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Sample records for hysteroscopy randomized study

  1. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial.

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    Angioli, Roberto; De Cicco Nardone, Carlo; Plotti, Francesco; Cafà, Ester Valentina; Dugo, Nella; Damiani, Patrizio; Ricciardi, Roberto; Linciano, Francesca; Terranova, Corrado

    2014-01-01

    To investigate the effects of music on anxiety and perception of pain during office hysteroscopy. Prospective randomized trial (Canadian Task Force classification I). Major university medical center. Three hundred fifty-six patients were enrolled between July 2012 and January 2013. Hysteroscopy was performed in a dedicated ambulatory room, using vaginoscopy and without any type of anesthesia. A Bettocchi hysteroscope 5 mm in diameter was used. All procedures were performed by the same surgeon, a gynecologist with special interest in hysteroscopy. Data collected included age, body mass index, number of vaginal deliveries, educational achievement level, and history of endometrial surgery (curettage and/or hysteroscopy). For each patient, vital parameters such as blood pressure, heart rate, and respiratory rate were recorded 15 minutes before the procedure and during hysteroscopy after traversing the cervix. Wait time before surgery and the duration of the procedure were also recorded. A completed Italian version of the state anxiety questionnaire (State-Trait Anxiety Inventory) and a visual analog scale (VAS) were administered to each patient before and after the procedure. The t test and Mann-Whitney U test was used when appropriate to compare the 2 groups. Statistical significance was accepted at p = .05. During surgery, systolic blood pressure and heart rate were significantly lower in the music group compared with the no music group. Women in the music group experienced significantly lower anxiety after hysteroscopy and less pain during the procedure, and a significant decrease in both anxiety and pain scores after hysteroscopy. Postoperative State-Trait Anxiety Inventory form Y1 and VAS scores were significantly lower in the music group. Music can be useful as a complementary method to control anxiety and reduce perception of pain. The patient is more relaxed and experiences less discomfort. Copyright © 2014. Published by Elsevier Inc.

  2. Does fluid hysteroscopy increase the stage or worsen the prognosis in patients with endometrial cancer? A randomized controlled trial.

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    Sáinz de la Cuesta, Ricardo; Espinosa, Jose Angel; Crespo, Ernesto; Granizo, Juan José; Rivas, Francisca

    2004-08-10

    To determine whether fluid hysteroscopic directed biopsies, in patients with endometrial cancer upstages the tumor and worsens the prognosis. Between January 1996 and September 2001, a total of 62 consecutive patients with endometrial cancer, treated at our institution, were randomized 3:2 to have or not to have a fluid hysteroscopic biopsy just prior to surgery. A total of 38 patients underwent a hysteroscopy after the induction of anesthesia. All patients had pelvic washings performed, followed by a hysterectomy, bilateral salpingooforectomy and pelvic +/- para-aortic lymph node dissections. Only stages I and II endometrioid type tumors or stage IIIa, secondary to positive pelvic washings, were included in the study. Eight patients in the hysteroscopy group and four patients in the control group were excluded for various reasons. Patients received post-operative radiation therapy depending on the surgical-pathological risk factors. The median follow up was 34 months. Fisher's Exact Test was performed to compare differences between the hysteroscopic (n = 30) and the control (n = 20) groups. We found three patients (10%) with positive washings in the hysteroscopic group compared to one (5%) among the controls (P = 0.64), with a statistical power of <20%. If the differences would persist, we would need 588 patients in each arm to obtain a power of 80%, and reach definitive conclusions. The Odds Ratio (OR) of performing a hysteroscopy and upstaging the tumor in this study was: 2.1 95% CI (0.20-21.09). Prognostic variables were compared between both groups and no differences were observed. All patients but one (dead due to intercurrent disease), were alive and with no evidence of disease at the completion of the study. Fluid hysteroscopy and directed biopsies may have a small risk of upstaging early endometrial cancers, but does not seem to influence prognosis.

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

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    Chapa, Hector O; Venegas, Gonzalo

    2015-01-01

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

  4. Office Hysteroscopy in Infertility

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    Mojghan Barati

    2009-01-01

    Full Text Available Background: For patients undergoing in vitro fertilization, lower pregnancy rates are observed inthe presence of uterine cavity anomalies and correction of these anomalies has been associated withimproved pregnancy rates. Office hysteroscopy has been proven to have superior sensitivity andspecificity in evaluation of the endometrial cavity. Diagnostic hysteroscopy can be performed inan office with minimal discomfort and at a much lower cost than in an operating room. Our studywas done to evaluate the importance of office hysteroscopy in diagnosis of pathology in normalappearing infertility work up.Materials and Methods: This study was performed from September 1, 2006 till September 1, 2008at Imam Khomayni hospital, Ahwaz, Iran. All infertile patients who had unexplained infertilityor uterine factor infertility were enrolled in the study and underwent office hysteroscopy. Theparticipants were divided into two groups. Group one was composed of 54 patients with unexplainedinfertility and group two was composed of 53 patients with abnormal vaginal sonography orhysterosalpangography.Results: Of the 54 patients with unexplained infertility; 33 patients (61.2% had normal and 21patients (38.8% had abnormal hysteroscopic findings. Among 53 patients in the uterine factorgroup, there were 7 women (13.3% who had a normal hysteroscopy and abnormal sonography orhysterography.Conclusion: In group one (unexplained infertility, there was a 38.8% positive finding in officehysteroscopy in spite of normal hysterosalpingography and sonography results. Therefore, it seemsthat office hysteroscopy should be a part of a routine work up in infertile patients.

  5. Different Routes of Misoprostol for Same-Day Cervical Priming Prior to Operative Hysteroscopy: A Randomized Blinded Trial.

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    Ganer Herman, Hadas; Kerner, Ram; Gluck, Ohad; Feit, Hagit; Keidar, Ran; Bar, Jacob; Sagiv, Ron

    To compare the effectiveness of and patient satisfaction with different routes of misoprostol administration for short-term cervical priming before operative hysteroscopy. Randomized blinded trial (Canadian Task Force classification I). University hospital. One hundred and twenty patients undergoing operative hysteroscopy. Patients were randomly assigned to receive 400 μg of misoprostol administered orally (n = 40), vaginally (n = 40), or sublingually (n = 40) for cervical priming at 1.5 to 4 hours before undergoing operative hysteroscopy. The primary outcome was preoperative cervical dilatation. Secondary outcomes included cervical consistency, ease of dilation and time of dilation, patient discomfort, and side effects. No differences were noted among the 3 groups in terms of patient age, parity, previous vaginal delivery, menopausal status, and time interval from preparation to procedure. Patients in the 3 groups reported similar discomfort and side effects. Initial mean cervical dilatation was 6.1 ± 2.0 mm in the oral group, 6.4 ± 2.1 in the vaginal group, and 6.4 ± 1.8 mm in the sublingual group (p = .75). Cervical consistency and ease of dilation were similar among the groups. The mean time of dilation was 37.2 ± 30.6 seconds in the oral group, 31.7 ± 29.0 seconds in the vaginal group, and 31.5 ± 21.7 seconds in the sublingual group (p = .59). Additional subanalyses according to menopausal status and parity did not demonstrate any differences among the groups. Same-day cervical priming for operative hysteroscopy is achieved equally with all routes of misoprostol administration, with similar patient satisfaction and side effects. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

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

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    Sussan S. Mohammadi

    2015-05-01

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

  7. Evaluation of the Risk of Spreading Endometrial Cell by Hysteroscopy: A Prospective Longitudinal Study

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    Rievani de Sousa Damião

    2009-01-01

    Results. Four patients were excluded for presenting endometrial cells in PW1. In the 72 patients left, there was no passage of cells for the peritoneal cavity. In group 1, 88% presented secretory endometrial phase with correlation of 80% between hysteroscopy and biopsy. Conclusion. Hysteroscopy performed under a low pressure of CO2 does not cause spreading of endometrial cells into the peritoneal cavity.

  8. Antibiotics Prophylaxis for Operative Hysteroscopy.

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    Muzii, Ludovico; Di Donato, Violante; Boni, Terenzio; Gaglione, Raffaele; Marana, Riccardo; Mazzon, Ivan; Imperiale, Ludovica; De Medici, Caterina; Ruggiero, Alfonso; Panici, Pierluigi Benedetti

    2017-04-01

    To evaluate the incidence of infectious complications and effect of prophylactic antibiotic administration during operative hysteroscopic procedures. A multicentric randomized controlled trial was conducted between January 2012 and December 2013. Women (n = 180) affected by endometrial hyperplasia, myomas, or endometrial polyps undergoing operative hysteroscopy were randomized to receive cefazolin 2 g intravenously 30 minutes prior to the procedure (n = 91) and no treatment (n = 89). No statistical difference in terms of postoperative fever (2.4% vs 2.3%, P = .99), endometritis (0% vs 0%), pain (6.0% vs 10.4%, P = .40), cervicitis-vaginitis (0% vs 0%), pelvic abscess (0% vs 0%), pelvic inflammatory disease (0% vs 0%), and bleeding (0% vs 0%) was noticed. No statistical difference in terms of side effects attributable to antibiotic prophylaxis such as allergy (0% vs 4.8%, P = .12), nausea (10.7% vs 17.4%, P = .27), vomiting (3.6% vs 4.6%, P = .99), diarrhea (4.8% vs 5.4%, P = .99), cephalea (9.5% vs 3.5%, P = .13), dizziness (4.8% vs 2.3%, P = .44), and meteorism (5.4% vs 3.4%, P = .99) was noticed. The results of the current study support the recommendation not to prescribe routine antibiotic prophylaxis prior to operative hysteroscopy.

  9. Pain evaluation in outpatients undergoing diagnostic anesthesia-free hysteroscopy in a teaching hospital: a cohort study.

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    de Carvalho Schettini, Juliana A; Ramos de Amorim, Melania Maria; Ribeiro Costa, Aurélio Antônio; Albuquerque Neto, Luiz Cavalcante

    2007-01-01

    To evaluate and determine the main causes for pain occurrence and intensity in outpatients undergoing anesthesia-free hysteroscopy in a medical school hospital. Cohort study (Canadian Task Force classification II-2). Diagnosis Center of the Instituto Materno-Infantil de Pernambuco. One hundred seventy-one outpatients undergoing anesthesia-free diagnostic hysteroscopy. To assess pain occurrence, intensity, and associated factors reported by patients undergoing anesthesia-free diagnostic hysteroscopy. Pain frequency and intensity were determined by visual analog scale (VAS) at the end of the procedure and at 15-, 30-, and 60-minute intervals. Data analysis of clinical, obstetric, and gynecologic history and its association with pain was performed. Association through chi2 test (Pearson), risk ratio with 95% CI, and multiple logistic regression were used for statistical analysis. Pain score was higher immediately after the procedure with a median of 6, decreasing to 3, 1, and 0 at 15-, 30-, and 60-minute intervals, respectively. Multiple logistic regression was performed, and the only parameters remaining that were significantly associated with pain were menopause, speculum placement, and the absence of previous vaginal delivery. Anesthesia-free diagnostic hysteroscopy is often associated with pain, and it has been determined that menopause, speculum placement, and absence of previous vaginal delivery are factors associated with pain occurrence and intensity.

  10. The use of misoprostol for cervical priming prior to hysteroscopy: a systematic review and analysis

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    Hua Y

    2016-09-01

    Full Text Available Ying Hua, Wenwen Zhang, Xiaoli Hu, Ansu Yang, Xueqiong Zhu Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, People’s Republic of China Abstract: The effects of misoprostol use on cervical priming prior to hysteroscopy have been controversial. Therefore, a systematic literature review and meta-analysis of studies were conducted to assess the effect of misoprostol on cervical priming prior to hysteroscopy. All studies published before July 2014 with data related to the use of misoprostol for cervical priming compared with placebo or no medication prior to hysteroscopy, were identified. Twenty-five randomized controlled trials involving 2,203 females were systematically analyzed. The results showed that, compared with placebo or no medication, the use of misoprostol prior to hysteroscopy led to a significant relief of the need for cervical dilatation, resulted in a significantly greater cervical width, had fewer hysteroscopy complications, and mild and insignificant side effects. Subgroup analyses revealed that the regimen of 200 or 400 µg vaginal misoprostol may be a simple and effective method for cervical priming, especially prior to operative hysteroscopy. Keywords: misoprostol, hysteroscopy, cervical priming, cervical dilatation, complications, systematic review 

  11. The value of diagnostic hysteroscopy with biopsy in the preoperative of endometrial ablation

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    Yatabe, Salete; Pereira, Ana Maria Gomes; Takeda, Gilberto Kendi; Depes, Daniela de Baptista; Lopes, Reginaldo Guedes Coelho

    2011-01-01

    ABSTRACT Objective: To assess the value of diagnostic hysteroscopy with biopsy in the preoperative preparation for endometrial ablation. Methods: It was a prospective non-randomized study conducted at the division of Gynecologic Endoscopy of Hospital do Servidor Público Estadual “Francisco Morato de Oliveira” from March 2007 to May 2009. A total of 45 patients with abnormal uterine bleeding, and referred to endometrial ablation were included. All women underwent a diagnostic hysteroscopy, a...

  12. A multi-centre randomised controlled study of pre-IVF outpatient hysteroscopy in women with recurrent IVF implantation failure: Trial of Outpatient Hysteroscopy - [TROPHY] in IVF

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    Khalaf Yacoub

    2009-12-01

    Full Text Available Abstract Background The success rate of IVF treatment is low. A recent systematic review and meta-analysis found that the outcome of IVF treatment could be improved in patients who have experienced recurrent implantation failure if an outpatient hysteroscopy (OH is performed before starting the new treatment cycle. However, the trials were of variable quality, leading to a call for a large and high-quality randomised trial. This protocol describes a multi-centre randomised controlled trial to test the hypothesis that performing an OH prior to starting an IVF cycle improves the live birth rate of the subsequent IVF cycle in women who have experienced two to four failed IVF cycles. Methods and design Eligible and consenting women will be randomised to either OH or no OH using an internet based trial management programme that ensures allocation concealment and employs minimisation for important stratification variables including age, body mass index, basal follicle stimulating hormone level and number of previous failed IVF cycles. The primary outcome is live birth rate per IVF cycle started. Other outcomes include implantation, clinical pregnancy and miscarriage rates. The sample size for this study has been estimated as 758 participants with 379 participants in each arm. Interim analysis will be conducted by an independent Data Monitoring Committee (DMC, and final analysis will be by intention to treat. A favourable ethical opinion has been obtained (REC reference: 09/H0804/32. Trail Registration The trial has been assigned the following ISRCTN number: ISRCTN35859078

  13. Risk of vasovagal syndrome during outpatient hysteroscopy.

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    Agostini, Aubert; Bretelle, Florence; Ronda, Isabelle; Roger, Valérie; Cravello, Ludovic; Blanc, Bernard

    2004-05-01

    To evaluate influence of hysteroscope type and media used during outpatient hysteroscopy on vasovagal syndrome risk. Prospective observational study (Canadian Task Force classification II-1). University hospital. Two thousand seventy-nine women undergoing outpatient hysteroscopy without analgesia. Office hysteroscopy with a flexible or rigid hysteroscope and normal saline or CO(2). Fifteen cases of vasovagal syndrome were reported. The rate of vasovagal syndrome was higher with use of a rigid hysteroscope (12/647 [1.85%]) vs. a flexible hysteroscope (3/1432 [0.21%]), p =.00013; p =.009 after adjustment for medium used; and with the use of CO2 (10/426 [2.34%]) vs. saline solution (5/1653 [0.30%]), p vasovagal syndrome is higher with the use of a rigid hysteroscope and CO2, regardless of the indication for hysteroscopy or the parity and menopausal status of the patient.

  14. The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial

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    Smit Janine G

    2012-08-01

    Full Text Available Abstract Background In in vitro fertilization (IVF and intracytoplasmatic sperm injection (ICSI treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11–45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9–13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS, prior to a first IVF/ICSI cycle. Methods/design Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle

  15. A COMPARATIVE STUDY OF CLINICAL EXAMINATION, ULTRASOUND FINDINGS, DIAGNOSTIC HYSTEROSCOPY WITH HISTOPATHOLOGICAL EXAMINATION REPORT OF ENDOMETRIUM IN PATIENTS WITH ABNORMAL UTERINE BLEEDING

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    Sathenahalli Devegowda Prathibha

    2016-08-01

    Full Text Available BACKGROUND AND OBJECTIVES Abnormal Uterine Bleeding (AUB is a very frequent gynaecological complaint and occurs across the entire age spectrum, approximately 75000 hysterectomies are carried out each year with 30% of these for menstrual problems alone. These menstrual aberrations occur more commonly at extremes of reproductive life. The introduction of hysteroscopy has opened a new dimension in evaluation of patient with AUB replacing the blind technique of Dilatation and Curettage. The present study was undertaken to know the accuracy of various tests with Histopathology. MATERIALS AND METHODS The present prospective study was carried out on 100 patients from reproductive, perimenopausal and postmenopausal age group with abnormal uterine bleeding in Dr. B. R. Ambedkar Medical College and Hospital. RESULTS In the present study, in relation to histopathological examination, clinical findings and hysteroscopy had better accuracy (72% as compared to ultrasound findings (41% in diagnosis of abnormal uterine bleeding. CONCLUSION Hysteroscopy guided biopsy and histopathology complements each other in the evaluation of patient with abnormal uterine bleeding for accurate diagnosis and further treatment.

  16. Role of hysteroscopy prior to assisted reproduction techniques.

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    Bakas, Panagiotis; Hassiakos, Dimitrios; Grigoriadis, Charalampos; Vlahos, Nikolaos; Liapis, Angelos; Gregoriou, Odysseas

    2014-01-01

    To determine whether diagnostic hysteroscopy before assisted reproduction techniques (ΑRT) in women without known disease of the uterine cavity is necessary. Prospective cohort clinical study. Reproductive medicine clinic. The study group consisted of 217 infertile women attending the Reproductive Clinic for examination before undergoing ART, either in vitro fertilization or intracytoplasmic sperm injection. Patients underwent transvaginal sonography (TVS) and hysterosalpingography (HSG) for initial evaluation. If there were no abnormal intrauterine findings, diagnostic hysteroscopy was additionally performed. The safety and diagnostic value of hysteroscopy before ART was examined. Diagnostic hysteroscopy was performed successfully, without complications, in all 217 women. Ninety-five (43.7%) had a history of ART failures (group 1), and 122 (56.3%) had undergone no previous ART attempts (group 2). In 148 women (68.2%), findings at hysteroscopy were normal, whereas in 69 (31.8%), hysteroscopy revealed intrauterine lesions (polyps, septa, submucosal leiomyomas, or synechiae) that led to operative hysteroscopy. The most common intrauterine abnormality was the presence of endometrial polyps in 26 patients (12%). The total percentage of abnormal intrauterine findings was higher in women with a history of repeated ART failures in comparison with those with no history of ART attempts. No statistically significant difference in the outcome of in vitro fertilization or intracytoplasmic sperm injection was observed between women with normal hysteroscopic findings and patients with hysteroscopically corrected endometrial disease. Sensitivity of diagnostic hysteroscopy is significantly higher than TVS and HSG in the diagnosis of intrauterine lesions. Diagnostic hysteroscopy should be performed before ART in all patients, including women with normal TVS and/or HSG findings, because a significant percentage of them have undiagnosed uterine disease that may impair the success of

  17. Value of hysteroscopy in management of unexplained infertility

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    Elbareg, Aisha M; Essadi, Fathi M; Kamal I. Anwar; Mohamed O. Elmehashi

    2014-01-01

    Objective: To assess the value of hysteroscopy in unexplained infertility. Methods: 200 infertile women in whom standard infertility investigations revealed no abnormalities were included in the study between January 2009 and December 2013. All women underwent hysteroscopy for diagnosis and treatment of any uterine lesion which was previously undetected by hysterosalpingography (HSG). Treated women were followed up for one year during which pregnancy rate was determined. As all other cause...

  18. Office Operative Hysteroscopy: An Update.

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    Salazar, Christina Alicia; Isaacson, Keith

    2017-08-10

    Hysteroscopy is considered the gold standard for the evaluation of intracavitary pathology in both premenopausal and postmenopausal patients associated with abnormal uterine bleeding, as well as for the evaluation of infertile patients with suspected cavity abnormalities. Office-based operative hysteroscopy allows patients to resume activities immediately and successfully integrates clinical practice into a "see and treat" modality, avoiding the added risks of anesthesia and the inconvenience of the operating room. For 2017, the Centers for Medicare and Medicaid Services has provided a substantial increase in reimbursement for a select number of office-based hysteroscopic procedures. This review provides an update on the indications, equipment, and procedures for office hysteroscopy, as well as the management of complications that may arise within an office-based practice. Copyright © 2017. Published by Elsevier Inc.

  19. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis.

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    Healy, Mae Wu; Schexnayder, Brian; Connell, Matthew T; Terry, Nancy; DeCherney, Alan H; Csokmay, John M; Yauger, Belinda J; Hill, Micah J

    2016-09-01

    Despite years of studies evaluating prevention strategies for intrauterine adhesion formation after operative hysteroscopy, it is still unclear which strategies are most effective. The objective of the study was to perform a systematic review and meta-analysis to evaluate the effectiveness of postoperative prevention strategies on intrauterine adhesion formation following operative hysteroscopy. Literature searches were conducted in MEDLINE, Embase, ClinicalTrials.gov, and Cochrane Library databases. Inclusion criteria were published randomized controlled clinical trials from 1989 to 2014 comparing any postoperative preventative measures of intrauterine adhesion after hysteroscopy. The main outcome measure was a reduction in postoperative intrauterine adhesion. Heterogeneity of the studies was evaluated using a Q test and an I(2) index. Analyses were performed using a random-effects model with outcome data reported as relative risk with 95% confidence interval. Twelve studies were included in the systematic review. Eight studies compared similar treatment methods and were included in the meta-analysis. Three studies evaluated hyaluronic acid gel, of which 2 reported a significant decrease in intrauterine adhesion with treatment. The meta-analysis demonstrated a significant reduction of intrauterine adhesion when using hyaluronic acid gel. Two studies evaluated polyethylene oxide-sodium carboxymethylcellulose gel, 1 of which demonstrated a decrease in intrauterine adhesion with treatment. A meta-analysis showed a significant reduction of intrauterine adhesion with polyethylene oxide-sodium carboxymethyl cellulose gel. However, these 3 studies demonstrating a benefit of the gels in preventing adhesion formation were all conducted by the same research group. Other research groups have not confirmed these results. A sensitivity analysis excluding these trials from this single group demonstrated no benefit to adhesion prevention with either gel formation. Three studies

  20. Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility.

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    Bosteels, Jan; Weyers, Steven; Kasius, Jenneke; Broekmans, Frank J; Mol, Ben Willem J; D'Hooghe, Thomas M

    2015-11-09

    Limited observational evidence suggests potential benefit for subfertile women undergoing operative hysteroscopy with several anti-adhesion therapies (e.g. insertion of an intrauterine device (IUD) or balloon, hormonal treatment, barrier gels or human amniotic membrane grafting) to decrease intrauterine adhesions (IUAs). To assess the effectiveness of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility. We searched the following databases from inception to March 2015: the Cochrane Menstrual Disorders and Subfertility Specialised Register, the Cochrane Central Register of Controlled Trials (2015, Issue 2), MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and other electronic sources of trials, including trial registers, sources of unpublished literature and reference lists. We handsearched The Journal of Minimally Invasive Gynecology, and we contacted experts in the field. Randomised comparisons of anti-adhesion therapies versus placebo, no treatment or any other anti-adhesion therapy following operative hysteroscopy in subfertile women. The primary outcome was live birth or ongoing pregnancy. Secondary outcomes were clinical pregnancy, miscarriage and IUAs present at second look, along with their mean adhesion scores or severity. Two review authors independently selected studies, assessed risk of bias, extracted data and evaluated quality of the evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) method. We included 11 randomised studies on use of an inserted device versus no treatment (two studies; 84 women) or another inserted device (one study; 162 women), hormonal treatment versus no treatment or placebo (two studies; 131 women), gel versus no treatment (five studies; 383 women) and graft versus no graft (one study; 43 women). The total number of women randomly assigned was 924

  1. Standardizing hysteroscopy teaching: development of a curriculum using the Delphi method.

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    Neveu, Marie-Emmanuelle; Debras, Elodie; Niro, Julien; Fernandez, Hervé; Panel, Pierre

    2017-06-20

    Hysteroscopy is performed often and in many indications but is challenging to learn. Hands-on training in live patients faces ethical, legal, and economic obstacles. Virtual reality simulation may hold promise as a hysteroscopy training tool. No validated curriculum specific in hysteroscopy exists. The aim of this study was to develop a hysteroscopy curriculum, using the Delphi method to identify skill requirements. Based on a literature review using the key words "curriculum," "simulation," and "hysteroscopy," we identified five technical and non-technical areas in which skills were required. Twenty hysteroscopy experts from different French hospital departments participated in Delphi rounds to select items in these five areas. The rounds were to be continued until 80-100% agreement was obtained for at least 60% of items. A curriculum was built based on the selected items and was evaluated in residents. From November 2014 to April 2015, 18 of 20 invited experts participated in three Delphi rounds. Of the 51 items selected during the first round, only 25 (49%) had 80-100% agreement during the second round, and a third round was therefore conducted. During this last round, 80-100% agreement was achieved for 31 (61%) items, which were used to create the curriculum. All 14 residents tested felt that a simulator training session was acceptable and helped them to improve their skills. We describe a simulation-based hysteroscopy curriculum focusing on skill requirements identified by a Delphi procedure. Its development allows standardization of training programs offered to residents.

  2. Comparison between findings of saline infusion sonohysterography and office hysteroscopy in patients with recurrent implantation failure

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    Ahmed Reda

    2016-01-01

    Full Text Available Aim: This study aims to determine the accuracy of saline infusion sonohysterography (SIS in the diagnosis of intrauterine pathologies in women with recurrent implantation failure (RIF. Settings and Design: This is a prospective cross-over study which was carried out during the period between December 2013 and July 2014. Materials and Methods: The study involved sixty subfertile women with a history of RIF. All cases underwent a transvaginal ultrasonography, SIS and then an office hysteroscopy (1 day after SIS during early follicular phase. SIS was carried out by same sonographer, and then hysteroscopy was carried out by same gynecologist who was kept blind to findings at SIS. Statistical Analysis: Was done using IBM© SPSS© Statistics version 22. The sensitivity of SIS was calculated as it equals: True positive by SIS/all positive (true cases by hysteroscopy and specificity was calculated as it equals: True negative by SIS/all negatives (normal by hysteroscopy. Results: Overall uterine abnormalities were significantly less likely to be identified with SIS compared to hysteroscopy (P = 0.002, but analysis of each finding separately demonstrated a comparable difference between SIS and hysteroscopy (P > 0.05. We found that the sensitivity, specificity, positive predictive value, and negative predictive value of SIS to detect intrauterine pathology is 41.2%, 100%, 100%, and 81.1%, respectively. Conclusion: Our findings suggest a good role of SIS in the workup for RIF saving more invasive procedure for selected cases.

  3. Office hysteroscopy, transvaginal ultrasound and endometrial histology: a comparison in infertile patients

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    Devleta Balić

    2011-05-01

    Full Text Available Objective. To evaluate accuracy of transvaginal sonography (TVS and hysteroscopy in detection of intrauterine pathology in infertile women. Subjects and methods. This retrospective study was conducted in 56 infertile women with abnormal transvaginal ultrasound findings of the uterine cavity which was performed during the midfollicular phase as a part of routine infertility workup. Hysteroscopy was performed between 6th and 10th day of cycle. Results. The mean age of the subjects was 31.9±4.0. The most frequent ultrasound finding was endometrial polyp in 34 (60.7% patients, septate uterus in 8 (14.3% patients, submucosal myoma in 7 (12.5% patients, endometrial hyperplasia in 5 (8.9% patients and Syndroma Ascherman in 2 (3.6% patients. Hysteroscopy confirmed 20 (35.7% polyps, the same number of myomas, septate uterus and Syndroma Ascherman as detected by ultrasound, (7 (12.5%, 8 (14.3% and 2 (3.6%, respectively and 19 (33.9% endometrial hyperplasia. In 46 women with histological excamination, the sensitivity of TVS and hysteroscopy in the diagnosis of endometrial polyps were identical - 100%, while the specificity was higher in hysteroscopy than in TVS (92.3% versus 56.4%, p<0.001. The sensitivity of TVS in the diagnosis of endometrial hyperplasia was higher than that of hysteroscopy (86.4% versus 22.7%, p<0.001, while specificity was identical, of 100%. Accordance between hysteroscopy and histology was good (k=0.79, between ultrasound and histology was moderete (k=0.59. Conclusion. Hysteroscopy appeared to be more reliable in diagnosis than TVS. The use of a high frequency ultrasound probe leads us to a lack of diagnostic clarity between endometrial polyps and hyperplasia.

  4. The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial

    OpenAIRE

    Mak, N; Reinders, I. M. A.; Slockers, S. A.; Westen, E. H. M. N.; Maas, J. W. M.; M.Y. Bongers

    2017-01-01

    Background Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. Methods A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients? level of pain dur...

  5. [COMPLICATIONS OF DIAGNOSTIC AND OPERATIVE HYSTEROSCOPY--REVIEW].

    Science.gov (United States)

    Stankova, T; Ganovska, A; Stoianova, M; Kovachev, S

    2015-01-01

    Hysteroscopy is a diagnostic or surgical mini-Invasive gynecologic operating procedure. The complications of this standard procedure are relatively rare. According to retrospective studies they are 0.95-13.6%. They occur more often by an operative rather than a diagnostic hysteroscopy. These complications could be divided into two groups of an approximately equal occurrence--due to a dilation and passing through the cervix uteri (cervical laceration, creative a false cervix uteri, perforation, bleeding, impossibility to pass through the inner orifice of the cervical canal, insufficiency of the cervix uteri) and due to the operative technique itself (uterine perforation, fluid overload, thermal or mechanical trauma of the inner urinaiy and gastrointestinal tract, infection, rupture of the uterus during a subsequent pregnancy). The most occurring complication is namely the uterine perforation--1-9%, the most severe could indeed be the fluid overload--0.01-11%. The gynecologist performing the hysteroscopy should be well grounded in the typical complications. Unveiling and performing a quick intervention of the latter could prevent unwanted consequences for the patient and the legal issues that could follow occur.

  6. Incidence of uterine perforation during hysteroscopy in a teaching ...

    African Journals Online (AJOL)

    Background: Uterine perforation during diagnostic hysteroscopy is relatively rare event in an experience hand. They however occur more frequently with operative hysteroscopy than with diagnostic hysteroscopy. The exact incidence differ from centre to centre depending on the indication for the procedure and the ...

  7. Efficacy of auto-crosslinked hyaluronan gel for adhesion prevention in laparoscopy and hysteroscopy: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mais, Valerio; Cirronis, Maria G; Peiretti, Michele; Ferrucci, Giuliano; Cossu, Ester; Melis, Gian B

    2012-01-01

    Prevention of postoperative adhesions is a clinical need. We undertook a systematic review to explore the available clinical evidence of the efficacy of auto-crosslinked hyaluronan gel for postoperative adhesion prevention following endoscopic gynecological surgery. An electronic database search of MEDLINE, Cochrane Database of Systematic Reviews and EMBASE, and a comprehensive hand-search of reference lists of published and review articles were performed. No language restrictions were applied. Randomized controlled trials (RCTs) on the use of auto-crosslinked hyaluronan gel for the prevention of postoperative adhesions in gynecological surgery were included in the meta-analysis if they reported outcomes as evaluated at a blind second-look assessment. Three authors independently selected studies and extracted data on study characteristics, quality and accuracy. The Jadad scoring system was used for validity assessment. Meta-analysis was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The outcome was the incidence of postoperative adhesions based on a binary response (present or not present). Only five RCTs were eligible for inclusion in the meta-analysis. The incidence of postoperative adhesions in patients who received auto-crosslinked hyaluronan gel was significantly lower than in patients who underwent standard surgery only. The gel prevented both intraperitoneal adhesions after laparoscopic myomectomy (OR 0.248, 95% CI 0.098, 0.628) and intrauterine adhesions after hysteroscopic surgery (OR 0.408, 95% CI 0.217, 0.766). Further RCTs are needed to assess the efficacy of auto-crosslinked hyaluronan gel in women undergoing different laparoscopic intra-abdominal surgical procedures. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  8. Avaliação da dor na histeroscopia diagnóstica por vaginoscopia utilizando-se, como meio de distensão, solução salina à temperatura corporal: Ensaio clínico randomizado Evaluation of pain in diagnostic hysteroscopy by vaginoscopy using normal saline at body temperature as distension medium: A randomized controlled trial

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    Zares Maria Melo Cavalcanti de Almeida

    2008-01-01

    Full Text Available OBJETIVO: comparar a histeroscopia diagnóstica por vaginoscopia com soro fisiológico na temperatura corporal com a técnica tradicional, em relação à dor, satisfação da paciente e exeqüibilidade do procedimento. MÉTODOS: ensaio clínico randomizado, envolvendo 184 mulheres, encaminhadas entre maio e dezembro de 2006, para serem submetidas à histeroscopia diagnóstica. As participantes foram randomizadas para realizar o procedimento pela técnica proposta, com acesso por vaginoscopia, sem espéculo ou pinçamento do colo e utilizando soro fisiológico a 36ºC como meio distensor, ou pela técnica tradicional, utilizando CO2.Em ambas as técnicas, foi utilizada óptica de 2,7 mm. A dor foi avaliada pela escala visual analógica (EVA, durante e a cada cinco minutos após o procedimento. RESULTADOS: a dor, na técnica proposta, teve pontuação média de 1,60 e, na técnica tradicional, de 3,39 (pPURPOSE: to compare diagnostic hysteroscopy through vaginoscopy, using warm saline solution, with traditional technique, regarding to pain, patient satisfaction and feasibility of the procedure. METHODS: randomized clinical trial, involving 184 women, referred for diagnostic hysteroscopy, between May and December of 2006. Participants were randomized to be submitted to hysteroscopy by the proposed technique, which consisted of access through vaginoscopy using normal saline at 36ºC as distension medium, no speculum or cervical grasping, or by the traditional technique with CO2. In both techniques, a 2.7 mm hysteroscope was used. Pain was assessed by the analogical visual scale, during the procedure and every five minutes after it. RESULTS: the mean pain score was 1.60 in the proposed technique and 3.39 in the traditional technique (p<0.01. Lower pain scores were also observed after 5, 10 and 15 minutes (p<0,01 as well as after 20 minutes (p=0.056. In the proposed technique, 82.4% of the procedures were feasible, while, in the traditional technique

  9. Evaluation of hysteroscopy as a complementary exam in the investigation of chronic pelvic pain.

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    Bruno Hállan Meneses Dias

    2013-09-01

    Full Text Available Introduction: Chronic pelvic pain (CPP is a difficult condition to identify and many disorders are correlated. This study investigates the role of hysteroscopy as a complementary exam in the diagnosis of CPP. Methods: One hundred ninety-one medical records of women with indication to perform a hysteroscopy and presented CPP were reviewed. Results: The analysis showed abnormalities in 99 patients. Of these, more than 70% presented conditions that could cause CPP. Cervical stenosis and findings suggestive of adenomyosis were the most frequent ocurrences. Conclusions: Hysteroscopy is useful to detect pathological conditions of the cervix and uterine cavity that may coexist with chronic pelvic pain.

  10. Role of hysteroscopy and endometrial biopsy in women with unexplained infertility.

    Science.gov (United States)

    Makled, Ahmed Khairy; Farghali, Mohamed Mahmoud; Shenouda, Demiana Samir

    2014-01-01

    This study was designed to evaluate the role of hysteroscopy and endometrial biopsy in women with unexplained infertility. Women with unexplained infertility were included in this prospective study, evaluated with transvaginal sonography and diagnostic hysteroscopy. Diagnostic hysteroscopy was performed between the 7th and 11th day of the cycle. The criteria for hysteroscopic findings were based on the cervical canal, uterine cavity, endometrium, visualization of the ostium tubae and lesions of the utero-tubal junction. After the hysteroscopic examination, endometrial biopsy was performed using a Pipelle endometrial suction curette. Patients were classified according to the hysteroscopy results into four groups: patients with no abnormality detected (14), patients with cervical abnormalities (six), patients with endometrial abnormalities (73) and patients with uterine abnormalities (seven). One hundred women with unexplained infertility were included. All patients underwent diagnostic hysteroscopy, except for seven patients: six patients had stenotic external or internal cervical ostium and one had inadequate visualization as the uterine cavity was filled with blood. Based on hysteroscopic findings, 31 patients were finally diagnosed with endometrial polyps; 14 endometritis; 15 endometrial hyperplasia; six submucous myomas; seven intrauterine synechiae (73 cases = endometrial abnormalities group); seven congenital uterine anomalies (uterine abnormalities group), six cervical stenosis (cervical abnormalities group) and 14 women without any uterine abnormalities (no abnormalities group). Analysis of samples obtained using the Pipelle endometrial suction curette was non-diagnostic in 16 cases; the most common endometrial pathological feature detected by this analysis was endometritis (15%). Routine hysteroscopy and endometrial biopsy should be used as a basic part of the work-up for women with unexplained infertility.

  11. ROLE OF HYSTEROSCOPY IN THE MANAGEMENT OF SECONDARY POSTPARTUM HAEMORRHAGE

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    Krupa Patalay

    2016-03-01

    Full Text Available INTRODUCTION Secondary postpartum haemorrhage [PPH] or puerperal haemorrhage, though rare can sometimes cause severe morbidity needing prolonged hospitalisation. Majority of the cases can be managed medically, a few of them requiring surgical interventions. With retained placental tissue being a common cause, emptying the uterus in the puerperium can be difficult and dangerous too as the wall is soft and perforation chances are high. Hysteroscopic evaluation of the puerperal uterus gives us a better picture of the retained bits of placental tissue, and helps in complete evacuation of the tissue without causing much trauma to the fragile uterine wall. It is also more specific than ultrasonogram [USG] to rule out the presence of retained tissue. MATERIAL AND METHODS 17 patients who had secondary PPH and did not respond to the initial medical management were included in the study. Hysteroscopy was done in these cases. Definitive pathology was found in 12 cases; 7 cases had polypoidal tissue [retained bits of placenta], 3 cases had placental tissue adherent to the caesarean scar [placenta accreta] and 2 cases had submucous fibroids. RESULTS In cases which had retained placental bits, the tissue could be visualised, its exact location noted and the entire tissue could be removed without inciting much trauma to the uterine wall. In cases with placenta accreta, gentle extraction of the adherent tissue could be done without traumatising the scar. In one case which had multiple fibroids with irregular uterine cavity, hysteroscopy helped in localising the retained tissue. CONCLUSION Hysteroscopy is a useful modality in managing cases of secondary PPH, who have persistent bleeding in the postpartum period.

  12. The value of diagnostic hysteroscopy with biopsy in the preoperative of endometrial ablation

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    Salete Yatabe

    2011-12-01

    Full Text Available Objective: To assess the value of diagnostic hysteroscopy with biopsy in the preoperative preparation for endometrial ablation. Methods: It was a prospective non-randomized study conducted at the division of Gynecologic Endoscopy of Hospital do Servidor Público Estadual “Francisco Morato de Oliveira” from March 2007 to May 2009. A total of 45 patients with abnormal uterine bleeding, and referred to endometrial ablation were included. All women underwent a diagnostic hysteroscopy, and were treated with a GnRH analogous – goserelin – 10.8 mg before surgery. The endometrial ablation was performed with a surgical resectoscope. Patients were submitted to one directed endometrial biopsy, one guided endometrial biopsy with Novak curette, and to endometrial ablation, which was considered as reference for pathological examination with samples from the biopsies. Data were analyze using the SPSS-v16 software, and considered significance at p = 0.05. Results: The mean age of women was 44.20 years (33-56, parity of 2.67 (0-9, uterus size of 139.99 calculated in cc (42-278, and the mean duration of symptoms was 3.68 years (0.5-15. The guided endometrial biopsy showed sensitivity of 80% for endometrium without atypia, and the directed endometrial biopsy had sensitivity of 60%. For proliferative endometrium the directed endometrial biopsy showed sensitivity of 76 and 100% for secretory endometrium, which was higher than the guided endometrial biopsy with 53 and 50%, respectively. Conclusion: The directed biopsy before endometrial ablation had lower sensitivity than guided biopsy for endometrium without atypia, however it was higher for proliferative and secretory endometrium.

  13. Laparoscopy and hysteroscopy in a Tertiary Hospital: A 4 year review

    African Journals Online (AJOL)

    Results: The total number of patients who had diagnostic laparoscopy within the 4‑year study period was 221, but only 197 files were retrieved, giving a retrieval rate of 89.1%. The total number of patients who had diagnostic hysteroscopy was 28, but only 23 case files were retrieved, giving a retrieval rate of 82.1%.

  14. Hysteroscopy in Libyan women with Recurrent Pregnancy Loss ...

    African Journals Online (AJOL)

    Background: Hysteroscopy is an efficient procedure of management in many gynecologic conditions. There are few published data on hysteroscopy and recurrent pregnancy loss especially in developing countries. Objectives: To assess hysteroscopic findings in patients with consecutive miscarriages, and to compare the ...

  15. Evaluation of intrauterine adhesion treatment by laser hysteroscopy

    Science.gov (United States)

    Mutrynowski, Andrzej; Zabielska, Renata

    1996-03-01

    Hysteroscopy, which is a kind of endoscopy, makes it possible to evaluate macroscopically the cervical canal, uterine cavity, and the uterine opening of the oviducts. Laser hysteroscopy is used for removing septa and intrauterine adhesions, polyps, small submucosus myomas, and for endometrium ablation in abnormal metrorrhagias. The paper aims at the initial evaluation of laser hysteroscopy in removing intrauterine adhesions in the cases of 41 infertile women. Among all infertile patients 16 women (39%) conceived. Among others 1 woman (2.5%) did not want to conceive and 19 had other causes of infertility. Thirteen (93%) out of 14 patients with hypomenorrhea before surgery reported improvement of the menstruation cycle after the treatment. Five patients (12%) had adhesions for the second time. The patients had the second laser hysteroscopy. The control diagnostic hysteroscopy showed no adhesions in those cases.

  16. MRT letter: visual attention driven framework for hysteroscopy video abstraction.

    Science.gov (United States)

    Ejaz, Naveed; Mehmood, Irfan; Baik, Sung Wook

    2013-06-01

    Diagnostic hysteroscopy is a popular method for investigating the regions in the female reproductive system. The videos generated by hysteroscopy sessions of patients are recurrently archived in medical libraries. Gynecologists often need to browse these libraries in search of similar cases or for reviewing old videos of a patient. Diagnostic hysteroscopy videos contain a lot of information with abundant redundancy. Key frame extraction-based video summarization can be used to reduce this huge amount of data. Moreover, key frames can be used for browsing and indexing of hysteroscopy videos. In this article, a domain specific visual attention driven framework for summarization of hysteroscopy videos is proposed. The visual attention model is materialized by computing saliency based on color, texture, and motion. The experimental results, in comparison with other techniques, demonstrate the efficacy of the proposed framework. Copyright © 2013 Wiley Periodicals, Inc.

  17. Off ice Hysteroscopy in Patients with Abnormal Uterine Bleeding and Normal Transvaginal Sonography

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    Mojgan Barati

    2008-01-01

    Full Text Available Background: Abnormal uterine bleeding (AUB is one of the most common clinical problemsin gynecology. Transvaginal sonography (TVS and hysteroscopy are two diagnostic methods forpatients with AUB. For most of the patients with AUB, diagnostic hysteroscopy can be done inclinic with minimal discomfort and much lower expense than operative room.Materials and Methods: In our clinical trial study, from March 21, 2005 to March 20, 2007,patients with AUB in Ahwaz Imam Khomayni hospital, after history and physical examinationsunderwent TVS. Of those, 147 patients with normal TVS entered the study and were considered foroutpatient hysteroscopy. Patients with endometrial cavity lesion were scheduled for operation room,and those with empty endometrial cavity aspiration biopsy were done outpatiently. Specimens weresent to pathologist for examination.Results: All the patients were divided into three groups: group 1 or minority was under 30 yearsold (7 women, group 2 was 30-40 years, and group 3 or majority was over 40 years old (96women. 115 patients (78.2% had normal and 32 patients (21.8% had abnormal hysteroscopicresults. 116 patients (78.8% had normal and 31 patients (21.2% had abnormal pathologic results;moreover, cervical canal polyp was the most common lesion hysteroscopically and pathologicallyin all groups.Conclusion: Of 147 patients (100% with AUB and normal TVS, 32 patients (21.8% wereabnormal hysteroscopically. Cervical canal polyps may be missed by transvaginal sonography, butcan be diagnosed by hysteroscopy. In patients with AUB and normal TVS, hysteroscopy can beused as the second step.

  18. Hysteroscopy as a standard procedure for assessing endometrial lesions among postmenopausal women

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    Camila Toffoli Ribeiro

    Full Text Available CONTEXT AND OBJECTIVES: Endometrial cancer is the most prevalent type of malignant neoplasia of the genital tract. The objective of this study was to calculate the sensitivity, specificity, accuracy and positive and negative predictive values for diagnostic hysteroscopy, in comparison with histopathological tests, for all lesions of the endometrial cavity. DESIGN AND SETTING: Retrospective descriptive study at the public tertiary-level university hospital of Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo. METHODS: Diagnostic hysteroscopy was indicated in the following instances: endometrial thickness > 4 mm in asymptomatic patients; postmenopausal bleeding; and irregular endometrium or endometrium difficult to assess from ultrasound, with or without vaginal bleeding. Ultrasound evaluations were carried out no more than three months prior to hysteroscopy. RESULTS: There were 510 patients, with a mean age of 61.1 ± 2.0 years and mean time elapsed since the menopause of 12.7 ± 2.5 years. Endometrial biopsies were performed on 293 patients (57.5%. Histopathological analysis showed that 18 patients presented endometrial carcinoma or typical or atypical hyperplasia, and none of them presented endometrial thickness of less than 8 mm. No significant differences were found between the median thicknesses of the various benign lesions (p > 0.05. In our data, the sensitivity, specificity, accuracy and positive and negative predictive values for cancer or hyperplasia were 94.4%, 97.0%, 96.8%, 68% and 99.6%, respectively. CONCLUSIONS: Our results suggest that hysteroscopy is valuable as a diagnostic tool for malignant/hyperplastic and benign lesions, except for submucous myomas, for which the sensitivity was only 52.6%.

  19. Implementation of an outpatient hysteroscopy clinic at Waikato Women's Hospital report of the first 60 cases.

    Science.gov (United States)

    Roman, J D; Trivedi, A N

    1999-07-09

    To study the implementation of an outpatient hysteroscopy clinic at Waikato Women's Hospital and to assess the procedures carried out without the use of local anaesthesia. This was a prospective observational study. The main indication for the procedure was menorrhagia in 32 patients (53.34%). Fifteen per cent patients were post-menopausal. The commonest pathology found was fibroids in 14 patients (23.34%). The procedure was considered completed when a detailed examination of the uterine cavity had been done. This was possible in 54 cases (90%). The main reasons for an incomplete/abandoned procedure (10% patients) were troublesome bleeding, blurred camera lens, post-menopausal stenosis and a possible false passage. Only six patients (10%) needed a paracervical block and therefore 90% underwent the procedure without the use of local anaesthesia. An endometrial biopsy was performed selectively in 47 patients and an adequate specimen was obtained in 43 cases (91.49%). Only five patients later underwent a hysteroscopy and D & C in the main theatre and therefore general anaesthesia was avoided in 55 patients (91.67%). Conclusions. Performance of outpatient hysteroscopy in an adequately selected group of patients is successful in a considerable number of patients. This office procedure may be done without local anaesthesia in 90% of cases.

  20. [Is the hysteroscopy the right choice for therapy of placental remnants?].

    Science.gov (United States)

    Hrazdirová, L; Kuzel, D; Zizka, Z

    2012-02-01

    The evaluation of the effectiveness and safety of hysteroscopic management of residual trophoblastic tissue and to verify the miniinvasivity with the second-look hysteroscopy. Prospective study. Department of Gynecology and Obstetrics, First Faculty od Medicine, Charles University and General Teaching Hospital, Prague. From 11/2007 to 6/2011, 58 patiens with abnormal uterine bleeding longer than 6 weeks after delivery or abortion underwent ultrasound examination with fading of hyperechogenic content larger than 15mm in AP projection. There was the bipolar resectoscopic system used under general anestesia. Second-look office hysteroscopy was recommended to all patiens 4-6 weeks after a primary procedure. Median operative time was 15 (7-36) minutes, median time of hospitalisation was 7.1 hours. In four patients was necessary to divide the procedure into two phases (after 14 days). There was no serious uterine bleeding or inflamation in our study group. Only one serious surgical complication was registered: an uterine perforation in patient after 2 cesarean sections, there was the laparoscopic suture provided. The second-look hysteroscopy was provided in 45 patients (77.6%). There was normal intrauterine finding in 16 (35.6%) patients, in 29 patients (64.4%) a small residual trophoblastic tissue was resected. There was no secondary intrauterine adhesive process described. Hysteroscopic resection is a safe and efficient operative technique, which is suitable for management of larger trophoblastic tissue left after delivery or abortion.

  1. Toxic Shock Syndrome within 24 H of an Office Hysteroscopy.

    Science.gov (United States)

    Bhagat, Nanak; Karthikeyan, Akilandeshwari; Kalkur, Sanjaya

    2017-01-01

    Office hysteroscopy is now a common procedure performed to look at the endometrial cavity and is relatively free of serious complications. A 68-year-old lady, previously fit and well, presented with abdominal pain, rigors, sweats, and vomiting within 24 h of an outpatient hysteroscopy for postmenopausal bleeding. She was diagnosed with streptococcal toxic shock syndrome (STSS) due to Group A beta-hemolytic streptococci. She was managed in the Intensive Care Unit, with inotropic and antibiotic support. She recovered eventually and was discharged home with oral antibiotics. Toxic shock syndrome due to Streptococci is an unusual occurrence, whose incidence has been slowly increasing over the years. However, this appears to be the first case of STSS manifesting within 24 h following an outpatient hysteroscopy.

  2. Value of hysteroscopy in management of unexplained infertility

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    Aisha M. Elbareg

    2014-12-01

    Conclusion: As a cause of unexplained infertility, subtle uterine abnormalities are diagnosed only during hysteroscopy and they are relatively common in infertility women. Although the presence of these abnormalities is not detected by the basic investigations for infertility, their correction seems to be necessary when infertility is desired and other infertility causes are excluded.

  3. Comparison of Sensitivity & Specificity of Transvaginal Sonography, Saline Infusion Sonohysterography and Hysteroscopy in Evaluation of Women with Abnormal Uterine Bleeding

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    K Shojaie

    2009-10-01

    Full Text Available Introduction: Bleeding disorders are a common problem in daily practice, especially in premenopausal women. In our investigation, we compared the sensitivity and specificity of three different diagnostic methods Trans-vaginal sonography(TVS, saline infusion sonohystrography(SIS and Hysteroscopy. Methods: It was a cross- sectional study with a study population of ninety-nine women suffering fromAUB attending the outpatient clinic of Imam and Razi hospital in Ahvaz- Iran. They were evaluated by three different diagnostic methods and the results were compared. This study started from March 2008 to December 2008. The sensitivity, specificity, positive predictive and negative predictive values were measured in TVS, SIS, and finally these two methods were compared with hysteroscopy (as a gold standard. Results: The sensitivity and specificity of TVS was 74.2% and 49.7%, respectively, while that of SIS was 91.6% and 86%, respectively. The positive predictive value and negative predictive value of TVS was 71.9% and 54.3%, respectively, while that of SIS was 85.9% and 85.75%, respectively. The sensitivity, specificity, the positive predictive and negative predictive values of SIS was more than TVS, and it was similar to hysteroscopy. Conclusion: The findings obtained in the present study indicate that in AUB, sensitivity, specificity, positive and negative predictive value of SIS is more than TVS and therefore can be considered as a first step for diagnosis of AUB.

  4. The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial.

    Science.gov (United States)

    Mak, N; Reinders, I M A; Slockers, S A; Westen, E H M N; Maas, J W M; Bongers, M Y

    2017-01-01

    Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients' level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients' level of pain after the procedure, anxiety and satisfaction of patient and doctor. No positive effect of music on patients' perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups. This study showed no positive effect of music on patients' level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music. Dutch Trial Register, NTR4924.

  5. Use of Flexible Hysteroscopy in Prepubertal Aged Girls with Genital Complaints

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    Fu-Tsai Kung

    2005-12-01

    Conclusion: The advantages of safety, convenience, and effectiveness suggest that flexible hysteroscopy under anesthesia is a good substitute for traditional vaginoscopy and may help in the diagnosis of genital complaints in selected prepubertal patients in the pediatric gynecology clinic.

  6. Prevalence of uterine diseases in healthy women with hysteroscopy as part of routine gynecological evaluation

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    J.C. Paredes Palma

    2016-10-01

    Conclusions: Hysteroscopy showed a high prevalence of detecting uterine pathologies that were never previously described in a population of healthy women in a common sample of patients attending the outpatient Hospital Pemex Picacho.

  7. Comparison of 3 dimensional sonohysterography and hysteroscopy in Premenopausal women with abnormal uterine bleeding

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    Yasser I. Abd Elkhalek

    2016-09-01

    Conclusion: 3-D sonohysterography is a very safe, well tolerated and effective modality for evaluation of intracavitary uterine abnormalities and is an accurate alternative technique for hysteroscopy among the premenopausal women that suffers from abnormal uterine bleeding (AUB.

  8. Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility

    NARCIS (Netherlands)

    Bosteels, Jan; Weyers, Steven; D'Hooghe, Thomas M.; Torrance, Helen; Broekmans, Frank J.|info:eu-repo/dai/nl/145488594; Chua, Su Jen; Mol, Ben Willem J.

    2017-01-01

    Background: Observational evidence suggests a potential benefit with several anti-adhesion therapies in women undergoing operative hysteroscopy (e.g. insertion of an intrauterine device or balloon, hormonal treatment, barrier gels or human amniotic membrane grafting) for decreasing intrauterine

  9. Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility

    NARCIS (Netherlands)

    Bosteels, Jan; Weyers, Steven; Kasius, Jenneke; Broekmans, Frank J.; Mol, Ben Willem J.; D'Hooghe, Thomas M.

    2015-01-01

    Background Limited observational evidence suggests potential benefit for subfertile women undergoing operative hysteroscopy with several anti-adhesion therapies (e. g. insertion of an intrauterine device (IUD) or balloon, hormonal treatment, barrier gels or human amniotic membrane grafting) to

  10. Roles of sonography and hysteroscopy in the detection of premalignant and malignant polyps in women presenting with postmenopausal bleeding and thickened endometrium.

    Science.gov (United States)

    Cavkaytar, Sabri; Kokanali, Mahmut Kuntay; Ceran, Ufuk; Topcu, Hasan Onur; Sirvan, Levent; Doganay, Melike

    2014-01-01

    To assess the role of sonographic endometrial thickness and hysteroscopic polyp size in predicting premalignant and malignant polyps in postmenopausal women. A total of 328 postmenopausal women with abnormal uterine bleeding and thickened endometrium underwent operative hysteroscopy due to detection of endometrial polyps were included in this retrospective study. Preoperative endometrial thickness measured by transvaginal ultrasonography and polyp size on hysteroscopy were noted. Hysteroscopic resection with histology was performed for endometrial polyps. Endometrial thickness and polyp size were evaluated on the basis of final diagnosis established by histologic examination. Receiver operator characteristic curves were calculated to assess the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of endometrial thickness and polyp size for detecting premalignant and malignant polyps. Premalignant and malignant polyps were identified in 26 (7.9%) of cases. Sonographic measurement showed a greater endometrial thickness in cases of premalignant and malignant polyps when compared to benign polyps. On surgical hysteroscopy, premalignant and malignant polyps were also larger. Endometrial thickness demonstrated a sensitivity of 53.8%, specificity of 85.8%, PPV of 24.6% and NPV of 95.6% at a cut-off limit of 11.5 mm with diagnostic accuracy of 83.2%. Polyp size has a diagnostic accuracy of 94.8% with a sensitivity of 92.3%, specificity of 95.0%, PPV of 61.5% and NPV of 99.3% at a cut-off point of 19.5mm. Endometrial thickness measured by transvaginal ultrasonography is not sufficient in predicting premalignant and malignant endometrial polyps in postmenopausal women with abnormal uterine bleeding and thickened endometrium. Polyp size on hysteroscopy is a more accurate parameter, because of better sensitivity and specificity. However, while polyp size ≥ 19.5mm seems to have a great accuracy for predicting premalignancy and

  11. Endometrial Volume Measured by VOCAL Compared to Office Hysteroscopy for Diagnosis of Endometrial Polyps in Premenopausal Women with Abnormal Uterine Bleeding

    Directory of Open Access Journals (Sweden)

    Mohamed Laban

    2016-01-01

    Full Text Available The aim is to compare hysteroscopy, two-dimensional transvaginal ultrasound (2D TVUS, and three-dimensional (3D Virtual Organ Computer-aided AnaLysis™ (VOCAL to detect endometrial polyps (EPs in premenopausal women with abnormal uterine bleeding (AUB. This prospective study was done at Ain Shams Maternity Hospital, Egypt, from March 5, 2015, to December 30, 2015, enrolling 118 premenopausal women with AUB. 2D TVUS, 3D VOCAL, and hysteroscopy were done. 109 patients reached final analysis. 36 women (33% were diagnosed with EP by 2D TVUS. 50 (45.9% had EP by hysteroscopy. Endometrial thickness was 10.1 mm by 2D TVUS and endometrial volume was 4.92 mL by VOCAL in women with EP by hysteroscopy compared to 9.9 mm and 3.50 mL in women with no EP, respectively (P=0.223; P=0.06. 2D TVUS has sensitivity, specificity, and positive and negative predictive values of 54%, 84.7%, 75%, and 68.5%, respectively. Endometrial thickness of >7.5 mm has sensitivity, specificity, positive and negative predictive values, and overall accuracy of 82%, 37.3%, 52.6%, 71%, and 57.8%, respectively. Endometrial volume of >1.2 mL has sensitivity, specificity, positive and negative predictive values, and overall accuracy of 90%, 42.4%, 57%, 83.3%, and 64.2%, respectively. 3D VOCAL may be used as a noninvasive method for the diagnosis of EP in premenopausal women with AUB.

  12. Is outpatient hysteroscopy accurate for the diagnosis of endometrial pathology among perimenopausal and postmenopausal women?

    Science.gov (United States)

    Bar-On, Shikma; Ben-David, Alon; Rattan, Gilad; Grisaru, Dan

    2018-02-01

    To assess the histological and visual accuracy of outpatient hysteroscopy. This was a retrospective analysis of all women referred to a tertiary center outpatient hysteroscopy clinic between March 2011 and October 2016 for the following indications: postmenopausal bleeding, suspected polyp, and/or thick endometrium. Histological accuracy was evaluated by comparing specimens obtained in hysteroscopy with those obtained by hysterectomy, and visual accuracy was evaluated by comparing visual findings with those obtained by biopsies. Sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratio were calculated to assess visual accuracy. The mean age of participants was 54.14 (interquartile range 43.0-64.0). A total of 408 pathological specimens were obtained from outpatient hysteroscopies during the 712 visits recorded in the clinic log. Histological accuracy was evaluated in 15 participants who eventually underwent hysterectomy. Total percent of agreement between hysteroscopy biopsies and final pathology obtained by hysterectomy was 73% (kappa = 0.47). Overall visual accuracy was calculated with a 93.1% sensitivity, 52.1% specificity, 90.4% positive predictive value, and 61.0% negative predictive value. Visual accuracy for benign pathology was generally higher compared with that for pre and malignant lesions. Visual accuracy was satisfactory for the diagnosis of endometrial carcinoma with sensitivity and specificity of 71.4% and 98.9%, respectively, but poor for diagnosing hyperplasia with sensitivity and specificity of 25.0% and 96.6%, respectively. Outpatient hysteroscopy is an adequate and reliable tool for the evaluation of benign pathology in the uterine cavity. Visual findings may not suffice, and directed biopsies may be required to improve diagnostic accuracy.

  13. The Role of Hysteroscopy in the Diagnosis and Treatment of Adenomyosis

    Directory of Open Access Journals (Sweden)

    Attilio Di Spiezio Sardo

    2017-01-01

    Full Text Available Uterine adenomyosis is a common gynecologic disorder in women of reproductive age, characterized by the presence of ectopic endometrial glands and stroma within the myometrium. Dysmenorrhea, abnormal uterine bleeding, chronic pelvic pain, and deep dyspareunia are common symptoms of this pathological condition. However, adenomyosis is often an incidental finding in specimens obtained from hysterectomy or uterine biopsies. The recent evolution of diagnostic imaging techniques, such as transvaginal sonography, hysterosalpingography, and magnetic resonance imaging, has contributed to improving accuracy in the identification of this pathology. Hysteroscopy offers the advantage of direct visualization of the uterine cavity while giving the option of collecting histological biopsy samples under visual control. Hysteroscopy is not a first-line treatment approach for adenomyosis and it represents a viable option only in selected cases of focal or diffuse “superficial” forms. During office hysteroscopy, it is possible to enucleate superficial focal adenomyomas or to evacuate cystic haemorrhagic lesions of less than 1.5 cm in diameter. Instead, resectoscopic treatment is indicated in cases of superficial adenomyotic nodules > 1.5 cm in size and for diffuse superficial adenomyosis. Finally, endometrial ablation may be performed with the additional removal of the underlying myometrium.

  14. Uso do spray de lidocaína em histeroscopia diagnóstica Use of lidocaine spray in diagnostic hysteroscopy

    Directory of Open Access Journals (Sweden)

    Júlio César Rosa e Silva

    2007-04-01

    patients participated in the study, which was conducted from March 2004 to March 2005. The patients were randomly assigned to one of two groups: one group receiving topical lidocaine spray (lidocaine group - LdG and the other, receiving no medication before the procedure (control group - CG. In the LdG patients, thirty milligrams of 10% lidocaine spray were applied to the surface of the cervix five minutes before hysteroscopy started. Immediately, after the end of the procedure, the patients from both groups were asked to respond to a questionnaire about pain and to quantify the pain, in centimeters, using a 10-cm non-graduated visual analog scale. The unpaired t test, the Mann-Whitney test and the chi2 test were used for statistical analyses, considering p significant if lower than 0.05. RESULTS: there was no statistically significant difference between groups regarding age, parity or percentage of patients in menacme or menopause, or regarding the indications for the procedure and the hysteroscopic findings. A biopsy was necessary in 57 of the 132 LdG patients and in 48 of the 129 CG patients (p=0.96. The mean pain score was 4.3±2.9 in LdG and 3.9±2.5 in CG (p=0.2. A difference in the mean pain score was observed only among patients in menacme and menopause receiving or not the lidocaine spray, with p=0.01 and p=0.04 respectively. CONCLUSIONS: the use of lidocaine spray during diagnostic hysteroscopy does not minimize the discomfort and pain of the patients and therefore should not be applied.

  15. a randomized, placebo- controlled study

    OpenAIRE

    Hall, Franziska van

    2012-01-01

    Introduction: Repetitive transcranial magnetic stimulation (rTMS) is a well-tolerated non-invasive method, which has also been proved to have mild antidepressant effects and is used as “add-on“-therapy in treating pharmaco-resistant major depression. Objective: The efficacy of an escitalopram plus rTMS-combination-treatment was evaluated and compared to escitalopram plus sham rTMS. Methods: We designed a four week-, randomized, rater-blinded, and controlled add-on study with two trea...

  16. Multivariate assessment of cervical invasion of endometrial carcinoma. Comparison of transvaginal ultrasonography, hysteroscopy, and magnetic resonance imaging

    Energy Technology Data Exchange (ETDEWEB)

    Miyagi, Yasunari; Yamada, Shinako; Miyagi, Yuji [Okayama Univ. (Japan). School of Medicine] [and others

    1997-07-01

    From 1991 to 1995, 71 patients with endometrial cancer at Okayama University Medical School underwent transvaginal ultrasonography with a 6.5-MHz transducer, MRI at 1.5 T, and hysteroscopy using a rigid hysteroscope. The findings of these examinations were compared against pathologic results. The sensitivity/specificity/accuracy were 0.73/0.89/0.86 for transvaginal ultrasonography, 0.73/0.88/0.85 for MRI, and 0.73/0.80/0.79 for hysteroscopy. The coefficient values for transvaginal ultrasonography/MRI/hysteroscopy were 0.69/0.62/-0.21 and 1.99/1.89/0.79 in quantification theory second family analysis and logistic regression, respectively. Misdiagnosed cases had the following factors: large tumor volume; tumor near the internal os; tumor descending from the uterine cavity; polypoid tumor in the endocervix; artifacts due to the use of a cervix dilator made from stems of the seaweed Laminaria japonica; endocervical glandular involvement only; and atypical signals on MRI. For the preoperative assessment of cervical invasion, transvaginal ultrasonography and MRI were the most reliable. Hysteroscopy was least reliable, because of a large number of false-positive results. The use of these examinations in combination, especially transvaginal ultrasonography and MRI, would be of great value in surgical planning for endometrial cancer, considering the factors responsible for misdiagnosis. (K.H.)

  17. Three-dimensional ultrasound versus office hysteroscopy in assessment of pain and bleeding with intrauterine contraceptive device

    Directory of Open Access Journals (Sweden)

    Mona M. Aboulghar

    2011-06-01

    Conclusions: Patients with abnormal bleeding and pain with IUCD have frequent abnormally positioned IUCD and associated ovarian pathology. 3D US has high diagnostic accuracy and should be the first line of investigation. Office hysteroscopy should be performed only in suspected embedded IUCD or other endometrial abnormality.

  18. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  19. Avaliação da dor em histeroscopia ambulatorial: comparação entre duas técnicas Pain evaluation in office hysteroscopy: comparison of two techniques

    Directory of Open Access Journals (Sweden)

    Daniela Barreto Fraguglia Quental Diniz

    2010-01-01

    Full Text Available OBJETIVO: comparar a dor referida pelas pacientes submetidas à histeroscopia pela técnica convencional com gás carbônico (CO2 e a vaginohisteroscopia com soro fisiológico (SF 0,9%. MÉTODOS: estudo prospectivo de coorte, realizado em um serviço de histeroscopia ambulatorial. Foram incluídas 117 pacientes com indicação para realizarem o exame, alocadas aleatoriamente em dois grupos. Todas responderam a um questionário epidemiológico e quantificaram a dor esperada antes do exame e sentida após seu término em uma escala verbal de dor de 0 a 10. Para a técnica convencional, foram utilizados espéculo, tração do colo, inserção de ótica de 30º e camisa diagnóstica com diâmetro total 5 mm. A cavidade foi distendida com CO2 sob pressão de 100 mmHg controlada por histeroinsuflador e a biópsia realizada com cureta de Novak. A vaginoscopia foi realizada sem toque, por distensão da vagina com líquido, visualização direta do colo e introdução de ótica com duas camisas de fluxo contínuo com canal acessório de perfil ovalado, totalizando também 5 mm de diâmetro para o conjunto. Foi utilizado SF 0,9% como meio de distensão e a pressão, definida como a necessária para adequada visualização do canal e da cavidade com pressurizador pneumático externo. A biópsia foi realizada de forma dirigida com pinça endoscópica. Foram calculados média e desvio padrão para as variáveis quantitativas e frequência para as qualitativas. O teste t de Student foi utilizado para comparar médias e o teste do qui-quadrado ou exato de Fischer (quando nPURPOSE: to compare the pain reported by patients submitted to hysteroscopy by the standard technique with carbon dioxide (CO2 and to vaginal hysteroscopy with physiological saline (0.9% NaCl. METHODS: this was a prospective cohort study conducted at an ambulatory hysteroscopy service. A total of 117 patients with indication for the exam were included, being randomly assigned to one of the

  20. Ear acupoint detection before and after hysteroscopy: is it possible to clarify the representation of the uterus on the outer ear?

    Science.gov (United States)

    Romoli, Marco; Allais, Gianni; Bellu, Daniela; De Ramundo, Biagina; Gabellari, Ilaria Castagnoli; Giommi, Andrea; Benedetto, Chiara

    2010-12-01

    In the auricular maps introduced over the past 50 years by the French and Chinese schools, most organs and systems overlap consistently. One exception is the reproductive system, which shows a markedly different somatotopic representation-for example, for the uterus and the ovary. To identify the distribution of points with increased tenderness to pressure or with reduced electrical resistance, on the outer ear of a group of women undergoing hysteroscopy. For diagnostic purposes the auricles of 78 women were examined before and after hysteroscopy using a pain-pressure test and electrical skin resistance test. The points identified were transcribed onto a graphic system called Sectogram. Spatial cluster analysis was used to identify the statistically significant clusters of sectors with a higher concentration of points appearing after hysteroscopy. The points identified after hysteroscopy tend to be concentrated in specific areas not previously recognised and which only partially overlap with the French and Chinese representation of the uterus. When auricular acupuncture is applied to reduce discomfort during hysteroscopy, particular attention must be paid when choosing the points/areas to be stimulated, which are not only those indicated in the Chinese or French maps.

  1. [Evaluation of postmenopausal uterine bleeding by endometrial biopsy in-office hysteroscopy vs endometrial biopsy with manual vacuum aspiration in the office. Preliminary report].

    Science.gov (United States)

    Hernández, José Arias; Franco, María Eugenia Lozano; Mendizábal, David Pablo Bulnes; Broca, Yrma Bocanegra; Escoto, Adrián Fores

    2009-11-01

    To compare endometrial biopsy by hysteroscopy vs manual endouterine aspiration in office, in patients of Climateric Clinic from Hospital Regional de Alta Especialidad de la Mujer Tabasco, with postmenopausal uterine bleeding. There were included patients that come from October 30 2007 to December 20 2008 to Climateric Clinic, with abnormal uterine bleeding and without hormonal replacement therapy. There were taken biopsy by hysteroscopy and AMEU. The histopathology results were compared. A total of 25 women were evaluated. The average age was 53 years (+/- 5.6). The delivery average was 3 births (+/- 1). We found polyps in 9 (37%) patients, endometrial atrophy in 3 (13%), cystic hyperplasia in 2 (8%), proliferative endometrium in 4 (17%), submucous myomas in 5 (21%) and neoplasia in 1 (4%). The correlation between endometrial biopsy by hysteroscopy and AMEU was 100% for endometrial atrophy, cystic hyperplasia, proliferativo endometrium and neoplasia. There was not correlation between manual endouterine aspiration and endometrial biopsy by hysteroscopy for polyps and submucous myomas. We didn't have complications during the procedures. Hysteroscopic endometrial biopsy seems to have the same histopathology results than AMEU for endometrial atrophy, cystic hyperplasia, proliferative endometrium and neoplasia, not for miomas and polyps. Hysteroscopy can give us the possibility to see miomas and polyps and treat surgical pathology at the same moment almost in all cases.

  2. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial

    OpenAIRE

    Jack, Darby W.; Asante, Kwaku Poku; Blair J. Wylie; Chillrud, Steve N.; Whyatt, Robin M.; Ae-Ngibise, Kenneth A.; Quinn, Ashlinn K.; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-01-01

    Background: Household air pollution exposure is a major health risk, but validated interventions remain elusive. Methods/Design The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed seve...

  3. Mendelian randomization studies in coronary artery disease.

    Science.gov (United States)

    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

  4. Randomized study of zinc supplementation during pregnancy

    Energy Technology Data Exchange (ETDEWEB)

    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.

  5. Three-month treatment with triptorelin, letrozole and ulipristal acetate before hysteroscopic resection of uterine myomas: prospective comparative pilot study.

    Science.gov (United States)

    Bizzarri, Nicolò; Ghirardi, Valentina; Remorgida, Valentino; Venturini, Pier Luigi; Ferrero, Simone

    2015-09-01

    To compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas. Single center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35 mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75 mg every 28 days; group T; n=20), letrozole (2.5 mg/day; group L; n=11) or ulipristal acetate (5 mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas. All medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005). Preoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  6. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  7. Randomized controlled study of CBT in bronchial asthma

    OpenAIRE

    Grover Naveen; D′Souza G; Thennarasu K; Kumaraiah V

    2007-01-01

    The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured...

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

    African Journals Online (AJOL)

    A Prospective Randomized Clinical Study of the Influence of Primary Closure or Dressing on. Post‑operative Morbidity after Mandibular Third. Molar Surgery. Peter E Egbor, Birch ... third molar surgery. Materials and Methods: This was a randomized clinical .... three sided buccal mucoperiosteal flap was made and reflected.

  9. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

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

  10. A Randomized Controlled Trial Study on the Effect of Adding ...

    African Journals Online (AJOL)

    A Randomized Controlled Trial Study on the Effect of Adding Dexmedetomidine to Bupivacaine in Supraclavicular Block Using Ultrasound Guidance. ... BACKGROUND: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study ...

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

    African Journals Online (AJOL)

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

  12. A Monte Carlo study of adsorption of random copolymers on random surfaces

    CERN Document Server

    Moghaddam, M S

    2003-01-01

    We study the adsorption problem of a random copolymer on a random surface in which a self-avoiding walk in three dimensions interacts with a plane defining a half-space to which the walk is confined. Each vertex of the walk is randomly labelled A with probability p sub p or B with probability 1 - p sub p , and only vertices labelled A are attracted to the surface plane. Each lattice site on the plane is also labelled either A with probability p sub s or B with probability 1 - p sub s , and only lattice sites labelled A interact with the walk. We study two variations of this model: in the first case the A-vertices of the walk interact only with the A-sites on the surface. In the second case the constraint of selective binding is removed; that is, any contact between the walk and the surface that involves an A-labelling, either from the surface or from the walk, is counted as a visit to the surface. The system is quenched in both cases, i.e. the labellings of the walk and of the surface are fixed as thermodynam...

  13. Randomized controlled study of CBT in bronchial asthma

    Directory of Open Access Journals (Sweden)

    Grover Naveen

    2007-01-01

    Full Text Available The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured interview schedule, Asthma Symptom Checklist, Asthma di-ary, Asthma Bother Profile, Hospital Anxiety & Depression Scale, AQLQ and Peak Expiratory Flow Rate. Within group comparison showed significant improvement in both groups at the post assessment. Between group comparisons showed that CBT group reported significantly greater change than that of SM group. Cognitive behavior therapy helps in improving the managment of asthma.

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

    Science.gov (United States)

    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…

  15. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... KEYWORDS: Duodenum, dyspepsia, Helicobacter pylori, gastritis, stomach. A Prospective, Randomized Study Comparing 7-day and 14-day. Quadruple Therapies as First-line Treatments for Helicobacter pylori. Infection in Patients with Functional Dyspepsia. A Yağbasan, DÖ Coşkun1, Ö Özbakir2, ...

  16. Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities

    NARCIS (Netherlands)

    Bosteels, Jan; Kasius, Jenneke; Weyers, Steven; Broekmans, Frank J.; Mol, Ben W illem J; D'Hooghe, Thomas M.

    2015-01-01

    BACKGROUND: Observational studies suggest higher pregnancy rates after the hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum or intrauterine adhesions, which are detectable in 10% to 15% of women seeking treatment for subfertility. OBJECTIVES: To assess the effects of

  17. Impact of preprocedural anxiety levels on pain perception in patients undergoing office hysteroscopy

    Directory of Open Access Journals (Sweden)

    Mahmut Kuntay Kokanali

    2014-09-01

    Conclusion: The pain that study participants felt during and soon after OH was negatively affected by preprocedural anxiety levels. Some factors, such as reducing the waiting time before the procedure, might be useful in reducing anxiety levels.

  18. Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities

    NARCIS (Netherlands)

    Bosteels, Jan; Kasius, Jenneke; Weyers, Steven; Broekmans, Frank J.; Mol, Ben Willem J.; D'Hooghe, Thomas M.

    2013-01-01

    Background Observational studies suggest higher pregnancy rates after the hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum or intrauterine adhesions, which are detectable in 10% to 15% of women seeking treatment for subfertility. Objectives To assess the effects of the

  19. Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities

    NARCIS (Netherlands)

    Bosteels, Jan; Kasius, Jenneke; Weyers, Steven; Broekmans, Frank J.; Mol, Ben Willem J.; D'Hooghe, Thomas M.

    2015-01-01

    Background Observational studies suggest higher pregnancy rates after the hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum or intrauterine adhesions, which are detectable in 10% to 15% of women seeking treatment for subfertility. Objectives To assess the effects of the

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

    Science.gov (United States)

    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. © 2015 The authors.

  1. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke

    2014-01-01

    Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play an impor...... evaluation. Choice of patient-important outcomes and sufficient sample sizes are crucial issues in planning RCTs to demonstrate the clinical benefit of using PET.......Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome...

  2. Acupuncture in alcoholism treatment: a randomized out-patient study.

    Science.gov (United States)

    Sapir-Weise, R; Berglund, M; Frank, A; Kristenson, H

    1999-01-01

    Seventy-two alcoholics were treated with acupuncture to the ear in a randomized single-blind controlled design over 10 weeks. Orthodox points and incorrect points 3-5 mm from orthodox points were used. No initial differences were found regarding social characteristics, the responses to the Swedish version of the Alcohol Use Inventory and the Three-dimensional Personality Questionnaire, indicating a successful randomization. There were non-significant tendencies towards gender differential response after acupuncture treatment (P = 0.07). There was no difference in the number of drinking days or level of craving between treatment and control patients. Among females, those in the treatment group reported reduction of anxiety after 1 month, more often than those in the control group (P < 0.05). Response to acupuncture was not related to personality or drinking pattern. Patients' experience of needle placement was similar in the study and control groups. The effects of acupuncture were less pronounced than those previously reported.

  3. Empirical evidence of study design biases in randomized trials

    DEFF Research Database (Denmark)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma

    2016-01-01

    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 ...) 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...

  4. Alcohol consumption and cognitive performance: a Mendelian randomization study.

    Science.gov (United States)

    Kumari, Meena; Holmes, Michael V; Dale, Caroline E; Hubacek, Jaroslav A; Palmer, Tom M; Pikhart, Hynek; Peasey, Anne; Britton, Annie; Horvat, Pia; Kubinova, Ruzena; Malyutina, Sofia; Pajak, Andrzej; Tamosiunas, Abdonas; Shankar, Aparna; Singh-Manoux, Archana; Voevoda, Mikhail; Kivimaki, Mika; Hingorani, Aroon D; Marmot, Michael G; Casas, Juan P; Bobak, Martin

    2014-09-01

    To use Mendelian randomization to assess whether alcohol intake was causally associated with cognitive function. Mendelian randomization using a genetic variant related to alcohol intake (ADH1B rs1229984) was used to obtain unbiased estimates of the association between alcohol intake and cognitive performance. Europe. More than 34 000 adults. Any versus no alcohol intake and units of intake in the previous week was measured by questionnaire. Cognitive function was assessed in terms of immediate and delayed word recall, verbal fluency and processing speed. Having consumed any versus no alcohol was associated with higher scores by 0.17 standard deviations (SD) [95% confidence interval (CI) = 0.15, 0.20] for immediate recall, 0.17 SD (95% CI = 0.14, 0.19) for delayed recall, 0.17 SD (95% CI = 0.14, 0.19) for verbal fluency and 0.12 SD (95% CI = 0.09, 0.15) for processing speed. The minor allele of rs1229984 was associated with reduced odds of consuming any alcohol (odds ratio = 0.87; 95% CI = 0.80, 0.95; P = 0.001; R(2)  = 0.1%; F-statistic = 47). In Mendelian randomization analysis, the minor allele was not associated with any cognitive test score, and instrumental variable analysis suggested no causal association between alcohol consumption and cognition: -0.74 SD (95% CI = -1.88, 0.41) for immediate recall, -1.09 SD (95% CI = -2.38, 0.21) for delayed recall, -0.63 SD (95% CI = -1.78, 0.53) for verbal fluency and -0.16 SD (95% CI = -1.29, 0.97) for processing speed. The Mendelian randomization analysis did not provide strong evidence of a causal association between alcohol consumption and cognitive ability. © 2014 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  5. Cognitive training in Alzheimer's disease: a controlled randomized study.

    Science.gov (United States)

    Giovagnoli, A R; Manfredi, V; Parente, A; Schifano, L; Oliveri, S; Avanzini, G

    2017-08-01

    This controlled randomized single-blind study evaluated the effects of cognitive training (CT), compared to active music therapy (AMT) and neuroeducation (NE), on initiative in patients with mild to moderate Alzheimer's disease (AD). Secondarily, we explored the effects of CT on episodic memory, mood, and social relationships. Thirty-nine AD patients were randomly assigned to CT, AMT, or NE. Each treatment lasted 3 months. Before, at the end, and 3 months after treatment, neuropsychological tests and self-rated scales assessed initiative, episodic memory, depression, anxiety, and social relationships. At the end of the CT, initiative significantly improved, whereas, at the end of AMT and NE, it was unchanged. Episodic memory showed no changes at the end of CT or AMT and a worsening after NE. The rates of the patients with clinically significant improvement of initiative were greater after CT (about 62%) than after AMT (about 8%) or NE (none). At the 3-month follow-up, initiative and episodic memory declined in all patients. Mood and social relationships improved in the three groups, with greater changes after AMT or NE. In patients with mild to moderate AD, CT can improve initiative and stabilize memory, while the non-cognitive treatments can ameliorate the psychosocial aspects. The combining of CT and non-cognitive treatments may have useful clinical implications.

  6. Early rehabilitation of cancer patients - a randomized controlled intervention study.

    Science.gov (United States)

    Arving, Cecilia; Thormodsen, Inger; Brekke, Guri; Mella, Olav; Berntsen, Sveinung; Nordin, Karin

    2013-01-07

    Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. Patients (≥ 18 years) with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis. This RCT

  7. Cystatin C and Cardiovascular Disease: A Mendelian Randomization Study.

    Science.gov (United States)

    van der Laan, Sander W; Fall, Tove; Soumaré, Aicha; Teumer, Alexander; Sedaghat, Sanaz; Baumert, Jens; Zabaneh, Delilah; van Setten, Jessica; Isgum, Ivana; Galesloot, Tessel E; Arpegård, Johannes; Amouyel, Philippe; Trompet, Stella; Waldenberger, Melanie; Dörr, Marcus; Magnusson, Patrik K; Giedraitis, Vilmantas; Larsson, Anders; Morris, Andrew P; Felix, Janine F; Morrison, Alanna C; Franceschini, Nora; Bis, Joshua C; Kavousi, Maryam; O'Donnell, Christopher; Drenos, Fotios; Tragante, Vinicius; Munroe, Patricia B; Malik, Rainer; Dichgans, Martin; Worrall, Bradford B; Erdmann, Jeanette; Nelson, Christopher P; Samani, Nilesh J; Schunkert, Heribert; Marchini, Jonathan; Patel, Riyaz S; Hingorani, Aroon D; Lind, Lars; Pedersen, Nancy L; de Graaf, Jacqueline; Kiemeney, Lambertus A L M; Baumeister, Sebastian E; Franco, Oscar H; Hofman, Albert; Uitterlinden, André G; Koenig, Wolfgang; Meisinger, Christa; Peters, Annette; Thorand, Barbara; Jukema, J Wouter; Eriksen, Bjørn Odvar; Toft, Ingrid; Wilsgaard, Tom; Onland-Moret, N Charlotte; van der Schouw, Yvonne T; Debette, Stéphanie; Kumari, Meena; Svensson, Per; van der Harst, Pim; Kivimaki, Mika; Keating, Brendan J; Sattar, Naveed; Dehghan, Abbas; Reiner, Alex P; Ingelsson, Erik; den Ruijter, Hester M; de Bakker, Paul I W; Pasterkamp, Gerard; Ärnlöv, Johan; Holmes, Michael V; Asselbergs, Folkert W

    2016-08-30

    Epidemiological studies show that high circulating cystatin C is associated with risk of cardiovascular disease (CVD), independent of creatinine-based renal function measurements. It is unclear whether this relationship is causal, arises from residual confounding, and/or is a consequence of reverse causation. The aim of this study was to use Mendelian randomization to investigate whether cystatin C is causally related to CVD in the general population. We incorporated participant data from 16 prospective cohorts (n = 76,481) with 37,126 measures of cystatin C and added genetic data from 43 studies (n = 252,216) with 63,292 CVD events. We used the common variant rs911119 in CST3 as an instrumental variable to investigate the causal role of cystatin C in CVD, including coronary heart disease, ischemic stroke, and heart failure. Cystatin C concentrations were associated with CVD risk after adjusting for age, sex, and traditional risk factors (relative risk: 1.82 per doubling of cystatin C; 95% confidence interval [CI]: 1.56 to 2.13; p = 2.12 × 10(-14)). The minor allele of rs911119 was associated with decreased serum cystatin C (6.13% per allele; 95% CI: 5.75 to 6.50; p = 5.95 × 10(-211)), explaining 2.8% of the observed variation in cystatin C. Mendelian randomization analysis did not provide evidence for a causal role of cystatin C, with a causal relative risk for CVD of 1.00 per doubling cystatin C (95% CI: 0.82 to 1.22; p = 0.994), which was statistically different from the observational estimate (p = 1.6 × 10(-5)). A causal effect of cystatin C was not detected for any individual component of CVD. Mendelian randomization analyses did not support a causal role of cystatin C in the etiology of CVD. As such, therapeutics targeted at lowering circulating cystatin C are unlikely to be effective in preventing CVD. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Mental practice enhances surgical technical skills: a randomized controlled study.

    Science.gov (United States)

    Arora, Sonal; Aggarwal, Rajesh; Sirimanna, Pramudith; Moran, Aidan; Grantcharov, Teodor; Kneebone, Roger; Sevdalis, Nick; Darzi, Ara

    2011-02-01

    To assess the effects of mental practice on surgical performance. Increasing concerns for patient safety have highlighted a need for alternative training strategies outside the operating room. Mental practice (MP), "the cognitive rehearsal of a task before performance," has been successful in sport and music to enhance skill. This study investigates whether MP enhances performance in laparoscopic surgery. After baseline skills testing, 20 novice surgeons underwent training on an evidence-based virtual reality curriculum. After randomization using the closed envelope technique, all participants performed 5 Virtual Reality (VR) laparoscopic cholecystectomies (LC). Mental practice participants performed 30 minutes of MP before each LC; control participants viewed an online lecture. Technical performance was assessed using video Objective Structured Assessment of Technical Skills-based global ratings scale (scored from 7 to 35). Mental imagery was assessed using a previously validated Mental Imagery Questionnaire. Eighteen participants completed the study. There were no intergroup differences in baseline technical ability. Learning curves were demonstrated for both MP and control groups. Mental practice was superior to control (global ratings) for the first LC (median 20 vs 15, P = 0.005), second LC (20.5 vs 13.5, P = 0.001), third LC (24 vs 15.5, P imagery for the MP group was also significantly superior to the control group across all sessions (P imagery significantly correlated with better quality of performance (ρ 0.51–0.62, Ps < 0.05). This is the first randomized controlled study to show that MP enhances the quality of performance based on VR laparoscopic cholecystectomy. This may be a time- and cost-effective strategy to augment traditional training in the OR thus potentially improving patient care.

  9. Humans cannot consciously generate random numbers sequences: Polemic study.

    Science.gov (United States)

    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.

  10. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  11. Yoga in Correctional Settings: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Nóra Kerekes

    2017-10-01

    Full Text Available BackgroundThe effect of yoga in the reduction of depressive symptoms, anxiety, stress, anger as well as in the increased ability of behavioral control has been shown. These effects of yoga are highly relevant for prison inmates who often have poor mental health and low impulse control. While it has been shown that yoga and meditation can be effective in improving subjective well-being, mental health, and executive functioning within prison populations, only a limited number of studies have proved this, using randomized controlled settings.MethodsA total of 152 participants from nine Swedish correctional facilities were randomly assigned to a 10-week yoga group (one class a week; N = 77 or a control group (N = 75. Before and after the intervention period, participants answered questionnaires measuring stress, aggression, affective states, sleep quality, and psychological well-being and completed a computerized test measuring attention and impulsivity.ResultsAfter the intervention period, significant improvements were found on 13 of the 16 variables within the yoga group (e.g., less perceived stress, better sleep quality, an increased psychological and emotional well-being, less aggressive, and antisocial behavior and on two within the control group. Compared to the control group, yoga class participants reported significantly improved emotional well-being and less antisocial behavior after 10 weeks of yoga. They also showed improved performance on the computerized test that measures attention and impulse control.ConclusionIt can be concluded that the yoga practiced in Swedish correctional facilities has positive effects on inmates’ well-being and on considerable risk factors associated with recidivism, such as impulsivity and antisocial behavior. Accordingly, the results show that yoga practice can play an important part in the rehabilitation of prison inmates.

  12. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    Science.gov (United States)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  13. A randomized pilot study of naturopathic medicine in multiple sclerosis.

    Science.gov (United States)

    Shinto, Lynne; Calabrese, Carlo; Morris, Cynthia; Yadav, Vijayshree; Griffith, Debbie; Frank, Rachel; Oken, Barry S; Baldauf-Wagner, Sara; Bourdette, Dennis

    2008-06-01

    Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. To assess quality of life in MS subjects who received interventions designed to "model" the "whole practice" of naturopathy. A pilot, randomized, controlled study with a 6-month intervention period. Participants who met criteria for clinically definite MS. The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.

  14. The Analysis of Random Effects in Modeling Studies.

    Science.gov (United States)

    Scheirer, C. James; Geller, Sanford E.

    1979-01-01

    Argues that in research on the effects of modeling, models must be analyzed as a random factor in order to avoid a positive bias in the results. The concept of a random factor is discussed, worked examples are provided, and a practical solution to the problem is proposed. (JMB)

  15. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-10-15

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

  16. Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial.

    Science.gov (United States)

    Avis, Nancy E; Coeytaux, Remy R; Isom, Scott; Prevette, Kristen; Morgan, Timothy

    2016-06-01

    The aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. A total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. The VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P acupuncture group was 29.4% (P acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. We found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.

  17. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  18. Music and preoperative anxiety: a randomized, controlled study.

    Science.gov (United States)

    Wang, Shu-Ming; Kulkarni, Lina; Dolev, Jackqulin; Kain, Zeev N

    2002-06-01

    Music may decrease the anxiety experienced by patients before surgery. Previous studies of this issue were hindered with multiple methodological problems. In this investigation, we examined this hypothesis while using a rigorous study design and objective outcome measures. Adult patients undergoing anesthesia and surgery were randomly assigned to two study groups. Subjects in Group 1 (n = 48) listened to a 30-min patient-selected music session, and subjects in Group 2 (n = 45) received no intervention. By using self-report validated behavioral (State-Trait Anxiety Inventory) and physiological measures of anxiety (heart rate, blood pressure, and electrodermal activity and serum cortisol, epinephrine, and norepinephrine), patients were evaluated before, during, and after administration of the intervention. We found that after intervention, subjects in the Music group reported significantly lower anxiety levels as compared with the Control group (F(1,91) = 15.4, P = 0.001). That is, the postintervention anxiety level of subjects in the Music group decreased by 16% as compared with the preintervention level, whereas the anxiety level of the Control group did not change significantly. Two-way repeated-measures analysis of variance performed for the electrodermal activity, blood pressure, heart rate, cortisol, and catecholamine data demonstrated no group difference and no time x group interaction (P = not significant). In conclusion, under the conditions of this study, patients who listened to music before surgery reported lower levels of state anxiety. Physiological outcomes did not differ, however, between the two study groups. Patients who listen to music of their choice during the preoperative period report less anxiety.

  19. A randomized, prospective study of adjunctive Ampicillin in preterm labor

    Directory of Open Access Journals (Sweden)

    Tehranian A

    1999-09-01

    Full Text Available Acute amniotic fluid infection has emerged as a possible cause of many heretofore unexplained preterm births. Our purpose was to determine the effect of ampicillin in the prolongation of pregnancies receiving tocolysis for preterm labor. A blinded, placebo-controlled, randomized trial was conducted to study ampicillin in women hospitalized for preterm labor between 24 and 37 weeks' gestation. A total of 60 patients with intact membranes and without chorioamnionitis who were receiving magnesium sulfate were screened. Thirty women with preterm labor received ampicillin, and 30 received placebos. The primary end point was prolongation of gestation. There was no difference in age of delivery (37.6±9.7 days vs 36.08±3.9 days, P=0.085 and no difference in retardation of delivery (4.7±3.1 vs 4.1±2.1, P=0.39. The mean degree of preterm delivery were 0.62±1.93 and 1.8±3.3 weeks in ampicillin and placebo groups, respectively (not significant, P>0.1. Conclusions: Ampicillin had no effect on interval to delivery or duration of pregnancy in women treated for preterm labor. So rotine clinical use of ampicillin during tocolysis should not be recommended.

  20. TVT versus TOT, 2-year prospective randomized study.

    Science.gov (United States)

    Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

    2013-06-01

    To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

  1. Robotic telementoring/telesurgical system and randomized evaluation study.

    Science.gov (United States)

    Patriciu, Alexandru; Challacombe, Benjamin; Dasgupta, Prokar; Kavoussi, Louis; Stoianovici, Dan

    2005-01-01

    The paper presents a new telementoring system incorporating audio-video communication and remote robotic control. The system was developed around an off the shelf ISDN video conferencing system enhanced with video annotation and remote robot control features. The user can remotely control a robot of perform needle alignment and insertion in a Percutaneous access procedure. Particular attention was devoted to ensure the safety of the procedure. The data connection is continuously monitored and in the event of a failure the robot control is switched to the local operator. Two series of randomized trials were performed between Baltimore and London. The accuracy and procedure time were evaluated for manual needle placement, local robotic needle placement and remotely controlled robotic needle placement. The test showed that while the procedure time is not improved by the robotic approach there is an improvement in the accuracy of the procedure. The study showed also that there is no significant difference between the locally controlled robotic needled placement and the remotely controlled robotic needle placement. Thus, the proposed system can be safely used for remote robotic percutaneous access procedures.

  2. Retromolar laryngoscopy: a randomized crossover vocal cords visualization study.

    Science.gov (United States)

    Reiterer, Christian; Waltl, Barbara; Kabon, Barbara; Schramm, Wolfgang

    2017-08-01

    Vocal cords visualization is a major determinant for successful tracheal intubation. The aim of our study was to compare vocal cord visualization by using conventional direct laryngoscopy with retromolar direct laryngoscopy in patients with an existing retromolar gap at the right mandible. We enrolled 100 adults needing endotracheal intubation for elective surgery. In each patient, the vocal cords were visualized and scored according to Cormack and Lehane with a Macintosh blade #3 for conventional technique and with a Miller blade #4 for the retromolar technique in a randomized sequence. Finally, tracheal intubation was performed primarily by conventional laryngoscopy and in the case of failing retromolar laryngoscopy was used as the rescue method. Overall 100 laryngoscopies with the conventional method and 100 laryngoscopies with the retromolar method were scored according to Cormack and Lehane. The retromolar technique achieved significant (P=0.000003) lower Cormack and Lehane scores compared to the conventional technique. In eleven patients, intubation by conventional laryngoscopy failed and seven of those patients were successfully intubated by the retromolar technique. A BURP-maneuver significantly improved vocal cord visualization during both methods. In summary, laryngoscopy via the retromolar method by using a Miller blade #4 lead to a significantly better vocal cord visualization compared to the conventional method performed with a Macintosh blade #3 in patients with an existing retromolar gap on the right side.

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

    Science.gov (United States)

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

    2016-04-20

    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.

  4. The Statistical Power of the Cluster Randomized Block Design with Matched Pairs--A Simulation Study

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark

    2010-01-01

    This study uses simulation techniques to examine the statistical power of the group- randomized design and the matched-pair (MP) randomized block design under various parameter combinations. Both nearest neighbor matching and random matching are used for the MP design. The power of each design for any parameter combination was calculated from…

  5. Perspectives on randomization and readiness for change in a workplace intervention study

    DEFF Research Database (Denmark)

    Nabe-Nielsen, Kirsten; Persson, Roger; Nielsen, Karina

    2015-01-01

    Randomization is often recommended above self-selection when allocating participants into intervention or control groups. One source of confounding in non-randomized studies is the participants’ attitudes towards the intervention. Because randomized workplace interventions are not always feasible...... refl ect the local leaders’ rather than the employees’ readiness for changes and that randomization may infl uence the participants’ attitude towards the intervention perhaps by evoking an experience of ‘winning or losing in the lottery’....

  6. Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome : A prospective randomized and non randomized study

    NARCIS (Netherlands)

    Schultz, WCMW; Gianotten, WL; vanderMeijden, WI; vandeWiel, HBM; Blindeman, L; Chadha, S; Drogendijk, AC

    This article describes the outcome of a behavioral approach with or without preceding surgical intervention in 48 women with the vulvar vestibulitis syndrome. In the first part of the study, 14 women with the vulvar vestibulitis syndrome were randomly assigned to one of two treatment programs:

  7. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  8. Cannabis use and risk of schizophrenia: a Mendelian randomization study.

    Science.gov (United States)

    Vaucher, J; Keating, B J; Lasserre, A M; Gan, W; Lyall, D M; Ward, J; Smith, D J; Pell, J P; Sattar, N; Paré, G; Holmes, M V

    2017-01-24

    Cannabis use is observationally associated with an increased risk of schizophrenia, but whether the relationship is causal is not known. Using a genetic approach, we took 10 independent genetic variants previously identified to associate with cannabis use in 32 330 individuals to determine the nature of the association between cannabis use and risk of schizophrenia. Genetic variants were employed as instruments to recapitulate a randomized controlled trial involving two groups (cannabis users vs nonusers) to estimate the causal effect of cannabis use on risk of schizophrenia in 34 241 cases and 45 604 controls from predominantly European descent. Genetically-derived estimates were compared with a meta-analysis of observational studies reporting ever use of cannabis and risk of schizophrenia or related disorders. Based on the genetic approach, use of cannabis was associated with increased risk of schizophrenia (odds ratio (OR) of schizophrenia for users vs nonusers of cannabis: 1.37; 95% confidence interval (CI), 1.09-1.67; P-value=0.007). The corresponding estimate from observational analysis was 1.43 (95% CI, 1.19-1.67; P-value for heterogeneity =0.76). The genetic markers did not show evidence of pleiotropic effects and accounting for tobacco exposure did not alter the association (OR of schizophrenia for users vs nonusers of cannabis, adjusted for ever vs never smoker: 1.41; 95% CI, 1.09-1.83). This adds to the substantial evidence base that has previously identified cannabis use to associate with increased risk of schizophrenia, by suggesting that the relationship is causal. Such robust evidence may inform public health messages about cannabis use, especially regarding its potential mental health consequences.Molecular Psychiatry advance online publication, 24 January 2017; doi:10.1038/mp.2016.252.

  9. Traditional acupuncture in migraine: a controlled, randomized study.

    Science.gov (United States)

    Facco, Enrico; Liguori, Aldo; Petti, Filomena; Zanette, Gastone; Coluzzi, Flaminia; De Nardin, Marco; Mattia, Consalvo

    2008-03-01

    To check the effectiveness of a true acupuncture treatment according to traditional Chinese medicine (TCM) in migraine without aura, comparing it to a standard mock acupuncture protocol, an accurate mock acupuncture healing ritual, and untreated controls. Migraine prevalence is high and affects a relevant rate of adults in the productive phase of their life. Acupuncture has been increasingly advocated and used in Western countries for migraine treatment, but the evidence of its effectiveness still remains weak. A large variability of treatments is present in published studies and no acupoint selection according to TCM has been investigated so far; therefore, the low level of evidence of acupuncture effectiveness might partly depend on inappropriate treatment. A prospective, randomized, controlled study was performed in 160 patients suffering from migraine without aura, assessed according to the ICD-10 classification. The patients were divided into the following 4 groups: (1) group TA, treated with true acupuncture (according to TCM) plus Rizatriptan; (2) group RMA, treated with ritualized mock acupuncture plus Rizatriptan; (3) group SMA, treated with standard mock acupuncture plus Rizatriptan; (4) group R, without prophylactic treatment with relief therapy only (Rizatriptan). The MIDAS Questionnaire was administered before treatment (T0), at 3 (T1) and 6 months (T2) from the beginning of treatment, and the MIDAS Index (MI) was calculated. Rizatriptan intake was also checked in all groups of patients at T0, T1, and T2. Group TA and RMA were evaluated according to TCM as well; then, the former was submitted to true acupuncture and the latter to mock acupuncture treatment resembling the same as TA. The statistical analysis was conducted with factorial ANOVA and multiple tests with a Bonferroni adjustment. A total of 127 patients completed the study (33 dropouts): 32 belonged to group TA, 30 to group RMA, 31 to group SMA, and 34 to group R. Before treatment the MI (T(0

  10. Randomized Controlled Studies and Alternative Designs in Outcome Studies: Challenges and Opportunities

    Science.gov (United States)

    Shadish, William R.

    2011-01-01

    This article reviews several decades of the author's meta-analytic and experimental research on the conditions under which nonrandomized experiments can approximate the results from randomized experiments (REs). Several studies make clear that we can expect accurate effect estimates from the regression discontinuity design, though its statistical…

  11. Study on genetic variability of Cassidula aurisfelis (snail) by random ...

    African Journals Online (AJOL)

    The genetic variability among individuals of Cassidula aurisfelis from Setiu Wetland, Terengganu Darul Iman was examined by using the random amplified polymorphic DNA (RAPD) technique. Ten oligonucleotide primers were screened and three primers were selected (OPA 02, OPA 04 and OPA 10) to amplify DNA from ...

  12. Randomized, Controlled Study of Adderall XR in ADHD

    OpenAIRE

    J Gordon Millichap

    2002-01-01

    The efficacy and safety of Adderall XR in the treatment of attention deficit/hyperactivity disorder and diurnal variation in responses were assessed by a multicenter, randomized, double-blind, parallel group, placebo-controlled trial at 47 sites, and reported from the Massachusetts General Hospital, Boston, MA.

  13. Randomized, Controlled Study of Adderall XR in ADHD

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2002-08-01

    Full Text Available The efficacy and safety of Adderall XR in the treatment of attention deficit/hyperactivity disorder and diurnal variation in responses were assessed by a multicenter, randomized, double-blind, parallel group, placebo-controlled trial at 47 sites, and reported from the Massachusetts General Hospital, Boston, MA.

  14. Study on genetic variability of Cassidula aurisfelis (snail) by random ...

    African Journals Online (AJOL)

    PRECIOUS

    2009-11-16

    Nov 16, 2009 ... genetic variability is Random Amplified Polymorphic. DNAs (RAPD) (Williams et al., 1990). The technique requires no prior knowledge of the genome and it needs ... quantity of DNA was measured by obtaining the absorbance read- ... 1994) and Numerical taxonomy and Multivariate Analysis System.

  15. Glutamine Randomized Studies in Early Life: The Unsolved Riddle of Experimental and Clinical Studies

    Directory of Open Access Journals (Sweden)

    Efrossini Briassouli

    2012-01-01

    Full Text Available Glutamine may have benefits during immaturity or critical illness in early life but its effects on outcome end hardpoints are controversial. Our aim was to review randomized studies on glutamine supplementation in pups, infants, and children examining whether glutamine affects outcome. Experimental work has proposed various mechanisms of glutamine action but none of the randomized studies in early life showed any effect on mortality and only a few showed some effect on inflammatory response, organ function, and a trend for infection control. Although apparently safe in animal models (pups, premature infants, and critically ill children, glutamine supplementation does not reduce mortality or late onset sepsis, and its routine use cannot be recommended in these sensitive populations. Large prospectively stratified trials are needed to better define the crucial interrelations of “glutamine-heat shock proteins-stress response” in critical illness and to identify the specific subgroups of premature neonates and critically ill infants or children who may have a greater need for glutamine and who may eventually benefit from its supplementation. The methodological problems noted in the reviewed randomized experimental and clinical trials should be seriously considered in any future well-designed large blinded randomized controlled trial involving glutamine supplementation in critical illness.

  16. Age at menarche and lung function: a Mendelian randomization study

    OpenAIRE

    Gill, Dipender; Sheehan, Nuala A; Wielscher, Matthias; Shrine, Nick; Amaral, Andre F. S.; Thompson, John R.; Granell, Raquel; Leynaert, Bénédicte; Real, Francisco Gómez; Hall, Ian P.; Tobin, Martin D; Auvinen, Juha; Ring, Susan M.; Jarvelin, Marjo-Riitta; Wain, Louise V

    2017-01-01

    A trend towards earlier menarche in women has been associated with childhood factors (e.g. obesity) and hypothesised environmental exposures (e.g. endocrine disruptors present in household products). Observational evidence has shown detrimental effects of early menarche on various health outcomes including adult lung function, but these might represent spurious associations due to confounding. To address this we used Mendelian randomization where genetic variants are used as proxies for age a...

  17. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

    Directory of Open Access Journals (Sweden)

    Dreyhaupt, Jens

    2017-05-01

    Full Text Available An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”. Compared with studies with individual randomization, studies with cluster randomization normally require (significantly larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies.Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  18. Hysteroscopy and the butyl-cyanoacrylate on experimental sterilization of rabbit uterine tubes Butil-cianoacrilato e histeroscopia na esterilização experimental de tubas uterinas de coelhas

    Directory of Open Access Journals (Sweden)

    Henri Chaplin Rivoire

    2007-10-01

    Full Text Available PURPOSE: To assess the sterilization effectiveness on uterine tube of rabbit by the cyanoacrylate adhesive. METHODS: Hysteroscopy tubal catheterization was performed randomly in 12 animals (24 uterine tubes assigned to the sham group (GS and 15 animals (30 uterine tubes to the n-butyl-cyanoacrylate (GB. The female rabbits were observed during 30, 90 and 180 days and mated to fertile males. The no pregnant rabbits were submitted to in vitro burst pressure test for patency by air insufflation (40 mmHg. The microscopic assessment was performed to parameters of damages in epithelium caused by the adhesive, the degree of inflammatory process, morphometry data values of tube diameter (UT (cm, mucosa thickness (MT and the myosalpinx thickness (MyT (mm. The mucosa cells densitometry (total optical density was expressed by the amount of DNA. The significance of the differences in histological scores and in thickness measurements were made by ANOVA test (P value OBJETIVO: Verificar a eficácia do adesivo de cianoacrilato na esterilização de tubas uterinas de coelhas. MÉTODOS: A cateterização tubária por histeroscopia foi realizada randomicamente em 12 animais (24 tubas uterinas formando o Grupo Sham (GS e 15 animais (30 tubas uterinas para o grupo do n-butil-cianoacrilato (GB. As coelhas foram observadas por 30, 90 e 180 dias e acasaladas com machos férteis. As tubas uterinas das fêmeas que não ficaram grávidas foram submetidas ao teste de pressão de rompimento in vitro, com insuflação de ar (40mmHg. A microscopia óptica estudou os danos causados ao epitélio pelo adesivo, o grau de processo inflamatório, a morfometria do diâmetro tubário (UT (cm, da mucosa (MT e do miosalpinge (MyT (mm. A densitometria das células da mucosa (Densidade Óptica Total foi expressa pela contagem do DNA. As significâncias dos diferentes escores histológicos e das medidas das camadas foram avaliadas pelo Teste de ANOVA (P<0,005. RESULTADOS: Em todos os

  19. Loss to follow-up in a randomized controlled trial study for pediatric weight management (EPOC)

    National Research Council Canada - National Science Library

    Warschburger, Petra; Kröller, Katja

    2016-01-01

      Background Attrition is a serious problem in intervention studies. The current study analyzed the attrition rate during follow-up in a randomized controlled pediatric weight management program (EPOC study...

  20. Permutation Test Approach for Ordered Alternatives in Randomized Complete Block Design: A Comparative Study

    OpenAIRE

    GOKPINAR, Esra; GUL, Hasan; GOKPINAR, Fikri; BAYRAK, Hülya; OZONUR, Deniz

    2013-01-01

    Randomized complete block design is one of the most used experimental designs in statistical analysis. For testing ordered alternatives in randomized complete block design, parametric tests are used if random sample are drawn from Normal distribution. If normality assumption is not provide, nonparametric methods are used. In this study, we are interested nonparametric tests and we introduce briefly the nonparametric tests, such as Page, Modified Page and Hollander tests. We also give Permutat...

  1. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies.

    Science.gov (United States)

    Page, Matthew J; Higgins, Julian P T; Clayton, Gemma; Sterne, Jonathan A C; Hróbjartsson, Asbjørn; Savović, Jelena

    2016-01-01

    To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Systematic review of meta-epidemiological studies. 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 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. Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed.

  2. Prediction Of Students’ Learning Study Periode By Using Random Forest Method (Case Study: Stikom Bali

    Directory of Open Access Journals (Sweden)

    I Made Budi Adnyana

    2016-10-01

    Full Text Available Graduation on time is one of the assessment elements of the college accreditation. Furthermore, graduation on time is an important issue because it indicates an effectiveness of college. Academic division of STIKOM Bali face many difficulties on predicting student graduation time because lack of information and analysis. Predictions of graduation time can help academic division in making appropriate strategy to shorten the study time. Data mining can be applied on this prediction problems using random forest classification methods. Random forest is a collection of of several tree, where each tree dependent on the pixels on each vector that selected randomly and independent .Sample data obtained from academic division of STIKOM Bali. This research use sample data of last 2 years graduated students, such as IPK, SKS, the number of inactive, and study time. The classification output consists of 2 class, “graduate on time” and “graduate over the time”. From the experimental result, 83.54 % accuracy value obtained.

  3. A Study of MAC Address Randomization in Mobile Devices and When it Fails

    Directory of Open Access Journals (Sweden)

    Martin Jeremy

    2017-10-01

    Full Text Available Media Access Control (MAC address randomization is a privacy technique whereby mobile devices rotate through random hardware addresses in order to prevent observers from singling out their traffic or physical location from other nearby devices. Adoption of this technology, however, has been sporadic and varied across device manufacturers. In this paper, we present the first wide-scale study of MAC address randomization in the wild, including a detailed breakdown of different randomization techniques by operating system, manufacturer, and model of device.

  4. A numerical study of rays in random media. [Monte Carlo method simulation

    Science.gov (United States)

    Youakim, M. Y.; Liu, C. H.; Yeh, K. C.

    1973-01-01

    Statistics of electromagnetic rays in a random medium are studied numerically by the Monte Carlo method. Two dimensional random surfaces with prescribed correlation functions are used to simulate the random media. Rays are then traced in these sample media. Statistics of the ray properties such as the ray positions and directions are computed. Histograms showing the distributions of the ray positions and directions at different points along the ray path as well as at given points in space are given. The numerical experiment is repeated for different cases corresponding to weakly and strongly random media with isotropic and anisotropic irregularities. Results are compared with those derived from theoretical investigations whenever possible.

  5. A randomized RSA study concentrating especially on continuous migration.

    Science.gov (United States)

    Molt, Mats; Ryd, Leif; Toksvig-Larsen, Sören

    2016-06-01

    Background and purpose - There is a general call for phased introduction of new implants, and one step in the introduction is an early evaluation of micromotion. We compared the micromotion in the Triathlon and its predecessor, the Duracon total knee prosthesis, concentrating especially on continuous migration over 5 years of follow-up. Patients and methods - 60 patients were randomized to receive either a cemented Triathlon total knee prosthesis or a cemented Duracon total knee prosthesis. 3-D tibial component migration was measured by radiostereometric analysis (RSA) at 3 months and at 1, 2, and 5 years. Results - There was no statistically significant difference in maximum total point motion (MTPM) between the 2 groups (p = 0.1). The mean MTPM at 5 years for the Duracon was 1.10 (SD 1.21) mm and for the Triathlon it was 0.66 (SD 0.38) mm. The numbers of continuously migrating prostheses were similar in the groups at the fifth year of follow-up; 6 of 21 prostheses in the Duracon group and 3 of 21 in the Triathlon group had migrated more than 0.3 mm between the second year and the fifth year of follow-up (p = 0.2). Interpretation - The Triathlon has a micromotion pattern similar to that of the Duracon total knee system at both short-term and medium-term follow-up, and may therefore, over time, show the same good long-term mechanical stability.

  6. Study on MAX-MIN Ant System with Random Selection in Quadratic Assignment Problem

    Science.gov (United States)

    Iimura, Ichiro; Yoshida, Kenji; Ishibashi, Ken; Nakayama, Shigeru

    Ant Colony Optimization (ACO), which is a type of swarm intelligence inspired by ants' foraging behavior, has been studied extensively and its effectiveness has been shown by many researchers. The previous studies have reported that MAX-MIN Ant System (MMAS) is one of effective ACO algorithms. The MMAS maintains the balance of intensification and diversification concerning pheromone by limiting the quantity of pheromone to the range of minimum and maximum values. In this paper, we propose MAX-MIN Ant System with Random Selection (MMASRS) for improving the search performance even further. The MMASRS is a new ACO algorithm that is MMAS into which random selection was newly introduced. The random selection is one of the edgechoosing methods by agents (ants). In our experimental evaluation using ten quadratic assignment problems, we have proved that the proposed MMASRS with the random selection is superior to the conventional MMAS without the random selection in the viewpoint of the search performance.

  7. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  8. Pilot study of the Korean Parent Training Program using a partial group randomized experimental study

    Science.gov (United States)

    Kim, Eunjung; Cain, Kevin; Boutain, Doris; Chun, Jin-Joo; Kim, Sangho; Im, Hyesang

    2017-01-01

    Problems Korean American (KA) children experience mental health problems due to difficulties in parenting dysfunction complicated by living in two cultures. Methods Korean Parent Training Program (KPTP) was pilot tested with 48 KA mothers of children (ages 3–8) using partial group randomized controlled experimental study design. Self-report survey and observation data were gathered. Findings Analyses using generalized estimating equation indicated the intervention group mothers increased effective parenting and their children decreased behavior problems and reported less acculturation conflict with mothers. Conclusions The KPTP is a promising way to promote effective parenting and increase positive child mental health in KA families. PMID:24645901

  9. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies.

    Directory of Open Access Journals (Sweden)

    Matthew J Page

    Full Text Available To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.Systematic review of meta-epidemiological studies.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.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.Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several

  10. Studies in astronomical time series analysis: Modeling random processes in the time domain

    Science.gov (United States)

    Scargle, J. D.

    1979-01-01

    Random process models phased in the time domain are used to analyze astrophysical time series data produced by random processes. A moving average (MA) model represents the data as a sequence of pulses occurring randomly in time, with random amplitudes. An autoregressive (AR) model represents the correlations in the process in terms of a linear function of past values. The best AR model is determined from sampled data and transformed to an MA for interpretation. The randomness of the pulse amplitudes is maximized by a FORTRAN algorithm which is relatively stable numerically. Results of test cases are given to study the effects of adding noise and of different distributions for the pulse amplitudes. A preliminary analysis of the optical light curve of the quasar 3C 273 is given.

  11. Double blind randomized phase II study with radiation + 5-fluorouracil ± celecoxib for resectable rectal cancer

    National Research Council Canada - National Science Library

    Debucquoy, Annelies; Roels, Sarah; Goethals, Laurence; Libbrecht, Louis; Cutsem, Eric Van; Geboes, Karel; Penninckx, Freddy; D’Hoore, André; McBride, William H; Haustermans, Karin

    2009-01-01

    To assess the feasibility and efficacy of the COX-2 inhibitor celecoxib in conjunction with preoperative chemoradiation for patients with locally advanced rectal cancer in a double blind randomized phase II study...

  12. Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

    Science.gov (United States)

    2016-08-01

    AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...design and skill decay model construction. Supply purchasing and acquisition for all four sites was also completed during this period. Working with

  13. Localization in random bipartite graphs: Numerical and empirical study

    Science.gov (United States)

    Slanina, František

    2017-05-01

    We investigate adjacency matrices of bipartite graphs with a power-law degree distribution. Motivation for this study is twofold: first, vibrational states in granular matter and jammed sphere packings; second, graphs encoding social interaction, especially electronic commerce. We establish the position of the mobility edge and show that it strongly depends on the power in the degree distribution and on the ratio of the sizes of the two parts of the bipartite graph. At the jamming threshold, where the two parts have the same size, localization vanishes. We found that the multifractal spectrum is nontrivial in the delocalized phase, but still near the mobility edge. We also study an empirical bipartite graph, namely, the Amazon reviewer-item network. We found that in this specific graph the mobility edge disappears, and we draw a conclusion from this fact regarding earlier empirical studies of the Amazon network.

  14. Schoolyard upgrade in a randomized controlled study design

    DEFF Research Database (Denmark)

    Christiansen, Lars Breum Skov; Toftager, Mette; Pawlowski, Charlotte Skau

    2017-01-01

    School recess physical activity is important for adolescent s health and development, and several studies have established evidence based on cross-sectional studies that it is influenced by the environment in the schoolyard. The aim of this study was to investigate the effect and variation across...... schools of a school-based intervention on students perceived opportunities for physical activity in the schoolyard, and to evaluate if an improved collective perception of opportunities was followed by an increase in PA during recess for the 13–15 year-old students. The intervention components included...... schoolyard renovation; mandatory outdoor recess; and increased adult supervision and support. Students collective perceptions were evaluated by a newly developed Schoolyard index (SYi) with seven items, and physical activity was objectively measured with accelerometer. We found variations in the change...

  15. Effects of hormone therapy on the endometrium in postmenopausal women: a one year randomized trial of low dose oral estradiol in association with a levonorgestrel-releasing intrauterine system or drospirenone

    Directory of Open Access Journals (Sweden)

    Luiza Schvartzman

    2013-09-01

    Full Text Available OBJECTIVES: to compare the endometrial effects and uterine bleeding patterns associated with treatment using (1 levonorgestrel-releasing intrauterine system (LNG-IUS and estradiol (1 mg/day, p.o. or (2 orally administered drospirenone (2 mg/day andestradiol (1 mg/day. METHODS: thirty-four patients (aged 52.53 ± 4.44 in the LNG-IUS group and 53.15 ± 4.018 in the DRSP group were randomized. The severity of menopausal symptoms was evaluated using the Kupperman index every three months. Transvaginal ultrasound, hysteroscopy and histological evaluation were repeated after 12 months. During this period, patients kept menstrual calendars. All categorical variables were described as percentages. Variables were tested for normal distribution and Student's t test was applied for independent samples and ANOVA forrepeated measures when appropriate. Data were considered to be significant when p<0.05. RESULTS: slight vaginal bleeding was reported in the first month of treatment by 53.3% of patients from the LNG-IUS/estradiol group compared with 7.7% of patients from the drospirenone/estradiol group. There were no differences in endometrial thickness between the two groups throughout the study period. End-of-study histological findings showed atrophic endometrium in 53.3% of patients in the LNG-IUS/estradiol group compared with 76.9% of patients in the drospirenone/estradiol group. CONCLUSIONS: our results suggest good endometrial protection with both HT regimens.

  16. Pediatric Basic Life Support Self-training is Comparable to Instructor-led Training: A randomized manikin study

    DEFF Research Database (Denmark)

    Vestergaard, L. D.; Løfgren, Bo; Jessen, C.

    2011-01-01

    Pediatric Basic Life Support Self-training is comparable to Instructor-led Training: A randomized manikin study.......Pediatric Basic Life Support Self-training is comparable to Instructor-led Training: A randomized manikin study....

  17. Mouth-to-mouth ventilation reduces interruptions in chest compressions during lifeguard CPR: A randomized manikin study,

    DEFF Research Database (Denmark)

    Løfgren, Bo; Adelborg, Kasper; Dalgas, Christian

    Mouth-to-mouth ventilation reduces interruptions in chest compressions during lifeguard CPR: A randomized manikin study.......Mouth-to-mouth ventilation reduces interruptions in chest compressions during lifeguard CPR: A randomized manikin study....

  18. Transcutaneus electrical nerve stimulation for overactive bladder increases rectal motor activity in children: a randomized controlled study

    DEFF Research Database (Denmark)

    Jønsson, Iben; Hagstrøm, Søren; Siggaard, Charlotte

    Transcutaneus electrical nerve stimulation for overactive bladder increases rectal motor activity in children: a randomized controlled study......Transcutaneus electrical nerve stimulation for overactive bladder increases rectal motor activity in children: a randomized controlled study...

  19. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    Objective: Standard triple therapy for Helicobacter pylori has a low eradication rate in Turkey. The aim of this study was to evaluate and compare the effectiveness of 7-day and 14-day lansoprazole, amoxicillin, clarithromycin, and bismuth subsalicylate (LACB) treatment regimens as first-line H. pylori eradication therapies.

  20. Mendelian randomization studies of biomarkers and type 2 diabetes

    NARCIS (Netherlands)

    Abbasi, Ali

    2015-01-01

    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

  1. A study of serial ranks via random graphs

    OpenAIRE

    Haeusler, Erich; Mason, David M.; Turova, Tatyana S.

    2000-01-01

    Serial ranks have long been used as the basis for nonparametric tests of independence in time series analysis. We shall study the underlying graph structure of serial ranks. This will lead us to a basic martingale which will allow us to construct a weighted approximation to a serial rank process. To show the applicability of this approximation, we will use it to prove two very general central limit theorems for Wald-Wolfowitz-type serial rank statistics.

  2. Localization of optical excitations on random surfaces: SNOM studies

    DEFF Research Database (Denmark)

    Bozhevolnyi, Sergey I.

    1999-01-01

    Localization of optical excitations on nanostructured metal surfaces and fractal colloid silver aggregates are studied by using a scanning near-field optical microscope (SNOM). The SNOM images obtained in both configurations exhibit spatially localized (within 150 to 250 nm) light intensity...... enhancement by up to two orders of magnitude. The observed phenomena are related to strong (Anderson) localization of quasi-two-dimensional light waves....

  3. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p .... With larger patient samples, it is possible, however, that a significant difference might have been achieved. The running costs for APD treatment were US $75 per day and for CAPD treatment US $61 per day. CONCLUSION: If APD treatment can help to keep selected patients vocationally or socially active, paying...

  4. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial

    OpenAIRE

    Goodman, Phyllis J.; Tangen, Catherine M.; Darke, Amy K.; Arnold, Kathryn B.; Hartline, JoAnn; Yee, Monica; Anderson, Karen; Caban-Holt, Allison; Christen, William G.; Patricia A Cassano; Lance, Peter; Eric A Klein; Crowley, John J.; Minasian, Lori M.; Meyskens, Frank L

    2016-01-01

    Background: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial’s development, NIH had invested substantial resources in evaluat...

  5. Effect of yoga on quality of life of CLBP patients: A randomized control study

    OpenAIRE

    Tekur Padmini; Chametcha Singphow; Hongasandra Ramarao; Raghuram Nagarathna

    2010-01-01

    Context: In two of the earlier Randomized Control Trials on yoga for chronic lower back pain (CLBP), 12 to 16 weeks of intervention were found effective in reducing pain and disability. Aim: To study the efficacy of a residential short term intensive yoga program on quality of life in CLBP. Materials and Methods: About 80 patients with CLBP (females 37) registered for a week long treatment at SVYASA Holistic Health Centre in Bengaluru, India. They were randomized into two groups (40 each). T...

  6. Randomized Trials in Developing Countries: Different Priorities and Study Design?

    Science.gov (United States)

    Marin, Benoît; Agbota, Gino Cédric; Preux, Pierre-Marie; Boumédiene, Farid

    2016-01-01

    Clinical trials are increasingly conducted in the field of neurology in developing countries. To our knowledge, no review has been performed to date about the temporal evolution, geographical distribution, pathological fields, and types of trials conducted. Besides, the validity of those clinical trials needs to be evaluated. Our main aim was to describe, using a systematic literature review, the clinical trials performed in the field of neurology in developing countries. The specific objectives were (1) to describe the pathologic fields, (2) to evaluate the methodology, and (3) to assess the validity of neurological clinical trials performed in developing countries. A systematic review of the literature was conducted accessing PubMed, Pascal, ScienceDirect, African Journal Online, and the Virtual Library of African Neurology. The 145 studies included allowed us to identify (1) an exponential evolution of the number of clinical trials, (2) the strong contributions from Asia, followed by Africa and Latin America, (3) a fairly good coverage of pathologic fields including noncommunicable diseases, (4) an increasing diversity of intervention type, (5) the lack of early-phase trials (phases I and IIa), and (5) the need of improvement for some critical methodological issues. There is a need (1) to develop structures dedicated to the early investigation of interventions in humans, and (2) for sustaining the development of structures specialized in the methodology of clinical research and of dedicated courses for researchers in tropical areas about good practice in clinical trials. This would help in improving methodological quality, appropriateness of data management, and statistical analysis. © 2016 S. Karger AG, Basel.

  7. A Randomized Double-Blind Crossover Study of Phase-Shift Sound Therapy for Tinnitus

    NARCIS (Netherlands)

    Heijneman, Karin M.; de Kleine, Emile; van Dijk, Pim

    Objective. The purpose of this study was to compare the efficacy of the treatment of tinnitus with a phase-shifting pure tone to that of the same tone treatment without phase shifting. Study Design. A double-blind crossover randomized controlled trial. Setting. This study was conducted at the

  8. Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients’ preference of either therapeutic modality. Methods This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment). Trial registration number NCT01869712 (in clinicaltrials.gov, on 22nd May 2013). PMID:25012121

  9. Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial.

    Science.gov (United States)

    Cao, Hui-Juan; Liu, Jian-Ping; Hu, Hui; Wang, Nissi S

    2014-07-10

    Conducting randomized controlled trials on traditional Chinese non-drug therapies has been limited by factors such as patient preference to specific treatment modality. The aim of this study is to investigate the feasibility of applying a partially randomized patient preference (PRPP) trial model in evaluating the efficacy of two types of traditional Chinese medicine therapies, acupuncture and cupping, for fibromyalgia while accounting for patients' preference of either therapeutic modality. This protocol was approved by the Institutional Ethics Committee of affiliated Dongfang Hospital, Beijing University of Chinese Medicine (approval number: 2013052104-2). One hundred participants with fibromyalgia will be included in this study. Diagnosis of fibromyalgia will be based on the American College of Rheumatology criteria. Before treatment, participants will be interviewed for their preference toward acupuncture or cupping therapy. Fifty participants with no preference will be randomly assigned to one of the two groups and another 50 participants with strong preference to either acupuncture or cupping will receive what they choose. For acupuncture and cupping therapy, the main acupoints used will be tender points (Ashi). Treatment will be three times a week for 5 consecutive weeks with a follow-up period of 12 weeks. Outcome measures will be qualitative (patient expectation and satisfaction) and quantitative (pain intensity, quality of life, depression assessment). NCT01869712 (in clinicaltrials.gov, on 22nd May 2013).

  10. Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) pilot study: a cluster randomized trial.

    Science.gov (United States)

    Kwong, Jeffrey C; Pereira, Jennifer A; Quach, Susan; Pellizzari, Rosana; Dusome, Edwina; Russell, Margaret L; Hamid, Jemila S; Feinberg, Yael; Winter, Anne-Luise; Gubbay, Jonathan B; Sirtonski, Brittany; Moher, Deanna; Sider, Doug; Finkelstein, Michael; Loeb, Mark

    2015-01-15

    School-based influenza immunization can effectively address accessibility barriers, but injected inactivated influenza vaccines (IIV) may not be acceptable to some children and parents in school settings. To better understand the feasibility of offering intranasal live attenuated influenza vaccines (LAIV) through schools, we assessed uptake, stakeholder acceptability, and cost of school-based delivery of LAIV compared to IIV. We piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario during the 2013-2014 influenza vaccination campaign. Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department. We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school. Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals. We compared the costs per dose of vaccine administered, including staff time and costs of vaccines and supplies. Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV (19.3% vs. 12.2%, p=0.02). Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines, and that LAIV was associated with increased efficiency and calmer children. All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake. The cost per vaccine dose administered was $38.67 for IIV and $43.50 for LAIV. Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety, but also slightly higher vaccine administration costs, compared to IIV. However, uptake was low for both groups. More effective strategies to promote

  11. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand

  12. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  13. Endometrial polyp or neoplasia? A case-control study in women with polyps at ultrasound.

    Science.gov (United States)

    Gambadauro, P; Martínez-Maestre, M Á; Schneider, J; Torrejón, R

    2015-06-01

    To identify factors associated with endometrial neoplasia in women diagnosed with endometrial polyp at transvaginal ultrasound. Within a population of 1390 consecutive patients undergoing hysteroscopy following an ultrasonographic diagnosis of polyps, we compared the cases with a final diagnosis of endometrial neoplasia with controls with benign endometrial polyps. The controls were selected randomly in a ratio of 4 : 1 (controls : cases). Bivariate statistical analysis and multiple logistic regression were used to measure the association between various variables and endometrial neoplasia. Sixteen cases of endometrial neoplasia were compared to 64 controls with confirmed benign endometrial polyps. All cases of neoplasia were among symptomatic women, while 40.62% of women with benign polyps had been referred to hysteroscopy after a routine ultrasound and were asymptomatic. Women with endometrial neoplasia were significantly older (mean age 64.19 ± 9.382 vs. 52.03 ± 9.846 years; p neoplasia were postmenopausal status and bleeding as a main symptom. At multivariate analysis with logistic regression, the only factors showing a statistically significant association with endometrial neoplasia were older age (odds ratio 1.102; 95% confidence interval 1.015-1.198) and bleeding (odds ratio 13.7; 95% confidence interval 1.486-126.278). When polyps are diagnosed at ultrasound, bleeding and an older age are independently associated with endometrial neoplasia. A significant proportion of asymptomatic women is referred to hysteroscopy because of a polyp seen at routine ultrasound, although malignancy is highly unlikely in these cases.

  14. A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.

    Science.gov (United States)

    Menon, Kusum; McNally, Dayre; O'Hearn, Katharine; Acharya, Anand; Wong, Hector R; Lawson, Margaret; Ramsay, Tim; McIntyre, Lauralyn; Gilfoyle, Elaine; Tucci, Marisa; Wensley, David; Gottesman, Ronald; Morrison, Gavin; Choong, Karen

    2017-06-01

    To determine the feasibility of conducting a randomized controlled trial of corticosteroids in pediatric septic shock. Randomized, double-blind, placebo controlled trial. Seven tertiary level PICUs in Canada. Children newborn to 17 years old inclusive with suspected septic shock. Administration of IV hydrocortisone versus placebo until hemodynamic stability is achieved or for a maximum of 7 days. One hundred seventy-four patients were potentially eligible of whom 101 patients met eligibility criteria. Fifty-seven patients were randomized, and 49 patients (23 and 26 patients in the hydrocortisone and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventilation, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge.

  15. A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study.

    Science.gov (United States)

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

    2009-12-01

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

  16. Monitoring of Gas Emboli During Hysteroscopic Surgery: A Prospective Study.

    Science.gov (United States)

    Liu, Sheng-Qun; Zhao, Su-Zhen; Li, Zhan-Wen; Lv, Su-Ping; Liu, Yue-Qiang; Li, Yi

    2017-04-01

    Previous studies have demonstrated a high frequency of gas emboli during hysteroscopy, but guidelines for the prevention, early detection, and intervention of gas embolism during hysteroscopic procedures are still lacking. This study aimed to gain a clearer understanding of risk factors and specific signs and symptoms associated with gas emboli. This prospective study enrolled 120 women scheduled for hysteroscopy using 5% glucose as distension medium. The gas bubbles were monitored sequentially in internal iliac vein, common iliac vein, inferior vena cava, superior vena cava, heart, and pulmonary artery under the gray-scale imaging of Doppler ultrasound. The frequency, extent, and the hemodynamic and respiratory effects of gas emboli were evaluated. The interventions and outcomes were recorded. The risk factors associated with gas emboli, and their relationship with the frequency and extent of gas emboli, were assessed. In our study, evidence of gas emboli under Doppler ultrasound monitoring was observed in 44 (36.7%) patients. The operation was continued and finished as soon as possible for patients presenting with stable vital signs or transient hemodynamic and respiratory changes, which resolved spontaneously without intervention. The operation was paused for patients presenting with significant hemodynamic changes or loss of consciousness, and the operation was resumed shortly after resumption of stable vital signs following symptomatic treatment. All patients in our study finished the operation and recovered without developing serious complications. Data analysis showed prolonged procedure duration and increased bleeding volume were both positively correlated with the frequency and extent of gas emboli. Our study demonstrated a high frequency of gas emboli during hysteroscopy. Doppler ultrasonic monitoring combined with a clearer understanding of specific signs, symptoms, and risk factors will facilitate early detection and intervention of gas emboli during

  17. Dairy consumption, systolic blood pressure, and risk of hypertension: Mendelian randomization study

    Science.gov (United States)

    This study examined whether previous observed inverse associations of dairy intake with systolic blood pressure and risk of hypertension were causal. A Mendelian randomization study was employed, using the single nucleotide polymorphism rs4988235 related to lactase persistence as an instrumental var...

  18. Ultrasonic root-end preparation in apical surgery : a prospective randomized study

    NARCIS (Netherlands)

    de Lange, Jan; Putters, Thomas; Baas, Erik M.; van Ingen, Johan M.

    2007-01-01

    Objective. The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment. Study design. A randomized prospective design was used in a standardized treatment protocol. Patients were allocated to treatment with an ultrasonic

  19. Surgical treatment of hidradenitis suppurativa with gentamicin sulfate: a prospective randomized study

    NARCIS (Netherlands)

    Buimer, Mathijs G.; Ankersmit, Miriam F. P.; Wobbes, Theo; Klinkenbijl, Jean H. G.

    2008-01-01

    This article describes and discusses a prospective randomized study with gentamicin sulfate in the surgical treatment of hidradenitis suppurativa. The purpose of the study was to investigate whether enclosure of antibiotics after primary excision and closure reduces the number of postoperative

  20. Psychological treatment of depression: A meta-analytic database of randomized studies

    NARCIS (Netherlands)

    Cuijpers, P.; Straten, van A.; Warmerdam, E.H.; Andersson, G.

    2008-01-01

    Abstract Background A large number of randomized controlled studies have clearly demonstrated that psychological interventions are effective in the treatment of depression. The number of studies in this area is increasing rapidly. In this paper, we present a database of controlled and comparative

  1. Melatonin for chronic sleep onset insomnia in children: A Randomized placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.G.; Nagtegaal, J.E.; Heijden, J.A.M. van der; Coenen, A.M.L.; Kerkhof, G.A.

    2001-01-01

    To establish the efficacy of melatonin treatment in childhood sleep onset insomnia, 40 elementary school children, 6 to 12 years of age, who suffered more than 1 year from chronic sleep onset insomnia, were studied in a double-blind, placebo-controlled study. The children were randomly assigned to

  2. A randomized crossover study of bee sting therapy for multiple sclerosis

    NARCIS (Netherlands)

    Wesselius, T; Heersema, DJ; Mostert, JP; Heerings, M; Admiraal-Behloul, F; Talebian, A; van Buchem, MA; De Keyser, J

    2005-01-01

    Background: Bee sting therapy is increasingly used to treat patients with multiple sclerosis (MS) in the belief that it can stabilize or ameliorate the disease. However, there are no clinical studies to justify its use. Methods: In a randomized, crossover study, we assigned 26 patients with

  3. Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Daniel, Casey L; Armstrong, Gregory T; Keske, Robyn R; Davine, Jessica A; McDonald, Aaron J; Sprunck-Harrild, Kim M; Coleman, Catherine; Haneuse, Sebastien J; Mertens, Ann C; Emmons, Karen M; Marghoob, Ashfaq A; Elkin, Elena B; Dusza, Stephen W; Robison, Leslie L; Geller, Alan C

    2015-03-24

    Advances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children's Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annually, as early detection has demonstrated markedly improved outcomes in the diagnosis and treatment of skin cancers. The goal of the present study is to increase rates of skin self-examinations and clinical skin examinations among adult survivors of childhood cancer treated with radiation. This randomized controlled trial uses a 3-group comparative effectiveness design comparing: (1) Patient Activation and Education (PAE) including text messaging, print and web-based tutorials over 12 months; (2) PAE plus physician activation (PAE + MD) adding physician activation/educational materials about survivors' increased skin cancer risk and conducting full-body skin exams; and (3) PAE plus physician activation, plus teledermoscopy (PAE + MD + TD) adding participant receipt of a dermatoscope intended to empower them to photograph suspect moles or lesions for review by the study dermatologist. The current study addresses barriers to screening in this population by providing educational and motivational information for both survivors and physicians regarding the value of periodic skin examinations. It also utilizes innovative mobile health technology to encourage and motivate (that is activate) survivors to conduct skin self-examinations, request physician exams, and obtain treatment when worrisome lesions are found. Finally, as a comparative effectiveness trial, this study isolates the effects of adding specific components to the patient activation intervention to test the most effective

  4. Hardy-Weinberg equilibrium testing of biological ascertainment for Mendelian randomization studies.

    Science.gov (United States)

    Rodriguez, Santiago; Gaunt, Tom R; Day, Ian N M

    2009-02-15

    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.

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

    Science.gov (United States)

    Steedman, Michael; Abouammoh, Marwan; Sharma, Sanjay

    2012-02-01

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

  6. Coadministration of lorcaserin and phentermine for weight management: A 12?week, randomized, pilot safety study

    OpenAIRE

    Smith, Steven R.; Garvey, W. Timothy; Greenway, Frank L.; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J.

    2017-01-01

    Objective To assess the short?term tolerability of lorcaserin alone or with two dose regimens of phentermine. Methods This was a 12?week, randomized, double?blind, pilot safety study of N?=?238 nondiabetic patients with obesity or overweight with ?1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting???1 of 9 potentially serotonergic adverse events (AE...

  7. Management of prelabor rupture of membranes at term. A randomized study

    DEFF Research Database (Denmark)

    Sperling, Lene; Schantz, A L; Wåhlin, A

    1993-01-01

    women with singleton pregnancies, cephalic presentations, gestational age of 36 completed weeks or more were allocated at random to induction with oxytocin either 6 hours after PROM (n = 62) (early) or 24 hours (n = 62) (late). Those eligible, but not participating in the study, totalled 238 women. MAIN...

  8. Results of artificial insemination at home by the partner with cryopreserved donor semen: a randomized study

    NARCIS (Netherlands)

    Hogerzeil, H. V.; Hamerlynck, J. V.; van Amstel, N.; Nagelkerke, N. J.; Lammes, F. B.

    1988-01-01

    The use of cryopreserved semen offers the possibility of home insemination by the instructed partner. A comparative study was designed whereby participants were randomly allocated to use home or clinic insemination for six cycles. If no pregnancy had occurred after six cycles, the site of

  9. Power and sample size calculations for Mendelian randomization studies using one genetic instrument.

    Science.gov (United States)

    Freeman, Guy; Cowling, Benjamin J; Schooling, C Mary

    2013-08-01

    Mendelian randomization, which is instrumental variable analysis using genetic variants as instruments, is an increasingly popular method of making causal inferences from observational studies. In order to design efficient Mendelian randomization studies, it is essential to calculate the sample sizes required. We present formulas for calculating the power of a Mendelian randomization study using one genetic instrument to detect an effect of a given size, and the minimum sample size required to detect effects for given levels of significance and power, using asymptotic statistical theory. We apply the formulas to some example data and compare the results with those from simulation methods. Power and sample size calculations using these formulas should be more straightforward to carry out than simulation approaches. These formulas make explicit that the sample size needed for Mendelian randomization study is inversely proportional to the square of the correlation between the genetic instrument and the exposure and proportional to the residual variance of the outcome after removing the effect of the exposure, as well as inversely proportional to the square of the effect size.

  10. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    Science.gov (United States)

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

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

    Science.gov (United States)

    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…

  12. Heterotopic ossification following internal fixation or arthroplasty for displaced femoral neck fractures: a prospective randomized study

    OpenAIRE

    Johansson, T.; Risto, O.; Knutsson, A.; Wahlström, O.

    2001-01-01

    One hundred hips in 99 patients of 75 years or older, with a displaced femoral neck fracture, were studied for heterotopic ossification (HO). The patients were randomized to either internal fixation or total hip arthroplasty (THA). In the THA group HO was found in 32 of 45 hips compared with 1 of 39 in the internal fixation group (P

  13. A Randomized Controlled Study Evaluating a Brief, Bystander Bullying Intervention with Junior High School Students

    Science.gov (United States)

    Midgett, Aida; Doumas, Diana; Trull, Rhiannon; Johnston, April D.

    2017-01-01

    A randomized controlled study evaluated a brief, bystander bullying intervention for junior high school students. Students in both groups reported an increase in knowledge and confidence to act as defenders and to utilize strategies to intervene on behalf of victims of bullying. Findings suggest possible carry-over effects from the intervention…

  14. Adiposity as a cause of cardiovascular disease: A Mendelian randomization study

    NARCIS (Netherlands)

    S. Hägg (Sara); M. Fall (Magnus); A. Ploner (Alexander); R. Mägi (Reedik); K. Fischer (Krista); G. Draisma (Gerrit); M. Kals (Mart); P.S. de Vries (Paul); A. Dehghan (Abbas); S.M. Willems (Sara); A.-P. Sarin; K. Kristiansson (Kati); M.-L. Nuotio (Marja-Liisa); A.S. Havulinna (Aki); R.F.A.G. de Bruijn (Renée); M.A. Ikram (Arfan); M. Kuningas (Maris); B.H.Ch. Stricker (Bruno); O.H. Franco (Oscar); B. Benyamin (Beben); C. Gieger (Christian); A.S. Hall (Alistair); V. Huikari (Ville); A. Jula (Antti); M.-R. Jarvelin (Marjo-Riitta); M. Kaakinen (Marika); J. Kaprio (Jaakko); M. Kobl (Michael); M. Mangino (Massimo); C.P. Nelson (Christopher P.); A. Palotie (Aarno); N.J. Samani (Nilesh); T.D. Spector (Timothy); D.P. Strachan (David); M.D. Tobin (Martin); J.B. Whitfield (John B.); A.G. Uitterlinden (André); V. Salomaa (Veikko); A.C. Syvanen; K. Kuulasmaa (Kari); P.K. Magnusson (Patrik); T. Esko (Tõnu); A. Hofman (Albert); E.J.C. de Geus (Eco); L. Lind (Lars); V. Giedraitis (Vilmantas); M. Perola (Markus); A. Evans (Alun); J. Ferrieres (Jean); J. Virtamo (Jarmo); F. Kee (F.); D.-A. Tregouet (David-Alexandre); D. Arveiler (Dominique); P. Amouyel (Philippe); F. Gianfagna (Francesco); P. Brambilla (Paolo); S. Ripatti (Samuli); C.M. van Duijn (Cornelia); A. Metspalu (Andres); I. Prokopenko (Inga); M.I. McCarthy (Mark); N.L. Pedersen (Nancy L.); E. Ingelsson (Erik)

    2015-01-01

    textabstractBackground: Adiposity, as indicated by body mass index (BMI), has been associated with risk of cardiovascular diseases in epidemiological studies. We aimed to investigate if these associations are causal, using Mendelian randomization (MR) methods. Methods: The associations of BMI with

  15. Incentive Pay Programs Do Not Affect Teacher Motivation or Reported Practices: Results from Three Randomized Studies

    Science.gov (United States)

    Yuan, Kun; Le, Vi-Nhuan; McCaffrey, Daniel F.; Marsh, Julie A.; Hamilton, Laura S.; Stecher, Brian M.; Springer, Matthew G.

    2013-01-01

    This study drew on teacher survey responses from randomized experiments exploring three different pay-for-performance programs to examine the extent to which these programs motivated teachers to improve student achievement and the impact of such programs on teachers' instruction, number of hours worked, job stress, and collegiality. Results showed…

  16. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  17. Preferred mesh-based inguinal hernia repair in a teaching setting: results of a randomized study.

    NARCIS (Netherlands)

    Nienhuijs, S.W.; Kortmann, B.B.M.; Boerma, M.; Strobbe, L.J.; Rosman, C.

    2004-01-01

    HYPOTHESIS: Surgeons' preferences for any of 3 methods of inguinal hernia repair are comparable in terms of operating time, incision length, perceived difficulty, and surgeon's satisfaction. DESIGN: Randomized patient-blinded study. SETTING: Teaching hospital. PATIENTS: A total of 334 patients

  18. Medical Students' Comfort with Pregnant Women with Substance-Use Disorders: A Randomized Educational Study

    Science.gov (United States)

    Albright, Brittany; Skipper, Betty; Riley, Shawne; Wilhelm, Peggy; Rayburn, William F.

    2012-01-01

    Objective: The study objective was to determine whether medical students' attendance at a rehabilitation residence for pregnant women with substance-use disorders yielded changes in their attitudes and comfort levels in providing care to this population. Methods: This randomized educational trial involved 96 consecutive medical students during…

  19. Genetic analysis of tolerance to infections using random regressions: a simulation study

    NARCIS (Netherlands)

    Kause, A.

    2011-01-01

    Tolerance to infections is the ability of a host to limit the impact of a given pathogen burden on host performance. This simulation study demonstrated the merit of using random regressions to estimate unbiased genetic variances for tolerance slope and its genetic correlations with other traits,

  20. The Random Forests Statistical Technique: An Examination of Its Value for the Study of Reading

    Science.gov (United States)

    Matsuki, Kazunaga; Kuperman, Victor; Van Dyke, Julie A.

    2016-01-01

    Studies investigating individual differences in reading ability often involve data sets containing a large number of collinear predictors and a small number of observations. In this article, we discuss the method of Random Forests and demonstrate its suitability for addressing the statistical concerns raised by such data sets. The method is…

  1. Does epicatechin contribute to the acute vascular function effects of dark chocolate? A randomized, crossover study

    NARCIS (Netherlands)

    Dower, James I.; Geleijnse, Marianne; Kroon, Paul A.; Philo, Mark; Mensink, Marco; Kromhout, Daan; Hollman, Peter C.H.

    2016-01-01

    Scope: Cocoa, rich in flavan-3-ols, improves vascular function, but the contribution of specific flavan-3-ols is unknown. We compared the effects of pure epicatechin, a major cocoa flavan-3-ol, and chocolate. Methods and results: In a randomized crossover study, twenty healthy men (40-80 years)

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

    Science.gov (United States)

    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…

  3. An experimental randomized study of six different ventilatory modes in a piglet model with normal lungs

    DEFF Research Database (Denmark)

    Nielsen, J B; Sjöstrand, U H; Henneberg, S W

    1991-01-01

    A randomized study of 6 ventilatory modes was made in 7 piglets with normal lungs. Using a Servo HFV 970 (prototype system) and a Servo ventilator 900 C the ventilatory modes examined were as follows: SV-20V, i.e. volume-controlled intermittent positive-pressure ventilation (IPPV); SV-20VIosc, i...

  4. Functional Stretching Exercise Submitted for Spastic Diplegic Children: A Randomized Control Study

    OpenAIRE

    Elshafey, Mohamed Ali; Abd-Elaziem, Adel; Gouda, Rana Elmarzouki

    2014-01-01

    Objective. Studying the effect of the functional stretching exercise in diplegic children. Design. Children were randomly assigned into two matched groups. Setting. Outpatient Clinic of the Faculty of Physical Therapy, Cairo University. Participants. Thirty ambulant spastic diplegic children, ranging in age from five to eight years, participated in this study. Interventions. The control group received physical therapy program with traditional passive stretching exercises. The study group re...

  5. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial.

    Science.gov (United States)

    Heisler, Michele; Burgess, Jennifer; Cass, Jeffrey; Chardos, John F; Guirguis, Alexander B; Jeffery, Sean M; Strohecker, Lorrie A; Tremblay, Adam S; Wu, Wen-Chih; Zulman, Donna M

    2017-05-26

    Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual's SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings. We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real

  6. Is Bonferroni correction more sensitive than Random Field Theory for most fMRI studies?

    CERN Document Server

    Tierney, Tim M; Carmichael, David W

    2016-01-01

    Random Field Theory has been used in the fMRI literature to address the multiple comparisons problem. The method provides an analytical solution for the computation of precise p-values when its assumptions are met. When its assumptions are not met the thresholds generated by Random Field Theory can be more conservative than Bonferroni corrections, which are arguably too stringent for use in fMRI. As this has been well documented theoretically it is surprising that a majority of current studies (~80%) would not meet the assumptions of Random Field Theory and therefore would have reduced sensitivity. Specifically most data is not smooth enough to meet the good lattice assumption. Current studies smooth data on average by twice the voxel size which is rarely sufficient to meet the good lattice assumption. The amount of smoothing required for Random Field Theory to produce accurate p-values increases with image resolution and decreases with degrees of freedom. There is no rule of thumb that is valid for all study...

  7. A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy.

    Science.gov (United States)

    O'Hara, Patrick J; Hertzer, Norman R; Mascha, Edward J; Krajewski, Leonard P; Clair, Daniel G; Ouriel, Kenneth

    2002-02-01

    The objective of this study was the determination of whether the choice of either autogenous saphenous vein (ASV) or synthetic material for patch angioplasty significantly influences the results after carotid endarterectomy (CEA). With Institutional Review Board approval, 195 patients (145 men and 50 women; mean age, 69 years) who underwent 207 CEAs were prospectively randomized to arteriotomy closure with ASV or synthetic patches from July 1996 to January 2000. One hundred and one patients (52%) were randomized to the ASV cohort, and 94 (48%) were randomized to the synthetic cohort. Aside from a slight gender imbalance (70% versus 79% male in the ASV versus the synthetic group), there were no clinically important differences in baseline demographic variables, risk factors, or surgical indications between the ASV and synthetic groups. With all 207 randomized procedures on an intent-to-treat basis, there were two early (or=60%) carotid stenosis was 4.8% (three of 62) for the ASV group and 6.3% (four of 63) for the synthetic group (P =.99). No significant differences in the stroke, mortality, or restenosis rates were shown between the ASV and the synthetic cohorts. While conceding the power limitations inherent in this study, we conclude that CEA may be safely performed with similar early results with ASV or synthetic patches.

  8. Modified step aerobics training and neuromuscular function in osteoporotic patients: a randomized controlled pilot study.

    Science.gov (United States)

    Behrens, Martin; Müller, Karoline; Kilb, Jill-Isabel; Schleese, Lennart; Herlyn, Philipp K E; Bruhn, Sven; Mittlmeier, Thomas; Schober, Hans-Christof; Fischer, Dagmar-C

    2017-02-01

    Training programs directed to improve neuromuscular and musculoskeletal function of the legs are scarce with respect to older osteoporotic patients. We hypothesized that a modified step aerobics training program might be suitable for this purpose and performed a randomized controlled pilot study to assess the feasibility of conducting a large study. Here we report on the training-related effects on neuromuscular function of the plantar flexors. Twenty-seven patients with an age of at least 65 years were enrolled and randomized into control and intervention group. The latter received supervised modified step aerobics training (twice weekly, 1 h per session) over a period of 6 months. At baseline, and after 3 and 6 months neuromuscular function of the plantar flexors, i.e., isometric maximum voluntary torque, rate of torque development and twitch torque parameters were determined in detail in all patients of both groups. Twenty-seven patients (median age 75 years; range 66-84 years) were randomized (control group n = 14; intervention group n = 13). After 3 and 6 months of training, maximum voluntary contraction strength in the intervention group was significantly higher by 7.7 Nm (9.1%; 95% CI 3.3-12.2 Nm, P training program in a large randomized trial. However, a detailed neuromuscular assessment appears feasible only in a subset of participants.

  9. Wrist-ankle acupuncture (WAA) for precompetition nervous syndrome: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Shu, Shi; Zhan, Mei; You, Yan-li; Qian, Xiao-lu; Li, Chun-ming; Zhou, Cheng-lin; Zhou, Shuang

    2015-09-07

    Precompetition nervous syndrome comprises an excessive nervous and anxiety response to the high-pressure environment preceding a sporting competition. The use of acupuncture as a treatment option for anxiety, and wrist-ankle acupuncture (WAA) specifically in this instance, has been identified as a growing trend within the Western world. In our previous study, we have confirmed the efficacy of WAA for pre-examination anxiety. In this paper, we present a randomized controlled single-blind trial evaluating the use of WAA for precompetition nervous syndrome, comparing it with the intervention of sham acupuncture. The study was designed as a randomized controlled single-blind trial to evaluate the effects of WAA for precompetition anxiety. The trial will be conducted in annual track and field events of Shanghai University of Sport. A total of 100 participants who meet inclusion criteria are randomly assigned by computerized randomization to receive WAA therapy or sham acupuncture. The group allocations and interventions are concealed to participants and statisticians. The Competition State Anxiety Scale (CSAI-2) is used as the primary outcome measure, while heart rate, blood pressure, respiratory frequency, tension syndrome curative effect evaluation and participants' feeling of acupuncture questionnaire are applied as secondary outcome measures. The results of this trial will confirm whether WAA is effective to treat precompetition anxiety in annual track and field events. Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-13003931; registration date: 22 October 2013).

  10. Aerobic exercise in obese diabetic patients with chronic kidney disease: a randomized and controlled pilot study

    Directory of Open Access Journals (Sweden)

    Cooper Cheryl

    2009-12-01

    Full Text Available Abstract Background Patients with obesity, diabetes, and chronic kidney disease (CKD are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. Methods We performed a 24-week randomized controlled feasibility study comparing aerobic exercise plus optimal medical management to medical management alone in patients with type 2 diabetes, obesity (body mass index [BMI] > 30 kg/m2, and stage 2-4 CKD (estimated glomerular filtration rate [eGFR] 15-90 mL/min/1.73 m2 with persistent proteinuria. Subjects randomized to exercise underwent thrice weekly aerobic training for 6 followed by 18 weeks of supervised home exercise. The primary outcome variable was change in proteinuria. Results Seven subjects randomized to exercise and 4 control subjects completed the study. Exercise training resulted in an increase in exercise duration during treadmill testing, which was accompanied by slight but insignificant decreases in resting systolic blood pressure and 24-hour proteinuria. Exercise did not alter GFR, hemoglobin, glycated hemoglobin, serum lipids, or C-reactive protein (CRP. Caloric intake and body weight and composition also did not change with exercise training. Conclusion Exercise training in obese diabetic patients with CKD is feasible and may have clinical benefits. A large-scale randomized controlled trial to determine the effects of exercise on renal functions, cardiovascular fitness, inflammation, and oxidative stress in diabetic patients with CKD is planned.

  11. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Davis-Lameloise, Nathalie; Hernan, Andrea; Janus, Edward D; Stewart, Elizabeth; Carter, Rob; Bennett, Catherine M; O'Reilly, Sharleen; Philpot, Benjamin; Vartiainen, Erkki; Dunbar, James A

    2013-01-31

    Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program 'Life! Taking action on diabetes' (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life

  12. Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

    Science.gov (United States)

    Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

    2015-02-01

    Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

  13. Topical Administration of Pirfenidone Increases Healing of Chronic Diabetic Foot Ulcers: A Randomized Crossover Study

    OpenAIRE

    Marcela Janka-Zires; Paloma Almeda-Valdes; Ana Cecilia Uribe-Wiechers; Sonia Citlali Juárez-Comboni; Joel López-Gutiérrez; Jarod Jazek Escobar-Jiménez; Francisco J Gómez-Pérez

    2016-01-01

    Only 30 percent of chronic diabetic foot ulcers heal after 20 weeks of standard treatment. Pirfenidone is a drug with biological, anti-inflammatory, and antifibrotic effects. The aim of this study was to evaluate the effect of topical pirfenidone added to conventional treatment in noninfected chronic diabetic foot ulcers. This was a randomized crossover study. Group 1 received topical pirfenidone plus conventional treatment for 8 weeks; after this period, they were switched to receive convent...

  14. Pain after microlaparoscopic cholecystectomy. A randomized double-blind controlled study

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2000-01-01

    BACKGROUND: Laparoscopic cholecystectomy (LC) is traditionally performed with two 10-mm and two 5-mm trocars. The effect of smaller port incisions on pain has not been established in controlled studies. METHODS: In a double-blind controlled study, patients were randomized to LC or cholecystectomy...... to LC (38%). The micro-LC instruments therefore need further technical development before this surgical technique can be used on a routine basis for laparoscopic cholecystectomy....

  15. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients.

    Science.gov (United States)

    Salonen, Bradley R; Bonnes, Sara L; Vallumsetla, Nishanth; Varayil, Jithinraj Edakkanambeth; Mundi, Manpreet S; Hurt, Ryan T

    2017-05-17

    Ethanol lock therapy (ELT) has been shown to reduce the rate of catheter-related bloodstream infection (CRBSI) in high-risk home parenteral nutrition (HPN) patients. The aim of this study was to determine whether ELT therapy for all patients newly started on HPN would reduce the incidence of CRBSI. This study was a prospective, double-blind, randomized controlled trial that was carried out from July 2014 to April 2016. The study participants were patients newly started on HPN, and they were randomly assigned to either treatment with ELT or our current standard of care with saline heparin locks. The primary outcome was occurrence of CRBSI. Thirty eight patients that were newly started on HPN were randomized to either treatment with ELT (n = 18) or to our current standard of care with heparin locks (n = 20). Four patients in the ELT group and one patient in the control arm had a CRBSI (p = 0.17). No significant adverse side effects were noted during the study. This study did not show improvement in the rate of CRBSI with ELT in all patients started on HPN. ELT therapy may be most helpful to reduce in CRBSI in high-risk HPN patients, but further studies with a randomized control trial design of high-risk patients are needed to further clarify this important issue in HPN patients. The study was registered at clinicaltrials.gov prior to patient enrollment (NCT02227329). Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  16. Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Timmerby, Nina; Austin, Stephen F; Ussing, Kristian

    2016-01-01

    conducted within this area indicate that family psychoeducation as a supplement to traditional treatment can effectively reduce the risk of relapse in patients with major depression as well as being beneficial for the relatives involved. However, the evidence is currently limited. This study......BACKGROUND: Major depressive disorder has been shown to affect many domains of family life including family functioning. Conversely, the influence of the family on the course of the depression, including the risk of relapse, is one reason for targeting the family in interventions. The few studies...... will investigate the effect of family psychoeducation compared to social support on the course of the illness in patients with major depressive disorder. METHOD/DESIGN: The study is designed as a dual center, two-armed, observer-blinded, randomized controlled trial. Relatives are randomized to participate in one...

  17. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

    Science.gov (United States)

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

    2017-03-31

    Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

  18. Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine: A study protocol.

    Science.gov (United States)

    Renjith, Vishnu; Pai, Aparna; Radhakrishnan, Kurupath; Nayak, Baby S; Devi, Elsa Sanatombi; Ladd, Elissa; George, Anice

    2017-10-11

    To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in, ). CTRI reference ID: CTRI/2015/10/006282. © 2017 John Wiley & Sons Ltd.

  19. Hypertension management in primary care: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Weltermann, Birgitta; Viehmann, Anja; Kersting, Christine

    2015-03-21

    Studies worldwide show insufficient blood pressure control rates, and effective management of hypertension remains a challenge in general practice. Although structured forms of care improved blood pressure in randomized controlled trials, little is known about their effects under routine primary care. This cluster randomized trial (CRT) evaluates the effects of a modern interactive medical education series for general practitioners on hypertension management, including practice redesign strategies. For this CRT, 24 primary care academic teaching practices of the University of Duisburg-Essen, Germany, are randomized into two study arms. With the objective of improving hypertension control, general practitioners of the intervention group participate in a three-session medical education program on structured hypertension management. The program aims at changing physician awareness and practice design. Various practice tools are provided: for example, checklists on valid blood pressure readings, medication selection, detection of secondary hypertension, and patient education. General practitioners of both study groups include hypertensive patients with and without hypertension-related diseases such as angiographically proven coronary disease, and peripheral or cerebral vascular disease. Blood pressure is measured by 24-hour readings. Analyses will focus on differences in blood pressure control and changes of practice management between intervention and control group. The study will determine the effectiveness of our practice redesign intervention on hypertension control. The intervention addresses general practitioners and practice assistants, while aiming at benefits on the patient level. Therefore, the cluster design is used to evaluate the effects. DRKS00006315 (date of registration: 14 July 2014).

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

    Science.gov (United States)

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

    2018-01-26

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

  1. Pregabalin for anxiety in patients with schizophrenia - A randomized, double-blind placebo-controlled study

    DEFF Research Database (Denmark)

    Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt

    2017-01-01

    INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...

  2. Effect of massage therapy on pain, anxiety, relaxation, and tension after colorectal surgery: A randomized study.

    Science.gov (United States)

    Dreyer, Nikol E; Cutshall, Susanne M; Huebner, Marianne; Foss, Diane M; Lovely, Jenna K; Bauer, Brent A; Cima, Robert R

    2015-08-01

    The purpose of this randomized controlled trial was to evaluate the effect of postoperative massage in patients undergoing abdominal colorectal surgery. One hundred twenty-seven patients were randomized to receive a 20-min massage (n = 61) or social visit and relaxation session (no massage; n = 66) on postoperative days 2 and 3. Vital signs and psychological well-being (pain, tension, anxiety, satisfaction with care, relaxation) were assessed before and after each intervention. The study results indicated that postoperative massage significantly improved the patients' perception of pain, tension, and anxiety, but overall satisfaction was unchanged. In conclusion, massage may be beneficial during postoperative recovery for patients undergoing abdominal colorectal surgery. Further studies are warranted to optimize timing and duration and to determine other benefits in this clinical setting. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. HypoCol (red yeast rice) lowers plasma cholesterol - a randomized placebo controlled study.

    Science.gov (United States)

    Bogsrud, Martin Prøven; Ose, Leiv; Langslet, Gisle; Ottestad, Inger; Strøm, Ellen Charlotte; Hagve, Tor-Arne; Retterstøl, Kjetil

    2010-08-01

    The primary endpoint in our study was to investigate the effect of a red yeast rice (RYR) product on plasma lipids. A randomized, double-blind, placebo controlled study was performed. Patients were randomized to either RYR (HypoCol, 4 capsules/day) (n=22) or placebo (n=20) for 16 weeks. Inclusion criteria were male or female, 18-75 years, LDL-cholesterol between 3.0 and 6.0 mmol/L, fasting triglyceride level less than 4.5 mmol/L. Patients receiving RYR experienced a significant reduction in LDL-cholesterol (23.0%) and total cholesterol (15.5%) compared to placebo after 16 weeks of treatment (pred yeast rice product demonstrated a significant cholesterol lowering effect compared to placebo, and was well tolerated in this Caucasian population.

  4. Vasopressin vs Dopamine for Treatment of Hypotension in ELBW Infants: A Randomized, Blinded Pilot Study

    Science.gov (United States)

    Rios, Danielle R.; Kaiser, Jeffrey R.

    2015-01-01

    Objective To evaluate vasopressin vs dopamine as initial therapy in ELBW infants with hypotension during the first 24 hours of life. Study design Hypotensive ELBW infants ≤ 30 weeks’ gestation and ≤ 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion. Normotensive infants not receiving vasopressor support served as a comparison group. Results Twenty hypotensive ELBW infants received vasopressin (n=10) or dopamine (n=10), and 50 were enrolled for comparison. Mean gestational age was 25.6 ± 1.4 weeks and birth weight 705 ± 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean BP (Kaplan-Meier curve, p=0.986); 90% of infants in each treatment group responded with adequate BP. The vasopressin group received fewer doses of surfactant (phypotension appeared safe. This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension. PMID:25641242

  5. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery

    DEFF Research Database (Denmark)

    Bulut, O; Aslak, K K; Levic, K

    2015-01-01

    BACKGROUND: Potential benefits of single-port laparoscopic surgery may include improved cosmetic results, less postoperative pain, surgical trauma and faster recovery. Results of randomized prospective studies with a focus on single-port rectal surgery have not yet been presented. The aim...... of the present study was to compare single-port and conventional laparoscopic surgery for rectal cancer in terms of short-term outcomes including postoperative pain and trauma-induced changes in certain bioactive substances. METHODS: Patients with non-metastasized rectal cancer were prospectively randomized...... groups for plasma IL-6 and TIMP-1 at all time points, while the CRP levels were significantly lower in the single-port group at 6 (p Abdominal incisions lengths were significantly shorter in the single-port group (p = 0.001). There was no significant...

  6. Phase I Randomized Safety Study of Twice Daily Dosing of Acidform Vaginal Gel: Candidate Antimicrobial Contraceptive

    OpenAIRE

    Keller, Marla J.; Carpenter, Colleen A.; Yungtai Lo; Einstein, Mark H.; Congzhou Liu; David N Fredricks; Herold, Betsy C.

    2012-01-01

    Background Acidform gel, an acid-buffering product that inactivates spermatozoa, may be an effective topical non-hormonal contraceptive. This study was designed to evaluate the safety of vaginal dosing and effects of Acidform on mucosal immune mediators, antimicrobial properties of genital secretions, and vaginal microbiota. Methods Thirty-six sexually abstinent U.S. women were randomized to apply Acidform or hydroxyethylcellulose (HEC) placebo gel twice daily for 14 consecutive days. Safety ...

  7. Mendelian Randomization Studies Do Not Support a Role for Vitamin D in Coronary Artery Disease.

    Science.gov (United States)

    Manousaki, Despoina; Mokry, Lauren E; Ross, Stephanie; Goltzman, David; Richards, J Brent

    2016-08-01

    Observational studies support a possible association between decreased vitamin D levels and risk of coronary artery disease (CAD); however, it remains unclear whether this relationship is causal. We aimed to evaluate whether genetically lowered vitamin D levels influence the risk of CAD using a Mendelian randomization approach. In this 2-stage Mendelian randomization study, we first identified single-nucleotide polymorphisms associated with 25-hydroxyvitamin D (25OHD) levels in the SUNLIGHT consortium (n=33 996), then tested them for possible violation of Mendelian randomization assumptions. A count of risk alleles was tested for association with 25OHD levels in a separate cohort (n=2347). Alleles were weighted by their relative effect on 25OHD and tested for their combined effect on CAD in the Coronary Artery Disease Genome-Wide Replication and Meta-Analysis (CARDIoGRAM) study (22 233 cases/64 762 controls). Four single-nucleotide polymorphisms were identified to be associated with 25OHD levels, all in or near genes implicated in 25OHD synthesis, transport or metabolism. A count of these risk alleles was strongly associated with 25OHD (n=2347, F-test statistic=49.7, P=2×10(-12)). None of the single-nucleotide polymorphisms associated with 25OHD levels were associated with CAD (all P values >0.6). The Mendelian randomization odds ratio (OR) for CAD was 0.99 (95% confidence interval, 0.84-1.17; P=0.93; I(2)=0) per SD decrease in log-transformed 25OHD levels. These results persisted after sensitivity analyses for population stratification and pleiotropy. Genetically lowered 25OHD levels were not associated with increased risk of CAD in a large, well-powered study, suggesting that previous associations between circulating 25OHD levels and CAD are possibly confounded or due to reverse causation. © 2016 American Heart Association, Inc.

  8. Continuous versus Intermittent Infusion of Vancomycin in Severe Staphylococcal Infections: Prospective Multicenter Randomized Study

    OpenAIRE

    Wysocki, Marc; Delatour, Frederique; Faurisson, François; Rauss, Alain; Pean, Yves; Misset, Benoit; Thomas, Frank; Timsit, Jean-François; Similowski, Thomas; Mentec, Herve; Mier, Laurence; Dreyfuss, Didier

    2001-01-01

    A continuous infusion of vancomycin (CIV) may provide an alternative mode of infusion in severe hospital-acquired methicillin-resistant staphylococcal (MRS) infections. A multicenter, prospective, randomized study was designed to compare CIV (targeted plateau drug serum concentrations of 20 to 25 mg/liter) and intermittent infusions of vancomycin (IIV; targeted trough drug serum concentrations of 10 to 15 mg/liter) in 119 critically ill patients with MRS infections (bacteremic infections, 35%...

  9. Luteal Phase Support in the Intrauterine Insemination (IUI) Cycles: A Randomized Double Blind, Placebo Controlled Study.

    OpenAIRE

    Batool Hossein Rashidi; Fatemeh Davari Tanha; Haleh Rahmanpour; Mahya Ghazizadeh

    2014-01-01

    Objective: To evaluate the impact of luteal phase support with vaginal progesterone on pregnancy rates in the intrauterine insemination (IUI) cycles, stimulated with clomiphene citrate and human menopausal gonadotropin (hMG), in sub fertile couples. Materials and methods: This prospective, randomized, double blind study was performed in a tertiary infertility center from March 2011 to January 2012. It consisted of 253 sub fertile couples undergoing ovarian stimulation for IUI cycles. They und...

  10. A Randomization Test for Controlling Population Stratification in Whole-Genome Association Studies

    OpenAIRE

    Kimmel, Gad; Jordan, Michael I.; Halperin, Eran; Shamir, Ron; Karp, Richard M.

    2007-01-01

    Population stratification can be a serious obstacle in the analysis of genomewide association studies. We propose a method for evaluating the significance of association scores in whole-genome cohorts with stratification. Our approach is a randomization test akin to a standard permutation test. It conditions on the genotype matrix and thus takes into account not only the population structure but also the complex linkage disequilibrium structure of the genome. As we show in simulation experime...

  11. Directed polymer in random media, in two dimensions: numerical study of the aging dynamics

    OpenAIRE

    Barrat, A

    1997-01-01

    Following a recent work by Yoshino, we study the aging dynamics of a directed polymer in random media, in 1+1 dimensions. Through temperature quench, and temperature cycling numerical experiments similar to the experiments on real spin glasses, we show that the observed behaviour is comparable to the one of a well known mean field spin glass model. The observation of various quantities (correlation function, ``clonation'' overlap function) leads to an analysis of the phase space landscape.

  12. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study

    Science.gov (United States)

    Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu

    2017-06-01

    The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) (n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) (n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 (p 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 (p patients.

  13. Diathermy excisional hemorrhoidectomy: a prospective randomized study comparing pedicle ligation and pedicle coagulation.

    Science.gov (United States)

    Bessa, Samer S

    2011-11-01

    In hemorrhoidectomy, pedicle coagulation has been claimed to be associated with less postoperative pain compared with pedicle ligation. This study was designed to compare the effects of pedicle ligation vs pedicle coagulation on postoperative pain in patients undergoing diathermy excisional hemorrhoidectomy. The study was conducted as a single-blind prospective randomized clinical trial. Patients were treated at a single tertiary-level teaching hospital (Main University Hospital) in Alexandria, Egypt, from February 2009 to October 2010. Patients with symptomatic grade III or IV hemorrhoids were eligible. Patients were randomly allocated to receive either pedicle coagulation or pedicle ligation during 3-quadrant diathermy excision hemorrhoidectomy. Patients reported postoperative pain daily on a visual analog scale (0-10, with 10 corresponding to the most severe pain) during the first 10 postoperative days. On-demand parenteral analgesic requirements were recorded during the first 24 hours after surgery. Operative time, postoperative complications, and wound healing rates at 6 weeks postoperatively were also recorded. No a priori power calculation could be performed, so it was not possible to tell whether nonsignificant differences were real or a result of chance. A total of 136 patients were randomly assigned, and 120 patients completed the study (60 in each group). The overall median pain score for the first 10 postoperative days was significantly lower in the pedicle coagulation group than in the pedicle ligation group (4.65 vs 6.56, P parenteral analgesic requirements during the first 24 hours postoperatively.

  14. Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Razzano, Cristina; Carbone, Stefano; Mangone, Massimiliano; Iannotta, M Raffaella; Battaglia, Alessandro; Santilli, Valter

    The initial treatment of plantar fasciitis should be conservative, with most cases responding to standard physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), heel pads, and stretching. In cases of chronic refractory symptoms, more invasive treatment could be necessary. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of the present prospective randomized controlled study was to evaluate whether the use of NIN for chronic plantar fasciitis could result in greater improvement in a foot functional score, lower levels of reported pain, reduced patient consumption of NSAIDs, and greater patient satisfaction compared with electric shockwave therapy in patients without a response to standard conservative treatment. The patients were randomized using random blocks to the NIN program (group 1) or electric shockwave therapy (group 2). The outcome measurements were the pain subscale of the validated Foot Function Index (PS-FFI), patient-reported subjective assessment of the level of pain using a standard visual analog scale, and daily intake of NSAID tablets (etoricoxib 60 mg). The study group was evaluated at baseline (time 0), week 4 (time 1), and week 12 (final follow-up point). Group 1 (55 patients) experienced significantly better results compared with group 2 (49 patients) in term of the PS-FFI score, visual analog scale score, and daily intake of etoricoxib 60 mg. NIN was an effective treatment of chronic resistant plantar fasciitis, with full patient satisfaction in >90% of cases. The present prospective randomized controlled study showed superior results for noninvasive neurostimulation compared with electric shockwave therapy, in terms of the functional score, pain improvement, and use of NSAIDs. Copyright © 2017 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

  15. A Randomized, Placebo-Controlled, Double-Blind Efficacy Study of Nefiracetam to Treat Poststroke Apathy.

    Science.gov (United States)

    Starkstein, Sergio E; Brockman, Simone; Hatch, Katherine K; Bruce, David G; Almeida, Osvaldo P; Davis, Wendy A; Robinson, Robert G

    2016-05-01

    To evaluate the efficacy of treatment with nefiracetam compared to placebo in poststroke apathy. A parallel group, randomized, placebo-controlled, double-blind two-center trial in patients with recent stroke and apathy was conducted in 2 tertiary teaching hospitals in Perth, Western Australia, between March 2010 and October 2014. Consenting patients hospitalized with stroke were screened for participation at the time of hospitalization and, if diagnosed with apathy 8-36 weeks later, they were randomized to 12 weeks of 900 mg/day nefiracetam or placebo. The primary efficacy parameter was change in apathy at 12 weeks defined by the 14-item Apathy Scale (AS). Of 2514 patients screened, only 377 (15%) were eligible for the study after the first screening, 233 declined further participation, and 144 were assessed for apathy at 8-36 weeks post stroke to confirm eligibility. Twenty patients out of 106 with a complete psychiatric assessment had apathy (19%). Of this sample, 13 patients were randomized. Overall, the AS score decreased by a mean of 7.0 points (95% CI = -14.6 to .6), but there was no significant between-group difference at week 12 (mean paired t-tests, P > .14). Treatment with nefiracetam did not prove to be more efficacious than placebo in ameliorating apathy in stroke. The main limitation was the very small sample randomized, highlighting the limitations of conducting drug trials for behavioral problems among stroke patients. Pharmacological studies of apathy in stroke will require a large multicenter study and a massive sample of patients. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  16. Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

    Science.gov (United States)

    Forray, Ariadna; Gilstad-Hayden, Kathryn; Suppies, Cristine; Bogen, Debra; Sofuoglu, Mehmet; Yonkers, Kimberly A

    2017-12-01

    Close to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking. This was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings. The trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (β=-0.10, 95% CI: -0.15, -0.04, p<0.01). No serious adverse events occurred during the trial. These preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use

  17. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies.

    Science.gov (United States)

    Trenkwalder, Claudia; Stocchi, Fabrizio; Poewe, Werner; Dronamraju, Nalina; Kenney, Chris; Shah, Amy; von Raison, Florian; Graf, Ana

    2016-07-01

    Two phase 2 randomized, double-blind studies were designed to evaluate efficacy and safety of immediate-release (study 1) and modified-release (study 2) mavoglurant formulations in PD l-dopa-induced dyskinesia. Patients were randomized to mavoglurant 100-mg or placebo (4:3) groups (study 1) and mavoglurant 200-mg, mavoglurant 150-mg, or placebo (2:1:1) groups (study 2). Primary outcome was antidyskinetic efficacy, as measured by change from baseline to week 12 in modified Abnormal Involuntary Movement Scale total score. Differences in least-squares mean (standard error) change in modified Abnormal Involuntary Movement Scale total score in week 12 did not reach statistical significance in either study (study 1: mavoglurant 100 mg twice a day versus placebo, 1.7 [1.31]; study 2: mavoglurant 150 mg twice a day (-1.3 [1.16]) and 200 mg twice a day (-0.2 [1.03]) versus placebo). Adverse events incidence was higher with mavoglurant than with placebo. Both studies failed to meet the primary objective of demonstrating improvement of dyskinesia with mavoglurant treatment. © 2016 International Parkinson and Movement Disorder Society. © 2016 International Parkinson and Movement Disorder Society.

  18. Nimodipine in aneurysmal subarachnoid hemorrhage: a randomized study of intravenous or peroral administration

    DEFF Research Database (Denmark)

    Kronvall, Erik; Undrén, Per; Rommer, Bertil Roland

    2009-01-01

    OBJECT: The calcium antagonist nimodipine has been shown to reduce the incidence of ischemic complications following aneurysmal subarachnoid hemorrhage (SAH). Although most randomized studies have been focused on the effect of the peroral administration of nimodipine, intravenous infusion...... is an alternative and the preferred mode of treatment in many centers. It is unknown whether the route of administration is of any importance for the clinical efficacy of the drug. METHODS: One hundred six patients with acute aneurysmal SAH were randomized to receive either peroral or intravenous nimodipine...... of patients with new infarctions on MR imaging. CONCLUSIONS: The results suggest that there is no clinically relevant difference in efficacy between peroral and intravenous administration of nimodipine in preventing DINDs or cerebral vasospasm following SAH....

  19. The value of including spirometry in health checks - a randomized controlled study in primary health care

    DEFF Research Database (Denmark)

    Ørts, Lene Maria; Ottesen, Anders Løkke; Bjerregaard, Anne-Louise

    Background Lung diseases are among the most frequent and most serious ailments in Denmark. Preventive health checks including spirometry can be used to detect lung diseases earlier. Over time the attendance at preventive health checks has decreased and at present the response rate is approximately...... 50%. Little is known about initiatives that can influence the attendance rate. Objectives To examine whether focused information on spirometry in the invitation material will influence the attendance in preventive health checks. Materiel/Methods Design: A randomized controlled study on information...... on spirometry embedded in “Check your health Prevention Program, CHPP” from 2015-16. CHPP is a house-hold cluster randomized controlled trial offering a preventive health check to 30-49 year olds in a Danish municipality during the years 2012 through to 2017 (n= 26,216), carried out in collaboration between...

  20. Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study.

    Science.gov (United States)

    Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

    2015-09-01

    The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.

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

    DEFF Research Database (Denmark)

    van Dijken, Jan WV; Pallesen, Ulla

    2016-01-01

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

  2. Consumer empowerment and self-advocacy outcomes in a randomized study of peer-led education.

    Science.gov (United States)

    Pickett, Susan A; Diehl, Sita M; Steigman, Pamela J; Prater, Joy D; Fox, Anthony; Shipley, Patricia; Grey, Dennis D; Cook, Judith A

    2012-08-01

    This study examined the effectiveness of the Building Recovery of Individual Dreams and Goals (BRIDGES) peer-led education intervention in empowering mental health consumers to become better advocates for their own care. A total of 428 adults with mental illness were randomly assigned to BRIDGES (intervention condition) or a services as usual wait list (control condition). Interviews were conducted at enrollment, at the end of the intervention, and 6-months post-intervention. Random regression results indicate that, compared to controls, BRIDGES participants experienced significant increases in overall empowerment, empowerment-self-esteem, and self-advocacy-assertiveness, and maintained these improved outcomes over time. Peer-led education interventions may provide participants with the information, skills and support they need to become more actively involved in the treatment decision-making process.

  3. Efficacy of nebulized L-epinephrine for treatment of croup: a randomized, double-blind study.

    Science.gov (United States)

    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 nebulized L-epinephrine compared to patients who received placebo. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  4. The antimyotonic effect of lamotrigine in non-dystrophic myotonias: a double-blind randomized study

    DEFF Research Database (Denmark)

    Andersen, Grete; Hedermann, Gitte; Witting, Nanna

    2017-01-01

    , and randomized patients in blocks of 10. Participants and investigators were all blinded to treatment until the end of the trial. In two 8-week periods, oral lamotrigine or placebo capsules were provided once daily, with increasing doses (from 25 mg, 50 mg, 150 mg to 300 mg) every second week. The primary....... Like mexiletine, lamotrigine is a sodium channel blocker, but unlike mexiletine, lamotrigine is available, inexpensive, and well tolerated. We investigated the potential of using lamotrigine for treatment of myotonia in patients with non-dystrophic myotonias. In this, randomized double-blind, placebo...... was registered at ClinicalTrials.gov (NCT02159963) and EudraCT (2013-003309-24). We included 26 patients (10 females, 16 males, age: 19-74 years) from 13 November 2013 to 6 July 2015. Twenty-two completed the entire study. One patient withdrew due to an allergic reaction to lamotrigine. Three patients withdrew...

  5. Stop the pain: study protocol for a randomized-controlled trial.

    Science.gov (United States)

    Warschburger, Petra; Calvano, Claudia; Becker, Sebastian; Friedt, Michael; Hudert, Christian; Posovszky, Carsten; Schier, Maike; Wegscheider, Karl

    2014-09-11

    Functional abdominal pain (FAP) is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data. In a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP (n = 56) or to an active control group (focusing on age-appropriate information delivery; n = 56). Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as self-efficacy. This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored. DRKS00005038 (date: 25 July 2013); NCT02030392 (date: 7 January 2014).

  6. Impact of random safety analyses on structure, process and outcome indicators: multicentre study.

    Science.gov (United States)

    Bodí, María; Oliva, Iban; Martín, Maria Cruz; Gilavert, Maria Carmen; Muñoz, Carlos; Olona, Montserrat; Sirgo, Gonzalo

    2017-12-01

    To assess the impact of a real-time random safety tool on structure, process and outcome indicators. Prospective study conducted over a period of 12 months in two adult patient intensive care units. Safety rounds were conducted three days a week ascertaining 37 safety measures (grouped into 10 blocks). In each round, 50% of the patients and 50% of the measures were randomized. The impact of this safety tool was analysed on indicators of structure (safety culture, healthcare protocols), process (improvement proportion related to tool application, IPR) and outcome (mortality, average stay, rate of catheter-related bacteraemias and rate of ventilator-associated pneumonia, VAP). A total of 1214 patient-days were analysed. Structure indicators: the use of the safety tool was associated with an increase in the safety climate and the creation/modification of healthcare protocols (sedation/analgesia and weaning). Process indicators: Twelve of the 37 measures had an IPR > 10%; six showed a progressive decrease in the IPR over the study period. Nursing workloads and patient severity on the day of analysis were independently associated with a higher IPR in half of the blocks of variables. Outcome indicators: A significant decrease in the rate of VAP was observed. The real-time random safety tool improved the care process and adherence to clinical practice guidelines and was associated with an improvement in structure, process and outcome indicators.

  7. Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Kim, Jung-Eun; Cho, Junghyo; Kwon, Ojin; Kim, Ae-Ran; Park, Hyo-Ju; Jung, So-Young; Kim, Joo-Hee; Kim, Mikyung; Lee, Hye-Yoon; Lee, Jun-Hwan

    2017-03-21

    The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women. This is a single-center, randomized, placebo-controlled, parallel-group design pilot trial. Fifty participants with climacteric syndrome will be randomly allocated to the GFW or placebo group in a 1:1 ratio. The participants will be administered GFW or placebo granules three times a day for 4 weeks and will be followed up for a further 4 weeks. The primary outcome is the mean change in menopause rating scale score at 5 weeks after randomization. Secondary outcomes include the World Health Organization quality of life-BREF scores, degrees of upward movement of qi and lower abdominal resistance and tenderness, blood stasis pattern questionnaire scores, and results of blood tests including assays for lipid profile, high sensitivity C-reactive protein, follicle-stimulating hormone, and estradiol. The feasibility outcomes include recruitment and completion rates and adherence to medication. The results of this study will provide basic data for the design of a large-scale clinical trial for evaluating the efficacy of GFW in the treatment of climacteric syndrome in women. Clinical Research Information Service (CRIS), Republic of Korea, KCT0002040 . Registered on 5 September 2016.

  8. Randomized clinical study for assessment of incision characteristics and pain associated with LESS versus laparoscopic cholecystectomy.

    Science.gov (United States)

    Madureira, Fernando Athayde Veloso; Manso, José Eduardo Ferreira; Madureira Fo, Delta; Iglesias, Antonio Carlos Garrido

    2013-03-01

    Laparoendoscopic single-site surgery (LESS) has emerged as a technique that uses a natural scar, the umbilicus, within which a multiple-entry portal is placed into a 3.0-4.0-cm single incision to perform operations. The objective of this study was to compare incision size, wound complications, and postoperative pain of LESS compared with those of laparoscopic cholecystectomy (LC). A prospective randomized controlled study was conducted between January and June 2011 at two university hospitals in Rio de Janeiro, Brazil. Fifty-seven patients were randomly assigned to undergo laparoscopic or LESS cholecystectomy. Skin and aponeurosis wound sizes were recorded. A 10-point visual analog scale (VAS) was used to assess pain at postoperative hours 3 and 24. Healing and wound complications were assessed at follow-up. A total of 57 patients, 53 women and 4 men with a mean age of 48.7 years, were randomly assigned to undergo LESS (n = 28) or LC (n = 29). The mean length of the umbilical skin incision was 4.0 cm (range = 2.1-5.8) in LESS and 2.7 cm (1.5-5.1) in LC (p hernias were not found in either group. The LESS single-port (SP) operations demand a bigger incision than LC surgery. However, there were no differences in healing, wound infections, and hernia development. We found a tendency of less postoperative pain associated with LESS/SP than with LC.

  9. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study.

    Science.gov (United States)

    Del Valle Rubido, Cristina; Solano Calvo, Juan Antonio; Rodríguez Miguel, Antonio; Delgado Espeja, Juan José; González Hinojosa, Jerónimo; Zapico Goñi, Álvaro

    2015-01-01

    To show the decrease in pain and better tolerance to inhalation analgesia with a 50% equimolar mixture of nitrogen protoxide and oxygen in hysteroscopic polypectomy compared with paracervical anesthesia and a control group. One hundred six patients scheduled for office hysteroscopy and polypectomy were divided into the following 3 groups: the control group, the nitrous oxide group, and the paracervical infiltration group. Patients were assigned sequentially (Canadian Task Force classification II-1). The study took place in a hysteroscopy outpatient clinic under the supervision of a gynecologist and 2 nurses trained to cooperate in the trial. One hundred six women from Area III of Madrid Community, Spain, who had been diagnosed with endometrial polyps at a gynecology office and were scheduled for office hysteroscopy and polypectomy agreed to participate in the study. Patients in group 1 (control group) received no treatment. Group 2 received inhaled nitrous oxide and group 3 paracervical infiltration with 1% lidocaine. Pain was assessed using the visual analog scale (0-10). Pain perceived by patients was lower in the nitrous Oxide group (mean: 3.55 ± 0.60, median: 3) versus the control group (mean: 5.49 ± 1.88, median: 6, p nitrous oxide group, and good for the paracervical infiltration group (p nitrous oxide group, whereas in the paracervical infiltration group, there were complications in more than 50% of the patients. No severe complications occurred. Nitrous oxide is a safe and effective analgesic technique for polipectomy office hysteroscopy compared with the paracervical infiltration and control groups. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

  10. Single-blind, randomized, pilot study combining shiatsu and amitriptyline in refractory primary headaches.

    Science.gov (United States)

    Villani, Veronica; Prosperini, Luca; Palombini, Fulvio; Orzi, Francesco; Sette, Giuliano

    2017-06-01

    Complementary alternative medicine, such as shiatsu, can represent a suitable treatment for primary headaches. However, evidence-based data about the effect of combining shiatsu and pharmacological treatments are still not available. Therefore, we tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive shiatsu plus amitriptyline, shiatsu alone, or amitriptyline alone for 3 months. Primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month. After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline. Although all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers (p < 0.05), there was no between-group difference in primary endpoint (p = ns). Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month (p < 0.05). Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment. Shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study. Trial registration 81/2010 (Ethical Committee, S. Andrea Hospital

  11. Psychoanalytic and cognitive-behavior therapy of chronic depression: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Beutel Manfred E

    2012-07-01

    Full Text Available Abstract Background Despite limited effectiveness of short-term psychotherapy for chronic depression, there is a lack of trials of long-term psychotherapy. Our study is the first to determine the effectiveness of controlled long-term psychodynamic and cognitive-behavioral (CBT treatments and to assess the effects of preferential vs. randomized assessment. Methods/design Patients are assigned to treatment according to their preference or randomized (if they have no clear preference. Up to 80 sessions of psychodynamic or psychoanalytically oriented treatments (PAT or up to 60 sessions of CBT are offered during the first year in the study. After the first year, PAT can be continued according to the ‘naturalistic’ usual method of treating such patients within the system of German health care (normally from 240 up to 300 sessions over two to three years. CBT therapists may extend their treatment up to 80 sessions, but focus mainly maintenance and relapse prevention. We plan to recruit a total of 240 patients (60 per arm. A total of 11 assessments are conducted throughout treatment and up to three years after initiation of treatment. The primary outcome measures are the Quick Inventory of Depressive Symptoms (QIDS, independent clinician rating and the Beck Depression Inventory (BDI after the first year. Discussion We combine a naturalistic approach with randomized controlled trials(RCTsto investigate how effectively chronic depression can be treated on an outpatient basis by the two forms of treatment reimbursed in the German healthcare system and we will determine the effects of treatment preference vs. randomization. Trial registration http://www.controlled-trials.com/ISRCTN91956346

  12. Multicenter, randomized, placebo-controlled phase III study of pyridoxalated hemoglobin polyoxyethylene in distributive shock (PHOENIX).

    Science.gov (United States)

    Vincent, Jean-Louis; Privalle, Christopher T; Singer, Mervyn; Lorente, José A; Boehm, Erwin; Meier-Hellmann, Andreas; Darius, Harald; Ferrer, Ricard; Sirvent, Josep-Maria; Marx, Gernot; DeAngelo, Joseph

    2015-01-01

    To compare the effectiveness and safety of the hemoglobin-based nitric oxide scavenger, pyridoxalated hemoglobin polyoxyethylene, against placebo in patients with vasopressor-dependent distributive shock. Multicenter, randomized, placebo-controlled, open-label study. Sixty-one participating ICUs in six European countries (Austria, Belgium, Germany, the Netherlands, Spain, and United Kingdom). All patients admitted with distributive shock, defined as the presence of at least two systemic inflammatory response syndrome criteria, persisting norepinephrine dependence and evidence of organ dysfunction/hypoperfusion despite adequate fluid resuscitation. Patients were randomized to receive 0.25 mL/kg/hr pyridoxalated hemoglobin polyoxyethylene (20 mg Hb/kg/hr) or an equal volume of placebo, infused for up to 150 hours, in addition to conventional vasopressor therapy. The study was stopped after interim analysis showed higher mortality in the pyridoxalated hemoglobin polyoxyethylene group and an increased prevalence of adverse events. At this time, 377 patients had been randomized to pyridoxalated hemoglobin polyoxyethylene (n = 183) or placebo (n = 194). Age, gender, type of patient (medical/surgical), and Acute Physiology and Chronic Health Evaluation II scores were similar between groups. Twenty-eight-day mortality rate was 44.3% in the pyridoxalated hemoglobin polyoxyethylene group versus 37.6% in the placebo group (OR, 1.29; 95% CI, 0.85-1.95; p = 0.227). In patients with higher organ dysfunction scores (Sepsis-related Organ Failure Assessment > 13), mortality rates were significantly higher in the pyridoxalated hemoglobin polyoxyethylene group when compared with those in placebo-treated patients (60.9% vs 39.2%; p = 0.014). Survivors who received pyridoxalated hemoglobin polyoxyethylene had a longer vasopressor-free time (21.3 vs 19.7 d; p = 0.035). In this randomized, controlled phase III trial in patients with vasopressor-dependent distributive shock

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

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

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

  14. Preventive home visits to older people in Denmark: methodology of a randomized controlled study

    DEFF Research Database (Denmark)

    Vass, Mikkel; Avlund, Kirsten; Hendriksen, Carsten

    2002-01-01

    BACKGROUND AND AIMS: Preventive home visits were introduced by legislation in Denmark in 1998. This ongoing randomized controlled intervention study introduces a model where preventive home visits to elderly people are carried out in a standardized way, focusing on early signs of disability...... a preventive program completely on their own. RESULTS: Baseline characteristics were similar in the intervention and control communities with regard to size, rural and urban characteristics and geriatric services, and the individual characteristics of participating persons living in these communities were also...... comparable. The intervention was well accepted and feasible. CONCLUSIONS: When results become available, the study should reveal the most important factors for preventive home visits to elderly people....

  15. Inflammatory Biomarkers and Risk of Schizophrenia: A 2-Sample Mendelian Randomization Study.

    Science.gov (United States)

    Hartwig, Fernando Pires; Borges, Maria Carolina; Horta, Bernardo Lessa; Bowden, Jack; Davey Smith, George

    2017-12-01

    Positive associations between inflammatory biomarkers and risk of psychiatric disorders, including schizophrenia, have been reported in observational studies. However, conventional observational studies are prone to bias, such as reverse causation and residual confounding, thus limiting our understanding of the effect (if any) of inflammatory biomarkers on schizophrenia risk. To evaluate whether inflammatory biomarkers have an effect on the risk of developing schizophrenia. Two-sample mendelian randomization study using genetic variants associated with inflammatory biomarkers as instrumental variables to improve inference. Summary association results from large consortia of candidate gene or genome-wide association studies, including several epidemiologic studies with different designs, were used. Gene-inflammatory biomarker associations were estimated in pooled samples ranging from 1645 to more than 80 000 individuals, while gene-schizophrenia associations were estimated in more than 30 000 cases and more than 45 000 ancestry-matched controls. In most studies included in the consortia, participants were of European ancestry, and the prevalence of men was approximately 50%. All studies were conducted in adults, with a wide age range (18 to 80 years). Genetically elevated circulating levels of C-reactive protein (CRP), interleukin-1 receptor antagonist (IL-1Ra), and soluble interleukin-6 receptor (sIL-6R). Risk of developing schizophrenia. Individuals with schizophrenia or schizoaffective disorders were included as cases. Given that many studies contributed to the analyses, different diagnostic procedures were used. The pooled odds ratio estimate using 18 CRP genetic instruments was 0.90 (random effects 95% CI, 0.84-0.97; P = .005) per 2-fold increment in CRP levels; consistent results were obtained using different mendelian randomization methods and a more conservative set of instruments. The odds ratio for sIL-6R was 1.06 (95% CI, 1.01-1.12; P = .02

  16. A randomization test for controlling population stratification in whole-genome association studies.

    Science.gov (United States)

    Kimmel, Gad; Jordan, Michael I; Halperin, Eran; Shamir, Ron; Karp, Richard M

    2007-11-01

    Population stratification can be a serious obstacle in the analysis of genomewide association studies. We propose a method for evaluating the significance of association scores in whole-genome cohorts with stratification. Our approach is a randomization test akin to a standard permutation test. It conditions on the genotype matrix and thus takes into account not only the population structure but also the complex linkage disequilibrium structure of the genome. As we show in simulation experiments, our method achieves higher power and significantly better control over false-positive rates than do existing methods. In addition, it can be easily applied to whole-genome association studies.

  17. Acupuncture for hot flashes: a randomized, sham-controlled clinical study.

    Science.gov (United States)

    Vincent, Ann; Barton, Debra L; Mandrekar, Jayawant N; Cha, Stephen S; Zais, Teresa; Wahner-Roedler, Dietlind L; Keppler, Marina A; Kreitzer, Mary Jo; Loprinzi, Charles

    2007-01-01

    Hot flashes are a significant problem in women going through the menopausal transition that can substantially affect quality of life. The world of estrogen therapy has been thrown into turmoil with the recent results of the Women's Health Initiative trial report. Pursuant to a growing interest in the use of alternative therapies to alleviate menopausal symptoms and a few pilot trials that suggested that acupuncture could modestly alleviate hot flashes, a prospective, randomized, single-blind, sham-controlled clinical trial was conducted in women experiencing hot flashes. Participants, after being randomized to medical versus sham acupuncture, received biweekly treatments for 5 weeks after a baseline assessment week. They were then followed for an additional 7 weeks. Participants completed daily hot flash questionnaires, which formed the basis for analysis. A total of 103 participants were randomized to medical or sham acupuncture. At week 6 the percentage of residual hot flashes was 60% in the medical acupuncture group and 62% in the sham acupuncture group. At week 12, the percentage of residual hot flashes was 73% in the medical acupuncture group and 55% in the sham acupuncture group. Participants reported no adverse effects related to the treatments. The results of this study suggest that the used medical acupuncture was not any more effective for reducing hot flashes than was the chosen sham acupuncture.

  18. Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shi Guang-Xia

    2012-11-01

    Full Text Available Abstract Background Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the theory of traditional Chinese medicine, acupoints located on both the adjacent and distal area of the disease can be needled to treat disease. Furthermore, the way of combining acupoints is for strengthening the curative effect. We aim to evaluate the efficacy of acupuncture at local points in combination with distal points in subjective tinnitus patients. Method This trial is a randomized, single-blind, controlled study. A total of 112 participants will be randomly assigned to one of four treatment groups receiving acupuncture treatment for 4 weeks. The primary outcome measure is subjective tinnitus loudness and annoyance perception, which is graded using the Visual Analogue Scale (VAS. The assessment is at baseline (before treatment initiation, 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion Completion of this trial will help to identify whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN29230777

  19. HDL Cholesterol, LDL Cholesterol, and Triglycerides as Risk Factors for CKD: A Mendelian Randomization Study.

    Science.gov (United States)

    Lanktree, Matthew B; Thériault, Sébastien; Walsh, Michael; Paré, Guillaume

    2017-07-26

    High-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride concentrations are heritable risk factors for vascular disease, but their role in the progression of chronic kidney disease (CKD) is unclear. 2-sample Mendelian randomization analysis of data derived from the largest published lipid and CKD studies. Effect of independent genetic variants significantly associated with lipid concentrations was obtained from the Global Lipids Genetics Consortium (n=188,577), and the effect of these same variants on estimated glomerular filtration rate (eGFR), CKD (defined as eGFRGenetics Consortium (n=133,814). Using conventional, multivariable, and Egger Mendelian randomization approaches, we assessed the causal association between genetically determined lipid concentrations and kidney traits. eGFR, dichotomous eGFRGenetically higher triglyceride concentrations appeared associated with higher eGFRs, but this finding was driven by a single pleiotropic variant in the glucokinase regulator gene (GCKR). After exclusion, genetically higher triglyceride concentration was not associated with any kidney trait. Individual patient-level phenotype and genotype information were unavailable. 2-sample Mendelian randomization analysis of data from the largest lipid and CKD cohorts supports genetically higher HDL cholesterol concentration as causally associated with better kidney function. There was no association between genetically altered LDL cholesterol or triglyceride concentration and kidney function. Further analysis of CKD outcomes in HDL cholesterol intervention trials is warranted. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  20. Balloon catheter vs. cervical vacuum cup for hysterosalpingography: a prospective, randomized, single-blinded study.

    Science.gov (United States)

    Ricci, Giuseppe; Guastalla, Pierpaolo; Ammar, Lydie; Cervi, Gina; Guarnieri, Silvia; Sartore, Andrea

    2007-06-01

    To compare the use of a balloon catheter device with the use of a cervical vacuum cup device in performing hysterosalpingography (HSG). Prospective, randomized, single-blinded study. Tertiary infertility center. Two hundred twenty-nine infertile women undergoing HSG. Subjects were randomized to undergo HSG using a cervical vacuum cup (n = 115) or a balloon catheter (n = 114). Randomization was performed according to Consolidated Standard of Reporting Trials (CONSORT) guidelines. The degree of pain experienced during and after the HSG, evaluated using a 100-mm visual analogue scale. The length of the procedure, the fluoroscopic time, the volume of contrast used, the difficulty of performing HSG, and the percentage of complications were also evaluated. Women in the cervical-cup group experienced more pain than those in the balloon catheter group during the contrast injection (median visual analogue scale pain scores, 13.0 vs. 6.5). The placement of the balloon catheter in comparison with the cervical cup was slightly easier to perform, although it required a somewhat longer time. The HSG using the cervical cup required less fluoroscopic time (median, 0.6 vs. 0.8 min). The balloon catheter appears to be better tolerated than the cervical cup, but the difference is minimal. The use of the cervical cup allows shortening of the patient radiation exposure.

  1. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

  2. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Bindu John

    2016-01-01

    Full Text Available Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n=34; control group, n=24. Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

  3. An empirical study of the complexity and randomness of prediction error sequences

    Science.gov (United States)

    Ratsaby, Joel

    2011-07-01

    We investigate a population of binary mistake sequences that result from learning with parametric models of different order. We obtain estimates of their error, algorithmic complexity and divergence from a purely random Bernoulli sequence. We study the relationship of these variables to the learner's information density parameter which is defined as the ratio between the lengths of the compressed to uncompressed files that contain the learner's decision rule. The results indicate that good learners have a low information density ρ while bad learners have a high ρ. Bad learners generate mistake sequences that are atypically complex or diverge stochastically from a purely random Bernoulli sequence. Good learners generate typically complex sequences with low divergence from Bernoulli sequences and they include mistake sequences generated by the Bayes optimal predictor. Based on the static algorithmic interference model of [18] the learner here acts as a static structure which "scatters" the bits of an input sequence (to be predicted) in proportion to its information density ρ thereby deforming its randomness characteristics.

  4. Cognitive Effects of Treating Obstructive Sleep Apnea in Alzheimer's Disease: A Randomized Controlled Study

    Science.gov (United States)

    Ancoli-Israel, Sonia; Palmer, Barton W.; Cooke, Jana R.; Corey-Bloom, Jody; Fiorentino, Lavinia; Natarajan, Loki; Liu, Lianqi; Ayalon, Liat; He, Feng; Loredo, Jose S.

    2008-01-01

    OBJECTIVE: To examine whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) in patients with Alzheimer's disease (AD) would result in improved cognitive function. DESIGN: Randomized double-blind placebo-controlled trial. Participants were randomized to either therapeutic CPAP for six weeks or placebo CPAP for three weeks followed by therapeutic CPAP for three weeks. SETTING: General clinical research center PARTICIPANTS: 52 men and women with mild-moderate AD and OSA INTERVENTION: Continuous positive airway pressure MEASUREMENTS: A complete neuropsychological test battery was administered before treatment, at three and at six-weeks. RESULTS: A comparison of subjects randomized to 3 weeks of therapeutic versus placebo CPAP suggested no significant improvements in cognition. A comparison of pre- versus post-treatment neuropsychological test scores after 3 weeks of therapeutic CPAP in both groups showed a significant improvement in cognition. The study was underpowered to make definitive statements about improvements within specific cognitive constructs. However, exploratory post-hoc examination of change scores for individual tests suggested improvements in episodic verbal learning and memory and some aspects of executive functioning such as cognitive flexibility, and mental processing speed. CONCLUSIONS: OSA may aggravate cognitive dysfunction in dementia and thus may be a reversible cause of cognitive loss in AD patients. OSA treatment seems to improve some of the cognitive functioning. Clinicians who care for AD patients should consider implementing CPAP treatment when OSA is present. PMID:18795985

  5. Random-effects meta-analysis: the number of studies matters.

    Science.gov (United States)

    Guolo, Annamaria; Varin, Cristiano

    2017-06-01

    This paper investigates the impact of the number of studies on meta-analysis and meta-regression within the random-effects model framework. It is frequently neglected that inference in random-effects models requires a substantial number of studies included in meta-analysis to guarantee reliable conclusions. Several authors warn about the risk of inaccurate results of the traditional DerSimonian and Laird approach especially in the common case of meta-analysis involving a limited number of studies. This paper presents a selection of likelihood and non-likelihood methods for inference in meta-analysis proposed to overcome the limitations of the DerSimonian and Laird procedure, with a focus on the effect of the number of studies. The applicability and the performance of the methods are investigated in terms of Type I error rates and empirical power to detect effects, according to scenarios of practical interest. Simulation studies and applications to real meta-analyses highlight that it is not possible to identify an approach uniformly superior to alternatives. The overall recommendation is to avoid the DerSimonian and Laird method when the number of meta-analysis studies is modest and prefer a more comprehensive procedure that compares alternative inferential approaches. R code for meta-analysis according to all of the inferential methods examined in the paper is provided.

  6. Psychological treatment of depression: A meta-analytic database of randomized studies

    Directory of Open Access Journals (Sweden)

    van Straten Annemieke

    2008-05-01

    Full Text Available Abstract Background A large number of randomized controlled studies have clearly demonstrated that psychological interventions are effective in the treatment of depression. The number of studies in this area is increasing rapidly. In this paper, we present a database of controlled and comparative outcome studies on psychological treatments of depression, based on a series of meta-analyses published by our group. The database can be accessed freely through the Internet. Description We conducted a comprehensive literature search of the major bibliographical databases (Pubmed; Psycinfo; Embase; Cochrane Central Register of Controlled Trials and we examined the references of 22 earlier meta-analyses of psychological treatment of depression. We included randomized studies in which the effects of a psychological therapy on adults with depression were compared to a control condition, another psychological intervention, or a combined treatment (psychological plus pharmacological. We conducted nine meta-analyses of subgroups of studies taken from this dataset. The 149 studies included in these 9 meta-analyses are included in the current database. In the 149 included studies, a total of 11,369 patients participated. In the database, we present selected characteristics of each study, including characteristics of the patients (the study population, recruitment method, definition of depression; characteristics of the experimental conditions and interventions (the experimental conditions, N per condition, format, number of sessions; and study characteristics (measurement times, measures used, attrition, type of analysis and country. Conclusion The data on the 149 included studies are presented in order to give other researchers access to the studies we collected, and to give background information about the meta-analyses we have published using this dataset. The number of studies examining the effects of psychological treatments of depression has increased

  7. Design of the Polish Colonoscopy Screening Program: a randomized health services study.

    Science.gov (United States)

    Kaminski, Michal F; Kraszewska, Ewa; Rupinski, Maciej; Laskowska, Milena; Wieszczy, Paulina; Regula, Jaroslaw

    2015-12-01

    Colonoscopy screening for colorectal cancer has been implemented without evidence from randomized controlled trials quantifying its benefit and invariably as an opportunistic program, both of which are contrary to the European Union guideline recommendations. The aim of this paper is to describe the rationale and design of the first population-based colonoscopy screening program (PCSP), which was launched in Poland in 2012 as a randomized health services (RHS) study. The PCSP is a natural extension of opportunistic colonoscopy screening implemented in 2000. It uses colonoscopy capacity, a quality assurance program, and a network of 92 centers built up during the opportunistic screening phase to develop a countrywide PCSP. Within the PCSP, single screening colonoscopy is offered to a target population aged 55-64 years. The PCSP uses an RHS design, which means that eligible individuals drawn from population registries are randomly assigned to immediate or postponed invitation to screening. Individuals from birth cohorts that will reach the upper age limit for screening before full implementation of the PCSP are randomly assigned, in a 1:1:1 ratio, to "immediate" screening, "postponed" screening, or a "never invited" control group. The RHS design is a natural platform that will evaluate the effectiveness of screening, and compare different age ranges for screening, invitation procedures, and quality improvement interventions. Up to 2015, 24 centers have been developed, with 34.2% geographic coverage and 851,535 individuals enrolled. The PCSP sets an example for implementation of population-based colonoscopy screening with experimental design to ensure proper evaluation of its effectiveness. © Georg Thieme Verlag KG Stuttgart · New York.

  8. Childhood adiposity and risk of type 1 diabetes: A Mendelian randomization study.

    Science.gov (United States)

    Censin, J C; Nowak, Christoph; Cooper, Nicholas; Bergsten, Peter; Todd, John A; Fall, Tove

    2017-08-01

    The incidence of type 1 diabetes (T1D) is increasing globally. One hypothesis is that increasing childhood obesity rates may explain part of this increase, but, as T1D is rare, intervention studies are challenging to perform. The aim of this study was to assess this hypothesis with a Mendelian randomization approach that uses genetic variants as instrumental variables to test for causal associations. We created a genetic instrument of 23 single nucleotide polymorphisms (SNPs) associated with childhood adiposity in children aged 2-10 years. Summary-level association results for these 23 SNPs with childhood-onset (Mendelian randomization analysis, we found support for an effect of childhood adiposity on T1D risk (odds ratio 1.32, 95% CI 1.06-1.64 per standard deviation score in body mass index [SDS-BMI]). A sensitivity analysis provided evidence of horizontal pleiotropy bias (p = 0.04) diluting the estimates towards the null. We therefore applied Egger regression and multivariable Mendelian randomization methods to control for this type of bias and found evidence in support of a role of childhood adiposity in T1D (odds ratio in Egger regression, 2.76, 95% CI 1.40-5.44). Limitations of our study include that underlying genes and their mechanisms for most of the genetic variants included in the score are not known. Mendelian randomization requires large sample sizes, and power was limited to provide precise estimates. This research has been conducted using data from the Early Growth Genetics (EGG) Consortium, the Genetic Investigation of Anthropometric Traits (GIANT) Consortium, the Tobacco and Genetics (TAG) Consortium, and the Social Science Genetic Association Consortium (SSGAC), as well as meta-analysis results from a T1D genome-wide association study. This study provides genetic support for a link between childhood adiposity and T1D risk. Together with evidence from observational studies, our findings further emphasize the importance of measures to reduce the

  9. Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial

    OpenAIRE

    Sofi, Francesco; Dinu, Monica; Pagliai, Giuditta; Cesari, Francesca; Marcucci, Rossella; Casini, Alessandro

    2016-01-01

    Background Nutrition is able to alter the cardiovascular health of the general population. However, the optimal dietary strategy for cardiovascular disease prevention is still far from being defined. Mediterranean and vegetarian diets are those reporting the greatest grade of evidence in the literature, but no experimental studies comparing these two dietary patterns are available. Methods/design This is an open randomized crossover clinical trial including healthy subjects with a low-to-medi...

  10. Do federal and state audits increase compliance with a grant program to improve municipal infrastructure (AUDIT study): study protocol for a randomized controlled trial

    National Research Council Canada - National Science Library

    De La O, Ana L; Martel García, Fernando

    2014-01-01

    .... This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service...

  11. The Ex-PRESS glaucoma shunt versus trabeculectomy in open-angle glaucoma: a prospective randomized study

    NARCIS (Netherlands)

    de Jong, Leo A. M. S.

    2009-01-01

    The purpose of this study was to establish the efficacy and safety of the Ex-PRESS (Optonol Ltd., Neve Ilan, Israel) mini glaucoma shunt in open-angle glaucoma. This was a prospective, randomized trial. Eyes from enrolled patients were randomly assigned to either Ex-PRESS implantation under a

  12. Mendelian randomization study of body mass index and colorectal cancer risk

    Science.gov (United States)

    Thrift, Aaron P.; Gong, Jian; Peters, Ulrike; Chang-Claude, Jenny; Rudolph, Anja; Slattery, Martha L.; Chan, Andrew T.; Locke, Adam E.; Kahali, Bratati; Justice, Anne E.; Pers, Tune H.; Gallinger, Steven; Hayes, Richard B; Baron, John A.; Caan, Bette J.; Ogino, Shuji; Berndt, Sonja I.; Chanock, Stephen J.; Casey, Graham; Haile, Robert W.; Du, Mengmeng; Harrison, Tabitha A.; Thornquist, Mark; Duggan, David J.; Le Marchand, Loïc; Lindor, Noralane M.; Seminara, Daniela; Song, Mingyang; Wu, Kana; Thibodeau, Stephen N.; Cotterchio, Michelle; Win, Aung Ko; Jenkins, Mark A.; Hopper, John L.; Ulrich, Cornelia M.; Potter, John D.; Newcomb, Polly A.; Hoffmeister, Michael; Brenner, Hermann; White, Emily; Hsu, Li; Campbell, Peter T.

    2015-01-01

    Background High body mass index (BMI) is consistently linked to increased risk of colorectal cancer (CRC) for men, whereas the association is less clear for women. As risk estimates from observational studies may be biased and/or confounded, we conducted a Mendelian randomization study to estimate the causal association between BMI and CRC. Methods We used data from 10,226 CRC cases and 10,286 controls of European ancestry. The Mendelian randomization analysis used a weighted genetic risk score, derived from 77 genome-wide association study identified variants associated with higher BMI, as an instrumental variable (IV). We compared the IV odds ratio (IV-OR) with the OR obtained using a conventional covariate-adjusted analysis. Results Individuals carrying greater numbers of BMI-increasing alleles had higher CRC risk (per weighted allele OR, 1.31; 95% confidence interval [CI], 1.10–1.57). Our IV estimation results support the hypothesis that genetically influenced BMI is directly associated with risk for CRC (IV-OR per 5 kg/m2, 1.50; 95% CI, 1.13–2.01). In the sex-specific IV analyses higher BMI was associated with higher risk of CRC among women (IV-OR per 5 kg/m2, 1.82; 95% CI, 1.26–2.61). For men, genetically influenced BMI was not associated with CRC (IV-OR per 5 kg/m2, 1.18; 95% CI, 0.73–1.92). Conclusions High BMI was associated with increased CRC risk for women. Whether abdominal obesity, rather than overall obesity, is a more important risk factor for men requires further investigation. Impact Overall, conventional epidemiologic and Mendelian randomization studies suggest a strong association between obesity and the risk of CRC. PMID:25976416

  13. Audio-recorded information to patients considering participation in cancer clinical trials - a randomized study.

    Science.gov (United States)

    Bergenmar, Mia; Johansson, Hemming; Wilking, Nils; Hatschek, Thomas; Brandberg, Yvonne

    2014-09-01

    Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial. Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent. A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge. The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.

  14. Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

    2015-07-15

    Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

  15. Driving with Intuition: A Preregistered Study about the EEG Anticipation of Simulated Random Car Accidents.

    Directory of Open Access Journals (Sweden)

    Gian Marco Duma

    Full Text Available The study of neural pre-stimulus or "anticipatory" activity opened a new window for understanding how the brain actively constructs the forthcoming reality. Usually, experimental paradigms designed to study anticipatory activity make use of stimuli. The purpose of the present study is to expand the study of neural anticipatory activity upon the temporal occurrence of dichotomic, statistically unpredictable (random stimuli within an ecological experimental paradigm. To this purpose, we used a simplified driving simulation including two possible, randomly-presented trial types: a car crash end trial and a no car crash end trial. Event Related Potentials (ERP were extracted -3,000 ms before stimulus onset. We identified a fronto-central negativity starting around 1,000 ms before car crash presentation. By contrast, a whole-scalp distributed positivity characterized the anticipatory activity observed before the end of the trial in the no car crash end condition. The present data are in line with the hypothesis that the brain may also anticipate dichotomic, statistically unpredictable stimuli, relaying onto different pre-stimulus ERP activity. Possible integration with car-smart-systems is also suggested.

  16. [EFFICACY OF SELF-MONITORING IN WEIGHT LOSS: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED STUDIES].

    Science.gov (United States)

    Estrada Ruelas, Katia; Bacardí-Gascon, Montserrat; Jiménez-Cruz, Arturo

    2015-12-01

    different studies have shown a strong relationship between self-monitoring and weight loss. The objective of this review was to analyze randomized clinical trials using self-monitoring as a strategy for weight loss. a search was conducted in PubMed database of randomized controlled trials using self-monitoring for weight loss in adults, published in English and Spanish, from January 1st, 2009 to April 30th, 2015. The sample size, age, weight loss, BMI, intervention strategy, duration, and retention rate, were recorded. six studies met the selection criteria. The intervention and the follow-up ranged from 3 to 12 months. The study population ranged from 18-74 years of age and included subjects from 50-329. Weight loss ranged from 1.14 to 2.1 kg in the control group and -1.27 to -6.1 kg in the intervention group. The six studies determined a greater weight loss in the self-monitoring group with moderate to high evaluation evidence. greater weight loss was consistently found in the self-monitoring group. These results suggest the need to use self-monitoring as a strategy for weight loss. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  17. Prevention of Cisplatin-Induced Hearing Loss by Intratympanic Dexamethasone: A Randomized Controlled Study.

    Science.gov (United States)

    Marshak, Tal; Steiner, Mariana; Kaminer, Margalith; Levy, Levana; Shupak, Avi

    2014-06-01

    To examine the role of intratympanic Dexamethasone (ITD) in the prevention of Cisplatin-induced hearing loss. Prospective randomized controlled clinical trial. Tertiary referral center. Twenty-six patients suffering from a neoplastic disease for which the treatment protocol included Cisplatin were recruited. Prior to each Cisplatin treatment session ITD was injected to the baseline randomly assigned ear while the other ear of the same patient served as the control. Audiometry and Distortion Product Otoacoustic Emissions (DPOAEs) test results of the baseline and follow-up examinations were compared within and between the study and control ears. The cumulative dose of Cisplatin was greater than 400 mg for the 15 subjects who completed the study. The pure tone threshold at 8000 Hz and pure tone average threshold at 4000 to 8000 Hz significantly increased in both the study (P control ears (P control (P control (P < .04) but not in the study ears. ITD significantly attenuated hearing loss at 6000 Hz and decreased the outer hair dysfunction in the DPOAE f2 range of 4000 to 8000 Hz. ITD might have potential in the reduction of Cisplatin-induced hearing loss. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  18. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study.

    Science.gov (United States)

    Lai, Jenny M; Francisco, Gerard E; Willis, F Buck

    2009-02-01

    Over 1.5 million Americans are diagnosed with a stroke each year, and excessive flexion or extension (hypertonia) of upper extremity joints are common secondary conditions. The purpose of this study was to compare the efficacy of botulinum toxin type-A and manual therapy, with the adjunct treatment of dynamic splinting on range of motion, spasticity, and elbow flexor hypertonia, in a randomized trial. Thirty-six subjects were recruited for this pilot study and all exhibited hypertonia in elbow flexion. Six patients were excluded due to noncompliance. Testing was done with pre/post active range of motion in elbow extension, and the Modified Ashworth Scale (extension) for spasticity. All patients received the current standard of care: botulinum toxin type-A injections and manual therapy. Experimental patients were randomly assigned adjunct treatment with Elbow Extension Dynasplint. Thirty patients completed the study (mean age [SD] 52+/-17 years). The percentage of change in active range of motion in elbow extension was greater for the experimental than for control subjects (33.5% vs. 18.7%). The Modified Ashworth Scale (extension) scores showed comparable changes of a mean 9.3% improvement for experimental versus 8.6% for the control subjects. This study confirmed the efficacy of botulinum toxin type-A in tone management and occupational therapy in contracture reduction. It also showed the value of dynamic splinting in maintaining gains in range of motion.

  19. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    Zhang-Jin Zhang

    Full Text Available BACKGROUND: Previous studies suggest that electroacupuncture possesses therapeutic benefits for depressive disorders. The purpose of this study was to determine whether dense cranial electroacupuncture stimulation (DCEAS could enhance the antidepressant efficacy in the early phase of selective serotonin reuptake inhibitor (SSRI treatment of major depressive disorder (MDD. METHODS: In this single-blind, randomized, controlled study, patients with MDD were randomly assigned to 9-session DCEAS or noninvasive electroacupuncture (n-EA control procedure in combination with fluoxetine (FLX for 3 weeks. Clinical outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17, Clinical Global Impression-severity (CGI-S, and Self-rating Depression Scale (SDS as well as the response and remission rates. RESULTS: Seventy-three patients were randomly assigned to n-EA (n = 35 and DCEAS (n = 38, of whom 34 in n-EA and 36 in DCEAS group were analyzed. DCEAS-treated patients displayed a significantly greater reduction from baseline in HAMD-17 scores at Day 3 through Day 21 and in SDS scores at Day 3 and Day 21 compared to patients receiving n-EA. DCEAS intervention also produced a higher rate of clinically significant response compared to n-EA procedure (19.4% (7/36 vs. 8.8% (3/34. The incidence of adverse events was similar in the two groups. CONCLUSIONS: DCEAS is a safe and effective intervention that augments the antidepressant efficacy. It can be considered as an additional therapy in the early phase of SSRI treatment of depressed patients. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88008690.

  20. No clear support for a role for vitamin D in Parkinson's disease: A Mendelian randomization study.

    Science.gov (United States)

    Larsson, Susanna C; Singleton, Andrew B; Nalls, Mike A; Richards, J Brent

    2017-08-01

    Observational studies have found that relative to healthy controls, patients with Parkinson's disease have lower circulating concentrations of 25-hydroxyvitamin D, a clinical biomarker of vitamin D status. However, the causality of this association is uncertain. We undertook a Mendelian randomization study to investigate whether genetically decreased 25-hydroxyvitamin D concentrations are associated with PD to minimize confounding and prevent bias because of reverse causation. As instrumental variables for the Mendelian randomization analysis, we used 4 single-nucleotide polymorphisms that affect 25-hydroxyvitamin D concentrations (rs2282679 in GC, rs12785878 near DHCR7, rs10741657 near CYP2R1, and rs6013897 near CYP24A1). Summary effect size estimates of the 4 single-nucleotide polymorphisms on PD were obtained from the International Parkinson's Disease Genomics Consortium (including 5333 PD cases and 12,019 controls). The estimates of the 4 single-nucleotide polymorphisms were combined using an inverse-variance weighted meta-analysis. Of the 4 single-nucleotide polymorphisms associated with 25-hydroxyvitamin D concentrations, one (rs6013897 in CYP24A1) was associated with PD (odds ratio per 25-hydroxyvitamin D-decreasing allele, 1.09; 95% confidence interval, 1.02-1.16; P = 0.008), whereas no association was observed with the other 3 single-nucleotide polymorphisms (P > 0.23). The odds ratio of PD per genetically predicted 10% lower 25-hydroxyvitamin D concentration, based on the 4 single-nucleotide polymorphisms, was 0.98 (95% confidence interval, 0.93-1.04; P = 0.56). This Mendelian randomization study provides no clear support that lowered 25-hydroxyvitamin D concentration is causally associated with risk of PD. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

  1. Exploring the Causal Pathway From Telomere Length to Coronary Heart Disease: A Network Mendelian Randomization Study.

    Science.gov (United States)

    Zhan, Yiqiang; Karlsson, Ida K; Karlsson, Robert; Tillander, Annika; Reynolds, Chandra A; Pedersen, Nancy L; Hägg, Sara

    2017-07-21

    Observational studies have found shorter leukocyte telomere length (TL) to be a risk factor for coronary heart disease (CHD), and recently the association was suggested to be causal. However, the relationship between TL and common metabolic risk factors for CHD is not well understood. Whether these risk factors could explain pathways from TL to CHD warrants further attention. To examine whether metabolic risk factors for CHD mediate the causal pathway from short TL to increased risk of CHD using a network Mendelian randomization design. Summary statistics from several genome-wide association studies were used in a 2-sample Mendelian randomization study design. Network Mendelian randomization analysis-an approach using genetic variants as the instrumental variables for both the exposure and mediator to infer causality-was performed to examine the causal association between telomeres and CHD and metabolic risk factors. Summary statistics from the ENGAGE Telomere Consortium were used (n=37 684) as a TL genetic instrument, CARDIoGRAMplusC4D Consortium data were used (case=22 233 and control=64 762) for CHD, and other consortia data were used for metabolic traits (fasting insulin, triglyceride, total cholesterol, low-density lipoprotein cholesterol, fasting glucose, diabetes mellitus, glycohemoglobin, body mass index, waist circumference, and waist:hip ratio). One-unit increase of genetically determined TL was associated with -0.07 (95% confidence interval, -0.01 to -0.12; P=0.01) lower log-transformed fasting insulin (pmol/L) and 21% lower odds (95% confidence interval, 3-35; P=0.02) of CHD. Higher genetically determined log-transformed fasting insulin level was associated with higher CHD risk (odds ratio, 1.86; 95% confidence interval, 1.01-3.41; P=0.04). Overall, our findings support a role of insulin as a mediator on the causal pathway from shorter telomeres to CHD pathogenesis. © 2017 American Heart Association, Inc.

  2. Aromatherapy for reducing colonoscopy related procedural anxiety and physiological parameters: a randomized controlled study.

    Science.gov (United States)

    Hu, Pei-Hsin; Peng, Yen-Chun; Lin, Yu-Ting; Chang, Chi-Sen; Ou, Ming-Chiu

    2010-01-01

    Colonoscopy is generally tolerated, some patients regarding the procedure as unpleasant and painful and generally performed with the patient sedated and receiving analgesics. The effect of sedation and analgesia for colonoscopy is limited. Aromatherapy is also applied to gastrointestinal endoscopy to reduce procedural anxiety. There is lack of information about aromatherapy specific for colonoscopy. In this study, we aimed to performed a randomized controlled study to investigate the effect of aromatherapy on relieve anxiety, stress and physiological parameters of colonoscopy. A randomized controlled trail was carried out and collected in 2009 and 2010. The participants were randomized in two groups. Aromatherapy was then carried out by inhalation of Sunflower oil (control group) and Neroli oil (Experimental group). The anxiety index was evaluated by State Trait Anxiety Inventory-state (STAI-S) score before aromatherapy and after colonoscopy as well as the pain index for post-procedural by visual analogue scale (VAS). Physiological indicators, such as blood pressure (systolic and diastolic blood pressure), heart rate and respiratory rate were evaluated before and after aromatherapy. Participates in this study were 27 subjects, 13 in control group and 14 in Neroli group with average age 52.26 +/- 17.79 years. There was no significance of procedural anxiety by STAI-S score and procedural pain by VAS. The physiological parameters showed a significant lower pre- and post-procedural systolic blood pressure in Neroli group than control group. Aromatic care for colonoscopy, although with no significant effect on procedural anxiety, is an inexpensive, effective and safe pre-procedural technique that could decrease systolic blood pressure.

  3. Postural control and shoulder steadiness in F-16 pilots: a randomized controlled study.

    Science.gov (United States)

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S; Toft, Palle; Jørgensen, Marie B; Søgaard, Karen; Sjøgaard, Gisela

    2014-04-01

    During maneuvering, fighter pilots experience loads of up to 50-70 kg on their necks. Neck disorders are common and have been linked to impairment in muscle control. We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain. The current study reports the results of the secondary objective, which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief. In a parallel, single-blinded, randomized controlled study, 55 F-16 pilots were evaluated at baseline and randomized to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. At follow-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain. Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity, and there may be a ceiling effect in the ability to improve these parameters. For individuals with highly developed physiological capacity, a battery of tests with more stringent demands should be considered, e.g., increased number of repetitions, prolonged duration of the tests, or testing with eyes closed.

  4. Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

    Science.gov (United States)

    Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

    2017-12-01

    To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

  5. TVT-Exact and midurethral sling (SLING-IUFT) operative procedures: a randomized study.

    Science.gov (United States)

    Aniuliene, Rosita; Aniulis, Povilas; Skaudickas, Darijus

    2015-01-01

    The aim of the study is to compare results, effectiveness and complications of TVT exact and midurethral sling (SLING-IUFT) operations in the treatment of female stress urinary incontinence (SUI). A single center nonblind, randomized study of women with SUI who were randomized to TVT-Exact and SLING-IUFT was performed by one surgeon from April 2009 to April 2011. SUI was diagnosed on coughing and Valsalva test and urodynamics (cystometry and uroflowmetry) were assessed before operation and 1 year after surgery. This was a prospective randomized study. The follow up period was 12 months. 76 patients were operated using the TVT-Exact operation and 78 patients - using the SLING-IUFT operation. There was no statistically significant differences between groups for BMI, parity, menopausal status and prolapsed stage (no patients had cystocele greater than stage II). Mean operative time was significantly shorter in the SLING-IUFT group (19 ± 5.6 min.) compared with the TVT-Exact group (27 ± 7.1 min.). There were statistically significant differences in the effectiveness of both procedures: TVT-Exact - at 94.5% and SLING-IUFT - at 61.2% after one year. Hospital stay was statistically significantly shorter in the SLING-IUFT group (1. 2 ± 0.5 days) compared with the TVT-Exact group (3.5 ± 1.5 days). Statistically significantly fewer complications occurred in the SLING-IUFT group. the TVT-Exact and SLING-IUFT operations are both effective for surgical treatment of female stress urinary incontinence. The SLING-IUFT involved a shorter operation time and lower complications rate., the TVT-Exact procedure had statistically significantly more complications than the SLING-IUFT operation, but a higher effectiveness.

  6. Study protocol: optimization of complex palliative care at home via telemedicine. A cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hasselaar Jeroen

    2011-08-01

    Full Text Available Abstract Background Due to the growing number of elderly with advanced chronic conditions, healthcare services will come under increasing pressure. Teleconsultation is an innovative approach to deliver quality of care for palliative patients at home. Quantitative studies assessing the effect of teleconsultation on clinical outcomes are scarce. The aim of this present study is to investigate the effectiveness of teleconsultation in complex palliative homecare. Methods/Design During a 2-year recruitment period, GPs are invited to participate in this cluster randomized controlled trial. When a GP refers an eligible patient for the study, the GP is randomized to the intervention group or the control group. Patients in the intervention group have a weekly teleconsultation with a nurse practitioner and/or a physician of the palliative consultation team. The nurse practitioner, in cooperation with the palliative care specialist of the palliative consultation team, advises the GP on treatment policy of the patient. The primary outcome of patient symptom burden is assessed at baseline and weekly using the Edmonton Symptom Assessment Scale (ESAS and at baseline and every four weeks using the Hospital Anxiety and Depression Scale (HADS. Secondary outcomes are self-perceived burden from informal care (EDIZ, patient experienced continuity of medical care (NCQ, patient and caregiver satisfaction with the teleconsultation (PSQ, the experienced problems and needs in palliative care (PNPC-sv and the number of hospital admissions. Discussion This is one of the first randomized controlled trials in palliative telecare. Our data will verify whether telemedicine positively affects palliative homecare. Trial registration The Netherlands National Trial Register NTR2817

  7. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study.

    Directory of Open Access Journals (Sweden)

    Martina Kollmann

    Full Text Available Early bonding by skin-to-skin contact (SSC has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC after cesarean section on neonatal adaptation, maternal pain and stress response.This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria between September 2013 and January 2014. Women were randomly assigned to intraoperative ("early" SCC (n = 17 versus postoperative ("late" SCC (n = 18. Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature, maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase.There was no evidence for differences in parameters reflecting neonatal transition or stress response between the 'Early SSC Group' and the 'Late SSC Group'. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group' (p = 0.004.This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group', which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial.ClinicalTrials.gov NCT01894880.

  8. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study

    DEFF Research Database (Denmark)

    Nielsen, T L; Eeftinck Schattenkerk, J K; Jensen, B N

    1992-01-01

    Fifty-nine human immunodeficiency virus type-1-infected patients with a microscopically proven first episode of moderate to severe Pneumocystis carinii pneumonia (PCP) were enrolled into a randomized European multicenter study. The effect of adjunctive corticosteroid (CS) therapy was assessed on (a...... (10%) in the CS group; p = 0.01. The 90-day survival was 69% in controls versus 87% in CS patients; p = 0.07. Based on these data we conclude that adjunctive CS therapy for moderate to severe PCP in AIDS patients reduces the acute mortality and the need for mechanical ventilation....

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

    Science.gov (United States)

    Lane, Joseph P; Stone, Vathsala I

    2015-01-01

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

  10. Studies in astronomical time series analysis. I - Modeling random processes in the time domain

    Science.gov (United States)

    Scargle, J. D.

    1981-01-01

    Several random process models in the time domain are defined and discussed. Attention is given to the moving average model, the autoregressive model, and relationships between and combinations of these models. Consideration is then given to methods for investigating pulse structure, procedures of model construction, computational methods, and numerical experiments. A FORTRAN algorithm of time series analysis has been developed which is relatively stable numerically. Results of test cases are given to study the effect of adding noise and of different distributions for the pulse amplitudes. A preliminary analysis of the light curve of the quasar 3C 272 is considered as an example.

  11. A randomized double-blind study evaluating Anandron associated with orchiectomy in stage D prostate cancer.

    Science.gov (United States)

    Namer, M; Toubol, J; Caty, A; Couette, J E; Douchez, J; Kerbrat, P; Droz, J P

    1990-12-20

    A randomized double-blind study with a 3-yr follow-up comparing the two arms "orchiectomy + Anandron (300 mg)" vs "orchiectomy + placebo" in 125 patients with stage D prostate cancer has confirmed the beneficial effects of the combined Anandron therapy on subjective parameters and on the best objective response (NPCP criteria), although these effects were not statistically significant, but failed to detect any improvement in time-to-disease progression or survival. Comparison with the results of other trials emphasizes the urgent need to establish suitable prognostic factors by further clinical research before evaluating the benefits of individual drugs.

  12. Directed polymer in random media in two dimensions: Numerical study of the aging dynamics

    Science.gov (United States)

    Barrat, A.

    1997-05-01

    Following a recent work by Yoshino [J. Phys. A 29, 1421 (1996)], we study the aging dynamics of a directed polymer in random media, in 1+1 dimensions. Through temperature quench and temperature cycling numerical experiments similar to the experiments on real spin glasses, we show that the observed behavior is comparable to that of a well-known mean-field spin glass model. The observation of various quantities (correlation function, ``clonation'' overlap function, etc.) leads to an analysis of the phase space landscape.

  13. Randomized controlled study of a retiree health promotion program. The Bank of American Study.

    Science.gov (United States)

    Leigh, J P; Richardson, N; Beck, R; Kerr, C; Harrington, H; Parcell, C L; Fries, J F

    1992-06-01

    The initial results of a 12-month controlled trial of a health promotion program in 5686 Bank of America retirees, randomized into full program, questionnaire only, and insurance claims only groups, were analyzed to determine whether the health promotion program was effective. Comparisons were between program and questionnaire only groups for self-reported health habit changes, health risk scores, medical care utilization, and days confined to home, and between all groups for insurance claims data. The intervention, or full program, included health habit questionnaires administered every 6 months, individualized time-oriented health risk appraisals, personal recommendation letters, self-management materials, and a health promotion book. Twelve-month changes in health habits, health status, and economic variables favored the full program group in 31 of 32 comparisons and were statistically significant at the .05 level in two-tailed tests in 19 comparisons and at the .01 level in two-tailed tests in 13 comparisons. Over 12 months, overall computed health risk scores decreased by 4.3% in the full program experimental group and increased by 7.2% in the questionnaire only control group. Total direct and indirect costs decreased by 11% in the experimental group and increased by 6.3% in the questionnaire only control group. Analysis of claims data confirmed these trends. A low-cost health promotion program for retirees was effective in changing health behaviors and has potential to decrease health care utilization.

  14. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  15. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

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

    Science.gov (United States)

    Furuhata, Hiroshi; Saito, Osamu

    2013-08-01

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

  17. Apolipoprotein e genotype, plasma cholesterol, and cancer: a Mendelian randomization study.

    LENUS (Irish Health Repository)

    Trompet, Stella

    2009-12-01

    Observational studies have shown an association between low plasma cholesterol levels and increased risk of cancer, whereas most randomized clinical trials involving cholesterol-lowering medications have not shown this association. Between 1997 and 2002, the authors assessed the association between plasma cholesterol levels and cancer risk, free from confounding and reverse causality, in a Mendelian randomization study using apolipoprotein E (ApoE) genotype. ApoE genotype, plasma cholesterol levels, and cancer incidence and mortality were measured during a 3-year follow-up period among 2,913 participants in the Prospective Study of Pravastatin in the Elderly at Risk. Subjects within the lowest third of plasma cholesterol level at baseline had increased risks of cancer incidence (hazard ratio (HR) = 1.90, 95% confidence interval (CI): 1.34, 2.70) and cancer mortality (HR = 2.03, 95% CI: 1.23, 3.34) relative to subjects within the highest third of plasma cholesterol. However, carriers of the ApoE2 genotype (n = 332), who had 9% lower plasma cholesterol levels than carriers of the ApoE4 genotype (n = 635), did not have increased risk of cancer incidence (HR = 0.86, 95% CI: 0.50, 1.47) or cancer mortality (HR = 0.70, 95% CI: 0.30, 1.60) compared with ApoE4 carriers. These findings suggest that low cholesterol levels are not causally related to increased cancer risk.

  18. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  19. Role of zinc in severe pneumonia: a randomized double bind placebo controlled study.

    Science.gov (United States)

    Shah, Gauri S; Dutta, Ashok K; Shah, Dheeraj; Mishra, Om P

    2012-08-02

    Pneumonia is a leading cause of morbidity and mortality in children. The aim of study was to evaluate the efficacy of Zinc supplementation in treatment of severe pneumonia in hospitalized children. A double blind randomized, placebo- controlled clinical trial conducted at a tertiary care centre of a teaching hospital. Children with diagnosis of severe pneumonia were randomly assigned to receive supplementation with either elemental zinc or placebo by mouth at the time of enrollment. From day 2, they received 10 mg of their assigned treatment by mouth twice a day for 7 days along with standard antimicrobial therapy. The baseline characteristics like age, sex, weight, weight Z score, height, height Z score, weight for height Z score and hemoglobin were comparable in both study groups. The respiratory rate, chest indrawing, cyanosis, stridor, nasal flaring, wheeze and fever in both groups recorded at enrollment and parameters did not differ significantly between the two groups. The outcome measures like time taken for resolution of severe pneumonia, pneumonia, duration of hospital stay, nil per oral, intravenous fluid, oxygen use, treatment requiring 2nd line of drug and 3rd line drug were evaluated and found to be same. The present study did not show a statistically significant reduction in duration of severe pneumonia, or reduction in hospital stay for children given daily zinc supplementation along with standard antimicrobial therapy. Therefore, zinc supplementation given during the acute episode does not help in short term clinical recovery from severe pneumonia.

  20. The ZEPHyR study: a randomized comparison of linezolid and vancomycin for MRSA pneumonia.

    Science.gov (United States)

    Chavanet, P

    2013-12-01

    Methicillin-resistant Staphylococcus aureus (MRSA) accounts for 10-40% of hospital-acquired pneumonia, and even more in intensive care units. The current guidelines for the treatment of MRSA nosocomial pneumonia include vancomycin and linezolid. The authors of 2 prospective randomized trials comparing vancomycin and linezolid in nosocomial pneumonia had concluded to the non-inferiority of linezolid. A slight superiority of linezolid was observed in the MRSA pneumonia subgroup, in terms of clinical success and survival, but no definite conclusion could be drawn. A prospective randomized study was made to compare a fixed linezolid dose to dose-optimized vancomycin for the treatment of bacteriologically proven MRSA nosocomial pneumonia (ZEPHyR Study). Among the 165 patients treated by linezolid (57.6%) in the PP population, 95 were clinically cured at the end of the study, compared to 81 of the 174 patients treated by vancomycin (46.6%) (IC 95% of the difference 0.5%-21.6%, P=0.042). Nephrotoxicity in the mITT population reached 8.4% in the linezolid group compared to 18.2% in the vancomycin group. LNZ was superior to vancomycin for the treatment of MRSA nosocomial pneumonia. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

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

    2015-06-01

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

  2. The Chronic CARe for diAbeTes study (CARAT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Birnbaum Beatrice

    2010-06-01

    Full Text Available Abstract Background Diabetes is a major challenge for the health care system and especially for the primary care provider. The Chronic Care Model represents an evidence-based framework for the care for chronically ill. An increasing number of studies showed that implementing elements of the Chronic Care Model improves patient relevant outcomes and process parameters. However, most of these findings have been performed in settings different from the Swiss health care system which is dominated by single handed practices. Methods/Design CARAT is a cluster randomized controlled trial with general practitioners as the unit of randomization (trial registration: ISRCTN05947538. The study challenges the hypothesis that implementing several elements of the Chronic Care Model via a specially trained practice nurse improves the HbA1c level of diabetes type II patients significantly after one year (primary outcome. Furthermore, we assume that the intervention increases the proportion of patients who achieve the recommended targets regarding blood pressure ( Discussion This study challenges the hypothesis that the Chronic Care Model can be easily implemented by a practice nurse focused approach. If our results will confirm this hypothesis the suggestion arises whether this approach should be implemented in other chronic diseases and multimorbid patients and how to redesign care in Switzerland.

  3. A prospective randomized study of the efficacy of "Turning Point," an inpatient violence intervention program.

    Science.gov (United States)

    Loveland-Jones, Catherine; Ferrer, Lucas; Charles, Scott; Ramsey, Frederick; van Zandt, Andrea; Volgraf, Jill; Santora, Thomas; Pathak, Abhijit; Dujon, Jay; Sjoholm, Lars; Rappold, Joseph; Goldberg, Amy

    2016-11-01

    From 2002 to 2011, there were more than 17,000 shootings in Philadelphia. "Turning Point," Temple University Hospital's inpatient violence intervention program, takes advantage of the teachable moment that occurs after violent injury. In addition to receiving traditional social work services, Turning Point patients watch their trauma bay resuscitation video and a movie about violence, meet with a gunshot wound survivor and an outpatient case manager, and also undergo psychiatric assessment. The purpose of this study was to determine the efficacy of Turning Point in changing attitudes toward guns and violence among victims of penetrating trauma. This prospective randomized study was conducted from January 2012 to January 2014. Patients who sustained a gunshot or stab wound were randomized to standard of care, which involved traditional social work services only, or Turning Point. The Attitudes Toward Guns and Violence Questionnaire was administered to assess attitude change. Analysis was performed with repeated-measures analysis of variance. A p violence. Turning Point is effective in changing attitudes toward guns and violence among victims of penetrating trauma. Longer follow-up is necessary to determine if this program can truly be a turning point in patients' lives. Therapeutic/care management study, level II.

  4. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

    Directory of Open Access Journals (Sweden)

    Lynne Shinto

    Full Text Available Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS. Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30. Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months.ClinicalTrials.gov NCT00122954.

  5. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

    Science.gov (United States)

    Shinto, Lynne; Marracci, Gail; Mohr, David C; Bumgarner, Lauren; Murchison, Charles; Senders, Angela; Bourdette, Dennis

    2016-01-01

    Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS) affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD) in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS). Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30). Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months. ClinicalTrials.gov NCT00122954.

  6. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

    Science.gov (United States)

    Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

    2015-03-01

    Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe

  7. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    Science.gov (United States)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-08-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)( n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)( n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0( p study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  8. A randomized controlled pilot study of motivational interviewing for patients with psychotic and drug use disorders.

    Science.gov (United States)

    Martino, Steve; Carroll, Kathleen M; Nich, Charla; Rounsaville, Bruce J

    2006-10-01

    This pilot study examined the efficacy of a two-session motivational interview adapted for dually diagnosed psychotic and drug-related disordered patients (DDMI) in comparison to a two-session standard psychiatric interview (SI). The study used a randomized controlled trial design. Participants received either DDMI or SI and were assessed at baseline, 4-, 8- and 12-week follow-up points. The principal analysis for examination of treatment effects across time was a random effects regression model. Both DDMI and SI interviews served as pre-admission intake interventions to an ambulatory specialty dual diagnosis intensive out-patient and partial hospital program. Forty-four treatment-seeking participants (DDMI = 24; SI = 20) who had co-occurring psychotic and drug-related disorders were assigned randomly to the treatment conditions. Measurements Primary outcomes were days of primary drug use, secondary drug use, alcohol use and psychotropic medication adherence, proportion of participants admitted into the program and days of attendance. DDMI and SI resulted in improved treatment outcomes, but there were no main effects for the sample as a whole. Separate examination of primary cocaine and primary marijuana using subsamples, however, suggested that DDMI resulted in significantly better primary drug treatment outcomes for the cocaine-using group, whereas SI resulted in significantly better primary drug treatment outcomes for the marijuana-using group. These findings indicate that MI may not work equally well for all types of psychotic disordered dually diagnosed patients and that alternative approaches may be as effective in fostering improved substance use treatment outcomes for subgroups of these individuals.

  9. Alcohol Withdrawal Prevention: A Randomized Evaluation of Lorazepam and Ethanol (AWARE) Pilot Study

    Science.gov (United States)

    Fullwood, Joyce E.; Mostaghimi, Zhila; Granger, Christopher B.; Washam, Jeffrey B.; Bride, Wanda; Zhao, Yanfang; Granger, Bradi B.

    2015-01-01

    Background Alcohol withdrawal syndrome, characterized by a hyperadrenergic state with confusion, agitation and hallucinations, has detrimental effects on patient safety in the context of acute myocardial infarction (MI). Unexpected hospitalization and sudden cessation of alcohol consumption may result in adverse outcomes including in-hospital complications, increased length of stay, and death. Strategies for safe and effective patient management have not been rigorously studied. Purpose We conducted a randomized evaluation of lorazepam and ethanol/lorazepam to evaluate the safety and efficacy of two strategies for the prevention of alcohol withdrawal syndrome in patients with acute coronary syndromes. Methods Patients (n=57) with myocardial infarction were screened for alcohol dependence using the CAGE questionnaire and randomized to lorazepam or to ethanol with lorazepam. Demographic group differences and complication rates were analyzed using chi square (categorical variables) and t-tests (continuous variables). Safety (composite complication rates) of the treatment strategy was evaluated using Fisher’s exact test. Length of stay was analyzed using Wilcoxon rank-sum test. Results Safety-associated complication rates (self-extubation, delirium tremens, re-infarction) were not different between groups (24% lorazepam vs. 18% ethanol; p=0.56). A trend toward fewer complications in the ethanol group was noted. In addition, no difference was detected between the treatment groups for days spent in the CCU (6.9% lorazepam vs. 2.4% ethanol; p = 0.32) or overall hospital stay (6.2% lorazepam vs. 6.4% ethanol; p = 0.72). Conclusions These findings suggest that a randomized evaluation of treatment strategies to prevent complications associated with alcohol withdrawal in acute MI is safe and feasible. A larger study may provide important evidence for improving clinical outcomes for patients experiencing alcohol withdrawal during acute myocardial infarction. PMID:23996419

  10. Can visual aides influence rehabilitation and length of stay following knee replacement? A randomized controlled study

    Directory of Open Access Journals (Sweden)

    Simon Abson

    2015-03-01

    Full Text Available Arthroplasty is increasingly performed within Australia, with a 2.7% rate increase of total knee arthroplasty (TKR over the last year. With an increasing burden on the public health system and increasing waiting lists, all efforts are being made to decrease length of stay and improve the post operative rehabilitation process. There is currently insufficient evidence to make a conclusive statement about visual aids and improved goal attainment post TKR. The purpose of this study is to evaluate one such visual aid clinical photographs of patients knee range of motion (ROM pre- and post-operatively and their effect on length of stay. Photographs of knee range of motion were obtained pre and post-operatively while the patient was anesthetized. In this study, a randomized, single blinded design allocated patients to either be shown or not shown their photographs on day 1 post operatively. Primary outcome measures were the number of days the patient remained in hospital. Secondary measures were Western Ontario and McMaster Universities Arthritis Index scores, Oxford Knee Scores, American Society of Anesthesiologists Score and knee ROM. Thirty-two patients (3 exclusions were randomized to the photo group and 27 patients (4 exclusions were randomized to the no photo group. The median length of stay between groups was not significantly different. Currently there is not enough evidence to conclude that visual aids effect length of stay or rehabilitation pathways. Further assessment with larger cohort groups is needed. Preoperative targeting and rehabilitation for patients with lower functional status may shorten post operative length of patient stay in our institution.

  11. Can visual aides influence rehabilitation and length of stay following knee replacement? A randomized controlled study.

    Science.gov (United States)

    Abson, Simon; Kenny, Benjamin; Rahim, Reza; Benz, Daniel; Hellman, Jorgen

    2015-03-03

    Arthroplasty is increasingly performed within Australia, with a 2.7% rate increase of total knee arthroplasty (TKR) over the last year. With an increasing burden on the public health system and increasing waiting lists, all efforts are being made to decrease length of stay and improve the post operative rehabilitation process. There is currently insufficient evidence to make a conclusive statement about visual aids and improved goal attainment post TKR. The purpose of this study is to evaluate one such visual aid clinical photographs of patients knee range of motion (ROM) pre-and post-operatively and their effect on length of stay. Photographs of knee range of motion were obtained pre and post-operatively while the patient was anesthetized. In this study, a randomized, single blinded design allocated patients to either be shown or not shown their photographs on day 1 post operatively. Primary outcome measures were the number of days the patient remained in hospital. Secondary measures were Western Ontario and McMaster Universities Arthritis Index scores, Oxford Knee Scores, American Society of Anesthesiologists Score and knee ROM. Thirty-two patients (3 exclusions) were randomized to the photo group and 27 patients (4 exclusions) were randomized to the no photo group. The median length of stay between groups was not significantly different. Currently there is not enough evidence to conclude that visual aids effect length of stay or rehabilitation pathways. Further assessment with larger cohort groups is needed. Preoperative targeting and rehabilitation for patients with lower functional status may shorten post operative length of patient stay in our institution.

  12. Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mistraletti, Giovanni; Mantovani, Elena S; Cadringher, Paolo; Cerri, Barbara; Corbella, Davide; Umbrello, Michele; Anania, Stefania; Andrighi, Elisa; Barello, Serena; Di Carlo, Alessandra; Martinetti, Federica; Formenti, Paolo; Spanu, Paolo; Iapichino, Gaetano

    2013-04-03

    A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. This 'educational research' project aims both to

  13. The effect of exercise on sleep and fatigue in rheumatoid arthritis: a randomized controlled study.

    Science.gov (United States)

    Durcan, Laura; Wilson, Fiona; Cunnane, Gaye

    2014-10-01

    Sleep disturbance and chronic fatigue are common in rheumatoid arthritis (RA) and contribute to disability, symptomatology, and healthcare use. It has long been recognized in other populations that exercise can improve sleep and diminish fatigue. The effect of exercise on sleep quality and fatigue in RA has not been evaluated. Ours is a randomized controlled study in RA to determine the effect of an exercise program on sleep quality and fatigue. These were measured using the Pittsburgh Sleep Quality Index and the Fatigue Severity Scale. Patients were randomized to either a 12-week, home-based exercise intervention or usual care. The exercise program consisted of specific exercises to target individual deficiencies identified using the Health Assessment Questionnaire (HAQ) with cardiovascular work as per the guidelines. The intervention group was evaluated on a 3-week basis. Full evaluation was carried out at baseline and at 12 weeks. Forty patients were randomized to the intervention with 38 controls. In the exercise intervention group, there was a statistically significant improvement in HAQ (p = 0.00), pain (p = 0.05), stiffness (p = 0.05), sleep quality (p = 0.04), and fatigue (p = 0.04). In our control group, there was a statistically significant improvement demonstrated in their overall perceptions of the benefits of exercise, but none of the other variables. Our study demonstrates that an exercise program resulted in significant improvement in sleep quality and fatigue. This is particularly interesting given the importance of fatigue as an outcome measure in RA and gives us yet another reason to prescribe exercise in this population.

  14. A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study).

    Science.gov (United States)

    Gringeri, A; Lundin, B; von Mackensen, S; Mantovani, L; Mannucci, P M

    2011-04-01

    Prevention of arthropathy is a major goal of hemophilia treatment. While studies in adults have demonstrated an impact of prophylaxis on the incidence of joint bleeds and patients' well-being in terms of improved quality of life (QoL), it is unclear whether or not prophylaxis influences the outcome and perception of well- of children with hemophilia. This randomized controlled study compared the efficacy of prophylaxis with episodic therapy in preventing hemarthroses and image-proven joint damage in children with severe hemophilia A (factor VIII <1%) over a 10-year time period. Forty-five children with severe hemophilia A, aged 1-7 years (median 4), with negative clinical-radiologic joint score at entry and at least one bleed during the previous 6 months, were consecutively randomized to prophylaxis with recombinant factor VIII (25 IU kg(-1) 3 × week) or episodic therapy with ≥25 IU kg(-1) every 12-24 h until complete clinical bleeding resolution. Safety, feasibility, direct costs and QoL were also evaluated. Twenty-one children were assigned to prophylaxis, 19 to episodic treatment. Children on prophylaxis had fewer hemarthroses than children on episodic therapy: 0.20 vs. 0.52 events per patient per month (P < 0.02). Plain-film radiology showed signs of arthropathy in six patients on prophylaxis (29%) vs. 14 on episodic treatment (74%) (P < 0.05). Prophylaxis was more effective when started early (≤36 months), with patients having fewer joint bleeds (0.12 joint bleeds per patient per month) and no radiologic signs of arthropathy. This randomized trial confirms the efficacy of prophylaxis in preventing bleeds and arthropathy in children with hemophilia, particularly when it is initiated early in life. © 2011 International Society on Thrombosis and Haemostasis.

  15. Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability.

    Science.gov (United States)

    Sullivan, Jason P; O'Brien, Conor S; Barger, Laura K; Rajaratnam, Shantha M W; Czeisler, Charles A; Lockley, Steven W

    2017-01-01

    Firefighters' schedules include extended shifts and long work weeks which cause sleep deficiency and circadian rhythm disruption. Many firefighters also suffer from undiagnosed sleep disorders, exacerbating fatigue. We tested the hypothesis that a workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening would improve firefighter health and safety compared to standard practice. Prospective station-level randomized, field-based intervention. US fire department. 1189 firefighters. Sleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals for respondents who screened positive for a sleep disorder. Firefighters were randomized by station. Using departmental records, in an intention-to-treat analysis, firefighters assigned to intervention stations which participated in education sessions and had the opportunity to complete sleep disorders screening reported 46% fewer disability days than those assigned to control stations (1.4 ± 5.9 vs. 2.6 ± 8.5 days/firefighter, respectively; p = .003). There were no significant differences in departmental injury or motor vehicle crash rates between the groups. In post hoc analysis accounting for intervention exposure, firefighters who attended education sessions were 24% less likely to file at least one injury report during the study than those who did not attend, regardless of randomization (OR [95% CI] 0.76 [0.60, 0.98]; χ2 = 4.56; p = .033). There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due to disability in firefighters.

  16. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  17. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy).

    Science.gov (United States)

    Stefanescu Schmidt, Ada C; Kereiakes, Dean J; Cutlip, Donald E; Yeh, Robert W; D'Agostino, Ralph B; Massaro, Joseph M; Hsieh, Wen-Hua; Mauri, Laura

    2017-05-02

    Thienopyridine plus aspirin beyond 1 year after coronary stenting reduces myocardial infarction (MI) risk and increases bleeding risk in comparison with aspirin alone. The hazard associated with late thienopyridine discontinuation and risk factors for MI after discontinuation are poorly defined. In the DAPT Study (Dual Antiplatelet Therapy), after percutaneous coronary intervention and 12 months of thienopyridine (clopidogrel or prasugrel) plus aspirin, eligible patients remained on aspirin and were randomly assigned to continued thienopyridine versus placebo for 18 months. At 30 months, patients stopped the study drug and were observed for 3 months. Cumulative incidence of MI was assessed over 3 months after randomization (months 12-15) and 3 months after study drug discontinuation (months 30-33). The MI hazard for each of these periods was assessed across randomized treatment arms and by DAPT score values <2 or ≥2. Among the 11 648 randomly assigned patients, the monthly cumulative incidence of MI was lower with continued thienopyridine versus placebo at 12 to 15 months (0.12% versus 0.37%, P<0.001, in all patients; 0.13% versus 0.27%, P=0.02, in patients not treated with paclitaxel-eluting stents), and higher at 30 to 33 months (0.30% versus 0.15%, P=0.013, in all patients; in patients without paclitaxel-eluting stents, 0.18% versus 0.17%, P=0.91). The majority of MIs in both time periods (74% and 76%) were not related to stent thrombosis. After multivariable adjustment, treatment arm independently predicted MI at months 12 to 15 (P<0.001) and 30 to 33 (P=0.011). During months 12 to 15, patients with DAPT scores <2 or ≥2 both had lower rates of MI with continued thienopyridine (MI monthly incidence 0.16% versus 0.51%, P<0.001, for scores ≥2; 0.08% versus 0.24%, P=0.012, for scores<2, interaction P=0.064). Discontinuing thienopyridine after either 12 or 30 months is associated with an early increase in MI risk, mainly unrelated to stent thrombosis; the

  18. Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study

    National Research Council Canada - National Science Library

    Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

    2014-01-01

    .... A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention...

  19. More information, less understanding: a randomized study on consent issues in neonatal research.

    Science.gov (United States)

    Freer, Yvonne; McIntosh, Neil; Teunisse, Saskia; Anand, Kanwaljeet J S; Boyle, Elaine M

    2009-05-01

    Valid consent for research requires comprehensive and understandable information to be disclosed to participants. The way that information is shared varies, but regulatory bodies usually determine style. Some reports have suggested that although information may be all-inclusive, it does little to support understanding. To explore the impact of various information-sharing approaches on parents' understanding of a research study and the validity of their consent. This was a randomized, controlled trial. Parents of immature but well infants admitted to a large tertiary NICU in Edinburgh, Scotland, were randomly assigned within 72 hours of their infant's admission to receive 1 of 2 information leaflets, with or without a standardized verbal explanation, for a hypothetical intensive care research study. The leaflets differed in length and in the amount of detail in which the study process, risks, benefits, and patient rights were described. A questionnaire was used to elicit understanding about the purpose of the research, design of the study, procedures involved, and the consent process. Forty-one parents participated in the study. Those who received the longer leaflet without verbal explanation gained only limited understanding of the purpose of the research. The procedures involved in the study were understood better by those who received the shorter leaflet. Issues relating to consent and study design were readily understood in all groups. Irrespective of documentation style, verbal explanation significantly improved understanding. Differences in understanding had little effect on whether a parent would enroll his or her infant into the study. Verbal explanation significantly enhances understanding of the research process for participants regardless of the style of written documentation. However, shorter written information may lead to better understanding than lengthy, more complex documentation.

  20. Bias analysis applied to Agricultural Health Study publications to estimate non-random sources of uncertainty

    Directory of Open Access Journals (Sweden)

    Lash Timothy L

    2007-11-01

    Full Text Available Abstract Background The associations of pesticide exposure with disease outcomes are estimated without the benefit of a randomized design. For this reason and others, these studies are susceptible to systematic errors. I analyzed studies of the associations between alachlor and glyphosate exposure and cancer incidence, both derived from the Agricultural Health Study cohort, to quantify the bias and uncertainty potentially attributable to systematic error. Methods For each study, I identified the prominent result and important sources of systematic error that might affect it. I assigned probability distributions to the bias parameters that allow quantification of the bias, drew a value at random from each assigned distribution, and calculated the estimate of effect adjusted for the biases. By repeating the draw and adjustment process over multiple iterations, I generated a frequency distribution of adjusted results, from which I obtained a point estimate and simulation interval. These methods were applied without access to the primary record-level dataset. Results The conventional estimates of effect associating alachlor and glyphosate exposure with cancer incidence were likely biased away from the null and understated the uncertainty by quantifying only random error. For example, the conventional p-value for a test of trend in the alachlor study equaled 0.02, whereas fewer than 20% of the bias analysis iterations yielded a p-value of 0.02 or lower. Similarly, the conventional fully-adjusted result associating glyphosate exposure with multiple myleoma equaled 2.6 with 95% confidence interval of 0.7 to 9.4. The frequency distribution generated by the bias analysis yielded a median hazard ratio equal to 1.5 with 95% simulation interval of 0.4 to 8.9, which was 66% wider than the conventional interval. Conclusion Bias analysis provides a more complete picture of true uncertainty than conventional frequentist statistical analysis accompanied by a

  1. Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study.

    Science.gov (United States)

    Pett, S L; Amin, J; Horban, A; Andrade-Villanueva, J; Losso, M; Porteiro, N; Madero, J S; Belloso, W; Tu, E; Silk, D; Kelleher, A; Harrigan, R; Clark, A; Sugiura, W; Wolff, M; Gill, J; Gatell, J; Clarke, A; Ruxrungtham, K; Prazuck, T; Kaiser, R; Woolley, I; Alberto Arnaiz, J; Cooper, D; Rockstroh, J K; Mallon, P; Emery, S

    2018-01-01

    The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants were randomized to continue their current PI/r-based regimen (PI/r) or to switch to MVC plus two N(t)RTIs (MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval (CI) for the difference was < -12% in the intention-to-treat (ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Eighty-two (PI/r) and 156 (MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks. © 2017 British HIV Association.

  2. Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Launonen Antti P

    2012-09-01

    Full Text Available Abstract Background Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. Methods/Design The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH score and the secondary outcome measures will be the EuroQol-5D (EQ-5D value, OSS, Constant-Murley Score, VAS, and 15D. Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. Discussion This publication

  3. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  4. A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes.

    Science.gov (United States)

    Avis, Nancy E; Legault, Claudine; Coeytaux, Remy R; Pian-Smith, May; Shifren, Jan L; Chen, Wunian; Valaskatgis, Peter

    2008-01-01

    To investigate the feasibility of conducting a randomized trial of the effect of acupuncture in decreasing hot flashes in peri- and postmenopausal women. Fifty-six women ages 44 to 55 with no menses in the past 3 months and at least four hot flashes per day were recruited from two clinical centers and randomized to one of three treatment groups: usual care (n = 19), sham acupuncture (n = 18), or Traditional Chinese Medicine acupuncture (n = 19). Acupuncture treatments were scheduled twice weekly for 8 consecutive weeks. The sham acupuncture group received shallow needling in nontherapeutic sites. The Traditional Chinese Medicine acupuncture group received one of four treatments based on a Traditional Chinese Medicine diagnosis. Usual care participants were instructed to not initiate any new treatments for hot flashes during the study. Daily diaries were used to track frequency and severity of hot flashes. The mean daily index score was based on the number of mild, moderate, and severe hot flashes. Follow-up analyses were adjusted for baseline values, clinical center, age, and body mass index. There was a significant decrease in mean frequency of hot flashes between weeks 1 and 8 across all groups (P = 0.01), although the differences between the three study groups were not significant. However, the two acupuncture groups showed a significantly greater decrease than the usual care group (P acupuncture significantly reduce hot flash frequency.

  5. Acupuncture in shoulder pain and functional impairment after neck dissection: A prospective randomized pilot study.

    Science.gov (United States)

    Deganello, Alberto; Battat, Nir; Muratori, Enrico; Cristofaro, Glauco; Buongiorno, Ana; Mannelli, Giuditta; Picconi, Mario; Giachetti, Rita; Borsotti, Giulia; Gallo, Oreste

    2016-08-01

    The efficacy of conventional physiotherapy and antiinflammatory/analgesic drugs in the management of shoulder pain and functional disability following neck dissection is often disappointing. Acupuncture is a safe and well-tolerated method. We report the results regarding our pilot trial of acupuncture versus conventional care in the management of postoperative shoulder pain and dysfunction after neck dissection. Pilot study. Patients at a tertiary university center with chronic pain or dysfunction attributed to neck dissection were randomly assigned to either weekly acupuncture or usual care (eg., physical therapy, analgesia, and/or antiinflammatory drugs) for 5 consecutive weeks. The Constant-Murley score, a composite measure of pain, function, and activities of daily living, was the primary outcome measure. As secondary end point, The Neck Dissection Impairment Index (NDII) was used to quantify site-specific, self-reported quality of life (QOL). After randomization, 48 patients completed the study (23 and 25 patients on acupuncture and control arms, respectively). Constant-Murley scores improved more in the acupuncture group (gain difference between groups 13.6, P pain and dysfunction related to neck dissection. 2b. Laryngoscope, 126:1790-1795, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

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

    Science.gov (United States)

    Ramzy, Eiad A

    2017-01-01

    This controlled, randomized study investigated the hypothesis that the combined use of pregabalin plus paroxetine for fibromyalgia management would be associated with comparable Somatic Symptoms Scale-8 (SSS-8) and Center for Epidemiological Studies Depression Scale (CESDS) scores, but higher tolerability than the combined use of pregabalin plus either amitriptyline or venlafaxine. After institutional ethics committee approval, 75 female subjects diagnosed with fibromyalgia and in receipt of pregabalin (75 mg/day) were randomly allocated to concurrently receive amitriptyline (25 mg/day; n = 24), venlafaxine (75 mg/day; n = 25), or paroxetine (25 mg/day; n = 26). All patients were assessed bimonthly for 6 consecutive months for changes in SSS-8 and CESDS scores, life satisfaction, mood, sleep quality, fatigue, medication tolerability, and adverse events. Compared with pregabalin plus amitriptyline or venlafaxine, the combined use of pregabalin plus paroxetine in fibromyalgia patients resulted in significantly lower SSS-8 and CESDS scores from 18 (P fibromyalgia and to enhance the quality of life in affected individuals. © 2016 World Institute of Pain.

  7. Upregulating Positive Affectivity in the Transdiagnostic Treatment of Emotional Disorders: A Randomized Pilot Study.

    Science.gov (United States)

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Quero, Soledad; Botella, Cristina

    2017-10-01

    Transdiagnostic cognitive-behavioral therapy for emotional disorders (ED) has proven to be effective. However, current transdiagnostic treatment protocols address only the regulation of negative affectivity, and they do not include treatment components to more directly target the regulation of positive affectivity. In this study, we propose to evaluate the preliminary efficacy and acceptability of a transdiagnostic treatment protocol for ED that includes, as an innovative feature, a specific treatment component to directly upregulate positive affectivity based on positive psychology interventions. A total of 24 participants were randomized to either a transdiagnostic treatment protocol ( n = 12) or a transdiagnostic treatment protocol with an additional component designed to regulate positive affectivity ( n = 12). Participants completed measures of anxiety, depression, positive and negative affectivity, and quality of life, as well as treatment acceptability at pre- and posttreatment and at the 3-month follow-up. Both interventions led to improvements in all measures at posttreatment, and these outcomes were maintained at the 3-month follow-up, with large effect sizes for all measures. The effect sizes for positive affect were larger in the condition that included the component to upregulate positive affectivity. Attrition rate was low, and both treatment protocols were well accepted by participants. The results obtained in this study indicate the feasibility of testing the treatment protocol in a larger, randomized, controlled trial, and they suggest the potential of including treatment components for directly upregulating positive affectivity in future research on transdiagnostic treatment protocols for ED.

  8. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

    Science.gov (United States)

    Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

    2015-07-01

    Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

  10. A Randomized, Head-to-Head Study of Virtual Reality Exposure Therapy for Posttraumatic Stress Disorder.

    Science.gov (United States)

    McLay, Robert N; Baird, Alicia; Webb-Murphy, Jennifer; Deal, William; Tran, Lily; Anson, Heather; Klam, Warren; Johnston, Scott

    2017-04-01

    Virtual reality exposure therapy (VRET) is one of the few interventions supported by randomized controlled trials for the treatment of combat-related posttraumatic stress disorder (PTSD) in active duty service members. A comparative effectiveness study was conducted to determine if virtual reality technology itself improved outcomes, or if similar results could be achieved with a control exposure therapy (CET) condition. Service members with combat-related PTSD were randomly selected to receive nine weeks of VRET or CET. Assessors, but not therapists, were blinded. PTSD symptom improvement was assessed one week and 3 months after the conclusion of treatment using the clinician-administered PTSD scale (CAPS). A small crossover component was included. Results demonstrated that PTSD symptoms improved with both treatments, but there were no statistically significant differences between groups. Dropout rates were higher in VRET. Of those who received VRET, 13/42 (31%) showed >30% improvement on the CAPS, versus 16/43 (37%) who received CET. Three months after treatment, >30% improvement was seen in 10/33 (30%) of VRET participants and 12/33 (36%) in CET. Participants who crossed over (n = 11) showed no statistically significant improvements in a second round of treatment, regardless of condition. This study supported the utility of exposure therapy for PTSD, but did not support additional benefit by the inclusion of virtual reality.

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

    Science.gov (United States)

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

    2017-06-01

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

  12. A study of factors affecting highway accident rates using the random-parameters tobit model.

    Science.gov (United States)

    Anastasopoulos, Panagiotis Ch; Mannering, Fred L; Shankar, Venky N; Haddock, John E

    2012-03-01

    A large body of previous literature has used a variety of count-data modeling techniques to study factors that affect the frequency of highway accidents over some time period on roadway segments of a specified length. An alternative approach to this problem views vehicle accident rates (accidents per mile driven) directly instead of their frequencies. Viewing the problem as continuous data instead of count data creates a problem in that roadway segments that do not have any observed accidents over the identified time period create continuous data that are left-censored at zero. Past research has appropriately applied a tobit regression model to address this censoring problem, but this research has been limited in accounting for unobserved heterogeneity because it has been assumed that the parameter estimates are fixed over roadway-segment observations. Using 9-year data from urban interstates in Indiana, this paper employs a random-parameters tobit regression to account for unobserved heterogeneity in the study of motor-vehicle accident rates. The empirical results show that the random-parameters tobit model outperforms its fixed-parameters counterpart and has the potential to provide a fuller understanding of the factors determining accident rates on specific roadway segments. Published by Elsevier Ltd.

  13. Comparison of Levetiracetam and sodium Valproate in migraine prophylaxis: A randomized placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Homa Sadeghian

    2015-01-01

    Full Text Available Background: Migraine is a chronic and disabling disorder. Treatment of migraine often comprises of symptomatic (abortive and preventive (prophylactic treatment. The current drugs used in migraine prophylaxis include antidepressant drugs (Serotonin Reuptake Inhibitors, Tricyclic antidepressants, and anti-epileptic drugs (valproate, gabapentin, etc. Objective: The objective of our study was to assess the efficacy and tolerability of levetiracetam in adult migraine prophylaxis, compared to valproate and placebo. Materials and Methods: We conducted a prospective, randomized, placebo-controlled study. A total of 85 patients were randomized to receive levetiracetam 500 mg/d (n = 27, valproate 500 mg/d (n = 32 or placebo (n = 26. The patients were evaluated for treatment efficacy after 6 months. Efficacy was assessed as a more than 50% decrease in headache frequency. Results: In levetiracetam group, 17 (63.0% patients experienced a more than 50% decrease in headache frequency, while this efficacy number was 21 (65.6% for valproate group and 4 (15.4% for placebo group. The difference was not statistically significant between levetiracetam and valproate, while it was significant when comparing either levetiracetam or valproate to placebo. Conclusion: Compared to placebo, levetiracetam offers improvement in headache frequency in patients with migraine. The efficacy of levetiracetam in migraine prophylaxis is comparable to currently used drugs such as valproate.

  14. Studies on spectral analysis of randomly sampled signals: Application to laser velocimetry data

    Science.gov (United States)

    Sree, David

    1992-01-01

    Spectral analysis is very useful in determining the frequency characteristics of many turbulent flows, for example, vortex flows, tail buffeting, and other pulsating flows. It is also used for obtaining turbulence spectra from which the time and length scales associated with the turbulence structure can be estimated. These estimates, in turn, can be helpful for validation of theoretical/numerical flow turbulence models. Laser velocimetry (LV) is being extensively used in the experimental investigation of different types of flows, because of its inherent advantages; nonintrusive probing, high frequency response, no calibration requirements, etc. Typically, the output of an individual realization laser velocimeter is a set of randomly sampled velocity data. Spectral analysis of such data requires special techniques to obtain reliable estimates of correlation and power spectral density functions that describe the flow characteristics. FORTRAN codes for obtaining the autocorrelation and power spectral density estimates using the correlation-based slotting technique were developed. Extensive studies have been conducted on simulated first-order spectrum and sine signals to improve the spectral estimates. A first-order spectrum was chosen because it represents the characteristics of a typical one-dimensional turbulence spectrum. Digital prefiltering techniques, to improve the spectral estimates from randomly sampled data were applied. Studies show that the spectral estimates can be increased up to about five times the mean sampling rate.

  15. Mendelian Randomization Study of Body Mass Index and Colorectal Cancer Risk

    DEFF Research Database (Denmark)

    Thrift, Aaron P.; Gong, Jian; Peters, Ulrike

    2015-01-01

    Background: High body mass index (BMI) is consistently linked to increased risk of colorectal cancer for men, whereas the association is less clear for women. As risk estimates from observational studies may be biased and/or confounded, we conducted a Mendelian randomization study to estimate...... the causal association between BMI and colorectal cancer. Methods: We used data from 10,226 colorectal cancer cases and 10,286 controls of European ancestry. The Mendelian randomization analysis used a weighted genetic risk score, derived from 77 genome-wide association study–identified variants associated...... cancer among women (IV-OR per 5 kg/m2, 1.82; 95% CI, 1.26–2.61). For men, genetically influenced BMI was not associated with colorectal cancer (IV-OR per 5 kg/m2, 1.18; 95% CI, 0.73–1.92). Conclusions: High BMI was associated with increased colorectal cancer risk for women. Whether abdominal obesity...

  16. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  17. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study A Randomized Controlled Trial

    Science.gov (United States)

    HENSEL, Kendi L.; BUCHANAN, Steve; BROWN, Sarah K.; RODRIGUEZ, Mayra; CRUSER, des Anges

    2014-01-01

    Objective To evaluate the efficacy of Osteopathic Manipulative Treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and improve selected outcomes of labor and delivery. Study Design PROMOTE was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were randomized to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included seven treatments over nine weeks. The OMT protocol included specific techniques administered by board-certified OMT specialists. Outcomes were assessed using self-report measures for pain and back-related functioning, and medical records for delivery outcomes. Results There were 136 women in the OMT group, 131 in PUT, and 133 in UCO. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back related functioning (P<.001 for both), with outcomes for the OMT group similar to that of the PUT, but both groups were significantly improved compared to UCO. For secondary outcome of meconium- stained amniotic fluid there were no differences between the groups. Conclusion OMT was effective for mitigating pain and functional deterioration compared to the UCO group; however OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during their third trimester. PMID:25068560

  18. Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mateen, Farrah J; Manalo, Natalie C; Grundy, Sara J; Houghton, Melissa A; Hotan, Gladia C; Erickson, Hans; Videnovic, Aleksandar

    2017-09-01

    Fatigue is the most commonly reported symptom among multiple sclerosis (MS) patients, more than a quarter of whom consider fatigue to be their most disabling symptom. However, there are few effective treatment options for fatigue. We aim to investigate whether supplemental exposure to bright white light will reduce MS-associated fatigue. Eligible participants will have clinically confirmed multiple sclerosis based on the revised McDonald criteria (2010) and a score ≥36 on the Fatigue Severity Scale (FSS). Participants will be randomized 1:1 to bright white light (10,000 lux; active condition) or dim red light (therapy. We will perform an intention-to-treat analysis, comparing the active and control groups to assess the postintervention difference in fatigue levels reported on FSS. Secondary outcome measures include change in global VAFS scores during the light therapy and self-reported quality of life in the Multiple Sclerosis Quality of Life-54. We present a study design and rationale for randomizing a nonpharmacological intervention for MS-associated fatigue, using bright light therapy. The study limitations relate to the logistical issues of a self-administered intervention requiring frequent participant self-report in a relapsing condition. Ultimately, light therapy for the treatment of MS-associated fatigue may provide a low-cost, noninvasive, self-administered treatment for one of the most prevalent and burdensome symptoms experienced by people with MS.

  19. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

    Directory of Open Access Journals (Sweden)

    Kallol K Roy

    2017-01-01

    Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

  20. Randomized crossover trial studying the effect of music on examination anxiety.

    Science.gov (United States)

    Lai, Hui-Ling; Chen, Pin-Wen; Chen, Chia-Jung; Chang, Hui-Kuan; Peng, Tai-Chu; Chang, Fwu-Mei

    2008-11-01

    The purpose of this study was to assess the effect of lento music on examination anxiety among nursing students. A randomized crossover classroom-based trial was conducted. Thirty-eight students with a mean age of 19.4 years (SD = .54) were randomly assigned to either a music/silence or a silence/music group sequence. The students in the music group were given a 40-min group-based music intervention in a classroom, whereas the students in the silence group received the regular test without music. Using paired t-tests, there were no significant different in pretest scores for state anxiety, examination anxiety, finger temperature and pulse rate between the two conditions. Nonetheless, the findings indicated that music intervention did effectively decrease examination anxiety and state anxiety as well as reducing pulse rate and increasing higher finger temperature (p = 0.05 to 0.001). In addition, significant differences were detected between the pretest and posttest measures for silence (p = 0.001). The results suggest that lento music is effective at anxiety reduction. This study provides evidence for nursing faculty and clinical educators to foster nursing students' mastering over the anxiety of examination by using lento music.

  1. A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study.

    Science.gov (United States)

    Mokhtari, Negar; Shirazi, Alireza-Sarraf; Ebrahimi, Masoumeh

    2017-11-01

    Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests (Protary files (P=0.000). Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words:Rotary technique, conventional technique, pulpectomy, primary teeth.

  2. Cognitive behavioural therapy in multiple sclerosis: a randomized controlled pilot study of acceptance and commitment therapy.

    Science.gov (United States)

    Nordin, Linda; Rorsman, Ia

    2012-01-01

    The aim of this study was to design a trial that could evaluate the effect of acceptance and commitment therapy as a group-intervention for multiple sclerosis patients with psychological distress. Randomized controlled trial with assessment at pretreatment, end of treatment, and at 3-month follow-up. Multiple sclerosis outpatients with elevated symptoms of anxiety and/or depression (n = 21). Patients were randomly assigned to acceptance and commitment therapy or relaxation training. Both treatments consisted of 5 sessions over 15 weeks containing didactic sessions, group discussions, and exercises. Outcome was assessed by self-rated symptoms of anxiety, depression, and a measure of acceptance. At 3-month follow-up, the relaxation training group had a significant decline in anxiety symptoms whereas the acceptance and commitment therapy group showed a maintained improvement in rated acceptance at follow-up. The results reflect the different emphases of the therapies. Acceptance and commitment therapy is aimed at living an active, valued life and increasing acceptance, while relaxation training focuses directly on coping strategies to handle emotional symptoms. The results are preliminary, but supportive of further study of brief group interventions for reducing psychological distress in patients with multiple sclerosis.

  3. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

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

    Science.gov (United States)

    Greene, Tom

    2015-01-01

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

  5. [The effect of Christmas joy on the mood among medical doctors - a randomized, blinded intervention study].

    Science.gov (United States)

    Ilkjær, Christine; Møller, Marianne B; Lauridsen, Mette H; Ilkjær, Susanne; Hjortdal, Vibeke E

    2016-12-12

    Each December Santa's elves spread Christmas joy (JN). Laughter and humour may influence health and stress level. No other study has investigated the effect of JN on the good spirit (DGH) among healthcare professionals. We performed a single-centre blinded intervention study with crossover at three hospital departments. JN intervention of three days was randomized. Median ± standard deviation was given. The level of significance was p Christmas atmosphere tended to increase DGH at the morning conferences. JN tended to have an additive effect. JN exposure may be beneficial. The study did not receive any funding. The trial was not registered and was kept secret for the participants in accordance with the tradition of Santa's elves.

  6. OXYTOCIN - AN EMERGING TREATMENT FOR OBESITY AND DYSGLYCEMIA: REVIEW OF RANDOMIZED CONTROLLED TRIALS AND COHORT STUDIES.

    Science.gov (United States)

    Barengolts, Elena

    2016-07-01

    The psychotropic mediator and neuropeptide hormone oxytocin (OXT) is emerging as a promising treatment of metabolic disorders (obesity and dysglycemia). This review focuses on studies relevant to OXT use and its mechanisms of action in metabolic disorders and wellness behavior motivation. Randomized controlled trials (RCTs) and cohort and preclinical studies identified in electronic databases were reviewed. There were only a few RCTs and cohort studies related to OXT and metabolic disorders. Anorexigenic and weight-loss effects of intranasal OXT (IOXT) were evaluated in 3 double-blind RCTs involving 85 subjects. A single dose of 24 IU reduced caloric intake by 122 kcal. The 24 IU 4-times daily dose for 8 weeks produced ~9-kg weight loss (Poxytocin OXTR = oxytocin receptor sOXT = serum oxytocin.

  7. Nonopioid versus opioid based general anesthesia technique for bariatric surgery: A randomized double-blind study

    Directory of Open Access Journals (Sweden)

    Mohamed Ahmed Mansour

    2013-01-01

    Full Text Available Objective: The objective of this study was to evaluate the efficacy and safety of giving general anesthesia without the use of any opioids either systemic or intraperitoneal in bariatric surgery. Methods: Prospective randomized controlled trial. Obese patients (body mass index >50 Kg/m 2 undergoing laparoscopic sleeve gastrectomies were recruited and provided an informed signed consent. Patients were randomized using a computer generated randomization table to receive either opioid or non-opioid based anesthesia. The patient and the investigator scoring patient outcome after surgery were blinded to the anesthetic protocol. Primary outcomes were hemodynamics in the form of "heart rate, systolic, diastolic, and mean arterial blood pressure" on induction and ½ hourly thereafter. Pain monitoring through visual analog scale (VAS 30 min after recovery, hourly for 2 h and every 4 h for 24 h was also recorded. Pain monitoring through VAS and post-operative nausea and vomiting 30 min after recovery were also recorded and finally patient satisfaction and acute pain nurse satisfaction. Results: There was no difference in background characteristics in both groups. There were no statistically significant differences in different outcomes as heart rate, mean blood pressure, O 2 saturation in different timings between groups at any of the determined eight time points but pain score and nurse satisfaction showed a trend to better performance with non-opioid treatment. Conclusion: Nonopioid based general anesthesia for Bariatric surgery is as effective as opioid one. There is no need to use opioids for such surgery especially that there was a trend to less pain in non-opioid anesthesia.

  8. A study into the distribution of gunshot residue particles in the random population.

    Science.gov (United States)

    Lucas, Nick; Brown, Hayley; Cook, Michael; Redman, Kahlee; Condon, Tanith; Wrobel, Harald; Kirkbride, K Paul; Kobus, Hilton

    2016-05-01

    When considering the impact and value of gunshot residues (GSR) as forensic trace evidence, the likelihood of a suspect producing a positive GSR analysis result without having direct exposure to a firearm is a major consideration. Therefore, the random prevalence of GSR and 'GSR-like' residues in the wider population is a highly pertinent question when considering the probative value of such evidence. The random prevalence of GSR in two Australian jurisdictions - Victoria and South Australia - was assessed through the collection and analysis of GSR samples obtained from randomly selected members of the public. Volunteers were asked to declare any firearms use, hobbies or potential firearms exposure before allowing their hands to be sampled using aluminium GSR sample stubs coated in adhesive tape. A total of 289 samples, 120 from Victoria and 169 from South Australia were collected and analysed using scanning electron microscopy coupled with energy dispersive X-ray microanalysis (SEM-EDS). Across all samples, three 'characteristic' three-component Pb/Ba/Sb particles were detected from a single subject in South Australia, corresponding to an overall prevalence of 0.3%. Two-component 'consistent' particles were more prevalent, with Pb/Sb particles being the most frequently occurring, in 8% of samples, and in South Australia only. A number of samples, approximately 7%, showed populations of single element particles of Pb, Ba and Sb, which has the potential to generate a false positive for GSR if using a bulk analysis technique such as NAA or AAS. The prevalence of GSR or 'GSR like' particles in this study matches closely with similar surveys conducted in other jurisdictions. Such surveys are a useful foundation for the creation of a probabilistic method for the assessment of GSR evidence. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. Propionibacterium acnes Suture Contamination in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Study.

    Science.gov (United States)

    Yamakado, Kotaro

    2018-01-17

    To examine the contamination rate of the anchor-suture and to determine the efficacy of 2 different surgical skin preparation solutions with or without a plastic adhesive drape from suture contamination in arthroscopic rotator cuff repair. A prospective randomized study was undertaken to evaluate 126 consecutive patients undergoing arthroscopic rotator cuff repair. Each shoulder was prepared with one of 2 randomly selected solutions according to an assigned envelope that indicated the procedure to be used: chlorhexidine-alcohol (1% chlorhexidine gluconate and 70% isopropyl alcohol) or povidone-iodine. Then, each group was further divided according to the usage of a plastic drape. The first cut-tails of the anchor-suture after cuff fixation were submitted to aerobic and anaerobic cultures. The overall rate of Propionibacterium acnes-positive cultures was 47% (14 of 31 cases) in the povidone-iodine group, 33% (11 of 33 cases) in the povidone-iodine with a drape group, 33% (10 of 30 cases) in the chlorhexidine-alcohol group, and 9.3% (3 of 32 cases) in the chlorhexidine-alcohol with a drape group. The positive culture rate in the chlorhexidine-alcohol with a drape group was lower than that in the povidone-iodine group (relative risk, 0.2; 95% confidence interval: 0.064-0.63; number needed to treat, 2.7; P suture contamination. However, the usage of a plastic drape slightly increased the risk of coagulase-negative Staphylococcus proliferation. Level I, therapeutic, prospective, randomized trial. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  10. Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

    Science.gov (United States)

    Smith, Steven R; Garvey, W Timothy; Greenway, Frank L; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J

    2017-05-01

    To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine. This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported. N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. © 2017 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  11. Randomized multi-centre study on the effect of training on tooth shade matching.

    Science.gov (United States)

    Olms, C; Klinke, Th; Pirek, P; Hannak, W B

    2013-12-01

    The aim of this study was to find out whether Toothguide Trainer, TT, and Toothguide Training Box, TTB, show any training effects, independent of the shade guide chosen. Students from four dental schools (N=78) were included in this study. The participants were randomized into a study, 42 students (age range: 19-27 years; 69% female, 31% male) and a control group of 36 students (age range: 19-30 years; 57% female, 43% male). The study group started with a double blind introduction test, followed by the TT and TTB training, finishing with the final test. The control group only passed the introduction and - after a break - the final test. Eight randomly chosen samples, seven of the Vita classical and one of the 3D-Master colour scale, were marked by barcodes. Colour matching was arranged by the Vita classical scale. The results of the pre- and final tests of both groups were combined. For every sample, the value ΔE was determined. The summation of all eight samples from the introduction and final tests offered a summarized ΔE value. The differences between introduction and final tests revealed the individual learning success. 47.6% of the study group showed statistically significant better results than the control group, 33% (p=0.031). TT and TTB show a positive effect of training on tooth shade matching independent of the colour scale used. Visual shade taking is the most frequent clinical method for shade determination. To increase better results in visual colour matching, TT and TTB training is used. This is the first study examining the training effect of TT and TTB using Vita classical scale. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Study of Electromagnetic Scattering From Material Object Doped Randomly With Thin Metallic Wires Using Finite Element Method

    Science.gov (United States)

    Deshpande, Manohar D.

    2005-01-01

    A new numerical simulation method using the finite element methodology (FEM) is presented to study electromagnetic scattering due to an arbitrarily shaped material body doped randomly with thin and short metallic wires. The FEM approach described in many standard text books is appropriately modified to account for the presence of thin and short metallic wires distributed randomly inside an arbitrarily shaped material body. Using this modified FEM approach, the electromagnetic scattering due to cylindrical, spherical material body doped randomly with thin metallic wires is studied.

  13. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    National Research Council Canada - National Science Library

    Seo, Byung-Kwan; Lee, Jun-Hwan; Kim, Pil-Kun; Baek, Yong-Hyeon; Jo, Dae-Jean; Lee, Sanghun

    2014-01-01

    ... in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA...

  14. Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: A randomized controlled pilot study

    NARCIS (Netherlands)

    Dronkers, J.J.; Lamberts, H.; Reutelingsperger, I.M.M.D.; Naber, R.H.; Dronkers-Landman, C.M.; Veldman, A.; Meeteren, N.L.U. van

    2010-01-01

    Objective: Investigation of the feasibility and preliminary effect of a short-term intensive preoperative exercise programme for elderly patients scheduled for elective abdominal oncological surgery. Design: Single-blind randomized controlled pilot study. Setting: Ordinary hospital in the

  15. Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study

    National Research Council Canada - National Science Library

    Hoving, Marjanke A; van Raak, Elisabeth P M; Spincemaille, Geert H J J; Palmans, Liesbeth J; Sleypen, Frans A M; Vles, Johan S H

    2007-01-01

    ...). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate...

  16. Dairy consumption and body mass index among adults: Mendelian randomization analysis of 184802 individuals from 25 studies

    Science.gov (United States)

    Associations between dairy intake and body mass index (BMI) have been inconsistently observed in epidemiological studies, and the causal relationship remains ill defined. We performed Mendelian randomization (MR) analysis using an established dairy intake-associated genetic polymorphism located upst...

  17. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

    Science.gov (United States)

    Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

    2017-01-17

     To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1

  18. Disseminating quality improvement: study protocol for a large cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    French Michael T

    2011-04-01

    Full Text Available Abstract Background Dissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment. Methods The study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment, increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services. Outcomes The study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes. Analysis We are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records, including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls. All randomized sites

  19. Cytokine inhibition in chronic fatigue syndrome patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Roerink, Megan E; Knoop, Hans; Bredie, Sebastian J H; Heijnen, Michael; Joosten, Leo A B; Netea, Mihai G; Dinarello, Charles A; van der Meer, Jos W M

    2015-10-05

    Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine network has been suspected to play a role in the pathophysiology of CFS. The disturbances of the cytokine network detected in CFS patients are highly variable, in part due to the lack of adequate controls in many studies. Furthermore, all studies have been performed on peripheral venous blood of patients. As cytokines mainly act in tissues, for example, the brain, the information that can be derived from peripheral blood cells is limited. The information regarding the possible role of cytokines in the pathophysiology could come from intervention studies in which the activities of relevant cytokines are reduced, for example, reducing interleukin-1, interleukin-6 or tumor necrosis factor. In this study, the clinical usefulness of anakinra, an IL-1 antagonist, will be assessed in patients with CFS. A randomized placebo-controlled, double-blind trial will be conducted. Fifty adult female patients meeting the Centers for Disease Control (CDC) criteria for CFS and without psychiatric co-morbidity will be included. After inclusion, patients will be randomized between treatment with anakinra (recombinant human interleukin-1 receptor antagonist) or placebo. Each group will be treated for 4 weeks. Outcome measures will be assessed at baseline, after 4 weeks of intervention, and 6 months after baseline assessment. The primary outcome measure will be fatigue severity at 4 weeks, measured with the validated Checklist of Individual Strength (CIS). Secondary outcome measures are functional impairment, physical and social functioning, psychological distress, pain severity, presence of accompanying symptoms, and cytokine and cortisol concentrations. This is the first randomized placebo-controlled trial that will evaluate the effect of interference with IL-1 on the experience of fatigue in patients with CFS. The

  20. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    Science.gov (United States)

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  1. Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

    Science.gov (United States)

    Bobb, Morgan R; Van Heukelom, Paul G; Faine, Brett A; Ahmed, Azeemuddin; Messerly, Jeffrey T; Bell, Gregory; Harland, Karisa K; Simon, Christian; Mohr, Nicholas M

    2016-07-01

    Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent. A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. A total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Telemedicine is noninferior to F2F consent for delivering research informed consent, with no detected

  2. Guided Imagery for Total Knee Replacement: A Randomized, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Jacobson, Ann F; Umberger, Wendy A; Palmieri, Patrick A; Alexander, Thomas S; Myerscough, Rodney P; Draucker, Claire B; Steudte-Schmiedgen, Susann; Kirschbaum, Clemens

    2016-07-01

    To determine the effect of guided imagery (GI) on functional outcomes of total knee replacement (TKR), explore psychological and neuroimmune mediators, and assess feasibility of study implementation. Investigator-blinded, randomized, placebo-controlled pilot study. Hospital, surgeon's office, participant's home. 82 persons undergoing TKR. Audiorecordings of TKR-specific GI scripts or placebo-control audiorecordings of audiobook segments. Gait velocity and Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function scale. Outcomes for 58 participants (29 receiving GI and 29 controls) were analyzed at 6 months after surgery. The most frequent reason for noncompletion was protocol-driven exclusion at 6 months for having the contralateral knee replaced before the study endpoint (n = 15). With imaging ability as a moderator, gait velocity, but not WOMAC Function score, was significantly improved at 6 months in the GI group. Participants in the GI group, but not the control group, had lower WOMAC Pain scores at 3 weeks after surgery than at baseline. Hair cortisol concentration was significantly lower at 6 months after surgery than at baseline in the GI group but not the control group. GI group participants had lower treatment adherence but greater treatment credibility than the control group. Randomized controlled trials of GI in the TKR population are feasible, but inclusion/exclusion criteria influence attrition. Further studies are needed to elaborate this study's findings, which suggest that guided imagery improves objective, but not patient-reported, outcomes of TKR. Hair cortisol concentration results suggest that engagement in a time-limited guided imagery intervention may contribute to stress reduction even after the intervention is terminated. Further investigation into optimal content and dosing of GI is needed.

  3. Does a mineral wristband affect balance? A randomized, controlled, double-blind study.

    Science.gov (United States)

    Hansson, Eva Ekvall; Beckman, Anders; Persson, Liselott

    2015-06-26

    Having good balance is a facilitating factor in the performance of everyday activities. Good balance is also essential in various sport activities in order to both get results and prevent injury. A common measure of balance is postural sway, which can be measured both antero-posteriorly and medio-laterally. There are several companies marketing wristbands whose intended function is to improve balance, strength and flexibility. Randomized controlled trials have shown that wristbands with holograms have no effect on balance but studies on wristbands with minerals seem to be lacking. The aim of this study was to investigate if the mineral wristband had any effect on postural sway in a group of healthy individuals. Randomized, controlled, double-blind study. The study group consisted of 40 healthy persons. Postural sway was measured antero-posteriorly and medio-laterally on a force plate, to compare: the mineral wristband, a placebo wristband, and without any wristband. The measurements were performed for 30 s, in four situations: with open eyes and closed eyes, standing on a firm surface and on foam. Analyses were made with multilevel technique. The use of wristband with or without minerals did not alter postural sway. Closed eyes and standing on foam both prolonged the dependent measurement, irrespective if it was medio-lateral or antero-posterior. Wearing any wristband (mineral or placebo) gave a small (0.22-0.36 mm/s) but not statistically significant reduction of postural sway compared to not wearing wristband. This study showed no effect on postural sway by using the mineral wristband, compared with a placebo wristband or no wristband. Wearing any wristband at all (mineral or placebo) gave a small but not statistically significant reduction in postural sway, probably caused by sensory input.

  4. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.

    Science.gov (United States)

    Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A

    2015-04-14

    Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.

  5. Intravenous chlorpromazine in the acute treatment of episodic tension-type headache: a randomized, placebo controlled, double-blind study

    OpenAIRE

    Marcelo Eduardo Bigal; Carlos Alberto Bordini; José Geraldo Speciali

    2002-01-01

    Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 ...

  6. Mitigating aflatoxin exposure to improve child growth in Eastern Kenya: study protocol for a randomized controlled trial

    OpenAIRE

    Hoffmann, Vivian; Jones, Kelly; Leroy, Jef

    2015-01-01

    Background While the few studies that have looked at the association between stunting and aflatoxin exposure have found surprisingly large effects, the results remain inconclusive due to a lack of randomized controlled studies. This protocol describes a non-blinded, cluster-randomized controlled trial with the specific objective of testing the impact of reduced aflatoxin exposure on (individual) child linear growth. Methods/Design Participants were recruited from among households containing w...

  7. Comparative study between computed tomography guided superior hypogastric plexus block and the classic posterior approach: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Ayman A Ghoneim

    2014-01-01

    Full Text Available Context: The classic posterior approach to superior hypogastric plexus block (SHPB is sometimes hindered by the iliac crest or a prominent transverse process of L5. The computed tomography (CT - guided anterior approach might overcome these difficulties. Aims: This prospective, comparative, randomized study was aimed to compare the CT guided anterior approach versus the classic posterior approach. Settings and Design: Controlled randomized study. Materials and Methods: A total of 30 patients with chronic pelvic cancer pain were randomized into either classic or CT groups where classic posterior approach or CT guided anterior approach were done, respectively. Visual analog score, daily analgesic morphine consumed and patient satisfaction were assessed just before the procedure, then, after 24 h, 1 week and monthly for 2 months after the procedure. Duration of the procedure was also recorded. Adverse effects associated with the procedure were closely observed and recorded. Statistical Analysis Used: Student′s t-test was used for comparison between groups. Results: Visual analog scale and morphine consumption decreased significantly in both groups at the measured times after the block compared with the baseline in the same group with no significant difference between both groups. The procedure was carried out in significantly shorter duration in the CT group than that in the classic group. The mean patient satisfaction scale increased significantly in both groups at the measured times after the block compared with the baseline in the same group. The patients in the CT groups were significantly more satisfied than those in classic group from day one after the procedure until the end of the study. Conclusions: The CT guided approach for SHPB is easier, faster, safer and more effective, with less side-effects than the classic approach.

  8. Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).

    Science.gov (United States)

    Mendes, Fernanda de Souza Nogueira Sardinha; Sousa, Andréa Silvestre; Souza, Fernando Cesar de Castro Cesar; Pinto, Vivian Liane Mattos; Silva, Paula Simplicio; Saraiva, Roberto Magalhães; Xavier, Sergio Salles; Veloso, Henrique Horta; Holanda, Marcelo Teixeira; Costa, Andréa Rodrigues; Carneiro, Fernanda Martins; Silva, Gilberto Marcelo Sperandio; Borges, Juliana Pereira; Tibirica, Eduardo; Pinheiro, Roberta Olmo; Lara, Flávio Alves; Hasslocher-Moreno, Alejandro Marcel; Brasil, Pedro Emmanuel Alvarenga Americano; Mediano, Mauro Felippe Felix

    2016-09-02

    The effects of exercise training on Chagas heart disease are still unclear. This study aimed to evaluate the effect of exercise training over functional capacity, cardiac function, quality of life, and biomarkers in Chagas heart disease. The PEACH study is a superiority randomized clinical trial which will include subjects who meet the following criteria: Chagas heart disease with a left ventricular ejection fraction below 45 % with or without heart failure symptoms; clinical stability in the last 3 months; adherence to clinical treatment; and age above 18 years. The exclusion criteria are: pregnancy; neuromuscular limitations; smoking; evidence of non-chagasic heart disease; systemic conditions that limit exercise practice or cardiopulmonary exercise test; unavailability to attend the center three times a week during the intervention period; and practitioners of regular exercise. The intervention group will perform an exercise training intervention three times per week during 6 months and will be compared to the control group without exercise. Both groups will undergo the same monthly pharmaceutical and nutritional counseling as well as standard medical treatment according to the Brazilian consensus on Chagas disease. The primary outcome is functional capacity based on peak exercise oxygen consumption during cardiopulmonary exercise testing. Secondary outcomes are: cardiac function; body composition; muscle respiratory strength; microvascular reactivity; cardiac rhythm abnormalities; autonomic function; biochemical; oxidative stress and inflammatory biomarkers; and quality of life. Subjects will be evaluated at baseline, and at 3 and 6 months after randomization. Thirty patients will be randomly assigned into exercise or control groups at a ratio of 1:1. Findings of the present study will be useful to determine if physical exercise programs should be included as an important additional therapy in the treatment of patients with Chagas heart disease. Clinical

  9. Exercise on prescription: a randomized study on the effect of counseling vs counseling and supervised exercise

    DEFF Research Database (Denmark)

    Sørensen, Jes Bak; Kragstrup, J.; Skovgaard, Thomas

    2008-01-01

    The aim of this study was to compare short- (0-4 months) and long-term (0-10 months) effects of high-intensive Exercise on Prescription (EoP) intervention (counseling and supervised exercise) implemented in primary healthcare in a number of Danish counties with a low-intensive intervention...... (counseling) using maximal oxygen uptake (VO(2max)) as the primary outcome. The study was conducted as a randomized trial in 2005-2006 with a high and a low-intensive group. All the patients referred to the EoP scheme by their GP in the counties of Vejle and Ribe, Denmark, were eligible for the trial....... The high-intensive EoP group received 4 months of group-based supervised training and attended five motivational counseling sessions. The low-intensive group only attended four motivational counseling sessions. Three hundred and twenty-seven patients entered the EoP scheme, and 52 (16%) volunteered...

  10. Electroconvulsive therapy vs. paroxetine in treatment-resistant depression -- a randomized study.

    Science.gov (United States)

    Folkerts, H W; Michael, N; Tölle, R; Schonauer, K; Mücke, S; Schulze-Mönking, H

    1997-11-01

    Failure to respond to adequate pharmacological treatment for major depression is now the most common indication for the use of electroconvulsive therapy (ECT). The advantages of ECT with respect to both speed and quality of response are clinically important issues, but surprisingly few studies have examined the efficacy of ECT in relation to newer antidepressant agents such as selective serotonin reuptake inhibitors (SSRIs). A total of 39 subjects with major depression and with at least two failed antidepressant trials (mean 4.9 trials) were randomized to either paroxetine treatment (n=18) or right unilateral (RUL) ECT (n=21). Up to the end of the study treatment we found a reduction in the HAMD score of 59% for the ECT group and of 29% for the paroxetine group (Pdepression, in terms of both degree and speed of response.

  11. Does high tobacco consumption cause psychological distress? A mendelian randomization study

    DEFF Research Database (Denmark)

    Skov-Ettrup, Lise S.; Nordestgaard, Børge G.; Petersen, Christina B.

    2017-01-01

    Background: Increasing evidence suggests that smoking influences mental health negatively. This study investigated whether high tobacco consumption is causally related to psychological distress in a Mendelian randomization design, using a variant in the nicotine acetylcholine receptor gene CHRNA3...... variable for tobacco consumption. Three dimensions of psychological distress were studied: Stress, fatigue, and hopelessness. Analyses with the CHRNA3 genotype were stratified by smoking status. Results: Self-reported amount of smoking was associated with all three dimensions of psychological distress......, homozygotes and heterozygotes for the CHRNA3 genotype had higher tobacco consumption than noncarriers. Nevertheless, the CHRNA3 genotype was not associated with psychological distress neither in current nor in former or never-smokers. For instance among current smokers, the OR for stress was 1.02 (95% CI 0...

  12. Group support for patients with metastatic cancer. A randomized outcome study.

    Science.gov (United States)

    Spiegel, D; Bloom, J R; Yalom, I

    1981-05-01

    The effects of weekly supportive group meetings for women with metastatic carcinoma of the breast were systematically evaluated in a one-year, randomized, prospective outcome study. The groups focused on the problems of terminal illness, including improving relationships with family, friends, and physicians and living as fully as possible in the face of death. We hypothesized that this invention would lead to improved mood, coping strategies, and self-esteem among those in the treatment group. Eighty-six patients were tested at four-month intervals. The treatment group had significantly lower mood-disturbance scores on the Profile of Mood States scale, had fewer maladaptive coping responses, and were less phobic than the control group. This study provides objective evidence that a supportive group intervention for patients with metastatic cancer results in psychological benefit. Mechanisms underlying the effectiveness of this group intervention are explored.

  13. Aloe versus silver sulfadiazine creams for second-degree burns: a randomized controlled study.

    Science.gov (United States)

    Khorasani, Ghasemali; Hosseinimehr, Seyed Jalal; Azadbakht, Mohammad; Zamani, Arman; Mahdavi, Mohammad Reza

    2009-01-01

    Burn injury is associated with a high incidence of death and disability; yet its management remains problematic and costly. We conducted this clinical study to evaluate the efficacy of aloe vera cream for partial thickness burn wounds and compare its results with those of silver sulfadiazine (SSD). Thirty patients with similar types of second-degree burns at two sites on different parts of the body were included in this study. Each patient had one burn treated with topical SSD and one treated with aloe cream, randomly. The rate of re-epithelialization and healing of the partial thickness burns was significantly faster in the site treated with aloe than in the site treated with SSD (15.9 +/- 2 vs 18.73 +/- 2.65 days, respectively; P cream over SSD cream for treating second-degree burns.

  14. The effect of Christmas joy on the mood among medical doctors - a randomized, blinded intervention study

    DEFF Research Database (Denmark)

    Ilkjær, Christine; Møller, Marianne Birkebæk; Lauridsen, Mette H

    2016-01-01

    Abstract INTRODUCTION: Each December Santa's elves spread Christmas joy (JN). Laughter and humour may influence health and stress level. No other study has investigated the effect of JN on the good spirit (DGH) among healthcare professionals. MATERIAL AND METHODS: We performed a single......-centre blinded intervention study with crossover at three hospital departments. JN intervention of three days was randomized. Median ± standard deviation was given. The level of significance was p ... from 0.02 in November to 0.03 in December (without JN) and further to 0.05 with JN. At one department, the rise was significant. At a department without morning coffee, the DGH level raised after JN intervention corresponding to the level at the departments with morning coffee before JN intervention...

  15. Risk of upper limb complaints due to computer use in older persons: a randomized study

    Directory of Open Access Journals (Sweden)

    Jolles Jelle

    2007-08-01

    Full Text Available Abstract Background We studied whether the twelve-month use of a standard computer would induce complaints of upper limb pain or functional limitations in older novice computer users. Methods Participants between 64 and 76 of age were randomly assigned to an Intervention group (n = 62, whose members received a personal computer and fast Internet access at their homes, or a No Intervention control group (n = 61, whose members refrained from computer use during the twelve month study period. Results Difference scores between baseline and twelve months assessments on both complaint (SFS and functional health scales (SF-36 did not differ between groups (all p > .05. Conclusion Prolonged, self-paced use of a standard computer interface does not put older persons at a risk of upper limb complaints or reduce functional health in older adults.

  16. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study.

    Science.gov (United States)

    Lee, Hyuk Jin; Cho, Young Jae; Gong, Hyun Sik; Rhee, Seung Hwan; Park, Hyun Soo; Baek, Goo Hyun

    2013-05-01

    Open carpal tunnel decompression under local anesthesia is routinely done by many surgeons. However, patients complain of pain during the injection of local anesthesia. This prospective, double-blind, randomized study was to compare the pain visual analog scale (VAS) scores of local anesthesia using lidocaine with and without sodium bicarbonate in patients with bilateral carpal tunnel syndrome. Twenty-five patients underwent bilateral simultaneous carpal tunnel decompression. All had topical anesthetic cream applied on the palm and wrist before the lidocaine block. In a randomized manner, half of the hands were blocked with nonbuffered lidocaine and half were blocked with buffered lidocaine. Pain was evaluated on a VAS score. The mean pain VAS score in the hand with buffered lidocaine was 4.6 ± 1.5 and 6.5 ± 1.5 for the hand with nonbuffered lidocaine. After adjustment for individual threshold of the pain, the mean pain VAS score changed into 4.6 ± 1.3 with buffered lidocaine and 6.6 ± 1.7 without buffered lidocaine. In open carpal tunnel surgery, the use of buffered lidocaine for local anesthesia reduces the anesthetic pain effectively. Therapeutic I. Copyright © 2013 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  17. Virtual reality training improves operating room performance: results of a randomized, double-blinded study.

    Science.gov (United States)

    Seymour, Neal E; Gallagher, Anthony G; Roman, Sanziana A; O'Brien, Michael K; Bansal, Vipin K; Andersen, Dana K; Satava, Richard M

    2002-10-01

    To demonstrate that virtual reality (VR) training transfers technical skills to the operating room (OR) environment. The use of VR surgical simulation to train skills and reduce error risk in the OR has never been demonstrated in a prospective, randomized, blinded study. Sixteen surgical residents (PGY 1-4) had baseline psychomotor abilities assessed, then were randomized to either VR training (MIST VR simulator diathermy task) until expert criterion levels established by experienced laparoscopists were achieved (n = 8), or control non-VR-trained (n = 8). All subjects performed laparoscopic cholecystectomy with an attending surgeon blinded to training status. Videotapes of gallbladder dissection were reviewed independently by two investigators blinded to subject identity and training, and scored for eight predefined errors for each procedure minute (interrater reliability of error assessment r > 0.80). No differences in baseline assessments were found between groups. Gallbladder dissection was 29% faster for VR-trained residents. Non-VR-trained residents were nine times more likely to transiently fail to make progress (P trained group (1.19 vs. 7.38 errors per case; P training skills from VR to OR sets the stage for more sophisticated uses of VR in assessment, training, error reduction, and certification of surgeons.

  18. Transcutaneous Electrical Nerve Stimulation Reduces Post-Thoractomy Ipsilateral Shoulder Pain. A Prospective Randomized Study.

    Science.gov (United States)

    Esteban González, Pedro; Novoa, Nuria M; Varela, Gonzalo

    2015-12-01

    The patient's position during an axillary thoracotomy can cause postoperative pain and decrease mobility of the ipsilateral shoulder. In this study, we assessed whether the implementation of a standardized analgesia program using transcutaneous electrical nerve stimulation (TENS) decreases local pain and improves ipsilateral shoulder mobility. Randomized, single-blind, single-center clinical trial of 50 patients who had undergone anatomical lung resection via axillary muscle-sparing thoracotomy. Patients were treated with TENS devices for 30 minutes every 8 hours, beginning on postoperative day 1. Pain and mobility of the affected limb were recorded at the same time on postoperative days 1 through 3. A visual analogue scale was used for pain assessment and shoulder mobility was assessed with a goniometer. Results were compared using a non-parametric test. Twenty-five patients were randomized to each group. Mean age of the control group was 62.7±9.3 years and 63.4±10.2 years in the experimental group. Shoulder mobility parameters were similar in both groups on all postoperative days. However, pain during flexion significantly decreased on day 2 (P=.03) and day 3 (P=.04) in the experimental group. The use of TENS decreases pain from shoulder flexion in patients undergoing axillary thoracotomy for pulmonary resection. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

  19. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    Science.gov (United States)

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (Pcryotherapy group than the control group for pain relief (P.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Hellen Livia Drumond Marra

    2015-01-01

    Full Text Available Transcranial magnetic stimulation (TMS is a noninvasive brain stimulation technique with potential to improve memory. Mild cognitive impairment (MCI, which still lacks a specific therapy, is a clinical syndrome associated with increased risk of dementia. This study aims to assess the effects of high-frequency repetitive TMS (HF rTMS on everyday memory of the elderly with MCI. We conducted a double-blinded randomized sham-controlled trial using rTMS over the left dorsolateral prefrontal cortex (DLPFC. Thirty-four elderly outpatients meeting Petersen’s MCI criteria were randomly assigned to receive 10 sessions of either active TMS or sham, 10 Hz rTMS at 110% of motor threshold, 2,000 pulses per session. Neuropsychological assessment at baseline, after the last session (10th and at one-month follow-up, was applied. ANOVA on the primary efficacy measure, the Rivermead Behavioural Memory Test, revealed a significant group-by-time interaction p=0.05, favoring the active group. The improvement was kept after one month. Other neuropsychological tests were heterogeneous. rTMS at 10 Hz enhanced everyday memory in elderly with MCI after 10 sessions. These findings suggest that rTMS might be effective as a therapy for MCI and probably a tool to delay deterioration.

  1. Low dose Mitomycin-C in severe vernal keratoconjunctivitis: A randomized prospective double blind study

    Directory of Open Access Journals (Sweden)

    Jain Arun

    2006-01-01

    Full Text Available Purpose: To study the efficacy and safety of low dose topical Mitomycin C (MMC in severe Vernal keratoconjunctivitis (VKC. Design: Placebo controlled double masked randomized clinical trial. Materials and Methods: Twenty-eight patients with severe VKC were randomly assigned to receive either topical MMC (0.01% (n=17 or distilled water (n=11 three times daily for a period of two weeks. Signs and symptoms were recorded on day of presentation and at the end of treatment period (2 weeks. Mann Whitney test was used to analyze the signs and symptoms in the two groups. Results: No statistically significant difference was observed in terms of severity of symptoms at presentation. At two weeks patients in the MMC group showed significant decrease in tearing, foreign body sensation, discharge, hyperemia, punctate keratitis, limbal edema and trantas spots. No adverse effect of MMC was observed. Conclusion: Short term low dose topical MMC is an effective and safe drug to control acute exacerbations in patients of severe VKC refractory to conventional treatment.

  2. A Randomized Controlled Trial Studying the Role of Dexamethasone in Scalp Nerve Blocks for Supratentorial Craniotomy.

    Science.gov (United States)

    Jose, Riya; Chakravarthy, Kalyana; Nair, Shalini; Joseph, Mathew; Jeyaseelan, Visalakshi; Korula, Grace

    2017-04-01

    The aim of this double-blinded randomized control study was to examine the role of the steroid dexamethasone as an adjuvant to lignocaine and ropivacaine in scalp nerve blocks in adults undergoing supratentorial craniotomy under general anesthesia. We compared the intraoperative anesthetic and postoperative analgesic requirement with and without the addition of dexamethasone to the local anesthetics. The consented 90 patients were randomized into 2 groups: one group received 8 mg (2 mL) of dexamethasone, whereas the other received 2 mL of normal saline along with the local anesthetics in the scalp nerve block administered soon after induction of general anesthesia. All patients received oral/intravenous dexamethasone perioperatively to decrease cerebral edema. The general anesthetic technique for induction, maintenance, and recovery was standardized in the 2 groups. The primary outcome assessed was the time to administration of the first dose of analgesic postoperatively. The secondary outcomes included intraoperative opioid requirement, time to emergence, and incidence of postoperative nausea and vomiting. There was no significant difference between the dexamethasone and saline groups with respect to time to first analgesic requirement, intraoperative fentanyl requirements, time to emergence from general anesthesia, and incidence of postoperative nausea and vomiting. Addition of dexamethasone as an adjuvant to local anesthetics in scalp nerve blocks in the setting of perioperative steroid therapy does not appear to provide any additional benefit with respect to prolongation of the duration of the block.

  3. Exploiting SNP correlations within random forest for genome-wide association studies.

    Directory of Open Access Journals (Sweden)

    Vincent Botta

    Full Text Available The primary goal of genome-wide association studies (GWAS is to discover variants that could lead, in isolation or in combination, to a particular trait or disease. Standard approaches to GWAS, however, are usually based on univariate hypothesis tests and therefore can account neither for correlations due to linkage disequilibrium nor for combinations of several markers. To discover and leverage such potential multivariate interactions, we propose in this work an extension of the Random Forest algorithm tailored for structured GWAS data. In terms of risk prediction, we show empirically on several GWAS datasets that the proposed T-Trees method significantly outperforms both the original Random Forest algorithm and standard linear models, thereby suggesting the actual existence of multivariate non-linear effects due to the combinations of several SNPs. We also demonstrate that variable importances as derived from our method can help identify relevant loci. Finally, we highlight the strong impact that quality control procedures may have, both in terms of predictive power and loci identification. Variable importance results and T-Trees source code are all available at www.montefiore.ulg.ac.be/~botta/ttrees/ and github.com/0asa/TTree-source respectively.

  4. Griffiths singularities in the random quantum Ising antiferromagnet: A tree tensor network renormalization group study

    Science.gov (United States)

    Lin, Yu-Ping; Kao, Ying-Jer; Chen, Pochung; Lin, Yu-Cheng

    2017-08-01

    The antiferromagnetic Ising chain in both transverse and longitudinal magnetic fields is one of the paradigmatic models of a quantum phase transition. The antiferromagnetic system exhibits a zero-temperature critical line separating an antiferromagnetic phase and a paramagnetic phase; the critical line connects an integrable quantum critical point at zero longitudinal field and a classical first-order transition point at zero transverse field. Using a strong-disorder renormalization group method formulated as a tree tensor network, we study the zero-temperature phase of the quantum Ising chain with bond randomness. We introduce a new matrix product operator representation of high-order moments, which provides an efficient and accurate tool for determining quantum phase transitions via the Binder cumulant of the order parameter. Our results demonstrate an infinite-randomness quantum critical point in zero longitudinal field accompanied by pronounced quantum Griffiths singularities, arising from rare ordered regions with anomalously slow fluctuations inside the paramagnetic phase. The strong Griffiths effects are signaled by a large dynamical exponent z >1 , which characterizes a power-law density of low-energy states of the localized rare regions and becomes infinite at the quantum critical point. Upon application of a longitudinal field, the quantum phase transition between the paramagnetic phase and the antiferromagnetic phase is completely destroyed. Furthermore, quantum Griffiths effects are suppressed, showing z <1 , when the dynamics of the rare regions is hampered by the longitudinal field.

  5. A prospective randomized study of the inflammatory responses to multiport and singleport laparoscopic hysterectomies.

    Science.gov (United States)

    Tormena, Renata Assef; Ribeiro, Sérgio Conti; Soares, José Maria; Maciel, Gustavo Arantes Rosa; Baracat, Edmund Chada

    2017-07-01

    To evaluate the inflammatory responses induced by laparoscopic hysterectomies with multiport and singleport approaches. This was a pilot prospective randomized study that included 42 women candidates for hysterectomy at School of Medicine, Hospital das Clínicas, USP. The patients were randomized to two groups: MP-TLH (total laparoscopic hysterectomy with 3 abdominal incisions), and SP-TLH (total laparoscopic hysterectomy with a single umbilical incision).We evaluated the inflammatory response (via CRP, IL-6, IL-10, TNFα, VEGF and leukogram assessments), surgical time, postoperative pain, blood loss and surgical complications in both groups. Both techniques were similar regarding C-reactive protein (p=.666), IL-6 (p=.833), IL-10 (p=.420), TNF-α(p=.098), VEGF (p=.092) and the leukogram (p=.712) measures. The operative time was significantly longer in the SP-TLH group than in the MP-TLH group (p=.001). The pain evaluation was similar in both groups (p=.170). Hemoglobin variation and the aspirated blood volume were similar in both groups (p=.493 and p=.347). There were no major complications. Multiport and singleport laparoscopic approaches are both safe methods for hysterectomy. Although SP-TLH resulted in a significantly longer operative time than MP-TLH, no differences were observed between the groups in inflammatory responses, blood loss and postoperative pain.

  6. Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Tseng, Chi-Chuan; Tseng, Alan; Chang, Chia-Hao

    2015-05-15

    Obesity-related diseases have a profound economic impact on health care systems. Laser acupuncture has been shown to have beneficial effects on obesity. However, to our knowledge, those trials were either non-randomized, non-blinded or included low-calorie diet control. We have, therefore, designed a patient-assessor-blinded, randomized, sham-controlled crossover trial to investigate the significance of laser acupuncture on obesity. 104 subjects above 20 years of age with a body mass index (BMI) of over 25 kg/m(2) will be divided into 2 groups: experimental and control. Each subject will receive the treatment relevant to their group 3 times a week for 8 weeks. After 8 weeks of treatment the subject will enter a 2-week washout period, after which the subjects will switch groups. Measurements will include BMI, body fat percentage, waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh circumference, body fat, blood pressure, heart rate, hunger and the 36-item Short-Form Health Survey (SF-36). The results of this study will provide the basis for future large-scale multicenter trials investigating the effects of laser acupuncture on obesity. ClinicalTrials.gov Identifier: NCT02167308 ; registration date: 14 June 2014.

  7. Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

    Science.gov (United States)

    Probst, Pascal; Knebel, Phillip; Grummich, Kathrin; Tenckhoff, Solveig; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-07-01

    Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

  8. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial.

    Science.gov (United States)

    Han, Gajin; Ko, Seok-Jae; Park, Jae-Woo; Kim, Jinsung; Yeo, Inkwon; Lee, Hyejung; Kim, Song-Yi; Lee, Hyangsook

    2014-03-22

    Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD. A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck's depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers' Institutional Review Boards. Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work. ClinicalTrials.gov Identifier: NCT01921504.

  9. Early rehabilitation of cancer patients – a randomized controlled intervention study

    Directory of Open Access Journals (Sweden)

    Arving Cecilia

    2013-01-01

    Full Text Available Abstract Background Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. Method Patients (≥ 18 years with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be

  10. Blinded randomized controlled study of a web-based otoscopy simulator in undergraduate medical education.

    Science.gov (United States)

    Stepniak, Camilla; Wickens, Brandon; Husein, Murad; Paradis, Josee; Ladak, Hanif M; Fung, Kevin; Agrawal, Sumit K

    2017-06-01

    OtoTrain is a Web-based otoscopy simulator that has previously been shown to have face and content validity. The objective of this study was to evaluate the effectiveness of this Web-based otoscopy simulator in teaching diagnostic otoscopy to novice learners STUDY DESIGN: Prospective, blinded randomized control trial. Second-year medical students were invited to participate in the study. A pretest consisted of a series of otoscopy videos followed by an open-answer format assessment pertaining to the characteristics and diagnosis of each video. Participants were then randomly divided into a control group and a simulator group. Following the pretest, both groups attended standard otology lectures, but the simulator group was additionally given unlimited access to OtoTrain for 1 week. A post-test was completed using a separate set of otoscopy videos. Tests were graded based on a comprehensive marking scheme. The pretest and post-test were anonymized, and the three evaluators were blinded to student allotment. A total of 41 medical students were enrolled in the study and randomized to the control group (n = 20) and the simulator group (n = 21). There was no significant difference between the two groups on their pretest scores. With the standard otology lectures, the control group had a 31% improvement in their post-test score (mean ± standard error of the mean, 30.4 ± 1.5) compared with their pretest score (23.3 ± 1.8) (P simulator group had the addition of OtoTrain to the otology lectures, and their score improved by 71% on their post-test (37.8 ± 1.6) compared to their pretest (22.1 ± 1.9) (P simulator group had a 24% higher score than the control group (P < .002). Inter-rater reliability between the blinded evaluators was excellent (r = 0.953, P < .001). The use of OtoTrain increased the diagnostic otoscopic performance in novice learners. OtoTrain may be an effective teaching adjunct for undergraduate medical students. 1b. Laryngoscope, 127:1306-1311, 2017.

  11. Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial.

    Science.gov (United States)

    van Vulpen, Jonna K; Siersema, Peter D; van Hillegersberg, Richard; Nieuwenhuijzen, Grard A P; Kouwenhoven, Ewout A; Groenendijk, Richard P R; van der Peet, Donald L; Hazebroek, Eric J; Rosman, Camiel; Schippers, Carlo C G; Steenhagen, Elles; Peeters, Petra H M; May, Anne M

    2017-08-18

    Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery. The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed

  12. Working memory and processing speed training in schizophrenia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cassetta, Briana D; Goghari, Vina M

    2016-01-26

    In most domains of cognition, individuals with schizophrenia are generally found to be one standard deviation below the mean of the controls. As a result, examining the impact of cognitive remediation in individuals with schizophrenia has been a burgeoning area of research. However, the state of the literature remains unclear as to which domains of cognition should be targeted to produce the most widespread and durable benefits for individuals with schizophrenia. One suggestion is that targeting lower-level cognitive processes that are important for higher-level and more complex aspects of cognition may produce the most widespread benefits in cognition and everyday functioning. Relatively few studies have examined the effects of working memory or processing speed training in schizophrenia, as most studies examine broad-based remediation programs. Thus, a need exists for targeted working memory and processing speed training studies to better understand the mechanisms of cognitive enhancement in patients. This study aims to 1) investigate near-transfer gains (that is, the transfer of learning to related contexts) associated with working memory and processing speed training in schizophrenia patients; 2) investigate far-transfer gains (that is, the transfer of learning to new contexts) associated with working memory and processing speed training (that is, gains in other neurocognitive domains and social cognition); and 3) investigate real-world gains associated with training (that is, gains in daily functioning). A double-blind randomized controlled trial with a three parallel group design will be conducted. A random sample of 81 patients with schizophrenia or schizoaffective disorder will be recruited through outpatient clinics at Foothills Hospital and community support programs in Calgary, Alberta. Participants will be randomly assigned using a computer-generated program in a 1:1:1 ratio to a working memory-training group, a processing speed-training group, or a no

  13. Language-specific strategy for programming hearing aids - A double-blind randomized controlled crossover study.

    Science.gov (United States)

    Matsumoto, Nozomu; Suzuki, Nobuyoshi; Iwasaki, Satoshi; Ishikawa, Kazuha; Tsukiji, Hiroki; Higashino, Yoshie; Tabuki, Tomoko; Nakagawa, Takashi

    2017-11-17

    Voice-aligned compression (VAC) is a method used in Oticon's hearing aids to provide more comfortable hearing without sacrificing speech discrimination. The complex, non-linear compression curve for the VAC strategy is designed based on the frequency profile of certain spoken Western languages. We hypothesized that hearing aids could be further customized for Japanese-speaking users by modifying the compression curve using the frequency profile of spoken Japanese. A double-blind randomized controlled crossover study was performed to determine whether or not Oticon's modified amplification strategy (VAC-J) provides subjectively preferable hearing aids for Japanese-speaking hearing aid users compared to the same company's original amplification strategy (VAC). The participants were randomized to two groups. The VAC-first group received a pair of hearing aids programmed using the VAC strategy and wore them for three weeks, and then received a pair of hearing aids programmed using VAC-J strategy and wore them for three weeks. The VAC-J-first group underwent the same study, but they received hearing aids in the reverse sequence. A Speech, Spatial and Qualities (SSQ) questionnaire was administered before beginning to use the hearing aids, at the end of using the first pair of hearing aids, and at the end of using the second pair of hearing aids. Twenty-five participants that met the inclusion/exclusion criteria from January 1 to October 31, 2016, were randomized to two groups. Twenty-two participants completed the study. There were no statistically significant differences in the increment of SSQ scores between the participants when using the VAC- or the VAC-J-programmed hearing aids. However, participants preferred the VAC-J strategy to the VAC strategy at the end of the study, and this difference was statistically significant. Japanese-speaking hearing aid users preferred using hearing aids that were fitted with the VAC-J strategy. Our results show that the VAC strategy

  14. Using music to reduce anxiety among older adults in the emergency department: a randomized pilot study.

    Science.gov (United States)

    Belland, Laura; Rivera-Reyes, Laura; Hwang, Ula

    2017-11-01

    An emergency department (ED) visit may be distressing and anxiety-provoking for older adults (age > 65 years). No studies have specifically evaluated the effect of music listening on anxiety in older adults in the ED. The objective of this pilot study was to evaluate the effect of music listening on anxiety levels in older ED patients. This was a randomized pilot study in the geriatric ED of an urban academic tertiary medical center. This was a sample of English-speaking adults (age > 65 years) who were not deaf (n = 35). Subjects consented to participate and were randomized to receive up to 60 min of music listening with routine care, while the control group received routine care with no music. Subjects in the music treatment group received headphones and an electronic tablet with pre-downloaded music, and were allowed to choose from 5 selections. The primary outcome was change in anxiety levels, measured by the state-trait anxiety inventory (STAI), at enrollment and 1 h later. A total of 35 participants were enrolled: 74% were female, 40% were white, and 40% were black; of these, 32 subjects completed the study protocol. When comparing control (n = 18) against intervention subjects (n = 17), there were no significant differences in enrollment STAI scores (43.00 ± 15.00 vs. 40.30 ± 12.80, P = 0.57). STAI scores 1 hour after enrollment (after the music intervention) were significantly reduced in the intervention subjects compared to the control subjects (with reduction of 10.00 ± 12.29 vs. 1.88 ± 7.97, P = 0.03). These pilot results suggest that music listening may be an effective tool for reducing anxiety among older adults in the ED.

  15. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

    2015-09-02

    The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

  16. Early embryo development in a sequential versus single medium: a randomized study

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    D'Hooghe Thomas M

    2010-07-01

    Full Text Available Abstract Background The success of in vitro fertilization techniques is defined by multiple factors including embryo culture conditions, related to the composition of the culture medium. In view of the lack of solid scientific data and in view of the current general belief that sequential media are superior to single media, the aim of this randomized study was to compare the embryo quality in two types of culture media. Methods In this study, the embryo quality on day 3 was measured as primary outcome. In total, 147 patients younger than 36 years treated with IVF/ICSI during the first or second cycle were included in this study. Embryos were randomly cultured in a sequential (group A or a single medium (group B to compare the embryo quality on day 1, day 2 and day 3. The embryo quality was compared in both groups using a Chi-square test with a significance level of 0.05. Results At day 1, the percentage of embryos with a cytoplasmic halo was higher in group B (46% than in group A (32%. At day 2, number of blastomeres, degree of fragmentation and the percentage of unequally sized blastomeres were higher in group B than in group A. At day 3, a higher percentage of embryos had a higher number of blastomeres and unequally sized blastomeres in group B. The number of good quality embryos (GQE was comparable in both groups. The embryo utilization rate was higher in group B (56% compared to group A (49%. Conclusions Although, no significant difference in the number of GQE was found in both media, the utilization rate was significantly higher when the embryos were cultured in the single medium compared to the sequential medium. The results of this study have a possible positive effect on the cumulative cryo-augmented pregnancy rate. Trial registration number NCT01094314

  17. A double SIMEX approach for bivariate random-effects meta-analysis of diagnostic accuracy studies

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    Annamaria Guolo

    2017-01-01

    Full Text Available Abstract Background Bivariate random-effects models represent a widely accepted and recommended approach for meta-analysis of test accuracy studies. Standard likelihood methods routinely used for inference are prone to several drawbacks. Small sample size can give rise to unreliable inferential conclusions and convergence issues make the approach unappealing. This paper suggests a different methodology to address such difficulties. Methods A SIMEX methodology is proposed. The method is a simulation-based technique originally developed as a correction strategy within the measurement error literature. It suits the meta-analysis framework as the diagnostic accuracy measures provided by each study are prone to measurement error. SIMEX can be straightforwardly adapted to cover different measurement error structures and to deal with covariates. The effortless implementation with standard software is an interesting feature of the method. Results Extensive simulation studies highlight the improvement provided by SIMEX over likelihood approach in terms of empirical coverage probabilities of confidence intervals under different scenarios, independently of the sample size and the values of the correlation between sensitivity and specificity. A remarkable amelioration is obtained in case of deviations from the normality assumption for the random-effects distribution. From a computational point of view, the application of SIMEX is shown to be neither involved nor subject to the convergence issues affecting likelihood-based alternatives. Application of the method to a diagnostic review of the performance of transesophageal echocardiography for assessing ascending aorta atherosclerosis enables overcoming limitations of the likelihood procedure. Conclusions The SIMEX methodology represents an interesting alternative to likelihood-based procedures for inference in meta-analysis of diagnostic accuracy studies. The approach can provide more accurate inferential

  18. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

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    Oliveira Sérgio A

    2007-01-01

    Full Text Available Abstract Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum. For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271

  19. Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Timmerby, Nina; Austin, Stephen F; Ussing, Kristian; Bech, Per; Csillag, Claudio

    2016-08-30

    Major depressive disorder has been shown to affect many domains of family life including family functioning. Conversely, the influence of the family on the course of the depression, including the risk of relapse, is one reason for targeting the family in interventions. The few studies conducted within this area indicate that family psychoeducation as a supplement to traditional treatment can effectively reduce the risk of relapse in patients with major depression as well as being beneficial for the relatives involved. However, the evidence is currently limited. This study will investigate the effect of family psychoeducation compared to social support on the course of the illness in patients with major depressive disorder. The study is designed as a dual center, two-armed, observer-blinded, randomized controlled trial. Relatives are randomized to participate in one of two conditions: either four sessions of manualized family psychoeducation or four sessions in a social support group led by a health care professional. Patients will not participate in the groups and will continue their treatment as usual. A total of 100 patients, each accompanied by one relative, will be recruited primarily from two outpatient clinics in the Capital Region of Denmark. The primary outcome is the occurrence of depressive relapse at 9-month follow-up defined as a score ≥7 on the Hamilton six-item subscale. Secondary outcomes will include time to relapse. It is hoped that the results from this study will help to clarify the mechanisms behind any beneficial changes due to family psychoeducation and provide information on the long-term effect of this intervention for both patient and relatives. If the results are positive, the family psychoeducation program may be suitable for implementation within a clinical setting. ClinicalTrials.gov Identifier: NCT02348827 , registered 5 January 2015.

  20. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

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    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-05-01

    Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Effect of Postoperative Administration of Pregabalin for Post-thoracotomy Pain: A Randomized Study.

    Science.gov (United States)

    Yoshimura, Noritaka; Iida, Hiroki; Takenaka, Motoyasu; Tanabe, Kumiko; Yamaguchi, Shinobu; Kitoh, Kazuhiro; Shirahashi, Koyo; Iwata, Hisashi

    2015-12-01

    The present study was performed to evaluate the effect of postoperative administration of pregabalin in patients who reported moderate-to-severe pain after epidural analgesia following thoracotomy. An open-label, randomized, controlled, parallel-group study. A single center in Japan. Consecutive patients (aged≥20 years) who reported moderate-to-severe pain after effectual 2-day epidural analgesia post-thoracotomy for lung cancer from February 2012 to March 2013. Patients were assigned to 2 groups: control (control treatment: acetaminophen, 400 mg, and codeine phosphate powder, 20 mg) or pregabalin (pregabalin, 75 mg, plus control treatment). The 12-week study period included 2-week study treatment and 10-week follow-up. For efficacy, the primary endpoint was the visual analog scale (VAS) scores for pain at rest and with coughing at week 2, and secondary endpoints were the VAS scores for pain and the neuropathic pain questionnaire at week 12. Fifty patients were randomized (25 per group). At week 2, the VAS scores for pain at rest (mean [SD]) were 29.5 (21.9) in the control group and 16.3 (15) in the pregabalin group (p = 0.02); for pain with coughing, the scores were 45.2 (20.9) and 28.8 (25.9), respectively (p = 0.02). VAS scores improved more in the pregabalin group than in the control group over the 12 weeks. Patients free from possible neuropathic pain were 48% of the control group and 88% of the pregabalin group, respectively (p = 0.001). Postoperative administration of pregabalin effectively reduced post-thoracotomy pain. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2017-03-01

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

  3. Physical therapy after prophylactic mastectomy with breast reconstruction: a prospective randomized study.

    Science.gov (United States)

    Unukovych, Dmytro; Johansson, Hemming; Johansson, Elizabeth; Arver, Brita; Liljegren, Annelie; Brandberg, Yvonne

    2014-08-01

    The rate of prophylactic mastectomies (PM) is increasing. Patients generally report high levels of health related quality of life and satisfaction after the procedure, whereas body image perception and sexuality may be negatively affected. The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM. Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible. The following patient-reported outcome measures were used at study baseline and 2 years postoperatively: the body image scale (BIS), the sexual activity questionnaire (SAQ), the short-form health survey (SF-36), the hospital anxiety and depression scale (HAD), and a study specific "pain/motion/sensation scale". Out of 125 patients invited to participate in this prospective randomized study, 43 (34%) consented and were randomized into the intervention (n = 24, 56%) or control (n = 19, 44%) groups. There were no statistically significant between-group differences found with respect to BIS, SAQ, SF-36, HAD, and "pain/motion/sensation". Two years postoperatively, more than half of the patients in both groups reported problems like feeling less attractive, less sexually attractive, their body feeling less whole, and being dissatisfied with their body. A majority marked a decreased sensation in breast area. The interest in a physiotherapy intervention was limited among women who had undergone PM. The intervention did not show any substantial effects. A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Comprehensive genotyping in dyslipidemia: mendelian dyslipidemias caused by rare variants and Mendelian randomization studies using common variants.

    Science.gov (United States)

    Tada, Hayato; Kawashiri, Masa-Aki; Yamagishi, Masakazu

    2017-04-01

    Dyslipidemias, especially hyper-low-density lipoprotein cholesterolemia and hypertriglyceridemia, are important causal risk factors for coronary artery disease. Comprehensive genotyping using the 'next-generation sequencing' technique has facilitated the investigation of Mendelian dyslipidemias, in addition to Mendelian randomization studies using common genetic variants associated with plasma lipids and coronary artery disease. The beneficial effects of low-density lipoprotein cholesterol-lowering therapies on coronary artery disease have been verified by many randomized controlled trials over the years, and subsequent genetic studies have supported these findings. More recently, Mendelian randomization studies have preceded randomized controlled trials. When the on-target/off-target effects of rare variants and common variants exhibit the same direction, novel drugs targeting molecules identified by investigations of rare Mendelian lipid disorders could be promising. Such a strategy could aid in the search for drug discovery seeds other than those for dyslipidemias.

  5. Bivariate random-effects meta-analysis and the estimation of between-study correlation

    Directory of Open Access Journals (Sweden)

    Lambert Paul C

    2007-01-01

    Full Text Available Abstract Background When multiple endpoints are of interest in evidence synthesis, a multivariate meta-analysis can jointly synthesise those endpoints and utilise their correlation. A multivariate random-effects meta-analysis must incorporate and estimate the between-study correlation (ρB. Methods In this paper we assess maximum likelihood estimation of a general normal model and a generalised model for bivariate random-effects meta-analysis (BRMA. We consider two applied examples, one involving a diagnostic marker and the other a surrogate outcome. These motivate a simulation study where estimation properties from BRMA are compared with those from two separate univariate random-effects meta-analyses (URMAs, the traditional approach. Results The normal BRMA model estimates ρB as -1 in both applied examples. Analytically we show this is due to the maximum likelihood estimator sensibly truncating the between-study covariance matrix on the boundary of its parameter space. Our simulations reveal this commonly occurs when the number of studies is small or the within-study variation is relatively large; it also causes upwardly biased between-study variance estimates, which are inflated to compensate for the restriction on ρ^ MathType@MTEF@5@5@+=feaafiart1ev1aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacH8akY=wiFfYdH8Gipec8Eeeu0xXdbba9frFj0=OqFfea0dXdd9vqai=hGuQ8kuc9pgc9s8qqaq=dirpe0xb9q8qiLsFr0=vr0=vr0dc8meaabaqaciaacaGaaeqabaqabeGadaaakeaaiiGacuWFbpGCgaqcaaaa@2E83@B. Importantly, this does not induce any systematic bias in the pooled estimates and produces conservative standard errors and mean-square errors. Furthermore, the normal BRMA is preferable to two normal URMAs; the mean-square error and standard error of pooled estimates is generally smaller in the BRMA, especially given data missing at random. For meta-analysis of proportions we then show that a generalised BRMA model is better still. This correctly uses a binomial

  6. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial.

    Science.gov (United States)

    Goodman, Phyllis J; Tangen, Catherine M; Darke, Amy K; Arnold, Kathryn B; Hartline, JoAnn; Yee, Monica; Anderson, Karen; Caban-Holt, Allison; Christen, William G; Cassano, Patricia A; Lance, Peter; Klein, Eric A; Crowley, John J; Minasian, Lori M; Meyskens, Frank L

    2016-08-12

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited. Four ancillary studies were added. Each drew from the same population but had independent objectives and an endpoint other than prostate cancer. These studies fell into two categories: those prospectively enrolling and following participants (studies of Alzheimer's disease and respiratory function) and those requiring a retrospective medical record review after a reported event (cataracts/age-related macular degeneration and colorectal screening). An examination of the challenges and opportunities of adding ancillary studies is provided. The impact of the ancillary studies on adherence to SELECT was evaluated using a Cox proportional hazards model. While the addition of ancillary studies appears to have improved participant adherence to the primary trial, this did not come without added complexity. Activation of the ancillary studies happened after the SELECT randomizations had begun resulting in accrual problems to some of the studies. Study site participation in the ancillary trials varied greatly and depended on the interest of the study site principal investigator. Procedures for each were integrated into the primary trial and all monitoring was done by the SELECT Data and Safety Monitoring Committee. The impact of the early

  7. Random fixed points and random differential inclusions

    Directory of Open Access Journals (Sweden)

    Nikolaos S. Papageorgiou

    1988-01-01

    Full Text Available In this paper, first, we study random best approximations to random sets, using fixed point techniques, obtaining this way stochastic analogues of earlier deterministic results by Browder-Petryshyn, KyFan and Reich. Then we prove two fixed point theorems for random multifunctions with stochastic domain that satisfy certain tangential conditions. Finally we consider a random differential inclusion with upper semicontinuous orientor field and establish the existence of random solutions.

  8. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Kangjun

    2011-06-01

    Full Text Available Abstract Background There are a variety of treatment options for Bell's palsy. Evidence from randomized controlled trials indicates corticosteroids can be used as a proven therapy for Bell's palsy. Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease. The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify whether prednisolone in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients. Methods/Design In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with prednisolone and/or acupuncture. In total, 1200 patients aged 18 to 75 years within 72 h of onset of acute, unilateral, peripheral facial palsy will be assessed. There are six treatment groups, with four treated according to different path-stages and two not. These patients are randomly assigned to be in one of the following six treatment groups, i.e. 1 placebo prednisolone group, 2 prednisolone group, 3 placebo prednisolone plus acute stage acupuncture group, 4 prednisolone plus acute stage acupuncture group, 5 placebo prednisolone plus resting stage acupuncture group, 6 prednisolone plus resting stage acupuncture group. The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain, the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period. Discussion The result of this trial will assess the

  9. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

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    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  10. The Effects of Experimentally Manipulated Social Status on Acute Eating Behavior: A Randomized, Crossover Pilot Study

    Science.gov (United States)

    Cardel, MI; Johnson, SL; Beck, J; Dhurandhar, E; Keita, AD; Tomczik, AC; Pavela, G; Huo, T; Janicke, DM; Muller, K; Piff, PK; Peters, JC; Hill, JO; Allison, DB

    2016-01-01

    Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19–25; 67% female; BMI ≥18.5 and ≤30 kg/m2). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of ‘privilege’ depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status

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

    Science.gov (United States)

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

    2015-01-30

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

  12. Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

    Science.gov (United States)

    Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

    2015-01-01

    Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

  13. Loss to follow-up in a randomized controlled trial study for pediatric weight management (EPOC).

    Science.gov (United States)

    Warschburger, Petra; Kröller, Katja

    2016-11-14

    Attrition is a serious problem in intervention studies. The current study analyzed the attrition rate during follow-up in a randomized controlled pediatric weight management program (EPOC study) within a tertiary care setting. Five hundred twenty-three parents and their 7-13-year-old children with obesity participated in the randomized controlled intervention trial. Follow-up data were assessed 6 and 12 months after the end of treatment. Attrition was defined as providing no objective weight data. Demographic and psychological baseline characteristics were used to predict attrition at 6- and 12-month follow-up using multivariate logistic regression analyses. Objective weight data were available for 49.6 (67.0) % of the children 6 (12) months after the end of treatment. Completers and non-completers at the 6- and 12-month follow-up differed in the amount of weight loss during their inpatient stay, their initial BMI-SDS, educational level of the parents, and child's quality of life and well-being. Additionally, completers supported their child more than non-completers, and at the 12-month follow-up, families with a more structured eating environment were less likely to drop out. On a multivariate level, only educational background and structure of the eating environment remained significant. The minor differences between the completers and the non-completers suggest that our retention strategies were successful. Further research should focus on prevention of attrition in families with a lower educational background. Current Controlled Trials ISRCTN24655766 . Registered 06 September 2008, updated 16 May 2012.

  14. Mendelian randomization estimates of alanine aminotransferase with cardiovascular disease: Guangzhou Biobank Cohort study.

    Science.gov (United States)

    Xu, Lin; Jiang, Chao Qiang; Lam, Tai Hing; Zhang, Wei Sen; Zhu, Feng; Jin, Ya Li; Thomas, G Neil; Cheng, Kar Keung; Schooling, C Mary

    2017-01-15

    Observational studies of the association of alanine aminotransferase (ALT) levels with ischaemic heart disease (IHD) and cardiovascular disease (CVD) risk factors are inconsistent, probably because of confounding and reverse causality. Mendelian randomization (MR) provides less confounded results. We used MR analysis to assess the associations of ALT (U/L) with IHD, diabetes and other CVD risk factors. We used instrumental variable analysis based on two single nucleotide polymorphism (SNPs) HSD17B13/MAPK10 (rs6834314) and PNPLA3/SAMM50 (rs738409) to assess the associations of ALT (U/L) with IHD, diabetes and other CVD risk factors in the Guangzhou Biobank Cohort Study (GBCS). Observationally in 19,925 participants ALT levels were strongly positively associated with self-reported IHD, systolic and diastolic blood pressure, low-density lipoprotein- and total cholesterol, triglycerides, fasting glucose, body mass index, waist circumference, heart rate (HR) and diabetes, but were not associated with uncorrected QT interval, HR-corrected QT interval or high-density lipoprotein-cholesterol. In the MR study, using a credible genetic instrument (F-statistic = 23) for ALT, ALT levels were negatively associated with IHD (odds ratio (OR) 0.92, 95% confidence interval (CI) 0.87 to 0.97) and triglycerides (β - 0.08, 95% CI - 0.13 to - 0.03), but were not associated with other CVD risk factors. Our results using Mendelian randomization suggest that ALT reduces the risk of IHD, probably through reducing triglyceride levels. The underlying mechanisms deserve further investigation. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial.

    Science.gov (United States)

    Vas, Jorge; Modesto, Manuela; Aguilar, Inmaculada; Santos-Rey, Koldo; Benítez-Parejo, Nicolás; Rivas-Ruiz, Francisco

    2011-02-28

    Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. ISRCTN trial number ISRCTN60217348 (19 October 2010).

  16. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  17. Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.

    Science.gov (United States)

    Gujjar, Arunodaya R; Nandhagopal, Ramachandiran; Jacob, Poovathoor C; Al-Hashim, Abdulhakeem; Al-Amrani, Khalfan; Ganguly, Shyam S; Al-Asmi, Abdullah

    2017-07-01

    Status Epilepticus (SE) is a common medical emergency carrying a high morbidity and mortality. Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures. Few prospective studies have addressed its use in SE. We aimed to examine the efficacy of intravenous LEV in controlling SE and cluster attacks of seizures (CS), in comparison with IV phenytoin (DPH), using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine to control ongoing seizure, were randomized to receive either medication. Rates of seizure control over 24h, adverse effects and outcomes were compared. A logistic regression model was used to identify outcome predictors. 52 patients with SE and 63 with CS received either LEV or DPH. In the SE group, LEV was effective in18/22(82%) and DPH in 22/30(73.3%) patients in controlling seizures. Among patients with CS, LEV was effective in 31/38(81.6%) and DPH in 20/25(80%). With the use of LEV, DPH or both, SE and CS were controlled among 92% and 96% of patients respectively. Adverse events included hypotension (in 2 on DPH) and transient agitation (2 on LEV). IV Levetiracetam controls status epilepticus or cluster seizures with an efficacy comparable to that of phenytoin. Use of these two agents consecutively may control >90% of all such conditions without resort to anaesthetic agents. Further studies should explore its efficacy in larger cohorts of epileptic emergencies. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  18. Adjuvant treatment with the bacterial lysate (OM-85 improves management of atopic dermatitis: A randomized study.

    Directory of Open Access Journals (Sweden)

    Christine Bodemer

    Full Text Available Environmental factors play a major role on atopic dermatitis (AD which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend.This study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®, in the treatment of established AD in children.Children aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF during the study period, evaluated by Hazard Ratio (HR derived from conditional Cox proportional hazard regression models accounting for repeated events.Among the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85% patients in the OM-85 group and 72 (88% in the placebo group. Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI: 0.67-0.96, also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98. No major side effect was reported, with comparable and good tolerability for OM-85 and placebo.Results show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD.

  19. Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

    Science.gov (United States)

    Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

    2015-11-01

    Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs. A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter+DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter+DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3-8; extraction). Enrollment commenced summer 2015 with results in summer 2016. This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. The CREST-E study of creatine for Huntington disease: A randomized controlled trial.

    Science.gov (United States)

    Hersch, Steven M; Schifitto, Giovanni; Oakes, David; Bredlau, Amy-Lee; Meyers, Catherine M; Nahin, Richard; Rosas, Herminia Diana

    2017-08-08

    To investigate whether creatine administration could slow progressive functional decline in adults with early symptoms of Huntington disease. We conducted a multicenter, randomized, double-blind, placebo-controlled study of up to 40 g daily of creatine monohydrate in participants with stage I and II HD treated for up to 48 months. The primary outcome measure was the rate of change in total functional capacity (TFC) between baseline and end of follow-up. Secondary outcome measures included changes in additional clinical scores, tolerability, and quality of life. Safety was assessed by adverse events and laboratory studies. At 46 sites in North America, Australia, and New Zealand, 553 participants were randomized to creatine (275) or placebo (278). The trial was designed to enroll 650 patients, but was halted for futility after the first interim analysis. The estimated rates of decline in the primary outcome measure (TFC) were 0.82 points per year for participants on creatine, 0.70 points per year for participants on placebo, favoring placebo (nominal 95% confidence limits -0.11 to 0.35). Adverse events, mainly gastrointestinal, were significantly more common in participants on creatine. Serious adverse events, including deaths, were more frequent in the placebo group. Subgroup analysis suggested that men and women may respond differently to creatine treatment. Our data do not support the use of creatine treatment for delaying functional decline in early manifest HD. NCT00712426. This study provides Class II evidence that for patients with early symptomatic HD, creatine monohydrate is not beneficial for slowing functional decline. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  1. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  2. Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

    2014-11-27

    Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a

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

    Directory of Open Access Journals (Sweden)

    Astha Palan

    2017-01-01

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

  4. Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer: Results of an RTOG Randomized Study

    Energy Technology Data Exchange (ETDEWEB)

    Laramore, George E. [Washington U.; Krall, John M. [Unlisted, PA; Thomas, Frank J. [Unlisted, OH; Griffin, Thomas W. [Washington U.; Maor, Moshe H. [Unlisted, TX; Hendrickson, Frank R. [Fermilab

    1985-01-01

    Between June 1977 and April 1983, the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized study investigating fast neutron radiation therapy in the treatment of patients with locally advanced (Stage C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation therapy or fast neutron irradiation used in a mixed-beam treatment schedule (neutron/photon). A total of 91 analyzable patients were entered in the study; 78 of them were treated without major protocol deviations. The two treatment groups were balanced in regard to all major prognostic variables. Actuarial curves for "overall" survival, "determinantal" survival and local/regional control are presented both for the entire group of 91 patients and the 78 patients treated within protocol guidelines. The overall local/regional tumor recurrence rate is 7% for the mixed-beam treated group of patients and is 22% for the photon (X ray) treated group of patients. The difference is statistically significant at the p = 0.05 level. For the entire group of 91 evaluable patients, the 5-year "overall" survival rate is 62% for the mixed-beam-treated group and 35% for the photon-treated group. This difference is also statistically significant (p less than 0.05). However, this statistical significance is lost when the smaller number of patients treated strictly within protocol guidelines is considered. The significance is regained (p less than 0.02) when one looks at "determinantal" survival, which uses active cancer at time of death as the failure endpoint. This study demonstrates that a regional treatment modality, in this case mixed-beam irradiation, can influence both local/regional tumor control and survival in patients with locally-advanced adenocarcinoma of the prostate gland.

  5. Adjuvant treatment with the bacterial lysate (OM-85) improves management of atopic dermatitis: A randomized study.

    Science.gov (United States)

    Bodemer, Christine; Guillet, Gerard; Cambazard, Frederic; Boralevi, Franck; Ballarini, Stefania; Milliet, Christian; Bertuccio, Paola; La Vecchia, Carlo; Bach, Jean-François; de Prost, Yves

    2017-01-01

    Environmental factors play a major role on atopic dermatitis (AD) which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend. This study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®), in the treatment of established AD in children. Children aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF) during the study period, evaluated by Hazard Ratio (HR) derived from conditional Cox proportional hazard regression models accounting for repeated events. Among the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85%) patients in the OM-85 group and 72 (88%) in the placebo group). Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI): 0.67-0.96), also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98). No major side effect was reported, with comparable and good tolerability for OM-85 and placebo. Results show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD.

  6. Patient Satisfaction With Propofol for Outpatient Colonoscopy: A Prospective, Randomized, Double-Blind Study.

    Science.gov (United States)

    Padmanabhan, Anantha; Frangopoulos, Christoforos; Shaffer, Lynn E T

    2017-10-01

    Previous literature has shown that propofol has ideal anesthetic properties for patients undergoing colonoscopy, a common procedure at outpatient surgery centers. However, there is a paucity of information regarding patient satisfaction with propofol. The aim of this study was to evaluate patient satisfaction with propofol compared with nonpropofol (fentanyl/midazolam) anesthesia for outpatient colonoscopies. Safety and complications were secondary end points. This study was a double-blind, randomized, parallel-group controlled clinical trial (NCT 02937506). This study was conducted at a single ambulatory surgery center at an urban teaching community health system. Patients were scheduled for outpatient colonoscopy. Those with high-risk cardiac or pulmonary disease were excluded. Anesthesia personnel administered either fentanyl/midazolam (n = 300) or propofol (n = 300) for sedation during outpatient colonoscopy. A single, highly experienced endoscopist performed all colonoscopies. The primary outcomes measured were patient satisfaction (5-point Likert scale) and procedure complications. Data were collected on the day of endoscopy by the nursing staff of the postanesthesia care unit. A subinvestigator blinded to the randomization called patients 24 to 72 hours after discharge to obtain data on postprocedure problems and status of resumption of normal activities. Analysis was intention-to-treat. Fewer patients who received propofol remembered being awake during the procedure (2% vs 17% for fentanyl, p propofol (p propofol group (2.7% vs 11.7%, p propofol over a combination of fentanyl/midazolam as their anesthetic for outpatient colonoscopies. From a patient and provider perspective, propofol appears to be superior to fentanyl/midazolam for outpatient colonoscopy. See Video Abstract at http://links.lww.com/DCR/A445.

  7. Issues relating to study design and risk of bias when including non-randomized studies in systematic reviews on the effects of interventions.

    Science.gov (United States)

    Higgins, Julian Pt; Ramsay, Craig; Reeves, Barnaby C; Deeks, Jonathan J; Shea, Beverley; Valentine, Jeffrey C; Tugwell, Peter; Wells, George

    2013-03-01

    Non-randomized studies may provide valuable evidence on the effects of interventions. They are the main source of evidence on the intended effects of some types of interventions and often provide the only evidence about the effects of interventions on long-term outcomes, rare events or adverse effects. Therefore, systematic reviews on the effects of interventions may include various types of non-randomized studies. In this second paper in a series, we address how review authors might articulate the particular non-randomized study designs they will include and how they might evaluate, in general terms, the extent to which a particular non-randomized study is at risk of important biases. We offer guidance for describing and classifying different non-randomized designs based on specific features of the studies in place of using non-informative study design labels. We also suggest criteria to consider when deciding whether to include non-randomized studies. We conclude that a taxonomy of study designs based on study design features is needed. Review authors need new tools specifically to assess the risk of bias for some non-randomized designs that involve a different inferential logic compared with parallel group trials. Copyright © 2012 John Wiley & Sons, Ltd. Copyright © 2012 John Wiley & Sons, Ltd.

  8. Train High Eat Low for Osteoarthritis study (THE LO study: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yareni Guerrero

    2015-10-01

    Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee.

  9. A national study of the psychological impact of bank robbery with a randomized control group

    DEFF Research Database (Denmark)

    Hansen, Maj; Armour, Cherie; Shevlin, Mark

    Despite, numerous annual bank robberies worldwide, research on the psychological sequelae of bank robberies is limited. We studied the prevalence of Acute Stress Disorder (ASD) (N = 458) and the prevalence of Posttraumatic Stress Disorder (PTSD) (n = 378) in a Danish national questionnaire survey...... of bank employees exposed to robbery (response rate: 73.6 %). Several related factors were also investigated including prior traumatic exposure, anxiety, and general traumatic symptoms. The results were compared to a randomized control group of bank employees never exposed to robbery (N= 303......). The estimated ASD rate was 11.1 % (n = 41), and the estimated PTSD rate was 6.2 % (n = 23). Both prevalence rates were limited by the avoidance diagnostic criteria. Preliminary results indicated that the control group scored significantly lower than the acute robbery group on general traumatization and anxiety...

  10. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  11. A Randomized Prospective Study on Outcomes of an Empathy Intervention among Second-year Student Pharmacists

    Science.gov (United States)

    Truong, Julie T; Ip, Eric J; Barnett, Mitchell J

    2015-01-01

    Objective. To determine the impact of a single, 3-day intervention on empathy levels as measured by the validated Jefferson Scale of Empathy-Health Profession Students version (JSE-HPS). Methods. Forty second-year student pharmacists were recruited to participate in a non-blinded prospective study. Subjects were randomized to an intervention group (n=20) or control group (n=20) and completed the JSE-HPS at baseline, 7 days postintervention, and 90 days postintervention. The intervention group consisted of a 3-day simulation, each day including a designated activity with loss of dominant hand usage, vision, and speech. Results. The 3-day simulation increased empathy levels in the intervention group compared to the control group 7 days postintervention (p=0.035). However, there were no effects on empathy levels 90 days postintervention (p=0.38). Conclusion. Empathy scores increased but were not sustained in the long-term with a 3-day empathy intervention. PMID:25861099

  12. Simulation study of localization of electromagnetic waves in two-dimensional random dipolar systems.

    Science.gov (United States)

    Wang, Ken Kang-Hsin; Ye, Zhen

    2003-12-01

    We study the propagation and scattering of electromagnetic waves by random arrays of dipolar cylinders in a uniform medium. A set of self-consistent equations, incorporating all orders of multiple scattering of the electromagnetic waves, is derived from first principles and then solved numerically for electromagnetic fields. For certain ranges of frequencies, spatially localized electromagnetic waves appear in such a simple but realistic disordered system. Dependence of localization on the frequency, radiation damping, and filling factor is shown. The spatial behavior of the total, coherent, and diffusive waves is explored in detail, and found to comply with a physical intuitive picture. A phase diagram characterizing localization is presented, in agreement with previous investigations on other systems.

  13. A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

    Science.gov (United States)

    Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

    2014-02-01

    Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P aromatherapy was significantly higher in the treatment group (P Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

  14. Medical versus surgical abortion: comparing satisfaction and potential confounders in a partly randomized study

    DEFF Research Database (Denmark)

    Rørbye, Christina; Nørgaard, Mogens; Nilas, Lisbeth

    2005-01-01

    ) or a surgical abortion (vacuum aspiration in general anaesthesia). The procedure was determined either by randomization (n = 111) or by choice (n = 922). Data on satisfaction, side effects and expectations were collected from questionnaires 2 and 8 weeks after termination. RESULTS: More women were very.......05. Satisfaction with the medical procedure was inversely correlated with GA and the intensity of pain, nausea, vomiting and dizziness, while satisfaction with the surgical procedure was unaffected by these side effects. Fewer women with a failed medical than a failed surgical abortion were satisfied (17% vs 62......BACKGROUND: The aim of the study was to compare satisfaction with medical and surgical abortion and to identify potential confounders affecting satisfaction. METHODS: 1033 women with gestational age (GA)

  15. Cold Water and Pauses in Illumination Reduces Pain During Photodynamic Therapy: A Randomized Clinical Study

    DEFF Research Database (Denmark)

    Wiegell, S.R.; Haedersdal, M.; Wulf, H.C.

    2009-01-01

    Pain is the main acute adverse event during photodynamic therapy of skin lesions. The objective of this randomized study was to evaluate the pain-relieving effect of pauses and cooling during illumination. Twenty-four patients with actinic keratoses were treated with photodynamic therapy in two...... symmetrical areas and cooled with either cold-water-spray or cold-water-pack (Coo]Pack). Treatment areas were cooled during either the first or second period of illumination, which were separated by a 3-min pause in illumination. Pain intensity was scored from 0 to 10. Water-spray reduced the mean pain score...... by 1.2 points (p=0.030) and CoolPack by 1.3 points (p=0.007) during the first half of the illumination. Pain intensity decreased during the pause by 3.7 points in water-spray patients (p

  16. Efficacy of short-term adjunctive subantimicrobial dose doxycycline in diabetic patients--randomized study.

    Science.gov (United States)

    Gilowski, L; Kondzielnik, P; Wiench, R; Płocica, I; Strojek, K; Krzemiński, T F

    2012-11-01

    To investigate the effectiveness of short-term adjunctive subantimicrobial dose doxycycline (SDD) treatment in patients with diabetes mellitus type 2 and chronic periodontitis (CP). Thirty-four patients with CP and type 2 diabetes mellitus were included in the placebo-controlled, double-blind study. After scaling and root planing (SRP), patients were randomly assigned to two groups, receiving either SDD or placebo bid for 3 months. The probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), approximal plaque index, glycated hemoglobin (HbA1c) level were recorded and gingival crevicular fluid (GCF) samples were collected at baseline and after 3-month therapy for the estimation of matrix metalloproteinase-8 levels. Clinical attachment level, PD, and BOP improved significantly in both groups after therapy (P diabetes and CP. © 2012 John Wiley & Sons A/S.

  17. Evaluation of the Quilting Technique for Reduction of Postmastectomy Seroma: A Randomized Controlled Study.

    Science.gov (United States)

    Khater, Ashraf; Elnahas, Waleed; Roshdy, Sameh; Farouk, Omar; Senbel, Ahmed; Fathi, Adel; Hamed, EmadEldeen; Abdelkhalek, Mohamed; Ghazy, Hosam

    2015-01-01

    Background. Postmastectomy seroma causes patients' discomfort, delays starting the adjuvant therapy, and may increase the possibility of surgical site infection. Objective. To evaluate quilting of the mastectomy flaps with obliteration of the axillary space in reducing postmastectomy seroma. Methods. A randomized controlled study was carried out among 120 females who were candidates for mastectomy and axillary clearance. The intervention group (N = 60) with quilting and the control group without quilting. All patients were followed up routinely for immediate and late complications. Results. There were no significant differences between the two groups as regards the demographic characteristics, postoperative pathological finding, and the immediate postoperative complications. The incidence of seroma was significantly lower in the intervention group compared with the control group (20% versus 78.3%, P method to significantly reduce the postoperative seroma in addition to significantly reducing the duration and volume of wound drainage. Therefore we recommend quilting of flaps as a routine step at the end of any mastectomy.

  18. Comparison of the effectiveness of two different interventions to reduce preoperative anxiety: A randomized controlled study.

    Science.gov (United States)

    Ertuğ, Nurcan; Ulusoylu, Özge; Bal, Ayça; Özgür, Hazal

    2017-06-01

    This study was conducted to determine and compare the effectiveness of nature sounds and relaxation exercises for reducing preoperative anxiety. A repeated measures randomized controlled trial design was used. We divided 159 preoperative patients into three groups: nature sounds (n = 53), relaxation exercises (n = 53), and control groups (n = 53). We evaluated anxiety using the visual analog scale and state anxiety inventory scores immediately before, immediately after, and 30 min after interventions in nature sounds and relaxation exercises groups, and silent rest in the control. We found no differences between the measurement values in the intervention groups, but we did observe a difference between the intervention and control groups. The two interventions were similarly effective in reducing preoperative anxiety. These simple and low-cost interventions can be used to reduce preoperative anxiety in surgical clinics. © 2017 John Wiley & Sons Australia, Ltd.

  19. Effectiveness of dance in patients with fibromyalgia: a randomized, single-blind, controlled study.

    Science.gov (United States)

    Baptista, Andrei Salvador; Villela, Ana Luiza; Jones, Anamaria; Natour, Jamil

    2012-01-01

    The aim of the present study was to assess the effectiveness of belly dance as a treatment option for patients with fibromyalgia. Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. The patients were evaluated with regard to pain (VAS), function (6MWT), quality of life (FIQ and SF-36), depression (Beck Inventory), anxiety (STAI) and self-image (BDDE). Evaluations were carried out at baseline, 16 weeks and 32 weeks by a blinded assessor. The dance group achieved significant improvements in VAS for pain (pfibromyalgia to reduce pain and improve functional capacity, quality of life and self-image.

  20. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study

    DEFF Research Database (Denmark)

    Werner, Louise B.; Hellgren, Lars; Raff, Marianne

    2011-01-01

    BACKGROUND: Phytanic acid produced in ruminants from chlorophyll may have preventive effects on the metabolic syndrome, partly due to its reported RXR and PPAR- α agonist activity. Milk from cows fed increased levels of green plant material, contains increased phytanic acid concentrations......, but it is unknown to what extent minor increases in phytanic acid content in dairy fat leads to higher circulating levels of phytanic acid in plasma of the consumers. OBJECTIVE: To investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human....... DESIGN: In a double-blind, randomized, 4 wk, parallel intervention study 14 healthy young subjects were given 45 g milk fat/d from test butter and cheese with 0.24 wt% phytanic acid or a control diet with 0.13 wt% phytanic acid. Difference in phytanic acid was obtained by feeding roughage with low...

  1. Group cognitive behavior therapy for chronic posttraumatic stress disorder: an initial randomized pilot study.

    Science.gov (United States)

    Beck, J Gayle; Coffey, Scott F; Foy, David W; Keane, Terence M; Blanchard, Edward B

    2009-03-01

    Individuals with posttraumatic stress disorder (PTSD) related to a serious motor vehicle accident were randomly assigned to either group cognitive behavioral treatment(GCBT) or a minimum contact comparison group (MCC).Compared to the MCC participants (n=16), individuals who completed GCBT (n=17) showed significant reductions in PTSD symptoms, whether assessed using clinical interview or a self-report measure. Among treatment completers, 88.3% of GCBT participants did not satisfy criteria for PTSD at posttreatment assessment, relative to31.3% of the MCC participants. Examination of anxiety,depression, and pain measures did not show a unique advantage of GCBT. Treatment-related gains were maintained over a 3-month follow-up interval. Patients reported satisfaction with GCBT, and attrition from this treatment was comparable with individually administered CBTs.Results are discussed in light of modifications necessitated by the group treatment format, with suggestions for future study of this group intervention.

  2. Effectiveness of exercise at workplace in physical fitness: uncontrolled randomized study.

    Science.gov (United States)

    Grande, Antônio José; Silva, Valter; Parra, Sérgio Alencar

    2014-01-01

    To investigate the effectiveness of workplace exercise for employee health by means of health-related physical activity components. A randomized uncontrolled study with 20 workers was carried out during three months to evaluate a workplace exercise program. The selected outcomes were flexibility, body mass, fat percentage, lean mass, blood pressure, and heart rate. For statistical analysis, the paired t test and the intent-to-treat analysis were used. There was a significant increase in weight, fat percentage, blood pressure, and heart rate. However the clinical significance was 10% in the size of the effect. The changes verified in the outcomes analyzed were not significant; the variables are within normality ranges proposed by academic organizations.

  3. Medical versus surgical abortion: comparing satisfaction and potential confounders in a partly randomized study

    DEFF Research Database (Denmark)

    Rørbye, Christina; Nørgaard, Mogens; Nilas, Lisbeth

    2005-01-01

    BACKGROUND: The aim of the study was to compare satisfaction with medical and surgical abortion and to identify potential confounders affecting satisfaction. METHODS: 1033 women with gestational age (GA) medical (600 mg mifepristone followed by 1 mg gemeprost...... satisfied or satisfied after a surgical than a medical abortion both after choosing method (92% vs 82%, P medical procedure than after randomization to the same procedure; 82% and 68%, respectively, P ....05. Satisfaction with the medical procedure was inversely correlated with GA and the intensity of pain, nausea, vomiting and dizziness, while satisfaction with the surgical procedure was unaffected by these side effects. Fewer women with a failed medical than a failed surgical abortion were satisfied (17% vs 62...

  4. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ito, Masaya; Okumura, Yasuyuki; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Miyamae, Mitsuhiro; Hirabayashi, Naotsugu; Kanie, Ayako; Nakagawa, Atsuo; Ono, Yutaka

    2016-03-18

    The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).

  5. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

    Directory of Open Access Journals (Sweden)

    Lavinia Fiorentino

    2009-12-01

    Full Text Available Lavinia Fiorentino1, John R McQuaid2, Lianqi Liu3, Loki Natarajan4, Feng He4, Monique Cornejo3, Susan Lawton3, Barbara A Parker6, Georgia R Sadler5, Sonia Ancoli-Israel31Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA, USA; 2Department of Psychiatry, University of California, San Francisco, CA, USA; 3Department of Psychiatry, 4Department of Family and Preventive Medicine, 5Department of Surgery, University of California, San Diego School of Medicine, La Jolla, CA, USA; 6Moores UCSD Cancer Center, La Jolla, CA, USAPurpose: Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I on sleep in breast cancer survivors.Patients and methods: Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions. Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group.Results: Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre–post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep.Conclusions: These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting.Keywords: insomnia, breast cancer, cognitive behavioral therapy

  6. Randomized study of teriflunomide effects on immune responses to neoantigen and recall antigens.

    Science.gov (United States)

    Bar-Or, Amit; Wiendl, Heinz; Miller, Barry; Benamor, Myriam; Truffinet, Philippe; Church, Meg; Menguy-Vacheron, Francoise

    2015-04-01

    To evaluate immune responses to neoantigen and recall antigens in healthy subjects treated with teriflunomide. This was a randomized, double-blind, placebo-controlled study. Subjects received oral teriflunomide (70 mg once daily for 5 days followed by 14 mg once daily for 25 days) or placebo for 30 days. Antibody responses were evaluated following rabies vaccination (neoantigen) applied at days 5, 12, and 31 of the treatment period. Occurrence of delayed-type hypersensitivity (DTH) to Candida albicans, Trichophyton, and tuberculin (recall antigens) was assessed before and at the end of treatment to investigate cellular memory response. Safety and pharmacokinetics were evaluated. Forty-six randomized subjects were treated (teriflunomide, n = 23; placebo, n = 23) and completed the rabies vaccination. Geometric mean titers for rabies antibodies were lower with teriflunomide at days 31 and 38 than with placebo. However, all subjects achieved sufficient seroprotection following rabies vaccination (titers well above the 0.5 IU/mL threshold). Overall, the DTH response to recall antigens in the teriflunomide group did not notably differ from responses in the placebo group. Following vaccination, geometric mean titers for rabies antibodies were lower with teriflunomide than with placebo. However, teriflunomide did not limit the ability to achieve seroprotective titers against this neoantigen. Evaluation of DTH showed that teriflunomide had no adverse impact on the cellular memory response to recall antigens. This study provides Class II evidence that in normal subjects treated with teriflunomide, antibody titer responses to rabies vaccination are lower than with placebo but sufficient for seroprotection.

  7. Continuous spinal anesthesia versus combined spinal epidural block for major orthopedic surgery: prospective randomized study

    Directory of Open Access Journals (Sweden)

    Luiz Eduardo Imbelloni

    Full Text Available CONTEXT AND OBJECTIVES: In major orthopedic surgery of the lower limbs, continuous spinal anesthesia (CSA and combined spinal epidural anesthesia (CSE are safe and reliable anesthesia methods. In this prospective randomized clinical study, the blockading properties and side effects of CSA were compared with single interspace CSE, among patients scheduled for major hip or knee surgery. DESIGN AND SETTING: Prospective clinical study conducted at the Institute for Regional Anesthesia, Hospital de Base, São José do Rio Preto. METHODS: 240 patients scheduled for hip arthroplasty, knee arthroplasty or femoral fracture treatment were randomly assigned to receive either CSA or CSE. Blockades were performed in the lateral position at the L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor blockade, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and postdural puncture headache (PDPH were recorded. At the end of the surgery, the catheter was removed and cerebrospinal fluid leakage was evaluated. RESULTS: Seven patients were excluded (three CSA and four CSE. There was significantly lower incidence of paresthesia in the CSE group. The resultant sensory blockade level was significantly higher with CSE. Complete motor blockade occurred in 110 CSA patients and in 109 CSE patients. Arterial hypotension was observed significantly more often in the CSE group. PDPH was observed in two patients of each group. CONCLUSION: Our results suggest that both CSA and CSE provided good surgical conditions with low incidence of complications. The sensory blockade level and hemodynamic changes were lower with CSA.

  8. Is Tamsulosin Effective after Shock Wave Lithotripsy for Pediatric Renal Stones? A Randomized, Controlled Study.

    Science.gov (United States)

    Shahat, Ahmed; Elderwy, Ahmad; Safwat, Ahmed S; Abdelkawi, Islam F; Reda, Ahmed; Abdelsalam, Yasser; Sayed, Mohamed; Hammouda, Hisham

    2016-04-01

    We assessed the effect of tamsulosin as an adjunctive therapy after shock wave lithotripsy for pediatric single renal pelvic stones. A total of 120 children with a unilateral single renal pelvic stone were included in a prospective randomized, controlled study. All children were randomized to 2 equal groups. Group 1 received tamsulosin (0.01 mg/kg once daily) as adjunctive therapy after shock wave lithotripsy in addition to paracetamol while group 2 received paracetamol only. Stone clearance was defined as no renal stone fragments or fragments less than 3 mm and no pelvicalyceal system dilatation. Our study included 69 boys and 51 girls with a median age of 3.5 years and a median stone size of 1.2 cm. There was no statistically significant difference between groups 1 and 2 in stone or patient criteria. Of the children 99 (82.5%) achieved stone clearance after the first session, including 50 in group 1 and 49 in group 2. All children in each group were cleared of stones after the second session. The overall complication rate was 14.2%. There was no statistically significant difference between single session stone clearance rates (p = 0.81) and complications rates (p = 0.432) in either group. On multivariate analysis using logistic regression smaller stone size (p = 0.016) and radiopaque stones (p = 0.019) were the only predictors of stone clearance at a single shock wave lithotripsy session. Tamsulosin therapy did not affect stone clearance (p = 0.649). Tamsulosin does not seem to improve renal stone clearance. Smaller and radiopaque renal stones have more chance of clearance after shock wave lithotripsy for pediatric single renal pelvic stones. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  9. Early active rehabilitation after arthroscopic rotator cuff repair: a prospective randomized pilot study.

    Science.gov (United States)

    Raschhofer, Rudolf; Poulios, Nikos; Schimetta, Wolfgang; Kisling, Rüdiger; Mittermaier, Christian

    2017-10-01

    To compare two different rehabilitation strategies, primary passive motion versus early isometric loading of the rotator cuff. Prospective randomized controlled observer-blinded pilot study. Institute of Physical Medicine and Rehabilitation. Thirty patients after rotator cuff surgery. All participants were randomly assigned to one of the two outpatient treatment groups: primary passive motion versus early isometric loading of the rotator cuff. Both groups were treated for 12 weeks and performed additionally a home exercise program. The primary outcome measure for functional assessment was the Constant Murley score. The secondary outcome measures were the Disabilities of the Arm, Shoulder and Hand score (DASH), active range of motion, pain level and strength. Patients were assessed before, 6, 12 and 24 weeks after surgery. Repeatedly measured metric variables were compared by the Quade rank analysis of covariance and revealed substantially better Constant Murley scores in the early activated group at all 3 assessments (6 weeks: 41 [31;45] versus 30 [23;37]; 12 weeks: 68 [56;77] versus 59 [53;62]; 24 weeks: 79 [76;81] versus 66 [62;74]; data as median [25%;75%]). Postoperative changes of Constant score were in favour of the active group with the biggest difference at week 12 (28 [38;12] versus 9 [27;-4]). Maximal pain levels showed clear more reduction 6 and 24 weeks after surgery in the early activated group. This pilot study with early isometric loading of the rotator cuff shows better function and less maximal pain. Further research is warranted to confirm our results.

  10. Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization.

    Science.gov (United States)

    Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E; Nordestgaard, Børge G; Nielsen, Sune F; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K; Rookus, Matti A; van den Hurk, Katja; de Kort, Wim L A M; Couch, Fergus J; Olson, Janet E; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; Dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M Pilar; Perez, Jose I A; Cox, Angela; Cross, Simon S; Reed, Malcolm W R; Andrulis, Irene L; Knight, Julia A; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J; Tomlinson, Ian; Kerin, Michael J; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A; Henderson, Brian E; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J; Martens, John W M; Tilanus-Linthorst, Madeleine M A; Collée, J Margriet; Hopper, John L; Southey, Melissa C; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E; Ambrosone, Christine B; Yannoukakos, Drakoulis; Giles, Graham G; Milne, Roger L; McLean, Catriona; Fasching, Peter A; Haeberle, Lothar; Ekici, Arif B; Beckmann, Matthias W; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K; Neuhausen, Susan L; Anton-Culver, Hoda; Kristensen, Vessela N; Grenaker Alnæs, Grethe I; Pierce, Brandon L; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S; John, Esther M; Gammon, Marilie D; Malone, Kathleen E; Tessier, Daniel C; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S; González-Neira, Anna; Pita, Guillermo; Alonso, M Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D P; Simard, Jacques; Hall, Per; Hunter, David J; Easton, Douglas F; Zheng, Wei

    2015-11-01

    Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control patients, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control patients. The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor-positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P adult height is a risk factor for breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  11. Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Erhayiem, Bara; Pavitt, Sue; Baxter, Paul; Andrews, Jacqueline; Greenwood, John P; Buch, Maya H; Plein, Sven

    2014-11-08

    The incidence of cardiovascular disease (CVD) in rheumatoid arthritis (RA) is increased compared to the general population. Immune dysregulation and systemic inflammation are thought to be associated with this increased risk. Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm. It remains unclear, however, whether using tumor necrosis factor inhibitors (TNFi) to achieve remission confer additional beneficial effects over standard therapy, especially on the development of CVD. Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA) is a prospective cardiovascular imaging study that bolts onto an existing single-centre, randomized controlled trial, VEDERA (Very Early versus Delayed Etanercept in Rheumatoid Arthritis). VEDERA will recruit 120 patients with early, treatment-naïve RA, randomized to TNFi therapy etanercept (ETN) combined with methotrexate (MTX), or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a 'treat-to-target' regimen. VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance (CMR) assessment with; cine imaging, rest/stress adenosine perfusion, tissue-tagging, aortic distensibility, T1 mapping and late gadolinium imaging. Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a 12-month period. All patients will enter an inflammatory arthritis registry for long-term follow-up. CADERA is a multi-parametric study describing cardiovascular abnormalities in early, treatment-naïve RA patients, with assessment of changes at one year between early biological therapy and conventional therapy. This trial was registered with Current Controlled Trials (registration number: ISRCTN50167738) on 8 November 2013.

  12. Effect of Chicory Extract Bath on Neonatal Bilirubin Levels: A Randomized Clinical Trial study

    Directory of Open Access Journals (Sweden)

    Leila Mohammadi Pirkashani

    2017-12-01

    Full Text Available Objective: Jaundice is a common problem in infants, particularly premature infants (60-80%. The most common treatment of neonatal jaundice is phototherapy; however, traditional and complementary medicine is preferred due to complications of phototherapy in newborns. This study evaluates the effect of Chicory extract bath on bilirubin levels of infants with jaundice hospitalized in educational hospitals in Isfahan, Iran.Methods: This study was a double blind randomized clinical trial in which participants included 64 mature infants with neonatal jaundice admitted to the selected hospitals of Isfahan. The infants were randomly assigned to two groups receiving phototherapy (n=32, and phototherapy with bath with 500 cc of chicory extract prepared by hydroalcoholic method and made in Iran (n=32. The infants were bathed by trained nurse with chicory extract before phototherapy as well as 24 and 48 hours after phototherapy; then, the infants received phototherapy. During treatment, serum bilirubin was measured and recorded every 24 hours continuously. Control infants only received phototherapy; during treatment, serum bilirubin was measured and recorded every 24 hours.Results: The results showed no significant difference in mean bilirubin levels between the two groups on admission (P=0.37, while mean bilirubin level of phototherapy infants was significantly higher than that of infants receiving phototherapy and chicory extract bath in 24 hours after (P=0.014, and 48 hours after intervention (P=0.011.Conclusion: The results showed that chicory extract bath with phototherapy can be effective in reducing neonatal jaundice. Keywords: Bilirubin, Chicory extract, Infants, Jaundice, Phototherapy.

  13. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Phuttharak Warinthorn

    2008-03-01

    Full Text Available Abstract Background An acute complication of thyroidectomy is fatal hematoma, which can produce an upper airway obstruction needing immediate intubation or tracheostomy. After neck surgery, we usually apply a pressure dressing with a non-woven, adhesive fabric to reduce bleeding and fluid collection at the operative bed. We conducted a prospective, randomized, controlled study to evaluate a pressure vs. a non-pressure dressing after thyroid surgery by monitoring blood and serum in the operative bed. Methods We studied 108 patients who underwent 116 thyroid surgeries at Srinagarind Hospital, Khon Kaen University, between December 2006 and September 2007. The patients were randomized to either the pressure dressing or non-pressure dressing group. Ultrasound of the neck was performed 24 ± 3 hours after surgery. The volume of fluid collection in the operative bed was calculated. All patients were observed for any post-operative respiratory distress, wound complications, tingling sensation or tetany. Results The distributions of age, sex, surgical indications and approaches were similar between the two groups. There was no statistically significant difference in the volume of fluid collection in the operative bed (p = 0.150 and the collected drained content (p = 0.798. The average time a drain was retained was 3 days. One patient in the pressure dressing group suffered cutaneous bruising while one patient in the non-pressure dressing group developed immediate hemorrhage after the skin sutures. Conclusion Pressure dressing after thyroidectomy does not have any significant impact on decreasing fluid collection at the operative bed. The use of pressure dressing after thyroidectomy may not therefore be justified. Trial Registration NCT00400465, ISRCTN52660978

  14. Psychophysiological effects of massage-myofascial release after exercise: a randomized sham-control study.

    Science.gov (United States)

    Arroyo-Morales, Manuel; Olea, Nicolas; Martínez, Marin Manuel; Hidalgo-Lozano, Amparo; Ruiz-Rodríguez, Concepción; Díaz-Rodríguez, Lourdes

    2008-12-01

    The aim of this study was to evaluate the effect of massage on neuromuscular recruitment, mood state, and mechanical nociceptive threshold (MNT) after high-intensity exercise. This was a prospective randomized clinical trial using between-groups design. The study was conducted at a university-based sports medicine clinic. Sixty-two (62) healthy active students age 18-26 participated. Participants, randomized into two groups, performed three 30-second Wingate tests and immediately received whole-body massage-myofascial induction or placebo (sham ultrasound/magnetotherapy) treatment. The duration (40 minutes), position, and therapist were the same for both treatments. Dependent variables were surface electromyography (sEMG) of quadriceps, profile of mood states (POMS) and mechanical nociceptive threshold (MNT) of trapezius and masseter muscles. These data were assessed at baseline and after exercise and recovery periods. Generalized estimating equations models were performed on dependent variables to assess differences between groups. Significant differences were found in effects of treatment on sEMG of Vastus Medialis (VM) (p = 0.02) and vigor subscale (p = 0.04). After the recovery period, there was a significant decrease in electromyographic (EMG) activity of VM (p = 0.02) in the myofascial-release group versus a nonsignificant increase in the placebo group (p = 0.32), and a decrease in vigor (p < 0.01) in the massage group versus no change in the placebo group (p = 0.86). Massage reduces EMG amplitude and vigor when applied as a passive recovery technique after a high-intensity exercise protocol. Massage may induce a transient loss of muscle strength or a change in the muscle fiber tension-length relationship, influenced by alterations of muscle function and a psychological state of relaxation.

  15. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  16. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pallavicini, Federica; Gaggioli, Andrea; Raspelli, Simona; Cipresso, Pietro; Serino, Silvia; Vigna, Cinzia; Grassi, Alessandra; Morganti, Luca; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

    2013-06-28

    Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health--Interreality--that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies

  17. Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Van Criekinge, Tamaya; Saeys, Wim; Hallemans, Ann; Vereeck, Luc; De Hertogh, Willem; Van de Walle, Patricia; Vaes, Nathalie; Lafosse, Christophe; Truijen, Steven

    2017-06-02

    Evidence is lacking concerning the effect of additional trunk rehabilitation on gait performance. Investigating gait performance by both clinical and biomechanical outcome measures might lead to new scientific insights into the importance of the trunk during gait rehabilitation in people suffering from stroke. This protocol was written according to the SPIRIT 2013 Statement. An assessor-blinded randomized controlled trial will be conducted in patients with impaired trunk control after stroke. A total of 60 patients will be randomly allocated to the control or the experimental group by means of sealed opaque envelopes. They will receive either 16 h of additional trunk exercises (experimental group) or cognitive exercises (controls) for 1 h a day, 4 days a week for 4 weeks. Patients will also receive 2 h of standard care consisting of physiotherapy and occupational therapy. Gait performance will be assessed clinically by the Tinetti Test and biomechanically by means of a full body gait analysis. In addition, the effect of the exercise protocol on the trunk itself and trunk activities of daily living will be assessed by the Trunk Impairment Scale and the Barthel Index. Despite the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. In the current study, a more sophisticated treatment protocol will be used to enlarge therapeutic improvements, the relationship between clinical and biomechanical measures of gait performance can be investigated, and the sustainability of the effects of trunk exercises over time will be examined. Since clinical improvements are of greater importance to patients and physiotherapists, clinical assessment scales will be used as primary outcome measures. ClinicalTrials.gov, ID: NCT02708888 . Registered on 2 March 2016.

  18. Voice Disorders in Teacher Students-A Prospective Study and a Randomized Controlled Trial.

    Science.gov (United States)

    Ohlsson, Ann-Christine; Andersson, Eva M; Södersten, Maria; Simberg, Susanna; Claesson, Silwa; Barregård, Lars

    2016-11-01

    Teachers are at risk of developing voice disorders, but longitudinal studies on voice problems among teachers are lacking. The aim of this randomized trial was to investigate long-term effects of voice education for teacher students with mild voice problems. In addition, vocal health was examined prospectively in a group of students without voice problems. First-semester students answered three questionnaires: one about background factors, one about voice symptoms (Screen6), and the Voice Handicap Index. Students with voice problems according to the questionnaire results were randomized to a voice training group or a control group. At follow-up in the sixth semester, all students answered Screen6 again together with four questions about factors that could have affected vocal health during their teacher education. The training group and the control group also answered the Voice Handicap Index a second time. At follow-up, 400 students remained in the study: 27 in the training group, 54 in the control group, and 319 without voice problems at baseline. Voice problems had decreased somewhat more in the training group than in the control group, but the difference was not statistically significant (P = 0.1). However, subgroup analyses showed significantly larger improvement among the students in the group with complete participation in the training program compared with the group with incomplete participation. Of the 319 students without voice problems at baseline, 14% had developed voice problems. Voice problems often develop in teacher students. Despite extensive dropout, our results support the hypothesis that voice education for teacher students has a preventive effect. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  19. Intervention study for smoking cessation in Spanish college students: pragmatic randomized controlled trial.

    Science.gov (United States)

    Pardavila-Belio, Miren I; García-Vivar, Cristina; Pimenta, Adriano Marçal; Canga-Armayor, Ana; Pueyo-Garrigues, Sara; Canga-Armayor, Navidad

    2015-10-01

    To evaluate the effectiveness of a nurse intervention aimed at helping college student smokers quit smoking. Single-blind, pragmatic randomized controlled trial which compares a multi-component intervention, tailored specifically to college students, with a brief advice session with a 6-month follow-up. This study was conducted at the University of Navarra, Spain. A total of 255 college student smokers (age range = 18-24 years) were randomized to an intervention group (n = 133) or to a control group (n = 122). A multi-component intervention based on the Theory of Triadic Influence of Flay was developed. The intervention consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The primary outcome was self-reported abstinence, with biochemical verification at 6 months. The secondary outcomes consisted of the mean number of cigarettes smoked per day, self-reported attempts to quit smoking and stage of change at 6 months. At the 6-month follow-up, the smoking cessation incidence was 21.1% in the intervention group compared with 6.6% in the control group (difference = 14.5 confidence interval = 6.1-22.8; relative risk = 3.41, 95% confidence interval = 1.62-7.20). The difference in the mean number of cigarettes at 6 months was significantly different (difference = -2.2, confidence interval = -3.6 to -0.9). A multi-component intervention tailored to college students and managed by a nurse is effective in increasing smoking cessation among college students. © 2015 Society for the Study of Addiction.

  20. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

    Science.gov (United States)

    Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

    2003-06-24

    To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

  1. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Holz Jonathan D

    2011-08-01

    Full Text Available Abstract Background Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD only moderately lower than young normal individuals. Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved. Methods/design We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5 and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety. Discussion If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated. Trial registration This study is registered at ClinicalTrials.gov, NCT01271647.

  2. Adiposity as a cause of cardiovascular disease: a Mendelian randomization study.

    Science.gov (United States)

    Hägg, Sara; Fall, Tove; Ploner, Alexander; Mägi, Reedik; Fischer, Krista; Draisma, Harmen H M; Kals, Mart; de Vries, Paul S; Dehghan, Abbas; Willems, Sara M; Sarin, Antti-Pekka; Kristiansson, Kati; Nuotio, Marja-Liisa; Havulinna, Aki S; de Bruijn, Renée F A G; Ikram, M Arfan; Kuningas, Maris; Stricker, Bruno H; Franco, Oscar H; Benyamin, Beben; Gieger, Christian; Hall, Alistair S; Huikari, Ville; Jula, Antti; Järvelin, Marjo-Riitta; Kaakinen, Marika; Kaprio, Jaakko; Kobl, Michael; Mangino, Massimo; Nelson, Christopher P; Palotie, Aarno; Samani, Nilesh J; Spector, Tim D; Strachan, David P; Tobin, Martin D; Whitfield, John B; Uitterlinden, André G; Salomaa, Veikko; Syvänen, Ann-Christine; Kuulasmaa, Kari; Magnusson, Patrik K; Esko, Tõnu; Hofman, Albert; de Geus, Eco J C; Lind, Lars; Giedraitis, Vilmantas; Perola, Markus; Evans, Alun; Ferrières, Jean; Virtamo, Jarmo; Kee, Frank; Tregouet, David-Alexandre; Arveiler, Dominique; Amouyel, Philippe; Gianfagna, Francesco; Brambilla, Paolo; Ripatti, Samuli; van Duijn, Cornelia M; Metspalu, Andres; Prokopenko, Inga; McCarthy, Mark I; Pedersen, Nancy L; Ingelsson, Erik

    2015-04-01

    Adiposity, as indicated by body mass index (BMI), has been associated with risk of cardiovascular diseases in epidemiological studies. We aimed to investigate if these associations are causal, using Mendelian randomization (MR) methods. The associations of BMI with cardiovascular outcomes [coronary heart disease (CHD), heart failure and ischaemic stroke], and associations of a genetic score (32 BMI single nucleotide polymorphisms) with BMI and cardiovascular outcomes were examined in up to 22,193 individuals with 3062 incident cardiovascular events from nine prospective follow-up studies within the ENGAGE consortium. We used random-effects meta-analysis in an MR framework to provide causal estimates of the effect of adiposity on cardiovascular outcomes. There was a strong association between BMI and incident CHD (HR = 1.20 per SD-increase of BMI, 95% CI, 1.12-1.28, P = 1.9.10(-7)), heart failure (HR = 1.47, 95% CI, 1.35-1.60, P = 9.10(-19)) and ischaemic stroke (HR = 1.15, 95% CI, 1.06-1.24, P = 0.0008) in observational analyses. The genetic score was robustly associated with BMI (β = 0.030 SD-increase of BMI per additional allele, 95% CI, 0.028-0.033, P = 3.10(-107)). Analyses indicated a causal effect of adiposity on development of heart failure (HR = 1.93 per SD-increase of BMI, 95% CI, 1.12-3.30, P = 0.017) and ischaemic stroke (HR = 1.83, 95% CI, 1.05-3.20, P = 0.034). Additional cross-sectional analyses using both ENGAGE and CARDIoGRAMplusC4D data showed a causal effect of adiposity on CHD. Using MR methods, we provide support for the hypothesis that adiposity causes CHD, heart failure and, previously not demonstrated, ischaemic stroke. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

  3. [Randomized prospective study of three different techniques for ultrasound-guided axillary brachial plexus block].

    Science.gov (United States)

    Ferraro, Leonardo Henirque Cunha; Takeda, Alexandre; Sousa, Paulo César Castello Branco de; Mehlmann, Fernanda Moreira Gomes; Junior, Jorge Kiyoshi Mitsunaga; Falcão, Luiz Fernando Dos Reis

    2017-06-23

    Randomized prospective study comparing two perivascular techniques with the perineural technique for ultrasound-guided axillary brachial plexus block (US-ABPB). The primary objective was to verify if these perivascular techniques are noninferior to the perineural technique. 240 patients were randomized to receive the techniques: below the artery (BA), around the artery (AA) or perineural (PN). The anesthetic volume used was 40mL of 0.375% bupivacaine. All patients received a musculocutaneous nerve blockade with 10mL. In BA technique, 30mL were injected below the axillary artery. In AA technique, 7.5mL were injected at 4 points around the artery. In PN technique, the median, ulnar, and radial nerves were anesthetized with 10mL per nerve. Confidence interval analysis showed that the perivascular techniques studied were not inferior to the perineural technique. The time to perform the blockade was shorter for the BA technique (300.4±78.4sec, 396.5±117.1sec, 487.6±172.6sec, respectively). The PN technique showed a lower latency time (PN - 655.3±348.9sec; BA -1044±389.5sec; AA-932.9±314.5sec), and less total time for the procedure (PN-1132±395.8sec; BA -1346.2±413.4sec; AA 1329.5±344.4sec). TA technique had a higher incidence of vascular puncture (BA - 22.5%; AA - 16.3%; PN - 5%). The perivascular techniques are viable alternatives to perineural technique for US-ABPB. There is a higher incidence of vascular puncture associated with the BA technique. Copyright © 2017. Publicado por Elsevier Editora Ltda.

  4. Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

    Science.gov (United States)

    Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

    2015-01-01

    To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, psmoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

    Science.gov (United States)

    Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

    2011-09-01

    To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  6. Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization

    Science.gov (United States)

    Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J.; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K.; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M.; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J.; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E.; Nordestgaard, Børge G.; Nielsen, Sune F.; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K.; Rookus, Matti A.; van den Hurk, Katja; de Kort, Wim L. A. M.; Couch, Fergus J.; Olson, Janet E.; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M. Pilar; Perez, Jose I. A.; Cox, Angela; Cross, Simon S.; Reed, Malcolm W. R.; Andrulis, Irene L.; Knight, Julia A.; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J.; Tomlinson, Ian; Kerin, Michael J.; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A.; Henderson, Brian E.; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J.; Martens, John W. M.; Tilanus-Linthorst, Madeleine M. A.; Collée, J. Margriet; Hopper, John L.; Southey, Melissa C.; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E.; Ambrosone, Christine B.; Yannoukakos, Drakoulis; Giles, Graham G.; Milne, Roger L.; McLean, Catriona; Fasching, Peter A.; Haeberle, Lothar; Ekici, Arif B.; Beckmann, Matthias W.; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J.; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M.; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J.; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K.; Neuhausen, Susan L.; Anton-Culver, Hoda; Kristensen, Vessela N.; Grenaker Alnæs, Grethe I.; Pierce, Brandon L.; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S.; John, Esther M.; Gammon, Marilie D.; Malone, Kathleen E.; Tessier, Daniel C.; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S.; González-Neira, Anna; Pita, Guillermo; Alonso, M. Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D. P.; Simard, Jacques; Hall, Per; Hunter, David J.; Easton, Douglas F.

    2015-01-01

    Background: Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. Methods: We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control subjects, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control subjects. Results: The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor–positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. PMID:26296642

  7. Use of N-acetylcysteine during liver procurement: a prospective randomized controlled study.

    Science.gov (United States)

    D'Amico, Francesco; Vitale, Alessandro; Piovan, Donatella; Bertacco, Alessandra; Ramirez Morales, Rafael; Chiara Frigo, Anna; Bassi, Domenico; Bonsignore, Pasquale; Gringeri, Enrico; Valmasoni, Michele; Garbo, Greta; Lodo, Enrico; D'Amico, Francesco Enrico; Scopelliti, Michele; Carraro, Amedeo; Gambato, Martina; Brolese, Alberto; Zanus, Giacomo; Neri, Daniele; Cillo, Umberto

    2013-02-01

    Antioxidant agents have the potential to reduce ischemia/reperfusion damage to organs for liver transplantation (LT). In this prospective, randomized study, we tested the impact of an infusion of N-acetylcysteine (NAC) during liver procurement on post-LT outcomes. Between December 2006 and July 2009, 140 grafts were transplanted into adult candidates with chronic liver disease who were listed for first LT, and according to a sequential, closed-envelope, single-blinded procedure, these patients were randomly assigned in a 1/1 ratio to an NAC protocol (69 patients) or to the standard protocol without NAC [71 patients (the control group)]. The NAC protocol included a systemic NAC infusion (30 mg/kg) 1 hour before the beginning of liver procurement and a locoregional NAC infusion (300 mg through the portal vein) just before cross-clamping. The primary endpoint was graft survival. The graft survival rates at 3 and 12 months were 93% and 90%, respectively, in the NAC group and 82% and 70%, respectively, in the control group (P = 0.02). An adjusted Cox analysis showed a significant NAC effect on graft survival at both 3 months [hazard ratio = 1.65, 95% confidence interval (CI) = 1.01-2.93, P = 0.04] and 12 months (hazard ratio = 1.73, 95% CI = 1.14-2.76, P ≤ 0.01). The incidence of postoperative complications was lower in the NAC group (23%) versus the control group (51%, P 1.8), the incidence of primary dysfunction of the liver was lower (P = 0.09) for the NAC group (15%) versus the control group (32%). In conclusion, the NAC harvesting protocol significantly improves graft survival. The effect of NAC on early graft function and survival seems higher when suboptimal grafts are used. Copyright © 2012 American Association for the Study of Liver Diseases.

  8. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Feng; Tang, De-Zhi; Cui, Xue-Jun; Holz, Jonathan D; Bian, Qin; Shi, Qi; Wang, Yong-Jun

    2011-08-02

    Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals). Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved. We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5) and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety. If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated. This study is registered at ClinicalTrials.gov, NCT01271647.

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

    Science.gov (United States)

    Bhurayanontachai, Patama; Saengkaew, Suwapat; Apiromruck, Penjamaporn

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

  10. Decision support system in prehospital care: a randomized controlled simulation study.

    Science.gov (United States)

    Hagiwara, Magnus Andersson; Sjöqvist, Bengt Arne; Lundberg, Lars; Suserud, Björn-Ove; Henricson, Maria; Jonsson, Anders

    2013-01-01

    Prehospital emergency medicine is a challenging discipline characterized by a high level of acuity, a lack of clinical information and a wide range of clinical conditions. These factors contribute to the fact that prehospital emergency medicine is a high-risk discipline in terms of medical errors. Prehospital use of Computerized Decision Support System (CDSS) may be a way to increase patient safety but very few studies evaluate the effect in prehospital care. The aim of the present study is to evaluate a CDSS. In this non-blind block randomized, controlled trial, 60 ambulance nurses participated, randomized into 2 groups. To compensate for an expected learning effect the groups was further divided in two groups, one started with case A and the other group started with case B. The intervention group had access to and treated the two simulated patient cases with the aid of a CDSS. The control group treated the same cases with the aid of a regional guideline in paper format. The performance that was measured was compliance with regional prehospital guidelines and On Scene Time (OST). There was no significant difference in the two group's characteristics. The intervention group had a higher compliance in the both cases, 80% vs. 60% (p<0.001) but the control group was complete the cases in the half of the time compare to the intervention group (p<0.001). The results indicate that this CDSS increases the ambulance nurses' compliance with regional prehospital guidelines but at the expense of an increase in OST. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Anesthesia management with ultrasound-guided thoracic paravertebral block for donor nephrectomy: A prospective randomized study.

    Science.gov (United States)

    Yenidünya, Ozlem; Bircan, Huseyin Yuce; Altun, Dilek; Caymaz, Ismail; Demirag, Alp; Turkoz, Ayda

    2017-02-01

    To determine the efficacy of ultrasound-guided thoracic paravertebral block intraoperatively and 24 hours postoperatively in patients undergoing donor nephrectomy. Prospective randomized controlled study. Private foundation university hospital; November 2014 to June 2015. Thirty-two patients undergoing donor nephrectomy (exclusion criteria: coagulation disorders, allergy to local anesthetics, and unwillingness to participate). The final study population comprised 30 patients (15 male, 15 female) randomly assigned to either Group P (paravertebral block, n=14) or Group M (morphine, n=16). In Group P, a unilateral paravertebral catheter was inserted 1 day preoperatively; on the day of surgery, a single-level unilateral paravertebral block was administered through the catheter before general anesthesia. Infusion of bupivacaine continued intraoperatively and postoperatively. Patients in Group M received only general anesthesia, and morphine patient-controlled analgesia was begun postoperatively. Intraoperative analgesic and anesthetic requirement, postoperative numerical rating scale pain scores, additional analgesic consumption during the postoperative period, and incidence of complications related to thoracic paravertebral block (TPVB) like pleural puncture, pneumothorax, epidural spread, injection into the subarachnoid space, intravascular injection, and Horner's syndrome and rate of opioid related adverse reactions like nausea and vomiting, itching, constipation, and respiratory depression. Intraoperative remifentanil consumption was significantly higher in Group M, and postoperative morphine consumption was significantly lower in Group P (Padverse reactions between the 2 groups. We didn't detect any complication related to TPVB in group P. Continuous thoracic paravertebral block provides good intraoperative stability with a low anesthetic requirement and reduces postoperative morphine consumption for up to 24 hours. Ultrasound guided technique enhanced the safety

  12. An open-label, randomized bioavailability study with alternative methods of administration of crushed ticagrelor tablets in healthy volunteers

    OpenAIRE

    Teng, Renli; Carlson, Glenn; Hsia, Judith

    2014-01-01

    Objective: To compare the bioavailability and safety profile of crushed ticagrelor tablets suspended in water and administered orally or via nasogastric tube, with that of whole tablets administered orally. Methods: In this single-center, open-label, randomized, three-treatment crossover study, 36 healthy volunteers were randomized to receive a single 90-mg dose of ticagrelor administered orally as a whole tablet or as crushed tablets suspended in water and given orally or via a nasogastric t...

  13. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  14. The effect of Vaccinium uliginosum extract on tablet computer-induced asthenopia: randomized placebo-controlled study

    OpenAIRE

    Park, Choul Yong; Gu, Namyi; Lim, Chi-Yeon; Oh, Jong-Hyun; Chang, Minwook; Kim, Martha; Rhee, Moo-Yong

    2016-01-01

    Background To investigate the alleviation effect of Vaccinium uliginosum extract (DA9301) on tablet computer-induced asthenopia. Methods This was a randomized, placebo-controlled, double-blind and parallel study (Trial registration number: 2013?95). A total 60 volunteers were randomized into DA9301 (n?=?30) and control (n?=?30) groups. The DA9301 group received DA9301 oral pill (1000?mg/day) for 4?weeks and the control group received placebo. Asthenopia was evaluated by administering a questi...

  15. Random forests on Hadoop for genome-wide association studies of multivariate neuroimaging phenotypes.

    Science.gov (United States)

    Wang, Yue; Goh, Wilson; Wong, Limsoon; Montana, Giovanni

    2013-01-01

    Multivariate quantitative traits arise naturally in recent neuroimaging genetics studies, in which both structural and functional variability of the human brain is measured non-invasively through techniques such as magnetic resonance imaging (MRI). There is growing interest in detecting genetic variants associated with such multivariate traits, especially in genome-wide studies. Random forests (RFs) classifiers, which are ensembles of decision trees, are amongst the best performing machine learning algorithms and have been successfully employed for the prioritisation of genetic variants in case-control studies. RFs can also be applied to produce gene rankings in association studies with multivariate quantitative traits, and to estimate genetic similarities measures that are predictive of the trait. However, in studies involving hundreds of thousands of SNPs and high-dimensional traits, a very large ensemble of trees must be inferred from the data in order to obtain reliable rankings, which makes the application of these algorithms computationally prohibitive. We have developed a parallel version of the RF algorithm for regression and genetic similarity learning tasks in large-scale population genetic association studies involving multivariate traits, called PaRFR (Parallel Random Forest Regression). Our implementation takes advantage of the MapReduce programming model and is deployed on Hadoop, an open-source software framework that supports data-intensive distributed applications. Notable speed-ups are obtained by introducing a distance-based criterion for node splitting in the tree estimation process. PaRFR has been applied to a genome-wide association study on Alzheimer's disease (AD) in which the quantitative trait consists of a high-dimensional neuroimaging phenotype describing longitudinal changes in the human brain structure. PaRFR provides a ranking of SNPs associated to this trait, and produces pair-wise measures of genetic proximity that can be directly

  16. Random forests on Hadoop for genome-wide association studies of multivariate neuroimaging phenotypes

    Science.gov (United States)

    2013-01-01

    Motivation Multivariate quantitative traits arise naturally in recent neuroimaging genetics studies, in which both structural and functional variability of the human brain is measured non-invasively through techniques such as magnetic resonance imaging (MRI). There is growing interest in detecting genetic variants associated with such multivariate traits, especially in genome-wide studies. Random forests (RFs) classifiers, which are ensembles of decision trees, are amongst the best performing machine learning algorithms and have been successfully employed for the prioritisation of genetic variants in case-control studies. RFs can also be applied to produce gene rankings in association studies with multivariate quantitative traits, and to estimate genetic similarities measures that are predictive of the trait. However, in studies involving hundreds of thousands of SNPs and high-dimensional traits, a very large ensemble of trees must be inferred from the data in order to obtain reliable rankings, which makes the application of these algorithms computationally prohibitive. Results We have developed a parallel version of the RF algorithm for regression and genetic similarity learning tasks in large-scale population genetic association studies involving multivariate traits, called PaRFR (Parallel Random Forest Regression). Our implementation takes advantage of the MapReduce programming model and is deployed on Hadoop, an open-source software framework that supports data-intensive distributed applications. Notable speed-ups are obtained by introducing a distance-based criterion for node splitting in the tree estimation process. PaRFR has been applied to a genome-wide association study on Alzheimer's disease (AD) in which the quantitative trait consists of a high-dimensional neuroimaging phenotype describing longitudinal changes in the human brain structure. PaRFR provides a ranking of SNPs associated to this trait, and produces pair-wise measures of genetic proximity

  17. How should debriefing be undertaken in web-based studies? Findings from a randomized controlled trial.

    Science.gov (United States)

    McCambridge, Jim; Kypri, Kypros; Wilson, Amanda

    2012-11-16

    Internet research may raise older ethical issues in new forms or pose new issues. It has been recommended that debriefing information online be kept very short, with further information including study results made available if requested by participants. There are no empirical studies that compare possible alternative methods of debriefing in online studies. To undertake a randomized controlled trial evaluating how to implement the recommended approach by assessing the effects of two different approaches on accessing of additional information. All 11,943 participants in the Effects of Study Design and Allocation (ESDA) study, which employed deception, were randomly assigned to one of two methods of debriefing: Group A received the debriefing information in the body of an email with links to protocol and results pages; Group B was presented with these links after clicking on an initial link in the body of the email to view the debriefing information on a website. Outcomes assessed were the proportions clicking on the links to the protocol and results summary and the time spent on these pages by those accessing them. The group who were presented with no debriefing information in the body of the email and went to a website for this information (Group B) were approximately twice as likely to subsequently access the protocol and the results summary. These differences between the two groups were highly statistically significant. Although these differences are clear, the overall proportions accessing such information were low, and there were no differences in mean time spent reading these pages. Only one quarter of Group B actually accessed debriefing information. In circumstances where the uptake of fuller information on study design, methods, and findings is deemed important, debriefing information may be better provided via a link and not included in the body of an email. Doing so may, however, reduce the extent of receiving any debriefing information at all. There is

  18. Treatment of upper respiratory tract infections in primary care: a randomized study using aromatic herbs.

    Science.gov (United States)

    Ben-Arye, Eran; Dudai, Nativ; Eini, Anat; Torem, Moshe; Schiff, Elad; Rakover, Yoseph

    2011-01-01

    This study is a prospective randomized double-blind controlled trial whose aim was to investigate the clinical effects of aromatic essential oils in patients with upper respiratory tract infections. The trial was conducted in six primary care clinics in northern Israel. A spray containing aromatic essential oils of five plants (Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus officinalis) as applied 5 times a day for 3 days and compared with a placebo spray. The main outcome measure was patient assessment of the change in severity of the most debilitating symptom (sore throat, hoarseness or cough). Sixty patients participated in the study (26 in the study group and 34 in the control group). Intention-to-treat analysis showed that 20 minutes following the spray use, participants in the study group reported a greater improvement in symptom severity compared to participants in the placebo group (P = .019). There was no difference in symptom severity between the two groups after 3 days of treatment (P = .042). In conclusion, spray application of five aromatic plants reported in this study brings about significant and immediate improvement in symptoms of upper respiratory ailment. This effect is not significant after 3 days of treatment.

  19. Treatment of Upper Respiratory Tract Infections in Primary Care: A Randomized Study Using Aromatic Herbs

    Directory of Open Access Journals (Sweden)

    Eran Ben-Arye

    2011-01-01

    Full Text Available This study is a prospective randomized double-blind controlled trial whose aim was to investigate the clinical effects of aromatic essential oils in patients with upper respiratory tract infections. The trial was conducted in six primary care clinics in northern Israel. A spray containing aromatic essential oils of five plants (Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus officinalisas applied 5 times a day for 3 days and compared with a placebo spray. The main outcome measure was patient assessment of the change in severity of the most debilitating symptom (sore throat, hoarseness or cough. Sixty patients participated in the study (26 in the study group and 34 in the control group. Intention-to-treat analysis showed that 20 minutes following the spray use, participants in the study group reported a greater improvement in symptom severity compared to participants in the placebo group (=.019. There was no difference in symptom severity between the two groups after 3 days of treatment (=.042. In conclusion, spray application of five aromatic plants reported in this study brings about significant and immediate improvement in symptoms of upper respiratory ailment. This effect is not significant after 3 days of treatment.

  20. Therapeutic Benefit of Smoked Cannabis in Randomized Placebo-Controlled Studies.

    Science.gov (United States)

    Bowen, Lynneice L; McRae-Clark, Aimee L

    2018-01-01

    The medicinal use of marijuana has been legalized in 28 states, with a wide range of specificity for approved medical conditions. Even with the emergence of non-combustion-based delivery systems, 90% of marijuana users in 2014 used smoked marijuana. This review summarizes the data available on the use of smoked marijuana for medical purposes. A literature search was performed to retrieve randomized controlled trials exploring the efficacy of smoked cannabis for treatment of a medical condition. Studies with the primary end point listed as the effect of smoked cannabis on a disease-specific characteristic were included. Open-label studies and studies using other administration methods were excluded. Seven studies met these criteria and were included in this review. Cannabis did not outperform placebo on experimentally evoked pain or the timed walk test. Clear evidence indicates that smoked cannabis reduces intraocular pressure, but the effect is too brief (less than 4 hrs) to be of therapeutic benefit for this chronic disorder. Consistent evidence also showed that smoked marijuana, even at lower concentrations of tetrahydrocannabinol, increased total daily calorie intake and number of eating occasions. Neither of the studies with quality of life as secondary outcome measures revealed statistically significantly improved outcomes with cannabis use. © 2017 Pharmacotherapy Publications, Inc.

  1. Indwell times, complications and costs of open vs closed safety peripheral intravenous catheters: a randomized study.

    Science.gov (United States)

    González López, J L; Arribi Vilela, A; Fernández del Palacio, E; Olivares Corral, J; Benedicto Martí, C; Herrera Portal, P

    2014-02-01

    Catheter-related infections (CRIs) caused by peripheral intravenous catheters (PIVCs) are an increasingly common iatrogenic complication. To prevent this, recommended timelines for routine replacement of PIVCs have increased from 48 h to 72 h and subsequently to 96 h, despite a lack of supporting scientific evidence. To compare closed-system (COS) PIVCs with open-system (MOS) PIVCs. This prospective, randomized controlled trial compared the indwell time of COS PIVCs without complications with that of MOS PIVCs, removed only by clinical indication. In total, 1199 PIVCs (642 inpatients) were randomized and 283 PIVCs were cultured. Sixteen catheters (11 patients) were lost to the study after randomization. In total, 104,469 catheter-hours (54,173 h in 584 COS and 50,296 h in 599 MOS) were recorded. The median dwell time was 137.1h for COS PIVCs and 96 h for MOS PIVCs (P = 0.001). Among PIVCs in place for ≥ 24 h, the median dwell time was 144.5h for COS PIVCs [95% confidence interval (CI) 123.4-165.6] and 99 h for MOS PIVCs (95% CI 87.2-110.8). Use of COS PIVCs reduced phlebitis rates by 29% (31 vs 45 cases/1000 catheter-days; P = 0.004). The probability that a MOS PIVC would last for 96 h was 79.9%, and the probability that a COS PIVC would last for 144 h was 80.4%. There were no significant differences in rates of bacterial colonization per 1000 catheter-days (51.1 COS vs 54.1 MOS) or CRI (5.76 COS vs 6.65 MOS). Nevertheless, there was a 20% relative risk reduction in CRI. Use of COS PIVCs reduced episodes of phlebitis and risk of infection at a cost of only € 0.09/day. When PIVCs are replaced based on clinical indication, COS PIVCs last for up to 144 h and MOS PIVCs last for up to 96 h without increased risk and with significant cost savings (€ 786,257/year/1000 beds). Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.