents for attenuating venous cannulation pain. Materials and Methods This prospective, randomized, placebo controlled and double blind study was conducted on 120 patients, aged 20-60years. They were of American Society of Anaesthesiologists (ASA) I or II physical status, of either sex, planned for elective surgeries. These patients were randomized into 4 groups, of 30 each. Equipotent doses of halothane (1ml), isoflurane (1.5ml), sevoflurane (2.7ml) and sterile water (2.5ml; Control) were topically administered on the volar surface of forearm wrapped with cotton and aluminium foil; venous cannulation was performed with 18G intravenous cannula after 30 min. These patients were assessed for the incidence and severity of pain upon venous cannulation {visual analog scale (VAS), 0-100mm; 0 = no pain and 100 = worst imaginable pain}. Data were analysed by one-way ANOVA, Chi-square test and Kruskal-Wallis test. The p<0.05 was considered as significant. Results A significant reduction in the incidence of venous cannulation pain was observed in the halothane (79%) group as compared to control (100%; p<0.05), isoflurane (100%; p<0.05) and sevoflurane (100%; p<0.05) groups. The severity of venous cannulation pain as assessed by median (interquartile range, Q1-Q3). VAS scores was reduced in the halothane {10 (10-20); p<0.001}, isoflurane {20 (10-30); p<0.001} and sevoflurane {20 (20-30); p<0.001} groups as compared to the control group {40 (30-40)}; VAS score in the halothane group was significantly less as compared to isoflurane (p<0.05) and sevoflurane (p<0.05) groups. Conclusion Topical application of halothane is most effective in reducing incidence and severity of

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

    PubMed

    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 < 0.05) in clinical results regarding the number (two or four) of mini 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 < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference

  1. A Randomized Study Comparing Skin Staples with Subcuticular Sutures for Wound Closure at Caesarean Section in Black-Skinned Women

    PubMed Central

    Abdus-Salam, Rukiyat Adeola; Bello, Folasade Adenike; Olayemi, Oladapo

    2014-01-01

    This study aimed to compare patients' satisfaction and outcome of caesarean section wound closure by skin staples and subcuticular suture at discharge and 6 weeks of postoperation. It was a randomized controlled trial of pregnant women scheduled for caesarean section at the University College Hospital, Ibadan, Nigeria, allocating them to wound closure by skin staples or subcuticular suture. Pain was assessed using the box numeric pain scale. Scar assessments were by patient, research nurse, and independent observers using the visual analogue scale, modified patient observer scar assessment scale, and patient satisfaction scale. Operation time (minutes) was significantly shorter in the staple group, 40.26 (±16.53) compared to 47.55 (±14.55) in the suture group (P = 0.025). Skin closure time (seconds) was significantly less in the staple group, 118.62 (±69.68) versus 388.70 (±170.40) in the suture group (P ≤ 0.001). There was no difference in pain experienced, wound assessment by the participants, and patients' satisfaction. Participants in the staple group scored higher on both scar assessment scales by the nurse (P = 0.044). Cost comparison analysis showed that staple use costs significantly more than suture use (P < 0.001). The perceived benefit of subcuticular suture over skin staples was not observed and participants were satisfied with both wound closure techniques. PMID:27437457

  2. Randomized Prospective Study of Endoscopic Rubber Band Ligation Compared With Bipolar Coagulation for Chronically Bleeding Internal Hemorrhoids

    PubMed Central

    Jutabha, Rome; Jensen, Dennis M.; Chavalitdhamrong, Disaya

    2013-01-01

    OBJECTIVES: Our purpose was to compare the efficacy, complications, success rate, recurrence rate at 1 year, and crossovers of rubber band ligation (RBL) with those of bipolar electrocoagulation (BPEC) treatment for chronically bleeding internal hemorrhoids. METHODS: A total of 45 patients of mean age 51.5 years, who had rectal bleeding from grade II or III hemorrhoids and in whom intensive medical therapy failed, were randomized in a prospective study comparing RBL with BPEC. Treatment failure was predefined as continued bleeding, occurrence of a major complication, or failure to reduce the size of all internal hemorrhoidal segments to grade I in ≤ 3 treatments. Patients were followed up for 1 year. RESULTS: With similar patients, rectal bleeding and other symptoms were controlled with significantly fewer treatments of RBL than of BPEC (2.3±0.2 vs. 3.8±0.4, P < 0.05), and RBL had a significantly higher success rate (92% vs. 62%, P< 0.05). RBL had more cases of severe pain during treatment (8% vs. 0%, P> 0.05), but significantly fewer failures and crossovers (8% vs. 38%). Symptomatic recurrence at 1 year was 10% RBL and 15% BPEC. CONCLUSIONS: For patients with chronically bleeding grade II or III internal hemorrhoids that are unresponsive to medical therapy, safety and complication rates of banding and BPEC were similar. The success rate was significantly higher with RBL than with BPEC. Symptom recurrence rates at 1 year were similar. PMID:19513028

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

    PubMed Central

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

    2017-01-01

    The aims of this study were to compare the therapeutic effects of a proton pump inhibitor (PPI), rabeprazole (RPZ), and a prokinetic agent, itopride (ITO), and to investigate the role of PPI in the treatment strategy for Japanese functional dyspepsia (FD) patients. We randomly assigned 134 patients diagnosed by Rome III criteria to 4 weeks treatment with RPZ 10 mg/day (n = 69) or ITO 150 mg/day (n = 65). Dyspeptic symptoms were evaluated using FD scores at baseline and after 1, 2 and 4 weeks of treatment. We also divided subjects into predominantly epigastric pain syndrome (EPS) or postprandial distress syndrome (PDS), and evaluated the efficacy of RPZ and ITO respectively. RPZ showed a significant decrease in the Rate of Change (RC) in FD score within 1 week, which was maintained until after 4 weeks, with RPZ a significant effect compared with ITO at all evaluation points. In addition, RPZ showed a significant decrease in FD score in subjects with both EPS and PDS, whereas a significant decrease in the RC with ITO was only shown in those with predominant PDS. Acid-suppressive therapy with RPZ is useful for PDS as well EPS in Japanese FD patients (UMIN Clinical Trials Registry number: UMIN 000013962). PMID:28366993

  4. Intralesional Mycobacterium w Vaccine Versus Cryotherapy in Treatment of Refractory Extragenital Warts: A Randomized, Open-Label, Comparative Study.

    PubMed

    Dhakar, Ashok K; Dogra, Sunil; Vinay, Keshavamurthy; Sarangal, Rishu; Kanwar, Amrinder J; Singh, Mini P

    2016-01-01

    Initial reports of immunotherapy using intralesional Mycobacterium w (Mw) vaccine have documented its useful role in treatment of genital and extragenital warts. To compare the efficacy and safety of intralesional Mw vaccine versus cryotherapy in the treatment of refractory extragenital warts. This was a prospective, randomized, comparative study of 66 patients. The outcome was assessed in terms of complete clearance of warts and change in Dermatology Life Quality Index (DLQI) score. Complete clearance of treated warts was seen in 66.7% (20/30) and 65.5% (19/29) of patients in the Mw and cryotherapy groups, respectively (P = .769). Clearance of distant warts was significantly (P = .004) high in the Mw group. Improvement in DLQI was greater in the Mw group. Both treatment modalities were well tolerated, and no major side effects occurred. Mw vaccine and cryotherapy are equally efficacious in treatment of refractory extragenital warts. Mw vaccine has an added advantage of clearance of distant warts. © The Author(s) 2015.

  5. Results from a randomized controlled study between total disc replacement and fusion compared with results from a spine register

    PubMed Central

    Berg, Svante; Tropp, Hans

    2010-01-01

    Background Difficulties in performing randomized controlled trials (RCTs) to evaluate new treatment options are increasing. Higher costs and patient unwillingness are the main obstacles. A spinal surgery register has been in use in Sweden for 11 years. Our aim was to determine whether this register can provide the same information as an RCT and whether register data compare favorably with RCT data, making RCTs unnecessary. If not the case, was patient selection or follow-up frequency the cause of any differences? Materials and methods We compared baseline data and outcome, retrieved from our register, between 2 surgical groups, total disc replacement (TDR) and fusion at 1 or 2 levels, performed for degenerative disc disease. One hundred fifty-two patients were part of an RCT, whereas four hundred fifty-five patients had been treated according to an active decision. These 2 subgroups were the subjects for comparison. Results The 2 subgroups were not similar at baseline. Patients who were fused in the non-RCT subgroup were older, had a higher Oswestry Disability Index, and were more frequently smokers than the other patients. The outcome for the non-RCT group showed larger differences in favor of TDR than the RCT did. The nonresponders in the non-RCT group showed worse life quality and disability at baseline, and patients who answered the 1-year follow-up questionnaire but not the 2-year follow-up questionnaire had an inferior clinical result compared with the other patients at 1 year. Conclusion Data from our register showed results similar to the RCT, but a register cannot fully replace an RCT study when evaluating a new treatment option if the RCT has narrower selection than just the diagnosis. In this RCT comparing TDR with posterior fusion, the normal exclusion criteria for TDR were used. These were not registered, so the register could not prevent a possible selection bias, which might also be caused by the nonresponders. PMID:25802653

  6. A randomized controlled study comparing 600 versus 1,200 microg oral misoprostol for medical management of incomplete abortion.

    PubMed

    Nguyen, Thi Nhu Ngoc; Blum, Jennifer; Durocher, Jill; Quan, Tran Thien Vinh; Winikoff, Beverly

    2005-12-01

    Although a number of studies have shown misoprostol's promise as a nonsurgical treatment for incomplete abortion, few have systematically examined treatment protocols. This study documents the effectiveness of 600 versus 1,200 microg oral misoprostol for this indication. From May 2002 to January 2003, 300 women with incomplete abortion were recruited at a large tertiary facility in Vietnam and randomized to either a single-dose (600 microg) or a repeated-dose (600 microg x 2) regimen of oral misoprostol for the treatment of their condition. Misoprostol effectively evacuated the uterus for nearly all women (94.6%; n=279), with most reporting bleeding for 4 days (+/-2.3) and pain/cramps lasting 1 day (+/-1.0). Women indicated that the side effects were tolerable (96%) and that their experience was satisfactory (95%). Oral misoprostol (600 or 1,200 microg) offers a safe, effective and acceptable treatment for incomplete abortion. Larger studies to assess the advantages and disadvantages of misoprostol as compared with standard surgical care are needed to assess its role in postabortion care programs worldwide.

  7. A randomized effectiveness study comparing trauma-focused cognitive behavioral therapy with therapy as usual for youth.

    PubMed

    Jensen, Tine K; Holt, Tonje; Ormhaug, Silje M; Egeland, Karina; Granly, Lene; Hoaas, Live C; Hukkelberg, Silje S; Indregard, Tore; Stormyren, Shirley D; Wentzel-Larsen, Tore

    2014-01-01

    The efficacy of trauma-focused cognitive behavioral therapy (TF-CBT) has been shown in several randomized controlled trials. However, few trials have been conducted in community clinics, few have used therapy as usual (TAU) as a comparison group, and none have been conducted outside of the United States. The objective of this study was to evaluate the effectiveness of TF-CBT in regular community settings compared with TAU. One hundred fifty-six traumatized youth (M age = 15.1 years, range = 10-18; 79.5% girls) were randomly assigned to TF-CBT or TAU. Intent-to-treat analysis using mixed effects models showed that youth receiving TF-CBT reported significantly lower levels of posttraumatic stress symptoms (est. = 5.78, d = 0.51), 95% CI [2.32, 9.23]; depression (est. = 7.00, d = 0.54), 95% CI [2.04, 11.96]; and general mental health symptoms (est. = 2.54, d = 0.45), 95% CI [0.50, 4.58], compared with youth in the TAU group. Youth assigned to TF-CBT showed significantly greater improvements in functional impairment (est. = -1.05, d = -0.55), 95% CI [-1.67, -0.42]. Although the same trend was found for anxiety reduction, this difference was not statistically significant (est. = 4.34, d = 0.30), 95% CI [-1.50, 10.19]. Significantly fewer youths in the TF-CBT condition were diagnosed with posttraumatic stress disorder compared to youths in the TAU condition, χ(2)(1, N = 116) = 4.61, p = .031, Phi = .20). Findings indicate that TF-CBT is effective in treating traumatized youth in community mental health clinics and that the program may also be successfully implemented in countries outside the United States.

  8. Randomized, double-blind, comparative study of grepafloxacin and amoxycillin in the treatment of patients with community-acquired pneumonia.

    PubMed

    O'Doherty, B; Dutchman, D A; Pettit, R; Maroli, A

    1997-12-01

    This randomized, multicentre, double-blind, double-dummy study assessed the efficacy and safety of 7 or 10 day regimens of grepafloxacin, 600 mg od, compared with amoxycillin, 500 mg tds, in the treatment of community-acquired pneumonia (CAP). A total of 264 patients were recruited at 43 centres (127 received grepafloxacin and 137 received amoxycillin), of whom 207 patients (78%) completed the study. Clinical and microbiological efficacy were assessed at the end-of-treatment visit (3-5 days after the last dose) and at the follow-up visit (28-42 days after the last dose). At follow-up, patients in the evaluable population treated with grepafloxacin demonstrated a clinical response rate (76%; 87/114) equivalent to that seen with amoxycillin (74%, 85/111, 95% CI = -12%, 10%) while, in the intent-to-treat population with a documented bacterial pathogen, the clinical success rate in the grepafloxacin group (78%, 29/37) was significantly higher than in the amoxycillin group (58%, 28/48), 95% CI = 2%, 43%). In patients from the evaluable population in whom the pathogens were documented the clinical success rate favoured grepafloxacin, compared with amoxycillin (79%, 26/33 versus 63%, 26/42, respectively; 95% CI = -5.2%, 38.1%). Microbiological eradication with grepafloxacin was statistically superior to amoxycillin in the evaluable population; the success rate was 89% (32/36) in the grepafloxacin group compared with 71% (32/45) for the amoxycillin group (95% CI = 2%, 37%). The pathogens most commonly isolated from patients were Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae. The success rates for infections caused by S. pneumoniae and H. influenzae at follow-up were higher with grepafloxacin than with amoxycillin. Grepafloxacin was well tolerated, with a safety profile comparable to that of amoxycillin. The therapeutic judgement of patients and investigators at the patient's last visit, as well as the assessment of individual respiratory signs

  9. Clinical efficacy of intra-articular injections in knee osteoarthritis: a prospective randomized study comparing hyaluronic acid and betamethasone

    PubMed Central

    Trueba Davalillo, Cesáreo Ángel; Trueba Vasavilbaso, Cesáreo; Navarrete Álvarez, José Mario; Coronel Granado, Pilar; García Jiménez, Ozcar Alejandro; Gimeno del Sol, Mercedes; Gil Orbezo, Félix

    2015-01-01

    Background Osteoarthritis (OA) is the most common joint disease and leading cause of disability. Intra-articular (IA) administration of hyaluronic acid (HA) or corticosteroids (CS) have been previously studied, though using insufficient number of patients or short follow-up periods. Objective We evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months. Methods We used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM). The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale). Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months. Results A total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1) compared to 8.2% (95% CI: 5.2–11.1) in BM (P<0.0001). Function improvement was higher in HA through every visit, and mean improvement at 12 months was 47.5% (95% CI: 45.6–49.3) in HA patients vs 13.2% (95% CI: 11.4–14.9) in the BM group (P<0.0001). All patients from both groups achieved the Minimal Clinically Important Improvement (MCII) for both pain and function up to 6 months. At 9 months and 12 months, the MCII figures were higher in HA group with ≥80% compared to ≤10% in BM group (P<0.0001). Adverse reactions were rare and related to the administration procedure. Conclusion Both treatments effectively controlled OA symptoms. BM showed higher short-term effectiveness, while HA showed better long-term effectiveness, maintaining clinical efficacy in a large number of patients 1 year after administration. PMID:27790040

  10. Randomized in situ clinical study comparing the ability of two new desensitizing toothpaste technologies to occlude patent dentin tubules.

    PubMed

    West, N X; Macdonald, E L; Jones, S B; Claydon, N C A; Hughes, N; Jeffery, P

    2011-01-01

    To compare the ability of two new desensitizing toothpaste technologies (one a 5% NovaMin-based toothpaste and the other an 8% arginine-based toothpaste) to occlude patent dentin tubules in a clinical environment relative to a negative control of water and a control toothpaste after four days of twice-daily brushing and dietary acidic challenges. The study design was a single-center, single-blind, randomized, split-mouth, four-treatment, two-period, crossover, in situ clinical study. Healthy subjects wore two lower intra-oral appliances, retaining four dentin samples for four treatment days for each period of the clinical study. Samples were brushed twice daily with a test product (days 1-4), with an additional acidic challenge introduced on two selective days. Scanning electron microscopy (SEM) images were taken of the dentin surface, and dentinal tubule occlusion assessed using a categorical scale. The results demonstrated that the 5% NovaMin toothpaste was statistically superior at occluding patent dentin tubules compared to water (p = 0.009) and the control toothpaste (p = 0.02) at day 4. In contrast, the treatment effect resulting from the 8% arginine toothpaste did not demonstrate the same degree of occlusive propensity, showing no significant difference to the water and control toothpaste at the day 4 time point. Application of the 5% NovaMin toothpaste to dentin showed better dentin tubule occlusion and retention abilities in an oral environment under dietary acid challenge conditions, more so than the 8% arginine toothpaste technology. Given modern dietary habits and practices, these results highlight differences in the acid resistance properties of occlusion technologies, and a potential impact on clinical performance.

  11. Post-operative ovarian adhesion formation after ovarian drilling: a randomized study comparing conventional laparoscopy and transvaginal hydrolaparoscopy.

    PubMed

    Giampaolino, Pierluigi; Morra, Ilaria; Tommaselli, Giovanni Antonio; Di Carlo, Costantino; Nappi, Carmine; Bifulco, Giuseppe

    2016-10-01

    To compare conventional laparoscopic ovarian drilling (LOD) with transvaginal hydrolaparoscopy (THL) ovarian drilling in terms of ovarian adhesion formation, evaluated using office THL during follow-up in CC-resistant anovulatory patients affected by PCOS. Prospective randomized study on 246 CC-resistant women with PCOS. The patients enrolled were divided into two groups, 123 were scheduled to undergo LOD and 123 to undergo THL ovarian drilling. Six months after the procedure all patients were offered office transvaginal hydrolaparoscopy (THL) follow-up, under local anesthesia to evaluate adhesion formation. Duration of the procedure was significantly shorter in the THL group in comparison with LOD group (p < 0.0001). No intra- or post-operative complication was observed in any of the patients in both groups. Post-operative THL follow-up after 6 months showed that 15 (15.5 %) patients in the THL group and 73 (70.2 %) in the LOD group showed the presence of ovarian adhesion. This difference was highly significant with a p value <0.0001 and a relative risk of 0.22 [95 % IC 0.133-0.350]. This study seems to indicate that THL ovarian drilling may reduce the risk of ovarian adhesion formation and could be used as a safe and effective option to reduce ovarian adhesion formation in patients undergoing ovarian drilling.

  12. Smile analysis in rhinoplasty: a randomized study for comparing resection and transposition of the depressor septi nasi muscle.

    PubMed

    Kalantar-Hormozi, Abdoljalil; Beiraghi-Toosi, Arash

    2014-02-01

    The depressor septi nasi muscle is responsible for smiling deformity. Its manipulation is beneficial in patients with muscle hypertrophy. In addition, it enhances the smile and tip-lip relationship. In this study, depressor septi nasi muscle excision through a transfixion incision is compared with its transposition through an upper labial sulcus incision. Two techniques of depressor septi nasi muscle treatment were performed randomly for rhinoplasty cases. Smile analysis in rhinoplasty, consisting of measurements of nasal length, nasal diagonal, tip projection, and upper lip height, and noting transverse upper labial crease in repose and full smile, was performed on preoperative and postoperative photographs. One hundred patients were studied in two equal groups. Preoperatively, tip projection and upper lip height were decreased significantly with smiling. Generally, the effect of smiling on all five parameters was decreased significantly following rhinoplasty. The two different techniques were not significantly different in decreasing the effects of smiling on nasal length, nasal diagonal, tip projection, upper lip height, or transverse crease. The two different techniques were the same in decreasing the effects of smiling. The authors recommend smile analysis in rhinoplasty, consisting of measurement of nasal length, nasal diagonal, tip projection, and upper lip height, and noting transverse upper labial crease in repose and during smiling, before rhinoplasty for preoperative evaluation and after the operation for outcome assessment. Depressor septi nasi muscle treatment should be considered if a decrease in tip projection or upper lip height with smiling or a transverse upper labial crease during smiling is extraordinary or unsightly. Therapeutic, II.

  13. [Random comparative study between intrauterine device Multiload Cu375 and TCu 380a inserted in the postpartum period].

    PubMed

    Lara Ricalde, Roger; Menocal Tobías, Gerardo; Ramos Pérez, Carlos; Velázquez Ramírez, Norma

    2006-06-01

    To evaluate safety and effectiveness of the intrauterine device Multiload Cu375 compared with the TCu 380A inserted in the postpartum period. In a randomized comparative study carried out in the National Perinatology Institute, intrauterine devices MLCu 375 and Tcu 380A were inserted to 157 patients who voluntary accepted, and previously signed informed consent. There were four instances for the intrauterine devices insertion: within 10 minutes after vaginal delivery, during cesarean section (immediate postplacental insertion) and postpartum-postcesarean insertion (in the time range of 10 min to 48 h). All insertions were made with ring forceps. From 1 h to 24 h later, abdominal ultrasound examinations were performed to assess the distances between the upper part of the device to the fundus of uterine cavity. Follow up visits were scheduled at 3, 6, 9 and 12 months. Net cumulative life table event rates of discontinuations were estimated at one year. The expulsion rates were 10.4 for the MLCu 375 and 7.7 for the TCu 380A and they were not influenced by the moment of the intrauterine device insertion, not by the cervical dilatation, neither by the distance of the intrauterine device to the fundus of uterine cavity. The removal rates for bleeding and pain were 4.9 and 4.8, the removal rates for non medical reasons were 3.7 and 4.9 respectively. There was one case of genital infection in the MLCu 375 group. There were no pregnancies, nor uterine perforation. The one year continuation rates were 77.1 and 82.6 respectively. There were no statistical significant differences in the comparative rates. The intrauterine device MLCu 375 is as safe and effective as the TCu380A when they are inserted in the postpartum period.

  14. A predictive enrichment procedure to identify potential responders to a new therapy for randomized, comparative controlled clinical studies.

    PubMed

    Li, Junlong; Zhao, Lihui; Tian, Lu; Cai, Tianxi; Claggett, Brian; Callegaro, Andrea; Dizier, Benjamin; Spiessens, Bart; Ulloa-Montoya, Fernando; Wei, Lee-Jen

    2016-09-01

    To evaluate a new therapy versus a control via a randomized, comparative clinical study or a series of trials, due to heterogeneity of the study patient population, a pre-specified, predictive enrichment procedure may be implemented to identify an "enrichable" subpopulation. For patients in this subpopulation, the therapy is expected to have a desirable overall risk-benefit profile. To develop and validate such a "therapy-diagnostic co-development" strategy, a three-step procedure may be conducted with three independent data sets from a series of similar studies or a single trial. At the first stage, we create various candidate scoring systems based on the baseline information of the patients via, for example, parametric models using the first data set. Each individual score reflects an anticipated average treatment difference for future patients who share similar baseline profiles. A large score indicates that these patients tend to benefit from the new therapy. At the second step, a potentially promising, enrichable subgroup is identified using the totality of evidence from these scoring systems. At the final stage, we validate such a selection via two-sample inference procedures for assessing the treatment effectiveness statistically and clinically with the third data set, the so-called holdout sample. When the study size is not large, one may combine the first two steps using a "cross-training-evaluation" process. Comprehensive numerical studies are conducted to investigate the operational characteristics of the proposed method. The entire enrichment procedure is illustrated with the data from a cardiovascular trial to evaluate a beta-blocker versus a placebo for treating chronic heart failure patients. © 2015, The International Biometric Society.

  15. Prospective randomized multicentre study comparing stapler haemorrhoidopexy with Doppler-guided transanal haemorrhoid dearterialization for third-degree haemorrhoids.

    PubMed

    Infantino, A; Altomare, D F; Bottini, C; Bonanno, M; Mancini, S; Yalti, T; Giamundo, P; Hoch, J; El Gaddal, A; Pagano, C

    2012-02-01

    Doppler-guided transanal haemorrhoid dearterialization (THD) and stapler haemorrhoidopexy (SH) have been demonstrated to be less painful than the Milligan-Morgan procedure. The aim of this study was to compare the effectiveness of THD vs SH in the treatment of third-degree haemorrhoids in an equivalent trial. One hundred and sixty-nine patients with third-degree haemorrhoids were randomized online to receive THD (n = 85) or SH (n = 84) in 10 Colorectal Units in which the staff were well trained in both techniques. The mean follow-up period was 17 (range 15-20) months. Early minor postoperative complications occurred in 30.6% of patients in the THD group and in 32.1% of patients in the SH group. Milder spontaneous pain and pain on defecation were reported in the THD group in the first postoperative week, but this was not statistically significant. Late complications were significantly higher (P = 0.028) in the SH group. Residual haemorrhoids persisted in 12 patients in the THD group and in six patients in the SH group (P = 0.14). Six patients in the SH group and 10 in the THD group underwent further treatment of haemorrhoids (P = 0.34). No differences were found in postoperative incontinence. The obstructed defecation score (ODS) was significantly higher in the SH group (P < 0.02). Improvement in quality of life was similar in both groups. Postoperative in-hospital stay was 1.14 days in the THD group and 1.31 days in the SH group (P = 0.03). Both THD and SH techniques are effective for the treatment of third-degree haemorrhoids in the medium term. THD has a better cost-effective ratio and lower (not significant) pain compared with SH. Postoperative pain and recurrence did not differ significantly between the two groups. © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.

  16. Eight-year results of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation.

    PubMed

    Gatault, Philippe; Bertrand, Dominique; Büchler, Matthias; Colosio, Charlotte; Hurault de Ligny, Bruno; Weestel, Pierre-François; Rerolle, Jean-Philippe; Thierry, Antoine; Sayegh, Johnny; Moulin, Bruno; Snanoudj, Renaud; Rivalan, Joseph; Heng, Anne-Elisabeth; Sautenet, Bénédicte; Lebranchu, Yvon

    2016-01-01

    We present the results at 8 years of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in kidney transplant recipients at low immunologic risk. We assessed estimated glomerular filtration (eGFR), graft, patient, and death-censored graft survival (log-rank compared), de novo DSA appearance, risk of malignancy, post-transplant diabetes mellitus (PTDM), and anemia. Intent-to-treat and on-treatment analyses were performed. Graft survival was similar in both groups (sirolimus: 73.3%, cyclosporine: 77.7, P = 0.574). No difference was observed between treatment groups concerning patient survival (P = 0.508) and death-censored graft survival (P = 0.858). In conditional intent-to-treat analysis, mean eGFR was greater in sirolimus than in cyclosporine group (62.5 ± 27.3 ml/min vs. 47.8 ± 17.1 ml/min, P = 0.004), in particular because graft function was excellent in patients maintained under sirolimus (eGFR = 74.0 ml/min). Importantly, no detrimental impact was observed in patients in whom sirolimus has been withdrawn (eGFR = 49.5 ml/min). Overall, 17 patients showed de novo DSAs, with no difference between the two groups (P = 0.520). Malignancy did not differ by treatment. An initial maintenance regimen based on sirolimus provides a long-term improvement in renal function for kidney transplant patients, especially for those maintained on sirolimus. © 2015 Steunstichting ESOT.

  17. A Randomized Cadaver Study Comparing First-Attempt Success Between Tibial and Humeral Intraosseous Insertions Using NIO Device by Paramedics

    PubMed Central

    Szarpak, Lukasz; Truszewski, Zenon; Smereka, Jacek; Krajewski, Paweł; Fudalej, Marcin; Adamczyk, Piotr; Czyzewski, Lukasz

    2016-01-01

    Abstract Medical personnel may encounter difficulties in obtaining intravenous (IV) access during cardiac arrest. The 2015 American Heart Association guidelines and the 2015 European Resuscitation Council guidelines for cardiopulmonary resuscitation (CPR) suggest that rescuers establish intraosseous (IO) access if an IV line is not easily obtainable. The aim of the study was to compare the success rates of the IO proximal tibia and proximal humerus head access performed by paramedics using the New Intraosseous access device (NIO; Persys Medical, Houston, TX, USA) in an adult cadaver model during simulated CPR. In an interventional, randomized, crossover, single-center cadaver study, a semi-automatic spring-load driven NIO access device was investigated. In total, 84 paramedics with less than 5-year experience in Emergency Medical Service participated in the study. The trial was performed on 42 adult cadavers. In each cadaver, 2 IO accesses to the humerus head, and 2 IO accesses to the proximal tibia were obtained. The success rate of the first IO attempt was 89.3% (75/84) for tibial access, and 73.8% (62/84) for humeral access (P = 0.017). The procedure times were significantly faster for tibial access [16.8 (interquartile range, IQR, 15.1–19.9] s] than humeral access [26.7 (IQR, 22.1–30.9) s] (P < 0.001). Tibial IO access is easier and faster to put in place than humeral IO access. Humeral IO access can be an alternative method to tibial IO access. Trial Registration: clinicaltrials.gov Identifier: NCT02700867. PMID:27196493

  18. A self-help book is better than sleep hygiene advice for insomnia: a randomized controlled comparative study.

    PubMed

    Bjorvatn, Bjørn; Fiske, Eldbjørg; Pallesen, Ståle

    2011-12-01

    The objective was to compare the effects of two types of written material for insomnia in a randomized trial with follow-up after three months. Insomniacs were recruited through newspaper advertisements to a web-based survey with validated questionnaires about sleep, anxiety, depression, and use of sleep medications. A self-help book focusing on cognitive behavioral therapy for insomnia was compared to standard sleep hygiene advice; 77 and 78 participants were randomized to self-help book or sleep hygiene advice, respectively. The response rate was 81.9%. The self-help book gave significantly better scores on the sleep questionnaires compared to sleep hygiene advice. The proportion using sleep medications was reduced in the self-help book group, whereas it was increased in the sleep hygiene group. Compared to pre-treatment, the self-help book improved scores on the sleep (effect sizes 0.61-0.62) and depression (effect size 0.18) scales, whereas the sleep hygiene advice improved scores on some sleep scales (effect sizes 0.24-0.28), but worsened another (effect size -0.36). In addition, sleep hygiene advice increased the number of days per week where they took sleep medications (effect size -0.50). To conclude, in this randomized controlled trial, the self-help book improved sleep and reduced the proportion using sleep medications compared to sleep hygiene advice. The self-help book is an efficient low-threshold intervention, which is cheap and easily available for patients suffering from insomnia. Sleep hygiene advice also improved sleep at follow-up, but increased sleep medication use. Thus, caution is warranted when sleep hygiene advice are given as a single treatment.

  19. A randomized side-by-side study comparing alexandrite laser at different pulse durations for port wine stains.

    PubMed

    Carlsen, Berit C; Wenande, Emily; Erlendsson, Andres M; Faurschou, Annesofie; Dierickx, Christine; Haedersdal, Merete

    2017-01-01

    Pulsed dye laser (PDL) represents the gold-standard treatment for port wine stains (PWS). However, approximately 20% of patients are poor responders and yield unsatisfactory end-results. The Alexandrite (Alex) laser may be a therapeutic alternative for selected PWS subgroups, but optimal laser parameters are not known. The aim of this study was to assess clinical PWS clearance and safety of Alex laser at a range of pulse durations. Sixteen individuals (14 previously PDL-treated) with deep red (n = 4), purple macular (n = 5) and purple hypertrophic (n = 7) PWS were included. Four side-by-side test areas were marked within each lesion. Three test areas were randomized to Alex laser at pulse durations of 3, 5, or 10 ms (8 mm spot, DCD 60/40), while the fourth was untreated. The lowest effective fluence to create purpura within the entire test spot was titrated and applied to intervention areas. Standardized clinical photographs were taken prior to, immediately after laser exposure and at 6-8 weeks follow up. Clinical PWS clearance and laser-related side effects were assessed using clinical photos. Alex laser at 3, 5, and 10 ms pulse durations demonstrated significant clearance compared to untreated controls (P < 0.001). Three milli second pulse duration exhibited improved clearance versus 5 ms (P = 0.016) and 10 ms (P = 0.004), while no difference between five and 10 ms was shown (P = 0.063). Though not significant, good responders (>50% clearance) were more likely to have purple hypertrophic PWS (5/7) compared to purple macular (2/5) and deep red lesions (1/4). Eight laser-exposed test areas (17%) developed hypopigmented atrophic scarring. Side effects tended to be more frequently observed with 5 ms (n = 4) and 10 ms (n = 3) versus 3 ms pulse duration (n = 1). Correspondingly, 3 ms was associated with a superior (n = 6) or comparable (n = 10) overall cosmetic appearance for all individuals. Alex

  20. [A randomized comparative study assessing once versus twice a day treatment of benign prostatic hyperplasia with terazosin].

    PubMed

    Suzuki, H; Ohnishi, T; Ikemoto, I; Ohishi, Y; Suzuki, Y; Yamazaki, H

    2001-02-01

    We compared the efficacy of once a day administration of terazosin hydrochloride with that of twice a day administration for benign prostatic hyperplasia (BPH) patients. Forty-two patients with BPH were randomly assigned to receive a maximum dose of 2 mg terazosin either once (n = 21) or twice (n = 21) a day. International prostate symptom score (IPSS), uroflowmetry and side effect profile were determined before and 4 weeks after randomization. Both groups were similar with respect to patient age, baseline IPSS and prostate volume. After 4 weeks of treatment with terazosin, significant improvement in IPSS, maximum flow rate and mean flow rate were observed in both groups. However, these improvements did not differ significantly between them. In addition, there were no differences in side effects between the groups. In conclusion, once a day administration of terazosin hydrochloride is as effective and safe as twice a day administration in patients with BPH.

  1. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.

    PubMed

    Harbeck, Nadia; Lipatov, Oleg; Frolova, Mona; Udovitsa, Dmitry; Topuzov, Eldar; Ganea-Motan, Doina Elena; Nakov, Roumen; Singh, Pritibha; Rudy, Anita; Blackwell, Kimberly

    2016-06-01

    This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1). Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 10(9)/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin. For DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09-0.23; 95% CI: -0.12-0.26). LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.

  2. A randomized multicenter study of remifentanil compared with alfentanil, isoflurane, or propofol in anesthetized pediatric patients undergoing elective strabismus surgery.

    PubMed

    Davis, P J; Lerman, J; Suresh, S; McGowan, F X; Coté, C J; Landsman, I; Henson, L G

    1997-05-01

    Remifentanil hydrochloride is a new, ultrashort-acting opioid metabolized by nonspecific plasma and tissue esterases. We conducted this multicenter study to examine the hemodynamic response and recovery profile of premedicated children undergoing strabismus repair who were randomly assigned to receive one of four treatment drugs (remifentanil, alfentanil, isoflurane, or propofol) along with nitrous oxide and oxygen for maintenance of anesthesia. Induction of anesthesia was by nitrous oxide, oxygen, and halothane or nitrous oxide, oxygen, and propofol. Anesthesia was then maintained with remifentanil 1.0 microgram/kg over 30-60 s, followed by a constant infusion of 1.0 microgram.kg-1.min-1, alfentanil 100 micrograms/kg bolus followed by a constant infusion of 2.5 micrograms.kg-1.min-1, propofol 2.5 mg/kg bolus followed by a constant infusion of 200 micrograms.kg-1.min-1, or isoflurane 1.0 minimum alveolar anesthetic concentration. The infusions of the anesthetics and the administration of the inhaled gases were adjusted clinically by predetermined protocols. Elapsed time intervals from the end of surgery to the time the patients were tracheally extubated and displayed purposeful movement, as well as the time the patients met the postanesthesia care unit (PACU) and hospital discharge times, were recorded. Heart rate and systolic and diastolic blood pressure were measured at fixed intervals. In addition, cardiovascular side effects (bradycardia, hypotension, and hypertension) as well as vomiting, pruritus, agitation, and postoperative hypoxemia were also noted. There were no significant differences in patient demographics among the treatment groups. There was no difference in the early recovery variables (times to extubation and purposeful movement) or the times to PACU and hospital discharge among groups. There were significant differences in side effects among the groups. Patients who received remifentanil had higher PACU objective pain-discomfort scores than those

  3. Acceptability, Feasibility, and Cost of Telemedicine for Nonacute Headaches: A Randomized Study Comparing Video and Traditional Consultations

    PubMed Central

    Alstadhaug, Karl Bjørnar; Bekkelund, Svein Ivar

    2016-01-01

    Background The feasibility of telemedicine in diagnosing and treating nonacute headaches, such as primary headaches (migraine and tension-type) and medication-overuse headaches has not been previously investigated. By eliminating the need of travel to specialists, telemedicine may offer significant time and money savings. Objectives Our objective was to estimate the acceptance of telemedicine and investigate the feasibility and cost savings of telemedicine consultations in diagnosing and treating nonacute headaches. Methods From September 2012 to March 2015, nonacute headache patients from Northern Norway who were referred to neurologists through an electronic application system were consecutively screened and randomized to participate in either telemedicine or traditional specialist visits. All patients were consulted by two neurologists at the neurological department in Tromsø University Hospital. Feasibility outcomes were compared between telemedicine and traditional groups. Baseline characteristics and costs were then compared between rural and urban patients. Travel costs were calculated by using the probabilistic method of the Norwegian traveling agency: the cheapest means of public transport for each study participant. Loss of pay was calculated based on the Norwegian full-time employee’s average salary: < 3.5 hours=a half day’s salary, > 3.5 hours spent on travel and consultation=one day’s salary. Distance and time spent on travel were estimated by using Google Maps. Results Of 557 headache patients screened, 479 were found eligible and 402 accepted telemedicine participation (83.9%, 402/479) and were included in the final analyses. Of these, 202 received traditional specialist consultations and 200 received telemedicine. All patients in the telemedicine group were satisfied with the video quality, and 198 (99%, 198/200) were satisfied with the sound quality. The baseline characteristics as well as headache diagnostics and follow-up appointments, and

  4. Acceptability, Feasibility, and Cost of Telemedicine for Nonacute Headaches: A Randomized Study Comparing Video and Traditional Consultations.

    PubMed

    Müller, Kai Ivar; Alstadhaug, Karl Bjørnar; Bekkelund, Svein Ivar

    2016-05-30

    The feasibility of telemedicine in diagnosing and treating nonacute headaches, such as primary headaches (migraine and tension-type) and medication-overuse headaches has not been previously investigated. By eliminating the need of travel to specialists, telemedicine may offer significant time and money savings. Our objective was to estimate the acceptance of telemedicine and investigate the feasibility and cost savings of telemedicine consultations in diagnosing and treating nonacute headaches. From September 2012 to March 2015, nonacute headache patients from Northern Norway who were referred to neurologists through an electronic application system were consecutively screened and randomized to participate in either telemedicine or traditional specialist visits. All patients were consulted by two neurologists at the neurological department in Tromsø University Hospital. Feasibility outcomes were compared between telemedicine and traditional groups. Baseline characteristics and costs were then compared between rural and urban patients. Travel costs were calculated by using the probabilistic method of the Norwegian traveling agency: the cheapest means of public transport for each study participant. Loss of pay was calculated based on the Norwegian full-time employee's average salary: < 3.5 hours=a half day's salary, > 3.5 hours spent on travel and consultation=one day's salary. Distance and time spent on travel were estimated by using Google Maps. Of 557 headache patients screened, 479 were found eligible and 402 accepted telemedicine participation (83.9%, 402/479) and were included in the final analyses. Of these, 202 received traditional specialist consultations and 200 received telemedicine. All patients in the telemedicine group were satisfied with the video quality, and 198 (99%, 198/200) were satisfied with the sound quality. The baseline characteristics as well as headache diagnostics and follow-up appointments, and the investigation, advice, and prescription

  5. Assessment of the Abuse Potential of the Orexin Receptor Antagonist, Suvorexant, Compared With Zolpidem in a Randomized Crossover Study.

    PubMed

    Schoedel, Kerri A; Sun, Hong; Sellers, Edward M; Faulknor, Janice; Levy-Cooperman, Naama; Li, Xiaodong; Kennedy, William P; Cha, Jang-Ho; Lewis, Nicole M; Liu, Wen; Bondiskey, Phung; McCrea, Jacqueline B; Panebianco, Deborah L; Troyer, Matthew D; Wagner, John A

    2016-08-01

    Suvorexant is a dual orexin receptor antagonist approved in the United States and Japan for the treatment of insomnia at a maximum dose of 20 mg. This randomized double-blind crossover study evaluated the abuse potential of suvorexant in 36 healthy recreational polydrug users with a history of sedative and psychedelic drug use. Single doses of suvorexant (40, 80, and 150 mg: 2-7.5 × maximum dose), zolpidem (15 and 30 mg: 1.5-3 × maximum dose), and placebo were administered, with a 10-day washout between treatments. Subjective and objective measures, including visual analog scales (VASs), Addiction Research Center Inventory, and cognitive/psychomotor tests, were evaluated for 24-hour postdose. Suvorexant had significantly greater peak effects on "drug liking" VAS (primary endpoint) than placebo. Although effects of suvorexant on abuse potential measures were generally similar to zolpidem, they remained constant across doses, whereas zolpidem often had greater effects at higher doses. Suvorexant (all doses) had significantly fewer effects than zolpidem 30 mg on secondary measures, such as "high" VAS, Bowdle VAS, and Addiction Research Center Inventory morphine-benzedrine group. The overall incidence of abuse-related adverse events, such as euphoric mood and hallucination, was numerically lower with suvorexant than zolpidem. In agreement with its classification as a schedule IV drug, suvorexant demonstrated abuse potential, compared with placebo. The abuse potential was similar to zolpidem using certain measures, but with a reduced incidence of abuse-related adverse events. Although this suggests that the overall abuse liability of suvorexant may be lower than zolpidem, the actual abuse rates will be assessed with the postmarketing experience.

  6. A Simulation Study Comparing Epidemic Dynamics on Exponential Random Graph and Edge-Triangle Configuration Type Contact Network Models.

    PubMed

    Rolls, David A; Wang, Peng; McBryde, Emma; Pattison, Philippa; Robins, Garry

    2015-01-01

    We compare two broad types of empirically grounded random network models in terms of their abilities to capture both network features and simulated Susceptible-Infected-Recovered (SIR) epidemic dynamics. The types of network models are exponential random graph models (ERGMs) and extensions of the configuration model. We use three kinds of empirical contact networks, chosen to provide both variety and realistic patterns of human contact: a highly clustered network, a bipartite network and a snowball sampled network of a "hidden population". In the case of the snowball sampled network we present a novel method for fitting an edge-triangle model. In our results, ERGMs consistently capture clustering as well or better than configuration-type models, but the latter models better capture the node degree distribution. Despite the additional computational requirements to fit ERGMs to empirical networks, the use of ERGMs provides only a slight improvement in the ability of the models to recreate epidemic features of the empirical network in simulated SIR epidemics. Generally, SIR epidemic results from using configuration-type models fall between those from a random network model (i.e., an Erdős-Rényi model) and an ERGM. The addition of subgraphs of size four to edge-triangle type models does improve agreement with the empirical network for smaller densities in clustered networks. Additional subgraphs do not make a noticeable difference in our example, although we would expect the ability to model cliques to be helpful for contact networks exhibiting household structure.

  7. Thromboprophylaxis in patients with hip fractures: a prospective, randomized, comparative study between Org 10172 and dextran 70.

    PubMed

    Bergqvist, D; Kettunen, K; Fredin, H; Faunø, P; Suomalainen, O; Soimakallio, S; Karjalainen, P; Cederholm, C; Jensen, L J; Justesen, T

    1991-05-01

    A prospective, randomized, assessor-blind trial has been undertaken to compare the thromboprophylactic effect and safety of the heparinoid Org 10172 (a mixture of low molecular-weight sulfated glycosaminoglycuronides) and dextran 70 in patients operated on for hip fracture. Prestudy biostatistical calculations led to the need for 260 patients. Three hundred eight patients were randomized and 19 were excluded after randomization, the majority because of postponed surgery. Analyses were made on the 289 patients on an intention-to-treat basis, as well as on the 247 patients given correct prophylaxis. Diagnosis of deep vein thrombosis was based on bilateral ascending phlebography on postoperative days 10 through 12. The frequency of deep vein thrombosis on an intention-to-treat basis was 10% in the Org 10172 group and 30% in the dextran 70 group and, on the basis of correct prophylaxis, 12% and 31%, respectively, both differences being significant (p less than 0.001). Two-month mortality rates were equal in the groups. Three fatal pulmonary emboli were seen in the dextran group. Significantly more patients in the dextran group received postoperative transfusions; no other differences in various hemorrhagic parameters were seen. Thus it can be concluded that Org 10172 has a significantly better thromboprophylactic effect than does dextran in patients with hip fractures without significant side effects.

  8. Randomized Study Comparing the Effect of Carbon Dioxide Insufflation on Veins Using 2 Types of Endoscopic and Open Vein Harvesting.

    PubMed

    Krishnamoorthy, Bhuvaneswari; Critchley, William R; Nair, Janesh; Malagon, Ignacio; Carey, John; Barnard, James B; Waterworth, Paul D; Venkateswaran, Rajamiyer V; Fildes, James E; Caress, Ann L; Yonan, Nizar

    2017-10-09

    The aim of the study was to assess whether the use of carbon dioxide insufflation has any impact on integrity of long saphenous vein comparing 2 types of endoscopic vein harvesting and traditional open vein harvesting. A total of 301 patients were prospectively randomized into 3 groups. Group 1 control arm of open vein harvesting (n = 101), group 2 closed tunnel (carbon dioxide) endoscopic vein harvesting (n = 100) and Group 3 open tunnel (carbon dioxide) endoscopic vein harvesting (open tunnel endoscopic vein harvesting) (n = 100). Each group was assessed to determine the systemic level of partial arterial carbon dioxide, end-tidal carbon dioxide, and pH. Three blood samples were obtained at baseline, 10 minutes after start of endoscopic vein harvesting, and 10 minutes after the vein was retrieved. Vein samples were taken immediately after vein harvesting without further surgical handling to measure the histological level of endothelial damage. A modified validated endothelial scoring system was used to compare the extent of endothelial stretching and detachment. The level of end-tidal carbon dioxide was maintained in the open tunnel endoscopic vein harvesting and open vein harvesting groups but increased significantly in the closed tunnel endoscopic vein harvesting group (P = 0.451, P = 0.385, and P < 0.001). Interestingly, partial arterial carbon dioxide also did not differ over time in the open tunnel endoscopic vein harvesting group (P = 0.241), whereas partial arterial carbon dioxide reduced significantly over time in the open vein harvesting group (P = 0.001). A profound increase in partial arterial carbon dioxide was observed in the closed tunnel endoscopic vein harvesting group (P < 0.001). Consistent with these patterns, only the closed tunnel endoscopic vein harvesting group demonstrated a sudden drop in pH over time (P < 0.001), whereas pH remained stable for both open tunnel endoscopic vein harvesting and open vein harvesting groups (P = 0.105 and P

  9. Prospective randomized comparative study of the effectiveness and safety of electrohydraulic and electromagnetic extracorporeal shock wave lithotriptors.

    PubMed

    Sheir, Khaled Z; Madbouly, Khaled; Elsobky, Emad

    2003-08-01

    We compared the efficacy of 2 shock wave energy sources, electrohydraulic (Dornier MFL 5000, Dornier MedTech, Wessling, Germany) and electromagnetic (DLS, Dornier Lithotriptor S, Dornier MedTech), for the treatment of urinary calculi. A prospective randomized study of 694 patients with urinary stones was conducted during 12 months to compare the efficacy of the 2 machines. Entrance criteria were radiopaque single or multiple stones at any location within the kidney or the ureter, 25 mm or smaller that had not previously been treated by any means. Patients with congenital anomalies were excluded from this study with all other contraindications for extracorporeal shock wave lithotripsy. Following lithotripsy a plain abdominal film and tomograms were done 1 week after each session to determine if there were residual stones and assess the need for re-treatment. Patients were evaluated 4 weeks after lithotripsy by plane abdominal x-ray and spiral computerized tomography. Success was defined as no residual stones. Univariate and multivariate statistical analyses were performed for different variables that may have an impact on the success rate, including the type of lithotriptor. Comparisons of treatment parameters, complications and success rate for both lithotriptors were done. Of 9 variables examined with univariate analysis 6 had a significant impact on the success rate. Of these 4 maintained their statistical impact on multivariate analysis. These were side, site of the stones, renal morphology and type of lithotriptor. Treatment time was significantly shortened for DLS (54 +/- 32.9 minutes compared to 65.7 +/- 44.7 for MFL, p <0.001). The re-treatment rate was lower for DLS at 34% versus 51.6% for the MFL (p <0.001). The overall success rate was 85.4%. It was 88.5% for DLS compared to 82.4% for MFL (p = 0.03). No statistically significant difference between the lithotriptors was noted for ureteral calculi (p >0.05). The success rate was higher in the DLS group for

  10. Cardiovascular Events in a Physical Activity Intervention Compared With a Successful Aging Intervention: The LIFE Study Randomized Trial.

    PubMed

    Newman, Anne B; Dodson, John A; Church, Timothy S; Buford, Thomas W; Fielding, Roger A; Kritchevsky, Stephen; Beavers, Daniel; Pahor, Marco; Stafford, Randall S; Szady, Anita D; Ambrosius, Walter T; McDermott, Mary M

    2016-08-01

    Whether sustained physical activity prevents cardiovascular disease (CVD) events in older adults is uncertain. To test the hypothesis that cardiovascular morbidity and mortality would be reduced in participants in a long-term physical activity program. The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial. Participants were recruited at 8 centers in the United States. We randomized 1635 sedentary men and women aged 70 to 89 years with a Short Physical Performance Battery (SPPB) score of 9 or less but able to walk 400 m. The physcial activity (PA) intervention was a structured moderate-intensity program, predominantly walking 2 times per week on site for 2.6 years on average. The successful aging intervention consisted of weekly health education sessions for 6 months, then monthly. Total CVD events, including fatal and nonfatal myocardial infarction, angina, stroke, transient ischemic attack, and peripheral artery disease, were adjudicated by committee, and silent myocardial infarction was assessed by serial electrocardiograms. A limited outcome of myocardial infarction, stroke, and CVD death was also studied. Outcome assessors and adjudicators were blinded to intervention assignment. The 1635 LIFE study participants were predominantly women (67%), with a mean (SD) age of 78.7 (5.2) years; 20% were African-American, 6% were Hispanic or other race or ethnic group, and 74% were non-Latino white. New CVD events occurred in 121 of 818 PA participants (14.8%) and 113 of 817 successful aging participants (13.8%) (HR, 1.10; 95% CI, 0.85-1.42). For the more focused combined outcome of myocardial infarction, stroke, or cardiovascular death, rates were 4.6% in PA and 4.5% in the successful aging group (HR, 1.05; 95% CI, 0.67-1.66). Among frailer participants with an SPPB score less than 8, total CVD rates were 14.2% in PA vs 17.7% in successful aging (HR, 0.76; 95% CI, 0.52-1.10), compared with 15.3% vs 10.5% among those

  11. A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

    PubMed Central

    Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

    2016-01-01

    Purpose The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. Methods A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. Results At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Conclusion Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery. PMID:27920490

  12. A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects.

    PubMed

    Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

    2016-01-01

    The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite(®) (bromfenac 0.075%) compared with DuraSite(®) vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery.

  13. Continuous Ropivacaine Subfascial Wound Infusion Compared With Intrathecal Morphine for Postcesarean Analgesia: A Prospective, Randomized Controlled, Double-Blind Study.

    PubMed

    Lalmand, Manon; Wilwerth, Madeleine; Fils, Jean-François; Van der Linden, Philippe

    2017-09-01

    After cesarean delivery, postoperative pain management allows early rehabilitation and helps prevent postpartum depression and chronic pain. Our present prospective, randomized controlled, double-blind study assessed the duration and effect of intrathecal analgesia and continuous ropivacaine wound infiltration versus a control group after cesarean delivery. The primary outcome was analgesia duration, defined as time to first morphine request. Secondary outcomes were cumulative postoperative morphine consumption, number of patients who did not require IV morphine, incidence of adverse effects, and time to first ambulation. A total of 192 full-term parturients undergoing elective cesarean delivery were randomly allocated into 3 groups (control, morphine, and catheter). All patients received spinal anesthesia with 10 mg bupivacaine 0.5% hyperbaric bupivacaine (2 mL) + 5 μg of sufentanil (1 mL) and a multiholed catheter inserted into the wound. In the control group, NaCl 0.9% was administered intrathecally (0.1 mL) and through the catheter. The morphine group received 100 μg morphine (0.1 mL) intrathecally and NaCl 0.9% infused through the wound catheter. The catheter group received 0.1 mL NaCl 0.9% intrathecally and ropivacaine 0.2% infused in the catheter. Each patient received a 15-mL bolus of the dedicated solution through the catheter, which was connected to an elastomeric pump infusor delivering the same solution at a rate of 10 mL/h for 30 hours. All patients also received multimodal analgesia including acetaminophen and diclofenac. Analgesia duration was defined as the time from spinal injection (T0) to first IV morphine requirement (T1) administered via a patient-controlled IV analgesia pump. Statistical data analyses included use of the Kruskal-Wallis rank-sum test followed by the post hoc Tukey test and χ test. The duration of postoperative analgesia was increased with intrathecal morphine (380 minutes; 215-1527) and ropivacaine wound infusion (351

  14. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

    PubMed

    Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

    2016-01-01

    Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects. This study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of

  15. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study

    PubMed Central

    Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

    2016-01-01

    Background Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. Methods This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014—June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Results Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects. Conclusion This study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for

  16. Noninfiltrative anesthesia for transrectal prostate biopsy: a randomized prospective study comparing lidocaine-prilocaine cream and lidocaine-ketorolac gel.

    PubMed

    Cormio, Luigi; Lorusso, Fabrizio; Selvaggio, Oscar; Perrone, Antonia; Sanguedolce, Francesca; Pagliarulo, Vincenzo; Bufo, Pantaleo; Carrieri, Giuseppe

    2013-01-01

    Periprostatic nerve block (PPNB) is the standard anesthesia for ultrasound (US) guided transrectal prostate biopsy (TPB), but periprostatic infiltration itself constitutes a major, though often neglected, source of discomfort even in patients receiving perianal-intrarectal lidocaine-prilocaine (PILP) cream before PPNB. Noninfiltrative anesthesia therefore represents an attractive alternative to periprostatic infiltration. With this in mind, we aimed to determine the efficacy and safety of perianal-intrarectal (PI) lidocaine gel, lidocaine-ketorolac gel, and lidocaine-prilocaine cream in relieving pain during TPB. Three hundred consecutive patients scheduled for US-guided TPB were randomized 1:1:1 to receive PI administration of 5 g 2.5% lidocaine gel 10 minutes before TPB (Group 1), or a mixture of 5 g 2.5% lidocaine gel and 0.3% ketorolac tromethamine solution 1 hour before TPB (Group 2), or 5 g 2.5% lidocaine and 2.5% prilocaine cream 20 minutes before TPB (Group 3). The 0-to-10 points visual analogue scale (VAS) was used for assessing pain at probe insertion and movements (VAS-1), at prostate sampling (VAS-2), and maximal procedural pain (MPP). Complications occurring up to 20 days after the procedure were also recorded. Four (1.3%) patients were excluded because of unbearable pain during the procedure, leaving Group 1 with 98 patients, Group 2 with 99, and Group 3 with 99; the 3 groups were comparable for patients' age, serum PSA, prostate volume, and cancer detection rate. The addition of either ketorolac or prilocaine to lidocaine significantly (P < 0.0001) reduced probe-related, sampling-related, and maximal procedural pain. Compared with lidocaine-prilocaine, lidocaine-ketorolac was less effective in relieving probe-related pain (mean VAS-1: 1.47 ± 1.30 vs. 0.39 ± 0.65; P < 0.0001) but more effective in relieving sampling-related pain (mean VAS-2: 0.76 ± 0.94 vs. 1.54 ± 1.02; P < 0.0001); there was no difference in MPP (mean 1.82 ± 1.21 vs. 1.67 ± 0

  17. Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial.

    PubMed

    Bush, Terry; Lovejoy, Jennifer; Javitz, Harold; Magnusson, Brooke; Torres, Alula Jimenez; Mahuna, Stacey; Benedict, Cody; Wassum, Ken; Spring, Bonnie

    2016-07-22

    Prevalence of multiple health risk behaviors is growing, and obesity and smoking are costly. Weight gain associated with quitting smoking is common and can interfere with quit success. Efficacy of adding weight management to tobacco cessation treatment has been tested with women in group sessions over an extended period of time, but has never been tested in real-world settings with men and women seeking help to quit. This paper describes the Best Quit study which tests the effectiveness of delivering tobacco and weight control interventions via existing quitline infrastructures. Eligible and consenting smokers (n = 2550) who call a telephone quitline will be randomized to one of three groups; the standard quitline or standard quitline plus a weight management program added either simultaneously or sequentially to the tobacco program. The study aims to test: 1) the effectiveness of the combined intervention on smoking cessation and weight, 2) the cost-effectiveness of the combined intervention on cessation and weight and 3) theoretically pre-specified mediators of treatment effects on cessation: reduced weight concerns, increased outcome expectancies about quitting and improved self-efficacy about quitting without weight gain. Baseline, 6 month and 12 month data will be analyzed using multivariate statistical analyses and groups will be compared on treatment adherence, quit rates and change in weight among abstinent participants. To determine if the association between group assignment and primary outcomes (30-day abstinence and change in weight at 6 months) is moderated by pre-determined baseline and process measures, interaction terms will be included in the regression models and their significance assessed. This study will generate information to inform whether adding weight management to a tobacco cessation intervention delivered by phone, mail and web for smokers seeking help to quit will help or harm quit rates and whether a simultaneous or sequential

  18. Postoperative Nutritional Effects of Early Enteral Feeding Compared with Total Parental Nutrition in Pancreaticoduodectomy Patients: A Prosepective, Randomized Study

    PubMed Central

    Park, Joon Seong; Chung, Hye-Kyung; Hwang, Ho Kyoung; Kim, Jae Keun

    2012-01-01

    The benefits of early enteral feeding (EEN) have been demonstrated in gastrointestinal surgery. But, the impact of EEN has not been elucidated yet. We assessed the postoperative nutritional status of patients who had undergone pancreaticoduodenectomy (PD) according to the postoperative nutritional method and compared the clinical outcomes of two methods. A prospective randomized trial was undertaken following PD. Patients were randomly divided into two groups; the EEN group received the postoperative enteral feed and the control group received the postoperative total parenteral nutrition (TPN) management. Thirty-eight patients were included in our analyses. The first day of bowel movement and time to take a normal soft diet was significantly shorter in EEN group than in TPN group. Prealbumin and transferrin were significantly reduced on post-operative day (POD) 7 and were slowly recovered until POD 90 in the TPN group than in the EEN group. EEN group rapidly recovered weight after POD 21 whereas it was gradually decreased in TPN group until POD 90. EEN after PD is associated with preservation of weight compared with TPN and impact on recovery of digestive function after PD. PMID:22379336

  19. Postoperative nutritional effects of early enteral feeding compared with total parental nutrition in pancreaticoduodectomy patients: a prosepective, randomized study.

    PubMed

    Park, Joon Seong; Chung, Hye-Kyung; Hwang, Ho Kyoung; Kim, Jae Keun; Yoon, Dong Sup

    2012-03-01

    The benefits of early enteral feeding (EEN) have been demonstrated in gastrointestinal surgery. But, the impact of EEN has not been elucidated yet. We assessed the postoperative nutritional status of patients who had undergone pancreaticoduodenectomy (PD) according to the postoperative nutritional method and compared the clinical outcomes of two methods. A prospective randomized trial was undertaken following PD. Patients were randomly divided into two groups; the EEN group received the postoperative enteral feed and the control group received the postoperative total parenteral nutrition (TPN) management. Thirty-eight patients were included in our analyses. The first day of bowel movement and time to take a normal soft diet was significantly shorter in EEN group than in TPN group. Prealbumin and transferrin were significantly reduced on post-operative day (POD) 7 and were slowly recovered until POD 90 in the TPN group than in the EEN group. EEN group rapidly recovered weight after POD 21 whereas it was gradually decreased in TPN group until POD 90. EEN after PD is associated with preservation of weight compared with TPN and impact on recovery of digestive function after PD.

  20. Naso-jejunal fluid resuscitation in predicted severe acute pancreatitis: Randomized comparative study with intravenous Ringer's lactate.

    PubMed

    Sharma, Vishal; Rana, Surinder S; Sharma, Ravi; Chaudhary, Vinita; Gupta, Rajesh; Bhasin, Deepak K

    2016-01-01

    Early management of severe acute pancreatitis (SAP) includes intravenous fluid resuscitation. To confirm feasibility of naso-jejunal (NJ) fluid resuscitation using oral hydration solution (ORS) and compare its efficacy with intravenous (IV) fluid resuscitation using Ringer Lactate (RL) in predicted SAP. All patients of predicted SAP (presence of SIRS or BISAP > 2) without significant co morbidities were randomized to NJ group (ORS: 20 ml/kg bolus and then 3 mL/kg/h) or IV group (RL infusion at same rate). The groups were compared vis-à-vis persistent organ failure (POF), pancreatic necrosis, and mortality. Seventy-seven patients were assessed and after exclusion, 49 patients were randomized to either NJ (24 patients) or IV group (25). The demographic and baseline clinical profile of both groups including BISAP score (2.25 ± 0.73 and 2.32 ± 0.56), hematocrit (40.2 ± 6.8 and 38.3 ± 6.6), blood urea nitrogen (16.88 ± 6.69 and 21.44 ± 17.56 mg/dL), and intra-abdominal pressure (14.55 ± 4.8 and 14.76 ± 5.5 cm of water) were similar. NJ resuscitation had to be stopped in two patients because of abdominal discomfort and distension. The change in intra abdominal pressure after 48 h of hydration was comparable in both groups. The occurrence of POF (66.67% and 68%), pancreatic necrosis (69.5% and 76%), intervention (5 each), surgery (1 each), and mortality (16.5% and 8%) were comparable (P > 0.05). In select group of patients with SAP, NJ fluid resuscitation with ORS is feasible and is equally efficacious as IV fluid resuscitation with RL. © 2015 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  1. [Caudal epidural steroid injection in the treatment of chronic discogenic low back pain. Comparative, prospective and randomized study].

    PubMed

    Cervera-Irimia, J; Tomé-Bermejo, F

    2013-01-01

    There is no consensus on the treatment of chronic low back pain of disc origin in the medical literature. The few prospective, randomized, controlled studies evaluating the effectiveness of caudal epidural steroid injections (CESI) have obtained contradictory results. The aim of this study is to evaluate the efficacy of CEI in reducing pain and improving the associated disability. This is a prospective, randomized, case-control study of a group of 46 patients with chronic low back disc pain. Patients were randomly allocated into 2 groups to either receive fluoroscopy guided CESI (CESI-group), or oral non-steroidal anti-inflammatory drugs (NSAID-group). All patients were clinically evaluated at 4, 12, and 24 weeks, and according to the indications of the Spanish Society for Study of Diseases of the Spine (GEER). Lumbar pain, measured by the visual analog scale (VAS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ), did not improve significantly during follow-up in any of the two study groups (P>.05). Younger patients, women, patients with shorter duration of symptoms, low physical job demand, without leg pain, and sport-active, included in CESI-group showed a trend towards better results, but none reached statistical significance (P>.05). The present study has not demonstrated the superiority of CESI over NSAIDs in treating chronic low back pain of disc origin. While CESI could show some improvement in patients with degenerative lumbar disc disease, we consider it should be used with caution, informing patients about realistic expectations on the success of treatment. Copyright © 2013 SECOT. Published by Elsevier Espana. All rights reserved.

  2. A randomized study comparing visual laser ablation and transurethral evaporation of prostate in the management of benign prostatic hyperplasia.

    PubMed

    Narayan, P; Tewari, A; Aboseif, S; Evans, C

    1995-12-01

    We evaluated the safety, efficacy, failure and complications of 2 techniques of laser prostatectomy for benign prostatic hyperplasia (BPH): transurethral evaporation of the prostate (evaporation) versus visual laser ablation of the prostate (coagulation) in a randomized trial. A total of 64 consecutive patients with symptomatic BPH was randomized to undergo evaporation (32) or coagulation (32). American Urological Association symptom score, peak urinary flow rate and post-void residual urine volume were measured at baseline, and at 1, 3, 6 and 12 months. Other parameters evaluated included prostate volume by transrectal ultrasound, total laser energy per patient and per cc volume of the prostate, number of laser fibers per prostate, duration of catheterization and hospitalization, need for re-catheterization, and failure and complication rates. Our main findings were that patients undergoing laser prostatectomy using the coagulation technique (visual laser ablation of the prostate) had higher reoperation rates (16% versus 0%, p = 0.0199) and were 4 times more likely to have prolonged postoperative urinary retention (25% versus 6.3%, p = 0.0389), evaporation and coagulation were effective at relieving symptoms of prostatism with significant improvement in American Urological Association symptom scores and post-void residual urine volumes compared to baseline, improvement in peak flow rates was significantly greater in patients undergoing evaporation at 1, 3, 6 and 12 months (p < 0.001) compared to coagulation, and a significantly greater amount of laser energy was required to evaporate a unit volume of prostate tissue compared to coagulation (2,251 J./cc versus 1,036 J./cc, p < 0.03). Between the 2 major techniques of laser prostatectomy, transurethral evaporation is associated with better results at up to 12 months of followup.

  3. A Simulation Study Comparing Epidemic Dynamics on Exponential Random Graph and Edge-Triangle Configuration Type Contact Network Models

    PubMed Central

    Rolls, David A.; Wang, Peng; McBryde, Emma; Pattison, Philippa; Robins, Garry

    2015-01-01

    We compare two broad types of empirically grounded random network models in terms of their abilities to capture both network features and simulated Susceptible-Infected-Recovered (SIR) epidemic dynamics. The types of network models are exponential random graph models (ERGMs) and extensions of the configuration model. We use three kinds of empirical contact networks, chosen to provide both variety and realistic patterns of human contact: a highly clustered network, a bipartite network and a snowball sampled network of a “hidden population”. In the case of the snowball sampled network we present a novel method for fitting an edge-triangle model. In our results, ERGMs consistently capture clustering as well or better than configuration-type models, but the latter models better capture the node degree distribution. Despite the additional computational requirements to fit ERGMs to empirical networks, the use of ERGMs provides only a slight improvement in the ability of the models to recreate epidemic features of the empirical network in simulated SIR epidemics. Generally, SIR epidemic results from using configuration-type models fall between those from a random network model (i.e., an Erdős-Rényi model) and an ERGM. The addition of subgraphs of size four to edge-triangle type models does improve agreement with the empirical network for smaller densities in clustered networks. Additional subgraphs do not make a noticeable difference in our example, although we would expect the ability to model cliques to be helpful for contact networks exhibiting household structure. PMID:26555701

  4. Comparative Evaluation of Commercially Available Freeze Dried Powdered Probiotics on Mutans Streptococci Count: A Randomized, Double Blind, Clinical Study

    PubMed Central

    Nagaraj, Anup; Ganta, Shravani; Sidiq, Mohsin; Pareek, Sonia; Vishnani, Preeti; Acharya, Siddharth; Singh, Kushpal

    2015-01-01

    Objectives: Probiotic approaches are being considered to eliminate pathogenic microorganisms and are an alternative and promising way to combat infections by using harmless bacteria to displace pathogenic microorganisms. The aim of this study was to evaluate the effectiveness of commercially available freeze dried powdered probiotics on mutans streptococci count among 12–15 year-old Indian schoolchildren. Materials and Methods: The study was conducted in two phases of in-vitro (phase I) and in-vivo (phase II) study, which was a double blind, randomized and placebo controlled clinical trial. A total of 33 schoolchildren between 12–15 years were included in the study. They were randomly allocated to three groups. Group A included 11 children using freeze dried Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium bifidum and Bifidobacterium lactis. Group B included 11 children using freeze dried lactic acid bacillus only. Group C included 11 children using placebo powder. The study was conducted over a period of three weeks and examination and sampling of the subjects were done on days 0 (baseline), seven, 14 and 21. Results: For both the intervention groups A and B, statistically significant reduction (P<0.05) in salivary mutans streptococci counts was recorded up to the second week. Conclusion: Oral administration of probiotics showed a short-term effect on reduction of mutans streptococci count and showed a preventive role in caries development. PMID:27252756

  5. Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent Fracture

    PubMed Central

    van den Bergh, Joop P. W.; Bouts, Marian E.; van der Veer, Eveline; van der Velde, Robert Y.; Janssen, Marcel J. W.; Geusens, Piet P.; Winkens, Bjorn; Oldenhof, Nico J. J.; van Geel, Tineke A. C. M.

    2013-01-01

    Introduction An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate. Methods In a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models. Results There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12. Conclusions Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent

  6. A prospective randomized study comparing tenckhoff catheters inserted using the triple incision method with standard swan neck catheters.

    PubMed

    Yip, Terence; Lui, Sing Leung; Tse, Kai Chung; Xu, Hong; Ng, Flora S K; Cheng, Suk Wai; Chan, Tak Mao; Lai, Kar Neng; Lo, Wai Kei

    2010-01-01

    The downward directed exit of the swan neck catheter may decrease the risk of exit-site infection (ESI). The percentage of migrations of the swan neck catheter seems to be less than the conventional Tenckhoff catheter and the swan neck catheter is more expensive and cannot be manipulated by guidewire technique if tip migration occurs. In this study, the conventional Tenckhoff catheter was used. The straight tunnel was converted to an arcuate one using the triple incision method, resulting in a downward directed exit. The arcuate tunnel was created by passing the catheter through an additional incision located between the paramedian incision and the exit site. We compared the infective and mechanical complications of the Tenckhoff catheter with a downward exit, implanted using the triple incision method, with the swan neck catheter. 101 new peritoneal dialysis patients were prospectively randomized to receive either the Tenckhoff catheter with a downward exit, implanted using the triple incision method, or the swan neck catheter. Each patient was followed up for 24 months. 50 patients were in the triple incision method group (TIMG) and 51 were in the swan neck catheter group (SNCG). Over a mean period of 18.9 +/- 8.0 months of follow-up, ESI occurred in 35 patients (70%) in TIMG and 37 patients (72.5%) in SNCG (p = 0.83). The ESI rates were 0.71 and 1.0 episodes/catheter-year in TIMG and SNCG respectively (p = 0.21). The peritonitis rates were similar in the 2 groups (0.64 episodes/year in TIMG and 0.68 episodes/year in SNCG, p = 0.47). More patients in TIMG had tip migration [15 patients (30%) in TIMG vs 10 patients (19.6%) in SNCG] but the difference was not statistically significant. Repositioning of the catheter by guidewire manipulation was successful in patients in TIMG but not in SNCG. Overall catheter survival at 12 and 24 months was 95% and 83% in TIMG and 93% and 79% in SNCG respectively (p = 0.72). By using the conventional Tenckhoff catheter with a

  7. A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries.

    PubMed

    Prado, Marcelo Pires; Mendes, Alberto Abussamra Moreira; Amodio, Daniel Tasseto; Camanho, Gilberto Luis; Smyth, Niall A; Fernandes, Tulio Diniz

    2014-03-01

    The objective of this study was to investigate functional results, the amount of time that patients missed from regular working activities, and the incidence of residual mechanical ankle instability following conservative treatment of a first episode of severe lateral ankle ligament sprain (with articular instability). This prospective and randomized study included 186 patients with severe lateral ankle ligament injuries, who were randomly assigned into 2 conservative treatment groups. In group A, participants were treated with a walking boot with weight-bearing allowed, pain management, ice, and elevation with restricted joint mobilization for 3 weeks. In group B, patients were treated with a functional brace for 3 weeks. After this period, patients from both groups were placed in a short, functional brace for an additional 3 weeks, during which they also started a rehabilitation program. No statistically significant difference was found in pain intensity score between the 2 groups; however, functional evaluations based on the AOFAS ankle and hindfoot score system showed a statistically significant improvement in the group treated with the functional brace. In addition, the average recovery period necessary for patients of group B to resume their duties was shorter than that for patients in group A. No significant difference was detected in residual mechanical ankle instability between the 2 groups. Patients with severe lateral ankle ligament lesions treated with a functional brace were shown to exhibit somewhat better results than those treated with a walking boot, and both methods presented a very low incidence of residual chronic instability. We found adequate conservative treatment was sufficient to reestablish ankle stability and that functional treatment had a marginally better clinical short-term outcome with a shorter average recovery period. Level I, prospective randomized study.

  8. A Prospective Randomized Study to Compare the Effectiveness of Honey Dressing vs. Povidone Iodine Dressing in Chronic Wound Healing.

    PubMed

    Gulati, Sonia; Qureshi, Ashia; Srivastava, Anurag; Kataria, Kamal; Kumar, Pratik; Ji, Acharya Balakrishna

    2014-06-01

    To compare the healing of chronic wounds with honey dressing vs. Povidone iodine dressing in adult subjects with chronic wounds of ≥6 weeks of duration, attending wound care clinic in Surgical Out Patient Department of All India Institute of Medical Sciences, Surgical Out Patient Department of Jai Prakash Narayan Apex Trauma center, New Delhi. Forty five subjects were randomized into two groups i.e., Honey & Povidone iodine dressing group. Dressing was done on alternate day basis for 6 weeks of followup period. Main outcome measure was complete healing at 6 weeks. Wound healing status was assessed at 2 weekly intervals till 6 weeks. Seven out of 22 subjects in honey treated group achieved complete healing as compared to none out of 20 subjects in Povidone iodine treated group. There was a significant decrease in the wound surface area, pain score & increase in comfort score in Honey dressing group in comparison to the Povidone Iodine group at 0.05 level of significance. Honey dressing is highly effective in achieving healing in chronic wounds as compared to Povidone iodine dressing.

  9. Balloon Angioplasty Combined with Primary Stenting Versus Balloon Angioplasty Alone in Femoropopliteal Obstructions: A Comparative Randomized Study

    SciTech Connect

    Vroegindeweij, Dammis; Vos, Louwerens D.; Tielbeek, Alexander V.; Buth, Jacob; Bosch, Harrie C.M. van den

    1997-11-15

    Purpose: To evaluate whether balloon angioplasty combined with stenting (ST) of symptomatic femoropopliteal disease would provide better results compared with balloon angioplasty alone (BA). Methods: Fifty-one patients were randomized between ST (24 patients) and BA (27 patients). Follow-up comprised clinical and hemodynamic assessment and color-flow duplex ultrasound examinations. Results: Residual stenosis ({>=} 30% diameter reduction) occurred in three BA patients, but not in the ST patients. By life-table analysis the cumulative rate of clinical and hemodynamic success after 1 year with ST was 74% (SE 9%) and for those with BA 85% (SE 7%) (p0.25). The primary patency at 1 year assessed by color-flow duplex ultrasound was 62% (SE 9%) for ST-treated patients and 74% (SE 8%) for BA patients (p0.22). Occlusion occurred in five ST patients (21%) compared with two BA patients (7%). Conclusion: ST does not improve clinical and hemodynamic outcome compared with BA. Moreover, the occlusion rate in ST-treated patients is higher.

  10. A Prospective Randomized Study Comparing Mini-surgical Percutaneous Dilatational Tracheostomy With Surgical and Classical Percutaneous Tracheostomy

    PubMed Central

    Hashemian, Seyed Mohammad-Reza; Digaleh, Hadi

    2015-01-01

    Abstract Although percutaneous dilatational tracheostomy (PDT) is more accessible and less time-demanding compared with surgical tracheostomy (ST), it has its own limitations. We introduced a modified PDT technique and brought some surgical knowledge to the bedside to overcome some standard percutaneous dilatational tracheostomy relative contraindications. PDT uses a blind route of tracheal access that usually requires perioperational imaging guidance to protect accidental injuries. Moreover, there are contraindications in certain cases, limiting widespread PDT application. Different PDT modifications and devices have been represented to address the problem; however, these approaches are not generally popular among professionals due to limited accessibility and/or other reasons. We prospectively analyzed the double-blinded trial, patient and nurse head evaluating the complications, and collected data from 360 patients who underwent PDT, ST, or our modified mini-surgical PDT (msPDT, Hashemian method). These patients were divided into 2 groups—contraindicated to PDT—and randomization was done for msPDT or PDT in PDT-indicated group and msPDT or ST for PDT-contraindicated patients. The cases were compared in terms of pre and postoperational complications. Data analysis demonstrated that the mean value of procedural time was significantly lower in the msPDT group, either compared with the standard PDT or the ST group. Paratracheal insertion, intraprocedural hypoxemia, and bleeding were also significantly lower in the msPDT group compared with the standard PDT group. Other complications were not significantly different between msPDT and ST patients. The introduced msPDT represented a semiopen incision, other than blinded PDT route of tracheal access that allowed proceduralist to withdraw bronchoscopy and reduced the total time of procedure. Interestingly, the most important improvement was performing msPDT on PDT-contraindicated patients with the complication rate

  11. Effects of mobile augmented reality learning compared to textbook learning on medical students: randomized controlled pilot study.

    PubMed

    Albrecht, Urs-Vito; Folta-Schoofs, Kristian; Behrends, Marianne; von Jan, Ute

    2013-08-20

    By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the "Profile of Mood States" questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a selectivity of RPB=0.2. For m

  12. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    PubMed

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  13. A Randomized Controlled Trial Comparing Mupirocin and Polysporin Triple Ointments in Peritoneal Dialysis Patients: The MP3 Study

    PubMed Central

    McQuillan, Rory F.; Chiu, Ernest; Nessim, Sharon; Lok, Charmaine E.; Roscoe, Janet M.; Tam, Paul; Jassal, Sarbjit Vanita

    2012-01-01

    Summary Background and objectives Infectious complications remain a significant cause of peritoneal dialysis (PD) technique failure. Topical ointments seem to reduce peritonitis; however, concerns over resistance have led to a quest for alternative agents. This study examined the effectiveness of applying topical Polysporin Triple ointment (P3) against mupirocin in a multi-centered, double-blind, randomized controlled trial. Design, setting, participants, & measurements PD patients routinely applied either P3 or mupirocin ointment to their exit site. Patients were followed for 18 months or until death or catheter removal. The primary study outcome was a composite endpoint of exit-site infection (ESI), tunnel infection, or peritonitis. Results Seventy-five of 201 randomized patients experienced a primary outcome event (51 peritonitis episodes, 24 ESIs). No difference was seen in the time to first event for P3 (13.2 months; 95% confidence interval, 11.9–14.5) and mupirocin (14.0 months; 95% confidence interval, 12.7–15.4) (P=0.41). Twice as many patients reported redness at the exit site in the P3 group (14 versus 6, P=0.10). Over the complete study period, a higher rate per year of fungal ESIs was seen in patients using P3 (0.07 versus 0.01; P=0.02) with a corresponding increase in fungal peritonitis (0.04 versus 0.00, respectively; P<0.05). Conclusions This study shows that P3 is not superior to mupirocin in the prophylaxis of PD-related infections. Colonization of the exit site with fungal organisms is of concern and warrants further study. As such, the use of P3 over mupirocin is not advocated in the prophylaxis of PD-related infections. PMID:22134627

  14. A randomized controlled trial comparing mupirocin and polysporin triple ointments in peritoneal dialysis patients: the MP3 Study.

    PubMed

    McQuillan, Rory F; Chiu, Ernest; Nessim, Sharon; Lok, Charmaine E; Roscoe, Janet M; Tam, Paul; Jassal, Sarbjit Vanita

    2012-02-01

    Infectious complications remain a significant cause of peritoneal dialysis (PD) technique failure. Topical ointments seem to reduce peritonitis; however, concerns over resistance have led to a quest for alternative agents. This study examined the effectiveness of applying topical Polysporin Triple ointment (P(3)) against mupirocin in a multi-centered, double-blind, randomized controlled trial. PD patients routinely applied either P(3) or mupirocin ointment to their exit site. Patients were followed for 18 months or until death or catheter removal. The primary study outcome was a composite endpoint of exit-site infection (ESI), tunnel infection, or peritonitis. Seventy-five of 201 randomized patients experienced a primary outcome event (51 peritonitis episodes, 24 ESIs). No difference was seen in the time to first event for P(3) (13.2 months; 95% confidence interval, 11.9-14.5) and mupirocin (14.0 months; 95% confidence interval, 12.7-15.4) (P=0.41). Twice as many patients reported redness at the exit site in the P(3) group (14 versus 6, P=0.10). Over the complete study period, a higher rate per year of fungal ESIs was seen in patients using P(3) (0.07 versus 0.01; P=0.02) with a corresponding increase in fungal peritonitis (0.04 versus 0.00, respectively; P<0.05). This study shows that P(3) is not superior to mupirocin in the prophylaxis of PD-related infections. Colonization of the exit site with fungal organisms is of concern and warrants further study. As such, the use of P(3) over mupirocin is not advocated in the prophylaxis of PD-related infections.

  15. Near elimination of ventricular pacing in SafeR mode compared to DDD modes: a randomized study of 422 patients.

    PubMed

    Davy, Jean-Marc; Hoffmann, Ellen; Frey, Axel; Jocham, Kurt; Rossi, Stefano; Dupuis, Jean-Marc; Frabetti, Lorenzo; Ducloux, Pascale; Prades, Emmanuel; Jauvert, Gaël

    2012-04-01

    SafeR performance versus DDD/automatic mode conversion (DDD/AMC) and DDD with a 250-ms atrioventricular (AV) delay (DDD/LD) modes was assessed toward ventricular pacing (Vp) reduction. After a 1-month run-in phase, recipients of dual-chamber pacemakers without persistent AV block and persistent atrial fibrillation (AF) were randomly assigned to SafeR, DDD/AMC, or DDD/LD in a 1:1:1 design. The main endpoint was the percentage of Vp (%Vp) at 2 months and 1 year after randomization, ascertained from device memories. Secondary endpoints include %Vp at 1 year according to pacing indication and 1-year AF incidence based on automatic mode switch device stored episodes. Among 422 randomized patients (73.2±10.6 years, 50% men, sinus node dysfunction 47.4%, paroxysmal AV block 30.3%, bradycardia-tachycardia syndrome 21.8%), 141 were assigned to SafeR versus 146 to DDD/AMC and 135 to DDD/LD modes. Mean %Vp at 2 months was 3.4±12.6% in SafeR versus 33.6±34.7% and 14.0±26.0% in DDD/AMC and DDD/LD modes, respectively (P<0.0001 for both). At 1 year, mean %Vp in SafeR was 4.5±15.3% versus 37.9±34.4% and 16.7±28.0% in DDD/AMC and DDD/LD modes, respectively (P<0.0001 for both). The proportion of patients in whom Vp was completely eliminated was significantly higher in SafeR (69%) versus DDD/AMC (15%) and DDD/LD (45%) modes (P<0.0001 for both), regardless of pacing indication. The absolute risk of developing permanent AF or of remaining in AF for >30% of the time was 5.4% lower in SafeR than in the DDD pacing group (ns). In this selected patient population, SafeR markedly suppressed unnecessary Vp compared with DDD modes. ©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.

  16. Bilateral compared with unilateral sacral nerve stimulation for faecal incontinence: results of a randomized, single-blinded crossover study.

    PubMed

    Duelund-Jakobsen, J; Buntzen, S; Lundby, L; Sørensen, M; Laurberg, S

    2015-12-01

    This randomized single-blinded crossover study aimed to investigate whether bilateral sacral nerve stimulation (SNS) is more efficient than unilateral stimulation for faecal incontinence (FI). Patients with FI who responded during a unilateral test stimulation, with a minimum improvement of 50% were eligible. Twenty-seven patients who were accepted to enter the trial were bilaterally implanted with two permanent leads and pacemakers. Patients were randomized into three periods of 4 weeks' stimulation including unilateral right, unilateral left and bilateral stimulation. Symptoms scores and bowel habit diaries were collected at baseline and in each study period. A 1-week washout was introduced between each study period. Twenty-seven (25 female) patients with a median age of 63 (36-84) years were bilaterally implanted from May 2009 to June 2012. The median number of episodes of FI per 3 weeks significantly decreased from 17 (3-54) at baseline to 2 (0-20) during stimulation on the right side, 2 (0-42) during stimulation on the left side and 1 (0-25) during bilateral stimulation. The Wexner incontinence score improved significantly from a median of 16 (10-20) at baseline to 9 (0-14) with right-side stimulation, 10 (0-15) with left-side stimulation and 9 (0-14) with bilateral stimulation. The differences between unilateral right or unilateral left and bilateral stimulation were non-significant, for FI episodes (P = 0.3) or for Wexner incontinence score (P = 0.9). Bilateral SNS therapy for FI is not superior to standard unilateral stimulation in the short term. Equal functional results can be obtained regardless of the side of implantation. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

  17. A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity.

    PubMed

    Catenacci, Victoria A; Pan, Zhaoxing; Ostendorf, Danielle; Brannon, Sarah; Gozansky, Wendolyn S; Mattson, Mark P; Martin, Bronwen; MacLean, Paul S; Melanson, Edward L; Troy Donahoo, William

    2016-09-01

    To evaluate the safety and tolerability of alternate-day fasting (ADF) and to compare changes in weight, body composition, lipids, and insulin sensitivity index (Si) with those produced by a standard weight loss diet, moderate daily caloric restriction (CR). Adults with obesity (BMI ≥30 kg/m(2) , age 18-55) were randomized to either zero-calorie ADF (n = 14) or CR (-400 kcal/day, n = 12) for 8 weeks. Outcomes were measured at the end of the 8-week intervention and after 24 weeks of unsupervised follow-up. No adverse effects were attributed to ADF, and 93% completed the 8-week ADF protocol. At 8 weeks, ADF achieved a 376 kcal/day greater energy deficit; however, there were no significant between-group differences in change in weight (mean ± SE; ADF -8.2 ± 0.9 kg, CR -7.1 ± 1.0 kg), body composition, lipids, or Si. After 24 weeks of unsupervised follow-up, there were no significant differences in weight regain; however, changes from baseline in % fat mass and lean mass were more favorable in ADF. ADF is a safe and tolerable approach to weight loss. ADF produced similar changes in weight, body composition, lipids, and Si at 8 weeks and did not appear to increase risk for weight regain 24 weeks after completing the intervention. © 2016 The Obesity Society.

  18. Carbon dioxide laser versus erbium:YAG laser in treatment of epidermal verrucous nevus: a comparative randomized clinical study.

    PubMed

    Osman, Mai Abdel Raouf; Kassab, Ahmed Nazmi

    2017-08-01

    A verrucous epidermal nevus (VEN) is a skin disorder that has been treated using different treatment modalities with varying results. Ablative lasers such as carbon dioxide laser (CO2) and erbium:yttrium-aluminum-garnet (Er:YAG) laser have been considered as the gold standard for the treatment of epidermal nevi. To evaluate and compare the efficacy, postoperative wound healing and side effects of pulsed CO2 laser and Er:YAG laser for the treatment of verrucous epidermal nevi. Twenty patients with localized VEN were randomly divided into two groups. Group 1 was administered CO2 laser and group 2 underwent Er:YAG laser treatment. A blinded physician evaluated the photographs and dermoscopic photomicrographs for the efficacy and possible side effects. All patients received one treatment session and were followed up over a 6-month period. Both lasers induced noticeable clinical improvement, but there were no significant differences between two lasers in treatment response, patient satisfaction, duration of erythema and side effects. The average time to re-epithelialization was 13.5 days with CO2 and 7.9 days with Er:YAG laser (p< .0005). No scarring was observed in Er:YAG laser group and no lesional recurrence was detected in CO2 laser group since treatment. Apart from re-epithelialization, both lasers showed equivalent outcomes with respect to treatment response, patient satisfaction, side effects and complications.

  19. Teaching Elliptical Excision Skills to Novice Medical Students: A Randomized Controlled Study Comparing Low- and High-Fidelity Bench Models

    PubMed Central

    Denadai, Rafael; Oshiiwa, Marie; Saad-Hossne, Rogério

    2014-01-01

    Background: The search for alternative and effective forms of training simulation is needed due to ethical and medico-legal aspects involved in training surgical skills on living patients, human cadavers and living animals. Aims: To evaluate if the bench model fidelity interferes in the acquisition of elliptical excision skills by novice medical students. Materials and Methods: Forty novice medical students were randomly assigned to 5 practice conditions with instructor-directed elliptical excision skills’ training (n = 8): didactic materials (control); organic bench model (low-fidelity); ethylene-vinyl acetate bench model (low-fidelity); chicken legs’ skin bench model (high-fidelity); or pig foot skin bench model (high-fidelity). Pre- and post-tests were applied. Global rating scale, effect size, and self-perceived confidence based on Likert scale were used to evaluate all elliptical excision performances. Results: The analysis showed that after training, the students practicing on bench models had better performance based on Global rating scale (all P < 0.0000) and felt more confident to perform elliptical excision skills (all P < 0.0000) when compared to the control. There was no significant difference (all P > 0.05) between the groups that trained on bench models. The magnitude of the effect (basic cutaneous surgery skills’ training) was considered large (>0.80) in all measurements. Conclusion: The acquisition of elliptical excision skills after instructor-directed training on low-fidelity bench models was similar to the training on high-fidelity bench models; and there was a more substantial increase in elliptical excision performances of students that trained on all simulators compared to the learning on didactic materials. PMID:24700937

  20. Randomized, controlled study comparing sitz-bath and no-sitz-bath treatments in patients with acute anal fissures.

    PubMed

    Gupta, Pravinj

    2006-08-01

    To determine the efficacy and safety of sitz baths in the management of acute anal fissures. Individual patients were randomized to either receive sitz baths or no sitz baths for 4 weeks in addition to oral psyllium husk. Patients were asked to soak their hips and buttocks in a tub containing plain lukewarm water for 10 min, once after defecation in the morning and again at bedtime. Each week, the patients were called to assess pain scores and healing of fissures, whereas the level of satisfaction was recorded at the end of 4 weeks. Main outcome measures were validated pain scores and levels of satisfaction. Fifty-eight subjects were recruited for this study. In all, 52 of them completed the trial (27 in the sitz bath group and 25 in the control group). Although the pain score was lesser in the sitz bath group than in the control group, it failed to reach statistical significance. There were no significant differences in fissure healing between the two groups over the 4-week study period. However, patients in the sitz bath group reported better satisfaction levels than the control group (P < 0.01). Although no serious adverse effects were observed, two patients from sitz bath group developed perianal skin rash. This study suggests that sitz baths improve patient satisfaction in acute anal fissures. However, the healing and overall pain relief was not significant enough to attract attention. It was also found to be associated with adverse effects in few patients.

  1. [Results of a double-blind, randomized comparative study of Wobenzym-placebo in patients with cervical syndrome].

    PubMed

    Tilscher, H; Keusch, R; Neumann, K

    1996-01-01

    The results of this study are based on 30 patients per treatment group. The primary objective of this trial was evidence of a superior analgesic effect of the verum group under concomitant treatment with physicotherapeutic measures. This objective was achieved and showed a small, but statistically significant and beneficial effect of Wobenzym in the pain self ratings of the patients. The results of erythrocyte sedimentation rates (Westergreen), leukocyte counts and lymphocyte counts as secondary study parameters indicate, that the antiphlogistic effects of Wobenzym provide an additional beneficial effect for the patients suffering from cervical syndrome compared to placebo. In combination with the available safety data of this study, the final interpretation of the authors of this study leads to a superior benefit/risk ratio judgement for Wobenzym compared to placebo.

  2. A Randomized Blinded Study of the Left Ventricular Myocardial Performance Index Comparing Epinephrine to Levosimendan following Cardiopulmonary Bypass

    PubMed Central

    Salgado Filho, Marcello Fonseca; Barral, Marselha; Barrucand, Louis; Cavalcanti, Ismar Lima; Verçosa, Nubia

    2015-01-01

    Background The objective was to evaluate the effect of epinephrine and levosimendan on the left ventricle myocardial performance index in patients undergoing on-pump coronary artery by-pass grafting (CABG). Methods In a double-blind, randomized clinical trial, 81 patients (age: 45–65 years) of both genders were randomly divided to receive either epinephrine at a dosage of 0.06 mcg.kg1.min-1 (epinephrine group, 39 patients) or levosimendan at 0.2 mcg.kg1.min-1 (levosimendan group, 42 patients) during the rewarming of cardiopulmonary by-pass (CPB). Hemodynamic data were collected 30 minutes after tracheal intubation, before chest open (pre-CPB) and 10 minutes after termination of protamine (post-CPB). As the primary outcome, we evaluated the left ventricle myocardial performance index by the Doppler echocardiography. The myocardial performance index is the sum of the isovolumetric contraction time and the isovolumetric relaxation time, divided by the ejection time. Secondary outcomes were systolic and diastolic evaluations of the left ventricle and postoperative troponin I and MB-CK levels. Results Of the 81 patients allocated to the research, we excluded 2 patients in the epinephrine group and 6 patients in the levosimendan group because they didn’t wean from CPB in the first attempt. There was no statistical difference between the groups in terms of patient characteristics, risk factors, or CPB time. The epinephrine group had a lower left ventricle myocardial performance index (p = 0.0013), higher cardiac index (p = 0.03), lower systemic vascular resistance index (p = 0.01), and higher heart rate (p = 0.04) than the levosimendan group at the post-CPB period. There were no differences between the groups in diastolic dysfunction. The epinephrine group showed higher incidence of weaning from CPB in the first attempt (95% vs 85%, p = 0.0001) when compared to the levosimendan group and the norepinephrine requirement was higher in the levosimenandan group than

  3. Increased Peritoneal Dialysis Exit Site Infections Using Topical Antiseptic Polyhexamethylene Biguanide Compared to Mupirocin: Results of a Safety Interim Analysis of an Open-Label Prospective Randomized Study

    PubMed Central

    Findlay, Andrew; Serrano, Charelle; Punzalan, Sally

    2013-01-01

    Prophylactic mupirocin for peritoneal catheter exit sites reduces exit site infection (ESI) risk but engenders antibiotic resistance. We present early interim safety analysis of an open-label randomized study comparing polyhexamethylene biguanide (PHMB) and mupirocin. A total of 106 patients randomized to 53 in each group were followed up for a mean of 12.68 months per patient. On safety analysis, the PHMB group had a significantly greater ESI rate than the mupirocin group (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.09 to 0.80), leading to discontinuation of the trial. PMID:23403425

  4. A randomized study comparing triptorelin or expectant management following conservative laparoscopic surgery for symptomatic stage III-IV endometriosis.

    PubMed

    Loverro, Giuseppe; Carriero, Carmine; Rossi, A Cristina; Putignano, Giuseppe; Nicolardi, Vittorio; Selvaggi, Luigi

    2008-02-01

    To investigate the role of adjuvant treatment with gonadotropin-releasing-hormone agonist (GnRHa) following conservative surgical treatment of endometriosis. Sixty patients in the reproductive age (mean age 28.6 years), with symptomatic stages III and IV endometriosis following laparoscopic surgery and without previous hormonal treatment were enrolled in a prospective, randomized, controlled trial to compare the effects of 3-month treatment with triptorelin depot-3.75 i.m. (30 patients) versus expectant management using placebo injection (30 patients). Six patients (one in triptorelin group and five in placebo group) were lost at follow-up, the remaining 54 were suitable for analysis. Pelvic pain persistence or recurrence, endometrioma relapses and pregnancy rate were evaluated during a 5-year follow-up. The results of 29 cases treated with triptorelin and 25 that received placebo did not show significant differences in pain recurrence (P=1, RR=0.94, 95% CI=0.57-1.55), endometrioma relapse (P=0.67, RR=1.29, 95% CI=0.66-2.50), and pregnancy rate in infertile women (P=0.80, RR=0.81, 95% CI=0.37-1.80). Curves of time of pain recurrence and pregnancy during 5-year follow-up did not show significant differences between the two groups (P=0.79 and P=0.51, respectively, using Mantel-Haenzsel logrank test). Triptorelin treatment after operative laparoscopy for stage III/IV endometriosis does not appear to be superior to expectant management in terms of prevention of symptoms recurrence and endometrioma relapse, and has no influence on pregnancy rate in endometriosis-associated infertility.

  5. [Effects of paroxetine with or without zolpidem on depression with insomnia: a multi-center randomized comparative study].

    PubMed

    Ji, Jian-Lin; Liu, Wen-Juan; Zhang, Ning; Chen, Zhi-Qing; Zheng, An-Lin; Mei, Qi-Yi; Pan, Ji-Yang; Zhao, Zhong-Xin; Tao, Ming; Wang, Yu-Ping; Wei, Jing

    2007-06-19

    To compare the effects of paroxetine with or without zolpidem on depression with insomnia. 229 consecutive outpatients with the diagnosis of major depression based on the CCMD-3 criteria who visited the departments of mental counseling, psychiatric, or neurology in 11 general hospitals the country over during a period of 4 weeks, were randomly allocated into 2 groups: paroxetine + zolpidem group (Group A, treated with paroxetine 10 - 20 mg/d and zolpidem 10 mg/d H. d. for 4 weeks) and paroxetine group (Group B, treated with paroxetine only), among which 221 underwent intention-to-treat analysis and 207 underwent completer analysis (CA). Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Pittsburg sleep quality index (PSQI), and 36-item Short Form Health Survey (SF-36) were used to evaluate the outcomes. One week after the beginning of treatment the reduction of PSQI score of Group A was 5.7, showing an improvement of sleep quality, significantly higher than that of Group B (1.6), and 4 weeks later the reduction of PSQI of Group A was 9.7 +/- 3.6, significantly higher than that of Group B (6.0 +/- 3.5, both P = 0.000). Four weeks after the beginning of treatment, the HAMD reduction rate of Group A was 68.5%, significantly higher than that of Group B (56.8%, P < 0.01), and the HAMA reduction rate of Group A was 66.2%, significantly higher than that of Group B (57.1%, P < 0.01), and the SF-36 score of Group A was 66 +/- 19 (last observation carry forward analysis) or 67 +/- 19 (CA), significantly higher than those of Group B (38 +/- 16 or 67 +/- 19 respectively, both P = 0.000). selective serotonin reuptake inhibitor antidepressant combined with hypnotic augments the effects of antidepressant on the depressive and anxiety symptoms.

  6. Comparative effects of atenolol and clonidine on polygraphically recorded sleep in hypertensive men: a randomized, double-blind, crossover study.

    PubMed

    Danchin, N; Genton, P; Atlas, P; Anconina, J; Leclere, J; Cherrier, F

    1995-01-01

    The effects on sleep of atenolol and clonidine were compared in 8 hypertensive men (mean age 46.9 years, range 16-56 years) without prior history of sleep disturbances. Polygraphic sleep recordings were performed at baseline (NO) and after a single oral dose of atenolol (100 mg) or clonidine (0.15 mg) at 6:00 pm at a 48-hour interval in a double-blind randomized crossover protocol. Both medications lowered arterial pressure to a similar extent. The subjective quality of sleep was judged satisfactory after both medications, the number of patients reporting dreams decreased from 5 (NO) to 1 after each treatment night. Total sleep time decreased slightly but not significantly after atenolol (440 +/- 63 min vs 474 +/- 47 min at baseline). Sleep latency was not affected after atenolol but significantly decreased after clonidine (16.9 +/- 21.6 vs 28.6 +/- 16.6 at baseline, p < 0.02). Although rapid-eye movement (REM) sleep time decreased after atenolol (71 +/- 30 min vs 95 +/- 30 min at baseline, p < 0.05), the percentage of REM sleep was unchanged (22 +/- 7% vs 23 +/- 5%). In contrast, clonidine strikingly reduced both REM sleep time (54 +/- 28 min vs 95 +/- 30 min at baseline, p < 0.002) and percentage of REM sleep (14 +/- 6% vs 23 +/- 5%, p < 0.0005). Thus atenolol tends to decrease total sleep time but does not affect the normal architecture of sleep, clonidine has a marked hypnotic effect, similar to that of some sedative medications and significantly reduces REM sleep.

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

    PubMed Central

    2013-01-01

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

  8. A prospective randomized controlled study comparing two doses of gestodene in cyclic combined HRT preparations on endometrial physiology.

    PubMed

    Okon, M A; Lee, S; Laird, S M; Li, T C

    2001-06-01

    Postmenopausal women taking oestradiol 17-beta 2 mg daily were randomized to receive either 25 or 50 microg gestodene from day 17 to 28 of the cycle in a double-blind study. Placental protein P14 (PP14) and CA 125 concentrations in uterine flushing, endometrial morphology and irregular bleeding after 12 cycles of study were observed. Eleven and 12 women in the 25 and 50 microg groups respectively completed the study. There were no significant differences in pre-treatment biochemical and morphological indices between the groups. The median PP14 concentration increased from 332 to 5800 ng/ml (P < 0.001) and from 145 to 27 160 ng/ml (P < 0.001) in the 25 and 50 microg gestodene groups respectively. No between-group significant rise of PP14 was observed. Similarly, no significant change was seen between the initial and post-treatment concentrations of CA 125 for either group. All biopsies were atrophic at inception of the study, and both regimens produced secretory endometrial transformation in the majority of biopsies. No between-group difference was observed in the morphometric indices measured, or any significant correlation between the concentrations of PP14 or CA 125 and morphology. The mean number of days of withdrawal bleeding (3.8 and 4.2 days for 25 and 50 microg respectively) were similar. In conclusion, both regimens produced a significant rise in uterine flushing concentrations of PP14, but not CA 125. PP14 is a sensitive biochemical marker in the assessment of endometrial response to hormone replacement therapy.

  9. Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis.

    PubMed

    Stanhope, Richard; Sörgel, Fritz; Gravel, Patricia; Pannatier Schuetz, Yannic B; Zabransky, Markus; Muenzberg, Michael

    2010-11-01

    This article discusses the bioequivalence of Omnitrope (Sandoz's rhGH biosimilar) and Genotropin (reference rhGH product), assessed in the first 2 clinical phase 1 studies conducted during the development of Omnitrope. Both of these phase 1 studies were randomized, double-blind, crossover studies, each involving 24 healthy volunteers who underwent pituitary somatrope cell down-regulation using octreotide. Three different formulations of recombinant human growth hormone (rhGH) were compared: Omnitrope lyophilisate, Omnitrope liquid and Genotropin (lyophilized powder for injection). Both pharmacokinetics (area under the curve [AUC], C(max), t(max) and t(1/2)) and pharmacodynamics (serum levels of insulin-like growth factor 1, insulin-like growth factor binding protein-3 and non-esterified fatty acid) were assessed after a single subcutaneous injection of 5 mg rhGH. The 3 formulations had comparable pharmacokinetics and pharmacodynamics. All the 90% confidence intervals of the ratios of the least squares means for the pharmacokinetic and pharmacodynamic parameters AUC and C(max) were within the predefined FDA and EMEA acceptance range of 80%-125% for bioequivalence. In addition, a comparative population pharmacokinetic analysis further supports that Omnitrope lyophilisate, Omnitrope liquid and Genotropin can be regarded as equivalent in terms of pharmacokinetics. Therefore, Omnitrope lyophilisate was demonstrated to be bioequivalent to both Genotropin and the Omnitrope liquid formulation.

  10. Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients.

    PubMed

    Hu, Ruiming; Xu, Feng; Sheng, Youyu; Qi, Sisi; Han, Yumei; Miao, Ying; Rui, Wenlong; Yang, Qinping

    2015-01-01

    Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy. © 2015 Wiley Periodicals, Inc.

  11. International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C.

    PubMed

    Zeuzem, Stefan; Pawlotsky, Jean-Michel; Lukasiewicz, Esther; von Wagner, Michael; Goulis, Ioannis; Lurie, Yoav; Gianfranco, Elia; Vrolijk, Jan-Maarten; Esteban, Juan I; Hezode, Christophe; Lagging, Martin; Negro, Francesco; Soulier, Alexandre; Verheij-Hart, Elke; Hansen, Bettina; Tal, Ronen; Ferrari, Carlo; Schalm, Solko W; Neumann, Avidan U

    2005-08-01

    The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response. Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C (n=270) treated with peginterferon alfa-2a (180 microg/week) and ribavirin (1000-1200 mg/day). After 6 weeks patients were classified as rapid (RVR), slow (SPR), flat (FPR), or null responders (NUR) and randomized within each viral kinetic class to continue therapy either with an individualized or standard regimen. Individualized therapy comprised peginterferon monotherapy (48 weeks) or shorter combination therapy (24 weeks) for RVR, triple therapy with histamine (1 mg/day) (48 weeks) or prolonged combination therapy (72 weeks) for SPR, triple therapy for FPR, and high-dose peginterferon (360 microg/week) plus ribavirin for NUR patients. Patients were categorized as RVR (n=171), SPR (n=65), FPR (n=10), or NUR (n=22). Overall end-of-treatment and sustained virologic response rates were 77 and 60% in the individualized and 77 and 66% in the standard treatment arm, respectively. Histamine in addition to peginterferon and ribavirin and high-dose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR, respectively. An improvement in virologic efficacy was not achieved with the available individualized treatment options.

  12. A randomized comparative effectiveness study of Healthy Directions 2--a multiple risk behavior intervention for primary care.

    PubMed

    Emmons, Karen M; Puleo, Elaine; Greaney, Mary L; Gillman, Matthew W; Bennett, Gary G; Haines, Jess; Sprunck-Harrild, Kim; Viswanath, K

    2014-07-01

    To evaluate the effectiveness of the Healthy Directions 2 (HD2) intervention in the primary care setting. HD2 was a cluster randomized trial (conducted 3/09-11/11). The primary sampling unit was provider (n=33), with secondary sampling of patients within provider (n=2440). Study arms included: 1) usual care (UC); 2) HD2--a patient self-guided intervention targeting 5 risk behaviors; and 3) HD2 plus 2 brief telephone coaching calls (HD2+CC). The outcome measure was the proportion of participants with a lower multiple risk behavior (MRB) score by follow-up. At baseline, only 4% of the participants met all behavioral recommendations. Both HD2 and HD2+CC led to improvements in MRB score, relative to UC, with no differences between the two HD2 conditions. Twenty-eight percent of the UC participants had improved MRB scores at 6 months, vs. 39% and 43% in HD2 and HD2+CC, respectively (ps≤.001); results were similar at 18 months (p≤.05). The incremental cost of one risk factor reduction in MRB score was $310 for HD2 and $450 for HD2+CC. Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors, were relatively low cost, and thus are potentially useful for routine implementation in similar health settings. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. A Randomized Comparative Effectiveness Study of Healthy Directions 2—A Multiple Risk Behavior Intervention for Primary Care

    PubMed Central

    Emmons, Karen M.; Puleo, Elaine; Greaney, Mary L.; Gillman, Matthew W.; Bennett, Gary G.; Haines, Jess; Sprunck-Harrild, Kim; Viswanath, Vish

    2014-01-01

    Objective To evaluate the effectiveness of the Healthy Directions 2 (HD2) intervention in the primary care setting. Methods HD2 was a cluster randomized trial (conducted 3/09 – 11/11). Primary sampling unit was provider (n=33), with secondary sampling of patients within provider (n=2,440). Study arms included: 1) usual care (UC); 2) HD2-- a patient self-guided intervention targeting 5 risk behaviors; or 3) HD2 plus 2 brief telephone coaching calls (HD2+CC). The outcome measure was proportion of participants with a lower multiple risk behavior score (MRB) by follow-up. Results At baseline, only 4% of participants met all behavioral recommendations. Both HD2 and HD2+CC led to improvements in MRB score, relative to UC, with no differences between the two HD2 conditions. Twenty-eight percent of UC participants had improved MRB scores at 6 mo., vs. 39% and 43% in HD2 and HD2+CC respectively (p’s≤.001); results were similar at 18 mo. (p≤.05). The incremental cost of one risk factor reduction in MRB score was $319 in HD2 and $440 for HD2+CC. Conclusions Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors, were relatively low cost, and thus are potentially useful for routine implementation in similar health settings. PMID:24642140

  14. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study

    PubMed Central

    Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-01-01

    Introduction Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. Aim The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. Materials and Methods In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Results Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. Conclusion The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions. PMID:27630951

  15. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study.

    PubMed

    Patel, Harsh S; Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-07-01

    Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions.

  16. A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies

    PubMed Central

    Özkurt, Zübeyde Nur; Suyanı, Elif; Haznedar, Rauf; Yağcı, Münci

    2016-01-01

    Objective: Non-responsiveness to hepatitis B virus (HBV) vaccines is not rare in hemato-oncological patients due to disease-associated or treatment-induced immune suppression. Although different strategies have been employed to improve the response rates, to date there is not an approved schedule for HBV immunization in patients with hematological malignancies. We designed a prospective randomized study to evaluate the efficacy of 3 different induction regimens for HBV vaccination. Materials and Methods: In the standard-dose (SD) group, total vaccine dose delivered was 40 µg and patients were vaccinated with 20 µg at weeks 0 and 4. In the high-dose dose-intensive (HDDI) group, total vaccine dose delivered was 80 µg and patients were vaccinated with 40 µg at weeks 0 and 4. In the high-dose time-intensive (HDTI) group, total vaccine dose delivered was 80 µg and patients were vaccinated with 20 µg at weeks 0, 2, 4, and 6. Results: In a cohort of 114 patients, 38.6% responded to HBV vaccination. The response rate in the SD arm, HDDI arm, and HDTI arm was 26.2%, 29.7%, and 44.4%, respectively (p>0.05). Age was the only variable identified as having a negative impact on response. Conclusion: Short of achieving statistical significance, a higher response rate was observed in the HDTI arm. Therefore, this study supports a high-dose, time-intensive HBV vaccine induction regimen in patients with hematological malignancies who are not on chemotherapy. PMID:27094506

  17. Leiomyoma infarction after uterine artery embolization: a prospective randomized study comparing tris-acryl gelatin microspheres versus polyvinyl alcohol microspheres.

    PubMed

    Siskin, Gary P; Beck, Avi; Schuster, Michael; Mandato, Kenneth; Englander, Meridith; Herr, Allen

    2008-01-01

    To determine the degree of leiomyoma infarction after uterine artery embolization (UAE) performed with tris-acryl gelatin microspheres or polyvinyl alcohol (PVA) microspheres. Patients determined to be candidates and scheduled for UAE were randomized prospectively to receive tris-acryl gelatin microspheres or PVA microspheres. The manufacturers' recommended technique was used for both products during the UAE procedures (including the recently described refined protocol for PVA microspheres). All patients underwent magnetic resonance (MR) imaging of the pelvis with contrast agent enhancement before and after the UAE procedure. On the postprocedural MR study, the degree of tumor infarction was assessed on postcontrast images. These findings were classified as follows: 100% infarction, 90%-99% infarction, 50%-89% infarction, and less than 50% infarction. Treatment failure was defined by enhancement of more than 10% of a patient's entire tumor burden. A total of 53 patients were enrolled in this study. Twenty-seven (mean age, 44.9 years) received PVA microspheres and 26 (mean age, 45.1 years) received tris-acryl gelatin microspheres. There were no significant differences in the preprocedural uterine volume, dominant tumor volume, location of dominant tumor, and presenting symptoms between populations. In the PVA microsphere group, treatment failure was seen in eight patients (29.6%). In the tris-acryl gelatin microsphere group, treatment failure was seen in one patient (3.8%), which was a significant difference between groups (P < or = .025). There was a significantly greater degree of tumor infarction in patients treated with tris-acryl gelatin microspheres during UAE than in patients who received PVA microspheres administered in accordance with a newly refined protocol. Given the known risk of recurrence in patients with persistent tumor enhancement after UAE, it is concluded that tris-acryl gelatin microspheres should be the preferred agent for UAE at this time.

  18. Five-year results of a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation: the SPIESSER study.

    PubMed

    Lebranchu, Y; Snanoudj, R; Toupance, O; Weestel, P-F; Hurault de Ligny, B; Buchler, M; Rerolle, J-P; Thierry, A; Moulin, B; Subra, J-F; Deteix, P; Le Pogamp, P; Finzi, L; Etienne, I

    2012-07-01

    Calcineurin inhibitors improve acute rejection rates and short-term graft survival in renal transplantation, but their continuous use may be deleterious. We evaluated the 5-year outcomes of sirolimus (SRL) versus cyclosporine (CsA) immunosuppressive treatment. This observational study was an extension of the SPIESSER study where deceased donor kidney transplant recipients were randomized before transplantation to a SRL- or CsA-based regimen and followed up 1 year. Data from 131 (63 SRL, 68 CsA) out of 133 patients living with a functional graft at 1 year were collected retrospectively at 5 years posttransplant. Seventy percent of CsA patients versus 54% of SRL patients were still on the allocated treatment at 5 years (p = 0.091), most discontinuations in each group being due to safety issues. In intent-to-treat, mean MDRD eGFR was higher with SRL: 54.2 versus 45.3 mL/min with CsA (p = 0.019); SRL advantage was greater in on-treatment analyses. There were no differences for patient survival (p = 0.873), graft survival (p = 0.121) and acute rejection (p = 0.284). Adverse events were more frequent with SRL (80% vs. 60%, p = 0.015). Results confirmed the high SRL discontinuation rate due to adverse events. Nevertheless, a benefit was evidenced on renal function in patients (more than 50%) still on treatment at 5 years. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

  19. The Study of Active Monitoring in Sweden (SAMS): A randomized study comparing two different follow-up schedules for active surveillance of low-risk prostate cancer

    PubMed Central

    Carlsson, Stefan; Holmberg, Erik; Holmberg, Lars; Johansson, Eva; Josefsson, Andreas; Nilsson, Annika; Nyberg, Maria; Robinsson, David; Sandberg, Jonas; Sandblom, Dag; Stattin, Pär

    2013-01-01

    Objective Only a minority of patients with low-risk prostate cancer needs treatment, but the methods for optimal selection of patients for treatment are not established. This article describes the Study of Active Monitoring in Sweden (SAMS), which aims to improve those methods. Material and methods SAMS is a prospective, multicentre study of active surveillance for low-risk prostate cancer. It consists of a randomized part comparing standard rebiopsy and follow-up with an extensive initial rebiopsy coupled with less intensive follow-up and no further scheduled biopsies (SAMS-FU), as well as an observational part (SAMS-ObsQoL). Quality of life is assessed with questionnaires and compared with patients receiving primary curative treatment. SAMS-FU is planned to randomize 500 patients and SAMS-ObsQoL to include at least 500 patients during 5 years. The primary endpoint is conversion to active treatment. The secondary endpoints include symptoms, distant metastases and mortality. All patients will be followed for 10–15 years. Results Inclusion started in October 2011. In March 2013, 148 patients were included at 13 Swedish urological centres. Conclusions It is hoped that the results of SAMS will contribute to fewer patients with indolent, low-risk prostate cancer receiving unnecessary treatment and more patients on active surveillance who need treatment receiving it when the disease is still curable. The less intensive investigational follow-up in the SAMS-FU trial would reduce the healthcare resources allocated to this large group of patients if it replaced the present standard schedule. PMID:23883427

  20. Randomized, open-label phase 2 study comparing frontline dovitinib versus sorafenib in patients with advanced hepatocellular carcinoma.

    PubMed

    Cheng, Ann-Lii; Thongprasert, Sumitra; Lim, Ho Yeong; Sukeepaisarnjaroen, Wattana; Yang, Tsai-Shen; Wu, Cheng-Chung; Chao, Yee; Chan, Stephen L; Kudo, Masatoshi; Ikeda, Masafumi; Kang, Yoon-Koo; Pan, Hongming; Numata, Kazushi; Han, Guohong; Balsara, Binaifer; Zhang, Yong; Rodriguez, Ana-Marie; Zhang, Yi; Wang, Yongyu; Poon, Ronnie T P

    2016-09-01

    Angiogenesis inhibition by the vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) inhibitor sorafenib provides survival benefit in hepatocellular carcinoma (HCC); however, angiogenic escape from sorafenib may occur due to angiogenesis-associated fibroblast growth factor receptor (FGFR) pathway activation. In addition to VEGFR and PDGFR, dovitinib inhibits FGFR. Frontline oral dovitinib (500 mg/day, 5 days on, 2 days off; n = 82) versus sorafenib (400 mg twice daily; n = 83) was evaluated in an open-label, randomized phase 2 study of Asian-Pacific patients with advanced HCC. The primary and key secondary endpoints were overall survival (OS) and time to tumor progression (TTP) as determined by a local investigator, respectively. Patients included in the study were ineligible for surgical and/or locoregional therapies or had disease progression after receiving these therapies. The median OS (95% confidence interval [CI]) was 8.0 (6.6-9.1) months for dovitinib and 8.4 (5.4-11.3) months for sorafenib. The median TTP (95% CI) per investigator assessment was 4.1 (2.8-4.2) months and 4.1 (2.8-4.3) months for dovitinib and sorafenib, respectively. Common any-cause adverse events included diarrhea (62%), decreased appetite (43%), nausea (41%), vomiting (41%), fatigue (35%), rash (34%), and pyrexia (30%) for dovitinib and palmar-plantar erythrodysesthesia syndrome (66%) and decreased appetite (31%) for sorafenib. Subgroup analysis revealed a significantly higher median OS for patients in the dovitinib arm who had baseline plasma soluble VEGFR1 (sVEGFR1) and hepatocyte growth factor (HGF) below median levels versus at or above the median levels (median OS [95% CI]: sVEGFR1, 11.2 [9.0-13.8] and 5.7 [4.3-7.0] months, respectively [P = .0002]; HGF, 11.2 [8.9-13.8] and 5.9 [5.0-7.6] months, respectively [P = 0.0002]). Dovitinib was well tolerated, but activity was not greater than sorafenib as a frontline systemic therapy for

  1. Adverse drug reaction monitoring with angiotensin converting enzyme inhibitors: A prospective, randomized, open-label, comparative study.

    PubMed

    Sangole, Nishant V; Dadkar, Vaishali N

    2010-02-01

    Angiotensin converting enzyme inhibitors (ACEIs) are known to possess different chemical structures, and change in structure of a drug can bring about change in its adverse drug reaction (ADR) profile. The study aims to observe the incidence and severity of ADRs between the di-carboxyl group containing ACEIs (d-ACEIs) versus phosphonate group containing ACEIs (p-ACEIs), in patients suffering from essential hypertension. One hundred and twenty patients with essential hypertension were randomized into four groups receiving enalapril, lisinopril, ramipril, and fosinopril. They were followed up for four months, to observe the clinical efficacy along with the associated ADRs. Mild, dry brassy cough (% incidence; 95% CI) was observed with d-ACEIs (6.6%; 0 to 15.6) versus p-ACEI (20%; 5.7 to 34.3), in which the cough observed was moderate-to-severe in intensity and two patients required treatment discontinuation (P < 0.05). No cases of hypotension were observed with the use of d-ACEIs, whereas, two patients on p-ACEI (6.6%; 0 to15.6) had hypotension (P < 0.05). Three patients (10%; 0 to 20.7) on d-ACEIs had nausea, which was not observed with p-ACEI treatment (0%) (P < 0.05). The phosphonate group in p-ACEIs may have a probable relationship with increase in the incidence and severity of ADRs such as dry brassy cough and hypotension. The di-carboxyl group in d-ACEIs may have a probable relationship with increase in the incidence of ADRs like nausea.

  2. Adverse drug reaction monitoring with angiotensin converting enzyme inhibitors: A prospective, randomized, open-label, comparative study

    PubMed Central

    Sangole, Nishant V.; Dadkar, Vaishali N.

    2010-01-01

    Objectives: Angiotensin converting enzyme inhibitors (ACEIs) are known to possess different chemical structures, and change in structure of a drug can bring about change in its adverse drug reaction (ADR) profile. The study aims to observe the incidence and severity of ADRs between the di-carboxyl group containing ACEIs (d-ACEIs) versus phosphonate group containing ACEIs (p-ACEIs), in patients suffering from essential hypertension. Materials and Methods: One hundred and twenty patients with essential hypertension were randomized into four groups receiving enalapril, lisinopril, ramipril, and fosinopril. They were followed up for four months, to observe the clinical efficacy along with the associated ADRs. Results: Mild, dry brassy cough (% incidence; 95% CI) was observed with d-ACEIs (6.6%; 0 to 15.6) versus p-ACEI (20%; 5.7 to 34.3), in which the cough observed was moderate-to-severe in intensity and two patients required treatment discontinuation (P < 0.05). No cases of hypotension were observed with the use of d-ACEIs, whereas, two patients on p-ACEI (6.6%; 0 to15.6) had hypotension (P < 0.05). Three patients (10%; 0 to 20.7) on d-ACEIs had nausea, which was not observed with p-ACEI treatment (0%) (P < 0.05). Conclusions: The phosphonate group in p-ACEIs may have a probable relationship with increase in the incidence and severity of ADRs such as dry brassy cough and hypotension. The di-carboxyl group in d-ACEIs may have a probable relationship with increase in the incidence of ADRs like nausea. PMID:20606833

  3. A comparative study of family-specific protein-ligand complex affinity prediction based on random forest approach

    NASA Astrophysics Data System (ADS)

    Wang, Yu; Guo, Yanzhi; Kuang, Qifan; Pu, Xuemei; Ji, Yue; Zhang, Zhihang; Li, Menglong

    2015-04-01

    The assessment of binding affinity between ligands and the target proteins plays an essential role in drug discovery and design process. As an alternative to widely used scoring approaches, machine learning methods have also been proposed for fast prediction of the binding affinity with promising results, but most of them were developed as all-purpose models despite of the specific functions of different protein families, since proteins from different function families always have different structures and physicochemical features. In this study, we proposed a random forest method to predict the protein-ligand binding affinity based on a comprehensive feature set covering protein sequence, binding pocket, ligand structure and intermolecular interaction. Feature processing and compression was respectively implemented for different protein family datasets, which indicates that different features contribute to different models, so individual representation for each protein family is necessary. Three family-specific models were constructed for three important protein target families of HIV-1 protease, trypsin and carbonic anhydrase respectively. As a comparison, two generic models including diverse protein families were also built. The evaluation results show that models on family-specific datasets have the superior performance to those on the generic datasets and the Pearson and Spearman correlation coefficients ( R p and Rs) on the test sets are 0.740, 0.874, 0.735 and 0.697, 0.853, 0.723 for HIV-1 protease, trypsin and carbonic anhydrase respectively. Comparisons with the other methods further demonstrate that individual representation and model construction for each protein family is a more reasonable way in predicting the affinity of one particular protein family.

  4. Continuous infraclavicular perineural infusion with clonidine and ropivacaine compared with ropivacaine alone: a randomized, double-blinded, controlled study.

    PubMed

    Ilfeld, Brian M; Morey, Timothy E; Enneking, F Kayser

    2003-09-01

    Although clonidine has been shown to increase the duration of local anesthetic action and prolong postoperative analgesia when included in single-injection nerve blocks, a controlled investigation of the efficacy of this practice to improve analgesia for continuous perineural local anesthetic infusion has not been reported. In this study, ambulatory patients (n = 34) undergoing moderately painful upper extremity orthopedic surgery received an infraclavicular brachial plexus block (mepivacaine 1.5%, epinephrine 2.5 micro g/mL, and bicarbonate 0.1 mEq/mL) and a perineural catheter before surgery. After surgery, patients were discharged home with a portable infusion pump delivering either ropivacaine 0.2% or ropivacaine 0.2% plus clonidine 1 micro g/mL via the catheter for 3 days (basal, 8 mL/h; patient-controlled bolus, 2 mL every 20 min). Investigators and patients were blinded to random group assignment. Daily end-points included pain scores, patient-controlled bolus doses, oral analgesic use, sleep quality, and symptoms of catheter- or infusion-related complications. Adding clonidine to ropivacaine resulted in a statistically significant decrease in the number of self-administered 2-mL bolus doses on postoperative Days 0 and 1 (P < 0.02), but this decreased actual local anesthetic consumption by an average of only 2-7 mL/d (P < 0.02). There were no statistically significant differences between the two groups for any of the other variables investigated, including sleep quality or oral analgesic requirements. We conclude that adding 1 micro g/mL of clonidine to a ropivacaine infraclavicular perineural infusion does not provide clinically relevant improvements in analgesia, sleep quality, or oral analgesic requirements for ambulatory patients having moderately painful upper extremity surgery.

  5. A randomized, comparative study of fluorometholone 0.2% and fluorometholone 0.1% acetate after photorefractive keratectomy.

    PubMed

    Vetrugno, M; Quaranta, G M; Maino, A; Cardia, L

    2000-01-01

    To compare the efficacy and tolerance of fluorometholone 0.1% acetate and fluorometholone 0.2% eyedrops in the postoperative management of photorefractive keratectomy (PRK). A randomised single-blind comparative study was performed on two groups of 30 patients who underwent myopic PRK. The first group was given fluorometholone 0.1% acetate and the second fluorometholone 0.2%. Uncorrected and best corrected visual acuity, haze, IOP and local tolerance were evaluated. Statistical analysis was done using parametric and non-parametric tests. Visual acuity did not differ in the two groups; both were homogeneous as far as refractive error and haze were concerned. Three patients (10%) treated with fluorometholone 0.2% and two patients (6.6%) with fluorometholone 0.1% acetate developed ocular hypertension, but this was not statistically significant. Fluorometholone 0.1% acetate was effective on inflammation after PRK, with the same efficacy as fluorometholone 0.2%.

  6. Effects of Mobile Augmented Reality Learning Compared to Textbook Learning on Medical Students: Randomized Controlled Pilot Study

    PubMed Central

    2013-01-01

    Background By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. Objective To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). Methods A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the “Profile of Mood States” questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Results Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a

  7. A Prospective Randomized Study Comparing Fibrin Glue Versus Prolene Suture for Mesh Fixation in Lichtenstein Inguinal Hernia Repair.

    PubMed

    Karigoudar, Ashirwad; Gupta, Arun Kumar; Mukharjee, Sourabh; Gupta, Nikhil; Durga, C K

    2016-08-01

    The aim of this study is to assess the advantages of fibrin glue over Prolene suture in fixation of the mesh in open inguinal hernia repair. Sixty-four cases of inguinal hernia underwent hernia repair by the Lichtenstein method in the department of surgery in PGIMER & Dr. RML Hospital, New Delhi. The patients were randomized prospectively into group A (fibrin glue group) and group B (Prolene suture group). In group A, fibrin glue was used for mesh fixation, and in group B, Prolene suture was used for mesh fixation. The mean age of patients in group A was 44.5 years and that of group B patients was 44.2 years. There was a significant difference in the duration of surgery, with the mean duration in fibrin glue group being 30.6 min and that of the suture group was 43.3 min. The mean visual analogue pain score of postoperative pain at 1, 6, 12, and 24 h was significantly higher in the suture group than in the fibrin glue group (p < 0.001). The mean total dose of analgesia in ampoules of tramadol was significantly less in the fibrin glue group (1.56 ampoules) than that in the suture group (4.125 ampoules) with p = 0.000. At the end of the first month, 25 % of subjects in the suture group presented with mild groin pain (p value = 0.0048). At the end of the second and third month, 22 % (p 68 value = 0.0048) and 12.5 % (p value = 0.1132) of subjects respectively presented with mild groin pain in the suture group. The present study demonstrates that the use of fibrin glue in place of Prolene suture for mesh fixation in open inguinal hernia repair can help decreasing the time required for surgery, reduce the intensity of postoperative pain, shorten the duration of hospital stay, and prevent the incidence of chronic groin pain.

  8. Topical treatment of tinea pedis using 6% coriander oil in unguentum leniens: a randomized, controlled, comparative pilot study.

    PubMed

    Beikert, F C; Anastasiadou, Z; Fritzen, B; Frank, U; Augustin, M

    2013-01-01

    The antifungal activity of coriander oil has already been demonstrated in vitro. Evaluation of the efficacy and tolerability of 6% coriander oil in unguentum leniens in the treatment of interdigital tinea pedis. Half-side comparative pilot study on subjects with symmetric, bilateral interdigital tinea pedis. Active drug and placebo control were applied twice daily on the affected areas, and follow-up visits were performed on days 14 and 28. 40 participants (mean age 52.5 years, 60% male) were included in the study. For 6% coriander oil in unguentum leniens, a highly significant improvement of the clinical signs (p < 0.0001) was observed during the entire observation period; the number of positive fungal cultures also tended to decrease (p = 0.0654). The tolerability of the tested substances was good. Coriander oil is effective and well tolerated in the treatment of interdigital tinea pedis. Copyright © 2013 S. Karger AG, Basel.

  9. Prospective study on burns treated with Integra®, a cellulose sponge and split thickness skin graft: comparative clinical and histological study--randomized controlled trial.

    PubMed

    Lagus, Heli; Sarlomo-Rikala, Maarit; Böhling, Tom; Vuola, Jyrki

    2013-12-01

    The aim of this study was to compare three different methods to cover excised burn wounds in a randomized controlled trial. Fascially excised burn wounds, measuring 10 cm × 5 cm, were covered with Integra(®), split thickness skin graft (STSG), and a viscose cellulose sponge Cellonex™ in each of ten adult patients. Integra(®) and Cellonex™ treated areas were covered with thin STSG on day 14. Biopsies were taken 3, 7, 14, and 21 days, 3 months, and 12 months after surgery, and samples were subjected to a range of immunohistochemical stains, in addition to hematoxylin and eosin (HE). Scar assessment was performed 3 and 12 months post-operatively with the Vancouver Scar Scale (VSS). Inflammation was not substantial in any of the study areas, but Cellonex™ had the most neutrophils, histiocytes, and lymphocytes with significant differences on days 7 and 14. Complete vascularization of Integra(®) seemed to occur later compared to the other materials. STSG had the most myofibroblasts on day 14 (p = 0.012). In VSS the quality of the scar improved in all materials from 3 to 12 months. The final results for all treatments after 12 months demonstrate equal clinical appearance, as well as histological and immunohistochemical findings. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  10. A comparative study of the clinical efficacy and safety of agomelatine with escitalopram in major depressive disorder patients: A randomized, parallel-group, phase IV study

    PubMed Central

    Urade, Chetan S.; Mahakalkar, Sunil M.; Tiple, Prashant G.

    2015-01-01

    Objective: To compare the efficacy of agomelatine with escitalopram in the treatment of major depressive disorder (MDD), improve sleep in MDD patients and study the adverse effects of agomelatine. Materials and Methods: Randomized, parallel-group, open-label study. The primary efficacy outcome was change from baseline to last post-baseline value in Hamilton depression rating scale and Leeds sleep evaluation questionnaire scale. Both parametric and nonparametric tests were applied for analysis. Results: Within-group and between-groups comparison of the mean HAMD17 scores showed statistically significant changes (P < 0.0001). Escitalopram showed early onset of response and remission compared to agomelatine at 10th week (P < 0.0001) and 14th week (P < 0.0001), respectively. In agomelatine, within-group and between-groups change of the mean LSEQ score was statistically significant at subsequent follow-up visits (P < 0.0001). Conclusion: Escitalopram is superior to agomelatine in efficacy, considering the early response, early remission, and better relief from symptoms of MDD in adults. Agomelatine may be preferred in MDD patients having insomnia as a predominant symptom. Liver function monitoring should be done in patients on long-term agomelatine therapy. PMID:26813706

  11. Comparing the treatment outcomes of potassium-titanyl-phosphate laser vaporization and transurethral electroresection for primary nonmuscle-invasive bladder cancer: A prospective, randomized study.

    PubMed

    Xu, Yansheng; Guan, Weimin; Chen, Weihao; Xie, Changliang; Ouyang, Yun; Wu, Yiguang; Liu, Cuilong

    2015-04-01

    In urology, potassium-titanyl-phosphate (KTP) laser is mainly used in the treatment of benign prostatic hyperplasia with a low rate of intraoperative and postoperative complications. A prospective, randomized study was undertaken to investigate the treatment outcomes of KTP laser vaporization for primary non-muscle-invasive bladder tumors (NMIBTs) as compared with conventional monopolar transurethral resection of bladder tumors (TURBT). This study was designed as a prospective, randomized trial. After institutional review board approval, 229 consecutive patients with NMIBTs were randomized to 2 groups. Among them, 116 patients underwent KTP laser vaporization of a bladder tumor (laser group) and 113 patients underwent standard transurethral electroresection of the bladder tumors using monopolar loop electrode (TURBT group). According to the prognostic factors for recurrence, all patients were divided into low, intermediate or high risk subgroups. The clinical data were recorded and compared between the two groups. Eighty-nine patients in laser group and 94 in TURBT group were evaluable for the study end points. The preoperative characteristics of the patients were comparable in the two groups. There was no statistical difference in operation time between the two groups. Patients in the laser group had fewer perioperative complications and more patients needed bladder irrigation in the TURBT group. Compared with laser group, patients in the TURBT group had longer catheterization time and hospitalization duration. There were no statistical differences in the oncologic results in term of 2-year recurrence rates as compared between the two groups. Our study demonstrated that using KTP laser, transurethral vaporization is an effective and safe treatment for the patients with primary NMIBT. Compared with traditional TURBT, the KTP laser surgery had fewer perioperative complications and similar oncological results. © 2015 Wiley Periodicals, Inc.

  12. Comparative Analysis of Local Anesthesia with 2 Different Concentrations of Adrenaline: A Randomized and Single Blind Study

    PubMed Central

    Managutti, Anil; Prakasam, Michael; Puthanakar, Nagraj; Menat, Shailesh; Shah, Disha; Patel, Harsh

    2015-01-01

    Background: Local anesthetic agents are more commonly used in dentistry to have painless procedure during surgical intervention in bone and soft tissue. There are many local anesthetic agents available with the wide selection of vaso-constrictive agents that improve the clinical efficacy and the duration of local anesthesia. Most commonly lignocaine with adrenaline is used in various concentrations. Systemically adrenaline like drugs can cause a number of cardiovascular disturbances while most are short lived, permanent injury or even death may follow in drug induced ventricular fibrillation, myocardial infarction or cerebro-vascular accidents. This study compared the efficacy and cardiovascular effects with the use of 2% lignocaine with two different concentrations. Materials and Methods: Forty patients underwent extractions of mandibular bilateral teeth using 2% lignocaine with two different concentrations - one with 1:80000 and the other with 1:200000. Results: There was no significant difference in the efficacy and duration with the 2% lignocaine with 2 different concentrations. 2% lignocaine with 1:80000 adrenaline concentration has significantly increased the heart rate and blood pressure especially systolic compared with the lignocaine with 1:200000. Conclusion: Though 2% lignocaine with 1:80000 is widely used in India, 1:200000 adrenaline concentrations do not much affect the cardiovascular parameters. So it is recommended to use 2% lignocaine with 1:200000 for cardiac patients. PMID:25878474

  13. A randomized, crossover, head-to-head comparison of eicosapentaenoic acid and docosahexaenoic acid supplementation to reduce inflammation markers in men and women: the Comparing EPA to DHA (ComparED) Study.

    PubMed

    Allaire, Janie; Couture, Patrick; Leclerc, Myriam; Charest, Amélie; Marin, Johanne; Lépine, Marie-Claude; Talbot, Denis; Tchernof, André; Lamarche, Benoît

    2016-08-01

    To date, most studies on the anti-inflammatory effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in humans have used a mixture of the 2 fatty acids in various forms and proportions. We compared the effects of EPA supplementation with those of DHA supplementation (re-esterified triacylglycerol; 90% pure) on inflammation markers (primary outcome) and blood lipids (secondary outcome) in men and women at risk of cardiovascular disease. In a double-blind, randomized, crossover, controlled study, healthy men (n = 48) and women (n = 106) with abdominal obesity and low-grade systemic inflammation consumed 3 g/d of the following supplements for periods of 10 wk: 1) EPA (2.7 g/d), 2) DHA (2.7 g/d), and 3) corn oil as a control with each supplementation separated by a 9-wk washout period. Primary analyses assessed the difference in cardiometabolic outcomes between EPA and DHA. Supplementation with DHA compared with supplementation with EPA led to a greater reduction in interleukin-18 (IL-18) (-7.0% ± 2.8% compared with -0.5% ± 3.0%, respectively; P = 0.01) and a greater increase in adiponectin (3.1% ± 1.6% compared with -1.2% ± 1.7%, respectively; P < 0.001). Between DHA and EPA, changes in CRP (-7.9% ± 5.0% compared with -1.8% ± 6.5%, respectively; P = 0.25), IL-6 (-12.0% ± 7.0% compared with -13.4% ± 7.0%, respectively; P = 0.86), and tumor necrosis factor-α (-14.8% ± 5.1% compared with -7.6% ± 10.2%, respectively; P = 0.63) were NS. DHA compared with EPA led to more pronounced reductions in triglycerides (-13.3% ± 2.3% compared with -11.9% ± 2.2%, respectively; P = 0.005) and the cholesterol:HDL-cholesterol ratio (-2.5% ± 1.3% compared with 0.3% ± 1.1%, respectively; P = 0.006) and greater increases in HDL cholesterol (7.6% ± 1.4% compared with -0.7% ± 1.1%, respectively; P < 0.0001) and LDL cholesterol (6.9% ± 1.8% compared with 2.2% ± 1.6%, respectively; P = 0.04). The increase in LDL-cholesterol concentrations for DHA compared with

  14. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

    PubMed

    Earhart, Gammon M; Duncan, Ryan P; Huang, John L; Perlmutter, Joel S; Pickett, Kristen A

    2015-02-05

    Effective treatment of locomotor dysfunction in Parkinson disease (PD) is essential, as gait difficulty is an early and major contributor to disability. Exercise is recommended as an adjunct to traditional treatments for improving gait, balance, and quality of life. Among the exercise approaches known to improve walking, tango and treadmill training have recently emerged as two promising therapies for improving gait, disease severity and quality of life, yet these two interventions have not been directly compared to each other. Prior studies have been helpful in identifying interventions effective in improving gait function, but have done little to elucidate the neural mechanisms underlying functional improvements. The primary objective of the proposed work is to compare the effects of three community-based exercise programs, tango, treadmill training and stretching, on locomotor function in individuals with PD. In addition, we aim to determine whether and how these interventions alter functional connectivity of locomotor control networks in the brain. One hundred and twenty right-handed individuals with idiopathic PD who are at least 30 years of age will be assigned in successive waves to one of three community-based exercise groups: tango dancing, treadmill training or stretching (control). Each group will receive three months of exercise training with twice weekly one-hour group classes. Each participant will be evaluated at three time points: pre-intervention (baseline), post-intervention (3 months), and follow-up (6 months). All evaluations will include assessment of gait, balance, disease severity, and quality of life. Baseline and post-intervention evaluations will also include task-based functional magnetic resonance imaging (fMRI) and resting state functional connectivity MRI. All MRI and behavioral measures will be conducted with participants OFF anti-Parkinson medication, with behavioral measures also assessed ON medication. This study will provide

  15. Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability

    PubMed Central

    de Francisco, Angel L.M.; Leidig, Michael; Covic, Adrian C.; Ketteler, Markus; Benedyk-Lorens, Ewa; Mircescu, Gabriel M.; Scholz, Caecilia; Ponce, Pedro; Passlick-Deetjen, Jutta

    2010-01-01

    Background. Phosphate binders are required to control serum phosphorus in dialysis patients. A phosphate binder combining calcium and magnesium offers an interesting therapeutic option. Methods. This controlled randomized, investigator-masked, multicentre trial investigated the effect of calcium acetate/magnesium carbonate (CaMg) on serum phosphorus levels compared with sevelamer hydrochloride (HCl). The study aim was to show non-inferiority of CaMg in lowering serum phosphorus levels into Kidney Disease Outcome Quality Initiative (K/DOQI) target level range after 24 weeks. Three hundred and twenty-six patients from five European countries were included. After a phosphate binder washout period, 255 patients were randomized in a 1:1 fashion. Two hundred and four patients completed the study per protocol (CaMg, N = 105; dropouts N = 18; sevelamer-HCl, N = 99; dropouts N = 34). Patient baseline characteristics were similar in both groups. Results. Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed. The area under the curve for serum phosphorus (P = 0.0042) and the number of visits above K/DOQI (≤1.78 mmol/L, P = 0.0198) and Kidney disease: Improving global outcomes (KDIGO) targets (≤1.45 mmol/L, P = 0.0067) were significantly lower with CaMg. Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia. An asymptomatic increase in serum magnesium occurred in CaMg-treated patients (treatment difference 0.2597 mmol/L, P < 0.0001). There was no difference in the number of patients with adverse events. Conclusion. CaMg was non-inferior to the comparator at controlling serum phosphorus levels at Week 25. There was no change in ionized calcium; there was minimal increase in total serum calcium and a small

  16. Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up

    PubMed Central

    Irgens, Audun C.; Hoffart, Asle; Nysæter, Tor E.; Haaland, Vegard Ø.; Borge, Finn-Magnus; Pripp, Are H.; Martinsen, Egil W.; Dammen, Toril

    2017-01-01

    Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT (N = 24), TFT (N = 24) or a wait-list condition (WLC) (N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT (n = 12) or TFT (n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT (N = 12 + 24 = 36) to TFT (N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample’s t-test, the Fisher’s exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC (p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT (p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919. PMID:28676782

  17. Randomized controlled trial comparing submucosal endoscopy with mucosal resection and endoscopic submucosal dissection in the esophagus and stomach: Animal study.

    PubMed

    Takizawa, Kohei; Knipschield, Mary A; Gostout, Christopher J

    2017-06-30

    In Western countries, endoscopic submucosal dissection (ESD) has not prevailed as a result of training problems and a target patient population. We have previously reported a hybrid ESD technique, submucosal endoscopy with mucosal resection (SEMR), in which the submucosal dissection is carried out chiefly by blunt balloon dissection. We have also reported successful application in the porcine colon. In the present study, we compared the safety and efficacy of SEMR with ESD in the porcine esophagus and stomach. SEMR and ESD were carried out in eight domestic pigs under general anesthesia. Resection sites were marked by circumferential coagulation. After circumferential ESD knife mucosal incision, submucosal fluid cushion (SFC) was created. In the SEMR group, the balloon catheter was inserted deep into the SFC. The balloon was then inflated and pulled back toward the endoscope tip repeatedly, altering the direction, to disrupt the submucosa. Residual strands were cut with an IT-knife. En bloc resection rates, procedure times, complications and dissection difficulty scales (DDS) were recorded prospectively. DDS were rated using a visual analog scale. Thirty-two resections (8 SEMR/8 ESD in the esophagus; 8 SEMR/8 ESD in the stomach) were done with no major adverse events. There was no statistical difference between the two techniques in either location in the above categories measured. SEMR and traditional ESD are comparable techniques in safety and effectiveness when carried out in the esophagus and stomach. SEMR may serve as a more appealing technical option for endoscopists who are unable to sustain a traditional ESD practice volume. © 2017 Japan Gastroenterological Endoscopy Society.

  18. Participants' experiences of care during a randomized controlled trial comparing a lay-facilitated angina management programme with usual care: a qualitative study using focus groups

    PubMed Central

    Nelson, Pauline; Cox, Helen; Furze, Gill; Lewin, Robert JP; Morton, Veronica; Norris, Heather; Patel, Nicky; Elton, Peter; Carty, Richard

    2013-01-01

    Aim This paper is a report of a qualitative study conducted as part of a randomized controlled trial comparing a lay-facilitated angina management programme with usual care. Its aim was to explore participants' beliefs, experiences, and attitudes to the care they had received during the trial, particularly those who had received the angina management intervention. Background Angina affects over 50 million people worldwide. Over half of these people have symptoms that restrict their daily life and would benefit from knowing how to manage their condition. Design A nested qualitative study within a randomized controlled trial of lay-facilitated angina management. Method We conducted four participant focus groups during 2008; three were with people randomized to the intervention and one with those randomized to control. We recruited a total of 14 participants to the focus groups, 10 intervention, and 4 control. Findings Although recruitment to the focus groups was relatively low by comparison to conventional standards, each generated lively discussions and a rich data set. Data analysis demonstrated both similarities and differences between control and intervention groups. Similarities included low levels of prior knowledge about angina, whereas differences included a perception among intervention participants that lifestyle changes were more easily facilitated with the help and support of a lay-worker. Conclusion Lay facilitation with the Angina Plan is perceived by the participants to be beneficial in supporting self-management. However, clinical expertise is still required to meet the more complex information and care needs of people with stable angina. PMID:22738415

  19. Comparing the effectiveness of "plasma knife" tonsillectomy with two well-established tonsillectomy techniques: cold dissection and bipolar electrocautery. A prospective randomized study.

    PubMed

    Sadikoglu, Fatih; Kurtaran, Hanifi; Ark, Nebil; Ugur, K Serife; Yilmaz, Turker; Gozdemir, Muhammed; Mutlu, Cemil; Aktas, Davut

    2009-09-01

    To evaluate the effectiveness of a new device "plasma knife" for tonsillectomy by comparing to two well-established tonsillectomy techniques: cold dissection, and bipolar electrocautery. A prospective, randomized study conducted on 110 patients undergoing tonsillectomy. Subjects were randomized to plasma knife (PKT), cold dissection (CDT) and bipolar electrocautery (BET) groups. Operative time, intraoperative blood loss and postoperative complications were recorded. Pain/discomfort level of patients and healing time of the tonsillar fossae were assessed postoperatively. Data were recorded and statistically analyzed. Operative time with plasma knife and bipolar electrocautery were associated with a significant decrease in operative time compared to cold dissection (p<0.05). Intraoperative blood loss was significantly decreased with plasma knife, compared to cold dissection and bipolar electrocautery (p<0.05). Less postoperative pain was observed with plasma knife compared to bipolar electrocautery but more postoperative pain was observed with both compared to CDT (p<0.05). Postoperative healing time was longer with plasma knife and bipolar electrocautery, compared to cold dissection (p<0.05). Plasma knife is a useful and safe device in tonsillectomy. Its use reduces intraoperative blood loss and provides a fast tonsillectomy with acceptable morbidity.

  20. Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol

    PubMed Central

    2014-01-01

    Background Various treatments are available for reducible unstable fractures of the distal radius, such as closed reduction combined with fixation by external fixator (EF), and rigid internal fixation using a locked volar plate (VP). Although there are studies comparing these methods, there is no conclusive evidence indicating which treatment is best. The hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome (patient-reported). Methods/Design The study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP. Patients will be randomly assigned (assignment ratio 1:1) using sealed opaque envelopes. This trial will include consecutive adult patients with an acute (up to 15 days) displaced, unstable fracture of the distal end of the radius of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen–Association for the Study of Internal Fixation classification and type II or type III by the IDEAL32 classification, without previous surgical treatments of the wrist. The surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described. Evaluations will be performed at 2, and 8 weeks, 3, 6 and 12 months, with the primary outcomes being measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and measurement of pain (Visual Analog Pain Scale and digital algometer). Secondary outcomes will include radiographic parameters, objective functional evaluation (goniometry and dynamometry), and the rate of complications and method failure according to the intention-to-treat principle. Final postoperative evaluations (6 and 12 months) will be performed by independent blinded evaluators. For the Student’s t-test, a difference of 10 points in the DASH score, with a 95% confidence interval, a statistical power of 80%, and 20% sampling error

  1. [Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study)].

    PubMed

    Pujet, J C; Keddad, K; Sévenier, F; Jolivet-Landreau, I

    2002-01-01

    The objective was to compare, during a 5-day therapy, the efficacy and tolerability of an antihistaminic antitussive syrup, oxomemazine, combining a small quantity of guaifenesine (T), with a centrally acting antitussive, clobutinol (S), in adult patients aged from 18 to 70 years and presenting with a dry cough of infectious origin. This study was performed by 22 general practitioners and 130 ambulatory patients were enrolled. The primary criterion of this multicenter, randomized, single blind study was to compare the evolution of cough intensity using a Visual Analog Squale (VAS) graduated from 0 to 10 cm. Nine secondary criteria including tolerability were also assessed. With regard to cough intensity, the treatments were not equivalent. A greater reduction was observed with T (-5.2 +/- 2.3 versus -4.3 +/- 2.3). This result was confirmed by a further reduction in cough intensity at days: 2 (p = 0.04), 4 (p = 0.05), and 5 (p = 0.02). The frequency of cough disappearance before the end of the study was significantly greater for T than for S: 46% versus 29% (p = 0.05). The time before disappearance of the cough was 4.0 + 1.1 days for both medicines. Induction of sleep and the frequency of nocturnal wakening were significantly better for T from day 4 (p = 0.02). The drowsiness induced by T meant that diurnal quality of life was better with S on days 1 (p = 0.002) and 2 (p = 0.01). Tolerability was similar for both medicines. In conclusion, as a symptomatic treatment of dry cough, T is efficient and well tolerated. Moreover, we have observed a tendency towards superior efficacy of T than S. T is therefore a useful alternative in the therapeutic armamentarium available to the general practitioner.

  2. Is Prophylactic Drainage of Peritoneal Cavity after Gut Surgery Necessary?: A Non-Randomized Comparative Study from a Teaching Hospital

    PubMed Central

    Rai, Pranil; Misra, Gorakh

    2015-01-01

    Introduction Prophylactic use of intra-peritoneal drain is commonly practiced by surgeons in the hope of early detection of complication and reducing mortality and morbidity. The aim of the study was to determine evidence based value of prophylactic drainage of peritoneal cavity in cases of secondary peritonitis and resection and anastomosis of small and large bowel. Materials and Methods One hundred and seventy one (171) cases were included in the study from March 2012-May 2013 that underwent laparotomy for peptic ulcer perforation (PUP), simple and complicated acute appendicitis (appendicular perforation with localized/generalized peritonitis), small bowel obstruction (SBO) and sigmoid volvulus, traumatic and non-traumatic perforation of small and large bowel. Appropriate management was done after resuscitation and investigation. After completion of operation peritoneal cavity was either drained or not drained according operator’s preference. They were divided into drain and non-drain groups. Surgical outcome and postoperative complications ≤30 days of operation was noted and compared between two groups. Results No significant difference was observed between drained group and non-drained group in terms of age (32.08±15.99 vs. 35.57 ± 16.42 years), Sex (76M: 42F vs. 40M: 13F), weight 50.9 ± 11.75 vs. 48.4 ± 16.1 kg), height (1.6 ± 0.13 vs. 1.5 ± 0.18 Meter), BMI (20 ± 4.7 vs. 20 ± 7.2), ASA score (p= >0.05). However there was significant difference was observed between drained group and non-drained groups in terms of length of hospital stay (9 ± 4 vs 5 ± 3.4 days), operative duration (115.6 ± 41.0 vs. 80 ± 38.1 minutes), infection rates in dirty wound (40.0% vs 12.5%) and overall postoperative complications (35.85% vs16.11%). Conclusion Based on these results, present study suggests that prophylactic drainage of peritoneal cavity after gastrointestinal surgery is not necessary as it does not offer additional benefits for the patients undergoing gut

  3. Comparing the satisfaction and efficacy of Cyclofem and contraceptive pills among females in Northern Iran: A randomized controlled trial study.

    PubMed

    Jamali, Bita; Kiapoor, Azade; Firoozbakht, Mozhgan; Kazeminavaei, Fatemeh; Taghlili, Fatemeh

    2014-10-01

    Hormonal contraceptives are the most effective method for birth control, though they may have some default or complications. This research aimed to comparison of the efficacy and satisfaction of Cyclofem with oral contraceptives (OCs) among females. A descriptive-comparative method was conducted on 80 women who were selected through cluster sampling during November 2011-December 2012. The selected subjects start using OCs or Cyclofem for the 1(st) time in their life. They evaluated in 2 times frames, at the beginning of the study and then 3 and 6 months after the contraceptive precautions. The data were collected by questionnaire. The data were analysed using parametric and nonparametric test in SPSS 16 software. The reasons for discontinuation of the methods were varied, in which 50% of the sample group were Cyclofem users who discontinued because of menstrual changes and the desire to use other methods, and 50% were the OC users whose reason was medical problems, and absent-mindedness was the last reason for 35.7% of the cases. The efficacy of the both (OCs and Cyclofem) was high and only one unwanted pregnancy occurred at the end of the 6(th) month among OC users. There was no significant difference in term of satisfaction of two groups at the end of 3-6 months (PV = 0.433). The results indicated that Cyclofem can be well used by those women who desire for an easy and effective method which is not disturbing the sexual activity and does not also need to be used daily, but the users should be consulted before using the method.

  4. Comparing the satisfaction and efficacy of Cyclofem and contraceptive pills among females in Northern Iran: A randomized controlled trial study

    PubMed Central

    Jamali, Bita; Kiapoor, Azade; Firoozbakht, Mozhgan; Kazeminavaei, Fatemeh; Taghlili, Fatemeh

    2014-01-01

    Hormonal contraceptives are the most effective method for birth control, though they may have some default or complications. This research aimed to comparison of the efficacy and satisfaction of Cyclofem with oral contraceptives (OCs) among females. A descriptive-comparative method was conducted on 80 women who were selected through cluster sampling during November 2011-December 2012. The selected subjects start using OCs or Cyclofem for the 1st time in their life. They evaluated in 2 times frames, at the beginning of the study and then 3 and 6 months after the contraceptive precautions. The data were collected by questionnaire. The data were analysed using parametric and nonparametric test in SPSS 16 software. The reasons for discontinuation of the methods were varied, in which 50% of the sample group were Cyclofem users who discontinued because of menstrual changes and the desire to use other methods, and 50% were the OC users whose reason was medical problems, and absent-mindedness was the last reason for 35.7% of the cases. The efficacy of the both (OCs and Cyclofem) was high and only one unwanted pregnancy occurred at the end of the 6th month among OC users. There was no significant difference in term of satisfaction of two groups at the end of 3-6 months (PV = 0.433). The results indicated that Cyclofem can be well used by those women who desire for an easy and effective method which is not disturbing the sexual activity and does not also need to be used daily, but the users should be consulted before using the method. PMID:25364692

  5. Randomized comparative study of moxalactam and cefazolin in the treatment of acute urinary tract infections in adults.

    PubMed Central

    Lea, A S; Sudan, A W; Wood, B A; Gentry, L O

    1982-01-01

    Eighty-nine patients with clinical and laboratory evidence of acute urinary tract infection were randomized to therapy with either moxalactam (500 mg) or cefazolin (1 g) every 12 h. Escherichia coli was the predominant pathogen in both groups (92.6 versus 90.2%). Therapy was continued for 3 days after the patient defervesced. The minimum hospital stay was 5 days. Sequential urine cultures were obtained on day 3, at discharge, and 5 to 10 days after the cessation of therapy. THe average duration of hospital stay was 5.6 days for both groups of patients. THe incidence of recurrent infection was similar in uncomplicated patients (9.1 versus 10%) and in complicated patients with a condition predisposing them to urinary tract infections (43 versus 42%). Moxalactam-treated patients had a higher incidence of reversible hepatic enzyme elevation (36%) and Streptococcus faecalis superinfections (12.2%). Moxalactam is as effective as cefazolin for the elimination of gram-negative pathogens from the urine of patients with acute urinary tract infections, but it is associated with a higher incidence of reversible side effects. PMID:6214996

  6. A randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single enantiomer (+)-mefloquine compared with racemic mefloquine in healthy persons.

    PubMed

    Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg

    2010-12-01

    Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (-) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (-)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted.

  7. Randomized study comparing the efficacy of a self-retaining bicanaliculus intubation stent with Crawford intubation in patients with canalicular obstruction

    PubMed Central

    Tabatabaie, Syed Ziaeddin; Rajabi, Mohammad Taher; Rajabi, Mohammad Bagher; Eshraghi, Bahram

    2012-01-01

    Background The purpose of this study was to compare the efficacy of self-retaining stent (SRS) bicanalicular intubation with bicanalicular silicone (Crawford) intubation in patients with canalicular and punctal obstruction. Methods In this prospective, randomized clinical trial, 38 patients with canalicular or punctal obstruction (25 partial, 13 complete) and epiphora were randomized into two groups. Twenty-one patients (14 with partial and seven with complete obstruction) underwent SRS intubation and 17 patients underwent bicanalicular silicon intubation in a randomized fashion. Results After a mean follow-up of 6 months following tube removal, 16 (76%, 12 partial, four complete) of the 21 eyes in the SRS intubation group and 13 (76%, 10 partial, three complete) in the bicanalicular silicon intubation group had a successful outcome and remained symptom-free. For partial obstructions, the success rate was 85% and 90% for the SRS and bicanalicular silicon intubation groups, respectively. The corresponding values for complete obstruction were 63% and 50% for the SRS and bicanalicular silicon intubation groups, respectively. Conclusion SRS could effectively substitute for a more extensive procedure such as bicanalicular silicon intubation in patients with canalicular obstruction, particularly those with partial obstruction. The newly developed SRS intubation procedure has the advantages of simple, easy implementation and extubation, low cost, and a lower rate of trauma when compared with bicanalicular silicon intubation. PMID:22259230

  8. Comparing McGRATH® MAC, C-MAC®, and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study.

    PubMed

    Shin, Myungju; Bai, Sun Joon; Lee, Ki-Young; Oh, Ein; Kim, Hyun Joo

    2016-01-01

    We hypothesized that the McGRATH MAC would decrease the time of intubation compared to C-MAC for novices. Thirty-nine medical students who had used the Macintosh blade to intubate a manikin fewer than 3 times were recruited. The participants performed sequential intubations on the manikin in two simulated settings that included a normal airway and a difficult airway (tongue edema). The intubation time, success rate of intubation, Cormack-Lehane grade at laryngoscopy, and difficulty using the device were recorded. Each participant was asked to identify the device that was most useful. The intubation time decreased significantly and by a similar amount to the McGRATH MAC and C-MAC compared to the Macintosh blade (P < 0.001 and P = 0.017, resp.). In the difficult airway, the intubation times were similar among the three devices. The McGRATH MAC and C-MAC significantly increased the success rate of intubation, improved the Cormack-Lehane grade, and decreased the difficulty score compared to the Macintosh blade in both airway settings. The majority of participants selected the McGRATH MAC as the most useful device. The McGRATH MAC and C-MAC may offer similar benefits for intubation compared to the Macintosh blade in normal and difficult airway situations.

  9. Comparing McGRATH® MAC, C-MAC®, and Macintosh Laryngoscopes Operated by Medical Students: A Randomized, Crossover, Manikin Study

    PubMed Central

    Shin, Myungju; Lee, Ki-Young

    2016-01-01

    We hypothesized that the McGRATH MAC would decrease the time of intubation compared to C-MAC for novices. Thirty-nine medical students who had used the Macintosh blade to intubate a manikin fewer than 3 times were recruited. The participants performed sequential intubations on the manikin in two simulated settings that included a normal airway and a difficult airway (tongue edema). The intubation time, success rate of intubation, Cormack-Lehane grade at laryngoscopy, and difficulty using the device were recorded. Each participant was asked to identify the device that was most useful. The intubation time decreased significantly and by a similar amount to the McGRATH MAC and C-MAC compared to the Macintosh blade (P < 0.001 and P = 0.017, resp.). In the difficult airway, the intubation times were similar among the three devices. The McGRATH MAC and C-MAC significantly increased the success rate of intubation, improved the Cormack-Lehane grade, and decreased the difficulty score compared to the Macintosh blade in both airway settings. The majority of participants selected the McGRATH MAC as the most useful device. The McGRATH MAC and C-MAC may offer similar benefits for intubation compared to the Macintosh blade in normal and difficult airway situations. PMID:27703983

  10. Randomized Cross-Sectional Study to Compare HIV-1 Specific Antibody and Cytokine Concentrations in Female Genital Secretions Obtained by Menstrual Cup and Cervicovaginal Lavage

    PubMed Central

    Archary, Derseree; Liebenberg, Lenine J.; Werner, Lise; Tulsi, Sahil; Majola, Nelisile; Naicker, Nivashnee; Dlamini, Sarah; Hope, Thomas J.; Samsunder, Natasha; Abdool Karim, Salim S.; Morris, Lynn; Passmore, Jo-Ann S.; Garrett, Nigel J.

    2015-01-01

    Introduction Optimizing methods for genital specimen collection to accurately characterize mucosal immune responses is a priority for the HIV prevention field. The menstrual cup (MC) has been proposed as an alternative to other methods including cervicovaginal lavage (CVL), but no study has yet formally compared these two methods. Methods Forty HIV-infected, antiretroviral therapy-naïve women from the CAPRISA 002 acute HIV infection cohort study were randomized to have genital fluid collected using the MC with subsequent CVL, or by CVL alone. Qualitative data, which assessed levels of comfort and acceptability of MC using a 5-point Likert scale, was collected. Luminex multiplex assays were used to measure HIV-specific IgG against multiple gene products and 48 cytokines. Results The majority (94%) of participants indicated that insertion, wearing and removal of the MC was comfortable. Nineteen MCs with 18 matching, subsequent CVLs and 20 randomized CVLs were available for analysis. Mucosal IgG responses against four HIV-antigens were detected in 99% of MCs compared to only 80% of randomized CVLs (p = 0.029). Higher specific antibody activity and total antibodies were observed in MCs compared to CVL (all p<0.001). In MCs, 42/48 (88%) cytokines were in the detectable range in all participants compared to 27/48 (54%) in CVL (p<0.001). Concentrations of 22/41 cytokines (53.7%) were significantly higher in fluid collected by MC. Both total IgG (r = 0.63; p = 0.005) and cytokine concentrations (r = 0.90; p<0.001) correlated strongly between MC and corresponding post-MC CVL. Conclusions MC sampling improves the detection of mucosal cytokines and antibodies, particularly those present at low concentrations. MC may therefore represent an ideal tool to assess immunological parameters in genital secretions, without interfering with concurrent collection of conventional CVL samples. PMID:26147923

  11. A randomized clinical study for comparative evaluation of Aloe Vera and 0.2% chlorhexidine gluconate mouthwash efficacy on de-novo plaque formation

    PubMed Central

    Chhina, Shivjot; Singh, Avnish; Menon, Ipseeta; Singh, Rickypal; Sharma, Anubhav; Aggarwal, Vartika

    2016-01-01

    Objective: To comparatively assess the antiplaque efficacy of Aloe vera mouthwash and 0.2% chlorhexidine gluconate mouthwash on de novo plaque formation. Materials and Methods: This was a randomized, single blind, parallel, controlled clinical study with 90 healthy participants, with mean age of 27.19 ± 12.08 years. After thorough oral prophylaxis, participants were instructed to discontinue mechanical plaque control. Participants were divided randomly into three groups; pure Aloe vera mouthwash was dispensed to the test group; control group received 0.2% chlorhexidine gluconate mouthwash; in Placebo group, flavored distilled water was used as oral rinse twice daily. Effect on 4-day de novo plaque formation was assessed by comparing pre-rinsing Quigley Hein Modified Plaque Scores were analyzed statistically using analysis of variance and Student's t-test. Results: Post-rinsing control group showed the least plaque score which was comparable to the test group. Both the control group and test group showed significant difference with the placebo group. Conclusions: Herbal mouthwash containing Aloe vera mouthwash has comparable antiplaque efficacy as the gold standard 0.2% chlorhexidine gluconate with fewer side effects and can be considered as an alternative. PMID:27382543

  12. Eviprostat has an identical effect compared to pollen extract (Cernilton) in patients with chronic prostatitis/chronic pelvic pain syndrome: a randomized, prospective study.

    PubMed

    Iwamura, Hiromichi; Koie, Takuya; Soma, Osamu; Matsumoto, Teppei; Imai, Atsushi; Hatakeyama, Shingo; Yoneyama, Takahiro; Hashimoto, Yasuhiro; Ohyama, Chikara

    2015-12-07

    Previously reported results of a prospective, randomized placebo-controlled study showed that the pollen extract (Cernilton) significantly improved total symptoms, pain, and quality of life in patients with inflammatory prostatitis/chronic pelvic pain syndrome (CP/CPPS) without severe side effects. A phytotherapeutic agent, Eviprostat, is reportedly effective in a rat model of nonbacterial prostatitis. The aim of the present study was to compare the efficacy and safety of Eviprostat to that of the pollen extract in the management of CP/CPPS. The patients with category III CP/CPPS were randomized to receive either oral capsules of Eviprostat (two capsules, q 8 h) or the pollen extract (two capsules, q 8 h) for 8 weeks. The primary endpoint of the study was symptomatic improvement in the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI and the International Prostate Symptom Score (IPSS) at baseline and after 4 and 8 weeks. In the intention-to-treat analysis, 100 men were randomly allocated to Eviprostat (n = 50) or the pollen extract (n = 50). Response (defined as a decrease in the NIH-CPSI total score by at least 25 %) in the Eviprostat group and the pollen extract group was 88.2 and 78.1 %, respectively. There was no significant difference in the total, pain, urinary, and quality of life (QOL) scores of the NIH-CPSI between the two groups at 8 weeks. This was also the case with the total, voiding, and storage symptoms of the IPSS. There were no severe adverse events observed in any patients in this study. Both the pollen extract and Eviprostat significantly reduced the symptoms of category III CP/CPPS without any adverse events. Eviprostat may have an identical effect on category III CP/CPPS compared the pollen extract. The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000019618); registration date: 3 November 2015.

  13. Amplitude-oriented exercise in Parkinson's disease: a randomized study comparing LSVT-BIG and a short training protocol.

    PubMed

    Ebersbach, Georg; Grust, Ute; Ebersbach, Almut; Wegner, Brigitte; Gandor, Florin; Kühn, Andrea A

    2015-02-01

    LSVT-BIG is an exercise for patients with Parkinson's disease (PD) comprising of 16 1-h sessions within 4 weeks. LSVT-BIG was compared with a 2-week short protocol (AOT-SP) consisting of 10 sessions with identical exercises in 42 patients with PD. UPDRS-III-score was reduced by -6.6 in LSVT-BIG and -5.7 in AOT-SP at follow-up after 16 weeks (p < 0.001). Measures of motor performance were equally improved by LSVT-BIG and AOT-SP but high-intensity LSVT-BIG was more effective to obtain patient-perceived benefit.

  14. A randomized and placebo-controlled study to compare the skin-lightening efficacy and safety of lignin peroxidase cream vs. 2% hydroquinone cream.

    PubMed

    Mauricio, Tess; Karmon, Yoram; Khaiat, Alain

    2011-12-01

      Historically, the most effective treatments for skin lightening have contained hydroquinone. However, there is a need for an effective alternative.   The purpose of this study was to evaluate the skin-lightening efficacy and safety of lignin peroxidase (LIP) creams using a regimen of both day and night products compared with twice-daily application of 2% hydroquinone cream and placebo in Asian women.   This was a randomized, double-blind, placebo-controlled, split-face, single-center study of 51 patients. Patients were randomized to receive day and night LIP cream on one randomly selected side of their face and either 2% hydroquinone cream or placebo on the other.   A statistically significant change from baseline in the melanin index was observed in LIP-treated skin, with a mean reduction of 7.6% (P < 0.001) on Day 31. Conversely, hydroquinone and placebo did not provide a statistically significant lightening effect when instrumentally measured. Dermatologist scoring demonstrated a significant improvement in overall fairness as early as 8 days after treatment initiation in the LIP-treated group, which was not observed in the other groups. Overall, patients preferred the LIP creams.   The application of day/night LIP cream provided a significantly more rapid and observable skin-lightening effect than hydroquinone 2% cream or placebo. © 2011 Wiley Periodicals, Inc.

  15. Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs. other triptans.

    PubMed

    Franconi, Flavia; Finocchi, Cinzia; Allais, Gianni; Omboni, Stefano; Tullo, Vincenzo; Campesi, Ilaria; Reggiardo, Giorgio; Benedetto, Chiara; Bussone, Gennaro

    2014-05-01

    Migraine is three times as common in females as in males, and attacks may be more severe and difficult to treat in women. However, no study specifically addressed possible gender differences in response to antimigraine therapy. The objective of this study was to review the efficacy of frovatriptan vs. other triptans, in the acute treatment of migraine in subgroups of subjects classified according to gender (men vs. women) through a pooled analysis of three individual randomized Italian studies. 414 patients suffering from migraine with or without aura were randomized to frovatriptan 2.5 mg or rizatriptan 10 mg (study 1), frovatriptan 2.5 mg or zolmitriptan 2.5 mg (study 2), frovatriptan 2.5 mg or almotriptan 12.5 mg (study 3). All studies had a multicenter, randomized, double-blind, crossover design. After treating 1-3 episodes of migraine in no more than 3 months with the first treatment, patients switched to the other treatment for the next 3 months. In this analysis, traditional migraine endpoints were compared between the 66 men and 280 women of the intent-to-treat population. At baseline, long-term and debilitating migraine attacks were more frequently reported by women than men. During the observation period, the proportion of pain-free attacks at 2 h did not significantly differ between frovatriptan and the comparators in either men (32 vs. 38 %, p = NS) or women (30 vs. 33 %, p = NS). Pain relief was also similar between treatments for both genders (men: 56 % frovatriptan vs. 57 % comparators; women: 55 vs. 57 %; p = NS for both). The rate of relapse was significantly lower with frovatriptan than with the comparators in men (24 h: 10 vs. 30 %; 48 h: 21 vs. 39 %; p < 0.05) as well as in women (24 h: 14 vs. 23 %; 48 h: 28 vs. 40 %; p < 0.05). The rate of adverse drug reactions was significantly larger with comparators, irrespectively of gender. Although migraine presents in a more severe form in women, frovatriptan seems to retain its good efficacy and

  16. A randomized comparative prospective study of platelet-rich plasma, platelet-rich fibrin, and hydroxyapatite as a graft material for mandibular third molar extraction socket healing.

    PubMed

    Dutta, Shubha Ranjan; Passi, Deepak; Singh, Purnima; Sharma, Sarang; Singh, Mahinder; Srivastava, Dhirendra

    2016-01-01

    The purpose of this study was to compare the efficacy of platelet-rich plasma (PRP), platelet-rich fibrin (PRF), and hydroxyapatite (HA) for reduction of pain and swelling, absence of dry socket, soft tissue healing, and bone regeneration after mandibular third molar extraction in human patients. Forty patients requiring extraction of mandibular third molars were randomly grouped as control, PRP, PRF, and HA-treated. The patients were assessed for postoperative pain, swelling, dry socket, and soft tissue healing on the 3(rd), 7(th), and 14(th) day of postoperative periods depending on the standard methods. Radiological assessment of the extraction site was done at 1, 2, and 6 months interval to compare the change in bone density in the sockets in control and treated patients. Pain and swelling were less on PRP and PRF site when compared to HA and control site. PRP and PRF site showed better soft tissue healing when compared to HA and control site. Radiographic assessment showed comparatively lesser bone density values in PRP, PRF, and control site at 1, 2, and 6 months than HA site. Our study showed that PRP and PRF are better graft materials than HA regarding pain, swelling, dry socket, and soft tissue healing. Bone regeneration is induced promptly by HA as compared to other graft materials. However, a more elaborate study with a larger number of clinical cases is very much essential to be more conclusive regarding the efficacy of the graft materials.

  17. A randomized comparative prospective study of platelet-rich plasma, platelet-rich fibrin, and hydroxyapatite as a graft material for mandibular third molar extraction socket healing

    PubMed Central

    Dutta, Shubha Ranjan; Passi, Deepak; Singh, Purnima; Sharma, Sarang; Singh, Mahinder; Srivastava, Dhirendra

    2016-01-01

    Aim: The purpose of this study was to compare the efficacy of platelet-rich plasma (PRP), platelet-rich fibrin (PRF), and hydroxyapatite (HA) for reduction of pain and swelling, absence of dry socket, soft tissue healing, and bone regeneration after mandibular third molar extraction in human patients. Materials and Methods: Forty patients requiring extraction of mandibular third molars were randomly grouped as control, PRP, PRF, and HA-treated. The patients were assessed for postoperative pain, swelling, dry socket, and soft tissue healing on the 3rd, 7th, and 14th day of postoperative periods depending on the standard methods. Radiological assessment of the extraction site was done at 1, 2, and 6 months interval to compare the change in bone density in the sockets in control and treated patients. Results: Pain and swelling were less on PRP and PRF site when compared to HA and control site. PRP and PRF site showed better soft tissue healing when compared to HA and control site. Radiographic assessment showed comparatively lesser bone density values in PRP, PRF, and control site at 1, 2, and 6 months than HA site. Conclusion: Our study showed that PRP and PRF are better graft materials than HA regarding pain, swelling, dry socket, and soft tissue healing. Bone regeneration is induced promptly by HA as compared to other graft materials. However, a more elaborate study with a larger number of clinical cases is very much essential to be more conclusive regarding the efficacy of the graft materials. PMID:28163478

  18. Randomized clinical trial comparing two mastectomy techniques.

    PubMed

    Rodd, Caroline D; Velchuru, Vamsi R; Holly-Archer, Frances; Clark, Allan; Pereira, Jerome H

    2007-06-01

    The unit was considering the routine use of diathermy scissors for standard mastectomy surgery. We therefore aimed to assess scientifically the outcome of patients following the use of this instrument in their operation before accepting it as a routine procedure. A single blind randomized control trial compared the outcome of patients undergoing simple mastectomy using either the standard scalpel blade technique or the bipolar cutting scissors technique. Each arm of the trial contained 30 patients. The two primary outcome measures were blood loss intraoperatively and the operating time. There was a significant difference between the two groups, with a statistically significant benefit in the scissors group in terms of the secondary outcome measures of chest wall clearance and skin flap development as assessments of surgical completeness of mastectomy. There is no evidence of any other secondary outcome measures differing between the treatment groups. There is strong evidence that using electric scissors reduces intraoperative blood loss and operating time. There is some evidence that the scissors may provide better surgical completeness of mastectomy.

  19. Treatment of uncomplicated hemorrhoids with a Hemor-Rite® cryotherapy device: a randomized, prospective, comparative study

    PubMed Central

    Guindic, Luis Charúa

    2014-01-01

    Hemorrhoids are one of the most common ailments known. Often described as “varicose veins of the anus and rectum”, hemorrhoids are enlarged, bulging blood vessels in, and about the anus and lower rectum. About 75% of people will have hemorrhoids at some point in their lives. This paper shares the results from the clinical evaluation conducted to study effects of cryotherapy in treating uncomplicated hemorrhoids. The device used in the study is based on topically-applied cold therapy which can produce vasoconstriction in the tissues, tissue hypoxia, analgesia, and muscle relaxation. Cryotherapy was shown to be statistically similar or superior to proctology ointment in some of the parameters studied such as reduction of pain and hemorrhage. Overall it was observed that cryotherapy device contributes to improving the quality of life of patients with hemorrhoids. PMID:24474845

  20. A phase III, randomized, non-inferiority study comparing the efficacy and safety of biosimilar filgrastim versus originator filgrastim for chemotherapy-induced neutropenia in breast cancer patients

    PubMed Central

    Hegg, Roberto; Mattar, André; de Matos, João Nunes; Pedrini, José Luiz; Aleixo, Sabina Bandeira; Rocha, Roberto Odebrecht; Cramer, Renato Peixoto; van-Eyll-Rocha, Sylvie

    2016-01-01

    OBJECTIVES: To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the non-inferiority of the test drug relative to the originator. METHODS: This phase III non-inferiority study had a randomized, multicenter, and open-label design. The patients were randomized at a ratio of 1:1 with a follow-up period of 6 weeks for each patient. In both study arms, filgrastim was administered subcutaneously at a daily dose of 5 mg/kg body weight. The primary endpoint was the rate of grade 4 neutropenia in the first treatment cycle. The secondary endpoints were the duration of grade 4 neutropenia, the generation of anti-filgrastim antibodies, and the rates of adverse events, laboratory abnormalities, febrile neutropenia, and neutropenia of any grade. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of the test drug compared with the originator drug; the upper limit of the 90% confidence interval (CI) for the rate of neutropenia between the two groups (12.61%) was lower than the established margin of non-inferiority. The two treatments were similar with respect to the secondary endpoints and safety. CONCLUSION: The efficacy and safety profile of the test drug were similar to those of the originator product based on the rate of grade 4 neutropenia in the first treatment cycle. This study supports Anvisa's approval of the first biosimilar drug manufactured by the Brazilian industry (Fiprima®). PMID:27759847

  1. A randomized comparative study of patients undergoing myocardial revascularization with or without cardiopulmonary bypass surgery: The MASS III Trial

    PubMed Central

    Hueb, Whady; Lopes, Neuza HM; Gersh, Bernard J; Castro, Cláudio C; Paulitsch, Felipe S; Oliveira, Sergio A; Dallan, Luis A; Hueb, Alexandre C; Stolf, Noedir A; Ramires, José AF

    2008-01-01

    The MASS III Trial is a large project from a single institution, The Heart Institute of the University of Sao Paulo, Brazil (InCor), enrolling patients with coronary artery disease and preserved ventricular function. The aim of the MASS III Trial is to compare medical effectiveness, cerebral injury, quality of life, and the cost-effectiveness of coronary surgery with and without of cardiopulmonary bypass in patients with multivessel coronary disease referred for both strategies. The primary endpoint should be a composite of cardiovascular mortality, cerebrovascular accident, nonfatal myocardial infarction, and refractory angina requiring revascularization. The secondary end points in this trial include noncardiac mortality, presence and severity of angina, quality of life based on the SF-36 Questionnaire, and cost-effectiveness at discharge and at 5-year follow-up. In this scenario, we will analyze the cost of the initial procedure, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events during the follow-up. Exercise capacity will be assessed at 6-months, 12-months, and the end of follow-up. A neurocognitive evaluation will be assessed in a subset of subjects using the Brain Resource Center computerized neurocognitive battery. Furthermore, magnetic resonance imaging will be made to detect any cerebral injury before and after procedures in patients who undergo coronary artery surgery with and without cardiopulmonary bypass. Clinical Trial registration information ISRCTN59539154 Off-pump vs. on-pump surgery in patients with Stable CAD MASS III PMID:18755039

  2. A double-masked, randomized, 1-year study comparing the corneal effects of dorzolamide, timolol, and betaxolol. Dorzolamide Corneal Effects Study Group.

    PubMed

    Lass, J H; Khosrof, S A; Laurence, J K; Horwitz, B; Ghosh, K; Adamsons, I

    1998-08-01

    To compare the long-term effects of dorzolamide hydrochloride (Trusopt, Merck and Co Inc, White-house Station, NJ), timolol maleate, and betaxolol hydrochloride on corneal endothelial cell density and corneal thickness. This 1-year multicenter study was conducted in 298 patients with ocular hypertension or open-angle glaucoma who had a baseline central corneal endothelial cell density greater than 1500 cells/mm2 and central corneal thickness less than 0.68 mm in each eye. Patients were randomized to 0.5% betaxolol twice daily, 0.5% timolol twice daily, or 2.0% dorzolamide 3 times daily. Specular microscopy and ultrasonic pachymetry of the central cornea was performed at baseline and 6 and 12 months following institution of therapy. Endothelial cell densities were determined by a single masked observer. The mean percent changes from baseline for both outcome measures were similar in all 3 treatment groups at both 6 and 12 months. After 1 year of treatment, the mean percent loss in endothelial cell density from baseline was 3.6%, 4.5%, and 4.2% for the dorzolamide, timolol, and betaxolol groups, respectively. The mean percent change from baseline for corneal thickness was 0.47%, -0.25%, and 0.39% for the dorzolamide, timolol, and betaxolol groups, respectively. Dorzolamide is equivalent to timolol and betaxolol in terms of the change in central endothelial cell density and thickness after 1 year of therapy. All 3 treatments exhibit good long-term corneal tolerability in patients with normal corneas at baseline.

  3. Prevention of NSAID-Associated Gastroduodenal Injury in Healthy Volunteers-A Randomized, Double-Blind, Multicenter Study Comparing DA-9601 with Misoprostol

    PubMed Central

    Lee, Kang Nyeong; Lee, Oh Young; Choi, Myung-Gyu; Choi, Seok Reyol; Lee, Dong Ho; Lee, Yong Chan; Kim, Tae Nyeun; Choi, Suck Chei; Rew, Jong Sun

    2011-01-01

    In addition to inhibiting cyclooxygenase and prostaglandin, nonsteroidal anti-inflammatory drugs (NSAIDs) may cause gastroduodenal injuries due to reactive oxygen species produced by recruited inflammatory cells. DA-9601 is a novel antioxidant with anti-inflammatory and cyto-protective effects. This study was conducted to compare the efficacy and safety of DA-9601 with misoprostol for preventing NSAID-associated gastroduodenal injury. In this randomized, double-blind, multicenter, noninferiority trial we compared the extents of protection of gastric and duodenal mucosae by endoscopy after 4 weeks of treatment with DA-9601 60 mg or misoprostol 200 µg three times daily, in subjects with normal baseline endoscopic findings who received an NSAID twice daily for 4 weeks. A total of 266 subjects were randomized to treatment. At week 4, the gastric protection rates with DA-9601 and misoprostol were 85.1% and 95.2%, respectively; the difference between the groups was -10.1% (var = 0.001), which was shown to indicate noninferiority of DA-9601 compared to misoprostol. Adverse events were lower in the DA-9601 group, 56.4% (95% CI, 48.0%-64.8%) than in the misoprostol group, 69.2% (95% CI, 61.3%-77.0%) (P = 0.031). DA-9601 is not inferior to misoprostol for preventing NSAID-associated gastroduodenal injury, and superior to it with respect to treatment-related side effects. PMID:21860559

  4. Photodynamic Therapy for Actinic Keratoses: A Randomized Prospective Non-sponsored Cost-effectiveness Study of Daylight-mediated Treatment Compared with Light-emitting Diode Treatment.

    PubMed

    Neittaanmäki-Perttu, Noora; Grönroos, Mari; Karppinen, Toni; Snellman, Erna; Rissanen, Pekka

    2016-02-01

    Daylight-mediated photodynamic therapy (DL-PDT) is considered as effective as conventional PDT using artificial light (light-emitting diode (LED)-PDT) for treatment of actinic keratoses (AK). This randomized prospective non-sponsored study assessed the cost-effectiveness of DL-PDT compared with LED-PDT. Seventy patients with 210 AKs were randomized to DL-PDT or LED-PDT groups. Effectiveness was assessed at 6 months. The costs included societal costs and private costs, including the time patients spent in treatment. Results are presented as incremental cost-effectiveness ratio (ICER). The total costs per patient were significantly lower for DL-PDT (€132) compared with LED-PDT (€170), giving a cost saving of €38 (p = 0.022). The estimated probabilities for patients' complete response were 0.429 for DL-PDT and 0.686 for LED-PDT; a difference in probability of being healed of 0.257. ICER showed a monetary gain of €147 per unit of effectiveness lost. DL-PDT is less costly and less effective than LED-PDT. In terms of cost-effectiveness analysis, DL-PDT provides lower value for money compared with LED-PDT.

  5. Prevention of NSAID-associated gastroduodenal injury in healthy volunteers-a randomized, double-blind, multicenter study comparing DA-9601 with misoprostol.

    PubMed

    Lee, Kang Nyeong; Lee, Oh Young; Choi, Myung-Gyu; Choi, Seok Reyol; Lee, Dong Ho; Lee, Yong Chan; Kim, Tae Nyeun; Choi, Suck Chei; Rew, Jong Sun; Seol, Sang-Yong

    2011-08-01

    In addition to inhibiting cyclooxygenase and prostaglandin, nonsteroidal anti-inflammatory drugs (NSAIDs) may cause gastroduodenal injuries due to reactive oxygen species produced by recruited inflammatory cells. DA-9601 is a novel antioxidant with anti-inflammatory and cyto-protective effects. This study was conducted to compare the efficacy and safety of DA-9601 with misoprostol for preventing NSAID-associated gastroduodenal injury. In this randomized, double-blind, multicenter, noninferiority trial we compared the extents of protection of gastric and duodenal mucosae by endoscopy after 4 weeks of treatment with DA-9601 60 mg or misoprostol 200 µg three times daily, in subjects with normal baseline endoscopic findings who received an NSAID twice daily for 4 weeks. A total of 266 subjects were randomized to treatment. At week 4, the gastric protection rates with DA-9601 and misoprostol were 85.1% and 95.2%, respectively; the difference between the groups was -10.1% (var = 0.001), which was shown to indicate noninferiority of DA-9601 compared to misoprostol. Adverse events were lower in the DA-9601 group, 56.4% (95% CI, 48.0%-64.8%) than in the misoprostol group, 69.2% (95% CI, 61.3%-77.0%) (P = 0.031). DA-9601 is not inferior to misoprostol for preventing NSAID-associated gastroduodenal injury, and superior to it with respect to treatment-related side effects.

  6. Algometry with a clothes peg compared to an electronic pressure algometer: a randomized cross-sectional study in pain patients

    PubMed Central

    2011-01-01

    Background Hypersensitivity of the central nervous system is widely present in pain patients and recognized as one of the determinants of chronic pain and disability. Electronic pressure algometry is often used to explore aspects of central hypersensitivity. We hypothesized that a simple pain provocation test with a clothes peg provides information on pain sensitivity that compares meaningfully to that obtained by a well-established electronic pressure algometer. "Clinically meaningful" was defined as a medium (r = 0.3-0.5) or high (r > 0.5) correlation coefficient according to Cohen's conventions. Methods We tested 157 in-patients with different pain types. A calibrated clothes peg was applied for 10 seconds and patients rated the pain intensity on a 0 to 10 numerical rating scale. Pressure pain detection threshold (PPdt) and pressure pain tolerance threshold (PPtt) were measured with a standard electronic algometer. Both methods were performed on both middle fingers and ear lobes. In a subgroup of 47 patients repeatability (test-retest reliability) was calculated. Results Clothes peg values correlated with PPdt values for finger testing with r = -0.54 and for earlobe testing with r = -0.55 (all p-values < 0.001). Clothes peg values also correlated with PPtt values for finger testing with r = -0.55 (p < 0.001). Test-retest reliability (repeatability) showed equally stable results for clothes peg algometry and the electronic algometer (all r-values > 0.89, all p-values < 0.001). Conclusions Information on pain sensitivity provided by a calibrated clothes peg and an established algometer correlate at a clinically meaningful level. PMID:21787399

  7. Comparing multilevel and Bayesian spatial random effects survival models to assess geographical inequalities in colorectal cancer survival: a case study.

    PubMed

    Dasgupta, Paramita; Cramb, Susanna M; Aitken, Joanne F; Turrell, Gavin; Baade, Peter D

    2014-10-04

    Multilevel and spatial models are being increasingly used to obtain substantive information on area-level inequalities in cancer survival. Multilevel models assume independent geographical areas, whereas spatial models explicitly incorporate geographical correlation, often via a conditional autoregressive prior. However the relative merits of these methods for large population-based studies have not been explored. Using a case-study approach, we report on the implications of using multilevel and spatial survival models to study geographical inequalities in all-cause survival. Multilevel discrete-time and Bayesian spatial survival models were used to study geographical inequalities in all-cause survival for a population-based colorectal cancer cohort of 22,727 cases aged 20-84 years diagnosed during 1997-2007 from Queensland, Australia. Both approaches were viable on this large dataset, and produced similar estimates of the fixed effects. After adding area-level covariates, the between-area variability in survival using multilevel discrete-time models was no longer significant. Spatial inequalities in survival were also markedly reduced after adjusting for aggregated area-level covariates. Only the multilevel approach however, provided an estimation of the contribution of geographical variation to the total variation in survival between individual patients. With little difference observed between the two approaches in the estimation of fixed effects, multilevel models should be favored if there is a clear hierarchical data structure and measuring the independent impact of individual- and area-level effects on survival differences is of primary interest. Bayesian spatial analyses may be preferred if spatial correlation between areas is important and if the priority is to assess small-area variations in survival and map spatial patterns. Both approaches can be readily fitted to geographically enabled survival data from international settings.

  8. Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns.

    PubMed

    Piatkowski, A; Drummer, N; Andriessen, A; Ulrich, D; Pallua, N

    2011-08-01

    A prospective, randomized, controlled single center study was designed to evaluate clinical efficacy of a polyhexanide containing bio-cellulose dressing (group B) compared to a silver-sulfadiazine cream (group A) in sixty partial-thickness burn patients. Local ethics committee approval was obtained and patients consented. Parameters were: pain reduction (VAS), healing time and wound bed condition, comparing day 0 (start) versus day 14 (end), as well as, ease of dressing use and treatment costs. All completed the study (n=30/n=30) and were included in the ITT analysis, with a total of 72 burns (group A: n=38, group B: n=34). We noted no differences in healing time. Pain reduction was significantly faster and better in group B (p<0.01). There were fewer dressing changes in group B, compared to group A. Ease of use for the bio-cellulose dressing was rated better compared to group A. In group B, € 95.20 was saved for a 10 day treatment period, compared to group A. Group B demonstrated a better and faster pain reduction in the treated partial-thickness burns, compared to group A. The results indicate the polyhexanide containing bio-cellulose dressing to be a safe and cost effective treatment for partial-thickness burns. Copyright © 2011 Elsevier Ltd and ISBI. All rights reserved.

  9. Comparative analysis of Cutanplast and Spongostan nasal packing after endoscopic sinus surgery: a prospective, randomized, multicenter study.

    PubMed

    Cho, Kyu-Sup; Park, Chan-Hwi; Hong, Sung-Lyong; Kim, Min-Jung; Kim, Joo-Yeon; Kim, Yong-Wan; Koo, Soo-Kweon; Roh, Hwan-Jung

    2015-07-01

    Commercial gelatin-based packing materials are available under different names and compositions to be used after endoscopic sinus surgery (ESS). The purpose of this study was to investigate the efficacy of Spongostan and Cutanplast nasal packing on patients' subjective symptoms, hemostasis, and wound healing following ESS. One hundred adult patients with chronic sinusitis requiring the same extent of ESS were included. Following surgery, one nasal cavity was packed with Cutanplast and the other one with Spongostan. Patients' subjective symptoms while the packing was in situ, hemostatic properties, degree of remaining amount of packing materials, postoperative wound healing, and the cost of the pack were evaluated. Cutanplast and Spongostan are equally effective in the control of postoperative bleeding following ESS. However, Cutanplast packing was significantly more comfortable than Spongostan for nasal obstruction, postnasal drip, rhinorrhea, and headache. Furthermore, the Cutanplast packing was significantly less painful at all time points. The remaining amount of the pack was significantly lower in the Cutanplast than Spongostan packing. Spongostan packing appears to impair wound healing within the sinus cavities up to 3 months postoperatively. Cutanplast was less expensive than Spongostan as used in this study. Cutanplast may be more useful gelatin-based packing material than Spongostan in terms of efficacy and cost-benefit after ESS.

  10. Effects of case management in community aged care on client and carer outcomes: a systematic review of randomized trials and comparative observational studies.

    PubMed

    You, Emily Chuanmei; Dunt, David; Doyle, Colleen; Hsueh, Arthur

    2012-11-14

    Case management has been applied in community aged care to meet frail older people's holistic needs and promote cost-effectiveness. This systematic review aims to evaluate the effects of case management in community aged care on client and carer outcomes. We searched Web of Science, Scopus, Medline, CINAHL (EBSCO) and PsycINFO (CSA) from inception to 2011 July. Inclusion criteria were: no restriction on date, English language, community-dwelling older people and/or carers, case management in community aged care, published in refereed journals, randomized control trials (RCTs) or comparative observational studies, examining client or carer outcomes. Quality of studies was assessed by using such indicators as quality control, randomization, comparability, follow-up rate, dropout, blinding assessors, and intention-to-treat analysis. Two reviewers independently screened potentially relevant studies, extracted information and assessed study quality. A narrative summary of findings were presented. Ten RCTs and five comparative observational studies were identified. One RCT was rated high quality. Client outcomes included mortality (7 studies), physical or cognitive functioning (6 studies), medical conditions (2 studies), behavioral problems (2 studies) , unmet service needs (3 studies), psychological health or well-being (7 studies) , and satisfaction with care (4 studies), while carer outcomes included stress or burden (6 studies), satisfaction with care (2 studies), psychological health or well-being (5 studies), and social consequences (such as social support and relationships with clients) (2 studies). Five of the seven studies reported that case management in community aged care interventions significantly improved psychological health or well-being in the intervention group, while all the three studies consistently reported fewer unmet service needs among the intervention participants. In contrast, available studies reported mixed results regarding client physical

  11. Prevalence of burnout in Polish anesthesiologists and anesthetist nursing professionals: A comparative non-randomized cross-sectional study.

    PubMed

    Misiołek, Aleksandra; Gil-Monte, Pedro R; Misiołek, Hanna

    2015-10-01

    The purpose of the study was to assess the burnout levels in nurses (N = 161) versus physicians (N = 373). The levels of burnout were evaluated by the Polish adaptation of the Spanish Burnout Inventory (Cronbach's alpha > .70). High burnout level was found in 18.63 percent nurses and 12.06 percent anesthesiologists, and critical level in 3.74 percent nurses and 5.90 percent anesthetists. There were statistically significant differences in Burnout global score, Enthusiasm toward the job, Psychological exhaustion, and Indolence subscales between nurses and physicians. No significant differences were found between sexes in any variable.

  12. Eradication of methicillin-resistant Staphylococcus aureus in pressure ulcers comparing a polyhexanide-containing cellulose dressing with polyhexanide swabs in a prospective randomized study.

    PubMed

    Wild, Thomas; Bruckner, Maria; Payrich, Martina; Schwarz, Christoph; Eberlein, Thomas; Andriessen, Anneke

    2012-01-01

    The study evaluated eradication of methicillin-resistant Staphylococcus aureus (MRSA) from pressure ulcers comparing swabs containing polyhexanide with a cellulose dressing + polyhexanide. After receiving approval from the ethics committee and informed consent, patients from the centers were recruited. Prospective randomized study. Thirty patients (n = 15/n = 15), not responding to wound disinfection after a washout period of 2 weeks, were included in the intention-to-treat analysis. This study was performed on hospital patients. Patients had pressure ulcers containing MRSA. For the control group, cleansing was performed with polyhexanide swabs (20 minutes), after which a foam dressing was applied. The study group received a polyhexanide-containing cellulose dressing. For bacterial analysis, semiquantitative swab cultures (Robert Koch Institute recommendations) were taken on days 0, 7, and 14 and during 3 consecutive days. The groups were comparable at baseline. At day 7, in the control group, 6 of 15 (40%) MRSA eradication. For the study group, there were 13 of 15 (86.67%) who showed MRSA eradication. At day 14, in the control group, there were 10 of 15 (66.67%) who had MRSA eradication, compared with the study group, where 15 of 15 (100%; P < .05) had the MRSA eradicated. Wound disinfection with polyhexanide was shown to be successful in both groups, showing superior results for the study group.

  13. Comparing Inpatient Satisfaction Collected via a Web-Based Questionnaire Self-Completion and Through a Telephone Interview: An Ancillary Study of the SENTIPAT Randomized Controlled Trial.

    PubMed

    Feldman, Sarah F; Lapidus, Nathanael; Cosnes, Jacques; Tiret, Emmanuel; Fonquernie, Laurent; Cabane, Jean; Chazouilleres, Olivier; Surgers, Laure; Beaussier, Marc; Valleron, Alain-Jacques; Carrat, Fabrice; Hejblum, Gilles

    2017-08-23

    Assessing the satisfaction of patients about the health care they have received is relatively common nowadays. In France, the satisfaction questionnaire, I-Satis, is deployed in each institution admitting inpatients. Internet self-completion and telephone interview are the two modes of administration for collecting inpatient satisfaction that have never been compared in a multicenter randomized experiment involving a substantial number of patients. The objective of this study was to compare two modes of survey administration for collecting inpatient satisfaction: Internet self-completion and telephone interview. In the multicenter SENTIPAT (acronym for the concept of sentinel patients, ie, patients who would voluntarily report their health evolution on a dedicated website) randomized controlled trial, patients who were discharged from the hospital to home and had an Internet connection at home were enrolled between February 2013 and September 2014. They were randomized to either self-complete a set of questionnaires using a dedicated website or to provide answers to the same questionnaires administered during a telephone interview. As recommended by French authorities, the analysis of I-Satis satisfaction questionnaire involved all inpatients with a length of stay (LOS), including at least two nights. Participation rates, questionnaire consistency (measured using Cronbach alpha coefficient), and satisfaction scores were compared in the two groups. A total of 1680 eligible patients were randomized to the Internet group (n=840) or the telephone group (n=840). The analysis of I-Satis concerned 392 and 389 patients fulfilling the minimum LOS required in the Internet and telephone group, respectively. There were 39.3% (154/392) and 88.4% (344/389) responders in the Internet and telephone group, respectively (P<.001), with similar baseline variables. Internal consistency of the global satisfaction score was higher (P=.03) in the Internet group (Cronbach alpha estimate

  14. Early Psychological Preventive Intervention For Workplace Violence: A Randomized Controlled Explorative and Comparative Study Between EMDR-Recent Event and Critical Incident Stress Debriefing.

    PubMed

    Tarquinio, Cyril; Rotonda, Christine; Houllé, William A; Montel, Sébastien; Rydberg, Jenny Ann; Minary, Laetitia; Dellucci, Hélène; Tarquinio, Pascale; Fayard, Any; Alla, François

    2016-11-01

    This randomized controlled trial study aims to investigate the efficacy of an early psychological intervention called EMDR-RE compared to Critical Incident Stress Debriefing on 60 victims of workplace violence, which were divided into three groups: 'EMDR-RE' (n = 19), 'CISD' (n = 23), and 'delayed EMDR-RE' (n = 18). EMDR-RE and CISD took place 48 hours after the event, whilst third intervention was delayed by an additional 48 hours. Results showed that after 3 months PCLS and SUDS scores were significantly lower with EMDR-RE and delayed EMDR-RE compared to CISD. After 48 hours and 3 months, none of the EMDR-RE-treated victims showed PTSD symptoms.

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

    PubMed

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

    2017-09-01

    The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS trial is to compare rates of intraoperative hypotension after anesthesia and to identify risk factors for intraoperative hypotension. A total of 722 infants ≤60 weeks postmenstrual age undergoing inguinal herniorrhaphy were randomized to either bupivacaine regional anesthesia (RA) or sevoflurane GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born at <26 weeks of gestation. Moderate hypotension was defined as mean arterial pressure measurement of <35 mm Hg. Any hypotension was defined as mean arterial pressure of <45 mm Hg. Epochs were defined as 5-minute measurement periods. The primary outcome was any measured hypotension <35 mm Hg from start of anesthesia to leaving the operating room. This analysis is reported primarily as intention to treat (ITT) and secondarily as per protocol. The relative risk of GA compared with RA predicting any measured hypotension of <35 mm Hg from the start of anesthesia to leaving the operating room was 2.8 (confidence interval [CI], 2.0-4.1; P < .001) by ITT analysis and 4.5 (CI, 2.7-7.4, P < .001) as per protocol analysis. In the GA group, 87% and 49%, and in the RA group, 41% and 16%, exhibited any or moderate hypotension by ITT, respectively. In multivariable modeling, group assignment (GA versus RA), weight at the time of surgery, and minimal intraoperative temperature were risk factors for hypotension. Interventions for hypotension occurred more commonly in the GA group compared with the RA group (relative risk, 2.8, 95% CI, 1.7-4.4 by ITT). RA reduces the incidence of hypotension and the chance of intervention to treat it compared with sevoflurane anesthesia in young infants undergoing inguinal

  16. Comparative tolerability and harms of individual statins: a study-level network meta-analysis of 246 955 participants from 135 randomized, controlled trials.

    PubMed

    Naci, Huseyin; Brugts, Jasper; Ades, Tony

    2013-07-01

    Our objective was to estimate the comparative harms of individual statins using both placebo-controlled and active-comparator trials. We systematically reviewed randomized trials evaluating different statins in participants with and without cardiovascular disease. We performed random-effects pairwise and network meta-analyses to quantify the relative harms of individual statins. We included 55 two-armed placebo-controlled and 80 two- or multiarmed active-comparator trials including 246,955 individuals. According to pairwise meta-analyses, individual statins were not different than control in terms of myalgia, creatine kinase elevation, cancer, and discontinuations because of adverse events. Statins as a class resulted in significantly higher odds of diabetes mellitus (odds ratio, 1.09; 95% confidence interval, 1.02-1.16) and transaminase elevations (odds ratio, 1.51; 95% confidence interval, 1.24-1.84) compared with control. When individual statins were compared in network meta-analyses, there were numerous statistically detectable differences, favoring simvastatin and pravastatin. According to dose-level comparisons, individual statins resulted in higher odds of discontinuations with higher doses of atorvastatin and rosuvastatin. Similarly, higher doses of atorvasatin, fluvastatin, lovastatin, and simvastatin were associated with higher odds of transaminase elevations. Simvastatin at its highest doses was associated with creatine kinase elevations (odds ratio, 4.14; 95% credible interval, 1.08-16.24). Meta-regression analyses adjusting for study-level age at baseline, low-density lipoprotein cholesterol level, and publication year did not explain heterogeneity. There was no detectable inconsistency in the network. As a class, adverse events associated with statin therapy are not common. Statins are not associated with cancer risk but do result in a higher odds of diabetes mellitus. Among individual statins, simvastatin and pravastatin seem safer and more tolerable

  17. The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study.

    PubMed

    Garcia, Esther; Robert, Marta; Peris, Francesc; Nakamura, Hiroshi; Sato, Noriko; Terazawa, Yoshikatsu

    2009-01-01

    Blonanserin is a novel atypical antipsychotic agent with potent dopamine D(2) and serotonin 5-HT(2) antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents. To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia. This was a 6-week, randomized, double-blind, placebo- and haloperidol-controlled, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >/=70 and a Clinical Global Impression - Severity of Illness (CGI-S) score >/=4 ('moderately ill') [with no decrease >/=20% or >/=1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables. All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p < 0.001); blonanserin 10 mg was significantly superior to blonanserin 2.5 mg (-30.18 vs -20.6; p < 0.001), but blonanserin 5 mg (-27.19) and haloperidol 10 mg (-28.16) were not. All active treatments showed greater efficacy against the positive symptoms of schizophrenia, and blonanserin (5 and 10 mg) was more effective against the negative symptoms than haloperidol. Blonanserin was well tolerated at all doses and there was no evidence of clinically important weight gain, orthostatic hypotension, corrected QT interval prolongation or clinically relevant changes in laboratory test results. Haloperidol caused persistent elevation in prolactin levels, but this was not

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

    PubMed Central

    Buhari, Faiza Sulaiman; Selvaraj, Venkatesh

    2016-01-01

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

  19. Maintenance of the response to dimethyl sulfoxide treatment using hyperbaric oxygen in interstitial cystitis/painful bladder syndrome: a prospective, randomized, comparative study.

    PubMed

    Gallego-Vilar, Daniel; García-Fadrique, Gonzalo; Povo-Martin, Ivan; Salvador-Marin, Manuel; Gallego-Gomez, Juan

    2013-01-01

    Interstitial cystitis (IC)/painful bladder syndrome (PBS) is a difficult disease to manage and creates critical limitations in patients' daily lives. Our objective was to determine the efficacy of hyperbaric oxygen (HBO) therapy in the maintenance of response after the administration of intravesical dimethyl sulfoxide (DMSO). We conducted an open, prospective, randomized, comparative pilot study with women diagnosed with IC/PBS according to the European Society for the Study of Interstitial Cystitis criteria. In the first phase, DMSO was given to all patients. In the second phase, we used 1:1 randomization and administered HBO to 10 women. The evaluated variables were pain (through a visual analog scale), frequency and urgency of voids, nocturia, and quality of life using the O'Leary-Sant Interstitial Cystitis Score/Problem Index and the King's Health Questionnaire. In the second phase, we measured the length of time that clinical improvement was maintained. The mean age was 47.6 years (SD 18.4). Out of 20 patients, 14 experienced clinical improvement after DMSO in all of the evaluated symptoms (p < 0.05; 95% CI). After the second phase, all patients who received HBO had a more substantive and prolonged maintenance of the effects of DMSO. In this study, HBO improved the maintenance of the beneficial effects of DMSO among women with IC/PBS. Copyright © 2013 S. Karger AG, Basel.

  20. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

    PubMed

    Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

    2013-02-15

    Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

  1. Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, multicenter, Italian, comparative study versus zolmitriptan.

    PubMed

    Allais, Gianni; Tullo, Vincenzo; Benedetto, Chiara; Zava, Dario; Omboni, Stefano; Bussone, Gennaro

    2011-05-01

    Menstrually related migraine (MRM) is a particularly difficult-to-treat pain condition, associated with substantial disability. Aim of this study was to compare the efficacy and safety of frovatriptan and zolmitriptan in the treatment of MRM attacks, analyzing data from a multicenter, randomized, double blind, cross-over study. We analyzed the subset of 76 regularly menstruating women who participated in one head-to-head multicenter, randomized, double blind, cross-over clinical trial and who took the study drugs to treat MRM attacks. In a randomized sequence, each patient received frovatriptan 2.5 mg or zolmitriptan 2.5 mg: after treating three episodes of migraine in no more than 3 months with the first treatment, the patient had to switch to the other treatment. MRM was defined according to the criteria listed in the Appendix of the last Classification of Headache disorders of the International Headache Society. A total of 73 attacks, classified as MRM, were treated with frovatriptan and 65 with zolmitriptan. Rate of pain relief at 2 h was 52% for frovatriptan and 53% for zolmitriptan (p = NS), while rate of pain free at 2 h was 22 and 26% (p = NS), respectively. At 24 h, 74 and 83% of frovatriptan-treated and 69 and 82% of zolmitriptan-treated patients were pain free and had pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.05) lower with frovatriptan (15 vs. 22% zolmitriptan). Frovatriptan proved to be effective in the immediate treatment of MRM attacks, similarly to zolmitriptan, but showed lower recurrence rates, and thus a better sustained relief.

  2. Comparative study between 2 different doses of pregabalin and lidocaine on pain following propofol injection: A double-blind, randomized clinical consort study.

    PubMed

    Choi, Eunkyung; Kim, Donggyeong; Jeon, Younghoon

    2016-12-01

    Propofol, an intravenous anesthetic, often causes pain on injection, which can be very distressful to patients. We investigated the analgesic effect of pregabalin on pain following propofol injection, compared with lidocaine. In a randomized, double-blind, prospective trial, 120 patients were randomized into 3 groups of 40 each; who received oral placebo and intravenous lidocaine 40 mg with venous occlusion for 1 minute (group L, n = 40), oral pregabalin 75 mg and intravenous normal saline with venous occlusion for 1 minute (group LP, n = 40), and oral pregabalin 150 mg and intravenous normal saline with venous occlusion for 1 minute (group HP, n = 40) as pretreatment, followed by administration of 1% propofol 0.5 mg/kg. Pain intensity was measured on a 4-point scale (0 = no, 1 = mild, 2 = moderate, and 3 = severe pain). Any side effects associated with pretreatment substances were recorded during the first 24 hours after surgery. A total of 120 patients completed this trial. Demographic data were similar between groups. The incidence of pain following propofol injection was significantly reduced in group HP (50%) and group L (55%) compared with group LP (92.5%) (P < 0.05, respectively). The incidences of moderate pain in group HP (12.5%) and group L (15%) were significantly decreased compared with group LP (37.5%; both, P < 0.05). There were no significant differences in the incidence of side effects such as headache and dizziness between groups. Pretreatment with oral pregabalin 150 mg and intravenous lidocaine 40 mg with venous occlusion equally reduced pain from propofol injection.

  3. Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study.

    PubMed

    Sharpe, Michael D; van Rassel, Barbara; Haddara, Wael

    2013-10-01

    Thyroxine (T4) administration is advocated in the management of organ donors; however, the bioavailability of oral thyroxine is unknown in this patient population. The primary objective of this study was to compare the percentage of the study time (from study drug administration to organ procurement) that patients in the oral vs the intravenous group required inotropic support. Secondary objectives included plasma levels of T3 and T4 and number of organs donated following oral vs intravenous T4 administration. Randomized double-blinded study. Adult medical-surgical intensive care unit. Thirty-two adult solid organ donors. Patients were randomized to receive either an oral or intravenous dose of T4 (2 μg·kg⁻¹). All patients received an oral and intravenous study drug preparation, one of which was a placebo. The study was double-blinded, and randomization occurred in blocks of four and six. The number and duration of inotropic/vasopressor therapies and free serum levels of T3 and T4 were determined hourly until procurement. Following T4 administration, all patients remained on inotropic/vasopressor therapy for the same mean (SD) duration [93 (3)%] of the study period. There was a similar and gradual decrease in the number and dosages of inotropes/vasopressors required in both groups. There was no difference in T3 or T4 levels between groups. Oral bioavailability of T4 was 93% of the intravenous group at six hours and 91% overall. At six hours, the mean area under the curve for T4 was similar between the intravenous group [92.2 (33); 95% confidence interval (CI) 76 to 108.4] and the oral group [86.1 (14); 95% CI 79.4 to 92.8]. Orally administered T4 is well absorbed and achieves a bioavailability of approximately 91-93% of intravenous T4 in organ donors. Inotropic/vasopressor requirements and hemodynamic responses following oral or intravenous thyroxine administration were comparable. Oral T4 is suitable for hormonal therapy for organ donors. This trial was

  4. On-demand treatment of acute heartburn with the antacid hydrotalcite compared with famotidine and placebo: randomized double-blind cross-over study.

    PubMed

    Holtmeier, Wolfgang; Holtmann, Gerald; Caspary, Wolfgang F; Weingärtner, Ulrike

    2007-07-01

    Antacids are widely used in the self-treatment of gastroesophageal reflux-induced complaints, but respective studies are lacking. To compare the efficacy and safety of hydrotalcite with the H2 receptor antagonist famotidine and placebo in the on-demand treatment of acute heartburn under daily practice conditions. Five hundred sixty-two individuals in 4 centers were randomized in a double-blind, double-dummy, 3-fold cross-over study to single-dose treatments of 1000 mg hydrotalcite, 10 mg famotidine, or placebo. Heartburn severity and relief was measured with numerical and visual rating scales. A significantly better heartburn relief score was achieved 60 minutes after administration of hydrotalcite compared with placebo (primary end point, P<0.0001). Better efficacy was also observed 30 minutes and 3 hours after the intake of hydrotalcite in comparison with famotidine or placebo. A significant decrease in heartburn severity compared with placebo occurred within 10 minutes for hydrotalcite and was faster compared with both controls. For subjects self-administering antacids for episodic heartburn, antacid hydrotalcite provides symptom relief significantly faster and, within the first 3 hours postdosing, more effective than famotidine or placebo. These results suggest that on-demand treatment of hydrotalcite is an effective and well-tolerated therapy for heartburn.

  5. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of Early Aggressive Rheumatoid Arthritis Trial.

    PubMed

    Moreland, Larry W; O'Dell, James R; Paulus, Harold E; Curtis, Jeffrey R; Bathon, Joan M; St Clair, E William; Bridges, S Louis; Zhang, Jie; McVie, Theresa; Howard, George; van der Heijde, Désirée; Cofield, Stacey S

    2012-09-01

    To assess whether it is better to intensively treat all patients with early rheumatoid arthritis (RA) using combinations of drugs or to reserve this approach for patients who do not have an appropriate response (as determined by a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate [DAS28-ESR] of ≥ 3.2 at week 24) to methotrexate (MTX) monotherapy, and to assess whether combination therapy with MTX plus etanercept is superior to the combination of MTX plus sulfasalazine plus hydroxychloroquine. The Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) study is a 2-year, randomized, double-blind trial. A 2 × 2 factorial design was used to randomly assign subjects to 1 of 4 treatment arms: immediate treatment with MTX plus etanercept, immediate oral triple therapy (MTX plus sulfasalazine plus hydroxychloroquine), or step-up from MTX monotherapy to one of the combination therapies (MTX plus etanercept or MTX plus sulfasalazine plus hydroxychloroquine) at week 24 if the DAS28-ESR was ≥ 3.2. All treatment arms included matching placebos. The primary outcome was an observed-group analysis of DAS28-ESR values from week 48 to week 102. At week 24 (beginning of the step-up period), subjects in the 2 immediate-treatment groups demonstrated a greater reduction in the DAS28-ESR compared with those in the 2 step-up groups (3.6 versus 4.2; P < 0.0001); no differences between the combination-therapy regimens were observed. Between week 48 and week 102, subjects randomized to the step-up arms had a DAS28-ESR clinical response that was not different from that of subjects who initially received combination therapy, regardless of the treatment arm. There was no significant difference in the DAS28-ESR between subjects randomized to oral triple therapy and those randomized to receive MTX plus etanercept. By week 102, there was a statistically significant difference in the change in radiographic measurements from baseline between the group receiving MTX

  6. Emergency skill training--a randomized controlled study on the effectiveness of the 4-stage approach compared to traditional clinical teaching.

    PubMed

    Greif, Robert; Egger, Lars; Basciani, Reto M; Lockey, Andrew; Vogt, Andreas

    2010-12-01

    The "4-stage approach" has been widely accepted for practical skill training replacing the traditional 2 stages ("see one, do one"). However, the superior effectiveness of the 4-stage approach was never proved. To evaluate whether skill training with the 4-stage approach results in shorter performance time needed for a successful percutaneous needle-puncture cricothyroidotomy, and consequently in a reduced number of attempts needed to perform the skill in <60s compared to traditional teaching. Randomized controlled single-blinded parallel group study at the University Hospital Bern. With IRB approval and informed consent 128 undergraduate medical students were randomized in four groups: traditional teaching, no stage 2, no stage 3, and 4-stage approach for the training of cricothyroidotomy. Everyone watched a video of the cricothyroidotomy as stage 1 followed by skill training in the respective teaching group. Participants had to perform the cricothyroidotomy 10 times on skin-covered pig larynxes. Performance time was measured from skin palpation to trachea ventilation. Study participants filled out a self-rating on competency during the training. Performance time for each attempt was comparable in all groups and improved similarly to reach a performance time of <60 s. Self-rating revealed that all groups felt equally competent throughout. Even if the 4-stage approach is widely accepted and used as a didactic method for skill teaching we could not find evidence that its use or omitting stage 2 or 3 results in superior learning of an emergency skill compared to traditional teaching. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  7. Kojic Acid vis-a-vis its Combinations with Hydroquinone and Betamethasone Valerate in Melasma: A Randomized, Single Blind, Comparative Study of Efficacy and Safety

    PubMed Central

    Deo, Kirti S.; Dash, Kedar N.; Sharma, Yugal K.; Virmani, Neha C.; Oberai, Chetan

    2013-01-01

    Background: Melasma is a relatively common, acquired symmetric hypermelanosis characterized by irregular light to gray-brown macules involving sun-exposed areas. Kojic acid, with its depigmenting potential due to tyrosinase inhibition and suppression of melanogenesis, has become a vital component of the dermatologists’ armamentarium against melasma. Aim: To study and compare the efficacy of kojic acid 1% alone, vis-a-vis its separate combinations with 2% hydroquinone or 0.1% betamethasone valerate and a combination of all these three agents with respect to the duration of symptoms and level of pigmentation in the therapy of melasma. Materials and Methods: Eighty patients from a single tertiary care center objectively assessed by calculating the melasma area severity index (MASI) and randomized (simple randomization) into four parallel groups (A, B, C, and D) of 20 each were prescribed once daily local application at night, (participants blinded regarding the difference in identity of interventions), as follows: Group A – kojic acid 1% cream. Group B – kojic acid 1% and hydroquinone 2% cream. Group C – kojic acid 1% and betamethasone valerate 0.1% cream. Group D – kojic acid 1%, hydroquinone 2%, and betamethasone valerate 0.1% cream. Strict photoprotection and use of a SPF 15 sunscreen was advised during the day. Patients were evaluated every 2 weeks and a fall in MASI score was calculated at the end of the study period of 12 weeks by the same investigator. Results: The response was compared according to percentage decrease in MASI score. Efficacy was evaluated among the groups at the end of 3 months using bivariate analysis and calculated by using the paired ‘t’ test. The clinical efficacy of group B was the highest followed closely by group D and group A, that of group C being the lowest. Conclusion: Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations. PMID:23918998

  8. Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant Toxicity: A Randomized, Controlled Pilot Study in a Swine Model

    DTIC Science & Technology

    2014-11-01

    ORIGINAL CONTRIBUTION Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant ...Maria Castaneda, MS Abstract Objectives: Tricyclic antidepressants (TCAs) are highly lipophilic medications used to treat posttraumatic stress disorder...Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant Toxicity: A Randomized, Controlled

  9. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults.

    PubMed

    Jimenez-Cruz, Fernando; Jasovich, Abel; Cajigas, Jaime; Jiang, Qi; Imbeault, Danielle; Woods, Gail L; Gesser, Richard M

    2002-07-01

    To compare the efficacy and safety of ertapenem, a new once-daily parenteral beta-lactam, with that of ceftriaxone for the initial empiric treatment of adults with complicated urinary tract infections (cUTIs). In a multicenter, prospective, double-blind study, patients with cUTIs were stratified as to whether they had acute pyelonephritis or other cUTIs (without pyelonephritis) and randomized to receive ertapenem, 1 g once a day, or ceftriaxone, 1 g once a day. After 3 days, patients with a satisfactory clinical response could be switched to an oral antimicrobial agent. Of 258 randomized patients, 97 (55.4%) in the ertapenem group and 53 (63.9%) in the ceftriaxone group were evaluated microbiologically. Almost all patients in each treatment group were switched to oral therapy. The mean duration of therapy was similar in both treatment groups: parenteral, approximately 4 days; total, approximately 13 days. The most common pathogen was Escherichia coli. At the primary efficacy endpoint, 5 to 9 days after treatment, 85.6% of patients who received ertapenem and 84.9% who received ceftriaxone had a favorable microbiologic response, indicating that the two treatment groups were equivalent. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this study, ertapenem was as effective as ceftriaxone for the initial treatment of cUTI in adults, was generally well tolerated, and had a similar safety profile.

  10. Er:YAG Laser Versus Cold Knife Excision in the Treatment of Nondysplastic Oral Lesions: A Randomized Comparative Study for the Postoperative Period.

    PubMed

    Broccoletti, Roberto; Cafaro, Adriana; Gambino, Alessio; Romagnoli, Ercole; Arduino, Paolo Giacomo

    2015-12-01

    The aim of this prospective study was to estimate the effects of Erbium substituted: Yttrium Aluminium Garnet (Er:YAG) laser, compared with traditional scalpel, on the early postoperative sequelae of nondysplastic oral lesion removal. There is limited evidence that laser surgery could exhibit advantages over scalpel in oral mucosal surgery. The investigators studied a cohort of 344 patients; 394 lesions were randomized and treated. Outcome statistically evaluated variables were: age, gender, the site and size of investigated lesions, visual analogue score (VAS) of pain, the Oral Health Impact Profile questionnaire (OHIP-14) and the Quality of Life test (QOL), and number of analgesics taken in the 1st week after surgery. Significant differences were found if considering the surgical time, VAS, and QOL and OHIP-14 questionnaires; regarding those data, the Er:YAG laser appeared to be faster and less painful than traditional scalpel (p < 0.05). For bigger lesions, patients statistically took more painkillers if they had undergone traditional surgery. Considering the site of the treated lesions, Er:YAG laser was less painful, especially in the gingiva and palate (p < 0.05). This is the first randomized controlled surgical trial reported for the management of nondysplastic oral lesions with the use of an Er:YAG laser. With many limitations, the present report identifies significant difference in the immediate postoperative surgical period between the two treatments, meaning that the Er:YAG laser seemed to be less painful, and better accepted by patients, than traditional scalpel.

  11. Efficacy and safety of valsartan compared to enalapril in hypertensive children: a 12-week, randomized, double-blind, parallel-group study.

    PubMed

    Schaefer, Franz; Litwin, Mieczyslaw; Zachwieja, Jacek; Zurowska, Aleksandra; Turi, Sandor; Grosso, Amie; Pezous, Nicole; Kadwa, Mahomed

    2011-12-01

    This study compares efficacy and safety of valsartan with enalapril in hypertensive children aged 6-17 years. This was a 12-week, randomized, double-blind, parallel-group, active-controlled study. After a single-blind placebo run-in period (4-28 days), patients with mean sitting systolic blood pressure (BP) (MSSBP) at least 95th percentile for age, gender, and height were randomized to receive half the assigned dose for first week, and force-titrated to full dose for 11 weeks (≥18 to <35 kg - valsartan: 80 mg, enalapril: 10 mg; ≥35 to <80 kg - valsartan: 160 mg, enalapril: 20 mg; ≥80 to ≤160 kg - valsartan: 320 mg, enalapril: 40 mg). The primary efficacy variable was changed from baseline in MSSBP to show noninferiority of valsartan to enalapril. Other efficacy variables were changed from baseline in MSDBP, SBP control rate, and 24-h ambulatory BP parameters. Of 300 randomized patients, 281 (94%) completed the study. At week 12, MSSBP reductions were similar for valsartan and enalapril (primary endpoint of noninferiority, P < 0.0001). Least square mean BP reductions from baseline of -15.4/-9.4 mmHg were observed for valsartan compared with -14.1/-8.5 mmHg for enalapril. A similar proportion of patients achieved SBP control (valsartan: 67%; enalapril: 70%). In the subset of patients who underwent ambulatory BP assessments, valsartan provided greater reductions than enalapril in mean 24-h SBP (valsartan: -9.8 mmHg, enalapril: -7.2 mmHg: P = 0.03). The overall incidence of AEs was similar (valsartan 60%, enalapril 58%) with headache, cough, and nasopharyngitis reported most frequently. Valsartan and enalapril provided comparable BP reductions and effective BP control and were well tolerated in hypertensive children aged 6-17 years.

  12. Two center, randomized pilot study of migraine prophylaxis comparing paradigms using pre-emptive frovatriptan or daily topiramate: research and clinical implications.

    PubMed

    Cady, Roger K; Voirin, James; Farmer, Kathleen; Browning, Rebecca; Beach, M E; Tarrasch, Jeanne

    2012-05-01

    To compare the efficacy and clinical benefit of 2 paradigms of migraine prevention using pre-emptive frovatriptan and daily topiramate. The study compares the paradigms of pre-emptive use of frovatriptan, a drug approved for acute migraine, and the daily use of topiramate, a Federal Drug Administration-approved and -accepted standard for migraine prophylaxis. Traditionally, preventive treatment of migraine required daily medication. However, recent studies suggest that pre-emptive prophylaxis may be beneficial to those migraineurs who can predict an attack of migraine based on premonitory symptoms and treat during that phase. A total of 76 adult subjects with a diagnosis of migraine were screened for the study. During a 1-month baseline period, subjects demonstrated through a daily diary that they predicted at least 50% of migraine attacks during the premonitory phase and treated with their usual medication. Of these, 55 were randomized to either Group A (daily topiramate) or Group B (frovatriptan during premonitory symptoms); 44 completed the study. The treatment period lasted 2 months. The subjects answered the Migraine-Specific Quality of Life Questionnaire at randomization, and at Weeks 4 and 8. The revised Patient Perception of Migraine Questionnaire was answered 24 hours after taking frovatriptan (Group A, for break-through headaches; Group B, treatment during premonitory symptoms). The number of migraine attacks and headache days per month decreased significantly from baseline for both Groups A and B. Subjects in Group A had considerably more adverse events leading to study withdrawal than in Group B (18% vs 4%). Though this study was not powered to directly compare the efficacy of the 2 drugs, topiramate showed superiority over frovatriptan at Month 2 in reduction of headache days, which was a secondary end point in the study (P = .036). This pilot study demonstrated that statistical benefit for reduction of headache days over baseline for both pre

  13. A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol

    PubMed Central

    2014-01-01

    Background Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. Methods/Design This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. Discussion The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and

  14. A comparative study of grasping-type scissors forceps and insulated-tip knife for endoscopic submucosal dissection of early gastric cancer: a randomized controlled trial

    PubMed Central

    Nagai, Kengo; Uedo, Noriya; Yamashina, Takeshi; Matsui, Fumi; Matsuura, Noriko; Ito, Takashi; Yamamoto, Sachiko; Hanaoka, Noboru; Takeuchi, Yoji; Higashino, Koji; Ishihara, Ryu; Iishi, Hiroyasu

    2016-01-01

    Background and study aims: Endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is technically difficult for beginners. Few comparative studies of technical feasibility, efficacy, and safety using various devices have been reported. This study evaluated the feasibility, efficacy, and safety of ESD for EGC < 2 cm using grasping-type scissors forceps (GSF) or insulated-tip knife (IT2) for three resident endoscopists. Patients and methods: This was a randomized phase II study in a cancer referral center. A total of 108 patients with 120 EGCs were enrolled with the following characteristics: differentiated-type mucosal EGC, without ulcers or scars, < 2 cm (86 men, 22 women; median age 72 years). All lesions were stratified according to operator and tumor location (antrum or corpus), assigned randomly to two groups (GSF or IT2), and resected by ESD. Self-completion rate, complete resection rate, procedure time, and adverse events were evaluated as main outcome measures. Results: There was no difference in self-completion rate between the IT2 group (77 %, 47/61, P = 0.187) and the GSF group (66 %, 37/56). Also, there were no differences in en bloc resection rate (98 %, 60/61 vs. 93 %, 52/56, P = 0.195) and adverse events (3.3 %, 2/61 vs. 7.1 %, 4/56, P = 0.424). Median (min [range]) procedure time in the IT2 group (47 [33 – 67], P = 0.003) was shorter than that in the GSF group (66 [40 – 100]). Limitations of this study were the small sample size and single center design. Conclusions: ESD with GSF did not show a statistically significant advantage in improvement of self-completion rate over IT2. (Study registration: UMIN 000005048) PMID:27556074

  15. Intravenous analgesia with opioids versus femoral nerve block with 0.2% ropivacaine as preemptive analgesic for fracture femur: A randomized comparative study

    PubMed Central

    Singh, Arvinder Pal; Kohli, Vaneet; Bajwa, Sukhminder Jit Singh

    2016-01-01

    Background and Objective: Femoral fractures are extremely painful and pain invariably worsens on any movement. Anesthesia for fracture femur surgery is usually provided by spinal block. This study was undertaken to compare the analgesic effects of femoral nerve block (FNB) using nerve stimulator with 0.2% ropivacaine (15 ml) and intravenous (I.V.) fentanyl before patient positioning for fracture femur surgery under spinal anesthesia. Materials and Methods: A prospective, randomized, double-blind, comparative study was conducted on 60 American Society of Anesthesiologists I and II patients (18–60 years) scheduled for femur surgery under combined spinal epidural anesthesia. Patients in Group I (n = 30), were administered FNB using nerve stimulator with 0.2% ropivacaine (15 ml) and in Group II patients (n = 30), I.V. fentanyl 0.5 μg/kg was given as preemptive analgesia. Parameters observed included time to spinal anesthesia, intra-operative and postoperative visual analog scale (VAS) for any pain and postoperative epidural top-ups dosages. Results: Demographic profile was comparable in both the groups. VAS at 2 min in Group I was 5.63 and in Group II it was 8.00. Satisfaction score was better in Group I as compared to Group II patients. Time to administer subarachnoid block was 17.80 min in patients of Group I as compared to 25.03 min in Group II patients. Postoperatively, VAS scores were lower in Group I than Group II patients. The frequency of epidural top-ups was higher in Group II than in Group I patients. Conclusions: FNB is comparatively better in comparison to I.V. fentanyl when used as preemptive and postoperative analgesic in patients being operated for fracture femur. PMID:27212771

  16. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study.

    PubMed

    Peolsson, Anneli; Landén Ludvigsson, Maria; Tigerfors, Ann-Marie; Peterson, Gunnel

    2016-02-01

    To determine whether 3 months of neck-specific exercises (NSEs) could benefit individuals with chronic whiplash-associated disorder (WAD) who were on a waiting list (WL) for treatment. A prospective, randomized controlled study. Primary health care. Individuals (N=41; 31 women, 10 men; mean age ± SD, 38±11.2y) with chronic (6-36mo) WAD, grades 2 and 3, were analyzed. Patients were randomly assigned to NSEs or no treatment for 3 months. Neck-specific disability (Neck Disability Index [NDI]), neck pain (visual analog scale), general pain-related disability (Pain Disability Index [PDI]), self-perceived performance ability (Self-Efficacy Scale [SES]), and health-related quality of life (EuroQol 5 dimensions [EQ-5D]) were measured. NSEs significantly improved the NDI, SES, and EQ-5D compared with WL (P<.01). There was significant improvement (P<.0001) over time in all outcomes for NSEs, and apart from the PDI, significant worsening (P=.002-.0002) over time for the untreated group. NSEs were more beneficial than no intervention while on a WL for individuals with chronic WAD. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2015-12-01

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

  18. Lymphoid irradiation in intractable rheumatoid arthritis. A double-blind, randomized study comparing 750-rad treatment with 2,000-rad treatment

    SciTech Connect

    Hanly, J.G.; Hassan, J.; Moriarty, M.; Barry, C.; Molony, J.; Casey, E.; Whelan, A.; Feighery, C.; Bresnihan, B.

    1986-01-01

    Twenty patients with intractable rheumatoid arthritis were treated with 750-rad or 2,000-rad lymphoid irradiation in a randomized double-blind comparative study. Over a 12-month followup period, there was a significant improvement in 4 of 7 and 6 of 7 standard parameters of disease activity following treatment with 750 rads and 2,000 rads, respectively. Transient, short-term toxicity was less frequent with the lower dose. In both groups, there was a sustained peripheral blood lymphopenia, a selective depletion of T helper (Leu-3a+) lymphocytes, and reduced in vitro mitogen responses. These changes did not occur, however, in synovial fluid. These results suggest that 750-rad lymphoid irradiation is as effective as, but less toxic than, that with 2,000 rads in the management of patients with intractable rheumatoid arthritis.

  19. Three-dimensional component alignment and functional outcome in computer-navigated total knee arthroplasty: a prospective, randomized study comparing two navigation systems.

    PubMed

    Harvie, Paul; Sloan, Karen; Beaver, Richard J

    2011-12-01

    Computer navigation in total knee arthroplasty produces better component alignment than conventional techniques. Different navigation systems exist. We undertook a prospective, randomized study comparing 2 navigations systems (Stryker Full Navigation and Stryker Articular Surface Mounted [ASM] navigation systems). Three-dimensional component alignment (Perth computed tomographic knee protocol) and function at 1 year (Knee Society Scores) were assessed. Forty patients participated (20 fully navigated and 20 ASM-navigated total knee arthroplasties). Cohorts were well matched according to sex, age, and body mass index. No statistically significant difference was seen in any parameter of 3-dimensional component alignment or function between cohorts. Operative time for the ASM cohort was significantly less than the fully navigated cohort (P = .001). Both systems performed equally well, and therefore, surgeon preference should determine which system is used.

  20. A randomized, double-blind study comparing the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children.

    PubMed

    Chen, Catherine; Koch, Laine H; Dice, James E; Dempsey, Kimberly K; Moskowitz, Alan B; Barnes-Eley, Myra L; Hubbard, Thomas W; Williams, Judith V

    2010-01-01

    Our objective was to compare the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children. Forty children aged 1-11 years with clinically diagnosed tinea capitis were randomized to receive selenium sulfide shampoo 1% or ciclopirox shampoo 1% twice a week as adjuncts to an 8-week course of ultramicronized griseofulvin dosed at 10-12 mg/kg/day. At weeks 2, 4, and 8, subjects returned to the clinic for evaluation and scalp cultures. Subjects then returned for follow-up visits 4 weeks after completing treatment. Overall, by 8 weeks, 30 of 33 (90.9%) treated children demonstrated mycological cure. Selenium sulfide shampoo 1% and ciclopirox shampoo 1% were equally effective as adjunctive treatments for tinea capitis in children in our study.

  1. Assessment of the efficacy of phentolamine to prevent radial artery spasm during cardiac catheterization procedures: a randomized study comparing phentolamine vs. verapamil.

    PubMed

    Ruiz-Salmerón, Rafael J; Mora, Ramón; Masotti, Mónica; Betriu, Amadeo

    2005-10-01

    The objective of this study was to evaluate phentolamine as radial artery spasmolytic in transradial catheterization procedures. Radial artery spasm is a relatively frequent complication during transradial approach, causing patient discomfort or even making it impossible to continue the procedure. As radial artery spasm is mediated by the stimulation of alpha-adrenoreceptors, the use of the alpha-blocker phentolamine could make sense as spasmolytic. We designed a randomized double-blind study to compare phentolamine vs. verapamil, the standard spasmolytic agent. Five hundred patients (250 in each arm) submitted to a transradial cardiac catheterization were consecutively included and randomly assigned to receive 2.5 mg of verapamil or 2.5 mg of phentolamine after sheath insertion. Both vasodilator agents induced a significant radial artery diameter increase (from 2.22 +/- 0.53 to 2.48 +/- 0.57 mm, P < 0.001 for verapamil, and from 2.20 +/- 0.53 to 2.45 +/- 0.53 mm, P < 0.001 for phentolamine). However, verapamil was more efficacious to prevent radial artery spasm (13.2% compared with 23.2% in phentolamine-treated patients; P = 0.004). Follow-up (20 +/- 18 days) evaluation of the radial artery patency by plestismography and pulse oximetry showed no differences between the two groups in the rate of radial occlusion (3.0% vs. 3.2% in verapamil and phentolamine treated patients, respectively). Phentolamine was an effective radial vasodilator agent, although it showed less ability to prevent radial artery spasm than verapamil. Radial artery occlusion rate was almost identical for both vasodilators. Thus, phentolamine could be a valid alternative to verapamil as a radial artery spasmolytic agent.

  2. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study

    PubMed Central

    Kim, Sung-Hoon; Hong, Jeong-Yeon; Kim, Won Oak; Karm, Myong-Hwan; Hwang, Jai-Hyun

    2013-01-01

    Background Postoperative nausea and vomiting (PONV) continues to be a major problem, because PONV is associated with delayed recovery and prolonged hospital stay. Although the PONV guidelines recommended the use of 5-hydroxy-tryptamine (5-HT3) receptor antagonists as the first-line prophylactic agents in patients categorized as high-risk, there are few studies comparing the efficacies of ondansetron, ramosetron, and palonosetron. The aim of present study was to compare the prophylactic antiemetic efficacies of three 5HT3 receptor antagonists in high-risk patients after laparoscopic surgery. Methods In this prospective, randomized, double-blinded trial, 109 female nonsmokers scheduled for elective laparoscopic surgery were randomized to receive intravenous 4 mg ondansetron (n = 35), 0.3 mg ramosetron (n = 38), or 75 µg palonosetron (n = 36) before anesthesia. Fentanyl-based intravenous patient-controlled analgesia was administered for 48 h after surgery. Primary antiemetic efficacy variables were the incidence and severity of nausea, the frequency of emetic episodes during the first 48 h after surgery, and the need to use a rescue antiemetic medication. Results The overall incidence of nausea/retching/vomiting was lower in the palonosetron (22.2%/11.1%/5.6%) than in the ondansetron (77.1%/48.6%/28.6%) and ramosetron (60.5%/28.9%/18.4%) groups. The rescue antiemetic therapy was required less frequently in the palonosetron group than the other groups (P < 0.001). Kaplan-Meier analysis showed that the order of prophylactic efficacy in delaying the interval to use of a rescue emetic was palonosetron, ramosetron, and ondansetron. Conclusions Single-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery. PMID:23814652

  3. Two-Level Circumferential Lumbar Fusion Comparing Midline and Paraspinal Posterior Approach: 5-Year Interim Outcomes of a Randomized, Blinded, Prospective Study.

    PubMed

    Buttermann, Glenn R; Mullin, William J

    2015-11-01

    A prospective randomized and blinded comparative study of 2 patient groups with >5-year follow-up. To compare the clinical outcomes and postoperative posterior muscle changes in patients with advanced degenerative disk disease undergoing 2-level circumferential spinal fusion using a posterior midline versus a paraspinal approach. Lumbar spinal fusion is often performed using a circumferential (anterior and posterior) technique. Paraspinal muscle alterations occur during the retraction of the muscles required for posterior instrumentation and fusion bed preparation, which may adversely affect outcomes. Patients with advanced 2-level lumbar degenerative disk disease were randomized into 2 groups of 25 each for the approach to the posterior spine for their anterior-posterior fusion. A midline posterior skin incision was universal, but all patients were blinded to the fascial incision and exposure to the posterior spine. All had intertransverse and facet joint fusions with pedicle screw instrumentation. Outcomes (visual analog back and leg pain scale, pain drawing, Oswestry disability index, and self-assessment of procedure success) were assessed at various periods postoperatively. Preoperative and >1-year postoperative magnetic resonance images (MRI), including paraspinal muscles, were read by a radiologist who was blinded to the surgical approach and outcomes. No difference in operative time, blood loss, implant costs, or any other intraoperative parameter existed between the 2 patient groups. Although clinical improvement for all outcome scales was significant for both groups postoperatively, there was no difference between groups. Postoperative MRI T2 relaxation values were significantly increased at the operative levels and distally, but the changes were similar for both groups. Midline and paraspinal approaches result in similar outcomes in 2-level spinal fusions. We were unable to demonstrate that a paraspinal muscle-splitting approach to 2-level fusion was

  4. A randomized controlled trial comparing mupirocin versus Polysporin Triple for the prevention of catheter-related infections in peritoneal dialysis patients (the MP3 study).

    PubMed

    Jassal, Sarbjit V; Lok, Charmaine E

    2008-01-01

    Peritonitis remains the most serious complication of peritoneal dialysis (PD). Gram-positive organisms are among the most common causes of PD peritonitis; however, recent trends show increasing rates of gram-negative and fungal infections. Strategies to prevent peritonitis include the use of prophylactic topical mupirocin at the site where the PD catheter exits from the abdominal wall; however, mupirocin does not afford protection against gram-negative or fungal infections. The aim of this study is to determine if the incidence of catheter-related infections (exit-site infection, tunnel infection, or peritonitis) is significantly reduced by the routine application of Polysporin Triple antibiotic ointment (Pfizer Canada, Markham, Ontario, Canada) in comparison to mupirocin ointment. The Mupirocin Versus Polysporin Triple Study (MP3) is a multicenter, randomized, double-blinded controlled study comparing Polysporin Triple (P3) against the current standard of care. The aim of the study is to recruit 200 patients being treated with or starting on PD and randomize them to receive either mupirocin or P3 at the catheter exit site. Patients will be followed for 18 months or until death or transfer from PD to an alternate treatment modality. The primary outcome will be the time to first catheter-related infection. Catheter-related infections will be strictly defined using current guidelines and categorized into exit-site infections, infective peritonitis, or tunnel infections. The primary analysis will be an intention-to-treat analysis. The results of this study will help determine if the use of P3 is superior to mupirocin ointment in the prevention of catheter-related infections and will help guide evidence-based best practices.

  5. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial.

    PubMed

    Lienhardt, Christian; Cook, Sharlette V; Burgos, Marcos; Yorke-Edwards, Victoria; Rigouts, Leen; Anyo, Gladys; Kim, Sang-Jae; Jindani, Amina; Enarson, Don A; Nunn, Andrew J

    2011-04-13

    Fixed-dose combinations (FDCs) of drugs for treatment of tuberculosis have been advocated to prevent the emergence of drug resistance. To assess the efficacy and safety of a 4-drug FDC for the treatment of tuberculosis. The Study C trial, a parallel-group, open-label, noninferiority, randomized controlled trial conducted in 11 sites in Africa, Asia, and Latin America between 2003 and 2008. Patients were 1585 adults with newly diagnosed smear-positive pulmonary tuberculosis. Patients were randomized to receive daily treatment with 4 drugs (rifampicin, isoniazid, pyrazinamide, ethambutol) given as an FDC (n = 798 patients) or separately (n = 787) in the 8-week intensive phase of treatment. Favorable treatment outcome, defined as negative culture result at 18 months post randomization and not having already been classified as unfavorable. Noninferiority was dependent on consistent results from a per-protocol and modified intention-to-treat analysis, using 2 different models for the latter, classifying all changes of treatment or refusal to continue treatment (eg, bacteriological failure/relapse, adverse event, default, drug resistance) as unfavorable (model 1) and classifying changes of treatment for reasons other than therapeutic outcomes according to their 18-month bacteriological outcome if available (post hoc model 2). The prespecified noninferiority margin was 4%. In the per-protocol analysis, 555 of 591 patients (93.9%) had a favorable outcome in the FDC group vs 548 of 579 (94.6%) in the separate-drugs group (risk difference, -0.7% [90% confidence interval {CI}, -3.0% to 1.5%]). In the model 1 analysis, 570 of 684 patients (83.3%) had a favorable outcome in the FDC group vs 563 of 664 (84.8%) in the separate-drugs group (risk difference, -1.5% [90% CI, -4.7% to 1.8%]). In the post hoc model 2 analysis, 591 of 658 patients (89.8%) in the FDC group and 589 of 647 (91.0%) in the separate-drugs group had a favorable outcome (risk difference, -1.2% [90% CI, -3.9% to

  6. A Randomized Study Comparing the Sniffing Position with Simple Head Extension for Glottis Visualization and Difficulty in Intubation during Direct Laryngoscopy

    PubMed Central

    Akhtar, Mehmooda; Ali, Zulfiqar; Hassan, Nelofar; Mehdi, Saqib; Wani, Gh Mohammad; Mir, Aabid Hussain

    2017-01-01

    Background: Proper positioning of the head and neck is important for an optimal laryngeal visualization. Traditionally, sniffing position (SP) is recommended to provide a superior glottic visualization, during direct laryngoscopy, enhancing the ease of intubation. Various studies in the last decade of this belief have challenged the need for sniffing position during intubation. We conducted a prospective study comparing the sniffing head position with simple head extension to study the laryngoscopic view and intubation difficulty during direct laryngoscopy. Materials and Methods: Five-hundred patients were included in this study and randomly distributed to SP or simple head extension. In the sniffing group, an incompressible head ring was placed under the head to raise its height by 7 cm from the neutral plane followed by maximal extension of the head. In the simple extension group, no headrest was placed under the head; however, maximal head extension was given at the time of laryngoscopy. Various factors as ability to mask ventilate, laryngoscopic visualization, intubation difficulty, and posture of the anesthesiologist during laryngoscopy and tracheal intubation were noted. In the incidence of difficult laryngoscopy (Cormack Grade III and IV), Intubation Difficulty Scale (IDS score) was compared between the two groups. Results: There was no significant difference between two groups in Cormack grades. The IDS score differed significantly between sniffing group and simple extension group (P = 0.000) with an increased difficulty during intubation in the simple head extension. Patients with simple head extension needed more lifting force, increased use of external laryngeal manipulation, and an increased use of alternate techniques during intubation when compared to SP. Conclusion: We conclude that compared to the simple head extension position, the SP should be used as a standard head position for intubation attempts under general anesthesia. PMID:28928584

  7. An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis.

    PubMed

    Koc, Erol; Arca, Ercan; Kose, Osman; Akar, Ahmet

    2009-01-01

    Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region. While ketoconazole is often used, pimecrolimus has been used successfully in SD. To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD. A total of 48 patients with SD were included in the study. Patients were randomized into two groups: 23 and 25 patients in the pimecrolimus and ketoconazole groups, respectively. Clinical measures were assessed by erythema, scaling and infiltration, which were evaluated using a four-point scale (0 to 3) at 2, 6, and 12 weeks. Of these 48 patients, 38 completed the study (18 and 20 patients in the pimecrolimus and ketoconazole groups, respectively). The mean percentage decrease in clinical severity scores from baseline to the last follow-up period was 86.2% and 86.1% in the pimecrolimus and ketoconazole groups, respectively. Both pimecrolimus and ketoconazole were effective in SD. Differences between the two groups were not statistically significant. Side effects were observed more frequently with pimecrolimus than with ketoconazole and this difference was statistically significant. Our study showed that pimecrolimus had a comparable efficacy profile with that of ketoconazole, but side effects appeared more frequently in the pimecrolimus group than in the ketoconazole group.

  8. Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

    PubMed Central

    2011-01-01

    Background Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE) is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation. Methods/Design A single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. Intervention: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months. Discussion Organisation/Responsibility The ACUPEND - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Interdisciplinary Endoscopy Center (IEZ) of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent

  9. Rebamipide May Be Comparable to H2 Receptor Antagonist in Healing Iatrogenic Gastric Ulcers Created by Endoscopic Mucosal Resection: A Prospective Randomized Pilot Study

    PubMed Central

    Kim, Yu Jin; Lee, Sang Kil; Kim, Jie Hyun; Lee, Yong Chan

    2010-01-01

    Endoscopic mucosal resection (EMR) results in the formation of iatrogenic gastric ulcers and the optimal treatments for such ulcers are still unclear. We aimed to evaluate the efficacy of rebamipide in the management of EMR-induced ulcers by comparing it with an H2 receptor antagonist. After EMR, patients were randomly assigned into either rebamipide or famotidine groups. All patients received a one-week lansoprazole 30 mg q.d. therapy followed by three-week famotidine (20 mg b.i.d.) or rebamipide (100 mg t.i.d.) therapy. Four weeks after the treatments, ulcer sizes, stages, bleeding rates, and ulcer-related symptoms were compared using endoscopy and a questionnaire. A total of 63 patients were enrolled in this study. Finally, 51 patients were analyzed, 26 in rebamipide and 25 in famotidine group. Baseline characteristics were not significantly different between the two groups. Four weeks after EMR, the two groups were comparable in terms of ulcer reduction ratio (P=0.297), and ulcer stage (P=1.000). Moreover, no difference was observed with regard to ulcer-related symptoms, drug compliance, adverse drug event rates, and bleeding rates. Our data suggest that rebamipide is not inferior to famotidine in healing iatrogenic gastric ulcers, and could be a therapeutic option in the treatment of such ulcers. PMID:20358002

  10. Area-specific modulation of neural activation comparing escitalopram and citalopram revealed by pharmaco-fMRI: a randomized cross-over study.

    PubMed

    Windischberger, Christian; Lanzenberger, Rupert; Holik, Alexander; Spindelegger, Christoph; Stein, Patrycja; Moser, Ulrike; Gerstl, Florian; Fink, Martin; Moser, Ewald; Kasper, Siegfried

    2010-01-15

    Area-specific and stimulation-dependent changes of human brain activation by selective serotonin reuptake inhibitors (SSRI) are an important issue for improved understanding of treatment mechanisms, given the frequent prescription of these drugs in depression and anxiety disorders. The aim of this neuroimaging study was to investigate differences in BOLD-signal caused by administration of the SSRIs escitalopram and citalopram using pharmacological functional magnetic resonance imaging (pharmaco-fMRI). Eighteen healthy subjects participated in a placebo-controlled, randomized, double-blind study in cross-over repeated measures design. Each volunteer performed facial emotional discrimination and a sensorimotor control paradigm during three scanning sessions. Citalopram (20 mg/d), escitalopram (10 mg/d) and placebo were administered for 10 days each with a drug-free period of at least 21 days. Significant pharmacological effects on BOLD-signal were found in the amygdala, medial frontal gyrus, parahippocampal, fusiform and middle temporal gyri. Post-hoc t-tests revealed decreased BOLD-signal in the right amygdala and left parahippocampal gyrus in both pharmacological conditions, compared to placebo. Escitalopram, compared to citalopram, induced a decrease of BOLD-signal in the medial frontal gyrus and an increase in the right fusiform and left parahippocampal gyri. Drug effects were concentrated in brain regions with dense serotonergic projections. Both escitalopram and citalopram attenuated BOLD-signal in the amygdala and parahippocampal cortex to emotionally significant stimuli compared to control stimuli. We believe that reduced reactivity in the medial frontal gyrus found for escitalopram compared to citalopram administration might explain the response differences between study drugs as demonstrated in previous clinical trials.

  11. Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection.

    PubMed

    Kohno, Shigeru; Yen, Muh-Yong; Cheong, Hee-Jin; Hirotsu, Nobuo; Ishida, Tadashi; Kadota, Jun-ichi; Mizuguchi, Masashi; Kida, Hiroshi; Shimada, Jingoro

    2011-11-01

    Antiviral medications with activity against influenza viruses are important in controlling influenza. We compared intravenous peramivir, a potent neuraminidase inhibitor, with oseltamivir in patients with seasonal influenza virus infection. In a multinational, multicenter, double-blind, double-dummy randomized controlled study, patients aged ≥ 20 years with influenza A or B virus infection were randomly assigned to receive either a single intravenous infusion of peramivir (300 or 600 mg) or oral administration of oseltamivir (75 mg twice a day [b.i.d.] for 5 days). To demonstrate the noninferiority of peramivir in reducing the time to alleviation of influenza symptoms with hazard model analysis and a noninferiority margin of 0.170, we planned to recruit 1,050 patients in South Korea, Japan, and Taiwan. A total of 1,091 patients (364 receiving 300 mg and 362 receiving 600 mg of peramivir; 365 receiving oseltamivir) were included in the intent-to-treat infected population. The median durations of influenza symptoms were 78.0, 81.0, and 81.8 h in the groups treated with 300 mg of peramivir, 600 mg of peramivir, and oseltamivir, respectively. The hazard ratios of the 300- and 600-mg-peramivir groups compared to the oseltamivir group were 0.946 (97.5% confidence interval [CI], 0.793, 1.129) and 0.970 (97.5% CI, 0.814, 1.157), respectively. Both peramivir groups were noninferior to the oseltamivir group (97.5% CI, <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg-peramivir group, but the incidence of severe reactions in either peramivir group was not different from that in the oseltamivir group. Thus, a single intravenous dose of peramivir may be an alternative to a 5-day oral dose of oseltamivir for patients with seasonal influenza virus infection.

  12. A randomized, multicenter phase 3 study comparing 2% rebamipide (OPC-12759) with 0.1% sodium hyaluronate in the treatment of dry eye.

    PubMed

    Kinoshita, Shigeru; Oshiden, Kazuhide; Awamura, Saki; Suzuki, Hiroyuki; Nakamichi, Norihiro; Yokoi, Norihiko

    2013-06-01

    To investigate the efficacy of 2% rebamipide ophthalmic suspension compared with 0.1% sodium hyaluronate ophthalmic solution for the treatment of patients with dry eye. Randomized, multicenter, active-controlled parallel-group study. One hundred eighty-eight patients with dry eye. Following a 2-week screening period, patients were allocated randomly to receive 2% rebamipide or 0.1% sodium hyaluronate, administered as 1 drop in each eye 4 or 6 times daily, respectively, for 4 weeks. There were 2 primary end points: changes in the fluorescein corneal staining (FCS) score to determine noninferiority of 2% rebamipide and changes in the lissamine green conjunctival staining (LGCS) score to determine superiority. Secondary objective end points were Schirmer's test results and tear film breakup time (TBUT). Secondary subjective end points were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision) score and the patients' overall treatment impression score. In the primary analysis, the mean change from baseline in FCS scores verified noninferiority, indicated significant improvement, and, in LGCS scores, verified the superiority of 2% rebamipide to 0.1% sodium hyaluronate. Values for the Schirmer's test and TBUT were comparable between the 2 groups. For 2 dry eye-related ocular symptoms--foreign body sensation and eye pain--2% rebamipide showed significant improvements over 0.1% sodium hyaluronate. Patients had a significantly more favorable impression of 2% rebamipide than of 0.1% sodium hyaluronate; 64.5% rated treatment as improved or markedly improved versus 34.7%, respectively. No serious adverse events were observed. Administration of 2% rebamipide was effective in improving both the objective signs and subjective symptoms of dry eye. Those findings, in addition to the well-tolerated profile of 2% rebamipide, clearly show that it is an effective therapeutic method for dry eye. Proprietary or commercial disclosure

  13. A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

    PubMed

    Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

    2017-08-01

    A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

  14. Study protocol for a randomized, controlled trial comparing the efficacy of two educational interventions to improve inhalation techniques in patients with chronic obstructive pulmonary disease (COPD): TIEPOC Study

    PubMed Central

    Leiva-Fernández, José; Leiva-Fernández, Francisca; Vázquez-Alarcón, Rubén L; García-Ruiz, Antonio; Prados-Torres, Daniel; Barnestein-Fonseca, Pilar

    2014-01-01

    Background: An appropriate inhalation technique and adherence to treatment are both critical determinants of the success of chronic obstructive pulmonary disease (COPD) management. We have observed that up to 75% of patients do not use a successful inhalation technique. Knowledge evaluation and frequent reassessment of inhaler use, together with education of patients and healthcare professionals, can significantly improve the benefits that patients with COPD will derive from inhaler therapy. The objective of this study is to test the efficacy of two educational interventions to improve inhalation techniques in patients with COPD. Methods: Multicenter randomized controlled trial with 296 patients diagnosed with COPD selected by a non-probabilistic method of sampling from seven Spanish Primary Care Centers. The patients will be divided into three groups by block randomization. The three groups are: 1) control; 2) Intervention A; and 3) Intervention B. The control group will comprise patients with no explanations or written information; the Intervention A group will comprise patients to whom we give written information only; and the Intervention B group will comprise patients to whom we give written information plus instructor training. Every patient in each group will be visited four times during the year of the study at the health centers. Discussion: Our hypothesis is that the application of educational interventions (A or B) in patients with COPD who use inhaler therapy will increase the number of patients who perform a correct inhalation technique by at least 25%. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, where feasible within the context of clinical practice. PMID:24991223

  15. Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study.

    PubMed

    Bern, Murray M; Hazel, Diane; Deeran, Elizabeth; Richmond, John R; Ward, Daniel M; Spitz, Damon J; Mattingly, David A; Bono, James V; Berezin, Ronna H; Hou, Laura; Miley, Gerald B; Bierbaum, Benjamin E

    2015-01-01

    Deep vein thrombosis (DVT) and pulmonary emboli (PE), known together as venous thromboembolic (VTE) disease remain major complications following elective hip and knee surgery. This study compares three chemoprophylactic regimens for VTE following elective primary unilateral hip or knee replacement, one of which was designed to minimize risk of post-operative bleeding. Patients were randomized and stratified for hip vs. knee to receive A: variable dose warfarin (first dose on the night preceding surgery with subsequent target INR 2.0-2.5), B: 2.5 mg fondaparinux daily starting 6-18 h postoperatively, or C: fixed 1.0 mg dose warfarin daily starting 7 days preoperatively. All treatments continued until bilateral leg venous ultrasound day 28 ± 2 or earlier upon a VTE event. The study examined primary endpoints including leg DVT, PE or death due to VTE and secondary endpoints including effects on D-dimer, estimated blood loss (EBL) at surgery and hemorrhagic complications. Three hundred fifty-five patients were randomized. None was lost to follow-up. Taking 1.0 mg warfarin for seven days preoperatively did not prolong the prothrombin time (PT). Two patients in Arm C had asymptomatic distal DVT. One major bleed occurred in Arm B and one in Arm C (ischemic colitis). Elevated d-dimer did not predict delayed VTE for one year. Fixed low dose warfarin started preoperatively is equivalent to two other standards of care under study (95 % CI: -0.0428, 0.0067 for both) as VTE prophylaxis for the patients having elective major joint replacement surgery. ClinicalTrials.gov identifier # NCT00767559 FDA IND: 103,716.

  16. A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis.

    PubMed

    Sethi, S; Fogarty, C; Fulambarker, A

    2004-08-01

    To demonstrate that 5 days of treatment with a new fluoroquinolone, gemifloxacin, is at least as effective as 7 days of treatment with levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB). Randomized, double-blind, double dummy, multicentre, parallel group study Sixty different medical centers in US, UK and Germany. A total of 360 adults (>40 years of age) with AECB were randomly assigned to receive gemifloxacin 320 mg once daily for 5 days or levofloxacin 500mg once daily for 7 days. The primary efficacy parameter was a clinical response at follow-up (Days 14-21). In total, 335/360 patients completed the study (93.1%). Seven patients receiving gemifloxacin withdrew from the study compared to 18 patients receiving levofloxacin; this difference was statistically significant (Fisher's exact test: p=0.02). In the intent-to-treat (ITT) population, the clinical success rate at follow-up (Days 14-21) was 85.2% (155/182) with gemifloxacin and 78.1% (139/178) with levofloxacin. Clinical success rate in the per-protocol (PP) population was 88.2% (134/152) with gemifloxacin and 85.1% (126/148) with levofloxacin. At long-term follow-up (Days 28-35), the clinical success rates in the PP population were 83.7% (123/147) with gemifloxacin and 78.4% (109/139) with levofloxacin. The difference in success rates was 5.26% (95% CI: -3.83, 14.34). The clinical efficacy of gemifloxacin 320 mg once daily for 5 days in AECB was at least as good as levofloxacin 500 mg once daily for 7 days. Fewer withdrawals and superior clinical efficacy at long-term follow-up were also seen with gemifloxacin.

  17. Frovatriptan versus almotriptan for acute treatment of menstrual migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study.

    PubMed

    Bartolini, Marco; Giamberardino, Maria Adelaide; Lisotto, Carlo; Martelletti, Paolo; Moscato, Davide; Panascia, Biagio; Savi, Lidia; Pini, Luigi Alberto; Sances, Grazia; Santoro, Patrizia; Zanchin, Giorgio; Omboni, Stefano; Ferrari, Michel D; Fierro, Brigida; Brighina, Filippo

    2012-07-01

    The objective of the study was to compare the efficacy and safety of frovatriptan and almotriptan in women with menstrually related migraine (IHS Classification of Headache disorders) enrolled in a multicenter, randomized, double-blind, cross-over study. Patients received frovatriptan 2.5 mg or almotriptan 12.5 mg in a randomized sequence: after treating 3 episodes of migraine in no more than 3 months with the first treatment, the patient was switched to the other treatment. 67 of the 96 female patients of the intention-to-treat population of the main study had regular menstrual cycles and were thus included in this subgroup analysis. 77 migraine attacks classified as related to menses were treated with frovatriptan and 78 with almotriptan. Rate of pain relief at 2 and 4 h was 36 and 53 % for frovatriptan and 41 and 50 % for almotriptan (p = NS between treatments). Rate of pain free at 2 and 4 h was 19 and 47 % with frovatriptan and 29 and 54 % for almotriptan (p = NS). At 24 h, 62 % of frovatriptan-treated and 67 % of almotriptan-treated patients had pain relief, while 60 versus 67 % were pain free (p = NS). Recurrence at 24 h was significantly (p < 0.05) lower with frovatriptan (8 vs. 21 % almotriptan). This was the case also at 48 h (9 vs. 24 %, p < 0.05). Frovatriptan was as effective as almotriptan in the immediate treatment of menstrually related migraine attacks. However, it showed a more favorable sustained effect, as shown by a lower rate of migraine recurrence.

  18. Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

    PubMed

    Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

    2017-08-08

    Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

  19. Training symmetry of weight distribution after stroke: a randomized controlled pilot study comparing task-related reach, Bobath and feedback training approaches.

    PubMed

    Mudie, M H; Winzeler-Mercay, U; Radwan, S; Lee, L

    2002-09-01

    To determine (1) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and (2) whether improvements could be generalized to weight distribution in standing. Inpatient rehabilitation unit. Forty asymmetrical acute stroke subjects were randomly allocated to one of four groups in this pilot study. Changes in weight distribution were compared between the 10 subjects of each of three treatment groups (task-specific reach, Bobath, or Balance Performance Monitor [BPM] feedback training) and a no specific treatment control group. One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was randomly allocated. Measurements were performed using the BPM daily before treatment sessions, two weeks after cessation of treatment and 12 weeks post study. Weight distribution was calculated in terms of mean balance (percentage of total body weight) or the mean of 300 balance points over a 30-s data run. In the short term, the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke (p = 0.004). Training with the BPM and no training were also significant (p = 0.038 and p = 0.035 respectively) and task-specific reach training failed to reach significance (p = 0.26). At 12 weeks post study 83% of the BPM training group, 38% of the task-specific reach group, 29% of the Bobath group and 0% of the untrained group were found to be distributing their weight to both sides. Some generalization of symmetry training in sitting to standing was noted in the BPM training group which appeared to persist long term. Results should be treated with caution due to the small group sizes. However, these preliminary findings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position.

  20. A prospective, randomized crossover study comparing direct inspection by light microscopy versus projected images for teaching of hematopathology to medical students.

    PubMed

    Carlson, Aaron M; McPhail, Ellen D; Rodriguez, Vilmarie; Schroeder, Georgene; Wolanskyj, Alexandra P

    2014-01-01

    Instruction in hematopathology at Mayo Medical School has evolved from instructor-guided direct inspection under the light microscope (laboratory method), to photomicrographs of glass slides with classroom projection (projection method). These methods have not been compared directly to date. Forty-one second-year medical students participated in this pilot study, a prospective, randomized, crossover study measuring educational performance during a hematology pathophysiology course. The students were randomized to one of two groups. All students received the same didactic lectures in the classroom and subsequent case-based review of peripheral blood smears using either laboratory or projection methods, on day one with a crossover to the other method on day two. Pre- and post-test examinations centered on morphology recognition measured educational performance on each day, followed by a questionnaire identifying the student's favored method. There was no significant difference in the pre-test and post-test scores between the two teaching methods (rank-sum P = 0.43). Students overwhelmingly preferred the projection method and perceived it as superior (76%), although post-test scores were not significantly different. Student's recommended method was split with 50% favoring the projection method, 43% favoring a combined approach, and 23% noting logistical challenges to the laboratory. In this study, the laboratory and projection method were equivalent in terms of educational performance for hematopathology among medicals students. A classroom-based approach such as the projection method is favored, given the large class sizes in undergraduate medical education, as well as the ergonomic challenges and additional resources required for large group instruction in a laboratory setting.

  1. Comparative effects of artemisia vulgaris and charcoal moxa stimulating Zhongwan (CV 12) on body temperature in healthy participants: a cross-over single-blind randomized study.

    PubMed

    Go, Ho-Yeon; Lee, Ju Ah; Park, Sunyoung; Park, Sunju; Park, Jeong-Su; Cheon, Chunhoo; Ko, Seong-Gyu; Kong, Kyung-Hwan; Jun, Chan-yong; Park, Jong-hyeong; Shin, Mi-Ran; Lee, Se-Hoon

    2015-10-01

    To evaluate the efficacy, safety, satisfaction, discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa. This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan (CV 12) is a cross-over single-blinded, randomized clinical trial. A total of 40 healthy subjects (24 males and 16 females) participated in this study. Two subjects dropped out of the trial. Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design. After treatment, the patients underwent a 30 minute waiting period, and then the temperatures at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4) were measured using digital infrared thermal imaging. After the use of Artemisia vulgaris moxa, the patients' body temperatures were slightly lowered at Tanzhong (CV 17), Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After the use of charcoal moxa, the patients' body temperatures were somewhat increased at Zhongwan (CV 12) and Guanyuan (CV 4), but the changes were not statistically significant. After Artemisia vulgaris moxa use, the body temperature difference between Zhongwan (CV 12) and Guanyuan (CV 4) was significantly increased. After charcoal moxa use, the body temperature difference between Tanzhong (CV 17) and Zhongwan (CV 12) was significantly decreased in males and in the whole group. This change was caused by the difference in the moxibustion type and by gender differences. This pilot study found that moxibustion did not raise the body temperature, but temperature differences between acupoints were affected. Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.

  2. Intense pulsed light versus photodynamic therapy using liposomal methylene blue gel for the treatment of truncal acne vulgaris: a comparative randomized split body study.

    PubMed

    Moftah, Nayera Hassan; Ibrahim, Shady Mahmoud; Wahba, Nadine Hassan

    2016-05-01

    Acne vulgaris is an extremely common skin condition. It often leads to negative psychological consequences. Photodynamic therapy (PDT) using intense pulsed light has been introduced for effective treatment of acne. The objective was to study the effect of PDT in truncal acne vulgaris using liposomal methylene blue (LMB) versus IPL alone. Thirty-five patients with varying degrees of acne were treated with topical 0.1 % LMB hydrogel applied on the randomly selected one side of the back, and after 60 min the entire back was exposed to IPL. The procedure was done once weekly for three sessions and patients were re-evaluated 1 month after the third session by two independent dermatologists. Acne severity was graded using the Burton scale. Patient satisfaction using Cardiff Acne Disability Index (CADI) was recorded before and after treatment. On LMB-pretreated side, inflammatory acne lesion counts were significantly decreased by 56.40 % compared with 34.06 % on IPL alone. Marked improvement was seen on LMB-pretreated side in 11.5 % of patients compared with 2.8 % on IPL alone. There was a correlation between CADI score and overall improvement. Our study concluded that LMB-IPL is more effective than IPL alone, safe with tolerable pain in the treatment of acne vulgaris on the back. LMB-IPL is more effective than IPL alone, safe with tolerable pain in the treatment of acne vulgaris on the back.

  3. A randomized cross-over study comparing the performance of HD integra™ central concentrate system versus pre-produced concentrate in hemodialysis.

    PubMed

    Fauziah, K; Go, K W; Ghazali, A; Zaki, M; Lim, T O

    2017-04-03

    Pre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption. We conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting. Microbial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%. Modern CCS is bacteriologically safe and its performance statistically equivalent to PPC.

  4. A double-blind randomized comparative study of triamcinolone hexacetonide and dexamethasone intra-articular injection for the treatment of knee joint arthritis in rheumatoid arthritis.

    PubMed

    Hajialilo, Mehrzad; Ghorbanihaghjo, Amir; Valaee, Leyla; Kolahi, Sousan; Rashtchizadeh, Naderh; Amirkhiz, Maryam Bannazadeh; Malekmahdavi, Ida; Khabbazi, Alireza

    2016-12-01

    Intra-articular glucocorticoid (GC) injection has been used for more than half a century in the treatment of refractory synovitis in patients with rheumatoid arthritis (RA). There are limited data about the efficacy of intra-articular injection of various preparations of GCs on inflamed joint. The aim of this study was to compare the efficacy and side effects of intra-articular injection of dexamethasone (DEX) and triamcinolone hexacetonide (TH) in the treatment of knee joint arthritis in RA. In a double-blind randomized clinical trial, 70 patients with RA and knee joint arthritis were recruited to the study. Swelled knee joints were injected with 40 mg TH or 8 mg DEX randomly. The primary outcome measures were reduction of knee joint swelling and pain 1 and 3 weeks after joint injection. The secondary outcome measures were relapse of knee arthritis at 2, 4, and 6 months after injection and side effects of intra-articular injection. Difference in the knee circumferences between DEX and TH groups at weeks 1 and 3 was not significant. The average times of pain reduction after injection were 3.4 ± 2.3 and 2.3 ± 1.8 days in TH and DEX, respectively. There were no differences of knee pain between the two groups. Relapse of knee arthritis was occurred in two (6.7 %) and three (9.4 %) patients in the DEX and TH groups, respectively. Intra-articular injection of DEX like TH causes rapid and long-term reduction of knee pain and swelling in patients with RA and is safe.

  5. A Randomized Controlled Trial Comparing the Effects of Sitagliptin and Glimepiride on Endothelial Function and Metabolic Parameters: Sapporo Athero-Incretin Study 1 (SAIS1)

    PubMed Central

    Nomoto, Hiroshi; Miyoshi, Hideaki; Furumoto, Tomoo; Oba, Koji; Tsutsui, Hiroyuki; Inoue, Atsushi; Atsumi, Tatsuya; Manda, Naoki; Kurihara, Yoshio; Aoki, Shin

    2016-01-01

    Objectives The DPP-4 inhibitors are incretin-related drugs that improve hyperglycemia in a glucose-dependent manner and have been reported to exert favorable effects on atherosclerosis. However, it has not been fully elucidated whether DPP-4 inhibitors are able to improve endothelial function in patients with type 2 diabetes. Therefore, we investigated the efficacy of sitagliptin, a DPP-4 inhibitor, on endothelial function and glycemic metabolism compared with that of the sulfonylurea glimepiride. Materials and Methods In this multicenter, prospective, randomized parallel-group comparison study, 103 outpatients with type 2 diabetes (aged 59.9 ± 9.9 years with HbA1c levels of 7.5 ± 0.4%) with dietary cure only and/or current metformin treatment were enrolled and randomly assigned to receive sitagliptin or glimepiride therapy once daily for 26 weeks. Flow-mediated dilation (FMD), a comprehensive panel of hemodynamic parameters (Task Force® Monitor), and serum metabolic markers were assessed before and after the treatment. Results During the study period, no statistically significant change in %FMD was seen in both groups (sitagliptin, 5.6 to 5.6%; glimepiride, 5.6 to 6.0%). Secretory units of islets in transplantation, TNF-α, adiponectin and biological antioxidant potential significantly improved in the sitagliptin group, and superoxide dismutase also tended to improve in the sitagliptin group, while improvements in HbA1c levels were similar between groups. Cardiac index, blood pressure and most other metabolic parameters were not different. Conclusions Regardless of glycemic improvement, early sitagliptin therapy did not affect endothelial function but may provide favorable effects on beta-cell function and on inflammatory and oxidative stress in patients with type 2 diabetes without advanced atherosclerosis. Trial Registration UMIN Clinical Trials Registry System UMIN 000004955 PMID:27711199

  6. Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

    PubMed Central

    Tröger, Wilfried; Jezdić, Svetlana; Ždrale, Zdravko; Tišma, Nevena; Hamre, Harald J.; Matijašević, Miodrag

    2009-01-01

    Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia. Patients and Methods: We conducted a prospective randomized open label pilot study with 95 patients randomized into three groups. Two groups received Iscador® M special (IMS) or a different mistletoe preparation, respectively, additionally to chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluoro-uracil (CAF). A control group received CAF with no additional therapy. Here we report the comparison IMS (n = 30) vs. control (n = 31). Quality of life including fatigue was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30). Neutropenia was defined as neutrophil counts <1,000/μl and assessed at baseline and one day before each CAF cycle. Results: In the descriptive analysis all 15 scores of the EORTC-QLQ-C30 showed better quality of life in the IMS group compared to the control group. In 12 scores the differences were significant (p < 0.02) and nine scores showed a clinically relevant and significant difference of at least 5 points. Neutropenia occurred in 3/30 IMS patients and in 8/31 control patients (p = 0.182). Conclusions: This pilot study showed an improvement of quality of life by treating breast cancer patients with IMS additionally to CAF. CAF-induced neutropenia showed a trend to lower frequency in the IMS group. PMID:21556248

  7. Comparing short to standard duration of antibiotic therapy for patients hospitalized with cellulitis (DANCE): study protocol for a randomized controlled trial.

    PubMed

    Cranendonk, Duncan R; Opmeer, Brent C; Prins, Jan M; Wiersinga, W Joost

    2014-05-05

    Recommended therapy duration for patients hospitalized with cellulitis is 10-14 days. Unnecessary use of antibiotics is one of the key factors driving resistance. Recent studies have shown that antibiotic therapy for cellulitis in outpatients can safely be shortened, despite residual inflammation. This study will compare in hospitalized patients the safety and effectiveness of shortening antibiotic therapy for cellulitis from 12 to 6 days. In a multicenter, randomized, double-blind, non-inferiority trial, adult patients admitted with cellulitis will be included. Cellulitis is defined as warmth, erythema, and induration of the skin and/or subcutaneous tissue, with or without pain (including erysipelas). All patients will initially be treated with intravenous flucloxacillin, and will be evaluated after 5-6 days. Those who have improved substantially (defined as being afebrile, and having a lower cellulitis severity score) will be randomized at day 6 between additional 6 days of oral flucloxacillin (n = 198) or placebo (n = 198). Treatment success is defined as resolution of cellulitis on day 14 (disappearance of warmth and tenderness, improvement of erythema and edema), without the need of additional antibiotics for cellulitis by day 28. Secondary endpoints are relapse rate (up to day 90), speed of recovery (using a cellulitis severity score until day 28, and VAS scores on pain and swelling until day 90), quality of life (using the SF-36 and EQ-5D questionnaires) and costs (associated with total antibiotic use and health-care resource utilization up to day 90). Inclusion is planned to start in Q2 2014. ClinicalTrials.gov (NCT02032654) and the Netherlands Trial Register (NTR4360).

  8. Comparing short to standard duration of antibiotic therapy for patients hospitalized with cellulitis (DANCE): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Recommended therapy duration for patients hospitalized with cellulitis is 10–14 days. Unnecessary use of antibiotics is one of the key factors driving resistance. Recent studies have shown that antibiotic therapy for cellulitis in outpatients can safely be shortened, despite residual inflammation. This study will compare in hospitalized patients the safety and effectiveness of shortening antibiotic therapy for cellulitis from 12 to 6 days. Methods/design In a multicenter, randomized, double-blind, non-inferiority trial, adult patients admitted with cellulitis will be included. Cellulitis is defined as warmth, erythema, and induration of the skin and/or subcutaneous tissue, with or without pain (including erysipelas). All patients will initially be treated with intravenous flucloxacillin, and will be evaluated after 5–6 days. Those who have improved substantially (defined as being afebrile, and having a lower cellulitis severity score) will be randomized at day 6 between additional 6 days of oral flucloxacillin (n = 198) or placebo (n = 198). Treatment success is defined as resolution of cellulitis on day 14 (disappearance of warmth and tenderness, improvement of erythema and edema), without the need of additional antibiotics for cellulitis by day 28. Secondary endpoints are relapse rate (up to day 90), speed of recovery (using a cellulitis severity score until day 28, and VAS scores on pain and swelling until day 90), quality of life (using the SF-36 and EQ-5D questionnaires) and costs (associated with total antibiotic use and health-care resource utilization up to day 90). Discussion Inclusion is planned to start in Q2 2014. Trial registration ClinicalTrials.gov (NCT02032654) and the Netherlands Trial Register (NTR4360). PMID:24885384

  9. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial.

    PubMed

    Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Obaro, Stephen K; Ezeanolue, Chinenye O; Ogedegbe, Gbenga G

    2013-06-08

    A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015. This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized 'baby shower.' The baby shower includes refreshments, gifts exchange, and an educational game show testing participants' knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the effect of HBI on the rate of

  10. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial

    PubMed Central

    2013-01-01

    Background A total of 22 priority countries have been identified by the WHO that account for 90% of pregnant women living with HIV. Nigeria is one of only 4 countries among the 22 with an HIV testing rate for pregnant women of less than 20%. Currently, most pregnant women must access a healthcare facility (HF) to be screened and receive available prevention of mother-to-child HIV transmission (PMTCT) interventions. Finding new approaches to increase HIV testing among pregnant women is necessary to realize the WHO/ President's Emergency Plan for AIDS Relief (PEPFAR) goal of eliminating new pediatric infections by 2015. Methods This cluster randomized trial tests the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) versus a clinic-based approach on the rates of HIV testing and PMTCT completion among a cohort of church attending pregnant women. Recruitment occurs at the level of the churches and participants (in that order), while randomization occurs only at the church level. The trial is unblinded, and the churches are informed of their randomization group. Eligible participants, pregnant women attending study churches, are recruited during prayer sessions. HBI is delivered by trained community health nurses and church-based health advisors and provides free, integrated on-site laboratory tests (HIV plus hemoglobin, malaria, hepatitis B, sickle cell gene, syphilis) during a church-organized ‘baby shower.’ The baby shower includes refreshments, gifts exchange, and an educational game show testing participants’ knowledge of healthy pregnancy habits in addition to HIV acquisition modes, and effective PMTCT interventions. Baby receptions provide a contact point for follow-up after delivery. This approach was designed to reduce barriers to screening including knowledge, access, cost and stigma. The primary aim is to evaluate the effect of HBI on the HIV testing rate among pregnant women. The secondary aims are to evaluate the

  11. Use of a cognitive ergonomics approach to compare usability of a multidose dry powder inhaler and a capsule dry powder inhaler: an open-label, randomized, controlled study.

    PubMed

    Franks, Mark; Briggs, Pamela

    2004-11-01

    Usability (ease of use) is an important feature of inhalers to ensure optimal dose delivery The aim of this study was to compare the usability of a multidose dry powder inhaler (mDPI) and a capsule dry powder inhaler (cDPI) in older individuals, using a range of qualitative and quantitative techniques from the field of cognitive ergonomics. Participants aged >50 years were enrolled in this 2-visit, open-label, randomized, controlled, parallel-group study conducted at Northumbria University, Newcastle upon Tyne, United Kingdom. Participants who had used an inhaler or were inhaler naive were randomized to use the mDPI or cDPI. At visit 1, the inhaler procedure was demonstrated twice by the investigator. Participants then repeated the procedure (although they were not expected to inhale because no drug was to be administered) until they made 3 consecutive correct attempts. They also undertook a range of tests to assess their confidence in using the device, manual dexterity, and self-efficacy At visit 2 (2 days later), participants made a single inhaler attempt before receiving any demonstrations from the investigator; this was intended to simulate clinical practice, in which the patient may not use an inhaler for a few days after it is prescribed. Participants then completed the inhaler procedure 10 times while undertaking a concurrent distracter task. The number of critical errors (ie, those having a high impact on dose delivery) was recorded for all attempts. To facilitate subsequent correlation analyses, an overall performance measure was derived from a combination of the results of the single inhaler trial and the 10 trials with a distracter. Eighty individuals (51 women, 29 men; mean [SD] age, 74.1 [7.5] years) participated in the study(40 participants per device). Forty of the participants (50%) had used an inhaler previously; 40 (50%) were inhaler naive. Based on the overall performance measure, participants testing the mDPI made significantly fewer critical

  12. Randomized, prospective, observational simulation study comparing residents' needle-guided vs free-hand ultrasound techniques for central venous catheter access.

    PubMed

    Ball, R D; Scouras, N E; Orebaugh, S; Wilde, J; Sakai, T

    2012-01-01

    Short-axis ultrasound-guided placement of central venous catheters (CVCs) is widely accepted as safe practice. However, utilizing the long-axis approach could further improve safety, as it allows for better visualization of the needle as it is advanced to the target vessel. However, the long-axis approach has not widely been used due to the technical difficulty. Recently, a new needle guidance device has become available to aid in the long-axis approach. We hypothesized that the use of a needle guide paired with the long-axis approach would facilitate puncture of the target vessel in a simulation model more effectively than similar free-hand techniques. A prospective observational study of anaesthesia residents using a CVC partial-task training device was conducted. Each resident performed needle puncture of the target vessel with three different techniques, assigned in random order: short-axis free hand (S-FH), long-axis free hand (L-FH), and long-axis needle guide (NG). To prove the effectiveness of the needle guide, the fraction of time the needle tip remained in view of the ultrasound was recorded and compared. Time required for completing the task and the number of needle sticks and needle re-directions were compared. Thirty-three residents participated in the study. The fraction of time the needle tip remained in view of the ultrasound was significantly higher for the residents using NG [0.90 (0.10)] compared with residents using the other techniques [L-FH: 0.36 (0.20), S-FH: 0.18 (0.10)] (P<0.001). For each resident, the use of the needle guide in the long-axis approach increased visualization by 352 (276)% compared with that of L-FH and by 1028 (1804) % compared with that of S-FH. There was no significant difference in time required to puncture the target between NG [23.7 (14.6) s] and L-FH [30.3 (36.5) s] (P=0.21); however, both were significantly longer than S-FH [17.0 (13.3) s] (P=0.012). The numbers of needle sticks and of needle re-directions did not

  13. A randomized 12-week study to compare the gingivitis and plaque reduction benefits of a rotation-oscillation power toothbrush and a sonic power toothbrush.

    PubMed

    Goyal, C R; Qaqish, J; He, Tao; Grender, Julie; Walters, Pat; Biesbrock, Aaron R

    2009-01-01

    Sonic and rotation-oscillation power toothbrushes are popular and effective, but have been shown to differ in relative benefits. The objective of this 12-week investigation was to compare the efficacy of a rotation-oscillation powered toothbrush and a newly introduced sonic toothbrush in the reduction of gingivitis and dental plaque. This was a randomized, controlled, examiner-blind, two-treatment, parallel-group study to assess gingivitis reduction and plaque reductions after twice-daily brushing with either the rotation-oscillation brush or the sonic toothbrush over 12 weeks. The Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) were used to determine gingivitis benefits at Week 6 and Week 12, and plaque was scored at these visits before and after supervised brushing using the Rustogi Modified Navy Plaque Index (RMNPI). In 171 evaluable subjects, gingivitis reduction benefits were significantly greater for the rotation-oscillation brush group than for those using the sonic toothbrush, with relative mean benefits favoring the rotation-oscillation brush of 29.4% for GBI and 8.2% for MGI at 12 weeks (p < or = 0.01). The rotation-oscillation brush produced significantly lower RMNPI plaque by 33.3% compared to the sonic toothbrush (p < 0.001) at Week 12. The rotation-oscillation power toothbrush was significantly more efficacious than the sonic toothbrush in removing plaque, in reducing gingivitis, and lowering the number of bleeding sites after 12 weeks of twice-daily brushing.

  14. Ability of paramedics to perform endotracheal intubation during continuous chest compressions: a randomized cadaver study comparing Pentax AWS and Macintosh laryngoscopes.

    PubMed

    Truszewski, Zenon; Czyzewski, Lukasz; Smereka, Jacek; Krajewski, Paweł; Fudalej, Marcin; Madziala, Marcin; Szarpak, Lukasz

    2016-09-01

    The aim of the trial was to compare the time parameters for intubation with the use of the Macintosh (MAC) laryngoscope and Pentax AWS-S100 videolaryngoscope (AWS; Pentax Corporation, Tokyo, Japan) with and without chest compression (CC) by paramedics during simulated cardiopulmonary resuscitation in a cadaver model. This was a randomized crossover cadaver trial. Thirty-five paramedics with no experience in videolaryngoscopy participated in the study. They performed intubation in two emergency scenarios: scenario A, normal airway without CC; scenario B, normal airway with continuous CC. The median time to first ventilation with the use of the AWS and the MAC was similar in scenario A: 25 (IQR, 22-27) seconds vs. 24 (IQR, 22.5-26) seconds (P=.072). A statistically significant difference in TTFV between AWS and MAC was noticed in scenario B (P=.011). In scenario A, the first endotracheal intubation (ETI) attempt success rate was achieved in 97.1% with AWS compared with 94.3% with MAC (P=.43). In scenario B, the success rate after the first ETI attempt with the use of the different intubation methods varied and amounted to 88.6% vs. 77.1% for AWS and MAC, respectively (P=.002). The Pentax AWS offered a superior glottic view as compared with the MAC laryngoscope, which was associated with a higher intubation rate and a shorter intubation time during an uninterrupted CC scenario. However, in the scenario without CC, the results for AWS and MAC were comparable. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study.

    PubMed

    Bassi, Marco; Luigiano, Carmelo; Ghersi, Stefania; Fabbri, Carlo; Gibiino, Giulia; Balzani, Lucio; Iabichino, Giuseppe; Tringali, Alberto; Manta, Raffaele; Mutignani, Massimiliano; Cennamo, Vincenzo

    2017-05-18

    There are 2 techniques described for selective bile duct guidewire cannulation, the touch (T) technique (engaging the papilla with a sphincterotome and then advancing the guidewire) and the no-touch (NT) technique (engaging the papilla only with the guidewire). The aim of this prospective, multicenter randomized study was to compare the outcomes of the 2 guidewire cannulation techniques. Three hundred consecutive patients with naïve papillae were enrolled in 2 groups (150 to T group and 150 to NT group). A maximum of 15 biliary cannulation attempts, for no longer than 5 minutes, or a maximum of 5 unintentional cannulations of the pancreatic duct for each group were performed. If biliary cannulation failed, the patient was crossed over to the other technique with the same parameters. The primary outcome was the guidewire cannulation success rate using either the T or NT technique. Secondary outcomes were the number of attempts and cannulation duration, number of pancreatic duct cannulations, and adverse events. The primary cannulation rate was significantly higher in the T group compared with the NT group (88% vs 54%, P < .001), and the cannulation rate was significantly higher using the T technique compared with the NT technique also after crossover (77% vs 17%, P < .001). The mean number of cannulation attempts was 4.6 in the T group versus 5.5 in the NT group (P = .006), and the duration of cannulation before crossover (P < .001) and overall cannulation duration after crossover (P < .001) were significantly lower in the T group. The number of unintended pancreatic duct cannulations was statistically higher using the T technique compared with the NT technique (P = .037). The rates of adverse events did not significantly differ between the 2 groups. Our results clearly indicated that the T technique is superior to the NT technique for biliary cannulation. (Clinical trial registration number: NCT01954602.). Copyright © 2017 American Society for

  16. A randomized controlled study comparing intrathecal hyperbaric bupivacaine-fentanyl mixture and isobaric bupivacaine-fentanyl mixture in common urological procedures

    PubMed Central

    Upadya, Madhusudan; Neeta, S; Manissery, Jesni Joseph; Kuriakose, Nigel; Singh, Rakesh Raushan

    2016-01-01

    Background and Aims: Bupivacaine is available in isobaric and hyperbaric forms for intrathecal use and opioids are used as additives to modify their effects. The aim of this study was to compare the efficacy and haemodynamic effect of intrathecal isobaric bupivacaine-fentanyl mixture and hyperbaric bupivacaine-fentanyl mixture in common urological procedures. Methods: One hundred American Society of Anesthesiologists physical status 1 and 2 patients undergoing urological procedures were randomized into two groups. Group 1 received 3 ml of 0.5% isobaric bupivacaine with 25 μg fentanyl while Group 2 received 3 ml of 0.5% hyperbaric bupivacaine with 25 μg fentanyl. The parameters measured include heart rate, blood pressure, respiratory rate, onset and duration of motor and sensory blockade. Student's unpaired t-test and the χ2 test were used to analyse the results, using the SPSS version 11.5 software. Results: The haemodynamic stability was better with isobaric bupivacaine fentanyl mixture (Group 1) than with hyperbaric bupivacaine fentanyl mixture (Group 2). The mean onset time in Group 1 for both sensory block (4 min) and motor block (5 min) was longer compared with Group 2. The duration of sensory block (127.8 ± 38.64 min) and motor block (170.4 ± 27.8 min) was less with isobaric bupivacaine group compared with hyperbaric bupivacaine group (sensory blockade 185.4 ± 16.08 min and motor blockade 201.6 ± 14.28 min). Seventy percent of patients in Group 2 had maximum sensory block level of T6 whereas it was 53% in Group 1. More patients in Group 1 required sedation compared to Group 2. Conclusion: Isobaric bupivacaine fentanyl mixture was found to provide adequate anaesthesia with minimal incidence of haemodynamic instability. PMID:26962255

  17. A randomized controlled study comparing room air with carbon dioxide for abdominal pain, distention, and recovery time in patients undergoing colonoscopy.

    PubMed

    Chen, Yen-Ju; Lee, Jennifer; Puryear, Magaly; Wong, Roy K H; Lake, Jason M; Maydonovitch, Corrine L; Belle, Lavern; Moawad, Fouad J

    2014-01-01

    Colonoscopy remains the gold standard for colorectal cancer screening. Many barriers to the procedure exist including the possibility of abdominal discomfort that may occur with insufflation. Carbon dioxide (CO2), which is rapidly absorbed in the blood stream, is an alternate method used to distend the lumen during colonoscopy. The goal of this study was to compare patient discomfort, abdominal girth, and recovery time in 2 groups of patients randomized to CO2 versus room air insufflation during colonoscopy. Using a Wong-Baker score, we found statistical difference in postprocedural discomfort levels (CO2 Group: 1.15 ± 2.0 vs. room air: 0.41 ± 0.31, p = .015) and a significantly greater increase in abdominal girth over CO2 immediately postprocedure (room air: 1.06 ± 1.29 inches vs. CO2: 0.56 ± 0.73 inches, p = .054) girth immediately postprocedure; however, recovery time was similar between the 2 study arms (CO2: 9.1 ± 16.2 minutes vs. room air: 10.2 ± 18.6 minutes, p = .713). Further studies are needed to determine whether CO2 is cost-effective and improves patient satisfaction with colonoscopy.

  18. Cyanoacrylate Injection Compared with Band Ligation for Acute Gastric Variceal Hemorrhage: A Meta-Analysis of Randomized Controlled Trials and Observational Studies

    PubMed Central

    Huai, Jiaping; Chen, Yanping

    2014-01-01

    Background. Cyanoacrylate injection (GVO) and band ligation (GVL) are effective treatments for gastric variceal hemorrhage. However, data on the optimal treatment are still controversial. Methods. For our overall analysis, relevant studies were identified from several databases. For each outcome, data were pooled using a fixed-effect or random-effects model according to the result of a heterogeneity test. Results. Seven studies were included. Compared with GVL, GVO was associated with increased likelihood of hemostasis of active bleeding (odds ratio [OR] = 2.32; 95% confidence interval [CI] = 1.19–4.51) and a longer gastric variceal rebleeding-free period (hazard ratio = 0.37; 95% CI = 0.24–0.56). No significant differences were observed between GVL and GVO for mortality (hazard ratio = 0.66; 95% CI = 0.43–1.02), likelihood of variceal obliteration (OR = 0.89; 95% CI = 0.52–1.54), number of treatment sessions required for complete variceal eradication (weighted mean difference = −0.45; 95% CI = −1.14–0.23), or complications (OR = 1.02; 95% CI = 0.48–2.19). Conclusion. GVO may be superior to GVL for achieving hemostasis and preventing recurrence of gastric variceal rebleeding but has no advantage over GVL for mortality and complications. Additional studies are warranted to enable definitive conclusions. PMID:24868204

  19. Dimethyl sulfoxide with lignocaine versus eutectic mixture of local anesthetics: prospective randomized study to compare the efficacy of cutaneous anesthesia in shock wave lithotripsy.

    PubMed

    Kumar, Santosh; Kumar, Sunil; Ganesamoni, Raguram; Mandal, Arup K; Prasad, Seema; Singh, Shrawan K

    2011-06-01

    The objective of the study was to compare the efficacy of dimethyl sulfoxide (DMSO) mixed with lignocaine and eutectic mixture of local anesthetics (EMLA) cream as topically applied surface anesthetics in relieving pain during shock wave lithotripsy (SWL) in a prospective randomized study. Of the 160 patients, 80 patients received DMSO with lignocaine and 80 patients received EMLA cream, applied to the skin of the flank at the area of entry of shock waves. SWL was done with Seimens lithostar multiline lithotripter. The pain during the procedure was assessed using visual analog and verbal rating scores. The mean visual analog scale scores for the two groups were 3.03 for DMSO group and 4.43 for EMLA group. The difference of pain score on visual analog scale was statistically significant (p < 0.05). Similarly, the pain scores as rated on the verbal rating scale were also evaluated; the mean score on verbal rating scale were 2.34 for DMSO group and 3.00 for the EMLA group. The difference between the pain score on verbal rating scale was also found to be statistically significant (p < 0.05). Our study showed that DMSO with lignocaine is a better local anesthetic agent for SWL than EMLA cream. The stone fragmentation and clearance rates are also better in the DMSO group.

  20. Comparative efficacy of nimesulide and ketoprofen on inflammatory events in third molar surgery: a split-mouth, prospective, randomized, double-blind study.

    PubMed

    Pouchain, E C; Costa, F W G; Bezerra, T P; Soares, E C S

    2015-07-01

    This study aimed to compare the effect of nimesulide and ketoprofen on inflammatory parameters related to the surgical removal of third molars. A split-mouth, prospective, randomized, double-blind study was conducted in patients undergoing removal of four third molars. Eighteen eligible patients were allocated to one of two groups to receive treatment two times a day with either ketoprofen 100 mg or nimesulide 100 mg for a period of 3 days. The rescue medication intake (number) and pain intensity were evaluated at 6, 12, 24, and 48 h, and at 7 days postoperatively. Swelling and maximum mouth opening were evaluated at 24 h, 72 h, and 7 days postoperatively. The peak pain score occurred at 6h after surgery in the nimesulide group and at 12h in the ketoprofen group. There was no statistically significant difference between the groups, although pain relief was observed after 48 h in the nimesulide group and after 7 days in the ketoprofen group. For each group, there was a statically significant difference in pain scores among the studied periods (P<0.0001). None of the patients required rescue medication. There was a statistically significant difference in maximum mouth opening between the preoperative and postoperative periods (P<0.0001). Ketoprofen and nimesulide were effective at controlling pain, swelling, and trismus after the surgical removal of third molars.

  1. Two randomized, controlled, comparative studies of the stratum corneum integrity benefits of two cosmetic niacinamide/glycerin body moisturizers vs. conventional body moisturizers.

    PubMed

    Christman, Jeremy C; Fix, Deborah K; Lucus, Sawanna C; Watson, Debrah; Desmier, Emma; Wilkerson, Rolanda J Johnson; Fixler, Charles

    2012-01-01

    Despite numerous body moisturizers being available, cosmetic xerosis continues to be a leading skin problem for consumers. We performed two 35-day studies to evaluate the ability of a variety of body moisturizers containing various levels of oils/lipids, humectants, as well as other ingredients (e.g., niacinamide) to improve stratum corneum integrity. 63 and 58 female subjects were enrolled and randomized in an incomplete block design to six of nine products (eight moisturizers or no treatment control) in studies 1 and 2, respectively. The primary endpoints included visual dryness by a qualified skin grader, skin hydration as measured by Corneometer, and barrier integrity as measured by transepidermal water loss (TEWL). The primary comparisons for the two niacinamide/glycerin moisturizers were to the other six moisturizers and to the no treatment control for each endpoint. The two niacinamide/glycerin moisturizers demonstrated an overall better solution towards rapid and prolonged improvement of cosmetic xerosis due to functional improvement of stratum corneum barrier function compared to no treatment and the other moisturizers tested. These studies establish the benefit of including niacinamide in a body moisturizer to improve the integrity of the stratum corneum and thus reduce cosmetic xerosis over time.

  2. Comparing the effectiveness of the 0.018-inch versus the 0.022-inch bracket slot system in orthodontic treatment: study protocol for a randomized controlled trial.

    PubMed

    El-Angbawi, Ahmed M F; Bearn, David R; McIntyre, Grant T

    2014-10-06

    Edgewise fixed orthodontic appliances are available in two different bracket slot sizes (0.018 and 0.022 inch). Both systems are used by clinicians worldwide with some orthodontists claiming the superiority and clinical advantages of one system over the other. However, the scientific evidence supporting this area is scarce and weak. This leaves the clinician's choice of bracket slot system to clinical preference. We aim to compare the 0.018-inch and 0.022-inch pre-adjusted bracket slot systems in terms of the effectiveness of orthodontic treatment. This is a prospective, multicenter, randomized clinical trial, undertaken in the secondary care hospital environment in the NHS Tayside region of Scotland (United Kingdom). A total of 216 orthodontic patients will be recruited in three centers in secondary care hospitals in NHS Tayside. The participants will be randomly allocated to treatment with either the 0.018-inch or 0.022-inch bracket slot systems (n = 108 for each group) using Victory series™ conventional pre-adjusted bracket systems (3 M Unitek, Monrovia, United States). Baseline records and outcome data collected during and at the end of orthodontic treatment will be assessed. The primary outcome measures will be the duration of orthodontic treatment in the maxillary and mandibular arches. The secondary outcome measures will be the number of scheduled appointments for orthodontic treatment in the maxillary and mandibular arches, treatment outcome using Peer Assessment Rating index (PAR), orthodontically induced inflammatory root resorption (as measured using periapical radiographs) and the patient's perception of wearing orthodontic appliances. The results from the current study will serve as evidence to guide the clinician in deciding whether the difference in bracket slot size has a significant impact on the effectiveness of orthodontic treatment. Registered with ClinicalTrials.gov on 5 March 2014, registration number: NCT02080338.

  3. Gesture-Controlled Image Management for Operating Room: A Randomized Crossover Study to Compare Interaction Using Gestures, Mouse, and Third Person Relaying

    PubMed Central

    Dubois-Ferrière, Victor; Budry, Sylvain; Hoffmeyer, Pierre; Lovis, Christian

    2016-01-01

    Objective In this work, we aim at comparing formally three different interaction modes for image manipulation that are usable in a surgery setting: 1) A gesture-controlled approach using Kinect ®; 2) oral instructions to a third part dedicated to manipulate the images; and 3) direct manipulation using a mouse. Materials and Methods Each participant used the radiology image viewer Weasis with the three interaction modes. In a crossover randomized controlled trial participants were attributed block wise to six experimental groups. For each group, the order for testing the three modes was randomly assigned. Nine standardized scenarios were used. Results 30 physicians and senior medical students participated in the experiment. Efficiency, measured as time used to pass the scenario, was best when using the mouse (M = 109.10s, SD = 25.96), followed by gesture-controlled (M = 214.97s, SD = 46.29) and oral instructions (M = 246.33s, SD = 76.50). Satisfaction, measured by a questionnaire, was rated highest in the condition mouse (M = 6.63, SD = 0.56), followed by gesture-controlled (M = 5.77, SD = 0.93) and oral instructions (M = 4.40, SD = 1.71). Differences in efficiency and satisfaction rating were significant. No significant difference in effectiveness, measured with error rates, was found. Discussion The study shows with formal evaluation that the use of gestures is advantageous over instructions to a third person. In particular, the use of gestures is more efficient than verbalizing instructions. The given gestures could be learned easily and reliability of the tested gesture-control system is good. Conclusion Under the premise that mouse cannot be used directly during surgery, gesture-controlled approaches demonstrate to be superior to oral instructions for image manipulation. PMID:27082758

  4. Effect of zolpidem on sleep architecture and its next-morning residual effect in insomniac patients: a randomized crossover comparative study with brotizolam.

    PubMed

    Uchimura, Naohisa; Nakajima, Toru; Hayash, Kunihiko; Nose, Iwao; Hashizume, Yuji; Ohyama, Tetsu; Habukawa, Mitsunari; Kotorii, Nozomu; Kuwahara, Hiroo; Maeda, Hisao

    2006-01-01

    This study was conducted to determine the effect of zolpidem (ZOL) 10 mg orally on the sleep architecture and the next-morning residual effect in patients with non-organic insomnia (ICD-10) as compared to the effect of brotizolam (BTM) 0.25 mg orally, a widely used short-acting benzodiazepine (BZD) hypnotic in Japan, in a randomized, crossover comparative study. Fourteen patients with non-organic insomnia (3 males and 11 females; mean age of 54.9+/-S.D. 8.9 years). First three nights with placebo, middle three nights with either ZOL 10 mg or BTM 0.25 mg, and last three nights again with placebo in each session (a total of two sessions). Primary endpoints were polysomnography findings of sleep stages, sleep parameters, and sleep latency (SL) in the morning to examine calculable sleepiness as a residual effect. Secondary endpoint was sleep quality assessed by self-assessment questionnaire. At 150 min after Tmax, both ZOL and BTM significantly increased stage 2 (S2), and ZOL showed significantly longer slow wave sleep (SWS; stage 3+4) as compared to BTM. Stage wake was significantly increased by ZOL at the first withdrawal night and by BTM at the second withdrawal night. ZOL did not affect SL after rising, whereas BTM showed significantly shorter SL. Both drugs reduced the number of nocturnal awakenings and improved subjective sleep quality. The common adverse drug reaction (ADR) was sleepiness (3 patients) in each treatment. All events were mild. No serious adverse events occurred. ZOL is as effective as BTM in improving subjective sleep quality in patients with psychophysiological insomnia (PPI). ZOL has advantages over BTM in having a unique profile of increasing SWS with less next-morning residual effect.

  5. Lay health educators and print materials for the promotion of colorectal cancer screening among Korean Americans: A randomized comparative effectiveness study.

    PubMed

    Jo, Angela M; Nguyen, Tung T; Stewart, Susan; Sung, Min J; Gildengorin, Ginny; Tsoh, Janice Y; Tong, Elisa K; Lo, Penny; Cuaresma, Charlene; Sy, Angela; Lam, Hy; Wong, Ching; Jeong, Matthew; Chen, Moon S; Kagawa-Singer, Marjorie

    2017-07-15

    Colorectal cancer (CRC) is the second most commonly diagnosed cancer among Korean American men and women. Although CRC screening is effective in reducing the burden of this disease, studies have shown that Korean Americans have low screening rates. The authors conducted a 2-arm cluster randomized controlled trial comparing a brochure (print) with a brochure and lay health educator (LHE) outreach (print + LHE) in increasing CRC screening rates among Korean American individuals. Self-administered written surveys at baseline and at 6 months assessed knowledge of CRC and its screening, ever screening, and being up to date with screening. A total of 28 LHEs recruited 348 participants aged 50 to 75 years from their social networks. Significant percentages of participants reported not having health insurance (29.3%) or a usual source of care (35.6%). At 6 months postintervention, the print + LHE participants had a greater increase in knowledge compared with those in the print arm (P = .0013). In multivariable analyses, both groups had significant increases in ever screening (print plus LHE: odds ratio [OR], 1.60 [95% confidence interval (95% CI), 1.26-2.03] and print: OR, 1.42 [95% CI, 1.10-1.82]) and being up to date with screening (print plus LHE: OR, 1.63 [95% CI, 1.23-2.16] and print: OR, 1.40 [95% CI, 1.04-1.89]). However, these increases did not differ significantly between the study arms. Having insurance and having seen a provider within the past year were found to be positively associated with screening. Compared with a brochure, LHE outreach yielded greater increases in knowledge but resulted in similar increases in CRC screening in a Korean American population with barriers to health care access. More work is needed to appropriately address logistical and system barriers in this community. Cancer 2017;123:2705-15. © 2017 American Cancer Society. © 2017 American Cancer Society.

  6. Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

    PubMed

    Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

    2016-03-01

    Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

  7. A Randomized Controlled Trial to Compare 2 Scalable Interventions for Lower Urinary Tract Symptom Prevention: Main Outcomes of the TULIP Study.

    PubMed

    Sampselle, Carolyn M; Newman, Diane K; Miller, Janis M; Kirk, Keri; DiCamillo, Mary Ann; Wagner, Todd H; Raghunathan, Trivellor E; Diokno, Ananias C

    2017-06-01

    We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  8. Short-term efficacy to conventional blind injection versus ultrasound-guided injection of local corticosteroids in tenosynovitis in patients with inflammatory chronic arthritis: A randomized comparative study.

    PubMed

    Gutierrez, Marwin; Di Matteo, Andrea; Rosemffet, Marcos; Cazenave, Tomas; Rodriguez-Gil, Gustavo; Diaz, Cristina Hernandez; Rios, Lucio Ventura; Zamora, Natalia; Guzman, Maria del Carmen Gonzalez; Carrillo, Ignacio; Okano, Tadashi; Salaffi, Fausto; Pineda, Carlos

    2016-03-01

    To compare the short-term efficacy of conventional blind injection (CBI) versus ultrasound-guided injection (USGI) of corticosteroids (CS) injection in tenosynovitis in patients with chronic arthritis and to investigate if the USGI is a less painful procedure and if there are differences in the changes of US findings during the post injection follow-up. Patients presenting tenosynovitis requiring CS injection were involved. After clinical and US evaluation, patients were randomized to receive CBI or USGI. Efficacy of procedure was assessed by the improvement in both Health Assessment Questionnaire (HAQ) and pain visual analogue scale (VAS), including procedure-VAS global-VAS and local-VAS, after 1 and 4 weeks post-procedure. Power Doppler (PD) and greyscale (GS) US findings were also object of the follow-up. CBI or USGI under an aseptic technique were performed according the local guidelines using 20mg of methylprednisolone acetate. A total of 114 patients were randomized to receive CBI (54 patients) or USGI (60 patients) procedure. No significant difference was observed in terms of gender, age and pain duration among CBI and USGI groups at baseline. USGI proved to be significantly less painful than CBI (P=0.0001). AUC analysis showed that during the follow up visits, the USGI procedure had significantly better response in HAQ, local-VAS and global-VAS (P=0.0001, P=0.012 and P=0.0001 respectively) compared to CBI. During the follow up period, a significant greater reduction in the PD scores was found in the USGI group compared to the CBI group (P=0.0002), whereas no statistical differences were found in the GS findings between the groups (P=0.5627). Our study demonstrates superiority of USGI over CBI for CS injections in painful tenosynovitis, having better short-term outcomes measured by functional, clinical and US scores. These data support the use of USGI for tenosynovits in typical inpatient and/or outpatient in rheumatological practices. Copyright © 2015 Soci

  9. Patient directed self management of pain (PaDSMaP) compared to treatment as usual following total knee replacement: study protocol for a randomized controlled trial.

    PubMed

    Donell, Simon; Deane, Katherine; Swift, Louise; Barton, Garry; Balls, Paula; Darrah, Clare; Gray, Richard

    2012-11-05

    In 2009, 665 patients underwent total knee replacements (TKRs) at the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH), representing nearly 1% of the national total. Pain control following the operation can be poor, and this can cause poor mobilization and potential long-term adverse events. Although high levels of pain are not associated with patient dissatisfaction, brief periods of pain may lead to neuronal remodeling and sensitization. Patient controlled oral analgesia (PCOA) may improve pain relief; however, the evidence to date has been inconclusive. Patient directed self management of pain (PaDSMaP) is a single center randomized controlled trial, which aims to establish if patient self-medication improves, or is equivalent to, treatment as usual and to create an educational package to allow implementation elsewhere. Patients eligible for a TKR will be recruited and randomized in the outpatient clinic. All patients will undergo their operations according to normal clinical practice but will be randomized into two groups. Once oral medication has commenced, one group will have pain relief administered by nursing staff in the usual way (treatment as usual; TAU), whilst the second group will self manage their pain medication (patient directed self management of pain; PaDSMaP). Those recruited for self-medication will undergo a training program to teach the use of oral analgesics according to the World Health Organization (WHO) pain cascade and how to complete the study documentation. The primary endpoint of the trial is the visual analogue scale (VAS) pain score at 3 days or discharge, whichever is sooner. The follow-up time is 6 weeks with a planned trial period of 3 years. The secondary objectives are satisfaction with the management of patient pain post-operatively whilst an inpatient after primary TKR; overall pain levels and pain on mobilization; satisfaction with pain management information provided; global outcomes, such as quality of

  10. A randomized, placebo-controlled double-blinded comparative clinical study of five over-the-counter non-pharmacological topical analgesics for myofascial pain: single session findings

    PubMed Central

    2012-01-01

    Objectives To investigate the effects of topical agents for the treatment of Myofascial Pain Syndrome (MPS) and Myofascial Trigger Point (MTRP). Methods Subjects with an identifiable trigger point in the trapezius muscle, age 18-80 were recruited for a single-session randomized, placebo-blinded clinical study. Baseline measurements of trapezius muscle pressure pain threshold (PPT: by pressure algometer) along with right and left cervical lateral flexion (rangiometer) were obtained by a blinded examiner. An assessor blinded to the outcomes assessments applied one of 6 topical formulations which had been placed in identical plastic containers. Five of these topicals were proposed active formulations; the control group was given a non-active formulation (PLA). Five minutes after the application of the formula the outcome measures were re-tested. Data were analyzed with a 5-way ANOVA and Holms-adjusted t-tests with an alpha level of 0.05. Results 120 subjects were entered into the study (63 females; ages 16-82); 20 subjects randomly allocated into each group. The pre- and post-treatment results for pressure threshold did show significant intra-group increases for the Ben-Gay Ultra Strength Muscle Pain Ointment (BG), the Professional Therapy MuscleCare Roll-on (PTMC roll-on) and Motion Medicine Cream (MM) with an increased threshold of 0.5 kg/cm2 (+/-0.15), 0.72 kg/cm2 (+/-0.17) and 0.47 Kg/cm2 (+/-0.19) respectively. With respect to the inter-group comparisons, PTMC roll-on showed significant increases in pressure threshold compared with Placebo (PLA) (p = 0.002) and Icy Hot Extra Strength Cream (IH) (p = 0.006). In addition, BG demonstrated significant increases in pressure threshold compared with PLA (p = 0.0003). Conclusions With regards to pressure threshold, PTMC roll-on, BG and MM showed significant increases in pain threshold tolerance after a short-term application on a trigger points located in the trapezius muscle. PTMC roll-on and BG were both shown to be

  11. A randomized, placebo-controlled double-blinded comparative clinical study of five over-the-counter non-pharmacological topical analgesics for myofascial pain: single session findings.

    PubMed

    Avrahami, Daniel; Hammond, Amanda; Higgins, Ceara; Vernon, Howard

    2012-03-21

    To investigate the effects of topical agents for the treatment of Myofascial Pain Syndrome (MPS) and Myofascial Trigger Point (MTRP). Subjects with an identifiable trigger point in the trapezius muscle, age 18-80 were recruited for a single-session randomized, placebo-blinded clinical study. Baseline measurements of trapezius muscle pressure pain threshold (PPT: by pressure algometer) along with right and left cervical lateral flexion (rangiometer) were obtained by a blinded examiner. An assessor blinded to the outcomes assessments applied one of 6 topical formulations which had been placed in identical plastic containers. Five of these topicals were proposed active formulations; the control group was given a non-active formulation (PLA). Five minutes after the application of the formula the outcome measures were re-tested. Data were analyzed with a 5-way ANOVA and Holms-adjusted t-tests with an alpha level of 0.05. 120 subjects were entered into the study (63 females; ages 16-82); 20 subjects randomly allocated into each group. The pre- and post-treatment results for pressure threshold did show significant intra-group increases for the Ben-Gay Ultra Strength Muscle Pain Ointment (BG), the Professional Therapy MuscleCare Roll-on (PTMC roll-on) and Motion Medicine Cream (MM) with an increased threshold of 0.5 kg/cm2 (+/-0.15), 0.72 kg/cm2 (+/-0.17) and 0.47 Kg/cm2 (+/-0.19) respectively. With respect to the inter-group comparisons, PTMC roll-on showed significant increases in pressure threshold compared with Placebo (PLA) (p = 0.002) and Icy Hot Extra Strength Cream (IH) (p = 0.006). In addition, BG demonstrated significant increases in pressure threshold compared with PLA (p = 0.0003). With regards to pressure threshold, PTMC roll-on, BG and MM showed significant increases in pain threshold tolerance after a short-term application on a trigger points located in the trapezius muscle. PTMC roll-on and BG were both shown to be superior vs placebo while PTMC was also

  12. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study

    PubMed Central

    2013-01-01

    Background Cancer-related fatigue (CRF) is one of the most common and distressing side effects of cancer and its treatment. During and after radiotherapy breast cancer patients often suffer from CRF which frequently impairs quality of life (QoL). Despite the high prevalence of CRF in breast cancer patients and the severe impact on the physical and emotional well-being, effective treatment methods are scarce. Physical activity for breast cancer patients has been reported to decrease fatigue, to improve emotional well-being and to increase physical strength. The pathophysiological and molecular mechanisms of CRF and the molecular-biologic changes induced by exercise, however, are poorly understood. In the BEST trial we aim to assess the effects of resistance training on fatigue, QoL and physical fitness as well as on molecular, immunological and inflammatory changes in breast cancer patients during adjuvant radiotherapy. Methods/design The BEST study is a prospective randomized, controlled intervention trial investigating the effects of a 12-week supervised progressive resistance training compared to a 12-week supervised muscle relaxation training in 160 patients with breast cancer undergoing adjuvant radiotherapy. To determine the effect of exercise itself beyond potential psychosocial group effects, patients in the control group perform a group-based progressive muscle relaxation training. Main inclusion criterion is histologically confirmed breast cancer stage I-III after lumpectomy or mastectomy with indication for adjuvant radiotherapy. Main exclusion criteria are acute infectious diseases, severe neurological, musculosceletal or cardiorespiratory disorders. The primary endpoint is cancer-related fatigue; secondary endpoints include immunological and inflammatory parameters analyzed in peripheral blood, saliva and urine. In addition, QoL, depression, physical performance and cognitive capacity will be assessed. Discussion The BEST study is the first randomized

  13. A randomized pilot study comparing the role of PEEP, O2 flow, and high-flow air for weaning of ventilatory support in very low birth weight infants.

    PubMed

    Yang, Chang-Yo; Yang, Mei-Chin; Chu, Shih-Ming; Chiang, Ming-Chou; Lien, Reyin

    2017-09-06

    There is a lack of evidence to guide step-wise weaning of positive pressure respiratory support for premature infants. This study sought to compare the efficacy of three weaning protocols we designed to facilitate weaning of very low birth weight (VLBW, less than 1500 g) preterm infants from nasal continuous positive airway pressure (NCPAP) support. This was a prospective, randomized, controlled trial of VLBW preterm infants who received positive pressure ventilatory support in our neonatal intensive care unit (NICU) from April 2008 through March 2009. When these infants were weaned to CPAP as their last step of respiratory support, they would be randomly assigned to one of the following three groups as their further weaning methods (M): (M1) CPAP group, (M2) O2 flow group, and (M3) air flow group. The time period they needed to wean off any kind of respiratory support, as well as the likelihood of developing relevant prematurity related morbidities, were compared among patients using different weaning modalities. 181 patients were enrolled in the study. Their gestational age (GA) and birth weight (BW) were 29.1 ± 2.5, 28.7 ± 2.4, 28.7 ± 2.4 (mean ± SD) weeks and 1142 ± 232, 1099 ± 234, 1083 ± 219 g, in M1, M2 and M3, respectively. The time (period) needed to wean off support was 16.0 ± 10.0 days (M1), 11.6 ± 6.4 days (M2), and 15.0 ± 8.9 days (M3), respectively (p = .033). Incidence of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) were both significantly higher in the O2 flow group (p = .048). Although using low oxygen flow significantly shortens CPAP weaning time, it may increase risks of BPD and ROP, both known to be related to oxygen toxicity. Unless the infant has BPD and is O2-dependent, clinicians should consider using air flow or just splinting with no support at all when weaning NCPAP. Copyright © 2017. Published by Elsevier B.V.

  14. Nutritional evaluation of rapeseed protein compared to soy protein for quality, plasma amino acids, and nitrogen balance--a randomized cross-over intervention study in humans.

    PubMed

    Fleddermann, Manja; Fechner, Anita; Rößler, Andrea; Bähr, Melanie; Pastor, Anja; Liebert, Frank; Jahreis, Gerhard

    2013-08-01

    Plant proteins such as rapeseed have received little attention for human nutrition due to their high level of antinutritive compounds. Today, newer technologies can eliminate such compounds. The present intervention study aimed to evaluate nutritional and physiological properties of two manufactured canola proteins with special focus on their bioavailability in humans. 28 healthy male subjects (ø 25 years) consumed 30.0 g protein (canola protein isolate--CPI, canola protein hydrolyzate--CPH or soy protein isolate--SPI) in a randomized, double-blind, cross-over study. Blood samples were regularly drawn over the 8-h postprandial period and a 24-h urine sample was collected. True digestibility of the canola proteins determined in a separate rat assay showed 93.3% for CPI and 97.3% for CPH. In humans, consumption of either 30.0 g canola protein or soy protein mixed in a drink led to significant increases in plasma amino acids after 62.3 and 83.6 min, respectively. While the CPH produced an earlier response compared to CPI and SPI, total amino acid response (AUC for 8 h) was comparable between all interventions. The nitrogen balance between the three proteins tested showed no statistical differences. High digestibility of rapeseed protein was found in rats. In humans, this is the first intervention study showing rapeseed protein (both isolate and hydrolyzate) as having a high nutritional quality and can be considered to be as efficient as soy protein for a postprandial amino acid response. This trial was registered at ClinicalTrials.gov Identifier: NCT01481584. Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  15. a Comparative Study Between Pair-Point Clique and Multi-Point Clique Markov Random Field Models for Land Cover Classification

    NASA Astrophysics Data System (ADS)

    Hu, B.; Li, P.

    2013-07-01

    Markov random field (MRF) is an effective method for description of local spatial-temporal dependence of image and has been widely used in land cover classification and change detection. However, existing studies only use pair-point clique (PPC) to describe spatial dependence of neighbouring pixels, which may not fully quantify complex spatial relations, particularly in high spatial resolution images. In this study, multi-point clique (MPC) is adopted in MRF model to quantitatively express spatial dependence among pixels. A modified least squares fit (LSF) method based on robust estimation is proposed to calculate potential parameters for MRF models with different types. The proposed MPC-MRF method is evaluated and quantitatively compared with traditional PPCMRF in urban land cover classification using high resolution hyperspectral HYDICE data of Washington DC. The experimental results revealed that the proposed MPC-MRF method outperformed the traditional PPC-MRF method in terms of classification details. The MPC-MRF provides a sophisticated way of describing complex spatial dependence for relevant applications.

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

    PubMed Central

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

    2017-01-01

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

  17. Monochromatic excimer light versus combination of topical steroid with vitamin D3 analogue in the treatment of nonsegmental vitiligo: a randomized blinded comparative study.

    PubMed

    Abdel Latif, Azmy Ahmed; Ibrahim, Shady Mahmoud Attia

    2015-01-01

    Vitiligo is a difficult disease to treat, socially stigmatizing its patients. Monochromatic excimer light (MEL) was developed for use in dermatology and adapted for the treatment of vitiligo. Comparing the efficacy of MEL versus topical combination therapy of vitamin D3 analogue and steroid in the treatment of nonsegmental vitiligo. Forty-four patients with localized and stable nonsegmental vitiligo participated in the present study. In each patient, two lesions were selected and divided randomly into two groups, group A was treated with daily topical combination of calcipotriol and betamethasone and group B was treated with biweekly sessions of MEL for 3 months. Efficacy based on repigmentation percentages were blindly evaluated by two independent physicians and patient's satisfaction. There was significant improvement in both treatment modalities at the end of the study, but without significant differences in both groups. There was a significant difference between both groups regarding the onset of repigmentation (p-value < 0.05), whereas group B showed early sign of repigmentation in first 4 weeks of treatment in 16 patients versus 7 patients in group A. Both treatment modalities offered encouraging results and both are promising lines for the treatment of vitiligo.

  18. Precision Gains from Publically Available School Proficiency Measures Compared to Study-Collected Test Scores in Education Cluster-Randomized Trials. NCEE 2010-4003

    ERIC Educational Resources Information Center

    Deke, John; Dragoset, Lisa; Moore, Ravaris

    2010-01-01

    In randomized controlled trials (RCTs) where the outcome is a student-level, study-collected test score, a particularly valuable piece of information is a study-collected baseline score from the same or similar test (a pre-test). Pre-test scores can be used to increase the precision of impact estimates, conduct subgroup analysis, and reduce bias…

  19. A Randomized Comparative Study on the Efficacy of Intracoronary Infusion of Autologous Bone Marrow Mononuclear Cells and Mesenchymal Stem Cells in Patients With Dilated Cardiomyopathy.

    PubMed

    Xiao, Wentao; Guo, Suping; Gao, Chuanyu; Dai, Guoyou; Gao, Yongjv; Li, Muwei; Wang, Xianpei; Hu, Dayi

    2017-02-13

    Stem cell therapy has shown therapeutic benefit in dilated cardiomyopathy (DCM), but doubt remains about the most appropriate stem cell subpopulation. The current study compared the efficacy of intracoronary administration of bone marrow mononuclear cells (BMMC) or mesenchymal stem cells (BMSC) in patients with DCM.Fifty-three patients with DCM and reduced (< 40%) left ventricular ejection fraction (LVEF), were randomized to intracoronary infusion of BMMC (BMMC group, n = 16) or BMSC (BMSC group, n = 17) or equal volume normal saline (CTRL group, n = 20). LVEF, New York Heart Association (NYHA) class, left ventricular end-diastolic diameter (LVEDd), and myocardial perfusion were assessed at baseline and at 3-month and 12-month follow-ups. Major adverse cardiovascular events (MACE) were also recorded.At the 3-month follow-up, LVEF, NYHA class, and myocardial perfusion had improved significantly in the BMSC group (P = 0.004, 0.020 and 0.019, respectively) along with significant changes in LVEF and NYHA class in the BMMC group compared with CTRL (P = 0.042 and 0.047, respectively), however, LVEDd remained unchanged. In comparison with CTRL, LVEF, NYHA class, and myocardial perfusion improved significantly in the BMSC group at the 12-month follow-up (P = 0.005, 0.050 and 0.038 respectively), but not in the BMMC group (P > 0.05). There were no significant differences between the transplantation groups during follow-up (P > 0.05). There were no differences in MACE among the 3 groups (P = 0.817).Intracoronary bone marrow stem cell transplantation in DCM is safe and effective, while BMSC and BMMC infusion possess comparable effectiveness.

  20. Clinical efficacy of olopatadine hydrochloride ophthalmic solution 0.2% compared with placebo in patients with allergic conjunctivitis or rhinoconjunctivitis: a randomized, double-masked environmental study.

    PubMed

    Abelson, Mark B; Gomes, Paul J; Vogelson, Cullen T; Pasquine, Terri A; Gross, Robert D; Turner, F Darell; Wells, David T; Bergamini, Michael V W; Robertson, Stella M

    2004-08-01

    Previous studies have suggested that olopatadine hydrochloride ophthalmic solution 0.2% administered once daily is effective for up to 24 hours after instillation and is well tolerated in adults and children aged > or =3 years. The goal of this study was to evaluate the efficacy and safety profile of olopatadine 0.2% compared with placebo in patients with seasonal allergic conjunctivitis or rhinoconjunctivitis. This was a 10-week, randomized, placebo-controlled, double-masked environmental study conducted during the spring allergy season (April-August) of 2003. Patients assessed their ocular signs and symptoms in terms of frequency (whole-unit scale from 0 to 5) and severity (half-unit scale from 0 to 4), and grass pollen counts were obtained daily for each investigative site. Responder analyses were conducted by pollen level (frequency based) and pollen period (severity based) to evaluate the clinical significance of differences in ocular itching and redness between treatment groups. Two hundred sixty patients (137 females, 123 males) were enrolled in the study, including 28 children aged between 11 and 17 years; the overall population was 74% white, 11% black, 4% Hispanic, and 11% other. The frequency-based responder analyses of ocular itching and redness showed that when grass pollen counts were high (>20 gr/m(3) air), a respective 21% and 14% of patients in the olopatadine 0.2% group assessed the frequency of ocular itching and redness as >2, compared with 47% and 31% of patients in the placebo group (P < 0.001 for ocular itching; P < 0.003 for redness). The results of the severity-based responder analyses by peak pollen period were consistent with those of the frequency-based analyses. Compared with placebo, olopatadine 0.2% was associated with significant reductions in calculated mean scores for ocular itching and redness by pollen level and by pollen period. No patient was discontinued from the study because of a treatment-related adverse event, and no

  1. Comparative Efficacy and Tolerability of 5-Loxin® and Aflapin® Against Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study

    PubMed Central

    Sengupta, Krishanu; Krishnaraju, Alluri V.; Vishal, Amar A.; Mishra, Artatrana; Trimurtulu, Golakoti; Sarma, Kadainti VS; Raychaudhuri, Smriti K; Raychaudhuri, Siba P

    2010-01-01

    Aflapin® is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the comparative efficacy and tolerability of 5-Loxin® and Aflapin® in the treatment of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN80793440). Sixty OA subjects were included in the study. The subjects received either 100 mg (n=20) of 5-Loxin® or 100 mg (n=20) of Aflapin® or a placebo (n=20) daily for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. A battery of biochemical parameters in serum, urine and hematological parameters in citrated whole blood were performed to assess the safety of 5-Loxin® and Aflapin® in OA subjects. Fifty seven subjects completed the study. At the end of the study, both 5-Loxin® and Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Interestingly, significant improvements in pain score and functional ability were recorded as early as 7 days after initiation of the study in the treatment group supplemented with 100 mg Aflapin. Corroborating the improvements in pain scores in treatment groups, our in vitro studies provide evidences that Aflapin® is capable of inhibiting cartilage degrading enzyme MMP-3 and has the potential to regulate the inflammatory response by inhibiting ICAM-1. Aflapin® and 5-Loxin® reduce pain and improve physical functions significantly in OA subjects. Aflapin exhibited better efficacy compared to 5-Loxin®. In comparison with placebo

  2. The ENKI-2 water-jet system versus Dual Knife for endoscopic submucosal dissection of colorectal lesions: a randomized comparative animal study.

    PubMed

    Ciocîrlan, Mihai; Pioche, Mathieu; Lepilliez, Vincent; Gonon, Nicolas; Roume, Roland; Noel, Guillaume; Pinset, Christian; Ponchon, Thierry

    2014-02-01

    The ENKI-2 water-jet system for endoscopic submucosal dissection (ESD) combines submucosal saline pressure injection with dissection. The aim of this study was to compare ENKI-2 with a standard device in terms of procedure time and perforation rate during colorectal ESD. In this randomized comparative study, 10 30-mm-diameter lesions were created in the colon and rectum of 10 healthy adult pigs. The ESD procedure time and perforation rates were recorded for the ENKI-2 system and a standard Dual Knife method. Each pig had half the lesions dissected by ENKI-2 and half dissected by Dual Knife. One experienced and one inexperienced endoscopist took part in the study. A total of 95 lesions were dissected (47 by ENKI-2 and 48 by Dual Knife). The experienced endoscopist was able to excise comparably sized 30-mm lesions using both techniques. The dissection time was shorter for ENKI-2 (18.9 vs. 25.6 minutes; P = 0.034) and the perforation rate was lower compared with the Dual Knife (one perforation [4 %] vs. nine perforations [36 %]; P = 0.011). The inexperienced endoscopist performed significantly larger dissections using the ENKI-2 (934 ± 405 mm2 vs. 673 ± 312 mm2; P = 0.021) despite pre-marking similarly sized artificial lesions. Multivariate analysis demonstrated that for all lesions the dissection time was significantly longer for lesions in the proximal colon (P = 0.001) and the distal colon (P < 0.0001) and shorter for the experienced operator (P < 0.0001). ENKI-2 shortened the dissection time, but not significantly (P = 0.093). In experienced hands, the ENKI-2 system shortens dissection time and reduces the perforation rate. This effect was not statistically significant for an inexperienced operator. Dissection was faster in the rectum than the colon. © Georg Thieme Verlag KG Stuttgart · New York.

  3. Randomized Trial Comparing the Electronic Composite Psychosocial Screener YouthCHAT With a Clinician-Interview Assessment for Young People: A Study Protocol.

    PubMed

    Thabrew, Hiran; Corter, Arden; Goodyear-Smith, Felicity; Goldfinch, Mary

    2017-07-31

    Psychosocial problems such as depression, anxiety, and substance abuse are common and burdensome in young people, particularly those with long-term physical conditions such as asthma and diabetes. In New Zealand, "screening" for such problems is undertaken routinely only with Year 9 students in low-decile schools and opportunistically in pediatric settings using a nonvalidated and time-consuming clinician-administered Home, Education/employment, Eating, Activity, Drugs, Sexuality, Suicide/depression, Safety (HEEADSSS) interview. The Youth version, Case-finding and Help Assessment Tool (YouthCHAT) is a relatively new, locally developed, eTablet-based composite screener for identifying similar psychosocial issues to HEEADSSS. Based on individually validated screening instruments, it is self-administered within minutes. Preliminary testing has revealed its acceptability to young people, but further research is required to expand its modules to cover all HEEADSSS domains, to evaluate its acceptability for young people with and without long-term physical conditions, and to compare its effectiveness against HEEADSSS. Our aim is to (1) ascertain acceptability and utility of YouthCHAT for children with long-term physical illness and high school students, (2) validate three additional YouthCHAT domains against comparable HEEADSSS domains, and (3) compare the performance of YouthCHAT and HEEADSSS in the high school setting. During the first phase of the study, three additional YouthCHAT domains were codesigned with high school students. During the second phase of the study, the updated version of YouthCHAT will be administered to 30 young people with long-term physical conditions, and to 150 high school students either before or after HEEADSSS in the form of a randomized trial with counter-balanced design. Primary outcomes include comparability between HEEADSSS and YouthCHAT in detecting psychosocial issues, and time to administer; acceptability of YouthCHAT as an acceptable

  4. Multi-institutional randomized clinical study on the comparative effects of intracavital chemotherapy alone versus immunotherapy alone versus immunochemotherapy for malignant effusion

    PubMed Central

    Nio, Y; Nagami, H; Tamura, K; Tsubono, M; Nio, M; Sato, M; Kawabata, K; Hayashi, H; Shiraishi, T; Imai, S; Tsuchitani, T; Mizuta, J; Nakagawa, M; Fukumoto, M

    1999-01-01

    The current prospective randomized study was designed to compare the effects of intracavitary (i.c.) chemotherapy vs immunotherapy vs immunochemotherapy for malignant effusion. Between 1992 and 1995, a total of 42 patients with malignant effusion were registered, and 41 patients were eligible for statistical analysis. The primary diseases of the eligible patients included 27 gastric, four colorectal, four pancreatic, three lung, two liver and one oesophageal cancers. The patients with malignant effusion were randomly assigned into one of three i.c. therapeutic regimens: chemotherapy alone with weekly injection of anticancer agents (ACAs: cisplatin, mitomycin-C, adriamycin, etc.) (Group A, n = 13); immunotherapy alone with weekly injection of streptococcal preparation OK-432 (Group B, n = 14); or immunochemotherapy with ACAs and OK-432 (Group C, n = 14). The response of the effusion, patient survival and the kinetics of cytokines in the effusion were compared. There were no differences in the patients' backgrounds. The side-effects of the regimens included pain, anorexia, fever, leucopenia and anaemia and there were no differences in their incidence among the three groups. One patient died after cisplatin (CDDP) administration in Group A. Cytologic examination revealed that tumour cells in the effusion disappeared in 23% of Group A cases, 36% of Group B cases and 36% of Group C cases. The malignant effusion did not disappear in any of the Group A cases; however, the effusion disappeared in 29% of Group B cases and 43% of Group C cases (P = 0.03, Group A vs Group C). Furthermore, the 50% survival period was 1.6 months for Group A, 2.4 months for Group B and 3.5 months for Group C. The 6-month survival rate was 7% for Group A, 6% for Group B and 34% for Group C, and the 1-year survival rate was 0%, 0% and 17% respectively (P = 0.048, Group A vs Group C by the log-rank test). The analysis of the cytokine kinetics revealed a prominent increase in the level of

  5. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up.

    PubMed

    Moosmayer, Stefan; Lund, Gerty; Seljom, Unni S; Haldorsen, Benjamin; Svege, Ida C; Hennig, Toril; Pripp, Are H; Smith, Hans-Jørgen

    2014-09-17

    There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears. We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed. A single-center, pragmatic, randomized controlled study with follow-ups after six months and one, two, and five years was conducted in a secondary-care institution. One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair (n = 52) or physiotherapy (n = 51). The primary outcome measure was the Constant score. Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score; the physical component summary measure of the Short Form 36 Health Survey; the measurement of pain, strength, and shoulder motion; patient satisfaction; and findings from magnetic resonance imaging and sonography. Analysis was by intention to treat. The five-year follow-up rate was 98%. Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair. The results from primary tendon repair were superior to those from physiotherapy plus secondary repair, with between-group mean differences of 5.3 points on the Constant score (p = 0.05), 9.0 points on the American Shoulder and Elbow Surgeons score (p < 0.001), 1.1 cm on a 10-cm visual analog scale for pain (p < 0.001), and 1.0 cm on a 10-cm visual analog scale for patient satisfaction (p = 0.03). In 37% of tears treated with physiotherapy only, there were increasing tear sizes on ultrasound of >5 mm, over five years, associated with an inferior outcome. Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment, the differences were small and may be below clinical importance. In the physiotherapy treatment group, there were increasing tear sizes and inferior outcomes

  6. Primary implant stability in augmented sinuslift-sites after completed bone regeneration: a randomized controlled clinical study comparing four subantrally inserted biomaterials

    PubMed Central

    Troedhan, Angelo; Schlichting, Izabela; Kurrek, Andreas; Wainwright, Marcel

    2014-01-01

    Implant-Insertion-Torque-Value (ITV) proved to be a significant clinical parameter to predict long term implant success-rates and to decide upon immediate loading. The study evaluated ITVs, when four different and commonly used biomaterials were used in sinuslift-procedures compared to natural subantral bone in two-stage-implant-procedures. The tHUCSL-INTRALIFT-method was chosen for sinuslifting in 155 sinuslift-sites for its minimal invasive transcrestal approach and scalable augmentation volume. Four different biomaterials were inserted randomly (easy-graft CRYSTAL n = 38, easy-graft CLASSIC n = 41, NanoBone n = 42, BioOss n = 34), 2 ccm in each case. After a mean healing period of 8,92 months uniform tapered screw Q2-implants were inserted and Drill-Torque-Values (DTV) and ITV were recorded and compared to a group of 36 subantral sites without need of sinuslifting. DTV/ITV were processed for statistics by ANOVA-tests. Mean DTV/ITV obtained in Ncm were: Control Group 10,2/22,2, Bio-Oss 12,7/26,2, NanoBone 17,5/33,3, easy-graft CLASSIC 20,3/45,9, easy-graft CRYSTAL 23,8/56,6 Ncm, significance-level of differences throughout p < 0,05. Within the limits of this study the results suggest self-hardening solid-block-like bone-graft-materials to achieve significantly better DTV/ITV than loose granulate biomaterials for its suspected improvement of vascularization and mineralization of the subantral scaffold by full immobilization of the augmentation site towards pressure changes in the human sinus at normal breathing. PMID:25073446

  7. Primary implant stability in augmented sinuslift-sites after completed bone regeneration: a randomized controlled clinical study comparing four subantrally inserted biomaterials.

    PubMed

    Troedhan, Angelo; Schlichting, Izabela; Kurrek, Andreas; Wainwright, Marcel

    2014-07-30

    Implant-Insertion-Torque-Value (ITV) proved to be a significant clinical parameter to predict long term implant success-rates and to decide upon immediate loading. The study evaluated ITVs, when four different and commonly used biomaterials were used in sinuslift-procedures compared to natural subantral bone in two-stage-implant-procedures. The tHUCSL-INTRALIFT-method was chosen for sinuslifting in 155 sinuslift-sites for its minimal invasive transcrestal approach and scalable augmentation volume. Four different biomaterials were inserted randomly (easy-graft CRYSTAL n = 38, easy-graft CLASSIC n = 41, NanoBone n = 42, BioOss n = 34), 2 ccm in each case. After a mean healing period of 8,92 months uniform tapered screw Q2-implants were inserted and Drill-Torque-Values (DTV) and ITV were recorded and compared to a group of 36 subantral sites without need of sinuslifting. DTV/ITV were processed for statistics by ANOVA-tests. Mean DTV/ITV obtained in Ncm were: Control Group 10,2/22,2, Bio-Oss 12,7/26,2, NanoBone 17,5/33,3, easy-graft CLASSIC 20,3/45,9, easy-graft CRYSTAL 23,8/56,6 Ncm, significance-level of differences throughout p < 0,05. Within the limits of this study the results suggest self-hardening solid-block-like bone-graft-materials to achieve significantly better DTV/ITV than loose granulate biomaterials for its suspected improvement of vascularization and mineralization of the subantral scaffold by full immobilization of the augmentation site towards pressure changes in the human sinus at normal breathing.

  8. Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

    PubMed Central

    Jung, Hye-Kyung; Lee, Kwang Jae; Choi, Myung-Gyu; Park, Hyojin; Lee, Joon Seong; Rhee, Poong-Lyul; Kim, Nayoung; Park, Kyung Sik; Choi, Suck Chei; Lee, Oh Young; Huh, Kyu Chan; Song, Geun Am; Hong, Su Jin; Sohn, Chong Il; Jung, Hwoon-Yong; Lee, Yong Chan; Rew, Jong Sun; Jee, Sam Ryong; Kwon, Joong Goo

    2016-01-01

    Background/Aims The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. Methods In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. Results The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. Conclusions DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD. PMID:26811504

  9. Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study.

    PubMed

    Nitikman, Michael; Mulpuri, Kishore; Reilly, Christopher W

    2017-03-01

    Modern technology puts into question the effectiveness of using pen and paper as a means of collecting information from web-enabled patients. This study aimed to validate and test the reliability of using the Internet as a method of administering health-related quality of life questionnaires in a pediatric spine population. A prospective randomized crossover study was conducted. Patients aged 11 to 18 with idiopathic scoliosis were invited to participate, and informed consent was obtained from a scoliosis outpatient clinic setting. Participants were randomized to one of 4 groups determining the method of questionnaire administration [Scoliosis Research Society 30 (SRS-30) and Pediatric Outcomes Data Collection Instrument (PODCI)]. Both questionnaires were completed at 2 separate timepoints and 2 weeks apart to prevent recall bias. Groups included: Paper/Paper, Paper/Internet, Internet/Paper, and Internet/Internet. Paired-samples t tests were used to determine the test-retest reliability of each group. Analysis was stratified for surveys returned within or outside of the allotted 4-week timeframe following enrollment. Of the 96 participants who completed and returned both sets of questionnaires, 26 were allocated to the Paper/Paper group (27%), 20 to the Paper/Internet group (21%), 26 to the Internet/Paper group (27%), and 24 to the Internet/Internet group (25%). The second iteration of questionnaires was returned on time by 69 of the participants (71.2%). Of the late questionnaires, 18 (67%) were paper forms. Overall, no differences were observed between Internet-administered compared with pen and paper-administered questionnaires (P=0.206). No differences were observed within any group individually for either the SRS-30 or PODCI questionnaire. In addition, no significant differences were observed within groups for surveys returned within or outside of the 4-week timeframe. Eighty-four percent of the participants who completed both paper and Internet versions of

  10. Impact of the «Conversation Map™» tools on understanding of diabetes by Spanish patients with type 2 diabetes mellitus: a randomized, comparative study.

    PubMed

    Penalba, Maite; Moreno, Luis; Cobo, Amelia; Reviriego, Jesús; Rodríguez, Angel; Cleall, Simon; Reaney, Matthew

    2014-12-01

    This paper presents results from the Spanish subpopulation of a study comparing Conversation Maps™ (CM)-based education with regular care (RC) in type 2 diabetes mellitus (T2DM). Adult patients with T2DM who were considered as not demonstrating ideal disease management were randomly assigned to CM or RC with assessments following (Visit 2), and at follow-up 6 months after (Visit 3), the final CM session. The primary endpoint was diabetes knowledge at Visit 3. 310 patients were randomised to receive CM education (n=148) or RC (n=162). Median knowledge scores were ranked significantly higher in the CM group than the RC group at Visit 2 and Visit 3 (p<0.001). No significant differences in clinical and other outcomes were identified between the interventions, except satisfaction with care (p<0.001, Visit 2; p=0.055, Visit 3) and perception of goal attainment (p<0.001 and p = 0.046, respectively) that were both higher in the CM group. In these patients from Spain, CM was superior to RC in terms of diabetes knowledge 6 months after education was completed, suggesting that CM should be considered for use in patients requiring diabetes education. Copyright © 2014 SEEN. Published by Elsevier Espana. All rights reserved.

  11. [Influence of acupuncture on postoperative pain, nausea and vomiting after visceral surgery : a prospective, randomized comparative study of metamizole and standard treatment].

    PubMed

    Grube, T; Uhlemann, C; Weiss, T; Meissner, W

    2009-08-01

    The objective of this study was to assess repeated needle acupuncture in the treatment of postoperative pain and nausea after visceral surgery. Sixty-six patients undergoing visceral surgery (hysterectomy, cholecystectomy) were randomly assigned to group A (three sessions of needle acupuncture, n=21), group M (3x1000 mg metamizole, n=20), or group K (control, n=25). All patients received patient-controlled analgesia (PCA) using piritramide. To adjust for nonspecific effects due to physician-patient interaction during acupuncture sessions in group A, patients in groups M and K also received three standardized visits. Primary outcome parameters were defined as pain intensity, analgesic consumption, and frequency of nausea and vomiting in a period up to the morning of the second postoperative day. Patients in group A reported significant less pain, nausea, and vomiting compared to patients in group K. Mean cumulative piritramide consumption was significantly lower in group A (25.0 mg) than in group M (34.5 mg) and group K (55.2 mg). Repeated needle acupuncture may be effective in postoperative pain relief and the treatment of nausea and vomiting in the postoperative period. These effects seem not to be due solely to interaction between the acupuncturist and the patient.

  12. Ajoene in the topical short-term treatment of tinea cruris and tinea corporis in humans. Randomized comparative study with terbinafine.

    PubMed

    Ledezma, E; López, J C; Marin, P; Romero, H; Ferrara, G; De Sousa, L; Jorquera, A; Apitz Castro, R

    1999-06-01

    Ajoene (CAS 92284-99-6), an organic trisulphur originally isolated from garlic, has an antimycotic activity which has been widely demonstrated both in vitro and in vivo. The objective of this work was to compare the safety and effectiveness of ajoene (0.6%, gel) with terbinafine (CAS 91161-71-6) (1%, cream) for the treatment of tinea corporis and tinea cruris. The patients selected were 60 soldiers with clinical and mycological diagnosis of either dermatophytosis. They were distributed at random in two treatment groups, one treated with ajoene at 0.6% and the other with terbinafine at 1%. All patients were evaluated clinically and mycologically 30 and 60 days after completion of the treatment, which was considered effective when clinical signs and symptoms had disappeared and the mycological cultures were negative. Thirty days after treatment, the percent healing rate was 77 and 75 for the groups treated with ajoene and terbinafine, respectively. Sixty days after treatment, the healing rate 73% and 71% for the groups treated with ajoene and terbinafine, respectively. These results and those obtained in previous studies confirm that ajoene is a new agent for the topic treatment of superficial mycoses, and for the first time show the therapeutic usefulness of an inhibitor of phospholipids biosynthesis in eukaryotes.

  13. Comparative efficacy and tolerability of pholcodine and dextromethorphan in the management of patients with acute, non-productive cough : a randomized, double-blind, multicenter study.

    PubMed

    Equinozzi, Roberto; Robuschi, Maria

    2006-01-01

    The aim of this study was to compare the efficacy and tolerability of pholcodine with that of dextromethorphan, one of the most used cough sedative products, in patients with acute, non-productive cough. 129 adults with a diagnosis of acute, frequent, non-productive cough participated in a randomized, double-blind, parallel-group, multicenter trial. Medications were in a syrup formulation and were taken orally three times daily for 3 days. The efficacy endpoints were the change from baseline in the daytime and night-time cough frequency on 5-point scales at day 3, and cough intensity. A reduction of 1.4 and 1.3 points in the mean daytime cough frequency at day 3 was seen in the pholcodine and dextromethorphan groups, respectively, in the per-protocol population. The reduction in mean night-time cough was 1.3 for both groups. Cough intensity reduction was 0.7 for pholcodine and 0.8 for dextromethorphan. These findings indicate that the efficacy of a 3-day course of pholcodine is similar to that of dextromethorphan in the treatment of adult patients with acute, non-productive cough. Both medications were well tolerated.

  14. The use of FOCUS Harmonic scalpel compared to conventional haemostasis (knot and tie ligation) for thyroid surgery: a prospective randomized study.

    PubMed

    Cannizzaro, Matteo Angelo; Lo Bianco, Salvatore; Borzì, Laura; Cavallaro, Andrea; Buffone, Antonino

    2014-01-01

    Haemostasis is crucial in thyroid surgery to avoid intraoperative and postoperative complications. In the present study, we evaluated the efficiency and the safety of Harmonic scalpel when compared to conventional suture ligation in open total thyroidectomy. We enrolled 265 patients who underwent total thyroidectomy for multinodular disease since October 2011 up to October 2013. They were randomized into two groups: 141 in group HS (Harmonic Scalpel), 124 in group CT (Conventional tecnique). We recorded the following data: operative time, post-operative blood loss, length of hospital stay and complications. The patients were monitored for 48 hours after surgery. Several differences were observed between the two groups (HS vs CT): the use of Harmonic scalpel was associated to a significant reduction of surgical operative time (110 min in CT vs 79.36 min in HS, p = 0.00001) and also associated to a lower blood loss (97.38 ml in CT vs 68.72 ml in HS, p = 0.00001). The length of stay was significantly shorter in the HS group (2.75 days in CT vs 1.93 days in HS) Complication rate was similar in the two groups. According to our experience, the Harmonic scalpel represents a safe alternative to conventional haemostasis in thyroid surgery, allowing for a significant reduction of operative time, blood loss and hospitalization. The rate of complication demonstrated no significant difference among the two groups.

  15. [Randomized comparative study for the assessment of a new therapeutic schedule of fosfomycin trometamol in postmenopausal women with uncomplicated lower urinary tract infection].

    PubMed

    Palou, J; Angulo, J C; Ramón de Fata, F; García-Tello, A; González-Enguita, C; Boada, A; Sanz, M

    2013-03-01

    To compare two therapeutic regimes in terms of bacterial eradication of post-menopausal with uncomplicated acute cystitis who complete antibiotic treatment. A multicenter, randomized, prospective and controlled study between two short antibiotic regimes: fosfomycin trometamol (FMT) 3g, 2 doses separated by 72hours and ciprofloxacin 250mg every 12hours for 3 days. A total of 118 post-menopausal women were enrolled in the study. They underwent an initial urine culture to know the responsible microorganism and susceptibility to treatment. This was repeated 5-7 days and 4 weeks after the treatment to evaluate bacterial eradication. Clinical symptoms and treatment safety were also evaluated. There were microbiological data at the onset of the treatment in 82 women (69.49%). Of these, 27 did not have positive culture at the first visit (30.51%), 76 (64.41%) fulfilled all the protocol requirements and adverse effects from the treatment were collected in 113 (95.76%) of the patients enrolled in the study. The germs isolated most frequently were Escherichia coli (E. coli) (76.83%), Klebsiella pneumoniae (K. pneumoniae) (7.32%), Proteus mirabilis (P. mirabilis) (4.89%) and Enterococo sp. (3.66%). In terms of efficacy, no differences were detected in the proportion of patients who achieved bacterial eradication between the two study arms: 62.16% of the patients who received FMT and 58.97% of those treated with ciprofloxacin (chi-square, p=0.78). The proportion of patients who achieved clinical cure was also similar (86.49% for FMT and 82.05% for ciprofloxacin; square, p=0.59). These results indicate similar efficacy of both antibiotics in the treatment of uncomplicated lower tract urinary infection in post-menopausal women. In regards to safety data, the proportion of global adverse effects associated to the treatments was 3.45% for FMT and 9.09% for ciprofloxacin. Treatment compliance was 100% for FMT and 83.64% for ciprofloxacin. The FMT administered at a dose of 3g every

  16. Endotoxinemia and benzodiazepine-like substances in compensated cirrhotic patients: a randomized study comparing the effect of rifaximine alone and in association with a symbiotic preparation.

    PubMed

    Lighthouse, J.; Naito, Y.; Helmy, A.; Hotten, P.; Fuji, H.; Min, C.H.; Yoshioka, M.; Marotta, F.

    2004-03-01

    Aim: The aim of the present investigation was to test study benzodiazepines (BZDs) profile in patients with viral cirrhosis under different combinations of rifaximine and of a novel symbiotic. Methods: Our study groups consisted of 30 patients with a confirmed diagnosis of HCV-related Child B liver cirrhosis. Patients were randomly allocated into three groups: rifaximine 400mg t.i.d. for 2 weeks; (B) SCM-III (Lactobacillus acidophilus, Lactobacillus helveticus and Bifidobacteria in a ion- and vitamin-enriched medium, Named srl, Italy) 10ml t.i.d. for 2 weeks; (C) rifaximine 400mg t.i.d. for 1 week followed by SCM-III 10ml t.i.d. for 5 weeks. At weekly interval, blood samples were withdrawn to test BZD-like substances, ammonia and endotoxin. Results: Rifaximine treatment brought about a significant early drop of BZDs ( [Formula: see text] versus pre-treatment and versus control) till fourth week of observation when a gradual increase took place with return to pre-treatment values at the sixth week. Symbiotic treatment was comparably effective while given to patients but significantly elevated BZDs level were noted starting from the third week. Similar phenomena were noted for endotoxin and ammonia although symbiotic seemed more effective against endotoxin and rifaximine against ammonia increase. However, the sequential treatment rifaximine-symbiotic brought about a sustained normalization of BZDs, ammonia and endotoxin throughout the 6-week study. Conclusion: The present pilot study suggests that a rifaximine-symbiotic regimen could be an effective tool in compensated liver cirrhosis to limit some triggering factors of hepatic encephalopathy while being amenable to long-term use and devoid of significant side effects.

  17. Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study.

    PubMed

    Jain, Minish M; Gupte, Smita U; Patil, Shekhar G; Pathak, Anand B; Deshmukh, Chetan D; Bhatt, Niraj; Haritha, Chiramana; Govind Babu, K; Bondarde, Shailesh A; Digumarti, Raghunadharao; Bajpai, Jyoti; Kumar, Ravi; Bakshi, Ashish V; Bhattacharya, Gouri Sankar; Patil, Poonam; Subramanian, Sundaram; Vaid, Ashok K; Desai, Chirag J; Khopade, Ajay; Chimote, Geetanjali; Bapsy, Poonamalle P; Bhowmik, Shravanti

    2016-02-01

    Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hypersensitivity reactions as well as leaching of plasticizers from polyvinyl chloride bags and infusion sets. Currently, nab-paclitaxel, an albumin-bound paclitaxel in nanometer range continues to be the preferred taxane formulation used in clinic. This study (CTRI/2010/091/001116) investigated the efficacy and tolerability of a polyoxyethylated castor oil- and albumin-free formulation of paclitaxel [paclitaxel injection concentrate for nanodispersion (PICN)] compared with nab-paclitaxel in women with refractory MBC. The current study was a multicenter, open-label, parallel-group, randomized, comparative phase II/III trial evaluating the efficacy and safety of PICN (260 mg/m(2) [n = 64] and 295 mg/m(2) [n = 58] every 3 weeks) compared with nab-paclitaxel (260 mg/m(2) every 3 weeks [n = 58]) in women 18 and 70 years old with confirmed MBC. Overall response rate (ORR) was assessed with imaging every 2 cycles. An independent analysis of radiologic data was performed for evaluable patients. Progression-free survival (PFS) was a secondary efficacy measure. Independent radiologist-assessed ORRs in the evaluable population of women aged ≥70 years were 35, 49, and 43 % in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Median PFS in the evaluable population was 23, 35, and 34 weeks in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Adverse events occurred in similar proportions of patients across treatment arms. Hypersensitivity reactions were not frequently observed with the clinical use of PICN across the treatment cohorts. In women with metastatic breast cancer, PICN at 260 and 295 mg/m(2

  18. A comparative prospective randomized clinical study of MTA and IRM as root-end filling materials in single-rooted teeth in endodontic surgery.

    PubMed

    Lindeboom, Jerome A H; Frenken, Joost W F H; Kroon, Frans H M; van den Akker, Hans P

    2005-10-01

    Randomized clinical prospective study to evaluate the application of MTA and IRM as retrograde sealers in surgical endodontics. One hundred single-rooted teeth were surgically treated. After randomization, MTA or IRM was used as a retrosealer. Radiographs were taken 1 week, 3 months, and 1 year postoperatively. Assessment was performed by 2 independent assessors 1 year after surgery. Both treatment groups were homogeneous in their composition, and clinical features and radiographic findings were classified according to Rud's classification. Complete healing was observed in 64% of the MTA-treated teeth vs 50% of the IRM-treated teeth. Incomplete healing was seen in 28% (MTA) vs 36% (IRM), and unsatisfactory in 6% (MTA) vs 14% (IRM). Only 1 failure was seen (MTA). No statistically significant differences were found between the 2 retrofilling materials. As root-end filling materials in this clinical prospective randomized design on single rooted teeth, MTA and IRM had the same clinical effectiveness.

  19. Effectiveness of mechanical traction as a non-surgical treatment for carpal tunnel syndrome compared to care as usual: study protocol for a randomized controlled trial.

    PubMed

    Meems, Margreet; Den Oudsten, Brenda; Meems, Berend-Jan; Pop, Victor

    2014-05-22

    Carpal tunnel syndrome (CTS) is a common condition (prevalence of 4%) where the median nerve is compressed within the carpal tunnel resulting in numbness, tingling, and pain in the hand. Current non-surgical treatment options (oral medication, corticosteroid injections, splinting, exercise, and mobilization) show limited effects, especially in the long-term. Carpal tunnel release (CTR) surgery is effective in 70 to 75% of patients, but is relatively invasive and can be accompanied by complications. In an observational study, mechanical traction proved to be effective in up to 70% of patients directly after treatment and in 60% after two years follow-up. This randomized controlled trial (RCT) will examine the effectiveness of mechanical traction compared to care as usual in CTS. Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group (mechanical traction) or the control group (care as usual). Participants in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. Primary outcome is symptom severity and functional status, which are measured with the Boston Carpel Tunnel Questionnaire (BCTQ). Secondary outcomes are quality of life (WHOQOL-BREF), health related resource utilization, and absenteeism from work. Outcomes will be assessed at baseline, and at 3, 6, and 12 months after inclusion. Linear mixed effect models will be used to determine the change from baseline at 12 months on the BCTQ, WHOQOL-BREF, absenteeism from work and health related resource utilization. The baseline measurement, change from baseline at three and six months, as well as duration of symptoms until inclusion, age, gender, and co-morbidity will be included as covariates The Pearson's correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome. Since current non-surgical treatment options are not effective long

  20. Effectiveness of mechanical traction as a non-surgical treatment for carpal tunnel syndrome compared to care as usual: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Carpal tunnel syndrome (CTS) is a common condition (prevalence of 4%) where the median nerve is compressed within the carpal tunnel resulting in numbness, tingling, and pain in the hand. Current non-surgical treatment options (oral medication, corticosteroid injections, splinting, exercise, and mobilization) show limited effects, especially in the long-term. Carpal tunnel release (CTR) surgery is effective in 70 to 75% of patients, but is relatively invasive and can be accompanied by complications. In an observational study, mechanical traction proved to be effective in up to 70% of patients directly after treatment and in 60% after two years follow-up. This randomized controlled trial (RCT) will examine the effectiveness of mechanical traction compared to care as usual in CTS. Methods/Design Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group (mechanical traction) or the control group (care as usual). Participants in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. Primary outcome is symptom severity and functional status, which are measured with the Boston Carpel Tunnel Questionnaire (BCTQ). Secondary outcomes are quality of life (WHOQOL-BREF), health related resource utilization, and absenteeism from work. Outcomes will be assessed at baseline, and at 3, 6, and 12 months after inclusion. Linear mixed effect models will be used to determine the change from baseline at 12 months on the BCTQ, WHOQOL-BREF, absenteeism from work and health related resource utilization. The baseline measurement, change from baseline at three and six months, as well as duration of symptoms until inclusion, age, gender, and co-morbidity will be included as covariates The Pearson’s correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome. Discussion Since current non

  1. A Randomized Controlled Study Comparing Efficacy of Classical and Gow-Gates Technique for Providing Anesthesia During Surgical Removal of Impacted Mandibular Third Molar: A Split Mouth Design.

    PubMed

    Madan, Nanjappa; Shashidhara Kamath, Kateel; Gopinath, A L; Yashvanth, A; Vaibhav, Nagaraj; Praveen, G

    2017-06-01

    Reliable profound mandibular block anesthesia is questionable when depositing the anesthetic solution at the lingula. The Gow-Gates technique is an useful alternative to the classical inferior alveolar nerve block and the incidence of unsuccessful anesthesia may be as high as classical technique. The aim of this study is to compare the clinical efficacy, degree of patient acceptability, advantages, disadvantages and limitations of the classical and Gow-Gates techniques for providing anesthesia in patients undergoing bilateral symmetrical surgical removal of impacted mandibular third molar under local anesthesia. The split mouth design study was conducted on 100 patients aged between 20 to 40 years undergoing surgical removal of bilateral symmetrical impacted mandibular third molar performed by the same maxillofacial surgeon. 2 ml of 2 % lignocaine hydrochloride with 1:80,000 adrenaline was used as a standard local anesthetic solution in all the cases. By using four-digit numbers from a random number table, either Gow-Gates or classical inferior alveolar nerve block were randomly assigned to either left or right sides in each patient. The injections were administered by another surgeon who was blinded to the experiment. The patient was assessed for Pain experienced during injection, frequency of positive aspirations, Onset and duration of anesthesia and Nerves anesthetized. Results were statistically analyzed by Mann-Whitney and chi square test. A 'P' value of less than 0.05 was considered for statistical significance. Higher mean pain during injection was recorded in classical group, was found to be statistically significant. No significant association was observed between aspiration and the groups. Higher mean onset of anesthesia was recorded in Gow-gates group, was found to be statistically significant. Higher mean duration of anesthesia was recorded in Gow-gates group, was not statistically significant. Higher success rate was recorded in Gow-gates group and

  2. Acquisition of suture skills during medical graduation by instructor-directed training: a randomized controlled study comparing senior medical students and faculty surgeons.

    PubMed

    Denadai, Rafael; Toledo, Andréia Padilha; Oshiiwa, Marie; Saad-Hossne, Rogério

    2013-06-01

    Due to shortage of time and limited availability of faculty surgeons to teach basic surgical skills during medical graduation, the search for alternative ways of simulated training with feedback is needed. The purpose of this study was to compare the simulated teaching of suture skills to novice medical students by senior medical students and by experienced faculty surgeons. Forty-eight novice medical students were randomly assigned to three practice conditions on bench model (n = 16): self-directed suture training (control), senior medical student-directed suture skills' training, or experienced faculty surgeon-directed suture skills' training. Pre- and post-tests were applied. Global Rating Scale with blinded evaluation and self-perceived confidence based on Likert scale were used to assess all suture performances in pre- and post-training. Effect size was also calculated. The analysis made after training showed that the students who received feedback from the instructors had better performance based on the Global Rating Scale (all p < 0.0000) and felt more confident to carry out sutures (all p < 0.0000) when compared to the control. There was no significant difference (all p > 0.05) between the student-directed teaching and faculty-directed teaching groups. The magnitude of the effect (instructor-directed training suture) was considered large (>0.80) in all measurements. The acquisition of suture skills after student-directed training was similar to the training supervised by faculty surgeon, and the increase in suture performances of trainees that received instructor administered training was superior to self-directed learning.

  3. Semi-elemental formula or polymeric formula: is there a better choice for enteral nutrition in acute pancreatitis? Randomized comparative study.

    PubMed

    Tiengou, Laurent-Eric; Gloro, Romain; Pouzoulet, Julien; Bouhier, Karine; Read, Marie-Hélène; Arnaud-Battandier, Franck; Plaze, Jean-Marie; Blaizot, Xavier; Dao, Thông; Piquet, Marie-Astrid

    2006-01-01

    Jejunal nutrition is recommended during acute pancreatitis. The use of semi-elemental formulas presents several theoretical advantages over polymeric formulas, but their clinical value has been poorly documented. Our aim was to evaluate in patients with acute pancreatitis the effect of enteral nutrition by a semi-elemental formula compared with a polymeric formula. A randomized prospective pilot study, stratified according to severity, was performed in 30 consecutive patients with acute pancreatitis requiring jejunal nutrition. The semi-elemental group received 35 kcal/kg/d of Peptamen (n = 15), and the polymeric group received the same quantity of Sondalis-Iso (n = 15). Tolerance was evaluated after 7 days of enteral nutrition (D7) on visual analog scale (VAS), stool frequency, and 24-hour steatorrhea/creatorrhea. Outcome was evaluated by weight loss, length of hospital stay, and infection rate. Results were calculated as mean +/- SEM, t-test, or chi2. Patients of the 2 groups were comparable in terms of age, gender, and severity. Tolerance was good in both groups (semi-elemental vs polymeric: VAS, 7.4 +/- 0.6 vs 7.1 +/- 0.6, not significant (NS); number of stools per 24 hours, 1.7 +/- 0.4 vs 1.8 +/- 0.4, NS). Steatorrhea and creatorrhea were lower than normal in both groups. In semi-elemental group, the length of hospital stay was shorter (23 +/- 2 vs 27 +/- 1, p = .006) and weight loss was less marked (1 +/- 1 vs 2 +/- 0, p = .01). One patient in semi-elemental group and 3 patients in polymeric group developed an infection (NS). Semi-elemental and polymeric nutrition are very well tolerated in patients with acute pancreatitis. Nutrition with a semi-elemental formula supports the hypothesis of a more favorable clinical course than nutrition with a polymeric formula, but this conclusion needs to be established in larger adequately powered clinical trials.

  4. Comparative effectiveness of 3-dimensional vs 2-dimensional and high-definition vs standard-definition neuroendoscopy: a preclinical randomized crossover study.

    PubMed

    Marcus, Hani J; Hughes-Hallett, Archie; Cundy, Thomas P; Di Marco, Aimee; Pratt, Philip; Nandi, Dipankar; Darzi, Ara; Yang, Guang-Zhong

    2014-04-01

    Although the potential benefits of 3-dimensional (3-D) vs 2-dimensional (2-D) and high-definition (HD) vs standard-definition (SD) endoscopic visualization have long been recognized in other surgical fields, such endoscopes are generally considered too large and bulky for use within the brain. The recent development of 3-D and HD neuroendoscopes may therefore herald improved depth perception, better appreciation of anatomic details, and improved overall surgical performance. To compare simultaneously the effectiveness of 3-D vs 2-D and HD vs SD neuroendoscopy. Ten novice neuroendoscopic surgeons were recruited from a university hospital. A preclinical randomized crossover study design was adopted to compare 3-D vs 2-D and HD vs SD neuroendoscopy. The primary outcomes were time to task completion and accuracy. The secondary outcomes were perceived task workload using the NASA (National Aeronautics and Space Administration) Task Load Index and subjective impressions of the endoscopes using a 5-point Likert scale. Time to task completion was significantly shorter when using the 3-D vs the 2-D neuroendoscopy (P = .001), and accuracy of probe placement was significantly greater when using the HD vs the SD neuroendoscopy (P = .009). We found that 3-D endoscopy significantly improved perceived depth perception (P < .001), HD endoscopy significantly improved perceived image quality (P < .001), and both improved participants' overall impression (P < .001). Three-dimensional neuroendoscopy and HD neuroendoscopy have differing but complementary effects on surgical performance, suggesting that neither alone can completely compensate for the lack of the other. There is therefore strong preclinical evidence to justify 3-D HD neuroendoscopy.

  5. A randomized controlled trial comparing traditional training in cardiopulmonary resuscitation (CPR) to self-directed CPR learning in first year medical students: The two-person CPR study.

    PubMed

    Roppolo, Lynn P; Heymann, Rahm; Pepe, Paul; Wagner, James; Commons, Bradford; Miller, Ronna; Allen, Emilie; Horne, Leyla; Wainscott, Michael P; Idris, Ahamed H

    2011-03-01

    The primary purpose of this study was to compare two, shorter, self-directed methods of cardiopulmonary resuscitation (CPR) education for healthcare professionals (HCP) to traditional training with a focus on the trainee's ability to perform two-person CPR. First-year medical students with either no prior CPR for HCP experience or prior training greater than 5 years were randomized to complete one of three courses: 1) HeartCode BLS System, 2) BLS Anytime, or 3) Traditional training. Only data from the adult CPR skills testing station was reviewed via video recording by certified CPR instructors and the Laerdal PC Skill Reporter software program (Laerdal Medical, Stavanger, Norway). There were 180 first-year medical students who met inclusion criteria: 68 were HeartCode BLS System, 53 BLS Anytime group, and 59 traditional group Regarding two-person CPR, 57 (84%) of Heartcode BLS students and 43 (81%) of BLS Anytime students were able to initiate the switch compared to 39 (66%) of traditional course students (p = 0.04). There were no significant differences in the quality of chest compressions or ventilations between the three groups. There was a trend for a much higher CPR skills testing pass rate for the traditional course students. However, failure to "clear to analyze or shock" while using the AED was the most common reason for failure in all groups. The self-directed learning groups not only had a high level of success in initiating the "switch" to two-person CPR, but were not significantly different from students who completed traditional training. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  6. A single center, randomized, comparative, prospective clinical study to determine the efficacy of the VelaSmooth system versus the Triactive system for the treatment of cellulite.

    PubMed

    Nootheti, Pavan K; Magpantay, Angela; Yosowitz, Gail; Calderon, Steve; Goldman, Mitchel P

    2006-12-01

    One area of cosmetic concern for women of all races is the unsightly appearance of cellulite in the buttocks area and lower extremities. Two modern technological advances claim to improve cellulite and provide reproducible results, TriActive and VelaSmooth. The TriActive laser is intended to reduce the appearance of cellulite through the combination of low-energy diode laser, contact cooling, suction, and massage. The VelaSmooth is based on a combination of two different ranges of electromagnetic energy: infrared light and radio frequency (RF) combined with mechanical manipulation of the skin. This single center study was designed to evaluate the efficacy of the VelaSmooth versus TriActive in the reduction of the appearance of cellulite. Twenty female patients were treated twice a week for 6 weeks with the randomization of TriActive on one side and VelaSmooth on the other side. Patients were evaluated with photographs and circumferential thigh measurements before treatment and after the final treatment. Although there was improvement in the reduction of cellulite for each device individually, there was no significant difference between VelaSmooth or TriActive devices in the following categories: reduction of thigh circumference, photographic evaluation, and perceived change in before and after photographic grading. There was a statistically significant increase in the incidence of post-treatment bruising with the VelaSmooth compared to TriActive. In conclusion, both the TriActive and VelaSmooth provide improvement of cellulite. When comparing differences in efficacy, the average mean percent change calculated was roughly the same for both treatments and showed no statistical difference. (c) 2006 Wiley-Liss, Inc.

  7. Comparative Effectiveness of 3-Dimensional vs 2-Dimensional and High-Definition vs Standard-Definition Neuroendoscopy: A Preclinical Randomized Crossover Study

    PubMed Central

    Hughes-Hallett, Archie; Cundy, Thomas P.; Di Marco, Aimee; Pratt, Philip; Nandi, Dipankar; Darzi, Ara; Yang, Guang-Zhong

    2013-01-01

    BACKGROUND: Although the potential benefits of 3-dimensional (3-D) vs 2-dimensional (2-D) and high-definition (HD) vs standard-definition (SD) endoscopic visualization have long been recognized in other surgical fields, such endoscopes are generally considered too large and bulky for use within the brain. The recent development of 3-D and HD neuroendoscopes may therefore herald improved depth perception, better appreciation of anatomic details, and improved overall surgical performance. OBJECTIVE: To compare simultaneously the effectiveness of 3-D vs 2-D and HD vs SD neuroendoscopy. METHODS: Ten novice neuroendoscopic surgeons were recruited from a university hospital. A preclinical randomized crossover study design was adopted to compare 3-D vs 2-D and HD vs SD neuroendoscopy. The primary outcomes were time to task completion and accuracy. The secondary outcomes were perceived task workload using the NASA (National Aeronautics and Space Administration) Task Load Index and subjective impressions of the endoscopes using a 5-point Likert scale. RESULTS: Time to task completion was significantly shorter when using the 3-D vs the 2-D neuroendoscopy (P = .001), and accuracy of probe placement was significantly greater when using the HD vs the SD neuroendoscopy (P = .009). We found that 3-D endoscopy significantly improved perceived depth perception (P < .001), HD endoscopy significantly improved perceived image quality (P < .001), and both improved participants’ overall impression (P < .001). CONCLUSION: Three-dimensional neuroendoscopy and HD neuroendoscopy have differing but complementary effects on surgical performance, suggesting that neither alone can completely compensate for the lack of the other. There is therefore strong preclinical evidence to justify 3-D HD neuroendoscopy. ABBREVIATIONS: HD, high definition SD, standard definition PMID:24220007

  8. Nutrient adequacy during weight loss interventions: a randomized study in women comparing the dietary intake in a meal replacement group with a traditional food group

    PubMed Central

    Ashley, Judith M; Herzog, Holly; Clodfelter, Sharon; Bovee, Vicki; Schrage, Jon; Pritsos, Chris

    2007-01-01

    Background Safe and effective weight control strategies are needed to stem the current obesity epidemic. The objective of this one-year study was to document and compare the macronutrient and micronutrient levels in the foods chosen by women following two different weight reduction interventions. Methods Ninety-six generally healthy overweight or obese women (ages 25–50 years; BMI 25–35 kg/m2) were randomized into a Traditional Food group (TFG) or a Meal Replacement Group (MRG) incorporating 1–2 meal replacement drinks or bars per day. Both groups had an energy-restricted goal of 5400 kJ/day. Dietary intake data was obtained using 3-Day Food records kept by the subjects at baseline, 6 months and one-year. For more uniform comparisons between groups, each diet intervention consisted of 18 small group sessions led by the same Registered Dietitian. Results Weight loss for the 73% (n = 70) completing this one-year study was not significantly different between the groups, but was significantly different (p ≤ .05) within each group with a mean (± standard deviation) weight loss of -6.1 ± 6.7 kg (TFG, n = 35) vs -5.0 ± 4.9 kg (MRG, n = 35). Both groups had macronutrient (Carbohydrate:Protein:Fat) ratios that were within the ranges recommended (50:19:31, TFG vs 55:16:29, MRG). Their reported reduced energy intake was similar (5729 ± 1424 kJ, TFG vs 5993 ± 2016 kJ, MRG). There was an improved dietary intake pattern in both groups as indicated by decreased intake of saturated fat (≤ 10%), cholesterol (<200 mg/day), and sodium (< 2400 mg/day), with increased total servings/day of fruits and vegetables (4.0 ± 2.2, TFG vs 4.6 ± 3.2, MRG). However, the TFG had a significantly lower dietary intake of several vitamins and minerals compared to the MRG and was at greater risk for inadequate intake. Conclusion In this one-year university-based intervention, both dietitian-led groups successfully lost weight while improving overall dietary adequacy. The group

  9. [Comparative study between fast and slow induction of propofol given by target-controlled infusion: expected propofol concentration at the effect site. Randomized controlled trial].

    PubMed

    Simoni, Ricardo Francisco; Miziara, Luiz Eduardo de Paula Gomes; Esteves, Luis Otávio; Silva, Diógenes de Oliveira; Ribeiro, Cristina Alves; Smith, Mariana Oki; Paula, Leonardo Ferreira de; Cangiani, Luis Henrique

    2015-01-01

    studies have shown that rate of propofol infusion may influence the predicted propofol concentration at the effect site (Es). The aim of this study was to evaluate the Es predicted by the Marsh pharmacokinetic model (ke0 0.26min(-1)) in loss of consciousness during fast or slow induction. the study included 28 patients randomly divided into two equal groups. In slow induction group (S), target-controlled infusion (TCI) of propofol with plasma, Marsh pharmacokinetic model (ke0 0.26min(-1)) with target concentration (Tc) at 2.0-μg.mL(-1) were administered. When the predicted propofol concentration at the effect site (Es) reached half of Es value, Es was increased to previous Es + 1μg.mL(-1), successively, until loss of consciousness. In rapid induction group (R), patients were induced with TCI of propofol with plasma (6.0μg.ml(-1)) at Es, and waited until loss of consciousness. in rapid induction group, Tc for loss of consciousness was significantly lower compared to slow induction group (1.67±0.76 and 2.50±0.56μg.mL(-1), respectively, p=0.004). the predicted propofol concentration at the effect site for loss of consciousness is different for rapid induction and slow induction, even with the same pharmacokinetic model of propofol and the same balance constant between plasma and effect site. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

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

    PubMed Central

    Johari, Sarika; Gandhi, Tejal

    2016-01-01

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

  11. Study protocol for a randomized controlled trial of telephone-delivered cognitive behavior therapy compared with befriending for treating depression and anxiety in older adults with COPD

    PubMed Central

    Doyle, Colleen; Dunt, David; Ames, David; Fearn, Marcia; You, Emily (Chuanmei); Bhar, Sunil

    2016-01-01

    Background COPD is an umbrella term to describe chronic lung diseases that cause limitations in lung airflow, including emphysema and chronic bronchitis. The prevalence of depression and anxiety in people with COPD is high, although these comorbidities are often undiagnosed, untreated, or undertreated. There is a need to identify efficacious treatments for depression and anxiety in people with COPD. Cognitive behavior therapy (CBT) for the treatment of anxiety and depression has a strong evidence base. There has been some success delivering this treatment over the telephone in limited studies. The aim of this study is to evaluate the efficacy of both telephone-administered CBT and befriending on outcomes for patients with diagnosed COPD who have at least mild levels of depression and/or anxiety. Methods The protocol described in this paper is of a pragmatic randomized controlled trial comparing eight sessions of telephone CBT to an active social control, referred to as befriending. Primary outcome measures will include depression and anxiety symptoms, and secondary outcome measures will include quality of life, self-efficacy, and COPD symptom severity. Participants’ satisfaction with the intervention and therapeutic alliance will also be assessed. Measures will be taken pre- and postdelivery of the intervention and again at 8 weeks following the intervention. Conclusion People with COPD often have limitations to their mobility because of their breathlessness. They are often already attending many medical appointments and could be reluctant to attend for face-to-face psychological treatment. The results of this study should identify the relative efficacy of CBT delivered over the telephone to this population, which, if successful, may be a cost-effective and more palatable alternative to face-to-face treatment of depression or anxiety for this population. PMID:26929616

  12. Comparable efficacy of standardized Ayurveda formulation and hydroxychloroquine sulfate (HCQS) in the treatment of rheumatoid arthritis (RA): a randomized investigator-blind controlled study.

    PubMed

    Chopra, Arvind; Saluja, Manjit; Tillu, Girish; Venugopalan, Anuradha; Narsimulu, Gumdal; Handa, Rohini; Bichile, Lata; Raut, Ashwinikumar; Sarmukaddam, Sanjeev; Patwardhan, Bhushan

    2012-02-01

    Hydroxychloroquine sulfate (HCQS) is a popular disease-modifying antirheumatic drug (DMARD) despite modest efficacy and toxicity. Ayurveda (ancient India medicinal system) physicians treat rheumatoid arthritis (RA) with allegedly safer herbal formulations. We report a head-to-head comparison in an exploratory drug trial. The objective is to compare standardized Ayurvedic formulations and HCQS in the treatment of RA. One hundred twenty-one patients with active moderately severe RA (ACR 1988 classified) were randomized into a 24-week investigator-blind, parallel efficacy, three-arm (two Ayurvedic and HCQS) multicenter drug trial study; polyherb (Tinospora cordifolia and Zingiber officinale based) and monoherb (Semecarpus anacardium). Study measures included joint counts (pain/tenderness and swelling), pain visual analogue scale, global disease assessments, and health assessment questionnaire. Oral meloxicam (fixed-dosage schedule) was prescribed to all patients during the initial 16 weeks. Patients on prednisolone could continue a fixed stable dose (<7.5 mg daily). Rescue oral use of paracetamol was permitted and monitored. All groups matched well at baseline. An intent-to-treat analysis (ANOVA, significance P < 0.05) did not show significant differences by treatment groups. In the polyherb, monoherb, and HCQS arms, 44%, 36%, and 51%, respectively, showed ACR 20 index improvement. Several efficacy measures improved significantly in the HCQS and polyherb groups with no difference between the groups (corrected P). However, the latter was individually superior to monoherb. Only mild adverse events (gut and skin, and none withdrew) were reported with no differences between the groups. Forty-two patients dropped out. This preliminary drug trial controlled for HCQS demonstrated a standardized Ayurvedic polyherb drug to be effective and safe in controlling active RA. A better-designed study with a longer evaluation period is recommended.

  13. A Randomized Cadaver Study Comparing First-Attempt Success Between Tibial and Humeral Intraosseous Insertions Using NIO Device by Paramedics: A Preliminary Investigation.

    PubMed

    Szarpak, Lukasz; Truszewski, Zenon; Smereka, Jacek; Krajewski, Paweł; Fudalej, Marcin; Adamczyk, Piotr; Czyzewski, Lukasz

    2016-05-01

    Medical personnel may encounter difficulties in obtaining intravenous (IV) access during cardiac arrest. The 2015 American Heart Association guidelines and the 2015 European Resuscitation Council guidelines for cardiopulmonary resuscitation (CPR) suggest that rescuers establish intraosseous (IO) access if an IV line is not easily obtainable.The aim of the study was to compare the success rates of the IO proximal tibia and proximal humerus head access performed by paramedics using the New Intraosseous access device (NIO; Persys Medical, Houston, TX, USA) in an adult cadaver model during simulated CPR.In an interventional, randomized, crossover, single-center cadaver study, a semi-automatic spring-load driven NIO access device was investigated. In total, 84 paramedics with less than 5-year experience in Emergency Medical Service participated in the study. The trial was performed on 42 adult cadavers. In each cadaver, 2 IO accesses to the humerus head, and 2 IO accesses to the proximal tibia were obtained.The success rate of the first IO attempt was 89.3% (75/84) for tibial access, and 73.8% (62/84) for humeral access (P = 0.017). The procedure times were significantly faster for tibial access [16.8 (interquartile range, IQR, 15.1-19.9] s] than humeral access [26.7 (IQR, 22.1-30.9) s] (P < 0.001).Tibial IO access is easier and faster to put in place than humeral IO access. Humeral IO access can be an alternative method to tibial IO access. clinicaltrials.gov Identifier: NCT02700867.

  14. Efficacy and tolerability of a polysaccharide-resin-honey based cough syrup as compared to carbocysteine syrup for children with colds: a randomized, single-blinded, multicenter study.

    PubMed

    Cohen, Herman Avner; Hoshen, Moshe; Gur, Shmuel; Bahir, Arie; Laks, Yoseph; Blau, Hannah

    2017-02-01

    Available pediatric treatments for acute cough are limited by lack of demonstrated efficacy. The objective of this trial is to compare the effects of a polysaccharide-resin-honey based cough syrup, and carbocysteine syrups on nocturnal and daytime cough associated with childhood upper respiratory tract infections (URIs). Using a single-blind randomization design, the study recruited children from 4 general pediatric community clinics. Participants included 150 children aged 2 to 5 years with an URI, nocturnal and daytime cough and illness duration of ≤7 days. To be eligible, children had to be free of medication on the day before presentation. A survey was administered to parents on 4 consecutive days beginning from the day of presentation in clinic. Children received the study preparation on the first evening and then 3 times per day for 3 further days. Main outcome measures were cough frequency, cough severity, bothersome nature of cough, and quality of sleep for both child and parent. Both preparations were well tolerated and cough improved over the study period. After one night and on all survey days, there was a significantly better result for polysaccharide-resin-honey (P<0.05) for all the main outcome measures. The trend of improvement over the 4 days was steeper for polysaccharide-resin-honey (P<0.05) with regards to all cough parameters. Both polysaccharide-resin-honey and carbocysteine cough syrups were well tolerated in children over 2 years of age. The polysaccharide-resin-honey syrup was associated with a more rapid and greater improvement in all clinical cough symptoms measured, beginning from the first night of therapy. Both nocturnal and daytime cough improved, as did sleep quality for both children and parents.

  15. A phase II/III randomized study to compare the efficacy and safety of rigosertib plus gemcitabine versus gemcitabine alone in patients with previously untreated metastatic pancreatic cancer†

    PubMed Central

    O'Neil, B. H.; Scott, A. J.; Ma, W. W.; Cohen, S. J.; Aisner, D. L.; Menter, A. R.; Tejani, M. A.; Cho, J. K.; Granfortuna, J.; Coveler, L.; Olowokure, O. O.; Baranda, J. C.; Cusnir, M.; Phillip, P.; Boles, J.; Nazemzadeh, R.; Rarick, M.; Cohen, D. J.; Radford, J.; Fehrenbacher, L.; Bajaj, R.; Bathini, V.; Fanta, P.; Berlin, J.; McRee, A. J.; Maguire, R.; Wilhelm, F.; Maniar, M.; Jimeno, A.; Gomes, C. L.; Messersmith, W. A.

    2015-01-01

    Background Rigosertib (ON 01910.Na), a first-in-class Ras mimetic and small-molecule inhibitor of multiple signaling pathways including polo-like kinase 1 (PLK1) and phosphoinositide 3-kinase (PI3K), has shown efficacy in preclinical pancreatic cancer models. In this study, rigosertib was assessed in combination with gemcitabine in patients with treatment-naïve metastatic pancreatic adenocarcinoma. Materials and methods Patients with metastatic pancreatic adenocarcinoma were randomized in a 2:1 fashion to gemcitabine 1000 mg/m2 weekly for 3 weeks of a 4-week cycle plus rigosertib 1800 mg/m2 via 2-h continuous IV infusions given twice weekly for 3 weeks of a 4-week cycle (RIG + GEM) versus gemcitabine 1000 mg/m2 weekly for 3 weeks in a 4-week cycle (GEM). Results A total of 160 patients were enrolled globally and randomly assigned to RIG + GEM (106 patients) or GEM (54). The most common grade 3 or higher adverse events were neutropenia (8% in the RIG + GEM group versus 6% in the GEM group), hyponatremia (17% versus 4%), and anemia (8% versus 4%). The median overall survival was 6.1 months for RIG + GEM versus 6.4 months for GEM [hazard ratio (HR), 1.24; 95% confidence interval (CI) 0.85–1.81]. The median progression-free survival was 3.4 months for both groups (HR = 0.96; 95% CI 0.68–1.36). The partial response rate was 19% versus 13% for RIG + GEM versus GEM, respectively. Of 64 tumor samples sent for molecular analysis, 47 were adequate for multiplex genetic testing and 41 were positive for mutations. The majority of cases had KRAS gene mutations (40 cases). Other mutations detected included TP53 (13 cases) and PIK3CA (1 case). No correlation between mutational status and efficacy was detected. Conclusions The combination of RIG + GEM failed to demonstrate an improvement in survival or response compared with GEM in patients with metastatic pancreatic adenocarcinoma. Rigosertib showed a similar safety profile to that seen in previous trials using the IV

  16. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee--study protocol for a randomized controlled trial.

    PubMed

    Witt, Claudia M; Michalsen, Andreas; Roll, Stephanie; Morandi, Antonio; Gupta, Shivnarain; Rosenberg, Mark; Kronpass, Ludwig; Stapelfeldt, Elmar; Hissar, Syed; Müller, Matthias; Kessler, Christian

    2013-05-23

    Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis. In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ≥40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum. This trial

  17. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee – study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis. Methods and design In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ≥40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy

  18. Randomized, Prospective Double-Blinded Study Comparing 3 Different Doses of 5-Aminolevulinic Acid for Fluorescence-Guided Resections of Malignant Gliomas.

    PubMed

    Stummer, Walter; Stepp, Herbert; Wiestler, Otmar D; Pichlmeier, Uwe

    2017-08-01

    Five-aminolevulinic acid (5-ALA) is used for fluorescence-guided resections of malignant glioma at a dose of 20 mg/kg; yet, it is unknown whether lower doses may also provide efficacy. To perform a double-blinded randomized study comparing 3 different doses of 5-ALA. Twenty-one patients with suspected malignant glioma were randomly assigned to 0.2, 2, or 20 mg/kg 5-ALA. Investigators were unaware of dose. Intraoperatively, regions of interest were first defined in tumor core, margin, and adjacent white matter under white light. Under violet-blue illumination, the surgeon's impression of fluorescence was recorded per region, followed by spectrometry and biopsy. Plasma was collected after administration and analyzed for 5-ALA and protoporphyrin IX (PPIX) content. The positive predictive value of fluorescence was 100%. Visual and spectrometric fluorescence assessment showed 20 mg/kg to elicit the strongest fluorescence in tumor core and margins, which correlated with cell density. Spectrometric and visual fluorescence correlated significantly. A 10-fold increase in 5-ALA dose (2-20 mg/kg) resulted in a 4-fold increase of fluorescence contrast between marginal tumor and adjacent brain. t max for 5-ALA was 0.94 h for 20 mg/kg (0.2 kg: 0.50 h, 2 mg/kg: 0.61 h). Integrated PPIX plasma levels were 255.8 and 779.9 mcg*h/l (2 vs 20 mg/kg). Peak plasma concentrations were observed at 1.89 ± 0.71 and 7.83 ± 0.68 h (2 vs 20 mg/kg; average ± Standard Error of Mean [SEM]). The highest visible and measurable fluorescence was yielded by 20 mg/kg. No fluorescence was elicited at 0.2 mg/kg. Increasing 5-ALA doses did not result in proportional increases in tissue fluorescence or PPIX accumulation in plasma, indicating that doses higher than 20 mg/kg will not elicit useful increases in fluorescence.

  19. The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

    PubMed

    Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

    2011-01-01

    PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also

  20. The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Approximately 85% of vaginal deliveries are accompanied by perineal trauma. The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma. Methods/design This is a single-centre, randomized controlled trial, with computer-generated randomization in a 1:1 allocation ratio. Women planning their first vaginal delivery (n = 650) are randomized to primary delivery of either the anterior or posterior shoulder. The primary outcome is any perineal trauma. Additional outcomes are the perineal injury subtypes, postpartum bleeding, umbilical artery pH, Apgar score at 5 minutes and any neonatal birth trauma. Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery. All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears. The trial is being undertaken at a Danish community hospital with 1,600 yearly deliveries. Data will be analyzed according to the intention-to-treat principle. Recruitment started in January 2013 and the trial is planned to proceed for 24 months. Discussion Most delivery assistance techniques are based on tradition and heritage and lack objective evidence. This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial. The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique. Trial registration ClinicalTrials.gov: NCT01937546. PMID:25047001

  1. Comparative effects of propofol, landiolol, and nicardipine on hemodynamic and bispectral index responses to endotracheal intubation: a prospective, randomized, double-blinded study.

    PubMed

    Miyazaki, Masumi; Kadoi, Yuji; Takashi, Sudo; Sawano, Yukari; Shimada, Hitoshi

    2008-06-01

    To examine the comparative effects of propofol, landiolol, and nicardipine on hemodynamic responses and bispectral index (BIS) changes to endotracheal intubation. Operating room of a university-affiliated general hospital. 27 ASA physical status I and II patients who were scheduled to undergo elective general surgical, urological, or gynecological procedures with general anesthesia. Prospective, randomized, double-blinded study. Patients were divided into three groups as follows: Group 1 received propofol, 1 mg/kg; Group 2 received landiolol, 0.1 mg/kg; and Group 3 received nicardipine, 1 mg. After baseline measurements were recorded, anesthesia was induced with propofol, fentanyl, and vecuronium. Patients' lungs were ventilated with 100% oxygen for 120 seconds, at which time one of one of the study drugs was administered. Laryngoscopy and tracheal intubation were performed 4 minutes after anesthetic induction. Cardiac index (CI) and stroke volume index (SVI) were monitored continuously. Bispectral index was also monitored continuously from 5 minutes after tracheal intubation. Heart rate values in Group 3 increased 30 seconds after intubation; this increase lasted for 1 minute after intubation. Systolic blood pressure in all three groups decreased after induction of anesthesia and before tracheal intubation, and values returned closer to baseline values 30 seconds after intubation. In the propofol group, CI and SVI decreased after administration of additional propofol, lasting for 30 seconds after intubation. The BIS values rapidly decreased after induction of anesthesia, with no intergroup differences noted in BIS values (propofol group, 39+/-7; landiolol group, 44+/-14; nicardipine group, 41+/-9). However, BIS was significantly lower in the propofol group than in the other two groups from 30 seconds to 5 minutes after intubation. Landiolol, 0.1 mg/kg, before intubation provides effective hemodynamic stability in the postintubation period.

  2. Fructose acute effects on glucose, insulin, and triglyceride after a solid meal compared with sucralose and sucrose in a randomized crossover study.

    PubMed

    Gallagher, Clare; Keogh, Jennifer B; Pedersen, Eva; Clifton, Peter M

    2016-06-01

    Fructose, which is a sweetener with a low glycemic index, has been shown to elevate postprandial triglyceride compared with glucose. There are limited data on the effect of fructose in a solid mixed meal containing starch and protein. We determined the effects of sucrose, fructose, and sucralose on triglyceride, glucose, and insulin in an acute study in healthy, overweight, and obese individuals. The study had a randomized crossover design. Twenty-seven participants with a mean age of 44 y and a mean body mass index (in kg/m(2)) of 26 completed the study. Fructose (52 g), sucrose (65 g), and sucralose (0.1 g) were delivered as sweet-taste-balanced muffins with a total fat load (66 g). Blood samples were taken at baseline and every 30 min for 4-h glucose, triglyceride, and insulin concentrations, and the area under the curve (AUC) and the incremental area under the curve (iAUC) were analyzed. No significant difference was shown between the 3 sweeteners for triglyceride and glucose concentrations and the AUC. The glucose iAUC was lower for fructose than for sucrose and sucralose (P < 0.05). Insulin concentrations differed significantly by the type of muffin (P = 0.001), the interaction of time by type of muffin (P = 0.035), the AUC (P < 0.001), and the iAUC (P < 0.001). Fructose had a significantly lower insulin response than that of either sucrose (P-treatment = 0.006) or sucralose (P-treatment = 0.041). Fructose, at a moderate dose, did not significantly elevate triglyceride compared with sucrose or sucralose and lowered the glucose iAUC. These results indicate that these sweeteners, at an equivalent sweetness, can be used in normal solid meals. Fructose showed a lower insulin response, which may be beneficial in the long term in individuals at risk of type 2 diabetes. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12615000279527. © 2016 American Society for Nutrition.

  3. A randomized, blinded, controlled and multi-centered field study comparing the efficacy and safety of Bravecto™ (fluralaner) against Frontline™ (fipronil) in flea- and tick-infested dogs

    PubMed Central

    2014-01-01

    Background Fluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs. Methods A randomized, investigator-blinded, multi-centered field study compared the flea- and tick-control efficacy for dogs over a 12-week period with either a single oral dose of Bravecto™ (fluralaner) formulated as a chewable tablet or with three sequential topical Frontline™ (fipronil) treatments. Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas. A total of 108 tick-infested dogs were treated with Bravecto™ (fluralaner) and 54 tick-infested dogs were treated with Frontline™ (fipronil). Dogs in 115 flea-infested households received Bravecto™ (fluralaner) and dogs in 61 flea-infested households received Frontline™ (fipronil). Flea and tick counts were conducted on all dogs at weeks 2, 4, 8, and 12 following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group. Additionally, the percentages of tick-free and flea-free households were determined. Results At weeks 2, 4, 8, and 12, Bravecto™ (fluralaner) flea-control efficacy in treated households was 99.2%, 99.8%, 99.8%, and 99.9% respectively, while Frontline™ (fipronil) efficacy was 94.1%, 93.0%, 96.0%, and 97.3%, respectively. Bravecto™ (fluralaner) tick-control efficacy on treated dogs at weeks 2, 4, 8, and 12 was 99.9%, 99.9%, 99.7%, and 100%, respectively, and Frontline™ (fipronil) tick efficacy was 97.6%, 93.8%, 100%, and 100%, respectively. Of dogs showing clinical flea allergy dermatitis (FAD) signs at the study start, 85.7% in the Bravecto™ (fluralaner)-treated group and 55.6% in the Frontline™ (fipronil)-treated group were evaluated at each time point as showing no clinical signs of FAD until study completion. Conclusions

  4. A randomized, blinded, controlled and multi-centered field study comparing the efficacy and safety of Bravecto (fluralaner) against Frontline (fipronil) in flea- and tick-infested dogs.

    PubMed

    Rohdich, Nadja; Roepke, Rainer K A; Zschiesche, Eva

    2014-03-04

    Fluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs. A randomized, investigator-blinded, multi-centered field study compared the flea- and tick-control efficacy for dogs over a 12-week period with either a single oral dose of Bravecto (fluralaner) formulated as a chewable tablet or with three sequential topical Frontline (fipronil) treatments. Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas. A total of 108 tick-infested dogs were treated with Bravecto (fluralaner) and 54 tick-infested dogs were treated with Frontline (fipronil). Dogs in 115 flea-infested households received Bravecto (fluralaner) and dogs in 61 flea-infested households received Frontline (fipronil). Flea and tick counts were conducted on all dogs at weeks 2, 4, 8, and 12 following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group. Additionally, the percentages of tick-free and flea-free households were determined. At weeks 2, 4, 8, and 12, Bravecto (fluralaner) flea-control efficacy in treated households was 99.2%, 99.8%, 99.8%, and 99.9% respectively, while Frontline (fipronil) efficacy was 94.1%, 93.0%, 96.0%, and 97.3%, respectively. Bravecto (fluralaner) tick-control efficacy on treated dogs at weeks 2, 4, 8, and 12 was 99.9%, 99.9%, 99.7%, and 100%, respectively, and Frontline (fipronil) tick efficacy was 97.6%, 93.8%, 100%, and 100%, respectively. Of dogs showing clinical flea allergy dermatitis (FAD) signs at the study start, 85.7% in the Bravecto™ (fluralaner)-treated group and 55.6% in the Frontline (fipronil)-treated group were evaluated at each time point as showing no clinical signs of FAD until study completion. Bravecto (fluralaner) administered once orally to dogs in a chewable

  5. An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia.

    PubMed

    Huang, Xinfang; Du, Hui; Gu, Jieruo; Zhao, Dongbao; Jiang, Lindi; Li, Xinfu; Zuo, Xiaoxia; Liu, Yi; Li, Zhanguo; Li, Xiangpei; Zhu, Ping; Li, Juan; Zhang, Zhiyi; Huang, Anbin; Zhang, Yuanchao; Bao, Chunde

    2014-07-01

    Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia. Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of <6.0 mg/dL at the last three monthly measurements. The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol (P < 0.0001) and febuxostat 40 mg (P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non-inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups. The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  6. The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: multicenter, randomized, double blind, placebo controlled trial.

    PubMed

    Park, Dae-Myung; Kim, Seok-Hwan; Park, Yang-Chun; Kang, Wee-Chang; Lee, Sang-Ryong; Jung, In-Chul

    2014-12-02

    Gamisoyo-San (GSS) is a well-known Traditional Korean Medicine shown to be effective on mood disorders. The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations. Multicenter, randomized, double-blinded, placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010. They were given Gamisoyo-San individual extract mixture (extraction done for each crude materia medica separately) or Gamisoyo-San multi-compound extract (extraction done for whole materia medica at once) or controlled medication. Hamilton Rating Scale for Anxiety (HAM-A), Korean State-Trait Anxiety Inventory (K-STAI), Penn State Worry Questionnaire (PSWQ), Korean Beck Depression Inventroy (K-BDI), Symptom Checklist-90-Revised (SCL-90-R), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were evaluated. We also applied Pattern Identification tool for 'JingJi and ZhengChong (, Traditional Korean Medicine term which correlates with generalized anxiety disorder)' to patients to evaluate different responses among 9 patterns. HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group, but the difference was insignificant. WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group. In Heart blood deficiency pattern, the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group. Gamisoyo-San did not improve anxiety level of GAD patients. However, it can be useful to improve quality of life, and reduce depressive, obsessive-compulsive, somatic symptoms of generalized anxiety disorder. Gamisoyo-San multi-compound seemed more effective than

  7. Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial.

    PubMed

    Calon, Tim G A; van Hoof, Marc; van den Berge, Herbert; de Bruijn, Arthur J G; van Tongeren, Joost; Hof, Janny R; Brunings, Jan Wouter; Jonhede, Sofia; Anteunis, Lucien J C; Janssen, Miranda; Joore, Manuela A; Holmberg, Marcus; Johansson, Martin L; Stokroos, Robert J

    2016-11-09

    Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma. A multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation. This is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft

  8. Comparing Brief Internet-Based Compassionate Mind Training and Cognitive Behavioral Therapy for Perinatal Women: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Stanley, Meagan L; Barrera, Alinne Z; Cree, Michelle; Heineberg, Yotam; Gilbert, Paul

    2016-01-01

    Background Depression that occurs during the perinatal period has substantial costs for both the mother and her baby. Since in-person care often falls short of meeting the global need of perinatal women, Internet interventions may function as an alternate to help women who currently lack adequate access to face-to-face psychological resources. However, at present there are insufficient empirically supported Internet-based resources for perinatal women. Objective The aim of this study is to compare the relative efficacy of Internet-based cognitive behavioral therapy (CBT) to a novel Internet-based compassionate mind training approach (CMT) across measures of affect, self-reassurance, self-criticizing, self-attacking, self-compassion, depression, and anxiety. While CBT has been tested and has some support as an Internet tool for perinatal women, this is the first trial to look at CMT for perinatal women over the Internet. Methods Participants were recruited through Amazon Mechanical Turk (MTurk) and professional networks. Following completion of demographic items, participants were randomly assigned to either the CBT or CMT condition. Each condition consisted of 45-minute interactive didactic and follow-up exercises to be completed over the course of two weeks. Results Post course data was gathered at two weeks. A 2x2 repeated measures analysis of variance will be conducted to analyze differences between conditions at post course. Conclusions The implications of the trial will be discussed as well as the strengths and limitations of MTurk as a tool for recruitment. We will also briefly introduce the future directions along this same line of research. Trial Registration ClinicalTrials.gov NCT02469324; https://clinicaltrials.gov/ct2/show/NCT02469324 (Archived by WebCite at http://www.webcitation.org/6fkSG3yuW) PMID:27084301

  9. Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction.

    PubMed

    Marechal, C; Berthiller, J; Tosetti, S; Cogniat, B; Desombres, H; Bouvet, L; Kassai, B; Chassard, D; de Queiroz Siqueira, M

    2017-02-01

    The operating theatre, anaesthesia induction and separation from parents create fear and anxiety in children. Anxiety leads to adverse behavioral changes appearing and sometimes persisting during the post