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Sample records for randomized comparative study

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes: The Triabetes Study

    PubMed Central

    Courcoulas, Anita P.; Goodpaster, Bret H.; Eagleton, Jessie K; Belle, Steven H.; Kalarchian, Melissa A.; Lang, Wei; Toledo, Frederico G. S.; Jakicic, John M.

    2014-01-01

    IMPORTANCE Address unanswered questions about the role of bariatric surgery for people with diabetes. OBJECTIVE Determine feasibility of a randomized controlled trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating type 2 diabetes mellitus in grade 1 and 2 obese participants. DESIGN, SETTING, PARTICIPANTS A 12-month, 3-arm RCT at a single center including 69 participants age 25–55 years, BMI 30–40 with type 2 diabetes. INTERVENTIONS Two surgical procedures; Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric band (LAGB) and an intensive lifestyle weight loss intervention (LWLI). MAIN OUTCOMES AND MEASURES Primary outcomes in the intention to treat (ITT) cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control. RESULTS 667 potential participants were screened of whom 69 (10.3%) were randomized, 30 (43.5%) with grade 1 obesity. Mean age was 47.3±6.4 years, 81% were women, and mean glycated hemoglobin was 7.9±2.0. After randomization, 7 (10%) participants refused to undergo their allocated intervention (3 RYGB, 1 LAGB, 3 LWLI) and 1 RYGB was excluded for current smoking. Twenty subjects underwent RYGB, 21 LAGB, and 20 LWLI with retention at 12 months of 90%, 86%, and 70%, respectively. In the ITT cohort with multiple imputation for missing data, RYGB participants had the greatest weight loss compared to LAGB and LWLI with average weight loss of 27%, 17%, 10% from baseline, respectively (p<.0001). Partial/complete remission of diabetes was 50%/17% in RYGB, 27%/23% in LAGB and 0%/0% in LWLI (p=.0005/.047, partial/complete) and there were significant reductions in medication usage in both surgical groups. There were no deaths and 3 serious adverse events; 1 RYGB ulcer was treated medically and 2 LAGB were re-hospitalized for dehydration. CONCLUSIONS This study highlights several potential challenges to successfully completing a larger RCT for

  7. Randomized study comparing postoperative pain between coblation and bipolar scissor tonsillectomy.

    PubMed

    Hasan, Hanna; Raitiola, Hannu; Chrapek, Wojciech; Pukander, Juhani

    2008-07-01

    Coblation tonsillectomy has shown promising results with respect to postoperative pain when compared with other techniques. Our study was designed to compare this technique with bipolar scissor tonsillectomy. Forty adult patients with a history of chronic or recurrent tonsillitis referred for standard tonsillectomy were recruited and randomized into two groups. Twenty were operated with Coblator and 20 with bipolar scissors. Exclusion criteria were a history of quinsy, bleeding disorder, or any major health problems. All participants completed the study. Postoperative pain, return to normal diet, and estimated need for sick leave were utilized as parameters. Data on operative time, difficulty of tissue removal, and hemostasis were also analyzed. Operative time was longer (P < 0.001) and tissue removal as well as hemostasis control were more difficult (P = 0.005, P = 0.013) with Coblator than with bipolar scissors. Participants in Coblator group assessed higher pain scores 1 and 3 h postoperatively (P = 0.044, P = 0.036). From the time of extubation, patients had access to an opioid (fentanyl) via a self-controlled analgesia device. The number of doses of analgesics needed during the hospital stay was significantly higher in the Coblator group (P = 0.020). During the 14-day follow-up, no significant differences were found in pain scores, return to solid food or subjective working ability between the groups. Considering the overall outcome of the patients the results did not favor coblation technique over bipolar scissors.

  8. 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

  9. Coblation vs. Electrocautery Tonsillectomy: A Prospective Randomized Study Comparing Clinical Outcomes in Adolescents and Adults

    PubMed Central

    Hong, Sung-Moon; Cho, Jae-Gu; Chae, Sung Won; Lee, Heung-Man

    2013-01-01

    Objectives Coblation is operated in low temperature, so it is proposed that tonsillectomy with coblation involves less postoperative pain and allows accelerated healing of the tonsillar fossae compared with other methods involving heat driven processes. However, the results of the previous studies showed that the effect of coblation tonsillectomy has been equivocal in terms of postoperative pain and hemorrhage. Though, most of the previous studies which evaluated coblation tonsillectomy were performed in children. Recently, electrocautery tonsillectomy has been used most widely because of the reduced intraoperative blood loss and shorter operative time compared to other techniques. This prospective study compared intraoperative records and postoperative clinical outcomes in adolescents and adults following coblation and electrocautery tonsillectomies. Methods Eighty patients over 16 years of age with histories of recurrent tonsillitis were enrolled. The patients were randomly allocated into coblation (n=40) and electrocautery tonsillectomy groups (n=40). All operations were performed by one surgeon who was skilled in both surgical techniques. Intraoperative parameters and postoperative outcomes were checked. Results Postoperative pain and otalgia were not significantly different between the two groups; however, there was a tendency towards reduced pain and otalgia in the coblation group. More cotton balls for swabbing the operative field were used introoperatively in the electrocautery group (P=0.00). There was no significant difference in postoperative hemorrhage, wound healing, commencement of a regular diet, and foreign body sensation between the groups. Conclusion Only cotton use, which represented the amount of blood loss, was less in the coblation tonsillectomy group. Coblation tonsillectomy warrants further study with respect to the decreased postoperative pain and otalgia. PMID:23799166

  10. 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

  11. Airtraq, LMA CTrach and Macintosh Laryngoscopes in Tracheal Intubation Training: A Randomized Comparative Manikin Study

    PubMed Central

    Saraçoğlu, Ayten; Dal, Didem; Baygın, Ömer; Göğüş, Fevzi Yılmaz

    2016-01-01

    Objective Training students on simulators before allowing their direct contact with patients is well accepted. There is no clinical or manikin-based simulation study in the literature comparing tracheal intubation with Airtraq, laryngeal mask airway (LMA) CTrach and Macintosh laryngoscopes performed by medical students having no prior intubation experience. Methods After obtaining written informed consents, 123 participants were included in the study. The participants were asked to intubate the manikin five times with each device randomly. After all the participants had completed their fifth intubations, the measurements were performed. The primary outcome variables were the first-attempt success rate and the time for a successful intubation, while the secondary outcome variables were to determine the scores of dental trauma, the difficulty visual analogue scale and the optimization manoeuvres. Results The LMA CTrach group revealed a significantly higher number of intubation attempts. The mean time for a successful intubation was the longest in the LMA CTrach group (17.66±8.22 s, p<0.05). Students defined the Airtraq as the easiest to use and the Macintosh laryngoscope as the most difficult device to use and learn. Dental trauma severity was significantly lower in the Airtraq group than in the other groups (p<0.05), and it was found to be 0 in 81.1% in the Airtraq group. The head extension optimization manoeuvre rate was significantly higher with the Macintosh laryngoscope than with the Airtraq laryngoscope (p<0.05). Conclusion This study, in which different types of laryngoscopes were compared, revealed that the Airtraq laryngoscope has advantages, such as shorter intubation duration, less additional optimization manoeuvres, less dental trauma intensity and is easier to learn compared with the LMA CTrach and Macintosh laryngoscopes. PMID:27366562

  12. Comparative effect of triamcinolone, nedocromil and montelukast on asthma control in children: A randomized pragmatic study.

    PubMed

    Stelmach, Iwona; Majak, Pawel; Jerzynska, Joanna; Stelmach, Wlodzimierz; Kuna, Piotr

    2004-08-01

    Asthma severity can be judged by measurements of symptoms, lung function, and medication requirements. The objective was to compare the effect of a 4-wk monotherapy with low-dose triamcinolone, montelukast and nedocromil on asthma control, lung function, eosinophil blood count, and bronchial hyper-reactivity in children with mild to moderate asthma allergic to dust mite. Two hundred fifty-six children, aged 6-18 yr, with mild to moderate asthma, participated in an 8-wk study. This was a three-arm, randomized no blinding or placebo pragmatic trial comparing the effect of triamcinolone acetonide (400 microg/day), inhaled nedocromil and montelukast sodium on clinical parameters of asthma [score, forced expiratory volume in 1 s (FEV(1))], PC20H, and eosinophil blood count. Two hundred forty-six children completed the study. After 4 wk of treatment with triamcinolone and montelukast, FEV(1) and PC20H significantly increased, and mean total symptoms score and mean number of eosinophil count in serum significantly decreased. Triamcinolone had a stronger effect on PC20H than montelukast. Nedocromil improved total asthma symptoms score and lung function. There was a reduction in the daytime and night-time symptom scores after treatment with all three drugs. Triamcinolone and montelukast had a stronger effect on asthma symptoms than nedocromil. There were statistically significant differences in reduction of nocturnal asthma symptoms between the triamcinolone and nedocromil groups (p < 0.001) and between montelukast and nedocromil (p = 0.001) groups, but not between the triamcinolone and montelukast groups. There was a reduction in beta-agonists use after treatment with all three drugs, with the strongest effect of triamcinolone. The study showed the strongest effect of low-dose inhaled steroids on clinical symptoms, lung function, bronchial hyper-reactivity and eosinophil blood count when compared to other asthma medications.

  13. 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

  14. RANDOMIZED PROSPECTIVE STUDY COMPARING TRANSVERSE AND EXTRACORTICAL FIXATION IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

    PubMed Central

    da Silva Guarilha, Eduardo; de Andrade Fígaro Caldeira, Paulo Roberto; de Almeida Lira Neto, Ozorio; Navarro, Marcelo Schmidt; Milani, Antonio; Filho, Mario Carneiro

    2015-01-01

    Objective: This study had the objective of prospectively comparing transverse fixation (Cross-Pin™) with extracortical fixation (EZLoc™) for the femur, in surgical reconstruction of the anterior cruciate ligament, from a clinical, biomechanical and functional point of view. Methods: Between April 2007 and November 2009, 50 patients with acute or chronic anterior cruciate ligament injuries underwent arthroscopic reconstruction using the homologous flexor tendons (gracilis and semitendinosus). Randomization of the femoral fixation method was done by means of a draw at the time of the procedure. Patients were excluded if they presented multiple ligament lesions, fractures, previous surgery, autoimmune disease and impairment of the contralateral knee. The Lysholm scale, SF36 quality-of-life questionnaire and KT1000™ arthrometer were used. Results: After a mean follow-up of 18.1 months, there were no statistically significant differences between the groups regarding the Lysholm scale and KT1000™ measurements. However, the SF36 questionnaire showed a statistical difference such that transverse fixation was superior regarding pain and vitality. Conclusion: Both techniques were shown to be efficient for transfemoral fixation, but with almost no statistically significant difference between them. We believe that new studies will be necessary for better understanding of these differences. PMID:27042646

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

    PubMed Central

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

    2016-01-01

    Objective 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). Method Participants included 86 toddlers (range 22 – 36 months) with ASD and their primary caregiver. Caregiver-child dyads were randomized to receive ten 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 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 six-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. Conclusions 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 # NCT00999778. PMID:25822242

  16. A comparative study of Gaussian geostatistical models and Gaussian Markov random field models1

    PubMed Central

    Song, Hae-Ryoung; Fuentes, Montserrat; Ghosh, Sujit

    2008-01-01

    Gaussian geostatistical models (GGMs) and Gaussian Markov random fields (GM-RFs) are two distinct approaches commonly used in spatial models for modeling point referenced and areal data, respectively. In this paper, the relations between GGMs and GMRFs are explored based on approximations of GMRFs by GGMs, and approximations of GGMs by GMRFs. Two new metrics of approximation are proposed: (i) the Kullback-Leibler discrepancy of spectral densities and (ii) the chi-squared distance between spectral densities. The distances between the spectral density functions of GGMs and GMRFs measured by these metrics are minimized to obtain the approximations of GGMs and GMRFs. The proposed methodologies are validated through several empirical studies. We compare the performance of our approach to other methods based on covariance functions, in terms of the average mean squared prediction error and also the computational time. A spatial analysis of a dataset on PM2.5 collected in California is presented to illustrate the proposed method. PMID:19337581

  17. A randomized control study comparing the pharyngolaryngeal morbidity of laryngeal mask airway versus endotracheal tube

    PubMed Central

    Venugopal, A.; Jacob, Ron Mathew; Koshy, Rachel Cherian

    2016-01-01

    Introduction: Endotracheal tube (ETT) has been associated with various pharyngolaryngeal morbidities (PLMs) following general anesthesia (GA). Laryngeal mask airway (LMA), currently the most commonly used supraglottic airway device, has several advantageous over the ETT but has been associated with varying results of PLM. The aim of our study was to compare the PLM between them and to know whether LMA is a better alternative. Materials and Methods: One hundred and seventy American Society of Anesthesiologists Grades 1 and 2 women scheduled for elective mastectomy were included in the study, 85 each in either group, E Group (intubated with ETT) and L Group (using LMA) on a random basis. All patients received GA with controlled ventilation using a muscle relaxant. PLMs such as hoarseness, pain on phonation, sore throat, and difficulty in swallowing were documented by an interview done postoperatively. Peroperative parameters such as intubation attempts, trauma during airway device insertion, and intraoperative incidents were also analyzed. A sample size of 85 patients in each group was calculated in order to achieve a study power of 0.8 and alpha level was taken as 0.05. Data were analyzed using SPSS version 16 using Chi-square test, Mann–Whitney U-test and Fisher's exact test were used as nonparametric tests. A two-tailed P< 0.05 was considered significant. Results: Patients in E Group had statistically significant increased incidence of a sore throat and voice complaints whereas L Group showed a statistically significant increase of swallowing problems. There was also a significant correlation between traumatic insertion and sore throat, pain on swallowing in the L Group, which could be due to direct trauma. Conclusions: ETT was associated with an increased incidence of voice problems and sore throat whereas LMA had an increased incidence of dysphagia and odynophagia. Use of LMA changes the pharyngolaryngeal profile to a more acceptable one. PMID:27212745

  18. 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.

  19. 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

  20. 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…

  1. A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer.

    PubMed

    Lin, Ying; Liu, Jianlun; Zhang, Xiaohua; Li, Li; Hu, Rui; Liu, Jian; Deng, Yongchuan; Chen, Dedian; Zhao, Yangbing; Sun, Shengrong; Ma, Rong; Zhao, Ying; Liu, Jinping; Zhang, Yang; Wang, Xijing; Li, Yafen; He, Pingqing; Li, Enxiao; Xu, Zheli; Wu, Yaqun; Tong, Zhongsheng; Wang, Xiaojia; Huang, Tao; Liang, Zhongxiao; Wang, Shui; Su, Fengxi; Lu, Yunfei; Zhang, Helong; Feng, Guosheng; Wang, Shenming

    2014-09-01

    Tamoxifen and anastrozole are widely used as adjuvant treatment for early stage breast cancer, but their hepatotoxicity is not fully defined. We aimed to compare hepatotoxicity of anastrozole with tamoxifen in the adjuvant setting in postmenopausal breast cancer patients. Three hundred and fifty-three Chinese postmenopausal women with hormone receptor-positive early breast cancer were randomized to anastrozole or tamoxifen after optimal primary therapy. The primary end-point was fatty liver disease, defined as a liver-spleen ratio <0.9 as determined using a computed tomography scan. The secondary end-points included abnormal liver function and treatment failure during the 3-year follow up. The cumulative incidence of fatty liver disease after 3 years was lower in the anastrozole arm than that of tamoxifen (14.6% vs 41.1%, P < 0.0001; relative risk, 0.30; 95% CI, 0.21-0.45). However, there was no difference in the cumulative incidence of abnormal liver function (24.6% vs 24.7%, P = 0.61). Interestingly, a higher treatment failure rate was observed in the tamoxifen arm compared with anastrozole and median times to treatment failure were 15.1 months and 37.1 months, respectively (P < 0.0001; HR, 0.27; 95% CI, 0.20-0.37). The most commonly reported adverse events were 'reproductive system disorders' in the tamoxifen group (17.1%), and 'musculoskeletal disorders' in the anastrozole group (14.6%). Postmenopausal women with hormone receptor-positive breast cancer receiving adjuvant anastrozole displayed less fatty liver disease, suggesting that this drug had a more favorable hepatic safety profile than tamoxifen and may be preferred for patients with potential hepatic dysfunction.

  2. 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…

  3. 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.

  4. Mobile bearing UKA compared to fixed bearing TKA: a randomized prospective study.

    PubMed

    Sun, Peng-Fei; Jia, Yu-Hua

    2012-03-01

    We prospectively evaluated a consecutive series of 56 patients with unicompartmental knee arthritis who underwent unicompartmental knee replacement or total knee arthroplasty and received an average of 52months of follow-up. These patients were enrolled in a prospective randomized clinical trial. There were no significant differences in the pre-operative parameters of both groups. All the patients were followed up and evaluated preoperatively and yearly, the data was collected and statistical analysis was performed. At an average of 52months after surgery the mean Knee Society score was 80.5 (range: 70-100) and 78.9 (range: 70-87) for Unicompartmental knee replacement and total knee arthroplasty, mean range of postoperative motion for TKA is 115(0)±4(0) and 117(0)±7(0) for the group of UKA, with the numbers available, the difference between the two groups could not be shown to be significant. The average operation time of UKA and TKA is 68.8min and 81.5min(p<0.01). Blood drainage after operation had a significant difference between the two groups (p<0.01). Seven cases of UKA were converted to total knee arthroplasty - all of them within the first 2years of starting the procedure and all of them in relatively young patients. From the study we concluded that mobile bearing UKA can obtain similar clinical effect with TKA by surgeons who have the adequate training and experience. After the learning curve UKA should be considered the primary treatment option for unicompartmental knee arthritis.

  5. 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.

  6. 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

  7. [Sleep disorders in Parkinson's disease without dementia: a comparative randomized controlled study of melatonin and clonazepam].

    PubMed

    Litvinenko, I V; Krasakov, I V; Tikhomirova, O V

    2012-01-01

    We studied 38 patients with Parkinson's disease (PD) without dementia (mean age, 67.3±4.8 years; 15 males, 23 females) with complaints on sleep disorders. Quality of sleep was assessed with the Parkinson's disease sleep scale (PDSS) and the Epworth Sleepiness Scale (ESS) as well as with overnight polysomnographic (PSG) study at baseline and at the end of the trial. The effectiveness of sleep was estimated as TST/TIB x100% (TIB - habitual time in bed, TST - habitual total sleeping time). REM latency (LREM), periodic limb movements (PLM) (total number and sleep index) were measured as well. All patients underwent neuropsychological testing using MMSE, five-word test, digit span and the Hamilton scale (HAM-D). Patients were allocated to 2 groups. Group 1 (n=20) received melatonin in addition to the previous dopaminergic treatment in dose 3 mg 30 minutes before bedtime for 6 weeks, group 2 (n=18) received clonazepam 2 mg at night (with gradual titration over 4 weeks from 0,5 mg). Compared to baseline, melatonin and clonazepam reduced sleep disorders in patients: PDSS scores from 89.9±8.9 to 129.5±9.4 (p=0.0001) and from 91.0±8.7 to 110.1±12.4 scores (p=0.03), respectively. However, the daytime sleepiness (ESS) was significantly increased (from 3.8±1.2 to 7.3±2.2 scores; p=0.0002) in the clonazepam group. In the melatonin group, ESS scores were 4.1±1.4 before treatment and 4.7±1.4 after treatment (p=0.06). Patients treated with melatonin had better scores on the MMSE (p=0.00009), five-word test (p=0.009), Hamilton scale (p=0.00009) at the end of the study period as compared with the clonazepam group. Changes in total point scores on the PSG at the end of week 6, as compared with the beginning of the trial, were in favor of the group treated with melatonin, with significant changes in the LS (p=0.004), total sleep time/time in bad (TST/TIB) (p=0,001) sections. The number of REM sleep epochs remained lower in patients treated with clonazepam (p=0.0001). The data

  8. 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. PMID:24471459

  9. 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.

  10. 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

  11. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness

    PubMed Central

    Cohen, Steven P.; Peterlin, B. Lee; Fulton, Larry; Neely, Edward T.; Kurihara, Connie; Gupta, Anita; Mali, Jimmy; Fu, Diana C.; Jacobs, Michael B.; Plunkett, Anthony R.; Verdun, Aubrey J.; Stojanovic, Milan P.; Hanling, Steven; Constantinescu, Octav; White, Ronald L.; McLean, Brian C.; Pasquina, Paul F.; Zhao, Zirong

    2015-01-01

    Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline −2.743 ± 2.487 vs −1.377 ± 1.970; P <0.001), than the steroid group, which persisted through the 6-month follow-up. Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline−1.925 ± 3.204 vs−0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline −2.738 ± 2.753 vs −1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures. PMID:26447705

  12. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness.

    PubMed

    Cohen, Steven P; Peterlin, B Lee; Fulton, Larry; Neely, Edward T; Kurihara, Connie; Gupta, Anita; Mali, Jimmy; Fu, Diana C; Jacobs, Michael B; Plunkett, Anthony R; Verdun, Aubrey J; Stojanovic, Milan P; Hanling, Steven; Constantinescu, Octav; White, Ronald L; McLean, Brian C; Pasquina, Paul F; Zhao, Zirong

    2015-12-01

    Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline -2.743 ± 2.487 vs -1.377 ± 1.970; P < 0.001), than the steroid group, which persisted through the 6-month follow-up. Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline -1.925 ± 3.204 vs -0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline -2.738 ± 2.753 vs -1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures.

  13. 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…

  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. 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.

  16. Comparative study of amrutbhallataka and glucosamine sulphate in osteoarthritis: Six months open label randomized controlled clinical trial

    PubMed Central

    Raut, Ashwinikumar; Bichile, Lata; Chopra, Arvind; Patwardhan, Bhushan; Vaidya, Ashok

    2013-01-01

    Background: AmrutBhallatak (ABFN02), a ‘rasayana’ drug from Ayurveda is indicated in degenerative diseases and arthritis. Objective: To evaluate safety and efficacy of ABFN02 in osteoarthritis (OA) and compare it with Glucosamine sulphate (GS) Materials and Methods: This was a randomized open comparative study. Ambulant OPD patients of OA knees (n = 112) were enrolled for 24 weeks. Tablets (750mg each) of GS and ABFN02 were matched. Three groups of patients: (A) GS, one tablet × twice/day × 24 weeks. (B) ABFN02, incremental pulse dosage (one tablet x twice/day × two weeks, two tablets × twice/day × two weeks, three tablets × twice/day × two weeks), two such cycles of drug and non-drug phases alternately for six weeks each (C) ABFN02 continuous dosage akin to GS. Pain visual analogue score (Pain-VAS) and Western Ontario and Mc-Master University Osteoarthritis Index (WOMAC) were the primary outcome measures. Secondary outcome measures were Health assessment questionnaire (HAQ), paracetamol consumption, 50 feet walking, physician and patient global assessment, knee stiffness, knee status, urinary CTX II, serum TNFa-SRI, SRII and MRI knee in randomly selected patients. Results: ABFNO2 and GS demonstrated, adherence to treatment 87.75% and 74.3%, reduction in Pain-VAS at rest 61.05% and 57.1%, reduction in pain-VAS on activity 57.4% and 59.8%, WOMAC score drop 62.8% and 59.1% respectively. Secondary outcome measures were comparable in all groups. Safety measures were also comparable. No serious adverse events reported. However, asymptomatic reversible rise in liver enzymes was noted in the ABFNO2 group. Conclusions: ABFN02 has significant activity in OA; the formulation needs further investigation. PMID:24459390

  17. 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.

  18. 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

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

    PubMed

    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

    2015-07-01

    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.

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

    PubMed Central

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

    2014-01-01

    Objective: 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. Materials and Methods: 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. Results: 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. Conclusion: 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. PMID:25395761

  1. A randomized controlled experimental study comparing chitosan coated polypropylene mesh and Proceed™ mesh for abdominal wall defect closure

    PubMed Central

    Jayanth, S.T.; Pulimood, Anna; Abraham, Deepak; Rajaram, A.; Paul, M.J.; Nair, Aravindan

    2015-01-01

    Background Abdominal wall defects and hernias are commonly repaired with synthetic or biological materials. Adhesions and recurrences are a common problem. A study was conducted to compare Chitosan coated polypropylene mesh and a polypropylene–polydioxanone composite with oxidized cellulose coating mesh (Proceed™) in repair of abdominal wall defect in a Rabbit hernia model. Methods A randomized controlled experimental study was done on twelve New Zealand white rabbits. A ventral abdominal defect was created in each of the rabbits. The rabbits were divided into two groups. In one group the defect was repaired with Chitosan coated polypropylene mesh and Proceed mesh™ in the other. The rabbits were operated in two phases. They were followed up at four weeks and twelve weeks respectively after which the rabbits were sacrificed. They were evaluated by open exploration and histopathological examination. Their efficacy in reducing adhesion and ability of remodeling and tissue integration were studied. Results There was no statistical significance in the area of adhesion, the force required to remove the adhesions, tissue integration and remodeling between Chitosan and Proceed™ group. Histological analysis revealed that the inflammatory response, fibrosis, material degradation and remodeling were similar in both the groups. There were no hernias, wound infection or dehiscence in any of the studied animals. Conclusion Chitosan coated polypropylene mesh was found to have similar efficacy to Proceed™ mesh. Chitosan coated polypropylene mesh, can act as an anti adhesive barrier when used in the repair of incisional hernias and abdominal wall defects. PMID:26594357

  2. 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

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

    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

  4. A prospective randomized control study comparing classic laryngeal mask airway with Guedel's airway for tracheal tube exchange and smooth extubation

    PubMed Central

    Jain, Shruti; Nazir, Nazia; Khan, Rashid M.; Ahmed, Syed M.

    2016-01-01

    Introduction: Extubation in deep plane of anesthesia followed by Guedel's oropharyngeal airway (OPA™) insertion is a routine method to avoid hemodynamic changes associated with tracheal extubation. Exchange of endotracheal tube (ETT) with Classic laryngeal mask airway (LMA™) prior to emergence from anesthesia also serves similar purpose. We had compared the hemodynamic changes involved during this ETT/LMA™ and ETT/OPA™ exchange technique. Material and Methods: This was a randomized prospective study on ASA I and 2 patients undergoing elective surgery under general anesthesia. These patients were randomly divided into two groups i.e. OPA group and LMA group of 50 patients each. Hemodynamic parameters i.e. systolic blood pressure (SBP) and heart rate (HR) were recorded during exchange of ETT with OPA™ or LMA™. Coughing / bucking during removal of OPA™ and LMA™, and presence of post operative sore throat for both the groups were also graded and recorded. Data within the groups have been analyzed using paired “t” test while those between the groups were analyzed using unpaired “t” test. Chi square test was used to analyze grades of coughing and post operative sore throat. Results: In both groups, hemodynamic parameters rose significantly as OPA™/LMA™ was placed (P < 0.05) and then started declining. Hemodynamic parameters continued to fall in LMA group after extubation. However in OPA group, hemodynamic parameters continued to rise even after extubation and declined only when OPA™ was removed. There was no statistical significant difference between the LMA and OPA group in respect to coughing and post operative sore throat. Conclusion: LMA™ is superior to OPA™ for exchange of ETT as it provides greater hemodynamic stability. PMID:27746550

  5. 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

  6. Topical bupivacaine compared to bupivacaine infiltration for post-tonsillectomy pain relief in children: a prospective randomized controlled clinical study.

    PubMed

    Haksever, Mehmet; Özmen, Süay; Akduman, Davut; Solmaz, Fevzi

    2014-09-01

    The objective of this study is to compare the topical administration of bupivacaine hydrochloride, saline and bupivacaine hydrochloride infiltration on post-tonsillectomy pain in children. Sixty children undergoing tonsillectomy were enrolled in the study. Patients were randomized into three groups using sealed envelopes. Group 1 (n = 20) received topical 0.5 % bupivacaine hydrochloride, group 2 (n = 20) received topical 0.9 % NaCl (saline), and group 3 (n = 20) received 0.5 % bupivacaine hydrochloride infiltrated around each tonsil. Pain was evaluated using McGrath's face scale. Pain scores in topical bupivacaine hydrochloride group was significantly lesser than the topical saline group at 5th, 13th, 17th and 21st hours, until the 6th day (p < 0.017). Moreover, pain scores of topical bupivacaine hydrochloride group was superior to bupivacaine hydrochloride infiltration group at 5th, 13th, 17th hours and 2nd, 3rd, 4th and 5th day (p < 0.017). There were significantly lesser morbidities in topical bupivacaine hydrochloride than saline group in 1st and 4th day (p < 0.017). Topical administration of bupivacaine hydrochloride proved to provide more efficient pain control than bupivacaine hydrochloride infiltration.

  7. Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study.

    PubMed

    Shi, Yuan-Kai; Chen, Qiang; Zhu, Yun-Zhong; He, Xiao-Hui; Wang, Hua-Qing; Jiang, Ze-Fei; Chang, Jian Hua; Liu, Yun-Peng; Wang, An-Lan; Luo, De-Yun; Zhang, Yang; Ke, Xiao-Yan; Li, Wei-Lian; Zhang, Wei-Jing; Wang, Xiu-Wen; Zhang, Yi-Ping; Wang, Jian-Min; Liu, Xiao-Qing

    2013-07-01

    The purpose of this study was to compare the efficacy and safety of a single subcutaneous injection of pegylated filgrastim with daily filgrastim as a prophylaxis for neutropenia induced by commonly used chemotherapy regimens. Fifteen centers enrolled 337 chemotherapy-naive cancer patients with normal bone marrow function. All patients randomized into AOB and BOA arms received two cycles of chemotherapy. Patients received a single dose of pegylated filgrastim 100 µg/kg in cycle 1 (AOB) or cycle 2 (BOA) and daily doses of filgrastim 5 µg/kg/day in cycle 1 (BOA) or cycle 2 (AOB). Efficacy and safety parameters were recorded. The primary end point was the rate of protection against grade 4 neutropenia after chemotherapy [defined as the rate at which the absolute neutrophil count (ANC) remained >0.5×10(9)/l throughout the entire cycle]. Ninety-four percent of patients receiving pegylated filgrastim or filgrastim did not develop grade 4 neutropenia. The incidence of ANC<1.0×10(9)/l was 16.0% (50/313) after support with either pegylated filgrastim or filgrastim. The incidences of febrile neutropenia and antibiotic administration were similar in both groups. Notably, faster ANC recovery was observed with pegylated filgrastim support. The ANC nadir was also earlier with pegylated filgrastim (day 7) support than with filgrastim support (day 9), although the depth of nadir was not significantly different. A single subcutaneous injection of pegylated filgrastim 100 μg/kg provided adequate and safe neutrophil support comparable with daily subcutaneous injections of unmodified filgrastim 5 μg/kg/day in patients receiving commonly used standard-dose mild-to-moderate myelosuppressive chemotherapy regimens.

  8. 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

  9. A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia

    PubMed Central

    Manjunatha, R.; Pundarikaksha, H. P.; Madhusudhana, H. R.; Amarkumar, J.; Hanumantharaju, B. K.

    2016-01-01

    Objectives: Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting elderly males, often associated with lower urinary tract symptoms (LUTS). α1-blockers are the mainstay in symptomatic therapy of BPH. Because of their greater uroselectivity and minimal hemodynamic effects, alfuzosin, tamsulosin, and silodosin are generally preferred. The aim of this study was to compare the efficacy and tolerability of alfuzosin, tamsulosin, and silodosin in patients with BPH and LUTS. Methods: Ninety subjects with BPH and LUTS were randomized into three groups of thirty in each, to receive alfuzosin sustained release (SR) 10 mg, tamsulosin 0.4 mg, or silodosin 8 mg for 12 weeks. The primary outcome measure was a change in the International Prostate Symptom Score (IPSS), and the secondary outcome measures were changes in individual subjective symptom scores, quality of life score (QLS), and peak flow rate (Qmax) from baseline. The treatment response was monitored at 2, 4, 8, and 12 weeks. Results: IPSS improved by 88.18%, 72.12%, and 82.23% in alfuzosin SR, tamsulosin and silodosin groups (P < 0.001) at 12 weeks. Improvement in QLS was >75% in all the three groups (P < 0.001). A significant improvement in Qmax was seen with alfuzosin and tamsulosin (P = 0.025 and P < 0.001) but not with silodosin (P = 0.153). However, the intergroup differences in IPSS, QLS, and Qmax were not significant. Ejaculatory dysfunction was more common with silodosin and corrected QT (QTc) prolongation occurred only with alfuzosin (two subjects) and tamsulosin (three subjects). Conclusion: Alfuzosin, tamsulosin, and silodosin showed similar efficacy in improvement of LUTS secondary to BPH, with good tolerability, acceptability, and minimum hemodynamic adverse effects. Alfuzosin, tamsulosin, and silodosin are comparable in efficacy in symptomatic management of BPH. The occurrence of QTc prolongation in three subjects with tamsulosin in the present study is an unexpected adverse

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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

  16. Professional brushing study comparing the effectiveness of sonic brush heads with manual toothbrushes: a single blinded, randomized clinical trial.

    PubMed

    Pelka, Anna-Kristina; Nagler, Tonia; Hopp, Imke; Petschelt, Anselm; Pelka, Matthias Anton

    2011-08-01

    The aim of this study was to evaluate the plaque removal efficacy of four toothbrushes: the Philips Sonicare Elite with medium and mini brush heads, the Elmex Sensitive, and the American Dental Association (ADA) reference toothbrush. This study was a randomized, controlled, investigator-blinded, four-brush crossover design study, which examined plaque removal following a consecutive repeated use. All brushes were used on each participant in a randomly assigned quadrant of the mouth. A total of 90 subjects participated in the study. Prior to the experiment, they received a professional prophylaxis and were requested to refrain from toothbrushing for 48 h. Teeth were professionally brushed consecutively for 10 to 90 s per quadrant. A Turesky-modified Quigley Hein Index score was assessed at baseline and after each brushing interval by one blinded investigator. Results showed reduction of mean plaque scores for all brushes with time from 10 to 90 s. After 30 s (2-min whole mouth equivalent) of brushing, the Sonicare brushes cleaned 19, the ADA brush 16, and the Elmex Sensitive 10 of in average 28 tooth surfaces. With time, the number of additional cleaned surfaces decreased. Time is an important variable in the evaluation of plaque-removing efficacy since absolute efficacy increases with time and differs per toothbrush. No differences could be found between the two brush heads of the Sonicare.

  17. Truview EVO2 and standard Macintosh laryngoscope for tracheal intubation during cardiopulmonary resuscitation: a comparative randomized crossover study.

    PubMed

    Gaszynska, Ewelina; Gaszynski, Tomasz

    2014-09-01

    The aim of this study was to compare the performance of the Truview EVO2 laryngoscope in manikin-simulated cardiopulmonary resuscitation (CPR) and no-CPR scenarios with standard intubation technique. Participants performed 4 scenarios in random order: endotracheal intubation (ETI) using Macintosh laryngoscope (MCL), Truview EVO2 laryngoscope in no-CPR patient scenario, and intubation during uninterrupted chest compressions using both laryngoscopes. The participants were directed to make 3 attempts in each scenario. Primary outcomes were time to tracheal intubation (TTI) and intubation success, whereas secondary outcomes were cumulative success ratio and the number of esophageal intubation (EI). TTI and success ratios were reported per attempt. Thirty paramedics completed the study. Median TTI with Truview EVO2 with CPR was 36 (interquartile range [IQR] 29.00-52.00), 22.5 (IQR 18.33-35.00), and 18 (IQR 11.00-23.00) seconds; MCL with CPR was 23 (IQR 18.92-36.90), 16.8 (IQR 14.00-22.31), and 14.5 (IQR 11.12-16.36) seconds; Truview EVO2 without CPR was 28.6 (IQR 24.02-38.34), 21.7 (IQR 17.00-25.00), and 13 (IQR 11.90-17.79) seconds; MCL without CPR was 17 (IQR 13.23-22.29), 13 (IQR 12.09-15.26), and 12.4 (IQR 10.08-19.84) seconds for first, second, and third attempts, respectively. The P values for differences in TTI between Truview EVO2 and MCL were P < 0.0001, P = 0.0540, and P = 0.7550 in CPR scenario and P = 0.0080, P = 0.1570, and P = 0.7652 in no-CPR scenario for first, second, and third attempts, respectively. The success ratios for each of the scenarios were as follows: in CPR scenario it was 0.73 versus 0.53 (P = 0.0558), 0.83 versus 0.76 (P = 0.2633), and 1 versus 0.8 (P = 0.0058); in no-CPR scenario it was 0.63 versus 0.73 (P = 0.2068), 0.86 versus 0.86, and 0.97 versus 1 (P = 0.1637) for Truview EVO2 vs MCL in first, second, and third attempts, respectively. The cumulative success ratio related to the time of ETI

  18. Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol

    PubMed Central

    Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Habibi, Mojtaba; Bowen, Sarah; Noroozi, Alireza

    2015-01-01

    Background: In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. Patients and Methods: This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. Discussion: This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article. PMID:26251659

  19. A randomized comparative study of sulbactam plus ampicillin vs. metronidazole plus cefotaxime in the management of acute appendicitis in children.

    PubMed

    Foster, M C; Kapila, L; Morris, D L; Slack, R C

    1986-01-01

    Sulbactam is a beta-lactamase inhibitor that, when combined with ampicillin, gives the latter antibiotic a broad spectrum of activity, making it suitable for use as a prophylactic agent in acute appendicitis. In a single-blind, randomized trial, the efficacy of sulbactam plus ampicillin was compared with that of metronidazole plus cefotaxime. Thirty-five children undergoing appendectomy received intravenous sulbactam and ampicillin, while 38 children received metronidazole and cefotaxime. Single doses were given unless the appendix was considered gangrenous or perforated, in which case the drugs were administered for 72 hr. There were three wound infections in the group given sulbactam and ampicillin and five in the group given metronidazole and cefotaxime. The combination of sulbactam and ampicillin was well tolerated and appeared to be at least as effective as that of metronidazole and cefotaxime in the prevention of sepsis following appendectomy. PMID:3026017

  20. 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

  1. Open comparative, randomized controlled clinical study of a new immunostimulating bacterial lysate in the prophylaxis of upper respiratory tract infections.

    PubMed

    Macchi, Alberto; Vecchia, Laura Della

    2005-01-01

    One hundred and fourteen patients with a medical history of recurrent upper respiratory tract infections (at least four episodes in the year preceding this open comparative study) were randomly assigned to three groups of 38 patients each. The first group received, by sublingual route, Ismigen, a new immunostimulating lysate (Polivalent Mechanical Bacterial Lysate, PMBL) obtained by mechanical lysis of 48 billion bacteria commonly responsible for upper respiratory tract infections; the second group received an oral immunostimulating lysate (CLBL) obtained by chemical lysis of 36 billion bacteria. A third group served as control and did not receive any immunostimulating treatment (Control NT). One tablet a day of PMBL was given to the first group for the first ten days during three consecutive months; the patients of the second group received one capsule a day of CLBL with the same treatment schedule. At the end of the treatment period the patients of the 3 groups were followed up for 3 months. The primary end point was the number of acute upper respiratory tract infections (URTIs) that occurred during the three months of treatment and three months of follow-up. Secondary endpoints were: the number of patients free from disease, the duration of infectious episodes, the number of working days lost because of disease, the need for a concomitant antibiotic treatment, and the safety of the two treatments. During the treatment period the mean number (+/- SD) of URTIs per patient was 0.34 (0.48) in the PMBL group, 1.0 (0.83) and 1.23 (0.77) in the CLBL and Control NT groups, respectively. Results of PMBL treatment were significantly better (p < 0.05) than the results in the other two groups; CLBL was not significantly different from the control group. In the three months of follow-up, the mean number (+/- SD) of URTIs per patient was: 0.42 (0.55) in the PMBL group, 0.92 (0.67) in the CLBL group, and 1.55 (0.88) in the Control NT group. The PMBL group was significantly

  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. Randomized placebo-controlled study comparing a leukotriene receptor antagonist and a nasal glucocorticoid in seasonal allergic rhinitis.

    PubMed

    Pullerits, T; Praks, L; Skoogh, B E; Ani, R; Lötvall, J

    1999-06-01

    Allergic rhinitis is an inflammatory disorder associated with local leukotriene release during periods of symptoms. Therefore, it has been suggested that antileukotrienes may be beneficial in the treatment of this disease. Leukotriene receptor antagonists have recently become available for asthma treatment, but little is known of their effects on allergic rhinitis. We have evaluated the effects of the leukotriene receptor antagonist zafirlukast versus placebo in patients with allergic rhinitis during the grass pollen season, using the nasal glucocorticoid beclomethasone dipropionate (BDP) as a positive treatment control. Thirty-three patients with seasonal allergic rhinitis were in a double-blind, double-dummy fashion randomized to treatments with oral zafirlukast (20 mg twice a day), intranasal beclomethasone dipropionate (200 microg twice a day), or placebo. The treatment was initiated 3 wk prior to the expected beginning of the grass pollen season. Patients completed a daily symptom-score list for sneezing, rhinorrhea, nasal itch, and nasal blockage during the 50-d treatment period. Nasal biopsies for quantification of local tissue eosinophilia (immunohistochemistry; EG2) were taken 1 mo before initiation of treatment and immediately after the peak of grass pollen season. Patients receiving treatment with zafirlukast had degrees of nasal symptoms similar to those in the placebo group, whereas the BDP group had significantly less symptoms compared with both treatments (p = 0.01 and p = 0.005, respectively). The numbers of activated eosinophils in the nasal tissue increased significantly during the pollen season in both the zafirlukast and the placebo groups, but not in the BDP group. These results obtained with a limited number of patients do not support any clinical efficacy of regular treatment with an oral antileukotriene in seasonal allergic rhinitis but rather favor the use of a nasal glucocorticoid. PMID:10351924

  4. 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. PMID:26031764

  5. 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.

  6. 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

  7. Whole body vibration compared to conventional physiotherapy in patients with gonarthrosis: a protocol for a randomized, controlled study

    PubMed Central

    2010-01-01

    Background Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is generally higher than that of coxarthrosis. Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through either mobility or medication. Non-pharmacologic treatment is the first step, followed by the addition of analgesic medication, and ultimately by surgery. The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function, which in turn both prevents formation of and delays progression of OA. A modification of conventional physiotherapy, whole body vibration has been successfully employed for several years. Since its introduction, this therapy is in wide use at our facility not only for gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance. Methods/Design This study is a randomized, therapy-controlled trial in a primary care setting at a university hospital. Patients presenting to our outpatient clinic with initial symptoms of gonarthrosis will be assessed against inclusion and exclusion criteria. After patient consent, 6 weeks of treatment will ensue. During the six weeks of treatment, patients will receive one of two treatments, conventional physiotherapy or whole-body-vibration exercises of one hour three times a week. Follow-up examinations will be performed immediately after treatment and after another 6 and 20 weeks, for a total study duration of 6 months. 20 patients will be included in each therapy group. Outcome measurements will include objective analysis of motion and ambulation as well as examinations of balance and isokinetic force. The Western Ontario and McMaster Universities Arthritis Index and SF-12 scores, the patients' overall status, and clinical examinations of the affected joint will be carried out. Discussion As new physiotherapy techniques develop for the

  8. 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

  9. 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

  10. 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

  11. [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.

  12. [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. PMID:12611200

  13. 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

  14. Randomized Comparative Study of the Serum Antihemagglutinin and Antineuraminidase Antibody Responses to Six Licensed Trivalent Influenza Vaccines

    PubMed Central

    Couch, Robert B.; Atmar, Robert L.; Keitel, Wendy A; Quarles, John; Wells, Janet; Arden, Nancy; Niño, Diane

    2012-01-01

    Background Serum antibody to the hemagglutinin (HA) surface protein of influenza virus induced by influenza vaccinations is a correlate of protection against influenza. The neuraminidase (NA) protein is also on the surface of the virus; antibody to it has been shown to impair virus release from infected cells and to reduce the intensity of influenza infections in animal models and in humans challenged with infectious virus. Recently we have shown that NA inhibiting antibody can independently contribute to immunity to naturally-occurring influenza immunity in the presence of antibody to the HA. Purpose The present study was conducted to evaluate induction of antibody to the NA and the HA by commercially available influenza vaccines. Methods Healthy young adults were vaccinated with one of five commercially available trivalent inactivated vaccines or live influenza vaccine. Frequencies of serum antibody and fold geometric mean titer (GMT) increases four weeks later were measured to each of the three vaccine viruses (A/H1N1, A/H3N2, B) in hemagglutination-inhibition (HAI) and neutralization (neut) assays. Frequency and fold GMT increase in neuraminidase-inhibition (NI) antibody titers were measured to the influenza A viruses (A/H1N1, A/H3N2). Results No significant reactogenicity occurred among the vaccinated subjects. The Fluvirin inactivated vaccine induced more anti-HA antibody responses and a higher fold GMT increase than the other inactivated vaccines but there were no major differences in response frequencies or fold GMT increase among the inactivated vaccines. Both the frequency of antibody increase and fold GMT increase were significantly lower for live vaccine than for any inactivated vaccine in HAI and neut assays for all three vaccine viruses. Afluria inactivated vaccine induced more N1 antibody and Fluarix induced more N2 antibody than the other vaccines but all inactivated vaccines induced serum NI antibody. The live vaccine failed to elicit any NI

  15. 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

  16. Treatment of post-transplant premalignant skin disease: a randomized intrapatient comparative study of 5-fluorouracil cream and topical photodynamic therapy

    PubMed Central

    Perrett, C.M.; McGregor, J.M.; Warwick, J.; Karran, P.; Leigh, I.M.; Proby, C.M.; Harwood, C.A.

    2008-01-01

    Summary Background Organ transplant recipients (OTR) are at high risk of developing non-melanoma skin cancer and premalignant epidermal dysplasia (carcinoma in situ/Bowen’s disease and actinic keratoses). Epidermal dysplasia is often widespread and there are few comparative studies of available treatments. Objectives To compare topical methylaminolaevulinate (MAL) photodynamic therapy (PDT) with topical 5% fluorouracil (5-FU) cream in the treatment of post-transplant epidermal dysplasia. Methods Eight OTRs with epidermal dysplasia were recruited to an open-label, single-centre, randomized, intrapatient comparative study. Treatment with two cycles of topical MAL PDT 1 week apart was randomly assigned to one area of epidermal dysplasia, and 5-FU cream was applied twice daily for 3 weeks to a clinically and histologically comparable area. Patients were reviewed at 1, 3 and 6 months after treatment. The main outcome measures were complete resolution rate (CRR), overall reduction in lesional area, treatment-associated pain and erythema, cosmetic outcome and global patient preference. Results At all time points evaluated after completion of treatment, PDT was more effective than 5-FU in achieving complete resolution: eight of nine lesional areas cleared with PDT (CRR 89%, 95% CI: 0·52-0·99), compared with one of nine lesional areas treated with 5-FU (CRR 11%, 95% CI: 0·003-0·48) (P = 0·02). The mean lesional area reduction was also proportionately greater with PDT than with 5-FU (100% vs. 79% respectively). Cosmetic outcome and patient preference were also superior in the PDT-treated group. Conclusions Compared with topical 5-FU, MAL PDT was a more effective and cosmetically acceptable treatment for epidermal dysplasia in OTRs and was preferred by patients. Further studies are now required to confirm these results and to examine the effect of treating epidermal dysplasia with PDT on subsequent development of squamous cell carcinoma in this high risk population

  17. 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

  18. 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

  19. A Prospective, Randomized Comparative Study of Patient Perceptions and Preferences of Two Types of Indwelling Voice Prostheses

    ERIC Educational Resources Information Center

    Hancock, Kelli; Ward, Elizabeth; Lawson, Nadine; van As-Brooks, Corina J.

    2012-01-01

    Background: Technical and device life issues are frequently the focus of post-laryngectomy rehabilitation studies examining indwelling voice prostheses. Patient perceptions and preferences are considered less often. Aims: To determine patient perceptions of two indwelling voice prostheses across parameters relating to device use and maintenance…

  20. Survival in patients with metastatic breast cancer: analysis of randomized studies comparing oral aromatase inhibitors versus megestrol.

    PubMed

    Messori, A; Cattel, F; Trippoli, S; Vaiani, M

    2000-10-01

    In patients with metastatic breast cancer, second-line therapy with aromatase inhibitors can improve survival in comparison with megestrol. We conducted a meta-analysis to assess the effectiveness of aromatase inhibitors versus megestrol. After a Medline search, three trials (evaluating letrozole, anastrozole or exemestane versus megestrol) were included in the survival meta-analysis. Our methodology retrieved patient-level information on survival. In comparison with megestrol, aromatase inhibitors prolonged survival at levels of statistical significance (relative death risk for oral aromatase inhibitors=0.79, 95% confidence interval 0.69-0.91; p=0.0011). A lifetime analysis of the pooled survival curves of aromatase inhibitors versus megestrol found a mean survival gain of 4.1 months per patient. Aromatase inhibitors confer a significant survival benefit to patients with metastatic breast cancer as compared with megestrol. A preliminary calculation of the cost per life year gained shows that the pharmacoeconomic profile of these drugs is favorable. PMID:11129731

  1. A single-blind, randomized study to compare the efficacy of two ear drop preparations ('Audax' and 'Cerumol') in the softening of ear wax.

    PubMed

    Dummer, D S; Sutherland, I A; Murray, J A

    1992-01-01

    A parallel group, single-blind, randomized study was carried out in a general practice to compare the effectiveness and tolerability of two ear drop preparations ('Audax' and 'Cerumol') in the softening of ear wax in 50 adult patients with impacted or hardened ear wax. Assessments were made on entry of the amount, colour and consistency of the ear wax, symptoms, and objective hearing. Patients were then allocated at random to receive one or other preparation and instructed to use the drops, morning and evening, for 4 days after which they were reassessed. Details were recorded of any side-effects or discomfort caused by the study medication and both physician and patients were asked to give their overall opinion of treatment efficacy. Both treatments were shown to be effective in the softening of ear wax and were well tolerated, there being no significant difference between the two groups in these parameters. However, patients who had abnormal hearing before treatment had a significantly greater improvement in objective hearing after treatment with 'Audax' ear drops compared to those patients treated with 'Cerumol' ear drops. There were no between-treatment differences in either either the physician's or patient's overall assessments of effectiveness.

  2. Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Although prompt reperfusion treatment restores normal epicardial flow, microvascular dysfunction may persist in some patients with acute coronary syndrome (ACS). Impaired myocardial perfusion is caused by intraluminal platelets, fibrin thrombi and neutrophil plugging; antiplatelet agents play a significant role in terms of protecting against thrombus microembolization. A novel antiplatelet agent, ticagrelor, is a non-thienopyridine, direct P2Y12 blocker that has shown greater, more rapid and more consistent platelet inhibition than clopidogrel. However, the effects of ticagrelor on the prevention of microvascular dysfunction are uncertain. The present study is a comparison between clopidogrel and ticagrelor use for preventing microvascular dysfunction in patients with ST elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI, respectively). Methods/design The TIME trial is a single-center, randomized, open-label, parallel-arm study designed to demonstrate the superiority of ticagrelor over clopidogrel. A total of 152 patients with a spectrum of STEMI or NSTEMI will undergo prospective random assignment to clopidogrel or ticagrelor (1:1 ratio). The primary endpoint is an index of microcirculatory resistance (IMR) measured after percutaneous coronary intervention (PCI); the secondary endpoint is wall motion score index assessed at 3 months by using echocardiography. Discussion The TIME trial is the first study designed to compare the protective effect of clopidogrel and ticagrelor on coronary microvascular dysfunction in patients with STEMI and NSTEMI. Trial registration ClinicalTrials.gov: NCT02026219. Registration date: 24 December 2013. PMID:24885437

  3. Endoscopic ultrasound-guided puncture suture device versus metal clip for gastric defect closure after endoscopic full-thickness resection: A randomized, comparative, porcine study

    PubMed Central

    Sun, Beibei; Guo, Jintao; Ge, Nan; Sun, Siyu; Wang, Sheng; Liu, Xiang; Wang, Guoxin; Feng, Linlin

    2016-01-01

    Objective: The secure closure of the wall defect is a critical stage of endoscopic full-thickness resection (EFTR). The aim of this study was to compare the closure of post-EFTR defects using an endoscopic ultrasound-guided puncture suture device (PSD) with the metal clip (MC) technique in a randomized, comparative, porcine study. Methods: We performed a randomized comparative survival study that included 18 pigs. The circular EFTR defects with a diameter of approximately 20 mm were closed with either a PSD or MC. Serum levels of interleukin-6 (IL-6) were determined preoperatively and on a postoperative day (POD) 1, 3, and 7. Three animals from each group were sacrificed at the end of the 7th, 14th, and 30th POD. Tissue samples retrieved from the closure sites were examined macroscopically and microscopically. Results: Resection and closure were performed in 18 pigs (100%) without major perioperative complications. The mean closure time was significantly longer in the MC group than in the PSD group (25.00 ± 3.16 min vs. 1.56 ± 0.39 min; P < 0.05). Preoperative and POD 7 serum levels of IL-6 did not differ between the two groups. However, on POD 1, the IL-6 levels were observed to be significantly greater in the MC group than in the PSD group (P < 0.005). No significant differences between the PSD and MC groups were observed at necropsy. Conclusion: In this in vivo porcine model, PSD is a feasible device that achieves post-EFTR defect closure with a much shorter closure time and with less immunological responses than the MC technique. PMID:27503160

  4. Laparoscopic adjustable gastric banding. A prospective randomized study comparing the Swedish Adjustable Gastric Band and the MiniMizer Extra: one-year results

    PubMed Central

    Brimas, Gintautas; Strupas, Kęstutis

    2011-01-01

    Introduction A number of different adjustable gastric bands are available for laparoscopic adjustable gastric banding (LAGB). Few attempts have been made to compare the influence of band design differences for efficiency and complication rate and conflicting results have emerged from comparative studies. Aim To compare SAGB (Swedish Adjustable Gastric Band) and MiniMizer Extra adjustable gastric bands. Material and methods One hundred and three patients were included in the prospective randomized study. All patients underwent LAGB. The SAGB was used in 49 and MiniMizer Extra in 54 patients. The primary endpoint was weight loss, and secondary endpoints were complication rate, correction of co-morbidities and improvement of quality of life. Results There were no early complications. A significant difference in the proportion of patients who have reached good or excellent weight loss results (≥ 50% of initial excess body mass index loss) was found in favour of the MiniMizer Extra group (29.6% vs. 8.2%, p = 0.006). No difference was found in other weight loss parameters, resolution of co-morbidities and improvement of quality of life. One oesophageal dilatation and one leakage were diagnosed in the MiniMizer Extra group. Five band penetrations (9.3%) were diagnosed in the MiniMizer Extra group and no penetrations in the SAGB group (p = 0.069). Conclusions No major significant differences were found between the compared bands. Further results need to be confirmed by longer follow-up. PMID:23255982

  5. A prospective randomized study comparing alfuzosin and tamsulosin in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia

    PubMed Central

    Agrawal, Madhu S.; Yadav, Abhishek; Yadav, Himanshu; Singh, Amit K.; Lavania, Prashant; Jaiman, Richa

    2009-01-01

    Objective: Prospective randomized study to compare the efficacy and safety of alfuzosin and tamsulosin in patients suffering from acute urinary retention caused by benign prostatic hyperplasia (BPH). Methods: Patients with acute urinary retention (AUR) due to BPH (total 150) were catheterized and randomized into three groups: Group A: alfuzosin 10 mg (50 patients), Group B: tamsulosin 0.4 mg (50 patients), Group C: placebo (50 patients). After three days, catheter was removed, and patients were put on trial without catheter (TWOC). Patients with successful TWOC were followed up for three months, taking into account the prostate symptom score (AUA Score), post-void residual urine volume (PVRV), and peak flow rate (PFR). ANOVA was used for statistical analysis. Results: Both group A (alfuzosin) and group B (tamsulosin) had similar results of TWOC (group A – 66%, group B – 70%), which were significantly superior than group C (placebo) – 36%. In follow up, three (9.1%) patients in group A, three (8.6%) patients in group B and eight (44.4%) patients in group C had retention of urine, requiring recatheterization. These patients were withdrawn from the study. After three months, alfuzosin- or tamsulosin-treated patients showed a significant decrease in AUA score and PVRV; and a significant increase in PFR as compared to placebo. Conclusions: TWOC was more successful in men treated with either alfuzosin or tamsulosin and the subsequent need for recatheterization was also reduced. Tamsulosin was comparable to alfuzosin in all respects, except a small but significant side effect of retrograde ejaculation. PMID:19955671

  6. A randomized crossover study to evaluate LDL-cholesterol lowering effect of a generic product of simvastatin (Unison Company) compared to simvastatin (Zocor) in hypercholesterolemic subjects.

    PubMed

    Assawawitoontip, Surin; Wiwanitkit, Viroj

    2002-06-01

    It is agreed that people with a high blood LDL-cholesterol level will have a higher risk of coronary heart disease (CAD) than those with low blood LDL-cholesterol level. Because of the present National Drug Strategy of Thailand, the promotion of "in-country production" of a generic drug has been established. Simvastatin is one of the drugs in this strategy. In this, the primary report of a randomized crossover study with washout period for a cholesterol lowering effect in a generic product of simvastatin (Unison company) which was compared to the original simvastatin (Zocor) hypercholesterolemic to the subjects were presented. Simvastatin used in this study were derived from two sources. The first group was the original product (Zocor), dosage 10 mg, Lot No IC4/36(N) from Merck Sharp & Dohme Company and the second group was a generic product, dosage 10 mg, Lot No T05/080 and T06/109 from Unison Company. All simvastatin tablets from the first and second sources were inserted into closed capsule of the same shape and called drug A and drug B, respectively. Both the physician in-charge and the subjects in this study were blinded for the content inside the capsule (Double blind). Thirty drug capsules were put into a sachet and distributed to the subject at each visit. The interval between each visit was 4 weeks. All subjects were asked to bring back the residual capsule within the sachet to the researcher at each visit in order to evaluate the subject's compliance. All subjects had physical examination and blood tests at each visit. Furthermore, all subjects were advised to practice diet control and regular in-take of the drug capsule daily after their evening meal. All 48 subjects were randomly allocated into 2 groups. This study was run as a randomized crossover study. After taking the drugs for the first 8 weeks, no statistically significant difference of blood LDL-cholesterol between the first and second group was detected. After a 4 week washout period, crossover

  7. Partnership for Health-2, A Web-Based Versus Print Smoking Cessation Intervention for Childhood and Young Adult Cancer Survivors: Randomized Comparative Effectiveness Study

    PubMed Central

    Puleo, Elaine; Sprunck-Harrild, Kim; Ford, Jennifer; Ostroff, Jamie S; Hodgson, David; Greenberg, Mark; Diller, Lisa; de Moor, Janet; Tyc, Vida

    2013-01-01

    Background Smoking among cancer survivors increases the risk of late effects and second cancers. This article reports on Partnership for Health-2 (PFH-2)—an effort to develop an effective and scalable version of Partnership for Health (PFH), which was a previously tested peer-delivered telephone counseling program that doubled smoking cessation rates among childhood cancer survivors who smoke. Objective This paper presents results from a randomized controlled trial evaluating the effectiveness of PFH-2 in targeted and tailored Web-based versus print formats. The overall goal was to determine whether the intervention outcomes in these self-guided scalable formats approximate what was found in a more intensive telephone counseling program. Methods This study was a randomized controlled trial with a 15-month follow-up that included 374 smokers who were survivors of childhood or young adult cancers, recruited from five survivorship clinics. Participants were randomly assigned to a Web-based or print format of the PFH intervention; all had access to free pharmacotherapy. The website was designed to provide new content at each log-on, and a peer counselor moderated a forum/chat feature. The primary outcome was smoking status at 15 months post randomization. Results In total, 58.3% (77/132) of Web participants logged on at least once (mean visits 3.25). Using multiple imputation methods for missing data, there were similar rates of cessation in the two arms (print: 20/128, 15.6%; Web: 33/201, 6.4%), and no differences in quit attempts or readiness to quit. The quit rates were equivalent to those found in our previous telephone counseling intervention. There were high rates of satisfaction with both of the PFH-2 interventions. Conclusions The print and Web formats yielded equivalent levels of success to those found with our telephone-delivered intervention and are comparable to other Internet treatment studies. This study provides important options for survivorship

  8. Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone

    PubMed Central

    Chandurkar, Nitin; Chandanwale, A. S.; Ambade, Ratnakar; Gupta, Anil; Bartakke, Girish

    2009-01-01

    Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18–70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)–tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober’s test and lateral body bending test) and patient’s and investigator’s global efficacy assessment. aceclofenac–tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac–tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac–tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain. PMID:19421791

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. Electromagnetic navigation in total knee arthroplasty-a single center, randomized, single-blind study comparing the results with conventional techniques.

    PubMed

    Blyth, Mark J G; Smith, Julie R; Anthony, Iain C; Strict, Neville E; Rowe, Philip J; Jones, Bryn G

    2015-02-01

    We report on the results of a randomized study (n=200) to compare total knee arthroplasty performed using conventional instrumentation or electromagnetic computer assisted surgical technique. 92% of navigated and 85% of conventional knees were implanted within ±3° from neutral mechanical alignment; there was no statistically significant difference between these proportions. There was also no difference in femoral or tibial rotation assessed by CT scan. At 1year follow up there was no statistical difference between the two groups in American Knee Society Score, Oxford Knee Scores, patient satisfaction, quality of life, hospital length of stay, complication rates or other adverse events. Tourniquet time in the navigated group was longer. Proving value for navigation in total knee arthroplasty surgery remains a challenge.

  15. Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects.

    PubMed

    Qayyum, Aisha; Najmi, Muzammil Hasan; Abbas, Mateen

    2013-11-01

    Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen (100mg) either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC(0-t), AUC(0-oo), Cmax, Tmax, t½, Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC(0-24), AUC(0-oo) and Cmax for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value (p-0.05). ANOVA gave p-values which were more than the specified value (p-0.05) for sequence, subject, period and formulation. Test formulation of flurbiprofen (tablet Flurso) was found to meet the criteria for bioequivalence to branded product (tablet Ansaid) based on pharmacokinetic parameters.

  16. A randomized study comparing three groups of vein harvesting methods for coronary artery bypass grafting: endoscopic harvest versus standard bridging and open techniques

    PubMed Central

    Krishnamoorthy, Bhuvaneswari; Critchley, William R.; Glover, Alex T.; Nair, Janesh; Jones, Mark T.; Waterworth, Paul D.; Fildes, James E.; Yonan, Nizar

    2012-01-01

    OBJECTIVES The use of an open vein harvesting (OVH) technique for saphenous vein harvesting (SVH) is associated with wound complications and delayed patient mobilization. This has led to the development of minimally invasive vein harvesting (MIVH) techniques, such as standard bridging and endoscopic SVH (EVH). This randomized trial was established to assess immediate clinical outcome and patient satisfaction in our centre. METHODS A total of 150 consecutive patients were prospectively randomized into three groups. Group 1 consisted of 50 patients who underwent OVH, Group 2 consisted of 50 patients who underwent a standard bridging technique (SBT) and Group 3 consisted of 50 patients who underwent EVH. Each group was assessed for the incidence of wound infection, postoperative pain and satisfaction and the number of vein repairs using previously validated scoring systems. RESULTS The MIVH techniques reduced the pain at hospital (P < 0.001) and at 6 weeks (P < 0.001), and improved cosmesis (P < 0.001), compared with the OVH group. Patient satisfaction was greatest in the EVH group followed by the SBT and then the OVH group. The clinical markers of inflammation were reduced with an MIVHt. There were more vein repairs in the EVH compared with the OVH (P < 0.001) and the SBT (P = 0.04) groups. CONCLUSIONS This study demonstrates that MIVH reduces wound morbidity. We believe that each technique has advantages and disadvantages, which should be considered during the selection of a harvesting procedure by both the patient and the surgeon. PMID:22611182

  17. Randomized comparative study of left versus right radial approach in the setting of primary percutaneous coronary intervention for ST-elevation myocardial infarction

    PubMed Central

    Fu, Qiang; Hu, Hongyu; Wang, Dezhao; Chen, Wei; Tan, Zhixu; Li, Qun; Chen, Buxing

    2015-01-01

    Background Growing evidence suggests that the left radial approach (LRA) is related to decreased coronary procedure duration and fewer cerebrovascular complications as compared to the right radial approach (RRA) in elective percutaneous coronary intervention (PCI). However, the feasibility of LRA in primary PCI has yet to be studied further. Therefore, the aim of this study was to investigate the efficacy of LRA compared with RRA for primary PCI in ST-elevation myocardial infarction (STEMI) patients. Materials and methods A total of 200 consecutive patients with STEMI who received primary PCI were randomized to LRA (number [n]=100) or RRA (n=100). The study endpoint was needle-to-balloon time, defined as the time from local anesthesia infiltration to the first balloon inflation. Radiation dose by measuring cumulative air kerma (CAK) and CAK dose area product, as well as fluoroscopy time and contrast volume were also investigated. Results There were no significant differences in the baseline characteristics between the two groups. The coronary procedural success rate was similar between both radial approaches (98% for left versus 94% for right; P=0.28). Compared with RRA, LRA had significantly shorter needle-to-balloon time (16.0±4.8 minutes versus 18.0±6.5 minutes, respectively; P=0.02). Additionally, fluoroscopy time (7.4±3.4 minutes versus 8.8±3.5 minutes, respectively; P=0.01) and CAK dose area product (51.9±30.4 Gy cm2 versus 65.3±49.1 Gy cm2, respectively; P=0.04) were significantly lower with LRA than with RRA. Conclusion Primary PCI can be performed via LRA with earlier blood flow restoration in the infarct-related artery and lower radiation exposure when compared with RRA; therefore, the LRA may become a feasible and attractive alternative to perform primary PCI for STEMI patients. PMID:26150704

  18. Comparative Study of Intravenous Iron Versus Intravenous Ascorbic Acid for Treatment of Functional Iron Deficiency in Patients Under Hemodialysis: A Randomized Clinical Trial

    PubMed Central

    Sedighi, Omid; Makhlough, Atieh; Janbabai, Ghasem; Neemi, Mohammad

    2013-01-01

    Background Functional iron deficiency (FID) may cause erythropoietin resistance in patients under hemodialysis (HD). Since the role of chronic inflammation or oxidative stress in its pathogenesis is unclear, controversy remains to whether intravenous iron or intravenous ascorbic acid (an antioxidant) can improve this anemia due to decreased iron availability. Objectives The current study compared the effect of intravenous iron versus intravenous ascorbic acid in the management of FID in HD patients. Patients and Methods Forty HD patients with hemoglobin (Hb) ≤ 11 g/dL, serum ferritin ≥ 500 ng/mL and transferrin saturation (TSAT) ≤ 25% were randomly divided into two groups. 20 patients received 100 mg of intravenous (IV) iron (group I), and 20 patients received 300 mg of IV ascorbic acid (group II) postdialysis, twice a week for 5 consecutive weeks. Hb and iron metabolism indices were measured before the onset of the study and after 12 weeks following therapy. Results Twenty one percent of all HD patients, exhibited high serum ferritin, low TSAT and sufficient data for analysis. Both Group I (n = 20) and Group II (n = 20) patients showed a significant increase in Hb, serum iron, and TSAT (P < 0.001). There were no significant differences between both groups in increasing Hb (P = 0.076), serum iron (P = 0.589), serum ferritin (0.725), and TSAT (P = 0.887). Conclusions This study showed that both IV iron and IV ascorbic acid can improve FID in HD patients. A larger randomized trial is warranted to determine the optimal management of FID in HD patients. PMID:24350091

  19. 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.

  20. 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

  1. 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

  2. Prospective Randomized Study Comparing Combined Phaco-ExPress and Phacotrabeculectomy in Open Angle Glaucoma Treatment: 12-Month Follow-Up

    PubMed Central

    Konopińska, Joanna; Deniziak, Marta; Saeed, Emil; Bartczak, Agnieszka; Zalewska, Renata; Mariak, Zofia; Rękas, Marek

    2015-01-01

    Purpose of the Study. To compare the efficacy and safety of phacotrabeculectomy (P-Trab) and phacoemulsification with the ExPress (P-ExPress) mini glaucoma shunt implantation. Study Plan. Prospective randomized study. Material and Methods. 85 eyes with cataract and unregulated open angle glaucoma. There were 46 eyes in the P-ExPress and 39 the P-Trab group. Intraocular pressure (IOP), the number of antiglaucoma medications, qualified and complete surgical success (defined as IOP ≤ 18.0 mmHg), visual acuity (CDVA), the number of endothelial cells, and postoperative complications and additional procedures were assessed. Results. After 12 months of observation, the average IOP in the P-Express group went from 26.4 ± 9.3 down to 17.1 ± 5 mmHg (P < 0.05) and from 27.9 ± 12.9 down to 15.9 ± 2.7 mmHg in the P-Trab group (P < 0.05). No significant differences in the amount of medications used after surgery and CDVA were discovered between the groups. In the P-ExPress group, greater loss of endothelial cells was noted (CDloss%), compared to the P-Trab group. Conclusions. Both P-ExPress and P-Trab have comparable efficacy and similar early postoperative complication profile. The presence of additional implant (as is the case of the ExPress mini glaucoma shunt implantation) may cause progressive loss of endothelial cells. PMID:26137318

  3. Effect of a new moisturizing lotion on immediate and cumulative skin hydration: Two randomized, intra-individual, vehicle- and comparator-controlled studies.

    PubMed

    Nogueira, Alessandra; Sidou, Farzaneh; Brocard, Sylvie

    2011-08-01

    Moisturizers increase skin hydration and can serve as adjunctive care in dermatologic conditions such as xerosis, psoriasis vulgaris, atopic dermatitis and ichthyosis, in which dry skin is implicated. A non-irritating hydrating lotion (CDA lotion) was recently developed. We assessed the effect of CDA lotion on skin hydration in two randomized, evaluator-blind and intra-individual comparison studies. After a single application, CDA lotion induced significantly greater hydration than the non-treated control for at least 24 hours (p < 0.001). After 4 days of twice-daily application, compared with the non-treated control, CDA lotion induced significantly greater skin hydration up to 3 days after treatment cessation (p < 0.05) and significant improvement in the clinical skin dryness score up to 7 days after treatment cessation (p < 0.05). The immediate and cumulative hydration effects of CDA lotion were also compared to those of several currently available moisturizing products. In summary, application of CDA lotion increases skin hydration and alleviates the condition of skin dryness.

  4. 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.

  5. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study.

    PubMed

    Brox, Jens Ivar; Reikerås, Olav; Nygaard, Øystein; Sørensen, Roger; Indahl, Aage; Holm, Inger; Keller, Anne; Ingebrigtsen, Tor; Grundnes, Oliver; Lange, Johan Emil; Friis, Astrid

    2006-05-01

    The effectiveness of lumbar fusion for chronic low back pain after surgery for disc herniation has not been evaluated in a randomized controlled trial. The aim of the present study was to compare the effectiveness of lumbar fusion with posterior transpedicular screws and cognitive intervention and exercises. Sixty patients aged 25-60 years with low back pain lasting longer than 1 year after previous surgery for disc herniation were randomly allocated to the two treatment groups. Experienced back surgeons performed transpedicular fusion. Cognitive intervention consisted of a lecture intended to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The primary outcome measure was the Oswestry Disability Index (ODI). Outcome data were analyzed on an intention-to-treat basis. Ninety-seven percent of the patients, including seven of eight patients who had either not attended treatment (n=5) or changed groups (n=2), completed 1-year follow-up. ODI was significantly improved from 47 to 38 after fusion and from 45 to 32 after cognitive intervention and exercises. The mean difference between treatments after adjustment for gender was -7.3 (95% CI -17.3 to 2.7, p=0.15). The success rate was 50% in the fusion group and 48% in the cognitive intervention/exercise group. For patients with chronic low back pain after previous surgery for disc herniation, lumbar fusion failed to show any benefit over cognitive intervention and exercises. PMID:16545523

  6. Multi-Center Randomized Phase II Study Comparing Cediranib plus Gefitinib with Cediranib plus Placebo in Subjects with Recurrent/Progressive Glioblastoma

    PubMed Central

    Brown, Nicholas; McBain, Catherine; Nash, Stephen; Hopkins, Kirsten; Sanghera, Paul; Saran, Frank; Phillips, Mark; Dungey, Fiona; Clifton-Hadley, Laura; Wanek, Katharina; Krell, Daniel; Jeffries, Sarah; Khan, Iftekhar; Smith, Paul; Mulholland, Paul

    2016-01-01

    Background Cediranib, an oral pan-vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, failed to show benefit over lomustine in relapsed glioblastoma. One resistance mechanism for cediranib is up-regulation of epidermal growth factor receptor (EGFR). This study aimed to determine if dual therapy with cediranib and the oral EGFR inhibitor gefitinib improved outcome in recurrent glioblastoma. Methods and Findings This was a multi-center randomized, two-armed, double-blinded phase II study comparing cediranib plus gefitinib versus cediranib plus placebo in subjects with first relapse/first progression of glioblastoma following surgery and chemoradiotherapy. The primary outcome measure was progression free survival (PFS). Secondary outcome measures included overall survival (OS) and radiologic response rate. Recruitment was terminated early following suspension of the cediranib program. 38 subjects (112 planned) were enrolled with 19 subjects in each treatment arm. Median PFS with cediranib plus gefitinib was 3.6 months compared to 2.8 months for cediranib plus placebo (HR; 0.72, 90% CI; 0.41 to 1.26). Median OS was 7.2 months with cediranib plus gefitinib and 5.5 months with cediranib plus placebo (HR; 0.68, 90% CI; 0.39 to 1.19). Eight subjects (42%) had a partial response in the cediranib plus gefitinib arm versus five patients (26%) in the cediranib plus placebo arm. Conclusions Cediranib and gefitinib in combination is tolerated in patients with glioblastoma. Incomplete recruitment led to the study being underpowered. However, a trend towards improved survival and response rates with the addition of gefitinib to cediranib was observed. Further studies of the combination incorporating EGFR and VEGF inhibition are warranted. Trial Registration ClinicalTrials.gov NCT01310855 PMID:27232884

  7. Anti-albuminuric effect of losartan versus amlodipine in hypertensive Japanese patients with type 2 diabetes mellitus: A prospective, open-label, randomized, comparative study

    PubMed Central

    Ohno, Yasuhiro; Nishimura, Akiyoshi; Iwai, Hiroshi; Hirota, Noriyuki; Yamauchi, Takaaki; Fujimoto, Mika; Miyatake, Toshiyuki; Arai, Hiroshi; Aoki, Norihiko

    2007-01-01

    Abstract Background The antiproteinuric effect of the angiotensin II receptor-antagonist losartan has been observed in patients with type 2 diabetes mellitus (T2DM). Proteinuria is considered to be a predictor of the progression of kidney disease. Objective The aims of the present study were to compare and examine the ability of losartan and amlodipine to ameliorate albuminuria in hypertensive Japanese patients (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) with T2DM and whether the change in albuminuria was associated with a change in glomerular filtration rate (GFR). Methods This prospective, open-label, randomized, comparative study was conducted over 3 months at the Kinki University School of Medicine, Osaka-Sayama, Japan. Hypertensive patients with T2DM were enrolled and randomly assigned to 1 of 2 study groups receiving either losartan (25–100 mg/d) or the calcium channel-blocker amlodipine (2.5–5 mg/d). Urinary albumin excretion (UAE), creatinine clearance, and GFR were recorded at study initiation (baseline) and study end (month 3). The GFR was measured from the fractional renal accumulation of 99mTc-diethylenetriaminepentaacetic acid. Adverse events (AEs) were monitored by a clinical research nurse during the examination. Results Fifty patients were asked to enroll and 38 returned the informed written consent. Thirty-five Japanese patients were included in the final study analysis. Seventeen patients were assigned to the losartan group (male sex, 10 [58.8%]; mean [SD] age, 58.1 [8.2] years) and 18 were assigned to the amlodipine group (male sex, 10 [55.6%]; mean [SD] age, 57.4 [8.9] years); no significant between-group difference in demographics was observed. A significant decrease from baseline to month 3 of mean (SD) UAE was observed in the losartan group (352.5 [556.6] mg/d vs 275.7 [466.1] mg/d; P = 0.048). No significant difference in mean (SD) UAE was observed in the amlodipine group for the same time period (298

  8. A comparative study of toluidine blue-mediated photodynamic therapy versus topical corticosteroids in the treatment of erosive-atrophic oral lichen planus: a randomized clinical controlled trial.

    PubMed

    Jajarm, Hasan Hoseinpour; Falaki, Farnaz; Sanatkhani, Majid; Ahmadzadeh, Meysam; Ahrari, Farzaneh; Shafaee, Hooman

    2015-07-01

    Recently, photodynamic therapy (PDT) has been suggested as a new treatment option that is free from side effects for erosive-atrophic oral lichen planus (OLP). The purpose of this study was to compare the effect of toluidine blue-mediated photodynamic therapy (TB-PDT) with local corticosteroids on treatment of erosive-atrophic OLP. In this randomized clinical trial, 25 patients with keratotic-atrophic-erosive oral lichen planus were allocated randomly into two groups. Group 1 (experimental): topical application of toluidine blue with micropipette was applied, and after 10 min, the patients were treated with a 630-nm GaAlAs laser (power density: 10 mW/cm(2)) during two visits. Group 2 (control) used mouthwash diluted with dexamethasone (tab 0/5 in 5 ml water) for 5 min, and then, it was spat out, and after 30 min, the mouth was rinsed with 30 drops of nystatin 100,000 units for 5 min and again spat out. Demographic data, type, and severity of the lesions and pain were recorded before and after treatment and then at the 1-month follow-up visit. Response rate was defined based on changes in intensity of the lesions and pain. In the experimental and control groups, sign scores of changes significantly reduced after treatment respectively (p = 0.021) and (p = 0.002), but between the two groups, no significant difference was observed (p = 0.72). In the experimental (p = 0.005) and control groups (p = 0.001), the intensity of lesions significantly reduced after treatment and there was a significant difference between the two groups (p = 0.001). The mean amount of improvement in pain was significantly greater in the control group compared with the experimental group (p < 0.001) (α = 0.05). Our study showed that TB-PDT with laser was effective in the management of OLP.

  9. 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

  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 Study of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a in Combination with Ribavirin and Telaprevir in Patients with Genotype-1 Chronic Hepatitis C

    PubMed Central

    Flisiak, Robert; Shiffman, Mitchell; Arenas, Juan; Cheinquer, Hugo; Nikitin, Igor; Dong, Yuping; Rana, Khurram; Srinivasan, Subasree

    2016-01-01

    Background A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. Methods Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks. The primary endpoint was the proportion of patients who achieved a sustained virologic response at post treatment week 12 (SVR12), which was tested for noninferiority of Lambda/RBV/TVR. Results A total of 838 patients were enrolled, and 617 were treated; 411 and 206 patients received Lambda/RBV/TVR and Alfa/RBV/TVR, respectively. The majority of patients were treatment-naïve, with HCV GT-1b and a high baseline viral load (≥800,000 IU/mL). Less than 10% of patients had cirrhosis (Lambda, 7.5%; Alfa, 6.8%). Lambda/RBV/TVR did not meet the criterion for noninferiority (lower bound of the treatment difference interval was -12.3%); the SVR12 in all patients (modified intent-to-treat) was 76.2% in the Lambda arm and 82.0% in the Alfa arm. Overall, the frequency of adverse events in each arm was comparable (Lambda, 91.7%; Alfa, 97.1%). As expected based on the safety profile of the 2 interferons, there were more hepatobiliary events observed in the Lambda arm and more hematologic events in the Alfa arm. Conclusions In this comparison of Lambda/RBV/TVR and Alfa/RBV/TVR in patients who were treatment-naïve or had relapsed on prior Alfa/RBV treatment, Lambda failed to demonstrate noninferiority based on SVR12 results. Treatment with Lambda/RBV/TVR was associated with a higher incidence of relapse. More patients discontinued Lambda/RBV/TVR treatment during the first 4 weeks of study treatment

  12. A comparative evaluation of the efficacy of probiotic and chlorhexidine mouthrinses on clinical inflammatory parameters of gingivitis: A randomized controlled clinical study

    PubMed Central

    Nadkerny, Purnima Vidyesh; Ravishankar, Potluri Leela; Pramod, Virupapuram; Agarwal, Lavanya Abhay; Bhandari, Saurabh

    2015-01-01

    Background: The aim of our clinical trial was to assess and compare the antiplaque and anti-inflammatory potential of a probiotic mouthwash with 0.2% chlorhexidine and saline. Materials and Methods: A randomized parallel group study was designed for a period of 4 weeks on 45 systemically healthy subjects between 20 and 30 years having chronic gingivitis. The study population was divided into three groups. Group A - 15 subjects were advised experimental (probiotic) mouthwash. Group B - 15 subjects were advised positive control (chlorhexidine) mouthwash and Group C - 15 subjects into a negative control group (normal saline). Oral prophylaxis was done for all groups at baseline. After the proper oral hygiene instructions, all the three groups were instructed to rinse their mouth with 10 ml of their respective mouthrinse, undiluted for 1 min twice daily, 30 min after brushing. Clinical parameters such as plaque index (PI), gingival index (GI), and oral hygiene index simplified (OHI-S) were assessed at baseline, 2 weeks and 4 weeks, respectively. Results: At day 28, the PI, GI, and OHI-S were significantly reduced by all treatment modalities ranking probiotic and chlorhexidine is greater than saline. Conclusion: The probiotic mouthrinses tested was effectively used as an adjunct to mechanical plaque control in the prevention of plaque and gingivitis. Thus, the probiotic mouthrinse has a great therapeutic potential. PMID:26941513

  13. 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.

  14. Randomized, Double-Blind, Multicenter Safety and Efficacy Study of Rifalazil Compared with Azithromycin for Treatment of Uncomplicated Genital Chlamydia trachomatis Infection in Women

    PubMed Central

    Geisler, William M.; Pascual, Maria Luz G.; Mathew, Judy; Koltun, William D.; Morgan, Franklin; Batteiger, Byron E.; Mayes, Annette; Tao, Sijia; Hurwitz, Selwyn J.; Sayada, Chalom

    2014-01-01

    A randomized, double-blind study comparing single-dose chlamydia therapies of oral rifalazil (25 mg) and azithromycin (1 g) was conducted in 82 women with uncomplicated genital Chlamydia trachomatis infection. The microbiologic cure rate of C. trachomatis with rifalazil (n = 33) was 84.8% at the visit on day 22 to 26 (test-of-cure visit), versus 92.1% with azithromycin (n = 38), and the number of treatment failures in each group was 5 and 3, respectively. The difference in cure rate was −7.3%, with a lower limit of the 95% confidence interval (95% CI) of −22.5, and thus, noninferiority was not established at the prespecified margin (lower limit of CI of −15%). The overall treatment-emergent adverse event (TEAE) and treatment-related TEAE rates were lower in the rifalazil group (68% and 55%) than in the azithromycin group (71% and 62%), respectively. Subjects classified as treatment failures at day 22 to 26 had a lower mean plasma concentration of rifalazil at the visit on day 8 to 12 than those classified as treatment cures, but this difference was not significant; however, the levels were similar for both groups at the visit on day 22 to 26. A single 25-mg dose of rifalazil was well tolerated and eradicated C. trachomatis in most of these women with uncomplicated genital C. trachomatis infection. (The study was registered at clinicaltrials.gov under registration no. NCT01631201). PMID:24798277

  15. The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care. Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening. This trial seeks to fill this gap and contribute information about the benefits, harms, and costs of routine screening for dementia in primary care. Methods/Design Single-blinded, parallel, randomized controlled clinical trial with 1:1 allocation. A total of 4,000 individuals aged ≥65 years without a diagnosis of dementia, cognitive impairment, or serious mental illness receiving care at primary care practices within two cities in Indiana. Subjects will be randomized to either i) screening for dementia using the Memory Impairment Screen Telephone version or ii) no screening for dementia. Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression. Research assistants will administer the 15-item Health Utility Index, Patient Health Questionnaire, Generalized Anxiety Disorder Scale, and Medical Outcomes Study at baseline, 1, 6, and 12 months. Information about advanced care planning will be collected at baseline and 12 months. All enrollees’ medical records will be reviewed to collect data on health care utilization and costs. Discussion We have two primary hypotheses; first, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening. Second, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health

  16. Double-blind, placebo-controlled, randomized, right-left study comparing calcipotriol monotherapy with a combined treatment of calcipotriol and diflucortolone valerate in chronic plaque psoriasis.

    PubMed

    Salmhofer, W; Maier, H; Soyer, H P; Hönigsmann, H; Hödl, S

    2000-01-01

    A double-blind, randomized clinical study was conducted to compare the efficacy and tolerability of twice-daily topical calcipotriol treatment with a combination treatment of calcipotriol once a day in the morning and diflucortolone valerate in the evening. Sixty-three patients with a clinical diagnosis of chronic plaque psoriasis and comparable psoriatic lesions on both sides of the body were included. After a washout phase of 1 week, psoriatic lesions were treated for 4 weeks with calcipotriol ointment twice daily on one side of the body and a combination of calcipotriol and diflucortolone valerate ointment on the other side. The treatment period was followed by a period of 4 weeks without any treatment. The psoriasis area and severity index (PASI) was used to compare the 2 groups. Furthermore, the overall therapeutic results were assessed independently by the investigators and by the patients. Both treatment regimens showed a significant, nearly identical, reduction in PASI. The mean PASI for calcipotriol alone was 5.7 at baseline, 1.9 after 4 weeks of treatment and 3.8 at the end of the follow-up period. For combination therapy, these values were 5.7, 1.8 and 3.8, respectively. There was a statistically significant advantage in favor of combined calcipotriol and diflucortolone valerate treatment at weeks 1 and 2 (p < 0.05); however, at the end of the treatment phase the difference between the 2 therapies was not significant. Subjective evaluation of efficacy by both the investigators and the patients revealed no difference between the 2 treatments. The frequency of side effects (e.g. irritation) was low in both groups. In conclusion, both therapies were effective for the treatment of chronic plaque-type psoriatic lesions. The combination of calcipotriol and a topical steroid appeared to produce a more rapid clinical response and was shown to be as effective as calcipotriol therapy alone. PMID:11234559

  17. 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

    2014-01-01

    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

  18. 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.

  19. A randomized cross-over study to compare PUVA and extracorporeal photopheresis in the treatment of plaque stage (T2) mycosis fungoides.

    PubMed

    Child, F J; Mitchell, T J; Whittaker, S J; Scarisbrick, J J; Seed, P T; Russell-Jones, R

    2004-05-01

    PUVA is a well-established and effective treatment for plaque stage mycosis fungoides (MF) but its use is limited on a long-term basis because of the risk of cutaneous carcinogenesis. A further disadvantage is that nonexposed areas (sanctuary sites) often develop persistent disease. Therefore it is important to find alternative methods of treatment. Extracorporeal photopheresis (ECP) is a form of photochemotherapy that involves exposure of white blood cells to UVA with psoralens and can be effective in Sézary syndrome and erythrodermic cutaneous T-cell lymphoma. The aim of this study was to compare the efficacy of PUVA and ECP in the treatment of patients with T2 plaque stage (Stage 1B) MF who had a detectable peripheral blood T-cell clone. The study was of a cross-over design. Sixteen patients were randomized to receive either PUVA twice weekly for 3 months followed by ECP once monthly for 6 months at relapse, or vice-versa. Response was assessed by monthly skin scores and peripheral blood T-cell clonality. Ten patients received PUVA initially and six ECP initially. Eight patients completed the study. Skin scores taken at the completion of each treatment arm in patients who completed the study were 113 units better (confidence interval, 42-184 units) following 3 months PUVA than 6 months ECP (P = 0.002). Peripheral blood T-cell clones were detectable in all patients post-treatment. This study indicates that ECP is not effective in the treatment of plaque stage (1B/T2) MF even in patients with molecular evidence of a peripheral blood T-cell clone. Although PUVA was more effective than ECP, neither treatment modality cleared malignant T-cells from the peripheral blood.

  20. 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.

  1. 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

  2. Faster reduction in hyperinflation and improvement in lung ventilation inhomogeneity promoted by aclidinium compared to glycopyrronium in severe stable COPD patients. A randomized crossover study.

    PubMed

    Santus, Pierachille; Radovanovic, Dejan; Di Marco, Fabiano; Raccanelli, Rita; Valenti, Vincenzo; Centanni, Stefano

    2015-12-01

    Standard spyrometric assessment in chronic obstructive pulmonary disease (COPD) only evaluates bronchial obstruction. However, airflow limitation and hyperinflation are the main pathophysiological factors responsible for dyspnoea and reduced exercise tolerance in patients with COPD. This study evaluated the effects of aclidinium bromide 400 μg and glycopyrronium bromide 50 μg on these parameters. Patients with stable severe/very severe COPD were randomized in this double-blind, double-dummy, crossover, Phase IV study. Patients received single doses of each drug on separate days. Primary endpoints were changes in residual volume (RV) and intra-thoracic gas volume (ITGV), assessed by full-body plethysmography. Other endpoints included changes variations in lung ventilation inhomogeneity (Phase III slope of single-breath nitrogen washout test, SBN2), dyspnoea visual analogue scale, and pulmonary specific total airway resistances. Assessments were performed at baseline and 5, 15, 30, 60, and 180 min post-administration. Thirty-seven patients were randomized (31 male; mean age 71 years). Aclidinium and glycopyrronium significantly improved ITGV versus baseline at all-time points (p < 0.05). Significant improvements in RV were observed after 5 min with aclidinium and after 60 min with glycopyrronium. RV improvements were significantly greater with aclidinium than glycopyrronium from 5 to 60 min post-administration (p < 0.05). Both treatments improved dyspnoea versus baseline at all-time points (p < 0.05). Aclidinium significantly improved ventilation inhomogeneity versus baseline at all-time points; no significant changes were observed for glycopyrronium. For the first time two long-acting muscarinic antagonists have been compared in acute conditions with body plethysmography and SBN2 test. We demonstrated that both aclidinium and glycopyrronium significantly reduce hyperinflation and dyspnoea in severe and very severe COPD patients. Aclidinium however

  3. 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

  4. Cyclosporine and Extracorporeal Photopheresis are Equipotent in Treating Severe Atopic Dermatitis: A Randomized Cross-Over Study Comparing Two Efficient Treatment Modalities

    PubMed Central

    Koppelhus, Uffe; Poulsen, Johan; Grunnet, Niels; Deleuran, Mette Søndergaard; Obitz, Erik

    2014-01-01

    Background: Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. Objectives: To compare the efficacy of CsA (3 mg/kg/day) and ECP (administered two consecutive days twice a month) in a cohort of patients with severe AD. Methods: A randomized cross-over study involving twenty patients with severe AD (SCORAD index 41-89) refractory to other treatments. The patients were allocated to a 4-month course of either of the two treatment modalities. Individual relapse periods (2–8 weeks) were interspersed before cross-over to the other treatment modality. Treatment efficacy was evaluated by SCORAD, PRURITUS (VAS-index 0–10), “overall global assessment” and serological biomarkers; sIL-2Rα, sE-selectin, eosinophilocytes, basophilocytes, and sIgE. Results: 15 patients completed treatment. Both treatments lead to a marked and significant decrease in SCORAD and pruritus index. The average reduction of the SCORAD and pruritus index, respectively was a little higher for ECP treatment compared to CsA treatment; however, the differences did not reach statistical significance. The “overall global assessment” was significantly better in patients who underwent ECP therapy as compared to CsA treatment. None of the biomarkers showed significant changes after either treatment when compared to the initial values. Conclusion: ECP administered on two consecutive days twice a month to patients with severe AD has similar potency as CsA administered daily in a moderate dose. ECP is a treatment alternative in patients with severe AD that do not tolerate or are refractory to conventional

  5. 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

  6. A Comparative Study on the Efficacy of Ibuprofen and Celecoxib on the Intensity of Perineal Pain Following Episiotomy: A Randomized Clinical Trial

    PubMed Central

    Suhrabi, Zainab; Taghinejad, Hamid

    2013-01-01

    Background: Pain is a worldwide problem that often originates from disease process, and diagnostic and treatment procedures such as surgical operations. Objectives: This trial was performed to compare the effectiveness of two analgesics for the management of perineal pain caused by episiotomy. Materials and Methods: A total of 170 nulliparous women who gave birth vaginally with episiotomy between March 2009 and November 2010 were randomly assigned to receive either ibuprofen or celecoxib which were given orally every 6 or 12 hours, respectively. Pain levels were measured before the intervention, and at 1, 2, 4, 8 and 12 hours after providing the first dose on a 10-cm visual analogue scale. Results: The results showed that the two groups had no significant differences regarding demographic characteristics, maternal, neonatal, and post-delivery factors, and mean premedication pain severity. Means of pain severity were different between the two groups as patients in the celecoxib group had lower means than the other group at 1,2,4,8 and 12 hours (4.01 ± 1.8 vs. 4.46 ± 1.9, 3.17 ± 1.9 vs. 3.79 ± 1.7, 2.89 ± 1.3 vs. 2.96 ± 1.5, 2.19 ± 1.8 vs. 2.55 ± 1.4, and 1.98 ± 1.1 vs. 2.45 ± 1.2, respectively) after administration of analgesics. Conclusions: Patients who received celecoxib had lower VAS in comparison with others. Although these differences were not significant, as celecoxib has longer half-life, fewer upper GI symptoms, and is better tolerated based on the previous studies, and this study is in favor of using it. PMID:24693414

  7. 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

  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. Narrow-band imaging does not improve detection of colorectal polyps when compared to conventional colonoscopy: a randomized controlled trial and meta-analysis of published studies

    PubMed Central

    2011-01-01

    Background A colonoscopy may frequently miss polyps and cancers. A number of techniques have emerged to improve visualization and to reduce the rate of adenoma miss. Methods We conducted a randomized controlled trial (RCT) in two clinics of the Gastrointestinal Department of the Sanitas University Foundation in Bogota, Colombia. Eligible adult patients presenting for screening or diagnostic elective colonoscopy were randomlsy allocated to undergo conventional colonoscopy or narrow-band imaging (NBI) during instrument withdrawal by three experienced endoscopists. For the systematic review, studies were identified from the Cochrane Library, PUBMED and LILACS and assessed using the Cochrane risk of bias tool. Results We enrolled a total of 482 patients (62.5% female), with a mean age of 58.33 years (SD 12.91); 241 into the intervention (NBI) colonoscopy and 241 into the conventional colonoscopy group. Most patients presented for diagnostic colonoscopy (75.3%). The overall rate of polyp detection was significantly higher in the conventional group compared to the NBI group (RR 0.75, 95%CI 0.60 to 0.96). However, no significant differences were found in the mean number of polyps (MD -0.1; 95%CI -0.25 to 0.05), and the mean number of adenomas (MD 0.04 95%CI -0.09 to 0.17). Meta-analysis of studies (regardless of indication) did not find any significant differences in the mean number of polyps (5 RCT, 2479 participants; WMD -0.07 95% CI -0.21 to 0.07; I2 68%), the mean number of adenomas (8 RCT, 3517 participants; WMD -0.08 95% CI -0.17; 0.01 to I2 62%) and the rate of patients with at least one adenoma (8 RCT, 3512 participants, RR 0.96 95% CI 0.88 to 1,04;I2 0%). Conclusion NBI does not improve detection of colorectal polyps when compared to conventional colonoscopy (Australian New Zealand Clinical Trials Registry ACTRN12610000456055). PMID:21943365

  10. Short-term effect of a new mouthrinse formulation on oral malodour after single use in vivo: a comparative, randomized, single-blind, parallel-group clinical study.

    PubMed

    Wilhelm, D; Gysen, K; Himmelmann, A; Krause, C; Wilhelm, K-P

    2010-09-01

    This study aimed to compare a new chlorhexidine (CHX)-free mouthrinse containing amine fluoride/stannous fluoride (ASF) against a benchmark containing CHX with respect to their effect on oral malodour after single use. A total of 42 male and female subjects with an intraoral cause of bad breath, each with an organoleptic rating (OR) of at least 2 and a total volatile sulfur compound (VSC) concentration higher than 130 ppb, participated in the study. Subjects were allocated to one of three treatment groups (i.e. CHX-free ASF mouthrinse, CHX benchmark mouthrinse or water) according to a randomization list. Participants received written instructions on precautions to be taken for optimal breath analysis. Eight trained and qualified odour judges assessed the subjects' malodour by OR at baseline and 30 min and 4 h after single use of the mouthrinses. Additionally, VSC levels were measured at baseline and 4 h after using the mouthrinse. Treatment with water alone led already to some reduction in OR with mean differences to baseline of -1.13 at 30 min and -0.64, 4 h after treatment. Both CHX-free ASF product (-1.51) and CHX (-1.48) provided a significantly stronger OR reduction than water at 30 min (p < 0.05). Only CHX-free ASF treatment showed a sustained benefit in terms of significantly better OR reduction after 4 h (-1.17, p < 0.05), whereas CHX (-0.81) was not significantly different from water (-0.64, p = 0.517). Both ASF (-90.9%) and CHX (-81.6%) reduced VSC levels significantly stronger than water (-53.5%; p < 0.001). OR and VSC readings in the group using the CHX mouthrinse did not differ significantly from those in the group using the CHX-free ASF formulation. The newly developed CHX-free ASF mouthrinse significantly reduced oral malodour after single use, both in terms of OR and VSC levels. Efficacy was comparable to that of the CHX benchmark product.

  11. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with Type 2 diabetes1

    PubMed Central

    Home, P D; Bailey, C J; Donaldson, J; Chen, H; Stewart, M W

    2007-01-01

    Aims To compare the efficacy and safety of either continuing or discontinuing rosiglitazone + metformin fixed-dose combination when starting insulin therapy in people with Type 2 diabetes inadequately controlled on oral therapy. Methods In this 24-week double-blind study, 324 individuals with Type 2 diabetes inadequately controlled on maximum dose rosiglitazone + metformin therapy were randomly assigned to twice-daily premix insulin therapy (target pre-breakfast and pre-evening meal glucose ≤ 6.5 mmol/l) in addition to either rosiglitazone + metformin (8/2000 mg) or placebo. Results Insulin dose at week 24 was significantly lower with rosiglitazone + metformin (33.5 ± 1.5 U/day, mean ± se) compared with placebo [59.0 ± 3.0 U/day; model-adjusted difference −26.6 (95% CI −37.7, −15,5) U/day, P < 0.001]. Despite this, there was greater improvement in glycaemic control [HbA1c rosiglitazone + metformin vs. placebo 6.8 ± 0.1 vs. 7.5 ± 0.1%; difference −0.7 (−0.8, −0.5)%, P < 0.001] and more individuals achieved glycaemic targets (HbA1c < 7.0% 70 vs. 34%, P < 0.001). The proportion of individuals reporting at least one hypoglycaemic event during the last 12 weeks of treatment was similar in the two groups (rosiglitazone + metformin vs. placebo 25 vs. 27%). People receiving rosiglitazone + metformin in addition to insulin reported greater treatment satisfaction than those receiving insulin alone. Both treatment regimens were well tolerated but more participants had oedema [12 (7%) vs. 4 (3%)] and there was more weight gain [3.7 vs. 2.6 kg; difference 1.1 (0.2, 2.1) kg, P = 0.02] with rosiglitazone + metformin. Conclusions Addition of insulin to rosiglitazone + metformin enabled more people to reach glycaemic targets with less insulin, and was generally well tolerated. PMID:17403121

  12. Continuous epidural block versus continuous popliteal nerve block for postoperative pain relief after major podiatric surgery in children: a prospective, comparative randomized study.

    PubMed

    Dadure, Christophe; Bringuier, Sophie; Nicolas, Florence; Bromilow, Luke; Raux, Olivier; Rochette, Alain; Capdevila, Xavier

    2006-03-01

    Foot and ankle surgery in children is very painful postoperatively. Adverse effects from opioids and continuous epidural block (CEB) limit their use in children. Continuous popliteal nerve blocks (CPNB) have not been studied for this indication in children. In this prospective, randomized study we evaluated the effectiveness and adverse events of CPNB or CEB in children after podiatric surgery. Fifty-two children scheduled for foot surgery were separated into four groups by age and analgesia technique. After general anesthesia, 0.5 to 1 mL/kg of an equal-volume mixture of 0.25% bupivacaine and 1% lidocaine with 1:200000 epinephrine was injected via epidural or popliteal catheters. In the postoperative period, 0.1 mL x kg(-1) x h(-1) (group CPNB) or 0.2 mL x kg(-1) x h(-1) (group CEB) of 0.2% ropivacaine was administered for 48 h. Niflumic acid was routinely used. Adverse events were noted in each treatment group. Postoperative pain during motion was evaluated at 1, 6, 12, 18, 24, 36, and 48 h. Requirement for rescue analgesia (first-line propacetamol 30 mg/kg 4 times daily or second-line 0.2 mg/kg IV nalbuphine), and motor blockade were recorded. Parental satisfaction was noted at 48 h. Twenty-seven patients were included in the CEB groups and 25 in CPNB groups. There were 32 children 1 to 6 yr of age (CPNB = 15; CEB = 17) and 20 children 7 to 12 yr of age (CPNB = 10; CEB = 10). The demographic data were comparable among groups. Postoperative analgesia was excellent for the two continuous block techniques and in the two age groups. Motor block intensity was equal between techniques. Adverse events (postoperative nausea or vomiting, urinary retention, and premature discontinuation of local anesthetic infusion in the 1- to 6-yr-old group) were significantly more frequent in the CEB group (P < 0.05). Eighty-six percent of the parents in the CEB groups and 100% in the CPNB groups were satisfied. We conclude that although both CEB and CPNB resulted in excellent

  13. Efficacy and Safety of Modified Pranlukast (Prakanon®) Compared with Pranlukast (Onon®): A Randomized, Open-Label, Crossover Study

    PubMed Central

    Kim, Seo W.; Kim, Hunam; Ryu, Yon J.; Lee, Jin H.; Shim, Sung S.; Kim, Yoo K.; Chang, Jung H.

    2016-01-01

    Introduction: Pranlukast is a leukotriene receptor antagonist (LTRA) that is used as an additional controller of mild to moderate asthma. This study compared the efficacy and side effects of two bioequivalent preparations of pranlukast: original pranlukast (Onon®; Ono Pharmaceutical, Japan) and a modified formulation of pranlukast (Prakanon®; Yuhan Co, Korea) in patients with mild to moderate asthma. Methods: Of the 34 subjects screened, 30 patients who were using standard medication to control asthma and scored less than 20 points on the Asthma Control Test™ (ACT) were assigned randomly to one of the two groups in a prospective, open label, crossover study: group 1 received Prakanon® (150 mg/day) and group 2 received Onon® (450 mg/day) for 8 weeks each; after a 1-week rest period, the groups were switched to the alternative medication for further 8 weeks and monitored for 2 more weeks without study medication. Evaluation parameters included the ACT, quality of life questionnaire adult Korean asthmatics (QLQAKA), pulmonary function tests, peripheral blood tests, vital signs, and adverse events. Results: Thirty patients were enrolled and 21 completed the trial: 10 in group 1 and 11 in group 2. The baseline data of the two groups did not differ. No statistical significant differences were observed in efficacy and lung function at each time and in changes from baseline value between the two kinds of pranlukast. The final asthma control rate was 81% with Prakanon® and 76% with Onon®. There were no differences in vital signs and laboratory data at each time and in changes from baseline value between the two drugs. There were no differences in adverse events between the two drugs. The most common side effect was abdominal pain. Drug compliance was high, without differences between the two drugs. Conclusion: These findings suggest that Prakanon® which is an improved formulation of pranlukast at a lower dose than the original formulation, Onon®, has a similar

  14. Randomized, observer-blind, split-face study to compare the irritation potential of 2 topical acne formulations over a 14-day treatment period.

    PubMed

    Ting, William

    2012-08-01

    This randomized, observer-blind, split-face study assessed the irritation potential and likelihood of continued use of clindamycin phosphate 1.2%--benzoyl peroxide (BPO) 2.5% gel or adapalene 0.1%--BPO 2.5% gel once daily over a 14-day treatment period in 21 participants (11 males; 10 females) with acne who were 18 years or older. Investigator clinical assessment (erythema and dryness) and self-assessment (dryness and burning/stinging) were performed at baseline and each study visit (days 1-14) using a 4-point scale (O = none; 3 = severe). Transepidermal water loss (TEWL) and corneometry measurements were performed at baseline and days 3, 5, 7, 9, 11, and 14. Lesions were counted at baseline and on day 14. Participant satisfaction questionnaires were completed on days 7 and 14. At the end of the study, investigators reported none or only mild erythema in 86% (18/21) of participants treated with clindamycin phosphate 1.2%--BPO 2.5% gel compared with 62% (13/21) of participants treated with adapalene 0.1%--BPO 2.5% gel. No severe erythema was reported with clindamycin phosphate 1.2%--BPO 2.5% gel. Adapalene 0.1%--BPO 2.5% gel was prematurely discontinued due to severe erythema in 1 participant on day 5 and a second participant on day 9. Additionally, 2 more participants reported severe erythema on day 14. Mean erythema scores were 0.9 (mean change from baseline, 0.7) with clindamycin phosphate 1.2%--BPO 2.5% gel and 1.4 (mean change from baseline, 1.3) with adapalene 0. 1%--BPO 2.5% gel on day 14 (P < .05 for days 6-14). Similar results were seen with dryness. Mean scores were 0.5 (mean change from baseline, 0.4) and 1.0 (mean change from baseline, 1.0), respectively (P < .05 for days 6-14). Self-assessment, TEWL, and corneometry results underscored the investigator clinical assessment. Participant preference and likelihood of continued usage was greater with clindamycin phosphate 1.2%--BPO 2.5% gel. Continued use and efficacy results for the treatment of acne were

  15. FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject®) to placebo in patients with acute isovolemic anemia after gastrectomy - study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Isovolemic anemia (decrease in hemoglobin concentration with normal or even increased blood volume) after gastric cancer surgery may negatively influence short- and long-term outcomes. Therefore correction of isovolemic postoperative anemia is supposed to be beneficial. This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g/dl at 12 weeks after randomization. Methods and design Gastric cancer patients after oncologic resection and postoperative hemoglobin level ≥ 7 g/dl to <10 g/dl at postoperative days 5 to 7 will be eligible for trial inclusion. After randomization, 450 patients (225 per group) are going to be subjected either to administration of ferric carboxymaltose (treatment group) or normal (0.9%) saline (placebo group). Patients will be blinded to the intervention. Patients will undergo evaluation for hemoglobin level, hematology and quality of life assessment 3 and 12 weeks after randomization. Discussion Correction of isovolemic postoperative anemia in gastric cancer patients after oncologic resection is considered to be beneficial. Administration of ferric carboxymaltose is considered to be superior to placebo for anemia correction without the possible risks of red blood cell transfusion. Further, improved quality of life for patients with quick recovery of hemoglobin levels is expected. Trial registration NCT01725789 (international: http://www.clinicaltrials.gov) and NCCCTS-12-644 (NCC, Korea). PMID:24708660

  16. Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD

    PubMed Central

    2014-01-01

    Background The New Forest Parenting Programme (NFPP) is a home-delivered, evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder (ADHD) in preschool children. It has been adapted for use with ‘hard-to-reach’ or ‘difficult-to-treat’ children. This trial will compare the adapted-NFPP with a generic parenting group-based programme, Incredible Years (IY), which has been recommended for children with preschool-type ADHD symptoms. Methods/design This multicentre randomized controlled trial comprises three arms: adapted-NFPP, IY and treatment as usual (TAU). A sample of 329 parents of preschool-aged children with a research diagnosis of ADHD enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio 3:3:1. Participants in the adapted-NFPP and IY arms receive an induction visit followed by 12 weekly parenting sessions of 1½ hours (adapted-NFPP) or 2½ hours (IY) over 2.5 years. Adapted-NFPP will be delivered as a one-to-one home-based intervention; IY, as a group-based intervention. TAU participants are offered a parenting programme at the end of the study. The primary objective is to test whether the adapted-NFPP produces beneficial effects in terms of core ADHD symptoms. Secondary objectives include examination of the treatment impact on secondary outcomes, a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function. The primary outcome is change in ADHD symptoms, as measured by the parent-completed version of the SNAP-IV questionnaire, adjusted for pretreatment SNAP-IV score. Secondary outcome measures are: a validated index of behaviour during child’s solo play; teacher-reported SNAP-IV (ADHD scale); teacher and parent SNAP-IV (ODD) Scale; Eyberg Child Behaviour Inventory - Oppositional Defiant Disorder scale; Revised Client Service Receipt Inventory - Health

  17. Effect of directly observed antiretroviral therapy compared to self-administered antiretroviral therapy on adherence and virological outcomes among HIV-infected prisoners: a randomized controlled pilot study.

    PubMed

    White, Becky L; Golin, Carol E; Grodensky, Catherine A; Kiziah, C Nichole; Richardson, Amy; Hudgens, Michael G; Wohl, David A; Kaplan, Andrew H

    2015-01-01

    The effect of directly observed therapy (DOT) versus self-administered therapy (SAT) on antiretroviral (ART) adherence and virological outcomes in prison has never been assessed in a randomized, controlled trial. Prisoners were randomized to receive ART by DOT or SAT. The primary outcome was medication adherence [percent of ART doses measured by the medication event monitoring system (MEMS) and pill counts] at the end of 24 weeks. The changes in the plasma viral loads from baseline and proportion of participants virological suppressed (<400 copies/mL) at the end of 24 weeks were assessed. Sixty-six percent (90/136) of eligible prisoners declined participation. Participants in the DOT arm (n = 20) had higher viral loads than participants in the SAT (n = 23) arm (p = 0.23). Participants, with complete data at 24 weeks, were analyzed as randomized. There were no significant differences in median ART adherence between the DOT (n = 16, 99% MEMS [IQR 93.9, 100], 97.1 % pill count [IQR 95.1, 99.3]) and SAT (n = 21, 98.3 % MEMS [IQR 96.0, 100], 98.5 % pill count [95.8, 100]) arms (p = 0.82 MEMS, p = 0.40 Pill Count) at 24 weeks. Participants in the DOT arm had a greater reduction in viral load of approximately -1 log 10 copies/mL [IQR -1.75, -0.05] compared to -0.05 [IQR -0.45, 0.51] in the SAT arm (p value = 0.02) at 24 weeks. The proportion of participants achieving virological suppression in the DOT vs SAT arms was not statistically different at 24 weeks (53 % vs 32 %, p = 0.21). These findings suggest that DOT ART programs in prison settings may not offer any additional benefit on adherence than SAT programs. PMID:25055766

  18. Faster onset of antidepressant effects of citalopram compared with sertraline in drug-naïve first-episode major depressive disorder in a Chinese population: a 6-week double-blind, randomized comparative study.

    PubMed

    Hsu, Ju-Wei; Su, Tung-Ping; Huang, Chen-Ying; Chen, Ying-Sheue; Chou, Yuan-Hwa

    2011-10-01

    Several previous studies, including a meta-analysis, reported no significant differences between various selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depressive disorder. However, because of the different chemical structure of SSRIs and the difference in the frequency of serotonin transporter polymorphisms between ethnic groups, a head-to-head comparative study between SSRIs in different populations may be enlightening. We compared the efficacy and adverse effect profiles of citalopram and sertraline in a double-blinded randomized clinical trial in a Chinese population of drug-naïve patients with first-episode major depressive disorder. Fifty-one patients were randomly assigned to citalopram or sertraline treatment. The Montgomery-Åsberg Depression Rating Scale (MADRS) was used as the primary outcome. Efficacy and adverse effects were analyzed in an intent-to-treat population. Efficacy was analyzed using a last-observation-carried-forward method for early terminators. There were no significant differences in demographic characteristics at baseline. No significant differences were found in MADRS scores between citalopram and sertraline at baseline (36.6 ± 5.5 vs 38.2 ± 4.9; P = 0.322) or at the end of treatment (week 6; 10.8 ± 10.0 vs 16.7 ± 11.3; P = 0.082). However, MADRS scores in the citalopram group were significantly lower at week 1 (25.2 ± 8.5 vs 30.4 ± 6.1; P = 0.029) and week 3 (15.9 ± 10.0 vs 22.1 ± 8.7; P = 0.037). Overall, treatment-emergent adverse effects were reported by 14.3% and 28.6% of patients in the citalopram and sertraline groups, respectively. In conclusion, citalopram and sertraline were both efficacious and well tolerated. However, citalopram exhibited a significantly faster onset than sertraline during the early weeks of treatment and tended to have a better efficacy in overall treatment, although the statistic was not significant.

  19. A 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm) in acne vulgaris: a randomized, double-blind comparative study.

    PubMed

    Habbema, L; Koopmans, B; Menke, H E; Doornweerd, S; De Boulle, K

    1989-10-01

    A double-blind, randomized multi-centre study was performed to evaluate the efficacy of a 4% erythromycin and zinc combination (Zineryt) versus 2% erythromycin (Eryderm). One-hundred and twenty-two patients suffering from acne vulgaris were treated with either Zineryt lotion or 2% erythromycin lotion. Acne grading and lesion counts for comedones, papules, pustules, nodules and macules were performed at each visit at 0, 1, 2, 4, 8 and 12 weeks. Treatment with Zineryt lotion was found to be more effective than with 2% erythromycin as regards the reduction in number of the acne lesions and the severity grade of the acne.

  20. Betrixaban compared with warfarin in patients with atrial fibrillation: results of a phase 2, randomized, dose-ranging study (Explore-Xa)

    PubMed Central

    Connolly, Stuart J.; Eikelboom, John; Dorian, Paul; Hohnloser, Stefan H.; Gretler, Daniel D.; Sinha, Uma; Ezekowitz, Michael D.

    2013-01-01

    Aims Patients with atrial fibrillation (AF) are at increased risk of stroke. Betrixaban is a novel oral factor Xa inhibitor administered once daily, mostly excreted unchanged in the bile and with low (17%) renal excretion. Methods and results Patients with AF and more than one risk factor for stroke were randomized to one of three blinded doses of betrixaban (40, 60, or 80 mg once daily) or unblinded warfarin, adjusted to an international normalized ratio of 2.0–3.0. The primary outcome was major or clinically relevant non-major bleeding. The mean follow-up was 147 days. Among 508 patients randomized, the mean CHADS2 score was 2.2; 87% of patients had previously received vitamin K antagonist therapy. The time in therapeutic range on warfarin was 63.4%. There were one, five, five, and seven patients with a primary outcome on betrixaban 40, 60, 80 mg daily, or warfarin, respectively. The rate of the primary outcome was lowest on betrixaban 40 mg (hazard ratio compared with warfarin = 0.14, exact stratified log-rank P-value 0.04, unadjusted for multiple testing). Rates of the primary outcome with betrixaban 60 or 80 mg were more similar to those of wafarin. Two ischaemic strokes occurred, one each on betrixaban 60 and 80 mg daily. There were two vascular deaths, one each on betrixaban 40 mg and warfarin. Betrixaban was associated with higher rates of diarrhoea than warfarin. Conclusion Betrixaban was well tolerated and had similar or lower rates of bleeding compared with well-controlled warfarin in patients with AF at risk for stroke. PMID:23487517

  1. Comparative Evaluation of Dexmedetomidine and Magnesium Sulphate on Propofol Consumption, Haemodynamics and Postoperative Recovery in Spine Surgery: A Prospective, Randomized, Placebo Controlled, Double-blind Study

    PubMed Central

    Srivastava, Vinit K.; Mishra, Abhishek; Agrawal, Sanjay; Kumar, Sanjay; Sharma, Sunil; Kumar, Raj

    2016-01-01

    Purpose: Dexmedetomidine and magnesium sulfate have been used in anesthesia as adjuvant to provide hemodynamic stability and anesthetic agents sparing effect. We compared these effects of dexmedetomidine and magnesium sulfate in spine surgeries. Methods: Ninety patients were randomly assigned to three groups. Group D received dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.5 µg/kg/h throughout the surgery. Group M received magnesium sulfate loading dose 50 mg/kg over a period of 15 minutes and maintenance 15 mg/kg/h throughout the surgery. Group C received same volume of normal saline. Heart rate (HR) and blood pressure values were recorded at various intervals. The induction and maintenance doses of anesthetics and recovery parameters were also recorded. Results: Heart rate in group D and group M were significantly decreased (p<0.05) during the whole intraoperative period compared to preoperative values. There was a significant difference in HR values between group C, D and M, during the whole intraoperaive period (p<0.05). Blood pressure values were statistically significantly lower in the group D and group M compared to group C after intubation and all time observations of surgery (p<0.05). Both drugs reduced the anesthetic agent’s requirement during surgery. However, the recovery parameters were statistically significant increase with magnesium sulphate compared to dexmedetomidine and control groups. Conclusion: Dexmedetomidine is more effective than magnesium sulfate for maintaining the hemodynamic stability in spine surgeries. Both these drugs also reduce the requirements of anesthetic agents. Recovery from dexmedetomidine is as rapid as control group compared to magnesium sulfate. PMID:27123421

  2. Role of butorphanol and ondansetron premedication in reducing postoperative shivering after general and spinal anesthesia: A randomized comparative study from North India

    PubMed Central

    Rai, Sujeet; Verma, Satyajeet; Pandey, H. P.; Yadav, Pramod; Patel, Amit

    2016-01-01

    Background: Postoperative shivering (PAS) is a common problem following general and spinal anesthesia and may lead to multiple complications. This placebo-controlled, randomized study was performed to evaluate the efficacy of Ondansetron and butorphanol premedication reduces shivering after general and spinal anaesthesia. Aims: The aim of this study to highlight the efficacy of Butorphenol and ondosteron in controlling postoperative shivering. Materials and Methods: This clinical trial included 180 patients scheduled for elective general surgery, E.N.T., Ophthamological operations, randomly divided to six groups. Three groups in which General Anaesthesia was used i.e. Group 1-ondansetron 8 mg intravenously(IV).Group 2 butorphanol 2 mg IV and Group 3 – saline 4 ml IV. And three groups where spinal Anaesthesia was used i.e. Group 4-Ondosteron 8 mg IV, Group 5 butorphanol 2 mg IV and Group 6 – saline 4 ml IV 3-5 minutes before anaesthesia. Patients were observed in terms of vital signs, side effects and shivering. Settings and Design: The type of the study was double blind randomized trial. Statistical Analysis Used: Statistical Package for Social Sciences version 13.0 statistical analysis software. Results: Postoperative shivering was observed in 15.5%, 22.2% and 60% in general anaesthesia groups I II and III respectively. The reduction of core and dermal temperature during the anaesthesia and recovery, changes in systolic and diastolic blood pressure and heart rate were similar in all three groups (i.e. Group I,II,III). In spinal anaesthesia groups, PAS occurred 10%, 13.3% and 43.3% in group IV, V, VI respectively. The reduction of core temperature is similar in all three groups of spinal anaesthesia. But heart rate and mean arterial pressure increase were significant in control saline group in post operative recovery time. No complication seen in any of the six groups. Conclusion: This study suggested that use of Butorphanol and Ondansteron both are effective

  3. Comparative Effects of Dexmedetomidine and Propofol on US-Guided Radiofrequency Ablation of Hepatic Neoplasm Under Monitored Anesthesia Care: A Randomized Controlled Study.

    PubMed

    Joung, Kyoung-Woon; Choi, Seong-Soo; Jang, Dong-Min; Kong, Yu-Gyeong; Lee, Hwa-Mi; Shim, Ji-Hoon; Won, Hyung-Jin; Shin, Yong-Moon; Kim, Pyo-Nyun; Song, Myung-Hee

    2015-08-01

    Percutaneous radiofrequency ablation (RFA) is a useful and safe procedure for treating hepatic neoplasm. However, liver RFA causes severe pain, which thereby increases the demand for monitored anesthesia care (MAC). Here, we compared the efficacy and safety of propofol and dexmedetomidine, which are commonly administered during MAC when performing RFA to assess hepatic neoplasm.In this randomized controlled trial, 40 patients were randomly allocated to 2 groups for elective RFA. Patients received either dexmedetomidine (group D) or propofol (group P). Both groups received the continuous infusion of remifentanil for pain control. The primary outcomes were opioid consumption and differences in partial pressure of arterial carbon dioxide (PaCO2) between pre- and postprocedure RFA. In addition, hemodynamic parameters, patient satisfaction, and interventional radiologist satisfaction were determined.There were significant differences in opioid consumption (50.1 ± 16.8 ng/kg/min [group D] vs 71.2 ± 18.7 ng/kg/min [group P]; P = 0.001) and delta PaCO2 (10.4 ± 6.4 mm Hg vs 17.2 ± 9.2 mm Hg, respectively; P = 0.016). Moreover, respiratory rates were significantly different between groups during RFA (P < 0.001). However, blood pressure and heart rate did not significantly change during RFA. Neither patient nor interventional radiologist satisfaction was significantly different between groups.Dexmedetomidine provides better respiratory stability and reduces opioid consumption in comparison with propofol when administered under MAC when performing RFA for hepatic neoplasm.

  4. Randomized controlled comparative study on effect of training to improve lower limb motor paralysis in convalescent patients with post-stroke hemiplegia

    PubMed Central

    Kawakami, Kenji; Miyasaka, Hiroyuki; Nonoyama, Sayaka; Hayashi, Kazuya; Tonogai, Yusuke; Tanino, Genichi; Wada, Yosuke; Narukawa, Akihisa; Okuyama, Yuko; Tomita, Yutaka; Sonoda, Shigeru

    2015-01-01

    [Purpose] The motor paralysis-improving effect on the hemiplegic lower limb was compared among mirror therapy, integrated volitional-control electrical stimulation, therapeutic electrical stimulation, repetitive facilitative exercises, and the standard training method in post-stroke hemiplegia patients. [Subjects and Methods] Eighty one stroke patients admitted to a convalescent rehabilitation ward were randomly allocated to the above 5 treatment groups. Each patient performed functional training of the paralytic lower limb for 20 minutes a day for 4 weeks, and changes in the lower limb function were investigated using the Stroke Impairment Assessment Set. [Results] The hip and knee joint functions did not significantly improve in the standard training control group, but significant improvements were observed after 4 weeks in the other intervention groups. Significant improvement was noted in the ankle joint function in all groups. [Conclusion] Although the results were influenced by spontaneous recovery and the standard training in the control group, the hip and knee joints were more markedly improved by the interventions in the other 4 groups of patients with moderate paralysis, compared to the control group. PMID:26504331

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

    PubMed Central

    Gomersall, Timothy; Bowen, Audrey

    2013-01-01

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

  6. A randomized crossover study comparing trehalose/hyaluronate eyedrops and standard treatment: patient satisfaction in the treatment of dry eye syndrome.

    PubMed

    Pinto-Bonilla, Juan Carlos; Del Olmo-Jimeno, Alberto; Llovet-Osuna, Fernando; Hernández-Galilea, Emiliano

    2015-01-01

    Dry eye is a common disorder in routine ophthalmological practice, and a better understanding of the complex pathophysiology is leading to improved treatment. Thealoz Duo(®) is a novel artificial tear preparation containing two active ingredients: Trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. In a randomized, single center, open label, crossover study, 17 adult patients with moderate-to-severe dry eye syndrome were randomized to treatment with Thealoz Duo(®) (combining trehalose and hyaluronic acid) or Systane(®). Patients received 7 days of treatment. The primary efficacy variable was patient satisfaction evaluated by a 0-100 visual analog scale evaluated on days 0 and 7 of treatment. Secondary parameters included ocular surface disease index (OSDI), symptoms of dry eye, ocular staining scores (fluorescein and lissamine green), ocular clinical signs, Schirmer test, tear breakup time, and global efficacy assessed by the patient and the investigator. Seventeen patients were included. Patient satisfaction improved from 44.5±19.0 to 70.2±19.2 mm during Thealoz Duo(®) treatment and from 47.2±23 to 57.1±19.1 mm during Systane(®) treatment (P=0.043, mixed-effects analysis of covariance). Two secondary efficacy parameters (dry eye symptoms and the impact of their symptoms on work) showed statistically significant advantages for Thealoz Duo(®) over Systane(®). There were no statistically significant advantages for Systane(®) over Thealoz Duo(®) for any measured parameter. No adverse events were reported. Thealoz Duo(®) appears to be an effective combination of two active ingredients for the treatment of dry eye and is at least as effective as Systane(®).

  7. A randomized crossover study comparing trehalose/hyaluronate eyedrops and standard treatment: patient satisfaction in the treatment of dry eye syndrome

    PubMed Central

    Pinto-Bonilla, Juan Carlos; del Olmo-Jimeno, Alberto; Llovet-Osuna, Fernando; Hernández-Galilea, Emiliano

    2015-01-01

    Dry eye is a common disorder in routine ophthalmological practice, and a better understanding of the complex pathophysiology is leading to improved treatment. Thealoz Duo® is a novel artificial tear preparation containing two active ingredients: Trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. In a randomized, single center, open label, crossover study, 17 adult patients with moderate-to-severe dry eye syndrome were randomized to treatment with Thealoz Duo® (combining trehalose and hyaluronic acid) or Systane®. Patients received 7 days of treatment. The primary efficacy variable was patient satisfaction evaluated by a 0–100 visual analog scale evaluated on days 0 and 7 of treatment. Secondary parameters included ocular surface disease index (OSDI), symptoms of dry eye, ocular staining scores (fluorescein and lissamine green), ocular clinical signs, Schirmer test, tear breakup time, and global efficacy assessed by the patient and the investigator. Seventeen patients were included. Patient satisfaction improved from 44.5±19.0 to 70.2±19.2 mm during Thealoz Duo® treatment and from 47.2±23 to 57.1±19.1 mm during Systane® treatment (P=0.043, mixed-effects analysis of covariance). Two secondary efficacy parameters (dry eye symptoms and the impact of their symptoms on work) showed statistically significant advantages for Thealoz Duo® over Systane®. There were no statistically significant advantages for Systane® over Thealoz Duo® for any measured parameter. No adverse events were reported. Thealoz Duo® appears to be an effective combination of two active ingredients for the treatment of dry eye and is at least as effective as Systane®. PMID:25926736

  8. Topical nicotinamide in combination with calcipotriol for the treatment of mild to moderate psoriasis: A double-blind, randomized, comparative study

    PubMed Central

    Siadat, Amir Hossein; Iraji, Fariba; Khodadadi, Mehdi; Jary, Maryam Kalateh

    2013-01-01

    Background: Current treatment strategies of psoriasis are not completely satisfactorily. By inhibiting inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments. We investigated whether the combination of topical calcipotriol and nicotinamide is more effective than calcipotriol alone in treatment of psoriasis. Materials and Methods: Adult patients with mild to moderate psoriasis were randomized to receive topical calcipotriol 0.005% and nicotinamide 4% in combination or calcipotriol 0.005% alone, twice daily for 12 weeks. Patients were visited by a dermatologist at baseline and then after the first and third month of therapy, and psoriasis severity was evaluated using the modified psoriasis area and severity index (PASI). Also, patient's satisfaction was evaluated at the end of the trial using a 10-point rating scale. Results: Sixty-five patients (35 males, mean age = 36.5 ± 8.5 years) completed the trial. Lesions on both sides were similar regarding baseline PASI score. At the end of the trial, PASI score was more reduced with calcipotriol+nicotinamide compared to calcipotriol alone (83.6 ± 7.9% vs. 77.8 ± 9.7%, P < 0.001). Patients were also more satisfied with the improvement of lesions with calcipotriol+nicotinamide compared with calcipotriol alone (P < 0.001). Side effects included mild erythema and pruritus (4.6%) and moderate burning and sensitivity to light (3.0%). Conclusions: Nicotinamide can enhance the efficacy of calcipotriol when used in combination for topical psoriasis treatment, and it may be a good adjuvant to the current treatment regimens of psoriasis. PMID:24520552

  9. Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004.

    PubMed

    Creutzig, Ursula; Zimmermann, Martin; Bourquin, Jean-Pierre; Dworzak, Michael N; Fleischhack, Gudrun; Graf, Norbert; Klingebiel, Thomas; Kremens, Bernhard; Lehrnbecher, Thomas; von Neuhoff, Christine; Ritter, Jörg; Sander, Annette; Schrauder, André; von Stackelberg, Arend; Starý, Jan; Reinhardt, Dirk

    2013-07-01

    Outcomes of patients with acute myeloid leukemia (AML) improve significantly by intensification of induction. To further intensify anthracycline dosage without increasing cardiotoxicity, we compared potentially less cardiotoxic liposomal daunorubicin (L-DNR) to idarubicin at a higher-than-equivalent dose (80 vs 12 mg/m(2) per day for 3 days) during induction. In the multicenter therapy-optimization trial AML-BFM 2004, 521 of 611 pediatric patients (85%) were randomly assigned to L-DNR or idarubicin induction. Five-year results in both treatment arms were similar (overall survival 76% ± 3% [L-DNR] vs 75% ± 3% [idarubicin], Plogrank = .65; event-free survival [EFS] 59% ± 3% vs 53% ± 3%, Plogrank = .25; cumulative incidence of relapse 29% ± 3% vs 31% ± 3%, P(Gray) = .75), as were EFS results for standard (72% ± 5% vs 68% ± 5%, Plogrank = .47) and high-risk (51% ± 4% vs 46% ± 4%, Plogrank = .45) patients. L-DNR resulted in significantly better probability of EFS in patients with t(8;21). Overall, treatment-related mortality was lower with L-DNR than idarubicin (2/257 vs 10/264 patients, P = .04). Grade 3/4 cardiotoxicity was rare after induction (4 L-DNR vs 5 idarubicin). Only 1 L-DNR and 3 idarubicin patients presented with subclinical or mild cardiomyopathy during follow-up. In conclusion, at the given dose, L-DNR has overall antileukemic activity comparable to idarubicin, promises to be more active in subgroups, and causes less treatment-related mortality. This trial was registered at www.clinicaltrials.gov as #NCT00111345. PMID:23704089

  10. Effectiveness of Hexetidine 0.1% Compared to Chlorhexidine Digluconate 0.12% in Eliminating Candida Albicans Colonizing Dentures: A Randomized Clinical In Vivo Study

    PubMed Central

    Aoun, Georges; Saadeh, Maria; Berberi, Antoine

    2015-01-01

    Background: Denture hygiene is an important factor in the prevention and treatment of denture stomatitis (DS). This study aimed to evaluate the efficacy of two different mouthwashes (chlorhexidine digluconate 0.12% and hexetidine 0.1%) in eliminating Candida albicans on dentures. Materials and Methods: A total of 60 denture wearers (20 men, 40 women; age range 40-80 years) with clinical evidence of DS were randomly divided into 2 test groups and 1 control group. The dentures of each test group were treated by immersion in one of the two mouthwashes while those of the control group were immersed in distilled water. Swab samples from the palatal surfaces of the upper dentures were collected before and after of cleaner use and examined mycologically. Results: Reduction in the number of colony-forming units of Candida albicans after immersion of the dentures with chlorhexidine digluconate 0.12% was significantly greater than that of the group using hexetidine 0.1% and those of the control group. Conclusion: Hexetidine 0.1% solution tested for the first time as a product of disinfection of the acrylic dentures showed average results after immersion of 8 night hours for 4 days and was less effective than chlorhexidine digluconate 0.12%. PMID:26464531

  11. Phase II, Randomized, Double-Blind, Multicenter Study Comparing the Safety and Pharmacokinetics of Tefibazumab to Placebo for Treatment of Staphylococcus aureus Bacteremia

    PubMed Central

    Weems, J. John; Steinberg, James P.; Filler, Scott; Baddley, John W.; Corey, G. Ralph; Sampathkumar, Priya; Winston, Lisa; John, Joseph F.; Kubin, Christine J.; Talwani, Rohit; Moore, Thomas; Patti, Joseph M.; Hetherington, Seth; Texter, Michele; Wenzel, Eric; Kelley, Violet A.; Fowler, Vance G.

    2006-01-01

    Tefibazumab (Aurexis), a humanized monoclonal antibody that binds to the surface-expressed adhesion protein clumping factor A, is under development as adjunctive therapy for serious Staphylococcus aureus infections. Sixty patients with documented S. aureus bacteremia (SAB) were randomized and received either tefibazumab at 20 mg/kg of body weight as a single infusion or a placebo in addition to an antibiotic(s). The primary objective of the study was determining safety and pharmacokinetics. An additional objective was to assess activity by a composite clinical end point (CCE). Baseline characteristics were evenly matched between groups. Seventy percent of infections were healthcare associated, and 57% had an SAB-related complication at baseline. There were no differences between the treatment groups in overall adverse clinical events or alterations in laboratory values. Two patients developed serious adverse events that were at least possibly related to tefibazumab; one hypersensitivity reaction was considered definitely related. The tefibazumab plasma half-life was 18 days. Mean plasma levels were <100 μg/ml by day 14. A CCE occurred in six patients (four placebo and two tefibazumab patients) and included five deaths (four placebo and one tefibazumab patient). Progression in the severity of sepsis occurred in four placebo and no tefibazumab patients. Tefibazumab was well tolerated, with a safety profile similar to those of other monoclonal antibodies. Additional trials are warranted to address the dosing range and efficacy of tefibazumab. PMID:16870768

  12. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia

    PubMed Central

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    Background Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. Material/Methods In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. Results A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). Conclusions Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH. PMID:27260129

  13. A Randomized, Open-Label, Comparative Study of Efficacy and Safety of Tolterodine Combined with Tamsulosin or Doxazosin in Patients with Benign Prostatic Hyperplasia.

    PubMed

    Cao, Yanwei; Wang, Yonghua; Guo, Lei; Yang, Xuecheng; Chen, Tao; Niu, Haitao

    2016-01-01

    BACKGROUND Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. MATERIAL AND METHODS In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. RESULTS A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). CONCLUSIONS Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH.

  14. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial

    PubMed Central

    Thow, Megan; Ferguson, Stuart G

    2016-01-01

    Background Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was

  15. Randomized trial of guiding hypertension management using central aortic blood pressure compared with best-practice care: principal findings of the BP GUIDE study.

    PubMed

    Sharman, James E; Marwick, Thomas H; Gilroy, Deborah; Otahal, Petr; Abhayaratna, Walter P; Stowasser, Michael

    2013-12-01

    Arm cuff blood pressure (BP) may overestimate cardiovascular risk. Central aortic BP predicts mortality and could be a better method for patient management. We sought to determine the usefulness of central BP to guide hypertension management. This was a prospective, open-label, blinded-end point study in 286 patients with hypertension randomized to treatment decisions guided by best-practice usual care (n=142; using office, home, and 24-hour ambulatory BP) or, in addition, by central BP intervention (n=144; using SphygmoCor). Therapy was reviewed every 3 months for 12 months, and recommendations were provided to each patient and his/her doctor on antihypertensive medication titration. Outcome measures were as follows: medication quantity (daily defined dose), quality of life, and left ventricular mass (3-dimensional echocardiography). There was 92% compliance with recommendations on medication titration, and quality of life improved in both groups (post hoc P<0.05). For usual care, there was no change in daily defined dose (all P>0.10), but with intervention there was a significant stepwise decrease in daily defined dose from baseline to 3 months (P=0.008) and each subsequent visit (all P<0.001). Intervention was associated with cessation of medication in 23 (16%) patients versus 3 (2%) in usual care (P<0.001). Despite this, there were no differences between groups in left ventricular mass index, 24-hour ambulatory BP, home systolic BP, or aortic stiffness (all P>0.05). We conclude that guidance of hypertension management with central BP results in a significantly different therapeutic pathway than conventional cuff BP, with less use of medication to achieve BP control and no adverse effects on left ventricular mass, aortic stiffness, or quality of life.

  16. The safety and effectiveness of a long-acting transdermal fentanyl solution compared with oxymorphone for the control of postoperative pain in dogs: a randomized, multicentered clinical study

    PubMed Central

    Martinez, S A; Wilson, M G; Linton, D D; Newbound, G C; Freise, K J; Lin, T-L; Clark, T P

    2014-01-01

    A prospective, double-blinded, positive-controlled, multicenter, noninferiority study was conducted to evaluate the safety and effectiveness of transdermal fentanyl solution (TFS) compared with oxymorphone for the control of postoperative pain in dogs. Five hundred and two (502) client-owned dogs were assigned to a single dose of TFS (2.7 mg/kg) applied 2–4 h prior to surgery or oxymorphone hydrochloride (0.22 mg/kg) administered subcutaneously 2–4 h prior to surgery and q6h through 90 h. Pain was evaluated over 4 days by blinded observers using a modified Glasgow composite pain scale, and the a priori criteria for treatment failure was a pain score ≥8 or adverse event necessitating withdrawal. Four TFS- and eight oxymorphone-treated dogs were withdrawn due to lack of pain control. Eighteen oxymorphone-treated, but no TFS-treated dogs were withdrawn due to severe adverse events. The one-sided upper 95% confidence interval of the difference between TFS and oxymorphone treatment failure rates was −5.3%. Adverse events associated with oxymorphone were greater in number and severity compared with TFS. It was concluded that a single administration of TFS was safe and noninferior to repeated injections of oxymorphone for the control of postoperative pain over 4 days at the dose rates of both formulations used in this study. PMID:24344787

  17. Comparative effects of unilateral and bilateral subthalamic nucleus deep brain stimulation on gait kinematics in Parkinson's disease: a randomized, blinded study.

    PubMed

    Lizarraga, Karlo J; Jagid, Jonathan R; Luca, Corneliu C

    2016-08-01

    Gait dysfunction in Parkinson's disease (PD) does not always respond to bilateral subthalamic nucleus deep brain stimulation (STN-DBS). Since right hemisphere motor networks may be dominant for gait control, identical stimulation of asymmetric circuits could account for gait dysfunction. We compared the effects of bilateral and unilateral STN-DBS on gait kinematics in PD patients who developed gait impairment after STN-DBS. Twenty-two PD patients with >50 % improvement in motor scores, but dopamine-resistant gait dysfunction 6-12 months after bilateral STN-DBS were blindly tested off dopaminergic effects in four randomly assigned DBS conditions: bilateral, right-sided, left-sided and off stimulation. Motor scores (MDS-UPDRS III), gait scores (MDS-UPRDS 2.11-2.13 + 3.9-3.13), turning time (seconds), stride length (meters) and velocity (meters/second) were measured 1 h after DBS changes. Motor and gait scores significantly improved with bilateral versus unilateral STN-DBS. Stride length and velocity (0.95 ± 0.06, 0.84 ± 0.07) significantly improved with bilateral (1.09 ± 0.04, 0.95 ± 0.05), right-sided (1.06 ± 0.04, 0.92 ± 0.05) and left-sided stimulation (1.01 ± 0.05, 0.90 ± 0.05) (p < 0.05). Stride length significantly improved with right-sided versus left-sided (0.05 ± 0.02) and bilateral versus left-sided stimulation (0.07 ± 0.02) (p < 0.05). Turning time (4.89 ± 0.6) tended to improve with bilateral (4.13 ± 0.5) (p = 0.15) and right-sided (4.27 ± 0.6) (p = 0.2) more than with left STN-DBS (4.69 ± 0.5) (p = 0.5). Bilateral STN-DBS yields greater improvement in motor and gait scores in PD patients. Yet, unilateral stimulation has similar effects on gait kinematics. Particularly, right-sided stimulation might produce slightly greater improvements. Although the clinical relevance of differential programming of right versus left-sided STN-DBS is unclear, this approach could be considered in the management of

  18. Safety and Efficacy of Gadobutrol for Contrast-enhanced Magnetic Resonance Imaging of the Central Nervous System: Results from a Multicenter, Double-blind, Randomized, Comparator Study

    PubMed Central

    Gutierrez, Juan E; Rosenberg, Martin; Seemann, Jörg; Breuer, Josy; Haverstock, Daniel; Agris, Jacob; Balzer, Thomas; Anzalone, Nicoletta

    2015-01-01

    PURPOSE Contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) with gadolinium-based contrast agents (GBCAs) is standard of care for CNS imaging and diagnosis because of the visualization of lesions that cause blood–brain barrier breakdown. Gadobutrol is a macrocyclic GBCA with high concentration and high relaxivity. The objective of this study was to compare the safety and efficacy of gadobutrol 1.0 M vs unenhanced imaging and vs the approved macrocyclic agent gadoteridol 0.5 M at a dose of 0.1 mmol/kg bodyweight. MATERIALS AND METHODS Prospective, multicenter, double-blind, crossover trial in patients who underwent unenhanced MRI followed by enhanced imaging with gadobutrol or gadoteridol. Three blinded readers assessed the magnetic resonance images. The primary efficacy variables included number of lesions detected, degree of lesion contrast-enhancement, lesion border delineation, and lesion internal morphology. RESULTS Of the 402 treated patients, 390 patients received study drugs. Lesion contrast-enhancement, lesion border delineation, and lesion internal morphology were superior for combined unenhanced/gadobutrol-enhanced imaging vs unenhanced imaging (P < 0.0001 for all). Compared with gadoteridol, gadobutrol was non-inferior for all primary variables and superior for lesion contrast-enhancement, as well as sensitivity and accuracy for detection of malignant disease. The percentage of patients with at least one drug-related adverse event was similar for gadobutrol (10.0%) and gadoteridol (9.7%). CONCLUSION Gadobutrol is an effective and well-tolerated macrocyclic contrast agent for MRI of the CNS. Gadobutrol demonstrates greater contrast-enhancement and improved sensitivity and accuracy for detection of malignant disease than gadoteridol, likely because of its higher relaxivity. PMID:25922578

  19. Comparative Packaging Study

    NASA Technical Reports Server (NTRS)

    Perchonok, Michele; Antonini, David

    2008-01-01

    This viewgraph presentation describes a comparative packaging study for use on long duration space missions. The topics include: 1) Purpose; 2) Deliverables; 3) Food Sample Selection; 4) Experimental Design Matrix; 5) Permeation Rate Comparison; and 6) Packaging Material Information.

  20. A Randomized Case-Series Study Comparing the Stability of Implant with Two Different Surfaces Placed in Fresh Extraction Sockets and Immediately Loaded.

    PubMed

    Vanden Bogaerde, Leonardo; Sennerby, Lars

    2016-01-01

    Background. Hydrophilic and moderately rough implant surfaces have been proposed to enhance the osseointegration response. Aim. The aim of this study was to compare early changes of stability for two implants with identical macrodesign but with different surface topographies. Materials and Methods. In 11 patients, a total of 22 implants (11 bimodal (minimally rough, control) and 11 proactive (moderately rough and hydrophilic, test), Neoss Ltd., Harrogate, UK) were immediately placed into fresh extraction sockets and immediately loaded. The peak insertion torque (IT) was measured in Ncm at placement. Resonance Frequency Analysis (RFA) measurements were made at baseline and 2, 4, 6, and 12 weeks after surgery. Results. The two implant types showed similar IT and RFA values at placement (NS). A dip of RFA values after 2 weeks followed by an increase was observed, where the test implant showed a less pronounced decrease and a more rapid recovery than the control implant. The test implants were significantly more stable than the control ones after 12 weeks. Conclusions. The results from the present study indicated that the hydrophilic and rougher test implant was more resistant to immediate loading and showed a significantly higher stability than the smoother control implant after 12 weeks.

  1. A Randomized Case-Series Study Comparing the Stability of Implant with Two Different Surfaces Placed in Fresh Extraction Sockets and Immediately Loaded.

    PubMed

    Vanden Bogaerde, Leonardo; Sennerby, Lars

    2016-01-01

    Background. Hydrophilic and moderately rough implant surfaces have been proposed to enhance the osseointegration response. Aim. The aim of this study was to compare early changes of stability for two implants with identical macrodesign but with different surface topographies. Materials and Methods. In 11 patients, a total of 22 implants (11 bimodal (minimally rough, control) and 11 proactive (moderately rough and hydrophilic, test), Neoss Ltd., Harrogate, UK) were immediately placed into fresh extraction sockets and immediately loaded. The peak insertion torque (IT) was measured in Ncm at placement. Resonance Frequency Analysis (RFA) measurements were made at baseline and 2, 4, 6, and 12 weeks after surgery. Results. The two implant types showed similar IT and RFA values at placement (NS). A dip of RFA values after 2 weeks followed by an increase was observed, where the test implant showed a less pronounced decrease and a more rapid recovery than the control implant. The test implants were significantly more stable than the control ones after 12 weeks. Conclusions. The results from the present study indicated that the hydrophilic and rougher test implant was more resistant to immediate loading and showed a significantly higher stability than the smoother control implant after 12 weeks. PMID:27042180

  2. A Randomized Case-Series Study Comparing the Stability of Implant with Two Different Surfaces Placed in Fresh Extraction Sockets and Immediately Loaded

    PubMed Central

    Vanden Bogaerde, Leonardo; Sennerby, Lars

    2016-01-01

    Background. Hydrophilic and moderately rough implant surfaces have been proposed to enhance the osseointegration response. Aim. The aim of this study was to compare early changes of stability for two implants with identical macrodesign but with different surface topographies. Materials and Methods. In 11 patients, a total of 22 implants (11 bimodal (minimally rough, control) and 11 proactive (moderately rough and hydrophilic, test), Neoss Ltd., Harrogate, UK) were immediately placed into fresh extraction sockets and immediately loaded. The peak insertion torque (IT) was measured in Ncm at placement. Resonance Frequency Analysis (RFA) measurements were made at baseline and 2, 4, 6, and 12 weeks after surgery. Results. The two implant types showed similar IT and RFA values at placement (NS). A dip of RFA values after 2 weeks followed by an increase was observed, where the test implant showed a less pronounced decrease and a more rapid recovery than the control implant. The test implants were significantly more stable than the control ones after 12 weeks. Conclusions. The results from the present study indicated that the hydrophilic and rougher test implant was more resistant to immediate loading and showed a significantly higher stability than the smoother control implant after 12 weeks. PMID:27042180

  3. Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study

    PubMed Central

    Chéreau, Elisabeth; Uzan, Catherine; Boutmy-Deslandes, Emmanuelle; Zohar, Sarah; Bézu, Corinne; Mazouni, Chafika; Garbay, Jean-Rémi; Daraï, Emile; Rouzier, Roman

    2016-01-01

    Objective The aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection. Setting This prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres. Participants All female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure. Interventions Patients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner. Primary and Secondary Outcome Measures The primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph. Results Ninety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia. Conclusions With this phase 2 preliminary study, even if our results indicate a trend towards a reduction in

  4. Design, conduct, and analyses of Breast International Group (BIG) 1-98: A randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer

    PubMed Central

    Giobbie-Hurder, Anita; Price, Karen N; Gelber, Richard D

    2010-01-01

    Background Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. Purpose To present the design, history, and analytic challenges of the Breast International Group (BIG) 1-98 trial: an international, multicenter, randomized, double-blind, phase-III study comparing the aromatase inhibitor letrozole with tamoxifen in this clinical setting. Methods From 1998–2003, BIG 1-98 enrolled 8028 women to receive monotherapy with either tamoxifen or letrozole for 5 years, or sequential therapy of 2 years of one agent followed by 3 years of the other. Randomization to one of four treatment groups permitted two complementary analyses to be conducted several years apart. The first, reported in 2005, provided a head-to-head comparison of letrozole versus tamoxifen. Statistical power was increased by an enriched design, which included patients who were assigned sequential treatments until the time of the treatment switch. The second, reported in late 2008, used a conditional landmark approach to test the hypothesis that switching endocrine agents at approximately 2 years from randomization for patients who are disease-free is superior to continuing with the original agent. Results The 2005 analysis showed the superiority of letrozole compared with tamoxifen. The patients who were assigned tamoxifen alone were unblinded and offered the opportunity to switch to letrozole. Results from other trials increased the clinical relevance about whether or not to start treatment with letrozole or tamoxifen, and analysis plans were expanded to evaluate sequential versus single-agent strategies from randomization. Limitations Due to the unblinding of patients assigned tamoxifen alone, analysis of updated data will require ascertainment of the influence of selective crossover from tamoxifen to letrozole. Conclusions BIG 1-98 is an example of an enriched design, involving

  5. Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura. Danish I.T.P. Study Group.

    PubMed

    Rosthøj, S; Nielsen, S; Pedersen, F K

    1996-08-01

    Forty-three children with newly diagnosed idiopathic thrombocytopenic purpura (ITP), platelet count (PC) below 20 x 10(9)l-1, and either continued bleeding or failure to show a spontaneous rise in the PC after a 3 day observation period were randomized to treatment with either intravenous immunoglobulin (IVIG) infusions 1 g kg-1 (n = 23) or intravenous methylprednisolone pulse therapy (MPPT) 30 mg kg-1 (n = 20) on two consecutive days. After 72 h, IVIG had induced greater platelet responses (mean PC 188 x 10(9) versus 77 x 10(9)l-1, 2p < 0.001) and raised the PC to a haemostatically safe level above 50 x 10(9)l-1 more frequently (91 versus 50%, one-sided exact p = 0.003). Children responding poorly were then given the alternative treatment in addition. After 6 days, a normal PC of over 150 x 10(9)l-1 had been obtained more frequently in the group given first-line IVIG (70 versus 50%, p = 0.16). The relapse rates during 6 months of follow-up were not significantly different (26 versus 40%, p = 0.26). Cross-over treatment in 11 children with relapse confirmed the superior response to IVIG. The treatment given was restricted to the two initial infusions more often in the IVIG group (70 versus 35%, p = 0.05). These results indicate that IVIG may be preferable to MPPT as the initial treatment for ITP. PMID:8863869

  6. Comparative Immunogenicity of HIV-1 gp140 Vaccine Delivered by Parenteral, and Mucosal Routes in Female Volunteers; MUCOVAC2, A Randomized Two Centre Study

    PubMed Central

    Cope, Alethea V.; Bartolf, Angela; Morris, Georgina; Yan, Celine; Baden, Susan; Cole, Tom; Carter, Darrick; Brodnicki, Elizabeth; Shen, Xiaoying; Joseph, Sarah; DeRosa, Stephen C.; Peng, Lili; Yu, Xuesong; Ferrari, Guido; Seaman, Mike; Montefiori, David C.; Frahm, Nicole; Tomaras, Georgia D.; Stöhr, Wolfgang; McCormack, Sheena; Shattock, Robin J.

    2016-01-01

    Background Defining optimal routes for induction of mucosal immunity represents an important research priority for the HIV-1 vaccine field. In particular, it remains unclear whether mucosal routes of immunization can improve mucosal immune responses. Methods In this randomized two center phase I clinical trial we evaluated the systemic and mucosal immune response to a candidate HIV-1 Clade C CN54gp140 envelope glycoprotein vaccine administered by intramuscular (IM), intranasal (IN) and intravaginal (IVAG) routes of administration in HIV negative female volunteers. IM immunizations were co-administered with Glucopyranosyl Lipid Adjuvant (GLA), IN immunizations with 0.5% chitosan and IVAG immunizations were administered in an aqueous gel. Results Three IM immunizations of CN54 gp140 at either 20 or 100 μg elicited significantly greater systemic and mucosal antibodies than either IN or IVAG immunizations. Following additional intramuscular boosting we observed an anamnestic antibody response in nasally primed subjects. Modest neutralizing responses were detected against closely matched tier 1 clade C virus in the IM groups. Interestingly, the strongest CD4 T-cell responses were detected after IN and not IM immunization. Conclusions These data show that parenteral immunization elicits systemic and mucosal antibodies in women. Interestingly IN immunization was an effective prime for IM boost, while IVAG administration had no detectable impact on systemic or mucosal responses despite IM priming. Clinical Trials Registration EudraCT 2010-019103-27 and the UK Clinical Research Network (UKCRN) Number 11679 PMID:27159166

  7. A Prospective, Randomized Crossover Study Comparing Direct Inspection by Light Microscopy versus Projected Images for Teaching of Hematopathology to Medical Students

    ERIC Educational Resources Information Center

    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…

  8. A prospectively randomized trial carried out by the German Hodgkin Study Group (GHSG) for elderly patients with advanced Hodgkin's disease comparing BEACOPP baseline and COPP-ABVD (study HD9elderly).

    PubMed

    Ballova, V; Rüffer, J-U; Haverkamp, H; Pfistner, B; Müller-Hermelink, H K; Dühmke, E; Worst, P; Wilhelmy, M; Naumann, R; Hentrich, M; Eich, H T; Josting, A; Löffler, M; Diehl, V; Engert, A

    2005-01-01

    In contrast to younger patients, the prognosis of elderly patients with advanced Hodgkin's disease (HD) has not improved substantially over the last 20 years. We thus carried out a prospectively randomized study (HD9(elderly)) to compare the BEACOPP regimen in this setting against standard COPP-ABVD. Between February 1993 and 1998, 75 patients aged 66-75 years with newly diagnosed HD in advanced stages were recruited into the HD9 trial as a separate stratum (HD9(elderly)). Patients were assigned to eight alternating cycles of COPP and ABVD or eight cycles of BEACOPP in baseline doses. Radiotherapy was given to initial bulky or residual disease. In total, 68 of 75 registered patients were assessable: 26 were treated with COPP-ABVD and 42 with BEACOPP baseline. There were no significant differences between COPP-ABVD and BEACOPP in terms of complete remission (76%), overall survival (50%) and freedom from treatment failure (FFTF) (46%) at 5 years. At a median follow-up of 80 months, a total of 37 patients died: 14/26 patients (54%) treated with COPP-ABVD and 23/42 patients (55%) with BEACOPP. Two patients (8%) treated with COPP-ABVD and nine patients (21%) treated with BEACOPP died of acute toxicity. Hodgkin-specific FFTF at 5 years was 55% after COPP-ABVD and 74% after BEACOPP (P=0.13). Thus, there are no differences in survival between these regimens in elderly patients.

  9. AVP-825 Breath-Powered Intranasal Delivery System Containing 22 mg Sumatriptan Powder vs 100 mg Oral Sumatriptan in the Acute Treatment of Migraines (The COMPASS Study): A Comparative Randomized Clinical Trial Across Multiple Attacks

    PubMed Central

    Tepper, Stewart J; Cady, Roger K; Silberstein, Stephen; Messina, John; Mahmoud, Ramy A; Djupesland, Per G; Shin, Paul; Siffert, Joao

    2015-01-01

    Objective The objective of this study was to compare the efficacy, tolerability, and safety of AVP-825, an investigational bi-directional breath-powered intranasal delivery system containing low-dose (22 mg) sumatriptan powder, vs 100 mg oral sumatriptan for acute treatment of migraine in a double-dummy, randomized comparative efficacy clinical trial allowing treatment across multiple migraine attacks. Background In phases 2 and 3, randomized, placebo-controlled trials, AVP-825 provided early and sustained relief of moderate or severe migraine headache in adults, with a low incidence of triptan-related adverse effects. Methods This was a randomized, active-comparator, double-dummy, cross-over, multi-attack study (COMPASS; NCT01667679) with two ≤12-week double-blind periods. Subjects experiencing 2-8 migraines/month in the past year were randomized 1:1 using computer-generated sequences to AVP-825 plus oral placebo tablet or an identical placebo delivery system plus 100 mg oral sumatriptan tablet for the first period; patients switched treatment for the second period in this controlled comparative design. Subjects treated ≤5 qualifying migraines per period within 1 hour of onset, even if pain was mild. The primary end-point was the mean value of the summed pain intensity differences through 30 minutes post-dose (SPID-30) using Headache Severity scores. Secondary outcomes included pain relief, pain freedom, pain reduction, consistency of response across multiple migraines, migraine-associated symptoms, and atypical sensations. Safety was also assessed. Results A total of 275 adults were randomized, 174 (63.3%) completed the study (ie, completed the second treatment period), and 185 (67.3%) treated at least one migraine in both periods (1531 migraines assessed). There was significantly greater reduction in migraine pain intensity with AVP-825 vs oral sumatriptan in the first 30 minutes post-dose (least squares mean SPID-30 = 10.80 vs 7.41, adjusted mean

  10. Iodixanol Has a Favourable Fibrinolytic Profile Compared to Iohexol in Cardiac Patients Undergoing Elective Angiography: A Double-Blind, Randomized, Parallel Group Study

    PubMed Central

    Treweeke, Andrew T.; Maskrey, Benjamin H.; Hickson, Kirsty; Miller, John H.; Leslie, Stephen J.; Megson, Ian L.

    2016-01-01

    Background There is no consensus and a limited evidence base for choice of contrast agents (CA) in angiography. This study evaluated the impact of iohexol and iodixanol CA on fibrinolytic factors (tissue plasminogen activator [t-PA] and plasminogen activator inhibitor-1 [PAI-1]), as well as platelet-monocyte conjugates in cardiac patients undergoing elective angiography in a double-blind, randomised parallel group study. Methods Patients (men, 50–70 years old; n = 12) were randomised to receive either iohexol (Omnipaque; n = 6) or iodixanol (Visipaque; n = 6) during elective angiography at Raigmore Hospital, Inverness, UK. Arterial and venous blood samples were drawn prior to CA delivery and following angiography. Assessment of platelet-monocyte conjugation, t-PA and PAI-1 antigen and activity was conducted in samples pre- and post-angiography. Outcome Plasma t-PA antigen was depressed equally in the study groups after angiography, but there was a greater reduction in PAI-1 antigen in the group receiving iodixanol. These findings corresponded to a substantial reduction in t-PA activity in patients receiving iohexol, with no change in those receiving iodixanol (P = 0.023 between the CA groups). Both CAs caused a reduction in platelet-monocyte conjugation, with no difference between the groups. No adverse events were reported during the trial. Conclusion Avoiding reduced plasma t-PA activity might be an important consideration in choosing iodixanol over iohexol in patients at risk of thrombosis following angiography. The trial is registered on the ISRCTN register (ISRCTN51509735) and funded by the Coronary Thrombosis Trust and National Health Service (Highland) R&D Endowments. The funders had no influence over study design or reporting. Trial Registration Controlled-Trials.com ISRCTN51509735 PMID:26784323

  11. Fractional Erbium laser in the treatment of photoaging: randomized comparative, clinical and histopathological study of ablative (2940nm) vs. non-ablative (1540nm) methods after 3 months*

    PubMed Central

    Borges, Juliano; Cuzzi, Tullia; Mandarim-de-Lacerda, Carlos Alberto; Manela-Azulay, Mônica

    2014-01-01

    BACKGROUND Fractional non-ablative lasers keep the epidermis intact, while fractional ablative lasers remove it, making them theoretically more effective. OBJECTIVES To evaluate the clinical and histological alterations induced by fractional photothermolysis for treating photoaging, comparing the possible equivalence of multiple sessions of 1540nm Erbium, to one session of 2940nm Erbium. METHODS Eighteen patients (mean age 55.9) completed the treatment with three sessions of 1540nm fractional Erbium laser on one side of the face (50 mJ/mB, 15ms, 2 passes), and one session of 2940nm on the other side (5mJ/mB, 0.25ms, 2 passes). Biopsies were performed before and 3 months after treatment. Clinical, histological and morphometric evaluations were carried out. RESULTS All patients presented clinical improvement with no statistically significant difference (p> 0.05) between the treated sides. Histopathology revealed a new organization of collagen and elastic fibers, accompanied by edema, which was more evident with the 2940nm laser. This finding was confirmed by morphometry, which showed a decrease in collagen density for both treatments, with a statistical significance for the 2940nm laser (p > 0.001). CONCLUSIONS Three 1540nm sessions were clinically equivalent to one 2940nm session. The edema probably contributed to the positive results after three months, togheter with the new collagen and elastic fibers organization. The greater edema after the 2940nm session indicates that dermal remodeling takes longer than with 1540nm. It is possible that this histological superiority relates to a more prolonged effect, but a cohort longer than three months is needed to confirm that supposition. PMID:24770501

  12. A comparative, randomized, controlled study on clinical efficacy and dental staining reduction of a mouthwash containing Chlorhexidine 0.20% and Anti Discoloration System (ADS)

    PubMed Central

    Marrelli, Massimo; Amantea, Massimiliano; Tatullo, Marco

    2015-01-01

    Summary Introduction A good control of bacterial plaque is an essential factor for the success of periodontal therapy, therefore it is the main objective that the clinician together with the patient must get to have a healthy periodontium. The plaque control with mouthwashes is the most important home therapy as it helps to reduce the formation of plaque between the mechanical removal with a toothbrush. Aim Authors analyzed the clinical data from a trial carried out with 3 different mouthwashes containing 0.2% Chlorhexidine (CHX). In addition, the ADS (Anti Discoloration System - Curaden Healthcare) was tested in comparison with the other mouthwashes without this system. Materials and methods We tested antiplaque activity showed by 3 of the most commercialized mouthwashes, moreover, we tested the ability in reducing the dental staining related to the oral assumption of Chlorhexidine. Discussion and conclusion Our results demonstrated the clinical efficacy of the 3 mouthwashes with CHX. Particularly performing was the anti discoloration system (Curaden Healthcare), with a clinical detection of dental stainings significantly less than the others tested. This study demonstrated the clinical efficacy of ADS system in the reduction of tooth staining, without a loss of antiplaque activity with respect to the competing mouthwashes containing CHX. PMID:26330902

  13. A phase 2, randomized, double-blind, multicenter study comparing siltuximab plus best supportive care (BSC) with placebo plus BSC in anemic patients with International Prognostic Scoring System low- or intermediate-1-risk myelodysplastic syndrome.

    PubMed

    Garcia-Manero, Guillermo; Gartenberg, Gary; Steensma, David P; Schipperus, Martin R; Breems, Dimitri A; de Paz, Raquel; Valcárcel, David; Kranenburg, Britte; Reddy, Manjula; Komrokji, Rami S

    2014-09-01

    Interleukin-6 (IL-6) may play an important role in the pathophysiology of anemia of inflammation associated with myelodysplastic syndrome (MDS). This double-blind, placebo-controlled, phase 2 study assessed the efficacy and safety of siltuximab, a chimeric anti-IL-6 monoclonal antibody, in patients with low- and intermediate-1-risk MDS who require transfusions for MDS anemia. Patients were randomized in a 2:1 ratio to siltuximab 15 mg kg(-1) every 4 weeks + best supportive care (BSC) or placebo + BSC for 12 weeks. The primary endpoint was reduction in red blood cell (RBC) transfusions to treat MDS anemia, defined as ≥50% relative decrease and ≥2-unit absolute decrease in RBC transfusions. Fifty and 26 patients were randomized to the siltuximab and placebo groups, respectively. The study did not meet its prespecified hypothesis, with six (12%) patients in the siltuximab group and one (3.8%) in the placebo group having reductions in RBC transfusions (P = 0.271). At the time of the planned futility analysis, the prespecified cutoff criteria were not met, and the study was terminated early due to lack of efficacy. No unexpected safety findings were observed. In conclusion, compared to placebo, treatment with siltuximab did not reduce RBC transfusions in transfusion-dependent patients with low- and intermediate-1-risk MDS. Future studies might explore siltuximab in patients with less iron overload and with elevated IL-6 levels and/or using higher doses for MDS.

  14. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. Methods The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting. The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical

  15. A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes

    PubMed Central

    2015-01-01

    OBJECTIVE To evaluate the weight loss effectiveness of a ‘YMCA Model’ for the Diabetes Prevention Program (DPP) lifestyle intervention METHODS 509 overweight/obese, low-income, non-diabetic, adult primary care patients with elevated blood glucose were individually randomized to (1) standard care plus brief lifestyle counseling (SC); or (2) being offered a group-based adaption of the DPP offered free-of-charge by the YMCA (YDPP). Primary outcome was mean difference in weight loss at 12 months. Intention-to-treat (ITT) analyses used longitudinal linear or logistic regression, with missing observations multiply imputed. Instrumental variables (IV) regression estimated weight loss effectiveness among participants completing ≥9 intervention lessons. RESULTS In the YDPP arm, 161 (62.6%) participants attended ≥1 lesson and 103 (40.0%) completed ≥9 lessons. In ITT analysis, mean 12-month weight loss was 2.3 kg (95% CI 1.1 to 3.4 kg) more for YDPP arm participants, compared to SC. In IV analyses, persons attending ≥9 lessons had a 5.3 kg (95% CI, 2.8 to 7.9 kg) greater weight loss than with standard care alone. CONCLUSIONS The YMCA model for DPP delivery achieves meaningful weight losses at 12 months among low income adults. TRIAL REGISTRATION National Clinical Trials Registry (NCT00656682) PMID:26378828

  16. Comparative study of the efficacy and safety between blonanserin and risperidone for the treatment of schizophrenia in Chinese patients: A double-blind, parallel-group multicenter randomized trial.

    PubMed

    Li, Huafang; Yao, Chen; Shi, Jianguo; Yang, Fude; Qi, Shuguang; Wang, Lili; Zhang, Honggeng; Li, Jie; Wang, Chuanyue; Wang, Chuansheng; Liu, Cui; Li, Lehua; Wang, Qiang; Li, Keqing; Luo, Xiaoyan; Gu, Niufan

    2015-10-01

    This randomized, double-blind study compared the efficacy and safety of blonanserin and risperidone to treat Chinese schizophrenia patients aged ≥18 and < 65 years. Patients with Positive and Negative Syndrome Scale (PANSS) total scores ≥70 and ≤ 120 were randomized to receive blonanserin or risperidone using a gradual dose-titration method (blonanserin tablets: 8-24 mg/day; risperidone tablets: 2-6 mg/day), twice daily. Treatment populations consisted of 128 blonanserin-treated patients and 133 risperidone-treated patients. Intention-to-treat analysis was performed using the last observation carried forward method. Reductions of PANSS total scores by blonanserin and risperidone treatment were -30.59 and -33.56, respectively. Risperidone treatment was associated with elevated levels of serum prolactin (67.16% risperidone versus 52.31% blonanserin) and cardiac-related abnormalities (22.39% risperidone versus 12.31% blonanserin), and blonanserin patients were more prone to extrapyramidal side effects (48.46% blonanserin versus 29.10% risperidone). In conclusion, blonanserin was as effective as risperidone for the treatment of Chinese patients with schizophrenia. The overall safety profiles of these drugs are comparable, although blonanserin was associated with a higher incidence of EPS and risperidone was associated with a higher incidence of prolactin elevation and weight gain. Thus, blonanserin is useful for the treatment of Chinese schizophrenia patients. PMID:26343601

  17. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    PubMed

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  18. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    PubMed

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  19. Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus.

    PubMed

    Li, Mengyi; Huang, Xuemin; Ye, Hui; Chen, Yao; Yu, Jing; Yang, Jinxia; Zhang, Xuezhi

    2016-01-01

    Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A) tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15) and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c) and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P < 0.001). No significant difference was found when compared with acarbose group (P = 0.652). Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P < 0.05), without any significant differences compared with acarbose group (P = 0.748 and 0.558, resp.). The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76%) and 5 of 15 patients in acarbose group (33.33%) suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes. PMID:27547230

  20. Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus

    PubMed Central

    Chen, Yao

    2016-01-01

    Aims. To evaluate the efficacy and safety of mulberry twig alkaloid (SZ-A) tablet compared with acarbose in patients with type 2 diabetes. Methods. This clinical trial enrolled 38 patients who were randomized into two groups (SZ-A: 23; acarbose: 15) and were treated for 24 weeks. Patients and clinical trial staffs were masked to treatment assignment throughout the study. The primary outcome measures were glycated hemoglobin (HbA1c) and 1-hour and 2-hour postprandial and fasting plasma glucose levels from baseline to the end of treatment. Analysis included all patients who completed this study. Results. By the end of this study, HbA1c level in SZ-A group was decreased from baseline significantly (P < 0.001). No significant difference was found when compared with acarbose group (P = 0.652). Similarly, 1-hour and 2-hour postprandial plasma glucose levels in SZ-A group were decreased from baseline statistically (P < 0.05), without any significant differences compared with acarbose group (P = 0.748 and 0.558, resp.). The fasting plasma glucose levels were not significantly changed in both groups. One of 23 patients in SZ-A group (4.76%) and 5 of 15 patients in acarbose group (33.33%) suffered from gastrointestinal adverse events. Conclusions. Compared with acarbose, SZ-A tablet was effective and safe in glycemic control in patients with type 2 diabetes. PMID:27547230

  1. Operations dashboard: comparative study

    NASA Astrophysics Data System (ADS)

    Ramly, Noor Nashriq; Ismail, Ahmad Zuhairi; Aziz, Mohd Haris; Ahmad, Nurul Haszeli

    2011-10-01

    In this present days and age, there are increasing needs for companies to monitor application and infrastructure health. Apart from having proactive measures to secure their application and infrastructure, many see monitoring dashboards as crucial investment in disaster preparedness. As companies struggle to find the best solution to cater for their needs and interest for monitoring their application and infrastructure's health, this paper summarizes the studies made on several known off-the-shelf operations dashboard and in-house developed dashboard. A few criteria of good dashboard are collected from previous studies carried out by several researchers and rank them according to importance and business needs. The finalized criteria that will be discussed in later sections are data visualization, performance indicator, dashboard personalization, audit capability and alert/ notification. Comparative studies between several popular dashboards were then carried out to determine whether they met these criteria that we derived from the first exercise. The findings hopefully can be used to educate and provide an overview of selecting the best IT application and infrastructure operations dashboard that suit business needs, thus become the main contribution of this paper.

  2. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy

    PubMed Central

    Bai, Wen-Jun; Li, Hong-Jun; Dai, Yu-Tian; He, Xue-You; Huang, Yi-Ran; Liu, Ji-Hong; Sorsaburu, Sebastian; Ji, Chen; Jin, Jian-Jun; Wang, Xiao-Feng

    2015-01-01

    The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naïve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naïve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe. PMID:25370206

  3. Comparative Pre-Emptive Analgesic Efficacy Study of Novel Antiepileptic Agents Lamotrigine and Topiramate in Patients Undergoing Major Surgeries at a Tertiary Care Hospital: A Randomized Double Blind Clinical Trial

    PubMed Central

    Gupta, Ankush; Bhosale, Uma A.; Shah, Priyank; Yegnanarayan, Radha; Sardesai, Shalini

    2016-01-01

    Background Central nervous sensitization, following surgical injury, leads to postoperative pain hypersensitivity due to lowered pain threshold in peripheral nociceptors and increased excitability of spinal neurons. Pre-emptive analgesia is intended to decrease pain perception and overall analgesic need by use of drug regimen, seizing CNS sensitization before exposure to painful stimuli. Few studies support pre-emptive analgesic efficacy of novel antiepileptic agent Gabapentin. Though Topiramate and Lamotrigine have been proven analgesic in animal models of chronic pain and clinical studies of Gabapentin-resistant neuropathic pain, literature search revealed scarce data on its pre-emptive analgesic efficacy. Purpose This study is designed to study and compare the pre-emptive analgesic efficacy of Lamotrigine, Topiramate, and Diclofenac sodium in postoperative pain control. Methods This randomized clinical trial included 90 patients of either sex, between 18 and 70 years undergoing major surgeries. Patients were randomly allocated to control and test groups and received respective treatment 30 min before induction of anesthesia. Aldrete's and pain scores were recorded using the Visual Analog Scale, Facial and Behavioral Rating Scale at awakening and at 1, 2, 4, 6, and 24 h. Postoperative rescue analgesic consumption for 24 h was recorded. Results Significantly higher pain scores were observed in the Topiramate group postoperatively for 2 h on all pain scales (p < 0.05), whereas in the control group it was significantly higher at 1 h (p < 0.05). Lamotrigine-treated patients were more comfortable throughout the study with significantly less (p < 0.05) postoperative analgesic requirement. Conclusions Study results strongly suggest the pre-emptive analgesic efficacy of a single oral dose of Lamotrigine over Diclofenac and Topiramate in postoperative pain control. PMID:27721585

  4. Comparative waste forms study

    SciTech Connect

    Wald, J.W.; Lokken, R.O.; Shade, J.W.; Rusin, J.M.

    1980-12-01

    A number of alternative process and waste form options exist for the immobilization of nuclear wastes. Although data exists on the characterization of these alternative waste forms, a straightforward comparison of product properties is difficult, due to the lack of standardized testing procedures. The characterization study described in this report involved the application of the same volatility, mechanical strength and leach tests to ten alternative waste forms, to assess product durability. Bulk property, phase analysis and microstructural examination of the simulated products, whose waste loading varied from 5% to 100% was also conducted. The specific waste forms investigated were as follows: Cold Pressed and Sintered PW-9 Calcine; Hot Pressed PW-9 Calcine; Hot Isostatic Pressed PW-9 Calcine; Cold Pressed and Sintered SPC-5B Supercalcine; Hot Isostatic pressed SPC-5B Supercalcine; Sintered PW-9 and 50% Glass Frit; Glass 76-68; Celsian Glass Ceramic; Type II Portland Cement and 10% PW-9 Calcine; and Type II Portland Cement and 10% SPC-5B Supercalcine. Bulk property data were used to calculate and compare the relative quantities of waste form volume produced at a spent fuel processing rate of 5 metric ton uranium/day. This quantity ranged from 3173 L/day (5280 Kg/day) for 10% SPC-5B supercalcine in cement to 83 L/day (294 Kg/day) for 100% calcine. Mechanical strength, volatility, and leach resistance tests provide data related to waste form durability. Glass, glass-ceramic and supercalcine ranked high in waste form durability where as the 100% PW-9 calcine ranked low. All other materials ranked between these two groupings.

  5. Randomized, comparative study of the efficacy and safety of artesunate plus amodiaquine, administered as a single daily intake versus two daily intakes in the treatment of uncomplicated falciparum malaria

    PubMed Central

    Ndiaye, Jean Louis A; Faye, Babacar; Diouf, Amadou M; Kuété, Thomas; Cisse, Moustapha; Seck, Papa A; Brasseur, Phillipe; Same-Ekobo, Albert; Lameyre, Valerie; Gaye, Oumar

    2008-01-01

    Background Artesunate plus amodiaquine is a coblistered ACT, given as a single daily intake. It has been suggested that, in view of the number of tablets to be taken (particularly in adults), it may be possible to improve compliance by allowing patients to divide the daily dose. The objectives of this randomized, comparative, open-label, multicentre study, conducted in Senegal and in Cameroon in 2005, was to demonstrate the non-inferiority and to compare the safety of artesunate plus amodiaquine, as a single daily intake versus two daily intakes. Methods A three-day treatment period and 14-day follow-up period was performed in any subject weighting more than 10 kg, presenting with a malaria paroxysm confirmed by parasitaemia ≥ 1,000/μl, after informed consent. Patients were randomly allocated into one of the two regimens, with dosage according to bodyweight range. All products were administered by an authorized person, blinded to both the investigating physician and the biologist. The primary endpoint was an adequate response to treatment on D14 (WHO definition). The two-sided 90% confidence interval of the difference was calculated on intent to treat (ITT) population; the acceptance limit for non-inferiority was 3%. The safety was evaluated by incidence of adverse events. Results Three-hundred and sixteen patients were included in the study. The two patient groups were strictly comparable on D0. The adequate responses to treatment were similar for the two treatment regimens on D14, PCR-corrected (99,4% in the one-daily intake group versus 99,3% in the comparative group). The statistical analyses demonstrated the non-inferiority of administering artesunate/amodiaquine as two intakes. The drug was well tolerated. The main adverse events were gastrointestinal disorders (2.5%) and pruritus (2.5%); safety profiles were similar in the two groups. Conclusion This pilot study confirms the efficacy and good tolerability of artesunate plus amodiaquine, administrated

  6. Analysis of the habitat of Henslow's sparrows and Grasshopper sparrows compared to random grassland areas

    SciTech Connect

    Maier, Kristen; Walton, Rod; Kasper, Peter; /Fermilab

    2005-01-01

    Henslow's Sparrows are endangered prairie birds, and Grasshopper Sparrows are considered rare prairie birds. Both of these birds were abundant in Illinois, but their populations have been declining due to loss of the grasslands. This begins an ongoing study of the birds habitat so Fermilab can develop a land management plan for the Henslow's and Grasshoppers. The Henslow's were found at ten sites and Grasshoppers at eight sites. Once the birds were located, the vegetation at their sites was studied. Measurements of the maximum plant height, average plant height, and duff height were taken and estimates of the percent of grass, forbs, duff, and bare ground were recorded for each square meter studied. The same measurements were taken at ten random grassland sites on Fermilab property. Several t-tests were performed on the data, and it was found that both Henslow's Sparrows and Grasshopper Sparrows preferred areas with a larger percentage of grass than random areas. Henslow's also preferred areas with less bare ground than random areas, while Grasshoppers preferred areas with more bare ground than random areas. In addition, Grasshopper Sparrows preferred a lower percentage of forbs than was found in random areas and a shorter average plant height than the random locations. Two-sample variance tests suggested significantly less variance for both Henslow's Sparrows and Grasshopper Sparrows for maximum plant height in comparison to the random sites. For both birds, the test suggested a significant difference in the variance of the percentage of bare ground compared to random sites, but only the Grasshopper Sparrow showed significance in the variation in the percentage of forbs.

  7. A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia

    PubMed Central

    2013-01-01

    Background We compared the time to discontinuation due to lack of tolerability over 24 weeks in patients suffering from schizophrenia treated with pomaglumetad methionil (LY2140023 monohydrate, the prodrug of metabotropic glutamate 2/3 receptor agonist, LY404039) or standard of care (SOC: olanzapine, risperidone, or aripiprazole). Methods Study HBBR was a multicenter, randomized, open-label study comparing the long-term safety and tolerability of LY2140023 with SOC for schizophrenia. Patients had moderate symptomatology with prominent negative symptoms and evidence of functional impairment. Those who met entry criteria were randomized to open-label treatment with either LY2140023 (target dose: 40 mg twice daily [BID]; n = 130) or SOC (n = 131). Results There was no statistically significant difference between LY2140023 and SOC for time to discontinuation due to lack of tolerability (primary objective; P = .184). The Kaplan-Meier estimates revealed comparable time to event profiles. Only 27% of LY2140023 and 45% of SOC patients completed the 24-week open-label, active treatment phase. Twenty-seven patients (20.8%) in the LY2140023 group and 15 patients (11.5%) in the SOC group discontinued due to lack of efficacy (P = .044). Twenty-three patients (17.7%) in the LY2140023 group and 19 patients (14.5%) in the SOC group discontinued due to adverse events (physician and subject decision combined, P = .505). The incidence of serious adverse events was comparable between groups. LY2140023-treated patients reported significantly more treatment-emergent adverse events of vomiting, agitation, and dyspepsia, while SOC-treated patients reported significantly more akathisia and weight gain. The incidence of treatment-emergent parkinsonism (P = .011) and akathisia (P = .029) was significantly greater in SOC group. Improvement in PANSS total score over the initial 6 to 8 weeks of treatment was similar between groups, but improvement was

  8. A Multicenter, Prospective, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared with Placebo in Type 2 Diabetes Mellitus Patients Having Hypertriglyceridemia Not Controlled with Atorvastatin Therapy (PRESS VI)

    PubMed Central

    Pai, Vikas; Jha, Pramod; Jariwala, Gunjan; Mukhopadhyay, Satinath; Bhansali, Anil; Joshi, Shashank

    2014-01-01

    Abstract Background: Dyslipidemia due to diabetes is characterized by hypertriglyceridemia and reduced levels of high-density lipoprotein cholesterol (HDL-C) and elevated or normal levels of low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM). The objectives of this Phase III study were to evaluate the safety, tolerability, and efficacy of saroglitazar (ZYH1) 2-mg and 4-mg tablets (Lipaglyn™; Zydus Cadila, Ahmedabad, India) compared with placebo in patients with diabetic dyslipidemia who are not controlled with atorvastatin 10 mg therapy. Subjects and Methods: This was a 16-week prospective, multicenter, randomized, double-blind, placebo controlled, three-arm Phase III study in subjects with hypertriglyceridemia (>200 and <500 mg/dL) with T2DM not controlled with atorvastatin 10 mg. The study consisted of a run-in period of 4 weeks of life-style modification followed by 12 weeks of treatment with saroglitazar (2-mg or 4-mg) or placebo tablets. The primary end point was the change in plasma triglyceride level compared with baseline and the placebo arm at the end of Week 12. The secondary exploratory end points were change in lipid profile and fasting plasma glucose at Week 12. In total, 302 subjects were randomized to receive one of the treatments, saroglitazar 2 mg (n=101) or saroglitazar 4 mg (n=99), or matching placebo (n=102). Patients who received study medication and had undergone at least one post baseline efficacy evaluation were included in the efficacy analysis. Results: At Week 12, saroglitazar 2-mg and 4-mg tablets significantly reduced mean plasma triglyceride levels by −45.5±3.03% and −46.7±3.02% (mean±SE), respectively, and the difference was significant (P<0.001) compared with placebo. Saroglitazar 2 mg demonstrated significant decrease in levels of non-HDL-C, very LDL-C, total cholesterol, and fasting plasma glucose. Additionally, saroglitazar 4 mg also significantly reduced LDL-C and apolipoprotein

  9. Understanding greater cardiomyocyte functions on aligned compared to random carbon nanofibers in PLGA

    PubMed Central

    Asiri, Abdullah M; Marwani, Hadi M; Khan, Sher Bahadar; Webster, Thomas J

    2015-01-01

    Previous studies have demonstrated greater cardiomyocyte density on carbon nanofibers (CNFs) aligned (compared to randomly oriented) in poly(lactic-co-glycolic acid) (PLGA) composites. Although such studies demonstrated a closer mimicking of anisotropic electrical and mechanical properties for such aligned (compared to randomly oriented) CNFs in PLGA composites, the objective of the present in vitro study was to elucidate a deeper mechanistic understanding of how cardiomyocyte densities recognize such materials to respond more favorably. Results showed lower wettability (greater hydrophobicity) of CNFs embedded in PLGA compared to pure PLGA, thus providing evidence of selectively lower wettability in aligned CNF regions. Furthermore, the results correlated these changes in hydrophobicity with increased adsorption of fibronectin, laminin, and vitronectin (all proteins known to increase cardiomyocyte adhesion and functions) on CNFs in PLGA compared to pure PLGA, thus providing evidence of selective initial protein adsorption cues on such CNF regions to promote cardiomyocyte adhesion and growth. Lastly, results of the present in vitro study further confirmed increased cardiomyocyte functions by demonstrating greater expression of important cardiomyocyte biomarkers (such as Troponin-T, Connexin-43, and α-sarcomeric actin) when CNFs were aligned compared to randomly oriented in PLGA. In summary, this study provided evidence that cardiomyocyte functions are improved on CNFs aligned in PLGA compared to randomly oriented in PLGA since CNFs are more hydrophobic than PLGA and attract the adsorption of key proteins (fibronectin, laminin, and vironectin) that are known to promote cardiomyocyte adhesion and expression of important cardiomyocyte functions. Thus, future studies should use this knowledge to further design improved CNF:PLGA composites for numerous cardiovascular applications. PMID:25565806

  10. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England

    PubMed Central

    2013-01-01

    Background Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Methods/design Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. Design: parallel group patient-level pragmatic randomized controlled trial. Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders. Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice. Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and

  11. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidemia (PRESS V)

    PubMed Central

    Pai, Vikas; Paneerselvam, A; Mukhopadhyay, Satinath; Bhansali, Anil; Kamath, Dinesh; Shankar, V; Gambhire, Dhiraj; Joshi, Shashank; Patel, Pankaj

    2014-01-01

    Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia. In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m2; hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation. The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: −78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD −115.4 ± 68.11 mg/dL), respectively, as compared to pioglitazone -15.5% (absolute change ± SD: −33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no

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

    PubMed

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

    2010-11-01

    Several extended-release methylphenidate medications are available for treatment of children with ADHD. Pharmacokinetic investigations suggest that the serum levels of methylphenidate are partially altered when the medication is taken without breakfast. Clinical data comparing different breakfast situations are missing. In this study, different breakfast compositions and their influence on treatment with Ritalin LA are investigated. A total of 150 patients were enrolled in a rater-blinded, randomized crossover trial that compared a minimal breakfast with a standard breakfast in patients under stable treatment with Ritalin LA. Ratings for clinical efficacy were carried out after 1 week by teachers and parents (FBB-ADHS), as well as physicians (CGI). Additionally, a math test was administered to the patients. Of the total patients, 144 finished the trial with a breakfast compliance of 93%. All of the clinical rating scales showed consistently no difference between the two breakfast conditions. Non-inferiority of minimal breakfast versus standard breakfast was shown to be statistically significant (FBB-AHDS(Teacher): 0.97 with minimal breakfast, 1.01 with standard breakfast, P < 0.0001). The clinical efficacy of Ritalin LA is not influenced by breakfast and works independently of food intake.

  13. Compared with the intake of commercial vegetable juice, the intake of fresh fruit and komatsuna (Brassica rapa L. var. perviridis) juice mixture reduces serum cholesterol in middle-aged men: a randomized controlled pilot study

    PubMed Central

    2014-01-01

    Background Vegetables and fruits are rich in vitamins, minerals and, dietary fiber and contribute to the prevention and improvement of obesity and metabolic syndrome. However, inadequate intake of vegetable and fruit is a concern in Japan. We therefore produced a juice mixture of fresh fruit and komatsuna (Brassica rapa L. var. perviridis: B. rapa) with the aim to investigate the effects of this juice mixture on anthropometric data, blood parameters, and dietary intake differences. Methods This study was performed as a single blind and randomized controlled trial. Subjects were 16 men (mean age, 46.4 ± 7.1 years), and they were divided into two groups (control group and intervention group). The intervention group consumed the juice mixture of fresh fruit and B. rapa. The control group consumed commercial vegetable juice. Subjects consumed juice twice a day throughout the weekday, for 4 weeks. We prepared both juices with an equivalent energy balance. Results Weight and body mass index (BMI) of the control group after 4 weeks were significantly increased compared with baseline values. Serum total cholesterol (T-Chol) and low-density lipoprotein cholesterol (LDL-Chol) of the intervention group after 4 weeks were significantly reduced compared with baseline values. Furthermore, intake of total vegetables and fruits were significantly increased compared with baseline values in both groups. Conclusions Both vegetable juices contributed to improved intake of total vegetables and fruit. Compared with the intake of commercial vegetable juice, the intake of fresh fruit and B. rapa juice is highly effective in reducing serum cholesterol. Short-term intake of fresh fruit and B. rapa juice was shown to enhance cholesterol metabolism. PMID:24961537

  14. Safety and pharmacokinetics of single and multiple intravenous bolus doses of diclofenac sodium compared with oral diclofenac potassium 50 mg: A randomized, parallel-group, single-center study in healthy subjects.

    PubMed

    Munjal, Sagar; Gautam, Anirudh; Okumu, Franklin; McDowell, James; Allenby, Kent

    2016-01-01

    In a randomized, parallel-group, single-center study in 42 healthy adults, the safety and pharmacokinetic parameters of an intravenous formulation of 18.75 and 37.5 mg diclofenac sodium (DFP-08) following single- and multiple-dose bolus administration were compared with diclofenac potassium 50 mg oral tablets. Mean AUC0-inf values for a 50-mg oral tablet and an 18.75-mg intravenous formulation were similar (1308.9 [393.0]) vs 1232.4 [147.6]). As measured by the AUC, DFP-08 18.75 mg and 37.5 mg demonstrated dose proportionality for extent of exposure. One subject in each of the placebo and DFP-08 18.75-mg groups and 2 subjects in the DFP-08 37.5-mg group reported adverse events that were considered by the investigator to be related to the study drug. All were mild in intensity and did not require treatment. Two subjects in the placebo group and 1 subject in the DFP-08 18.75-mg group reported grade 1 thrombophlebitis; no subjects reported higher than grade 1 thrombophlebitis after receiving a single intravenous dose. The 18.75- and 37.5-mg doses of intravenous diclofenac (single and multiple) were well tolerated for 7 days. Additional efficacy and safety studies are required to fully characterize the product.

  15. An open, parallel, randomized, comparative, multicenter study to evaluate the cost-effectiveness, performance, tolerance, and safety of a silver-containing soft silicone foam dressing (intervention) vs silver sulfadiazine cream.

    PubMed

    Silverstein, Paul; Heimbach, David; Meites, Herbert; Latenser, Barbara; Mozingo, David; Mullins, Fred; Garner, Warren; Turkowski, Joseph; Shupp, Jeffrey; Glat, Paul; Purdue, Gary

    2011-01-01

    An open, parallel, randomized, comparative, multicenter study was implemented to evaluate the cost-effectiveness, performance, tolerance, and safety of a silver-containing soft silicone foam dressing (Mepilex Ag) vs silver sulfadiazine cream (control) in the treatment of partial-thickness thermal burns. Individuals aged 5 years and older with partial-thickness thermal burns (2.5-20% BSA) were randomized into two groups and treated with the trial products for 21 days or until healed, whichever occurred first. Data were obtained and analyzed on cost (direct and indirect), healing rates, pain, comfort, ease of product use, and adverse events. A total of 101 subjects were recruited. There were no significant differences in burn area profiles within the groups. The cost of dressing-related analgesia was lower in the intervention group (P = .03) as was the cost of background analgesia (P = .07). The mean total cost of treatment was $309 vs $513 in the control (P < .001). The average cost-effectiveness per treatment regime was $381 lower in the intervention product, producing an incremental cost-effectiveness ratio of $1688 in favor of the soft silicone foam dressing. Mean healing rates were 71.7 vs 60.8% at final visit, and the number of dressing changes were 2.2 vs 12.4 in the treatment and control groups, respectively. Subjects reported significantly less pain at application (P = .02) and during wear (P = .048) of the Mepilex Ag dressing in the acute stages of wound healing. Clinicians reported the intervention dressing was significantly easier to use (P = .03) and flexible (P = .04). Both treatments were well tolerated; however, the total incidence of adverse events was higher in the control group. The silver-containing soft silicone foam dressing was as effective in the treatment of patients as the standard care (silver sulfadiazine). In addition, the group of patients treated with the soft silicone foam dressing demonstrated decreased pain and lower costs associated

  16. Comparative Packaging Study

    NASA Technical Reports Server (NTRS)

    Perchonok, Michele H.; Oziomek, Thomas V.

    2009-01-01

    Future long duration manned space flights beyond low earth orbit will require the food system to remain safe, acceptable and nutritious. Development of high barrier food packaging will enable this requirement by preventing the ingress and egress of gases and moisture. New high barrier food packaging materials have been identified through a trade study. Practical application of this packaging material within a shelf life test will allow for better determination of whether this material will allow the food system to meet given requirements after the package has undergone processing. The reason to conduct shelf life testing, using a variety of packaging materials, stems from the need to preserve food used for mission durations of several years. Chemical reactions that take place during longer durations may decrease food quality to a point where crew physical or psychological well-being is compromised. This can result in a reduction or loss of mission success. The rate of chemical reactions, including oxidative rancidity and staling, can be controlled by limiting the reactants, reducing the amount of energy available to drive the reaction, and minimizing the amount of water available. Water not only acts as a media for microbial growth, but also as a reactant and means by which two reactants may come into contact with each other. The objective of this study is to evaluate three packaging materials for potential use in long duration space exploration missions.

  17. A Comparative Study of Sparse Associative Memories

    NASA Astrophysics Data System (ADS)

    Gripon, Vincent; Heusel, Judith; Löwe, Matthias; Vermet, Franck

    2016-07-01

    We study various models of associative memories with sparse information, i.e. a pattern to be stored is a random string of 0s and 1s with about log N 1s, only. We compare different synaptic weights, architectures and retrieval mechanisms to shed light on the influence of the various parameters on the storage capacity.

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  19. Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support—Results of a Prospective, Randomized, Comparative Study

    PubMed Central

    Pirard, Céline; Loumaye, Ernest; Wyns, Christine

    2015-01-01

    Background. The aim of this pilot study was to evaluate intranasal buserelin for luteal phase support and compare its efficacy with standard vaginal progesterone in IVF/ICSI antagonist cycles. Methods. This is a prospective, randomized, open, parallel group study. Forty patients underwent ovarian hyperstimulation with human menopausal gonadotropin under pituitary inhibition with gonadotropin-releasing hormone antagonist, while ovulation trigger and luteal support were achieved using intranasal GnRH agonist (group A). Twenty patients had their cycle downregulated with buserelin and stimulated with hMG, while ovulation trigger was achieved using 10,000 IU human chorionic gonadotropin with luteal support by intravaginal progesterone (group B). Results. No difference was observed in estradiol levels. Progesterone levels on day 5 were significantly lower in group A. However, significantly higher levels of luteinizing hormone were observed in group A during the entire luteal phase. Pregnancy rates (31.4% versus 22.2%), implantation rates (22% versus 15.4%), and clinical pregnancy rates (25.7% versus 16.7%) were not statistically different between groups, although a trend towards higher rates was observed in group A. No luteal phase lasting less than 10 days was recorded in either group. Conclusion. Intranasal administration of buserelin is effective for providing luteal phase support in IVF/ICSI antagonist protocols. PMID:25945092

  20. A randomized, double-blind study comparing the efficacy and safety of a combination of formoterol and ciclesonide with ciclesonide alone in asthma subjects with moderate-to-severe airflow limitation

    PubMed Central

    Salvi, Sundeep S; Vaidya, Abhijit J; Kodgule, Rahul R; Gogtay, Jaideep A

    2016-01-01

    Context: The combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) is widely used in the treatment of moderate-to-severe asthma uncontrolled by ICS alone. Aims: To evaluate the efficacy and safety of a new ICS-LABA combination inhaler containing Formoterol (F) and Ciclesonide (C). Settings and Design: A double-blind, double-dummy, parallel group fashion, multi-centric study. Subjects and Methods: A total of 169 asthma patients received Ciclesonide 80 μg once daily during a 4-week run-in period, after which, they were randomized to receive either C (80 μg) or a combination of F (4.5 μg) and C (80 μg) (FC) both delivered through a hydro-fluro-alkane pressurized-metered-dose inhaler as 1 puff twice daily, for 6 weeks. Statistical Analysis Used: Inter-group differences were compared using t-test for independent samples at a significance level of 5%. Results: From baseline, the improvements in forced expiratory volume in 1 s at 1, 3, and 6 weeks was significantly higher in the FC group compared to Group C (110 ml vs. 40 ml, 140 ml vs. 20 ml, and 110 ml vs. 40 ml, respectively, all P < 0.05). From baseline, the improvements in mean morning peak expiratory flow at 1, 3, and 6 weeks was significantly higher in the FC group compared to Group C (17 L/min vs.−3 L/min, 22 L/min vs. 3 L/min, and 30 ml vs. 8 L/min respectively, all P < 0.05). The changes in symptom scores were similar in both the groups. The adverse events in the FC group were not significantly different from those in the C group. Conclusions: FC provides better improvement than C alone in terms of lung function and symptoms without increased risk of adverse events in asthma patients. PMID:27185990

  1. Filgrastim-Stimulated Bone Marrow Compared with Filgrastim-Mobilized Peripheral Blood in Myeloablative Sibling Allografting for Patients with Hematologic Malignancies: A Randomized Canadian Blood and Marrow Transplant Group Study.

    PubMed

    Couban, Stephen; Aljurf, Mahmoud; Lachance, Sylvie; Walker, Irwin; Toze, Cynthia; Rubinger, Morel; Lipton, Jeffrey H; Lee, Stephanie J; Szer, Richard; Doocey, R; Lewis, Ian D; Huebsch, Lothar; Howson-Jan, Kang; Lalancette, Michel; Almohareb, Fahad; Chaudhri, Nadeem; Ivison, Sabine; Broady, Raewyn; Levings, Megan; Fairclough, Diane; Devins, Gerald; Szwajcer, David; Foley, Ronan; Smith, Clayton; Panzarella, Tony; Kerr, Holly; Kariminia, Amina; Schultz, Kirk R

    2016-08-01

    In adult hematopoietic cell transplantation (HCT), filgrastim-mobilized peripheral blood (G-PB) has largely replaced unstimulated marrow for allografting. Although the use of G-PB results in faster hematopoietic recovery, it is also associated with more chronic graft-versus-host disease (cGVHD). A potential alternative allograft is filgrastim-stimulated marrow (G-BM), which we hypothesized may be associated with prompt hematopoietic recovery but with less cGVHD. We conducted a phase 3, open-label, multicenter randomized trial of 230 adults with hematologic malignancies receiving allografts from siblings after myeloablative conditioning to compare G-PB with G-BM. The primary endpoint was time to treatment failure, defined as a composite of extensive cGVHD, relapse/disease progression, and death. With a median follow-up of 36 months (range, 9.6 to 48), comparing G-BM with G-PB, there was no difference between the 2 arms with respect to the primary outcome of this study (hazard ratio [HR], .91; 95% confidence interval [CI], .68 to 1.22; P = .52). However, the cumulative incidence of overall cGVHD was lower with G-BM (HR, .66; 95% CI, .46 to .95; P = .007) and there was no difference in the risk of relapse or progression (P = .35). The median times to neutrophil recovery (P = .0004) and platelet recovery (P = .012) were 3 days shorter for recipients allocated to G-PB compared with those allocated to G-BM, but there were no differences in secondary engraftment-related outcomes, such as time to first hospital discharge (P = .17). In addition, there were no graft failures in either arm. This trial demonstrates that, compared with G-PB, the use of G-BM allografts leads to a significantly lower rate of overall cGVHD without a loss of the graft-versus-tumor effect and comparable overall survival. Our findings suggest that further study of this type of allograft is warranted.

  2. Lung Function Monitoring; A Randomized Agreement Study

    PubMed Central

    Berntsen, Sveinung; Stølevik, Solvor B.; Mowinckel, Petter; Nystad, Wenche; Stensrud, Trine

    2016-01-01

    Objective: To determine the agreement between devices and repeatability within devices of the forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF) and forced expiratory flow at 50% of FVC (FEF50) values measured using the four spirometers included in the study. Methods: 50 (24 women) participants (20-64 years of age) completed maximum forced expiratory flow manoeuvres and measurements were performed using the following devices: MasterScreen, SensorMedics, Oxycon Pro and SpiroUSB. The order of the instruments tested was randomized and blinded for both the participants and the technicians. Re-testing was conducted on a following day within 72 hours at the same time of the day. Results: The devices which obtained the most comparable values for all lung function variables were SensorMedics and Oxycon Pro, and MasterScreen and SpiroUSB. For FEV1, mean difference was 0.04 L (95% confidence interval; -0.05, 0.14) and 0.00 L (-0.06, 0.06), respectively. When using the criterion of FVC and FEV1 ≤ 0.150 L for acceptable repeatability, 67% of the comparisons of the measured lung function values obtained by the four devices were acceptable. Overall, Oxycon Pro obtained most frequently values of the lung function variables with highest precision as indicated by the coefficients of repeatability (CR), followed by MasterScreen, SensorMedics and SpiroUSB (e.g. min-max CR for FEV1; 0.27-0.46). Conclusion: The present study confirms that measurements obtained by the same device at different times can be compared; however, measured lung function values may differ depending on spirometers used. PMID:27583055

  3. The very-rapid and the ultra-rapid virologic response to two treatment options in patients with chronic hepatitis C: an interim report of a prospective randomized comparative effectiveness study

    PubMed Central

    Yakoot, Mostafa; Abdo, Alaa M; Yousry, Ahmed; Helmy, Sherine

    2015-01-01

    Background We aimed in this interim report to compare two registered generic sofosbuvir products for the degree and speed of virologic response to a dual antiviral treatment protocol within the first 2 weeks of treatment. Methods Data collected during the period of this interim report from the first 25 patients randomized to either one of two generic sofosbuvir products (Grateziano or Gratisovir) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose were analyzed for both the degree and speed of virus load reduction at the end of 1 and 2 weeks from starting treatment. Results The baseline Log10 transformed virus load (Log polymerase chain reaction) showed a fairly similar marked and significant reduction in both groups by more than 4 and 5 Logs at the end of week 1 and 2 of starting treatment, respectively. The differences between the two treatment groups at both analysis points were not statistically significant (P>0.05) by repeated measures factorial analysis of variance test. The differences in proportions of patients with ultra-rapid virologic response at the end of week 1 and very-rapid virologic response at the end of week 2 in both groups were also not statistically significant (P>0.05). Conclusion We can conclude from this interim report that the two generic products Gratisovir and Grateziano are almost equally fast and efficacious in reducing the hepatitis C virus load in our study setting. PMID:26628861

  4. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery

    PubMed Central

    Tuuli, Methodius G.; Liu, Jingxia; Stout, Molly J.; Martin, Shannon; Cahill, Alison G.; Odibo, Anthony O.; Colditz, Graham A.; Macones, George A.

    2016-01-01

    BACKGROUND Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States. METHODS In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine–alcohol for preoperative skin antisepsis was superior to the use of iodine–alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine–alcohol or iodine–alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention. RESULTS From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine–alcohol and 575 to iodine–alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine–alcohol group and in 42 (7.3%) in the iodine–alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P = 0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine–alcohol group and 4.9% in the iodine–alcohol group (P = 0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P = 0.07). The frequency of adverse skin reactions was similar in the two groups. CONCLUSIONS The use of chlorhexidine–alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine–alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.) PMID:26844840

  5. First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse

    PubMed Central

    2013-01-01

    Background Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness. Methods/Design The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged < 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. ‘Low educational qualifications’ is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment. The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services. Discussion This is the first study of the

  6. Evaluation of bioequivalence of five 0.1 mg dutasteride capsules compared to one 0.5 mg dutasteride capsule: a randomized study in healthy male volunteers

    PubMed Central

    Fossler, Michael J.; Collins, David A.; Ino, Hiroko; Sarai, Nobuaki; Ravindranath, Ramiya; Bowen, Chester L.; Burns, Olivia

    2015-01-01

    Objective To evaluate the bioequivalence of five 0.1 mg dutasteride capsules to one 0.5 mg dutasteride capsule in healthy adult male subjects under fasting conditions. Methods This was a single-center, open-label, randomized, single dose, two-way cross-over study (ClinicalTrials.gov identifier NCT01929330). Thirty-six healthy male subjects aged 18–65 years received 5 × 0.1 mg dutasteride softgel capsules and 1 × 0.5 mg dutasteride softgel capsule in a randomized order, with a minimum washout of 28 days between each drug administration. Serial blood samples were collected for the measurement of serum dutasteride concentrations by a validated HPLC-MS/MS method. Dutasteride pharmacokinetic parameters were calculated using non-compartmental analysis. Maximum concentration (Cmax) and area under the concentration-time curve to the last quantifiable concentration (AUC[0–t]) were compared between treatments. Safety and tolerability were monitored throughout the study. Results Five 0.1 mg dutasteride capsules were demonstrated to be bioequivalent to 1 × 0.5 mg dutasteride capsule, as the 90% confidence intervals for Cmax and AUC were within the accepted bioequivalence range of 0.80–1.25. The geometric least squares means ratios and associated 90% confidence intervals for 5 × 0.1 mg capsules vs 1 × 0.5 mg capsule were 1.01 (0.97–1.05) for Cmax and 0.91 (0.84–1.00) for AUC(0–t). Adverse events (AEs) were reported for 42% (15/36) and 36% (12/33) of subjects in the 5 × 0.1 mg and 1 × 0.5 mg dosing sessions, respectively. The most frequent AE for both treatments was headache. No subject had a serious AE. Conclusions Five 0.1 mg dutasteride capsules were shown to be bioequivalent to one 0.5 mg dutasteride capsule in healthy adult male subjects under fasted conditions, suggesting that the two dose strengths can be interchanged. Both treatments were generally well tolerated in healthy male subjects. PMID

  7. Laparoscopic Pectopexy: A Prospective, Randomized, Comparative Clinical Trial of Standard Laparoscopic Sacral Colpocervicopexy with the New Laparoscopic Pectopexy—Postoperative Results and Intermediate-Term Follow-Up in a Pilot Study

    PubMed Central

    Schiermeier, Sven; Alkatout, Ibrahim; Anapolski, Michael

    2015-01-01

    Abstract Purpose: The purpose of the study was to compare the outcome of laparoscopic sacral colpocervicopexy with laparoscopic pectopexy. Our aim was to show that the safety and effectiveness of the new technique is similar to the traditional technique. We expected differences regarding defecation disorders. Patients and Methods: We randomly assigned patients to two treatment groups: 44 in the pectopexy and 41 in the sacropexy group. If necessary, the operative procedures were planned in a so-called multicompartment setting regarding the different pelvic floor disorders. All defects were managed at the same time. Eighty-one patients were examined 12 to 37 months after treatment (mean follow-up 20.67 months). Results: The long-term follow-up (21.8 months for pectopexy and 19.5 months for sacropexy) showed a clear difference regarding de novo defecation disorders (0% in the pectopexy vs 19.5% in the sacropexy group). The incidence of de novo stress urinary incontinence was 4.8% (pectopexy) vs 4.9% (sacropexy). The incidence of rectoceles (9.5% vs 9.8%) was similar in both groups. No de novo lateral defect cystoceles were found after pectopexy, whereas 12.5% were found after sacropexy. The apical descensus relapse rates, 2.3% for pectopexy vs 9.8% for sacropexy, were not statistically significant. The occurrence of de novo anterior defect cystoceles and rectoceles revealed no significant differences. Conclusion: Laparoscopic pectopexy is a novel method of vaginal prolapse therapy that offers clear practical advantages compared with laparoscopic sacropexy. Because laparoscopic pectopexy does not reduce the pelvic space, it results in a zero percentage of defecation disorders. PMID:25350228

  8. Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal life support and early invasive assessment compared to standard of care. A randomized parallel groups comparative study proposal. “Prague OHCA study”

    PubMed Central

    2012-01-01

    Background Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized studies of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population that would benefit from ECLS. We aim to perform a prospective randomized study comparing prehospital intraarrest hypothermia combined with mechanical chest compression device, intrahospital ECLS and early invasive investigation and treatment in all patients with OHCA of presumed cardiac origin compared to a standard of care. Methods This paper describes methodology and design of the proposed trial. Patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS (advanced cardiac life support) by emergency medical service (EMS) team and after performance of all initial procedures (defibrillation, airway management, intravenous access establishment) will be randomized to standard vs. hyperinvasive arm. In hyperinvasive arm, mechanical compression device together with intranasal evaporative cooling will be instituted and patients will be transferred directly to cardiac center under ongoing CPR (cardiopulmonary resuscitation). After admission, ECLS inclusion/exclusion criteria will be evaluated and if achieved, veno-arterial ECLS will be started. Invasive investigation and standard post resuscitation care will follow. Patients in standard arm will be managed on scene. When ROSC achieved, they will be transferred to cardiac center and further treated as per recent guidelines. Primary outcome 6 months survival with good neurological outcome (Cerebral Performance Category 1–2). Secondary outcomes will include 30 day neurological and cardiac recovery. Discussion Authors introduce and offer a protocol of a proposed randomized study comparing a combined “hyperinvasive approach” to a standard of care in refractory OHCA. The protocol is opened for sharing by other cardiac centers with available ECLS and

  9. Comparing connected structures in ensemble of random fields

    NASA Astrophysics Data System (ADS)

    Rongier, Guillaume; Collon, Pauline; Renard, Philippe; Straubhaar, Julien; Sausse, Judith

    2016-10-01

    Very different connectivity patterns may arise from using different simulation methods or sets of parameters, and therefore different flow properties. This paper proposes a systematic method to compare ensemble of categorical simulations from a static connectivity point of view. The differences of static connectivity cannot always be distinguished using two point statistics. In addition, multiple-point histograms only provide a statistical comparison of patterns regardless of the connectivity. Thus, we propose to characterize the static connectivity from a set of 12 indicators based on the connected components of the realizations. Some indicators describe the spatial repartition of the connected components, others their global shape or their topology through the component skeletons. We also gather all the indicators into dissimilarity values to easily compare hundreds of realizations. Heat maps and multidimensional scaling then facilitate the dissimilarity analysis. The application to a synthetic case highlights the impact of the grid size on the connectivity and the indicators. Such impact disappears when comparing samples of the realizations with the same sizes. The method is then able to rank realizations from a referring model based on their static connectivity. This application also gives rise to more practical advices. The multidimensional scaling appears as a powerful visualization tool, but it also induces dissimilarity misrepresentations: it should always be interpreted cautiously with a look at the point position confidence. The heat map displays the real dissimilarities and is more appropriate for a detailed analysis. The comparison with a multiple-point histogram method shows the benefit of the connected components: the large-scale connectivity seems better characterized by our indicators, especially the skeleton indicators.

  10. Randomized, double-blind, placebo-controlled and active-controlled study to assess the relative abuse potential of oxycodone HCl-niacin tablets compared with oxycodone alone in nondependent, recreational opioid users

    PubMed Central

    Webster, Lynn R; Rolleri, Robert L; Pixton, Glenn C; Sommerville, Kenneth W

    2012-01-01

    Background Abuse-deterrent formulations attempt to address public health and societal concerns regarding opioid abuse. Oxycodone HCl-niacin tablets combine oxycodone HCl with niacin and functional inactive excipients to create potential barriers to oral, intranasal, and intravenous abuse. This study compared the relative abuse potential of oral immediate-release oxycodone HCl-niacin with that of oral immediate-release oxycodone HCl and placebo in nondependent, recreational opioid users. Methods Forty-nine participants received oxycodone HCl-niacin 40/240 mg and 80/480 mg, oxycodone 40 mg and 80 mg, and placebo in a randomized, double-blind, placebo-controlled and active-controlled, five-way crossover study. Primary endpoints based on a bipolar 100 mm visual analog scale for drug liking were area under effect curve (AUE0–1h, AUE0–2h, AUE0–3h), peak disliking, and effect at 0.5 hours post-dose (E0.5h). Other endpoints included take drug again assessment, overall drug liking, and pupillometry. Results There were statistically significant differences between oxycodone HCl-niacin and oxycodone HCl doses for all primary endpoints (P < 0.0001, all comparisons), suggesting reduced abuse potential with oxycodone HCl-niacin. Take drug again and overall drug liking showed greater liking of oxycodone alone. Oxycodone HCl-niacin 80/480 mg had consistently lower liking assessments than oxycodone HCl-niacin 40/240 mg, suggesting a dose-response to the aversive effects of niacin. Opioid-related adverse events were similar for equivalent oxycodone doses. The treatment-emergent adverse events most specifically associated with oxycodone HCl-niacin (ie, skin-burning sensation, warmth, and flushing) were consistent with the expected vasocutaneous effects of niacin. No serious adverse events were reported. Conclusion Oxycodone HCl-niacin tablets may, in a dose-dependent manner, decrease the potential for oral abuse of oxycodone without unexpected adverse events or clinically

  11. Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.

    PubMed

    Nedelcu, Marius; Verhaeghe, Pierre; Skalli, Mehdi; Champault, Gerard; Barrat, Christophe; Sebbag, Hugues; Reche, Fabian; Passebois, Laurent; Beyrne, Daniel; Gugenheim, Jean; Berdah, Stephane; Bouayed, Amine; Michel Fabre, Jean; Nocca, David

    2016-03-01

    The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p

  12. Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.

    PubMed

    Nedelcu, Marius; Verhaeghe, Pierre; Skalli, Mehdi; Champault, Gerard; Barrat, Christophe; Sebbag, Hugues; Reche, Fabian; Passebois, Laurent; Beyrne, Daniel; Gugenheim, Jean; Berdah, Stephane; Bouayed, Amine; Michel Fabre, Jean; Nocca, David

    2016-03-01

    The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p

  13. What Does a Random Line Look Like: An Experimental Study

    ERIC Educational Resources Information Center

    Turner, Nigel E.; Liu, Eleanor; Toneatto, Tony

    2011-01-01

    The study examined the perception of random lines by people with gambling problems compared to people without gambling problems. The sample consisted of 67 probable pathological gamblers and 46 people without gambling problems. Participants completed a number of questionnaires about their gambling and were then presented with a series of random…

  14. Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial

    PubMed Central

    2014-01-01

    Background The incidence of strokes in industrialized nations is on the rise, particularly in the older population. In Canada, a minority of individuals who have had a stroke actually receive intensive rehabilitation because most stroke patients do not have access to services or because their motor recovery was judged adequate to return home. Thus, there is a considerable need to organize home-based rehabilitation services for everyone who has had a stroke. To meet this demand, telerehabilitation, particularly from a service center to the patient’s home, is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged home. Methods/Design This non-inferiority study will include patients who have returned home post-stroke without requiring intensive rehabilitation. To be included in the study, participants will: 1) not be referred to an Intensive Functional Rehabilitation Unit, 2) have a Rankin score of 2 or 3, and 3) have a balance problem (Berg Balance Scale score between 46 and 54). Participants will be randomly assigned to either the teletreatment group or the home visits group. Except for the delivery mode, the intervention will be the same for both groups, that is, a personalized Tai Chi-based exercise program conducted by a trained physiotherapist (45-minute session twice a week for eight consecutive weeks). The main objective of this research is to test the non-inferiority of a Tai Chi-based exercise program provided via telerehabilitation compared to the same program provided in person at home in terms of effectiveness for retraining balance in individuals who have had a stroke but do not require intensive functional rehabilitation. The main outcome of this study is balance and mobility measured with the Community Balance and Mobility Scale. Secondary outcomes include physical and psychological capacities related to balance and mobility, participants’ quality of life, satisfaction with services

  15. Randomized, open-label, blinded-endpoint, crossover, single-dose study to compare the pharmacodynamics of torasemide-PR 10 mg, torasemide-IR 10 mg, and furosemide-IR 40 mg, in patients with chronic heart failure

    PubMed Central

    Ballester, Maria Rosa; Roig, Eulàlia; Gich, Ignasi; Puntes, Montse; Delgadillo, Joaquín; Santos, Benjamín; Antonijoan, Rosa Maria

    2015-01-01

    Purpose Diuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics. Methods Randomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours. Results Ten patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096±0.03 mmol/μg vs 0.015±0.0007 mmol/μg; P<0.0001). Mictional urgency was lower and more delayed with torasemide-PR than with furosemide-IR. Conclusion In a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to

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

    PubMed

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

    2016-10-01

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

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

    PubMed Central

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

    2016-01-01

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

  18. Will patients accept randomization to psychoanalysis? A feasibility study.

    PubMed

    Caligor, Eve; Hilsenroth, Mark J; Devlin, Michael; Rutherford, Bret R; Terry, Madeleine; Roose, Steven P

    2012-04-01

    The feasibility of using a randomized design in a psychoanalytic outcome study was evaluated. Our hypothesis was that it would be feasible to randomize patients to psychoanalysis three or four times weekly on the couch for five years, supportive expressive therapy once or twice weekly for up to forty sessions, and cognitive behavior therapy once or twice weekly for up to forty sessions. Successful randomization was defined as a 30% recruitment rate among eligible patients. Recruitment began in September 2009 and closed in April 2010. A total of 132 subjects responded to study advertisements, 107 of whom (81%) were triaged out. The remaining 25 were scheduled for the first of two clinical interviews, and 21 of 25 (88%) completed the interview. Eleven of the 25 (44%) were determined to be eligible based on inclusion and exclusion criteria. Eight of the 11 accepted the idea of randomization and completed the diagnostic assessment phase. Calculated on the basis of 8 of 11 eligible patients accepting randomization, the 95% confidence interval was that 39% to 92% of eligible subjects would participate in a larger study of this design. Our findings support the feasibility of implementing an RCT comparing psychoanalysis as defined by the American Psychoanalytic Association (three or four times weekly on the couch for approximately five years) with shorter-term dynamic or cognitive behavioral therapy once or twice a week. Pre-treatment characteristics of these eight patients are presented, as are initial reliability data for the treatment adherence scales used in this trial.

  19. A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC): Japan Clinical Oncology Group Study JCOG1017.

    PubMed

    Shien, Tadahiko; Nakamura, Kenichi; Shibata, Taro; Kinoshita, Takayuki; Aogi, Kenjiro; Fujisawa, Tomomi; Masuda, Norikazu; Inoue, Kenichi; Fukuda, Haruhiko; Iwata, Hiroji

    2012-10-01

    This trial is being conducted to confirm the superiority, in terms of overall survival, of primary tumour resection plus systemic therapy to systemic therapy alone in patients with Stage IV breast cancer who are not refractory to primary systemic therapy. The inclusion criteria for the study are as follows: untreated patients with histologically confirmed invasive breast cancer with one or more measurable metastatic lesions diagnosed by radiological examination. All patients receive primary systemic therapy according to the estrogen receptor and human epidermal growth factor receptor type-2 status of the primary breast cancer after the first registration. After 3 months, the patients without disease progression are randomized to the primary tumour resection plus systemic therapy arm or the systemic therapy alone arm. The primary endpoint is the overall survival, and the secondary endpoints are proportion of patients without tumour progression at the metastatic sites, yearly local recurrence-free survival, proportion of local ulcer/local bleeding, yearly primary tumour resection-free survival, adverse events of chemotherapy, operative morbidity and serious adverse events. The patient recruitment was commenced in May 2011. Enrolment of 410 patients for randomization is planned over a 5 year recruitment period. We hereby report the details of the study.

  20. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study.

    PubMed

    Povsic, Thomas J; Roe, Matthew T; Ohman, Erik Magnus; Steg, Philippe Gabriel; James, Stefan; Plotnikov, Alexei; Mundl, Hardi; Welsh, Robert; Bode, Christoph; Gibson, Charles Michael

    2016-04-01

    Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to be associated with a significant reduction in the composite of cardiovascular death, myocardial infarction, and stroke, and resulted in a nominal reduction in cardiovascular death, when added to background DAPT in the ATLAS ACS 2-TIMI 51 trial; however, there was excessive bleeding with this "triple-therapy" approach. The combination of rivaroxaban with P2Y12 inhibition in a "dual-pathway" approach may be an effective therapeutic regimen for the treatment of ACS, given the known importance of P2Y12 inhibition after stenting and intriguing data that the combination of an anticoagulant with clopidogrel after stenting in patients with atrial fibrillation appears an attractive option to this patient population. GEMINI-ACS-1 is a prospective, randomized, double-dummy, double-blind, active-controlled trial that will assess the safety of dual antithrombotic therapy (rivaroxaban [2.5 mg twice daily] + P2Y12 inhibitor) as compared with DAPT (aspirin [100 mg] + P2Y12 inhibitor) within 10 days of an ACS event in 3,000 patients. Patients will be randomized in a 1:1 ratio stratified by intended P2Y12 inhibitor use (clopidogrel 75 mg daily or ticagrelor 90 mg twice daily), with 1500 patients expected in each P2Y12 inhibitor strata. The primary end point is Thrombolysis in Myocardial Infarction clinically significant bleeding (major, minor, or requiring medical attention). The exploratory efficacy determination will be a composite of cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis. GEMINI-ACS-1 will assess the safety and feasibility of dual antithrombotic therapy with rivaroxaban and a P2Y

  1. Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc

    PubMed Central

    Majd, Mohammed E.; Isaza, Jorge E.; Blumenthal, Scott L.; McAfee, Paul C.; Guyer, Richard D.; Hochschuler, Stephen H.; Geisler, Fred H.; Garcia, Rolando; Regan, John J.

    2007-01-01

    Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. Methods In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. Results The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. Conclusions The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study. PMID:25802575

  2. Efficient and robust method for comparing the immunogenicity of candidate vaccines in randomized clinical trials.

    PubMed

    Gilbert, Peter B; Sato, Alicia; Sun, Xiao; Mehrotra, Devan V

    2009-01-14

    In randomized clinical trials designed to compare the magnitude of vaccine-induced immune responses between vaccination regimens, the statistical method used for the analysis typically does not account for baseline participant characteristics. This article shows that incorporating baseline variables predictive of the immunogenicity study endpoint can provide large gains in precision and power for estimation and testing of the group mean difference (requiring fewer subjects for the same scientific output) compared to conventional methods, and recommends the "semiparametric efficient" method described in Tsiatis et al. [Tsiatis AA, Davidian M, Zhang M, Lu X. Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: a principled yet flexible approach. Stat Med 2007. doi:10.1002/sim.3113] for practical use. As such, vaccine clinical trial programs can be improved (1) by investigating baseline predictors (e.g., readouts from laboratory assays) of vaccine-induced immune responses, and (2) by implementing the proposed semiparametric efficient method in trials where baseline predictors are available. PMID:19022314

  3. ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

    PubMed Central

    van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

    2014-01-01

    SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

  4. k-core percolation on complex networks: Comparing random, localized, and targeted attacks.

    PubMed

    Yuan, Xin; Dai, Yang; Stanley, H Eugene; Havlin, Shlomo

    2016-06-01

    The type of malicious attack inflicting on networks greatly influences their stability under ordinary percolation in which a node fails when it becomes disconnected from the giant component. Here we study its generalization, k-core percolation, in which a node fails when it loses connection to a threshold k number of neighbors. We study and compare analytically and by numerical simulations of k-core percolation the stability of networks under random attacks (RA), localized attacks (LA) and targeted attacks (TA), respectively. By mapping a network under LA or TA into an equivalent network under RA, we find that in both single and interdependent networks, TA exerts the greatest damage to the core structure of a network. We also find that for Erdős-Rényi (ER) networks, LA and RA exert equal damage to the core structure, whereas for scale-free (SF) networks, LA exerts much more damage than RA does to the core structure. PMID:27415275

  5. How breadth of degree distribution influences network robustness: comparing localized and random attacks.

    PubMed

    Yuan, Xin; Shao, Shuai; Stanley, H Eugene; Havlin, Shlomo

    2015-09-01

    The stability of networks is greatly influenced by their degree distributions and in particular by their breadth. Networks with broader degree distributions are usually more robust to random failures but less robust to localized attacks. To better understand the effect of the breadth of the degree distribution we study two models in which the breadth is controlled and compare their robustness against localized attacks (LA) and random attacks (RA). We study analytically and by numerical simulations the cases where the degrees in the networks follow a bi-Poisson distribution, P(k)=αe^{-λ_{1}}λ_{1}^{k}/k!+(1-α)e^{-λ_{2}}λ_{2}^{k}/k!,α∈[0,1], and a Gaussian distribution, P(k)=Aexp(-(k-μ)^{2}/2σ^{2}), with a normalization constant A where k≥0. In the bi-Poisson distribution the breadth is controlled by the values of α, λ_{1}, and λ_{2}, while in the Gaussian distribution it is controlled by the standard deviation, σ. We find that only when α=0 or α=1, i.e., degrees obeying a pure Poisson distribution, are LA and RA the same. In all other cases networks are more vulnerable under LA than under RA. For a Gaussian distribution with an average degree μ fixed, we find that when σ^{2} is smaller than μ the network is more vulnerable against random attack. When σ^{2} is larger than μ, however, the network becomes more vulnerable against localized attack. Similar qualitative results are also shown for interdependent networks. PMID:26465441

  6. How breadth of degree distribution influences network robustness: Comparing localized and random attacks

    NASA Astrophysics Data System (ADS)

    Yuan, Xin; Shao, Shuai; Stanley, H. Eugene; Havlin, Shlomo

    2015-09-01

    The stability of networks is greatly influenced by their degree distributions and in particular by their breadth. Networks with broader degree distributions are usually more robust to random failures but less robust to localized attacks. To better understand the effect of the breadth of the degree distribution we study two models in which the breadth is controlled and compare their robustness against localized attacks (LA) and random attacks (RA). We study analytically and by numerical simulations the cases where the degrees in the networks follow a bi-Poisson distribution, P (k ) =α e-λ1λ/1kk ! +(1 -α ) e-λ2λ/2kk ! ,α ∈[0 ,1 ] , and a Gaussian distribution, P (k ) =A exp(-(k/-μ) 22 σ2 ), with a normalization constant A where k ≥0 . In the bi-Poisson distribution the breadth is controlled by the values of α , λ1, and λ2, while in the Gaussian distribution it is controlled by the standard deviation, σ . We find that only when α =0 or α =1 , i.e., degrees obeying a pure Poisson distribution, are LA and RA the same. In all other cases networks are more vulnerable under LA than under RA. For a Gaussian distribution with an average degree μ fixed, we find that when σ2 is smaller than μ the network is more vulnerable against random attack. When σ2 is larger than μ , however, the network becomes more vulnerable against localized attack. Similar qualitative results are also shown for interdependent networks.

  7. Comparative effects of propranolol and verapamil alone and in combination on left ventricular function and volumes in patients with chronic exertional angina: a double-blind, placebo-controlled, randomized, crossover study with radionuclide ventriculography

    SciTech Connect

    Johnston, D.L.; Gebhardt, V.A.; Donald, A.; Kostuk, W.J.

    1983-12-01

    With the use of equilibrium radionuclide ventriculography the effects on left ventricular (LV) function of 160 mg oral propranolol daily and 360 mg verapamil daily alone and in combination were compared in 18 patients with chronic exertional angina. A randomized, double-blind, placebo-controlled, crossover protocol was used. The reduction in exercise rate-pressure product induced by the combination (118 +/- 28 mm Hg/min) was significantly greater than that by propranolol (135 +/- 27 mm Hg/min) or verapamil alone (163 +/- 28 mm Hg/min). In patients at rest, neither single nor combined therapy altered global or regional left ventricular ejection fractions (EFs). Verapamil, but not propranolol, increased cardiac volumes of resting subjects; used in combination, no further increase in LV volume occurred. With placebo, exercise global EF did not decrease from the level at rest and therefore no drug effect could be demonstrated for this parameter of LV function. By an evaluation of normalized regional EF measurements the combination was shown to reduce exercise-induced hypokinesis (placebo 52 +/- 20%, combination 61 +/- 23%. No significant improvement was noted with propranolol or verapamil alone; only the combination prevented a significant increase in end-systolic and end-diastolic volumes during exercise. Thus, propranolol and verapamil, used alone in moderate doses, exert no beneficial effect on exercise LV function as measured by EF and volume changes, and resting function deteriorates slightly with verapamil.

  8. Mendelian randomization studies in coronary artery disease.

    PubMed

    Jansen, Henning; Samani, Nilesh J; Schunkert, Heribert

    2014-08-01

    Epidemiological research over the last 50 years has discovered a plethora of biomarkers (including molecules, traits or other diseases) that associate with coronary artery disease (CAD) risk. Even the strongest association detected in such observational research precludes drawing conclusions about the causality underlying the relationship between biomarker and disease. Mendelian randomization (MR) studies can shed light on the causality of associations, i.e whether, on the one hand, the biomarker contributes to the development of disease or, on the other hand, the observed association is confounded by unrecognized exogenous factors or due to reverse causation, i.e. due to the fact that prevalent disease affects the level of the biomarker. However, conclusions from a MR study are based on a number of important assumptions. A prerequisite for such studies is that the genetic variant employed affects significantly the biomarker under investigation but has no effect on other phenotypes that might confound the association between the biomarker and disease. If this biomarker is a true causal risk factor for CAD, genotypes of the variant should associate with CAD risk in the direction predicted by the association of the biomarker with CAD. Given a random distribution of exogenous factors in individuals carrying respective genotypes, groups represented by the genotypes are highly similar except for the biomarker of interest. Thus, the genetic variant converts into an unconfounded surrogate of the respective biomarker. This scenario is nicely exemplified for LDL cholesterol. Almost every genotype found to increase LDL cholesterol level by a sufficient amount has also been found to increase CAD risk. Pending a number of conditions that needed to be fulfilled by the genetic variant under investigation (e.g. no pleiotropic effects) and the experimental set-up of the study, LDL cholesterol can be assumed to act as the functional component that links genotypes and CAD risk and

  9. A scientific nutrition strategy improves time trial performance by ≈6% when compared with a self-chosen nutrition strategy in trained cyclists: a randomized cross-over study.

    PubMed

    Hottenrott, Kuno; Hass, Erik; Kraus, Manon; Neumann, Georg; Steiner, Martin; Knechtle, Beat

    2012-08-01

    We investigated whether an athlete's self-chosen nutrition strategy (A), compared with a scientifically determined one (S), led to an improved endurance performance in a laboratory time trial after an endurance exercise. S consisted of about 1000 mL·h(-1) fluid, in portions of 250 mL every 15 min, 0.5 g sodium·L(-1), 60 g glucose·h(-1), 30 g fructose·h(-1), and 5 mg caffeine·kg body mass(-1). Eighteen endurance-trained cyclists (16 male; 2 female) were tested using a randomized crossover-design at intervals of 2 weeks, following either A or S. After a warm-up, a maximal oxygen uptake test was performed. Following a 30-min break, a 2.5-h endurance exercise on a bicycle ergometer was carried out at 70% maximal oxygen uptake. After 5 min of rest, a time trial of 64.37 km (40 miles) was completed. The ingested nutrition was recorded every 15 min. In S, the athletes completed the time trial faster (128 vs. 136 min; p ≤ 0.001) and with a significantly higher power output (212 vs. 184 W; p ≤ 0.001). The intake of fluid, energy (carbohydrate-, mono-, and disaccharide), and sodium was significantly higher in S compared with A (p ≤ 0.001) during the endurance exercise. In the time trial, only sodium intake was significantly higher in S (p ≤ 0.001). We concluded that a time trial performance after a 2.5-h endurance exercise in a laboratory setting was significantly improved following a scientific nutrition strategy.

  10. Randomized study of zinc supplementation during pregnancy

    SciTech Connect

    Hambidge, K.M.; Oliva-Rasbach, J.; Jacobs, M.; Purcell, S.; Statland, C.; Poirier, J.

    1986-03-05

    The hypothesis underlying this study was that a daily dietary Zn supplement during pregnancy would be associated with higher values for selected indices of Zn nutriture than corresponding values for non-Zn-supplemented subjects, if, and only if, Zn status of the unsupplemented control group was sub-optimal. The 12 test and 17 control subjects were healthy, apparently well-nourished anglos who were enrolled before the 12th week of gestation. Mean age=29 yrs, mean parity=0.8. Test subjects received a daily supplement of 15 mg Zn (mean compliance=90%) from the time of enrollment until 3 months post-partum. The supplement was taken at bedtime while other vitamin/mineral preparations were taken before breakfast. Blood samples were obtained at 4 week intervals from enrollment. Selected preliminary results: plasma Zn declined progressively with length of gestation to a nadir of 53 +/- 6 ..mu..g/dl at 10 months. (Non-pregnant mean 77 +/- 7). As in a previous, non-randomized, study the rate of decline for the test group did not differ from that of the control group. Mean monthly neutrophil Zn ranged from 43 +/- 8 - 50 +/- 14 ..mu..g/10/sup 10/ cells; there was not consistent pattern across gestation. Serum alkaline phosphatase activity and pre-albumin of the test group did not differ from the control group. These data did not give any indication of sub-optimal Zn nutriture in this pregnant population.

  11. Evaluation of a randomized intervention to increase adoption of comparative effectiveness research by community health organizations.

    PubMed

    Williams, Jessica Roberts; Williams, Weston O; Dusablon, Tracy; Blais, Marissa Puckett; Tregear, Stephen J; Banks, Duren; PhD, Kevin D Hennessy

    2014-07-01

    This randomized controlled trial examined the influence of two strategies (informational packets alone and in conjunction with Webinars) aimed at increasing the adoption of motivational interviewing (MI), a patient-centered behavioral health practice supported by evidence from comparative effectiveness studies, among community health organizations responsible for delivering mental and behavioral health services. Data were obtained from 311 directors and staff across 92 community organizations. Hierarchical linear modeling was used to examine changes in decision to adopt MI. The mediating effects of multiple contextual variables were also examined. Results showed that both strategies positively influenced the decision to adopt. The positive impact on decision to adopt was significantly greater among individuals that received informational packets in conjunction with Webinars. Baseline attitudes toward evidence-based practices and pressures for change appeared to mediate this effect. PMID:24091611

  12. A randomized trial comparing two approaches to weight loss: Differences in weight loss maintenance

    PubMed Central

    Carels, Robert A; Burmeister, Jacob M; Koball, Afton M; Oehlhof, Marissa W; Hinman, Nova; LeRoy, Michelle; Bannon, Erin; Ashrafioun, Lee; Storfer-Isser, Amy; Darby, Lynn A; Gumble, Amanda

    2013-01-01

    This study compared treatment outcomes for a new weight loss program that emphasized reducing unhealthy relationships with food, body image dissatisfaction, and internalized weight bias (New Perspectives) to a weight loss program that emphasizes environmental modification and habit formation and disruption (Transforming Your Life). Fifty-nine overweight and obese adults (body mass index ≥ 27 kg/m2) were randomly assigned to either a 12-week New Perspectives or Transforming Your Life intervention. Despite equivalent outcomes at the end of treatment, the Transforming Your Life participants were significantly more effective at maintaining their weight loss than New Perspectives participants during the 6-month no-treatment follow-up period. PMID:23349402

  13. Randomly and Non-Randomly Missing Renal Function Data in the Strong Heart Study: A Comparison of Imputation Methods.

    PubMed

    Shara, Nawar; Yassin, Sayf A; Valaitis, Eduardas; Wang, Hong; Howard, Barbara V; Wang, Wenyu; Lee, Elisa T; Umans, Jason G

    2015-01-01

    Kidney and cardiovascular disease are widespread among populations with high prevalence of diabetes, such as American Indians participating in the Strong Heart Study (SHS). Studying these conditions simultaneously in longitudinal studies is challenging, because the morbidity and mortality associated with these diseases result in missing data, and these data are likely not missing at random. When such data are merely excluded, study findings may be compromised. In this article, a subset of 2264 participants with complete renal function data from Strong Heart Exams 1 (1989-1991), 2 (1993-1995), and 3 (1998-1999) was used to examine the performance of five methods used to impute missing data: listwise deletion, mean of serial measures, adjacent value, multiple imputation, and pattern-mixture. Three missing at random models and one non-missing at random model were used to compare the performance of the imputation techniques on randomly and non-randomly missing data. The pattern-mixture method was found to perform best for imputing renal function data that were not missing at random. Determining whether data are missing at random or not can help in choosing the imputation method that will provide the most accurate results.

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  15. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group.

    PubMed

    Forstpointner, Roswitha; Dreyling, Martin; Repp, Roland; Hermann, Sandra; Hänel, Annette; Metzner, Bernd; Pott, Christiane; Hartmann, Frank; Rothmann, Frank; Rohrberg, Robert; Böck, Hans-Peter; Wandt, Hannes; Unterhalt, Michael; Hiddemann, Wolfgang

    2004-11-15

    In follicular lymphoma (FL) and mantle cell lymphoma (MCL) the monoclonal antibody rituximab may improve the prognosis when combined with chemotherapy. This was investigated in a prospective randomized study in patients with relapsed disease. A total of 147 patients were randomized to receive 4 courses of chemotherapy with 25 mg/m(2) fludarabine on days 1 to 3, 200 mg/m(2) cyclophosphamide on days 1 to 3, and 8 mg/m(2) mitoxantrone on day 1 (FCM), alone or combined with rituximab (375 mg/m(2); R-FCM). Of 128 evaluable patients, 62 were randomized for FCM and 66 for R-FCM. R-FCM revealed an overall response rate of 79% (33% complete remission [CR], 45% partial remission [PR]) as compared with 58% for FCM alone (13% CR, 45% PR; P = .01), with similar results in a subgroup analysis of FL (94% vs 70%) and MCL (58% vs 46%). In the total group, the R-FCM arm was significantly superior concerning progression-free survival (PFS; P = .0381) and overall survival (OS; P = .0030). In FL PFS was significantly longer in the R-FCM arm (P = .0139) whereas in MCL a significantly longer OS was observed (P = .0042). There were no differences in clinically relevant side effects in both study arms. Hence, the addition of rituximab to FCM chemotherapy significantly improves the outcome of relapsed or refractory FL and MCL.

  16. Analysis of the Habitat of Henslow's Sparrows and Grasshopper Sparrows Compared to Random Grassland Areas

    SciTech Connect

    Maier, K.; Walton, R.; Kasper, P.

    2006-01-01

    ABSTRAC T Henslow’s Sparrows are endangered prairie birds, and Grasshopper Sparrows are considered rare prairie birds. Both of these birds were abundant in Illinois, but their populations have been declining due to loss of the grasslands. This begins an ongoing study of the birds’ habitat so Fermilab can develop a land management plan for the Henslow’s and Grasshoppers. The Henslow’s were found at ten sites and Grasshoppers at eight sites. Once the birds were located, the vegetation at their sites was studied. Measurements of the maximum plant height, average plant height, and duff height were taken and estimates of the percent of grass, forbs, duff, and bare ground were recorded for each square meter studied. The same measurements were taken at ten random grassland sites on Fermilab property. Several t-tests were performed on the data, and it was found that both Henslow’s Sparrows and Grasshopper Sparrows preferred areas with a larger percentage of grass than random areas. Henslow’s also preferred areas with less bare ground than random areas, while Grasshoppers preferred areas with more bare ground than random areas. In addition, Grasshopper Sparrows preferred a lower percentage of forbs than was found in random areas and a shorter average plant height than the random locations. Two-sample variance tests suggested significantly less variance for both Henslow’s Sparrows and Grasshopper Sparrows for maximum plant height in comparison to the random sites.

  17. An open label, randomized, fixed-dose, crossover study comparing efficacy and safety of sildenafil citrate and saffron (Crocus sativus Linn.) for treating erectile dysfunction in men naïve to treatment.

    PubMed

    Safarinejad, M R; Shafiei, N; Safarinejad, S

    2010-01-01

    Saffron (Crocus sativus Linn.) have been perceived by the public as a strong aphrodisiac herbal product. However, studies addressing the potential beneficial effects of saffron on erectile function (EF) in men with ED are lacking. Our aim was to evaluate the efficacy and safety of saffron administration on EF in men with ED. After a 4-week baseline assessment, 346 men with ED (mean age 46.6+/-8.4 years) were randomized to receive on-demand sildenafil for 12 weeks followed by 30 mg saffron twice daily for another 12 weeks or vice versa, separated by a 2-week washout period. To determine the type of ED, penile color duplex Doppler ultrasonography before and after intracavernosal injection with 20 microg prostaglandin E(1), pudendal nerve conduction tests and impaired sensory-evoked potential studies were performed. Subjects were assessed with an International Index of Erectile Function (IIEF) questionnaire, Sexual Encounter Profile (SEP) diary questions, patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Global Efficacy Question (GEQ) 'Has the medication you have been taking improved your erections?' No significant improvements were observed with regard to the IIEF sexual function domains, SEP questions and EDITS scores with saffron administration. The mean changes from baseline values in IIEF-EF domain were +87.6% and +9.8% in sildenafil and placebo groups, respectively (P=0.08). We did not observe any improvement in 15 individual IIEF questions in patients while taking saffron. Treatment satisfaction as assessed by partner versions of EDITS was found to be very low in saffron patients (72.4 vs 25.4, P=0.001). Mean per patient 'yes' responses to GEQ was 91.2 and 4.2% for sildenafil and saffron, respectively (P=0.0001). These findings do not support a beneficial effect of saffron administration in men with ED.

  18. A prospective, randomized, double-blind study of vaginal microflora and epithelium in women using a tampon with an apertured film cover compared with those in women using a commercial tampon with a cover of nonwoven fleece.

    PubMed

    Chase, David J; Schenkel, Berenike P; Fahr, Anne-Marie; Eigner, Ulrich

    2007-04-01

    Healthy women with normal menstrual cycles were randomly assigned to use either a test tampon during cycle 1 and a reference tampon during cycle 2 or a reference tampon during cycle 1 and a test tampon during cycle 2. Tampons were identical except for their cover materials: apertured film for the test tampon and nonwoven fleece for the reference tampon. Product use was doubly blinded. Qualitative and quantitative analyses of vaginal cultures were done pre-, mid-, and postmenstrually for a broad panel of microorganisms, colposcopy was performed, and diary reports were collected; 101 of 105 enrolled subjects completed the study. Midmenstrual findings for a variety of organisms differed from pre- and postmenstrual observations whether subjects were using test or reference tampons. No statistically significant differences were noted in prevalence or colony counts at premenstrual versus mid- and postmenstrual visits for most microorganisms. Prevalences of Gardnerella and anaerobic gram-negative rods were significantly different between tampons at the premenstrual visit, when unusually low values were observed for the test and reference tampons, respectively. None of the changes or differences in microflora were considered to be clinically significant. It is noteworthy, however, that declines in the prevalence and abundance of Lactobacillus during the menstrual periods were less pronounced during the use of both test and reference tampons than those reported from previous studies. Colposcopy showed no abnormal findings with either tampon and no changes in vaginal or cervical epithelial integrity. Thus, all evidence from both microbiological and colposcopic evaluations indicates that the apertured film cover of the test tampon is as safe as the nonwoven cover of the reference tampon.

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

    PubMed

    Timms, M S; Temple, R H

    2002-06-01

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

  20. [Comparative studies of face recognition].

    PubMed

    Kawai, Nobuyuki

    2012-07-01

    Every human being is proficient in face recognition. However, the reason for and the manner in which humans have attained such an ability remain unknown. These questions can be best answered-through comparative studies of face recognition in non-human animals. Studies in both primates and non-primates show that not only primates, but also non-primates possess the ability to extract information from their conspecifics and from human experimenters. Neural specialization for face recognition is shared with mammals in distant taxa, suggesting that face recognition evolved earlier than the emergence of mammals. A recent study indicated that a social insect, the golden paper wasp, can distinguish their conspecific faces, whereas a closely related species, which has a less complex social lifestyle with just one queen ruling a nest of underlings, did not show strong face recognition for their conspecifics. Social complexity and the need to differentiate between one another likely led humans to evolve their face recognition abilities.

  1. Consumption of high-fat meal containing cheese compared with vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomized controlled cross-over study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Dietary recommendations suggest decreased consumption of SFA to minimize CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomized...

  2. Probiotic Compared with Standard Milk for High-caries Children: A Cluster Randomized Trial.

    PubMed

    Rodríguez, G; Ruiz, B; Faleiros, S; Vistoso, A; Marró, M L; Sánchez, J; Urzúa, I; Cabello, R

    2016-04-01

    The aim of this study was to compare milk supplemented with probiotic lactobacilli with standard milk for the increment of caries in preschool children after 10 mo of intervention. The study was a triple-blind, placebo-controlled randomized trial. Participants were children aged 2 and 3 y (n = 261) attending 16 nursery schools in a metropolitan region in Chile. Nursery schools were randomly assigned to 2 parallel groups: children in the intervention group were given 150 mL of milk supplemented with Lactobacillus rhamnosus SP1 (10(7) CFU/mL), while children in the control group were given standard milk. Interventions took place on weekdays for 10 mo. Data were collected through a clinical examination of participants. The primary outcome measure was the increment of caries in preschool children. This was assessed using the International Caries Detection and Assessment System (ICDAS). The dropout rate was 21%. No differences in caries prevalence were detected between the groups at baseline (P = 0.68). After 10 mo of probiotic intake, the caries prevalence was 54.4% in the probiotic group and 65.8% in the control group. The percentage of new individuals who developed cavitated lesions (ICDAS 5-6) in the control group (24.3%) was significantly higher than that in the probiotic group (9.7%). The increment of dental caries showed an odds ratio of 0.35 (P < 0.05) in favor of the probiotic group. At the cavitated lesion level, the increment of new caries lesions within the groups showed 1.13 new lesions per child in the probiotic group compared with 1.75 lesions in the control group (P < 0.05). The probiotic group showed an increment of 0.58 ± 1.17 new lesions compared with 1.08 ± 1.70 new lesions observed in the control group. The difference in caries increment was significant at the cavitated lesion level (P < 0.01). In conclusion, the regular long-term intake of probiotic-supplemented milk may reduce caries development in high-caries preschool children (Clinical

  3. A randomized Phase II clinical study of combining panitumumab and bevacizumab, plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) compared with FOLFIRI alone as second-line treatment for patients with metastatic colorectal cancer and KRAS mutation

    PubMed Central

    Liu, Yuguo; Luan, Lijuan; Wang, Xingli

    2015-01-01

    Background This study investigated the efficacy and safety of a new treatment strategy of combining panitumumab and bevacizumab, plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) versus FOLFIRI alone as second-line chemotherapy for metastatic colorectal cancer (mCRC) patients with known V-Ki-ras2 Kirsten rat sarcoma viral oncogene (KRAS) mutation status. Methods Patients with mCRC who had known KRAS tumor status and unsuccessful previous oxaliplatin-based chemotherapy were included in the study. They were randomly assigned to two groups to receive panitumumab and bevacizumab plus FOLFIRI, or FOLFIRI alone. In panitumumab and bevacizumab plus FOLFIRI group, patients were given 4 mg/kg panitumumab and bevacizumab plus FOLFIRI every 2 weeks. Results In all, 65 patients were assigned to panitumumab and bevacizumab plus FOLFIRI group, and 77 to FOLFIRI alone group. For WT KRAS patients, the median progression-free survival (PFS) was 5.7 months (95% confidence interval [CI], 2.4–7.5 months) for panitumumab and bevacizumab plus FOLFIRI and 3.8 months (95% CI, 3.0–6.7 months) for FOLFIRI alone; median overall survival (OS) was 15.2 months (95% CI, 8.9–19.7 months) for panitumumab and bevacizumab plus FOLFIRI and 11.0 months (95% CI, 8.2–15.4 months) for FOLFIRI alone. For MU KRAS patients, median PFS was 5.1 months (95% CI, 2.7–10.2 months) for panitumumab and bevacizumab plus FOLFIRI and 4.1 months (95% CI, 2.5–8.4 months) for FOLFIRI alone; median OS was 12.8 months (95% CI, 7.8–15.8 months) for panitumumab and bevacizumab plus FOLFIRI and 10.5 months (95% CI, 6.1–15.3 months) for FOLFIRI alone. Grade 3 and 4 adverse events were associated with panitumumab and bevacizumab plus FOLFIRI but tolerable among patients. Conclusion Patients with mCRC can be safely and efficiently treated with second-line chemotherapy of combining panitumumab and bevacizumab plus FOLFIRI, despite their KRAS mutation status. PMID:25999741

  4. A non-comparative randomized phase II study of two doses of ATN-224, a copper/zinc superoxide dismutase inhibitor, in patients with biochemically recurrent hormone-naïve prostate cancer

    PubMed Central

    Lin, Jianqing; Zahurak, Marianna; Beer, Tomasz M.; Ryan, Charles. J.; Wilding, George; Mathew, Paul; Morris, Michael; Callahan, Jennifer. A.; Gordon, Gilad; Reich, Steven D.; Carducci, Michael A.; Antonarakis, Emmanuel S.

    2011-01-01

    Objective ATN-224 (choline tetrathiomolybdate) is an oral Cu2+/Zn2+-superoxide dismutase 1 (SOD1) inhibitor with preclinical antitumor activity. We hypothesized that ATN-224 may induce antitumor effects as an antiangiogenic agent at low dose-levels while possessing direct antitumor activity at higher dose-levels. The objective of this study was to screen its clinical activity in patients with biochemically recurrent hormone-naïve prostate cancer. Methods Biochemically-recurrent prostate cancer patients with prostate specific antigen doubling times (PSADT) <12 months, no radiographic evidence of metastasis, and no hormonal therapy within 6 months (with serum testosterone levels >150 ng/dL) were eligible. ATN-224 was administered at two dose-levels, 300 mg (n=23) or 30 mg (n=24) daily, by way of randomization. PSA progression was defined as a ≥50% increase (and >5 ng/mL) in PSA from baseline or post-treatment nadir. Endpoints included the proportion of patients who were free of PSA progression at 24 weeks, changes in PSA slope/PSADT, and safety. The study was not powered to detect differences between the two treatment groups. Results At 24 weeks, 59% (95% CI 33–82%) of men in the low-dose arm and 45% (95% CI 17–77%) in the high-dose arm were PSA progression-free. Median PSA progression-free survival was 30 weeks (95% CI 21–40+) and 26 weeks (95% CI 24–39+) in the low-dose and high-dose groups, respectively. Pre- and on-treatment PSA kinetics analyses showed a significant mean PSA slope decrease (p=0.006) and a significant mean PSADT increase (p=0.032) in the low-dose arm only. Serum ceruloplasmin levels, a biomarker for ATN-224 activity, were lowered in the high-dose group, but did not correlate with PSA changes. Conclusions Low-dose ATN-224 (30 mg daily) may have biologic activity in men with biochemically-recurrent prostate cancer, as suggested by an improvement in PSA kinetics. However, the clinical significance of PSA kinetics changes in this patient

  5. Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer

    PubMed Central

    2014-01-01

    Introduction The purpose of this study was to retrospectively explore the relationship between human epidermal growth factor receptor 2 (HER2) messenger RNA (mRNA) expression and efficacy in patients receiving trastuzumab plus docetaxel (HT) or trastuzumab emtansine (T-DM1). Methods Patients with HER2-positive, locally advanced or metastatic breast cancer (MBC) were randomly assigned to HT (n = 70) or T-DM1 (n = 67). HER2 status was assessed locally using immunohistochemistry or fluorescence in situ hybridization and confirmed retrospectively by central testing. HER2 mRNA expression was assessed using quantitative reverse transcriptase polymerase chain reaction. Results HER2 mRNA levels were obtained for 116/137 patients (HT = 61; T-DM1 = 55). Median pretreatment HER2 mRNA was 8.9. The risk of disease progression in the overall population was lower with T-DM1 than with HT (hazard ratio (HR) = 0.59; 95% confidence interval (CI) 0.36 to 0.97). This effect was more pronounced in patients with HER2 mRNA ≥ median (HR = 0.39; 95% CI 0.18 to 0.85) versus < median (HR = 0.85; 95% CI 0.44 to 1.67). In the T-DM1 arm, median progression-free survival (PFS) was not reached in patients with HER2 mRNA ≥ median and was 10.6 months in patients with HER2 mRNA < median. In the HT arm, PFS was 8.8 versus 9.8 months in patients with HER2 mRNA ≥ median versus < median, respectively. The effect of HER2 mRNA expression on objective response rates was less pronounced. Conclusions This exploratory analysis suggests that while overall, patients with HER2-positive MBC show improved PFS with T-DM1 relative to HT, the effect is enhanced in patients with tumor HER2 mRNA ≥ median. Trial registration ClinicalTrials.gov NCT00679341 PMID:24887458

  6. Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

    PubMed

    Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2015-01-01

    Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P < .05). No significant difference was found between the study groups regarding hair count either at month 3 or month 6 (> .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P < .05). Scalp itching, however, was more frequent in the minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

  7. Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

    PubMed

    Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2015-01-01

    Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P < .05). No significant difference was found between the study groups regarding hair count either at month 3 or month 6 (> .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P < .05). Scalp itching, however, was more frequent in the minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA. PMID:25842469

  8. Efficacy of desvenlafaxine 50 mg compared with placebo in patients with moderate or severe major depressive disorder: a pooled analysis of six randomized, double-blind, placebo-controlled studies.

    PubMed

    Papakostas, George I; Culpepper, Larry; Fayyad, Rana S; Musgnung, Jeff; Guico-Pabia, Christine J

    2013-11-01

    This study assessed the efficacy of desvenlafaxine 50 mg/day compared with placebo for treating moderate or severe major depressive disorder (MDD). Data were pooled from six double-blind, placebo-controlled, desvenlafaxine 50 mg/day fixed-dose studies in adults with MDD. The primary endpoint was improvement in 17-item Hamilton Rating Scale for Depression (HAM-D17) scores from baseline at week 8. HAM-D17 changes were evaluated in patients with moderate (18study, and baseline in the model. The pooled analysis included 2189 patients (desvenlafaxine 50 mg, n=1150; placebo, n=1039). Of those, 694 (32%) patients had severe depression at baseline. Desvenlafaxine improved HAM-D17 scores versus placebo in patients with either moderate [desvenlafaxine, adjusted mean (±SE), -10.26±0.24; placebo, -8.87±0.26; P<0.001] or severe MDD (desvenlafaxine, -11.91±0.40; placebo, -9.85±0.42; P<0.001). Both moderately and severely depressed patients had significantly higher rates of response and remission with desvenlafaxine treatment compared with placebo (all P's≤0.029). Results were similar when baseline severity was defined by Montgomery-Åsberg Depression Rating Scale or Sheehan Disability Scale scores. Desvenlafaxine 50 mg/day significantly improved depressive symptoms regardless of severity at baseline and was effective in treating both moderate and severe MDD.

  9. A randomized, double-masked, parallel-group, comparative study to evaluate the clinical efficacy and safety of 1% azithromycin–0.1% dexamethasone combination compared to 1% azithromycin alone, 0.1% dexamethasone alone, and vehicle in the treatment of subjects with blepharitis

    PubMed Central

    Hosseini, Kamran; Lindstrom, Richard L; Foulks, Gary; Nichols, Kelly K

    2016-01-01

    Purpose To evaluate the clinical efficacy and safety of a 1% azithromycin–0.1% dexamethasone combination in DuraSite (“combination”) compared to 0.1% dexamethasone in DuraSite, 1% azithromycin in DuraSite, and vehicle in the treatment of subjects with blepharitis. Materials and methods This was a Phase III, double-masked, vehicle-controlled, four-arm study in which 907 subjects with blepharitis were randomized to combination (n=305), 0.1% dexamethasone (n=298), 1% azithromycin (n=155), or vehicle (n=149). Ten study visits were scheduled: screening visit, days 1 and 4 (dosing phase) and 15, and months 1–6 (follow-up phase). On day 1, subjects applied one drop of the study drug to the eyelid of the inflamed eye(s) twice daily, and continued with twice-daily dosing for 14 days. After completing 14 days of dosing, subjects were followed for 6 months for efficacy and safety. Results A total of 57 subjects (6.3%) had complete clinical resolution at day 15: 25 (8.2%), 17 (5.7%), 8 (5.2%), and 7 (4.7%) subjects in the combination-, 0.1% dexamethasone-, 1% azithromycin-, and vehicle-treatment groups, respectively. The combination was superior to 1% azithromycin and vehicle alone, but not to 0.1% dexamethasone alone. Mean composite (total) clinical sign and symptom scores improved in all four treatment groups during the post-treatment evaluation phase for the intent-to-treat population, but outcomes were superior when a drop containing 0.1% dexamethasone was utilized. Clinical response was noted as early as day 4, and persisted as long as 6 months. Most adverse events were considered mild in severity and not related to the study drug. Conclusion A higher percentage of subjects in the combination group achieved complete clinical resolution of the signs and symptoms of blepharitis at day 15 than with 1% azithromycin and vehicle, but outcomes were similar to treatment with 0.1% dexamethasone alone. The combination was well tolerated. PMID:27570444

  10. Sex work: a comparative study.

    PubMed

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status.

  11. Sex work: a comparative study.

    PubMed

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status. PMID:24671729

  12. Randomized Comparative Trial of a Social Cognitive Skills Group for Children With Autism Spectrum Disorder

    PubMed Central

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

    2015-01-01

    Objective This study evaluated the efficacy of a targeted social skills training group in school-aged children with autism spectrum disorder (ASD). The intervention, NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training), is a 12-session cognitive-behavioral intervention (CBI) for verbal, school-aged children targeting ASD-specific social behavioral impairments. Method Sixty-nine children with ASD, 8 to 11 years of age with verbal IQs greater than 70, participated in a randomized comparative trial to examine the efficacy of NETT relative to a facilitated play group. Treatment outcomes included caregiver reports of social behavior and neuropsychological assessments of social cognition conducted by blinded raters. Outcomes were collected at baseline, endpoint, and three months posttreatment. Results Significant improvements were found on social behavior outcomes such as nonverbal communication, empathic responding, and social relations in the NETT condition relative to the active control at endpoint. Verbal IQ and age moderated the interaction effect on social behavior with higher verbal IQ and older age associated with improvements in the CBI condition. No significant improvements were found on social cognitive outcomes. No significant group differences were found at three-month follow-up conducted with approximately half the sample (n=34). Conclusion These data indicate that targeted CBI social skills groups such as NETT improve social communication deficits in verbal, school-aged children with ASD. The moderating effects of high verbal IQ suggest a need to consider participant and treatment characteristics associated with outcomes in future studies. PMID:25721186

  13. Patient preference compared with random allocation in short-term psychodynamic supportive psychotherapy with indicated addition of pharmacotherapy for depression.

    PubMed

    Van, Henricus L; Dekker, Jack; Koelen, Jurrijn; Kool, Simone; van Aalst, Gerda; Hendriksen, Marielle; Peen, Jaap; Schoevers, Robert

    2009-03-01

    Depressed patients randomized to psychotherapy were compared with those who had been chosen for psychotherapy in a treatment algorithm, including addition of an antidepressant in case of early nonresponse. There were no differences between randomized and by-preference patients at baseline in adherence and outcome. About half of the early nonresponders refused the additional medication. However, no clear effect of medication addition on ultimate outcome could be demonstrated. In total, 37% of the patients achieved remission. The study suggested that randomization of patients does not induce a great influence on outcome. It might be warranted to continue an initially ineffective psychotherapy for depression, because a considerable number of patients do have a pattern of delayed response.

  14. Randomized trial comparing mindfulness-based relapse prevention with relapse prevention for women offenders at a residential addiction treatment center.

    PubMed

    Witkiewitz, Katie; Warner, Kaitlin; Sully, Betsy; Barricks, Adria; Stauffer, Connie; Thompson, Brian L; Luoma, Jason B

    2014-04-01

    Reincarceration rates are high among substance-involved criminal offenders. This study (conducted during 2010-2011 in an urban area and funded by a Washington State University-Vancouver mini-grant) used a randomized design to examine the effectiveness of mindfulness-based relapse prevention (MBRP) as compared to relapse prevention (RP), as part of a residential addictions treatment program for women referred by the criminal-justice system (N = 105). At 15-week follow up, regression analyses found women in MBRP, compared to RP, reported significantly fewer drug use days and fewer legal and medical problems. Study limitations and future research directions for studying the efficacy of MBRP are discussed.

  15. Point-of-care clinical documentation: assessment of a bladder cancer informatics tool (eCancerCareBladder): a randomized controlled study of efficacy, efficiency and user friendliness compared with standard electronic medical records

    PubMed Central

    Bostrom, Peter J; Toren, Paul J; Xi, Hao; Chow, Raymond; Truong, Tran; Liu, Justin; Lane, Kelly; Legere, Laura; Chagpar, Anjum; Zlotta, Alexandre R; Finelli, Antonio; Fleshner, Neil E; Grober, Ethan D

    2011-01-01

    Objective To compare the use of structured reporting software and the standard electronic medical records (EMR) in the management of patients with bladder cancer. The use of a human factors laboratory to study management of disease using simulated clinical scenarios was also assessed. Design eCancerCareBladder and the EMR were used to retrieve data and produce clinical reports. Twelve participants (four attending staff, four fellows, and four residents) used either eCancerCareBladder or the EMR in two clinical scenarios simulating cystoscopy surveillance visits for bladder cancer follow-up. Measurements Time to retrieve and quality of review of the patient history; time to produce and completeness of a cystoscopy report. Finally, participants provided a global assessment of their computer literacy, familiarity with the two systems, and system preference. Results eCancerCareBladder was faster for data retrieval (scenario 1: 146 s vs 245 s, p=0.019; scenario 2: 306 vs 415 s, NS), but non-significantly slower to generate a clinical report. The quality of the report was better in the eCancerCareBladder system (scenario 1: p<0.001; scenario 2: p=0.11). User satisfaction was higher with the eCancerCareBladder system, and 11/12 participants preferred to use this system. Limitations The small sample size affected the power of our study to detect differences. Conclusions Use of a specific data management tool does not appear to significantly reduce user time, but the results suggest improvement in the level of care and documentation and preference by users. Also, the use of simulated scenarios in a laboratory setting appears to be a valid method for comparing the usability of clinical software. PMID:21816957

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

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  17. A Study of Head Start Effectiveness Using a Randomized Design.

    ERIC Educational Resources Information Center

    Abbott-Shim, Martha; Lambert, Richard; McCart, Frances

    Although an extensive body of literature exists on the impact of Head Start, very few studies have used an experimental design with random assignment, a key methodological component needed to increase the weight of evaluation findings. This study used a randomized design with a wide range of outcomes related to school readiness to assess the…

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

    ERIC Educational Resources Information Center

    Shepherd, Jonathan P.

    2003-01-01

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

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

    SciTech Connect

    Kuhan, G. Antoniou, G. A.; Nikam, M.; Mitra, S.; Farquharson, F.; Brittenden, J.; Chalmers, N.

    2013-06-15

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

  20. Monotherapy with Levetiracetam Versus Older AEDs: A Randomized Comparative Trial of Effects on Bone Health.

    PubMed

    Hakami, Tahir; O'Brien, Terence J; Petty, Sandra J; Sakellarides, Mary; Christie, Jemma; Kantor, Susan; Todaro, Marian; Gorelik, Alexandra; Seibel, Markus J; Yerra, Raju; Wark, John D

    2016-06-01

    Long-term anti-epileptic drug (AED) therapy is associated with increased fracture risk. This study tested whether substituting the newer AED levetiracetam has less adverse effects on bone than older AEDs. An open-label randomized comparative trial. Participants had "failed" initial monotherapy for partial epilepsy and were randomized to substitution monotherapy with levetiracetam or an older AED (carbamazepine or valproate sodium). Bone health assessments, performed at 3 and 15 months, included areal bone mineral density (aBMD) and content at lumbar spine (LS), total hip (TH), forearm (FA), and femoral neck (FN), radial and tibial peripheral quantitative computed tomography and serum bone turnover markers. Main outcomes were changes by treatment group in aBMD at LS, TH, and FA, radial and tibial trabecular BMD and cortical thickness. 70/84 patients completed assessments (40 in levetiracetam- and 30 in older AED group). Within-group analyses showed decreases in both groups in LS (-9.0 %; p < 0.001 in levetiracetam vs. -9.8 %; p < 0.001 in older AED group), FA (-1.46 %; p < 0.001 vs. -0.96 %; p < 0.001, respectively) and radial trabecular BMD (-1.46 %; p = 0.048 and -2.31 %; p = 0.013, respectively). C-terminal telopeptides of type I collagen (βCTX; bone resorption marker) decreased in both groups (-16.1 %; p = 0.021 vs. -15.2 %; p = 0.028, respectively) whereas procollagen Ι N-terminal peptide (PΙNP; bone formation marker) decreased in older AED group (-27.3 %; p = 0.008). The treatment groups did not differ in any of these measures. In conclusion, use of both levetiracetam and older AEDs was associated with bone loss over 1 year at clinically relevant fracture sites and a reduction in bone turnover. PMID:26842957

  1. Gerontopsychological studies using NAI ('Nürnberger Alters-Inventar') on patients with organic psychosyndrome (DSM III, Category 1) treated with centrophenoxine in a double blind, comparative, randomized clinical trial.

    PubMed

    Pék, G; Fülöp, T; Zs-Nagy, I

    1989-07-01

    A double blind clinical trial was performed on 50 persons (25 men, 25 women) over the age 60 (average age: 77 years). They suffered from dementias of medium level (DSM III, Category 1, ICD No. 299), and had been residents in an old age home longer than 3 months at the start of the trial. The patients were treated first for 2 weeks by placebo tablets and their initial performance was recorded during this period by using the Nuremberg Gerontopsychological Inventory (NAI). This was then followed by a treatment for 8 weeks with the nootropic drug, centrophenoxine (CPH), the dose of which was 2 g/day distributed in 2 x 2 tablets of Helfergin500 (Promonta, Hamburg, FRG), or with placebo tablets of identical size, then the NAI test was repeated again. Verum or placebo treatment was selected randomly and the code was revealed only after having elaborated all the results of the trial. During the treatment period four drop-outs occurred for intercurrent diseases. Evaluation was based on a semi-quantitative, intra-individual comparison of the performance before and after treatment. The results obtained suggest that CPH treatment may be useful in dementias of medium level in quite old groups of patients, since 48% of the verum group displayed improvements in the memory functions against 28% of the placebo group. CPH seems to be a useful and harmless drug in the treatment and most probably also in prevention of the dementias.

  2. Balloon dilation of benign esophageal rings or strictures: a randomized clinical trial comparing two different inflation times.

    PubMed

    Wallner, O; Wallner, B

    2014-01-01

    Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time with 2 minutes inflation time, regarding the efficacy. Twenty patients with symptomatic strictures were prospectively studied in a randomized fashion. The 10-second group required an average of 1.4 dilations per patient; the 2-minute group required an average of 1.5 dilations per patient. This pilot study indicates that 10 seconds inflation time is as effective as 2 minutes. Because the treatment is both painful and unpleasant, this is an important finding.

  3. Comparative Studies in Special Education.

    ERIC Educational Resources Information Center

    Mazurek, Kas, Ed.; Winzer, Margret A., Ed.

    This text presents 26 case studies which examine special education provisions for children in the world today. The reports focus on the current state of special education in selected nations and major issues and controversies in the field of special education within those nations. Each case study addresses the following themes: (1) prevalence of…

  4. Comparing Tehran STOCK Exchange as AN Emerging Market with a Mature Market by Random Matrix Approach

    NASA Astrophysics Data System (ADS)

    Namaki, A.; Raei, R.; Jafari, G. R.

    We analyze cross-correlation between return fluctuations of stocks of an emerging market by using random matrix theory (RMT). We test the statistics of eigenvalues of cross-correlation (C) between stocks of the Tehran Price Index (TEPIX) as an emerging market and compare these with a mature market (US market). According to the "null hypothesis," a random correlation matrix constructed from mutually uncorrelated time series, the deviation from the Gaussian orthogonal ensemble of RTM is a good criterion. We find that a majority of the eigenvalues of C fall within the bulk (RMT bounds between λ+ and λ-) for the eigenvalues of the random correlation matrices. Further, we find that the distribution of eigenvector components for the eigenvectors corresponding to the largest deviating eigenvalues, display systematic deviations from the RMT prediction. Analyzing the components of the deviating eigenvectors by Inverse Participation Ratio, leads us to know that the largest eigenvalue corresponds to an influence common to the whole market. Our analysis of the other deviating eigenvectors shows distinct industries, whose identities corresponds to the structure of the Iran business environment.

  5. Randomized Trial of a Smartphone Mobile Application Compared to Text Messaging to Support Smoking Cessation

    PubMed Central

    Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.

    2014-01-01

    Abstract Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and quitting behavior (quit attempts, point-prevalence, 30-day point-prevalence, and continued abstinence) were assessed in posttests. Results: Overall, 60% of smokers used mobile services (REQ-Mobile, 61%, mean of 128.5 messages received; onQ, 59%, mean of 107.8 messages), and 75% evaluated REQ-Mobile as user-friendly. A majority of smokers reported being abstinent at posttest (6 weeks, 53% of completers; 12 weeks, 66% of completers [44% of all cases]). Also, 37% (25%of all cases) reported 30-day point-prevalence abstinence, and 32% (22% of all cases) reported continuous abstinence at 12 weeks. OnQ produced more abstinence (p<0.05) than REQ-Mobile. Use of both services predicted increased 30-day abstinence at 12 weeks (used, 47%; not used, 20%; p=0.03). Conclusions: REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging. Text messaging may work better because it is simple, well known, and delivered to a primary inbox. These advantages may disappear as smokers become more experienced with new handsets. Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging. PMID:24350804

  6. Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

    PubMed Central

    2013-01-01

    Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary

  7. [Prophylaxis of postoperative thromboembolism. Randomized prospective study].

    PubMed

    Manso, L C; Milheiro, A; Castro e Sousa, F

    1996-01-01

    The difference between a non fractioned heparin (Liquemine) and another of low molecular weight (Fraxiparine) was compared through: hemostasis difficulties, during and after surgery; the use of transfusions; clinical signs of inferior limb vein thrombosis or pulmonary emboli; laboratory results of blood (hemogramme, biochemistry, coagulation) and urine. The results observed in 500 patients, (250 of each heparin) statistically treated, show that no difference was found between the two groups of patients, which lead us to conclude that both heparins have the same effect. Low molecular weight has the advantage of being administrated only once a day.

  8. Double-blind randomized study comparing the efficacies and safeties of a short (3-day) course of azithromycin and a 5-day course of amoxicillin in patients with acute exacerbations of chronic bronchitis.

    PubMed Central

    Mertens, J C; van Barneveld, P W; Asin, H R; Ligtvoet, E; Visser, M R; Branger, T; Hoepelman, A I

    1992-01-01

    The efficacies and safeties of a three-dose regimen of azithromycin (500 mg once daily for 3 days) and a 15-dose regimen of amoxicillin (500 mg three times daily for 5 days) were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. A total of 92% of patients suffered a type 1 exacerbation. Treatment success, defined as cure or major improvement, was achieved in all patients in the azithromycin group by day 5, compared with 23 (92%) of 25 patients in the amoxicillin group. On day 12, these data were 24 of 25 (96%) in the azithromycin group and 20 of 25 (80%) in the amoxicillin group (results were not significantly different). Several pathogens were isolated (MIC ranges [micrograms per milliliter] in parentheses): Haemophilus influenzae or Haemophilus parainfluenzae was isolated 23 times (azithromycin, less than or equal to 0.06 to 32; amoxicillin, 0.12 to 2); Streptococcus pneumoniae was isolated from 11 patients (azithromcyin, less than or equal to 0.06 greater than 256; amoxicillin, less than or equal to 0.06 to 0.25); Moraxella (Branhamella) catarrhalis was isolated from eight patients (azithromycin, less than or equal to 0.06; amoxicillin, less than or equal to 0.06 to 16); and other members of the family Enterobacteriaceae were isolated from eight patients. One patient treated with azithromycin had Legionella pneumophila pneumonia, and another in that group had a significant rise in titer of antibody against influenza A virus. One patient treated with amoxicillin also had a significant rise in titer of antibody against influenza A virus. Microbiological response rates were comparable. One patient who received azithromycin developed abnormal liver function. Two patients treated with amoxicillin developed abnormal liver functions, one developed exanthema, and one treatment was stopped because of nausea. It is concluded that a three-dose (3-day) regimen of azithromycin is as effective clinically and microbiologically as a

  9. A numerical study of the 3D random interchange and random loop models

    NASA Astrophysics Data System (ADS)

    Barp, Alessandro; Barp, Edoardo Gabriele; Briol, François-Xavier; Ueltschi, Daniel

    2015-08-01

    We have studied numerically the random interchange model and related loop models on the three-dimensional cubic lattice. We have determined the transition time for the occurrence of long loops. The joint distribution of the lengths of long loops is Poisson-Dirichlet with parameter 1 or \\frac{1}{2}.

  10. A comparative study on monitored anesthesia care

    PubMed Central

    Sen, Jayashree; Sen, Bitan

    2014-01-01

    Aim: The aim of this study is to compare the effectiveness, hemodynamic changes and duration of sedation and analgesia between combinations of fortwin-phenergan-midazolam (FPM) and ketamine - midazolam (KM) along with local anesthesia for the surgeries done under the umbrella of monitored anesthesia care. Materials and Methods: A total of 50 patients undergoing surgeries as tympanoplasty, septoplasty, lip repair, dacrocystectomy and cataract under local anesthesia, randomly received either intravenous (IV) fortwin 0.3 mg/kg over 1 min followed by IV midazolam 0.04 mg/kg plus IV phenergan 12.5 mg (Group FPM) or IV ketamine 0.3 mg/kg over 1 min plus IV midazolam 0.04 mg/kg (Group KM). Sedation was titrated to Ramsay sedation score (RSS) of 3. Patients’ mean arterial pressure (MAP), heart rate (HR), saturation peripheral pulse, duration of sedation and need for intraoperative rescue sedation/analgesic were recorded and compared. Satisfaction of patients (using a 1-7 point Likert verbal rating scale) and readiness for discharge towards (time to Aldrete score of 10) were also determined. Result: Group KM had significant rise in HR (20-25%) and MAP (25-30%) from 30 min after the bolus dose given until the end of the surgery in contrast to Group FPM. The target sedation level (RSS ≥ 3) was higher in Group FPM (n = 23 [92%]) as compared with Group KM (n = 12 [48%]). Time until need for rescue sedation was 66.96 ± 17.19 min in FPM and 32.80 ± 8.90 min in KM group. The patient satisfaction (Likert scale) is more with the FPM group (6.12 ± 0.83 vs. 4.40 ± 1.20). Conclusion: We found that the combination of FPM is superior to the KM combination as per the hemodynamic changes, duration of analgesia, patients’ satisfaction and efficacy of the drugs are concerned. PMID:25886327

  11. Resampling the N9741 Trial to Compare Tumor Dynamic Versus Conventional End Points in Randomized Phase II Trials

    PubMed Central

    Sharma, Manish R.; Gray, Elizabeth; Goldberg, Richard M.; Sargent, Daniel J.; Karrison, Theodore G.

    2015-01-01

    Purpose The optimal end point for randomized phase II trials of anticancer therapies remains controversial. We simulated phase II trials by resampling patients from N9741, a randomized phase III trial of chemotherapy regimens for metastatic colorectal cancer, and compared the power of various end points to detect the superior therapy (FOLFOX [infusional fluorouracil, leucovorin, and oxaliplatin] had longer overall survival than both IROX [irinotecan plus oxaliplatin] and IFL [irinotecan and bolus fluorouracil plus leucovorin]). Methods Tumor measurements and progression-free survival (PFS) data were obtained for 1,471 patients; 1,002 had consistently measured tumors and were resampled (5,000 replicates) to simulate two-arm, randomized phase II trials with α = 0.10 (one sided) and 20 to 80 patients per arm. End points included log ratio of tumor size at 6, 12, and 18 weeks relative to baseline; time to tumor growth (TTG), estimated using a nonlinear mixed-effects model; and PFS. Arms were compared using rank sum tests for log ratio and TTG and a log-rank test for PFS. Results For FOLFOX versus IFL, TTG and PFS had similar power, with both exceeding the power of log ratio at 18 weeks; for FOLFOX versus IROX, TTG and log ratio at 18 weeks had similar power, with both exceeding the power of PFS. The best end points exhibited > 80% power with 60 to 80 patients per arm. Conclusion TTG is a powerful end point for randomized phase II trials of cytotoxic therapies in metastatic colorectal cancer; it was either comparable or superior to PFS and log ratio at 18 weeks. Additional studies will be needed to clarify the potential of TTG as a phase II end point. PMID:25349295

  12. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial

    PubMed Central

    Bochner, Bernard H.; Dalbagni, Guido; Sjoberg, Daniel D.; Silberstein, Jonathan; Keren Paz, Gal E.; Donat, S. Machele; Coleman, Jonathan A.; Mathew, Sheila; Vickers, Andrew; Schnorr, Geoffrey C.; Feuerstein, Michael A.; Rapkin, Bruce; Parra, Raul O.; Herr, Harry W.; Laudone, Vincent P.

    2015-01-01

    Background Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk. Objective To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques. Design, setting, and participants A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively. Intervention Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach. Outcome measurements and statistical analysis Primary outcomes were overall 90-d grade 2–5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score. Results and limitations The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2–5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, −21% to −13%; p = 0.7). The similar rates of grade 2–5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p = 0.027) but significantly longer operative time than the ORC group (p < 0.001). Pathologic

  13. Rationale and design of the Randomized Evaluation of patients with Stable angina Comparing Utilization of noninvasive Examinations (RESCUE) trial.

    PubMed

    Stillman, Arthur E; Gatsonis, Constantine; Lima, João A C; Black, William C; Cormack, Jean; Gareen, Ilana; Hoffmann, Udo; Liu, Tao; Mavromatis, Kreton; Schnall, Mitchell D; Udelson, James E; Woodard, Pamela K

    2016-09-01

    RESCUE is a phase III, randomized, controlled, multicenter, comparative efficacy study, designed to compare two diagnostic imaging/treatment paradigms that use coronary computed tomography angiography (CCTA) or single photon emission computed tomography myocardial perfusion imaging (SPECT MPI) for assisting in the diagnosis of ischemic heart disease in patients with stable angina symptoms, and guiding subsequent treatment. The study is based on the hypothesis that CCTA as a diagnostic tool is associated with no increase in cardiac risk, decreased cost, and reduced radiation exposure compared with SPECT MPI. The RESCUE trial was funded by the Agency for Healthcare Research and Quality (AHRQ) and the American College of Radiology Imaging Network (ACRIN) Fund for Imaging Innovation, began in 2011, and completed in 2014. PMID:27595676

  14. DEAE-Dextran in the treatment of primary hypercholesterolemia and/or hypercholesterolemia combined with hypertriglyceridemia. A multicentric randomized study on the efficacy of DEAE-Dextran compared with Cholestyramine.

    PubMed

    Fedele, F

    2003-01-01

    This study was carried out to verify the therapeutic homogeneity between DEAE-Dextran and Cholestyramine. Blood levels of total cholesterol, HDL, LDL and triglycerides were evaluated in 202 patients affected by dyslipidemia and treated with DEAD-D at 2.5 g/day or with Cholestyramine at 12 g/day for 30 days. At the end of treatment both drugs caused significant reduction of total cholesterol, LDL and triglycerides blood levels; DEAD-D was generally more effective than Cholestyramine, in particular on triglycerides values (30.6% and 13.7% of reduction respectively), and produced also a significant increase in HDL cholesterol, differently from Cholestyramine that was ineffective on this parameter.

  15. Comparing the Performance of Japan's Earthquake Hazard Maps to Uniform and Randomized Maps

    NASA Astrophysics Data System (ADS)

    Brooks, E. M.; Stein, S. A.; Spencer, B. D.

    2015-12-01

    The devastating 2011 magnitude 9.1 Tohoku earthquake and the resulting shaking and tsunami were much larger than anticipated in earthquake hazard maps. Because this and all other earthquakes that caused ten or more fatalities in Japan since 1979 occurred in places assigned a relatively low hazard, Geller (2011) argued that "all of Japan is at risk from earthquakes, and the present state of seismological science does not allow us to reliably differentiate the risk level in particular geographic areas," so a map showing uniform hazard would be preferable to the existing map. Defenders of the maps countered by arguing that these earthquakes are low-probability events allowed by the maps, which predict the levels of shaking that should expected with a certain probability over a given time. Although such maps are used worldwide in making costly policy decisions for earthquake-resistant construction, how well these maps actually perform is unknown. We explore this hotly-contested issue by comparing how well a 510-year-long record of earthquake shaking in Japan is described by the Japanese national hazard (JNH) maps, uniform maps, and randomized maps. Surprisingly, as measured by the metric implicit in the JNH maps, i.e. that during the chosen time interval the predicted ground motion should be exceeded only at a specific fraction of the sites, both uniform and randomized maps do better than the actual maps. However, using as a metric the squared misfit between maximum observed shaking and that predicted, the JNH maps do better than uniform or randomized maps. These results indicate that the JNH maps are not performing as well as expected, that what factors control map performance is complicated, and that learning more about how maps perform and why would be valuable in making more effective policy.

  16. Surgical Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial

    PubMed Central

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

    2013-01-01

    Objective To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture. Methods Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3-4) and 4-6 weeks post-operatively. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score and patient scar satisfaction score. Analyses were by intent-to-treat. Results Of 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture; P <0.001 (RR 14.1; 95% CI 1.9-106). Of 350 (87.9%) with follow up at 4-6 weeks, the cumulative risk of the primary outcome at 4-6 weeks was 14.5% for staples and 5.9% for suture; P=0.008 (RR 2.5; 95% CI 1.2-5.0). Operative time, pain scores at 72-96 hours and at 6 weeks, cosmesis score, and patient satisfaction score did not differ by group. Conclusion Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery. PMID:23262925

  17. Randomized, Double-Blind, Phase II, Multicenter Study Evaluating the Safety/Tolerability and Efficacy of JNJ-Q2, a Novel Fluoroquinolone, Compared with Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infection ▿ †

    PubMed Central

    Covington, Paul; Davenport, J. Michael; Andrae, David; O'Riordan, William; Liverman, Lisa; McIntyre, Gail; Almenoff, June

    2011-01-01

    JNJ-Q2 is a fluoroquinolone with broad coverage including methicillin-resistant Staphylococcus aureus (MRSA). A double-blind, multicenter, phase II noninferiority study treated 161 patients for 7 to 14 days, testing the efficacy of JNJ-Q2 (250 mg, twice a day [BID]) versus linezolid (600 mg, BID) in patients with acute bacterial skin and skin structure infections (ABSSSI). The prespecified criterion for noninferiority was 15%. Primary intent-to-treat analysis was unable to declare noninferiority, as the risk difference lower bound of the 95% confidence interval between treatments was 19% at 36 to 84 h postrandomization for the composite end point of lesion assessment and temperature. Prespecified clinical cure rates 2 to 14 days after completion of therapy were similar (83.1% for JNJ-Q2 versus 82.1% for linezolid). Post hoc analyses revealed that JNJ-Q2 was statistically noninferior to linezolid (61.4% versus 57.7%, respectively; P = 0.024) based on the 2010 FDA guidance, which defines treatment success as lack of lesion spread and afebrile status within 48 to 72 h postrandomization. Despite evidence of systemic disease, <5% of patients presented with fever, suggesting fever is not a compelling surrogate measure of systemic disease resolution for this indication. Nausea and vomiting were the most common adverse events. Of the patients, 86% (104/121) had S. aureus isolated from the infection site; 63% of these were MRSA. The results suggest JNJ-Q2 shows promise as an effective treatment for ABSSSI, demonstrating (i) efficacy for early clinical response (i.e., lack of spread of lesions and absence of fever at 48 to 72 h), and (ii) cure rates for ABSSSI pathogens (especially MRSA) consistent with the historical literature. PMID:21947389

  18. Full Bayes Poisson gamma, Poisson lognormal, and zero inflated random effects models: Comparing the precision of crash frequency estimates.

    PubMed

    Aguero-Valverde, Jonathan

    2013-01-01

    In recent years, complex statistical modeling approaches have being proposed to handle the unobserved heterogeneity and the excess of zeros frequently found in crash data, including random effects and zero inflated models. This research compares random effects, zero inflated, and zero inflated random effects models using a full Bayes hierarchical approach. The models are compared not just in terms of goodness-of-fit measures but also in terms of precision of posterior crash frequency estimates since the precision of these estimates is vital for ranking of sites for engineering improvement. Fixed-over-time random effects models are also compared to independent-over-time random effects models. For the crash dataset being analyzed, it was found that once the random effects are included in the zero inflated models, the probability of being in the zero state is drastically reduced, and the zero inflated models degenerate to their non zero inflated counterparts. Also by fixing the random effects over time the fit of the models and the precision of the crash frequency estimates are significantly increased. It was found that the rankings of the fixed-over-time random effects models are very consistent among them. In addition, the results show that by fixing the random effects over time, the standard errors of the crash frequency estimates are significantly reduced for the majority of the segments on the top of the ranking.

  19. Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

    2011-01-01

    Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

  20. Randomized trial comparing mindfulness-based relapse prevention with relapse prevention for women offenders at a residential addiction treatment center.

    PubMed

    Witkiewitz, Katie; Warner, Kaitlin; Sully, Betsy; Barricks, Adria; Stauffer, Connie; Thompson, Brian L; Luoma, Jason B

    2014-04-01

    Reincarceration rates are high among substance-involved criminal offenders. This study (conducted during 2010-2011 in an urban area and funded by a Washington State University-Vancouver mini-grant) used a randomized design to examine the effectiveness of mindfulness-based relapse prevention (MBRP) as compared to relapse prevention (RP), as part of a residential addictions treatment program for women referred by the criminal-justice system (N = 105). At 15-week follow up, regression analyses found women in MBRP, compared to RP, reported significantly fewer drug use days and fewer legal and medical problems. Study limitations and future research directions for studying the efficacy of MBRP are discussed. PMID:24611849

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

    PubMed Central

    Jha, Abhishek; Bhashyam, Mamtha

    2016-01-01

    Background With introduction of many herbal medicines, dentistry has recently evidenced shift of approach for treating many inflammatory oral diseases by using such modalities. Aloe vera is one such product exhibiting multiple benefits and has gained considerable importance in clinical research recently. Aim To compare the efficacy of Aloevera and Chlorhexidine mouthwash on Periodontal Health. Material and Methods Thirty days randomized controlled trial was conducted among 390 dental students. The students were randomized into two intervention groups namely Aloe Vera (AV) chlorhexidine group (CHX) and one control (placebo) group. Plaque index and gingival index was recorded for each participant at baseline, 15 days and 30 days. The findings were than statistically analyzed, ANOVA and Post Hoc test were used. Results There was significant reduction (p<0.05) in the mean scores of all the parameters with Aloe Vera (AV) and chlorhexidine group. Post hoc test showed significant difference (p<0.000) in mean plaque and gingival index scores of aloe Vera and placebo and chlorhexidine and placebo group. No significant difference (p<0.05) was observed between AloeVera and chlorhexidine group. Conclusions Being an herbal product AloeVera has shown equal effectiveness as Chlorhexidine. Hence can be used as an alternative product for curing and preventing gingivitis. Key words:Aloe vera, chlorhexidine, dental plaque, gingivitis. PMID:27703614

  2. A randomized trial comparing mebendazole and secnidazole for the treatment of giardiasis.

    PubMed

    Escobedo, A A; Cañete, R; Gonzalez, M E; Pareja, A; Cimerman, S; Almirall, P

    2003-07-01

    To compare the efficacy of the two drugs in the treatment of giardiasis, 146 children (aged 5-15 years) with confirmed Giardia lamblia infection were randomly allotted to treatment with mebendazole (200 mg three times daily for 3 days) or secnidazole (30 mg/kg, in a single dose). Parasitological response to treatment was evaluated in each child by the microscopical examination of faecal samples collected 3, 5 and 7 days after he or she had completed treatment. Although the frequency of cure was higher for secnidazole (79.4%) than for mebendazole (78.1%), the difference was not statistically significant (P > 0.05). Both treatment regimens were well tolerated, with only mild, transient and self-limiting side-effects reported. Mebendazole may be preferable to secnidazole in the treatment of giardiasis cases who have an history of intolerance to 5-nitromidazoles, and where infections with Giardia and soil-transmitted helminths frequently co-occur.

  3. A randomized trial comparing mebendazole and secnidazole for the treatment of giardiasis.

    PubMed

    Escobedo, A A; Cañete, R; Gonzalez, M E; Pareja, A; Cimerman, S; Almirall, P

    2003-07-01

    To compare the efficacy of the two drugs in the treatment of giardiasis, 146 children (aged 5-15 years) with confirmed Giardia lamblia infection were randomly allotted to treatment with mebendazole (200 mg three times daily for 3 days) or secnidazole (30 mg/kg, in a single dose). Parasitological response to treatment was evaluated in each child by the microscopical examination of faecal samples collected 3, 5 and 7 days after he or she had completed treatment. Although the frequency of cure was higher for secnidazole (79.4%) than for mebendazole (78.1%), the difference was not statistically significant (P > 0.05). Both treatment regimens were well tolerated, with only mild, transient and self-limiting side-effects reported. Mebendazole may be preferable to secnidazole in the treatment of giardiasis cases who have an history of intolerance to 5-nitromidazoles, and where infections with Giardia and soil-transmitted helminths frequently co-occur. PMID:12930613

  4. Comparative emissions of random orbital sanding between conventional and self-generated vacuum systems.

    PubMed

    Liverseed, David R; Logan, Perry W; Johnson, Carl E; Morey, Sandy Z; Raynor, Peter C

    2013-03-01

    Conventional abrasive sanding generates high concentrations of particles. Depending on the substrate being abraded and exposure duration, overexposure to the particles can cause negative health effects ranging from respiratory irritation to cancer. The goal of this study was to understand the differences in particle emissions between a conventional random orbital sanding system and a self-generated vacuum random orbital sanding system with attached particle filtration bag. Particle concentrations were sampled for each system in a controlled test chamber for oak wood, chromate painted (hexavalent chromium) steel panels, and gel-coated (titanium dioxide) fiberglass panels using a Gesamtstaub-Probenahmesystem (GSP) sampler at three different locations adjacent to the sanding. Elevated concentrations were reported for all particles in the samples collected during conventional sanding. The geometric mean concentration ratios for the three substrates ranged from 320 to 4640 times greater for the conventional sanding system than the self-generated vacuum sanding system. The differences in the particle concentration generated by the two sanding systems were statistically significant with the two sample t-test (P < 0.0001) for all three substances. The data suggest that workers using conventional sanding systems could utilize the self-generated vacuum sanding system technology to potentially reduce exposure to particles and mitigate negative health effects.

  5. Comparative Emissions of Random Orbital Sanding between Conventional and Self-Generated Vacuum Systems

    PubMed Central

    Liverseed, David R.

    2013-01-01

    Conventional abrasive sanding generates high concentrations of particles. Depending on the substrate being abraded and exposure duration, overexposure to the particles can cause negative health effects ranging from respiratory irritation to cancer. The goal of this study was to understand the differences in particle emissions between a conventional random orbital sanding system and a self-generated vacuum random orbital sanding system with attached particle filtration bag. Particle concentrations were sampled for each system in a controlled test chamber for oak wood, chromate painted (hexavalent chromium) steel panels, and gel-coated (titanium dioxide) fiberglass panels using a Gesamtstaub-Probenahmesystem (GSP) sampler at three different locations adjacent to the sanding. Elevated concentrations were reported for all particles in the samples collected during conventional sanding. The geometric mean concentration ratios for the three substrates ranged from 320 to 4640 times greater for the conventional sanding system than the self-generated vacuum sanding system. The differences in the particle concentration generated by the two sanding systems were statistically significant with the two sample t-test (P < 0.0001) for all three substances. The data suggest that workers using conventional sanding systems could utilize the self-generated vacuum sanding system technology to potentially reduce exposure to particles and mitigate negative health effects. PMID:23065674

  6. A Randomized Comparative Trial on the Therapeutic Efficacy of Topical Aloe vera and Calendula officinalis on Diaper Dermatitis in Children

    PubMed Central

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

    2012-01-01

    Introduction. Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of Aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Methods. Sixty-six infants with DD (aged < 3 years) were randomized to receive either Aloe cream (n = 32) or Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Results. Although improvement in the severity of DD was observed in both treatment groups (P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites compared to Aloe group (P = 0.001). No adverse effect was reported from either of the medications. Discussion. The evidence from this study suggests that topical Aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants. PMID:22606064

  7. Comparative Efficacy of Oil Pulling and Chlorhexidine on Oral Malodor: A Randomized Controlled Trial

    PubMed Central

    Devi M, Aruna; Narang, Ridhi; V, Swathi; Makkar, Diljot Kaur

    2014-01-01

    Background: Oral malodor affects a large section of population. Traditional Indian folk remedy, oil pulling not only reduces it but can also bring down the cost of treatment. Aims: To compare the efficacy of oil pulling and chlorhexidine in reducing oral malodor and microbes. Materials and Methods: Three week randomized controlled trial was conducted among 60 students of three hostels of Maharani College of science and arts and commerce and Smt V.H.D.College of Home Science. The hostels were randomized into two intervention groups namely chlorhexidine group, sesame oil and one control (placebo) group. Twenty girls were selected from each hostel based on inclusion and exclusion criteria. Informed consent was obtained. The parameters recorded at the baseline (day 0) and post intervention on day 22 were plaque index (PI), gingival index (GI), objective (ORG1) and subjective (ORG2) organoleptic scores and anaerobic bacterial colony (ABC) count. Intra and inter group comparisons were made using Kruskal Wallis test, Wilcoxan sign rank test, ANOVA and student t-test. Results: There was significant reduction (p<0.05) in the mean scores of all the parameters within sesame oil and chlorhexidine group. Among the groups significant difference was observed in objective and subjective organoleptic scores. Post hoc test showed significant difference (p<0.000) in mean organoleptic scores of sesame oil and placebo and chlorhexidine and placebo group. No significant difference (p<0.05) was observed between sesame oil and chlorhexidine group. Conclusion: Oil pulling with sesame oil is equally efficacious as chlorhexidine in reducing oral malodor and microbes causing it. It should be promoted as a preventive home care therapy. PMID:25584309

  8. Randomized study designs for lifestyle interventions: a tutorial.

    PubMed

    Younge, John O; Kouwenhoven-Pasmooij, Tessa A; Freak-Poli, Rosanne; Roos-Hesselink, Jolien W; Hunink, Mg Myriam

    2015-12-01

    Unhealthy lifestyle behaviours are considered modifiable risk factors for many diseases. Lifestyle interventions that target these behaviours need rigorous evaluation to assess their effectiveness. The randomized controlled trial is the study design of choice when it comes to the evaluation of interventions. However, lifestyle interventions are often complex and subject to several important issues, such as patient preference and non-adherence, that may threaten the internal and external validity of studies. There is a strong demand for high-quality randomized controlled trials of interventions that promote healthy lifestyle behaviours. With this tutorial we aim to provide guidance in the choice of an optimal randomized controlled trial design in future trials of lifestyle interventions.

  9. Comparing couples' and individual voluntary counseling and testing for HIV at antenatal clinics in Tanzania: a randomized trial.

    PubMed

    Becker, Stan; Mlay, Rose; Schwandt, Hilary M; Lyamuya, Eligius

    2010-06-01

    Voluntary counseling and testing (VCT) for couples (CVCT) is an important HIV-prevention effort in sub-Saharan Africa where a substantial proportion of HIV transmission occurs within stable partnerships. This study aimed to determine the acceptance and effectiveness of CVCT as compared to individual VCT (IVCT). 1,521 women attending three antenatal clinics in Dar es Salaam were randomized to receive IVCT during that visit or CVCT with their husbands at a subsequent visit. The proportion of women receiving test results in the CVCT arm was significantly lower than in the IVCT arm (39 vs. 71%). HIV prevalence overall was 10%. In a subgroup analysis of HIV-positive women, those who received CVCT were more likely to use preventive measures against transmission (90 vs. 60%) and to receive nevirapine for themselves (55 vs. 24%) and their infants (55 vs. 22%) as compared to women randomized to IVCT. Uptake of CVCT is low in the antenatal clinic setting. Community mobilization and couple-friendly clinics are needed to promote CVCT.

  10. Physics studies in Europe; a comparative study

    NASA Astrophysics Data System (ADS)

    Steenstrup, S.; Donà dalle Rose, L. F.; Jones, W. G.; Tugulea, L.; van Steenwijk, F. J.

    2002-09-01

    What are the differences and similarities between physics studies at different universities across Europe (here the definition of Europe is broad)? How much does a student have to work to obtain a degree in physics? Questions like those prompted EUPEN (European Physics Education Network) to make a survey. During 1997 and 1998 the working groups of EUPEN sent out a number of questionnaires to a number of institutions and to individual students. In this report we focus on issues relating to the workload to obtain a degree in physics as expressed in contact hours - lectures, problem solving, laboratory work - and private study time. The different teaching/learning styles are also considered. Some of the results have already been presented at conferences.

  11. Microbiota-based Signature of Gingivitis Treatments: A Randomized Study

    PubMed Central

    Huang, Shi; Li, Zhen; He, Tao; Bo, Cunpei; Chang, Jinlan; Li, Lin; He, Yanyan; Liu, Jiquan; Charbonneau, Duane; Li, Rui; Xu, Jian

    2016-01-01

    Plaque-induced gingivitis can be alleviated by various treatment regimens. To probe the impacts of various anti-gingivitis treatments on plaque microflora, here a double blinded, randomized controlled trial of 91 adults with moderate gingivitis was designed with two anti-gingivitis regimens: the brush-alone treatment and the brush-plus-rinse treatment. In the later group, more reduction in both Plaque Index (TMQHI) and Gingival Index (mean MGI) at Day 3, Day 11 and Day 27 was evident, and more dramatic changes were found between baseline and other time points for both supragingival plaque microbiota structure and salivary metabonomic profiles. A comparison of plaque microbiota changes was also performed between these two treatments and a third dataset where 50 subjects received regimen of dental scaling. Only Actinobaculum, TM7 and Leptotrichia were consistently reduced by all the three treatments, whereas the different microbial signatures of the three treatments during gingivitis relieve indicate distinct mechanisms of action. Our study suggests that microbiota based signatures can serve as a valuable approach for understanding and potentially comparing the modes of action for clinical treatments and oral-care products in the future. PMID:27094556

  12. Microbiota-based Signature of Gingivitis Treatments: A Randomized Study.

    PubMed

    Huang, Shi; Li, Zhen; He, Tao; Bo, Cunpei; Chang, Jinlan; Li, Lin; He, Yanyan; Liu, Jiquan; Charbonneau, Duane; Li, Rui; Xu, Jian

    2016-01-01

    Plaque-induced gingivitis can be alleviated by various treatment regimens. To probe the impacts of various anti-gingivitis treatments on plaque microflora, here a double blinded, randomized controlled trial of 91 adults with moderate gingivitis was designed with two anti-gingivitis regimens: the brush-alone treatment and the brush-plus-rinse treatment. In the later group, more reduction in both Plaque Index (TMQHI) and Gingival Index (mean MGI) at Day 3, Day 11 and Day 27 was evident, and more dramatic changes were found between baseline and other time points for both supragingival plaque microbiota structure and salivary metabonomic profiles. A comparison of plaque microbiota changes was also performed between these two treatments and a third dataset where 50 subjects received regimen of dental scaling. Only Actinobaculum, TM7 and Leptotrichia were consistently reduced by all the three treatments, whereas the different microbial signatures of the three treatments during gingivitis relieve indicate distinct mechanisms of action. Our study suggests that microbiota based signatures can serve as a valuable approach for understanding and potentially comparing the modes of action for clinical treatments and oral-care products in the future. PMID:27094556

  13. Comparative efficacy of tadalafil versus tamsulosin as the medical expulsive therapy in lower ureteric stone: a prospective randomized trial

    PubMed Central

    Mylarappa, Prasad; Aggarwal, Kuldeep; Patil, Avinash; Joshi, Prarthan; Desigowda, Ramesh

    2016-01-01

    Introduction In recent years, medical expulsive therapy has been used in the management of distal ureteric stones as a supplement to conservative treatment. Therefore, we conducted a prospective randomized study to evaluate the possible role of tadalafil individually in comparison with proven tamsulosin therapy in ureteric stone expulsion. The aim of this study is to compare the safety and efficacy of a phosphodiesterase-5 inhibitor (tadalafil) and an α-1 blocker (tamsulosin) as medical expulsive therapy for distal ureteric calculi. Material and methods Between August 2014 and October 2015, 207 patients who presented with distal ureteric stones of size 5–10 mm were randomly divided into two groups: tadalafil (Group A) and tamsulosin (Group B). Therapy was given for a maximum of 4 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up, endoscopic treatment and adverse effects of drugs were noted. Both groups were compared for normally distributed data by percentage, analysis of variance, and T-test. All the classified and categorical data were analyzed for both groups using the chi-square test. Results A statistically significant expulsion rate of 84.0% in Group A compared with 68.0% in Group B (P value = 0.0130), and shorter stone expulsion time in Group A (14.7±3.8) in comparison to Group B (16.8 ±4.5) was observed. Statistically significant differences were noted in renal colic episodes and analgesic requirement in Group A than Group B. No serious adverse effects were noted. Conclusions Tadalafil is safe, efficacious, and well tolerated as medical expulsive therapy for distal ureteric stones. This study showed that tadalafil increases ureteric stone expulsion quite significantly along with better control of pain and significantly lower analgesic requirement. PMID:27551555

  14. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    PubMed

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans. PMID:6749701

  15. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents.

    PubMed

    Diwan, J; Dhand, R; Jindal, S K; Malik, S K; Sharma, P L

    1982-08-01

    The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.

  16. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small-group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to 1 of 3 groups (n = 44 in each…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  18. Cognitive Behavioral Principles within Group Mentoring: A Randomized Pilot Study

    ERIC Educational Resources Information Center

    Jent, Jason F.; Niec, Larissa N.

    2009-01-01

    This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group…

  19. Randomized trial comparing ceftriaxone with cefonicid for treatment of spontaneous bacterial peritonitis in cirrhotic patients.

    PubMed Central

    Gómez-Jiménez, J; Ribera, E; Gasser, I; Artaza, M A; Del Valle, O; Pahissa, A; Martínez-Vázquez, J M

    1993-01-01

    We compared cefonicid (2 g every 12 h) and ceftriaxone (2 g every 24 h) for their efficacy and safety in treating spontaneous bacterial peritonitis in cirrhotic patients in an open randomized clinical trial (30 patients in each group). Clinical, laboratory, and bacteriologic characteristics were similar in both groups. Ceftriaxone-susceptible strains were isolated on 44 occasions (94%), and cefonicid-susceptible strains were isolated on 43 occasions (91.5%). The antibiotic concentration in ascitic fluid/MIC ratio for ceftriaxone was > 100 throughout the dose interval (24 h), while it was lower for cefonicid (between 1 and 18). A total of 100% of patients treated with ceftriaxone, and 94% of those treated with cefonicid were cured of their infections (P was not significant). Hospitalization mortality was 37% in the cefonicid group and 30% in the ceftriaxone group (P was not significant). The time that elapsed between the initiation of treatment and the patient's death was shorter in the cefonicid group patients (5.3 +/- 3.90 days) than in the ceftriaxone group patients (11.8 +/- 9.15 days) (P < 0.05). None of the patients presented with superinfections, and only two patients treated with cefonicid and three patients treated with ceftriaxone developed colonizations with Enterococcus faecalis or Candida albicans. Ceftriaxone and cefonicid are safe and useful agents for treating cirrhotic spontaneous bacterial peritonitis, although the pharmacokinetic characteristics of ceftriaxone seem to be more advantageous than those of cefonicid. PMID:8215267

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

    PubMed

    Shepherd, Jonathan P

    2003-06-01

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

  1. Cognitive Behavioral Therapy vs. Tai Chi for Late Life Insomnia and Inflammatory Risk: A Randomized Controlled Comparative Efficacy Trial

    PubMed Central

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

    2014-01-01

    Study Objectives: To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Design: Randomized controlled, comparative efficacy trial. Setting: Los Angeles community. Patients: 123 older adults with chronic and primary insomnia. Interventions: Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Measurements: Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. Results: CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P < 0.01), and also showed greater and more sustained improvement in sleep quality, sleep parameters, fatigue, and depressive symptoms than TCC and SS (all P values < 0.01). As compared to SS, CBT was associated with a reduced risk of high CRP levels (> 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07–0.97] P < 0.05). Remission of insomnia was associated with lower levels of CRP (P < 0.05) at 16 months. TCC was associated with improvements in sleep quality, fatigue, and depressive symptoms as compared to SS (all P's < 0.05), but not insomnia remission. PSG measures did not change. Conclusions: Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. Clinical Trial Registration: ClinicalTrials.gov, NCT00280020 Citation: Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, Yokomizo M, Lavretsky H, Carroll JE, Motivala SJ, Bootzin R, Nicassio P. Cognitive behavioral

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

    PubMed Central

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

    2014-01-01

    Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care. PMID:25709653

  3. Encoding Sequential Information in Semantic Space Models: Comparing Holographic Reduced Representation and Random Permutation

    PubMed Central

    Recchia, Gabriel; Sahlgren, Magnus; Kanerva, Pentti; Jones, Michael N.

    2015-01-01

    Circular convolution and random permutation have each been proposed as neurally plausible binding operators capable of encoding sequential information in semantic memory. We perform several controlled comparisons of circular convolution and random permutation as means of encoding paired associates as well as encoding sequential information. Random permutations outperformed convolution with respect to the number of paired associates that can be reliably stored in a single memory trace. Performance was equal on semantic tasks when using a small corpus, but random permutations were ultimately capable of achieving superior performance due to their higher scalability to large corpora. Finally, “noisy” permutations in which units are mapped to other units arbitrarily (no one-to-one mapping) perform nearly as well as true permutations. These findings increase the neurological plausibility of random permutations and highlight their utility in vector space models of semantics. PMID:25954306

  4. Report on a randomized trial comparing two forms of immobilization of the head for fractionated stereotactic radiotherapy

    SciTech Connect

    Bednarz, Greg; Machtay, Mitchell; Werner-Wasik, Maria; Downes, Beverly; Bogner, Joachim; Hyslop, Terry; Galvin, James; Evans, James; Curran, Walter Jr.; Andrews, David

    2009-01-15

    Fractionated stereotactic radiotherapy (SRT) requires accurate and reproducible immobilization of the patient's head. This randomized study compared the efficacy of two commonly used forms of immobilization used for SRT. Two routinely used methods of immobilization, which differ in their approach to reproduce the head position from day to day, are the Gill-Thomas-Cosman (GTC) frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient's upper dentition and thus is in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom fitted to the front and back of the patient's head. After patients signed an IRB-approved informed consent form, eligible patients were randomized to either GTC frame or mask for their course of SRT. Patients were treated as per standard procedure; however, prior to each treatment a set of digital kilovolt images (ExacTrac, BrainLabAB, Germany) was taken. These images were fused with reference digitally reconstructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary end point of the study was to compare the two systems with respect to mean and standard deviations using the distance to isocenter measure. A total of 84 patients were enrolled (69 patients evaluable with detailed positioning data). A mixed-effect linear regression and two-tiled t test were used to compare the distance measure for both the systems. There was a statistically significant (p<0.001) difference between mean distances for these systems, suggesting that the GTC frame was more accurate. The mean 3D displacement and standard deviations were 3.17+1.95 mm for mask and 2.00+1.04 mm for frame. Both immobilization techniques were highly effective, but the GTC frame was more accurate. To optimize the accuracy of SRT, daily kilovolt image guidance is recommended with either immobilization system.

  5. Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial: protocol for a randomized, controlled, multicenter study comparing the Solitaire revascularization device with IV tPA with IV tPA alone in acute ischemic stroke

    PubMed Central

    Saver, Jeffrey L; Goyal, Mayank; Bonafe, Alain; Diener, Hans-Christoph; Levy, Elad I; Pereira, Vitor M; Albers, Gregory W; Cognard, Christophe; Cohen, David J; Hacke, Werner; Jansen, Olav; Jovin, Tudor G; Mattle, Heinrich P; Nogueira, Raul G; Siddiqui, Adnan H; Yavagal, Dileep R; Devlin, Thomas G; Lopes, Demetrius K; Reddy, Vivek; du Mesnil de Rochemont, Richard; Jahan, Reza

    2015-01-01

    Rationale Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. Aim The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. Design The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. Procedures Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. Study Outcomes The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. Analysis Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0–2). PMID:25777831

  6. Examining the Internal Validity and Statistical Precision of the Comparative Interrupted Time Series Design by Comparison with a Randomized Experiment

    ERIC Educational Resources Information Center

    St.Clair, Travis; Cook, Thomas D.; Hallberg, Kelly

    2014-01-01

    Although evaluators often use an interrupted time series (ITS) design to test hypotheses about program effects, there are few empirical tests of the design's validity. We take a randomized experiment on an educational topic and compare its effects to those from a comparative ITS (CITS) design that uses the same treatment group as the…

  7. Mendelian randomization studies of biomarkers and type 2 diabetes.

    PubMed

    Abbasi, Ali

    2015-12-01

    Many biomarkers are associated with type 2 diabetes (T2D) risk in epidemiological observations. The aim of this study was to identify and summarize current evidence for causal effects of biomarkers on T2D. A systematic literature search in PubMed and EMBASE (until April 2015) was done to identify Mendelian randomization studies that examined potential causal effects of biomarkers on T2D. To replicate the findings of identified studies, data from two large-scale, genome-wide association studies (GWAS) were used: DIAbetes Genetics Replication And Meta-analysis (DIAGRAMv3) for T2D and the Meta-Analyses of Glucose and Insulin-related traits Consortium (MAGIC) for glycaemic traits. GWAS summary statistics were extracted for the same genetic variants (or proxy variants), which were used in the original Mendelian randomization studies. Of the 21 biomarkers (from 28 studies), ten have been reported to be causally associated with T2D in Mendelian randomization. Most biomarkers were investigated in a single cohort study or population. Of the ten biomarkers that were identified, nominally significant associations with T2D or glycaemic traits were reached for those genetic variants related to bilirubin, pro-B-type natriuretic peptide, delta-6 desaturase and dimethylglycine based on the summary data from DIAGRAMv3 or MAGIC. Several Mendelian randomization studies investigated the nature of associations of biomarkers with T2D. However, there were only a few biomarkers that may have causal effects on T2D. Further research is needed to broadly evaluate the causal effects of multiple biomarkers on T2D and glycaemic traits using data from large-scale cohorts or GWAS including many different genetic variants. PMID:26446360

  8. Alpha-blockade and thiazide treatment of hypertension. A double-blind randomized trail comparing doxazosin and hydrochlorothiazide.

    PubMed

    Grimm, R H; Flack, J M; Schoenberger, J A; Gonzalez, N M; Liebson, P R

    1996-05-01

    This trial involved 107 patients in a two-group, parallel, double-blind, randomized study comparing the diuretic, hydrochlorothiazide (HCTZ) (dose 25 to 50 mg) and the alpha 1 antagonist, doxazosin (dose 2 to 16 mg). All randomized participants were followed for at least 1 year. Participants were recruited from the community. The study was carried out in four phases: Phase I-Baseline; Phase II-Monotherapy Titration; Phase III-Combination Therapy Titration; and Phase IV-Maintenance. The following measures were carried out: blood pressure, biochemistries, lipids/lipoproteins, quality of life, ambulatory electrocardiograms, echocardiograms, adverse experiences, and drug adherence. Both drugs were well tolerated, with only 4% taken off doxazosin and 7% off HCTZ. Adverse experiences were uncommon and mostly mild. Both drugs were effective in managing hypertension over 1 year of therapy. There was no difference noted in terms of efficacy of blood pressure lowering between the two study drugs, nor was there any evidence of tolerance developing or of any serious adverse effects. Average final doses for drugs were 7.8 mg for doxazosin and 36 mg for HCTZ. The results show that, over the course of 1 year, both drugs significantly lowered systolic and diastolic pressures compared to baseline; doxazosin (-19 and -16 mm Hg); HCTZ (-22 and 15 mm Hg). Blood pressure lowering was not significantly different between drugs. Sitting heart rate was not affected by drugs. Changes in quality of life measures were similar between groups. Echocardiographic measures at 1 year showed significant between-drug differences in change in left internal end systolic and diastolic dimensions and end systolic stress. Both doxazosin and HCTZ were effective drugs over 1 year for treating hypertension.

  9. Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

    PubMed Central

    2014-01-01

    Background In recent years, several oral antidiabetic drugs with new mechanisms of action have become available, expanding the number of treatment options. Sodium/glucose cotransporter-2 (SGLT2) inhibitors are a new class of oral antidiabetic drugs with an insulin-independent mechanism promoting urinary glucose excretion. We report the results of a combined Phase 2 and 3 clinical study (Japic CTI-101349) of the SGLT2 inhibitor tofogliflozin (CSG452, RG7201) in Japanese patients with type 2 diabetes mellitus. Methods The efficacy and safety of tofogliflozin were assessed in this multicenter, placebo-controlled, randomized, double-blind parallel-group study involving 230 patients with type 2 diabetes mellitus with inadequate glycemic control on diet/exercise therapy. Between 30 October 2010 and 28 February 2012, patients at 33 centers were randomized to either placebo (n = 56) or tofogliflozin (10, 20, or 40 mg; n = 58 each) orally, once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at week 24. Results Overall, 229 patients were included in the full analysis set (placebo: n = 56; tofogliflozin 10 mg: n = 57; tofogliflozin 20 and 40 mg: n = 58 each). The least squares (LS) mean change (95% confidence interval) from baseline in HbA1c at week 24 was −0.028% (−0.192 to 0.137) in the placebo group, compared with −0.797% (−0.960 to −0.634) in the tofogliflozin 10 mg group, −1.017% (−1.178 to −0.856) in the tofogliflozin 20 mg group, and −0.870% (−1.031 to −0.709) in the tofogliflozin 40 mg group (p < 0.0001 for the LS mean differences in all tofogliflozin groups vs placebo). There were also prominent decreases in fasting blood glucose, 2-h postprandial glucose, and body weight in all tofogliflozin groups compared with the placebo group. The main adverse events were hyperketonemia, ketonuria, and pollakiuria. The incidence of hypoglycemia was low. Furthermore, most adverse events were

  10. Numerical and Analytic Studies of Random-Walk Models.

    NASA Astrophysics Data System (ADS)

    Li, Bin

    We begin by recapitulating the universality approach to problems associated with critical systems, and discussing the role that random-walk models play in the study of phase transitions and critical phenomena. As our first numerical simulation project, we perform high-precision Monte Carlo calculations for the exponents of the intersection probability of pairs and triplets of ordinary random walks in 2 dimensions, in order to test the conformal-invariance theory predictions. Our numerical results strongly support the theory. Our second numerical project aims to test the hyperscaling relation dnu = 2 Delta_4-gamma for self-avoiding walks in 2 and 3 dimensions. We apply the pivot method to generate pairs of self-avoiding walks, and then for each pair, using the Karp-Luby algorithm, perform an inner -loop Monte Carlo calculation of the number of different translates of one walk that makes at least one intersection with the other. Applying a least-squares fit to estimate the exponents, we have obtained strong numerical evidence that the hyperscaling relation is true in 3 dimensions. Our great amount of data for walks of unprecedented length(up to 80000 steps), yield a updated value for the end-to-end distance and radius of gyration exponent nu = 0.588 +/- 0.001 (95% confidence limit), which comes out in good agreement with the renormalization -group prediction. In an analytic study of random-walk models, we introduce multi-colored random-walk models and generalize the Symanzik and B.F.S. random-walk representations to the multi-colored case. We prove that the zero-component lambdavarphi^2psi^2 theory can be represented by a two-color mutually -repelling random-walk model, and it becomes the mutually -avoiding walk model in the limit lambda to infty. However, our main concern and major break-through lies in the study of the two-point correlation function for the lambda varphi^2psi^2 theory with N > 0 components. By representing it as a two-color random-walk expansion

  11. A novel, efficient, randomized selection trial comparing combinations of drug therapy for ALS.

    PubMed

    Gordon, Paul H; Cheung, Ying-Kuen; Levin, Bruce; Andrews, Howard; Doorish, Carolyn; Macarthur, Robert B; Montes, Jacqueline; Bednarz, Kate; Florence, Julaine; Rowin, Julie; Boylan, Kevin; Mozaffar, Tahseen; Tandan, Rup; Mitsumoto, Hiroshi; Kelvin, Elizabeth A; Chapin, John; Bedlack, Richard; Rivner, Michael; McCluskey, Leo F; Pestronk, Alan; Graves, Michael; Sorenson, Eric J; Barohn, Richard J; Belsh, Jerry M; Lou, Jau-Shin; Levine, Todd; Saperstein, David; Miller, Robert G; Scelsa, Stephen N

    2008-08-01

    Combining agents with different mechanisms of action may be necessary for meaningful results in treating ALS. The combinations of minocycline-creatine and celecoxib-creatine have additive effects in the murine model. New trial designs are needed to efficiently screen the growing number of potential neuroprotective agents. Our objective was to assess two drug combinations in ALS using a novel phase II trial design. We conducted a randomized, double-blind selection trial in sequential pools of 60 patients. Participants received minocycline (100 mg)-creatine (10 g) twice daily or celecoxib (400 mg)-creatine (10 g) twice daily for six months. The primary objective was treatment selection based on which combination best slowed deterioration in the ALS Functional Rating Scale-Revised (ALSFRS-R); the trial could be stopped after one pool if the difference between the two arms was adequately large. At trial conclusion, each arm was compared to a historical control group in a futility analysis. Safety measures were also examined. After the first patient pool, the mean six-month decline in ALSFRS-R was 5.27 (SD=5.54) in the celecoxib-creatine group and 6.47 (SD=9.14) in the minocycline-creatine group. The corresponding decline was 5.82 (SD=6.77) in the historical controls. The difference between the two sample means exceeded the stopping criterion. The null hypothesis of superiority was not rejected in the futility analysis. Skin rash occurred more frequently in the celecoxib-creatine group. In conclusion, the celecoxib-creatine combination was selected as preferable to the minocycline-creatine combination for further evaluation. This phase II design was efficient, leading to treatment selection after just 60 patients, and can be used in other phase II trials to assess different agents.

  12. A novel, efficient, randomized selection trial comparing combinations of drug therapy for ALS

    PubMed Central

    GORDON, PAUL H.; CHEUNG, YING-KUEN; LEVIN, BRUCE; ANDREWS, HOWARD; DOORISH, CAROLYN; MACARTHUR, ROBERT B.; MONTES, JACQUELINE; BEDNARZ, KATE; FLORENCE, JULAINE; ROWIN, JULIE; BOYLAN, KEVIN; MOZAFFAR, TAHSEEN; TANDAN, RUP; MITSUMOTO, HIROSHI; KELVIN, ELIZABETH A.; CHAPIN, JOHN; BEDLACK, RICHARD; RIVNER, MICHAEL; MCCLUSKEY, LEO F.; PESTRONK, ALAN; GRAVES, MICHAEL; SORENSON, ERIC J.; BAROHN, RICHARD J.; BELSH, JERRY M.; LOU, JAU-SHIN; LEVINE, TODD; SAPERSTEIN, DAVID; MILLER, ROBERT G.; SCELSA, STEPHEN N.

    2015-01-01

    Combining agents with different mechanisms of action may be necessary for meaningful results in treating ALS. The combinations of minocycline-creatine and celecoxib-creatine have additive effects in the murine model. New trial designs are needed to efficiently screen the growing number of potential neuroprotective agents. Our objective was to assess two drug combinations in ALS using a novel phase II trial design. We conducted a randomized, double-blind selection trial in sequential pools of 60 patients. Participants received minocycline (100 mg)-creatine (10 g) twice daily or celecoxib (400 mg)-creatine (10 g) twice daily for six months. The primary objective was treatment selection based on which combination best slowed deterioration in the ALS Functional Rating Scale-Revised (ALSFRS-R); the trial could be stopped after one pool if the difference between the two arms was adequately large. At trial conclusion, each arm was compared to a historical control group in a futility analysis. Safety measures were also examined. After the first patient pool, the mean six-month decline in ALSFRS-R was 5.27 (SD=5.54) in the celecoxib-creatine group and 6.47 (SD=9.14) in the minocycline-creatine group. The corresponding decline was 5.82 (SD=6.77) in the historical controls. The difference between the two sample means exceeded the stopping criterion. The null hypothesis of superiority was not rejected in the futility analysis. Skin rash occurred more frequently in the celecoxib-creatine group. In conclusion, the celecoxib-creatine combination was selected as preferable to the minocycline-creatine combination for further evaluation. This phase II design was efficient, leading to treatment selection after just 60 patients, and can be used in other phase II trials to assess different agents. PMID:18608093

  13. Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

    PubMed

    Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Su, H Irene

    2016-04-01

    Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

  14. Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

    PubMed

    Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Su, H Irene

    2016-04-01

    Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions. PMID:27015968

  15. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

    PubMed

    Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

    2016-08-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  16. Comparing the effects of Bentonite & Calendula on the improvement of infantile diaper dermatitis: A randomized controlled trial

    PubMed Central

    Mahmoudi, Mansoreh; Adib-Hajbaghery, Mohsen; Mashaiekhi, Mahdi

    2015-01-01

    Background & objectives: Infantile diaper dermatitis is a common, acute inflammatory reaction of the skin around diaper among infants. This study was undertaken to compare the effect of topical application of Bentonite and Calendula creams on the improvement of infantile diaper dermatitis. Methods: This double blind randomized controlled trial was undertaken on 100 patients of infantile diaper dermatitis. The 100 participants were randomly assigned into two groups of 50 each, and were prescribed the coded medicine. The mothers were trained to apply the cream and level of improvement was judged by observing the affected area on the first visit and then after three days of receiving treatment. Results: The mean age of infants was 6.45±5.53 months in Calendula group and 7.35±6.28 months in Bentonite group. Overall, 88 per cent of lesions in the Bentonite group started improving in the first six hours while this rate was 54 per cent in Calendula group (P<0.001). The risk ratio for the improvement in the first six hours was 2.99 folds in the Bentonite group. Also, lesions in 86 per cent infants in the Bentonite group and 52 per cent in the Calendula group were completely improved in the first three days after treatment (P<0.001). Interpretation & conclusions: Our results showed that in comparison with Calendula, Bentonite had faster healing effect and was more effective on the improvement of infantile diaper dermatitis (IRCT ID: IRCT 2012112811593N1). PMID:26831423

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

    PubMed

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

    2016-01-01

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

  18. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial

    PubMed Central

    2016-01-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  19. A prospective randomized trial comparing the harmonic scalpel with conventional knot tying in thyroidectomy.

    PubMed

    Kilic, Mehmet; Keskek, Mehmet; Ertan, Tamer; Yoldas, Omer; Bilgin, Aydin; Koc, Mahmut

    2007-01-01

    Currently, thyroidectomies are performed with very little morbidity. This study was undertaken to investigate whether the use of the harmonic scalpel during thyroid surgery has any advantage over the conventional technique. Eighty patients were randomly assigned to 2 groups. The patients in group 1 (n=40) underwent thyroidectomy performed with conventional knot tying and the electrocautery technique; in patients in group 2 (n=40), the harmonic scalpel was used for the procedure. Significant differences were observed between these 2 surgical techniques in terms of operative time, number of ligatures used, amount of bleeding, average length of incision, total amount of drainage fluid, and cosmetic satisfaction (P<.05). With the harmonic scalpel technique, there was a nearly 18% reduction in operative time. No significant differences were noted between mean hospital stay and postoperative pain (P>.05). No patient in either group had permanent recurrent laryngeal nerve palsy or hypoparathyroidism. The harmonic scalpel significantly shortens the duration of thyroidectomies; it can be used safely and effectively in thyroid surgery with no additional morbidity.

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

    PubMed Central

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

    2008-01-01

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

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

    PubMed

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

    2010-11-01

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

  2. No Sustained Attention Differences in a Longitudinal Randomized Trial Comparing Mindfulness Based Stress Reduction versus Active Control

    PubMed Central

    MacCoon, Donal G.; MacLean, Katherine A.; Davidson, Richard J.; Saron, Clifford D.; Lutz, Antoine

    2014-01-01

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

  3. Dose-Effect Relationship in Chemoradiotherapy for Locally Advanced Rectal Cancer: A Randomized Trial Comparing Two Radiation Doses

    SciTech Connect

    Jakobsen, Anders; Ploen, John; Vuong, Te; Appelt, Ane; Lindebjerg, Jan; Rafaelsen, Soren R.

    2012-11-15

    Purpose: Locally advanced rectal cancer represents a major therapeutic challenge. Preoperative chemoradiation therapy is considered standard, but little is known about the dose-effect relationship. The present study represents a dose-escalation phase III trial comparing 2 doses of radiation. Methods and Materials: The inclusion criteria were resectable T3 and T4 tumors with a circumferential margin of {<=}5 mm on magnetic resonance imaging. The patients were randomized to receive 50.4 Gy in 28 fractions to the tumor and pelvic lymph nodes (arm A) or the same treatment supplemented with an endorectal boost given as high-dose-rate brachytherapy (10 Gy in 2 fractions; arm B). Concomitant chemotherapy, uftoral 300 mg/m{sup 2} and L-leucovorin 22.5 mg/d, was added to both arms on treatment days. The primary endpoint was complete pathologic remission. The secondary endpoints included tumor response and rate of complete resection (R0). Results: The study included 248 patients. No significant difference was found in toxicity or surgical complications between the 2 groups. Based on intention to treat, no significant difference was found in the complete pathologic remission rate between the 2 arms (18% and 18%). The rate of R0 resection was different in T3 tumors (90% and 99%; P=.03). The same applied to the rate of major response (tumor regression grade, 1+2), 29% and 44%, respectively (P=.04). Conclusions: This first randomized trial comparing 2 radiation doses indicated that the higher dose increased the rate of major response by 50% in T3 tumors. The endorectal boost is feasible, with no significant increase in toxicity or surgical complications.

  4. Linagliptin monotherapy compared with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis: a 12-week randomized trial

    PubMed Central

    Mori, Katsuhito; Emoto, Masanori; Shoji, Tetsuo; Inaba, Masaaki

    2016-01-01

    Objective Focusing on efficacy and tolerability, we compared linagliptin monotherapy with voglibose monotherapy in patients with type 2 diabetes undergoing hemodialysis (HD). Research design and methods In this multicenter, randomized, open-label, parallel-group, active-controlled study, 78 patients were randomized (1:1) to receive a 12-week treatment with 5 mg linagliptin once daily or 0.2 mg voglibose three times a day. To assess whether linagliptin was superior to voglibose, the primary efficacy end point was the change in glycated hemoglobin (HbA1c) level between baseline and week 12. Secondary efficacy end points included changes between baseline and week 12 in glycated albumin (GA) and casual plasma glucose (PG) levels. Results At week 12, the adjusted mean HbA1c levels had decreased by −0.60% after treatment with linagliptin and by −0.20% after treatment with voglibose (treatment difference: −0.40%, 95% CI −0.74% to −0.06%, p=0.022). A significant reduction in casual PG level was also observed after treatment with linagliptin compared with treatment with voglibose. Relative to voglibose, linagliptin tended to elicit reductions in GA, although without statistical significance. No hypoglycemic symptoms or severe hypoglycemia occurred during the study. Conclusions In patients with type 2 diabetes undergoing HD, linagliptin monotherapy provided significantly better glycemic control without severe hypoglycemia than voglibose monotherapy. Linagliptin represents a promising agent for glycemic management in patients with type 2 diabetes undergoing HD. Trial registration number UMIN000007635; results. PMID:27547421

  5. Randomized Controlled Trial Comparing Flexible and Continuous Positive Airway Pressure Delivery: Effects on Compliance, Objective and Subjective Sleepiness and Vigilance

    PubMed Central

    Bakker, Jessie; Campbell, Angela; Neill, Alister

    2010-01-01

    Study Objectives: Positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) can be limited by suboptimal compliance. C-Flex technology (Philips Respironics, PA, USA) reduces pressure during expiration, aiming to improve comfort and therefore compliance. This may be of particular relevance to patients requiring high pressures. Many studies thus far have suffered from design limitations and small sample sizes. This study aimed to compare compliance with C-Flex and CPAP, as well as analyzing objective and subjective sleepiness and vigilance. Design: Three-month, double-blinded, parallel-arm randomized controlled trial. Setting: A university-based sleep laboratory. Patients: 76 consecutive patients with severe OSA (mean ± SD AHI 60.2 ± 32.9 events/hour, ESS 13.6 ± 4.5/24, BMI 35.6 ± 7.8 kg/m2), without significant cardiac, respiratory, psychiatric, or sleep comorbidities. Interventions: Patients were randomized to C-Flex (dip level 2) or CPAP. Measurements and Results: Patients underwent titration with C-Flex/CPAP (mean pressure 11.6 cm H2O). Modified maintenance of wakefulness tests (mod-MWT), psychomotor vigilance tasks (PVT) and questionnaires were administered at baseline and after one and 3 months. Median compliance was 5.51 and 5.89 h/ night in the C-Flex and CPAP groups respectively (P = 0.82). There were no significant differences between groups in terms of PVT reaction time, subjective sleepiness, sleep quality, health-related quality of life, or treatment comfort. There was no significant difference between the groups regarding the change in mod-MWT sleep latency values. Conclusions: In patients with severe OSA both CPAP and C-Flex resulted in substantial improvements in sleepiness, vigilance, and quality of life. The use of C-Flex did not result in greater compliance, and neither treatment appeared superior. Citation: Bakker J; Campbell A; Neill A. Randomized controlled trial comparing flexible and continuous positive airway pressure

  6. ARTS: automated randomization of multiple traits for study design

    PubMed Central

    Maienschein-Cline, Mark; Lei, Zhengdeng; Gardeux, Vincent; Abbasi, Taimur; Machado, Roberto F.; Gordeuk, Victor; Desai, Ankit A.; Saraf, Santosh; Bahroos, Neil; Lussier, Yves

    2014-01-01

    Summary: Collecting data from large studies on high-throughput platforms, such as microarray or next-generation sequencing, typically requires processing samples in batches. There are often systematic but unpredictable biases from batch-to-batch, so proper randomization of biologically relevant traits across batches is crucial for distinguishing true biological differences from experimental artifacts. When a large number of traits are biologically relevant, as is common for clinical studies of patients with varying sex, age, genotype and medical background, proper randomization can be extremely difficult to prepare by hand, especially because traits may affect biological inferences, such as differential expression, in a combinatorial manner. Here we present ARTS (automated randomization of multiple traits for study design), which aids researchers in study design by automatically optimizing batch assignment for any number of samples, any number of traits and any batch size. Availability and implementation: ARTS is implemented in Perl and is available at github.com/mmaiensc/ARTS. ARTS is also available in the Galaxy Tool Shed, and can be used at the Galaxy installation hosted by the UIC Center for Research Informatics (CRI) at galaxy.cri.uic.edu. Contact: mmaiensc@uic.edu Supplementary information: Supplementary data are available at Bioinformatics online. PMID:24493035

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

    PubMed

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

    2003-12-01

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

  8. Supplemental Reading Strategy Instruction for Adolescents: A Randomized Trial and Follow-up Study

    ERIC Educational Resources Information Center

    Cantrell, Susan Chambers; Almasi, Janice F.; Rintamaa, Margaret; Carter, Janis C.

    2016-01-01

    In this study, the authors examine the impact of a yearlong supplemental reading course involving daily instruction in the learning strategies curriculum on lower achieving adolescent students' reading achievement and motivation. Using a multiple-cohort randomized treatment-control group design over 4 years, they compared achievement and…

  9. Efficacy of Virtual Patients in Medical Education: A Meta-Analysis of Randomized Studies

    ERIC Educational Resources Information Center

    Consorti, Fabrizio; Mancuso, Rosaria; Nocioni, Martina; Piccolo, Annalisa

    2012-01-01

    A meta-analysis was performed to assess the Effect Size (ES) from randomized studies comparing the effect of educational interventions in which Virtual patients (VPs) were used either as an alternative method or additive to usual curriculum versus interventions based on more traditional methods. Meta-analysis was designed, conducted and reported…

  10. Concepts for a theoretical and experimental study of lifting rotor random loads and vibrations, Phase 1

    NASA Technical Reports Server (NTRS)

    Hohenemser, K. H.; Gaonkar, G. H.

    1967-01-01

    A number of lifting rotor conditions with random inputs are discussed. The present state of random process theory, applicable to lifting rotor problems is sketched. Possible theories of random blade flapping and random blade flap-bending are outlined and their limitations discussed. A plan for preliminary experiments to study random flapping motions of a see-saw rotor is developed.

  11. Teaching the Comparative Approach to American Studies.

    ERIC Educational Resources Information Center

    Seaberg, Stanley

    The rationale behind this book of five suggested or sample comparative units contains several elements: 1) an interdisciplinary social science approach to studying the American past, present, and future; and 2) a view of our country's history in terms of a world setting and in the light on contemporary concerns. The global comparative method…

  12. Comparative Rhetoric: Applications in African Studies.

    ERIC Educational Resources Information Center

    Neher, William W.

    Comparative rhetoric studies the mode of public address among a specified group of people and the theories and values governing their public address in specific cultural contexts. Two ways to consider the subject of values in comparative rhetoric involve values as norms and values as appeals. Values assumed to be held by the audience are the bases…

  13. Comparative Environmental Threat Analysis: Three Case Studies.

    ERIC Educational Resources Information Center

    Latour, J. B.; Reiling, R.

    1994-01-01

    Reviews how carrying capacity for different environmental problems is operationalized. Discusses whether it is possible to compare threats, using the exceeding of carrying capacity as a yardstick. Points out problems in comparative threat analysis using three case studies: threats to European groundwater resources, threats to ecosystems in Europe,…

  14. Multicenter, Randomized Clinical Trial To Compare the Safety and Efficacy of LFF571 and Vancomycin for Clostridium difficile Infections

    PubMed Central

    Mullane, Kathleen; Lee, Christine; Bressler, Adam; Buitrago, Martha; Weiss, Karl; Dabovic, Kristina; Praestgaard, Jens; Leeds, Jennifer A.; Blais, Johanne

    2014-01-01

    Clostridium difficile infection causes serious diarrheal disease. Although several drugs are available for treatment, including vancomycin, recurrences remain a problem. LFF571 is a semisynthetic thiopeptide with potency against C. difficile in vitro. In this phase 2 exploratory study, we compared the safety and efficacy (based on a noninferiority analysis) of LFF571 to those of vancomycin used in adults with primary episodes or first recurrences of moderate C. difficile infection. Patients were randomized to receive 200 mg of LFF571 or 125 mg of vancomycin four times daily for 10 days. The primary endpoint was the proportion of clinical cures at the end of therapy in the per-protocol population. Secondary endpoints included clinical cures at the end of therapy in the modified intent-to-treat (mITT) population, the time to diarrhea resolution, and the recurrence rate. Seventy-two patients were randomized, with 46 assigned to receive LFF571. Based on the protocol-specified definition, the rate of clinical cure for LFF571 (90.6%) was noninferior to that of vancomycin (78.3%). The 30-day sustained cure rates for LFF571 and vancomycin were 56.7% and 65.0%, respectively, in the per-protocol population and 58.7% and 60.0%, respectively, in the modified intent-to-treat population. Using toxin-confirmed cases only, the recurrence rates were lower for LFF571 (19% versus 25% for vancomycin in the per-protocol population). LFF571 was generally safe and well tolerated. The incidence of adverse events (AEs) was higher for LFF571 (76.1% versus 69.2% for vancomycin), although more AEs in the vancomycin group were suspected to be related to the study drug (38.5% versus 32.6% for LFF571). One patient receiving LFF571 discontinued the study due to an AE. (This study has been registered at ClinicalTrials.gov under registration no. NCT01232595.) PMID:25534727

  15. Multicenter, randomized clinical trial to compare the safety and efficacy of LFF571 and vancomycin for Clostridium difficile infections.

    PubMed

    Mullane, Kathleen; Lee, Christine; Bressler, Adam; Buitrago, Martha; Weiss, Karl; Dabovic, Kristina; Praestgaard, Jens; Leeds, Jennifer A; Blais, Johanne; Pertel, Peter

    2015-03-01

    Clostridium difficile infection causes serious diarrheal disease. Although several drugs are available for treatment, including vancomycin, recurrences remain a problem. LFF571 is a semisynthetic thiopeptide with potency against C. difficile in vitro. In this phase 2 exploratory study, we compared the safety and efficacy (based on a noninferiority analysis) of LFF571 to those of vancomycin used in adults with primary episodes or first recurrences of moderate C. difficile infection. Patients were randomized to receive 200 mg of LFF571 or 125 mg of vancomycin four times daily for 10 days. The primary endpoint was the proportion of clinical cures at the end of therapy in the per-protocol population. Secondary endpoints included clinical cures at the end of therapy in the modified intent-to-treat (mITT) population, the time to diarrhea resolution, and the recurrence rate. Seventy-two patients were randomized, with 46 assigned to receive LFF571. Based on the protocol-specified definition, the rate of clinical cure for LFF571 (90.6%) was noninferior to that of vancomycin (78.3%). The 30-day sustained cure rates for LFF571 and vancomycin were 56.7% and 65.0%, respectively, in the per-protocol population and 58.7% and 60.0%, respectively, in the modified intent-to-treat population. Using toxin-confirmed cases only, the recurrence rates were lower for LFF571 (19% versus 25% for vancomycin in the per-protocol population). LFF571 was generally safe and well tolerated. The incidence of adverse events (AEs) was higher for LFF571 (76.1% versus 69.2% for vancomycin), although more AEs in the vancomycin group were suspected to be related to the study drug (38.5% versus 32.6% for LFF571). One patient receiving LFF571 discontinued the study due to an AE. (This study has been registered at ClinicalTrials.gov under registration no. NCT01232595.).

  16. Comparative Review of Elementary Social Studies Textbooks.

    ERIC Educational Resources Information Center

    Waters, Barbara A.

    Four elementary social studies textbook series are reviewed and compared with particular attention paid to the extent to which the textbooks are globally oriented. The trend of emphasizing global education in the social studies also is discussed. As used in this paper, "global education" includes the study of world geography, world history, and…

  17. A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women.

    PubMed

    Culver, James; Strauss, Robert A; Brody, Seth; Dorman, Karen; Timlin, Sally; McMahon, Michael J

    2004-04-01

    The objective of this study was to compare the efficacy and safety of intracervical Foley catheter with concurrent use of oxytocin versus vaginal misoprostol for labor induction in nulliparous women. Nulliparous women with Bishop score <6 who presented for labor induction were randomized to either 25 microg vaginal misoprostol every 4 hours followed by oxytocin, if indicated, or intracervical Foley catheter with simultaneous use of oxytocin. Among the 162 patients enrolled, 79 (49%) received misoprostol and 83 (51%) received Foley/oxytocin. We were unable to demonstrate a statistically significant difference between the misoprostol group and Foley/oxytocin group in the incidence of cesarean delivery (35% versus 29%; p = 0.37). The induction-to-delivery time was significantly shorter in the Foley/oxytocin group (18 versus 24 hours; p < 0.01). No differences in intrapartum complications, neonatal outcomes, or maternal morbidity were found. When compared with vaginal misoprostol, intracervical Foley catheter combined with oxytocin has a similar efficacy and safety profile for labor induction in nulliparous women. Foley/oxytocin results in a shorter induction-to-vaginal delivery time compared with misoprostol.

  18. Prevention of Intraoperative Awareness with Explicit Recall in an Unselected Surgical Population: A Randomized Comparative Effectiveness Trial

    PubMed Central

    Mashour, George A.; Shanks, Amy; Tremper, Kevin K.; Kheterpal, Sachin; Turner, Christopher R.; Ramachandran, Satya Krishna; Picton, Paul; Schueller, Christa; Morris, Michelle; Vandervest, John C.; Lin, Nan; Avidan, Michael S.

    2012-01-01

    Background Intraoperative awareness with explicit recall occurs in approximately 0.15% of all surgical cases. Efficacy trials based on the Bispectral Index™ (BIS) monitor and anesthetic concentrations have focused on high-risk patients, but there are no effectiveness data applicable to an unselected surgical population. Methods We conducted a randomized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center. Surgical cases were randomized to alerting algorithms based on either BIS values or anesthetic concentrations. The primary outcome was the incidence of definite intraoperative awareness; prespecified secondary outcomes included postanesthetic recovery variables. Results The study was terminated due to futility. At interim analysis the incidence of definite awareness was 0.12% (11/9376) (95% CI 0.07 to 0.21%) in the anesthetic concentration group and 0.08% (8/9460) (95% CI 0.04 to 0.16%) in the BIS group (p = 0.48). There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting. By post hoc secondary analysis, the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared to a cohort receiving no intervention (p = 0.001; 95% CI 1.7 to 13.1). Conclusion This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocols based on either BIS values or anesthetic concentration. By post hoc analysis, a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared to routine care. PMID:22990178

  19. Performance of Empirical Bayes Estimators of Level-2 Random Parameters in Multilevel Analysis: A Monte Carlo Study for Longitudinal Designs

    ERIC Educational Resources Information Center

    Candel, Math J. J. M.; Winkens, Bjorn

    2003-01-01

    Multilevel analysis is a useful technique for analyzing longitudinal data. To describe a person's development across time, the quality of the estimates of the random coefficients, which relate time to individual changes in a relevant dependent variable, is of importance. The present study compares three estimators of the random coefficients: the…

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

    ERIC Educational Resources Information Center

    Niccols, Alison

    2008-01-01

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

  1. Comparative evaluation of Space Transportation System (STS)-3 flight and acoustic test random vibration response of the OSS-1 payload

    NASA Technical Reports Server (NTRS)

    On, F. J.

    1983-01-01

    A comparative evaluation of the Space Transportation System (STS)-3 flight and acoustic test random vibration response of the Office of Space Science-1 (OSS-1) payload is presented. The results provide insight into the characteristics of vibroacoustic response of pallet payload components in the payload bay during STS flights.

  2. Randomized Trial Comparing Two Treatment Strategies Using Prize-Based Reinforcement of Abstinence in Cocaine and Opiate Users

    ERIC Educational Resources Information Center

    Preston, Kenzie L.; Ghitza, Udi E.; Schmittner, John P.; Schroeder, Jennifer R.; Epstein, David H.

    2008-01-01

    We compared two strategies of prize-based contingency management (CM) in methadone-maintained outpatients. Urine was tested thrice weekly for 5 weeks pre-CM, 12 weeks CM, and 8 weeks post-CM. Participants were randomly assigned to a cocaine contingency (four prize draws for each cocaine-negative urine, N = 29) or an opiate-cocaine contingency (one…

  3. Comparing Tailored and Untailored Text Messages for Smoking Cessation: A Randomized Controlled Trial among Adolescent and Young Adult Smokers

    ERIC Educational Resources Information Center

    Skov-Ettrup, L. S.; Ringgaard, L. W.; Dalum, P.; Flensborg-Madsen, T.; Thygesen, L. C.; Tolstrup, J. S.

    2014-01-01

    The aim was to compare the effectiveness of untailored text messages for smoking cessation to tailored text messages delivered at a higher frequency. From February 2007 to August 2009, 2030 users of an internet-based smoking cessation program with optional text message support aged 15-25 years were consecutively randomized to versions of the…

  4. Couple and Individual Adjustment for 2 Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    ERIC Educational Resources Information Center

    Christensen, Andrew; Atkins, David C.; Yi, Jean; Baucom, Donald H.; George, William H.

    2006-01-01

    Follow-up data across 2 years were obtained on 130 of 134 couples who were originally part of a randomized clinical trial comparing traditional versus integrative behavioral couple therapy (TBCT vs. IBCT; A. Christensen et al., 2004). Both treatments produced similar levels of clinically significant improvement at 2 years posttreatment (69% of…

  5. Comparative analyses between retained introns and constitutively spliced introns in Arabidopsis thaliana using random forest and support vector machine.

    PubMed

    Mao, Rui; Raj Kumar, Praveen Kumar; Guo, Cheng; Zhang, Yang; Liang, Chun

    2014-01-01

    One of the important modes of pre-mRNA post-transcriptional modification is alternative splicing. Alternative splicing allows creation of many distinct mature mRNA transcripts from a single gene by utilizing different splice sites. In plants like Arabidopsis thaliana, the most common type of alternative splicing is intron retention. Many studies in the past focus on positional distribution of retained introns (RIs) among different genic regions and their expression regulations, while little systematic classification of RIs from constitutively spliced introns (CSIs) has been conducted using machine learning approaches. We used random forest and support vector machine (SVM) with radial basis kernel function (RBF) to differentiate these two types of introns in Arabidopsis. By comparing coordinates of introns of all annotated mRNAs from TAIR10, we obtained our high-quality experimental data. To distinguish RIs from CSIs, We investigated the unique characteristics of RIs in comparison with CSIs and finally extracted 37 quantitative features: local and global nucleotide sequence features of introns, frequent motifs, the signal strength of splice sites, and the similarity between sequences of introns and their flanking regions. We demonstrated that our proposed feature extraction approach was more accurate in effectively classifying RIs from CSIs in comparison with other four approaches. The optimal penalty parameter C and the RBF kernel parameter [Formula: see text] in SVM were set based on particle swarm optimization algorithm (PSOSVM). Our classification performance showed F-Measure of 80.8% (random forest) and 77.4% (PSOSVM). Not only the basic sequence features and positional distribution characteristics of RIs were obtained, but also putative regulatory motifs in intron splicing were predicted based on our feature extraction approach. Clearly, our study will facilitate a better understanding of underlying mechanisms involved in intron retention.

  6. Comparative Analyses between Retained Introns and Constitutively Spliced Introns in Arabidopsis thaliana Using Random Forest and Support Vector Machine

    PubMed Central

    Mao, Rui; Raj Kumar, Praveen Kumar; Guo, Cheng; Zhang, Yang; Liang, Chun

    2014-01-01

    One of the important modes of pre-mRNA post-transcriptional modification is alternative splicing. Alternative splicing allows creation of many distinct mature mRNA transcripts from a single gene by utilizing different splice sites. In plants like Arabidopsis thaliana, the most common type of alternative splicing is intron retention. Many studies in the past focus on positional distribution of retained introns (RIs) among different genic regions and their expression regulations, while little systematic classification of RIs from constitutively spliced introns (CSIs) has been conducted using machine learning approaches. We used random forest and support vector machine (SVM) with radial basis kernel function (RBF) to differentiate these two types of introns in Arabidopsis. By comparing coordinates of introns of all annotated mRNAs from TAIR10, we obtained our high-quality experimental data. To distinguish RIs from CSIs, We investigated the unique characteristics of RIs in comparison with CSIs and finally extracted 37 quantitative features: local and global nucleotide sequence features of introns, frequent motifs, the signal strength of splice sites, and the similarity between sequences of introns and their flanking regions. We demonstrated that our proposed feature extraction approach was more accurate in effectively classifying RIs from CSIs in comparison with other four approaches. The optimal penalty parameter C and the RBF kernel parameter in SVM were set based on particle swarm optimization algorithm (PSOSVM). Our classification performance showed F-Measure of 80.8% (random forest) and 77.4% (PSOSVM). Not only the basic sequence features and positional distribution characteristics of RIs were obtained, but also putative regulatory motifs in intron splicing were predicted based on our feature extraction approach. Clearly, our study will facilitate a better understanding of underlying mechanisms involved in intron retention. PMID:25110928

  7. A comparative in-vivo evaluation of the alignment efficiency of 5 ligation methods: A prospective randomized clinical trial

    PubMed Central

    Reddy, Vijaya Bhaskara; Kumar, Talapaneni Ashok; Prasad, Mandava; Nuvvula, Sivakumar; Patil, Rajedra Goud; Reddy, Praveen Kumar

    2014-01-01

    Objectives: To conduct a prospective randomized study comparing the efficiency of 5 different ligation systems (ELL; elastomeric ligature, SSL; stainless steel ligature, LL; leone slide ligature, PSL; passive self-ligation and ASL; active self-ligation) over the duration of mandibular crowding alleviation. Materials and Methods: Fifty consecutive patients (54.2% male, 45.8% female; mean age: 16.69 years) satisfying the inclusion criteria were randomly allocated to 5 ligation groups with an equal sample size of 10 per group. The 5 groups received treatment with 0.022-inch MBT pre-adjusted edge-wise technique (ELL: Gemini 3M Unitek, SSL: Gemini 3M Unitek, LL: Gemini 3M Unitek, PSL: SmartClip 3M Unitek and ASL: In-Ovation R Euro GAC International). The models and cephalograms were evaluated for anterior arch alignment, extraction space closure, and lower incisal inclinations at pre-treatment T1 and at the end of initial alignment T2. Analysis of variance (ANOVA) and Post-hoc tests were used for data analysis. Results: Forty-eight participants completed the study, and SL systems showed a significant difference over CL groups in time to alignment, passive space closure, and incisal inclination. Multiple regression showed a reduction of 5.28 days in time to alignment by changing the ligation group in the order of ELL to ASL group and 1 mm increase in initial irregularity index increases time to alignment by 11.68 days. Conclusion: Self-ligation brackets were more efficient than conventional ligation brackets during initial leveling and alignment. PMID:24966742

  8. Comparing the Therapeutic Effects of Garlic Tablet and Oral Metronidazole on Bacterial Vaginosis: A Randomized Controlled Clinical Trial

    PubMed Central

    Mohammadzadeh, Farnaz; Dolatian, Mahrokh; Jorjani, Masoome; Alavi Majd, Hamid; Borumandnia, Nasrin

    2014-01-01

    Background: Bacterial vaginosis (BV) is one of the most common gynecological infections during reproductive age. Although metronidazole is one of the most effective medications recommended as the first-line treatment, it has various side effects. Because of the side effects and contraindications of some chemical medicines, using herbs has been investigated in treating BV. Objectives: The aim of this study was to compare the effect of garlic tablet (Garsin) and oral metronidazole in clinical treatment of the BV in women referred to Resalat Health Center, affiliated with Mazandaran University of Medical Sciences, in 2013. Patients and Methods: This randomized clinical trial was conducted on 120 married women aged 18 to 44 years who were diagnosed with BV by Amsel’s clinical criteria and Gram staining. Enrolled women were randomly allocated to two groups of 60 patients and were treated with either garlic tablet or oral metronidazole for seven days. Amsel’s criteria and Gram stain were assessed seven to ten days after beginning the treatment period and side effects were registered. Results: Amsel’s criteria were significantly decreased after treatment with garlic or metronidazole (70% and 48.3%, respectively; P < 0.001). Therapeutic effects of garlic on BV were similar to that of metronidazole (63.3% and 48.3%, respectively; P = 0.141). There were significant differences between the two treatment groups in terms of side effects; metronidazole was associated with more complications (P = 0.032). Conclusions: This study reveals that garlic could be a suitable alternative for metronidazole in treatment of BV in those interested in herbal medicines or those affected by side effects of metronidazole. PMID:25237588

  9. LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Computed tomography is widely used to diagnose acute appendicitis. Many adolescents and young adults are exposed to the associated radiation. A recent single-institution trial has reported promising results for low-dose computed tomography; however, this technique has not yet been widely adopted. LOCAT (low-dose computed tomography for appendicitis trial), a multi-institution randomized controlled non-inferiority trial, aims to compare low-dose computed tomography and standard-dose computed tomography as the first-line imaging tests for adolescents and young adults, and therefore to test the generalizability of the previous single-institution trial results. Methods/Design Participants with suspected appendicitis are randomly assigned to either the low-dose group (with a typical effective dose of 2 mSv) or the standard-dose group (as used in normal practice at each participating site, typically 8 mSv). The primary end point is the negative appendectomy rate (the percentage of the number of uninflamed appendices that were removed among all non-incidental appendectomies), which is a consequence of false-positive diagnoses, with a non-inferiority margin of 4.5 percentage points. The key secondary end point is the appendiceal perforation rate, which is a consequence of delayed (or false-negative) diagnoses. Participant recruitment will be continued until the number of non-incidental appendectomies for each group exceeds 444. The total number of expected participants approximates 3,000, including those not undergoing appendectomy. Discussion In addition to the study protocol, we elaborate on several challenging or potentially debatable components of the study design, including the broad eligibility criteria, choice of the primary end point, potential effect of using advanced imaging techniques on study results, determining and adjusting the radiation doses, ambiguities in reference standards, rationale for the non-inferiority margin, use of the intention

  10. The quality of control groups in non-randomized studies published in Journal of Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Malay, Sunitha; Chung, Kevin C.

    2016-01-01

    Purpose To evaluate control group selection in non-randomized studies published in the Journal of Hand Surgery American (JHS). Methods We reviewed all papers published in JHS in 2013 to identify studies that used non-randomized control groups. Data collected included type of study design and control group characteristics. We then appraised studies to determine if authors discussed confounding and selection bias and how they controlled for confounding. Results Thirty-seven non-randomized studies were published in JHS in 2013. The source of control was either the same institution as the study group, a different institution, a database, or not provided in the manuscript. Twenty-nine (78%) studies statistically compared key characteristics between control and study group. Confounding was controlled with matching, exclusion criteria, or regression analysis. Twenty-two (59%) papers explicitly discussed the threat of confounding and 18(49%) identified sources of selection bias. Conclusions In our review of non-randomized studies published in JHS, papers had well-defined controls that were similar to the study group, allowing for reasonable comparisons. However, we identified substantial confounding and bias that were not addressed as explicit limitations, which might lead the reader to overestimate the scientific validity of the data. Clinical relevance Incorporating a brief discussion of control group selection in scientific manuscripts should help readers interpret the study more appropriately. Authors, reviewers, and editors should strive to address this component of clinical importance. PMID:25447000

  11. OSAKA Trial: A Randomized, Controlled Trial Comparing Tacrolimus QD and BD in Kidney Transplantation

    PubMed Central

    Albano, Laetitia; Banas, Bernhard; Klempnauer, Juergen L.; Glyda, Maciej; Viklicky, Ondrej; Kamar, Nassim

    2013-01-01

    Background The once-daily (QD), prolonged-release formulation of tacrolimus has been shown to improve adherence versus twice-daily (BD) tacrolimus. Treatment nonadherence in transplant recipients has been associated with poor graft outcomes. Methods This open-label, parallel-group study randomized adults with end-stage renal disease undergoing primary kidney transplantation or retransplantation to an initial dose of tacrolimus BD 0.2 mg/kg per day (Arm 1; n=309), QD 0.2 mg/kg per day (Arm 2; n=302), QD 0.3 mg/kg per day (Arm 3; n=304) all with mycophenolate mofetil and corticosteroids (tapered) over 24 weeks, or tacrolimus QD 0.2 mg/kg per day with mycophenolate mofetil, basiliximab, and corticosteroids given only perioperatively (Arm 4; n=283). The primary composite endpoint (efficacy failure; per protocol set) was defined as graft loss, biopsy-confirmed acute rejection, or graft dysfunction at week 24. Graft dysfunction was defined as estimated glomerular filtration rate Modification of Diet in Renal Disease-4 formula of less than 40 mL/min/1.73 m2. The prespecified noninferiority margin was 12.5%. Results The per protocol set included 976 patients: 237, 263, 246, and 230 patients in Arms 1 to 4, respectively. Noninferiority of the composite endpoint was demonstrated for Arm 2 versus Arm 1; Kaplan–Meier estimates of efficacy failure were 42.2% and 40.6%, respectively (difference, −1.6%; 95% confidence interval [CI], −12.2% to 9.0%). Noninferiority to Arm 1 was not confirmed for Arm 3 (difference, −3.5%; 95% CI, −13.6% to 6.6%) or Arm 4 (difference, −7.1%; 95% CI, −16.1% to 1.9%). Graft dysfunction (estimated glomerular filtration rate <40 mL/min/1.73 m2) was the main determinant of composite-endpoint efficacy failure across all arms. Conclusions In patients representative of the European kidney transplant population, tacrolimus QD-based immunosuppression (0.2 mg/kg/day), without induction, showed similar efficacy to 0.2 mg/kg per day tacrolimus BD

  12. Bone mineral density in HIV participants randomized to raltegravir and lopinavir/ritonavir compared with standard second line therapy

    PubMed Central

    Martin, Allison; Moore, Cecilia; Mallon, Patrick W.G.; Hoy, Jennifer; Emery, Sean; Belloso, Waldo; Phanuphak, Praphan; Ferret, Samuel; Cooper, David A.; Boyd, Mark A.

    2013-01-01

    Objective: To compare changes over 48 weeks in bone mineral density (BMD) between participants randomized to lopinavir/ritonavir (LPV/r) + raltegravir (RAL) or LPV/r + 2–3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) as second line therapy. Design: 48-week open-label sub-study of the Second Line trial conducted in South Africa, India, Thailand, Malaysia and Argentina. Methods: Dual energy X-ray absorptiometry scans of proximal femur and lumbar spine were performed at baseline and week 48. Linear regression was used to compare means of differences between arms. McNemars test compared osteopenia and osteoporosis. Associations between percentage BMD changes and baseline variables were assessed by multivariate linear regression. Results: Two hundred and ten participants were randomized. Analyses were adjusted for sex, BMI and smoking status. Mean (95% CI) proximal femur BMD% reduced over 48 weeks by −5.2% (−6.7 to −3.8%) in the LPV/r+2-3N(t)RTIs arm and by −2.9% (−4.3 to −1.5%) in the LPV/r+RAL arm (P = 0.0001). Lumbar spine BMD reduced by −4.2% (−5.7 to −2.7%) in the LPV/r+2-3N(t)RTIs arm and by −2.0% (−3.5 to −0.6%) in the LPV/r+RAL arm (P = 0.0006). The incidence of osteopenia (7.6%) and osteoporosis (2.0%) assessed over 48 weeks were similar between arms. Reduced BMD over 48 weeks was significantly associated with longer duration of tenofovir on study [% change (SE) −1.58 (0.38) femur, −1.65 (0.38) spine, P = 0.0001] and low baseline BMI [% change (SE) 0.5 (0.13) femur, 0.17 (0.07) spine; P < 0.01]. Conclusion: An N(t)RTI-sparing antiretroviral regimen of LPV/r and raltegravir as second line therapy is associated with less bone loss than a LPV/r regimen containing N(t)RTIs. PMID:23921615

  13. A Randomized Controlled Trial Comparing Transforaminal Lumbar Interbody Fusion and Uninstrumented Posterolateral Fusion in the Degenerative Lumbar Spine.

    PubMed

    Jalalpour, Kourosh; Neumann, Pavel; Johansson, Christer; Hedlund, Rune

    2015-08-01

    Study Design Randomized controlled trial. Objective Despite a large number of publications of outcomes after spinal fusion surgery, there is still no consensus on the efficacy of the several different fusion methods. The aim of this study was to determine whether transforaminal lumbar interbody fusion (TLIF) results in an improved clinical outcome compared with uninstrumented posterolateral fusion (PLF) in the surgical treatment for chronic low back pain. Methods This study included 135 patients with degenerative disk disease (n = 96) or postdiskectomy syndrome (n = 39). Inclusion criteria were at least 1 year of back pain with or without leg pain in patients aged 20 to 65 with one- or two-level disease. Exclusion criteria were sequestration of disk hernia, psychosocial instability, isthmic spondylolisthesis, drug abuse, and previous spine surgery other than diskectomy. Pain was assessed by visual analog scale (pain index). Functional disability was quantified by the disability rating index and Oswestry Disability Index. The global outcome was assessed by the patient and classified as much better, better, unchanged, or worse. The patients were randomized to conventional uninstrumented PLF (n = 67) or TLIF (n = 68). PLF was performed in a standardized fashion using autograft. TLIF was performed with pedicle titanium screw fixation and a porous tantalum interbody spacer with interbody and posterolateral autograft. The clinical outcome measurements were obtained preoperatively and at 12 and 24 months postoperatively. The 2-year follow-up rate was 98%. Results The two treatment groups improved significantly from preoperatively to 2 years' follow-up. At final follow-up, the results in the TLIF group were significantly superior to those in the PLF group in pain index (2.0 versus 3.9, p = 0.007) and in disability rating index (22 versus 36, p = 0.003). The Oswestry Disability Index was better in the TLIF group (20 versus 28, p = 0

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

    PubMed

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

    2016-03-01

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

  15. A Randomized Trial Comparing Mail versus In-Office Distribution of the CAHPS Clinician and Group Survey

    PubMed Central

    Anastario, Michael P; Rodriguez, Hector P; Gallagher, Patricia M; Cleary, Paul D; Shaller, Dale; Rogers, William H; Bogen, Karen; Safran, Dana Gelb

    2010-01-01

    Objective To assess the effect of survey distribution protocol (mail versus handout) on data quality and measurement of patient care experiences. Data Sources/Study Setting Multisite randomized trial of survey distribution protocols. Analytic sample included 2,477 patients of 15 clinicians at three practice sites in New York State. Data Collection/Extraction Methods Mail and handout distribution modes were alternated weekly at each site for 6 weeks. Principal Findings Handout protocols yielded an incomplete distribution rate (74 percent) and lower overall response rates (40 percent versus 58 percent) compared with mail. Handout distribution rates decreased over time and resulted in more favorable survey scores compared with mailed surveys. There were significant mode–physician interaction effects, indicating that data cannot simply be pooled and adjusted for mode. Conclusions In-office survey distribution has the potential to bias measurement and comparison of physicians and sites on patient care experiences. Incomplete distribution rates observed in-office, together with between-office differences in distribution rates and declining rates over time suggest staff may be burdened by the process and selective in their choice of patients. Further testing with a larger physician and site sample is important to definitively establish the potential role for in-office distribution in obtaining reliable, valid assessment of patient care experiences. PMID:20579126

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

    PubMed

    Miller, Ted R; Hendrie, Delia

    2015-12-01

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

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

    PubMed

    Miller, Ted R; Hendrie, Delia

    2015-12-01

    The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale. PMID:26507844

  18. Comparing Algorithms for Graph Isomorphism Using Discrete- and Continuous-Time Quantum Random Walks

    SciTech Connect

    Rudinger, Kenneth; Gamble, John King; Bach, Eric; Friesen, Mark; Joynt, Robert; Coppersmith, S. N.

    2013-07-01

    Berry and Wang [Phys. Rev. A 83, 042317 (2011)] show numerically that a discrete-time quan- tum random walk of two noninteracting particles is able to distinguish some non-isomorphic strongly regular graphs from the same family. Here we analytically demonstrate how it is possible for these walks to distinguish such graphs, while continuous-time quantum walks of two noninteracting parti- cles cannot. We show analytically and numerically that even single-particle discrete-time quantum random walks can distinguish some strongly regular graphs, though not as many as two-particle noninteracting discrete-time walks. Additionally, we demonstrate how, given the same quantum random walk, subtle di erences in the graph certi cate construction algorithm can nontrivially im- pact the walk's distinguishing power. We also show that no continuous-time walk of a xed number of particles can distinguish all strongly regular graphs when used in conjunction with any of the graph certi cates we consider. We extend this constraint to discrete-time walks of xed numbers of noninteracting particles for one kind of graph certi cate; it remains an open question as to whether or not this constraint applies to the other graph certi cates we consider.

  19. Comparing Algorithms for Graph Isomorphism Using Discrete- and Continuous-Time Quantum Random Walks

    DOE PAGESBeta

    Rudinger, Kenneth; Gamble, John King; Bach, Eric; Friesen, Mark; Joynt, Robert; Coppersmith, S. N.

    2013-07-01

    Berry and Wang [Phys. Rev. A 83, 042317 (2011)] show numerically that a discrete-time quan- tum random walk of two noninteracting particles is able to distinguish some non-isomorphic strongly regular graphs from the same family. Here we analytically demonstrate how it is possible for these walks to distinguish such graphs, while continuous-time quantum walks of two noninteracting parti- cles cannot. We show analytically and numerically that even single-particle discrete-time quantum random walks can distinguish some strongly regular graphs, though not as many as two-particle noninteracting discrete-time walks. Additionally, we demonstrate how, given the same quantum random walk, subtle di erencesmore » in the graph certi cate construction algorithm can nontrivially im- pact the walk's distinguishing power. We also show that no continuous-time walk of a xed number of particles can distinguish all strongly regular graphs when used in conjunction with any of the graph certi cates we consider. We extend this constraint to discrete-time walks of xed numbers of noninteracting particles for one kind of graph certi cate; it remains an open question as to whether or not this constraint applies to the other graph certi cates we consider.« less

  20. A Mendelian Randomization Study of Plasma Homocysteine and Multiple Myeloma

    PubMed Central

    Xuan, Yang; Li, Xiao-Hong; Hu, Zhong-Qian; Teng, Zhi-Mei; Hu, Dao-Jun

    2016-01-01

    Observational studies have demonstrated an association between elevated homocysteine (Hcy) level and risk of multiple myeloma (MM). However, it remains unclear whether this relationship is causal. We conducted a Mendelian randomization (MR) study to evaluate whether genetically increased Hcy level influences the risk of MM. We used the methylenetetrahydrofolate reductase (MTHFR) C677T polymorphism as an instrumental variable, which affects the plasma Hcy levels. Estimate of its effect on plasma Hcy level was based on a recent genome-wide meta-analysis of 44,147 individuals, while estimate of its effect on MM risk was obtained through meta-analysis of case-control studies with 2,092 cases and 4,954 controls. By combining these two estimates, we found that per one standard-deviation (SD) increase in natural log-transformed plasma Hcy levels conferred a 2.67-fold increase in risk for MM (95% confidence interval (CI): 1.12–6.38; P = 2.7 × 10−2). Our study suggests that elevated Hcy levels are causally associated with an increased risk of developing MM. Whether Hcy-lowering therapy can prevent MM merits further investigation in long-term randomized controlled trials (RCTs). PMID:27126524

  1. Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial

    PubMed Central

    van Bakelen, N. B.; Vermeulen, K. M.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; Stegenga, B.; Bos, R. R. M.

    2015-01-01

    Background Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs. Aim The aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery. Materials and Methods This multicenter RCT was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO), a Le Fort-I osteotomy, or a bi-maxillary osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Costs were assessed from a societal perspective. Health outcomes in the incremental cost-effectiveness ratio (ICER) were bone healing (8 weeks) and plate removal (2 years). Results In 25 out of the 117 patients who were randomized to the biodegradable group, the maxillofacial surgeon made the decision to switch to the titanium system intra-operatively. This resulted in an Intention-To-Treat (ITT-)analysis and a Treatment-Received (TR-) analysis. Both analyses indicated that operations performed with titanium plates and screws had better health outcomes. In the TR-analysis the costs were lower in the biodegradable group, in the ITT-analysis costs were lower in the titanium group. Conclusion and Discussion The difference in costs between the ITT and the TR analyses can be explained by the intra-operative switches: In the TR-analysis the switches were analysed in the titanium group. In the ITT-analysis they were analysed in the biodegradable group. Considering the cost-effectiveness the titanium system is preferable to the biodegradable system in the regular treatment spectrum of mandibular, Le Fort-I, and zygomatic fractures, and BSSO’s, Le Fort-I osteotomies and bimaxillary osteotomies. Trial Registration Controlled

  2. Comparing the effect of ketamine and benzydamine gargling with placebo on post-operative sore throat: A randomized controlled trial

    PubMed Central

    Faiz, Seyed Hamid Reza; Rahimzadeh, Poupak; Poornajafian, Alireza; Nikzad, Naghme

    2014-01-01

    Background: Air way intubation for general anesthesia usually leads to sore throat after surgery. Ketamine plays an important role to block a number of receptors related to pain. Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug that has been used to improve oropharyngeal disorders. In this study, it was intended to compare the effect of gargling different solutions before the surgery on post-operative sore throat (POST) in patients who underwent general anesthesia for hysterectomy. Materials and Methods: A total of 60 patients who underwent the elective hysterectomy were entered to the randomized controlled trial regarding to the eligibility criteria. Patients were simply randomly allocated to three groups and received one code. Every code was representative for a specific drug: 20 cc normal saline (control group) or 1.5 mg benzydamine in 20 cc solution or 20 mg ketamine in 20 cc solutions. All the research teams were blinded to the received solutions. POST was evaluated with numerical rating scale. The data were entered to SPSS software and analysis of variance (ANOVA) and Kruskal-Wallis one-way analysis of variance test, were performed. Results: The mean ages of ketamine, benzydamine, and normal saline recipients were not significantly different. The trend of the severity of sore throat during the first 24 h after the operation in ketamine recipients was significantly lower than the other two groups (P < 0.001). Conclusion: The pain scale after surgery was reduced by using both ketamine and benzydamine, but the ketamine effect was more noticeable. PMID:25371873

  3. Comparative Effect of Cinnamon and Ibuprofen for Treatment of Primary Dysmenorrhea: A Randomized Double-Blind Clinical Trial

    PubMed Central

    Jaafarpour, Molouk; Hatefi, Masoud; Khajavikhan, Javaher

    2015-01-01

    Background and Aims Primary dysmenorrheal has a negative impact on women's quality of life. The purpose of this study was to compare the effect of Cinnamon and Ibuprofen for treatment of primary dysmenorrheal in a sample of Iranian female college students from Ilam University of Medical Sciences (western Iran). Materials and Methods In a randomized, double-blind trial, out of 114, control group received placebo (empty capsules contain starch, TDS, n= 38) a test group received Ibuprofen (capsule containing 400mg Ibuprofen, TDS, n=38), or another test group received Cinnamon (capsule containing 420 mg Cinnamon, TDS, n= 38) in 24 h. To determine severity of pain, we used the VAS scale. Pain intensity and duration of pain were monitored in the group during first 72 h of cycle. Results The mean pain severity score and mean duration of pain in Ibuprofen and Cinnamon were less than placebo group respectively (p< 0.001). Of 4 hours after the intervention there were no statistically significant differences between the Cinnamon and placebo group (p> 0.05). Of eight hours after the intervention, the mean pain severity in the cinnamon group was significantly lower than placebo group (p< 0.001). At various time intervals the mean pain severity in the Ibuprofen group were significantly less than Cinnamon and placebo groups (p< 0.001). Conclusion Cinnamon compared with placebo significantly reduced the severity and duration of pain during menstruation, but this effect was lower compared with Ibuprofen. Cinnamon can be regarded as a safe and effective treatment for primary dysmenorrhea. More researches are recommended to study the efficacy of Cinnamon on reducing menstrual bleeding. PMID:26023601

  4. A Randomized Trial Comparing the Cost-Effectiveness of 2 Approaches for Treating Unilateral Nasolacrimal Duct Obstruction

    PubMed Central

    Lee, Katherine A.; Chandler, Danielle L.; Repka, Michael X.; Beck, Roy W.; Foster, Nicole C.; Frick, Kevin D.; Golden, Richard P.; Lambert, Scott R.; Melia, Michele; Tien, D. Robbins; Weakley, David R.

    2012-01-01

    Objective To compare the cost-effectiveness of two approaches for treating unilateral nasolacrimal duct obstruction (NLDO) Methods 163 infants 6 to <10 months old with unilateral NLDO were randomly assigned to immediate office-based nasolacrimal duct probing (N=82) or to six months of observation/non-surgical management (N=81) followed by facility-based probing for persistent symptoms. Main Outcome Measures Treatment success was defined as the absence of clinical signs of NLDO (epiphora, increased tear lake, mucous discharge) upon masked examination at 18 months of age. Cost of treatment between randomization and 18 months of age included costs for all surgeries and medications. Results In the observation/deferred facility probing group, NLDO resolved within 6 months without surgery in 44 of the 67 patients (66%, 95% confidence interval (CI)=54% to 76%) who completed the 6-month visit. Twenty-two (27%) of the 81 patients in the observation/deferred facility probing group underwent surgery, 4 of whom were operated within the initial 6 months. At 18 months of age, 69 (92%) of 75 immediate office probing group patients were treatment successes, compared with 58 (82%) of 71 observation/deferred facility probing group patients (difference=10%, 95%CI=−1% to 21%). The average cost of treatment was $562 in the immediate office probing group compared with $701 in the observation/deferred facility probing group (difference=−$139, 95%CI=−$377 to $94). The immediate office probing group had 3.0 fewer months of symptoms (95%CI=−1.8 to −4.0). Conclusions The immediate office probing approach is likely more cost effective than observation followed by deferred facility probing if needed. Adoption of the immediate office probing approach would result in probing about two-thirds of infants who would have resolved with 6 months of non-surgical management, but would largely avoid the need for probing under general anesthesia. Application to Clinical Practice Although

  5. The Student Teaching Experience: A Comparative Study.

    ERIC Educational Resources Information Center

    Butler, Judy D.

    This paper describes a 1996 study that compared the student teaching experiences of a traditional and a nontraditional student to ascertain what differences in their experiences might imply about teacher preparation. The two students kept journals that could be written in at any time of the day. They recorded their impressions of their situation…

  6. Comparing quantum versus Markov random walk models of judgements measured by rating scales

    PubMed Central

    Wang, Z.; Busemeyer, J. R.

    2016-01-01

    Quantum and Markov random walk models are proposed for describing how people evaluate stimuli using rating scales. To empirically test these competing models, we conducted an experiment in which participants judged the effectiveness of public health service announcements from either their own personal perspective or from the perspective of another person. The order of the self versus other judgements was manipulated, which produced significant sequential effects. The quantum and Markov models were fitted to the data using the same number of parameters, and the model comparison strongly supported the quantum over the Markov model. PMID:26621984

  7. A Randomized Clinical Trial Comparing the Effect of Different Haemostatic Agents for Haemostasis of the Liver after Hepatic Resection

    PubMed Central

    Seyyed Sadeghi, Mir Salim; Sanei, Behnam; Hashemzadeh, Shahryar

    2013-01-01

    Introduction. Operative blood loss is still a great obstacle to liver resection, and various topical hemostatic agents were introduced to reduce it. The aim of the current study is to evaluate effects of 3 different types of these agents. Methods. In this randomized clinical trial, 45 patients undergoing liver resection were assigned to receive TachoSil, Surgicel, and Glubran 2 for controlling bleeding. Intraoperative and postoperative findings were compared between groups. Results. Postoperative bleeding (0 versus 33.3%, P = 0.04) and drainage volume first day after surgery (281.33 ± 103.98 versus 150.00 ± 60.82 mL, P = 0.02) were significantly higher in Surgicel than in TachoSil group. Postoperative complications included bile leak (3 cases in Surgicel, 1 case in TachoSil and Glubran 2), noninfectious collection (2 cases in TachoSil and Surgicel and 1 case in Glubran 2), perihepatic abscess, and massive hematoma around hepatectomy site both in Surgicel group. There was no death during the study period. Conclusion. Due to higher complications in Surgicel group, its application as hemostatic agent after liver resection is not recommended. Better results in TachoSil in comparison to the other two are indicative of its better efficacy and superiority in controlling hemostasis. PMID:24159254

  8. Comparative studies on serological tests for syphilis

    PubMed Central

    Nakamura, Keizo; Ishizaka, Kimishige

    1954-01-01

    A comparative study was undertaken by the authors to determine the most reliable of the serodiagnostic tests for syphilis in current use in Japan. The criteria for the selection of sera, the way in which the standard tests were chosen, and the statistical method used for evaluating the results are described, and some of the detailed results are given. Five tests—the VDRL test, the agglutination test, Ogata's test, the Kahn test (with cardiolipin antigen), and Browning's test modified by Taniguchi (with cardiolipin antigen)—were found to be comparable in reliability to the Kolmer (Lederle) and VDRL (Lederle) tests employed in the USA. PMID:14364183

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

    PubMed Central

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

    2014-01-01

    Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Results: Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P < 0.05); however, the difference was not clinically significant (<1°C). The rate of fall of temperature was highest in the combination group. Number of afebrile children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1st h (P = 0.04). Highest fall of temperature was noted in the 1st h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Conclusion: Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated. PMID:24551584

  10. How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain

    PubMed Central

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

    2012-01-01

    Background For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. Methods We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters. Principal Findings From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02–0.60), which improved after consensus discussions to 0.20–1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. Conclusion Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments. PMID:22389699

  11. A systematic review and meta-analysis of randomized controlled trials comparing interventions for peristomal skin care.

    PubMed

    Tam, Ka-Wai; Lai, Jun-Hung; Chen, Hung-Chou; Hou, Wen-Hsuan; Ko, Wang-Sheng; Chen, Shu-Ling; Huang, Tsai-Wei

    2014-10-01

    Standard skin care procedures for percutaneous endoscopic gastrostomy (PEG) tubes and peristomal skin care for colostomy and ileostomy patients are not always sufficient to prevent peristomal skin problems. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to compare the effectiveness of standard peristomal skin care to adjunctive techniques or barriers (including glycogel dressings, gelatin- and pectin-based skin barriers, glycerin hydrogel wound dressing, Acacia senegal fiber pockets, hydrocolloid powder crusting, and German chamomile) to manage or treat patients with a stoma. Using systematic literature search techniques, all healthcare databases were searched up through September 2014. No language restrictions were applied. Studies were included if they met criteria for published RCTs or quasi-RCTs that evaluated the outcome of standardized peristomal skin care and other adjunctive techniques or barriers used among patients with a stoma or PEG tube. A meta-analysis was performed to calculate a pooled effect size by using random-effect models for the primary (skin irritation/reaction) and secondary (length of pouch wear time) outcomes. Six RCTs comprising 418 total patients were identified. Four evaluated the outcome of colostomy or ileostomy peristomal skin care, and no significant differences were detected in the incidence of skin problems (RR 0.67; 95% CI: 0.31-1.41). In the two studies that included length of pouch wear time, no significant differences were observed (RR 0.48; 95% CI: 0.03-7.97). No significant differences were seen in the rate of skin irritations of gastrostomy patients (RR 0.56; 95% CI: 0.20-1.59), but the difference in treatment outcomes of peristomal damage in patients with a colostomy was significant (P = 0.01). The limited number of studies, study quality, heterogeneity of variability in peristomal care strategies and techniques, clinical factors, and nonuniform reporting of clinical parameters

  12. Hardy-Weinberg Equilibrium Testing of Biological Ascertainment for Mendelian Randomization Studies

    PubMed Central

    Rodriguez, Santiago; Gaunt, Tom R.

    2009-01-01

    Mendelian randomization (MR) permits causal inference between exposures and a disease. It can be compared with randomized controlled trials. Whereas in a randomized controlled trial the randomization occurs at entry into the trial, in MR the randomization occurs during gamete formation and conception. Several factors, including time since conception and sampling variation, are relevant to the interpretation of an MR test. Particularly important is consideration of the “missingness” of genotypes that can be originated by chance, genotyping errors, or clinical ascertainment. Testing for Hardy-Weinberg equilibrium (HWE) is a genetic approach that permits evaluation of missingness. In this paper, the authors demonstrate evidence of nonconformity with HWE in real data. They also perform simulations to characterize the sensitivity of HWE tests to missingness. Unresolved missingness could lead to a false rejection of causality in an MR investigation of trait-disease association. These results indicate that large-scale studies, very high quality genotyping data, and detailed knowledge of the life-course genetics of the alleles/genotypes studied will largely mitigate this risk. The authors also present a Web program (http://www.oege.org/software/hwe-mr-calc.shtml) for estimating possible missingness and an approach to evaluating missingness under different genetic models. PMID:19126586

  13. A randomized trial of topical anesthesia comparing lidocaine versus lidocaine plus xylometazoline for unsedated transnasal upper gastrointestinal endoscopy

    PubMed Central

    Cheung, Justin; Goodman, Karen J; Bailey, Robert; Fedorak, Richard N; Morse, John; Millan, Mario; Guzowski, Tom; van Zanten, Sander Veldhuyzen

    2010-01-01

    BACKGROUND: The optimal topical anesthesia regimen for unsedated transnasal endoscopy is unknown. The addition of a nasal decongestant, such as xylometazoline (X), to a topical anesthestic may improve patient comfort. OBJECTIVE: To determine the effectiveness of lidocaine (L) versus L plus X (LX) for anesthesia in unsedated transnasal endoscopy. METHODS: Consecutive participants of the Aklavik Helicobacter pylori project were prospectively randomly assigned to receive LX or L for unsedated transnasal 4.9 mm ultrathin endoscopy. The primary outcome was overall procedure discomfort on a validated 10-point visual analogue scale (1 = no discomfort, 10 = severe discomfort). Secondary outcomes included pain, endoscope insertion difficulty, gagging, adverse events and encounter times. Results were presented as mean ± SD, difference in mean, 95% CI. RESULTS: A total of 181 patients were randomly assigned to receive LX (n=94) and L (n=87). Baseline characteristics between the two groups were similar (mean age 40 years, 59% women). Overall, patient procedural discomfort with LX and L were 4.2±2.4 versus 3.9±2.1, respectively (0.29; 95% CI −0.39 to 0.96). Transnasal insertion difficulty was significantly lower with LX than with L (2.4±2.1 versus 3.2±2.8, respectively [−0.80; 95% CI −1.54 to −0.06]). Compared with L, the use of LX was associated with significantly less time needed to apply anesthesia (2.4±1.8 min versus 3.5±2.2 min, respectively [−1.10; 95% CI −1.71 min to −0.50 min]) and less time for insertion (3.2±1.8 min versus 3.9±2.2 min, respectively [−0.70 min; 95% CI −1.30 min to −0.10 min]). Epistaxis was rare but occurred less frequently with LX (1.1%) than with L (4.6%) (P=0.19). CONCLUSIONS: LX did not improve patient comfort for transnasal endoscopy compared with L alone. However, LX was associated with less difficulty with endoscope transnasal insertion and reduced insertion time. Further studies on the optimal regimen and dosing of

  14. Brain MRI Segmentation with Multiphase Minimal Partitioning: A Comparative Study

    PubMed Central

    Angelini, Elsa D.; Song, Ting; Mensh, Brett D.; Laine, Andrew F.

    2007-01-01

    This paper presents the implementation and quantitative evaluation of a multiphase three-dimensional deformable model in a level set framework for automated segmentation of brain MRIs. The segmentation algorithm performs an optimal partitioning of three-dimensional data based on homogeneity measures that naturally evolves to the extraction of different tissue types in the brain. Random seed initialization was used to minimize the sensitivity of the method to initial conditions while avoiding the need for a priori information. This random initialization ensures robustness of the method with respect to the initialization and the minimization set up. Postprocessing corrections with morphological operators were applied to refine the details of the global segmentation method. A clinical study was performed on a database of 10 adult brain MRI volumes to compare the level set segmentation to three other methods: “idealized” intensity thresholding, fuzzy connectedness, and an expectation maximization classification using hidden Markov random fields. Quantitative evaluation of segmentation accuracy was performed with comparison to manual segmentation computing true positive and false positive volume fractions. A statistical comparison of the segmentation methods was performed through a Wilcoxon analysis of these error rates and results showed very high quality and stability of the multiphase three-dimensional level set method. PMID:18253474

  15. Midterm Clinical and First Reproductive Results of a Randomized Controlled Trial Comparing Uterine Fibroid Embolization and Myomectomy

    SciTech Connect

    Mara, Michal Maskova, Jana; Fucikova, Zuzana; Kuzel, David; Belsan, Tomas; Sosna, Ondrej

    2008-01-15

    The purpose of this study was to compare the midterm results of a radiological and surgical approach to uterine fibroids. One hundred twenty-one women with reproductive plans who presented with an intramural fibroid(s) larger than 4 cm were randomly selected for either uterine artery embolization (UAE) or myomectomy. We compared the efficacy and safety of the two procedures and their impact on patient fertility. Fifty-eight embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. One hundred eighteen patients have finished at least a 12-month follow-up; the mean follow-up in the entire study population was 24.9 months. Embolized patients underwent a significantly shorter procedure and required a shorter hospital stay and recovery period. They also presented with a lower CRP concentration on the second day after the procedure (p < 0.0001 for all parameters). There were no significant differences between the two groups in the rate of technical success, symptomatic effectiveness, postprocedural follicle stimulating hormone levels, number of reinterventions for fibroid recurrence or regrowth, or complication rates. Forty women after myomectomy and 26 after UAE have tried to conceive, and of these we registered 50 gestations in 45 women. There were more pregnancies (33) and labors (19) and fewer abortions (6) after surgery than after embolization (17 pregnancies, 5 labors, 9 abortions) (p < 0.05). Obstetrical and perinatal results were similar in both groups, possibly due to the low number of labors after UAE to date. We conclude that UAE is less invasive and as symptomatically effective and safe as myomectomy, but myomectomy appears to have superior reproductive outcomes in the first 2 years after treatment.

  16. Randomized controlled trial comparing the effects of Nd:YAG prostate ablation with or without KTP laser bladder neck incision

    NASA Astrophysics Data System (ADS)

    Langley, Stephen; Gallegos, Christopher; Moisey, Clifford

    1997-05-01

    A randomized, double blind, power determined, prospective study compared patients with benign prostatic hyperplasia undergoing endoscopic laser ablation of prostate, ELAP, -- Group 1 -- to those with KTP bladder neck incision and ELAP -- Group 2. A dual wavelength Laserscope KPT/532TM laser was used with add/stat side-firing fibers. Post-operatively a urethral catheter was inserted, which was removed at 18 hours. Patients unable to void at this stage where then re-catheterized, discharged and readmitted two weeks later for catheter removal. Patients were followed up at three month intervals. Eighty eight patients were studied, pre-operatively there was no statistical difference between Group 1 and Group 2 in mean age, 68.0, 68.4 yrs; prostate size 28, 29 g; post void residual, PVR, 141, 126 ml; max flow rate, Qmax, 9.8, 9.4 ml/s; or AUA score 18.0, 20.4; respectively. Post-operatively 57% of Group 1 patients were able to void on catheter removal at 18 hours compared to 80% from Group 2; p less than 0.05, (chi) 2. After one month, two patients from Group 2 and one from Group 1 failed to void and required further surgery. At six months, data for Group 1 and 2 respectively: PVR equals 78.7, 61.4 ml, Qmax equals 16.2, 18.1 ml/s, AUA score equals 9.6, 6.38, p less than 0.005 for each. Group 2 had a significantly greater improvement in AUA7 score than Group 1.

  17. A randomized double blind study of two oral contraceptives.

    PubMed

    Sanhueza, H; Sivin, I; Kumar, S; Kessler, M; Carrasco, A; Yee, J

    1979-07-01

    To study the question of whether one brand of oral contraceptives may be as acceptable as another for use of publicly-assisted family planning programs, a double blind study of two well-known brands, Ovral and Norinyl, was undertaken in Costa Rica and Trinidad. The pills were randomly assigned to 1,200 women. Common side effects - nausea, dizziness, vomiting, headaches - were associated with both Norinyl and Ovral. Differences in event rates for these conditions were much more marked by country than by the pill used. Ovral was associated with increases in skin problems, notably chloasma, in Cost Rica. A higher percentage of women using Norinyl reported intermenstrual bleeding and spotting in both countries. In Costa Rica continuation rates for Norinyl were adversely affected by this. With these exceptions there appear to be no important differences between the brands that would affect their use in family planning programs. PMID:477315

  18. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  19. [The randomized study of efficiency of preoperative photodynamic].

    PubMed

    Akopov, A L; Rusanov, A A; Molodtsova, V P; Gerasin, A V; Kazakov, N V; Urtenova, M A; Chistiakov, I V

    2013-01-01

    The authors made a prospective randomized comparison of results of preoperative photodynamic therapy (PhT) with chemotherapy, preoperative chemotherapy in initial unresectable central non-small cell lung cancer in stage III. The efficiency and safety of preoperative therapy were estimated as well as the possibility of subsequent surgical treatment. The research included patients in stage IIIA and IIIB of central non-small cell lung cancer with lesions of primary bronchi and lower section of the trachea, which initially were unresectable, but potentially the patients could be operated on after preoperative treatment. The photodynamic therapy was performed using chlorine E6 and the light of wave length 662 nm. Since January 2008 till December 2011,42 patients were included in the research, 21 patients were randomized in the group for photodynamic therapy and 21--in group without PhT. These groups were compared according to their sex, age, stage of the disease and histological findings. After nonadjuvant treatment the remissions were reached in 19 (90%) patients of the group with PhT and in 16 (76%) patients without PhT and all the patients were operated on. The explorative operations were made on 3 patients out of 16 operated on in the group without PhT (19%). In the group PhT 14 pneumonectomies and 5 lobectomies were perfomed opposite 10 pneumonectomies and 3 lobectomies in group without PhT. The degree of radicalism of resection appears to be reliably higher in the group PhT (RO-89%, R1-11% as against RO-54%, R1-46% in group without PhT), p = 0.038. The preoperative endobronchial PhT conducted with chemotherapy was characterized by efficiency and safety, allowed the surgical treatment and elevated the degree of radicalism of this treatment in selected patients, initially assessed as unresectable. PMID:23808222

  20. A 5-year randomized trial to compare 1 or 2 implants for implant overdentures.

    PubMed

    Bryant, S R; Walton, J N; MacEntee, M I

    2015-01-01

    The hypothesis of this 5-y randomized clinical trial was that there would be no significant difference in the satisfaction of edentulous participants with removable complete overdentures attached to 1 or 2 mandibular implants. Secondary aims were to test changes in satisfaction between and within the groups from baseline to 5 y and differences between the groups in implant survival and prosthodontic maintenance over 5 y. Each of the 86 participants (mean age, 67 y) was randomly allocated to receive either 1 implant in the midline (group 1) or 2 implants in the canine areas (group 2) attached to a mandibular overdenture opposing a maxillary complete denture. Satisfaction was self-assessed by participants on a visual analog scale at baseline prior to implants, as well as at 2 mo and 1, 3, and 5 y with implant overdentures, whereas implant survival and prosthodontic maintenance were assessed by clinical examination. After 5 y, 29 participants in group 1 and 33 in group 2 were available, with most dropouts due to death. Satisfaction with the implant denture after 5 y was significantly (P < 0.001) higher than at baseline in both groups and remained with no significant difference (P = 0.32) between the groups. No implants failed in group 1 but 5 failed before loading in 4 participants in group 2. Most participants required maintenance or occasionally denture replacement, and although differences between the groups were not statistically significant, group 1 experienced almost twice as many fractured dentures usually adjacent to the implant attachment. We conclude that there were no significant differences after 5 y in satisfaction or survival of implants with mandibular overdentures retained by 1 implant or 2 implants. Additional research is required to confirm long-term treatment effectiveness of single-implant dentures and the implications of prosthetic maintenance with implant overdentures (ClinicalTrials.gov: NCT02117856).

  1. Randomized trial comparing exercise therapy, alternating cold and hot therapy, and low intensity laser therapy for chronic lumbar muscle strain

    NASA Astrophysics Data System (ADS)

    Liu, Xiaoguang; Li, Jie; Liu, Timon Chengyi; Yuan, Jianqin; Luo, Qingming

    2008-12-01

    The purpose of this study was to compare the effects of exercise therapy, alternating cold and hot (ACH) therapy and low intensity laser (LIL) therapy in patients with chronic lumbar muscle strain (CLMS). Thirty-two patients were randomly allocated to four groups: exercise group, ACH group, LIL group, and combination group of exercise, ACH and LIL, eight in each group. Sixteen treatments were given over the course of 4 weeks. Lumbar muscle endurance, flexion and lateral flexion measures, visual analogue scale (VAS) and lumbar disability questionnaire (LDQ) were used in the clinical and functional evaluations before, immediately after, and 4 weeks after treatment. It was found that the values of endurance, VAS and LDQ in all groups were significantly improved from before to after treatment (P < 0.01). The combination group showed significantly larger reduction on pain level and functional disability than the other groups immediately and 4 weeks after treatment (P < 0.01). Pain level reduced significantly more in the ACH group than in the exercise group or the LIL group immediately and 4 weeks after treatment (P < 0.05). Lumbar muscle endurance and spinal ranges of motion in all groups were improved after treatment but there was no significant difference between any therapy groups. In conclusion, exercise therapy, ACH therapy and LIL therapy were effective in the treatment of CLMS. ACH therapy was more effective than exercise therapy or LIL therapy. The combination therapy of exercise, ACH and LIL had still better rehabilitative effects on CLMS.

  2. Prospective randomized trial comparing shock wave lithotripsy and flexible ureterorenoscopy for lower pole stones smaller than 1 cm.

    PubMed

    Sener, Nevzat Can; Imamoglu, M Abdurrahim; Bas, Okan; Ozturk, Ufuk; Goktug, H N Goksel; Tuygun, Can; Bakirtas, Hasan

    2014-04-01

    In this study, we aimed to compare the success and complications of flexible ureterorenoscopy (F-URS) with its advanced technology and the accomplished method of shock wave lithotripsy (SWL) in the treatment of lower pole stones smaller than 1 cm. One hundred and forty patients were randomized as 70 undergoing SWL (Group 1) and 70 undergoing F-URS (Group 2). Patients were evaluated by plain X-ray and urinary ultrasound 1 week and after 3 months following SWL. The same procedure was done for F-URS patients 1 week after surgery and after 3 months. Success rates were established the day following the procedure and after 3 months. Fragmentation less than 3 mm was considered success. Mean operative time was 44 ± 7.4 min for Group 2 and mean fluoroscopy duration was 51 ± 12 s. In F-URS group, all the patients were stone free after 3 months (100 %). Group 1 had 2.7 ± 0.4 sessions of SWL. Sixty-four patients were stone free in that group after 3 months (91.5 %). The procedure yielded significant success in FURS group, even though patients underwent SWL for 2.7 ± 0.4 sessions and F-URS for 1 session (p < 0.05). With higher success and similar complication rates, fewer sessions per treatment, and advances in technology and experience, we believe F-URS has a potential to be the first treatment option over SWL in the future.

  3. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies

    PubMed Central

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma; Sterne, Jonathan A. C.; Hróbjartsson, Asbjørn; Savović, Jelena

    2016-01-01

    Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic review of meta-epidemiological studies. Methods We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome (“mortality” versus “other objective” versus “subjective”). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic. Results We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Conclusions Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of

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

    PubMed Central

    Cristante, Alexandre Fogaça; Rocha, Ivan Diasda; Marcon, Raphael Martus; de Barros Filho, Tarcísio Eloy Pessoa

    2016-01-01

    OBJECTIVES: Hydrodiscectomy is a new technique used for percutaneous spinal discectomy that employs a high-intensity stream of water for herniated disc ablation and tissue aspiration. No previous clinical study has examined the effects of percutaneous hydrodiscectomy. The aim of this study is to evaluate the outcomes of hydrodiscectomy compared to open microdiscectomy regarding pain, function, satisfaction, complications and recurrence rates. METHODS: In this randomized clinical trial, patients referred to our tertiary hospital for lumbar back pain were recruited and included in the study if they had disc protrusion or small herniation in only one level, without neurological deficits and with no resolution after six weeks of conservative treatment. One group underwent open microdiscectomy, and the other group underwent percutaneous microdiscectomy via hydrosurgery. Function was evaluated using the Oswestry Disability Index and pain was assessed using a visual analog scale. Evaluations were performed preoperatively, and then during the first week and at one, three, six and twelve months postoperatively. Personal satisfaction was verified. Clinicaltrials.gov: NCT01367860. RESULTS: During the study period, 20 patients were included in each arm and 39 completed one-year of follow-up (one patient died of unrelated causes). Both groups exhibited equal improvement on the visual analog scale and Oswestry evaluations after treatment, without any significant differences. The improvement in the lumbar visual analog scale score was not significant in the hydrodiscectomy group (p=0.138). The rates of infection, pain, recurrence and satisfaction were similar between the two groups. CONCLUSION: Percutaneous hydrodiscectomy was demonstrated to be as effective as open microdiscectomy for reducing pain. The rates of complications and recurrence of herniation were similar between groups. Patient satisfaction with the treatment was also similar between groups. PMID:27276397

  5. Red blood cell transfusion triggers in acute leukemia: a randomized pilot study

    PubMed Central

    DeZern, Amy E.; Williams, Katherine; Zahurak, Marianna; Hand, Wesley; Stephens, R. Scott; King, Karen E.; Frank, Steven M.; Ness, Paul M.

    2016-01-01

    BACKGROUND Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy. STUDY DESIGN AND METHODS A randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused. RESULTS Ninety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9–9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1–13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms. CONCLUSION This study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting. PMID:27198129

  6. A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy*

    PubMed Central

    Aadam, A. Aziz; Wani, Sachin; Amick, Ashley; Shah, Janak N.; Bhat, Yasser M.; Hamerski, Christopher M.; Klapman, Jason B.; Muthusamy, V. Raman; Watson, Rabindra R.; Rademaker, Alfred W.; Keswani, Rajesh N.; Keefer, Laurie; Das, Ananya; Komanduri, Srinadh

    2016-01-01

    Background and study aims: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established. The primary aim of this study was to compare the diagnostic yield (DY) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for pancreatic and non-pancreatic masses. Patients and methods: Consecutive patients referred for EUS-TA underwent randomization to EUS-FNA or EUS-FNB at four tertiary-care medical centers. A maximum of three passes were allowed for the initial method of EUS-TA and patients were crossed over to the other arm based on on-site specimen adequacy. Results: A total of 140 patients were enrolled. The overall DY was significantly higher with specimens obtained by EUS-FNB compared to EUS-FNA (90.0 % vs. 67.1 %, P = 0.002). While there was no difference in the DY between the two groups for pancreatic masses (FNB: 91.7 % vs. FNA: 78.4 %, P = 0.19), the DY of EUS-FNB was higher than the EUS-FNA for non-pancreatic lesions (88.2 % vs. 54.5 %, P = 0.006). Specimen adequacy was higher for EUS-FNB compared to EUS-FNA for all lesions (P = 0.006). There was a significant rescue effect of crossover from failed FNA to FNB in 27 out of 28 cases (96.5 %, P = 0.0003). Decision analysis showed that the strategy of EUS-FNB was cost saving compared to EUS-FNA over a wide range of cost and outcome probabilities. Conclusions: Results of this RCT and decision analysis demonstrate superior DY and specimen adequacy for solid mass lesions sampled by EUS-FNB. PMID:27227104

  7. Yoga Improves Academic Performance in Urban High School Students Compared to Physical Education: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hagins, Marshall; Rundle, Andrew

    2016-01-01

    Yoga programs within schools have become more widespread but research regarding the potential effect on academic achievement remains limited. This study cluster-randomized 112 students within a single New York City public high school to participate in either school-based yoga or physical education (PE) for an entire academic year. The primary…

  8. Humans cannot consciously generate random numbers sequences: Polemic study.

    PubMed

    Figurska, Małgorzata; Stańczyk, Maciej; Kulesza, Kamil

    2008-01-01

    It is widely believed, that randomness exists in Nature. In fact such an assumption underlies many scientific theories and is embedded in the foundations of quantum mechanics. Assuming that this hypothesis is valid one can use natural phenomena, like radioactive decay, to generate random numbers. Today, computers are capable of generating the so-called pseudorandom numbers. Such series of numbers are only seemingly random (bias in the randomness quality can be observed). Question whether people can produce random numbers, has been investigated by many scientists in the recent years. The paper "Humans can consciously generate random numbers sequences..." published recently in Medical Hypotheses made claims that were in many ways contrary to state of art; it also stated far-reaching hypotheses. So, we decided to repeat the experiments reported, with special care being taken of proper laboratory procedures. Here, we present the results and discuss possible implications in computer and other sciences. PMID:17888582

  9. A randomized comparative trial of two low-dose oral isotretinoin regimens in moderate to severe acne vulgaris

    PubMed Central

    Dhaked, Daulat Ram; Meena, Ram Singh; Maheshwari, Anshul; Agarwal, Uma Shankar; Purohit, Saroj

    2016-01-01

    Background: Oral isotretinoin is highly effective in all forms and grades of acne, even in lower dosages (<0.5 mg/kg/day). There is a paucity of comparative data on the various low-dose regimens of oral isotretinoin in the Indian literature. Objectives: To assess and compare the efficacy and tolerability of two low-dose oral isotretinoin treatment regimens (20 mg daily and 20 mg alternate days) in moderate to severe acne vulgaris. Materials and Methods: A total of 240 patients with moderate to severe acne vulgaris were selected and randomized into two groups and treated with a fixed dose of 20 mg of isotretinoin (Group A - daily and Group B - alternate days) for 24 weeks and followed up for 12 weeks post therapy. Results: A total of 234 patients completed the study. At the end of therapy, decrease in the total acne loads up to 98.99% (Group A) and 97.69% (Group B) was achieved from the baseline (P < 0.01), excellent response was observed in 98.3% (Group A) and 93.96% (Group B) patients (P = 0.166). In the severe acne, Group A performed significantly better than Group B until the end of 36 weeks. While in the moderate acne, significant difference in the response between both groups was observed only up to 12 weeks. No serious side effect was observed. Conclusion: Both isotretinoin regimens were well tolerated and found to be an effective treatment for moderate to severe acne vulgaris. However, in moderate acne 20 mg alternate day regimen may be preferred. A 20 mg daily regimen is a better choice for severe acne in terms of response. Limitation: Small sample size and short follow-up period. PMID:27730033

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

    PubMed Central

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

    2015-01-01

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

  11. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    PubMed Central

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  12. Cognitive Behavioral Principles Within Group Mentoring: A Randomized Pilot Study

    PubMed Central

    JENT, JASON F.; NIEC, LARISSA N.

    2010-01-01

    This study evaluated the effectiveness of a group mentoring program that included components of empirically supported mentoring and cognitive behavioral techniques for children served at a community mental health center. Eighty-six 8- to 12-year-old children were randomly assigned to either group mentoring or a wait-list control group. Group mentoring significantly increased children’s reported social problem-solving skills and decreased parent-reported child externalizing and internalizing behavior problems after controlling for other concurrent mental health services. Attrition from the group mentoring program was notably low (7%) for children. The integration of a cognitive behavioral group mentoring program into children’s existing community mental health services may result in additional reductions in externalizing and internalizing behavior problems. PMID:20582243

  13. Comparative studies of atherosclerosis in swine

    PubMed Central

    Bijlenga, G.; Dahme, E.; Detweiler, D. K.; Gresham, G. A.; Grünberg, W.; Howard, A. N.; Kagan, A. R.; Kaplan, M. M.; van Nie, C. J.; Rubarth, S.; Sternby, N. H.; Stünzi, H.; Uemura, K.; Whitney, J. C.

    1967-01-01

    A survey of spontaneously occurring fatty streaks and fibrous plaques, considered as atherosclerosis, in 1637 swine in different European countries and the USA, using a standardized procedure, was undertaken to determine whether significant differences exist in the occurrence and extent of the disease in various groups of animals. At the same time a preliminary study on the possible relation of any differences observed in atherosclerosis to certain environmental and constitutional factors was carried out with the ultimate goal of contributing to the understanding of analogous problems in man. Statistically significant increases of fatty streaks and fibrous plaques were noted in relation to: (a) increasing age, starting at 6 to 7 months, the earliest age period studied; (b) geographical locality; and (c) considerable as compared with moderate or slight physical activity at 1 year of age. Although not statistically significant, there was also a suggestive trend towards more atherosclerosis in pigs consuming soft water as compared with those consuming hard water. While these correlations may represent contributory factors to the increases of the changes noted in the abdominal aortas, it is not possible to pinpoint the importance of individual components because of the limited data and the large number of variables involved in this preliminary study. Studies in swine and other animals are being encouraged in which all variables but one are being kept constant to determine their possible role in the development of atherosclerotic lesions. PMID:5299676

  14. Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial

    PubMed Central

    Zhao, Jingyuan; Song, Xueqin; Ai, Xiaoqing; Gu, Xiaojing; Huang, Guangbiao; Li, Xue; Pang, Lijuan; Ding, Minli; Ding, Shuang; Lv, Luxian

    2015-01-01

    Objective The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia. Methods One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8. Results One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups. Conclusions Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia. Trial Registration chictr.org Chi

  15. A randomized controlled trial comparing mandibular local anesthesia techniques in children receiving nitrous oxide-oxygen sedation.

    PubMed Central

    Naidu, Sinuba; Loughlin, Pat; Coldwell, Susan E.; Noonan, Carolyn J.; Milgrom, Peter

    2004-01-01

    The aim of this study was to test the hypothesis that dental pain control using infiltration/intrapapillary injection was less effective than inferior alveolar block/long buccal infiltration anesthesia in children. A total of 101 healthy children, aged 5-8 years, who had no contraindication for local anesthetic and who needed a pulpotomy treatment and stainless steel crown placement in a lower primary molar were studied. A 2-group randomized blinded controlled design was employed comparing the 2 local anesthesia techniques using 2% lidocaine, 1:100,000 epinephrine. All children were given 40% nitrous oxide. Children self-reported pain using the Color Analogue Scale. The study was conducted in a private pediatric dental practice in Mount Vernon, Wash. Overall pain levels reported by the children were low, and there were no differences between conditions at any point in the procedure. Pain reports for clamp placement were block/long buccal 2.8 and infiltration/intrapapillary 1.9 (P = .1). Pain reports for drilling were block/long buccal 2.0 and infiltration/intrapapillary 1.8 (P = .7). Nine percent of children required supplementary local anesthetic: 4 of 52 (7.7%) in the block/long buccal group and 5 of 49 (10.2%) in the infiltration/intrapapillary group (P = .07). The hypothesis that block/long buccal would be more effective than infiltration/intrapapillary was not supported. There was no difference in pain control effectiveness between infiltration/intrapapillary injection and inferior alveolar block/long buccal infiltration using 2% lidocaine with 1:100,000 epinephrine when mandibular primary molars received pulpotomy treatment and stainless steel crowns. PMID:15106686

  16. Assessing the use of existing data to compare plains fish assemblages collected from random and fixed sites in Colorado

    USGS Publications Warehouse

    Zuellig, Robert E.; Crockett, Harry J.

    2013-01-01

    The U.S. Geological Survey, in cooperation with Colorado Parks and Wildlife, assessed the potential use of combining recently (2007 to 2010) and formerly (1992 to 1996) collected data to compare plains fish assemblages sampled from random and fixed sites located in the South Platte and Arkansas River Basins in Colorado. The first step was to determine if fish assemblages collected between 1992 and 1996 were comparable to samples collected at the same sites between 2007 and 2010. If samples from the two time periods were comparable, then it was considered reasonable that the combined time-period data could be used to make comparisons between random and fixed sites. In contrast, if differences were found between the two time periods, then it was considered unreasonable to use these data to make comparisons between random and fixed sites. One-hundred samples collected during the 1990s and 2000s from 50 sites dispersed among 19 streams in both basins were compiled from a database maintained by Colorado Parks and Wildlife. Nonparametric multivariate two-way analysis of similarities was used to test for fish-assemblage differences between time periods while accounting for stream-to-stream differences. Results indicated relatively weak but significant time-period differences in fish assemblages. Weak time-period differences in this case possibly were related to changes in fish assemblages associated with environmental factors; however, it is difficult to separate other possible explanations such as limited replication of paired time-period samples in many of the streams or perhaps differences in sampling efficiency and effort between the time periods. Regardless, using the 1990s data to fill data gaps to compare random and fixed-site fish-assemblage data is ill advised based on the significant separation in fish assemblages between time periods and the inability to determine conclusive explanations for these results. These findings indicated that additional sampling will

  17. EFQPSK Versus CERN: A Comparative Study

    NASA Technical Reports Server (NTRS)

    Borah, Deva K.; Horan, Stephen

    2001-01-01

    This report presents a comparative study on Enhanced Feher's Quadrature Phase Shift Keying (EFQPSK) and Constrained Envelope Root Nyquist (CERN) techniques. These two techniques have been developed in recent times to provide high spectral and power efficiencies under nonlinear amplifier environment. The purpose of this study is to gain insights into these techniques and to help system planners and designers with an appropriate set of guidelines for using these techniques. The comparative study presented in this report relies on effective simulation models and procedures. Therefore, a significant part of this report is devoted to understanding the mathematical and simulation models of the techniques and their set-up procedures. In particular, mathematical models of EFQPSK and CERN, effects of the sampling rate in discrete time signal representation, and modeling of nonlinear amplifiers and predistorters have been considered in detail. The results of this study show that both EFQPSK and CERN signals provide spectrally efficient communications compared to filtered conventional linear modulation techniques when a nonlinear power amplifier is used. However, there are important differences. The spectral efficiency of CERN signals, with a small amount of input backoff, is significantly better than that of EFQPSK signals if the nonlinear amplifier is an ideal clipper. However, to achieve such spectral efficiencies with a practical nonlinear amplifier, CERN processing requires a predistorter which effectively translates the amplifier's characteristics close to those of an ideal clipper. Thus, the spectral performance of CERN signals strongly depends on the predistorter. EFQPSK signals, on the other hand, do not need such predistorters since their spectra are almost unaffected by the nonlinear amplifier, Ibis report discusses several receiver structures for EFQPSK signals. It is observed that optimal receiver structures can be realized for both coded and uncoded EFQPSK

  18. Comparative study of hydrogenated and lithiated superhalogens

    NASA Astrophysics Data System (ADS)

    Xu, Li-Na; Li, Ying; Liu, Jia-Yuan; Wu, Di; Sun, Yan-Bo; Li, Zhi-Ru

    2016-09-01

    The structural features, properties and stability of two kinds of representative superhalogen compounds, namely hydrogenated superhalogens and lithiated superhalogens, are theoretically studied in detail, providing further insight into the behavior of superhalogens. According to topological analysis of the electron localization function, most of superhalogen clusters as a whole combine with Li atom through ionic bond(s). In contrast, the H atom tends to bind with superhalogen by covalent bond although a portion of superhalogens are broken upon hydrogenation. In addition, the electric properties of these superhalogen compounds are also obtained and compared with those of traditional acid and salt molecules.

  19. Comparative Study of Vented vs. Unvented Crawlspaces

    SciTech Connect

    Biswas, Kaushik; Christian, Jeffrey E; Gehl, Anthony C

    2011-10-01

    There has been a significant amount of research in the area of building energy efficiency and durability. However, well-documented quantitative information on the impact of crawlspaces on the performance of residential structures is lacking. The objective of this study was to evaluate and compare the effects of two crawlspace strategies on the whole-house performance of a pair of houses in a mixed humid climate. These houses were built with advanced envelope systems to provide energy savings of 50% or more compared to traditional 2010 new construction. One crawlspace contains insulated walls and is sealed and semi-conditioned. The other is a traditional vented crawlspace with insulation in the crawlspace ceiling. The vented (traditional) crawlspace contains fiberglass batts installed in the floor chase cavities above the crawl, while the sealed and insulated crawlspace contains foil-faced polyisocyanurate foam insulation on the interior side of the masonry walls. Various sensors to measure temperatures, heat flux through crawlspace walls and ceiling, and relative humidity were installed in the two crawlspaces. Data from these sensors have been analyzed to compare the performance of the two crawlspace designs. The analysis results indicated that the sealed and insulated crawlspace design is better than the traditional vented crawlspace in the mixed humid climate.

  20. A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis

    PubMed Central

    2013-01-01

    Background Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study’s primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. Methods/Design A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, twomonths post treatment, and six monthspost treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. Discussion The results from the post

  1. A Randomized Controlled Trial Comparing Two Vocational Models for Persons with Severe Mental Illness

    ERIC Educational Resources Information Center

    Bond, Gary R.; Salyers, Michelle P.; Dincin, Jerry; Drake, Robert; Becker, Deborah R.; Fraser, Virginia V.; Haines, Michael

    2007-01-01

    The authors compared 2 approaches to vocational rehabilitation for individuals with severe mental illness: the individual placement and support (IPS) model of supported employment and the diversified placement approach (DPA), which emphasizes work readiness and offers a range of vocational options, including agency-run businesses and…

  2. Efficacy of nebulized L-epinephrine for treatment of croup: a randomized, double-blind study.

    PubMed

    Eghbali, Aziz; Sabbagh, Ali; Bagheri, Bahador; Taherahmadi, Hassan; Kahbazi, Manijeh

    2016-02-01

    The objective of this study was to compare the effect of L-epinephrine plus dexamethasone vs. dexamethasone for treatment of croup in children. A randomized, double-blind clinical trial was implemented on 174 patients with croup, aged from 6 months to 6 years, and admitted to the Amir Kabir Pediatric Hospital (Arak, Iran). After randomized allocation, patients were administered dexamethasone, and then, they received either saline or L-epinephrine. Westley croup scores, heart rate, respiratory rate, and blood pressure were recorded every half an hour for a total of 120 min. There was a significant difference in mean of croup scores between two groups (P < 0.009). In addition, a significant difference was seen on mean of heart rate between two groups (P < 0.026). Our results showed a considerable difference in reduction of velocity of croup scores in patients who received nebulized L-epinephrine compared to patients who received placebo.

  3. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy--Adolescent Skills Training to Group Counseling in Schools.

    PubMed

    Young, Jami F; Benas, Jessica S; Schueler, Christie M; Gallop, Robert; Gillham, Jane E; Mufson, Laura

    2016-04-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.

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

    PubMed Central

    Adalatkhah, Hassan; Sadeghi-Bazargani, Homayoun

    2015-01-01

    Background Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma. Aim To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma. Methods In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI), mexameter melanin assay, and patient satisfaction were investigated. Results Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2) in flutamide group patients versus 18 (SD 15.5) in control group (P<0.01). Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001). Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05). However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone. Conclusion Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the first clinical experience on efficacy of topical flutamide on melasma, it would be quite unreasonable to recommend clinical use of it before future studies replicate the results on its efficacy and safety. PMID:26345129

  5. Direction to an Internet Support Group Compared With Online Expressive Writing for People With Depression And Anxiety: A Randomized Trial

    PubMed Central

    Dean, Jeremy; Potts, Henry WW

    2016-01-01

    Background Depression and anxiety are common, often comorbid, conditions, and Internet support groups for them are well used. However, little rigorous research has been conducted on the outcome of these groups. Objective This study aimed to evaluate the efficacy of an Internet support group in reducing depression and anxiety, and increasing social support and life satisfaction. Methods A randomized trial compared direction to an existing Internet support group for depression and anxiety with an online expressive writing condition. A total of 863 (628 female) United Kingdom, United States, and Canadian volunteers were recruited via the Internet. Online, self-report measures of depression, anxiety, social support, and satisfaction with life were administered at baseline, 3, and 6 months. Results All four outcomes – depression, anxiety, social support, and satisfaction with life – improved over the 6 months of the study (all P<.001). There was no difference in outcome between the two conditions: participants responded similarly to the expressive writing and the Internet support group. Engagement with the Internet support group was low, it had high 6-month attrition (692/795, 87%) and low adherence, and it received mixed and often negative feedback. The main problems reported were a lack of comfort and connection with others, negative social comparisons, and the potential for receiving bad advice. Expressive writing had lower attrition (194/295, 65%) and participants reported that it was more acceptable. Conclusions Until further evidence accumulates, directing people with depression and anxiety to Internet support groups cannot be recommended. On the other hand, online expressive writing seems to have potential, and its use for people with depression and anxiety warrants further investigation. Trial Registration Trial Registration: Clinicaltrials.gov NCT01149265; https://clinicaltrials.gov/ct2/show/NCT01149265 (Archived by WebCite at http://www.webcitation.org/6h

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

    PubMed Central

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

    2015-01-01

    Background Central venous pressure (CVP) is used as a marker of cardiac preload to control intraoperative blood loss in open hepatectomies, while its reliability in laparoscopy is less certain. The aim of this randomized prospective trial was to evaluate the outcome of laparoscopic resections performed with stroke volume variation (SVV) or CVP monitoring. Methods All candidates for laparoscopic liver resection were assigned randomly to SVV or to CVP groups. Outcome was evaluated included conversion rate, cause of conversion, intraoperative blood loss, need for transfusions, length of surgery and postoperative results. Results Ninety consecutive patients were enrolled: both SVV and CVP groups included 45 patients each and were comparable in terms of patient and disease characteristics. A reduced rate of conversion was recorded in the SVV compared to the CVP group (6.7% and 17.8% respectively, p = 0.02). Blood loss was lower in the SVV group (150 mL), compared to the CVP group (300 mL, p = 0.04). Morbidity, mortality, length of stay and functional recovery were comparable. On multivariate analysis, lesion location, extent of hepatectomy and type of cardiac preload monitoring were associated significantly to risk of conversion. Conclusion SVV monitoring in laparoscopic liver surgery improves intraoperative outcome, thus enhancing the benefits of the minimally-invasive approach and fast-track protocols. PMID:26902132

  7. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte.

    PubMed

    Coiffier, Bertrand; Thieblemont, Catherine; Van Den Neste, Eric; Lepeu, Gérard; Plantier, Isabelle; Castaigne, Sylvie; Lefort, Sophie; Marit, Gérald; Macro, Margaret; Sebban, Catherine; Belhadj, Karim; Bordessoule, Dominique; Fermé, Christophe; Tilly, Hervé

    2010-09-23

    We report the outcome of patients included in the LNH-98.5 study, which compared cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) to rituximab plus CHOP (R-CHOP) therapy in 399 patients with diffuse large B-cell lymphoma (DLBCL) aged 60 to 80 years, with a median follow-up time of 10 years. Clinical event information was updated in all living patients (with the exception of 3 patients) in 2009. Survival end points were improved in patients treated with R-CHOP: the 10-year progression-free survival was 36.5%, compared with 20% with CHOP alone, and the 10-year overall survival was 43.5% compared with 27.6%. The same risk of death due to other diseases, secondary cancers, and late relapses was observed in both study arms. Relapses occurring after 5 years represented 7% of all disease progressions. The results from the 10-year analysis confirm the benefits and tolerability of the addition of rituximab to CHOP. Our findings underscore the need to treat elderly patients as young patients, with the use of curative chemotherapy. PMID:20548096

  8. The Study of Randomized Visual Saliency Detection Algorithm

    PubMed Central

    Xu, Weihong; Kuang, Fangjun; Gao, Shangbing

    2013-01-01

    Image segmentation process for high quality visual saliency map is very dependent on the existing visual saliency metrics. It is mostly only get sketchy effect of saliency map, and roughly based visual saliency map will affect the image segmentation results. The paper had presented the randomized visual saliency detection algorithm. The randomized visual saliency detection method can quickly generate the same size as the original input image and detailed results of the saliency map. The randomized saliency detection method can be applied to real-time requirements for image content-based scaling saliency results map. The randomization method for fast randomized video saliency area detection, the algorithm only requires a small amount of memory space can be detected detailed oriented visual saliency map, the presented results are shown that the method of visual saliency map used in image after the segmentation process can be an ideal segmentation results. PMID:24382980

  9. The study of randomized visual saliency detection algorithm.

    PubMed

    Chen, Yuantao; Xu, Weihong; Kuang, Fangjun; Gao, Shangbing

    2013-01-01

    Image segmentation process for high quality visual saliency map is very dependent on the existing visual saliency metrics. It is mostly only get sketchy effect of saliency map, and roughly based visual saliency map will affect the image segmentation results. The paper had presented the randomized visual saliency detection algorithm. The randomized visual saliency detection method can quickly generate the same size as the original input image and detailed results of the saliency map. The randomized saliency detection method can be applied to real-time requirements for image content-based scaling saliency results map. The randomization method for fast randomized video saliency area detection, the algorithm only requires a small amount of memory space can be detected detailed oriented visual saliency map, the presented results are shown that the method of visual saliency map used in image after the segmentation process can be an ideal segmentation results.

  10. Comparative study of heart sound localization algorithms

    NASA Astrophysics Data System (ADS)

    Moukadem, A.; Dieterlen, A.; Hueber, N.; Brandt, C.; Raymond, P.

    2011-05-01

    The purpose of this document is to present a comparative study of five algorithms of heart sound localization, one of which, is a method based on radial basis function networks applied in a novel approach. The advantages and disadvantages of each method are evaluated according to a data base of 50 subjects in which there are 25 healthy subjects selected from the University Hospital of Strasbourg (HUS) and from theMARS500 project (Moscow) and 25 subjects with cardiac pathologies selected from the HUS. This study is made under the control of an experienced cardiologist. The performance of each method is evaluated by calculating the area under a receiver operating curve (AUC) and the robustness is shown against different levels of additive white Gaussian noise.

  11. Body mass index and psychiatric disorders: a Mendelian randomization study

    PubMed Central

    Hartwig, Fernando Pires; Bowden, Jack; Loret de Mola, Christian; Tovo-Rodrigues, Luciana; Davey Smith, George; Horta, Bernardo Lessa

    2016-01-01

    Obesity is a highly prevalent risk factor for cardiometabolic diseases. Observational studies suggest that obesity is associated with psychiatric traits, but causal inference from such studies has several limitations. We used two-sample Mendelian randomization methods (inverse variance weighting, weighted median and MR-Egger regression) to evaluate the association of body mass index (BMI) with three psychiatric traits using data from the Genetic Investigation of Anthropometric Traits and Psychiatric Genomics consortia. Causal odds ratio estimates per 1-standard deviation increment in BMI ranged from 0.88 (95% CI: 0.62; 1.25) to 1.23 (95% CI: 0.65; 2.31) for bipolar disorder; 0.93 (0.78; 1.11) to 1.41 (0.87; 2.27) for schizophrenia; and 1.15 (95% CI: 0.92; 1.44) to 1.40 (95% CI: 1.03; 1.90) for major depressive disorder. Analyses removing potentially influential SNPs suggested that the effect estimates for depression might be underestimated. Our findings do not support the notion that higher BMI increases risk of bipolar disorder and schizophrenia. Although the point estimates for depression were consistent in all sensitivity analyses, the overall statistical evidence was weak. However, the fact that SNP-depression associations were estimated in relatively small samples reduced power to detect causal effects. This should be re-addressed when SNP-depression associations from larger studies become available. PMID:27601421

  12. Body mass index and psychiatric disorders: a Mendelian randomization study.

    PubMed

    Hartwig, Fernando Pires; Bowden, Jack; Loret de Mola, Christian; Tovo-Rodrigues, Luciana; Davey Smith, George; Horta, Bernardo Lessa

    2016-01-01

    Obesity is a highly prevalent risk factor for cardiometabolic diseases. Observational studies suggest that obesity is associated with psychiatric traits, but causal inference from such studies has several limitations. We used two-sample Mendelian randomization methods (inverse variance weighting, weighted median and MR-Egger regression) to evaluate the association of body mass index (BMI) with three psychiatric traits using data from the Genetic Investigation of Anthropometric Traits and Psychiatric Genomics consortia. Causal odds ratio estimates per 1-standard deviation increment in BMI ranged from 0.88 (95% CI: 0.62; 1.25) to 1.23 (95% CI: 0.65; 2.31) for bipolar disorder; 0.93 (0.78; 1.11) to 1.41 (0.87; 2.27) for schizophrenia; and 1.15 (95% CI: 0.92; 1.44) to 1.40 (95% CI: 1.03; 1.90) for major depressive disorder. Analyses removing potentially influential SNPs suggested that the effect estimates for depression might be underestimated. Our findings do not support the notion that higher BMI increases risk of bipolar disorder and schizophrenia. Although the point estimates for depression were consistent in all sensitivity analyses, the overall statistical evidence was weak. However, the fact that SNP-depression associations were estimated in relatively small samples reduced power to detect causal effects. This should be re-addressed when SNP-depression associations from larger studies become available. PMID:27601421

  13. Randomization to plant-based dietary approaches leads to larger short-term improvements in Dietary Inflammatory Index scores and macronutrient intake compared with diets that contain meat.

    PubMed

    Turner-McGrievy, Gabrielle M; Wirth, Michael D; Shivappa, Nitin; Wingard, Ellen E; Fayad, Raja; Wilcox, Sara; Frongillo, Edward A; Hébert, James R

    2015-02-01

    Studies have examined nutrient differences among people following different plant-based diets. However, all of these studies have been observational. The aim of the present study was to examine differences in nutrient intake and Dietary Inflammatory Index (DII) scores among overweight and obese (body mass index 25.0-49.9 kg/m(2)) adults randomized to receive dietary instruction on a vegan (n = 12), vegetarian (n = 13), pescovegetarian (n = 13), semivegetarian (n = 13), or omnivorous (n = 12) diet during a 6-month randomized controlled trial. Nutrient intake, nutrient adequacy, and DII score were assessed via two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Recall) at baseline and at 2 and 6 months. Differences in nutrient intake and the DII were examined using general linear models with follow-up tests at each time point. We hypothesized that individuals randomized to the vegan diet would have lower DII scores and greater improvements in fiber, carbohydrate, fat, saturated fat, and cholesterol at both 2 and 6 months as compared with the other 4 diets. Participants randomized to the vegan diet had significantly greater changes in most macronutrients at both time points, including fat and saturated fat, as well as cholesterol and, at 2 months, fiber, as compared with most of the other diet groups (Ps < .05). Vegan, vegetarian, and pescovegetarian participants all saw significant improvements in the DII score as compared with semivegetarian participants at 2 months (Ps < .05) with no differences at 6 months. Given the greater impact on macronutrients and the DII during the short term, finding ways to provide support for adoption and maintenance of plant-based dietary approaches, such as vegan and vegetarian diets, should be given consideration.

  14. Randomization to plant-based dietary approaches leads to larger short-term improvements in Dietary Inflammatory Index scores and macronutrient intake compared with diets that contain meat.

    PubMed

    Turner-McGrievy, Gabrielle M; Wirth, Michael D; Shivappa, Nitin; Wingard, Ellen E; Fayad, Raja; Wilcox, Sara; Frongillo, Edward A; Hébert, James R

    2015-02-01

    Studies have examined nutrient differences among people following different plant-based diets. However, all of these studies have been observational. The aim of the present study was to examine differences in nutrient intake and Dietary Inflammatory Index (DII) scores among overweight and obese (body mass index 25.0-49.9 kg/m(2)) adults randomized to receive dietary instruction on a vegan (n = 12), vegetarian (n = 13), pescovegetarian (n = 13), semivegetarian (n = 13), or omnivorous (n = 12) diet during a 6-month randomized controlled trial. Nutrient intake, nutrient adequacy, and DII score were assessed via two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Recall) at baseline and at 2 and 6 months. Differences in nutrient intake and the DII were examined using general linear models with follow-up tests at each time point. We hypothesized that individuals randomized to the vegan diet would have lower DII scores and greater improvements in fiber, carbohydrate, fat, saturated fat, and cholesterol at both 2 and 6 months as compared with the other 4 diets. Participants randomized to the vegan diet had significantly greater changes in most macronutrients at both time points, including fat and saturated fat, as well as cholesterol and, at 2 months, fiber, as compared with most of the other diet groups (Ps < .05). Vegan, vegetarian, and pescovegetarian participants all saw significant improvements in the DII score as compared with semivegetarian participants at 2 months (Ps < .05) with no differences at 6 months. Given the greater impact on macronutrients and the DII during the short term, finding ways to provide support for adoption and maintenance of plant-based dietary approaches, such as vegan and vegetarian diets, should be given consideration. PMID:25532675

  15. Comparison of random forest and parametric imputation models for imputing missing data using MICE: a CALIBER study.

    PubMed

    Shah, Anoop D; Bartlett, Jonathan W; Carpenter, James; Nicholas, Owen; Hemingway, Harry

    2014-03-15

    Multivariate imputation by chained equations (MICE) is commonly used for imputing missing data in epidemiologic research. The "true" imputation model may contain nonlinearities which are not included in default imputation models. Random forest imputation is a machine learning technique which can accommodate nonlinearities and interactions and does not require a particular regression model to be specified. We compared parametric MICE with a random forest-based MICE algorithm in 2 simulation studies. The first study used 1,000 random samples of 2,000 persons drawn from the 10,128 stable angina patients in the CALIBER database (Cardiovascular Disease Research using Linked Bespoke Studies and Electronic Records; 2001-2010) with complete data on all covariates. Variables were artificially made "missing at random," and the bias and efficiency of parameter estimates obtained using different imputation methods were compared. Both MICE methods produced unbiased estimates of (log) hazard ratios, but random forest was more efficient and produced narrower confidence intervals. The second study used simulated data in which the partially observed variable depended on the fully observed variables in a nonlinear way. Parameter estimates were less biased using random forest MICE, and confidence interval coverage was better. This suggests that random forest imputation may be useful for imputing complex epidemiologic data sets in which some patients have missing data.

  16. Comparative QSAR studies on peptide deformylase inhibitors.

    PubMed

    Lee, Ji Young; Doddareddy, Munikumar Reddy; Cho, Yong Seo; Choo, Hyunah; Koh, Hun Yeong; Kang, Jae-Hoon; No, Kyoung Tai; Pae, Ae Nim

    2007-05-01

    Comparative quantitative structure-activity relationship (QSAR) analyses of peptide deformylase (PDF) inhibitors were performed with a series of previously published (British Biotech Pharmaceuticals, Oxford, UK) reverse hydroxamate derivatives having antibacterial activity against Escherichia coli PDF, using 2D and 3D QSAR methods, comparative molecular field analysis (CoMFA), comparative molecular similarity indices analysis (CoMSIA), and hologram QSAR (HQSAR). Statistically reliable models with good predictive power were generated from all three methods (CoMFA r (2) = 0.957, q (2) = 0.569; CoMSIA r (2) = 0.924, q (2) = 0.520; HQSAR r (2) = 0.860, q (2) = 0.578). The predictive capability of these models was validated by a set of compounds that were not included in the training set. The models based on CoMFA and CoMSIA gave satisfactory predictive r (2) values of 0.687 and 0.505, respectively. The model derived from the HQSAR method showed a low predictability of 0.178 for the test set. In this study, 3D prediction models showed better predictive power than 2D models for the test set. This might be because 3D information is more important in the case of datasets containing compounds with similar skeletons. Superimposition of CoMFA contour maps in the active site of the PDF crystal structure showed a meaningful correlation between receptor-ligand binding and biological activity. The final QSAR models, along with information gathered from 3D contour and 2D contribution maps, could be useful for the design of novel active inhibitors of PDF. PMID:17333308

  17. A Mendelian randomization study of testosterone and cognition in men

    PubMed Central

    Zhao, Jie V.; Lam, Tai Hing; Jiang, Chaoqiang; Cherny, Stacey S.; Liu, Bin; Cheng, Kar Keung; Zhang, Weisen; Leung, Gabriel M.; Schooling, C Mary

    2016-01-01

    Testosterone replacement for older men is increasingly common, with some observations suggesting a protective effect on cognitive function. We examined the association of endogenous testosterone with cognitive function among older men in a Mendelian randomization study using a separate-sample instrumental variable (SSIV) analysis estimator to minimize confounding and reverse causality. A genetic score predicting testosterone was developed in 289 young Chinese men from Hong Kong, based on selected testosterone-related single nucleotide polymorphisms (rs10046, rs1008805 and rs1256031). The association of genetically predicted testosterone with delayed 10-word recall score and Mini-Mental State Examination (MMSE) score was assessed at baseline and follow-up using generalized estimating equation among 4,212 older Chinese men from the Guangzhou Biobank Cohort Study. Predicted testosterone was not associated with delayed 10-word recall score (−0.02 per nmol/L testosterone, 95% confidence interval (CI) −0.06–0.02) or MMSE score (0.06, 95% CI −0.002–0.12). These estimates were similar after additional adjustment for age, education, smoking, use of alcohol, body mass index and the Framingham score. Our findings do not corroborate observed protective effects of testosterone on cognitive function among older men. PMID:26864717

  18. A comparative study of professional student stress.

    PubMed

    Murphy, Robert J; Gray, Sarah A; Sterling, Gerald; Reeves, Kathleen; DuCette, Joseph

    2009-03-01

    A study was conducted involving a group of 290 medical and dental students to directly compare perceived stress levels encountered during their education. A modified questionnaire based on Garbee et al.'s Dental Environmental Stress survey was provided to the students by either email or paper. The purpose of the investigation was to determine if the sources of stress reported by medical and dental students, both male and female, were due to common factors. A multivariate statistical analysis was also conducted to measure stress differences by year in school. Through factor analysis, the survey question responses were grouped into five causal categories: academic performance, faculty relations, patient and clinic responsibilities, personal life issues, and professional identity. The overall findings show that dental students had greater levels of stress than medical students in three of the five categories. The only category in which medical students demonstrated greater stress levels than dental students was in professional identity. Measures of comparative levels of stress between male and female students for either profession did not demonstrate any significant differences. Stress levels related to clinical work varied significantly between the type of professional student and his or her year in school. PMID:19289722

  19. Efficacy and safety of cinnarizine in the prophylaxis of migraine headaches in children: an open, randomized comparative trial with propranolol.

    PubMed

    Togha, Mansoureh; Malamiri, Reza Azizi; Rashidi-Ranjbar, Neda; Asa, Solmaz; Mahvelati, Farhad; Ashrafi, Mahmoud Reza

    2012-03-01

    Migraine headaches are common in children. Early diagnosis and appropriate interventions are mandatory to prevent decades of suffering and diminished quality of life. There is need for data regarding the efficacy and safety of prophylactic agents in children with migraine; therefore, we designed a randomized clinical trial to compare the efficacy and safety of cinnarizine with that of a well-known prophylactic agent (propranolol) in the prophylaxis of pediatric migraine headache. A total of 120 patients aged between 6 and 17 years were recruited and 113 patients succeeded in completing all phases of the trial. Of them, 57 patients were given cinnarizine, and propranolol was administered in 56 patients. Reduction in headache frequency was the main response to treatment. Cinnarizine reduced the baseline headache frequency by more than 50% in 74.6% of patients and the mean headache frequency per month was reduced from 11.851 ± 0.739 (mean ± SEM) to 3.358 ± 0.739 (mean ± SEM) attacks per month (P < 0.001). In the propranolol group, more than 50% reduction of the baseline headache frequency was seen in 72.5% of patients and the mean headache frequency per month was reduced from 10.264 ± 0.830 (mean ± SEM) to 2.774 ± 0.830 (mean ± SEM) attacks per month (P < 0.001). No significant difference was seen in 50% reduction of the baseline headache frequency between treatment groups (P = 0.358). No significant adverse effects were reported. In this open study, cinnarizine appeared thus as effective as propranolol and safe for the prophylaxis of migraine in children, but this remains to be confirmed in a double-blind placebo-controlled trial. PMID:22427290

  20. Hamstring pain and muscle strains following anterior cruciate ligament reconstruction: a prospective, randomized trial comparing hamstring graft harvest techniques.

    PubMed

    D'Alessandro, Peter; Wake, Giulia; Annear, Peter

    2013-04-01

    There is limited information in the literature regarding hamstring pain and muscle strains in patients following anterior cruciate ligament (ACL) reconstruction using hamstring autograft. We sought to investigate whether dividing hamstring tendons distal to the musculotendinous junction rather than forcefully stripping tendons away from the muscle belly during graft harvest resulted in a lower incidence of hamstring pain, muscle strains, and leg flexion strength deficit following commencement of sport-specific training postoperatively. Patients were randomized to either the "Cut" or "Push" groups of hamstring tendon harvesting. All other operative techniques were uniform. A total of 34 (cut = 20, push = 14) patients had a mean follow-up of 30 months, and assessments were conducted by a blinded single practitioner. A customized hamstring strain questionnaire and visual analogue pain score provided information for the study's primary focus: evaluation of postoperative hamstring pain and muscle strains. Leg flexion strength was also measured and a full knee assessment was conducted. The Cincinnati sports activity rating scale (SARS) was used to account for varying degrees of sporting participation and intensity since reconstruction. The "Cut" group's mean visual analogue score was 10.05 mm, significantly lower than the "Push" group (24.66 mm, p = 0.0398). The Cut group also recorded a significant reduction in the incidence of hamstring strains following ACL reconstruction (5/20 patients 25%) compared with the Push group (7/14 patients 50%, p = 0.045). There was no difference in leg flexion strength between the groups. Of the patients who reported hamstring strains, there was no significant difference in the mean Cincinnati SARS between the groups, nor any difference in overall knee function. The incidence of hamstring pain and muscle strains was significantly reduced in patients receiving the "cut" technique of harvesting hamstring tendons in ACL reconstruction

  1. RTOG 9804: A Prospective Randomized Trial for Good-Risk Ductal Carcinoma In Situ Comparing Radiotherapy With Observation

    PubMed Central

    McCormick, Beryl; Winter, Kathryn; Hudis, Clifford; Kuerer, Henry Mark; Rakovitch, Eileen; Smith, Barbara L.; Sneige, Nour; Moughan, Jennifer; Shah, Amit; Germain, Isabelle; Hartford, Alan C.; Rashtian, Afshin; Walker, Eleanor M.; Yuen, Albert; Strom, Eric A.; Wilcox, Jeannette L.; Vallow, Laura A.; Small, William; Pu, Anthony T.; Kerlin, Kevin; White, Julia

    2015-01-01

    Purpose The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ (DCIS), a breast cancer diagnosis found frequently in mammographically detected cancers, to test the benefit of radiotherapy (RT) after breast-conserving surgery compared with observation. Patients and Methods This prospective randomized trial (1998 to 2006) in women with mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm, compared RT with observation after surgery. The study was designed for 1,790 patients but was closed early because of lower than projected accrual. Six hundred thirty-six patients from the United States and Canada were entered; tamoxifen use (62%) was optional. Ipsilateral local failure (LF) was the primary end point; LF and contralateral failure were estimated using cumulative incidence, and overall and disease-free survival were estimated using the Kaplan-Meier method. Results Median follow-up time was 7.17 years (range, 0.01 to 11.33 years). Two LFs occurred in the RT arm, and 19 occurred in the observation arm. At 7 years, the LF rate was 0.9% (95% CI, 0.0% to 2.2%) in the RT arm versus 6.7% (95% CI, 3.2% to 9.6%) in the observation arm (hazard ratio, 0.11; 95% CI, 0.03 to 0.47; P < .001). Grade 1 to 2 acute toxicities occurred in 30% and 76% of patients in the observation and RT arms, respectively; grade 3 or 4 toxicities occurred in 4.0% and 4.2% of patients, respectively. Late RT toxicity was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of patients. Conclusion In this good-risk subset of patients with DCIS, with a median follow-up of 7 years, the LF rate was low with observation but was decreased significantly with the addition of RT. Longer follow-up is planned because the timeline for LF in this setting seems protracted. PMID:25605856

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

    PubMed Central

    2012-01-01

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

  3. Comparative microscopy study of Vibrio cholerae flagella

    NASA Astrophysics Data System (ADS)

    Konnov, Nikolai P.; Baiburin, Vil B.; Zadnova, Svetlana P.; Volkov, Uryi P.

    1999-06-01

    A fine structure of bacteria flagella is an important problem of molecular cell biology. Bacteria flagella are the self-assembled structures that allow to use the flagellum protein in a number of biotechnological applications. However, at present, there is a little information about high resolution scanning probe microscopy study of flagellum structure, in particular, about investigation of Vibrio cholerae flagella. In our lab have been carried out the high resolution comparative investigation of V. cholerae flagella by means of various microscopes: tunneling (STM), scanning force (SFM) and electron transmission. As a scanning probe microscope is used designed in our lab versatile SPM with replaceable measuring heads. Bacteria were grown, fixed and treated according to the conventional techniques. For STM investigations samples were covered with Pt/Ir thin films by rotated vacuum evaporation, in SFM investigations were used uncovered samples. Electron microscopy of the negatively stained bacteria was used as a test procedure.

  4. Comparative Study of Airfoil Flow Separation Criteria

    NASA Astrophysics Data System (ADS)

    Laws, Nick; Kahouli, Waad; Epps, Brenden

    2015-11-01

    Airfoil flow separation impacts a multitude of applications including turbomachinery, wind turbines, and bio-inspired micro-aerial vehicles. In order to achieve maximum performance, some devices operate near the edge of flow separation, and others use dynamic flow separation advantageously. Numerous criteria exist for predicting the onset of airfoil flow separation. This talk presents a comparative study of a number of such criteria, with emphasis paid to speed and accuracy of the calculations. We evaluate the criteria using a two-dimensional unsteady vortex lattice method, which allows for rapid analysis (on the order of seconds instead of days for a full Navier-Stokes solution) and design of optimal airfoil geometry and kinematics. Furthermore, dynamic analyses permit evaluation of dynamic stall conditions for enhanced lift via leading edge vortex shedding, commonly present in small flapping-wing flyers such as the bumblebee and hummingbird.

  5. Supracostal percutaneous nephrolithotomy: A prospective comparative study

    PubMed Central

    Sinha, Maneesh; Krishnappa, Pramod; Subudhi, Santosh Kumar; Krishnamoorthy, Venkatesh

    2016-01-01

    Introduction: A widely prevalent fear of thoracic complications with the supracostal approach has led to its underutilization in percutaneous nephrolithotomy (PCNL). We frequently use the supracostal approach and compared the efficacy and thoracic complications of infracostal, supra 12th, and supra 11th punctures. Materials and Methods: This was a prospective study of patients who underwent PCNL between January 2005 and December 2012. The patients were divided into three groups based on the access: infracostal, supra 12th (between the 11th and 12th ribs) and supra 11th (between the 10th and 11th ribs). Clearance rates, fall in hemoglobin levels, transfusion rates, perioperative analgesic requirements, hospital stay and thoracic complications were compared. Results: Seven hundred patients were included for analysis. There were 179 (25.5%) patients in the supra 11th group, 187 (26.7%) patients in the supra 12th group and 334 (47.8%) patients in the infracostal group. The overall clearance rate was 78% with no difference in the three groups. The postoperative analgesic requirements were significantly higher in the supracostal groups and showed a graded increase from infracostal to supra 12th to supra 11th. During the study period, only 2 patients required angioembolization (0.3%) and none required open exploration. The number of patients requiring intercostal chest drain insertion was extremely low, at 1.6% and 2.2% in the supra 12th and supra 11th groups, respectively. Conclusions: Our results confirm the feasibility of the supracostal approach including punctures above the 11th rib, albeit at the cost of an increase in thoracic complications. Staying in the line of the calyx has helped us to minimize the most dreaded complication of bleeding requiring angioembolization. PMID:26941494

  6. School Playground Surfacing and Arm Fractures in Children: A Cluster Randomized Trial Comparing Sand to Wood Chip Surfaces

    PubMed Central

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

    2009-01-01

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

  7. Randomized trial comparing the velocities of the antihypertensive effects on home blood pressure of candesartan and candesart